health initiative trials: Topics by WorldWideScience.org

Sample records for health initiative trials

Dietary adherence in the Women's Health Initiative Dietary Modification Trial.

Science.gov (United States)

2004-04-01

This article describes adherence to a low-fat dietary pattern (less than 20% energy from fat, five or more fruit/vegetable and six or more grain servings daily) in Years 1 and 5 of the Women's Health Initiative Dietary Modification Trial, which was designed to examine the effects of a low-fat dietary pattern on risk of breast and colorectal cancers and other chronic diseases in postmenopausal women. Participants were randomly assigned to a low-fat dietary intervention arm (40%, n=19,542) or a usual diet control arm (60%, n=29,294). Women in the intervention arm completed 18 group sessions during the first year, followed by quarterly annual maintenance sessions. Adherence was assessed as control minus intervention (C-I) group differences in percent total energy from fat as estimated by a food frequency questionnaire. Based on these self-reported dietary data, mean C-I was 10.9 percentage points of energy from fat at Year 1, decreasing to 9.0 at Year 5. Factors associated with poorer adherence were being older, being African American or Hispanic (compared with white), having low income, and being obese. Group session attendance was strongly associated with better dietary adherence. There are many limitations of self-reported dietary data, particularly related to social desirability and intervention-associated bias. Nonetheless, these data indicate that long-term dietary change was achieved in this clinical trial setting and reinforce the potential of the ongoing trial to answer questions of public health importance.
Economic return from the Women's Health Initiative estrogen plus progestin clinical trial: a modeling study.

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Roth, Joshua A; Etzioni, Ruth; Waters, Teresa M; Pettinger, Mary; Rossouw, Jacques E; Anderson, Garnet L; Chlebowski, Rowan T; Manson, Joann E; Hlatky, Mark; Johnson, Karen C; Ramsey, Scott D

2014-05-06

The findings of the Women's Health Initiative (WHI) estrogen plus progestin (E+P) trial led to a substantial reduction in use of combined hormone therapy (cHT) among postmenopausal women in the United States. The economic effect of this shift has not been evaluated relative to the trial's $260 million cost (2012 U.S. dollars). To estimate the economic return from the WHI E+P trial. Decision model to simulate health outcomes for a "WHI scenario" with observed cHT use and a "no-WHI scenario" with cHT use extrapolated from the pretrial period. Primary analyses of WHI outcomes, peer-reviewed literature, and government sources. Postmenopausal women in the United States, aged 50 to 79 years, who did not have a hysterectomy. 2003 to 2012. Payer. Combined hormone therapy. Disease incidence, expenditure, quality-adjusted life-years, and net economic return. The WHI scenario resulted in 4.3 million fewer cHT users, 126,000 fewer breast cancer cases, 76,000 fewer cardiovascular disease cases, 263,000 more fractures, 145,000 more quality-adjusted life-years, and expenditure savings of $35.2 billion. The corresponding net economic return of the trial was $37.1 billion ($140 per dollar invested in the trial) at a willingness-to-pay level of $100,000 per quality-adjusted life-year. The 95% CI for the net economic return of the trial was $23.1 to $51.2 billion. No evaluation of indirect costs or outcomes beyond 2012. The WHI E+P trial made high-value use of public funds with a substantial return on investment. These results can contribute to discussions about the role of public funding for large, prospective trials with high potential for public health effects. National Heart, Lung, and Blood Institute.
Initial Readability Assessment of Clinical Trial Eligibility Criteria

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Kang, Tian; Elhadad, Noémie; Weng, Chunhua

2015-01-01

Various search engines are available to clinical trial seekers. However, it remains unknown how comprehensible clinical trial eligibility criteria used for recruitment are to a lay audience. This study initially investigated this problem. Readability of eligibility criteria was assessed according to (i) shallow and lexical characteristics through the use of an established, generic readability metric; (ii) syntactic characteristics through natural language processing techniques; and (iii) health terminological characteristics through an automated comparison to technical and lay health texts. We further stratified clinical trials according to various study characteristics (e.g., source country or study type) to understand potential factors influencing readability. Mainly caused by frequent use of technical jargons, a college reading level was found to be necessary to understand eligibility criteria text, a level much higher than the average literacy level of the general American population. The use of technical jargons should be minimized to simplify eligibility criteria text. PMID:26958204
Use of hormone replacement therapy in the Hong Kong public health sector after the Women's Health Initiative trial.

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Leung, K Y; Ling, Matina; Tang, G W K

2005-01-01

To determine the impact of Women Health Initiative (WHI) trial on the use of hormone replacement therapy (HRT) in the Hong Kong public health sector. The central prescription database of the Hospital Authority was used to describe the half-yearly trend in the use of HRT between July 2000 and December 2003. The data of hysterectomy was retrieved from another clinical database. Before the publication of the WHI trial in July 2002, conjugated equine estrogens (CEE) and its related products dominated HRT prescribing. Relative to the first half of 2002, there was an immediate and substantial decline by 43.5% in the prescriptions of combined CEE/progestogen products and a modest decline by 22.4% in the prescriptions of CEE-alone therapy in the second half of 2002. In the first half of 2003, a decline in the prescriptions of all HRT preparations except raloxifene was observed. However, in the second half of 2003, there were no more declines in overall HRT users. Relative to the first half of 2002, the decline in the overall HRT users in the first half of 2003 was more than 46% in women aged 50-69. The decline was greater in women with a history of hysterectomy (60.3%) than women without (38.6%), but was similar between gynaecology specialty (41.7%) and non-gynaecology specialty (43.9%). Similar to the U.S., an immediate and substantial decline in the use of CEE and its related products was observed in Hong Kong after the publication of the WHI trial.
The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial.

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Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

2011-06-09

Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.
The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS trial, an investigator initiated trial

Directory of Open Access Journals (Sweden)

Ongolo-Zogo Pierre

2011-06-01

Full Text Available Abstract Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.
Low-fat dietary pattern and weight change over 7 years: the Women's Health Initiative Dietary Modification Trial.

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Howard, Barbara V; Manson, JoAnn E; Stefanick, Marcia L; Beresford, Shirley A; Frank, Gail; Jones, Bobette; Rodabough, Rebecca J; Snetselaar, Linda; Thomson, Cynthia; Tinker, Lesley; Vitolins, Mara; Prentice, Ross

2006-01-04

Obesity in the United States has increased dramatically during the past several decades. There is debate about optimum calorie balance for prevention of weight gain, and proponents of some low-carbohydrate diet regimens have suggested that the increasing obesity may be attributed, in part, to low-fat, high-carbohydrate diets. To report data on body weight in a long-term, low-fat diet trial for which the primary end points were breast and colorectal cancer and to examine the relationships between weight changes and changes in dietary components. Randomized intervention trial of 48,835 postmenopausal women in the United States who were of diverse backgrounds and ethnicities and participated in the Women's Health Initiative Dietary Modification Trial; 40% (19,541) were randomized to the intervention and 60% (29,294) to a control group. Study enrollment was between 1993 and 1998, and this analysis includes a mean follow-up of 7.5 years (through August 31, 2004). The intervention included group and individual sessions to promote a decrease in fat intake and increases in vegetable, fruit, and grain consumption and did not include weight loss or caloric restriction goals. The control group received diet-related education materials. Change in body weight from baseline to follow-up. Women in the intervention group lost weight in the first year (mean of 2.2 kg, Pfruit servings, and a nonsignificant trend toward weight loss occurred with increasing intake of fiber. A low-fat eating pattern does not result in weight gain in postmenopausal women. Clinical Trial Registration ClinicalTrials.gov, NCT00000611.
Low-Fat Dietary Pattern Intervention and Health-Related Quality of Life: The Women's Health Initiative Randomized Controlled Dietary Modification Trial.

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Assaf, Annlouise R; Beresford, Shirley A A; Risica, Patricia Markham; Aragaki, Aaron; Brunner, Robert L; Bowen, Deborah J; Naughton, Michelle; Rosal, Milagros C; Snetselaar, Linda; Wenger, Nanette

2016-02-01

Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. This randomized controlled trial was analyzed as intent to treat. Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years. Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health
Low-fat dietary pattern and cardiovascular disease: results from the Women's Health Initiative randomized controlled trial.

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Prentice, Ross L; Aragaki, Aaron K; Van Horn, Linda; Thomson, Cynthia A; Beresford, Shirley Aa; Robinson, Jennifer; Snetselaar, Linda; Anderson, Garnet L; Manson, JoAnn E; Allison, Matthew A; Rossouw, Jacques E; Howard, Barbara V

2017-07-01

Background: The influence of a low-fat dietary pattern on the cardiovascular health of postmenopausal women continues to be of public health interest. Objective: This report evaluates low-fat dietary pattern influences on cardiovascular disease (CVD) incidence and mortality during the intervention and postintervention phases of the Women's Health Initiative Dietary Modification Trial. Design: Participants comprised 48,835 postmenopausal women aged 50-79 y; 40% were randomly assigned to a low-fat dietary pattern intervention (target of 20% of energy from fat), and 60% were randomly assigned to a usual diet comparison group. The 8.3-y intervention period ended in March 2005, after which >80% of surviving participants consented to additional active follow-up through September 2010; all participants were followed for mortality through 2013. Breast and colorectal cancer were the primary trial outcomes, and coronary heart disease (CHD) and overall CVD were additional designated outcomes. Results: Incidence rates for CHD and total CVD did not differ between the intervention and comparison groups in either the intervention or postintervention period. However, CHD HRs comparing these groups varied strongly with baseline CVD and hypertension status. Participants without prior CVD had an intervention period CHD HR of 0.70 (95% CI: 0.56, 0.87) or 1.04 (95% CI: 0.90, 1.19) if they were normotensive or hypertensive, respectively ( P -interaction = 0.003). The CHD benefit among healthy normotensive women was partially offset by an increase in ischemic stroke risk. Corresponding HRs in the postintervention period were close to null. Participants with CVD at baseline (3.4%) had CHD HRs of 1.47 (95% CI: 1.12, 1.93) and 1.61 (95% CI: 1.02, 2.55) in the intervention and postintervention periods, respectively. However, various lines of evidence suggest that results in women with CVD or hypertension at baseline are confounded by postrandomization use of cholesterol-lowering medications
A Reappraisal of Women’s Health Initiative Estrogen-Alone Trial: Long-Term Outcomes in Women 50–59 Years of Age

Directory of Open Access Journals (Sweden)

Eric Roehm

2015-01-01

Full Text Available The Women’s Health Initiative (WHI Estrogen-Alone Trial randomized postmenopausal women, 50 to 79 years of age, with prior hysterectomy, to conjugated equine estrogens (CEE or placebo with a 5.9-year median duration of CEE use. In 2013, the WHI published outcomes for additional extended follow-up. Reported here for the first time is an analysis of the number needed to treat with CEE rather than placebo for younger women (50–59 years to prevent an adverse long-term outcome. For every 76 women randomized to CEE at 50–59 years, one less myocardial infarction occurred during the 13-year cumulative long-term follow-up. For every 37 women randomized to CEE at 50–59 years, one less woman experienced a global index endpoint (including coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, and death during the 13-year follow-up. Younger women (50–59 years, compared to older women, had more favorable cumulative long-term outcomes for MI and global index. Though a subgroup analysis is not an adequate basis for making primary prevention guideline recommendations, the WHI Estrogen-Alone Trial outcomes strongly suggest that a similar course of estrogen initiated at 50–59 years in postmenopausal women with prior hysterectomy results in significant long-term health benefit.
EDCTP regional networks of excellence: initial merits for planned clinical trials in Africa.

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Miiro, George M; Oukem-Boyer, Odile Ouwe Missi; Sarr, Ousmane; Rahmani, Maerangis; Ntoumi, Francine; Dheda, Keertan; Pym, Alexander; Mboup, Souleymane; Kaleebu, Pontiano

2013-03-22

Achieving the Millennium Development Goals (MDGs) and combating hotspots with escalating but preventable communicable diseases remain major challenges in Africa. The European and Developing Countries Clinical Trials Partnership (EDCTP) intervened to combat poverty-related diseases including malaria, tuberculosis and HIV/AIDS, and to conduct multi-centre clinical trials and multi-disciplinary health research through an innovative model of regional Networks of Excellence (NoEs). We participated in a quasi-formative evaluation between October and December 2011 on the 4 regional-led research networks. These included the: Central Africa Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM); East African Consortium for Clinical Research (EACCR); West African Network of Excellence for TB, AIDS and Malaria (WANETAM), and the Trials of Excellence for Southern Africa (TESA) launched between 2009 and 2010. We shared a participatory appraisal of field reports, progress reports and presentations from each network to jointly outline the initial experiences of the merits, outputs and lessons learnt. The self-regulating democratic networks, with 64 institutions in 21 African countries, have trained over 1, 000 African scientists, upgraded 36 sites for clinical trials, leveraged additional € 24 million and generated 38 peer-reviewed publications through networking and partnerships. The shared initial merits and lessons learnt portray in part the strengthened capacity of these networks for improved research coordination and conduct of planned multi-center clinical trials in Africa. Increased funding by African agencies, governments and international health partners will ensure sustainability of these networks for research capacity development and demonstrate their commitment to achieving the MDGs in Africa.
Mobile access to virtual randomization for investigator-initiated trials.

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Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization
Changing organizational culture: using the CEO cancer gold standard policy initiatives to promote health and wellness at a school of public health.

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Towne, Samuel D; Anderson, Kelsey E; Smith, Matthew Lee; Dahlke, Deborah Vollmer; Kellstedt, Debra; Purcell, Ninfa Pena; Ory, Marcia G

2015-09-03

Worksite wellness initiatives for health promotion and health education have demonstrated effectiveness in improving employee health and wellness. We examined the effects of a multifaceted health promotion campaign on organizational capacity to meet requirements to become CEO Cancer Gold Standard Accredited. We conducted an online survey to assess perceived organizational values and support for the five CEO Cancer Gold Standard Pillars for cancer prevention: tobacco cessation; physical activity; nutrition; cancer screening and early detection; and accessing information on cancer clinical trials. Baseline and follow-up surveys were sent 6-months apart to faculty, staff, and students at a school of public health to test the impact of a multifaceted health promotion campaign on perceived organizational change. Descriptive analyses were used to characterize percent improvement. Multivariate logistic regression analyses were used to control for participants' university status. The current organizational culture highly supported tobacco cessation at both time points. Significant improvements (p screening, and early detection of cancer' and 'accessing cancer treatment and clinical trials'. Health promotion and education efforts using multiple approaches were effective to improve perceived organizational values and support for cancer prevention and early detection, and increase access to information about cancer clinical trials. Future studies are needed to examine broader impacts of implementing worksite health promotion initiatives.
Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

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Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.
Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

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Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

2018-03-01

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Relationship of Hypertension, Blood Pressure, and Blood Pressure Control With White Matter Abnormalities in the Women’s Health Initiative Memory Study (WHIMS)—MRI Trial

OpenAIRE

Kuller, Lewis H.; Margolis, Karen L.; Gaussoin, Sarah A.; Bryan, Nick R.; Kerwin, Diana; Limacher, Marian; Wassertheil-Smoller, Sylvia; Williamson, Jeff; Robinson, Jennifer G.

2010-01-01

This paper evaluates the relationship of blood pressure (BP) levels at Women’s Health Initiative (WHI) baseline, treatment of hypertension, and white matter abnormalities among women in conjugated equine estrogen (CEE) and medroxyprogesterone acetate and CEE-alone arms. The WHI Memory Study—Magnetic Resonance Imaging (WHIMS-MRI) trial scanned 1424 participants. BP levels at baseline were significantly positively related to abnormal white matter lesion (WML) volumes. Participants treated for h...
Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

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Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.
Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

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Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.
Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

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Beresford, Shirley A A; Johnson, Karen C; Ritenbaugh, Cheryl; Lasser, Norman L; Snetselaar, Linda G; Black, Henry R; Anderson, Garnet L; Assaf, Annlouise R; Bassford, Tamsen; Bowen, Deborah; Brunner, Robert L; Brzyski, Robert G; Caan, Bette; Chlebowski, Rowan T; Gass, Margery; Harrigan, Rosanne C; Hays, Jennifer; Heber, David; Heiss, Gerardo; Hendrix, Susan L; Howard, Barbara V; Hsia, Judith; Hubbell, F Allan; Jackson, Rebecca D; Kotchen, Jane Morley; Kuller, Lewis H; LaCroix, Andrea Z; Lane, Dorothy S; Langer, Robert D; Lewis, Cora E; Manson, JoAnn E; Margolis, Karen L; Mossavar-Rahmani, Yasmin; Ockene, Judith K; Parker, Linda M; Perri, Michael G; Phillips, Lawrence; Prentice, Ross L; Robbins, John; Rossouw, Jacques E; Sarto, Gloria E; Stefanick, Marcia L; Van Horn, Linda; Vitolins, Mara Z; Wactawski-Wende, Jean; Wallace, Robert B; Whitlock, Evelyn

2006-02-08

Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women. The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States. Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern. Invasive colorectal cancer incidence. A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal
Low-fat Dietary Pattern and Pancreatic Cancer Risk in the Women's Health Initiative Dietary Modification Randomized Controlled Trial.

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Jiao, Li; Chen, Liang; White, Donna L; Tinker, Lesley; Chlebowski, Rowan T; Van Horn, Linda V; Richardson, Peter; Lane, Dorothy; Sangi-Haghpeykar, Haleh; El-Serag, Hashem B

2018-01-01

Observational studies suggest that diet may influence pancreatic cancer risk. We investigated the effect of a low-fat dietary intervention on pancreatic cancer incidence. The Women's Health Initiative Dietary Modification (WHI-DM) trial is a randomized controlled trial conducted in 48 835 postmenopausal women age 50 to 79 years in the United States between 1993 and 1998. Women were randomly assigned to the intervention group (n = 19 541), with the goal of reducing total fat intake and increasing intake of vegetables, fruits, and grains, or to the usual diet comparison group (n = 29 294). The intervention concluded in March 2005. We evaluated the effect of the intervention on pancreatic cancer incidence with the follow-up through 2014 using the log-rank test and multivariable Cox proportional hazards regression model. All statistical tests were two-sided. In intention-to-treat analyses including 46 200 women, 92 vs 165 pancreatic cancer cases were ascertained in the intervention vs the comparison group (P = .23). The multivariable hazard ratio (HR) of pancreatic cancer was 0.86 (95% confidence interval [CI] = 0.67 to 1.11). Risk was statistically significantly reduced among women with baseline body mass indexes (BMIs) of 25 kg/m2 or higher (HR = 0.71, 95% CI = 0.53 to 0.96), but not among women with BMIs of less than 25 kg/m2 (HR = 1.62, 95% CI = 0.97 to 2.71, Pinteraction = .01). A low-fat dietary intervention was associated with reduced pancreatic cancer incidence in women who were overweight or obese in the WHI-DM trial. Caution needs to be taken in interpreting the findings based on subgroup analyses. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Development of an online clinical trial recruitment portal for the NIHR mental health BRC.

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Markham, Sarah

2016-01-01

; many said yes, they would. The manager of the BRC on reviewing the website, agreed that a final version of the website with the NIHR Mental Health BRC logo would be paid for and will form part of a new main website for the BRC in early 2016. ᅟ. Public & patient recruitment to clinical trials is viewed as one of the main barriers to the implementation of clinical trials. This difficulty is often attributed to the working culture of the NHS, rapid turnover of staff and patients and poor-gatekeeping in referring patients to suitable clinical trials. In response to the recruitment difficulties experienced by the Psychosis Studies Clinical Academic Group at the NIHR Mental Health Biomedical Research Centre, Denmark Hill, London, a member of the Office of Psychosis Studies at King's College London and a member (the author) of the King's Clinical Trials Unit, King's College London developed an initiative to create an online clinical trial recruitment portal/information hub for the NIHR Mental Health BRC. The primary purpose of this initiative being to promote patient and public awareness of and interest in participating in clinical trials.
Clinical Trials

Medline Plus

Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...
Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Directory of Open Access Journals (Sweden)

Rachel G. Greenberg

2018-03-01

In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.
Women's Health Initiative (WHI) Background and Overview

Science.gov (United States)

... Back To The Science / Women’s Health Initiative (WHI) Women’s Health Initiative (WHI) Project began 1991 Point of ... What is the goal of the WHI? The Women's Health Initiative (WHI), sponsored by the National Heart, ...
Health literacy and usability of clinical trial search engines.

Science.gov (United States)

Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

2014-01-01

Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.
Initiating and continuing behaviour change within a weight gain prevention trial: a qualitative investigation.

Science.gov (United States)

Kozica, Samantha; Lombard, Catherine; Teede, Helena; Ilic, Dragan; Murphy, Kerry; Harrison, Cheryce

2015-01-01

Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program. In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis. A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649) that participated in the prevention trial. Four behaviour change groups emerged were identified from participant interviews: (i) no change, (ii) relapse, (iii) intermittent and (iv) continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant's ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress. Initiating and continuing behaviour change is a complex process. Our
Open science initiatives: challenges for public health promotion.

Science.gov (United States)

Holzmeyer, Cheryl

2018-03-07

While academic open access, open data and open science initiatives have proliferated in recent years, facilitating new research resources for health promotion, open initiatives are not one-size-fits-all. Health research particularly illustrates how open initiatives may serve various interests and ends. Open initiatives not only foster new pathways of research access; they also discipline research in new ways, especially when associated with new regimes of research use and peer review, while participating in innovation ecosystems that often perpetuate existing systemic biases toward commercial biomedicine. Currently, many open initiatives are more oriented toward biomedical research paradigms than paradigms associated with public health promotion, such as social determinants of health research. Moreover, open initiatives too often dovetail with, rather than challenge, neoliberal policy paradigms. Such initiatives are unlikely to transform existing health research landscapes and redress health inequities. In this context, attunement to social determinants of health research and community-based local knowledge is vital to orient open initiatives toward public health promotion and health equity. Such an approach calls for discourses, norms and innovation ecosystems that contest neoliberal policy frameworks and foster upstream interventions to promote health, beyond biomedical paradigms. This analysis highlights challenges and possibilities for leveraging open initiatives on behalf of a wider range of health research stakeholders, while emphasizing public health promotion, health equity and social justice as benchmarks of transformation.
Surgeon General's Family Health History Initiative

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... Source Code The Surgeon General's Family Health History Initiative To help focus attention on the importance of ... health campaign, called the Surgeon General's Family History Initiative, to encourage all American families to learn more ...
Mobile Health Initiatives in Vietnam: Scoping Study.

Science.gov (United States)

Lam, Jeffrey A; Dang, Linh Thuy; Phan, Ngoc Tran; Trinh, Hue Thi; Vu, Nguyen Cong; Nguyen, Cuong Kieu

2018-04-24

Mobile health (mHealth) offers a promising solution to the multitude of challenges the Vietnamese health system faces, but there is a scarcity of published information on mHealth in Vietnam. The objectives of this scoping study were (1) to summarize the extent, range, and nature of mHealth initiatives in Vietnam and (2) to examine the opportunities and threats of mHealth utilization in the Vietnamese context. This scoping study systematically identified and extracted relevant information from 20 past and current mHealth initiatives in Vietnam. The study includes multimodal information sources, including published literature, gray literature (ie, government reports and unpublished literature), conference presentations, Web-based documents, and key informant interviews. We extracted information from 27 records from the electronic search and conducted 14 key informant interviews, allowing us to identify 20 mHealth initiatives in Vietnam. Most of the initiatives were primarily funded by external donors (n=15), while other initiatives were government funded (n=1) or self-funded (n=4). A majority of the initiatives targeted vulnerable and hard-to-reach populations (n=11), aimed to prevent the occurrence of disease (n=12), and used text messaging (short message service, SMS) as part of their intervention (n=14). The study revealed that Vietnamese mHealth implementation has been challenged by factors including features unique to the Vietnamese language (n=4) and sociocultural factors (n=3). The largest threats to the popularity of mHealth initiatives are the absence of government policy, lack of government interest, heavy dependence on foreign funding, and lack of technological infrastructure. Finally, while current mHealth initiatives have already demonstrated promising opportunities for alternative models of funding, such as social entrepreneurship or private business models, sustainable mHealth initiatives outside of those funded by external donors have not yet been
Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials.

Science.gov (United States)

Swica, Yael; Warren, Michelle P; Manson, JoAnn E; Aragaki, Aaron K; Bassuk, Shari S; Shimbo, Daichi; Kaunitz, Andrew; Rossouw, Jacques; Stefanick, Marcia L; Womack, Catherine R

2018-01-29

The aim of the study was to determine the effect of menopausal hormone therapy on incident hypertension in the two Women's Health Initiative hormone therapy trials and in extended postintervention follow-up. A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. This analysis includes the subsample of 18,015 women who did not report hypertension at baseline and were not taking antihypertensive medication. Women with an intact uterus received conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 5,994) or placebo (n = 5,679). Women with prior hysterectomy received CEE alone (0.625 mg/d) (n = 3,108) or placebo (n = 3,234). The intervention lasted a median of 5.6 years in the CEE plus MPA trial and 7.2 years in the CEE-alone trial with 13 years of cumulative follow-up until September 30, 2010. The primary outcome for these analyses was self-report of a new diagnosis of hypertension and/or high blood pressure requiring treatment with medication. During the CEE and CEE plus MPA intervention phase, the rate of incident hypertension was 18% higher for intervention than for placebo (CEE: hazard ratio [HR], 1.18; 95% CI, 1.09-1.29; CEE plus MPA: HR, 1.18; 95% CI, 1.09-1.27). This effect dissipated postintervention in both trials (CEE: HR, 1.06; 95% CI, 0.94-1.20; CEE plus MPA: HR, 1.02; 95% CI, 0.94-1.10). CEE (0.625 mg/d) administered orally, with or without CEE plus MPA, is associated with an increased risk of hypertension in older postmenopausal women. Whether lower doses, different estrogen formulations, or transdermal route of administration offer lower risks warrant further study.
Predicting Participant Consent in mHealth Trials – A Caregiver’s Perspective

Directory of Open Access Journals (Sweden)

Yvonne O'Connor

2017-11-01

Full Text Available Informed consent is sought prior to conducting a healthcare intervention on a person. When a healthcare intervention involves a young child, their caregiver is required to provide informed consent on their behalf. However, little is known on the behavioural intentions of participants to provide consent when a mobile health (mHealth intervention is involved in a clinical trial scenario. Understanding this phenomenon is important, without consent appropriate data may not be collected to empirically examine the implications of mHealth initiatives when delivering healthcare services to children in a ‘real world context’. The objective of this paper is to explore the behavioural intentions of caregivers to provide consent for children (under five years of age to participate in mHealth Randomised Control Trials (RCT in developing countries and subsequently develop a predictive model for consent giving. Data was captured vis-à-vis interviews with Malawian caregivers in Africa. The findings reveal that emotional response stimuli play a major role during the participant informed consent process resulting in the involvement (or not of a child within an RCT. The study contributes to, and opens up, avenues for critical research on the role of informed consent as part of RCT-related projects, especially concerning the involvement of children. This new knowledge may be leveraged to address participant uncertainties and subsequently improve the rate of paediatric recruitment in mHealth trial scenarios.
Defining precision: The precision medicine initiative trials NCI-MPACT and NCI-MATCH.

Science.gov (United States)

Coyne, Geraldine O'Sullivan; Takebe, Naoko; Chen, Alice P

"Precision" trials, using rationally incorporated biomarker targets and molecularly selective anticancer agents, have become of great interest to both patients and their physicians. In the endeavor to test the cornerstone premise of precision oncotherapy, that is, determining if modulating a specific molecular aberration in a patient's tumor with a correspondingly specific therapeutic agent improves clinical outcomes, the design of clinical trials with embedded genomic characterization platforms which guide therapy are an increasing challenge. The National Cancer Institute Precision Medicine Initiative is an unprecedented large interdisciplinary collaborative effort to conceptualize and test the feasibility of trials incorporating sequencing platforms and large-scale bioinformatics processing that are not currently uniformly available to patients. National Cancer Institute-Molecular Profiling-based Assignment of Cancer Therapy and National Cancer Institute-Molecular Analysis for Therapy Choice are 2 genomic to phenotypic trials under this National Cancer Institute initiative, where treatment is selected according to predetermined genetic alterations detected using next-generation sequencing technology across a broad range of tumor types. In this article, we discuss the objectives and trial designs that have enabled the public-private partnerships required to complete the scale of both trials, as well as interim trial updates and strategic considerations that have driven data analysis and targeted therapy assignment, with the intent of elucidating further the benefits of this treatment approach for patients. Copyright © 2017. Published by Elsevier Inc.
Clinical Trials

Medline Plus

Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...
Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

Science.gov (United States)

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be
[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

Science.gov (United States)

Benninger-Döring, G; Boos, J

2006-07-01

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.
The Alzheimer's Disease Neuroimaging Initiative 3: Continued innovation for clinical trial improvement

Energy Technology Data Exchange (ETDEWEB)

Weiner, Michael W. [Dept. of Veterans Affairs Medical Center, San Francisco, CA (United States); Univ. of California, San Francisco, CA (United States); Veitch, Dallas P. [Dept. of Veterans Affairs Medical Center, San Francisco, CA (United States); Aisen, Paul S. [Univ. of Southern California, San Diego, CA (United States); Beckett, Laurel A. [Univ. of California, Davis, CA (United States); Cairns, Nigel J. [Washington Univ. School of Medicine, St. Louis, MO (United States); Green, Robert C. [Brigham and Women' s Hospital and Harvard Medical School, Boston, MA (United States); Harvey, Danielle [Univ. of California, Davis, CA (United States); Jack, Clifford R. [Mayo Clinic, Rochester, MN (United States); Jagust, William [Univ. of California, Berkeley, CA (United States); Morris, John C. [Univ. of Southern California, San Diego, CA (United States); Petersen, Ronald C. [Mayo Clinic, Rochester, MN (United States); Salazar, Jennifer [Univ. of Southern California, San Diego, CA (United States); Saykin, Andrew J. [Indiana Univ. School of Medicine, Indianapolis, IN (United States); Shaw, Leslie M. [Eli Lilly and Company, Indianapolis, IN (United States); Toga, Arthur W. [Univ. of Southern California, Los Angeles, CA (United States); Trojanowski, John Q. [Univ. of Pennsylvania, Philadelphia, PA (United States)

2016-12-05

Overall, the goal of the Alzheimer's Disease Neuroimaging Initiative (ADNI) is to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI-3, which began on August 1, 2016, is a 5-year renewal of the current ADNI-2 study. ADNI-3 will follow current and additional subjects with normal cognition, mild cognitive impairment, and AD using innovative technologies such as tau imaging, magnetic resonance imaging sequences for connectivity analyses, and a highly automated immunoassay platform and mass spectroscopy approach for cerebrospinal fluid biomarker analysis. A Systems Biology/pathway approach will be used to identify genetic factors for subject selection/enrichment. Amyloid positron emission tomography scanning will be standardized using the Centiloid method. The Brain Health Registry will help recruit subjects and monitor subject cognition. Multimodal analyses will provide insight into AD pathophysiology and disease progression. Finally, ADNI-3 will aim to inform AD treatment trials and facilitate development of AD disease-modifying treatments.
Health professionals' attitudes towards suicide prevention initiatives.

Science.gov (United States)

Brunero, S; Smith, J; Bates, E; Fairbrother, G

2008-09-01

Preventing suicide can depend upon the ability of a range of different health professionals to make accurate suicide risk assessments and treatment plans. The attitudes that clinicians hold towards suicide prevention initiatives may influence their suicide risk assessment and management skills. This study measures a group of non-mental health professionals' attitude towards suicide prevention initiatives. Health professionals that had attended suicide prevention education showed significantly more positive attitudes towards suicide prevention initiatives. The findings in this study further support the effectiveness of educating non-mental health professionals in suicide risk awareness and management.
Mental health first aid training for high school teachers: a cluster randomized trial

Directory of Open Access Journals (Sweden)

Jorm Anthony F

2010-06-01

Full Text Available Abstract Background Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. Methods The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. Results The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Conclusions Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. Trial registration ACTRN12608000561381
Initiating and continuing behaviour change within a weight gain prevention trial: a qualitative investigation.

Directory of Open Access Journals (Sweden)

Samantha Kozica

Full Text Available Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program.In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis.A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649 that participated in the prevention trial.Four behaviour change groups emerged were identified from participant interviews: (i no change, (ii relapse, (iii intermittent and (iv continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant's ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress.Initiating and continuing behaviour change is a complex
eHealth and mHealth initiatives in Bangladesh: A scoping study

Science.gov (United States)

2014-01-01

Background The health system of Bangladesh is haunted by challenges of accessibility and affordability. Despite impressive gains in many health indicators, recent evidence has raised concerns regarding the utilization, quality and equity of healthcare. In the context of new and unfamiliar public health challenges including high population density and rapid urbanization, eHealth and mHealth are being promoted as a route to cost-effective, equitable and quality healthcare in Bangladesh. The aim of this paper is to highlight such initiatives and understand their true potential. Methods This scoping study applies a combination of research tools to explore 26 eHealth and mHealth initiatives in Bangladesh. A screening matrix was developed by modifying the framework of Arksey & O’Malley, further complemented by case study and SWOT analysis to identify common traits among the selected interventions. The WHO health system building blocks approach was then used for thematic analysis of these traits. Results Findings suggest that most eHealth and mHealth initiatives have proliferated within the private sector, using mobile phones. The most common initiatives include tele-consultation, prescription and referral. While a minority of projects have a monitoring and evaluation framework, less than a quarter have undertaken evaluation. Most of the initiatives use a health management information system (HMIS) to monitor implementation. However, these do not provide for effective sharing of information and interconnectedness among the various actors. There are extremely few individuals with eHealth training in Bangladesh and there is a strong demand for capacity building and experience sharing, especially for implementation and policy making. There is also a lack of research evidence on how to design interventions to meet the needs of the population and on potential benefits. Conclusion This study concludes that Bangladesh needs considerable preparation and planning to sustain eHealth

eHealth and mHealth initiatives in Bangladesh: a scoping study.

Science.gov (United States)

Ahmed, Tanvir; Lucas, Henry; Khan, Azfar Sadun; Islam, Rubana; Bhuiya, Abbas; Iqbal, Mohammad

2014-06-16

The health system of Bangladesh is haunted by challenges of accessibility and affordability. Despite impressive gains in many health indicators, recent evidence has raised concerns regarding the utilization, quality and equity of healthcare. In the context of new and unfamiliar public health challenges including high population density and rapid urbanization, eHealth and mHealth are being promoted as a route to cost-effective, equitable and quality healthcare in Bangladesh. The aim of this paper is to highlight such initiatives and understand their true potential. This scoping study applies a combination of research tools to explore 26 eHealth and mHealth initiatives in Bangladesh. A screening matrix was developed by modifying the framework of Arksey & O'Malley, further complemented by case study and SWOT analysis to identify common traits among the selected interventions. The WHO health system building blocks approach was then used for thematic analysis of these traits. Findings suggest that most eHealth and mHealth initiatives have proliferated within the private sector, using mobile phones. The most common initiatives include tele-consultation, prescription and referral. While a minority of projects have a monitoring and evaluation framework, less than a quarter have undertaken evaluation. Most of the initiatives use a health management information system (HMIS) to monitor implementation. However, these do not provide for effective sharing of information and interconnectedness among the various actors. There are extremely few individuals with eHealth training in Bangladesh and there is a strong demand for capacity building and experience sharing, especially for implementation and policy making. There is also a lack of research evidence on how to design interventions to meet the needs of the population and on potential benefits. This study concludes that Bangladesh needs considerable preparation and planning to sustain eHealth and mHealth initiatives successfully
A randomised controlled trial of early initiation of oral feeding after ...

African Journals Online (AJOL)

A randomised controlled trial of early initiation of oral feeding after Caesarean ... The outcome measures were rate of ileus symptoms, post operative presence of ... more rapid recovery and expressed their interest in earlier hospital discharge.
Low-fat dietary pattern and cancer incidence in the Women's Health Initiative Dietary Modification Randomized Controlled Trial.

Science.gov (United States)

Prentice, Ross L; Thomson, Cynthia A; Caan, Bette; Hubbell, F Allan; Anderson, Garnet L; Beresford, Shirley A A; Pettinger, Mary; Lane, Dorothy S; Lessin, Lawrence; Yasmeen, Shagufta; Singh, Baljinder; Khandekar, Janardan; Shikany, James M; Satterfield, Suzanne; Chlebowski, Rowan T

2007-10-17

The Women's Health Initiative Dietary Modification (DM) Randomized Controlled Trial evaluated the effects of a low-fat dietary pattern on chronic disease incidence, with breast cancer and colorectal cancer as primary outcomes. The trial protocol also listed ovarian cancer and endometrial cancer as outcomes that may be favorably affected by the intervention. A total of 48,835 postmenopausal women were randomly assigned during 1993-1998 to a DM intervention (n = 19,541) or comparison (usual diet; n = 29,294) group and followed up for an average of 8.1 years. The intervention goal was to reduce total fat intake to 20% of energy and to increase consumption of vegetables, fruits, and grains. Cancer outcomes were verified by pathology report review. We used weighted log-rank tests to compare incidence of invasive cancers of the ovary and endometrium, total invasive cancer, and invasive cancers at other sites between the groups. All statistical tests were two-sided. Ovarian cancer risk was lower in the intervention than in the comparison group (P = .03). Although the overall ovarian cancer hazard ratio (HR) was not statistically significantly less than 1.0, the hazard ratio decreased with increasing intervention duration (P(trend) = .01). For the first 4 years, the risk for ovarian cancer was similar in the intervention and control groups (0.52 cases per 1000 person-years in the intervention group versus 0.45 per 1000 person-years in the comparison group; HR = 1.16, 95% confidence interval [CI] = 0.73 to 1.84); over the next 4.1 years, the risk was lower in the intervention group (0.38 cases per 1000 person-years in the intervention group versus 0.64 per 1000 person-years in the comparison group; HR = 0.60, 95% CI = 0.38 to 0.96). Risk of cancer of the endometrium did not differ between the groups (P = .18). The estimated risk of total invasive cancer was slightly lower in the intervention group than in the control group (HR = 0.95, 95% CI = 0.89 to 1.01; P = .10). A low
Clinical Trials

Medline Plus

Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...
Trial protocol: a parallel group, individually randomized clinical trial to evaluate the effect of a mobile phone application to improve sexual health among youth in Stockholm County.

Science.gov (United States)

Nielsen, Anna; De Costa, Ayesha; Bågenholm, Aspasia; Danielsson, Kristina Gemzell; Marrone, Gaetano; Boman, Jens; Salazar, Mariano; Diwan, Vinod

2018-02-05

Genital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth. Sweden introduced an opportunistic screening approach in 1982 accompanied by treatment, partner notification and case reporting. After an initial decline in infection rate till the mid-90s, the number of reported cases has increased over the last two decades and has now stabilized at a high level of 37,000 reported cases in Sweden per year (85% of cases in youth). Sexual risk-taking among youth is also reported to have significantly increased over the last 20 years. Mobile health (mHealth) interventions could be particularly suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population. This paper presents a protocol for a randomized trial to study the effect of an interactive mHealth application (app) on condom use among the youth of Stockholm. 446 youth resident in Stockholm, will be recruited in this two arm parallel group individually randomized trial. Recruitment will be from Youth Health Clinics or via the trial website. Participants will be randomized to receive either the intervention (which comprises an interactive app on safe sexual health that will be installed on their smart phones) or a control group (standard of care). Youth will be followed up for 6 months, with questionnaire responses submitted periodically via the app. Self-reported condom use over 6 months will be the primary outcome. Secondary outcomes will include presence of an infection, Chlamydia tests during the study period and proxy markers of safe sex. Analysis is by intention to treat. This trial exploits the high mobile phone usage among youth to provide a phone app intervention in the area of sexual health. If successful, the results will have implications for health service delivery and health promotion among the youth. From a methodological perspective, this trial is expected to provide
How have Global Health Initiatives impacted on health equity?

Science.gov (United States)

Hanefeld, Johanna

2008-01-01

This review examines the impact of Global Health Initiatives (GHIs) on health equity, focusing on low- and middle-income countries. It is a summary of a literature review commissioned by the WHO Commission on the Social Determinants of Health. GHIs have emerged during the past decade as a mechanism in development assistance for health. The review focuses on three GHIs, the US President's Emergency Plan For AIDS Relief (PEPFAR), the World Bank's Multi-country AIDS Programme (MAP) and the Global Fund to Fight AIDS, TB and Malaria. All three have leveraged significant amounts of funding for their focal diseases - together these three GHIs provide an estimated two-thirds of external resources going to HIV/AIDS. This paper examines their impact on gender equity. An analysis of these Initiatives finds that they have a significant impact on health equity, including gender equity, through their processes of programme formulation and implementation, and through the activities they fund and implement, including through their impact on health systems and human resources. However, GHIs have so far paid insufficient attention to health inequities. While increasingly acknowledging equity, including gender equity, as a concern, Initiatives have so far failed to adequately translate this into programmes that address drivers of health inequity, including gender inequities. The review highlights the comparative advantage of individual GHIs, which point to an increased need for, and continued difficulties in, harmonisation of activities at country level. On the basis of this comparative analysis, key recommendations are made. They include a call for equity-sensitive targets, the collection of gender-disaggregated data, the use of policy-making processes for empowerment, programmes that explicitly address causes of health inequity and impact assessments of interventions' effect on social inequities.
Cost and cost-effectiveness of smear-positive tuberculosis treatment by Health Extension Workers in Southern Ethiopia: a community randomized trial.

Directory of Open Access Journals (Sweden)

Daniel G Datiko

Full Text Available UNLABELLED: Treatments by HEWs in the health posts and general health workers at health facility were compared along a community-randomized trial. Costs were analysed from societal perspective in 2007 in US $ using standard methods. We prospectively enrolled smear positive patients, and calculated cost-effectiveness as the cost per patient successfully treated. The total cost for each successfully treated smear-positive patient was higher in health facility ($158.9 compared with community ($61.7. Community-based treatment reduced the total, patient and caregiver cost by 61.2%, 68.1% and 79.8%, respectively. Involving HEWs added a total cost of $8.80 (14.3% of total cost on health service per patient treated in the community. CONCLUSIONS/SIGNIFICANCE: Community-based treatment by HEWs costs only 39% of what treatment by general health workers costs for similar outcomes. Involving HEWs in TB treatment is a cost effective treatment alternative to the health service, to the patients and the family. There is an economic and public health reason to consider involving HEWs in TB treatment in Ethiopia. However, community-based treatment requires initial investment to start its implementation, training and supervision. TRIAL REGISTRATION: ClinicalTrials.gov NCT00803322.
Global women's health: current clinical trials in low- and middle-income countries.

Science.gov (United States)

Merriel, A; Harb, H M; Williams, H; Lilford, R; Coomarasamy, A

2015-01-01

Clinical trials in low- and middle-income countries (LMICs) are necessary to develop evidence-based approaches to improve women's health. Understanding what research is currently being conducted will allow the identification of research gaps, avoidance of duplication, planning of future studies, collaboration amongst research groups, and geographical targeting for research investments. To provide an overview of active women's health trials in LMICs. The World Health Organization's International Clinical Trials Registry Platform was searched for trials registered between 1 April 2012 and 31 March 2014. Selected trials were randomised, conducted in LMICs, active, and with a women's health intervention or a significant outcome for the woman. Two reviewers extracted data. Analysis included geographical spread, speciality areas, pre-enrolment registration, study size, and funders. Of the 8966 records, 509 were eligible for inclusion. Gynaecology trials made up 57% of the research, whereas the remaining 43% of trials were in obstetrics. Research activity focused on fertility (17%), the antenatal period (15%), benign gynaecology (14%), intrapartum care (9%), and pre-invasive disease and cancers (8%). The majority of trials (84%) took place in middle-income countries (MICs). In low-income countries (LICs) 83% of research investigated obstetrics, and in MICs 60% of research investigated gynaecology. Most trials (80%) had a sample size of 500 or fewer participants. The median size of trials in LICs was 815 compared with 128 in MICs. Pre-enrolment registration occurred in 54% of trials. The majority (62%) of trials were funded locally. Many LMICs are active in women's health research. The majority of registered trials are located in MICs; however, the trials in LICs are often larger. The focus of research in MICs may be driven by local priorities and funding, with fertility being highly researched. In LICs, pregnancy is the focus, perhaps reflecting the international
Health Activities Project (HAP), Trial Edition III.

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Buller, Dave; And Others

Contained within this Health Activities Project (HAP) trial edition (set III) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into an Overview, Health Background, Materials, Setting Up, and…
Health Activities Project (HAP), Trial Edition II.

Science.gov (United States)

Buller, Dave; And Others

Contained within this Health Activities Project (HAP) trial edition (set II) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into a Synopsis, Health Background, Materials, Setting Up, and Activities…
Clinical trial registration in oral health journals.

Science.gov (United States)

Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

2015-03-01

Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. © International & American Associations for Dental Research.
World Health Organization "School Mental Health Manual"-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial.

Science.gov (United States)

Imran, Nazish; Rahman, Atif; Chaudhry, Nakhshab; Asif, Aftab

2018-05-24

The teacher's role in school mental health initiatives cannot be overemphasized. Despite global evidence of educational interventions in improving teachers' knowledge and attitudes regarding mental health, this area remains under researched in Pakistan. This paper presents a study protocol of a pilot randomized controlled trial to examine the effectiveness of a teacher training intervention for improving mental health literacy and self-efficacy among school teachers in urban Lahore, Pakistan. The randomized controlled trial will follow the CONSORT guidelines. Participants will be allocated to the Intervention group (receiving the World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School Mental Health Manual-based intervention in three 6-h, face-to-face sessions) or a waitlist control group (not receiving training during the study period). Participants will be teachers of private schools with similar broad demographic characteristics in an inner city area of Lahore. The primary outcome measures for the trial is teachers' mental health literacy. It will be assessed by using the previously applied (during WHO training of Master Trainers) self-administered questionnaire in both groups pre and post training and at 3 months' follow-up. Secondary outcomes include: for teachers: Teachers' self-efficacy (assessed by the Teachers' Sense of Self Efficacy Scale (TSES) short form.); for students (11-16 years): socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire (assessed at baseline and 3 months post intervention); for schools: the WHO School Psychosocial Profile Questionnaire (baseline and 3 months post intervention). Given the high prevalence of child mental health problems, stigma and lack of services, it is important to consider alternate avenues for promoting positive mental health among youth. This pilot study should establish the effectiveness of the WHO-EMRO School Mental Health Manual
Mental health first aid training for high school teachers: a cluster randomized trial.

Science.gov (United States)

Jorm, Anthony F; Kitchener, Betty A; Sawyer, Michael G; Scales, Helen; Cvetkovski, Stefan

2010-06-24

Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. ACTRN12608000561381.
African Development of AIDS Prevention Trials (ADAPT2) | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...
African Development of AIDS Prevention Trials (ADAPT2) | CRDI ...

International Development Research Centre (IDRC) Digital Library (Canada)

The African Development of AIDS Prevention Trials (ADAPT2) capacity building initiative is an African-Canadian partnership that aims to increase the number and quality of HIV prevention trials led by African researchers. Building on experience gained during ADAPT1 - funded by the Global Health Research Initiative ...
Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

NARCIS (Netherlands)

Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified
Predictors of initial weight loss among women with abdominal obesity: a path model using self-efficacy and health-promoting behaviour.

Science.gov (United States)

Choo, Jina; Kang, Hyuncheol

2015-05-01

To identify predictors of initial weight loss among women with abdominal obesity by using a path model. Successful weight loss in the initial stages of long-term weight management may promote weight loss maintenance. A longitudinal study design. Study participants were 75 women with abdominal obesity, who were enrolled in a 12-month Community-based Heart and Weight Management Trial and followed until a 6-month assessment. The Weight Efficacy Lifestyle, Exercise Self-Efficacy and Health Promoting Lifestyle Profile-II measured diet self-efficacy, exercise self-efficacy and health-promoting behaviour respectively. All endogenous and exogenous variables used in our path model were change variables from baseline to 6 months. Data were collected between May 2011-May 2012. Based on the path model, increases in both diet and exercise self-efficacy had significant effects on increases in health-promoting behaviour. Increases in diet self-efficacy had a significant indirect effect on initial weight loss via increases in health-promoting behaviour. Increases in health-promoting behaviour had a significant effect on initial weight loss. Among women with abdominal obesity, increased diet self-efficacy and health-promoting behaviour were predictors of initial weight loss. A mechanism by which increased diet self-efficacy predicts initial weight loss may be partially attributable to health-promoting behavioural change. However, more work is still needed to verify causality. Based on the current findings, intensive nursing strategies for increasing self-efficacy for weight control and health-promoting behaviour may be essential components for better weight loss in the initial stage of a weight management intervention. © 2015 John Wiley & Sons Ltd.
African Health Systems Initiative (AHSI) | IDRC - International ...

International Development Research Centre (IDRC) Digital Library (Canada)

The African Health Systems Initiative (AHSI) is a 10-year Canadian International ... for strengthening African-led health systems and human resources for health. ... IDRC congratulates first cohort of Women in Climate Change Science Fellows.
Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

Science.gov (United States)

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline
Canada-Africa Prevention Trials Network : Building African Capacity ...

International Development Research Centre (IDRC) Digital Library (Canada)

Canada-Africa Prevention Trials Network : Building African Capacity for HIV/AIDS Prevention Trials. The Canada-Africa Prevention Trials Network (CAPT Network) was formed through a capacity building grant from the Global Health Research Initiative (GHRI). The Network comprises eight African centres (four in Uganda, ...

Building African Capacity for HIV/AIDS Prevention Trials

International Development Research Centre (IDRC) Digital Library (Canada)

Canada-Africa Prevention Trials Network : Building African Capacity for HIV/AIDS Prevention Trials. The Canada-Africa Prevention Trials Network (CAPT Network) was formed through a capacity building grant from the Global Health Research Initiative (GHRI). The Network comprises eight African centres (four in Uganda, ...
Initiating antiretroviral therapy for HIV at a patient's first clinic visit: a cost-effectiveness analysis of the rapid initiation of treatment randomized controlled trial.

Science.gov (United States)

Long, Lawrence C; Maskew, Mhairi; Brennan, Alana T; Mongwenyana, Constance; Nyoni, Cynthia; Malete, Given; Sanne, Ian; Fox, Matthew P; Rosen, Sydney

2017-07-17

Determine the cost and cost-effectiveness of single-visit (same-day) antiretroviral treatment (ART) initiation compared to standard of care initiation. Cost-effectiveness analysis of individually randomized (1 : 1) pragmatic trial of single-visit initiation, which increased viral suppression at 10 months by 26% [relative risk (95% confidence interval) 1.26 (1.05-1.50)]. Primary health clinic in Johannesburg, South Africa. HIV positive, adult, nonpregnant patients not yet on ART or known to be eligible who presented at the clinic 8 May 2013 to 29 August 2014. Same-day ART initiation using point-of-care laboratory instruments and accelerated clinic procedures to allow treatment-eligible patients to receive antiretroviral medications at the same visit as testing HIV positive or having an eligible CD4 cell count. Comparison was to standard of care ART initiation, which typically required three to five additional clinic visits. Average cost per patient enrolled and per patient achieving the primary outcome of initiated 90 days or less and suppressed 10 months or less, and production cost per patient achieving primary outcome (all costs per primary outcome patients). The average cost per patient enrolled, per patient achieving the primary outcome, and production cost were $319, $487, and $738 in the standard arm and $451, $505, and $707 in the rapid arm. Same-day treatment initiation was more effective than standard initiation, more expensive per patient enrolled, and less expensive to produce a patient achieving the primary outcome. Omitting point-of-care laboratory tests at initiation and focusing on high-volume clinics have the potential to reduce costs substantially and should be evaluated in routine settings.
StaR Child Health: developing evidence-based guidance for the design, conduct and reporting of paediatric trials.

Science.gov (United States)

Van't Hoff, William; Offringa, Martin

2015-02-01

There has been a huge upsurge in clinical research in children in the last decade, stimulated in England by dedicated research infrastructure and support through the National Institute for Health Research. This infrastructure offering research design, expert review, trial management, research nurse, data support and dedicated facilities enables paediatricians to conduct more and better research. The challenge is how to design and conduct trials that will make a real difference to children's health. Standards for Research (StaR) in Child Health was founded in 2009 to address the paucity and shortcomings of paediatric clinical trials. This global initiative involves methodologists, clinicians, patient advocacy groups and policy makers dedicated to developing practical, evidence-based standards for enhancing the reliability and relevance of paediatric clinical research. In this overview, we highlight the contribution of StaR to this agenda, describe the international context, and suggest how StaR's future plans could be integrated with new and existing support for research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
A novel dynamic exercise initiative for older people to improve health and well-being: study protocol for a randomised controlled trial.

Science.gov (United States)

Sales, Myrla Patricia Reis; Polman, Remco; Hill, Keith D; Karaharju-Huisman, Tuire; Levinger, Pazit

2015-06-24

Exercise is an important and effective approach to preventing falls in older people, but adherence to exercise participation remains a persistent problem. A unique purpose-built exercise park was designed to provide a fun but physically challenging environment to support exercise in a community setting. This project is a randomised controlled trial designed to evaluate the effectiveness of an exercise intervention using an exercise park specifically designed for older people in reducing the risk of falls. This study will be a parallel randomised control trial with pre and post intervention design. One hundred and twenty people aged between 60 and 90 years old will be recruited from Melbourne suburbs and will be randomly allocated to either an exercise park intervention group (EPIG) or a control group (CG). The CG will receive social activities and an educational booklet on falls prevention. The BOOMER balance test will be used as the primary outcome measure. Secondary outcome measures will include hand grip strength, two minute walk test, lower limb strength test, spatio-temporal walking parameters, health related quality of life, feasibility, adherence, safety, and a number of other psychosocial measures. Outcome assessment will be conducted at baseline and at 18 and 26 weeks after intervention commencement. Participants will inform their falls and physical activity history for a 12-month period via monthly calendars. Mixed linear modelling incorporating intervention and control groups at the baseline and two follow up time points (18 weeks and 26 weeks after intervention commencement) will be used to assess outcomes. This planned trial will be the first to provide evidence if the exercise park can improve functional and physiological health, psychological and well-being. In addition, this study will provide empirical evidence for effectiveness and explore the barriers to participation and the acceptability of the senior exercise park in the Australian older
mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

Science.gov (United States)

Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

2018-02-15

Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback
Parabolic Trough Solar Collector Initial Trials

Directory of Open Access Journals (Sweden)

Ghalya Pikra

2012-03-01

Full Text Available This paper discusses initial trials of parabolic trough solar collector (PTSC in Bandung. PTSC model consists of concentrator, absorber and tracking system. Concentrator designs are made with 2m aperture width, 6m length and 0.75m focal distance. The design is equipped with an automatic tracking system which is driven using 12V and 24Watt DC motor with 0.0125rpm rotational speed. Absorber/receiver is designed with evacuated tube type, with 1 inch core diameter and tube made of AISI304 and coated with black oxide, the outer tube is borosilicate glass with a 70 mm diameter and 1.5 m length. Working fluid stored in single type of thermal storage tank, a single phase with 37.7 liter volume. PTSC model testing carried out for 2 hours and 10 minutes produces heat output and input of 11.5 kW and 0.64 kW respectively.
Health providers' perceptions of clinical trials : lessons from Ghana, Kenya and Burkina Faso

NARCIS (Netherlands)

Angwenyi, Vibian; Asante, Kwaku-Poku; Traoré, Abdoulaye; Febir, Lawrence Gyabaa; Tawiah, Charlotte; Kwarteng, Anthony; Ouédraogo, Alphonse; Sirima, Sodiomon Bienvenue; Owusu-Agyei, Seth; Imoukhuede, Egeruan Babatunde; Webster, Jayne; Chandramohan, Daniel; Molyneux, Sassy; Jones, Caroline

2015-01-01

BACKGROUND: Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice
Using Population Dose to Evaluate Community-level Health Initiatives.

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Harner, Lisa T; Kuo, Elena S; Cheadle, Allen; Rauzon, Suzanne; Schwartz, Pamela M; Parnell, Barbara; Kelly, Cheryl; Solomon, Loel

2018-05-01

Successful community-level health initiatives require implementing an effective portfolio of strategies and understanding their impact on population health. These factors are complicated by the heterogeneity of overlapping multicomponent strategies and availability of population-level data that align with the initiatives. To address these complexities, the population dose methodology was developed for planning and evaluating multicomponent community initiatives. Building on the population dose methodology previously developed, this paper operationalizes dose estimates of one initiative targeting youth physical activity as part of the Kaiser Permanente Community Health Initiative, a multicomponent community-level obesity prevention initiative. The technical details needed to operationalize the population dose method are explained, and the use of population dose as an interim proxy for population-level survey data is introduced. The alignment of the estimated impact from strategy-level data analysis using the dose methodology and the data from the population-level survey suggest that dose is useful for conducting real-time evaluation of multiple heterogeneous strategies, and as a viable proxy for existing population-level surveys when robust strategy-level evaluation data are collected. This article is part of a supplement entitled Building Thriving Communities Through Comprehensive Community Health Initiatives, which is sponsored by Kaiser Permanente, Community Health. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Cinnamon Bark, Water Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Science.gov (United States)

2016-12-14

Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus : A Randomized, Controlled Trial. Paul Crawford, MD Clinical Investigation...Title: “Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus : A Randomized, Controlled...as initial treatment for Type 2 diabetes mellitus : A randomized, controlled trial. IRB #: FWH20110004H Principal Investigator (PI) Rank / Civ
Kettlebell training for musculoskeletal and cardiovascular health: a randomized controlled trial

DEFF Research Database (Denmark)

Jay, Kenneth; Frisch, Dennis; Hansen, Klaus

2011-01-01

The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health.......The aim of this trial was to investigate the effectiveness of a worksite intervention using kettlebell training to improve musculoskeletal and cardiovascular health....
Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

Directory of Open Access Journals (Sweden)

Sydney Rosen

2016-05-01

Full Text Available High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.RapIT (Rapid Initiation of Treatment was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC and a hospital-based HIV clinic. Adult (≥18 y old, non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm" received a point-of-care (POC CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV dispensing. Patients in the standard-initiation arm of the study ("standard arm" followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing. Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition
Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

Directory of Open Access Journals (Sweden)

Carrasquillo O

2014-02-01

Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added
Longitudinal Cognitive Trajectories of Women Veterans from the Women's Health Initiative Memory Study.

Science.gov (United States)

Padula, Claudia B; Weitlauf, Julie C; Rosen, Allyson C; Reiber, Gayle; Cochrane, Barbara B; Naughton, Michelle J; Li, Wenjun; Rissling, Michelle; Yaffe, Kristine; Hunt, Julie R; Stefanick, Marcia L; Goldstein, Mary K; Espeland, Mark A

2016-02-01

A comparison of longitudinal global cognitive functioning in women Veteran and non-Veteran participants in the Women's Health Initiative (WHI). We studied 7,330 women aged 65-79 at baseline who participated in the WHI Hormone Therapy Trial and its ancillary Memory Study (WHIMS). Global cognitive functioning (Modified Mini-Mental State Examination [3MSE]) in Veterans (n = 279) and non-Veterans (n = 7,051) was compared at baseline and annually for 8 years using generalized linear modeling methods. Compared with non-Veterans, Veteran women were older, more likely to be Caucasian, unmarried, and had higher rates of educational and occupational attainment. Results of unadjusted baseline analyses suggest 3MSE scores were similar between groups. Longitudinal analyses, adjusted for age, education, ethnicity, and WHI trial assignment revealed differences in the rate of cognitive decline between groups over time, such that scores decreased more in Veterans relative to non-Veterans. This relative difference was more pronounced among Veterans who were older, had higher educational/occupational attainment and greater baseline prevalence of cardiovascular risk factors (e.g., smoking) and cardiovascular disease (e.g., angina, stroke). Veteran status was associated with higher prevalence of protective factors that may have helped initially preserve cognitive functioning. However, findings ultimately revealed more pronounced cognitive decline among Veteran relative to non-Veteran participants, likely suggesting the presence of risks that may impact neuropathology and the effects of which were initially masked by Veterans' greater cognitive reserve. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Special features of health services and register based trials – experiences from a randomized trial of childbirth classes

Directory of Open Access Journals (Sweden)

Sevón Tiina

2008-06-01

Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health
Measuring health systems strength and its impact: experiences from the African Health Initiative.

Science.gov (United States)

Sherr, Kenneth; Fernandes, Quinhas; Kanté, Almamy M; Bawah, Ayaga; Condo, Jeanine; Mutale, Wilbroad

2017-12-21

Health systems are essential platforms for accessible, quality health services, and population health improvements. Global health initiatives have dramatically increased health resources; however, funding to strengthen health systems has not increased commensurately, partially due to concerns about health system complexity and evidence gaps demonstrating health outcome improvements. In 2009, the African Health Initiative of the Doris Duke Charitable Foundation began supporting Population Health Implementation and Training Partnership projects in five sub-Saharan African countries (Ghana, Mozambique, Rwanda, Tanzania, and Zambia) to catalyze significant advances in strengthening health systems. This manuscript reflects on the experience of establishing an evaluation framework to measure health systems strength, and associate measures with health outcomes, as part of this Initiative. Using the World Health Organization's health systems building block framework, the Partnerships present novel approaches to measure health systems building blocks and summarize data across and within building blocks to facilitate analytic procedures. Three Partnerships developed summary measures spanning the building blocks using principal component analysis (Ghana and Tanzania) or the balanced scorecard (Zambia). Other Partnerships developed summary measures to simplify multiple indicators within individual building blocks, including health information systems (Mozambique), and service delivery (Rwanda). At the end of the project intervention period, one to two key informants from each Partnership's leadership team were asked to list - in rank order - the importance of the six building blocks in relation to their intervention. Though there were differences across Partnerships, service delivery and information systems were reported to be the most common focus of interventions, followed by health workforce and leadership and governance. Medical products, vaccines and technologies, and
Quality improvement initiatives: the missed opportunity for health plans.

Science.gov (United States)

Fernandez-Lopez, Sara; Lennert, Barbara

2009-11-01

The increase in healthcare cost without direct improvements in health outcomes, coupled with a desire to expand access to the large uninsured population, has underscored the importance of quality initiatives and organizations that provide more affordable healthcare by maximizing value. To determine the knowledge of managed care organizations about quality organizations and initiatives and to identify potential opportunities in which pharmaceutical companies could collaborate with health plans in the development and implementation of quality initiatives. We conducted a survey of 36 pharmacy directors and 15 medical directors of different plans during a Managed Care Network meeting in 2008. The represented plans cover almost 74 million lives in commercial, Medicare, and Medicaid programs, or a combination of them. The responses show limited knowledge among pharmacy and medical directors about current quality organizations and initiatives, except for quality organizations that provide health plan quality accreditation. The results also reveal an opportunity for pharmaceutical companies to collaborate with private health plans in the development of quality initiatives, especially those related to drug utilization, such as patient adherence and education and correct drug utilization. Our survey shows clearly that today's focus for managed care organizations is mostly limited to the organizations that provide health plan quality accreditation, with less focus on other organizations.
GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

NARCIS (Netherlands)

de Jong-Potjer, L. C.; Elsinga, J.; le Cessie, S.; van der Pal-de Bruin, K. M.; Neven, A. Knuistingh; Buitendijk, S. E.; Assendelft, W. J. J.

2006-01-01

BACKGROUND: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. METHODS: Randomised trial of usual care versus
GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

NARCIS (Netherlands)

Jong-Potjer, L.C. de; Elsinga, J.; Cessie, S. le; Pal-de Bruin, K.M. van der; Knuistingh Neven, A.; Buitendijk, S.E.; Assendelft, W.J.J.

2006-01-01

Background: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods: Randomised trial of usual care versus
Longitudinal Cognitive Trajectories of Women Veterans from the Women’s Health Initiative Memory Study

Science.gov (United States)

Padula, Claudia B.; Weitlauf, Julie C.; Rosen, Allyson C.; Reiber, Gayle; Cochrane, Barbara B.; Naughton, Michelle J.; Li, Wenjun; Rissling, Michelle; Yaffe, Kristine; Hunt, Julie R.; Stefanick, Marcia L.; Goldstein, Mary K.; Espeland, Mark A.

2016-01-01

Purpose of the Study: A comparison of longitudinal global cognitive functioning in women Veteran and non-Veteran participants in the Women’s Health Initiative (WHI). Design and Methods: We studied 7,330 women aged 65–79 at baseline who participated in the WHI Hormone Therapy Trial and its ancillary Memory Study (WHIMS). Global cognitive functioning (Modified Mini-Mental State Examination [3MSE]) in Veterans (n = 279) and non-Veterans (n = 7,051) was compared at baseline and annually for 8 years using generalized linear modeling methods. Results: Compared with non-Veterans, Veteran women were older, more likely to be Caucasian, unmarried, and had higher rates of educational and occupational attainment. Results of unadjusted baseline analyses suggest 3MSE scores were similar between groups. Longitudinal analyses, adjusted for age, education, ethnicity, and WHI trial assignment revealed differences in the rate of cognitive decline between groups over time, such that scores decreased more in Veterans relative to non-Veterans. This relative difference was more pronounced among Veterans who were older, had higher educational/occupational attainment and greater baseline prevalence of cardiovascular risk factors (e.g., smoking) and cardiovascular disease (e.g., angina, stroke). Implications: Veteran status was associated with higher prevalence of protective factors that may have helped initially preserve cognitive functioning. However, findings ultimately revealed more pronounced cognitive decline among Veteran relative to non-Veteran participants, likely suggesting the presence of risks that may impact neuropathology and the effects of which were initially masked by Veterans’ greater cognitive reserve. PMID:26615021
[Challenges in the organization of investigator initiated trials: in transplantation medicine].

Science.gov (United States)

Schnitzbauer, A A; Lamby, P E; Mutzbauer, I; von Hassel, J; Geissler, E K; Schlitt, H J

2011-03-01

Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Mental health first aid training by e-learning: a randomized controlled trial.

Science.gov (United States)

Jorm, Anthony F; Kitchener, Betty A; Fischer, Julie-Anne; Cvetkovski, Stefan

2010-12-01

Mental Health First Aid training is a course for the public that teaches how to give initial help to a person developing a mental health problem or in a mental health crisis. The present study evaluated the effects of Mental Health First Aid training delivered by e-learning on knowledge about mental disorders, stigmatizing attitudes and helping behaviour. A randomized controlled trial was carried out with 262 members of the Australian public. Participants were randomly assigned to complete an e-learning CD, read a Mental Health First Aid manual or be in a waiting list control group. The effects of the interventions were evaluated using online questionnaires pre- and post-training and at 6-months follow up. The questionnaires covered mental health knowledge, stigmatizing attitudes, confidence in providing help to others, actions taken to implement mental health first aid and participant mental health. Both e-learning and the printed manual increased aspects of knowledge, reduced stigma and increased confidence compared to waiting list. E-learning also improved first aid actions taken more than waiting list, and was superior to the printed manual in reducing stigma and disability due to mental ill health. Mental Health First Aid information received by either e-learning or printed manual had positive effects, but e-learning was better at reducing stigma.
Initial Validation of the Mental Health Provider Stigma Inventory

Science.gov (United States)

Kennedy, Stephanie C.; Abell, Neil; Mennicke, Annelise

2017-01-01

Objective: To conduct an initial validation of the mental health provider stigma inventory (MHPSI). The MHPSI assesses stigma within the service provider--client relationship on three domains--namely, attitudes, behaviors, and coworker influence. Methods: Initial validation of the MHPSI was conducted with a sample of 212 mental health employees…
Clinical Trials: A Crucial Key to Human Health Research

Science.gov (United States)

... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...
[Health-Promoting Schools Regional Initiative of the Americas].

Science.gov (United States)

Ippolito-Shepherd, Josefa; Cerqueira, Maria Teresa; Ortega, Diana Patricia

2005-01-01

In Latin America, comprehensive health promotion programmes and activities are being implemented in the school setting, which take into account the conceptual framework of the Health-Promoting Schools Regional Initiative of the Pan American Health Organization, Regional office of the World Health Organization (PAHO/WHO). These programmes help to strengthen the working relationships between the health and education sectors. The Health-Promoting Schools Regional Initiative, officially launched by PAHO/WHO in 1995, aims to form future generations to have the knowledge, abilities, and skills necessary for promoting and caring for their health and that of their family and community, as well as to create and maintain healthy environments and communities. The Initiative focuses on three main components: comprehensive health education, the creation and maintenance of healthy physical and psychosocial environments, and the access to health and nutrition services, mental health, and active life. In 2001, PAHO conducted a survey in 19 Latin American countries to assess the status and trends of Health-Promoting Schools in the Region, for the appropriate regional, subregional, and national planning of pertinent health promotion and health education programmes and activities. The results of this survey provided information about policies and national plans, multisectoral coordination mechanisms for the support of health promotion in the school settings, the formation and participation in national and international networks of Health-Promoting Schools and about the level of dissemination of the strategy. For the successful development of Health-Promoting Schools is essential to involve the society as a whole, in order to mobilise human resources and materials necessary for implementing health promotion in the school settings. Thus, the constitution and consolidation of networks has been a facilitating mechanism for the exchange of ideas, resources and experiences to strengthen
Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 2.

Science.gov (United States)

Giacoia, George P; Taylor-Zapata, Perdita; Mattison, Donald

2007-01-01

The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations to children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulations Initiative. The goal of this ongoing initiative is to address the issues and concerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration. In this second part of a two-part article, the activities of the various groups that constitute the Pediatric Formulations Initiative are discussed, in addition the Initiative's future activities and plans are outlined.
A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

Science.gov (United States)

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): a pilot randomised controlled trial.

Science.gov (United States)

Bonell, Chris; Fletcher, Adam; Fitzgerald-Yau, Natasha; Hale, Daniel; Allen, Elizabeth; Elbourne, Diana; Jones, Rebecca; Bond, Lyndal; Wiggins, Meg; Miners, Alec; Legood, Rosa; Scott, Stephen; Christie, Deborah; Viner, Russell

2015-07-01

Youth bullying and other aggressive behaviours are a major public health concern owing to their impact on adolescent physical and mental health and well-being. Whole-school restorative approaches have been identified as a promising method of addressing aggressive behaviour but there have been no randomised trials undertaken to examine their effects. To examine the feasibility and acceptability of implementing and trialling the INCLUSIVE (initiating change locally in bullying and aggression through the school environment) intervention in English secondary schools. Cluster randomised controlled pilot trial in eight schools (1 : 1 computer-generated random allocation post baseline by a statistician blind to the identity of clusters) and process evaluation. Secondary schools in England (purposively sampled to ensure diversity). Year 8 students (aged 12-13 years), teachers, other school staff and intervention providers. Whole-school restorative approach to address bullying and aggression, involving the following standard processes: school action group formation and external facilitation to review needs assessment data, identify priorities, and plan and monitor school-level actions; staff training in restorative practices; and a new social and emotional skills curriculum. Standard practice. (1) The primary outcome of interest was the feasibility and acceptability of delivering and trialling the intervention according to prespecified criteria; (2) process data were analysed to explore participants' experiences of implementing and trialling the intervention and how these varied according to school context; and (3) indicative primary outcomes (aggressive behaviour measures), secondary outcomes, intermediate outcomes and economic evaluation methods were piloted. Students (n = 1144 baseline; n = 1114 follow-up) and teachers (n = 387 baseline; n = 336 follow-up) were surveyed at the start and end of the 2011-12 academic year (baseline September 2011; follow
Women's Health Initiative estrogen plus progestin clinical trial: a study that does not allow establishing relevant clinical risks.

Science.gov (United States)

Aedo, Sócrates; Cavada, Gabriel; Blümel, Juan E; Chedraui, Peter; Fica, Juan; Barriga, Patricio; Brantes, Sergio; Irribarra, Cristina; Vallejo, María; Campodónico, Ítalo

2015-12-01

This study aims to determine time differences (differences in restricted mean survival times [RMSTs]) in the onset of invasive breast cancer, coronary heart disease, stroke, pulmonary embolism, colorectal cancer, and hip fracture between the placebo group and the conjugated equine estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg group of the Women's Health Initiative (WHI) trial based on survival curves of the original report and to provide adequate interpretation of the clinical effects of a given intervention. Distribution of survival function was obtained from cumulative hazard plots of the WHI report; Monte Carlo simulation was performed to obtain censored observations for each outcome, in which assumptions of the Cox model were evaluated once corresponding hazard ratios had been estimated. Using estimation methods such as numerical integration, pseudovalues, and flexible parametric modeling, we determined differences in RMSTs for each outcome. Obtained cumulative hazard plots, hazard ratios, and outcome rates from the simulated model did not show differences in relation to the original WHI report. The differences in RMST between placebo and conjugated equine estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg (in flexible parametric modeling) were 1.17 days (95% CI, -2.25 to 4.59) for invasive breast cancer, 7.50 days (95% CI, 2.90 to 12.11) for coronary heart disease, 2.75 days (95% CI, -0.84 to 6.34) for stroke, 4.23 days (95% CI, 1.82 to 6.64) for pulmonary embolism, -2.73 days (95% CI, -5.32 to -0.13) for colorectal cancer, and -2.77 days (95% CI, -5.44 to -0.1) for hip fracture. The differences in RMST for the outcomes of the WHI study are too small to establish clinical risks related to hormone therapy use.
Capacity Building for HIV/AIDS Prevention Trials | IDRC ...

International Development Research Centre (IDRC) Digital Library (Canada)

The Canadian International Development Agency (CIDA) is funding the Africa HIV/AIDS Prevention Trials Capacity Building Program under the umbrella of the Global Health Research Initiative (GHRI). The aim of the program is to build the capacity of African researchers and institutions to conduct anticipated clinical trials ...
Effect of Mobile-health on maternal health care service utilization in Eastern Ethiopia: study protocol for a randomized controlled trial.

Science.gov (United States)

Gelano, Tilayie Feto; Assefa, Nega; Bacha, Yadeta Dessie; Mahamed, Afendi Abdi; Roba, Kedir Teji; Hambisa, Mitiku Teshome

2018-02-12

Globally, the rapid development of mobile technology has created new ways of addressing public health challenges and shifted the paradigm of health care access and delivery. The primary aim of this study is to examine the effectiveness of Mobile-health on maternal health care service utilization in Eastern Ethiopia. Through, a cluster-randomized controlled trial, 640 participants will be selected based on their districts and respective health centers as the unit of randomization. All pregnant mothers who fulfill the inclusion criteria will be allocated to a mobile-phone-based intervention and existing standard of care or control with a 1:1 allocation ratio. The intervention consists of a series of 24 voice messages which will be sent every 2 weeks from the date of enrollment until the close-out time. The control group will receive existing standard of care without voice messages. Data related to outcome variables will be assessed at three phases of the data collection periods. The primary outcome measures will be the proportion of antenatal care visits and institutional delivery, whereas the secondary outcome measures will consist of the proportion of postnatal care visits and pregnancy outcomes. Risk ratios will be used to a measure the effect of intervention on the outcomes which will be estimated with 95% confidence interval and all the analyses will be done with consideration of clustering effect. This study should generate evidence on the effectiveness of mobile-phone-based voice messages for the early initiation of maternal health care service use and its uptake. It has been carefully designed with the assumption of obtaining higher levels of maternal health care service use among the treatment group as compared to the control. Pan African Clinical Trial Registry, www.panctr.org , ID: PACTR201704002216259 . Registered on 28 April 2017.
Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial.

Science.gov (United States)

Dray, Julia; Bowman, Jenny; Freund, Megan; Campbell, Elizabeth; Wolfenden, Luke; Hodder, Rebecca K; Wiggers, John

2014-07-18

Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health. The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas. A cluster randomised control trial will be conducted, with schools as the unit of randomisation. Initially, 32 secondary schools will be randomly allocated to a control or intervention group (12 control and 20 intervention). An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools. A survey of students in Grade 7 in both intervention and control schools will be conducted (baseline) and repeated three years later when the students are in Grade 10. The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems. At follow-up, the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness. The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools. The outcomes of the trial are of importance to youth, schools, mental health clinicians and policymakers. Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011.
Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: postintervention results.

Science.gov (United States)

Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda A; Braunschweig, Carol L; Gomez, Sandra L; Van Horn, Linda; Dyer, Alan R

2011-05-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the nine schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the nine control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and postintervention. At postintervention, children in the intervention schools engaged in more moderate-to-vigorous physical activity (MVPA) than children in the control schools (difference between adjusted group means = 7.46 min/day, P = 0.02). Also, children in the intervention group had less total screen time (-27.8 min/day, P = 0.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not on diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision.
Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT).

Science.gov (United States)

Guhl, Emily N; Schlusser, Courtney L; Henault, Lori E; Bickmore, Timothy W; Kimani, Everlyne; Paasche-Orlow, Michael K; Magnani, Jared W

2017-11-01

Atrial Fibrillation (AF) is a common cardiac arrhythmia that is challenging for patients and adversely impacts health-related quality of life (HRQoL). Long-term management of AF requires that patients adhere to complex therapies, understand difficult terminology, navigate subspecialty care, and have continued symptom monitoring with the goal of preventing adverse outcomes. Continued interventions to ameliorate the patient experience of AF are essential. The Atrial Fibrillation health Literacy Information Technology Trial (AF-LITT; NCT03093558) is an investigator-initiated, 2-arm randomized clinical trial (RCT). This RCT is a pilot in order to implement a novel, smartphone-based intervention to address the patient experience of AF. This pilot RCT will compare a combination of the Embodied Conversational Agent (ECA) and the Alive Cor Kardia Mobile heart rhythm monitor to the current standard of care. The study will enroll 180 adults with non-valvular AF who are receiving anticoagulation for stroke prevention and randomize them to receive a 30-day intervention (smartphone-based ECA/Kardia) or standard of care, which will include a symptom and adherence journal. The primary end-points are improvement in HRQoL and self-reported adherence to anticoagulation. The secondary end-points are the acceptability of the intervention to participants, its use by participants, and acceptability to referring physicians. The AF-LITT pilot aims to evaluate the efficacy of the ECA/Kardia to improve HRQoL and anticoagulant adherence, and to guide its implementation in a larger, multicenter clinical trial. The intervention has potential to improve HRQoL, adherence, and health care utilization in individuals with chronic AF. Copyright © 2017 Elsevier Inc. All rights reserved.
Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care

Directory of Open Access Journals (Sweden)

Weiderpass Elisabete

2008-08-01

Full Text Available Abstract Background Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study. Methods A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1 recruitment and participation, 2 completion of data collection, 3 realization of the intervention and 4 the public health nurses' experiences. Results 1 The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2 In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3 In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4 The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study. Conclusion The study protocol was mostly feasible to implement, which
Rigorous Clinical Trial Design in Public Health Emergencies Is Essential

DEFF Research Database (Denmark)

Ellenberg, Susan S; Keusch, Gerald T; Babiker, Abdel G

2018-01-01

Randomized clinical trials are the most reliable approaches to evaluating the effects of new treatments and vaccines. During the 2014-15 West African Ebola epidemic, many argued that such trials were neither ethical nor feasible in an environment of limited health infrastructure and severe disease...
Need for appropriate formulations for children: the national institute of child health and human development-pediatric formulations initiative, part 1.

Science.gov (United States)

Giacoia, George P; Taylor-Zapata, Perdita; Mattison, Donald

2007-01-01

The development and compounding of pharmacotherapeutic formulations that are suitable for infants and young children can be a challenging problem. This problem results from the lack of knowledge on the acceptability of different dosage forms and formulations in children in relation to age and developmental status, as well as the lack of reliable documentation of formulations used in pediatric clinical trials. As part of its mandate under the Best Pharmaceuticals for Children Act to improve pediatric therapeutics, the National Institute of Child Health and Human Development has sponsored the Pediatric Formulation Initiative. The goal of this ongoing initiative is to address the issues and concnerns associated with pediatric therapeutics by convening groups of researchers and experts in pediatric formulations from academia, pharmaceutical companies, the National Institutes of Health, and the U.S. Food and Drug Administration.
The Robustness of Designs for Trials with Nested Data against Incorrect Initial Intracluster Correlation Coefficient Estimates

Science.gov (United States)

Korendijk, Elly J. H.; Moerbeek, Mirjam; Maas, Cora J. M.

2010-01-01

In the case of trials with nested data, the optimal allocation of units depends on the budget, the costs, and the intracluster correlation coefficient. In general, the intracluster correlation coefficient is unknown in advance and an initial guess has to be made based on published values or subject matter knowledge. This initial estimate is likely…
Assessing the feasibility of eHealth and mHealth: a systematic review and analysis of initiatives implemented in Kenya.

Science.gov (United States)

Njoroge, Martin; Zurovac, Dejan; Ogara, Esther A A; Chuma, Jane; Kirigia, Doris

2017-02-10

The growth of Information and Communication Technology in Kenya has facilitated implementation of a large number of eHealth projects in a bid to cost-effectively address health and health system challenges. This systematic review aims to provide a situational analysis of eHealth initiatives being implemented in Kenya, including an assessment of the areas of focus and geographic distribution of the health projects. The search strategy involved peer and non-peer reviewed sources of relevant information relating to projects under implementation in Kenya. The projects were examined based on strategic area of implementation, health purpose and focus, geographic location, evaluation status and thematic area. A total of 114 citations comprising 69 eHealth projects fulfilled the inclusion criteria. The eHealth projects included 47 mHealth projects, 9 health information system projects, 8 eLearning projects and 5 telemedicine projects. In terms of projects geographical distribution, 24 were executed in Nairobi whilst 15 were designed to have a national coverage but only 3 were scaled up. In terms of health focus, 19 projects were mainly on primary care, 17 on HIV/AIDS and 11 on maternal and child health (MNCH). Only 8 projects were rigorously evaluated under randomized control trials. This review discovered that there is a myriad of eHealth projects being implemented in Kenya, mainly in the mHealth strategic area and focusing mostly on primary care and HIV/AIDs. Based on our analysis, most of the projects were rarely evaluated. In addition, few projects are implemented in marginalised areas and least urbanized counties with more health care needs, notwithstanding the fact that adoption of information and communication technology should aim to improve health equity (i.e. improve access to health care particularly in remote parts of the country in order to reduce geographical inequities) and contribute to overall health systems strengthening.
Lifestyle, Fitness and Health Promotion Initiative of the University of ...

African Journals Online (AJOL)

This study examined the health promotion initiative introduced by the Management of the University of Ilorin, Ngeria. In an attempt to ensure stress free academic society that would boost staff productivity and longevity, the university invested heavily on a number of lifestyle, fitness and health promotion initiatives. Descriptive ...
Physical Restraint Initiation in Nursing Homes and Subsequent Resident Health

Science.gov (United States)

Engberg, John; Castle, Nicholas G.; McCaffrey, Daniel

2008-01-01

Purpose: It is widely believed that physical restraint use causes mental and physical health decline in nursing home residents. Yet few studies exist showing an association between restraint initiation and health decline. In this research, we examined whether physical restraint initiation is associated with subsequent lower physical or mental…

Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

Science.gov (United States)

Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

2017-06-19

Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and
The maturation of randomised controlled trials in mental health ...

African Journals Online (AJOL)

The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...
Initiation of a phase-I trial of neutron capture therapy at the MIT research reactor

International Nuclear Information System (INIS)

Harling, O.K.; Bernard, J.A.; Yam, Chun-Shan

1995-01-01

The Massachusetts Institute of Technology (MIT), the New England Medical Center (NEMC), and Boston University Medical Center (BUMC) initiated a phase-1 trial of boron neutron capture therapy (BNCT) on September 6, 1994, at the 5-MW(thermal) MIT research reactor (MITR). A novel form of experimental cancer therapy, BNCT is being developed for certain types of highly malignant brain tumors such as glioblastoma and melanoma. The results of the phase-1 trials on patients with tumors in the legs or feet are described
Relationship of Hypertension, Blood Pressure, and Blood Pressure Control With White Matter Abnormalities in the Women’s Health Initiative Memory Study (WHIMS)—MRI Trial

Science.gov (United States)

Kuller, Lewis H.; Margolis, Karen L.; Gaussoin, Sarah A.; Bryan, Nick R.; Kerwin, Diana; Limacher, Marian; Wassertheil-Smoller, Sylvia; Williamson, Jeff; Robinson, Jennifer G.

2010-01-01

This paper evaluates the relationship of blood pressure (BP) levels at Women’s Health Initiative (WHI) baseline, treatment of hypertension, and white matter abnormalities among women in conjugated equine estrogen (CEE) and medroxyprogesterone acetate and CEE-alone arms. The WHI Memory Study—Magnetic Resonance Imaging (WHIMS-MRI) trial scanned 1424 participants. BP levels at baseline were significantly positively related to abnormal white matter lesion (WML) volumes. Participants treated for hypertension but who had BP ≥140/90 mm Hg had the greatest amount of WML volumes. Women with untreated BP ≥140/90 mm Hg had intermediate WML volumes. Abnormal WML volumes were related to hypertension in most areas of the brain and were greater in the frontal lobe than in the occipital, parietal, or temporal lobes. Level of BP at baseline was strongly related to amount of WML volumes. The results of the study reinforce the relationship of hypertension and BP control and white matter abnormalities in the brain. The evidence to date supports tight control of BP levels, especially beginning at younger and middle age as a possible and perhaps only way to prevent dementia. PMID:20433539
Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

Science.gov (United States)

Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

2013-01-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852
Evaluation of cluster-randomized trials on maternal and child health research in developing countries

DEFF Research Database (Denmark)

Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

2009-01-01

To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...
Age at menopause, reproductive history, and venous thromboembolism risk among postmenopausal women: the Women's Health Initiative Hormone Therapy clinical trials.

Science.gov (United States)

Canonico, Marianne; Plu-Bureau, Geneviève; O'Sullivan, Mary Jo; Stefanick, Marcia L; Cochrane, Barbara; Scarabin, Pierre-Yves; Manson, Joann E

2014-03-01

This study aims to investigate venous thromboembolism (VTE) risk in relation to age at menopause, age at menarche, parity, bilateral oophorectomy, and time since menopause, as well as any interaction with randomized hormone therapy (HT) assignment, among postmenopausal women. Using pooled data from the Women's Health Initiative HT clinical trials including 27,035 postmenopausal women aged 50 to 79 years who had no history of VTE, we assessed the risk of VTE in relation to age at menopause, age at menarche, parity, bilateral oophorectomy, and time since menopause by Cox proportional hazards models. Linear trends, quadratic relationships, and interactions of reproductive life characteristics with HT on VTE risk were systematically tested. During follow-up, 426 women reported a first VTE, including 294 non-procedure-related events. No apparent interaction of reproductive life characteristics with HT assignment on VTE risk was detected, and there was not a significant association between VTE and age at menarche, age at menopause, parity, oophorectomy, or time since menopause. However, analyses restricted to non-procedure-related VTE showed a U-shaped relationship between age at menopause and thrombotic risk that persisted after multivariable analysis (P menopause, those who had early menopause (age menopause (age >55 y) had a significantly increased VTE risk (hazard ratio [95% CI]: 1.8 [1.2-2.7] and 1.5 [1.0-2.4], respectively). Reproductive life characteristics have little association with VTE and do not seem to influence the effect of HT on thrombotic risk among postmenopausal women. Nevertheless, early and late onset of menopause might be newly identified risk factors for non-procedure-related VTE.
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

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Calis, Karim A; Archdeacon, Patrick; Bain, Raymond; DeMets, David; Donohue, Miriam; Elzarrad, M Khair; Forrest, Annemarie; McEachern, John; Pencina, Michael J; Perlmutter, Jane; Lewis, Roger J

2017-08-01

Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations. Results We define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of
Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers

Directory of Open Access Journals (Sweden)

Annalee Yassi

2014-05-01

Full Text Available Background: Community-based cluster-randomized controlled trials (RCTs are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster RCTs of population health interventions in low- and middle-income countries. Objective: We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships. Design: We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB and Human Immunodeficiency Virus (HIV prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies. Results: The checklist of critical factors was grouped into eight categories: 1 Building trust and shared ownership; 2 Conducting feasibility studies throughout the process; 3 Building capacity; 4 Creating an appropriate information system; 5 Conducting pilot studies; 6 Securing stakeholder support, with a view to scale-up; 7 Continuously refining methodological rigor; and 8 Explicitly addressing all ethical issues both at the start and continuously as they arise. Conclusion: Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.
THE EFFECT OF HORMONE THERAPY ON MEAN BLOOD PRESSURE AND VISIT-TO-VISIT BLOOD PRESSURE VARIABILITY IN POSTMENOPAUSAL WOMEN: RESULTS FROM THE WOMEN’S HEALTH INITIATIVE RANDOMIZED CONTROLLED TRIALS

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Shimbo, Daichi; Wang, Lu; Lamonte, Michael J.; Allison, Matthew; Wellenius, Gregory A.; Bavry, Anthony A.; Martin, Lisa W.; Aragaki, Aaron; Newman, Jonathan D.; Swica, Yael; Rossouw, Jacques E.; Manson, JoAnn E.; Wassertheil-Smoller, Sylvia

2014-01-01

Objectives Mean and visit-to-visit variability (VVV) of blood pressure are associated with an increased cardiovascular disease risk. We examined the effect of hormone therapy on mean and VVV of blood pressure in postmenopausal women from the Women’s Health Initiative (WHI) randomized controlled trials. Methods Blood pressure was measured at baseline and annually in the two WHI hormone therapy trials in which 10,739 and 16,608 postmenopausal women were randomized to conjugated equine estrogens (CEE, 0.625 mg/day) or placebo, and CEE plus medroxyprogesterone acetate (MPA, 2.5 mg/day) or placebo, respectively. Results At the first annual visit (Year 1), mean systolic blood pressure was 1.04 mmHg (95% CI 0.58, 1.50) and 1.35 mmHg (95% CI 0.99, 1.72) higher in the CEE and CEE+MPA arms respectively compared to corresponding placebos. These effects remained stable after Year 1. CEE also increased VVV of systolic blood pressure (ratio of VVV in CEE vs. placebo, 1.03, Pblood pressure increased at Year 1, and the differences in the CEE and CEE+MPA arms vs. placebos also continued to increase after Year 1. Further, both CEE and CEE+MPA significantly increased VVV of systolic blood pressure (ratio of VVV in CEE vs. placebo, 1.04, Pblood pressure. PMID:24991872
Pyrolysis of attapulgite clay blended with yak dung enhances pasture growth and soil health: Characterization and initial field trials.

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Rafiq, Muhammad Khalid; Joseph, Stephen D; Li, Fei; Bai, Yanfu; Shang, Zhanhuan; Rawal, Aditya; Hook, James M; Munroe, Paul R; Donne, Scott; Taherymoosavi, Sara; Mitchell, David R G; Pace, Ben; Mohammed, Mohanad; Horvat, Joseph; Marjo, Christopher E; Wagner, Avital; Wang, Yanlong; Ye, Jun; Long, Rui-Jun

2017-12-31

Recent studies have shown that the pyrolysis of biomass combined with clay can result in both lower cost and increase in plant yields. One of the major sources of nutrients for pasture growth, as well as fuel and building materials in Tibet is yak dung. This paper reports on the initial field testing in a pasture setting in Tibet using yak dung, biochar, and attapulgite clay/yak dung biochars produced at ratios of 10/90 and 50/50 clay to dung. We found that the treatment with attapulgite clay/yak dung (50/50) biochar resulted in the highest pasture yields and grass nutrition quality. We also measured the properties and yields of mixtures of clay/yak dung biochar used in the field trials produced at 400°C and 500°C to help determine a possible optimum final pyrolysis temperature and dung/clay ratio. It was observed that increasing clay content increased carbon stability, overall biochar yield, pore size, carboxyl and ketone/aldehyde functional groups, hematite and ferrous/ferric sulphate/thiosulphate concentration, surface area and magnetic moment. Decreasing clay content resulted in higher pH, CEC, N content and an enhanced ability to accept and donate electrons. The resulting properties were a complex function of both processing temperature and the percentage of clay for the biochars processed at both 400°C and 500°C. It is possible that the increase in yield and nutrient uptake in the field trial is related to the higher concentration of C/O functional groups, higher surface area and pore volume and higher content of Fe/O/S nanoparticles of multiple oxidation state in the 50/50 clay/dung. These properties have been found to significantly increase the abundance of beneficial microorganisms and hence improve the nutrient cycling and availability in soil. Further field trials are required to determine the optimum pyrolysis production conditions and application rate on the abundance of beneficial microorganisms, yields and nutrient quality. Copyright © 2017
Designing Work, Family & Health Organizational Change Initiatives.

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Kossek, Ellen Ernst; Hammer, Leslie B; Kelly, Erin L; Moen, Phyllis

2014-01-01

For decades, leaders and scholars have been advocating change efforts to improve work-life relationships. Yet most initiatives have lacked rigor and not been developed using scientific principles. This has created an evidence gap for employer support of work and personal life as a win-win for productivity and employees' well-being. This paper examines the approach used by the U.S. Work Family Health Network (WFRN) to develop an innovative workplace intervention to improve employee and family health. The change initiative was designed to reduce organizationally based work-family conflict in two contrasting contexts representative of major segments of today's U.S. workforce: health care employees and informational technology professionals. The WFRN Intervention (called STAR) had three theoretically based change elements. They were: 1) increase job control over work time and schedule; 2) increase supervisor social support for family and job effectiveness; and 3) improve organizational culture and job design processes to foster results orientation. Seven practical lessons for developing work-life interventions emerged from this groundbreaking endeavor.
Age of menopause and fracture risk in postmenopausal women randomized to calcium + vitamin D, hormone therapy, or the combination: results from the Women's Health Initiative Clinical Trials.

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Sullivan, Shannon D; Lehman, Amy; Nathan, Nisha K; Thomson, Cynthia A; Howard, Barbara V

2017-04-01

We previously reported that in the absence of hormone therapy (HT) or calcium/vitamin D (Ca/D) supplementation, earlier menopause age was associated with decreased bone mineral density and increased fracture risk in healthy postmenopausal women. Treatment with HT and Ca/D is protective against fractures after menopause. In this analysis, we asked if the age of menopause onset alters fracture risk in healthy postmenopausal women receiving HT, Ca/D, or a combination. Hazard ratios (HRs) for any fracture among 21,711 healthy postmenopausal women enrolled in the Women's Health Initiative Clinical Trial, who were treated with HT, Ca/D, or HT + Ca/D, and who reported age of nonsurgical menopause of menopause menopause 40 to 49 or ≥50 years, regardless of treatment intervention (HR [95% CI]: menopause menopause menopause age (menopause ages. The effect of menopause age on fracture risk was not altered by any of the treatment interventions (HT, Ca/D, HT + Ca/D), suggesting that early age of menopause is an independent contributor to postmenopausal fracture risk.
When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

Science.gov (United States)

Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

2017-09-25

Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial.

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Kimani-Murage, Elizabeth W; Kimiywe, Judith; Kabue, Mark; Wekesah, Frederick; Matiri, Evelyn; Muhia, Nelson; Wanjohi, Milka; Muriuki, Peterrock; Samburu, Betty; Kanyuira, James N; Young, Sera L; Griffiths, Paula L; Madise, Nyovani J; McGarvey, Stephen T

2015-09-28

Interventions promoting optimal infant and young child nutrition could prevent a fifth of under-5 deaths in countries with high mortality. Poor infant and young child feeding practices are widely documented in Kenya, with potential detrimental effects on child growth, health and survival. Effective strategies to improve these practices are needed. This study aims to pilot implementation of the Baby Friendly Community Initiative (BFCI), a global initiative aimed at promoting optimal infant and young child feeding practices, to determine its feasibility and effectiveness with regards to infant feeding practices, nutrition and health outcomes in a rural setting in Kenya. The study, employing a cluster-randomized trial design, will be conducted in rural Kenya. A total of 12 clusters, constituting community units within the government's Community Health Strategy, will be randomized, with half allocated to the intervention and the other half to the control arm. A total of 812 pregnant women and their respective children will be recruited into the study. The mother-child pairs will be followed up until the child is 6 months old. Recruitment will last approximately 1 year from January 2015, and the study will run for 3 years, from 2014 to 2016. The intervention will involve regular counseling and support of mothers by trained community health workers and health professionals on maternal, infant and young child nutrition. Regular assessment of knowledge, attitudes and practices on maternal, infant and young child nutrition will be done, coupled with assessment of nutritional status of the mother-child pairs and morbidity for the children. Statistical methods will include analysis of covariance, multinomial logistic regression and multilevel modeling. The study is funded by the NIH and USAID through the Program for Enhanced Research (PEER) Health. Findings from the study outlined in this protocol will inform potential feasibility and effectiveness of a community
An assessment of interactions between global health initiatives and country health systems.

Science.gov (United States)

Samb, Badara; Evans, Tim; Dybul, Mark; Atun, Rifat; Moatti, Jean-Paul; Nishtar, Sania; Wright, Anna; Celletti, Francesca; Hsu, Justine; Kim, Jim Yong; Brugha, Ruairi; Russell, Asia; Etienne, Carissa

2009-06-20

Since 2000, the emergence of several large disease-specific global health initiatives (GHIs) has changed the way in which international donors provide assistance for public health. Some critics have claimed that these initiatives burden health systems that are already fragile in countries with few resources, whereas others have asserted that weak health systems prevent progress in meeting disease-specific targets. So far, most of the evidence for this debate has been provided by speculation and anecdotes. We use a review and analysis of existing data, and 15 new studies that were submitted to WHO for the purpose of writing this Report to describe the complex nature of the interplay between country health systems and GHIs. We suggest that this Report provides the most detailed compilation of published and emerging evidence so far, and provides a basis for identification of the ways in which GHIs and health systems can interact to mutually reinforce their effects. On the basis of the findings, we make some general recommendations and identify a series of action points for international partners, governments, and other stakeholders that will help ensure that investments in GHIs and country health systems can fulfil their potential to produce comprehensive and lasting results in disease-specific work, and advance the general public health agenda. The target date for achievement of the health-related Millennium Development Goals is drawing close, and the economic downturn threatens to undermine the improvements in health outcomes that have been achieved in the past few years. If adjustments to the interactions between GHIs and country health systems will improve efficiency, equity, value for money, and outcomes in global public health, then these opportunities should not be missed.
Current environmental health problems and initiatives in Malaysia

International Nuclear Information System (INIS)

Sugunan Pillay, M.; Debbie Siru

1996-01-01

This paper discusses the various environmental changes that have taken place and the change health status of the people in Malaysia. This includes water pollution, air pollution, noise pollution, solid waste pollution, urbanisation and initiatives in environmental health protection via water resources, air quality, solid and toxic and hazardous waste , and urban management
Current environmental health problems and initiatives in Malaysia

Energy Technology Data Exchange (ETDEWEB)

Sugunan Pillay, M; Siru, Debbie [Ministry of Health Malaysia, Kuala Lumpur (Malaysia). Engineering Div.

1997-12-31

This paper discusses the various environmental changes that have taken place and the change health status of the people in Malaysia. This includes water pollution, air pollution, noise pollution, solid waste pollution, urbanisation and initiatives in environmental health protection via water resources, air quality, solid and toxic and hazardous waste , and urban management.
Health selection into neighborhoods among patients enrolled in a clinical trial

Directory of Open Access Journals (Sweden)

Mariana C. Arcaya

2017-12-01

Full Text Available Health selection into neighborhoods may contribute to geographic health disparities. We demonstrate the potential for clinical trial data to help clarify the causal role of health on locational attainment. We used data from the 20-year United Kingdom Prospective Diabetes Study (UKPDS to explore whether random assignment to intensive blood-glucose control therapy, which improved long-term health outcomes after median 10 years follow-up, subsequently affected what neighborhoods patients lived in. We extracted postcode-level deprivation indices for the 2710 surviving participants of UKPDS living in England at study end in 1996/1997. We observed small neighborhood advantages in the intensive versus conventional therapy group, although these differences were not statistically significant. This analysis failed to show conclusive evidence of health selection into neighborhoods, but data suggest the hypothesis may be worthy of exploration in other clinical trials or in a meta-analysis. Keywords: Neighborhoods, Self-selection, Health, Equity, Socioeconomic status
The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

Science.gov (United States)

McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

2013-01-01

Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

A common evaluation framework for the African Health Initiative

Science.gov (United States)

2013-01-01

Background The African Health Initiative includes highly diverse partnerships in five countries (Ghana, Mozambique, Rwanda, Tanzania, and Zambia), each of which is working to improve population health by strengthening health systems and to evaluate the results. One aim of the Initiative is to generate cross-site learning that can inform implementation in the five partnerships during the project period and identify lessons that may be generalizable to other countries in the region. Collaborators in the Initiative developed a common evaluation framework as a basis for this cross-site learning. Methods This paper describes the components of the framework; this includes the conceptual model, core metrics to be measured in all sites, and standard guidelines for reporting on the implementation of partnership activities and contextual factors that may affect implementation, or the results it produces. We also describe the systems that have been put in place for data management, data quality assessments, and cross-site analysis of results. Results and conclusions The conceptual model for the Initiative highlights points in the causal chain between health system strengthening activities and health impact where evidence produced by the partnerships can contribute to learning. This model represents an important advance over its predecessors by including contextual factors and implementation strength as potential determinants, and explicitly including equity as a component of both outcomes and impact. Specific measurement challenges include the prospective documentation of program implementation and contextual factors. Methodological issues addressed in the development of the framework include the aggregation of data collected using different methods and the challenge of evaluating a complex set of interventions being improved over time based on continuous monitoring and intermediate results. PMID:23819778
Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

Science.gov (United States)

Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

2014-07-01

The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.
The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project.

Science.gov (United States)

Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

2017-01-01

Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key stakeholders from several scientific domains early
Using the Hospital Nutrition Environment Scan to Evaluate Health Initiative in Hospital Cafeterias.

Science.gov (United States)

Derrick, Jennifer Willahan; Bellini, Sarah Gunnell; Spelman, Julie

2015-11-01

Health-promoting environments advance health and prevent chronic disease. Hospitals have been charged to promote health and wellness to patients, communities, and 5.3 million adults employed in United States health care environments. In this cross-sectional observational study, the Hospital Nutrition Environment Scan (HNES) was used to measure the nutrition environment of hospital cafeterias and evaluate the influence of the LiVe Well Plate health initiative. Twenty-one hospitals in the Intermountain West region were surveyed between October 2013 and May 2014. Six hospitals participated in the LiVe Well Plate health initiative and were compared with 15 hospitals not participating. The LiVe Well Plate health initiative identified and promoted a healthy meal defined as health initiative branding were also posted at point of purchase. Hospital cafeterias were scored on four subcategories: facilitators and barriers, grab-and-go items, menu offerings, and selection options at point of purchase. Overall, hospitals scored 35.3±13.7 (range=7 to 63) points of 86 total possible points. Cafeterias in health initiative hospitals had significantly higher mean nutrition composite scores compared with non-health initiative hospitals (49.2 vs 29.7; Penvironment of hospital cafeterias. Additional research is needed to quantify and strategize ways to improve nutrition environments within hospital cafeterias and assess the influence on healthy lifestyle behaviors. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.
Impact of the National Institutes of Health Focal Segmental Glomerulosclerosis (NIH FSGS) clinical trial on the treatment of steroid-resistant FSGS.

Science.gov (United States)

Canetta, Pietro A; Radhakrishnan, Jai

2013-03-01

Idiopathic focal segmental glomerulosclerosis (FSGS) is among the most common, morbid and treatment-resistant conditions faced by nephrologists. While glucocorticoids have traditionally been the mainstay of initial treatment, they induce remission in only a minority of patients. A variety of other immunosuppressants have been utilized against steroid-resistant FSGS, but few have been rigorously examined in well-controlled trials. Recently, the results were published from a National Institutes of Health (NIH)-sponsored multicenter randomized trial comparing cyclosporine (CSA) with a combination of mycophenolate mofetil (MMF) and pulse dexamethasone (DEX) for the treatment of steroid-resistant FSGS. No difference in treatment effectiveness was shown between the two groups, and adverse effects were comparable. This was the largest randomized trial ever undertaken in FSGS, but it was unfortunately underpowered to show clinically relevant differences in response rates. This shortcoming, along with particularities of the study population and outcome measures, makes it challenging to draw definitive conclusions from the trial results. Despite these limitations, the trial does provide valuable insights into treatment strategies for FSGS and offers important lessons for planning future research.
Does clinical equipoise apply to cluster randomized trials in health research?

Science.gov (United States)

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial
Global health initiative investments and health systems strengthening: a content analysis of global fund investments

OpenAIRE

Warren, Ashley E; Wyss, Kaspar; Shakarishvili, George; Atun, Rifat; de Savigny, Don

2013-01-01

Background: Millions of dollars are invested annually under the umbrella of national health systems strengthening. Global health initiatives provide funding for low- and middle-income countries through disease-oriented programmes while maintaining that the interventions simultaneously strengthen systems. However, it is as yet unclear which, and to what extent, system-level interventions are being funded by these initiatives, nor is it clear how much funding they allocate to disease-specific a...
Beacon communities' public health initiatives: a case study analysis.

Science.gov (United States)

Massoudi, Barbara L; Marcial, Laura H; Haque, Saira; Bailey, Robert; Chester, Kelley; Cunningham, Shellery; Riley, Amanda; Soper, Paula

2014-01-01

The Beacon Communities for Public Health (BCPH) project was launched in 2011 to gain a better understanding of the range of activities currently being conducted in population- and public health by the Beacon Communities. The project highlighted the successes and challenges of these efforts with the aim of sharing this information broadly among the public health community. The Beacon Community Program, designed to showcase technology-enabled, community-based initiatives to improve outcomes, focused on: building and strengthening health information technology (IT) infrastructure and exchange capabilities; translating investments in health IT to measureable improvements in cost, quality, and population health; and, developing innovative approaches to performance measurement, technology, and care delivery. Four multimethod case studies were conducted based on a modified sociotechnical framework to learn more about public health initiative implementation and use in the Beacon Communities. Our methodological approach included using document review and semistructured key informant interviews. NACCHO Model Practice Program criteria were used to select the public health initiatives included in the case studies. Despite differences among the case studies, common barriers and facilitators were found to be present in all areas of the sociotechnical framework application including structure, people, technology, tasks, overarching considerations, and sustainability. Overall, there were many more facilitators (range = 7-14) present for each Beacon compared to barriers (range = 4-6). Four influential promising practices were identified through the work: forging strong and sustainable partnerships; ensuring a good task-technology fit and a flexible and iterative design; fostering technology acceptance; and, providing education and demonstrating value. A common weakness was the lack of a framework or model for the Beacon Communities evaluation work. Sharing a framework or approach
Beacon Communities’ Public Health Initiatives: A Case Study Analysis

Science.gov (United States)

Massoudi, Barbara L.; Marcial, Laura H.; Haque, Saira; Bailey, Robert; Chester, Kelley; Cunningham, Shellery; Riley, Amanda; Soper, Paula

2014-01-01

Introduction: The Beacon Communities for Public Health (BCPH) project was launched in 2011 to gain a better understanding of the range of activities currently being conducted in population- and public health by the Beacon Communities. The project highlighted the successes and challenges of these efforts with the aim of sharing this information broadly among the public health community. Background: The Beacon Community Program, designed to showcase technology-enabled, community-based initiatives to improve outcomes, focused on: building and strengthening health information technology (IT) infrastructure and exchange capabilities; translating investments in health IT to measureable improvements in cost, quality, and population health; and, developing innovative approaches to performance measurement, technology, and care delivery. Methods: Four multimethod case studies were conducted based on a modified sociotechnical framework to learn more about public health initiative implementation and use in the Beacon Communities. Our methodological approach included using document review and semistructured key informant interviews. NACCHO Model Practice Program criteria were used to select the public health initiatives included in the case studies. Findings: Despite differences among the case studies, common barriers and facilitators were found to be present in all areas of the sociotechnical framework application including structure, people, technology, tasks, overarching considerations, and sustainability. Overall, there were many more facilitators (range = 7–14) present for each Beacon compared to barriers (range = 4–6). Discussion: Four influential promising practices were identified through the work: forging strong and sustainable partnerships; ensuring a good task-technology fit and a flexible and iterative design; fostering technology acceptance; and, providing education and demonstrating value. Conclusions: A common weakness was the lack of a framework or model for
Telemedicine, the effect of nurse-initiated telephone follow up, on health status and health-care utilization in COPD patients: a randomized trial.

Science.gov (United States)

Berkhof, Farida F; van den Berg, Jan W K; Uil, Steven M; Kerstjens, Huib A M

2015-02-01

Telemedicine, care provided by electronic communication, may serve as an alternative or extension to traditional outpatient visits. This pilot study determined the effects of telemedicine on health-care utilization and health status of chronic obstructive pulmonary disease (COPD) patients. One hundred and one patients were randomized, 52 patients received telemedicine care and 49 had traditional outpatient visits. The primary outcome was COPD-specific health status, measured with the Clinical COPD Questionnaire (CCQ). Secondary outcomes included St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36) and resource use in primary and secondary care. The mean age of the participants was 68 ± 9 years and the mean per cent of predicted forced expiratory volume in 1 s was 40.4 ± 12.5. The CCQ total score deteriorated by 0.14 ± 0.13 in the telemedicine group, and improved by -0.03 ± 0.14 in the control group (difference 0.17 ± 0.19, 95% confidence interval (CI): -0.21-0.55, P = 0.38). The CCQ symptom domain showed a significant and clinically relevant difference in favour of the control group, 0.52 ± 0.24 (95% CI: 0.04-0.10, P = 0.03). Similar results were found for the SGRQ, whereas results for SF-36 were inconsistent. Patients in the control group had significantly fewer visits to the pulmonologist in comparison to patients in the telemedicine group (P = 0.05). The same trend, although not significant, was found for exacerbations after 6 months. This telemedicine model of initiated phone calls by a health-care provider had a negative effect on health status and resource use in primary and secondary care, in comparison with usual care and therefore cannot be recommended in COPD patients in its current form. © 2014 Asian Pacific Society of Respirology.
Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

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Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

2018-04-19

We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We
Initiation of health-behaviour change among employees participating in a web-based health risk assessment with tailored feedback

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Kraaijenhagen Roderik A

2011-03-01

Full Text Available Abstract Background Primary prevention programs at the worksite can improve employee health and reduce the burden of cardiovascular disease. Programs that include a web-based health risk assessment (HRA with tailored feedback hold the advantage of simultaneously increasing awareness of risk and enhancing initiation of health-behaviour change. In this study we evaluated initial health-behaviour change among employees who voluntarily participated in such a HRA program. Methods We conducted a questionnaire survey among 2289 employees who voluntarily participated in a HRA program at seven Dutch worksites between 2007 and 2009. The HRA included a web-based questionnaire, biometric measurements, laboratory evaluation, and tailored feedback. The survey questionnaire assessed initial self-reported health-behaviour change and satisfaction with the web-based HRA, and was e-mailed four weeks after employees completed the HRA. Results Response was received from 638 (28% employees. Of all, 86% rated the program as positive, 74% recommended it to others, and 58% reported to have initiated overall health-behaviour change. Compared with employees at low CVD risk, those at high risk more often reported to have increased physical activity (OR 3.36, 95% CI 1.52-7.45. Obese employees more frequently reported to have increased physical activity (OR 3.35, 95% CI 1.72-6.54 and improved diet (OR 3.38, 95% CI 1.50-7.60. Being satisfied with the HRA program in general was associated with more frequent self-reported initiation of overall health-behaviour change (OR 2.77, 95% CI 1.73-4.44, increased physical activity (OR 1.89, 95% CI 1.06-3.39, and improved diet (OR 2.89, 95% CI 1.61-5.17. Conclusions More than half of the employees who voluntarily participated in a web-based HRA with tailored feedback, reported to have initiated health-behaviour change. Self-reported initiation of health-behaviour change was more frequent among those at high CVD risk and BMI levels. In
Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Mazzarino, Melissa; Kerr, Debra; Wajswelner, Henry; Morris, Meg E

2015-12-01

To critically analyze the benefits of Pilates on health outcomes in women. CINAHL, MEDLINE, PubMed, Science Direct, SPORTDiscus, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Trials, and Web of Science. Databases were searched using the terms Pilates and Pilates Method. Published randomized controlled trials (RCTs) were included if they comprised female participants with a health condition and a health outcome was measured, Pilates needed to be administered, and the article was published in English in a peer-reviewed journal from 1980 to July 2014. Two authors independently applied the inclusion criteria to potential studies. Methodological quality was assessed using the PEDro scale. A best-evidence grading system was used to determine the strength of the evidence. Thirteen studies met the inclusion criteria. PEDro scale values ranged from 3 to 7 (mean, 4.5; median, 4.0), indicating a relatively low quality overall. In this sample, Pilates for breast cancer was most often trialed (n=2). The most frequent health outcomes investigated were pain (n=4), quality of life (n=4), and lower extremity endurance (n=2), with mixed results. Emerging evidence was found for reducing pain and improving quality of life and lower extremity endurance. There is a paucity of evidence on Pilates for improving women's health during pregnancy or for conditions including breast cancer, obesity, or low back pain. Further high-quality RCTs are warranted to determine the effectiveness of Pilates for improving women's health outcomes. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
The invisibilization of health promotion in Australian public health initiatives.

Science.gov (United States)

O'Hara, Lily; Taylor, Jane; Barnes, Margaret

2018-02-01

The field of health promotion has arguably shifted over the past thirty years from being socially proactive to biomedically defensive. In many countries this has been accompanied by a gradual decline, or in some cases the almost complete removal of health promotion designated positions within Government health departments. The language or discourse used to describe the practice and discipline of health promotion is reflective of such changes. In this study, critical discourse analysis was used to determine the representation of health promotion as a practice and a discipline within 10 Australian Government weight-related public health initiatives. The analysis revealed the invisibilization of critical health promotion in favour of an agenda described as 'preventive health'. This was achieved primarily through the textual practices of overlexicalization and lexical suppression. Excluding document titles, there were 437 uses of the terms health promotion, illness prevention, disease prevention, preventive health, preventative health in the documents analysed. The term 'health promotion' was used sparingly (16% of total terms), and in many instances was coupled with the term 'illness prevention'. Conversely, the terms 'preventive health' and 'preventative health' were used extensively, and primarily used alone. The progressive invisibilization of critical health promotion has implications for the perceptions and practice of those identifying as health promotion professionals and for people with whom we work to address the social and structural determinants of health and wellbeing. Language matters, and the language and intent of critical health promotion will struggle to survive if its speakers are professionally unidentifiable or invisible. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Interventions for promoting the initiation of breastfeeding

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Lisa Dyson

Full Text Available BACKGROUND: Despite the widely documented health advantages of breastfeeding over formula feeding, initiation rates remain relatively low in many high-income countries, particularly among women in lower income groups. OBJECTIVE : To evaluate the effectiveness of interventions which aim to encourage women to breastfeed in terms of changes in the number of women who start to breastfeed. METHODS : Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2007, handsearched the Journal of Human Lactation, Health Promotion International and Health Education Quarterly from inception to 15 August 2007, and scanned reference lists of all articles obtained. Selection criteria: Randomized controlled trials, with or without blinding, of any breastfeeding promotion intervention in any population group except women and infants with a specific health problem. Data collection and analysis: One review author independently extracted data and assessed trial quality, checked by a second author. We contacted investigators to obtain missing information. MAIN RESULTS: Main results: Eleven trials were included. Statistical analyses were conducted on data from eight trials (1553 women. Five studies (582 women on low incomes in the USA with typically low breastfeeding rates showed breastfeeding education had a significant effect on increasing initiation rates compared to standard care (risk ratio (RR 1.57, 95% confidence interval (CI 1.15 to 2.15, P = 0.005. Subgroup analyses showed that one-to-one, needs-based, informal repeat education sessions and generic, formal antenatal education sessions are effective in terms of an increase in breastfeeding rates among women on low incomes regardless of ethnicity and feeding intention. Needs-based, informal peer support in the antenatal and postnatal periods was also shown to be effective in one study conducted among Latina women who were considering breastfeeding in the USA (RR 4.02, 95% CI
Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

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O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

2014-06-01

Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews
The soil health tool - theory and initial broad-scale application

Science.gov (United States)

Soil health has traditionally been judged in terms of production; however, it recently has gained a wider focus with a global audience, as soil condition is becoming an environmental quality, human health, and political issue. A crucial initial step in evaluating soil health is properly assessing t...
Grey literature in meta-analyses of randomized trials of health care interventions.

Science.gov (United States)

Hopewell, S; McDonald, S; Clarke, M; Egger, M

2007-04-18

The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most
Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial.

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Chan, Hui Yu; Ho, Roger Chun-Man; Mahendran, Rathi; Ng, Kheng Siang; Tam, Wilson Wai-San; Rawtaer, Iris; Tan, Chay Hoon; Larbi, Anis; Feng, Lei; Sia, Angelia; Ng, Maxel Kian-Wee; Gan, Goh Lee; Kua, Ee Heok

2017-08-29

Due to a rapidly ageing population in the world, it is increasingly pertinent to promote successful ageing strategies which are cost-effective, easily accessible, and more likely to be acceptable to the elderly. Past research associates exposure to natural environments and horticultural therapy (HT) with positive psychological, social and physical health benefits. This Randomized Controlled Trial (RCT) is designed to evaluate the efficacy of HT in promoting Asian elderly' mental health, cognitive functioning and physical health. 70 elderly participants aged 60 to 85 years old will be randomized to participate in either the active horticultural therapy group or be in the waitlist control. Sessions will be weekly for 12 weeks, and monthly for 3 months. Mental health will be assessed through self-reports of depressive and anxiety symptomatology, life satisfaction, social connectedness and psychological well-being, collaborated with immunological markers. Outcome measures of cognitive functioning and physical health include neuropsychological tests of cognitive function and basic health screening. Outcomes will be assessed at baseline, 3 months and 6 months post-intervention. This RCT comprehensively investigates the efficacy of a non-invasive intervention, HT, in enhancing mental health, cognitive functioning and physical health. The results have tremendous potential for supporting future successful ageing programs and applicability to larger populations. ClinicalTrials.gov NCT02495194 . Trial registration date: July 13, 2015. Retrospectively registered.
The robustness of designs for trials with nested data against incorrect initial intracluster correlation coefficient estimates

NARCIS (Netherlands)

Korendijk, E.J.H.; Moerbeek, M.; Maas, C.J.M.

2010-01-01

In the case of trials with nested data, the optimal allocation of units depends on the budget, the costs, and the intracluster correlation coefficient. In general, the intracluster correlation coefficient is unknown in advance and an initial guess has to be made based on published values or

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

Directory of Open Access Journals (Sweden)

Tatsuya Ito

Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.
RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

Science.gov (United States)

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final
Health technology assessment to optimize health technology utilization: using implementation initiatives and monitoring processes.

Science.gov (United States)

Frønsdal, Katrine B; Facey, Karen; Klemp, Marianne; Norderhaug, Inger Natvig; Mørland, Berit; Røttingen, John-Arne

2010-07-01

The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems. In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members' experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting. Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA. Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.
GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

Directory of Open Access Journals (Sweden)

Neven A Knuistingh

2006-11-01

Full Text Available Abstract Background Preconception counselling (PCC can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods Randomised trial of usual care versus GP-initiated PCC for women aged 18–40, in 54 GP practices in the Netherlands. Women completed the six-item Spielberger State Trait Anxiety Inventory (STAI before PCC (STAI-1 and after (STAI-2. After pregnancy women completed a STAI focusing on the first trimester of pregnancy (STAI-3. Results The mean STAI-1-score (n = 466 was 36.4 (95% CI 35.4 – 37.3. Following PCC there was an average decrease of 3.6 points in anxiety-levels (95% CI, 2.4 – 4.8. Mean scores of the STAI-3 were 38.5 (95% CI 37.7 – 39.3 in the control group (n = 1090 and 38.7 (95% CI 37.9 – 39.5 in the intervention group (n = 1186. Conclusion PCC from one's own GP reduced anxiety after participation, without leading to an increase in anxiety among the intervention group during pregnancy. We therefore conclude that GPs can offer PCC to the general population without fear of causing anxiety. Trial Registration: ISRCTN53942912
The Robustness of Designs for Trials With Nested Data Against Incorrect Initial Intracluster Correlation Coefficent Estimates

NARCIS (Netherlands)

Korendijk, E.J.H.; Moerbeek, M.; Maas, C.J.M.

2010-01-01

In the case of trials with nested data, the optimal allocation of units depends on the budget, the costs, and the intracluster correlation coefficient. In general, the intracluster correlation coefficient is unknown in advance and an initial guess has to be made based on published values or subject
Age of Menopause and Fracture Risk in Post-Menopausal Women Randomized to Calcium + Vitamin D, Hormone Therapy, or the combination: Results from the Women’s Health Initiative Clinical Trials

Science.gov (United States)

Sullivan, Shannon D.; Lehman, Amy; Nathan, Nisha K.; Thomson, Cynthia A.; Howard, Barbara V.

2016-01-01

OBJECTIVE We previously reported that in the absence of hormone therapy (HT) or calcium/vitamin D (Ca/D) supplementation, earlier menopause age was associated with decreased bone mineral density (BMD) and increased fracture risk in healthy post-menopausal women. Treatment with HT and Ca/D are protective against fractures after menopause. In this analysis, we asked if age of menopause onset alters fracture risk in healthy post-menopausal women receiving HT, Ca/Vit D, or the combination. METHODS Hazard ratios (HR) for any fracture among 21,711 healthy post-menopausal women enrolled in the Women’s Health Initiative Clinical Trial (WHI-CT), who were treated with HT, Ca/Vit D, or HT + Ca/D, and who reported age of non-surgical menopause of menopause menopause 40-49 or ≥50, regardless of treatment intervention [HR (95% CI): menopause menopause menopause age (menopause ages. The effect of menopause age on fracture risk was not altered by any of the treatment interventions (HT, Ca/D, HT+Ca/D), suggesting that early age of menopause is an independent contributor to postmenopausal fracture risk. PMID:27801706
The Value of Pre-Screening in the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease Trial.

Science.gov (United States)

Rios-Romenets, S; Giraldo-Chica, M; López, H; Piedrahita, F; Ramos, C; Acosta-Baena, N; Muñoz, C; Ospina, P; Tobón, C; Cho, W; Ward, M; Langbaum, J B; Tariot, P N; Reiman, E M; Lopera, F

2018-01-01

The Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) trial evaluates the anti-amyloid-β antibody crenezumab in cognitively unimpaired persons who, based on genetic background and age, are at high imminent risk of clinical progression, and provides a powerful test of the amyloid hypothesis. The Neurosciences Group of Antioquia implemented a pre-screening process with the goals of decreasing screen failures and identifying participants most likely to adhere to trial requirements of the API ADAD trial in cognitively unimpaired members of Presenilin1 E280A mutation kindreds. The pre-screening failure rate was 48.2%: the primary reason was expected inability to comply with the protocol, chiefly due to work requirements. More carriers compared to non-carriers, and more males compared to females, failed pre-screening. Carriers with illiteracy or learning/comprehension difficulties failed pre-screening more than non-carriers. With the Colombian API Registry and our prescreening efforts, we randomized 169 30-60 year-old cognitively unimpaired carriers and 83 non-carriers who agreed to participate in the trial for at least 60 months. Our findings suggest multiple benefits of implementing a pre-screening process for enrolling prevention trials in ADAD.
Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.

Science.gov (United States)

Aventin, Áine; Lohan, Maria; Maguire, Lisa; Clarke, Mike

2016-07-29

The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. The Jack Trial was funded by the UK National Institute for Health Research. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents' survey. With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. Reflecting on the methodological
Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

Science.gov (United States)

Knowles, Simon R; Ski, Chantal F; Langham, Robyn; O'Flaherty, Emmet; Thompson, David R; Rossell, Susan L; Moore, Gaye; Hsueh, Ya-Seng Arthur; Castle, David J

2016-09-09

Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community
Professional and Educational Initiatives, Supports, and Opportunities for Advanced Training in Public Health

OpenAIRE

Truong, Hoai-An; Patterson, Brooke Y.

2010-01-01

The United States is facing a public health workforce shortage and pharmacists have the opportunity and obligation to address this challenge in health care. There have been initiatives and supports from within and beyond the profession for the pharmacist's role in public health. This article identifies existing professional and educational initiatives for the pharmacist's expanded role in public health, as well as postgraduate and other advanced educational opportunities in public health. Rec...
"It is better to die": experiences of traditional health practitioners within the HIV treatment as prevention trial communities in rural South Africa (ANRS 12249 TasP trial).

Science.gov (United States)

Moshabela, Mosa; Zuma, Thembelihle; Orne-Gliemann, Joanna; Iwuji, Collins; Larmarange, Joseph; McGrath, Nuala

2016-01-01

The ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomized trial in rural South Africa uses a "test and treat" approach. Home-based testing services and antiretroviral treatment initiation satellite clinics were implemented in every cluster as part of the trial. A social science research agenda was nested within TasP with the aim of understanding the social, economic and contextual factors that affect individuals, households, communities and health systems with respect to TasP. Considering the rural nature of the trial setting, we sought to understand community perceptions and experiences of the TasP Trial interventions as seen through the eyes of traditional health practitioners (THPs). A qualitative study design was adopted using four repeat focus group discussions conducted with nine THPs, combined with community walks and photo-voice techniques, over a period of 18 months. A descriptive, interpretive and explanatory approach to analysis was adopted. Findings indicate that THPs engaged with the home-based testing services and HIV clinics established for TasP. Specifically, home-based testing services were perceived as relatively successful in increasing access to HIV testing. A major gap observed by THPs was linkage to HIV clinics. Most of their clients, and some of the THPs themselves, found it difficult to use HIV clinics due to fear of labelling, stigma and discrimination, and the ensuing personal implications of unsolicited disclosure. On the one hand, a growing number of patients diagnosed with HIV have found sanctuary with THPs as alternatives to clinics. On the other hand, THPs in turn have been struggling to channel patients suspected of HIV into clinics through referrals. Therefore, acceptability of the TasP test and treat approach by THPs is a major boost to the intervention, but further success can be achieved through strengthened ties with communities to combat stigma and effectively link patients into HIV care, including partnerships with THPs
Pet Ownership and Cancer Risk in the Women's Health Initiative.

Science.gov (United States)

Garcia, David O; Lander, Eric M; Wertheim, Betsy C; Manson, JoAnn E; Volpe, Stella L; Chlebowski, Rowan T; Stefanick, Marcia L; Lessin, Lawrence S; Kuller, Lewis H; Thomson, Cynthia A

2016-09-01

Pet ownership and cancer are both highly prevalent in the United States. Evidence suggests that associations may exist between this potentially modifiable factor and cancer prevention, though studies are sparse. The present report examined whether pet ownership (dog, cat, or bird) is associated with lower risk for total cancer and site-specific obesity-related cancers. This was a prospective analysis of 123,560 participants (20,981 dog owners; 19,288 cat owners; 1,338 bird owners; and 81,953 non-pet owners) enrolled in the Women's Health Initiative observational study and clinical trials. Cox proportional hazards models were used to estimate HR and 95% confidence intervals for the association between pet ownership and cancer, adjusted for potential confounders. There were no significant relationships between ownership of a dog, cat, or bird and incidence of cancer overall. When site-specific cancers were examined, no associations were observed after adjustment for multiple comparisons. Pet ownership had no association with overall cancer incidence. This is the first large epidemiologic study to date to explore relationships between pet ownership and cancer risk, as well as associated risks for individual cancer types. This study requires replication in other sizable, diverse cohorts. Cancer Epidemiol Biomarkers Prev; 25(9); 1311-6. ©2016 AACR. ©2016 American Association for Cancer Research.
Health benefit for the child and promotion of the common good were the two most important reasons for participation in the FinIP vaccine trial.

Science.gov (United States)

Nieminen, Heta; Syrjänen, Ritva K; Puumalainen, Taneli; Sirén, Päivi; Palmu, Arto A

2015-07-17

The Finnish Invasive Pneumococcal disease (FinIP) vaccine trial was a nationwide cluster-randomised double-blind trial designed to demonstrate the effectiveness of pneumococcal conjugate vaccine in vaccinated children and indirect effects in unvaccinated populations. Together with the parallel carriage/AOM trial, over 47,000 children were enrolled, 52% of the initial target. We conducted a questionnaire study to find out which factors affected parents' decision on their child's study participation. A questionnaire designed to evaluate parents' attitudes to vaccine trial participation in general and the FinIP trial in particular was mailed after the trial enrolment period had ended to parents of randomly selected children: 1484 who participated in the trial and 1485 who did not participate. Altogether 1438 parents (48%) responded to the questionnaire. The response rate was higher among FinIP participants (65%, 965/1484) than among FinIP non-participants (32%, 473/1485). The two most important reasons for giving consent to the FinIP trial were the potential benefit of immunisation against pneumococcal diseases (75% of consenters) and the promotion of the common good and public health (11%). The reasons reported as most important for declining consent were suspicions of vaccine safety (36%) and the double-blind trial design (12%). Up to 65% of the non-consenters declared that drug and vaccine trials should not be conducted in children at all. The expected health benefit for the child was by far the most important reason for consenting to the vaccine trial. Safety concern was the main reason for decline. Importance and necessity of clinical drug and vaccine trials among children and the rationale of the blinded studies should be thoroughly explained to the public. This may increase participation in future vaccine trials. Copyright © 2015 Elsevier Ltd. All rights reserved.
Melanoma risk prediction using a multilocus genetic risk score in the Women's Health Initiative cohort.

Science.gov (United States)

Cho, Hyunje G; Ransohoff, Katherine J; Yang, Lingyao; Hedlin, Haley; Assimes, Themistocles; Han, Jiali; Stefanick, Marcia; Tang, Jean Y; Sarin, Kavita Y

2018-07-01

Single-nucleotide polymorphisms (SNPs) associated with melanoma have been identified though genome-wide association studies. However, the combined impact of these SNPs on melanoma development remains unclear, particularly in postmenopausal women who carry a lower melanoma risk. We examine the contribution of a combined polygenic risk score on melanoma development in postmenopausal women. Genetic risk scores were calculated using 21 genome-wide association study-significant SNPs. Their combined effect on melanoma development was evaluated in 19,102 postmenopausal white women in the clinical trial and observational study arms of the Women's Health Initiative dataset. Compared to the tertile of weighted genetic risk score with the lowest genetic risk, the women in the tertile with the highest genetic risk were 1.9 times more likely to develop melanoma (95% confidence interval 1.50-2.42). The incremental change in c-index from adding genetic risk scores to age were 0.075 (95% confidence interval 0.041-0.109) for incident melanoma. Limitations include a lack of information on nevi count, Fitzpatrick skin type, family history of melanoma, and potential reporting and selection bias in the Women's Health Initiative cohort. Higher genetic risk is associated with increased melanoma prevalence and incidence in postmenopausal women, but current genetic information may have a limited role in risk prediction when phenotypic information is available. Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Culturally Safe Health Initiatives for Indigenous Peoples in Canada: A Scoping Review.

Science.gov (United States)

Brooks-Cleator, Lauren; Phillipps, Breanna; Giles, Audrey

2018-01-01

Background Cultural safety has the potential to improve the health disparities between Indigenous and non-Indigenous Canadians, yet practical applications of the concept are lacking in the literature. Purpose This study aims to identify the key components of culturally safe health initiatives for the Indigenous population of Canada to refine its application in health-care settings. Methods We conducted a scoping review of the literature pertaining to culturally safe health promotion programs, initiatives, services, or care for the Indigenous population in Canada. Our initial search yielded 501 publications, but after full review of 44 publications, 30 were included in the review. After charting the data, we used thematic analysis to identify themes in the data. Results We identified six themes: collaboration/partnerships, power sharing, address the broader context of the patient's life, safe environment, organizational and individual level self-reflection, and training for health-care providers. Conclusion While it is important to recognize that the provision of culturally safe initiatives depend on the specific interaction between the health-care provider and the patient, having a common understanding of the components of cultural safety, such as those that we identified through this research, will help in the transition of cultural safety from theory into practice.
Feminist initiatives on women's health in the Netherlands.

Science.gov (United States)

Schmitz, L

1984-04-01

In the 1960s the Dutch Women's Liberation organization "Dolle Mina" carried out a campaign in Holland to promote the use of oral contraceptives and tried to generate political support in the home and through street demonstrations. What was needed was an adequate abortion service with a corresponding abortion law, a free and adequate supply of contraceptives, and a non-sexist approach to and treatment of women in the field of sexuality, birth control, and medical servicces in general. About 15 years later, the Netherlands now has a flourishing women's health movement, including efforts in information provision, guidance, research, reference, schooling, and contact-building. The basic principles of the women's movement are; 1) the woman herself is the stardard; 2) problems women have with regard to their health are not to be observed in isolation from their social l ife and position; 3) women's acquaintance with feelings about the functioning of their own bodies form the basis of all therapies to improve women's health; 4) women must be offered the choice of existing methods of treatment and help procedures; 5) women should help each other with their common ailments, and heirarchical divisions such as helper-patient, and expert-nonexpert, should be removed; and 6) as often as possible help should be given to women in their own surroundings. Women's health centers have begun to take on a number of women's physical and psychosomatic complaints; 5 centers now operate in 5 different cities, and others are being developed. The Women's Health Center in Amsterdam was initiated in 1976 and caters to gynecological questions, breast examination problems, eating disorders, and drug addiction. Contracts between feminist health groups and the traditional health system are varied, and individuals involved in family planning groups are often also active in the feminist health acctiities. There is resistance to feminist initiatives, mainly from those working in traditional health
[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

Science.gov (United States)

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles
Physical activity initiated by employer and its health effects; an eight week follow-up study

Directory of Open Access Journals (Sweden)

Marit Skogstad

2016-05-01

Full Text Available Abstract Background While the health benefits of physical activity are well established, little is known about health effects of physical activity programs initiated by employer. Methods Background data and level of physical activity were collected by questionnaire among 78 men and 43 women working in road maintenance pre and post an 8-week physical activity motivational program. As a part of the program steps measured by accelerometer were registered online where team and individual performances could be continuously monitored. The physical activity levels were registered as 1 those physical active ≤1 time per week, 2 2–3 times per week and 3 ≥4 times a week. Maximal oxygen uptake (VO2max, blood pressure, resting heart rate (RHR and blood samples (glycosylated hemoglobin, lipids and C-reactive protein were obtained at baseline and after eight weeks. Mixed models were applied to evaluate associations between physical activity and health parameters. Results With ≤1 time per week as reference, exercising 2–3 times per week at baseline was associated with higher levels of VO2max. During follow-up, VO2max increased with 2.8 mL ∙ kg−1∙ min−1 (95 % CI = 1.4, 4.3. Women had more favorable body mass index (BMI, blood pressure, RHR and lipid profile than men. Total cholesterol, low density lipoprotein (LDL, RHR and diastolic blood pressure (dBP were lower among participants who exercised 2–3 times per week or ≥4 times a week, compared with those with ≤1 time per week. Half of the participants reported increased daily PA during follow-up, with high intensity PA such as jogging by 8.6 min (SD 14.6 and 8.3 min (SD 18.2, among women and men, respectively. During follow-up dBP increased among men. Further, total cholesterol and LDL were reduced by 0.12 mmol/L and 0.13 mmol/L, respectively (95 % CI = −022, –0.01 and −0.22,–0.04. Conclusions Exercise several times a week was associated with lower blood pressure and a
Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands

Directory of Open Access Journals (Sweden)

Deborah A. Hall

2015-04-01

Full Text Available In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018. The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on “Agreed Standards for Measurement: An International Perspective” with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss and eczema (Harmonizing outcome measures for eczema. Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative.
Randomised controlled trials and changing public health practice

Directory of Open Access Journals (Sweden)

Anne Cockcroft

2017-05-01

Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

The interplay of management accounting research and NPM health initiatives

DEFF Research Database (Denmark)

Malmmose, Margit

This paper investigates the development of management accounting research in the context of New Public Management (NPM) initiatives in health care. Drawing on concepts from diffusion theory and earlier literature reviews, the paper examines the interplay between management accounting research...... and health care reforms in relation to country of origin, development, theoretical approach, research method and topic. The study thus establishes a different focus; namely the interrelationship between the development of management accounting research and practical socio-political NPM innovations. The study...... shows that management accounting techniques are increasingly adopted in governmental health reforms and diffused across nations, themes and initiatives through time with the result that wider social practices become more and more integrated in management accounting research themes...
Community health promotion and medical provision for neonatal health-CHAMPION cluster randomised trial in Nagarkurnool district, Telangana (formerly Andhra Pradesh, India.

Directory of Open Access Journals (Sweden)

Peter Boone

2017-07-01

November 2007. After randomisation on 18 February 2008, participants, data collectors, and data analysts were not masked to allocation. The intervention was initiated on 1 August 2008. After an inception period, the assessment start date was 1 December 2008. The intervention ended on 31 May 2011, and data collection was completed on 30 November 2011. Primary analyses followed the intention to treat principle. In all, 14,137 women were enrolled in 232 control villages, and 15,532 in 232 intervention villages. Of these, 4,885 control women had 5,474 eligible pregnancies and gave birth to 4,998 eligible children. The corresponding numbers in intervention villages were 5,664 women, 6,351 pregnancies, and 5,798 children. Of the live-born babies, 343 (6.9% in the control arm and 303 (5.2% in the intervention arm died in their first 28 days of life (risk ratio 0.76, 95% CI 0.64 to 0.90, p = 0.0018; risk difference -1.59%, 95% CI -2.63% to -0.54%, suggesting that there were 92 fewer deaths (95% CI 31 to 152 as a result of the intervention. There were 9 (0.16% maternal deaths in the control arm compared to 13 (0.20% in the intervention arm (risk ratio 1.24, 95% CI 0.53 to 2.90, p = 0.6176; 1 death was reported as a serious adverse event. There was evidence of improved health knowledge and health practices including health service usage in the intervention arm compared to the control arm. Women in the intervention arm were more likely to rate their delivery and postnatal care as good or very good. The total cost of the CHAMPION interventions was US$1,084,955 ($11,769 per life saved, 95% CI $7,115 to $34,653. The main limitations of the study included that it could not be masked post-randomisation and that fetal losses were not divided into stillbirths and miscarriages because gestational age was not reliably reported.The CHAMPION trial showed that a package of interventions addressing health knowledge and health seeking behaviour, buttressing existing health services, and
Student-initiated revision in child health.

Science.gov (United States)

Alfaham, M; Gray, O P; Davies, D P

1994-03-01

Most teaching of child health in Cardiff takes place in block attachments of 8 weeks. There is an introductory seminar of 2 days followed by a 6-week clinical attachment in a district general hospital in Wales, and then a revision period of one week designed to help students formalize and structure their basic knowledge and to clarify aspects of child health which they may have had difficulty in understanding. The revision programme has to take into account: the short time available, the small number of teaching staff, the most relevant basic knowledge and active participation by the student. This paper describes how this week has been improved through the use of student-initiated revision (SIR). The students' appraisal of this revision and in particular SIR is presented.
New approaches to trials in glomerulonephritis.

Science.gov (United States)

Craig, Jonathan C; Tong, Allison; Strippoli, Giovanni F M

2017-01-01

Randomized controlled trials are required to reliably identify interventions to improve the outcomes for people with glomerulonephritis (GN). Unfortunately, although easier, observational studies are inherently unreliable even though the findings of both study designs agree most of the time. Currently there are ∼790 trials in GN, but suboptimal design and reporting, together with small sample sizes, mean that they may not be reliable for decision making. If the history is somewhat bleak, the future looks bright, with recent initiatives to improve the quality, size and relevance of clinical trials in nephrology, including greater patient engagement, trial networks, core outcome sets, registry-based trials and adaptive designs. Given the current state of the evidence informing the care of people with GN, disruptive technologies and pervasive culture change is required to ensure that the potential of trials to improve the health of people with this complex condition is to be realized. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
CHAMP: Cognitive behaviour therapy for health anxiety in medical patients, a randomised controlled trial

Directory of Open Access Journals (Sweden)

Murphy David

2011-06-01

Full Text Available Abstract Background Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population. Method/Design The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years. Discussion This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also
Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England.

Science.gov (United States)

Ponsford, Ruth; Allen, Elizabeth; Campbell, Rona; Elbourne, Diana; Hadley, Alison; Lohan, Maria; Melendez-Torres, G J; Mercer, Catherine H; Morris, Steve; Young, Honor; Bonell, Chris

2018-01-01

Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative
RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

Science.gov (United States)

Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

2013-07-02

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the
Hip-Hop to Health Jr. Randomized Effectiveness Trial

Science.gov (United States)

Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.

2015-01-01

Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively
Children’s Environmental Health Faculty Champions Initiative: A Successful Model for Integrating Environmental Health into Pediatric Health Care

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Rogers, Bonnie; McCurdy, Leyla Erk; Slavin, Katie; Grubb, Kimberly; Roberts, James R.

2009-01-01

Background Pediatric medical and nursing education lack the environmental health content needed to properly prepare health care professionals to prevent, recognize, manage, and treat environmental exposure–related diseases. The need for improvements in health care professionals’ environmental health knowledge has been expressed by leading institutions. However, few studies have evaluated the effectiveness of programs that incorporate pediatric environmental health (PEH) into curricula and practice. Objective We evaluated the effectiveness of the National Environmental Education Foundation’s (NEEF) Children’s Environmental Health Faculty Champions Initiative, which is designed to build environmental health capacity among pediatric health care professionals. Methods Twenty-eight pediatric health care professionals participated in a train-the-trainer workshop, in which they were educated to train other health care professionals in PEH and integrate identified PEH competencies into medical and nursing practice and curricula. We evaluated the program using a workshop evaluation tool, action plan, pre- and posttests, baseline and progress assessments, and telephone interviews. Results During the 12 months following the workshop, the faculty champions’ average pretest score of 52% was significantly elevated (p < 0.0001) to 65.5% on the first posttest and to 71.5% on the second posttest, showing an increase and retention of environmental health knowledge. Faculty champions trained 1,559 health care professionals in PEH, exceeding the goal of 280 health care professionals trained. Ninety percent of faculty champions reported that PEH had been integrated into the curricula at their institution. Conclusion The initiative was highly effective in achieving its goal of building environmental health capacity among health care professionals. The faculty champions model is a successful method and can be replicated in other arenas. PMID:19478972
Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

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Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
The Cross-Sectional Relationship Between Body Mass Index, Waist-Hip Ratio and Cognitive Performance in Postmenopausal Women Enrolled in the Women's Health Initiative (WHI)

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Kerwin, Diana R.; Zhang, Yinghua; Kotchen, Jane Morley; Espeland, Mark A.; Van Horn, Linda; McTigue, Kathleen M.; Robinson, Jennifer G.; Powell, Lynda; Kooperberg, Charles; Coker, Laura H.; Hoffmann, Raymond

2010-01-01

OBJECTIVES To determine if body weight (BMI) is independently associated with cognitive function in postmenopausal women and the relationship between body fat distribution as estimated by waist-hip-ratio (WHR) and cognitive function. DESIGN Cross-sectional data analysis SETTING Baseline data from the Women's Health Initiative (WHI) hormone trials. PARTICIPANTS 8745 postmenopausal women aged 65–79 years, free of clinical evidence of dementia and completed baseline evaluation in the Women's Health Initiative (WHI) hormone trials. MEASUREMENTS Participants completed a Modified Mini-Mental State Examination (3MSE), health and lifestyle questionnaires, and standardized measurements of height, weight, body circumferences and blood pressure. Statistical analysis of associations between 3MSE scores, BMI and WHR after controlling for known confounders. RESULTS With the exception of smoking and exercise, vascular disease risk factors, including hypertension, waist measurement, heart disease and diabetes, were significantly associated with 3MSE score and were included as co-variables in subsequent analyses. BMI was inversely related to 3MSE scores, for every 1 unit increase in BMI, 3MSE decrease 0.988 (p=.0001) after adjusting for age, education and vascular disease risk factors. BMI had the most pronounced association with poorer cognitive functioning scores among women with smaller waist measurements. Among women with the highest WHR, cognitive scores increased with BMI. CONCLUSION Increasing BMI is associated with poorer cognitive function in women with smaller WHR. Higher WHR, estimating central fat mass, is associated with higher cognitive function in this cross-sectional study. Further research is needed to clarify the mechanism for this association. PMID:20646100
International Society of Nephrology-Hydration and Kidney Health Initiative - Expanding Research and Knowledge.

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Moist, Louise M; Clark, William F; Segantini, Luca; Damster, Sandrine; Le Bellego, Laurent; Wong, Germaine; Tonelli, Marcello

2016-01-01

The purpose of this manuscript is to describe a collaborative research initiative to explore the role of hydration in kidney health. Our understanding of the effects of hydration in health and disease is surprisingly limited, particularly when we consider the vital role of hydration in basic human physiology. Recent initiatives and research outcomes have challenged the global medical community to expand our knowledge about hydration, including the differences between water, sugared beverages and other consumables. Identification of the potential mechanisms contributing to the benefits of hydration has stimulated the global nephrology community to advance research regarding hydration for kidney health. Hydration and kidney health has been a focus of research for several research centers with a rapidly expanding world literature and knowledge. The International Society of Nephrology has collaborated with Danone Nutricia Research to promote development of kidney research initiatives, which focus on the role of hydration in kidney health and the global translation of this new information. This initiative supports the use of existing data in different regions and countries to expand dialogue among experts in the field of hydration and health, and to increase scientific interaction and productivity with the ultimate goal of improving kidney health. © 2016 The Author(s) Published by S. Karger AG, Basel.
Student-Initiated Sexual Health Selective as a Curricular Tool

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Katie Johnson, BS

2015-06-01

Conclusions: The 1-week SHS was successfully implemented through the teamwork of a medical student and faculty champion. It resulted in more accurate knowledge and more open attitudes toward sexual health among participating medical students. Potential benefits to undergraduate medical educators are reviewed. Johnson K, Rullo J, and Faubion S. Student-initiated sexual health selective as a curricular tool. Sex Med 2015;3:118–127.
Meeting report: Initial World Health Organization consultation on herpes simplex virus (HSV) vaccine preferred product characteristics, March 2017.

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Gottlieb, Sami L; Giersing, Birgitte K; Hickling, Julian; Jones, Rebecca; Deal, Carolyn; Kaslow, David C

2017-12-07

The development of vaccines against herpes simplex virus (HSV) is an important global goal for sexual and reproductive health. A key priority to advance development of HSV vaccines is the definition of preferred product characteristics (PPCs), which provide strategic guidance on World Health Organization (WHO) preferences for new vaccines, specifically from a low- and middle-income country (LMIC) perspective. To start the PPC process for HSV vaccines, the WHO convened a global stakeholder consultation in March 2017, to define the priority public health needs that should be addressed by HSV vaccines and discuss the key considerations for HSV vaccine PPCs, particularly for LMICs. Meeting participants outlined an initial set of overarching public health goals for HSV vaccines in LMICs, which are: to reduce the acquisition of HIV associated with HSV-2 infection in high HIV-prevalence populations and to reduce the burden of HSV-associated disease, including mortality and morbidity due to neonatal herpes and impacts on sexual and reproductive health. Participants also considered the role of prophylactic versus therapeutic vaccines, whether both HSV-2 and HSV-1 should be targeted, important target populations, and infection and disease endpoints for clinical trials. This article summarizes the main discussions from the consultation. Copyright © 2017.
Effect of the PREPARE intervention on sexual initiation and condom use among adolescents aged 12–14: a cluster randomised controlled trial in Dar es Salaam, Tanzania

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Elia John Mmbaga

2017-04-01

Full Text Available Abstract Background Unsafe sexual practices continue to put adolescents at risk for a number of negative health outcomes in Tanzania. While there are some effective theory-based intervention packages with positive impact on important mediators of sexual behaviours, a context specific and tested intervention is urgently needed in Tanzania. Purpose To develop and evaluate an intervention that will have a significant effect in reducing sexual initiation and promoting condom use among adolescents aged 12–14 in Dar es Salaam, Tanzania. Design A school-based Cluster Randomised Controlled Trial was conducted during 2011–2014 in Kinondoni Municipality. Methods A total of 38 public primary schools were randomly selected, of which half were assigned to the intervention and half to the control group based on their size and geographic location. Participants were interviewed using a self-administered questionnaire at baseline before the PREPARE intervention and then, 6 and 12 months following intervention. The primary outcomes were self-reported sex initiation and condom use during the past 6 months. Data analysis was done using Generalized Estimating Equation (GEE modelling controlling for repeated measures and clustering of students within schools. Results A total of 5091 students were recruited at baseline, and interviewed again at 6 (n = 4783 and 12 months (n = 4370. Mean age of participants at baseline was 12.4 years. Baseline sociodemographic, psychometric and behavioural characteristics did not significantly differ between the two study arms. The GEE analysis indicated that the intervention had a significant effect on sexual initiation in both sexes after controlling for clustering and correlated repeated measures. A significantly higher level of action planning to use condoms was reported among female adolescent in the intervention arm than those in the control arm (p = 0.042. An effect on condom use behaviour was observed among male
A Performance Management Initiative for Local Health Department Vector Control Programs.

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Gerding, Justin; Kirshy, Micaela; Moran, John W; Bialek, Ron; Lamers, Vanessa; Sarisky, John

2016-01-01

Local health department (LHD) vector control programs have experienced reductions in funding and capacity. Acknowledging this situation and its potential effect on the ability to respond to vector-borne diseases, the U.S. Centers for Disease Control and Prevention and the Public Health Foundation partnered on a performance management initiative for LHD vector control programs. The initiative involved 14 programs that conducted a performance assessment using the Environmental Public Health Performance Standards. The programs, assisted by quality improvement (QI) experts, used the assessment results to prioritize improvement areas that were addressed with QI projects intended to increase effectiveness and efficiency in the delivery of services such as responding to mosquito complaints and educating the public about vector-borne disease prevention. This article describes the initiative as a process LHD vector control programs may adapt to meet their performance management needs. This study also reviews aggregate performance assessment results and QI projects, which may reveal common aspects of LHD vector control program performance and priority improvement areas. LHD vector control programs interested in performance assessment and improvement may benefit from engaging in an approach similar to this performance management initiative.
Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

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Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective
Mentoring a health technology assessment initiative in Kazakhstan.

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Muratov, Sergei; Hailey, David; Foerster, Vicki; Brady, Bruce; Juzwishin, Don; la Fleur, Philip; McGowan, Jessie

2014-04-01

The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of Kazakhstan Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project. Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work. The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.
Social determinants of health in Canada: Are healthy living initiatives there yet? A policy analysis

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Gore Dana

2012-08-01

Full Text Available Abstract Introduction Preventative strategies that focus on addressing the social determinants of health to improve healthy eating and physical activity have become an important strategy in British Columbia and Ontario for combating chronic diseases. What has not yet been examined is the extent to which healthy living initiatives implemented under these new policy frameworks successfully engage with and change the social determinants of health. Methods Initiatives active between January 1, 2006 and September 1, 2011 were found using provincial policy documents, web searches, health organization and government websites, and databases of initiatives that attempted to influence to nutrition and physical activity in order to prevent chronic diseases or improve overall health. Initiatives were reviewed, analyzed and grouped using the descriptive codes: lifestyle-based, environment-based or structure-based. Initiatives were also classified according to the mechanism by which they were administered: as direct programs (e.g. directly delivered, blueprints (or frameworks to tailor developed programs, and building blocks (resources to develop programs. Results 60 initiatives were identified in Ontario and 61 were identified in British Columbia. In British Columbia, 11.5% of initiatives were structure-based. In Ontario, of 60 provincial initiatives identified, 15% were structure-based. Ontario had a higher proportion of direct interventions than British Columbia for all intervention types. However, in both provinces, as the intervention became more upstream and attempted to target the social determinants of health more directly, the level of direct support for the intervention lessened. Conclusions The paucity of initiatives in British Columbia and Ontario that address healthy eating and active living through action on the social determinants of health is problematic. In the context of Canada's increasingly neoliberal political and economic policy, the
Osteoporosis in the Women's Health Initiative: Another Treatment Gap?

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Sattari, Maryam; Cauley, Jane A; Garvan, Cynthia; Johnson, Karen C; LaMonte, Michael J; Li, Wenjun; Limacher, Marian; Manini, Todd; Sarto, Gloria E; Sullivan, Shannon D; Wactawski-Wende, Jean; Beyth, Rebecca J

2017-08-01

Osteoporotic fractures are associated with high morbidity, mortality, and cost. We performed a post hoc analysis of the Women's Health Initiative (WHI) clinical trials data to assess osteoporosis treatment and identify participant characteristics associated with utilization of osteoporosis medication(s) after new diagnoses of osteoporosis or fracture. Information from visits prior to and immediately subsequent to the first fracture event or osteoporosis diagnosis were evaluated for medication use. A full logistic regression model was used to identify factors predictive of osteoporosis medication use after a fracture or a diagnosis of osteoporosis. The median length of follow-up from enrollment to the last WHI clinic visit for the study cohort was 13.9 years. Among the 13,990 women who reported new diagnoses of osteoporosis or fracture between enrollment and their final WHI visit, and also had medication data available, 21.6% reported taking an osteoporosis medication other than estrogen. Higher daily calcium intake, diagnosis of osteoporosis alone or both osteoporosis and fracture (compared with diagnosis of fracture alone), Asian or Pacific Islander race/ethnicity (compared with White/Caucasian), higher income, and hormone therapy use (past or present) were associated with significantly higher likelihood of osteoporosis pharmacotherapy. Women with Black/African American race/ethnicity (compared with White/Caucasian), body mass index ≥30 (compared with body mass index of 18.5-24.9), current tobacco use (compared with past use or lifetime nonusers), and history of arthritis were less likely to use osteoporosis treatment. Despite well-established treatment guidelines in postmenopausal women with osteoporosis or history of fractures, pharmacotherapy use was suboptimal in this study. Initiation of osteoporosis treatment after fragility fracture may represent an opportunity to improve later outcomes in these high-risk women. Specific attention needs to be paid to

Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

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van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

2014-06-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.
A survey of local health promotion initiatives for older people in Wales

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Williams Nefyn H

2008-06-01

Full Text Available Abstract Background As the demographic profile of the UK changes, policy makers and practitioners have to respond to health challenges presented by a progressively ageing population. The health promotion plan for older people, aged over 50 years, in Wales included eight key areas: physical activity, healthy eating, home safety and warmth, emotional health, health protection, smoking, alcohol and sexual health. The aim of this study was to describe the extent, content and regional variation of existing health promotion initiatives for older people in Wales, provided by statutory, voluntary and private sector agencies. Method A questionnaire was sent to senior health promotion specialists employed in the 22 local authority areas in Wales to ascertain details of all projects promoting health and wellbeing in the eight key areas where the priority population was aged over 50, or the majority of users were older people. Additional information was sought from project leads and websites. Results Eighteen questionnaires were returned; not all were fully completed. Four areas did not return a questionnaire. Additional information was obtained from internet searches but this mainly concerned national initiatives rather than local projects. In all, 120 projects were included, 11 were throughout Wales. Best provision was for physical activity, with 3 national and 42 local initiatives, but local provision was patchy. Healthy eating, and home safety and warmth had far fewer initiatives, as did health protection, which comprised two national immunisation campaigns. Smoking and alcohol misuse were poorly provided for, and there was no provision for older people's sexual health. Evaluation arrangements were poorly described. Half of those who responded identified unmet training needs. Conclusion The reasons for patchy provision of services were not clear. Increased efforts to improve the coverage of interventions known to be effective should be made. Rigorous
Study Protocol- An exploratory trial on health promoting schools at Dutch secondary schools

NARCIS (Netherlands)

Busch, Vincent; Leeuw, Rob J. de; Schrijvers, A.J.P.

2012-01-01

Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural
[A framework for evaluating ethical issues of public health initiatives: practical aspects and theoretical implications].

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Petrini, Carlo

2015-01-01

The "Framework for the Ethical Conduct of Public Health Initiatives", developed by Public Health Ontario, is a practical guide for assessing the ethical implications of evidence-generating public health initiatives, whether research or non-research activities, involving people, their biological materials or their personal information. The Framework is useful not only to those responsible for determining the ethical acceptability of an initiative, but also to investigators planning new public health initiatives. It is informed by a theoretical approach that draws on widely shared bioethical principles. Two considerations emerge from both the theoretical framework and its practical application: the line between practice and research is often blurred; public health ethics and biomedical research ethics are based on the same common heritage of values.
Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

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Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a
Pet Ownership and Cancer Risk in the Women’s Health Initiative

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Garcia, David O.; Lander, Eric M.; Wertheim, Betsy C.; Manson, JoAnn E.; Volpe, Stella L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Lessin, Lawrence S.; Kuller, Lewis H.; Thomson, Cynthia A.

2016-01-01

Background Pet ownership and cancer are both highly prevalent in the U.S. Evidence suggest associations may exist between this potentially modifiable factor and cancer prevention, though studies are sparse. The present report examined whether pet ownership (dog, cat, or bird) is associated with lower risk for total cancer and site-specific obesity-related cancers. Methods A prospective analysis of 123,560 participants (20,981 dog owners; 19,288 cat owners; 1,338 bird owners; and 81,953 non-pet owners) enrolled in the Women’s Health Initiative (WHI) observational study and clinical trials. Cox proportional hazards models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for the association between pet ownership and cancer, adjusted for potential confounders. Results There were no significant relationships between ownership of a dog, cat, or bird and incidence of cancer overall. When site-specific cancers were examined, no associations were observed after adjustment for multiple comparisons. Conclusion Pet ownership had no association with overall cancer incidence. Impact This is the first large epidemiological study to date to explore relationships between pet ownership and cancer risk, as well as associated risks for individual cancer types. This study requires replication in other sizable, diverse cohorts. PMID:27365150
Research Areas - Clinical Trials

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Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Health coaching by telephony to support self-care in chronic diseases: clinical outcomes from The TERVA randomized controlled trial

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Patja Kristiina

2012-06-01

Full Text Available Abstract Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR. A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals were identified from EMRs, and 1535 patients (59% gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80% participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%. No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration
Mapping of initiatives to increase membership in mutual health organizations in Benin

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Turcotte-Tremblay Anne-Marie

2012-12-01

Full Text Available Abstract Introduction Mutual health organizations (MHO have been implemented across Africa to increase access to healthcare and improve financial protection. Despite efforts to develop MHOs, low levels of both initial enrolment and membership renewals continue to threaten their financial viability. The purpose of this study was to map initiatives implemented to increase the pool of MHO members in Benin. Methods A multiple case study was conducted to assess MHOs supported by five major promoters in Benin. Three months of fieldwork resulted in 23 semi-structured interviews and two focus groups with MHO promoters, technicians, elected members, and health professionals affiliated with the MHOs. Fifteen non-structured interviews provided additional information and a valuable source of triangulation. Results MHOs have adopted a wide range of initiatives targeting different entry points and involving a variety of stakeholders. Initiatives have included new types of collective health insurance packages and efforts to raise awareness by going door-to-door and organizing health education workshops. Different types of partnerships have been established to strengthen relationships with healthcare professionals and political leaders. However, the selection and implementation of these initiatives have been limited by insufficient financial and human resources. Conclusions The study highlights the importance of prioritizing sustainable strategies to increase MHO membership. No single MHO initiative has been able to resolve the issue of low membership on its own. If combined, existing initiatives could provide a comprehensive and inclusive approach that would target all entry points and include key stakeholders such as household decision-makers, MHO elected members, healthcare professionals, community leaders, governmental authorities, medical advisors, and promoters. There is a need to evaluate empirically the implementation of these interventions. Mechanisms
Effectiveness of Baby‐friendly community health services on exclusive breastfeeding and maternal satisfaction: a pragmatic trial

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Langsrud, Øyvind; Løland, Beate F.; Tufte, Elisabeth; Tylleskär, Thorkild; Fretheim, Atle

2016-01-01

Abstract The WHO/UNICEF Baby‐friendly Hospital Initiative has been shown to increase breastfeeding rates, but uncertainty remains about effective methods to improve breastfeeding in community health services. The aim of this pragmatic cluster quasi‐randomised controlled trial was to assess the effectiveness of implementing the Baby‐friendly Initiative (BFI) in community health services. The primary outcome was exclusive breastfeeding until 6 months in healthy babies. Secondary outcomes were other breastfeeding indicators, mothers' satisfaction with the breastfeeding experience, and perceived pressure to breastfeed. A total of 54 Norwegian municipalities were allocated by alternation to the BFI in community health service intervention or routine care. All mothers with infants of five completed months were invited to participate (n = 3948), and 1051 mothers in the intervention arm and 981 in the comparison arm returned the questionnaire. Analyses were by intention to treat. Women in the intervention group were more likely to breastfeed exclusively compared with those who received routine care: 17.9% vs. 14.1% until 6 months [cluster adjusted odds ratio (OR) = 1.33; 95% confidence interval (CI): 1.03, 1.72; P = 0.03], 41.4% vs. 35.8% until 5 months [cluster adjusted OR = 1.39; 95% CI: 1.09, 1.77; P = 0.01], and 72.1% vs. 68.2% for any breastfeeding until 6 months [cluster adjusted OR = 1.24; 95% CI: 0.99, 1.54; P = 0.06]. The intervention had no effect on breastfeeding until 12 months. Maternal breastfeeding experience in the two groups did not differ, neither did perceived breastfeeding pressure from staff in the community health services. In conclusion, the BFI in community health services increased rates of exclusive breastfeeding until 6 months. © 2015 Blackwell Publishing Ltd PMID:27062084
Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

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Crichton Georgina E

2012-03-01

Full Text Available Abstract Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day or a low dairy control diet (LD, ≤1 serve/day for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347 on 24th October, 2008.
Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

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Morrison, Susan; John-Stewart, Grace; Egessa, John J; Mubezi, Sezi; Kusemererwa, Sylvia; Bii, Dennis K; Bulya, Nulu; Mugume, Francis; Campbell, James D; Wangisi, Jonathan; Bukusi, Elizabeth A; Celum, Connie; Baeten, Jared M

2015-01-01

During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART), despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.
Rapid Antiretroviral Therapy Initiation for Women in an HIV-1 Prevention Clinical Trial Experiencing Primary HIV-1 Infection during Pregnancy or Breastfeeding.

Directory of Open Access Journals (Sweden)

Susan Morrison

Full Text Available During an HIV-1 prevention clinical trial in East Africa, we observed 16 cases of primary HIV-1 infection in women coincident with pregnancy or breastfeeding. Nine of eleven pregnant women initiated rapid combination antiretroviral therapy (ART, despite having CD4 counts exceeding national criteria for ART initiation; breastfeeding women initiated ART or replacement feeding. Rapid ART initiation during primary HIV-1 infection during pregnancy and breastfeeding is feasible in this setting.
A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

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Rachel Pritchett

2013-01-01

Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.
Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

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Clark MD

2009-09-01

Full Text Available Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662
[Sexual initiation, masculinity and health: narratives of young men].

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Rebello, Lúcia Emilia Figueiredo de Sousa; Gomes, Romeu

2009-01-01

The main objective of this study was to analyze the narratives of young university students about the experience of sexual initiation. The theoretical and conceptual references used were the sexual scripts of our society that inform people about when, how, where and with whom they should have their sexual experiences, indicating how to act sexually and the reasons why they have to practice some kind of sexual activity. The method used was a qualitative study of narratives from the perspective of dialectic hermeneutics. The methodological design involves the comprehension of sceneries, contexts, environments and characters of the narratives about sexual initiation. The analysis refers to narratives of university students in the city of Rio de Janeiro. Among the meanings of sexual initiation, we emphasize sexual intercourse, the demarcation of a stage of life, the awakening to the opposite sex and the discovery of the body. We observed that the young men's narratives were coherent with what is considered masculine, present in the discourse of different generations. It is concluded that the young men should be encouraged to participate in actions combining health and education aimed at promotion of sexual and reproductive health.
A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

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Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

2017-01-01

Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…
Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

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Welch, Vivian; Jull, J; Petkovic, J; Armstrong, R; Boyer, Y; Cuervo, L G; Edwards, Sjl; Lydiatt, A; Gough, D; Grimshaw, J; Kristjansson, E; Mbuagbaw, L; McGowan, J; Moher, D; Pantoja, T; Petticrew, M; Pottie, K; Rader, T; Shea, B; Taljaard, M; Waters, E; Weijer, C; Wells, G A; White, H; Whitehead, M; Tugwell, P

2015-10-21

Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.
Clinical Trials

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Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...
A randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment entry.

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Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E; Vocci, Frank J

2014-09-01

Buprenorphine is a promising treatment for heroin addiction. However, little is known regarding its provision to pre-release prisoners with heroin dependence histories who were not opioid-tolerant, the relative effectiveness of the post-release setting in which it is provided, and gender differences in treatment outcome in this population. This is the first randomized clinical trial of prison-initiated buprenorphine provided to male and female inmates in the US who were previously heroin-dependent prior to incarceration. A total of 211 participants with 3-9 months remaining in prison were randomized to one of four conditions formed by crossing In-Prison Treatment Condition (received buprenorphine vs. counseling only) and Post-release Service Setting (at an opioid treatment center vs. a community health center). Outcome measures were: entered prison treatment; completed prison treatment; and entered community treatment 10 days post-release. There was a significant main effect (p=.006) for entering prison treatment favoring the In-Prison buprenorphine Treatment Condition (99.0% vs. 80.4%). Regarding completing prison treatment, the only significant effect was Gender, with women significantly (pPrison buprenorphine Treatment Condition (47.5% vs. 33.7%). Buprenorphine appears feasible and acceptable to prisoners who were not opioid-tolerant and can facilitate community treatment entry. However, concerns remain with in-prison treatment termination due to attempted diversion of medication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Facilitators of community participation in an Aboriginal sexual health promotion initiative.

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Hulme Chambers, Alana; Tomnay, Jane; Stephens, Kylie; Crouch, Alan; Whiteside, Mary; Love, Pettina; McIntosh, Leonie; Waples Crowe, Peter

2018-04-01

Community participation is a collaborative process aimed at achieving community-identified outcomes. However, approaches to community participation within Aboriginal health promotion initiatives have been inconsistent and not well documented. Smart and Deadly was a community-led initiative to develop sexual health promotion resources with young Aboriginal people in regional Victoria, Australia. The principles of community-centred practice, authentic participatory processes and respect for the local cultural context guided the initiative. The aim of this article is to report factors that facilitated community participation undertaken in the Smart and Deadly initiative to inform future projects and provide further evidence in demonstrating the value of such approaches. A summative evaluation of the Smart and Deadly initiative was undertaken approximately 2 years after the initiative ended. Five focus groups and 13 interviews were conducted with a purposive sample of 32 participants who were involved with Smart and Deadly in one of the following ways: project participant, stakeholder or project partner, or project developer or designer. A deductive content analysis was undertaken and themes were compared to the YARN model, which was specifically created for planning and evaluating community participation strategies relating to Aboriginal sexual health promotion. A number of factors that facilitated community participation approaches used in Smart and Deadly were identified. The overarching theme was that trust was the foundation upon which the facilitators of community participation ensued. These facilitators were cultural safety and cultural literacy, community control, and legacy and sustainability. Whilst the YARN model was highly productive in identifying these facilitators of community participation, the model did not have provision for the element of trust between workers and community. Given the importance of trust between the project team and the Aboriginal
African Health Systems Initiative (AHSI) | CRDI - Centre de ...

International Development Research Centre (IDRC) Digital Library (Canada)

The African Health Systems Initiative (AHSI) is a 10-year Canadian International Development Agency (CIDA)-supported program for strengthening African-led ... Le nouveau site Web et la nouvelle bibliothèque de ressources aideront à améliorer les systèmes d'information et d'enregistrement des faits d'état civil dans les ...
75 FR 44589 - Health Information Technology: Initial Set of Standards, Implementation Specifications, and...

Science.gov (United States)

2010-07-28

... Part III Department of Health and Human Services 45 CFR Part 170 Health Information Technology... Secretary 45 CFR Part 170 RIN 0991-AB58 Health Information Technology: Initial Set of Standards... of the National Coordinator for Health Information Technology (ONC), Department of Health and Human...
Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial.

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Maindal, Helle Terkildsen; Støvring, Henrik; Sandbaek, Annelli

2014-08-29

The periodic health check-up has been a fundamental part of routine medical practice for decades, despite a lack of consensus regarding its value in health promotion and disease prevention. A large-scale Danish population-based preventive programme 'Check your health' was developed based on available evidence of screening and successive accepted treatment, prevention for diseases and health promotion, and is closely aligned with the current health care system.The objective of the 'Check your health' [CORE] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years, and to establish the cost-effectiveness. The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals. All individuals within a well-defined geographical area in the Central Denmark Region, Denmark (DK) were randomised to be offered a preventive health check (Intervention group, n = 5250) or to maintain routine access to healthcare until a delayed intervention (Comparison group, n = 5255). The programme consists of a health examination which yields an individual risk profile, and according to this participants are assigned to one of the following interventions: (a) referral to a health promoting consultation in general practice, (b) behavioural programmes at the local Health Centre, or (c) no need for follow-up.The primary outcomes at 4 years follow-up are: ten-year-risk of fatal cardiovascular event (Heart-SCORE model), physical activity level (self-report and cardiorespiratory fitness), quality of life (SF12), sick leave and labour market attachment. Cost-effectiveness will be evaluated according to life years gained, direct costs and total health costs. Intention to treat analysis will be performed. Results from the largest Danish health check programme conducted within the current healthcare system, spanning the sectors which share responsibility for
Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

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Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

2013-01-01

Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…
Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial.

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Poulsen, Rie; Hoff, Andreas; Fisker, Jonas; Hjorthøj, Carsten; Eplov, Lene Falgaard

2017-12-02

Depression and anxiety are among the largest contributors to the global burden of disease and have negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's work ability, and up to 40% of the people on sick leave in Denmark have depression and/or anxiety. There is no clear evidence that treatment alone will provide sufficient support for vocational recovery in this group. Integrated vocational and health care services have shown good effects on return to work in other, similar welfare contexts. The purpose of the IBBIS (Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression) interventions is to improve and hasten the process of return to employment for people in Denmark on sick leave because of depression and anxiety. This three-arm, parallel-group, randomized superiority trial has been set up to investigate the effectiveness of the IBBIS mental health care intervention and the integrated IBBIS mental health care and IBBIS vocational rehabilitation intervention for people on sick leave because of depression and/or anxiety in Denmark. The trial has an investigator-initiated multicenter design. A total of 603 patients will be recruited from Danish job centers in 4 municipalities and randomly assigned to one of 3 groups: (1) IBBIS mental health care integrated with IBBIS vocational rehabilitation, (2) IBBIS mental health care and standard vocational rehabilitation, and (3) standard mental health care and standard vocational rehabilitation. The primary outcome is register-based return to work at 12 months. The secondary outcome measures are self-assessed level of depression (Beck Depression Inventory II), anxiety (Beck Anxiety Inventory), stress symptoms (Four-Dimensional Symptom Questionnaire), work and social functioning (Work and Social Adjustment Scale), and register-based recurrent sickness absence. This study will provide new knowledge
75 FR 62686 - Health Information Technology: Revisions to Initial Set of Standards, Implementation...

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2010-10-13

... Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and... Health Information Technology (ONC), Department of Health and Human Services. ACTION: Interim final rule... Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite...
An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

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Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

2013-05-29

Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.
NHS health checks through general practice: randomised trial of population cardiovascular risk reduction

Directory of Open Access Journals (Sweden)

Cochrane Thomas

2012-11-01

Full Text Available Abstract Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century. The Department of Health in England has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk. The aims of this study were to monitor population changes in cardiovascular disease (CVD risk factors over the first year of the new service and to assess the value of tailored lifestyle support, including motivational interview with ongoing support and referral to other services. Methods Randomised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent, England. Thirty eight general practices and 601 (365 usual care, 236 additional lifestyle support patients were recruited and randomised independently between September 2009 and February 2010. Changes in population CVD risk between baseline and one year follow-up were compared, using intention-to-treat analysis. The primary outcome was the Framingham 10 year CVD risk score. Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories. Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for: weight management, physical activity, cook and eat and positive thinking. Results Average population CVD risk decreased from 32.9% to 29.4% (p Conclusions The NHS Health Check service in Stoke on Trent resulted in significant reduction in estimated population CVD risk. There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction.
International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs

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Ricardo E. da Silva

2018-01-01

Full Text Available Introduction: Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs.Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials.Methods: The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO International Clinical Trials Registry Platform (ICTRP.Results: Non-communicable diseases such as diabetes, cancer, and asthma—studies which were financed mainly by industries—were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue.Conclusion: The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials.
Clinical Trials

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Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...
Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial

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2012-01-01

Background Adolescents with intellectual disability often have poor health and healthcare. This is partly as a consequence of poor communication and recall difficulties, and the possible loss of specialised paediatric services. Methods/Design A cluster randomised trial was conducted with adolescents with intellectual disability to investigate a health intervention package to enhance interactions among adolescents with intellectual disability, their parents/carers, and general practitioners (GPs). The trial took place in Queensland, Australia, between February 2007 and September 2010. The intervention package was designed to improve communication with health professionals and families’ organisation of health information, and to increase clinical activities beneficial to improved health outcomes. It consisted of the Comprehensive Health Assessment Program (CHAP), a one-off health check, and the Ask Health Diary, designed for on-going use. Participants were drawn from Special Education Schools and Special Education Units. The education component of the intervention was delivered as part of the school curriculum. Educators were surveyed at baseline and followed-up four months later. Carers were surveyed at baseline and after 26 months. Evidence of health promotion, disease prevention and case-finding activities were extracted from GPs clinical records. Qualitative interviews of educators occurred after completion of the educational component of the intervention and with adolescents and carers after the CHAP. Discussion Adolescents with intellectual disability have difficulty obtaining many health services and often find it difficult to become empowered to improve and protect their health. The health intervention package proposed may aid them by augmenting communication, improving documentation of health encounters, and improving access to, and quality of, GP care. Recruitment strategies to consider for future studies in this population include ensuring potential
Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Lennox Nicholas

2012-09-01

Full Text Available Abstract Background Adolescents with intellectual disability often have poor health and healthcare. This is partly as a consequence of poor communication and recall difficulties, and the possible loss of specialised paediatric services. Methods/Design A cluster randomised trial was conducted with adolescents with intellectual disability to investigate a health intervention package to enhance interactions among adolescents with intellectual disability, their parents/carers, and general practitioners (GPs. The trial took place in Queensland, Australia, between February 2007 and September 2010. The intervention package was designed to improve communication with health professionals and families’ organisation of health information, and to increase clinical activities beneficial to improved health outcomes. It consisted of the Comprehensive Health Assessment Program (CHAP, a one-off health check, and the Ask Health Diary, designed for on-going use. Participants were drawn from Special Education Schools and Special Education Units. The education component of the intervention was delivered as part of the school curriculum. Educators were surveyed at baseline and followed-up four months later. Carers were surveyed at baseline and after 26 months. Evidence of health promotion, disease prevention and case-finding activities were extracted from GPs clinical records. Qualitative interviews of educators occurred after completion of the educational component of the intervention and with adolescents and carers after the CHAP. Discussion Adolescents with intellectual disability have difficulty obtaining many health services and often find it difficult to become empowered to improve and protect their health. The health intervention package proposed may aid them by augmenting communication, improving documentation of health encounters, and improving access to, and quality of, GP care. Recruitment strategies to consider for future studies in this population
Clinical Trials

Medline Plus

Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...
An information and communication technology-based centralized clinical trial to determine the efficacy and safety of insulin dose adjustment education based on a smartphone personal health record application: a randomized controlled trial.

Science.gov (United States)

Kim, Gyuri; Bae, Ji Cheol; Yi, Byoung Kee; Hur, Kyu Yeon; Chang, Dong Kyung; Lee, Moon-Kyu; Kim, Jae Hyeon; Jin, Sang-Man

2017-07-18

A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data. PHRs not only enhance shared decision making with healthcare providers, but also enable remote monitoring and at-home-collection of detailed data. The benefits of PHRs can be maximized in insulin dose adjustment for patients starting or intensifying insulin regimens, as frequent self-monitoring of glucose, self-adjustment of insulin dose, and precise at-home data collection during the visit-to-visit period are important for glycemic control. The aim of this study is to examine the efficacy and safety of insulin dose adjustment based on a smartphone PHR application in patients with diabetes mellitus (DM) and to confirm the validity and stability of an information and communication technology (ICT)-based centralized clinical trial monitoring system. This is a 24-week, open-label, randomized, multi-center trial. There are three follow-up measures: baseline, post-intervention at week 12, and at week 24. Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM who initiate basal insulin or intensify their insulin regimen to a basal-bolus regimen are included. After education on insulin dose titration and prevention for hypoglycemia and a 1-week acclimation period, subjects are randomized in a 1:1 ratio to either an ICT-based intervention group or a conventional intervention group. Subjects in the conventional intervention group will save and send their health information to the server via a PHR application, whereas those in ICT-based intervention group will receive additional algorithm-based feedback messages. The health information includes level of blood glucose, insulin dose, details on hypoglycemia, food diary, and step count. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of study enrollment, without severe hypoglycemia or unscheduled clinic visits. This clinical trial
Clinical Trials of an Experimental Ebola Vaccine: A Canadian ...

International Development Research Centre (IDRC) Digital Library (Canada)

This initiative supports phases 2 and 3 clinical trials of an experimental Ebola vaccine. The experimental vaccine is based on an attenuated recombinant Vesicular Stomatitis Virus vector (VSV-EBOV). The Public Health Agency of Canada developed the vaccine and licensed it to NewLink Genetics and Merck. Early vaccine ...
Do transition towns have the potential to promote health and well-being? A health impact assessment of a transition town initiative.

Science.gov (United States)

Richardson, J; Nichols, A; Henry, T

2012-11-01

Climate change and energy vulnerability present significant challenges for the development and sustainability of our communities. The adverse effects will most likely impact on those already experiencing poverty, as energy and food costs will rise, thus increasing inequalities in health. Transition town initiatives seek to build cohesive sustainable communities to prepare for a future with limited oil and a changing climate. Increasingly, public health practitioners are interested in the role of transition towns as a community development initiative, and their potential to support the wider public health agenda. Health impact assessment (HIA) is an evidence-based process that aims to predict the positive and negative impacts of a strategy, proposal or development. The HIA process provides an opportunity to promote sustainable communities by ensuring that new strategies and developments are considered in the context of their contribution to the health and well-being of local populations. The aim of this study was to use an HIA to examine the potential health and well-being benefits of two related transition town initiatives. A rapid HIA to consider the potential lifestyle changes and health and well-being impacts of Transition Together/Transition Streets (TT/TS) projects. An HIA template was used to assess key documents related to the TT/TS initiatives and those related to the characteristics of the community. Additionally, meetings with 12 key informants (four involved in TT/TS and eight purposively selected for their local knowledge) were held using the HIA template to focus the discussion. The findings highlight the associated lifestyle changes such as increased physical activity and healthy eating, and possible social and well-being benefits of engagement in such an initiative. Engagement may be limited to those already concerned about environmental issues. This paper illustrates the important links between transition towns and the wider public health agenda
Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

Science.gov (United States)

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by
Health education for microcredit clients in Peru: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Fernald Lia CH

2011-01-01

that the intervention did not have sufficient intensity to change behavior, or that microcredit organizations may not be an appropriate setting for the administration of child health educational interventions of this type. Trial Registration This study is registered with ClinicalTrials.gov, NCT01047033.
Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

Science.gov (United States)

2014-01-01

Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

Management initiatives in a community-based health insurance scheme.

Science.gov (United States)

Sinha, Tara; Ranson, M Kent; Chatterjee, Mirai; Mills, Anne

2007-01-01

Community-based health insurance (CBHI) schemes have developed in response to inadequacies of alternate systems for protecting the poor against health care expenditures. Some of these schemes have arisen within community-based organizations (CBOs), which have strong links with poor communities, and are therefore well situated to offer CBHI. However, the managerial capacities of many such CBOs are limited. This paper describes management initiatives undertaken in a CBHI scheme in India, in the course of an action-research project. The existing structures and systems at the CBHI had several strengths, but fell short on some counts, which became apparent in the course of planning for two interventions under the research project. Management initiatives were introduced that addressed four features of the CBHI, viz. human resources, organizational structure, implementation systems, and data management. Trained personnel were hired and given clear roles and responsibilities. Lines of reporting and accountability were spelt out, and supportive supervision was provided to team members. The data resources of the organization were strengthened for greater utilization of this information. While the changes that were introduced took some time to be accepted by team members, the commitment of the CBHI's leadership to these initiatives was critical to their success. Copyright (c) 2007 John Wiley & Sons, Ltd.
The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study.

Science.gov (United States)

Jensen, Kamilla B; Morthorst, Britt R; Vendsborg, Per B; Hjorthøj, Carsten R; Nordentoft, Merete

2015-04-14

Studies show a high and growing prevalence of mental disorders in the population worldwide. 25% of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills. The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional care. An investigation of the effect of MHFA offered a Danish population is needed. The design is a randomized waitlist-controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated to be "mental health first-aiders" following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out. Outcomes measured are sensitive to interpretation, hence a challenge to uniform. This trial will add to the use of a mixed-methods design and exemplify how it can strengthen the analysis and take up the challenge of a sensitive outcome. https://clinicaltrials.gov identifier NCT02334020.
The effect of community-based health management on the health of the elderly: a randomized controlled trial from China

Directory of Open Access Journals (Sweden)

Chao Jianqian

2012-12-01

Full Text Available Abstract Background An aging population poses significant challenges to health care in China. Health management has been implemented to reduce the costs of care, raise health service utilization, increase health knowledge and improve quality of life. Several studies have tried to verify the effectiveness of health management in achieving these goals worldwide. However, there have been insufficient randomized control trials (RCTs to draw reliable conclusions. The few small-scale studies conducted in China include mostly the general population rather than the elderly. Our study is designed to evaluate the impact of community-based health management on the health of the elderly through an RCT in Nanjing, China. Methods Two thousand four hundred participants, aged 60 or older and who gave informed consent, were randomly allocated 1:1 into management and control groups, the randomization schedule was concealed from community health service center staff until allocation. Community-based health management was applied in the former while the latter was only given usual care. After 18 months, three categories of variables (subjective grading health indices, objective health indices and health service utilization were measured based on a questionnaire, clinical monitoring and diagnostic measurements. Differences between the two groups were assessed before and after the intervention and analyzed with t-test, χ2-test, and multiple regression analysis. Results Compared with the control group, the management group demonstrated improvement on the following variables (P Conclusion Community-based health management improved both subjective grading health indices, objective health indices and decreased the number of outpatient clinic visits, demonstrating effectiveness in improving elderly health. Trial registration ChiCTR-OCH-11001716
Effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement and mental health: results of a randomized controlled trial.

Directory of Open Access Journals (Sweden)

Jantien van Berkel

Full Text Available OBJECTIVES: The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness. METHODS: In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129 received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models. RESULTS: There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference and subgroups based on baseline work engagement scores showed no significant differences either. CONCLUSIONS: This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months. TRIAL REGISTRATION: Netherlands Trial Register NTR2199.
Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper.

Science.gov (United States)

Ryu, Borim; Kim, Nari; Heo, Eunyoung; Yoo, Sooyoung; Lee, Keehyuck; Hwang, Hee; Kim, Jeong-Whun; Kim, Yoojung; Lee, Joongseek; Jung, Se Young

2017-12-07

Personal health record (PHR)-based health care management systems can improve patient engagement and data-driven medical diagnosis in a clinical setting. The purpose of this study was (1) to demonstrate the development of an electronic health record (EHR)-tethered PHR app named MyHealthKeeper, which can retrieve data from a wearable device and deliver these data to a hospital EHR system, and (2) to study the effectiveness of a PHR data-driven clinical intervention with clinical trial results. To improve the conventional EHR-tethered PHR, we ascertained clinicians' unmet needs regarding PHR functionality and the data frequently used in the field through a cocreation workshop. We incorporated the requirements into the system design and architecture of the MyHealthKeeper PHR module. We constructed the app and validated the effectiveness of the PHR module by conducting a 4-week clinical trial. We used a commercially available activity tracker (Misfit) to collect individual physical activity data, and developed the MyHealthKeeper mobile phone app to record participants' patterns of daily food intake and activity logs. We randomly assigned 80 participants to either the PHR-based intervention group (n=51) or the control group (n=29). All of the study participants completed a paper-based survey, a laboratory test, a physical examination, and an opinion interview. During the 4-week study period, we collected health-related mobile data, and study participants visited the outpatient clinic twice and received PHR-based clinical diagnosis and recommendations. A total of 68 participants (44 in the intervention group and 24 in the control group) completed the study. The PHR intervention group showed significantly higher weight loss than the control group (mean 1.4 kg, 95% CI 0.9-1.9; Phealth tracker system and its potential to improve patient clinical profiles. ClinicalTrials.gov NCT03200119; https://clinicaltrials.gov/ct2/show/NCT03200119 (Archived by WebCite at http
Time to Treatment Initiation in People With Alzheimer Disease: A Meta-Analysis of Randomized Controlled Trials.

Science.gov (United States)

Tsoi, Kelvin K F; Hirai, Hoyee W; Chan, Joyce Y C; Kwok, Timothy C Y

2016-01-01

Alzheimer disease (AD) is a global health problem which afflicts millions of old age population worldwide. Acetylcholinesterase inhibitors and memantine are recognized drug treatments with limited clinical efficacy. It is uncertain if earlier initiation of these drugs will result in better outcomes in the longer term. To evaluate the benefit of early treatment among people with AD. Prospective randomized controlled trials were systematically searched from the OVID databases. The trials were eligible if study participants diagnosed with AD and were randomized to have early or late treatment. Any clinical assessment scales on cognitive function, physical function, behavioral problems, and the overall clinical status were the primary outcomes, and any reported adverse events were the secondary outcomes. Ten randomized trials were identified between 2000 and 2010. A total of 3092 participants with AD with mean age 75.8 years were randomly assigned to receive early treatment or treatment delayed by placebo intervention for around 6 months. Compared with late treatment, early AD drug treatment showed no significant benefit on cognitive function [mean difference (MD) of Alzheimer's Disease Assessment Scale- Cognitive Subscale = -0.49, 95% CI = -1.67 to 0.69], physical function (MD of Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory = 0.47, 95% CI = -1.44 to 2.39), behavioral problems (MD of Neuropsychiatric Inventory = -0.26, 95% CI = -2.70 to 2.18), and clinical status (MD of Clinician's Interview-Based Impression of Change plus Caregiver Input = 0.02, 95% CI = -0.23 to 0.27). Nausea was the most common adverse events in acetylcholinesterase inhibitor users, while memantine did not result in more side effects than the placebo group. For both drugs, early treatment had comparable adverse events when compared with late treatment. Earlier AD drug treatment by around 6 months did not result in significant difference in cognitive function, physical
Minigrants for Community Health: A Randomized Controlled Trial of Their Impact on Family Food Gardening.

Science.gov (United States)

Porter, Christine M; McCrackin, Peggy G; Naschold, Felix

2016-01-01

To evaluate the impact of minigrants on home food gardening and review 28 health-related minigrant programs reported in the literature for lessons relevant for using minigrant programs to promote community health. Randomized controlled trial of the impact of minigrants on square footage of food garden area and on garden initiation in 2010 versus 2011. Interviews with participants were also conducted and coded and the literature was reviewed for findings from other community health minigrant programs. Laramie, Wyoming. Sixty adults living in 53 households who attended a gardening training workshop in April 2011. A $40 minigrant in the form of a voucher, valid at a local gardening store. Minigrant recipients were more likely to increase their gardening space than the control group. The average increase for the intervention group was 39.2 ft (3.62 m) while the control group average garden plot size decreased slightly, on average, by 1.4 ft (-0.13 m). However, the data were not normally distributed and, therefore, nonparametric statistical tests were used. For the subset of 20 households that did not garden at all in 2010, minigrants also provided motivation to start gardening (8 of 10 minigrant households started a garden vs 2 of 10 control households). Results reported from other health minigrant programs are also positive, though few had quantitative outcomes or control groups for comparison. Even with very small amounts of money, minigrants show promise as an ethical, inexpensive, empowering, and effective health promotion strategy to enable families and communities to improve their health.
Initial arch wires for tooth alignment during orthodontic treatment with fixed appliances.

Science.gov (United States)

Jian, Fan; Lai, Wenli; Furness, Susan; McIntyre, Grant T; Millett, Declan T; Hickman, Joy; Wang, Yan

2013-04-30

Initial arch wires are the first arch wires to be inserted into the fixed appliance at the beginning of orthodontic treatment and are used mainly for the alignment of teeth by correcting crowding and rotations. With a number of different types of orthodontic arch wires available for initial tooth alignment, it is important to understand which wire is most efficient, as well as which wires cause the least amount of root resorption and pain during the initial aligning stage of treatment. This is an update of the review 'Initial arch wires for alignment of crooked teeth with ﬁxed orthodontic braces' first published in the Cochrane Database of Systematic Reviews 2010, Issue 4. To assess the effects of initial arch wires for alignment of teeth with fixed orthodontic braces in relation to alignment speed, root resorption and pain intensity. We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 2 August 2012), CENTRAL (The Cochrane Library 2012, Issue 7), MEDLINE via OVID (1950 to 2 August 2012) and EMBASE via OVID (1980 to 2 August 2012). We also searched the reference lists of relevant articles. There was no restriction with regard to publication status or language of publication. We contacted all authors of included studies to identify additional studies. We included randomised controlled trials (RCTs) of initial arch wires to align teeth with fixed orthodontic braces. Only studies involving participants with upper and/or lower full arch fixed orthodontic appliances were included. Two review authors were responsible for study selection, validity assessment and data extraction. All disagreements were resolved by discussion amongst the review team. Corresponding authors of included studies were contacted to obtain missing information. Nine RCTs with 571 participants were included in this review. All trials were at high risk of bias and a number of methodological limitations were identified. All trials had at least one
Advances in public health accreditation readiness and quality improvement: evaluation findings from the National Public Health Improvement Initiative.

Science.gov (United States)

McLees, Anita W; Thomas, Craig W; Nawaz, Saira; Young, Andrea C; Rider, Nikki; Davis, Mary

2014-01-01

Continuous quality improvement is a central tenet of the Public Health Accreditation Board's (PHAB) national voluntary public health accreditation program. Similarly, the Centers for Disease Control and Prevention launched the National Public Health Improvement Initiative (NPHII) in 2010 with the goal of advancing accreditation readiness, performance management, and quality improvement (QI). Evaluate the extent to which NPHII awardees have achieved program goals. NPHII awardees responded to an annual assessment and program monitoring data requests. Analysis included simple descriptive statistics. Seventy-four state, tribal, local, and territorial public health agencies receiving NPHII funds. NPHII performance improvement managers or principal investigators. Development of accreditation prerequisites, completion of an organizational self-assessment against the PHAB Standards and Measures, Version 1.0, establishment of a performance management system, and implementation of QI initiatives to increase efficiency and effectiveness. Of the 73 responding NPHII awardees, 42.5% had a current health assessment, 26% had a current health improvement plan, and 48% had a current strategic plan in place at the end of the second program year. Approximately 26% of awardees had completed an organizational PHAB self-assessment, 72% had established at least 1 of the 4 components of a performance management system, and 90% had conducted QI activities focused on increasing efficiencies and/or effectiveness. NPHII appears to be supporting awardees' initial achievement of program outcomes. As NPHII enters its third year, there will be additional opportunities to advance the work of NPHII, compile and disseminate results, and inform a vision of high-quality public health necessary to improve the health of the population.
The status of paediatric medicines initiatives around the world--What has happened and what has not?

Science.gov (United States)

Hoppu, Kalle; Anabwani, Gabriel; Garcia-Bournissen, Facundo; Gazarian, Madlen; Kearns, Gregory L; Nakamura, Hidefumi; Peterson, Robert G; Sri Ranganathan, Shalini; de Wildt, Saskia N

2012-01-01

This review was conducted to examine the current status of paediatric medicines initiatives across the globe. The authors made a non-systematic descriptive review of current world situation. Two regions, the United States (US) and the European Union (EU), and the World Health Organization (WHO) have introduced strong paediatric initiatives to improve children's health through improving access to better paediatric medicines. The experience from the US initiative indicates that it is possible to stimulate development and study of paediatric medicines and provide important new information for improvement of paediatric therapy. The early results from the EU initiative are similarly encouraging. In Canada, Japan, Australia and other developed countries, specific paediatric medicines initiatives have been less extensive and weaker, with modest results. Disappointingly, current evidence suggests that results from clinical trials outside the US often do not benefit children in the country in which the trials were largely conducted. Pharmaceutical companies that have derived a financial benefit commensurate with the cost of doing the paediatric trials in one country do not seem to be making the results of these trials available to all countries if there is no financial incentive to the company. The WHO campaign 'make medicines child size' has produced substantive accomplishments in building improved foundations to improve mechanisms that will enhance children's access to critical medicines in resource-limited settings. However, practically all of this work has been performed using an amalgamation of short-term funding from a variety of sources as opposed to a sustained, programmatic commitment. Although much still needs to be done, it's clear that with concerted efforts and appropriate resources, change is possible but slow. Retaining and fostering public and political interest in paediatric medicines is challenging, but pivotal for success.
Clinical Trials

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...
A mHealth Application for Chronic Wound Care: Findings of a User Trial

Directory of Open Access Journals (Sweden)

Marcia R. Friesen

2013-11-01

Full Text Available This paper reports on the findings of a user trial of a mHealth application for pressure ulcer (bedsore documentation. Pressure ulcers are a leading iatrogenic cause of death in developed countries and significantly impact quality of life for those affected. Pressure ulcers will be an increasing public health concern as the population ages. Electronic information systems are being explored to improve consistency and accuracy of documentation, improve patient and caregiver experience and ultimately improve patient outcomes. A software application was developed for Android Smartphones and tablets and was trialed in a personal care home in Western Canada. The software application provides an electronic medical record for chronic wounds, replacing nurses’ paper-based charting and is positioned for integration with facility’s larger eHealth framework. The mHealth application offers three intended benefits over paper-based charting of chronic wounds, including: (1 the capacity for remote consultation (telehealth between facilities, practitioners, and/or remote communities, (2 data organization and analysis, including built-in alerts, automatically-generated text-based and graph-based wound histories including wound images, and (3 tutorial support for non-specialized caregivers. The user trial yielded insights regarding the software application’s design and functionality in the clinical setting, and highlighted the key role of wound photographs in enhancing patient and caregiver experiences, enhancing communication between multiple healthcare professionals, and leveraging the software’s telehealth capacities.
Cognitive behavioral therapy for depressed adolescents exposed to interpersonal trauma: an initial effectiveness trial.

Science.gov (United States)

Shirk, Stephen R; Deprince, Anne P; Crisostomo, Patrice S; Labus, Jennifer

2014-03-01

Four clinical trials have shown that a history of interpersonal trauma is associated with diminished response to cognitive-behavioral therapy (CBT) for adolescent depression. An efficacious CBT protocol for adolescent depression was modified to address cognitive deficits and distortions associated with interpersonal trauma. Initial feasibility, acceptability, and treatment impact of the modified treatment (m-CBT) were evaluated in a randomized effectiveness trial conducted in community clinics. Clients were 43 referred adolescents with a depressive disorder and a history of interpersonal trauma. Adolescents either received m-CBT or usual care (UC) therapy. Results indicated that m-CBT was delivered with good fidelity by community clinicians, but that number of sessions completed was attenuated in both m-CBT and UC. Adolescents reported high levels of treatment satisfaction and acceptability for the new treatment. There were significant reductions in depressive symptoms over time, but no differences in outcomes between groups. Although the new treatment produced promising results, it did not outperform UC. Implications for treatment development are considered. (c) 2014 APA, all rights reserved.
Early smoking initiation, sexual behavior and reproductive health - a large population-based study of Nordic women

DEFF Research Database (Denmark)

Hansen, Bo Terning; Kjaer, Susanne Krüger; Plum, Christian Edinger Munk

2010-01-01

To investigate associations between early smoking initiation, risk-taking behavior and reproductive health.......To investigate associations between early smoking initiation, risk-taking behavior and reproductive health....
Mental health leadership and patient access to care: a public-private initiative in South Africa.

Science.gov (United States)

Szabo, Christopher Paul; Fine, Jennifer; Mayers, Pat; Naidoo, Shan; Zabow, Tuviah

2017-01-01

Mental health leadership is a critical component of patient access to care. More specifically, the ability of mental health professionals to articulate the needs of patients, formulate strategies and engage meaningfully at the appropriate level in pursuit of resources. This is not a skill set routinely taught to mental health professionals. A public-private mental health leadership initiative, emanating from a patient access to care programme, was developed with the aim of building leadership capacity within the South African public mental health sector. The express aim was to equip health care professionals with the requisite skills to more effectively advocate for their patients. The initiative involved participants from various sites within South Africa. Inclusion was based on the proposal of an ongoing "project", i.e. a clinician-initiated service development with a multidisciplinary focus. The projects were varied in nature but all involved identification of and a plan for addressing an aspect of the participants' daily professional work which negatively impacted on patient care due to unmet needs. Six such projects were included and involved 15 participants, comprising personnel from psychiatry, psychology, occupational therapy and nursing. Each project group was formally mentored as part of the initiative, with mentors being senior professionals with expertise in psychiatry, public health and nursing. The programme design thus provided a unique practical dimension in which skills and learnings were applied to the projects with numerous and diverse outcomes. Benefits were noted by participants but extended beyond the individuals to the health institutions in which they worked and the patients that they served. Participants acquired both the skills and the confidence which enabled them to sustain the changes that they themselves had initiated in their institutions. The initiative gave impetus to the inclusion of public mental health as part of the curriculum
Measuring quality in health care and its implications for pay-for-performance initiatives.

Science.gov (United States)

Chung, Kevin C; Shauver, Melissa J

2009-02-01

The quality of health care is important to American consumers, and discussion on quality will be a driving force toward improving the delivery of health care in America. Funding agencies are proposing a variety of quality measures, such as centers of excellence, pay-for-participation, and pay-for-performance initiatives, to overhaul the health care delivery system in this country. It is quite uncertain, however, whether these quality initiatives will succeed in curbing the unchecked growth in health care spending in this country, and physicians understandably are concerned about more intrusion into the practice of medicine. This article outlines the genesis of the quality movement and discusses its effect on the surgical community.
Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

Directory of Open Access Journals (Sweden)

Julia V Bailey

2015-10-01

The best way to assess the impact of the MenSS website was by recording STI diagnoses from clinical records. Response rates for the online questionnaire were poor despite offers of incentives. There were many challenges to conducting an online trial of a sexual health website including ethical committee concerns about email content, poor reliability of trial-related software, balancing data protection and security protocols against ease of access for participants, barriers to patient access to IT in NHS clinics, and trying to ensure that participants engage with a digital intervention for long enough. Whilst digital interventions have great potential for health promotion, we encountered significant obstacles to online research, and to implementation of an IDI in an NHS clinical setting.
Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

Directory of Open Access Journals (Sweden)

Rahu Mati

2008-08-01

Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may
Feasibility, Acceptability, and Initial Efficacy of a Knowledge-Contact Program to Reduce Mental Illness Stigma and Improve Mental Health Literacy in Adolescents

Science.gov (United States)

Pinto-Foltz, Melissa D.; Logsdon, M. Cynthia; Myers, John A.

2011-01-01

The purpose of this school-based cluster-randomized trial was to determine the initial acceptability, feasibility, and efficacy of an existing community-based intervention, In Our Own Voice, in a sample of US adolescent girls aged 13–17 years (n=156). In Our Own Voice is a knowledge-contact intervention that provides knowledge about mental illness to improve mental health literacy and facilitates intergroup contact with persons with mental illness as a means to reduce mental illness stigma. This longitudinal study was set in two public high schools located in a southern urban community of the U.S. Outcomes included measures of mental illness stigma and mental health literacy. Findings support the acceptability and feasibility of the intervention for adolescents who enrolled in the study. Findings to support the efficacy of In Our Own Voice to reduce stigma and improve mental health literacy are mixed. The intervention did not reduce mental illness stigma or improve mental health literacy at one week follow up. The intervention did not reduce mental illness stigma at 4 and 8 weeks follow up. The intervention did improve mental health literacy at 4 and 8 weeks follow up. Previous studies have assessed the preliminary efficacy In Our Own Voice among young adults; rarely has In Our Own Voice been investigated longitudinally and with adolescents in the United States. This study provides initial data on the effects of In Our Own Voice for this population and can be used to further adapt the intervention for adolescents. PMID:21624729
The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Clare Linda

2012-07-01

Full Text Available Abstract Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75 will be randomized to one of three conditions: control (an interview involving a general discussion about the center; goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement; or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring. All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life, cognitive (memory and executive function, and physical fitness (functional and metabolic domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com

Clinical Trials

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Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...
Clinical Trials

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Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...
Drug availability and health facility usage in a Bamako Initiative and ...

African Journals Online (AJOL)

Background: The availability of drugs on a continuous basis is paramount to the success of any health care system. The Bamako Initiative (BI) had provision of essential drugs as one of its key thrusts in order to improve the utilization of health facilities. This study compared the perceived availability of essential drugs and ...
The World Health Organization World Mental Health Survey Initiative.

Science.gov (United States)

Kessler, Ronald C; Haro, Josep Maria; Heeringa, Steven G; Pennell, Beth-Ellen; Ustün, T Bedirhan

2006-01-01

To present an overview of the World Health Organization World Mental Health (WMH) Survey Initiative. The discussion draws on knowledge gleaned from the authors' participation as principals in WMH. WMH has carried out community epidemiological surveys in more than two dozen countries with more than 200,000 completed interviews. Additional surveys are in progress. Clinical reappraisal studies embedded in WMH surveys have been used to develop imputation rules to adjust prevalence estimates for within- and between-country variation in accuracy. WMH interviews include detailed information about sub-threshold manifestations to address the problem of rigid categorical diagnoses not applying equally to all countries. Investigations are now underway of targeted substantive issues. Despite inevitable limitations imposed by existing diagnostic systems and variable expertise in participating countries, WMH has produced an unprecedented amount of high-quality data on the general population cross-national epidemiology of mental disorders. WMH collaborators are in thoughtful and subtle investigations of cross-national variation in validity of diagnostic assessments and a wide range of important substantive topics. Recognizing that WMH is not definitive, finally, insights from this round of surveys are being used to carry out methodological studies aimed at improving the quality of future investigations.
78 FR 78964 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

Science.gov (United States)

2013-12-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The meeting announced below concerns The Cooperative Re-Engagement Controlled Trial (CoRECT), Funding Opportunity...
What cell biologists should know about the National Institutes of Health BRAIN Initiative

OpenAIRE

Insel, Thomas R.; Koroshetz, Walter

2015-01-01

The BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative is an ambitious project to develop innovative tools for a deeper understanding of how the brain functions in health and disease. Early programs in the National Institutes of Health BRAIN Initiative focus on tools for next-generation imaging and recording, studies of cell diversity and cell census, and integrative approaches to circuit function. In all of these efforts, cell biologists can play a leading role.
Health-economic evaluation in implant trials: design considerations.

Science.gov (United States)

Alt, Volker; Pavlidis, Theodoros; Szalay, Gabor; Heiss, Christian; Schnettler, Reinhard

2009-01-01

In today's world, demonstration of the safety, efficacy, and quality of a new treatment strategy is no longer sufficient in many countries for market entry and reimbursement in the public healthcare system. This implies that new implants in orthopedic and orthopedic trauma surgery not only must be shown to lead to better medical outcome compared with the standard of care implant, but also must be shown to exhibit "good value" for the money for the public health-care system based on sound economic data from health-economic studies. The purpose of this article is to elucidate a framework for health-economic aspects alongside implant trials, with the assumption that the new implant is more costly but potentially better than the control implant. Cost-effectiveness, cost-utility, and cost-benefit studies are suitable for the assessment of the health-economic value of a new implant. The following criteria should be considered for a health-economic study design in the context with an implant: i) it should state medical benefits of the new implant compared with the control implant; ii) it should precise the type of health economic study; iii) it should define the methodological approach, perspective of the study, and types of costs; iv) if necessary, it should state discount costs and/benefits; and v) a sound sensitivity analysis should be included. Furthermore, close cooperation between researchers, clinicians, and health economists is essential.
Health care administrators' perspectives on the role of absorptive capacity for strategic change initiatives: a qualitative study.

Science.gov (United States)

Kash, Bita A; Spaulding, Aaron; Gamm, Larry; Johnson, Christopher E

2013-01-01

The dimensions of absorptive capacity (ACAP) are defined, and the importance of ACAP is established in the management literature, but the concept has not been applied to health care organizations attempting to implement multiple strategic initiatives. The aim of this study was to test the utility of ACAP by analyzing health care administrators' experiences with multiple strategic initiatives within two health systems. Results are drawn from administrators' assessments of multiple initiatives within two health systems using in-depth personal interviews with a total of 61 health care administrators. Data analysis was performed following deductive qualitative analysis guidelines. Interview transcripts were coded based on the four dimensions of ACAP: acquiring, assimilating, internalizing/transforming, and exploiting knowledge. Furthermore, we link results related to utilization of management resources, including number of key personnel involved and time consumption, to dimensions of ACAP. Participants' description of multiple strategic change initiatives confirmed the importance of the four ACAP dimensions. ACAP can be a useful framework to assess organizational capacity with respect to the organization's ability to concurrently implement multiple strategic initiatives. This capacity specifically revolves around human capital requirements from upper management based on the initiatives' location or stage within the ACAP framework. Strategic change initiatives in health care can be usefully viewed from an ACAP perspective. There is a tendency for those strategic initiatives ranking higher in priority and time consumption to reflect more advanced dimensions of ACAP (assimilate and transform), whereas few initiatives were identified in the ACAP "exploit" dimension. This may suggest that health care leaders tend to no longer identify as strategic initiatives those innovations that have moved to the exploitation stage or that less attention is given to the exploitation
Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial

Science.gov (United States)

Lokman, Suzanne; Volker, Danielle; Zijlstra-Vlasveld, Moniek C; Brouwers, Evelien PM; Boon, Brigitte; Beekman, Aartjan TF; Smit, Filip; Van der Feltz-Cornelis, Christina M

2017-01-01

Objective To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. Design A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. Setting Occupational health care in the Netherlands. Participants Employees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. Interventions In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. Outcomes Measures Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. Results From the employer’s perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee’s perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier’s perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. Conclusions The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a
Implementation of oral health initiatives by Australian rural communities: Factors for success.

Science.gov (United States)

Taylor, Judy; Carlisle, Karen; Farmer, Jane; Larkins, Sarah; Dickson-Swift, Virginia; Kenny, Amanda

2018-01-01

In this paper, we consider factors significant in the success of community participation in the implementation of new oral health services. Our analysis draws on data from the Rural Engaging Communities in Oral Health (Rural ECOH) study (2014-2016). We aimed to assess the Australian relevance of a Scottish community participation framework for health service development; Remote Service Futures. Internationally, community participation in planning of health initiatives is common, but less common in new service implementation. Health managers query the legitimacy of "lay" community members, whether they will persist, and whether they can act as change agents. Our data provide evidence that helps answer these queries. Six communities, located within regions covered by two large rural primary healthcare organisations (Medicare Locals), were selected in two Australian states. Two university-based facilitators worked with a group of local residents (for each community) to monitor implementation of new oral health initiatives designed through participatory processes. Data about implementation were collected through interviews with 28 key stakeholders at the beginning of implementation and 12 months later. Data were coded, themed and analysed abductively. Five themes emerged; the inter-relationship between community motivation to participate with the fortunes of the oral health initiatives, having the "right" people involved, continuing involvement of sponsors and/or significant people, trusting working relationships between participants and perceiving benefits from participation. Findings provide evidence of a role for community participation in implementing new community services if solid partnerships with relevant providers can be negotiated and services are seen to be relevant and useful to the community. © 2017 John Wiley & Sons Ltd.
Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Poulsen, Rie; Fisker, Jonas; Hoff, Andreas; Hjorthøj, Carsten; Eplov, Lene Falgaard

2017-12-02

Common mental disorders are important contributors to the global burden of disease and cause negative effects on both the individual and society. Stress-related disorders influence the individual's workability and cause early retirement pensions in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this group. Integrated vocational and health care services have shown good effects on return to work in other similar welfare contexts. The purpose of the Danish IBBIS (Integreret Behandlings- og BeskæftigelsesIndsats til Sygemeldte) study is to examine the efficacy of (1) a stepped mental health care intervention with individual stress coaching and/or group-based MBSR and (2) an integrated stepped mental health care with individual stress coaching and/or group-based MBSR and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark. This three-armed, parallel-group, randomized superiority trial is set up to investigate the effectiveness of a stepped mental health care intervention and an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark. The trial has an investigator-initiated multicenter design. Six hundred and three patients will be recruited from Danish vocational rehabilitation centers in four municipalities and randomly assigned into three groups: (1) IBBIS mental health care integrated with IBBIS vocational rehabilitation, (2) IBBIS mental health care and standard vocational rehabilitation, and (3) standard mental health care and standard vocational rehabilitation. The primary outcome is register-based return to work at 12 months. The secondary outcome measures are self-assessed level of depression (BDI), anxiety (BAI), distress symptoms (4DSQ), work- and social functioning (WSAS), and
Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

Science.gov (United States)

Koziol-McLain, Jane; McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-10-25

Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were
The EPICS Trial: Enabling Parents to Increase Child Survival through the introduction of community-based health interventions in rural Guinea Bissau

Directory of Open Access Journals (Sweden)

Frost Chris

2009-08-01

Full Text Available Abstract Background Guinea-Bissau is a small country in West Africa with a population of 1.7 million. The WHO and UNICEF reported an under-five child mortality of 203 per 1000, the 10th highest amongst 192 countries. The aim of the trial is to assess whether an intervention package that includes community health promotion campaign and education through health clubs, intensive training and mentoring of village health workers to diagnose and provide first-line treatment for children's diseases within the community, and improved outreach services can generate a rapid and cost-effective reduction in under-five child mortality in rural regions of Guinea-Bissau. Effective Intervention plans to expand the project to a much larger region if there is good evidence after two and a half years that the project is generating a cost-effective, sustainable reduction in child mortality. Methods/design This trial is a cluster-randomised controlled trial involving 146 clusters. The trial will run for 2.5 years. The interventions will be introduced in two stages: seventy-three clusters will receive the interventions at the start of the project, and seventy-three control clusters will receive the interventions 2.5 years after the first clusters have received all interventions if the research shows that the interventions are effective. The impact of the interventions and cost-effectiveness will be measured during the first stage. The package of interventions includes a community health promotion campaign and education through health clubs, and intensive training and mentoring of village health workers to diagnose and provide first-line treatment for common children's diseases within the community. It also includes improved outreach services to encourage provision of antenatal and post natal care and provide ongoing monitoring for village health workers. The primary outcome of the trial will be the proportion of children that die under 5 years of age during the trial
SMILE: Simple, Mental Health, Initiative in Learning and Education.

Science.gov (United States)

Ward, L J

2011-12-01

SMILE is a Simple, Mental health, Initiative in Learning and Education. SMILE was a pilot project introduced into an undergraduate clinical nursing program, Southern Cross University, Australia 2010. The program aimed to improve the knowledge and skills of third-year nursing students participating in their first clinical placement in mental healthcare. Complementary to the clinical nursing program and the university curriculum, SMILE provided further training and support for student learning in mental healthcare. The SMILE project was a structured 15-day education program that covered the following topics: suicide prevention; psychosis; drugs and alcohol education; mental state exam; families and carers in mental health; and the Mental Health Act. The education sessions were one hour in duration. The educational material and resources were created from current research, literature and health service policy. A problem-based learning approach was used to support this education project. The dynamic factor related to SMILE was that it was based in the field. SMILE enabled the students to bridge a theory-practice gap and expand upon their current knowledge base as well as participate in ward activity. Twenty students attending their first clinical placement in mental healthcare participated in SMILE and were asked to complete a pre- and post- evaluation questionnaire before starting and upon completion of the 15-day project. The students participating in SMILE reported a greater understanding of mental healthcare issues and expressed a developing knowledge base and improved practical skill level. SMILE was a positive initiative that provided valuable feedback and opportunity to improve on clinical education in mental healthcare.
Evaluating energy, health and carbon co-benefits from improved domestic space heating: A randomised community trial

International Nuclear Information System (INIS)

Preval, Nick; Chapman, Ralph; Pierse, Nevil; Howden-Chapman, Philippa

2010-01-01

In order to value the costs and benefits associated with improved space heating we analysed the Housing, Heating and Health Study, a randomised community trial involving installation of energy efficient and healthy heaters (heat pump, wood pellet burner or flued gas heater) in homes with basic insulation and poor heating, occupied by households which included a child with asthma. We compared the initial purchase and installation cost of heaters with changes in the number of visits to health professionals, time off work/school, caregiving, and pharmaceutical use for household members and changes in total household energy use and carbon emissions following the intervention. We used two scenarios to analyse the results over the predicted 12-year life-span of the heaters. The targeted approach (Scenario A - assuming high rates of household asthma throughout the period of analysis) produced enough health-related benefits to offset the cost of the heaters, and when total energy use and carbon emission savings were included in the analysis the ratio of benefits to costs was 1.09:1. The untargeted approach (Scenario B - assuming typical New Zealand asthma rates throughout the period of analysis) had a ratio of total benefits to costs of 0.31:1.
Evaluating energy, health and carbon co-benefits from improved domestic space heating. A randomised community trial

Energy Technology Data Exchange (ETDEWEB)

Preval, Nick; Pierse, Nevil; Howden-Chapman, Philippa [He Kainga Oranga/Housing and Health Research Programme, University of Otago, Wellington, PO Box 7343, Wellington South (New Zealand); Chapman, Ralph [School of Geography, Graduate Programme in Environmental Studies, Environment and Earth Sciences, Victoria University, PO Box 600, Wellington 6140 (New Zealand)

2010-08-15

In order to value the costs and benefits associated with improved space heating we analysed the Housing, Heating and Health Study, a randomised community trial involving installation of energy efficient and healthy heaters (heat pump, wood pellet burner or flued gas heater) in homes with basic insulation and poor heating, occupied by households which included a child with asthma. We compared the initial purchase and installation cost of heaters with changes in the number of visits to health professionals, time off work/school, caregiving, and pharmaceutical use for household members and changes in total household energy use and carbon emissions following the intervention. We used two scenarios to analyse the results over the predicted 12-year life-span of the heaters. The targeted approach (Scenario A - assuming high rates of household asthma throughout the period of analysis) produced enough health-related benefits to offset the cost of the heaters, and when total energy use and carbon emission savings were included in the analysis the ratio of benefits to costs was 1.09:1. The untargeted approach (Scenario B - assuming typical New Zealand asthma rates throughout the period of analysis) had a ratio of total benefits to costs of 0.31:1. (author)
Evaluating energy, health and carbon co-benefits from improved domestic space heating: A randomised community trial

Energy Technology Data Exchange (ETDEWEB)

Preval, Nick [He Kainga Oranga/Housing and Health Research Programme, University of Otago, Wellington, PO Box 7343, Wellington South (New Zealand); Chapman, Ralph, E-mail: Ralph.chapman@vuw.ac.n [School of Geography, Graduate Programme in Environmental Studies, Environment and Earth Sciences, Victoria University, PO Box 600, Wellington 6140 (New Zealand); Pierse, Nevil; Howden-Chapman, Philippa [He Kainga Oranga/Housing and Health Research Programme, University of Otago, Wellington, PO Box 7343, Wellington South (New Zealand)

2010-08-15

In order to value the costs and benefits associated with improved space heating we analysed the Housing, Heating and Health Study, a randomised community trial involving installation of energy efficient and healthy heaters (heat pump, wood pellet burner or flued gas heater) in homes with basic insulation and poor heating, occupied by households which included a child with asthma. We compared the initial purchase and installation cost of heaters with changes in the number of visits to health professionals, time off work/school, caregiving, and pharmaceutical use for household members and changes in total household energy use and carbon emissions following the intervention. We used two scenarios to analyse the results over the predicted 12-year life-span of the heaters. The targeted approach (Scenario A - assuming high rates of household asthma throughout the period of analysis) produced enough health-related benefits to offset the cost of the heaters, and when total energy use and carbon emission savings were included in the analysis the ratio of benefits to costs was 1.09:1. The untargeted approach (Scenario B - assuming typical New Zealand asthma rates throughout the period of analysis) had a ratio of total benefits to costs of 0.31:1.
A self-determination multiple risk intervention trial to improve smokers' health.

Science.gov (United States)

Williams, Geoffrey C; McGregor, Holly; Sharp, Daryl; Kouldes, Ruth W; Lévesque, Chantal S; Ryan, Richard M; Deci, Edward L

2006-12-01

Little is known about how interventions motivate individuals to change multiple health risk behaviors. Self-determination theory (SDT) proposes that patient autonomy is an essential factor for motivating change. An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested. The Smokers' Health Study is a randomized multiple risk behavior change intervention trial. Smokers were recruited to a tobacco treatment center. A total of 1.006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements. A 6-month clinical intervention (4 contacts) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care. Clinicians elicited patient perspectives and life strivings, provided absolute coronary artery disease risk estimates,enumerated effective treatment options, supported patient initiatives,minimized clinician control, assessed motivation for change, and developed a plan for change. Twelve-month prolonged tobacco abstinence, and change in percent calories from fat and low-density lipoprotein-cholesterol (LDL-C) from baseline to 18 months. RESULTS- Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence (6.2% vs 2.4%; odds ratio [OR]=2.7, P=.01, number needed to treat [NNT] =26), and reduced LDL-C (-8.9 vs -4.1 mg/dL; P=.05). There was no effect on percent calories from fat. An intervention focused on supporting smokers'autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence.
The impact of global health initiatives on the health system in Angola.

Science.gov (United States)

Craveiro, Isabel; Dussault, Gilles

2016-01-01

We assessed the impact of global health initiatives (GHIs) on the health care system of Angola, as a contribution to documenting how GHIs, such as the Global Fund, GAVI and PEPFAR, influence the planning and delivery of health services in low-income countries and how national systems respond. We collected the views of national and sub-national key informants through 42 semi-structured interviews between April 2009 and May 2011 (12 at the national level and 30 at the sub-national level). We used a snowball technique to identify respondents from government, donors and non-governmental organisations. GHIs stimulated the formulation of a health policy and of plans and strategies, but the country has yet to decide on its priorities for health. At the regional level, managers lack knowledge of how GHIs' function, but they assess the effects of external funds as positive as they increased training opportunities, and augment the number of workers engaged in HIV or other specific disease programmes. However, GHIs did not address the challenge of attraction and retention of qualified personnel in provinces. Since Angola is not entirely dependent on external funding, national strategic programmes and the interventions of GHIs co-habit well, in contrast to countries such as Mozambique, which heavily depend on external aid.
Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

Science.gov (United States)

McLean, Christine; Rohan, Maheswaran; Sisk, Rose; Dobbs, Terry; Nada-Raja, Shyamala; Wilson, Denise; Vandal, Alain C

2016-01-01

Background Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. Objective The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. Methods In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. Results The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated

Support for At-Risk Girls: A School-Based Mental Health Nursing Initiative.

Science.gov (United States)

Adamshick, Pamela

2015-09-01

Mental health problems often go undiagnosed or unaddressed until a crisis or extreme event brings the problem to the forefront. Youth are particularly at risk for lack of identification and treatment in regard to mental health issues. This article describes an advanced nursing practice mental health initiative for at-risk teenage girls based on Hildegard Peplau's nursing theory, group process, and healing through holistic health approaches. A support group, RICHES, was developed with focus on core components of relationships, identity, communication, health, esteem, and support. The acronym RICHES was chosen as the name of the support group. Selected themes and issues addressed in this school-based support group are illustrated in case vignettes. Through a collaborative approach with the community and school, this practice initiative presents a unique healing process that extends knowledge in the realm of intervention with at-risk teenage girls. Further research is needed on the efficacy of support groups to modify risk factors and to address goals for primary prevention in at-risk teenage girls. © The Author(s) 2014.
Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

Science.gov (United States)

James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

2016-08-01

Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.
Clinical Trials

Medline Plus

Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...
Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Doyle Conor

2011-10-01

Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.
How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

Directory of Open Access Journals (Sweden)

Wenxi Tang

2015-03-01

Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients
How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China.

Science.gov (United States)

Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

2015-01-01

While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. The integrated care system needs collaborative work from different levels
How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

Directory of Open Access Journals (Sweden)

Wenxi Tang

2015-03-01

Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion
Leveraging finances for public health system improvement: results from the Turning Point initiative.

Science.gov (United States)

Bekemeier, Betty; Riley, Catharine M; Berkowitz, Bobbie

2007-01-01

Reforming the public health infrastructure requires substantial system changes at the state level; state health agencies, however, often lack the resources and support for strategic planning and systemwide improvement. The Turning Point Initiative provided support for states to focus on large-scale system changes that resulted in increased funding for public health capacity and infrastructure development. Turning Point provides a test case for obtaining financial and institutional resources focused on systems change and infrastructure development-areas for which it has been historically difficult to obtain long-term support. The purpose of this exploratory, descriptive survey research was to enumerate the actual resources leveraged toward public health system improvement through the partnerships, planning, and implementation activities funded by the Robert Wood Johnson Foundation as a part of the Turning Point Initiative.
Electronic health records to facilitate clinical research

OpenAIRE

Cowie, Martin R.; Blomster, Juuso I.; Curtis, Lesley H.; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, J?rg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P.; Southworth, Mary Ross; Stough, Wendy Gattis

2016-01-01

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the pr...
Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial.

Science.gov (United States)

Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

2018-01-10

Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing
Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

Science.gov (United States)

Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

2018-03-05

The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and
Designing "Real-World" trials to meet the needs of health policy makers at marketing authorization.

Science.gov (United States)

Calvert, Melanie; Wood, John; Freemantle, Nick

2011-07-01

There is increasing interest in conducting "Real-World" trials that go beyond traditional assessment of efficacy and safety to examine market access and value for money questions before marketing authorization of a new pharmaceutical product or health technology. This commentary uses practical examples to demonstrate how high-quality evidence of the cost-effectiveness of an intervention may be gained earlier in the development process. Issues surrounding the design and analysis of "Real-World" trials to demonstrate relative cost-effectiveness early in the life of new technologies are discussed. The modification of traditional phase III trial designs, de novo trial designs, the combination of trial-based and epidemiological data, and the use of simulation model-based approaches to address reimbursement questions are described. Modest changes to a phase III trial protocol and case report form may be undertaken at the design stage to provide valid estimates of health care use and the benefits accrued; however, phase III designs often preclude "real-life" practice. Relatively small de novo trials may be used to address adherence to therapy or patient preference, although simply designed studies with active comparators enrolling large numbers of patients may provide evidence on long-term safety and rare adverse events. Practical examples demonstrate that it is possible to provide high-quality evidence of the cost-effectiveness of an intervention earlier in the development process. Payers and decision makers should preferentially adopt treatments with such evidence than treatments for which evidence is lacking or of lower quality. Copyright © 2011 Elsevier Inc. All rights reserved.
Factors Affecting Initial Intimate Partner Violence-Specific Health Care Seeking in the Tokyo Metropolitan Area, Japan.

Science.gov (United States)

Kamimura, Akiko; Bybee, Deborah; Yoshihama, Mieko

2014-09-01

This study examined the factors affecting a women's initial intimate partner violence (IPV)-specific health care seeking event which refers to the first health care seeking as a result of IPV in a lifetime. Data were collected using the Life History Calendar method in the Tokyo metropolitan area from 101 women who had experienced IPV. Discrete-time survival analysis was used to assess the time to initial IPV-specific health care seeking. IPV-related injury was the most significant factor associated with increased likelihood of seeking IPV-specific health care seeking for the first time. In the presence of a strong effect of formal help seeking, physical and sexual IPV were no longer significantly related to initial IPV-specific health care seeking. The results suggest some victims of IPV may not seek health care unless they get injured. The timing of receiving health care would be important to ensure the health and safety of victims. © The Author(s) 2014.
Global health initiative investments and health systems strengthening: a content analysis of global fund investments.

Science.gov (United States)

Warren, Ashley E; Wyss, Kaspar; Shakarishvili, George; Atun, Rifat; de Savigny, Don

2013-07-26

Millions of dollars are invested annually under the umbrella of national health systems strengthening. Global health initiatives provide funding for low- and middle-income countries through disease-oriented programmes while maintaining that the interventions simultaneously strengthen systems. However, it is as yet unclear which, and to what extent, system-level interventions are being funded by these initiatives, nor is it clear how much funding they allocate to disease-specific activities - through conventional 'vertical-programming' approach. Such funding can be channelled to one or more of the health system building blocks while targeting disease(s) or explicitly to system-wide activities. We operationalized the World Health Organization health system framework of the six building blocks to conduct a detailed assessment of Global Fund health system investments. Our application of this framework framework provides a comprehensive quantification of system-level interventions. We applied this systematically to a random subset of 52 of the 139 grants funded in Round 8 of the Global Fund to Fight AIDS, Tuberculosis and Malaria (totalling approximately US$1 billion). According to the analysis, 37% (US$ 362 million) of the Global Fund Round 8 funding was allocated to health systems strengthening. Of that, 38% (US$ 139 million) was for generic system-level interventions, rather than disease-specific system support. Around 82% of health systems strengthening funding (US$ 296 million) was allocated to service delivery, human resources, and medicines & technology, and within each of these to two to three interventions. Governance, financing, and information building blocks received relatively low funding. This study shows that a substantial portion of Global Fund's Round 8 funds was devoted to health systems strengthening. Dramatic skewing among the health system building blocks suggests opportunities for more balanced investments with regard to governance, financing, and
A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults.

Science.gov (United States)

Dolovich, Lisa; Oliver, Doug; Lamarche, Larkin; Agarwal, Gina; Carr, Tracey; Chan, David; Cleghorn, Laura; Griffith, Lauren; Javadi, Dena; Kastner, Monika; Longaphy, Jennifer; Mangin, Dee; Papaioannou, Alexandra; Ploeg, Jenny; Raina, Parminder; Richardson, Julie; Risdon, Cathy; Santaguida, P Lina; Straus, Sharon; Thabane, Lehana; Valaitis, Ruta; Price, David

2016-04-05

Healthcare systems are not well designed to help people maintain or improve their health. They are generally not person-focused or well-coordinated. The objective of this study is to evaluate the effectiveness of the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) approach in older adults. The overarching hypothesis is that using the Health TAPESTRY approach to achieve better integration of the health and social care systems into a person's life that centers on meeting a person's health goals and needs will result in optimal aging. This is a 12-month delayed intervention pragmatic randomized controlled trial. The study will be performed in Hamilton, Ontario, Canada in the two-site McMaster Family Health Team. Participants will include 316 patients who are 70 years of age or older. Participants will be randomized to the Health TAPESTRY approach or control group. The Health TAPESTRY approach includes intentional, proactive conversations about a person's life and health goals and health risks and then initiation of congruent tailored interventions that support achievement of those goals and addressing of risks through (1) trained volunteers visiting clients in their homes to serve as a link between the primary care team and the client; (2) the use of novel technology including a personal health record from the home to link directly with the primary healthcare team; and (3) improved processes for connections, system navigation, and care delivery among interprofessional primary care teams, community service providers, and informal caregivers. The primary outcome will be the goal attainment scaling score. Secondary outcomes include self-efficacy for managing chronic disease, quality of life, the participant perspective on their own aging, social support, access to health services, comprehensiveness of care, patient empowerment, patient-centeredness, caregiver strain, satisfaction with care, healthcare resource utilization, and cost
Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

Science.gov (United States)

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie

2017-01-01

Background Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary
Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Greenberg, Rachel G; Corneli, Amy; Bradley, John; Farley, John; Jafri, Hasan S; Lin, Li; Nambiar, Sumathi; Noel, Gary J; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.
Additional self-monitoring tools in the dietary modification component of The Women's Health Initiative.

Science.gov (United States)

Mossavar-Rahmani, Yasmin; Henry, Holly; Rodabough, Rebecca; Bragg, Charlotte; Brewer, Amy; Freed, Trish; Kinzel, Laura; Pedersen, Margaret; Soule, C Oehme; Vosburg, Shirley

2004-01-01

Self-monitoring promotes behavior changes by promoting awareness of eating habits and creates self-efficacy. It is an important component of the Women's Health Initiative dietary intervention. During the first year of intervention, 74% of the total sample of 19,542 dietary intervention participants self-monitored. As the study progressed the self-monitoring rate declined to 59% by spring 2000. Participants were challenged by inability to accurately estimate fat content of restaurant foods and the inconvenience of carrying bulky self-monitoring tools. In 1996, a Self-Monitoring Working Group was organized to develop additional self-monitoring options that were responsive to participant needs. This article describes the original and additional self-monitoring tools and trends in tool use over time. Original tools were the Food Diary and Fat Scan. Additional tools include the Keeping Track of Goals, Quick Scan, Picture Tracker, and Eating Pattern Changes instruments. The additional tools were used by the majority of participants (5,353 of 10,260 or 52% of participants who were self-monitoring) by spring 2000. Developing self-monitoring tools that are responsive to participant needs increases the likelihood that self-monitoring can enhance dietary reporting adherence, especially in long-term clinical trials.
Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

DEFF Research Database (Denmark)

Andersson, J; Angenete, E; Gellerstedt, M

2013-01-01

Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.......Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....
Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network.

Science.gov (United States)

Borschmann, Rohan; Patterson, Sue; Poovendran, Dilkushi; Wilson, Danielle; Weaver, Tim

2014-02-17

Recruitment to trials is complex and often protracted; selection bias may compromise generalisability. In the mental health field (as elsewhere), diverse factors have been described as hindering researcher access to potential participants and various strategies have been proposed to overcome barriers. However, the extent to which various influences identified in the literature are operational across mental health settings in England has not been systematically examined. A cross-sectional, online survey of clinical studies officers employed by the Mental Health Research Network in England to recruit to trials from National Health Service mental health services. The bespoke questionnaire invited participants to report exposure to specified influences on recruitment, the perceived impact of these on access to potential participants, and to describe additional positive or negative influences on recruitment. Analysis employed descriptive statistics, the framework approach and triangulation of data. Questionnaires were returned by 98 (58%) of 170 clinical studies officers who reported diverse experience. Data demonstrated a disjunction between policy and practice. While the particulars of trial design and various marketing and communication strategies could influence recruitment, consensus was that the culture of NHS mental health services is not conducive to research. Since financial rewards for recruitment paid to Trusts and feedback about studies seldom reaching frontline services, clinicians were described as distanced from research. Facing continual service change and demanding clinical workloads, clinicians generally did not prioritise recruitment activities. Incentives to trial participants had variable impact on access but recruitment could be enhanced by engagement of senior investigators and integrating referral with routine practice. Comprehensive, robust feasibility studies and reciprocity between researchers and clinicians were considered crucial to

Effectiveness of a universal health-promoting parenting program: a randomized waitlist-controlled trial of All Children in Focus.

Science.gov (United States)

Ulfsdotter, Malin; Enebrink, Pia; Lindberg, Lene

2014-10-18

Parenting programs have been highlighted as a way of supporting and empowering parents. As programs designed to promote children's health and well-being are scarce, a new health-promotion program, All Children in Focus, has been developed. The purpose of this trial was to evaluate the potential effectiveness of the program in promoting parental self-efficacy and child health and development, as well as to investigate possible moderators of these outcomes. A multicenter randomized waitlist-controlled trial was conducted. The trial included 621 parents with children aged 3-12 years. Parents were randomized to receive the intervention directly or to join a waitlist control group. Parents completed questionnaires at baseline, 2 weeks after the intervention, and 6 months post-baseline. To evaluate potential effects of the program, as well as any moderating variables, multilevel modeling with a repeated-measures design was applied. Parents in the intervention group reported that their self-efficacy (p parents in the control group. One variable was found to moderate both outcomes: parents' positive mental health. Furthermore, parents' educational level and number of children moderated parental self-efficacy, while the children's age moderated child health and development. Having a poor positive mental health, a university-level education, more than one child in the family, and older children, made the families benefit more. In the first randomized controlled trial of All Children in Focus, we found that the program appears to promote both parental self-efficacy and children's health and development in a general population. Additionally, we found that families may benefit differently depending on their baseline characteristics. This contributes to an existing understanding of the advantages of offering universal parenting programs as a public health approach to strengthening families. However, further research is needed to investigate long-term effects and mediating
Clinical Trials

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Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...
Does Integrated Behavioral Health Care Reduce Mental Health Disparities for Latinos? Initial Findings

Science.gov (United States)

Bridges, Ana J.; Andrews, Arthur R.; Villalobos, Bianca T.; Pastrana, Freddie A.; Cavell, Timothy A.; Gomez, Debbie

2014-01-01

Integrated behavioral health care (IBHC) is a model of mental health care service delivery that seeks to reduce stigma and service utilization barriers by embedding mental health professionals into the primary care team. This study explored whether IBHC service referrals, utilization, and outcomes were comparable for Latinos and non-Latino White primary care patients. Data for the current study were collected from 793 consecutive patients (63.8% Latino; M age = 29.02 years [SD = 17.96]; 35.1% under 18 years; 65.3% women; 54.3% uninsured) seen for behavioral health services in 2 primary care clinics during a 10.5 month period. The most common presenting concerns were depression (21.6%), anxiety (18.5%), adjustment disorder (13.0%), and externalizing behavior problems (9.8%). Results revealed that while Latino patients had significantly lower self-reported psychiatric distress, significantly higher clinician-assigned global assessment of functioning scores, and fewer received a psychiatric diagnosis at their initial visit compared to non-Latino White patients, both groups had comparable utilization rates, comparable and clinically significant improvements in symptoms (Cohen’s d values > .50), and expressed high satisfaction with integrated behavioral services. These data provide preliminary evidence suggesting integration of behavioral health services into primary care clinics may help reduce mental health disparities for Latinos. PMID:25309845
A Student-Led Global Health Education Initiative: Reflections on the Kenyan Village Medical Education Program

Science.gov (United States)

John, Christopher; Asquith, Heidi; Wren, Tom; Mercuri, Stephanie; Brownlow, Sian

2016-01-01

The Kenyan Village Medical Education Program is a student-led global health initiative that seeks to improve health outcomes in rural Kenya through culturally appropriate health education. The month-long program, which is organised by the Melbourne University Health Initiative (Australia), is conducted each January in southern rural Kenya. Significance for public health The Kenyan Village Medical Education (KVME) Program is a student-led global health initiative that involves exploring well-established strategies for the prevention of disease through workshops that are conducted in southern rural Kenya. These workshops are tailored to the unique needs and circumstances of rural Kenyan communities, and are delivered to community leaders, as well as to adults and children within the wider community. Aside from the KVME Program’s emphasis on reducing the burden of preventable disease through health education, the positive impact of the KVME Program on the Program’s student volunteers also deserves consideration. Throughout the month-long KVME Program, student volunteers are presented with opportunities to develop their understanding of cultural competency, the social and economic determinants of health, as well as the unique challenges associated with working in resource-poor communities. Importantly, the KVME Program also represents an avenue through which global health leadership can be fostered amongst student volunteers. PMID:27190974
Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

Science.gov (United States)

Turner, Katrina M; Percival, John; Kessler, David; Donovan, Jenny

2017-06-15

The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. There are important differences between usual-care and intervention arms that go beyond treatment received, and
The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial.

Science.gov (United States)

Clare, Linda; Hindle, John V; Jones, Ian R; Thom, Jeanette M; Nelis, Sharon M; Hounsome, Barry; Whitaker, Christopher J

2012-07-24

Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75) will be randomized to one of three conditions: control (an interview involving a general discussion about the center); goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement); or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring). All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life), cognitive (memory and executive function), and physical fitness (functional and metabolic) domains. Cost-effectiveness will also be examined. This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com).
An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.

Science.gov (United States)

Berglind, Daniel; Nyberg, Gisela; Willmer, Mikaela; Persson, Margareta; Wells, Michael; Forsell, Yvonne

2018-04-27

Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability. There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1). International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.
Clinical Trials

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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...
Clinical Trials

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Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...
Collecting and analysing cost data for complex public health trials: reflections on practice

Directory of Open Access Journals (Sweden)

Neha Batura

2014-02-01

Full Text Available Background: Current guidelines for the conduct of cost-effectiveness analysis (CEA are mainly applicable to facility-based interventions in high-income settings. Differences in the unit of analysis and the high cost of data collection can make these guidelines challenging to follow within public health trials in low- and middle- income settings. Objective: This paper reflects on the challenges experienced within our own work and proposes solutions that may be useful to others attempting to collect, analyse, and compare cost data between public health research sites in low- and middle-income countries. Design: We describe the generally accepted methods (norms for collecting and analysing cost data in a single-site trial from the provider perspective. We then describe our own experience applying these methods within eight comparable cluster randomised, controlled, trials. We describe the strategies used to maximise adherence to the norm, highlight ways in which we deviated from the norm, and reflect on the learning and limitations that resulted. Results: When the expenses incurred by a number of small research sites are used to estimate the cost-effectiveness of delivering an intervention on a national scale, then deciding which expenses constitute ‘start-up’ costs will be a nontrivial decision that may differ among sites. Similarly, the decision to include or exclude research or monitoring and evaluation costs can have a significant impact on the findings. We separated out research costs and argued that monitoring and evaluation costs should be reported as part of the total trial cost. The human resource constraints that we experienced are also likely to be common to other trials. As we did not have an economist in each site, we collaborated with key personnel at each site who were trained to use a standardised cost collection tool. This approach both accommodated our resource constraints and served as a knowledge sharing and capacity
Collecting and analysing cost data for complex public health trials: reflections on practice

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Batura, Neha; Pulkki-Brännström, Anni-Maria; Agrawal, Priya; Bagra, Archana; Haghparast-Bidgoli, Hassan; Bozzani, Fiammetta; Colbourn, Tim; Greco, Giulia; Hossain, Tanvir; Sinha, Rajesh; Thapa, Bidur; Skordis-Worrall, Jolene

2014-01-01

Background Current guidelines for the conduct of cost-effectiveness analysis (CEA) are mainly applicable to facility-based interventions in high-income settings. Differences in the unit of analysis and the high cost of data collection can make these guidelines challenging to follow within public health trials in low- and middle- income settings. Objective This paper reflects on the challenges experienced within our own work and proposes solutions that may be useful to others attempting to collect, analyse, and compare cost data between public health research sites in low- and middle-income countries. Design We describe the generally accepted methods (norms) for collecting and analysing cost data in a single-site trial from the provider perspective. We then describe our own experience applying these methods within eight comparable cluster randomised, controlled, trials. We describe the strategies used to maximise adherence to the norm, highlight ways in which we deviated from the norm, and reflect on the learning and limitations that resulted. Results When the expenses incurred by a number of small research sites are used to estimate the cost-effectiveness of delivering an intervention on a national scale, then deciding which expenses constitute ‘start-up’ costs will be a nontrivial decision that may differ among sites. Similarly, the decision to include or exclude research or monitoring and evaluation costs can have a significant impact on the findings. We separated out research costs and argued that monitoring and evaluation costs should be reported as part of the total trial cost. The human resource constraints that we experienced are also likely to be common to other trials. As we did not have an economist in each site, we collaborated with key personnel at each site who were trained to use a standardised cost collection tool. This approach both accommodated our resource constraints and served as a knowledge sharing and capacity building process within the
The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

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Swift Louise

2011-07-01

Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is
Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

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Gourgou-Bourgade, S; Cameron, D; Poortmans, P; Asselain, B; Azria, D; Cardoso, F; A'Hern, R; Bliss, J; Bogaerts, J; Bonnefoi, H; Brain, E; Cardoso, M J; Chibaudel, B; Coleman, R; Cufer, T; Dal Lago, L; Dalenc, F; De Azambuja, E; Debled, M; Delaloge, S; Filleron, T; Gligorov, J; Gutowski, M; Jacot, W; Kirkove, C; MacGrogan, G; Michiels, S; Negreiros, I; Offersen, B V; Penault Llorca, F; Pruneri, G; Roche, H; Russell, N S; Schmitt, F; Servent, V; Thürlimann, B; Untch, M; van der Hage, J A; van Tienhoven, G; Wildiers, H; Yarnold, J; Bonnetain, F; Mathoulin-Pélissier, S; Bellera, C; Dabakuyo-Yonli, T S

2015-05-01

Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
The Border Environmental Health Initiative-investigating the transboundary Santa Cruz watershed

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Norman, Laura M.; Callegary, James; van Riper, Charles; Gray, Floyd

2010-01-01

In 2004 the U.S. Geological Survey (USGS) launched the Border Environmental Health Initiative (BEHI), a major project encompassing the entire U.S.-Mexico border region. In 2009, a study of the Santa Cruz River Watershed (SCW), located in the border region of Arizona and Sonora, Mexico, was initiated as part of the BEHI. In this borderland region of the desert Southwest, human health and the ecosystems on which humans rely depend critically on limited water resources. Surface water is scarce during much of the year, and groundwater is the primary source for industrial, agricultural, and domestic use. In order to identify risks to water resources in the SCW, and the potential consequences to riparian ecosystems and ultimately human health, the USGS is using an interdisciplinary and integrative approach that incorporates the expertise of geographers, hydrologists, biologists, and geologists to track organic and inorganic contaminants and their effects from sources to sinks in sediment, water, plants, and animals. Existing groundwater and surface-water models are being used and modified to assess contaminant and sediment transport.
Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative

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Rachel G. Greenberg

2018-03-01

Of the 136 providers surveyed, 52/136 (38% had previously referred a pediatric patient to a trial, and only 17/136 (12% had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.
Effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement and mental health: Results of a randomized controlled trial

NARCIS (Netherlands)

Berkel, J. van; Boot, C.R.L.; Proper, K.I.; Bongers, P.M.; Beek, A.J. van der

2014-01-01

Objectives: The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multicomponent health promotion intervention on work engagement, mental health, need for recovery and mindfulness. Methods: In a randomized controlled trial design, 257 workers of two
Effectiveness of a Worksite Mindfulness-Related Multi-Component Health Promotion Intervention on Work Engagement and Mental Health: Results of a Randomized Controlled Trial

NARCIS (Netherlands)

van Berkel, J.; Boot, C.R.L.; Proper, K.I.; Bongers, P.M.; van der Beek, A.J.

2014-01-01

Objectives: The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multicomponent health promotion intervention on work engagement, mental health, need for recovery and mindfulness. Methods: In a randomized controlled trial design, 257 workers of two
Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial.

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Coghlan, John Gerry; Galiè, Nazzareno; Barberà, Joan Albert; Frost, Adaani E; Ghofrani, Hossein-Ardeschir; Hoeper, Marius M; Kuwana, Masataka; McLaughlin, Vallerie V; Peacock, Andrew J; Simonneau, Gérald; Vachiéry, Jean-Luc; Blair, Christiana; Gillies, Hunter; Miller, Karen L; Harris, Julia H N; Langley, Jonathan; Rubin, Lewis J

2017-07-01

Patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), in particular systemic sclerosis (SSc), had an attenuated response compared with idiopathic PAH in most trials. Thus, there is uncertainty regarding the benefit of PAH-targeted therapy in some forms of CTD-PAH. To explore the safety and efficacy of initial combination therapy with ambrisentan and tadalafil versus ambrisentan or tadalafil monotherapy in patients with CTD-PAH and SSc-PAH enrolled in the AMBITION trial. This was a post hoc analysis of patients with CTD-PAH and SSc-PAH from AMBITION, an event-driven, double-blind trial in patients with WHO functional class II/III PAH. Treatment-naive patients were randomised 2:1:1 to once-daily initial combination therapy with ambrisentan plus tadalafil or monotherapy with ambrisentan or tadalafil, respectively. The primary endpoint was time to the first clinical failure event (first occurrence of death, hospitalisation for worsening PAH, disease progression or unsatisfactory long-term clinical response). In the primary analysis set (N=500), 187 patients had CTD-PAH, of whom 118 had SSc-PAH. Initial combination therapy reduced the risk of clinical failure versus pooled monotherapy in each subgroup: CTD-PAH (HR 0.43 (95% CI 0.24 to 0.77)) and SSc-PAH (0.44 (0.22 to 0.89)). The most common AE was peripheral oedema, which was reported more frequently with initial combination therapy than monotherapy in the two PAH subgroups. The relative frequency of adverse events between those on combination therapy versus monotherapy was similar across subgroups. This post hoc subgroup analysis provides evidence that CTD-PAH and SSc-PAH patients benefit from initial ambrisentan and tadalafil combination therapy. NCT01178073, post results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

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Scheuermann, Taneisha S; Richter, Kimber P; Rigotti, Nancy A; Cummins, Sharon E; Harrington, Kathleen F; Sherman, Scott E; Zhu, Shu-Hong; Tindle, Hilary A; Preacher, Kristopher J

2017-12-01

To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States. Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822). Outcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. Usable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group. In the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence. © 2017 Society for the Study of Addiction.
An Evaluation of the Implementation and Impact of England's Mandated School-Based Mental Health Initiative in Elementary Schools

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Wolpert, Miranda; Humphrey, Neil; Deighton, Jessica; Patalay, Praveetha; Fugard, Andrew J. B.; Fonagy, Peter; Belsky, Jay; Vostanis, Panos

2015-01-01

We report on a randomized controlled trial of Targeted Mental Health in Schools (TaMHS), which is a nationally mandated school-based mental health program in England. TaMHS aimed to improve mental health for students with, or at risk of, behavioral and emotional difficulties by providing evidence-informed interventions relating to closer working…

[Constraints and opportunities for inter-sector health promotion initiatives: a case study].

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Magalhães, Rosana

2015-07-01

This article analyzes the implementation of inter-sector initiatives linked to the Family Grant, Family Health, and School Health Programs in the Manguinhos neighborhood in the North Zone of Rio de Janeiro, Brazil. The study was conducted in 2010 and 2011 and included document review, local observation, and 25 interviews with program managers, professionals, and staff. This was an exploratory case study using a qualitative approach that identified constraints and opportunities for inter-sector health experiences, contributing to the debate on the effectiveness of health promotion and poverty relief programs.
Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

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Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.
The Health Informatics Trial Enhancement Project (HITE: Using routinely collected primary care data to identify potential participants for a depression trial

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Lyons Ronan A

2010-04-01

Full Text Available Abstract Background Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered. Methods Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL database of routinely collected health records was interrogated, using Structured Query Language (SQL. Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation. Results The study population (N = 37263 comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement. Conclusions This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER.
Understanding the patient perspective on research access to national health records databases for conduct of randomized registry trials.

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Avram, Robert; Marquis-Gravel, Guillaume; Simard, François; Pacheco, Christine; Couture, Étienne; Tremblay-Gravel, Maxime; Desplantie, Olivier; Malhamé, Isabelle; Bibas, Lior; Mansour, Samer; Parent, Marie-Claude; Farand, Paul; Harvey, Luc; Lessard, Marie-Gabrielle; Ly, Hung; Liu, Geoffrey; Hay, Annette E; Marc Jolicoeur, E

2018-07-01

Use of health administrative databases is proposed for screening and monitoring of participants in randomized registry trials. However, access to these databases raises privacy concerns. We assessed patient's preferences regarding use of personal information to link their research records with national health databases, as part of a hypothetical randomized registry trial. Cardiology patients were invited to complete an anonymous self-reported survey that ascertained preferences related to the concept of accessing government health databases for research, the type of personal identifiers to be shared and the type of follow-up preferred as participants in a hypothetical trial. A total of 590 responders completed the survey (90% response rate), the majority of which were Caucasians (90.4%), male (70.0%) with a median age of 65years (interquartile range, 8). The majority responders (80.3%) would grant researchers access to health administrative databases for screening and follow-up. To this end, responders endorsed the recording of their personal identifiers by researchers for future record linkage, including their name (90%), and health insurance number (83.9%), but fewer responders agreed with the recording of their social security number (61.4%, pgranting researchers access to the administrative databases (OR: 1.69, 95% confidence interval: 1.03-2.90; p=0.04). The majority of Cardiology patients surveyed were supportive of use of their personal identifiers to access administrative health databases and conduct long-term monitoring in the context of a randomized registry trial. Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.
The Arctic Human Health Initiative: a legacy of the International Polar Year 2007-2009.

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Parkinson, Alan J

2013-01-01

The International Polar Year (IPY) 2007-2008 represented a unique opportunity to further stimulate cooperation and coordination on Arctic health research and increase the awareness and visibility of Arctic regions. The Arctic Human Health Initiative (AHHI) was a US-led Arctic Council IPY coordinating project that aimed to build and expand on existing International Union for Circumpolar Health (IUCH) and Arctic Council human health interests. The project aimed to link researchers with potential international collaborators and to serve as a focal point for human health research, education, outreach and communication activities during the IPY. The progress of projects conducted as part of this initiative up until the end of the Arctic Council Swedish chairmanship in May 2013 is summarized in this report. The overall goals of the AHHI was to increase awareness and visibility of human health concerns of Arctic peoples, foster human health research, and promote health strategies that will improve health and well-being of all Arctic residents. Proposed activities to be recognized through the initiative included: expanding research networks that will enhance surveillance and monitoring of health issues of concern to Arctic peoples, and increase collaboration and coordination of human health research; fostering research that will examine the health impact of anthropogenic pollution, rapid modernization and economic development, climate variability, infectious and chronic diseases, intentional and unintentional injuries, promoting education, outreach and communication that will focus public and political attention on Arctic health issues, using a variety of publications, printed and electronic reports from scientific conferences, symposia and workshops targeting researchers, students, communities and policy makers; promoting the translation of research into health policy and community action including implementation of prevention strategies and health promotion; and
Provider-Initiated Late Preterm Births in Brazil: Differences between Public and Private Health Services.

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Leal, Maria do Carmo; Esteves-Pereira, Ana Paula; Nakamura-Pereira, Marcos; Torres, Jacqueline Alves; Domingues, Rosa Maria Soares Madeira; Dias, Marcos Augusto Bastos; Moreira, Maria Elizabeth; Theme-Filha, Mariza; da Gama, Silvana Granado Nogueira

2016-01-01

A large proportion of the rise in prematurity worldwide is owing to late preterm births, which may be due to the expansion of obstetric interventions, especially pre-labour caesarean section. Late preterm births pose similar risks to overall prematurity, making this trend a concern. In this study, we describe factors associated with provider-initiated late preterm birth and verify differences in provider-initiated late preterm birth rates between public and private health services according to obstetric risk. This is a sub-analysis of a national population-based survey of postpartum women entitled "Birth in Brazil", performed between 2011 and 2012. We included 23,472 singleton live births. We performed non-conditional multiple logistic regressions assessing associated factors and analysing differences between public and private health services. Provider-initiated births accounted for 38% of late preterm births; 32% in public health services and 61% in private health services. They were associated with previous preterm birth(s) and maternal pathologies for women receiving both public and private services and with maternal age ≥35 years for women receiving public services. Women receiving private health services had higher rates of provider-initiated late preterm birth (rate of 4.8%) when compared to the ones receiving public services (rate of 2.4%), regardless of obstetric risk-adjusted OR of 2.3 (CI 1.5-3.6) for women of low obstetric risk and adjusted OR of 1.6 (CI 1.1-2.3) for women of high obstetric risk. The high rates of provider-initiated late preterm birth suggests a considerable potential for reduction, as such prematurity can be avoided, especially in women of low obstetric risk. To promote healthy births, we advise introducing policies with incentives for the adoption of new models of birth care.
Provider-Initiated Late Preterm Births in Brazil: Differences between Public and Private Health Services.

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Maria do Carmo Leal

Full Text Available A large proportion of the rise in prematurity worldwide is owing to late preterm births, which may be due to the expansion of obstetric interventions, especially pre-labour caesarean section. Late preterm births pose similar risks to overall prematurity, making this trend a concern. In this study, we describe factors associated with provider-initiated late preterm birth and verify differences in provider-initiated late preterm birth rates between public and private health services according to obstetric risk.This is a sub-analysis of a national population-based survey of postpartum women entitled "Birth in Brazil", performed between 2011 and 2012. We included 23,472 singleton live births. We performed non-conditional multiple logistic regressions assessing associated factors and analysing differences between public and private health services.Provider-initiated births accounted for 38% of late preterm births; 32% in public health services and 61% in private health services. They were associated with previous preterm birth(s and maternal pathologies for women receiving both public and private services and with maternal age ≥35 years for women receiving public services. Women receiving private health services had higher rates of provider-initiated late preterm birth (rate of 4.8% when compared to the ones receiving public services (rate of 2.4%, regardless of obstetric risk-adjusted OR of 2.3 (CI 1.5-3.6 for women of low obstetric risk and adjusted OR of 1.6 (CI 1.1-2.3 for women of high obstetric risk.The high rates of provider-initiated late preterm birth suggests a considerable potential for reduction, as such prematurity can be avoided, especially in women of low obstetric risk. To promote healthy births, we advise introducing policies with incentives for the adoption of new models of birth care.
Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency.

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Larson, Gregg S; Baseler, Beth R; Hoover, Marie L; Pierson, Jerome F; Tegli, Jemee K; Johnson, Melvin P; Kieh, Mark W S; McNay, Laura A; Njoh, Wissedi Sio

2017-07-01

Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.
Reference bias: presentation of extreme health states prior to eq-vas improves health-related quality of life scores. a randomised cross-over trial

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McPhail Steven

2010-12-01

Full Text Available Abstract Background Clinical practice and clinical research has made a concerted effort to move beyond the use of clinical indicators alone and embrace patient focused care through the use of patient reported outcomes such as health-related quality of life. However, unless patients give consistent consideration to the health states that give meaning to measurement scales used to evaluate these constructs, longitudinal comparison of these measures may be invalid. This study aimed to investigate whether patients give consideration to a standard health state rating scale (EQ-VAS and whether consideration of good and poor health state descriptors immediately changes their self-report. Methods A randomised crossover trial was implemented amongst hospitalised older adults (n = 151. Patients were asked to consider descriptions of extremely good (Description-A and poor (Description-B health states. The EQ-VAS was administered as a self-report at baseline, after the first descriptors (A or B, then again after the remaining descriptors (B or A respectively. At baseline patients were also asked if they had considered either EQ-VAS anchors. Results Overall 106/151 (70% participants changed their self-evaluation by ≥5 points on the 100 point VAS, with a mean (SD change of +4.5 (12 points (p Conclusions Health state self-reports may not be well considered. An immediate significant shift in response can be elicited by exposure to a mere description of an extreme health state despite no actual change in underlying health state occurring. Caution should be exercised in research and clinical settings when interpreting subjective patient reported outcomes that are dependent on brief anchors for meaning. Trial Registration Australian and New Zealand Clinical Trials Registry (#ACTRN12607000606482 http://www.anzctr.org.au
The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

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Thabane Lehana

2008-02-01

Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of
Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints

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Tone Langjordet Johnsen

2016-08-01

Full Text Available Abstract Background Subjective health complaints, such as musculoskeletal and mental health complaints, have a high prevalence in the general population, and account for a large proportion of sick leave in Norway. It may be difficult to prevent the occurrence of subjective health complaints, but it may be possible to influence employees’ perception and management of these complaints, which in turn may have impact on sick leave and return to work after sick leave. Long term sick leave has many negative health and social consequences, and it is important to gain knowledge about effective interventions to prevent and reduce long term sick leave. Methods/Design This study is a cluster randomised controlled trial to evaluate the effect of the modified atWork intervention, targeting non-specific musculoskeletal complaints and mental health complaints. This intervention will be compared to the original atWork intervention targeting only non-specific musculoskeletal complaints. Kindergartens in Norway are invited to participate in the study and will be randomly assigned to one of the two interventions. Estimated sample size is 100 kindergartens, with a total of approximately 1100 employees. Primary outcome is sick leave at unit level, measured using register data from the Norwegian Labour and Welfare Administration. One kindergarten equals one unit, regardless of number of employees. Secondary outcomes will be measured at the individual level and include coping, health, job satisfaction, social support, and workplace inclusion, collected through questionnaires distributed at baseline and at 12 months follow up. All employees in the included kindergartens are eligible for participating in the survey. Discussion The effect evaluation of the modified atWork intervention is a large and comprehensive project, providing evidence-based information on prevention of long-term sick leave, which may be of considerable benefit both from a societal
Cost Analysis of the STONE Randomized Trial: Can Health Care Costs be Reduced One Test at a Time?

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Melnikow, Joy; Xing, Guibo; Cox, Ginger; Leigh, Paul; Mills, Lisa; Miglioretti, Diana L; Moghadassi, Michelle; Smith-Bindman, Rebecca

2016-04-01

Decreasing the use of high-cost tests may reduce health care costs. To compare costs of care for patients presenting to the emergency department (ED) with suspected kidney stones randomized to 1 of 3 initial imaging tests. Patients were randomized to point-of-care ultrasound (POC US, least costly), radiology ultrasound (RAD US), or computed tomography (CT, most costly). Subsequent testing and treatment were the choice of the treating physician. A total of 2759 patients at 15 EDs were randomized to POC US (n=908), RAD US, (n=893), or CT (n=958). Mean age was 40.4 years; 51.8% were male. All medical care documented in the trial database in the 7 days following enrollment was abstracted and coded to estimate costs using national average 2012 Medicare reimbursements. Costs for initial ED care and total 7-day costs were compared using nonparametric bootstrap to account for clustering of patients within medical centers. Initial ED visit costs were modestly lower for patients assigned to RAD US: $423 ($411, $434) compared with patients assigned to CT: $448 ($438, $459) (Pcosts were not significantly different between groups: $1014 ($912, $1129) for POC US, $970 ($878, $1078) for RAD US, and $959 ($870, $1044) for CT. Hospital admissions contributed over 50% of total costs, though only 11% of patients were admitted. Mean total costs (and admission rates) varied substantially by site from $749 to $1239. Assignment to a less costly test had no impact on overall health care costs for ED patients. System-level interventions addressing variation in admission rates from the ED might have greater impact on costs.
Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

Science.gov (United States)

Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

2016-07-01

Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.
Promoting social inclusion in schools: a group-randomized trial of effects on student health risk behavior and well-being.

Science.gov (United States)

Patton, George C; Bond, Lyndal; Carlin, John B; Thomas, Lyndal; Butler, Helen; Glover, Sara; Catalano, Richard; Bowes, Glenn

2006-09-01

We sought to test the efficacy of an intervention that was designed to promote social inclusion and commitment to education, in reducing among students health risk behaviors and improving emotional well-being. The design was a cluster-randomized trial in 25 secondary schools in Victoria, Australia. The subjects were 8th-grade students (aged 13 to 14 y) in 1997 (n=2545) and subsequent 8th-grade students in 1999 (n=2586) and 2001 (n=2463). The main outcomes were recent substance use, antisocial behavior, initiation of sexual intercourse, and depressive symptoms. At 4-year follow-up, the prevalence of marked health risk behaviors was approximately 20% in schools in the comparison group and 15% in schools in the intervention group, an overall reduction of 25%. In ordinal logistic regression models a protective effect of intervention was found for a composite measure of health risk behaviors in unadjusted models (odds ratio [OR]= 0.69; 95% confidence interval [CI]= 0.50, 0.95) and adjusted models (OR= 0.71; CI =0.52, 0.97) for potential confounders. There was no evidence of a reduction in depressive symptoms. The study provides support for prevention strategies in schools that move beyond health education to promoting positive social environments.
Predictors on delay of initial health-seeking in new pulmonary tuberculosis cases among migrants population in East China.

Directory of Open Access Journals (Sweden)

Xinxu Li

Full Text Available OBJECTIVES: To determine the length of delay in initial health-seeking in new pulmonary tuberculosis (PTB cases among migrant population in the eastern part of China, and factors associated with it. METHODS: A cross-sectional study was conducted using a structured questionnaire in six counties in Shanghai, Guangdong and Jiangsu from May to October, 2008, to estimate the extent and factors responsible for delayed initial health-seeking of the new PTB cases. The interval between self-reported onset of TB symptoms and date of first attendance at any medical institution was determined. More than the median duration was defined as delayed health-seeking. RESULTS: A total of 323 new migrant PTB patients participated in the study. Only 6.5% had medical insurance. The median and mean durations to initial health-seeking were respectively 10 and 31 days. There was no significant association between socio-demographic factors and delayed initial health-seeking. Average monthly working days >24 (AOR, 1.61; 95% CI, 1.03-2.51, and hemoptysis or bloody sputum (AOR, 0.48; 95% CI, 0.28-0.85 were significantly associated with delayed initial health-seeking. CONCLUSIONS: Interventions to improve health seeking behavior among the migrant population in China must focus on strengthening their labor, medical security and health education.
Eastern Health Board Regional Orthodontic Service: an initial audit.

LENUS (Irish Health Repository)

Dowling, P A

1997-01-01

This initial audit of 600 recently assessed Eastern Health Board orthodontic patients suggests that a large number of them (47 per cent) requires referral for routine restorative and preventive dental care. Closer links are needed with general dental practitioners and community dental surgeons to resolve these needs. The trend for a high referral of females and Class 11 Division 1 malocclusion type correlated well with studies in other countries.
The Impact of Two Workplace-Based Health Risk Appraisal Interventions on Employee Lifestyle Parameters, Mental Health and Work Ability: Results of a Randomized Controlled Trial

Science.gov (United States)

Addley, K.; Boyd, S.; Kerr, R.; McQuillan, P.; Houdmont, J.; McCrory, M.

2014-01-01

Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental…
Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.

Science.gov (United States)

Beran, Roy G

2004-01-01

Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal
Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill.

Science.gov (United States)

Thomas, Kirsty; Wright, Stephen E; Watson, Gillian; Baker, Catherine; Stafford, Victoria; Wade, Clare; Chadwick, Thomas J; Mansfield, Leigh; Wilkinson, Jennifer; Shen, Jing; Deverill, Mark; Bonner, Stephen; Hugill, Keith; Howard, Philip; Henderson, Andrea; Roy, Alistair; Furneval, Julie; Baudouin, Simon V

2015-05-25

Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised controlled trials to determine the most effective rehabilitation strategy for critically ill patients at risk of critical illness-associated physical morbidity. In response to this, we will conduct a randomised controlled trial, comparing physiotherapy aimed at early and intensive patient mobilisation with routine care. We hypothesise that this intervention will improve physical outcomes and the mental health and functional well-being of survivors of critical illness. 308 adult patients who have received more than 48 h of non-invasive or invasive ventilation in Critical Care will be recruited to a patient-randomised, parallel group, controlled trial, comparing two intensities of physiotherapy. Participants will be randomised to receive either standard or intensive physiotherapy for the duration of their Critical Care admission. Outcomes will be recorded on Critical Care discharge, at 3 and 6 months following initial recruitment to the study. The primary outcome measure is physical health at 6 months, as measured by the SF-36 Physical Component Summary. Secondary outcomes include assessment of mental health, activities of daily living, delirium and ventilator-free days. We will also include a health economic analysis. The trial has ethical approval from Newcastle and North Tyneside 2 Research Ethics Committee (11/NE/0206). There is a Trial Oversight Committee including an independent chair. The results of the study will be submitted for publication in peer-reviewed journals and
Real-world comparison of health care utilization between duloxetine and pregabalin initiators with fibromyalgia

Directory of Open Access Journals (Sweden)

Peng X

2014-01-01

Full Text Available X Peng,1 P Sun,2 D Novick,1 J Andrews,1 S Sun2 1Eli Lilly and Company, Indianapolis, IN, USA; 2Kailo Research Group, Indianapolis, IN, USA Objectives: To compare health care utilization of duloxetine initiators and pregabalin initiators among fibromyalgia patients in a real-world setting. Methods: A retrospective cohort study was conducted based on a US national commercial health claims database (2006–2009. Fibromyalgia patients who initiated duloxetine or pregabalin in 2008, aged 18–64 years, and who maintained continuous health insurance coverage 1 year before and 1 year after initiation were assigned to duloxetine or pregabalin cohorts on the basis of their initiated agent. Patients who had pill coverage of the agents over the course of 90 days preceding the initiation were excluded. The two comparative cohorts were constructed using propensity score greedy match methods. Descriptive analysis and paired t-test were performed to compare health care utilization rates in the postinitiation year and the changes of these rates from the preinitiation year to the postinitiation year. Results: Both matched cohorts (n=1,265 pairs had a similar mean initiation age (49–50 years, percentage of women (87%–88%, and prevalence of baseline comorbid conditions (neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, hypertension, headache or migraine, and osteoarthritis. In the preinitiation year, both cohorts had similar inpatient, outpatient, and medication utilization rates (inpatient, 15.7%–16.1%; outpatient, 100.0%; medication, 97.9%–98.7%. The utilization rates diverged in the postinitiation year, with the pregabalin cohort using more fibromyalgia-related inpatient care (3.2% versus 2.2%; P<0.05, any inpatient care (19.3% versus 16.8%; P<0.05, and fibromyalgia-related outpatient care (62.1% versus 51.8%; P<0.05. From the preinitiation period to the postinitiation period, the duloxetine cohort

Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial

OpenAIRE

Martinez, Esteban; Gonzalez-Cordon, Ana; Ferrer, Elena; Domingo, Pere; Negredo, Eugenia; Gutierrez, Felix; Portilla, Joaquin; Curran, Adrià; Podzamczer, Daniel; Ribera, Esteban; Murillas, Javier; Bernardino, Jose I.; Santos, Ignacio; Carton, Jose A.; Peraire, Joaquim

2015-01-01

This article has been accepted for publication in Clinical Infectious Diseases ©2014 The Authors .Published by Oxford University Press on Clinical Infectious Disease 60.5. DOI: 10.1093/cid/ciu898 Background. It is unclear whether metabolic or body composition effects may differ between protease inhibitor-based regimens recommended for initial treatment of HIV infection. Methods. ATADAR is a phase IV, open-label, multicenter randomized clinical trial. Stable antiretroviral-naive HIV-in...
Using systems thinking in state health policymaking: an educational initiative.

Science.gov (United States)

Minyard, Karen J; Ferencik, Rachel; Ann Phillips, Mary; Soderquist, Chris

2014-06-01

In response to limited examples of opportunities for state policymakers to learn about and productively discuss the difficult, adaptive challenges of our health system, the Georgia Health Policy Center developed an educational initiative that applies systems thinking to health policymaking. We created the Legislative Health Policy Certificate Program - an in-depth, multi-session series for lawmakers and their staff - concentrating on building systems thinking competencies and health content knowledge by applying a range of systems thinking tools: behavior over time graphs, stock and flow maps, and a system dynamics-based learning lab (a simulatable model of childhood obesity). Legislators were taught to approach policy issues from the big picture, consider changing dynamics, and explore higher-leverage interventions to address Georgia's most intractable health challenges. Our aim was to determine how we could improve the policymaking process by providing a systems thinking-focused educational program for legislators. Over 3 years, the training program resulted in policymakers' who are able to think more broadly about difficult health issues. The program has yielded valuable insights into the design and delivery of policymaker education that could be applied to various disciplines outside the legislative process.
Calcium plus vitamin D supplementation and the risk of incident diabetes in the Women's Health Initiative.

Science.gov (United States)

de Boer, Ian H; Tinker, Lesley F; Connelly, Stephanie; Curb, J David; Howard, Barbara V; Kestenbaum, Bryan; Larson, Joseph C; Manson, JoAnn E; Margolis, Karen L; Siscovick, David S; Weiss, Noel S

2008-04-01

Experimental and epidemiologic studies suggest that calcium and vitamin D may reduce the risk of developing diabetes. We examined the effect of calcium plus vitamin D supplementation on the incidence of drug-treated diabetes in postmenopausal women. The Women's Health Initiative Calcium/Vitamin D Trial randomly assigned postmenopausal women to receive 1,000 mg elemental calcium plus 400 IU of vitamin D3 daily, or placebo, in a double-blind fashion. Among 33,951 participants without self-reported diabetes at baseline, we ascertained by treatment assignment new diagnoses of diabetes treated with oral hypoglycemic agents or insulin. Effects of the intervention on fasting measurements of glucose, insulin, and insulin resistance were examined among a subset of participants. Over a median follow-up time of 7 years, 2,291 women were newly diagnosed with diabetes. The hazard ratio for incident diabetes associated with calcium/vitamin D treatment was 1.01 (95% CI 0.94-1.10) based on intention to treat. This null result was robust in subgroup analyses, efficacy analyses accounting for nonadherence, and analyses examining change in laboratory measurements. Calcium plus vitamin D3 supplementation did not reduce the risk of developing diabetes over 7 years of follow-up in this randomized placebo-controlled trial. Higher doses of vitamin D may be required to affect diabetes risk, and/or associations of calcium and vitamin D intake with improved glucose metabolism observed in nonrandomized studies may be the result of confounding or of other components of foods containing these nutrients.
Mental health first aid training for nursing students: a protocol for a pragmatic randomised controlled trial in a large university.

Science.gov (United States)

Crawford, Gemma; Burns, Sharyn K; Chih, Hui Jun; Hunt, Kristen; Tilley, P J Matt; Hallett, Jonathan; Coleman, Kim; Smith, Sonya

2015-02-19

The impact of mental health problems and disorders in Australia is significant. Mental health problems often start early and disproportionately affect young people. Poor adolescent mental health can predict educational achievement at school and educational and occupational attainment in adulthood. Many young people attend higher education and have been found to experience a range of mental health issues. The university setting therefore presents a unique opportunity to trial interventions to reduce the burden of mental health problems. Mental Health First Aid (MHFA) aims to train participants to recognise symptoms of mental health problems and assist an individual who may be experiencing a mental health crisis. Training nursing students in MHFA may increase mental health literacy and decrease stigma in the student population. This paper presents a protocol for a trial to examine the efficacy of the MHFA training for students studying nursing at a large university in Perth, Western Australia. This randomised controlled trial will follow the CONSORT guidelines. Participants will be randomly allocated to the intervention group (receiving a MHFA training course comprising two face to face 6.5 hour sessions run over two days during the intervention period) or a waitlisted control group (not receiving MHFA training during the study). The source population will be undergraduate nursing students at a large university located in Perth, Western Australia. Efficacy of the MHFA training will be assessed by following the intention-to-treat principle and repeated measures analysis. Given the known burden of mental health disorders among student populations, it is important universities consider effective strategies to address mental health issues. Providing MHFA training to students offers the advantage of increasing mental health literacy, among the student population. Further, students trained in MHFA are likely to utilise these skills in the broader community, when they
The legacy of the Child Health and Nutrition Research Initiative (CHNRI).

Science.gov (United States)

Black, Robert E

2016-06-01

Under the Global Forum for Health Research, the Child Health and Nutrition Research Initiative (CHNRI) began its operations in 1999 and became a Swiss foundation in 2006. The vision of CHNRI was to improve child health and nutrition of all children in low- and middle-income countries (LMIC) through research that informs health policy and practice. Specific objectives included expanding global knowledge on childhood disease burden and cost-effectiveness of interventions, promoting priority setting in research, ensuring inclusion of institutions and scientists in LMIC in setting priorities, promoting capacity development in LMIC and stimulating donors and countries to increase resources for research. CHNRI created a knowledge network, funded research through multiple rounds of a global competitive process and published research papers and policy briefs. A signature effort was to develop a systematic methodology for prioritizing health and nutrition research investments. The "CHNRI method" has been extensively applied to global health problems and is now the most commonly used method for prioritizing health research questions.
Improving health-related fitness in children: the fit-4-Fun randomized controlled trial study protocol

Directory of Open Access Journals (Sweden)

Eather Narelle

2011-12-01

Full Text Available Abstract Background Declining levels of physical fitness in children are linked to an increased risk of developing poor physical and mental health. Physical activity programs for children that involve regular high intensity physical activity, along with muscle and bone strengthening activities, have been identified by the World Health Organisation as a key strategy to reduce the escalating burden of ill health caused by non-communicable diseases. This paper reports the rationale and methods for a school-based intervention designed to improve physical fitness and physical activity levels of Grades 5 and 6 primary school children. Methods/Design Fit-4-Fun is an 8-week multi-component school-based health-related fitness education intervention and will be evaluated using a group randomized controlled trial. Primary schools from the Hunter Region in NSW, Australia, will be invited to participate in the program in 2011 with a target sample size of 128 primary schools children (age 10-13. The Fit-4-Fun program is theoretically grounded and will be implemented applying the Health Promoting Schools framework. Students will participate in weekly curriculum-based health and physical education lessons, daily break-time physical activities during recess and lunch, and will complete an 8-week (3 × per week home activity program with their parents and/or family members. A battery of six health-related fitness assessments, four days of pedometery-assessed physical activity and a questionnaire, will be administered at baseline, immediate post-intervention (2-months and at 6-months (from baseline to determine intervention effects. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention program, assessments, process evaluation and statistical analyses are described. Discussion The Fit-4-Fun program is an innovative school-based intervention targeting fitness improvements in primary school children. The program will
Clinical Trials

Medline Plus

Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...
Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

Science.gov (United States)

Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

2016-02-01

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.
What Factors are Associated with Consumer Initiation of Shared Decision Making in Mental Health Visits?

OpenAIRE

Matthias, Marianne S.; Fukui, Sadaaki; Salyers, Michelle P.

2017-01-01

Understanding consumer initiation of shared decision making (SDM) is critical to improving SDM in mental health consultations, particularly because providers do not always invite consumer participation in treatment decisions. This study examined the association between consumer initiation of nine elements of SDM as measured by the SDM scale, and measures of consumer illness self-management and the consumer-provider relationship. In 63 mental health visits, three SDM elements were associated w...
Clinical Trials

Medline Plus

Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...
Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

Science.gov (United States)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.
Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study

Directory of Open Access Journals (Sweden)

Fassett Robert G

2010-06-01

Full Text Available Abstract Background The most appropriate time to initiate dialysis after surgical insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare immediate with delayed use. The primary objective is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting PD. Methods/Design This is a randomised controlled trial of patients who will start PD after insertion of Tenckhoff catheter at Royal Brisbane and Women's Hospital (RBWH or Rockhampton Base Hospital (RBH who meet the inclusion criteria. Patients will be stratified by site and diabetic status. The patients will be randomised to one of three treatment groups. Group 1 will start PD one week after Tenckhoff catheter insertion, group 2 at two weeks and group 3 at four weeks. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection after initiation of PD. Discussion The study will determine the most appropriate time to initiate PD after placement of a Tenckhoff catheter. Trial Registration ACTRN12610000076077
Clinical Trials

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Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and ...
Effectiveness of a Web-Based Tailored Intervention (E-health4Uth) and Consultation to Promote Adolescents’ Health: Randomized Controlled Trial

Science.gov (United States)

Bannink, Rienke; Broeren, Suzanne; Joosten-van Zwanenburg, Evelien; van As, Els; van de Looij-Jansen, Petra

2014-01-01

Background To promote well-being and health behaviors among adolescents, 2 interventions were implemented at 12 secondary schools. Adolescents in the E-health4Uth group received Web-based tailored messages focused on their health behaviors and well-being. Adolescents in the E-health4Uth and consultation group received the same tailored messages, but were subsequently referred to a school nurse for a consultation if they were at risk of mental health problems. Objective This study evaluated the effect of E-health4Uth and E-health4Uth and consultation on well-being (ie, mental health status and health-related quality of life) and health behaviors (ie, alcohol and drug use, smoking, safe sex). Methods A cluster randomized controlled trial was conducted among third- and fourth-year secondary school students (mean age 15.9, SD 0.69). School classes (clusters) were randomly assigned to (1) E-health4Uth group, (2) E-health4Uth and consultation group, or (3) control group (ie, care as usual). Adolescents completed a questionnaire at baseline and at 4-month follow-up assessing alcohol consumption, smoking, drug use, condom use, mental health via the Strengths and Difficulties Questionnaire (SDQ) and the Youth Self Report (YSR; only measured at follow-up), and health-related quality of life. Multilevel logistic, ordinal, and linear regression analyses were used to reveal differences in health behavior and well-being between the intervention groups and the control group at follow-up. Subsequently, it was explored whether demographics moderated the effects. Results Data from 1256 adolescents were analyzed. Compared to the control intervention, the E-health4Uth intervention, as a standalone intervention, showed minor positive results in health-related quality of life (B=2.79, 95% CI 0.72-4.87) and condom use during intercourse among adolescents of Dutch ethnicity (OR 3.59, 95% CI 1.71-7.55) not replicated in the E-health4Uth and consultation group. The E-health4Uth and
Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

Science.gov (United States)

Massett, Holly A; Dilts, David M; Bailey, Robert; Berktold, Jennifer; Ledsky, Rebecca; Atkinson, Nancy L; Mishkin, Grace; Denicoff, Andrea; Padberg, Rose Mary; Allen, Marin P; Silver, Karen; Carrington, Kelli; Johnson, Lenora E

2017-05-01

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.
The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

DEFF Research Database (Denmark)

Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.

2010-01-01

strategies are needed to reduce occupational hand eczema. METHODS/DESIGN: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified...... from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease...
Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

Directory of Open Access Journals (Sweden)

Evelyn Korkor Ansah

2009-01-01

Full Text Available Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly.2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used services more frequently than those in
#LancerHealth: Using Twitter and Instagram as a tool in a campus wide health promotion initiative.

Science.gov (United States)

Santarossa, Sara; Woodruff, Sarah J

2018-02-05

The present study aimed to explore using popular technology that people already have/use as a health promotion tool, in a campus wide social media health promotion initiative, entitled #LancerHealth . During a two-week period the university community was asked to share photos on Twitter and Instagram of What does being healthy on campus look like to you ?, while tagging the image with #LancerHealth . All publically tagged media was collected using the Netlytic software and analysed. Text analysis (N=234 records, Twitter; N=141 records, Instagram) revealed that the majority of the conversation was positive and focused on health and the university. Social network analysis, based on five network properties, showed a small network with little interaction. Lastly, photo coding analysis (N=71 unique image) indicated that the majority of the shared images were of physical activity (52%) and on campus (80%). Further research into this area is warranted.
Randomised controlled trial of tumour necrosis factor inhibitors against combination intensive therapy with conventional disease-modifying antirheumatic drugs in established rheumatoid arthritis: the TACIT trial and associated systematic reviews.

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Scott, David L; Ibrahim, Fowzia; Farewell, Vern; O'Keeffe, Aidan G; Ma, Margaret; Walker, David; Heslin, Margaret; Patel, Anita; Kingsley, Gabrielle

2014-10-01

DMARDs (adjusted linear regression coefficient -0.11, 95% CI -0.18 to -0.03; p = 0.009) whereas 6-month changes in HAQ and EQ-5D scores and 6- and 12-month changes in joint damage were similar between the initial cDMARD group and the initial TNFi group. Longitudinal analyses (adjusted general estimating equations) showed that the DAS28 was lower in the initial TNFi group in the first 6 months (coefficient -0.63, 95% CI -0.93 to -0.34; p < 0.001) but there were no differences between the groups in months 6-12. In total, 36 patients in the initial cDMARD group and 44 in the initial TNFi group achieved DAS28 remission. The onset of remission did not differ between groups (p = 0.085 on log-rank test). In total, 10 patients in the initial cDMARD group and 18 in the initial TNFi group experienced serious adverse events; stopping therapy because of toxicity occurred in 10 and six patients respectively. Economic evaluation showed that the cDMARD group had similar or better QALY outcomes than TNFi with significantly lower costs at 6 and 12 months. In the systematic reviews we identified 32 trials (including 20-1049 patients) on early RA and 19 trials (including 40-982 patients) on established RA that compared (1) cDMARDs with DMARD monotherapy; (2) TNFis/methotrexate with methotrexate monotherapy; and (3) cDMARDs with TNFis/methotrexate. They showed that cDMARDs and TNFis had similar efficacies and toxicities. Active RA patients who have failed methotrexate and another DMARD achieve equivalent clinical benefits at a lower cost from starting cDMARDs or from starting TNFis (reserving TNFis for non-responders). Only a minority of patients achieve sustained remission with cDMARDs or TNFis; new strategies are needed to maximise the frequency of remission. Current Control Trials ISRCTN37438295. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 66. See
Successful recruitment to trials: findings from the SCIMITAR+ Trial.

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Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

2018-01-19

Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

Free breakfasts in schools: design and conduct of a cluster randomised controlled trial of the Primary School Free Breakfast Initiative in Wales [ISRCTN18336527

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Hale Janine

2007-09-01

Full Text Available Abstract Background School-based breakfast provision is increasingly being seen as a means of improving educational performance and dietary behaviour amongst children. Furthermore, recognition is growing that breakfast provision offers potential as a means of addressing social inequalities in these outcomes. At present however, the evidence base on the effectiveness of breakfast provision in bringing about these improvements is limited. Methods/Design This paper describes the research design of a large scale evaluation of the effectiveness of the Welsh Assembly Government's Primary School Free Breakfast Initiative. A cluster randomised trial, with school as the unit of randomisation was used for the outcome evaluation, with a nested qualitative process evaluation. Quantitative outcome measures included dietary habits, attitudes, cognitive function, classroom behaviour, and school attendance. The study recruited 111 primary schools in Wales, of which 56 were randomly assigned to control condition and 55 to intervention. Participants were Year 5 and 6 students (aged 9–11 years in these schools. Data were collected for all 111 schools at each of three time points: baseline, 4 month and 12 month follow-up. This was achieved through a repeated cross-sectional survey of approximately 4350 students on each of these occasions. Of those students in Year 5 at baseline, 1975 provided data at one or both of the follow-ups, forming a nested cohort. The evaluation also included a nested process evaluation, using questionnaires, semi-structured interviews and case studies with students, school staff, and local authority scheme coordinators as key informants. Discussion An overview of the methods used for the evaluation is presented, providing an example of the feasibility of conducting robust evaluations of policy initiatives using a randomised trial design with nested process evaluation. Details are provided of response rates and the flow of participants
Developing a statewide public health initiative to reduce infant mortality in Oklahoma.

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Dooley, Suzanna; Patrick, Paul; Lincoln, Alicia; Cline, Janette

2014-01-01

The Preparing for a Lifetime, It's Everyone's Responsibility initiative was developed to improve the health and well- being of Oklahoma's mothers and infants. The development phase included systematic data collection, extensive data analysis, and multi-disciplinary partnership development. In total, seven issues (preconception/interconception health, tobacco use, postpartum depression, breastfeeding, infant safe sleep, preterm birth, and infant injury prevention) were identified as crucial to addressing infant mortality in Oklahoma. Workgroups were created to focus on each issue. Data and media communications workgroups were added to further partner commitment and support for policy and programmatic changes across multiple agencies and programs. Leadership support, partnership, evaluation, and celebrating small successes were important factors that lead to large scale adoption and support for the state-wide initiative to reduce infant mortality.
Health Care System Measures to Advance Preconception Wellness: Consensus Recommendations of the Clinical Workgroup of the National Preconception Health and Health Care Initiative.

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Frayne, Daniel J; Verbiest, Sarah; Chelmow, David; Clarke, Heather; Dunlop, Anne; Hosmer, Jennifer; Menard, M Kathryn; Moos, Merry-K; Ramos, Diana; Stuebe, Alison; Zephyrin, Laurie

2016-05-01

Preconception wellness reflects a woman's overall health before conception as a strategy to affect health outcomes for the woman, the fetus, and the infant. Preconception wellness is challenging to measure because it attempts to capture health status before a pregnancy, which may be affected by many different service points within a health care system. The Clinical Workgroup of the National Preconception Health and Health Care Initiative proposes nine core measures that can be assessed at initiation of prenatal care to index a woman's preconception wellness. A two-stage web-based modified Delphi survey and a face-to-face meeting of key opinion leaders in women's reproductive health resulted in identifying seven criteria used to determine the core measures. The Workgroup reached unanimous agreement on an aggregate of nine preconception wellness measures to serve as a surrogate but feasible assessment of quality preconception care within the larger health community. These include indicators for: 1) pregnancy intention, 2) access to care, 3) preconception multivitamin with folic acid use, 4) tobacco avoidance, 5) absence of uncontrolled depression, 6) healthy weight, 7) absence of sexually transmitted infections, 8) optimal glycemic control in women with pregestational diabetes, and 9) teratogenic medication avoidance. The focus of the proposed measures is to quantify the effect of health care systems on advancing preconception wellness. The Workgroup recommends that health care systems adopt these nine preconception wellness measures as a metric to monitor performance of preconception care practice. Over time, monitoring these baseline measures will establish benchmarks and allow for comparison within and among regions, health care systems, and communities to drive improvements.
Surgical Safety Training of World Health Organization Initiatives.

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Davis, Christopher R; Bates, Anthony S; Toll, Edward C; Cole, Matthew; Smith, Frank C T; Stark, Michael

2014-01-01

Undergraduate training in surgical safety is essential to maximize patient safety. This national review quantified undergraduate surgical safety training. Training of 2 international safety initiatives was quantified: (1) World Health Organization (WHO) "Guidelines for Safe Surgery" and (2) Department of Health (DoH) "Principles of the Productive Operating Theatre." Also, 13 additional safety skills were quantified. Data were analyzed using Mann-Whitney U tests. In all, 23 universities entered the study (71.9% response). Safety skills from WHO and DoH documents were formally taught in 4 UK medical schools (17.4%). Individual components of the documents were taught more frequently (47.6%). Half (50.9%) of the additional safety skills identified were taught. Surgical societies supplemented safety training, although the total amount of training provided was less than that in university curricula (P < .0001). Surgical safety training is inadequate in UK medical schools. To protect patients and maximize safety, a national undergraduate safety curriculum is recommended. © 2013 by the American College of Medical Quality.
Clinical trials as treatment option: bioethics and health care disparities in substance dependency.

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Timmermans, Stefan; McKay, Tara

2009-12-01

Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities - quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians - the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.
Clinical Trials

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Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...
Interactions between Global Health Initiatives and country health systems: the case of a neglected tropical diseases control program in Mali.

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Cavalli, Anna; Bamba, Sory I; Traore, Mamadou N; Boelaert, Marleen; Coulibaly, Youssouf; Polman, Katja; Pirard, Marjan; Van Dormael, Monique

2010-08-17

Recently, a number of Global Health Initiatives (GHI) have been created to address single disease issues in low-income countries, such as poliomyelitis, trachoma, neonatal tetanus, etc.. Empirical evidence on the effects of such GHIs on local health systems remains scarce. This paper explores positive and negative effects of the Integrated Neglected Tropical Disease (NTD) Control Initiative, consisting in mass preventive chemotherapy for five targeted NTDs, on Mali's health system where it was first implemented in 2007. Campaign processes and interactions with the health system were assessed through participant observation in two rural districts (8 health centres each). Information was complemented by interviews with key informants, website search and literature review. Preliminary results were validated during feedback sessions with Malian authorities from national, regional and district levels. We present positive and negative effects of the NTD campaign on the health system using the WHO framework of analysis based on six interrelated elements: health service delivery, health workforce, health information system, drug procurement system, financing and governance. At point of delivery, campaign-related workload severely interfered with routine care delivery which was cut down or totally interrupted during the campaign, as nurses were absent from their health centre for campaign-related activities. Only 2 of the 16 health centres, characterized by a qualified, stable and motivated workforce, were able to keep routine services running and to use the campaign as an opportunity for quality improvement. Increased workload was compensated by allowances, which significantly improved staff income, but also contributed to divert attention away from core routine activities. While the campaign increased the availability of NTD drugs at country level, parallel systems for drug supply and evaluation requested extra efforts burdening local health systems. The campaign budget
Interactions between Global Health Initiatives and country health systems: the case of a neglected tropical diseases control program in Mali.

Directory of Open Access Journals (Sweden)

Anna Cavalli

Full Text Available BACKGROUND: Recently, a number of Global Health Initiatives (GHI have been created to address single disease issues in low-income countries, such as poliomyelitis, trachoma, neonatal tetanus, etc.. Empirical evidence on the effects of such GHIs on local health systems remains scarce. This paper explores positive and negative effects of the Integrated Neglected Tropical Disease (NTD Control Initiative, consisting in mass preventive chemotherapy for five targeted NTDs, on Mali's health system where it was first implemented in 2007. METHODS AND FINDINGS: Campaign processes and interactions with the health system were assessed through participant observation in two rural districts (8 health centres each. Information was complemented by interviews with key informants, website search and literature review. Preliminary results were validated during feedback sessions with Malian authorities from national, regional and district levels. We present positive and negative effects of the NTD campaign on the health system using the WHO framework of analysis based on six interrelated elements: health service delivery, health workforce, health information system, drug procurement system, financing and governance. At point of delivery, campaign-related workload severely interfered with routine care delivery which was cut down or totally interrupted during the campaign, as nurses were absent from their health centre for campaign-related activities. Only 2 of the 16 health centres, characterized by a qualified, stable and motivated workforce, were able to keep routine services running and to use the campaign as an opportunity for quality improvement. Increased workload was compensated by allowances, which significantly improved staff income, but also contributed to divert attention away from core routine activities. While the campaign increased the availability of NTD drugs at country level, parallel systems for drug supply and evaluation requested extra efforts
Under the (legal radar screen: global health initiatives and international human rights obligations

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Hammonds Rachel

2012-11-01

Full Text Available Abstract Background Given that many low income countries are heavily reliant on external assistance to fund their health sectors the acceptance of obligations of international assistance and cooperation with regard to the right to health (global health obligations is insufficiently understood and studied by international health and human rights scholars. Over the past decade Global Health Initiatives, like the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund have adopted novel approaches to engaging with stakeholders in high and low income countries. This article explores how this experience impacted on acceptance of the international obligation to (help fulfil the right to health beyond borders. Methods The authors conducted an extensive review of international human rights law literature, transnational legal process literature, global public health literature and grey literature pertaining to Global Health Initiatives. To complement this desk work and deepen their understanding of how and why different legal norms evolve the authors conducted 19 in-depth key informant interviews with actors engaged with three stakeholders; the European Union, the United States and Belgium. The authors then analysed the interviews through a transnational legal process lens. Results Through according value to the process of examining how and why different legal norms evolve transnational legal process offers us a tool for engaging with the dynamism of developments in global health suggesting that operationalising global health obligations could advance the right to health for all. Conclusions In many low-income countries the health sector is heavily dependent on external assistance to fulfil the right to health of people thus it is vital that policies and tools for delivering reliable, long-term assistance are developed so that the right to health for all becomes more than a dream. Our research suggests that the Global Fund experience offers
Under the (legal) radar screen: global health initiatives and international human rights obligations

Science.gov (United States)

2012-01-01

Background Given that many low income countries are heavily reliant on external assistance to fund their health sectors the acceptance of obligations of international assistance and cooperation with regard to the right to health (global health obligations) is insufficiently understood and studied by international health and human rights scholars. Over the past decade Global Health Initiatives, like the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund) have adopted novel approaches to engaging with stakeholders in high and low income countries. This article explores how this experience impacted on acceptance of the international obligation to (help) fulfil the right to health beyond borders. Methods The authors conducted an extensive review of international human rights law literature, transnational legal process literature, global public health literature and grey literature pertaining to Global Health Initiatives. To complement this desk work and deepen their understanding of how and why different legal norms evolve the authors conducted 19 in-depth key informant interviews with actors engaged with three stakeholders; the European Union, the United States and Belgium. The authors then analysed the interviews through a transnational legal process lens. Results Through according value to the process of examining how and why different legal norms evolve transnational legal process offers us a tool for engaging with the dynamism of developments in global health suggesting that operationalising global health obligations could advance the right to health for all. Conclusions In many low-income countries the health sector is heavily dependent on external assistance to fulfil the right to health of people thus it is vital that policies and tools for delivering reliable, long-term assistance are developed so that the right to health for all becomes more than a dream. Our research suggests that the Global Fund experience offers lessons to build on. PMID
Under the (legal) radar screen: global health initiatives and international human rights obligations.

Science.gov (United States)

Hammonds, Rachel; Ooms, Gorik; Vandenhole, Wouter

2012-11-15

Given that many low income countries are heavily reliant on external assistance to fund their health sectors the acceptance of obligations of international assistance and cooperation with regard to the right to health (global health obligations) is insufficiently understood and studied by international health and human rights scholars. Over the past decade Global Health Initiatives, like the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund) have adopted novel approaches to engaging with stakeholders in high and low income countries. This article explores how this experience impacted on acceptance of the international obligation to (help) fulfil the right to health beyond borders. The authors conducted an extensive review of international human rights law literature, transnational legal process literature, global public health literature and grey literature pertaining to Global Health Initiatives. To complement this desk work and deepen their understanding of how and why different legal norms evolve the authors conducted 19 in-depth key informant interviews with actors engaged with three stakeholders; the European Union, the United States and Belgium. The authors then analysed the interviews through a transnational legal process lens. Through according value to the process of examining how and why different legal norms evolve transnational legal process offers us a tool for engaging with the dynamism of developments in global health suggesting that operationalising global health obligations could advance the right to health for all. In many low-income countries the health sector is heavily dependent on external assistance to fulfil the right to health of people thus it is vital that policies and tools for delivering reliable, long-term assistance are developed so that the right to health for all becomes more than a dream. Our research suggests that the Global Fund experience offers lessons to build on.
Considerations for community-based mHealth initiatives: insights from three Beacon Communities.

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Abebe, Nebeyou A; Capozza, Korey L; Des Jardins, Terrisca R; Kulick, David A; Rein, Alison L; Schachter, Abigail A; Turske, Scott A

2013-10-15

Mobile health (mHealth) is gaining widespread attention for its potential to engage patients in their health and health care in their daily lives. Emerging evidence suggests that mHealth interventions can be used effectively to support behavior change, but numerous challenges remain when implementing these programs at the community level. This paper provides an overview of considerations when implementing community-based mHealth initiatives, based on the experiences of three Beacon Communities across the United States that have launched text messaging (short message service, SMS) pilot programs aimed at diabetes risk reduction and disease management. The paper addresses lessons learned and suggests strategies to overcome challenges related to developing text message content, conducting marketing and outreach, enrolling participants, engaging providers, evaluating program effectiveness, and sustaining and scaling the programs.
Considerations for Community-Based mHealth Initiatives: Insights From Three Beacon Communities

Science.gov (United States)

2013-01-01

Mobile health (mHealth) is gaining widespread attention for its potential to engage patients in their health and health care in their daily lives. Emerging evidence suggests that mHealth interventions can be used effectively to support behavior change, but numerous challenges remain when implementing these programs at the community level. This paper provides an overview of considerations when implementing community-based mHealth initiatives, based on the experiences of three Beacon Communities across the United States that have launched text messaging (short message service, SMS) pilot programs aimed at diabetes risk reduction and disease management. The paper addresses lessons learned and suggests strategies to overcome challenges related to developing text message content, conducting marketing and outreach, enrolling participants, engaging providers, evaluating program effectiveness, and sustaining and scaling the programs. PMID:24128406
Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

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A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom
Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

Science.gov (United States)

Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

2015-01-01

Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a
Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

International Nuclear Information System (INIS)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

2016-01-01

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users
Clinical Trials

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Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...
Health provider responsiveness to social accountability initiatives in low- and middle-income countries: a realist review.

Science.gov (United States)

Lodenstein, Elsbet; Dieleman, Marjolein; Gerretsen, Barend; Broerse, Jacqueline E W

2017-02-01

Social accountability in the health sector has been promoted as a strategy to improve the quality and performance of health providers in low- and middle-income countries. Whether improvements occur, however, depends on the willingness and ability of health providers to respond to societal pressure for better care. This article uses a realist approach to review cases of collective citizen action and advocacy with the aim to identify key mechanisms of provider responsiveness. Purposeful searches for cases were combined with a systematic search in four databases. To be included in the review, the initiatives needed to describe at least one outcome at the level of frontline service provision. Some 37 social accountability initiatives in 15 countries met these criteria. Using a realist approach, retroductive analysis and triangulation of methods and sources were performed to construct Context-Mechanism-Outcome configurations that explain potential pathways to provider responsiveness. The findings suggest that health provider receptivity to citizens' demands for better health care is mediated by health providers' perceptions of the legitimacy of citizen groups and by the extent to which citizen groups provide personal and professional support to health providers. Some citizen groups activated political or formal bureaucratic accountability channels but the effect on provider responsiveness of such strategies was more mixed. Favourable contexts for health provider responsiveness comprise socio-political contexts in which providers self-identify as activists, health system contexts in which health providers depend on citizens' expertise and capacities, and health system contexts where providers have the self-perceived ability to change the system in which they operate. Rather than providing recipes for successful social accountability initiatives, the synthesis proposes a programme theory that can support reflections on the theories of change underpinning social
Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

Science.gov (United States)

Islam, Nadia; Gepts, Thomas; Lief, Isaac; Gore, Radhika; Levy, Natalie; Tanner, Michael; Fang, Yixin; Sherman, Scott E; Schwartz, Mark D

2018-04-19

Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language
The legacy of the Child Health and Nutrition Research Initiative (CHNRI

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Robert E Black

2016-06-01

Full Text Available Under the Global Forum for Health Research, the Child Health and Nutrition Research Initiative (CHNRI began its operations in 1999 and became a Swiss foundation in 2006. The vision of CHNRI was to improve child health and nutrition of all children in low– and middle–income countries (LMIC through research that informs health policy and practice. Specific objectives included expanding global knowledge on childhood disease burden and cost-effectiveness of interventions, promoting priority setting in research, ensuring inclusion of institutions and scientists in LMIC in setting priorities, promoting capacity development in LMIC and stimulating donors and countries to increase resources for research. CHNRI created a knowledge network, funded research through multiple rounds of a global competitive process and published research papers and policy briefs. A signature effort was to develop a systematic methodology for prioritizing health and nutrition research investments. The “CHNRI method” has been extensively applied to global health problems and is now the most commonly used method for prioritizing health research questions.

Potential reduced exposure products (PREPs) in industry trial testimony.

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Wayne, Geoffrey Ferris

2006-12-01

To identify patterns in trial testimony that may reflect on the intentions or expectations of tobacco manufacturers with regard to the introduction of potential reduced exposure products (PREPs). Research was conducted using the Deposition and Trial Testimony Archive (DATTA) collection of trial testimony and depositions housed online at Tobacco Documents Online (www.tobaccodocuments.org). Relevant testimony was identified through full-text searches of terms indicating PREPs or harm reduction strategies. The role and function of PREPs in testimony were classified according to common and contrasting themes. These were analysed in the context of broader trial arguments and against changes in time period and the market. Analysis of testimony suggests that the failure of PREPs in the market tempered initial industry enthusiasm and made protection of the conventional cigarette market its major priority. The "breakthrough" character of PREPs has been de-emphasised, with trial arguments instead positioning PREPs as simply another choice for consumers. This framework legitimises the sale of conventional brands, and shifts the responsibility for adoption of safer products from the manufacturer to the consumer. Likewise, testimony has abandoned earlier dramatic health claims made with regard to PREPs, which had undermined industry arguments regarding efforts to reduce harm in conventional products. More recent testimony advocates the broad acceptance of independent guidelines that would validate use of health claims and enable the industry to market PREPs to consumers. Trial testimony reflects the changing role and positioning of PREPs by the tobacco industry. The findings are of particular importance with regard to future evaluation and potential regulation of reduced harm products.
Use, acceptability and impact of booklets designed to support mental health self-management and help seeking in schools: results of a large randomised controlled trial in England.

Science.gov (United States)

Sharpe, Helen; Patalay, Praveetha; Vostanis, Panos; Belsky, Jay; Humphrey, Neil; Wolpert, Miranda

2017-03-01

Mental health booklets may provide a low-cost means of promoting mental health self-management and help seeking in schools. The aim of the study was to assess the (a) use, (b) acceptability and (c) impact of booklets for students in primary (10-11 years) and secondary school (12-13 years) alone and in conjunction with funding for targeted mental health support. This was a 2 × 2 factorial cluster randomized controlled trial, in which 846 schools in England were randomly allocated to receive/not receive: (1) booklets for students containing information on mental health self-management and help seeking, and (2) funding for mental health support as part of a national mental health initiative. 14,690 students (8139 primary, 6551 secondary) provided self-report on mental health, quality of life (baseline and 1 year follow-up) and help seeking (follow-up). (a) Approximately, 40 % primary school students and 20 % secondary school students reported seeing the booklets. (b) Of these, 87 % of primary school students reported that the booklet was 'very helpful' or 'quite helpful', compared with 73 % in secondary school. (c) There was no detectable impact of booklets on mental health, quality of life or help seeking, either alone or in conjunction with additional funding through the national mental health initiative. Lack of discernable impact of booklets underscores the need for caution in adopting such an approach. However, it is feasible that the impact was obscured by low uptake or that booklets may be more effective when used in a targeted way.
Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI, Kenya.

Directory of Open Access Journals (Sweden)

Gloria S Omosa-Manyonyi

2011-01-01

Full Text Available With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries--worst affected by the HIV pandemic--have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI at the University of Nairobi has conducted HIV vaccine clinical trials since 2001.Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West.Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4% met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4% for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrollment.Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants.Protocol IAVI VRC V001 [1]. ClinicalTrials.gov NCT00124007 Protocol IAVI 010 [2](registration with
#LancerHealth: Using Twitter and Instagram as a tool in a campus wide health promotion initiative

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Sara Santarossa

2018-04-01

Full Text Available The present study aimed to explore using popular technology that people already have/use as a health promotion tool, in a campus wide social media health promotion initiative, entitled #LancerHealth. During a two-week period the university community was asked to share photos on Twitter and Instagram of What does being healthy on campus look like to you?, while tagging the image with #LancerHealth. All publically tagged media was collected using the Netlytic software and analysed. Text analysis (N=234 records, Twitter; N=141 records, Instagram revealed that the majority of the conversation was positive and focused on health and the university. Social network analysis, based on five network properties, showed a small network with little interaction. Lastly, photo coding analysis (N=71 unique image indicated that the majority of the shared images were of physical activity (52% and on campus (80%. Further research into this area is warranted.
Clinical Trials

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...
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Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...
Clinical Trials

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Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...
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Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...
Clinical Trials

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Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...
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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...
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Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...
Clinical Trials

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Full Text Available ... What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might ... enroll in a clinical trial, a doctor or nurse will give you an informed consent form that ...
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Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...
Clinical Trials

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Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...
The Initiative to extend Medicare into Mexico: a case study in changing U.S. Health Care Policy

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Roberto A. Ibarra

2011-10-01

Full Text Available This study examines the geo-political activities of interest groups, governments and multinational corporations involved in an initiative to extend Medicare to U.S. retirees residing in Mexico. If the initiative to change the current Medicare policy succeeds, the relocation of Medicare-eligible populations from the U.S. to Mexico is likely to increase; the U.S. is expected to gain cost-savings for taxpayers on Medicare; Mexico can develop senior-housing and options for long-term care it currently lacks; and foreign-led multinational corporations will increase their profits and dominance, fostering even more privatization in Mexico’s health care sector. By exploring new issues about retirement migration and health this study seeks to gain knowledge about the phenomena in a number of areas. First, the retirement migration of North Americans to Latin America is an under-studied phenomenon in the fields of social gerontology, migration research, and health policy studies. Second, the Medicare in Mexico initiative is even less well-known among health policy scholars than the retirement migration phenomenon into Mexico. Yet this initiative is inherently international in scope and involves a number of US-based institutions and interest groups actively promoting the project from within Mexico. Thus, the initiative has important geo-political and socio-economic implications for reforming health care systems in the U.S. and Mexico.
Experience Corps: A dual trial to promote the health of older adults and children's academic success

Science.gov (United States)

Fried, Linda P.; Carlson, Michelle C.; McGill, Sylvia; Seeman, Teresa; Xue, Qian-Li; Frick, Kevin; Tan, Erwin; Tanner, Elizabeth K.; Barron, Jeremy; Frangakis, Constantine; Piferi, Rachel; Martinez, Iveris; Gruenewald, Tara; Martin, Barbara K.; Berry-Vaughn, Laprisha; Stewart, John; Dickersin, Kay; Willging, Paul R.; Rebok, George W.

2014-01-01

Background As the population ages, older adults are seeking meaningful, and impactful, post-retirement roles. As a society, improving the health of people throughout longer lives is a major public health goal. This paper presents the design and rationale for an effectiveness trial of Experience Corps™, an intervention created to address both these needs. This trial evaluates (1) whether senior volunteer roles within Experience Corps™ beneficially impact children's academic achievement and classroom behavior in public elementary schools and (2) impact on the health of volunteers. Methods Dual evaluations of (1) an intention-to-treat trial randomizing eligible adults 60 and older to volunteer service in Experience Corps™, or to a control arm of usual volunteering opportunities, and (2) a comparison of eligible public elementary schools receiving Experience Corps™ to matched, eligible control schools in a 1:1 control:intervention school ratio. Outcomes For older adults, the primary outcome is decreased disability in mobility and Instrumental Activities of Daily Living (IADL). Secondary outcomes are decreased frailty, falls, and memory loss; slowed loss of strength, balance, walking speed, cortical plasticity, and executive function; objective performance of IADLs; and increased social and psychological engagement. For children, primary outcomes are improved reading achievement and classroom behavior in Kindergarten through the 3rd grade; secondary outcomes are improvements in school climate, teacher morale and retention, and teacher perceptions of older adults. Summary This trial incorporates principles and practices of community-based participatory research and evaluates the dual benefit of a single intervention, versus usual opportunities, for two generations: older adults and children. PMID:23680986
Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

Science.gov (United States)

Tickle, Martin; Milsom, Keith M; Donaldson, Michael; Killough, Seamus; O'Neill, Ciaran; Crealey, Grainne; Sutton, Matthew; Noble, Solveig; Greer, Margaret; Worthington, Helen V

2011-10-10

Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental
Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency

DEFF Research Database (Denmark)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis

2017-01-01

OBJECTIVE: To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN: We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates...... of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines...... agencies since 2004. RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were...
Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials.

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Meurer, William J; Seewald, Nicholas J; Kidwell, Kelley

2017-04-01

Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial

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John A. Cunningham

2016-07-01

Full Text Available Abstract Background Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention in addition to an Internet intervention for problem gambling (G-only intervention in participants with gambling problems who do or do not have co-occurring mental health symptoms. Methods Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280 to take part in the study will be randomized to one of two versions of an online intervention for gamblers – an intervention that just targets gambling issues (G-only versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH. It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website. Discussion The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms. Trial registration ClinicalTrials.gov NCT02800096 ; Registration date: June 14, 2016.

Health initiatives to target obesity in surface transport industries: Review and implications for action

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Anjum Naweed

2015-06-01

Full Text Available Lifestyle-related chronic diseases pose a considerable burden to the individual and the wider society, with correspondingly negative effects on industry. Obesity is a particular problem for the Australasian road and rail industries where it is associated with specific cardiac and fatigue-related safety risks, and levels are higher than those found in the general population. Despite this recognition, and the introduction of National Standards, very little consensus exists regarding approaches to preventative health for surface transport workers. A review of evidence regarding effective health promotion initiatives is urgently needed to inform best practice in this cohort. This review draws together research informing the scope and effectiveness of health promotion programs, initiatives and interventions targeting overweight and obesity in safety critical surface transport domains including the truck, bus and rail industries. A number of health interventions demonstrated measurable successes, including incentivising, peer mentoring, verbal counselling, development of personalised health profiles, and offer of healthier on-site food choices – some of which also resulted in sizeable return on investment over the long term.
Clinical Trials

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Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...
Clinical Trials

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Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...
CDC/NACCHO Accreditation Support Initiative: advancing readiness for local and tribal health department accreditation.

Science.gov (United States)

Monteiro, Erinn; Fisher, Jessica Solomon; Daub, Teresa; Zamperetti, Michelle Chuk

2014-01-01

Health departments have various unique needs that must be addressed in preparing for national accreditation. These needs require time and resources, shortages that many health departments face. The Accreditation Support Initiative's goal was to test the assumption that even small amounts of dedicated funding can help health departments make important progress in their readiness to apply for and achieve accreditation. Participating sites' scopes of work were unique to the needs of each site and based on the proposed activities outlined in their applications. Deliverables and various sources of data were collected from sites throughout the project period (December 2011-May 2012). Awardees included 1 tribal and 12 local health departments, as well as 5 organizations supporting the readiness of local and tribal health departments. Sites dedicated their funding toward staff time, accreditation fees, completion of documentation, and other accreditation readiness needs and produced a number of deliverables and example documents. All sites indicated that they made accreditation readiness gains that would not have occurred without this funding. Preliminary evaluation data from the first year of the Accreditation Support Initiative indicate that flexible funding arrangements may be an effective way to increase health departments' accreditation readiness.
Videogames and Health Improvement: A Literature Review of Randomized Controlled Trials.

Science.gov (United States)

Rahmani, Esmaeel; Boren, Suzanne Austin

2012-10-01

There are potential benefits of playing videogames for health improvement such as increasing knowledge about health-related issues by playing educational games and fighting a sedentary lifestyle by playing exergames. The number of systematic review articles about "videogames" and "health improvement" is limited. Therefore, the purpose of this study is to review those randomized controlled trials (RCTs) with the topic of "videogames" and "health improvement." Several electronic databases were searched for RCTs testing videogames on health outcomes that were published in English between January 2000 and April 2012. Forty-five articles met the eligibility criteria and were categorized into five groups: (1) videogames and patient pain and stress reduction (nine articles), (2) videogames and patient behavioral change (19 articles), (3) videogames and patient rehabilitation (eight articles), (4) videogames as diagnostic tools (three articles), and (5) videogames and cognitive ability (six articles). Most of the articles have shown promising results in using videogames within various fields of healthcare. Although exergames are the most prominent choice regarding health improvement, videogames have the potential to be used as a pain management tool, diagnostic tool, or educational tool. They also can be used as a facilitator in physical rehabilitation or cognitive loss prevention. More RCTs are needed to fully uncover the benefits of using videogames for improving patients' health.
Clinical Trials

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Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...
A comparative review of patient safety initiatives for national health information technology

DEFF Research Database (Denmark)

Magrabi, Farah; Aarts, Jos; Nøhr, Christian

2013-01-01

OBJECTIVE: To collect and critically review patient safety initiatives for health information technology (HIT). METHOD: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified...... by searching the websites of regional and national agencies and programmes in a non-exhaustive set of exemplar countries including England, Denmark, the Netherlands, the USA, Canada and Australia. Initiatives were categorised by type and software systems covered. RESULTS: We found 27 patient safety initiatives...... were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security...
Nurse health and lifestyle modification versus standard care in 40 to 70 year old regional adults: study protocol of the Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) randomized controlled trial.

Science.gov (United States)

Carrington, Melinda J; Zimmet, Paul

2017-12-06

trial will provide evidence for the potential benefit of independent nurse-run clinics in the community and their cost-effectiveness in adults with MetS. Findings will enable more nurse-led clinics to be adopted outside of major cities and encompassing other chronic diseases as a key primary preventative initiative. MODERN is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12616000229471 ) on 19 February 2016 (retrospectively registered). Secondary identifiers: MODERN is an investigator-initiated trial funded by the National Health and Medical Research Council of Australia from 2014 to 2017 via a Project Grant (ID No. APP1069043) and was approved by the Australian Catholic University Human Research Ethics Committee (Project No: 2014 244 V) and the Department of Health Human Research Ethics Committee (Project No:38/2014) for the release of Medicare claims information.
Oral Health Promotion and Smoking Cessation Program Delivered via Tobacco Quitlines: The Oral Health 4 Life Trial.

Science.gov (United States)

McClure, Jennifer B; Bush, Terry; Anderson, Melissa L; Blasi, Paula; Thompson, Ella; Nelson, Jennifer; Catz, Sheryl L

2018-05-01

To assess the effects of a novel oral health promotion program (Oral Health 4 Life; OH4L) delivered through state-funded tobacco quitlines. Using a semipragmatic design to balance experimental control and generalizability, we randomized US quitline callers (n = 718) to standard care or standard care plus OH4L. We followed participants for 6 months to assess effects on professional dental care and smoking abstinence. We collected data between 2015 and 2017. Participants were racially diverse (42% non-White) and socioeconomically disadvantaged. Most (71%) reported fair or poor oral health, and all were overdue for routine dental care. At 6 months, professional dental care and abstinence did not significantly differ between arms, but abstinence favored the experimental arm and was significantly higher among experimental participants at 2 months in a complete case sensitivity analysis. OH4L was not effective for promoting dental care, but integrating oral health counseling with quitline counseling may offer some advantage for smoking cessation. Public Health Implications. We offer a model for conducting semipragmatic trials and partnering with tobacco quitlines to evaluate population-level public health interventions.
VISTA-Rehab: a resource for stroke rehabilitation trials.

Science.gov (United States)

Ali, Myzoon; Ashburn, Ann; Bowen, Audrey; Brodie, Eric; Corr, Susan; Drummond, Avril; Edmans, Judi; Gladman, John; Kalra, Lalit; Langhorne, Peter; Lees, Kennedy R; Lincoln, Nadina; Logan, Pip; Mead, Gillian; Patchick, Emma; Pollock, Alex; Pomeroy, Val; Sackley, Catherine; Sunnerhagen, Katherina S; van Vliet, Paulette; Walker, Marion; Brady, Marian

2010-12-01

Stroke rehabilitation is a complex intervention. Many factors influence the interaction between the patient and the elements of the intervention. Rehabilitation interventions are aimed at altering different domains of patient outcome including body functions, activity and participation. As a consequence, randomised clinical trials in this area are difficult to design. We developed an archive of stroke rehabilitation trials (VISTA-Rehab) to act as a resource to help trialists model and design future rehabilitation studies. We developed specific eligibility criteria for the entry of stroke rehabilitation trials into the archive. We established a Steering Committee to oversee projects and publications and commenced the recruitment of rehabilitation trials into this resource. As of August 2009, VISTA-Rehab contains data from 23 stroke rehabilitation trials (>3400 patients). Demographic data, including age [median=73, interquartile range (63,79)], gender (male=53%) and initial dependency [median baseline Barthel index score=6, interquartile range (9,19)], are available for all patients. Outcome measures include the modified Rankin Scale, Barthel Index, Rivermead Motor Assessment, Fugl-Meyer Assessment, General Health Questionnaire and Nottingham Extended Activities of Daily Living Scale. VISTA-Rehab expands the Virtual International Stroke Trials Archive to include rehabilitation trials. Anonymised data can be used to examine questions specific to stroke rehabilitation and to generate novel hypotheses. © 2010 The Authors. International Journal of Stroke © 2010 World Stroke Organization.
mHealth Interventions for Health System Strengthening in China: A Systematic Review.

Science.gov (United States)

Tian, Maoyi; Zhang, Jing; Luo, Rong; Chen, Shi; Petrovic, Djordje; Redfern, Julie; Xu, Dong Roman; Patel, Anushka

2017-03-16

With rapidly expanding infrastructure in China, mobile technology has been deemed to have the potential to revolutionize health care delivery. There is particular promise for mobile health (mHealth) to positively influence health system reform and confront the new challenges of chronic diseases. The aim of this study was to systematically review existing mHealth initiatives in China, characterize them, and examine the extent to which mHealth contributes toward the health system strengthening in China. Furthermore, we also aimed to identify gaps in mHealth development and evaluation. We systematically reviewed the literature from English and Chinese electronic database and trial registries, including PubMed, EMBASE, Cochrane, China National Knowledge of Infrastructure (CNKI), and World Health Organization (WHO) International Clinical Trials Registry Platform. We used the English keywords of mHealth, eHealth, telemedicine, telehealth, mobile phone, cell phone, text messaging, and China, as well as their corresponding Chinese keywords. All articles using mobile technology for health care management were included in the study. A total of 1704 articles were found using the search terms, and eventually 72 were included. Overall, few high quality interventions were identified. Most interventions were found to be insufficient in scope, and their evaluation was of inadequate rigor to generate scalable solutions and provide reliable evidence of effectiveness. Most interventions focused on text messaging for consumer education and behavior change. There were a limited number of interventions that addressed health information management, health workforce issues, use of medicines and technologies, or leadership and governance from a health system perspective. We provide four recommendations for future mHealth interventions in China that include the need for the development, evaluation and trials examining integrated mHealth interventions to guide the development of future mHealth
mHealth Interventions for Health System Strengthening in China: A Systematic Review

Science.gov (United States)

Zhang, Jing; Luo, Rong; Chen, Shi; Petrovic, Djordje; Redfern, Julie; Xu, Dong Roman; Patel, Anushka

2017-01-01

Background With rapidly expanding infrastructure in China, mobile technology has been deemed to have the potential to revolutionize health care delivery. There is particular promise for mobile health (mHealth) to positively influence health system reform and confront the new challenges of chronic diseases. Objective The aim of this study was to systematically review existing mHealth initiatives in China, characterize them, and examine the extent to which mHealth contributes toward the health system strengthening in China. Furthermore, we also aimed to identify gaps in mHealth development and evaluation. Methods We systematically reviewed the literature from English and Chinese electronic database and trial registries, including PubMed, EMBASE, Cochrane, China National Knowledge of Infrastructure (CNKI), and World Health Organization (WHO) International Clinical Trials Registry Platform. We used the English keywords of mHealth, eHealth, telemedicine, telehealth, mobile phone, cell phone, text messaging, and China, as well as their corresponding Chinese keywords. All articles using mobile technology for health care management were included in the study. Results A total of 1704 articles were found using the search terms, and eventually 72 were included. Overall, few high quality interventions were identified. Most interventions were found to be insufficient in scope, and their evaluation was of inadequate rigor to generate scalable solutions and provide reliable evidence of effectiveness. Most interventions focused on text messaging for consumer education and behavior change. There were a limited number of interventions that addressed health information management, health workforce issues, use of medicines and technologies, or leadership and governance from a health system perspective. Conclusions We provide four recommendations for future mHealth interventions in China that include the need for the development, evaluation and trials examining integrated mHealth
Parents' Perspectives of School Mental Health Promotion Initiatives Are Related to Parents' Self-Assessed Parenting Capabilities

Science.gov (United States)

Askell-Williams, Helen

2016-01-01

Achieving broad-scale parent engagement with school initiatives has proven elusive. This article reports survey data from 287 Maltese parents about their perceptions of the quality of their child's school's initiatives for promoting students' wellbeing and mental health. Findings indicate that, on average, parents rated school initiatives highly.…
Exercise and health-related quality of life during the first year following acute stroke. A randomized controlled trial.

Science.gov (United States)

Langhammer, Birgitta; Stanghelle, Johan K; Lindmark, Birgitta

2008-02-01

To evaluate the impact of two different physiotherapy exercise regimes in patients after acute stroke on health-related quality of life (HRQoL) and to investigate how the degree of motor and balance function, gait capacity, activities of daily living and instrumental activities of daily living influenced HRQoL. A longitudinal randomized controlled stratified trial of two interventions: the intensive exercise groups with scheduled intensive training during four periods of the first year after stroke and the regular exercise group with self-initiated training. There was a tendency of better HRQoL in the regular exercise group on NHP total score (p = 0.05). Patients with low scores in activities of daily living, balance and motor function and inability to perform 6-minute walk test on admission, scored lower on self-perceived health than patients with high scores and ability to perform the walking test. At 1 year post-stroke, total scores on NHP were moderately associated with motor function (r = -0.63), balance (r = -0.56), gait (r = -0.57), activities of daily living (r = -0.57) and instrumental activities of daily living (r = -0.49-0.58). The physical mobility sub-scale of NHP had the strongest association ranging from r = -0.47-0.82. The regular exercise group with self-initiated training seemed to enhance HRQoL more than the intensive exercise group with scheduled intensive training. The degree of motor function, balance, walking capacity and independence in activities of daily living is of importance for perceived HRQoL.
The Arctic Human Health Initiative: a legacy of the International Polar Year 2007–2009

Directory of Open Access Journals (Sweden)

Alan J. Parkinson

2013-08-01

Full Text Available Background . The International Polar Year (IPY 2007–2008 represented a unique opportunity to further stimulate cooperation and coordination on Arctic health research and increase the awareness and visibility of Arctic regions. The Arctic Human Health Initiative (AHHI was a US-led Arctic Council IPY coordinating project that aimed to build and expand on existing International Union for Circumpolar Health (IUCH and Arctic Council human health interests. The project aimed to link researchers with potential international collaborators and to serve as a focal point for human health research, education, outreach and communication activities during the IPY. The progress of projects conducted as part of this initiative up until the end of the Arctic Council Swedish chairmanship in May 2013 is summarized in this report. Design . The overall goals of the AHHI was to increase awareness and visibility of human health concerns of Arctic peoples, foster human health research, and promote health strategies that will improve health and well-being of all Arctic residents. Proposed activities to be recognized through the initiative included: expanding research networks that will enhance surveillance and monitoring of health issues of concern to Arctic peoples, and increase collaboration and coordination of human health research; fostering research that will examine the health impact of anthropogenic pollution, rapid modernization and economic development, climate variability, infectious and chronic diseases, intentional and unintentional injuries, promoting education, outreach and communication that will focus public and political attention on Arctic health issues, using a variety of publications, printed and electronic reports from scientific conferences, symposia and workshops targeting researchers, students, communities and policy makers; promoting the translation of research into health policy and community action including implementation of prevention
School-based strategies for oral health education of adolescents- a cluster randomized controlled trial

Directory of Open Access Journals (Sweden)

Haleem Abdul

2012-12-01

Full Text Available Abstract Background Oral health education (OHE in schools has largely been imparted by dental professionals. Considering the substantial cost of this expert-led approach, the strategies relying on teachers, peer-leaders and learners themselves have also been utilized. However the evidence for comparative effectiveness of these strategies is lacking in the dental literature. The present study was conducted to compare the effectiveness of dentist-led, teacher-led, peer-led and self-learning strategies of oral health education. Methods A two-year cluster randomized controlled trial following a parallel design was conducted. It involved five groups of adolescents aged 10-11 years at the start of the study. The trial involved process as well as four outcome evaluations. The present paper discusses the findings of the study pertaining to the baseline and final outcome evaluation, both comprising of a self-administered questionnaire, a structured interview and clinical oral examination. The data were analyzed using Generalized Estimating Equations. Results All the three educator-led strategies of OHE had statistically higher mean oral health knowledge (OHK, oral health behavior (OHB, oral hygiene status (OHS and combined knowledge, behavior and oral hygiene status (KBS scores than the self-learning and control groups (p Conclusions The dentist-led, teacher-led and peer-led strategies of oral health education are equally effective in improving the oral health knowledge and oral hygiene status of adolescents. The peer-led strategy, however, is almost as effective as the dentist-led strategy and comparatively more effective than the teacher-led and self-learning strategies in improving their oral health behavior. Trail registration SRCTN39391017
Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

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Noble Solveig

2011-10-01

Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs
Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

LENUS (Irish Health Repository)

Tickle, Martin

2011-10-10

Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will
Making sense of "consumer engagement" initiatives to improve health and health care: a conceptual framework to guide policy and practice.

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Mittler, Jessica N; Martsolf, Grant R; Telenko, Shannon J; Scanlon, Dennis P

2013-03-01

Policymakers and practitioners continue to pursue initiatives designed to engage individuals in their health and health care despite discordant views and mixed evidence regarding the ability to cultivate greater individual engagement that improves Americans' health and well-being and helps manage health care costs. There is limited and mixed evidence regarding the value of different interventions. Based on our involvement in evaluating various community-based consumer engagement initiatives and a targeted literature review of models of behavior change, we identified the need for a framework to classify the universe of consumer engagement initiatives toward advancing policymakers' and practitioners' knowledge of their value and fit in various contexts. We developed a framework that expanded our conceptualization of consumer engagement, building on elements of two common models, the individually focused transtheoretical model of behavior and the broader, multilevel social ecological model. Finally, we applied this framework to one community's existing consumer engagement program. Consumer engagement in health and health care refers to the performance of specific behaviors ("engaged behaviors") and/or an individual's capacity and motivation to perform these behaviors ("activation"). These two dimensions are related but distinct and thus should be differentiated. The framework creates four classification schemas, by (1) targeted behavior types (self-management, health care encounter, shopping, and health behaviors) and by (2) individual, (3) group, and (4) community dimensions. Our example illustrates that the framework can systematically classify a variety of consumer engagement programs, and that this exercise and resulting characterization can provide a structured way to consider the program and how its components fit program goals both individually and collectively. Applying the framework could help advance the field by making policymakers and practitioners aware
Engaging multilevel stakeholders in an implementation trial of evidence-based quality improvement in VA women's health primary care.

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Hamilton, Alison B; Brunner, Julian; Cain, Cindy; Chuang, Emmeline; Luger, Tana M; Canelo, Ismelda; Rubenstein, Lisa; Yano, Elizabeth M

2017-09-01

The Veterans Health Administration (VHA) has undertaken primary care transformation based on patient-centered medical home (PCMH) tenets. VHA PCMH models are designed for the predominantly male Veteran population, and require tailoring to meet women Veterans' needs. We used evidence-based quality improvement (EBQI), a stakeholder-driven implementation strategy, in a cluster randomized controlled trial across 12 sites (eight EBQI, four control) that are members of a Practice-Based Research Network. EBQI involves engaging multilevel, inter-professional leaders and staff as stakeholders in reviewing evidence and setting QI priorities. The goal of this analysis was to examine processes of engaging stakeholders in early implementation of EBQI to tailor VHA's medical home for women. Four inter-professional regional stakeholder planning meetings were conducted; these meetings engaged stakeholders by providing regional data about gender disparities in Veterans' care experiences. Subsequent to each meeting, qualitative interviews were conducted with 87 key stakeholders (leaders and staff). Stakeholders were asked to describe QI efforts and the use of data to change aspects of care, including women's health care. Interview transcripts were summarized and coded using a hybrid deductive/inductive analytic approach. The presentation of regional-level data about gender disparities resulted in heightened awareness and stakeholder buy-in and decision-making related to women's health-focused QI. Interviews revealed that stakeholders were familiar with QI, with regional and facility leaders aware of inter-disciplinary committees and efforts to foster organizational change, including PCMH transformation. These efforts did not typically focus on women's health, though some informal efforts had been undertaken. Barriers to engaging in QI included lack of communication across clinical service lines, fluidity in staffing, and lack of protected time. Inter-professional, multilevel

Evolution of the clinical trial landscape in Asia Pacific

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Yathindranath S

2014-07-01

being played by Asian pharmaceutical organizations. Consequently, indications under study are now including those with higher prevalence in Asia. Conclusion: Asia Pacific continues to be an important region for the conduct of clinical trials. With multiple initiatives underway at both local and regional levels aimed at improving the conduct of studies, it is expected that this trend will continue. Keywords: trends, economic development, health care, emerging markets
78 FR 8152 - Proposed Collection; Comment Request: Women's Health Initiative Observational Study

Science.gov (United States)

2013-02-05

... Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925... causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast... providers. Type of Respondents: Study participants, next-of-kin, and physician's office staff. The annual...
Clinical trial quality: From supervision to collaboration and beyond.

Science.gov (United States)

Meeker-O'Connell, Ann; Glessner, Coleen

2018-02-01

Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.
Social Health Maintenance Organizations: assessing their initial experience.

Science.gov (United States)

Newcomer, R; Harrington, C; Friedlob, A

1990-08-01

The Social/Health Maintenance Organization (S/HMO) is a four-site national demonstration. This program combines Medicare Part A and B coverage, with various extended and chronic care benefits, into an integrated health plan. The provision of these services extends both the traditional roles of HMOs and that of long-term care community-service case management systems. During the initial 30 months of operation the four S/HMOs shared financial risk with the Health Care Financing Administration. This article reports on this developmental period. During this phase the S/HMOs had lower-than-expected enrollment levels due in part to market competition, underfunding of marketing efforts, the limited geographic area served, and an inability to differentiate the S/HMO product from that of other Medicare HMOs. The S/HMOs were allowed to conduct health screening of applicants prior to enrolling them. The number of nursing home-certifiable enrollees was controlled through this mechanism, but waiting lists were never very long. Persons joining S/HMOs and other Medicare HMOs during this period were generally aware of the alternatives available. S/HMO enrollees favored the more extensive benefits; HMO enrollees considerations of cost. The S/HMOs compare both newly formed HMOs and established HMOs. On the basis of administrator cost, it is more efficient to add chronic care benefits to an HMO than to add an HMO component to a community care provider. All plans had expenses greater than their revenues during the start-up period, but they were generally able to keep service expenditures within planned levels.
A Systematic Review of Interventions to Improve Initiation of Mental Health Care Among Racial-Ethnic Minority Groups.

Science.gov (United States)

Lee-Tauler, Su Yeon; Eun, John; Corbett, Dawn; Collins, Pamela Y

2018-05-02

The objective of this systematic review was to identify interventions to improve the initiation of mental health care among racial-ethnic minority groups. The authors searched three electronic databases in February 2016 and independently assessed eligibility of 2,065 titles and abstracts on the basis of three criteria: the study design included an intervention, the participants were members of racial-ethnic minority groups and lived in the United States, and the outcome measures included initial access to or attitudes toward mental health care. The qualitative synthesis involved 29 studies. Interventions identified included collaborative care (N=10), psychoeducation (N=7), case management (N=5), colocation of mental health services within existing services (N=4), screening and referral (N=2), and a change in Medicare medication reimbursement policy that served as a natural experiment (N=1). Reduction of disparities in the initiation of antidepressants or psychotherapy was noted in seven interventions (four involving collaborative care, two involving colocation of mental health services, and one involving screening and referral). Five of these disparities-reducing interventions were tested among older adults only. Most (N=23) interventions incorporated adaptations designed to address social or cultural barriers to care. Interventions that used a model of integrated care reduced racial-ethnic disparities in the initiation of mental health care.
To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial.

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Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark

2017-08-07

Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes
South Asian participation in clinical trials: the views of lay people and health professionals.

Science.gov (United States)

Hussain-Gambles, Mah; Atkin, Karl; Leese, Brenda

2006-07-01

There is little UK-based empirical research on South Asian participation in clinical trials. The predominantly US literature rarely engages with mainstream debates about ethnicity, diversity and difference. This study was prompted by a lack of knowledge about how South Asian people perceive trial involvement and the risks and benefits involved. Face to face interviews were conducted with 25 health professionals (consultants, GPs, nursing staff, academics, non-medically trained trial co-ordinators, LREC and MREC members) and 60 South Asian lay people (20 Indians, 20 Pakistanis and 20 Bangladeshis) who had not taken part in a trial. The study took place in the Leeds and Bradford areas of England. It was found that lay South Asian attitudes towards clinical trial participation focused on similarities rather than differences with the general UK population, suggesting that the relevance of ethnicity should be kept in perspective. There was no evidence of antipathy amongst South Asians to the concept of clinical trials, and awareness was a correlate of social class, education and younger age. Lay factors that might affect South Asian participation in clinical trials included: age; language, social class; feeling of not belonging/mistrust; culture and religion. Approachable patients (of the same gender, social class and fluent in English) tended to be 'cherry picked' to clinical trials. This practice was justified because of a lack of time, resources and inadequate support. South Asian patients might be systematically excluded from trials due to the increased cost and time associated with their inclusion, particularly in relation to the language barrier. Under-representation might also be due to passive exclusion associated with cultural stereotypes. The paper concludes by applying the theoretical framework of institutional racism as a means of making sense of policy and practice. At the same time, caution is advocated against using ethnicity as the only form of
Amount of health care and self-care following a randomized clinical trial comparing flexion-distraction with exercise program for chronic low back pain

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Keenum Michael

2006-08-01

Full Text Available Abstract Background Previous clinical trials have assessed the percentage of participants who utilized further health care after a period of conservative care for low back pain, however no chiropractic clinical trial has determined the total amount of care during this time and any differences based on assigned treatment group. The objective of this clinical trial follow-up was to assess if there was a difference in the total number of office visits for low back pain over one year after a four week clinical trial of either a form of physical therapy (Exercise Program or a form of chiropractic care (Flexion Distraction for chronic low back pain. Methods In this randomized clinical trial follow up study, 195 participants were followed for one year after a four-week period of either a form of chiropractic care (FD or a form of physical therapy (EP. Weekly structured telephone interview questions regarded visitation of various health care practitioners and the practice of self-care for low back pain. Results Participants in the physical therapy group demonstrated on average significantly more visits to any health care provider and to a general practitioner during the year after trial care (p Conclusion During a one-year follow-up, participants previously randomized to physical therapy attended significantly more health care visits than those participants who received chiropractic care.
'teen Mental Health First Aid': a description of the program and an initial evaluation.

Science.gov (United States)

Hart, Laura M; Mason, Robert J; Kelly, Claire M; Cvetkovski, Stefan; Jorm, Anthony F

2016-01-01

Many adolescents have poor mental health literacy, stigmatising attitudes towards people with mental illness, and lack skills in providing optimal Mental Health First Aid to peers. These could be improved with training to facilitate better social support and increase appropriate help-seeking among adolescents with emerging mental health problems. teen Mental Health First Aid (teen MHFA), a new initiative of Mental Health First Aid International, is a 3 × 75 min classroom based training program for students aged 15-18 years. An uncontrolled pilot of the teen MHFA course was undertaken to examine the feasibility of providing the program in Australian secondary schools, to test relevant measures of student knowledge, attitudes and behaviours, and to provide initial evidence of program effects. Across four schools, 988 students received the teen MHFA program. 520 students with a mean age of 16 years completed the baseline questionnaire, 345 completed the post-test and 241 completed the three-month follow-up. Statistically significant improvements were found in mental health literacy, confidence in providing Mental Health First Aid to a peer, help-seeking intentions and student mental health, while stigmatising attitudes significantly reduced. teen MHFA appears to be an effective and feasible program for training high school students in Mental Health First Aid techniques. Further research is required with a randomized controlled design to elucidate the causal role of the program in the changes observed.
Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial

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Draper Alizon

2009-06-01

Full Text Available Abstract Background In London and the rest of the UK, diseases associated with poor diet, inadequate physical activity and mental illness account for a large proportion of area based health inequality. There is a lack of evidence on interventions promoting healthier behaviours especially in marginalised populations, at a structural or ecological level and utilising a community development approach. The Well London project financed by the Big Lottery 'Wellbeing' Fund and implemented by a consortium of London based agencies led by the Greater London Authority and the London Health Commission is implementing a set of complex interventions across 20 deprived areas of London. The interventions focus on healthy eating, healthy physical activity and mental health and wellbeing and are designed and executed with community participation complementing existing facilities and services. Methods/Design The programme will be evaluated through a cluster randomised controlled trial. Forty areas across London were chosen based on deprivation scores. Areas were characterised by high proportion of Black and Minority Ethnic residents, worklessness, ill-health and poor physical environments. Twenty areas were randomly assigned to the intervention arm of Well London project and twenty 'matched' areas assigned as controls. Measures of physical activity, diet and mental health are collected at start and end of the project and compared to assess impact. The quantitative element will be complemented by a longitudinal qualitative study elucidating pathways of influence between intervention activities and health outcomes. A related element of the study investigates the health-related aspects of the structural and ecological characteristics of the project areas. The project 'process' will also be evaluated. Discussion The size of the project and the fact that the interventions are 'complex' in the sense that firstly, there are a number of interacting components with a wide
The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

Directory of Open Access Journals (Sweden)

Campo Osaba Maria-Antonia

2012-03-01

responsibility for his/her own health. The rhythm of a weekly session during 8 weeks with recommended activities to put into practice, as well as the support of the group is an opportunity to incorporate healthy habits and make a commitment to self-care. The sheets handed out are a Health Manual that can always be consulted after the workshop ends. Trial registration Clinical Trials.gov Identifier: NCT01440738
Early food for future health: a randomized controlled trial evaluating the effect of an eHealth intervention aiming to promote healthy food habits from early childhood.

Science.gov (United States)

Helle, Christine; Hillesund, Elisabet Rudjord; Omholt, Mona Linge; Øverby, Nina Cecilie

2017-09-20

Childhood overweight and obesity is a global public health challenge. Primary prevention initiatives targeting parents have been called for to encourage a positive feeding environment and healthy eating habits that may lay a good foundation for future health. At the same time, there is a need for interventions which combine accessibility and scalability with cost effectiveness. Today's parents are extensive Internet-users, but only a few randomized controlled trials have investigated the use of Internet to promote healthy eating habits in early childhood. In Early Food for Future Health we have developed and will evaluate an Internet-based tool for parents of children between 6 and 12 months, aiming to increase knowledge about infant nutrition and foster protective feeding behavior. During springtime 2016, parents of children aged between 3 and 5 months were recruited through Norwegian child health centres and announcements on Facebook. After completing the baseline questionnaire, 718 parents were individually randomized to intervention- or control group. The intervention group received monthly emails with links to an age-appropriate web-site when their child was between 6 and 12 months. The control group received ordinary care from the child health centres. The data-collection is ongoing. All participants will be followed up at ages 12 and possibly 24 and 48 months, with questionnaires relating to eating behaviour and feeding practices, food variety and diet quality. Providing guidance and counseling to parents of infants is an important task for health authorities and the public child health services. Early Food for Future health is an intervention focusing on promoting early healthy food-habits which may prevent childhood overweight and obesity. If proven to be effective, Early Food for Future Health can be used by parents and public health nurses for supplementary guidance on feeding practices and diet. This study has the potential to provide greater
An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

Science.gov (United States)

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.
Anticipatory postural adjustment patterns during gait initiation across the adult lifespan.

Science.gov (United States)

Lu, Chiahao; Amundsen Huffmaster, Sommer L; Harvey, Jack C; MacKinnon, Colum D

2017-09-01

Gait initiation involves a complex sequence of anticipatory postural adjustments (APAs) during the transition from steady state standing to forward locomotion. APAs have four core components that function to accelerate the center of mass forwards and towards the initial single-support stance limb. These components include loading of the initial step leg, unloading of the initial stance leg, and excursion of the center of pressure in the posterior and lateral (towards the stepping leg) directions. This study examined the incidence, magnitude, and timing of these components and how they change across the lifespan (ages 20-79). 157 individuals performed five trials of self-paced, non-cued gait initiation on an instrumented walkway. At least one component of the APA was absent in 24% of all trials. The component most commonly absent was loading of the initial step leg (absent in 10% of all trials in isolation, absent in 10% of trials in conjunction with another missing component). Trials missing all four components were rare (1%) and were observed in both younger and older adults. There was no significant difference across decades in the incidence of trials without an APA, the number or type of APA components absent, or the magnitude or timing of the APA components. These data demonstrate that one or more components of the APA sequence are commonly absent in the general population and the spatiotemporal profile of the APA does not markedly change with ageing. Copyright © 2017 Elsevier B.V. All rights reserved.
Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.

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Larson, Gregg S; Carey, Cate; Grarup, Jesper; Hudson, Fleur; Sachi, Karen; Vjecha, Michael J; Gordin, Fred

2016-04-01

Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They
Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

DEFF Research Database (Denmark)

Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

2016-01-01

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...
The randomised controlled trial design: unrecognized opportunities for health sciences librarianship.

Science.gov (United States)

Eldredge, Jonathan D

2003-06-01

to describe the essential components of the Randomised Controlled Trial (RCT) and its major variations; to describe less conventional applications of the RCT design found in the health sciences literature with potential relevance to health sciences librarianship; to discuss the limited number of RCTs within health sciences librarianship. narrative review supported to a limited extent with PubMed and Library Literature database searches consistent with specific search parameters. In addition, more systematic methods, including handsearching of specific journals, to identify health sciences librarianship RCTs. While many RCTs within the health sciences follow more conventional patterns, some RCTs assume certain unique features. Selected examples illustrate the adaptations of this experimental design to answering questions of possible relevance to health sciences librarians. The author offers several strategies for controlling bias in library and informatics applications of the RCT and acknowledges the potential of the electronic era in providing many opportunities to utilize the blinding aspects of RCTs. RCTs within health sciences librarianship inhabit a limited number of subject domains such as education. This limited scope offers both advantages and disadvantages for making Evidence-Based Librarianship (EBL) a reality. The RCT design offers the potential to answer far more EBL questions than have been addressed by the design to date. Librarians need only extend their horizons through use of the versatile RCT design into new subject domains to facilitate making EBL a reality.
Climbing for preventing and treating health problems: a systematic review of randomized controlled trials

Directory of Open Access Journals (Sweden)

Fechtelpeter, Dennis

2011-01-01

Full Text Available Objective: To summarize the best available evidence on effectiveness of therapeutic or sport climbing in preventing or treating health problems. Methods: We searched Medline, Embase, CENTRAL, PsycINFO, PEDro, OTseeker and SportDiscus for randomized controlled trials published up to December 26, 2010. We included all trials assessing patient-relevant outcomes. Two reviewers independently selected relevant studies, assessed their methodological quality and extracted data. Quality of evidence was rated using the GRADE system. Data were entered into RevMan 5 to calculate effect sizes and 95% confidence intervals where appropriate.Results: Eligible for inclusion were four RCTs studying the effectiveness of climbing in (a geriatric patients, (b adults with multiple sclerosis, (c adults with chronic low-back pain and (d children with disabilities and poor motor function. The sample sizes ranged between 20 and 95. All trials had major methodological limitations. We found very low quality evidence that therapeutic climbing may improve activities of daily living in geriatric patients compared to physiotherapy as measured by the Barthel index (difference in mean change score: 2.32 [95%-CI: 0.45 to 4.19]. We found very low quality evidence that therapeutic climbing compared to standard exercise therapy may improve physical functioning (difference in mean change score: 16.15 [95%-CI: 4.45 to 27.85] and general physical health (13.14 [95%-CI: 3.61 to 22.67] as measured by the SF-36 in adults with chronic low back-pain. Conclusions: Evidence for the effectiveness of therapeutic climbing is limited to small trials at high risk of bias. The effects of therapeutic climbing are therefore unclear.
Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.

Science.gov (United States)

Haines, Terry P; O'Brien, Lisa; Mitchell, Deb; Bowles, Kelly-Ann; Haas, Romi; Markham, Donna; Plumb, Samantha; Chiu, Timothy; May, Kerry; Philip, Kathleen; Lescai, David; McDermott, Fiona; Sarkies, Mitchell; Ghaly, Marcelle; Shaw, Leonie; Juj, Genevieve; Skinner, Elizabeth H

2015-04-02

Disinvestment from inefficient or ineffective health services is a growing priority for health care systems. Provision of allied health services over the weekend is now commonplace despite a relative paucity of evidence supporting their provision. The relatively high cost of providing this service combined with the paucity of evidence supporting its provision makes this a potential candidate for disinvestment so that resources consumed can be used in other areas. This study aims to determine the effectiveness, cost-effectiveness and safety of the current model of weekend allied health service and a new stakeholder-driven model of weekend allied health service delivery on acute medical and surgical wards compared to having no weekend allied health service. Two stepped wedge, cluster randomised trials of weekend allied health services will be conducted in six acute medical/surgical wards across two public metropolitan hospitals in Melbourne (Australia). Wards have been chosen to participate by management teams at each hospital. The allied health services to be investigated will include physiotherapy, occupational therapy, speech therapy, dietetics, social work and allied health assistants. At baseline, all wards will be receiving weekend allied health services. Study 1 intervention will be the sequential disinvestment (roll-in) of the current weekend allied health service model from each participating ward in monthly intervals and study 2 will be the roll-out of a new stakeholder-driven model of weekend allied health service delivery. The order in which weekend allied health services will be rolled in and out amongst participating wards will be determined randomly. This trial will be conducted in each of the two participating hospitals at a different time interval. Primary outcomes will be length of stay, rate of unplanned hospital readmission within 28 days and rate of adverse events. Secondary outcomes will be number of complaints and compliments, staff absenteeism
Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

Science.gov (United States)

Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

2016-06-01

Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

A Personal Perspective on the Initial Federal Health-Based Regulation to Remove Lead from Gasoline

Science.gov (United States)

Bridbord, Kenneth; Hanson, David

2009-01-01

Objective This article describes the personal experience and perspective of the authors, who had primary responsibility for drafting the initial health-based regulation limiting lead content of gasoline during the early 1970s while employed by the U.S. Environmental Protection Agency (EPA). Data source Information used by the U.S. EPA in developing the initial health-based regulation limiting lead content of gasoline in December 1973 and studies documenting the impact of that and subsequent actions. Data extraction Among the lessons learned from this experience is the importance of having input from independent scientists to the regulatory decision-making process. This also demonstrates the critical role of independent peer-reviewed research, such as that supported by the National Institutes of Health, as well as research conducted by scientists from the Centers for Disease Control and Prevention, in delineating the consequences of lead exposure in the population. Data synthesis Removal of lead from gasoline in the United States has been described as one of the great public health achievements of the 20th century, but it almost did not happen. The experience of the authors in developing this regulation may be helpful to others involved in developing health-based regulatory policy in the future. Conclusion The initial U.S. EPA health-based regulation to remove lead from gasoline is clearly an example where science successfully affected public policy. The leadership of the U.S. EPA at that time deserves much credit for establishing an atmosphere in which this was possible. PMID:19672397
Silence is deadly: a cluster-randomised controlled trial of a mental health help-seeking intervention for young men

Directory of Open Access Journals (Sweden)

Alison L. Calear

2017-10-01

Full Text Available Abstract Background Young men are consistently less likely to seek help for mental health problems than their female peers. This is particularly concerning given the high rates of suicide among male adolescents. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for young people. The current trial aims to determine the effectiveness of the Silence is Deadly program in increasing positive help-seeking intentions for mental health problems and suicide among male secondary school students. Methods This study is a two-arm, cluster-randomised, controlled trial that will compare the Silence is Deadly program to a wait-list control condition. Eight Australian high schools will be recruited to the trial, with male students in grades 11 and 12 (16 to 18 years of age targeted for participation. The program is an innovative male-tailored suicide prevention intervention, comprising a presentation that emphasises role-modelling and legitimises help-seeking for personal and emotional problems, and a brief video that features celebrity athletes who counter existing male norms around help-seeking and encourage communication about personal and emotional issues. The program also includes a discussion of how to help a friend in distress and ends with a question and answer session. The primary outcome measure for the current study is help-seeking intentions. Secondary outcomes include help-seeking behaviour, help-seeking attitudes, help-seeking stigma, mental health symptoms, and suicidal ideation. Data will be collected pre-intervention, post-intervention, and at 3-month follow-up. Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effects repeated-measures analyses that account for clustering within schools. Discussion If proven to be effective, this targeted help-seeking intervention for
A case study: the initiative to improve RN scheduling at Hamilton Health Sciences.

Science.gov (United States)

Wallace, Laurel-Anne; Pierson, Sharon

2008-01-01

In 2003, Hamilton Health Sciences embarked on an initiative to improve and standardize nursing schedules and scheduling practices. The scheduling project was one of several initiatives undertaken by a corporate-wide Nursing Resource Group established to enhance the work environment and patient care and to ensure appropriate utilization of nursing resources across the organization's five hospitals. This article focuses on major activities undertaken in the scheduling initiative. The step-by-step approach described, plus examples of the scheduling resources developed and samples of extended-tour schedules, will all provide insight, potential strategies and practical help for nursing administrators, human resources (HR) personnel and others interested in improving nurse scheduling.
Moving science into state child and adolescent mental health systems: Illinois' evidence-informed practice initiative.

Science.gov (United States)

Starin, Amy C; Atkins, Marc S; Wehrmann, Kathryn C; Mehta, Tara; Hesson-McInnis, Matthew S; Marinez-Lora, A; Mehlinger, Renee

2014-01-01

In 2005, the Illinois State Mental Health Authority embarked on an initiative to close the gap between research and practice in the children's mental health system. A stakeholder advisory council developed a plan to advance evidence informed practice through policy and program initiatives. A multilevel approach was developed to achieve this objective, which included policy change, stakeholder education, and clinician training. This article focuses on the evidence-informed training process designed following review of implementation research. The training involved in-person didactic sessions and twice-monthly telephone supervision across 6 cohorts of community based clinicians, each receiving 12 months of training. Training content initially included cognitive behavioral therapy and behavioral parent training and was adapted over the years to a practice model based on common element concepts. Evaluation based on provider and parent report indicated children treated by training clinicians generally showed superior outcomes versus both a treatment-as-usual comparison group for Cohorts 1 to 4 and the statewide child population as a whole after 90 days of care for Cohorts 5 to 6. The results indicated primarily moderate to strong effects for the evidence-based training groups. Moving a large public statewide child mental health system toward more effective services is a complex and lengthy process. These results indicate training of community mental health providers in Illinois in evidence-informed practice was moderately successful in positively impacting child-level functional outcomes. These findings also influenced state policy in committing resources to continuing the initiative, even in difficult economic times.
ABFAB. Attachment to the breast and family attitudes to breastfeeding. The effect of breastfeeding education in the middle of pregnancy on the initiation and duration of breastfeeding: a randomised controlled trial [ISRCTN21556494

Directory of Open Access Journals (Sweden)

Waldenström Ulla

2003-08-01

Full Text Available Abstract Background It has proven difficult to reach World Health Organization (WHO recommendations that infants be exclusively breastfed from birth to six months of age 12, yet there is limited knowledge about interventions that are effective in increasing breastfeeding initiation and duration. Particularly lacking is evidence about how to maintain breastfeeding rates in countries which already have a high initiation of breastfeeding. This study aims to determine whether mid-pregnancy breastfeeding education, with a focus on either attitudes to breastfeeding or on technical aspects of breastfeeding, has an effect on rates of breastfeeding initiation and duration. Secondary aims of the study are to: explore what factors might affect the duration of breastfeeding and evaluate the interventions from the participant and childbirth facilitator perspectives. Methods/Design A randomised controlled trial (RCT design will be used. Women having their first baby, and planning to give birth as public patients at the Royal Women's Hospital (RWH, Melbourne, will be approached at 18–20 weeks of pregnancy and invited to participate in the study. Participants will be randomly allocated to a control group or one of two group interventions: a previously designed and trialled tool to teach practical aspects of breastfeeding or an exploration of family attitudes to breastfeeding. The latter was developed and piloted by the investigators in conjunction with the group facilitators, prior to trial commencement. The interventions are planned to take place at 20–25 weeks. Data will be collected by questionnaire at recruitment, at interview in hospital after the birth and by telephone interview six months later. Medical/obstetric outcomes will be obtained from the medical record. The sample size (972 was calculated to identify an increase in breastfeeding initiation from 75 to 85% and an increase from 40 to 50% in breastfeeding at six months.
Franco-German initiative for Chernobylsk health project

International Nuclear Information System (INIS)

2006-01-01

The works led within the framework of the French-German initiative ( I.F.A.) on the health of the populations exposed to the ionizing radiations concentrated on the main useful indicators of health for the study of the excess incidence of cancers after a relatively long latency period. No net difference of the tendencies of leukaemia incidence was revealing between exposed regions and not exposed regions of Ukraine, Belarus and Russia. As regards solid tumors, the rates of incidence presented the same tendencies of increase in the course of time whatever are the studied regions. On the other hand, the works showed a net increase of the rate of incidence of the thyroid cancers in the exposed regions, notably at the aged persons of less than ten years at the time of the accident. In Belarus, the national register of cancers allowed to bring to light a very high number of thyroid cancers, from the beginning 1990 at the children of less than 15 years and net increase of these cancers, since 1998, in the slice of 15/29 the years. So for this exposed population, the risk of thyroid cancer continues to express itself 20 years after the accident. Besides, no tangible difference from the point of view of the tendencies between exposed and not exposed regions was revealing for the congenital malformations. (N.C.)
A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

Directory of Open Access Journals (Sweden)

Chisholm Katharine

2012-03-01

Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors
Result of randomized control trial to increase breast health awareness among young females in Malaysia

Directory of Open Access Journals (Sweden)

Mehrnoosh Akhtari-Zavare

2016-08-01

Full Text Available Abstract Background Breast cancer is the most common cancer and the second principal cause of cancer deaths in women worldwide as well as in Malaysia. Breast self-examination (BSE has a role in raising breast cancer awareness among women and educational programs play an important role in breast cancer preventive behavior. The aim of this study is to develop, implement and evaluate the effectiveness of Breast Health Awareness program based on health belief model on knowledge of breast cancer and breast-selfexamination and BSE practice among female students in Malaysia. Methods A single-blind randomized controlled trial was carried out among 370 female undergraduate students from January 2011 to April 2012 in two selected public universities in Malaysia. Participants were randomized to either the intervention group or the control group. The educational program was delivered to the intervention group. The outcome measures were assessed at baseline, 6, and 12 months after implementing the health educational program. Chi-square, independent samples t-test and two-way repeated measures ANOVA (GLM were conducted in the course of the data analyses. Results Mean scores of knowledge on breast cancer (p<0.003, knowledge on breast self examination (p<0.001, benefits of BSE (p<0.00, barrier of BSE (0.01 and confidence of BSE practice (p<0.00 in the intervention group had significant differences in comparison with those of the control group 6 and 12 months after the intervention. Also, among those who never practiced BSE at baseline, frequency of BSE practice increased 6 and 12 months after the intervention (p<0.05. Conclusion The Breast Health Awareness program based on health the belief model had a positive effect on knowledge of breast cancer and breast self-examination and practice of BSE among females in Malaysia. Trial registration The ANZCTR clinical trial registry ( ACTRN12616000831482 , retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.
Pan-Canadian Respiratory Standards Initiative for Electronic Health Records (PRESTINE: 2011 National Forum Proceedings

Directory of Open Access Journals (Sweden)

M Diane Lougheed

2012-01-01

Full Text Available In a novel knowledge translation initiative, the Government of Ontario’s Asthma Plan of Action funded the development of an Asthma Care Map to enable adherence with the Canadian Asthma Consensus Guidelines developed under the auspices of the Canadian Thoracic Society (CTS. Following its successful evaluation within the Primary Care Asthma Pilot Project, respiratory clinicians from the Asthma Research Unit, Queen’s University (Kingston, Ontario are leading an initiative to incorporate standardized Asthma Care Map data elements into electronic health records in primary care in Ontario. Acknowledging that the issue of data standards affects all respiratory conditions, and all provinces and territories, the Government of Ontario approached the CTS Respiratory Guidelines Committee. At its meeting in September 2010, the CTS Respiratory Guidelines Committee agreed that developing and standardizing respiratory data elements for electronic health records are strategically important. In follow-up to that commitment, representatives from the CTS, the Lung Association, the Government of Ontario, the National Lung Health Framework and Canada Health Infoway came together to form a planning committee. The planning committee proposed a phased approach to inform stakeholders about the issue, and engage them in the development, implementation and evaluation of a standardized dataset. An environmental scan was completed in July 2011, which identified data definitions and standards currently available for clinical variables that are likely to be included in electronic medical records in primary care for diagnosis, management and patient education related to asthma and COPD. The scan, sponsored by the Government of Ontario, includes compliance with clinical nomenclatures such as SNOMED-CT® and LOINC®. To help launch and create momentum for this initiative, a national forum was convened on October 2 and 3, 2011, in Toronto, Ontario. The forum was designed to
Does initial job status affect midlife outcomes and mental health? Evidence from a survey in Japan

OpenAIRE

Oshio, Takashi; Inagaki, Seiichi

2013-01-01

This article examines how initial job status following graduation affects the midlife outcomes and mental health of Japanese workers, using micro data from a nationwide online survey of 3,117 men and 2,818 women aged 30-60. The focus was the impact of initial job status on socioeconomic/marital status and mental health during the person's midlife period. It was found that failure to obtain regular employment at the time of graduation raised the probabilities of unstable job status throughout ...
Home Health Quality Initiative

Data.gov (United States)

U.S. Department of Health & Human Services — The instrument-data collection tool used to collect and report performance data by home health agencies is called the Outcome and Assessment Information Set (OASIS)....
Improved Endpoints for Cancer Immunotherapy Trials

Science.gov (United States)

Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd

2010-01-01

Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737
Gastrointestinal tolerance and plasma status of carotenoids, EPA and DHA with a fiber-enriched tube feed in hospitalized patients initiated on tube nutrition: Randomized controlled trial.

Science.gov (United States)

Jakobsen, L H; Wirth, R; Smoliner, C; Klebach, M; Hofman, Z; Kondrup, J

2017-04-01

During the first days of tube feeding (TF) gastrointestinal (GI) complications are common and administration of sufficient nutrition is a challenge. Not all standard nutritionally complete formulas contain dietary fiber, fish oil or carotenoids, key dietary nutrients for health and wellbeing. The aim of this study was to investigate the effects of a fiber, fish oil and carotenoid enriched TF formula on diarrhea, constipation and nutrient bioavailability. A multi-center randomized, double-blind, controlled, parallel trial compared the effects of a dietary fiber, fish oil and carotenoid-enriched TF formula (test) with an isocaloric non-enriched formula (control) in 51 patients requiring initiation of TF. Incidence of diarrhea and constipation (based on stool frequency and consistency) was recorded daily. Plasma status of EPA, DHA and carotenoids was measured after 7 days. The incidence of diarrhea was lower in patients receiving the test formula compared with the control group (19% vs. 48%, p = 0.034). EPA and DHA status (% of total plasma phospholipids) was higher after 7 days in test compared with control group (EPA: p = 0.002, DHA: p = 0.082). Plasma carotenoid levels were higher after 7 days in the test group compared with control group (lutein: p = 0.024, α-carotene: p = 0.005, lycopene: p = 0.020, β-carotene: p = 0.054). This study suggests that the nutrient-enriched TF formula tested might have a positive effect on GI tolerance with less diarrhea incidence and significantly improved EPA, DHA and carotenoid plasma levels during the initiation of TF in hospitalized patients who are at risk of diarrhea and low nutrient status. This trial was registered at trialregister.nl; registration number 2924. Copyright © 2016. Published by Elsevier Ltd.
What Factors are Associated with Consumer Initiation of Shared Decision Making in Mental Health Visits?

Science.gov (United States)

Matthias, Marianne S; Fukui, Sadaaki; Salyers, Michelle P

2017-01-01

Understanding consumer initiation of shared decision making (SDM) is critical to improving SDM in mental health consultations, particularly because providers do not always invite consumer participation in treatment decisions. This study examined the association between consumer initiation of nine elements of SDM as measured by the SDM scale, and measures of consumer illness self-management and the consumer-provider relationship. In 63 mental health visits, three SDM elements were associated with self-management or relationship factors: discussion of consumer goals, treatment alternatives, and pros and cons of a decision. Limitations, implications, and future directions are discussed.
A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

Directory of Open Access Journals (Sweden)

Cinnamon S. Bloss

2016-01-01

Full Text Available Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large
Effects of ParentCorps in Prekindergarten on Child Mental Health and Academic Performance: Follow-up of a Randomized Clinical Trial Through 8 Years of Age.

Science.gov (United States)

Brotman, Laurie Miller; Dawson-McClure, Spring; Kamboukos, Dimitra; Huang, Keng-Yen; Calzada, Esther J; Goldfeld, Keith; Petkova, Eva

2016-12-01

Low-income minority children living in urban neighborhoods are at high risk for mental health problems and underachievement. ParentCorps, a family-centered, school-based intervention in prekindergarten, improves parenting and school readiness (ie, self-regulation and preacademic skills) in 2 randomized clinical trials. The longer-term effect on child mental health and academic performance is not known. To examine whether ParentCorps delivered as an enhancement to prekindergarten programs in high-poverty urban schools leads to fewer mental health problems and increased academic performance in the early elementary school years. This is a 3-year follow-up study of a cluster randomized clinical trial of ParentCorps in public schools with prekindergarten programs in New York City. Ten elementary schools serving a primarily low-income, black student population were randomized in 2005, and 4 consecutive cohorts of prekindergarten students were enrolled from September 12, 2005, through December 31, 2008. We report follow-up for the 3 cohorts enrolled after the initial year of implementation. Data analysis was performed from September 1, 2014, to December 31, 2015. ParentCorps included professional development for prekindergarten and kindergarten teachers and a program for parents and prekindergarten students (13 two-hour group sessions delivered after school by teachers and mental health professionals). Annual teacher ratings of mental health problems and academic performance and standardized tests of academic achievement in kindergarten and second grade by testers masked to the intervention or control group randomization. A total of 1050 children (4 years old; 518 boys [49.3%] and 532 girls [50.7%]) in 99 prekindergarten classrooms participated in the trial (88.1% of the prekindergarten population), with 792 students enrolled from 2006 to 2008. Most families in the follow-up study (421 [69.6%]) were low income; 680 (85.9%) identified as non-Latino black, 78 (9.8%) as
Return-to-work intervention versus usual care for sick-listed employees : Health-economic investment appraisal alongside a cluster randomised trial

NARCIS (Netherlands)

Lokman, S.; Volker, D.; Zijlstra-Vlasveld, M.C.; Brouwers, E.P.M.; Boon, B.; Beekman, A.T.; Smit, F.; van der Feltz-Cornelis, C.M.

2017-01-01

To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. A two-armed cluster randomised trial with occupational physicians (OPs) (n=62),
Women's Initiative for Nonsmoking-VII: evaluation of health service utilization and costs among women smokers with cardiovascular disease.

Science.gov (United States)

Froelicher, Erika Sivarajan; Sohn, Min; Max, Wendy; Bacchetti, Peter

2004-01-01

The Women's Initiative for Nonsmoking (WINS), a randomized clinical trial of a smoking cessation intervention for women with cardiovascular disease, permitted an assessment of the types and costs of health services women used during the 30 months after their hospitalization with cardiovascular disease. A prospective design nested within WINS was used for this study. A structured telephone interview guide included questions about medical services and 15 categories of prevention services, including cardiac rehabilitation at 6, 12, 24, and 30 months. Costs were estimated from state and national databases. The 277 women studied had a mean age of 60.7 +/- 10 years. They had smoked approximately 40 +/- 11.4 years. More than 50% of the women had one or more risk factors for cardiovascular disease. During the first 6 months after the index hospitalization, 94% had a physician visit, 39% had an emergency-room visit, and 36% had a hospital admission. Prevention services used were home healthcare by nurse or home health aide (26%), a cardiac rehabilitation program, including Multifit and Heart Smart (19%), and physical therapy (14%). Usage decreased over the 30 months. For the women who used any service, the mean total monthly cost per woman was 913 dollars +/- 1204 dollars. This is the first report on health service use by women smokers with cardiovascular disease. Data collection using a telephone interview guide proved feasible for evaluating health service use. The greatest costs resulted from hospital admissions and physician and emergency-room visits. Considering the high prevalence of risk factors in this cohort, secondary prevention services were severely underutilized. By increasing referrals to such services, physicians and nurses might influence women to reduce their risk for subsequent cardiovascular disease.
Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

Science.gov (United States)

Bottomley, Andrew; Pe, Madeline; Sloan, Jeff; Basch, Ethan; Bonnetain, Franck; Calvert, Melanie; Campbell, Alicyn; Cleeland, Charles; Cocks, Kim; Collette, Laurence; Dueck, Amylou C; Devlin, Nancy; Flechtner, Hans-Henning; Gotay, Carolyn; Greimel, Eva; Griebsch, Ingolf; Groenvold, Mogens; Hamel, Jean-Francois; King, Madeleine; Kluetz, Paul G; Koller, Michael; Malone, Daniel C; Martinelli, Francesca; Mitchell, Sandra A; Moinpour, Carol M; Musoro, Jammbe; O'Connor, Daniel; Oliver, Kathy; Piault-Louis, Elisabeth; Piccart, Martine; Pimentel, Francisco L; Quinten, Chantal; Reijneveld, Jaap C; Schürmann, Christoph; Smith, Ashley Wilder; Soltys, Katherine M; Taphoorn, Martin J B; Velikova, Galina; Coens, Corneel

2016-11-01

Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making. Copyright © 2016 Elsevier Ltd. All rights reserved.
The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

Science.gov (United States)

Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

2010-12-01

The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

Making Sense of “Consumer Engagement” Initiatives to Improve Health and Health Care: A Conceptual Framework to Guide Policy and Practice

Science.gov (United States)

Mittler, Jessica N; Martsolf, Grant R; Telenko, Shannon J; Scanlon, Dennis P

2013-01-01

Context Policymakers and practitioners continue to pursue initiatives designed to engage individuals in their health and health care despite discordant views and mixed evidence regarding the ability to cultivate greater individual engagement that improves Americans’ health and well-being and helps manage health care costs. There is limited and mixed evidence regarding the value of different interventions. Methods Based on our involvement in evaluating various community-based consumer engagement initiatives and a targeted literature review of models of behavior change, we identified the need for a framework to classify the universe of consumer engagement initiatives toward advancing policymakers' and practitioners' knowledge of their value and fit in various contexts. We developed a framework that expanded our conceptualization of consumer engagement, building on elements of two common models, the individually focused transtheoretical model of behavior and the broader, multilevel social ecological model. Finally, we applied this framework to one community's existing consumer engagement program. Findings Consumer engagement in health and health care refers to the performance of specific behaviors (“engaged behaviors”) and/or an individual's capacity and motivation to perform these behaviors (“activation”). These two dimensions are related but distinct and thus should be differentiated. The framework creates four classification schemas, by (1) targeted behavior types (self-management, health care encounter, shopping, and health behaviors) and by (2) individual, (3) group, and (4) community dimensions. Our example illustrates that the framework can systematically classify a variety of consumer engagement programs, and that this exercise and resulting characterization can provide a structured way to consider the program and how its components fit program goals both individually and collectively. Conclusions Applying the framework could help advance the field
The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

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Yang Hui

2011-02-01

Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526
The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

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van Dijk Frank JH

2011-05-01

Full Text Available Abstract Background Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS mental module may be an effective strategy to monitor and promote good (mental health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. Methods The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in
Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

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Ammendolia Carlo

2008-12-01

Full Text Available Abstract Background Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in improving recovery of patients with recent whiplash associated disorders. Methods and Design We designed a pragmatic randomized clinical trial. A total of 444 participants (148 in each of three arms who reside in Southern Ontario, Canada will be recruited from a large insurer. We will include individuals who are 18 years of age or older and who are diagnosed with Grade I or II Whiplash-associated Disorders. Participants will be randomized to physician-based education and activation or one of two rehabilitation programs of care currently in use in Ontario. Our primary outcome, self-rated global recovery and all secondary outcomes (neck pain intensity, whiplash disability, health-related quality of life, depressive symptomatology and satisfaction with care will be measured at baseline by a trial coordinator and at 6 weeks, 3, 6, 9 and 12 months follow-up by an interviewer who is blind to the participants' baseline characteristics and treatment allocation. We will also collect information on general health status, other injuries, comorbidities, expectation of recovery, work status, pain coping, legal representation, and co-interventions. The primary intention-to-treat analysis will compare time to recovery between the three interventions. This trial will have 90% power at an alpha of 0.05 to detect a 20% difference in the rate of perceived recovery at one year. Secondary analyses will compare the health outcomes, rate of recurrence and the rate of adverse
Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

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Côté, Pierre; Cassidy, J David; Carette, Simon; Boyle, Eleanor; Shearer, Heather M; Stupar, Maja; Ammendolia, Carlo; van der Velde, Gabrielle; Hayden, Jill A; Yang, Xiaoqing; van Tulder, Maurits; Frank, John W

2008-01-01

Background Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effective treatment for patients with whiplash-associated disorders. However, these findings have not been tested in a randomized controlled trial. The purpose of this study is to determine which of physician care or two rehabilitation programs of care is most effective in improving recovery of patients with recent whiplash associated disorders. Methods and Design We designed a pragmatic randomized clinical trial. A total of 444 participants (148 in each of three arms) who reside in Southern Ontario, Canada will be recruited from a large insurer. We will include individuals who are 18 years of age or older and who are diagnosed with Grade I or II Whiplash-associated Disorders. Participants will be randomized to physician-based education and activation or one of two rehabilitation programs of care currently in use in Ontario. Our primary outcome, self-rated global recovery and all secondary outcomes (neck pain intensity, whiplash disability, health-related quality of life, depressive symptomatology and satisfaction with care) will be measured at baseline by a trial coordinator and at 6 weeks, 3, 6, 9 and 12 months follow-up by an interviewer who is blind to the participants' baseline characteristics and treatment allocation. We will also collect information on general health status, other injuries, comorbidities, expectation of recovery, work status, pain coping, legal representation, and co-interventions. The primary intention-to-treat analysis will compare time to recovery between the three interventions. This trial will have 90% power at an alpha of 0.05 to detect a 20% difference in the rate of perceived recovery at one year. Secondary analyses will compare the health outcomes, rate of recurrence and the rate of adverse events between intervention
Clinical Trials

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Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...
Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

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Jolly, Kate; Ingram, Jenny; Clarke, Joanne; Johnson, Debbie; Trickey, Heather; Thomson, Gill; Dombrowski, Stephan U; Sitch, Alice; Dykes, Fiona; Feltham, Max G; Darwent, Kirsty; MacArthur, Christine; Roberts, Tracy

2018-01-01

Introduction Breast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities. We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care. Methods and analysis A two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess
Predicting initial client engagement with community mental health services by routinely measured data

NARCIS (Netherlands)

Roeg, D.P.K.; van de Goor, L.A.M.; Garretsen, H.F.L.

2015-01-01

Engagement is a determinant of how well a person will respond to professional input. This study investigates whether, in practice, routinely measured data predict initial client engagement with community mental health services. Engagement, problem severity, client characteristics, and duration
Addressing Gaps in Mental Health and Addictions Nursing Leadership: An Innovative Professional Development Initiative.

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Gehrs, Margaret; Strudwick, Gillian; Ling, Sara; Reisdorfer, Emilene; Cleverley, Kristin

2017-01-01

Mental health and addictions services are integral to Canada's healthcare system, and yet it is difficult to recruit experienced nurse leaders with advanced practice, management or clinical informatics expertise in this field. Master's-level graduates, aspiring to be mental health nurse leaders, often lack the confidence and experience required to lead quality improvement, advancements in clinical care, service design and technology innovations for improved patient care. This paper describes an initiative that develops nursing leaders through a unique scholarship, internship and mentorship model, which aims to foster confidence, critical thinking and leadership competency development in the mental health and addictions context. The "Mutual Benefits Model" framework was applied in the design and evaluation of the initiative. It outlines how mentee, mentor and organizational needs can drive strategic planning of resource investment, mentorship networks and relevant leadership competency-based learning plans to optimize outcomes. Five-year individual and organizational outcomes are described. © 2017 Longwoods Publishing.
The Smart Health Initiative in China: The Case of Wuhan, Hubei Province.

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Fan, Meiyu; Sun, Jian; Zhou, Bin; Chen, Min

2016-03-01

To introduce smart health in Wuhan, and provide some references for other cities. As the largest mega-city in central China, Wuhan is investing large amounts of resources to push forward the development of Smart Wuhan and Health Wuhan, and it has unique features. It is one of the centerpieces of China's New Healthcare Reform, and great hope is put on it to help solve the conflict between limited healthcare resources and the large population of patients. How to plan and design smart health is important. The construction of Wuhan Smart Health includes some aspects as follows, like requirement analysis, the establishment of objectives and blueprint, the architecture design of regional health information platform, evaluation and implementation, problems and solutions, and so on. Wuhan Smart Health has obtained some achievements in health network, information systems, resident's health records, information standard, and the first phase of municipal health information platform. The focus of this article is the whole construction process of smart health in Wuhan. Although there are some difficulties during this period, some smart health services and management have been reflected. Compared with other cities or countries, Wuhan Smart Health has its own advantages and disadvantages. This study aims to provide a reference for other cities. Because smart health of Wuhan is characteristic in construction mode. Though still in the initial stage, it has great potentials in the future.
Study Protocol - an exploratory trial on health promoting schools at Dutch secondary schools

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Vincent Busch

2012-07-01

Full Text Available Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural domains simultaneously via a combination of education, creating a healthy environment and introducing healthy behavioural policies. Additionally, extensive partnerships are formed between schools, parents, neighbourhoods and youth health authorities to coordinate health promotion efforts.Study design and data collection methods: The intervention will be implemented at two secondary schools. Results will be compared with two control schools (n≈1500. The intervention's effectiveness in changing student behaviours as well as physical and psychosocial health status along with qualitative lessons learned on the integration of youth health care services and school health education practices are the main aimed outcomes of this study. Data are collected via a mixed methods design combining an annual youth health (behaviour monitor with a qualitative process evaluation via interviews with key stakeholders.Data analysis: A multilevel analysis is performed combined with a systematic analysis of qualitative interview data.Conclusions: This study will produce an evaluation of a comprehensive health promoting school intervention that combines an integrated approach of schools, neighbourhoods, families and youth health services to improve adolescent health.
Mental health promotion initiatives for children and youth in contexts of poverty: the case of South Africa.

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Petersen, Inge; Swartz, Leslie; Bhana, Arvin; Flisher, Alan J

2010-09-01

In order to achieve sustainable development and a consequent reduction in levels of poverty, a multisectoral response to development incorporating pro-poor economic policies in low- to middle-income countries (LMICs) is required. An important aspect is strengthening the human capital asset base of vulnerable populations. This should include the promotion of mental health, which can play an important role in breaking the intergenerational cycle of poverty and mental ill-health through promoting positive mental health outcomes within the context of risk. For each developmental phase of early childhood, middle childhood and adolescence, this article provides: (i) an overview of the critical risk influences and evidence of the role of mental health promotion initiatives in mediating these influences; (ii) a background to these risk influences in South Africa; and (iii) a review of mental health promotion initiatives addressing distal upstream influences at a macro-policy level in South Africa, as well as evidence-based micro- and community-level interventions that have the potential to be scaled up. From this review, strengths and gaps in existing micro- and community-level evidence-based mental health promotion interventions as well as macro-policy-level initiatives are identified, and recommendations made for South Africa that may also have applicability for other LMICs.
The Child and Adolescent Trial for Cardiovascular Health (CATCH): intervention, implementation, and feasibility for elementary schools in the United States.

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Perry, C L; Sellers, D E; Johnson, C; Pedersen, S; Bachman, K J; Parcel, G S; Stone, E J; Luepker, R V; Wu, M; Nader, P R; Cook, K

1997-12-01

The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the largest school-based field trial ever sponsored by the National Institutes of Health. The trial demonstrated positive changes in the school food service and physical education program, as well as in students' cardiovascular health behaviors. Because the CATCH intervention programs were implemented in 56 schools (in four states) that were typical of schools throughout the United States, their reception by schools and degree of implementation provide evidence about their feasibility for schools nationally. Extensive process evaluation data were collected from students, teachers, school food service personnel, and physical education specialists throughout the three school years of the CATCH intervention. Four of the CATCH programs--school food service, physical education, classroom curricula, and home programs--were assessed over the three school years. The process data provide information on participation, dose, fidelity, and compatibility of the CATCH programs in the intervention schools for these programs. High levels of participation, dose, fidelity, and compatibility were observed for the four programs during the 3 school years. CATCH emerges as a model of a feasible multilevel health promotion program to improve eating and exercise behaviors for elementary schools in the United States.
Clinical Trials

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Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...
Clinical Trials

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Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...
Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

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Moodley Jothi

2010-04-01

Full Text Available Abstract Background South Africa, with its scientific capacity, good infrastructure and high HIV incidence rates, is ideally positioned to conduct large-scale HIV prevention trials. The HIV Prevention Research Unit of the South African Medical Research Council conducted four phase III and one phase IIb trials of women-initiated HIV prevention options in KwaZulu-Natal between 2003 and 2009. A total of 7046 women participated, with HIV prevalence between 25% and 45% and HIV incidence ranging from 4.5-9.1% per year. Unfortunately none of the interventions tested had any impact on reducing the risk of HIV acquisition; however, extremely valuable experience was gained, lessons learned and capacity built, while the communities gained associated benefits. Experience Our experience in conducting these trials ranged from setting up community partnerships to developing clinical research sites and dissemination of trial results. Community engagement included setting up community-based research sites with approval from both political and traditional leaders, and developing community advisory groups to assist with the research process. Community-wide education on HIV/sexually transmitted infection prevention, treatment and care was provided to over 90 000 individuals. Myths and misconceptions were addressed through methods such as anonymous suggestion boxes in clinic waiting areas and intensive education and counselling. Attempts were made to involve male partners to foster support and facilitate recruitment of women. Peer educator programmes were initiated to provide ongoing education and also to facilitate recruitment of women to the trials. Recruitment strategies such as door-to-door recruitment and community group meetings were initiated. Over 90% of women enrolled were retained. Community benefits from the trial included education on HIV prevention, treatment and care and provision of ancillary care (such as Pap smears, reproductive health care and
Caregiver reports of patient-initiated violence in psychosis.

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Onwumere, Juliana; Grice, Sarah; Garety, Philippa; Bebbington, Paul; Dunn, Graham; Freeman, Daniel; Fowler, David; Kuipers, Elizabeth

2014-07-01

Aggressive behaviour in psychosis is not uncommon. Community provision for people with psychosis has left informal caregivers to take on a greater role in their care. However, few studies have explored links between patient-initiated violence in mental health caregiving relationships and caregiver functioning. Our study investigated caregiver reports of aggressive acts committed by their relative with psychosis and their links to caregiver appraisals of the caregiving relationship and caregiver outcomes. Caregivers of patients with a recent relapse of psychosis, recruited to a psychological therapy trial, completed the audiotaped Camberwell Family Interview at baseline. This semi-structured interview includes questions on the quality of the relationship between caregiver and patient, and patient history of violence. Seventy-two transcripts of interviews were assessed for reports of patient-initiated violence. One-half of the caregiver sample (52.9%) reported an incident of patient-initiated violence during their interview; 62.2% of these involved violence toward themselves, and 24.3% toward property. Reports of patient violence were associated with caregiver ratings of hostility expressed toward patients, lower self-esteem, and emotion-focused coping. People caring on their own were more likely to report incidents of patient violence. Younger patients, males, and inpatients were more frequently identified as having a history of this kind of violence. Our findings suggested that caregiver reports of patient-initiated violence in psychosis are not uncommon. Mental health staff need to be aware of the risks of such violence for caregivers of people with psychosis, and consider appropriate procedures for minimizing it.
Readiness to Change Over Time: Change Commitment and Change Efficacy in a Workplace Health-Promotion Trial.

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Helfrich, Christian D; Kohn, Marlana J; Stapleton, Austin; Allen, Claire L; Hammerback, Kristen Elizabeth; Chan, K C Gary; Parrish, Amanda T; Ryan, Daron E; Weiner, Bryan J; Harris, Jeffrey R; Hannon, Peggy A

2018-01-01

Organizational readiness to change may be a key determinant of implementation success and a mediator of the effectiveness of implementation interventions. If organizational readiness can be reliably and validly assessed at the outset of a change initiative, it could be used to assess the effectiveness of implementation-support activities by measuring changes in readiness factors over time. We analyzed two waves of readiness-to-change survey data collected as part of a three-arm, randomized controlled trial to implement evidence-based health promotion practices in small worksites in low-wage industries. We measured five readiness factors: context (favorable broader conditions); change valence (valuing health promotion); information assessment (demands and resources to implement health promotion); change commitment (an intention to implement health promotion); and change efficacy (a belief in shared ability to implement health promotion). We expected commitment and efficacy to increase at intervention sites along with their self-reported effort to implement health promotion practices, termed wellness-program effort. We compared means between baseline and 15 months, and between intervention and control sites. We used linear regression to test whether intervention and control sites differed in their change-readiness scores over time. Only context and change commitment met reliability thresholds. Change commitment declined significantly for both control (-0.39) and interventions sites (-0.29) from baseline to 15 months, while context did not change for either. Only wellness program effort at 15 months, but not at baseline, differed significantly between control and intervention sites (1.20 controls, 2.02 intervention). Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1) intervention sites exhibited significantly smaller change in context scores relative to control sites
Readiness to Change Over Time: Change Commitment and Change Efficacy in a Workplace Health-Promotion Trial

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Christian D. Helfrich

2018-04-01

Full Text Available IntroductionOrganizational readiness to change may be a key determinant of implementation success and a mediator of the effectiveness of implementation interventions. If organizational readiness can be reliably and validly assessed at the outset of a change initiative, it could be used to assess the effectiveness of implementation-support activities by measuring changes in readiness factors over time.MethodsWe analyzed two waves of readiness-to-change survey data collected as part of a three-arm, randomized controlled trial to implement evidence-based health promotion practices in small worksites in low-wage industries. We measured five readiness factors: context (favorable broader conditions; change valence (valuing health promotion; information assessment (demands and resources to implement health promotion; change commitment (an intention to implement health promotion; and change efficacy (a belief in shared ability to implement health promotion. We expected commitment and efficacy to increase at intervention sites along with their self-reported effort to implement health promotion practices, termed wellness-program effort. We compared means between baseline and 15 months, and between intervention and control sites. We used linear regression to test whether intervention and control sites differed in their change-readiness scores over time.ResultsOnly context and change commitment met reliability thresholds. Change commitment declined significantly for both control (−0.39 and interventions sites (−0.29 from baseline to 15 months, while context did not change for either. Only wellness program effort at 15 months, but not at baseline, differed significantly between control and intervention sites (1.20 controls, 2.02 intervention. Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1 intervention sites exhibited significantly smaller change in
Hip-Hop to Health Jr. Randomized Effectiveness Trial: 1-Year Follow-up Results.

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Kong, Angela; Buscemi, Joanna; Stolley, Melinda R; Schiffer, Linda A; Kim, Yoonsang; Braunschweig, Carol L; Gomez-Perez, Sandra L; Blumstein, Lara B; Van Horn, Linda; Dyer, Alan R; Fitzgibbon, Marian L

2016-02-01

The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child's life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. RCT. Primarily African American children (aged 3-5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Eighteen preschools were randomly assigned in 2007-2008 to receive either (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors or (2) a 14-week teacher-delivered general health curriculum (control group). The primary outcome, BMI, was measured at baseline, postintervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively. This study is registered at www.clinicaltrials.gov NCT00241878. Copyright © 2016 American Journal of

Generation of political priority for global health initiatives: a framework and case study of maternal mortality.

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Shiffman, Jeremy; Smith, Stephanie

2007-10-13

Why do some global health initiatives receive priority from international and national political leaders whereas others receive little attention? To analyse this question we propose a framework consisting of four categories: the strength of the actors involved in the initiative, the power of the ideas they use to portray the issue, the nature of the political contexts in which they operate, and characteristics of the issue itself. We apply this framework to the case of a global initiative to reduce maternal mortality, which was launched in 1987. We undertook archival research and interviewed people connected with the initiative, using a process-tracing method that is commonly employed in qualitative research. We report that despite two decades of effort the initiative remains in an early phase of development, hampered by difficulties in all these categories. However, the initiative's 20th year, 2007, presents opportunities to build political momentum. To generate political priority, advocates will need to address several challenges, including the creation of effective institutions to guide the initiative and the development of a public positioning of the issue to convince political leaders to act. We use the framework and case study to suggest areas for future research on the determinants of political priority for global health initiatives, which is a subject that has attracted much speculation but little scholarship.
Initial Public Health Laboratory Response After Hurricane Maria - Puerto Rico, 2017.

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Concepción-Acevedo, Jeniffer; Patel, Anita; Luna-Pinto, Carolina; Peña, Rafael González; Cuevas Ruiz, Rosa Ivette; Arbolay, Héctor Rivera; Toro, Mayra; Deseda, Carmen; De Jesus, Victor R; Ribot, Efrain; Gonzalez, Jennifer-Quiñones; Rao, Gouthami; De Leon Salazar, Alfonsina; Ansbro, Marisela; White, Brunilís B; Hardy, Margaret C; Georgi, Joaudimir Castro; Stinnett, Rita; Mercante, Alexandra M; Lowe, David; Martin, Haley; Starks, Angela; Metchock, Beverly; Johnston, Stephanie; Dalton, Tracy; Joglar, Olga; Stafford, Cortney; Youngblood, Monica; Klein, Katherine; Lindstrom, Stephen; Berman, LaShondra; Galloway, Renee; Schafer, Ilana J; Walke, Henry; Stoddard, Robyn; Connelly, Robin; McCaffery, Elaine; Rowlinson, Marie-Claire; Soroka, Stephen; Tranquillo, Darin T; Gaynor, Anne; Mangal, Chris; Wroblewski, Kelly; Muehlenbachs, Atis; Salerno, Reynolds M; Lozier, Matthew; Sunshine, Brittany; Shapiro, Craig; Rose, Dale; Funk, Renee; Pillai, Satish K; O'Neill, Eduardo

2018-03-23

Hurricane Maria made landfall in Puerto Rico on September 20, 2017, causing major damage to infrastructure and severely limiting access to potable water, electric power, transportation, and communications. Public services that were affected included operations of the Puerto Rico Department of Health (PRDOH), which provides critical laboratory testing and surveillance for diseases and other health hazards. PRDOH requested assistance from CDC for the restoration of laboratory infrastructure, surveillance capacity, and diagnostic testing for selected priority diseases, including influenza, rabies, leptospirosis, salmonellosis, and tuberculosis. PRDOH, CDC, and the Association of Public Health Laboratories (APHL) collaborated to conduct rapid needs assessments and, with assistance from the CDC Foundation, implement a temporary transport system for shipping samples from Puerto Rico to the continental United States for surveillance and diagnostic and confirmatory testing. This report describes the initial laboratory emergency response and engagement efforts among federal, state, and nongovernmental partners to reestablish public health laboratory services severely affected by Hurricane Maria. The implementation of a sample transport system allowed Puerto Rico to reinitiate priority infectious disease surveillance and laboratory testing for patient and public health interventions, while awaiting the rebuilding and reinstatement of PRDOH laboratory services.
‘The phone reminder is important, but will others get to know about my illness?’ Patient perceptions of an mHealth antiretroviral treatment support intervention in the HIVIND trial in South India

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Rodrigues, Rashmi; Poongulali, S; Balaji, Kavitha; Atkins, Salla; Ashorn, Per; De Costa, Ayesha

2015-01-01

Objectives The recent explosion of mHealth applications in the area of HIV care has led to the development of mHealth interventions to support antiretroviral treatment adherence. Several of these interventions have been tested for effectiveness, but few studies have explored patient perspectives of such interventions. Exploring patient perspectives enhances the understanding of how an intervention works or why it does not. We therefore studied perceptions regarding an mHealth adherence intervention within the HIVIND trial in South India. Methods The study was conducted at three clinics in South India. The intervention comprised an automated interactive voice response (IVR) call and a pictorial short messaging service (SMS), each delivered weekly. Sixteen purposively selected participants from the intervention arm in the HIVIND trial were interviewed. All participants had completed at least 84 weeks since enrollment in the trial. Perceptions on the usefulness and perceived benefits and risks of receiving the intervention were sought. The interviews were transcribed and analysed using the framework approach to qualitative data analysis. Results Despite varying perceptions of the intervention, most participants found it useful. The intervention was perceived as a sign of ‘care’ from the clinic. The IVR call was preferred to the SMS reminder. Two-way communication was preferred to automated calls. Participants also perceived a risk of unintentional disclosure of their HIV status and stigma thereof via the intervention and took initiatives to mitigate this risk. Targeting reminders at those with poor adherence and those in need of social support was suggested. Conclusions mHealth adherence interventions go beyond their intended role to provide a sense of care and support to the recipient. Although automated interventions are impersonal, they could be a solution for scale up. Interventions that engage both the recipient and the healthcare provider have greater
The Beck Initiative: A Partnership to Implement Cognitive Therapy in a Community Behavioral Health System

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Stirman, Shannon Wiltsey; Buchhofer, Regina; McLaulin, J. Bryce; Evans, Arthur C.; Beck, Aaron T.

2010-01-01

The Beck Initiative is a partnership between researchers and clinicians at a large university and an urban behavioral health managed care system. Both partners share a commitment to ensuring that consumers in the community have access to competently delivered, individualized, evidence-based mental health care and that the providers who serve them have the support they need to deliver high-quality evidence-based treatments. Central features of the program are individualized training and consultation in cognitive therapy for each provider agency and policies to promote the sustainability of the initiative and its continuing evolution to meet the needs of providers and consumers. PMID:19797367
Effects of professional oral health care on elderly: randomized trial.

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Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

2014-11-01

To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Preparing the next generation of maternal and newborn health leaders: the maternal and newborn health champions initiatives.

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Dao, Blami; Otolorin, Emmanuel; Gomez, Patricia P; Carr, Catherine; Sanghvi, Harshad

2015-06-01

A champion in health care can be defined as any health professional who has the requisite knowledge and skills in a relevant health field, who is respected by his/her peers and supported by his/her supervisors, and who takes the lead to promote or introduce evidence-based interventions to improve the quality of care. Jhpiego used a common approach during two distinct initiatives to identify individuals in Africa, Asia, and Latin America and the Caribbean whose expertise in their clinical service area and whose leadership capacity could be strengthened to enable them to serve as champions for maternal and newborn health (MNH). These champions have gone on to contribute to the improvement of MNH in their respective countries and regions. The lessons learned from this approach are shared so they can be used by other organizations to design leadership development strategies for MNH in low-resource countries. Copyright © 2015. Published by Elsevier Ireland Ltd.
The Development of a Minority Recruitment Plan for Cancer Clinical Trials.

Science.gov (United States)

Trevino, Monica; Padalecki, Susan; Karnad, Anand; Parra, Alberto; Weitman, Steve; Nashawati, Melissa; Pollock, Brad H; Ramirez, Amelie; Thompson, Ian M

2013-09-01

Cancer does not occur in all ethnic and racial groups at similar rates. In addition, responses to treatment also vary in certain ethnic and racial groups. For Hispanics, the overall cancer incidence is generally lower yet for some specific tumor types, the incidence rates are higher compared to other populations. Although disparities are recognized for treatment outcomes and prevention methodologies for Hispanics and other minority populations, specific recruiting and reporting of minorities remains a challenge. In order to circumvent this problem, the Cancer Therapy and Research Center (CTRC) has developed a new minority recruitment plan for all cancer related clinical trials at this Institute. The overall goal of this initiative is to increase the accrual of minorities in cancer clinical trials by implementing several key interventions. The Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio established the Clinical Trials Accrual Task Force to develop and monitor interventions designed to increase accrual to cancer clinical trials, specifically the accrual of minorities with a focus on the Hispanic population that makes up 68% of the CTRC's catchment area. A Minority Accrual Plan (MAP) was implemented in March 2013 as part of the process for initiating and conducting cancer-related clinical trials at the CTRC. The Minority Accrual Plan focuses on Hispanic enrollment due to the characteristics of the South Texas population served by the CTRC but could be easily adapted to other populations. The CTRC has designed a process to prospectively address the challenge of deliberately enrolling minority subjects and accurately accounting for the results by implementing a Minority Accrual Plan for every cancer-related clinical trial at CTRC.
Quality of life after quitting smoking and initiating aerobic exercise.

Science.gov (United States)

Bloom, Erika Litvin; Minami, Haruka; Brown, Richard A; Strong, David R; Riebe, Deborah; Abrantes, Ana M

2017-10-01

Quitting smoking and aerobic exercise each improve health. Although smokers may be concerned that quitting smoking will reduce their quality of life (QOL), recent research has shown that cessation is associated with QOL benefits. Elements of smoking cessation interventions, such as exercise, may contribute to changes in QOL. However, it is unknown whether initiating exercise in the context of smoking cessation is associated with greater or different effects on QOL than smoking cessation alone. The current study is a secondary analysis of data from a randomized trial (n = 61) of an exercise intervention for smoking cessation. We hypothesized that smoking abstinence and engagement in exercise would have positive, additive effects on QOL at end-of-treatment, 6- and, 12-month follow-ups. Sedentary adult smokers were randomized to the exercise intervention or a health education control (HEC) group. Additionally, all participants received smoking cessation counseling and nicotine patches. Data were analyzed using actual engagement in exercise, rather than group assignment as a proxy for exercise engagement, because some HEC participants also began exercising. Abstinence was positively associated with higher total and physical health QOL at follow-up. Exercise was not associated with total QOL and only marginally associated with physical health QOL, but was positively related to overall sense of well-being. Emphasizing that smoking cessation is associated with higher QOL may help motivate smokers to initiate quit attempts.
Local adaptations to a global health initiative: penalties for home births in Zambia.

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Greeson, Dana; Sacks, Emma; Masvawure, Tsitsi B; Austin-Evelyn, Katherine; Kruk, Margaret E; Macwan'gi, Mubiana; Grépin, Karen A

2016-11-01

Global health initiatives (GHIs) are implemented across a variety of geographies and cultures. Those targeting maternal health often prioritise increasing facility delivery rates. Pressure on local implementers to meet GHI goals may lead to unintended programme features that could negatively impact women. This study investigates penalties for home births imposed by traditional leaders on women during the implementation of Saving Mothers, Giving Life (SMGL) in Zambia. Forty focus group discussions (FGDs) were conducted across four rural districts to assess community experiences of SMGL at the conclusion of its first year. Participants included women who recently delivered at home (3 FGDs/district), women who recently delivered in a health facility (3 FGDs/district), community health workers (2 FGDs/district) and local leaders (2 FGDs/district). Findings indicate that community leaders in some districts-independently of formal programme directive-used fines to penalise women who delivered at home rather than in a facility. Participants in nearly all focus groups reported hearing about the imposition of penalties following programme implementation. Some women reported experiencing penalties firsthand, including cash and livestock fines, or fees for child health cards that are typically free. Many women who delivered at home reported their intention to deliver in a facility in the future to avoid penalties. While communities largely supported the use of penalties to promote facility delivery, the penalties effectively introduced a new tax on poor rural women and may have deterred their utilization of postnatal and child health care services. The imposition of penalties is thus a punitive adaptation that can impose new financial burdens on vulnerable women and contribute to widening health, economic and gender inequities in communities. Health initiatives that aim to increase demand for health services should monitor local efforts to achieve programme targets in order
Improving children's health and development in British Columbia through nurse home visiting: a randomized controlled trial protocol.

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Catherine, Nicole L A; Gonzalez, Andrea; Boyle, Michael; Sheehan, Debbie; Jack, Susan M; Hougham, Kaitlyn A; McCandless, Lawrence; MacMillan, Harriet L; Waddell, Charlotte

2016-08-04

Nurse-Family Partnership is a nurse home visitation program that aims to improve the lives of young mothers and their children. The program focuses on women who are parenting for the first time and experiencing socioeconomic disadvantage. Nurse visits start as early in pregnancy as possible and continue until the child reaches age two years. The program has proven effective in the United States - improving children's mental health and development and maternal wellbeing, and showing long-term cost-effectiveness. But it is not known whether the same benefits will be obtained in Canada, where public services differ. The British Columbia Healthy Connections Project therefore involves a randomized controlled trial evaluating Nurse-Family Partnership's effectiveness compared with existing (usual) services in improving children's mental health and early development and mother's life circumstances. The trial's main aims are to: reduce childhood injuries by age two years (primary outcome indicator); reduce prenatal nicotine and alcohol use; improve child cognitive and language development and behaviour at age two years; and reduce subsequent pregnancies by 24 months postpartum. Potential explanatory factors such as maternal mental health (including self-efficacy) are also being assessed, as is the program's impact on exposure to intimate-partner violence. To inform future economic evaluation, data are also being collected on health and social service access and use. Eligible and consenting participants (N = 1040) are being recruited prior to 28 weeks gestation then individually randomized to receive existing services (comparison group) or Nurse-Family Partnership plus existing services (intervention group). Nurse-Family Partnership is being delivered following fidelity guidelines. Data are being collected during in person and telephone interviews at: baseline; 34-36 weeks gestation; and two, 10, 18 and 24 months postpartum. Additional data will be obtained via
Implementing Health Policy: Lessons from the Scottish Well Men's Policy Initiative.

Science.gov (United States)

Douglas, Flora; van Teijlingen, Edwin; Smith, Cairns; Moffat, Mandy

2015-01-01

Little is known about how health professionals translate national government health policy directives into action. This paper examines that process using the so-called Well Men's Services (WMS) policy initiative as a 'real world' case study. The WMS were launched by the Scottish Government to address men's health inequalities. Our analysis aimed to develop a deeper understanding of policy implementation as it naturally occurred, used an analytical framework that was developed to reflect the 'rational planning' principles health professionals are commonly encouraged to use for implementation purposes. A mixed-methods qualitative enquiry using a data archive generated during the WMS policy evaluation was used to critically analyze (post hoc) the perspectives of national policy makers, and local health and social care professionals about the: (a) 'policy problem', (b) interventions intended to address the problem, and (c) anticipated policy outcomes. This analysis revealed four key themes: (1) ambiguity regarding the policy problem and means of intervention; (2) behavioral framing of the policy problem and intervention; (3) uncertainty about the policy evidence base and outcomes, and; (4) a focus on intervention as outcome . This study found that mechanistic planning heuristics (as a means of supporting implementation) fails to grapple with the indeterminate nature of population health problems. A new approach to planning and implementing public health interventions is required that recognises the complex and political nature of health problems; the inevitability of imperfect and contested evidence regarding intervention, and, future associated uncertainties.
Understanding noninferiority trials

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Seokyung Hahn

2012-11-01

Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
Political Action Day: A Student-Led Initiative to Increase Health Advocacy Training Among Medical Students

Directory of Open Access Journals (Sweden)

Harbir Gill

2010-07-01

Full Text Available Background: Health advocacy is a critical aspect of the competent physician's role. It is identified as a core competency by several national physician regulatory organizations, yet few formal training programs exist. We developed an initiative to teach medical students health advocacy skills. Methods: At Political Action Day, students from Alberta medical schools lobbied the provincial government. A day of training seminars preceded Political Action Day that focused on teaching health advocacy and communication strategies. The following day, medical students met with elected representatives at the Legislative Assembly. An entry and exit survey was administered to students. Results: On October 26-27th, 2008, 40 students met with 38/83 (46% elected representatives including the Minister of Health and Wellness. Feedback from students and politicians suggests the event was effective in teaching advocacy skills. This initiative inspired students to be politically active in the future. Conclusions: Political Action Day helps fulfill the health advocacy competency objectives, and requires minimal curriculum time and resources for integration. It is an effective tool to begin teaching advocacy, and should be further expanded and replicated at other Canadian medical schools.
Clinical Trials

Medline Plus

Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...
Assessing the readability of ClinicalTrials.gov.

Science.gov (United States)

Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

2016-03-01

ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government
Evolving the multiple roles of 'patients' in health-care research: reflections after involvement in a trial of shared decision-making.

Science.gov (United States)

Thornton, Hazel; Edwards, Adrian; Elwyn, Glyn

2003-09-01

This paper offers 'consumer-led' reflections by steering group members of a patient-centred research study involving consumer advocates, patients' associations and patients, throughout the whole study, from pre- to post-study phases. ORIGINAL STUDY DESIGN: The study: 'Shared decision making and risk communication in general practice' incorporated systematic reviews, psychometric evaluation of outcome measures, and quantitative, qualitative and health economic analyses of a cluster randomized trial of professional skill development, all informed by consumer and patient engagement. The work was produced by a wide collaboration led by researchers from the Department of General Practice, University of Wales College of Medicine, Cardiff, including a consumers' advisory group and a patients' association. The study participants were 20 general practitioners from Gwent, their practice staff, and almost 800 patients at these practices. Consumers and patients contributed to several stages of the research from inception and design, securing of funding, implementation of the protocol, and interpretation and dissemination of the findings. 'Patient involvement' research initiatives that include an equally wide variety of 'user' participants as 'health-professional' participants, accountable to a 'Health in Partnership' funded project, require a user-led viewpoint to be presented and disseminated. This paper presents reflections on the processes of the research, the interpretations of study findings by the involved parties, and notes how this model is fundamental to effective research in the field of patient-centred health care if future practice, policy and research are to change.
Initiation of antiretroviral therapy at rural primary health care clinics in KwaZulu Natal

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Hilda Ganesen-Moothusamy

2013-05-01

Full Text Available South Africa bears the greatest burden of HIV infection globally with the most infected people living in KwaZulu-Natal (KZN. Decentralised medical care for HIV positive patients and antiretroviral therapy (ART delivery to primary health care facilities were proposed nationally to achieve adequate ART coverage for patients in need of treatment. This study described the HIV positive patients who accessed medical care and were initiated on ART at two existing government Primary Health Care (PHC clinics with no added donor support, in Ilembe, KZN. This was an observational descriptive study of ART initiation from 01 April 2008 to 30 April 2009. Data were collected from clinical records kept on site. HIV Testing and the pre-ART programmes which consisted of medical care prior to ART initiation are briefly described. Socio-economic, demographic and clinical characteristics of patients who were initiated on ART were sampled and described. A minority (2.95% of the study population tested for HIV of which 36.0%tested positive. Majority (60.0% of patients who joined the pre-ART programme care did not return. The ART sample consisted of 375 patients of whom 65.0%were women, 85.9%were unmarried, 61.6%were unemployed and 50.4%had a secondary level of education. Tuberculosis (TB prevalence and incidence at ART initiation were 22.1%and 14.7%respectively. The prevalence of Syphilis and Hepatitis B co-infections were 13.1%and 8.6 %respectively. Two thirds of female patients (66.4% received a Pap smear result of which the majority (62.3% were abnormal. Uptake for HIV testing followed by relevant CD4 testing was poor. High TB, Hepatitis B and Syphilis co-infection was noted amongst patients initiated on ART. Cervical cancer screening must be intensified. Although ART initiation with no added external resources was successful, record keeping was suboptimal.
The Refugee Health Nurse Liaison: a nurse led initiative to improve healthcare for asylum seekers and refugees.

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McBride, Jacquie; Russo, Alana; Block, Andrew

2016-12-01

Asylum seekers and refugees experience a range of barriers to health service access and competent use. The Refugee Health Nurse Liaison initiative was piloted at a hospital in a high-settlement region of Victoria, Australia. This initiative aimed to build capacity within the health sector to more effectively respond to the needs of asylum seekers and refugees. A mixed-methods evaluation was undertaken to: describe issues encountered by asylum seekers and refugees within the hospital setting; capture the nature of the Refugee Health Nurse Liaison position; and document key outputs. Throughout the pilot period, 946 patients were referred to the role, of which 99% received an assessment of physical, mental, and social health. Refugee Health Nurse Liaisons effectively provided clinical support, advocacy, education, referrals, and both formal and informal capacity building. Learnings from this model are transferable to services in high-settlement regions, and could have application in improving patient care more broadly.
Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Science.gov (United States)

2013-01-01

Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341
Multidisciplinary Point-of-Care Testing in South African Primary Health Care Clinics Accelerates HIV ART Initiation but Does Not Alter Retention in Care.

Science.gov (United States)

Stevens, Wendy S; Gous, Natasha M; MacLeod, William B; Long, Lawrence C; Variava, Ebrahim; Martinson, Neil A; Sanne, Ian; Osih, Regina; Scott, Lesley E

2017-09-01

Lack of accessible laboratory infrastructure limits HIV antiretroviral therapy (ART) initiation, monitoring, and retention in many resource-limited settings. Point-of-care testing (POCT) is advocated as a mechanism to overcome these limitations. We executed a pragmatic, prospective, randomized, controlled trial comparing the impact of POCT vs. standard of care (SOC) on treatment initiation and retention in care. Selected POC technologies were embedded at 3 primary health clinics in South Africa. Confirmed HIV-positive participants were randomized to either SOC or POC: SOC participants were venesected and specimens referred to the laboratory with patient follow-up as per algorithm (∼3 visits); POC participants had phlebotomy and POCT immediately on-site using Pima CD4 to assess ART eligibility followed by hematology, chemistry, and tuberculosis screening with the goal of receiving same-day adherence counseling and treatment initiation. Participant outcomes measured at recruitment 6 and 12 months after initiation. Four hundred thirty-two of 717 treatment eligible participants enrolled between May 2012 and September 2013: 198 (56.7%) SOC; 234 (63.6%) POC. Mean age was 37.4 years; 60.5% were female. Significantly more participants were initiated using POC [adjusted prevalence ratio (aPR) 0.83; 95% confidence interval (CI): 0.74 to 0.93; P ART was similar for both arms at 6 months (47 vs. 50%) (aPR 0.96; 95% CI: 0.79 to 1.16) and 12 months (32 vs. 32%) (aPR 1.05; 95% CI: 0.80 to 1.38), with similar mortality rates. Loss to follow-up at 12 months was higher for POC (36% vs. 51%) (aPR 0.82; 95% CI: 0.65 to 1.04). Adoption of POCT accelerated ART initiation but once on treatment, there was unexpectedly higher loss to follow-up on POC and no improvement in outcomes at 12 months over SOC.

Advances in outcomes measurement in rehabilitation medicine: current initiatives from the National Institutes of Health and the National Institute on Disability and Rehabilitation Research.

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Tulsky, David S; Carlozzi, Noelle E; Cella, David

2011-10-01

The articles in this supplement present recent advances in the measurement of patient-reported health-related quality-of-life (HRQOL) outcomes. Specifically, these articles highlight the combined efforts of the National Institutes of Health, National Institute for Neurological Disorders and Stroke, National Center on Medical Rehabilitation Research, National Institute on Disability and Rehabilitation Research, and Department of Veterans Affairs Rehabilitation Research and Development Service to improve HRQOL measurement. In addition, this supplement is intended to provide rehabilitation professionals with information about these efforts and the implications that these advances in outcomes measurement have for rehabilitation medicine and clinical practice. These new measurement scales use state-of-the-art method techniques, including item response theory and computerized adaptive testing. In addition, scale development involves both qualitative and quantitative methods, as well as the administration of items to hundreds or even thousands of research participants. The scales deliberately have been built with overlap of items between scales so that linkages and equivalency scores can be computed. Ultimately, these scales should facilitate direct comparison of outcomes instruments across studies and will serve as standard data elements across research trials without compromising the specificity of disease- or condition-targeted measures. This supplement includes the initial publications for many of these new measurement initiatives, each of which provides researchers and clinicians with better tools for evaluation of the efficacy of their interventions. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Measurement of Self-Monitoring Web Technology Acceptance and Use in an e-Health Weight-Loss Trial

OpenAIRE

Ma, Jun; Xiao, Lan; Blonstein, Andrea C.

2013-01-01

Background: Research on technology acceptance and use in e-health weight-loss interventions is limited. Using data from a randomized controlled trial of two e-health interventions, we evaluated the acceptance and use of a self-monitoring Web site for weight loss. Materials and Methods: We examined eight theoretical constructs about technology acceptance using adapted 5-point Likert scales and the association of measured Web site usage and weight loss. Results: All scales had hi...
Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive.

Science.gov (United States)

Morgan, Amy J; Rapee, Ronald M; Bayer, Jordana K

2017-08-01

Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15-2.79). This response rate increase of 11.1% (95% confidence interval = 2.8-19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07-2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07-1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.
Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial

Directory of Open Access Journals (Sweden)

Burciul Barry

2010-12-01

Full Text Available Abstract Background In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions. This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS, on staff retention and satisfaction, and quality of patient care. Methods/Design A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours, intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. Discussion The PALM PLUS trial
Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

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Lennox, Charlotte; Kirkpatrick, Tim; Taylor, Rod S; Todd, Roxanne; Greenwood, Clare; Haddad, Mark; Stevenson, Caroline; Stewart, Amy; Shenton, Deborah; Carroll, Lauren; Brand, Sarah L; Quinn, Cath; Anderson, Rob; Maguire, Mike; Harris, Tirril; Shaw, Jennifer; Byng, Richard

2018-01-01

Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

Science.gov (United States)

Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

2017-05-25

Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection. The methods are summarised as follows. cluster randomised trial. 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline. INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice. Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were
The role of business size in assessing the uptake of health promoting workplace initiatives in Australia

OpenAIRE

Taylor, A. W.; Pilkington, R.; Montgomerie, A.; Feist, H.

2016-01-01

Abstract Background Worksite health promotion (WHP) initiatives are increasingly seen as having potential for large-scale health gains. While health insurance premiums are directly linked to workplaces in the USA, other countries with universal health coverage, have less incentive to implement WHP programs. Size of the business is an important consideration with small worksites less likely to implement WHP programs. The aim of this study was to identify key intervention points and to provide ...
How Bioethics is Complementing Human Rights in Realizing Health Access for Clinical Trial Participants: The Case of Formative PrEP Access in South Africa.

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Singh, Jerome

2015-06-11

Following the demise of apartheid, human rights in South Africa are now constitutionally enshrined.The right to health in South Africa's Constitution has been credited with transforming the lives of millions of people by triggering programmatic reforms in HIV treatment and the prevention of mother to child transmission (MTCT) of HIV.However, a constitutionally enshrined right to health offers no guarantee that clinical trial participants will enjoy post-trial access to beneficial interventions. Using access to HIV pre-exposure prophylaxis (PrEP) in South Africa as an example, this paper argues that adherence to bioethics norms could realize the right to health for trial participants following the end of a clinical trial. Copyright 2015 Singh. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.
Applying a global justice lens to health systems research ethics: an initial exploration.

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Pratt, Bridget; Hyder, Adnan A

2015-03-01

Recent scholarship has considered what, if anything, rich people owe to poor people to achieve justice in global health and the implications of this for international research. Yet this work has primarily focused on international clinical research. Health systems research is increasingly being performed in low and middle income countries and is essential to reducing global health disparities. This paper provides an initial description of the ethical issues related to priority setting, capacity-building, and the provision of post-study benefits that arise during the conduct of such research. It presents a selection of issues discussed in the health systems research literature and argues that they constitute ethical concerns based on their being inconsistent with a particular theory of global justice (the health capability paradigm). Issues identified include the fact that priority setting for health systems research at the global level is often not driven by national priorities and that capacity-building efforts frequently utilize one-size-fits-all approaches.
Effect of health risk assessment and counselling on health behaviour and survival in older people: a pragmatic randomised trial.

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Andreas E Stuck

2015-10-01

Full Text Available Potentially avoidable risk factors continue to cause unnecessary disability and premature death in older people. Health risk assessment (HRA, a method successfully used in working-age populations, is a promising method for cost-effective health promotion and preventive care in older individuals, but the long-term effects of this approach are unknown. The objective of this study was to evaluate the effects of an innovative approach to HRA and counselling in older individuals for health behaviours, preventive care, and long-term survival.This study was a pragmatic, single-centre randomised controlled clinical trial in community-dwelling individuals aged 65 y or older registered with one of 19 primary care physician (PCP practices in a mixed rural and urban area in Switzerland. From November 2000 to January 2002, 874 participants were randomly allocated to the intervention and 1,410 to usual care. The intervention consisted of HRA based on self-administered questionnaires and individualised computer-generated feedback reports, combined with nurse and PCP counselling over a 2-y period. Primary outcomes were health behaviours and preventive care use at 2 y and all-cause mortality at 8 y. At baseline, participants in the intervention group had a mean ± standard deviation of 6.9 ± 3.7 risk factors (including unfavourable health behaviours, health and functional impairments, and social risk factors and 4.3 ± 1.8 deficits in recommended preventive care. At 2 y, favourable health behaviours and use of preventive care were more frequent in the intervention than in the control group (based on z-statistics from generalised estimating equation models. For example, 70% compared to 62% were physically active (odds ratio 1.43, 95% CI 1.16-1.77, p = 0.001, and 66% compared to 59% had influenza vaccinations in the past year (odds ratio 1.35, 95% CI 1.09-1.66, p = 0.005. At 8 y, based on an intention-to-treat analysis, the estimated proportion alive was 77.9% in
Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

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Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.
The Effects of Bikram Yoga on Health: Critical Review and Clinical Trial Recommendations

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Zoe L. Hewett

2015-01-01

Full Text Available Bikram yoga is a style of hatha yoga involving a standarized series of asanas performed to an instructional dialogue in a heated environment (40.6°C, 40% humidity. Several studies evaluating the effect of Bikram yoga on health-related outcomes have been published over the past decade. However, to date, there are no comprehensive reviews of this research and there remains a lack of large-scale, robustly-designed randomised controlled trials (RCT of Bikram yoga training. The purpose of this review is to contextualise and summarise trials that have evaluated the effects of Bikram yoga on health and to provide recommendations for future research. According to published literature, Bikram yoga has been shown to improve lower body strength, lower and upper body range of motion, and balance in healthy adults. Non-RCTs report that Bikram yoga may, in some populations, improve glucose tolerance, bone mineral density, blood lipid profile, arterial stiffness, mindfulness, and perceived stress. There is vast potential for further, improved research into the effects of Bikram yoga, particularly in unhealthy populations, to better understand intervention-related adaptations and their influence on the progression of chronic disease. Future research should adhere to CONSORT guidelines for better design and reporting to improve research quality in this field.
Where theory and practice of global health intersect: the developmental history of a Canadian global health initiative.

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Daibes, Ibrahim; Sridharan, Sanjeev

2014-01-01

This paper examines the scope of practice of global health, drawing on the practical experience of a global health initiative of the Government of Canada--the Teasdale-Corti Global Health Research Partnership Program. A number of challenges in the practical application of theoretical definitions and understandings of global health are addressed. These challenges are grouped under five areas that form essential characteristics of global health: equity and egalitarian North-South partnerships, interdisciplinary scope, focus on upstream determinants of health, global conceptualization, and global health as an area of both research and practice. Information in this paper is based on the results of an external evaluation of the program, which involved analysis of project proposals and technical reports, surveys with grantees and interviews with grantees and program designers, as well as case studies of three projects and a review of relevant literature. The philosophy and recent definitions of global health represent a significant and important departure from the international health paradigm. However, the practical applicability of this maturing area of research and practice still faces significant systemic and structural impediments that, if not acknowledged and addressed, will continue to undermine the development of global health as an effective means to addressing health inequities globally and to better understanding, and acting upon, upstream determinants of health toward health for all. While it strives to redress global inequities, global health continues to be a construct that is promoted, studied, and dictated mostly by Northern institutions and scholars. Until practical mechanisms are put in place for truly egalitarian partnerships between North and South for both the study and practice of global health, the emerging philosophy of global health cannot be effectively put into practice.
Stakeholder Education for Community-Wide Health Initiatives: A Focus on Teen Pregnancy Prevention.

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Finley, Cara; Suellentrop, Katherine; Griesse, Rebecca; House, Lawrence Duane; Brittain, Anna

2018-01-01

Teen pregnancies and births continue to decline due in part to implementation of evidence-based interventions and clinical strategies. While local stakeholder education is also thought to be critical to this success, little is known about what types of strategies work best to engage stakeholders. With the goal of identifying and describing evidence-based or best practice strategies for stakeholder education in community-based public health initiatives, we conducted a systematic literature review of strategies used for effective stakeholder education. Over 400 articles were initially retrieved; 59 articles met inclusion criteria. Strategies were grouped into four steps that communities can use to support stakeholder education efforts: identify stakeholder needs and resources, develop a plan, develop tailored and compelling messaging, and use implementation strategies. These strategies lay a framework for high-quality stakeholder education. In future research, it is important to prioritize evaluating specific activities taken to raise awareness, educate, and engage a community in community-wide public health efforts.
Result of randomized control trial to increase breast health awareness among young females in Malaysia.

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Akhtari-Zavare, Mehrnoosh; Juni, Muhamad Hanafiah; Said, Salmiah Md; Ismail, Irmi Zarina; Latiff, Latiffah A; Ataollahi Eshkoor, Sima

2016-08-08

Breast cancer is the most common cancer and the second principal cause of cancer deaths in women worldwide as well as in Malaysia. Breast self-examination (BSE) has a role in raising breast cancer awareness among women and educational programs play an important role in breast cancer preventive behavior. The aim of this study is to develop, implement and evaluate the effectiveness of Breast Health Awareness program based on health belief model on knowledge of breast cancer and breast-selfexamination and BSE practice among female students in Malaysia. A single-blind randomized controlled trial was carried out among 370 female undergraduate students from January 2011 to April 2012 in two selected public universities in Malaysia. Participants were randomized to either the intervention group or the control group. The educational program was delivered to the intervention group. The outcome measures were assessed at baseline, 6, and 12 months after implementing the health educational program. Chi-square, independent samples t-test and two-way repeated measures ANOVA (GLM) were conducted in the course of the data analyses. Mean scores of knowledge on breast cancer (pMalaysia. The ANZCTR clinical trial registry ( ACTRN12616000831482 ), retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.
Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

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Ørts, Lene Maria; Løkke, Anders; Bjerregaard, Anne-Louise; Maindal, Helle Terkildsen; Sandbæk, Annelli

2016-12-01

Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks. This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups. The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective. ClinicalTrials.gov: NCT
Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

International Nuclear Information System (INIS)

Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

2011-01-01

Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in
Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

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Bellera, C A; Penel, N; Ouali, M; Bonvalot, S; Casali, P G; Nielsen, O S; Delannes, M; Litière, S; Bonnetain, F; Dabakuyo, T S; Benjamin, R S; Blay, J-Y; Bui, B N; Collin, F; Delaney, T F; Duffaud, F; Filleron, T; Fiore, M; Gelderblom, H; George, S; Grimer, R; Grosclaude, P; Gronchi, A; Haas, R; Hohenberger, P; Issels, R; Italiano, A; Jooste, V; Krarup-Hansen, A; Le Péchoux, C; Mussi, C; Oberlin, O; Patel, S; Piperno-Neumann, S; Raut, C; Ray-Coquard, I; Rutkowski, P; Schuetze, S; Sleijfer, S; Stoeckle, E; Van Glabbeke, M; Woll, P; Gourgou-Bourgade, S; Mathoulin-Pélissier, S

2015-05-01

The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Communities defining environmental health: examples from the Colorado (U.S.A.) Healthy Communities Initiative.

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Conner, R F; Tanjasiri, S P

2000-01-01

Communities are increasingly defining 'health' for themselves, then becoming the main actors in actions to improve their health and well being. These community members work from a broad and inclusive definition of 'health' that often incorporates environmental health as a key aspect. They also assume an ecological, or systems, viewpoint that integrates many aspects of the community that affect health and well being, including housing, health, economy, education, transportation, youth and family issues, as well as health and illness care. This paper describes a program that involves 28 large and small, urban and rural communities in the United States state of Colorado that undertook this type of community-based health improvement project. The Colorado Healthy Communities Initiative (CHCI) was designed to bring together citizens in Colorado to work collaboratively to make their communities healthier. This paper describes the program's background, including its principles, processes, and participants, then focuses on the particular aspects of environmental health that communities included in their definitions of a 'healthy community'.
Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

Directory of Open Access Journals (Sweden)

Mountain Gail A

2011-01-01

Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

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