WorldWideScience

Sample records for health initiative trials

  1. Vitamin D supplementation and depression in the women's health initiative calcium and vitamin D trial.

    Science.gov (United States)

    Bertone-Johnson, Elizabeth R; Powers, Sally I; Spangler, Leslie; Larson, Joseph; Michael, Yvonne L; Millen, Amy E; Bueche, Maria N; Salmoirago-Blotcher, Elena; Wassertheil-Smoller, Sylvia; Brunner, Robert L; Ockene, Ira; Ockene, Judith K; Liu, Simin; Manson, Joann E

    2012-07-01

    While observational studies have suggested that vitamin D deficiency increases risk of depression, few clinical trials have tested whether vitamin D supplementation affects the occurrence of depression symptoms. The authors evaluated the impact of daily supplementation with 400 IU of vitamin D(3) combined with 1,000 mg of elemental calcium on measures of depression in a randomized, double-blinded US trial comprising 36,282 postmenopausal women. The Burnam scale and current use of antidepressant medication were used to assess depressive symptoms at randomization (1995-2000). Two years later, women again reported on their antidepressant use, and 2,263 completed a second Burnam scale. After 2 years, women randomized to receive vitamin D and calcium had an odds ratio for experiencing depressive symptoms (Burnam score ≥0.06) of 1.16 (95% confidence interval: 0.86, 1.56) compared with women in the placebo group. Supplementation was not associated with antidepressant use (odds ratio = 1.01, 95% confidence interval: 0.92, 1.12) or continuous depressive symptom score. Results stratified by baseline vitamin D and calcium intake, solar irradiance, and other factors were similar. The findings do not support a relation between supplementation with 400 IU/day of vitamin D(3) along with calcium and depression in older women. Additional trials testing higher doses of vitamin D are needed to determine whether this nutrient may help prevent or treat depression.

  2. Calcium plus vitamin D supplementation and height loss: findings from the Women's Health Initiative Calcium and Vitamin D clinical trial.

    Science.gov (United States)

    Crandall, Carolyn J; Aragaki, Aaron K; LeBoff, Meryl S; Li, Wenjun; Wactawski-Wende, Jean; Cauley, Jane A; Margolis, Karen L; Manson, JoAnn E

    2016-12-01

    The aim of this study was to determine the associations between calcium + vitamin D supplementation (vs placebo) and height loss in 36,282 participants of the Women's Health Initiative Calcium and Vitamin D trial. Post hoc analysis of data from a double-blind randomized controlled trial of 1,000 mg of elemental calcium as calcium carbonate with 400 IU of vitamin D3 daily (CaD) or placebo in postmenopausal women at 40 US clinical centers. Height was measured annually (mean follow-up 5.9 y) with a stadiometer. Average height loss was 1.28 mm/y among participants assigned to CaD versus 1.26 mm/y for women assigned to placebo (P = 0.35). Effect modification of the CaD intervention was not observed by age, race/ethnicity, or baseline intake of calcium or vitamin D. Randomization to the CaD group did not reduce the risk of clinical height loss (loss of ≥1.5 inches [3.8 cm]: hazard ratio (95% CI) = 1.00 (0.81, 1.23). A strong association (P < 0.001) was observed between age group and height loss. When we censored follow-up data in participants who became nonadherent to study pills, the results were similar to those of our primary analysis. Compared with placebo, the CaD supplement used in this trial did not prevent height loss in healthy postmenopausal women.

  3. 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.

  4. Overweight, Obesity, and Postmenopausal Invasive Breast Cancer Risk: A Secondary Analysis of the Women's Health Initiative Randomized Clinical Trials.

    Science.gov (United States)

    Neuhouser, Marian L; Aragaki, Aaron K; Prentice, Ross L; Manson, JoAnn E; Chlebowski, Rowan; Carty, Cara L; Ochs-Balcom, Heather M; Thomson, Cynthia A; Caan, Bette J; Tinker, Lesley F; Urrutia, Rachel Peragallo; Knudtson, Jennifer; Anderson, Garnet L

    2015-08-01

    More than two-thirds of US women are overweight or obese, placing them at increased risk for postmenopausal breast cancer. To investigate in this secondary analysis the associations of overweight and obesity with risk of postmenopausal invasive breast cancer after extended follow-up in the Women's Health Initiative (WHI) clinical trials. The WHI clinical trial protocol incorporated measured height and weight, baseline and annual or biennial mammography, and adjudicated breast cancer end points in 67 142 postmenopausal women ages 50 to 79 years at 40 US clinical centers. The women were enrolled from 1993 to 1998 with a median of 13 years of follow-up through 2010; 3388 invasive breast cancers were observed. Height and weight were measured at baseline, and weight was measured annually thereafter. Data were collected on demographic characteristics, personal and family medical history, and personal habits (smoking, physical activity). Women underwent annual or biennial mammograms. Breast cancers were verified by medical records reviewed by physician adjudicators. Women who were overweight and obese had an increased invasive breast cancer risk vs women of normal weight. Risk was greatest for obesity grade 2 plus 3 (body mass index [BMI], calculated as weight in kilograms divided by height in meters squared, >35.0) (hazard ratio [HR] for invasive breast cancer, 1.58; 95% CI, 1.40-1.79). A BMI of 35.0 or higher was strongly associated with risk for estrogen receptor-positive and progesterone receptor-positive breast cancers (HR, 1.86; 95% CI, 1.60-2.17) but was not associated with estrogen receptor-negative cancers. Obesity grade 2 plus 3 was also associated with advanced disease, including larger tumor size (HR, 2.12; 95% CI, 1.67-2.69; P = .02), positive lymph nodes (HR, 1.89; 95% CI, 1.46-2.45; P = .06), regional and/or distant stage (HR, 1.94; 95% CI, 1.52-2.47; P = .05), and deaths after breast cancer (HR, 2.11; 95% CI, 1.57-2.84; P

  5. A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF COMMUNITY-BASED DIETARY SODIUM REDUCTION – THE CHINA RURAL HEALTH INITIATIVE SODIUM REDUCTION STUDY

    Science.gov (United States)

    Li, Nicole; Yan, Lijing L.; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

    2013-01-01

    Background Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. Design This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24 hour urine. Trial status The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. Discussion The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. PMID:24176436

  6. 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)....

  7. The Clinical Trials Transformation Initiative (CTTI

    Directory of Open Access Journals (Sweden)

    Alberto Grignolo

    2011-01-01

    Full Text Available The Clinical Trials Transformation Initiative (CTTI is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patients into trials, increasing clinical trial costs, and declining investigator interest in participating in clinical trials. Although CTTI was created to address a crisis for US clinical research, it seeks to identify practice improvements that can be applied internationally, and is therefore engaging international collaborators with international efforts that have similar objectives. CTTI's approach is to involve all sectors in the selection, conduct, and interpretation of its projects; to keep the dialogue open across sectors; to provide evidence that can influence regulatory guidance, and to attempt to create a "level playing field" when recommending change. The hope is that a broad and diverse data-driven discussion of the important issues in clinical trials will lead to meaningful change for the benefit of all concerned, and importantly for patients.

  8. Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

    Science.gov (United States)

    Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

    2015-01-01

    Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications

  9. Telemedicine, the effect of nurse-initiated telephone follow up, on health status and health-care utilization in COPD patients : A randomized trial

    NARCIS (Netherlands)

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

    2015-01-01

    Background and objectiveTelemedicine, 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 (C

  10. The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Coulton Simon P

    2011-02-01

    Full Text Available Abstract Background The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physical and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost effectiveness of singing as a health intervention for this population group. Methods The proposed study is a pragmatic randomised controlled trial with two parallel arms. The primary hypothesis is that singing groups for older people improve both physical and mental aspects of quality of life when compared to usual activities. Potential participants will be volunteers over 60 years living in the community and recruited through publicity. Eligible and consenting participants will be randomized to either a singing group or a control group. Singing groups will take part in a twelve week planned programme of singing and control groups will continue with usual activities. The primary outcome measure will be the York SF-12, a health related quality of life measure which will be administered at baseline, three and six months after baseline. The study will evaluate both effectiveness and cost-effectiveness. Discussion This study proposes to add to the existing body of evidence on the value of singing for older people by using a rigorous methodological design, which includes a power calculation, a standardised intervention and assessment of cost-effectiveness. It should be regarded as a stage in a progressive programme of studies in this area. If group singing is found to be

  11. 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. 

  12. Ethics, Error, and Initial Trials of Efficacy

    OpenAIRE

    Hey, Spencer Phillips; Kimmelman, Jonathan

    2013-01-01

    Concerns about the frequency of failure in late stage drug development have prompted a series of proposals for improving the positive predictivity of trials where clinical activity is first evaluated—typically phase 2 trials. However, many proposed reforms entail ethical and social tradeoffs that might not be immediately apparent. We argue that trial reforms aimed at boosting phase 2 positive predictivity have important repercussions for human subjects, as well as the capacity of the research...

  13. Health Insurance Marketplace Quality Initiatives

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Affordable Care Act requires the U.S. Department of Health and Human Services (HHS) to develop quality data collection and reporting tools such as a Quality...

  14. Mobile access to virtual randomization for investigator-initiated trials.

    Science.gov (United States)

    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

  15. Bipolar CHOICE (Clinical Health Outcomes Initiative in Comparative Effectiveness): a pragmatic 6-month trial of lithium versus quetiapine for bipolar disorder.

    Science.gov (United States)

    Nierenberg, Andrew A; McElroy, Susan L; Friedman, Edward S; Ketter, Terence A; Shelton, Richard C; Deckersbach, Thilo; McInnis, Melvin G; Bowden, Charles L; Tohen, Mauricio; Kocsis, James H; Calabrese, Joseph R; Kinrys, Gustavo; Bobo, William V; Singh, Vivek; Kamali, Masoud; Kemp, David; Brody, Benjamin; Reilly-Harrington, Noreen A; Sylvia, Louisa G; Shesler, Leah W; Bernstein, Emily E; Schoenfeld, David; Rabideau, Dustin J; Leon, Andrew C; Faraone, Stephen; Thase, Michael E

    2016-01-01

    for bipolar disorder. ClinicalTrials.gov identifier for the Bipolar CHOICE study: NCT01331304. © Copyright 2016 Physicians Postgraduate Press, Inc.

  16. 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.

  17. Low-dose, non-supervised, health insurance initiated exercise for the treatment and prevention of chronic low back pain in employees. Results from a randomized controlled trial.

    Science.gov (United States)

    Haufe, Sven; Wiechmann, Klaus; Stein, Lothar; Kück, Momme; Smith, Andrea; Meineke, Stefan; Zirkelbach, Yvonne; Rodriguez Duarte, Samuel; Drupp, Michael; Tegtbur, Uwe

    2017-01-01

    Back pain is a major problem requiring pragmatic interventions, low in costs for health care providers and feasible for individuals to perform. Our objective was to test the effectiveness of a low-dose 5-month exercise intervention with small personnel investment on low back strength and self-perceived pain. Two hundred twenty-six employees (age: 42.7±10.2 years) from three mid-size companies were randomized to 5-month non-supervised training at home (3 times/week for 20 minutes) or wait-list-control. Health insurance professionals instructed the participants on trunk exercises at the start and then supervised participants once a month. Muscle strength for back extension increased after the 5-month intervention with a significant between-group difference (mean 27.4 Newton [95%CI 2.2; 60.3]) favoring the exercise group (p = 0.035). Low back pain was reduced more in subjects after exercise than control (mean difference -0.74 cm [95%CI -1.17; -0.27], p = 0.002). No between-group differences were observed for back pain related disability and work ability. After stratified analysis only subjects with preexisting chronic low back pain showed a between-group difference (exercise versus controls) after the intervention in their strength for back extension (mean 55.7 Newton [95%CI 2.8; 108.5], p = 0.039), self-perceived pain (mean -1.42 cm [95%CI -2.32; -0.51], p = 0.003) and work ability (mean 2.1 points [95%CI 0.2; 4.0], p = 0.032). Significant between-group differences were not observed in subjects without low back pain: strength for back extension (mean 23.4 Newton [95%CI -11.2; 58.1], p = 0.184), self-perceived pain (mean -0.48 cm [95%CI -0.99; 0.04], p = 0.067) and work ability (mean -0.1 points [95%CI -0.9; 0.9], p = 0.999). An interaction between low back pain subgroups and the study intervention (exercise versus control) was exclusively observed for the work ability index (p = 0.016). In middle-aged employees a low-dose, non-supervised exercise program implemented

  18. Health information technology: strategic initiatives, real progress.

    Science.gov (United States)

    Kolodner, Robert M; Cohn, Simon P; Friedman, Charles P

    2008-01-01

    We fully agree with Carol Diamond and Clay Shirky that deployment of health information technology (IT) is necessary but not sufficient for transforming U.S. health care. However, the recent work to advance health IT is far from an exercise in "magical thinking." It has been strategic thinking. To illustrate this, we highlight recent initiatives and progress under four focus areas: adoption, governance, privacy and security, and interoperability. In addition, solutions exist for health IT to advance rapidly without adversely affecting future policy choices. A broad national consensus is emerging in support of advancing health IT to enable the transformation of health and care.

  19. LIFESTYLE, FITNESS AND HEALTH PROMOTION INITIATIVE OF ...

    African Journals Online (AJOL)

    Osondu

    NIGERIA: AN EDUCATIONAL MEDIA INTERVENTION. *SHEHU, R.A. ... This study examined the health promotion initiative introduced by the Management of the University of. Ilorin, Ngeria. .... comprehensive social, and public process, it not.

  20. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    Science.gov (United States)

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

  1. The invisibilization of health promotion in Australian public health initiatives.

    Science.gov (United States)

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

    2016-07-19

    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.

  2. Do diet, folic acid, and vitamins matter? What did we learn from the Women's Health Initiative, the Women's Health Study, the Women's Antioxidant and Folic Acid Cardiovascular Study, and other clinical trials?

    Science.gov (United States)

    Wenger, Nanette K

    2007-01-01

    Data from recent randomized clinical trials have contributed substantially to our understanding of appropriate interventions for coronary heart disease in women. Addressed in this monograph are issues of diet, folic acid, and antioxidant vitamins. Importantly, these randomized clinical trials have helped to clarify conflicting information from observational data, and to aid clinicians and their women patients in making appropriate choices of coronary and cardiovascular preventive therapy.

  3. 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.

  4. 76 FR 22404 - Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative

    Science.gov (United States)

    2011-04-21

    ... HUMAN SERVICES Food and Drug Administration Analgesic Clinical Trials Innovation, Opportunities, and... Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative. The goal of the... major gaps in scientific information, which can slow down analgesic clinical trials and analgesic...

  5. Reproductive health education intervention trial.

    Science.gov (United States)

    Parwej, Saroj; Kumar, Rajesh; Walia, Indarjeet; Aggarwal, Arun K

    2005-04-01

    To measure the effectiveness of a reproductive health education package in improving the knowledge of adolescent girls aged 15-19 years in Chandigarh (India). A reproductive health education package, developed in consultation with parents, teachers and adolescents, was delivered to randomly sampled classes of two senior secondary schools and one school was selected as control. In one school, a nurse conducted 15 sessions for 94 students in three batches using conventional education approach. In another school she conducted sessions for a selected group of 20 adolescents who later disseminated the messages informally to their 84 classmates (peer education). Using a 70-item structured questionnaire the knowledge of 95 adolescents from conventional, 84 from peer, and 94 from control school were assessed before and one month after the last session. Change in the score in intervention and control groups was tested by ANOVA taking age and socio-economic status as covariates. Teachers, parents and students overwhelmingly (88%, 95.5% and 93% respectively) favoured reproductive health education program. Five percent of the respondents reported that someone in their class is having sexual relations, and 13% of the girls approved of pre-marital sexual relations. Reproductive health knowledge scores improved significantly after intervention in conventional education (27.28) and peer education group (20.77) in comparison to the controls (3.64). Post-test scores were not significantly different between peer education group and conventional education group (43.65 and 40.52 respectively) though the time consumed in delivering the peer education intervention was almost one third of the time taken to implement conventional education. Peer education and conventional education strategies were effective in improving the reproductive health knowledge of adolescent girls but peer strategy was less time consuming.

  6. Designing Work, Family & Health Organizational Change Initiatives.

    Science.gov (United States)

    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.

  7. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial.

    Science.gov (United States)

    Bello, George; Faragher, Brian; Sanudi, Lifah; Namakhoma, Ireen; Banda, Hastings; Malmborg, Rasmus; Thomson, Rachael; Squire, S Bertel

    2017-01-01

    The poor face barriers in accessing services for tuberculosis (TB) and Human Immuno-deficiency Virus (HIV) disease. A cluster randomised trial was conducted to investigate the effectiveness of engaging unpaid informal providers (IPs) to promote access in a rural district. The intervention consisted of training unpaid IPs in TB and HIV disease recognition, sputum specimen collection, appropriate referrals, and raising community awareness. In total, six clusters were defined in the study areas. Through a pair-matched cluster randomization process, three clusters (average cluster population = 200,714) were allocated to receive the intervention in the Early arm. Eleven months later the intervention was rolled out to the remaining three clusters (average cluster population = 209,564)-the Delayed arm. Treatment initiation rates for TB and Anti-Retroviral Therapy (ART) were the primary outcome measures. Secondary outcome measures included testing rates for TB and HIV. We report the results of the comparisons between the Early and Delayed arms over the 23 month trial period. Data were obtained from patient registers. Poisson regression models with robust standard errors were used to express the effectiveness of the intervention as incidence rate ratios (IRR). The Early and Delayed clusters were well matched in terms of baseline monthly mean counts and incidence rate ratios for TB and ART treatment initiation. However there were fewer testing and treatment initiation facilities in the Early clusters (TB treatment n = 2, TB testing n = 7, ART initiation n = 3, HIV testing n = 20) than in the Delayed clusters (TB treatment n = 4, TB testing n = 9, ART initiation n = 6, HIV testing n = 18). Overall there were more HIV testing and treatment centres than TB testing and treatment centres. The IRR was 1.18 (95% CI: 0.903-1.533; p = 0.112) for TB treatment initiation and 1.347 (CI:1.00-1.694; p = 0.049) for ART initiation in the first 12 months and the IRR were 0.552 (95% CI:0

  8. Partnerships and Pathways of Dissemination: The NIDA-SAMHSA Blending Initiative in the Clinical Trials Network

    Science.gov (United States)

    Martino, Steve; Brigham, Gregory S.; Higgins, Christine; Gallon, Steve; Freese, Thomas E.; Albright, Lonnetta M.; Hulsey, Eric G.; Krom, Laurie; Storti, Susan A.; Perl, Harold; Nugent, Cathrine D.; Pintello, Denise; Condon, Timothy P.

    2010-01-01

    Since 2001, the National Drug Abuse Treatment Clinical Trials Network (CTN) has worked to put the results of its trials into the hands of community treatment programs, in large part through its participation in the National Institute on Drug Abuse - Substance Abuse and Mental Health Services Administration Blending Initiative and its close involvement with the Center for Substance Abuse Treatment’s Addiction Technology Transfer Centers. This article describes 1) the CTN’s integral role in the Blending Initiative, 2) key partnerships and dissemination pathways through which the results of CTN trials are developed into blending products and then transferred to community treatment programs, and 3) three blending initiatives involving buprenorphine, motivational incentives, and motivational interviewing. The Blending Initiative has resulted in high utilization of its products, preparation of over 200 regional trainers, widespread training of service providers in most U.S. States, Puerto Rico, and the U.S. Virgin Islands, and movement toward the development of web-based implementation supports and technical assistance. Implications for future directions of the Blending Initiative and opportunities for research are discussed. PMID:20307793

  9. Incremental ECAP of thick continuous plates - machine and initial trials

    Science.gov (United States)

    Rosochowski, A.; Olejnik, L.

    2014-08-01

    Incremental ECAP (I-ECAP) can be used for SPD of continuous bars, plates and sheets. This paper describes design, construction and preliminary trials of a prototype machine capable of processing thick continuous plates. To increase productivity, a two-turn I-ECAP is used, which is equivalent to route C in conventional one-turn ECAP. The machine has a reciprocating punch inclined at 45°, a clamp holding the plate in the die during deformation and a feeder incrementally feeding the plate when it is not deformed; all these devices are driven by hydraulic actuators controlled by a PLC. The machine is capable of deforming materials at room temperature as well as elevated temperatures. The die is heated with electric heaters. The machine has also an integrated cooling system and a lubrication system. The material used for the initial trials was Al 1050 plate (10×50×1000) conversion coated with calcium aluminate and lubricated with dry soap. The process was carried out at room temperature using 1.6 mm feeding stroke and a low cycle frequency of approximately 0.2 Hz. The UFG structure after the first pass of the process revealed by STEM confirms process feasibility.

  10. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  11. 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.

  12. Reforms speed initiation of NCI-sponsored clinical trials

    Science.gov (United States)

    The process of opening a cancer clinical trial for patient accrual often takes years, and research has shown that trials which are slow to register patients often fail to finish. Following a thorough review, NCI’s Operational Efficiency Working Group prod

  13. Publication bias in clinical trials of electronic health records.

    Science.gov (United States)

    Vawdrey, David K; Hripcsak, George

    2013-02-01

    To measure the rate of non-publication and assess possible publication bias in clinical trials of electronic health records. We searched ClinicalTrials.gov to identify registered clinical trials of electronic health records and searched the biomedical literature and contacted trial investigators to determine whether the results of the trials were published. Publications were judged as positive, negative, or neutral according to the primary outcome. Seventy-six percent of trials had publications describing trial results; of these, 74% were positive, 21% were neutral, and 4% were negative (harmful). Of unpublished studies for which the investigator responded, 43% were positive, 57% were neutral, and none were negative; the lower rate of positive results was significant (pelectronic health record studies is similar to that in other biomedical studies. There appears to be a bias toward publication of positive trials in this domain. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Health Promoting Schools: Initiatives in Africa

    Science.gov (United States)

    Macnab, Andrew J.; Stewart, Donald; Gagnon, Faith A.

    2014-01-01

    Purpose: The purpose of this paper is to describe the rationale for and potential of World Health Organization (WHO) health promoting schools (HPS) in Africa. Design/Methodology/Approach: Overview of the related literature and presentations at the 2011 Stellenbosch international colloquium on HPS relating to sub-Saharan Africa. Findings: Schools…

  15. Health Promoting Schools: Initiatives in Africa

    Science.gov (United States)

    Macnab, Andrew J.; Stewart, Donald; Gagnon, Faith A.

    2014-01-01

    Purpose: The purpose of this paper is to describe the rationale for and potential of World Health Organization (WHO) health promoting schools (HPS) in Africa. Design/Methodology/Approach: Overview of the related literature and presentations at the 2011 Stellenbosch international colloquium on HPS relating to sub-Saharan Africa. Findings: Schools…

  16. [Art, health and prevention: initial collaborations].

    Science.gov (United States)

    Avila, Noemí; Orellana, Ana; Cano, Marta G; Antúnez, Noelia; Claver, Dolores

    2014-01-01

    This article presents a summary of the first 2 years of the collaboration between the Faculty of Fine Arts of the Universidad Complutense in Madrid and Madrid Health, an autonomous organism of Madrid Council. This collaboration has allowed the development of joint experiences and projects among distinct professionals with highly diverse profiles: health professionals (sexologists, psychiatrists, nurses, etc.), and teachers, researchers, artists and students in the Faculty of Fine Arts. As a result, these experiences could be the beginning of future collaborations between the arts, health and prevention. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

  17. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  18. 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…

  19. 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…

  20. Women's Health Initiative (WHI) Background and Overview

    Science.gov (United States)

    ... chronic diseases are the major causes of death, disability and frailty in older women of all races and socioeconomic backgrounds. This multi- ... CDC), and the National Institutes of Health. Eight University-based Prevention ... encouraged women of all races and socioeconomic backgrounds to adopt ...

  1. The per-protocol effect of immediate vs. deferred ART initiation in the START randomized trial

    DEFF Research Database (Denmark)

    Lodi, Sara; Sharma, Shweta; Lundgren, Jens D;

    2016-01-01

    OBJECTIVE: The START trial found a lower risk of a composite clinical outcome in HIV-positive individuals assigned to immediate initiation of antiretroviral therapy (ART) compared with those assigned to deferred initiation. However, 30% of those assigned to deferred initiation started ART earlier...

  2. Osteoporosis in the Women's Health Initiative: Another Treatment Gap?

    Science.gov (United States)

    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

  3. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

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

    2014-01-01

    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 accor

  4. Leadership Practices of Clinical Trials Office Leaders in Academic Health Centers

    Science.gov (United States)

    Naser, Diana D.

    2012-01-01

    In the ever-changing clinical research environment, academic health centers seek leaders who are visionary and innovative. Clinical trials offices across the country are led by individuals who are charged with promoting growth and change in order to maximize performance, develop unique research initiatives, and help institutions achieve a…

  5. 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

  6. Venturing into schools: Locating mental health initiatives in complex environments

    OpenAIRE

    Helen Askell-Williams; Lawson, Michael J.; Phillip T. Slee

    2009-01-01

    Schools provide viable settings for mental health promotion initiatives, such as programs to develop students’ social and emotional capabilities (SEC). Complexity in the school environments into which initiatives are introduced, such as diverse student capabilities, school structures, and teachers’ knowledge and confidence, will play an integral role in the success of those initiatives. This paper investigates the environments of schools about to receive the KidsMatter mental heath prom...

  7. 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.

  8. 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…

  9. 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…

  10. A strategic approach of E-health initiatives.

    Science.gov (United States)

    Asoh, Derek A; Rivers, Patrick A; Shih, Stephen C; Tsai, Kai-Li

    2008-01-01

    The Internet is transforming the US economy. Though it continues to lag behind other industries, healthcare has begun to incorporate this technology on a wider scale to reduce costs and more effectively address quality and patient-choice issues. This article presents the background of the US healthcare system, examines the application of e-health, advocates for the integration of e-health components and discusses the roles of major stakeholders in e-health as the basis for the strategic planning, initiation and implementation of integrated e-health systems. Strategic planning provides the opportunity for an insightful view and consideration of the impacts, expectations and responses of e-health stakeholders while implementing integrated e-health solutions for access to more cost-effective and better patient care delivery.

  11. Health workforce responses to global health initiatives funding: a comparison of Malawi and Zambia

    NARCIS (Netherlands)

    R. Brugha; J. Kadzandira; J. Simbaya; P. Dicker; V. Mwapasa; A. Walsh

    2010-01-01

    Background Shortages of health workers are obstacles to utilising global health initiative (GHI) funds effectively in Africa. This paper reports and analyses two countries' health workforce responses during a period of large increases in GHI funds. Methods Health facility record reviews were conduct

  12. Student-Initiated Sexual Health Selective as a Curricular Tool

    Directory of Open Access Journals (Sweden)

    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.

  13. Clinical trial designs for rare diseases: Studies developed and discussed by the International Rare Cancers Initiative

    Science.gov (United States)

    Bogaerts, Jan; Sydes, Matthew R.; Keat, Nicola; McConnell, Andrea; Benson, Al; Ho, Alan; Roth, Arnaud; Fortpied, Catherine; Eng, Cathy; Peckitt, Clare; Coens, Corneel; Pettaway, Curtis; Arnold, Dirk; Hall, Emma; Marshall, Ernie; Sclafani, Francesco; Hatcher, Helen; Earl, Helena; Ray-Coquard, Isabelle; Paul, James; Blay, Jean-Yves; Whelan, Jeremy; Panageas, Kathy; Wheatley, Keith; Harrington, Kevin; Licitra, Lisa; Billingham, Lucinda; Hensley, Martee; McCabe, Martin; Patel, Poulam M.; Carvajal, Richard; Wilson, Richard; Glynne-Jones, Rob; McWilliams, Rob; Leyvraz, Serge; Rao, Sheela; Nicholson, Steve; Filiaci, Virginia; Negrouk, Anastassia; Lacombe, Denis; Dupont, Elisabeth; Pauporté, Iris; Welch, John J.; Law, Kate; Trimble, Ted; Seymour, Matthew

    2015-01-01

    Background The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research. Settings The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional – usually randomised – clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. Results The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design. Interpretation Trials can be designed using a wide array of possibilities. There is no ‘one size fits all’ solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases. PMID:25542058

  14. A Text Message Delivered Smoking Cessation Intervention: The Initial Trial of TXT-2-Quit: Randomized Controlled Trial.

    Science.gov (United States)

    Bock, Beth; Heron, Kristin; Jennings, Ernestine; Morrow, Kathleen; Cobb, Victoria; Magee, Joshua; Fava, Joseph; Deutsch, Christopher; Foster, Robert

    2013-07-30

    Mobile technology offers the potential to deliver health-related interventions to individuals who would not otherwise present for in-person treatment. Text messaging (short message service, SMS), being the most ubiquitous form of mobile communication, is a promising method for reaching the most individuals. The goal of the present study was to evaluate the feasibility and preliminary efficacy of a smoking cessation intervention program delivered through text messaging. Adult participants (N=60, age range 18-52 years) took part in a single individual smoking cessation counseling session, and were then randomly assigned to receive either daily non-smoking related text messages (control condition) or the TXT-2-Quit (TXT) intervention. TXT consisted of automated smoking cessation messages tailored to individual's stage of smoking cessation, specialized messages provided on-demand based on user requests for additional support, and a peer-to-peer social support network. Generalized estimating equation analysis was used to assess the primary outcome (7-day point-prevalence abstinence) using a 2 (treatment groups)×3 (time points) repeated measures design across three time points: 8 weeks, 3 months, and 6 months. Smoking cessation results showed an overall significant group difference in 7-day point prevalence abstinence across all follow-up time points. Individuals given the TXT intervention, with higher odds of 7-day point prevalence abstinence for the TXT group compared to the Mojo group (OR=4.52, 95% CI=1.24, 16.53). However, individual comparisons at each time point did not show significant between-group differences, likely due to reduced statistical power. Intervention feasibility was greatly improved by switching from traditional face-to-face recruitment methods (4.7% yield) to an online/remote strategy (41.7% yield). Although this study was designed to develop and provide initial testing of the TXT-2-Quit system, these initial findings provide promising evidence

  15. Evaluation of a Worksite Cervical Screening Initiative to Increase Pap Smear Uptake in Malaysia: A Cluster Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Fauziah Abdullah

    2013-01-01

    Full Text Available Background. Despite the significant burden of cervical cancer, Malaysia like many middle-income countries relies on opportunistic cervical screening as opposed to a more organized population-based program. The aim of this study was to ascertain the effectiveness of a worksite screening initiative upon Papanicolaou smear test (Pap test uptake among educated working women in Malaysia. Methods. 403 female teachers who never or infrequently attended for a Pap test from 40 public secondary schools in Kuala Lumpur were recruited into a cluster randomized trial conducted between January and November 2010. The intervention group participated in a worksite cervical screening initiative whilst the control group received usual care from the existing cervical screening program. Multivariate logistic regression was performed to determine the impact of the intervention program on Pap smear uptake after 24 weeks of followup. Results. The proportion of women attending for a Pap test was significantly higher in the intervention than in the control group (18.1% versus 10.1%, P value < 0.05 with the worksite screening initiative doubling the Pap smear uptake, adjusted odds ratio 2.44 (95% CI: 1.29–4.62. Conclusion. Worksite health promotion interventions can effectively increase cervical smear uptake rates among eligible workers in middle-income countries. Policy makers and health care providers in these countries should include such interventions in strategies for reducing cervical cancer burden. This trial is registered with IRCT201103186088N1.

  16. 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

  17. 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

  18. 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...

  19. 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...

  20. Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start.

    Science.gov (United States)

    Quissell, David O; Bryant, Lucinda L; Braun, Patricia A; Cudeii, Diana; Johs, Nikolas; Smith, Vongphone L; George, Carmen; Henderson, William G; Albino, Judith

    2014-03-01

    Navajo Nation children have the greatest prevalence of early childhood caries in the United States. This protocol describes an innovative combination of community-based participatory research and clinical trial methods to rigorously test a lay native Community Oral Health Specialists-delivered oral health intervention, with the goal of reducing the progression of disease and improving family knowledge and behaviors. This cluster-randomized trial designed by researchers at the Center for Native Oral Health Research at the University of Colorado in conjunction with members of the Navajo Nation community compares outcomes between the manualized 2-year oral health fluoride varnish-oral health promotion intervention and usual care in the community (child-caregiver dyads from 26 Head Start classrooms in each study arm; total of 1016 dyads). Outcome assessment includes annual dental screening and an annual caregiver survey of knowledge, attitudes and behaviors; collection of cost data will support cost-benefit analyses. The study protocol meets all standards required of randomized clinical trials. Aligned with principles of community-based participatory research, extended interaction between members of the Navajo community and researchers preceded study initiation, and collaboration between project staff and a wide variety of community members informed the study design and implementation. We believe that the benefits of adding CBPR methods to those of randomized clinical studies outweigh the barriers and constraints, especially in studies of health disparities and in challenging settings. When done well, this innovative mix of methods will increase the likelihood of valid results that communities can use. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Use Case and Application Requirements for a Protocol Lifecycle Tracking Tool, with a Focus on the Trial Initiation Phase

    OpenAIRE

    London, Jack W; Elcombe, Sharon A.; Villasin, Alma; Sagenich, Corey; Davis, Paul

    2011-01-01

    The time required to initiate clinical trials, from declaration of the investigator’s intent to opening of the study for participant accrual, is cited as often being so long that clinical research is seriously impeded. Efforts to improve operational efficiency of trial initiation are confounded by the work flow complexity and the variations encountered with different types of trials and institutional environments. A computer Protocol Lifecycle Tracking (PLT) tool would enable study initiation...

  2. 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 subject

  3. 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

  4. 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

  5. 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

  6. 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

  7. Electronic health record project initiation and early planning in a community health center.

    Science.gov (United States)

    Cortelyou-Ward, Kendall; Noblin, Alice; Martin, Jeremy

    2011-01-01

    Community health centers exist to help their constituents become proactive in addressing their own health care needs and to improve the overall well-being of the community. However, they pose a different set of challenges when implementing an electronic health record system. This article applies 2 project management principles, initiation and early planning, to the electronic health record implementation in a community health center. Issues such as planning, financial considerations, and quality improvement are discussed.

  8. E-Health Initiative and Customer's Expectation: Case Brunei

    CERN Document Server

    Almunawar, Mohammad Nabil; Low, Patrick Kim Cheng; Anshari, Muhammad

    2012-01-01

    This paper is to determine the dimension of e-health services in Brunei Darussalam (Brunei) from customers' perspective. It is to identify, understand, analyze and evaluate public's expectation on e-health in Brunei. A questionnaire was designed to gather quantitative and qualitative data to survey patients, patient's family, and health practitioners at hospitals, clinics, or home care centers in Brunei starting from February to March, 2011. A 25-item Likert-type survey instrument was specifically developed for this study and administered to a sample of 366 patients. The data were analyzed to provide initial ideas and recommendation to policy makers on how to move forward with the e-health initiative as a mean to improve healthcare services. The survey revealed that there exists a high demand and expectation from people in Brunei to have better healthcare services accessible through an e-health system in order to improve health literacy as well as quality and efficiency of healthcare. Regardless of the limita...

  9. Exploring Australian health promotion and environmental sustainability initiatives.

    Science.gov (United States)

    Patrick, Rebecca; Kingsley, Jonathan

    2016-04-01

    Issue addressed Health promotion practitioners have important roles in applying ecosystem approaches to health and actively promoting environmental sustainability within community-level practice. The present study identified the nature and scope of health promotion activities across Australia that tackle environmental sustainability. Methods A mixed-method approach was used, with 82 participants undertaking a quantitative survey and 11 undertaking a qualitative interview. Purposeful sampling strategies were used to recruit practitioners who were delivering community-level health promotion and sustainability programs in Australia. The data were analysed thematically and interpretation was guided by the principles of triangulation. Results Study participants were at various stages of linking health promotion and environmental sustainability. Initiatives focused on healthy and sustainable food, active transport, energy efficiency, contact with nature and capacity building. Conclusion Capacity building approaches were perceived as essential to strengthening this field of practice. Healthy and sustainable food and active transport were suitable platforms for simultaneously promoting community health and sustainability. There was potential for expansion of programs that emphasise contact with nature and energy issues, as well as interventions that emphasise systems thinking and interdisciplinary approaches. So what? It was promising that Australian health promotion programs have started to address complexity rather than single issues, as evidenced by explicit engagement with environmental sustainability. However, more effort is required to enable a shift towards ecosystem approaches to health.

  10. Effectiveness of health and wellness initiatives for seniors.

    Science.gov (United States)

    Coberley, Carter; Rula, Elizabeth Y; Pope, James E

    2011-02-01

    Given the increasing prevalence of obesity and lifestyle-related chronic diseases in the United States and abroad, senior wellness initiatives have emerged as a means to stem the troubling trends that threaten the well-being and the economy of many nations. Seniors are an important demographic for such programs because this age group is growing, both as a proportion of the overall population and as a contributor to health care cost escalation. The goal of senior wellness programs is to improve the overall health of seniors through a variety of approaches, including increased physical activity, better nutrition, smoking cessation, and support of other healthy behaviors. Outcome metrics of particular interest are the effects of participation in these programs on health care utilization and expenditures. This review describes several studies that demonstrate reduced inpatient admissions and health care costs, as well as improved health-related quality of life as a direct result of participation in large-scale senior wellness programs. Programs that effectively engage seniors in, and change behavior as a direct result of, participation provide strong evidence that health improvements and decreased health care expenditures can be achieved. However, solutions to the challenges of broader enrollment and sustained participation in these programs would increase the impact of their outcomes and health-related benefits.

  11. Implementing nurse-initiated and managed antiretroviral treatment (NIMART in South Africa: a qualitative process evaluation of the STRETCH trial

    Directory of Open Access Journals (Sweden)

    Georgeu Daniella

    2012-07-01

    Full Text Available Abstract Background Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART access. However, the evidence for nurse-initiated and managed ART (NIMART in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. Methods This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. Results NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health

  12. Quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial.

    Science.gov (United States)

    Patwardhan, Soumil; Gogtay, Nithya; Thatte, Urmila; Pramesh, C S

    2014-01-01

    Literature on the quality and completeness of data and documentation in investigator-initiated research studies is scarce. We carried out a study to compare the quality of data and documentation in an investigator-initiated trial (IIT) with those in an industry-sponsored study. We retrospectively studied the archived data pertaining to 42 patients enrolled in two trials, 14 patients in an industry-sponsored study and 28 randomly selected patients from an IIT. Trial-related documents were examined and scored for the completeness of the acquisition of data and for storage as per a pre-formulated checklist. Weighted scores were given for each point on the checklist proportional to its relative importance in the data documentation process. A global score and sub-scores for specific modules were given for each subject. The scores in the two studies were compared using the Mann Whitney U test. The total score for general documents was similar in the IIT (14/14, 100%) and the sponsored study (24/25, 96%). The mean summary global score obtained for study-specific documents (maximum possible score, 32) in the IIT (27.1; 95% CI 26.4-27.8) was also not significantly different from that in the sponsored study (27.9; 95% CI 26.7-29.1; p=0.1291). Thus, investigator-initiated studies carried out by independent researchers in high-volume academic centres, even without active data monitoring and formal audits, appear to adhere to the high standards laid out in the International Conference on Harmonisation-Good Clinical Practices guidelines, ensuring accuracy and completeness in data documentation and archival.

  13. 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.

  14. 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

  15. Volunteering for Clinical Trials Can Help Improve Health Care for Everyone

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials Volunteering for Clinical Trials Can Help Improve Health Care for Everyone Past ... healthy people to help," says Melanie Modlin about clinical trials. "We have a role to play in helping ...

  16. 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

  17. Changing organizational culture: using the CEO cancer gold standard policy initiatives to promote health and wellness at a school of public health.

    Science.gov (United States)

    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 < .05) from baseline to follow-up were observed for questions measuring organizational values for 'prevention, 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.

  18. 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

  19. The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wikkelsoe Anne

    2012-07-01

    -PPH trial is investigator-initiated and aims to provide an evidence-based platform for the recommendations of the early use of fibrinogen concentrate in PPH. Trial registration ClincialTrials.gov NCT01359878.

  20. StaR Child Health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials.

    Science.gov (United States)

    Hartling, L; Wittmeier, K D M; Caldwell, P H; van der Lee, J H; Klassen, T P; Craig, J C; Offringa, M

    2011-11-01

    Standards for Research in (StaR) Child Health was founded in 2009 to address the paucity and shortcomings of pediatric clinical trials. This initiative involves international experts who are dedicated to developing practical, evidence-based standards to enhance the reliability and relevance of pediatric clinical research. Through a systematic "knowledge to action" plan, StaR Child Health will make efforts to improve and expand the evidence base for child health across the world.

  1. 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

  2. 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

  3. Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial.

    Science.gov (United States)

    Georgeu, Daniella; Colvin, Christopher J; Lewin, Simon; Fairall, Lara; Bachmann, Max O; Uebel, Kerry; Zwarenstein, Merrick; Draper, Beverly; Bateman, Eric D

    2012-07-16

    Task-shifting is promoted widely as a mechanism for expanding antiretroviral treatment (ART) access. However, the evidence for nurse-initiated and managed ART (NIMART) in Africa is limited, and little is known about the key barriers and enablers to implementing NIMART programmes on a large scale. The STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) programme was a complex educational and organisational intervention implemented in the Free State Province of South Africa to enable nurses providing primary HIV/AIDS care to expand their roles and include aspects of care and treatment usually provided by physicians. STRETCH used a phased implementation approach and ART treatment guidelines tailored specifically to nurses. The effects of STRETCH on pre-ART mortality, ART provision, and the quality of HIV/ART care were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation of the programme. This study was a qualitative process evaluation using in-depth interviews and focus group discussions with patients, health workers, health managers, and other key informants as well as observation in clinics. Research questions focused on perceptions of STRETCH, changes in health provider roles, attitudes and patient relationships, and impact of the implementation context on trial outcomes. Data were analysed collaboratively by the research team using thematic analysis. NIMART appears to be highly acceptable among nurses, patients, and physicians. Managers and nurses expressed confidence in their ability to deliver ART successfully. This confidence developed slowly and unevenly, through a phased and well-supported approach that guided nurses through training, re-prescription, and initiation. The research also shows that NIMART changes the working and referral relationships between health staff, demands significant training and support, and

  4. The Alzheimer's Disease Neuroimaging Initiative 3: Continued innovation for clinical trial improvement

    OpenAIRE

    Weiner, MW; Veitch, DP; Aisen, PS; Beckett, LA; Cairns, NJ; Green, RC; Harvey, D.; Jack, CR; Jagust, W.; Morris, JC; Petersen, RC; Salazar, J.; Saykin, AJ; Shaw, LM; Toga, AW

    2017-01-01

    © 2016 the Alzheimer's Association Introduction The overall 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. Methods 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 connec...

  5. No Increase in Fractures After Stopping Hormone Therapy: Results From the Women's Health Initiative.

    Science.gov (United States)

    Watts, Nelson B; Cauley, Jane A; Jackson, Rebecca D; LaCroix, Andrea Z; Lewis, Cora E; Manson, JoAnn E; Neuner, Joan M; Phillips, Lawrence S; Stefanick, Marcia L; Wactawski-Wende, Jean; Crandall, Carolyn

    2017-01-01

    The Women's Health Initiative (WHI) hormone therapy (HT) trials showed protection against hip and total fractures, but a later observational report suggested loss of benefit and a rebound increased risk after cessation of HT. The purpose of this study was to examine fractures after discontinuation of HT. Two placebo-controlled randomized trials served as the study setting. Study patients included WHI participants (N = 15,187) who continued active HT or placebo through the intervention period and who did not take HT in the postintervention period. Trial interventions included conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) in naturally menopausal women and CEE alone in women with prior hysterectomy. Total fractures and hip fractures through 5 years after discontinuation of HT were recorded. Hip fractures were infrequent (∼2.5 per 1000 person-years); this finding was similar between trials and in former HT and placebo groups. There was no difference in total fractures in the CEE + MPA trial for former HT vs former placebo users (28.9 per 1000 person-years and 29.9 per 1000 person-years, respectively; hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.87 to 1.09; P = 0.63); however, in the CEE-alone trial, total fractures were higher in former placebo users (36.9 per 1000 person-years) compared with the former active group (31.1 per 1000 person-years), a finding that was suggestive of a residual benefit of CEE against total fractures (HR, 0.85; 95% CI, 0.73 to 0.98; P = 0.03). We found no evidence for increased fracture risk, either sustained or transient, for former HT users compared with former placebo users after stopping HT. There was residual benefit for total fractures in former HT users from the CEE-alone study.

  6. Moxifloxacin and gatifloxacin for initial therapy of tuberculosis: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Ruan, Qiaoling; Liu, Qihui; Sun, Feng; Shao, Lingyun; Jin, Jialin; Yu, Shenglei; Ai, Jingwen; Zhang, Bingyan; Zhang, Wenhong

    2016-02-24

    Moxifloxacin (MOX) and gatifloxacin (GAT) have exhibited promising mycobactericidal activity, and a number of clinical trials have been conducted in recent decades to compare the treatment efficacy of MOX-containing and/or GAT-containing regimens with the standard regimen. The aim of this meta-analysis for clinical trials of MOX- or GAT-containing regimens was to evaluate their treatment efficacy and safety in initial therapy for drug-sensitive tuberculosis (TB). Databases were searched for randomized controlled trials, and nine studies with 6980 patients were included. We found that fluoroquinolone substitution for isoniazid or ethambutol in short-course regimens might result in more frequent unfavorable treatment outcomes compared with the standard regimen-in particular, an increased incidence of relapse. In a per-protocol analysis, MOX-containing regimens had slightly higher rates of sputum culture conversion at two months than the standard regimen (RR 1.08, 95% CI 1.04-1.11, P MOX- or GAT-containing regimens and the standard regimen. In conclusion, MOX or GAT might not have the ability to shorten treatment duration in the initial therapy for tuberculosis despite the non-inferiority or even slightly better efficacy in the early phase of treatment compared with the standard regimen. Furthermore, it is safe to include MOX or GAT in initial TB treatment.

  7. What public health strategies are needed to reduce smoking initiation?

    Science.gov (United States)

    Pierce, John P; White, Victoria M; Emery, Sherry L

    2012-03-01

    Smoking initiation is a key behaviour that determines the future health consequences of smoking in a society. There is a marked difference in smoking patterns around the world, driven by initiation rates. While a number of high-income countries have seen smoking prevalence decline markedly from peak, many low-income and middle-income countries appear to still be on an upward trend. Unlike cessation where changes are limited by nicotine dependence, rates of smoking initiation can change rapidly over a short time span. Interventions that can be effective in achieving this include increases in the price of tobacco products, mass media anti-smoking advertising, smoke-free policies, smoking curricula in schools, restrictions on marketing opportunities for the tobacco industry as well as social norms that lead to restrictions on adolescents' ability to purchase cigarettes. Comprehensive tobacco control programmes that aim to denormalise smoking behaviour in the community contain all of these interventions. Rapid reductions in smoking initiation in adolescents have been documented in two case studies of comprehensive tobacco control programmes in California and Australia. Consistent and inescapable messages from multiple sources appear to be key to success. However, the California experience indicates that the rapid decline in adolescent smoking will not continue if tobacco control expenditures and the relative price of cigarettes are reduced. These case studies provide strong additional evidence of the importance of countries implementing the provisions of the Framework Treaty on Tobacco Control.

  8. Ethical issues posed by cluster randomized trials in health research

    Directory of Open Access Journals (Sweden)

    Donner Allan

    2011-04-01

    Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

  9. Youth mental health first aid: a description of the program and an initial evaluation

    Directory of Open Access Journals (Sweden)

    Jorm Anthony F

    2011-01-01

    Full Text Available Abstract Background Adolescence is the peak age of onset for mental illness, with half of all people who will ever have a mental illness experiencing their first episode prior to 18 years of age. Early onset of mental illness is a significant predictor for future episodes. However, adolescents and young adults are less likely than the population as a whole to either seek or receive treatment for a mental illness. The knowledge and attitudes of the adults in an adolescent's life may affect whether or not help is sought, and how quickly. In 2007, the Youth Mental Health First Aid Program was launched in Australia with the aim to teach adults, who work with or care for adolescents, the skills needed to recognise the early signs of mental illness, identify potential mental health-related crises, and assist adolescents to get the help they need as early as possible. This paper provides a description of the program, some initial evaluation and an outline of future directions. Methods The program was evaluated in two ways. The first was an uncontrolled trial with 246 adult members of the Australian public, who completed questionnaires immediately before attending the 14 hour course, one month later and six months later. Outcome measures were: recognition of schizophrenia or depression; intention to offer and confidence in offering assistance; stigmatising attitudes; knowledge about adolescent mental health problems and also about the Mental Health First Aid action plan. The second method of evaluation was to track the uptake of the program, including the number of instructors trained across Australia to deliver the course, the number of courses they delivered, and the uptake of the YMHFA Program in other countries. Results The uncontrolled trial found improvements in: recognition of schizophrenia; confidence in offering help; stigmatising attitudes; knowledge about adolescent mental health problems and application of the Mental Health First Aid action

  10. Transdisciplinary Research and Evaluation for Community Health Initiatives

    Science.gov (United States)

    Harper, Gary W.; Neubauer, Leah C.; Bangi, Audrey K.; Francisco, Vincent T.

    2010-01-01

    Transdisciplinary research and evaluation projects provide valuable opportunities to collaborate on interventions to improve the health and well-being of individuals and communities. Given team members’ diverse backgrounds and roles or responsibilities in such projects, members’ perspectives are significant in strengthening a project’s infrastructure and improving its organizational functioning. This article presents an evaluation mechanism that allows team members to express the successes and challenges incurred throughout their involvement in a multisite transdisciplinary research project. Furthermore, their feedback is used to promote future sustainability and growth. Guided by a framework known as organizational development, the evaluative process was conducted by a neutral entity, the Quality Assurance Team. A mixed-methods approach was utilized to garner feedback and clarify how the research project goals could be achieved more effectively and efficiently. The multiple benefits gained by those involved in this evaluation and implications for utilizing transdisciplinary research and evaluation teams for health initiatives are detailed. PMID:18936267

  11. 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.

  12. Effects of acupuncture for initiation of labor: a double-blind randomized sham-controlled trial.

    Science.gov (United States)

    Ajori, Ladan; Nazari, Leila; Eliaspour, Dariush

    2013-05-01

    This double-blind randomized controlled trial was conducted to evaluate whether use of acupuncture could initiate labor at term and thus reduce post-term induction. Between 2010 and 2011, a total of 80 women at 38 weeks of gestation or greater were randomized to acupuncture and sham acupuncture groups. Acupuncture points LI4, SP6 and BL67 were needled bilaterally. The primary outcome was initiation of labor. The time from acupuncture to delivery, mode of delivery, fetal and maternal outcome and Apgar scores were recorded. The trial is registered at irct.ir, number IRCT201111218151N1. Eighty women were randomized and 75 women completed the study procedure. Age, BMI, parity and gestational age were similar in both groups. Spontaneous labor was initiated in 94.7 % of acupuncture group and 89.2 % of sham acupuncture group (p = 0.430). There were no statistically significant difference between groups for time from enrollment to delivery (p = 0.06). According to this study, it seems that acupuncture was not effective in labor initiation compared to sham acupuncture.

  13. [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.

  14. Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

    Science.gov (United States)

    Rodon, J; Soria, J C; Berger, R; Batist, G; Tsimberidou, A; Bresson, C; Lee, J J; Rubin, E; Onn, A; Schilsky, R L; Miller, W H; Eggermont, A M; Mendelsohn, J; Lazar, V; Kurzrock, R

    2015-08-01

    Advances in 'omics' technology and targeted therapeutic molecules are together driving the incorporation of molecular-based diagnostics into the care of patients with cancer. There is an urgent need to assess the efficacy of therapy determined by molecular matching of patients with particular targeted therapies. WINTHER is a clinical trial that uses cutting edge genomic and transcriptomic assays to guide treatment decisions. Through the lens of this ambitious multinational trial (five countries, six sites) coordinated by the Worldwide Innovative Networking Consortium for personalized cancer therapy, we discovered key challenges in initiation and conduct of a prospective, omically driven study. To date, the time from study concept to activation has varied between 19 months at Gustave Roussy Cancer Campus in France to 30 months at the Segal Cancer Center, McGill University (Canada). It took 3+ years to be able to activate US sites due to national regulatory hurdles. Access to medications proposed by the molecular analysis remains a major challenge, since their availability through active clinical trials is highly variable over time within sites and across the network. Rules regarding the off-label use of drugs, or drugs not yet approved at all in some countries, pose a further challenge, and many biopharmaceutical companies lack a simple internal mechanism to supply the drugs even if they wish to do so. These various obstacles should be addressed to test and then implement precision medicine in cancer. © 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.

  15. Protocol-writing support conferences for investigator-initiated clinical trials

    Directory of Open Access Journals (Sweden)

    Goto M

    2016-04-01

    Full Text Available Masaya Goto,1 Yoshihiro Muragaki,2 Atsushi Aruga1 1Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 2Intelligent Clinical Research and Innovation Center, Tokyo Women's Medical University, Tokyo, Japan Abstract: In investigator-initiated clinical trials, protocols with inappropriate methods might cause bias. However, insufficient data are available to determine which items are important or difficult to discuss in protocol development. We recorded protocol-writing support conferences to determine what items methodologists and investigators discussed. We obtained approval from all applicants to attend our Intelligent Clinical Research and Innovation Center writing support conferences, recorded all the discussions, characterized them, and sorted the items iteratively. In 1 year, we had 18 conferences: nine early protocol conferences and nine rejected protocol conferences. The latter were rejected by the institutional review board, which requested consultation. The most discussed item was outcomes, accounting for ~20% of the total discussion time. In three trials, the main problem was multiple primary outcomes. The second most discussed item was control. Early protocol conferences had more non-preliminary proposal items than rejected ones (P<0.001. This study showed important items (especially outcomes and control for investigators to write protocols. Early protocol-writing conferences helped investigators find questionable items. Keywords: investigator-initiated clinical trials, support, protocol-writing, conferences, recording

  16. StaR Child Health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials

    NARCIS (Netherlands)

    L. Hartling; K.D.M. Wittmeier; P.H. Caldwell; J.H. van der Lee; T.P. Klassen; J.C. Craig; M. Offringa

    2011-01-01

    Standards for Research in (StaR) Child Health was founded in 2009 to address the paucity and shortcomings of pediatric clinical trials. This initiative involves international experts who are dedicated to developing practical, evidence-based standards to enhance the reliability and relevance of pedia

  17. Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

    Science.gov (United States)

    Kravitz, Richard L; Franks, Peter; Feldman, Mitchell D; Tancredi, Daniel J; Slee, Christina A; Epstein, Ronald M; Duberstein, Paul R; Bell, Robert A; Jackson-Triche, Maga; Paterniti, Debora A; Cipri, Camille; Iosif, Ana-Maria; Olson, Sarah; Kelly-Reif, Steven; Hudnut, Andrew; Dvorak, Simon; Turner, Charles; Jerant, Anthony

    2013-11-06

    Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment. To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing. Randomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California. DEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control). Among depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted. Of the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control, -0.2 (95% CI, -1.2 to 0.8); IMCP vs control,  0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point

  18. Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory.

    Science.gov (United States)

    Richesson, Rachel L; Hammond, W Ed; Nahm, Meredith; Wixted, Douglas; Simon, Gregory E; Robinson, Jennifer G; Bauck, Alan E; Cifelli, Denise; Smerek, Michelle M; Dickerson, John; Laws, Reesa L; Madigan, Rosemary A; Rusincovitch, Shelley A; Kluchar, Cynthia; Califf, Robert M

    2013-12-01

    Widespread sharing of data from electronic health records and patient-reported outcomes can strengthen the national capacity for conducting cost-effective clinical trials and allow research to be embedded within routine care delivery. While pragmatic clinical trials (PCTs) have been performed for decades, they now can draw on rich sources of clinical and operational data that are continuously fed back to inform research and practice. The Health Care Systems Collaboratory program, initiated by the NIH Common Fund in 2012, engages healthcare systems as partners in discussing and promoting activities, tools, and strategies for supporting active participation in PCTs. The NIH Collaboratory consists of seven demonstration projects, and seven problem-specific working group 'Cores', aimed at leveraging the data captured in heterogeneous 'real-world' environments for research, thereby improving the efficiency, relevance, and generalizability of trials. Here, we introduce the Collaboratory, focusing on its Phenotype, Data Standards, and Data Quality Core, and present early observations from researchers implementing PCTs within large healthcare systems. We also identify gaps in knowledge and present an informatics research agenda that includes identifying methods for the definition and appropriate application of phenotypes in diverse healthcare settings, and methods for validating both the definition and execution of electronic health records based phenotypes.

  19. Challenges conducting comparative effectiveness research: the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE experience

    Directory of Open Access Journals (Sweden)

    Friedly JL

    2014-05-01

    Full Text Available Janna L Friedly,1,4 Zoya Bauer,2,4 Bryan A Comstock,3,4 Emily DiMango,5 Assiamira Ferrara,6 Susan S Huang,7 Elliot Israel,8 Jeffrey G Jarvik,2,4 Andrew A Nierenberg,9 Michael K Ong,10 David F Penson,11 Rebecca Smith-Bindman,12 Arthur E Stillman,13 William M Vollmer,6 Stephen M Warren,14 Chunliu Zhan,15 David Chu-Wen Hsia,15 Anne Trontell15 1Department of Rehabilitation Medicine, 2Department of Radiology, 3Department of Biostatistics, 4Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA, 5Columbia University Medical Center, New York, NY, 6Kaiser Foundation Research Institute, Oakland, 7Division of Infectious Diseases and Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA, 8Harvard Medical School, Pulmonary and Critical Care, Allergy and Immunology, Brigham and Women's Hospital, 9Massachusetts General Hospital, Boston, MA, 10Division of General Internal Medicine & Health Services Research, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, 11Vanderbilt University and Tennessee Valley VAHCC, Nashville, TN, 12Departments of Radiology and Biomedical Imaging, Health Policy, Epidemiology and Biostatistics, University of California, San Francisco, SF, 13Emory University, Atlanta, GA, 14Department of Plastic Surgery, Division of Clinical and Translational Research, NYU Langone Medical Center, New York, NY, 15Agency for Healthcare Research and Quality, Rockville, MD, USA Abstract: The Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE program, which includes 12 ongoing comparative effectiveness research (CER trials funded by the Agency for Healthcare Research and Quality under the American Recovery and Reinvestment Act of 2009, has had firsthand experience in dealing with the unique challenges of conducting CER since the trials started in the fall of 2010. This paper will explore the collective experience

  20. Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative.

    Science.gov (United States)

    Dzau, Victor J; McClellan, Mark B; McGinnis, J Michael; Burke, Sheila P; Coye, Molly J; Diaz, Angela; Daschle, Thomas A; Frist, William H; Gaines, Martha; Hamburg, Margaret A; Henney, Jane E; Kumanyika, Shiriki; Leavitt, Michael O; Parker, Ruth M; Sandy, Lewis G; Schaeffer, Leonard D; Steele, Glenn D; Thompson, Pamela; Zerhouni, Elias

    2017-04-11

    Recent discussion has focused on questions related to the repeal and replacement of portions of the Affordable Care Act (ACA). However, issues central to the future of health and health care in the United States transcend the ACA provisions receiving the greatest attention. Initiatives directed to certain strategic and infrastructure priorities are vital to achieve better health at lower cost. To review the most salient health challenges and opportunities facing the United States, to identify practical and achievable priorities essential to health progress, and to present policy initiatives critical to the nation's health and fiscal integrity. Qualitative synthesis of 19 National Academy of Medicine-commissioned white papers, with supplemental review and analysis of publicly available data and published research findings. The US health system faces major challenges. Health care costs remain high at $3.2 trillion spent annually, of which an estimated 30% is related to waste, inefficiencies, and excessive prices; health disparities are persistent and worsening; and the health and financial burdens of chronic illness and disability are straining families and communities. Concurrently, promising opportunities and knowledge to achieve change exist. Across the 19 discussion papers examined, 8 crosscutting policy directions were identified as vital to the nation's health and fiscal future, including 4 action priorities and 4 essential infrastructure needs. The action priorities-pay for value, empower people, activate communities, and connect care-recurred across the articles as direct and strategic opportunities to advance a more efficient, equitable, and patient- and community-focused health system. The essential infrastructure needs-measure what matters most, modernize skills, accelerate real-world evidence, and advance science-were the most commonly cited foundational elements to ensure progress. The action priorities and essential infrastructure needs represent major

  1. Franco-German initiative for Chernobylsk health project; Initiative Franco-Allemande pour Tchernobyl projet sante

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    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.)

  2. Internal migration and health: premarital sexual initiation in Nigeria.

    Science.gov (United States)

    Mberu, Blessing Uchenna; White, Michael J

    2011-04-01

    The high rates of youth migration to urban and economic centers, in the context of persistent poverty and devastating HIV/AIDS burden, have raised intricate social policy challenges in developing countries. Using the 2008 Nigeria Demographic and Health Survey data, descriptive statistics, Kaplan-Meier survival curves and discrete-time hazard regression models, this study examines the patterns of internal migration and sexual initiation among never-married Nigerian youth aged 15-24. We find that migrants generally show stronger association than non-migrants, and urban-rural and rural-rural migrants particularly show the strongest independent association with premarital sexual initiation. Other significant covariates are age, religion, ethnic origin, educational attainment, independent living arrangement, formal employment and exposure to the mass media. The findings highlight the direct importance of youth migration in understanding and addressing the challenges of premarital sexual behavior and the need for behavior change policies and programs to be sensitive to the complex contextual nuances across youth groups in one country. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    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

  4. Health initiatives for the prevention of skin cancer.

    Science.gov (United States)

    Greinert, Rüdiger; Breitbart, Eckhard W; Mohr, Peter; Volkmer, Beate

    2014-01-01

    Skin cancer is the most frequent type of cancer in white population worldwide. However, because the most prominent risk factor-solar UV-radiation and/or artificial UV from sunbeds-is known, skin cancer is highly preventable be primary prevention. This prevention needs, that the public is informed by simple and balanced messages about the possible harms and benefits of UV-exposure and how a person should behave under certain conditions of UV-exposure. For this purpose information and recommendations for the public must be age- and target-group specific to cover all periods of life and to reach all sub-groups of a population, continuously. There is a need that political institutions together with Health Institutions and Societies (e.g., European Commission, WHO, EUROSKIN, ICNIRP, etc.), which are responsible for primary prevention of skin cancer, find a common language to inform the public, in order not to confuse it. This is especially important in connection with the ongoing Vitamin D debate, where possible positive effects of UV have to be balanced with the well known skin cancer risk of UV. A continuously ongoing evaluation of interventions and programs in primary prevention is a pre-requisite to assess the effectiveness of strategies. There is surely no "no message fits all" approach, but balanced information in health initiatives for prevention of skin cancer, which use evidence-base strategies, will further be needed in the future to reduce the incidence, morbidity and mortality skin cancer.

  5. Integrating health-related quality of life into cross-national clinical trials.

    Science.gov (United States)

    Cella, D F; Wiklund, I; Shumaker, S A; Aaronson, N K

    1993-12-01

    When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Health providers' perceptions of clinical trials: lessons from Ghana, Kenya and Burkina Faso.

    Directory of Open Access Journals (Sweden)

    Vibian Angwenyi

    Full Text Available 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 requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso.We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99 and health managers (n=14; and group discussions with fieldworkers (n=9 discussions. Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach.Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed.Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising

  7. 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.

  8. Current initiatives in One Health: consolidating the One Health Global Network.

    Science.gov (United States)

    Vandersmissen, A; Welburn, S C

    2014-08-01

    The Global Response to Avian Influenza has led to a longer-term One Health movement, which addresses risks, including zoonoses, at the human-animal- environment interface, and requires the development of innovative partnerships at the political, institutional and technical levels. One Health is a sustainable and rational option when the cumulative effects of health hazards on food and economic security are considered, but demands long-term financial investment. Projections of growth in the demand for livestock production and consumption in Asia and Africa also call for effective One Health responses. However, an effective response also requires validated evidence of the socio-economic value that the One Health approach can provide. Implementing the One Health approach depends on forging strong links between human and animal health services, the environment and public policy. The authors present a list of some of the national and transnational partnerships established since 2006. Political support, good governance and effective policies and networks are crucial building blocks for One Health sustainability. The Global Response to Avian Influenza was initially established under the joint leadership of the European Union, the United States and the United Nations System Influenza Coordination Office. Since then it has supported numerous initiatives, including the World Health Organization (WHO)/Food and Agriculture Organization of the United Nations (FAO)/World Organisation for Animal Health (OIE) Global Early Warning System (GLEWS). Indeed, the Global Response to Avian Influenza paved the way for an unprecedented WHO/FAO/OIE tripartite partnership, which promoted the integration of foodborne, neglected zoonotic and tropical diseases within the One Health movement and led to the tripartite High-Level Technical Meeting of 2011 in Mexico. The One Health Global Network, which began as a proposition at an Expert Consultation in Winnipeg, Canada, in 2009, is now a reality

  9. Incorporating Electronic Business Initiatives in Health Services and Health Tourism: A Case Study of Malaysia

    Directory of Open Access Journals (Sweden)

    Mohammad Talh

    2005-01-01

    Full Text Available Telecommunications, information communication technology, miniaturization, computers and Internet went through shorter product life styles and achieved widespread diffusion and reformed the nature of business operation and enhanced competitive business environment instantly. This technological advancement has resulted in evolution and innovation of many products, services and business processes. The Internet has resulted in the emergence of virtual markets with four primary distinctive characteristics, which are real time, shared, open and global. The greatest feature of the Internet is the absence of intermediaries; the manufacturers are able to sell their product relatively easier to buyers via Internet. E-business today is no longer technological issue, but is also a business issue. Incorporating E-business initiatives in health services aims to go beyond the traditional modes of healthcare delivery and instead, provide greater access to better and higher quality healthcare. It is achieved by grabbing opportunities of enhanced multimedia and information technologies and developing new technological solutions. In addition, E-business initiative is incorporated in enhancing health tourism sector through cost cutting strategies and improving quality of patients' care. Thus, this paper attempts to discuss the current states of health services and health tourism and how the emergence of E-business initiative can be capitalized to further boost the industry in Malaysia.

  10. Use Case and Application Requirements for a Protocol Lifecycle Tracking Tool, with a Focus on the Trial Initiation Phase

    Science.gov (United States)

    London, Jack W.; Elcombe, Sharon A.; Villasin, Alma; Sagenich, Corey; Davis, Paul

    2011-01-01

    The time required to initiate clinical trials, from declaration of the investigator’s intent to opening of the study for participant accrual, is cited as often being so long that clinical research is seriously impeded. Efforts to improve operational efficiency of trial initiation are confounded by the work flow complexity and the variations encountered with different types of trials and institutional environments. A computer Protocol Lifecycle Tracking (PLT) tool would enable study initiation staff to manage the process, and the various clinical research stakeholders to monitor the progress of a study’s initiation, as well as obtain data on the work flow to identify those activities that are in need of operational efficiency improvement. The objective of our work was to develop use cases and system requirements for a PLT tool. The result of our study is a use case document that can serve as the specifications for developing a PLT application. PMID:22211177

  11. Involving local health departments in community health partnerships: evaluation results from the partnership for the public's health initiative.

    Science.gov (United States)

    Cheadle, Allen; Hsu, Clarissa; Schwartz, Pamela M; Pearson, David; Greenwald, Howard P; Beery, William L; Flores, George; Casey, Maria Campbell

    2008-03-01

    Improving community health "from the ground up" entails a comprehensive ecological approach, deep involvement of community-based entities, and addressing social determinants of population health status. Although the Centers for Disease Control and Prevention, the Office of the Surgeon General, and other authorities have called for public health to be an "inter-sector" enterprise, few models have surfaced that feature local health departments as a key part of the collaborative model for effecting community-level change. This paper presents evaluation findings and lessons learned from the Partnership for the Public's Health (PPH), a comprehensive community initiative that featured a central role for local health departments with their community partners. Funded by The California Endowment, PPH provided technical and financial resources to 39 community partnerships in 14 local health department jurisdictions in California to promote community and health department capacity building and community-level policy and systems change designed to produce long-term improvements in population health. The evaluation used multiple data sources to create progress ratings for each partnership in five goal areas related to capacity building, community health improvement programs, and policy and systems change. Overall results were generally positive; in particular, of the 37 partnerships funded continuously throughout the 5 years of the initiative, between 25% and 40% were able to make a high level of progress in each of the Initiative's five goal areas. Factors associated with partnership success were also identified by local evaluators. These results showed that health departments able to work effectively with community groups had strong, committed leaders who used creative financing mechanisms, inclusive planning processes, organizational changes, and open communication to promote collaboration with the communities they served.

  12. Laser immunotherapy: initial results from a human breast cancer pilot trial

    Science.gov (United States)

    Hode, Tomas; Guerra, Maria C.; Ferrel, Gabriela L.; Lunn, John A.; Adelsteinsson, Orn; Nordquist, Robert E.; Chen, Wei R.

    2010-02-01

    Laser Immunotherapy is an experimental treatment modality for late-stage, metastatic tumors, which targets solid primary and/or secondary tumors and utilizes an autologous vaccine-like approach to stimulate immune responses. Specifically, laser immunotherapy combines laser-induced in situ tumor devitalization with an immunoadjuvant for local immunostimulation. Here we report the initial results from a human breast cancer pilot trial with laser immunotherapy. Six stage III and IV cancer patients were treated, all of which were considered to be out of all other options, and preliminary data at the three-month examination are presented. The immediate goal of the trial was to determine the patient tolerance and the toxicity of the therapy, the optimal dose for the alteration of the course of the disease, and the reduction of the tumor burden. Each patient was individually evaluated for toxicity tolerance through physical exams and by appropriate supplemental and routine laboratory tests. Observable tumors in patients were followed with physical examination and radiological evaluations. Treatment efficacy was judged by the size and number of local and distant metastases before and after treatment.

  13. Health workforce responses to global health initiatives funding: a comparison of Malawi and Zambia

    Directory of Open Access Journals (Sweden)

    Brugha Ruairí

    2010-08-01

    Full Text Available Abstract Background Shortages of health workers are obstacles to utilising global health initiative (GHI funds effectively in Africa. This paper reports and analyses two countries' health workforce responses during a period of large increases in GHI funds. Methods Health facility record reviews were conducted in 52 facilities in Malawi and 39 facilities in Zambia in 2006/07 and 2008; quarterly totals from the last quarter of 2005 to the first quarter of 2008 inclusive in Malawi; and annual totals for 2004 to 2007 inclusive in Zambia. Topic-guided interviews were conducted with facility and district managers in both countries, and with health workers in Malawi. Results Facility data confirm significant scale-up in HIV/AIDS service delivery in both countries. In Malawi, this was supported by a large increase in lower trained cadres and only a modest increase in clinical staff numbers. Routine outpatient workload fell in urban facilities, in rural health centres and in facilities not providing antiretroviral treatment (ART, while it increased at district hospitals and in facilities providing ART. In Zambia, total staff and clinical staff numbers stagnated between 2004 and 2007. In rural areas, outpatient workload, which was higher than at urban facilities, increased further. Key informants described the effects of increased workloads in both countries and attributed staff migration from public health facilities to non-government facilities in Zambia to PEPFAR. Conclusions Malawi, which received large levels of GHI funding from only the Global Fund, managed to increase facility staff across all levels of the health system: urban, district and rural health facilities, supported by task-shifting to lower trained staff. The more complex GHI arena in Zambia, where both Global Fund and PEPFAR provided large levels of support, may have undermined a coordinated national workforce response to addressing health worker shortages, leading to a less effective

  14. The effect of acupressure on the initiation of labor: A randomized controlled trial.

    Science.gov (United States)

    Torkzahrani, Shahnaz; Mahmoudikohani, Fatemeh; Saatchi, Kiarash; Sefidkar, Reyhaneh; Banaei, Mojdeh

    2017-02-01

    Induction of labor is a common obstetric procedure. Acupressure is a natural method that is used for inducing uterine contractions. Nevertheless, few studies have examined the impact of acupressure on the induction of labor. The aim of this study was to evaluate the effect of acupressure on the initiation of labor. In this randomized clinical trial, 162 nulliparous pregnant women were admitted to the hospital. They were categorized into 3 groups; acupressure, sham acupressure and control. Acupressure points SP6, BL 60 and BL 32 were pressured bilaterally. The intervention was done by the researcher every other day between 9 am and 11 am. The intervention was carried out on women in the afternoon and the following day. Subjects were examined to determine the initiation of labor symptoms48 and 96h after the start of intervention and at the time of hospitalization. Data were analyzed using the ANOVA, Kruskal-Wallis and Chi-square tests (pinitiation of labor within 48h (P=0.464), and 49-96h after beginning the intervention (P=0.111) and 97h after beginning the intervention to the time of hospitalization for the spontaneous initiation of labor (P=0.897). There were no significant differences in the secondary outcomes between the groups. According to the finding of this study, it seems that acupressure treatment was not effective in initiating labor as compared with the sham acupressure and the routine care groups. Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  15. An Efficacy Trial of "Steps to Your Health", a Health Promotion Programme for Adults with Intellectual Disability

    Science.gov (United States)

    McDermott, Suzanne; Whitner, Wendy; Thomas-Koger, Marlo; Mann, Joshua R.; Clarkson, John; Barnes, Timothy L.; Bao, Haikun; Meriwether, Rebecca A

    2012-01-01

    Objective: Although there are evaluation and effectiveness studies of health promotion interventions for adults with intellectual disabilities (ID), randomized efficacy trials of such interventions are lacking. Design: A randomized active control intervention trial. Setting: The participants attended the health promotion classes in local…

  16. Luck Egalitarianism, Social Determinants and Public Health Initiatives

    DEFF Research Database (Denmark)

    Albertsen, Andreas

    2015-01-01

    People’s health is hugely affected by where they live, their occupational status and their socio-economic position. It has been widely argued that the presence of such social determinants in health provides good reasons to reject luck egalitarianism as a theory of distributive justice in health....... The literature provides different reasons why this responsibility-sensitive theory of distributive justice should not be applied to health. The critiques submit that (i) the social circumstances undermine or remove people’s responsibility for their health; (ii) responsibility sensitive health policies would...

  17. Feeding trials in organic food quality and health research.

    Science.gov (United States)

    Velimirov, Alberta; Huber, Machteld; Lauridsen, Charlotte; Rembiałkowska, Ewa; Seidel, Kathrin; Bügel, Susanne

    2010-01-30

    Feeding experiments comparing organically and conventionally produced food are performed to assess the overall impact on the animals' health as a model for the effects experienced by the human consumers. These experiments are based on systems research and characterized by their focus on production methods, whole food testing and procedures in accordance with the terms of organic farming. A short review of such experiments shows that the majority of these tests revealed effects of the organically produced feed on health parameters such as reproductive performance and immune responses. Systems research is not just about simple cause-effect chains, but rather about the pluralism of interactions in biological networks; therefore, the interpretation of the outcome of whole food experiments is difficult. Furthermore, the test diets of organic and conventional origin can be constituted in different ways, compensating for or maintaining existing differences in nutrient and energy contents. The science-based results suggest positive influences from organic feeds, but there is still a need for confirmation in animals and, finally, in humans. For this purpose animal feeding trials with feed from different production systems should be conducted, with the aims to define health indicators and to establish biomarkers as a basis for future dietary intervention studies in humans.

  18. 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.

  19. Luck Egalitarianism, Social Determinants and Public Health Initiatives

    DEFF Research Database (Denmark)

    Albertsen, Andreas

    2015-01-01

    People’s health is hugely affected by where they live, their occupational status and their socio-economic position. It has been widely argued that the presence of such social determinants in health provides good reasons to reject luck egalitarianism as a theory of distributive justice in health....... The literature provides different reasons why this responsibility-sensitive theory of distributive justice should not be applied to health. The critiques submit that (i) the social circumstances undermine or remove people’s responsibility for their health; (ii) responsibility sensitive health policies would...... adversely affect those who are worst off and; (iii) the luck egalitarian approach to health distracts from the important task of rectifying socio-economic influences on people's health and provides individualistic solutions to collective problems. But for each of these variants of the critique luck...

  20. 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

  1. Impact of global health governance on country health systems: the case of HIV initiatives in Nigeria

    Directory of Open Access Journals (Sweden)

    Charles Chikodili Chima

    2015-06-01

    Full Text Available Background: Three global health initiatives (GHIs – the US President’s Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the World Bank Multi–Country HIV/AIDS Program – finance most HIV services in Nigeria. Critics assert that GHIs burden fragile health systems in resource–poor countries and that health system limitations in these countries constrain the achievement of the objectives of GHIs. This study analyzed interactions between HIV GHIs and the Nigerian Health System and explored how the impact of the GHIs could be optimized. Methods: A country case study was conducted using qualitative methods, including: semi–structured interviews, direct observation, and archival review. Semi–structured interviews were held with key informants selected to reach a broad range of stakeholders including policymakers, program managers, service providers, representatives of donor agencies and their implementing partners; the WHO country office in Nigeria; independent consultants; and civil society organizations involved in HIV work. The fieldwork was conducted between June and August 2013. Findings: HIV GHIs have had a mixed impact on the health system. They have enhanced availability of and access to HIV services, improved quality of services, and strengthened health information systems and the role of non–state actors in health care. On the negative end, HIV donor funding has increased dependency on foreign aid, widened disparities in access to HIV services, done little to address the sustainability of the services, crowded out non–HIV health services, and led to the development of a parallel supply management system. They have also not invested significantly in the production of new health workers and have not addressed maldistribution problems, but have rather contributed to internal brain drain by luring health workers from the public sector to non–governmental organizations and have

  2. 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.

  3. Recent publications from the Alzheimer's Disease Neuroimaging Initiative: Reviewing progress toward improved AD clinical trials.

    Science.gov (United States)

    Weiner, Michael W; Veitch, Dallas P; Aisen, Paul S; Beckett, Laurel A; Cairns, Nigel J; Green, Robert C; Harvey, Danielle; Jack, Clifford R; Jagust, William; Morris, John C; Petersen, Ronald C; Saykin, Andrew J; Shaw, Leslie M; Toga, Arthur W; Trojanowski, John Q

    2017-04-01

    The Alzheimer's Disease Neuroimaging Initiative (ADNI) has continued development and standardization of methodologies for biomarkers and has provided an increased depth and breadth of data available to qualified researchers. This review summarizes the over 400 publications using ADNI data during 2014 and 2015. We used standard searches to find publications using ADNI data. (1) Structural and functional changes, including subtle changes to hippocampal shape and texture, atrophy in areas outside of hippocampus, and disruption to functional networks, are detectable in presymptomatic subjects before hippocampal atrophy; (2) In subjects with abnormal β-amyloid deposition (Aβ+), biomarkers become abnormal in the order predicted by the amyloid cascade hypothesis; (3) Cognitive decline is more closely linked to tau than Aβ deposition; (4) Cerebrovascular risk factors may interact with Aβ to increase white-matter (WM) abnormalities which may accelerate Alzheimer's disease (AD) progression in conjunction with tau abnormalities; (5) Different patterns of atrophy are associated with impairment of memory and executive function and may underlie psychiatric symptoms; (6) Structural, functional, and metabolic network connectivities are disrupted as AD progresses. Models of prion-like spreading of Aβ pathology along WM tracts predict known patterns of cortical Aβ deposition and declines in glucose metabolism; (7) New AD risk and protective gene loci have been identified using biologically informed approaches; (8) Cognitively normal and mild cognitive impairment (MCI) subjects are heterogeneous and include groups typified not only by "classic" AD pathology but also by normal biomarkers, accelerated decline, and suspected non-Alzheimer's pathology; (9) Selection of subjects at risk of imminent decline on the basis of one or more pathologies improves the power of clinical trials; (10) Sensitivity of cognitive outcome measures to early changes in cognition has been improved and

  4. Breastfeeding initiation at birth can help reduce health inequalities

    DEFF Research Database (Denmark)

    Robertson, Aileen

    2015-01-01

    The most socially isolated mothers may feel marginalised by our health services so that they feel excluded and not willing to seek support. They require different approaches to help them feel empowered and to increase their self-esteem. We have to learn how health services can better improve...

  5. "Razoo Health:" A Community-Based Nursing Education Initiative.

    Science.gov (United States)

    Kraus, Marjorie B.; Morgan, Connie M.; Matteson, Peggy S.

    2003-01-01

    In New Orleans, nursing faculty and students partnered with inner-city schools and churches to mobilize neighborhood assets and improve health care. Students learned community assessment skills and worked with empowered citizens who reclaimed their health resources. (Contains 28 references.) (SK)

  6. 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

  7. Reducing the risk of bias in health behaviour change trials: improving trial design, reporting or bias assessment criteria? A review and case study

    NARCIS (Netherlands)

    de Bruin, M.; McCambridge, J.; Prins, J.M.

    2015-01-01

    Objective: It has been suggested that randomised controlled trials (RCTs) of health behaviour change (HBC) interventions are less rigorously designed than - for example- drug trials. This study presents an approach to clarifying whether this is due to poor trial design, incomplete trial reporting

  8. Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach.

    Science.gov (United States)

    Cowan, James F; Micek, Mark; Cowan, Jessica F Greenberg; Napúa, Manuel; Hoek, Roxanne; Gimbel, Sarah; Gloyd, Stephen; Sherr, Kenneth; Pfeiffer, James T; Chapman, Rachel R

    2015-04-30

    Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy. This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care. This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care

  9. Early versus late initiation of rehabilitation after lumbar spinal fusion: economic evaluation alongside a randomized controlled trial

    DEFF Research Database (Denmark)

    Østergaard, Lisa G.; Christensen, Finn B.; Nielsen, Claus V.

    2013-01-01

    STUDY DESIGN: Economic evaluation conducted alongside a randomized controlled trial with 1-year follow-up. OBJECTIVE: To examine the cost-effectiveness of initiating rehabilitation 6 weeks after surgery as opposed to 12 weeks after surgery. SUMMARY OF BACKGROUND DATA: In a previously reported ran...

  10. Disease management strategy: initiative links pharmaceutical and mental health data.

    Science.gov (United States)

    Docherty, J P

    1996-02-01

    The emphasis in healthcare is shifting to practical applications of medical knowledge for the provision of more cost-effective care. This requires greater linkages among clinical information systems across multiple organizations. This article describes new initiatives in disease management to link the traditionally separate data systems fo pharmaceutical, behavioral and general medical care. The potential for improved patient care is highlighted. The author is an expert consultant for a large pharmaceutical manufacturer's disease state management initiative, and has an extensive leadership background in many segments of the behavioral healthcare industry.

  11. [The need of prenatal public health initiatives in Poland].

    Science.gov (United States)

    Jarosz, Mirosław J

    2012-11-01

    The author emphasizes the achievements of the Polish Gynecological Society in the field of improving the health indicators concerning perinatal mortality among infants during the last two decades in Poland. Attention is paid to the contribution of the members of the Society to organizational change in Polish health care after 1990, which resulted in the improvement of the care of mother and child. It is also underlined that the members of the Society contributed to the creation of early detection system of breast and cervical cancer in Poland. However it is noteworthy that in 'Polish Gynecology' - the publication of the Polish Gynecological Society - the number of reports devoted to risky health behaviors of women during periconceptional period and pregnancy is scarce. The author draws attention to the percentage of women who smoke cigarettes and consume alcohol before and during pregnancy Emphasis is also placed on the problem of nutritional disorders (mainly pathological methods of dieting) among Polish women during the reproductive period and in the first weeks of pregnancy (before the pregnancy is confirmed). These aspects may result in epigenetic changes shaping the phenotype of the offspring. The author refers to the Barker's theory of Developmental Origins of Adult Diseases and warns that the above-mentioned health behaviors of women may bring about negative effects for the offspring and future generations, namely susceptibility to chronic diseases: arterial hypertension, obesity type 2 diabetes and metabolic syndrome. Negative effects for the health of offspring may also result from low level of physical activity of women before and during pregnancy The author concludes that it is necessary to intensify the efforts of the Polish Gynecological Society in the area of prenatal public health.

  12. Health initiatives conducted outside hospitals and other medical settings

    DEFF Research Database (Denmark)

    Mik-Meyer, Nanna

    2016-01-01

    The aim of this essay is to critically reflect on the concept of health. ‘Health’ refers not only to the absence of biomedical diseases and bodily and mental dysfunctionalities; today, the concept is also synonymous with wellness, happiness, and a good life. However, this broad definition of what...... it means to be healthy nowadays produces a number of problems for citizens who struggle to meet the standards of this changed ideal of health. Consequently, unhealthy citizens, such as overweight individuals, possess not only a biomedically defined unhealthy body or mind; they are also, in a broader sense...

  13. Health initiatives conducted outside hospitals and other medical settings

    DEFF Research Database (Denmark)

    Mik-Meyer, Nanna

    2016-01-01

    The aim of this essay is to critically reflect on the concept of health. ‘Health’ refers not only to the absence of biomedical diseases and bodily and mental dysfunctionalities; today, the concept is also synonymous with wellness, happiness, and a good life. However, this broad definition of what...... it means to be healthy nowadays produces a number of problems for citizens who struggle to meet the standards of this changed ideal of health. Consequently, unhealthy citizens, such as overweight individuals, possess not only a biomedically defined unhealthy body or mind; they are also, in a broader sense...

  14. Association between Dietary Energy Density and Incident Type 2 Diabetes in the Women's Health Initiative.

    Science.gov (United States)

    Hingle, Melanie D; Wertheim, Betsy C; Neuhouser, Marian L; Tinker, Lesley F; Howard, Barbara V; Johnson, Karen; Liu, Simin; Phillips, Lawrence S; Qi, Lihong; Sarto, Gloria; Turner, Tami; Waring, Molly E; Thomson, Cynthia A

    2017-05-01

    Dietary energy density, or energy available in relation to gram intake, can inform disease risk. The objective of this study was to investigate the association between baseline dietary energy density and risk of incident type 2 diabetes in postmenopausal women. Dietary energy density, weight status, and type 2 diabetes incidence were prospectively characterized in a large cohort of postmenopausal women participating in one or more clinical trials or an observational study. The study involved 161,808 postmenopausal women recruited to the Women's Health Initiative observational study or clinical trials at 40 centers across the United States between 1993 and 1998. The primary outcome was incident type 2 diabetes. The association between dietary energy density quintiles and incident diabetes was tested using Cox proportional hazards regression. A total of 143,204 participants without self-reported diabetes at enrollment completed baseline dietary assessment and were followed for 12.7±4.6 years. Risk of diabetes developing was 24% greater for women in the highest dietary energy density quintile compared with the lowest after adjusting for confounders (95% CI 1.17 to 1.32). Body mass index (calculated as kg/m(2)) and waist circumference mediated the relationship between dietary energy density and diabetes. In waist circumference-stratified analysis, women in dietary energy density quintiles 2 to 5 with waist circumferences >88 cm were at 9% to 12% greater risk of diabetes developing compared with women with waist circumference ≤88 cm. In this prospective study, a higher baseline dietary energy density was associated with higher incidence of type 2 diabetes among postmenopausal women, both overall, and in women with elevated waist circumference. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  15. Impact of maternal and neonatal health initiatives on inequity in maternal health care utilization in Bangladesh.

    Science.gov (United States)

    Haider, Mohammad Rifat; Rahman, Mohammad Masudur; Moinuddin, Md; Rahman, Ahmed Ehsanur; Ahmed, Shakil; Khan, M Mahmud

    2017-01-01

    Despite remarkable progress in maternal and child health, inequity persists in maternal care utilization in Bangladesh. Government of Bangladesh (GOB) with technical assistance from United Nation Population Fund (UNFPA), United Nation Children's Fund (UNICEF) and World Health Organization (WHO) started implementing Maternal and Neonatal Health Initiatives in selected districts of Bangladesh (MNHIB) in 2007 with an aim to reduce inequity in healthcare utilization. This study examines the effect of MNHIB on inequity in maternal care utilization. Two surveys were carried out in four districts in Bangladesh- baseline in 2008 and end-line in 2013. The baseline survey collected data from 13,206 women giving birth in the preceding year and in end-line 7,177 women were interviewed. Inequity in maternal healthcare utilization was calculated pre and post-MNHIB using rich-to-poor ratio and concentration index. Mean age of respondents were 23.9 and 24.6 years in 2008 and 2013 respectively. Utilization of pregnancy-related care increased for all socioeconomic strata between these two surveys. The concentration indices (CI) for various maternal health service utilization in 2013 were found to be lower than the indices in 2008. However, in comparison to contemporary BDHS data in nearby districts, MNHIB was successful in reducing inequity in receiving ANC from a trained provider (CI: 0.337 and 0.272), institutional delivery (CI: 0.435 in 2008 to 0.362 in 2013), and delivery by skilled personnel (CI: 0.396 and 0.370). Overall use of maternal health care services increased in post-MNHIB year compared to pre-MNHIB year and inequity in maternal service utilization declined for three indicators out of six considered in the paper. The reductions in CI values for select maternal care indicators imply that the program has been successful not only in improving utilization of maternal health services but also in lowering inequality of service utilization across socioeconomic groups

  16. School-Based Health Promotion Initiative Increases Children's Physical Activity

    Science.gov (United States)

    Cluss, Patricia; Lorigan, Devin; Kinsky, Suzanne; Nikolajski, Cara; McDermott, Anne; Bhat, Kiran B.

    2016-01-01

    Background: Childhood obesity increases health risk, and modest physical activity can impact that risk. Schools have an opportunity to help children become more active. Purpose: This study implemented a program offering extra school-day activity opportunities in a rural school district where 37% of students were obese or overweight in 2005 and…

  17. Initiatives in the Romanian eHealth Landscape

    Directory of Open Access Journals (Sweden)

    Dan Andrei SITAR TAUT

    2011-01-01

    Full Text Available Even if the foundation in the field of eHealth was set almost half century ago, the current achievements’ status does not place Romania on a good position in a European ranking. The efforts made during the last years are promising, but they still cannot surpass the enormous gaps in many eHealth indicators. This is not a surprising fact because the eHealth level must be sustained by a healthy and stable sanitary system and infrastructure, which, in our country, is almost in collapse, especially now in the context of global economic and financial crisis. We consider being guilty for these circumstances the lack of a clear and solid mid-term strategy developed at the level of the Ministry of Health (MoH, harmonized in a global legal and regulatory framework as well, and also the non-correlated researcher groups interests. The good attitude of practitioners regarding the challenges of new technologies and the political will can still give a chance to the Romanian healthcare system and to its modern faces.

  18. A Cluster Randomized Controlled Trial of the MyFamilyPlan Online Preconception Health Education Tool.

    Science.gov (United States)

    Batra, Priya; Mangione, Carol M; Cheng, Eric; Steers, W Neil; Nguyen, Tina A; Bell, Douglas; Kuo, Alice A; Gregory, Kimberly D

    2017-01-01

    To evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits. Cluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome. Urban academic medical center (California). Eligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized. Intervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials. The primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score. Multilevel multivariate logistic regression. After adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected. MyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors.

  19. ‘teen Mental Health First Aid’: a description of the program and an initial evaluation

    OpenAIRE

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

    2016-01-01

    Background 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 trai...

  20. Field Trials of Health Interventions, 3rd edition

    OpenAIRE

    Smith, Peter G; Richard H. Morrow; David A Ross

    2015-01-01

    Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in “field trials”, which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial...

  1. Protocol for a randomised controlled trial of VAsopressin versus Noradrenaline as Initial therapy in Septic sHock (VANISH).

    Science.gov (United States)

    Gordon, Anthony C; Mason, Alexina J; Perkins, Gavin D; Ashby, Deborah; Brett, Stephen J

    2014-07-03

    Vasopressin is an alternative vasopressor in the management of septic shock. It spares catecholamine use but whether it improves outcome remains uncertain. Current evidence suggests that it may be most effective if used early and possibly in conjunction with corticosteroids. This trial will compare vasopressin to noradrenaline as initial vasopressor in the management of adult septic shock and investigate whether there is an interaction of vasopressin with corticosteroids. This is a multicentre, factorial (2×2), randomised, double-blind, placebo-controlled trial. 412 patients will be recruited from multiple UK intensive care units and randomised to receive vasopressin (0-0.06 U/min) or noradrenaline (0-12 µg/min) as a continuous intravenous infusion as initial vasopressor therapy. If maximum infusion rates of this first study drug are reached, the patient will be treated with either hydrocortisone (initially 50 mg intravenous bolus six-hourly) or placebo, before additional open-label catecholamine vasopressors are prescribed. The primary outcome of the trial will be the difference in renal failure-free days between treatment groups. Secondary outcomes include need for renal replacement therapy, survival rates, other organ failures and resource utilisation. The trial protocol and information sheets have received a favourable opinion from the Oxford A Research Ethics Committee (12/SC/0014). There is an independent Data Monitoring and Ethics Committee and independent membership of the Trial Steering Committee including patient and public involvement. The trial results will be published in peer-reviewed journals and presented at national and international scientific meetings. ISRCTN 20769191 and EudraCT 2011-005363-24. 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.

  2. Mobilized dental pulp stem cells for pulp regeneration: initiation of clinical trial.

    Science.gov (United States)

    Nakashima, Misako; Iohara, Koichiro

    2014-04-01

    Stem cell therapy is a potential strategy to regenerate the dentin-pulp complex, enabling the conservation and restoration of functional teeth. We assessed the efficacy and safety of pulp stem cell transplantation as a prelude before the initiation of clinical trials. Granulocyte-colony stimulating factor (G-CSF) induces subsets of dental pulp stem cells to form mobilized dental pulp stem cells (MDPSCs). Good manufacturing practice is a prerequisite for the isolation and expansion of MDPSCs that are enriched in stem cells, expressing a high level of trophic factors with properties of high proliferation, migration, and antiapoptotic effects and endowed with regenerative potential. The quality of clinical-grade MDPSCs was assured by the absence of abnormalities/aberrations in karyotype and the lack of tumor formation after transplantation in immunodeficient mice. Autologous transplantation of MDPSCs with G-CSF in pulpectomized teeth in dogs augmented the regeneration of pulp tissue. The combinatorial trophic effects of MDPSCs and G-CSF on cell migration, antiapoptosis, immunosuppression, and neurite outgrowth were also confirmed in vitro. Furthermore, MDPSCs from the aged donors were as potent as the young donors. It is noteworthy that there were no significant age-related changes in biological properties such as stability, regenerative potential, and expression of the senescence markers in MDPSCs. On the other hand, autologous transplantation of MDPSCs with G-CSF induced less regenerated pulp tissue in the aged dogs compared with the young dogs. In conclusion, the preclinical safety, feasibility, and efficacy of pulp regeneration by MDPSCs and G-CSF were established. Therefore, the standardization and establishment of regulatory guidelines for stem cell therapy in clinical endodontics is now a reality. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial.

    Science.gov (United States)

    Rattray, Carole; Wiener, Jeffrey; Legardy-Williams, Jennifer; Costenbader, Elizabeth; Pazol, Karen; Medley-Singh, Natalie; Snead, Margaret C; Steiner, Markus J; Jamieson, Denise J; Warner, Lee; Gallo, Maria F; Hylton-Kong, Tina; Kourtis, Athena P

    2015-12-01

    To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)]. We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use. At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9-1.9; 3-month: 25.6% vs. 23.1%, PR= 1.1, 95% CI=0.8-1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of .15). Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant. Published by Elsevier Inc.

  4. 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.

    Science.gov (United States)

    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

  5. Characteristics and outcomes of initial virologic suppressors during analytic treatment interruption in a therapeutic HIV-1 gag vaccine trial.

    Directory of Open Access Journals (Sweden)

    Jonathan Z Li

    Full Text Available BACKGROUND: In the placebo-controlled trial ACTG A5197, a trend favoring viral suppression was seen in the HIV-1-infected subjects who received a recombinant Ad5 HIV-1 gag vaccine. OBJECTIVE: To identify individuals with initial viral suppression (plasma HIV-1 RNA set point <3.0 log(10 copies/ml during the analytic treatment interruption (ATI and evaluate the durability and correlates of virologic control and characteristics of HIV sequence evolution. METHODS: HIV-1 gag and pol RNA were amplified and sequenced from plasma obtained during the ATI. Immune responses were measured by flow cytometric analysis and intracellular cytokine expression assays. Characteristics of those with and without initial viral suppression were compared using the Wilcoxon rank sum and Fisher's exact tests. RESULTS: Eleven out of 104 participants (10.6% were classified as initial virologic suppressors, nine of whom had received the vaccine. Initial virologic suppressors had significantly less CD4+ cell decline by ATI week 16 as compared to non-suppressors (median 7 CD4+ cell gain vs. 247 CD4+ cell loss, P = 0.04. However, of the ten initial virologic suppressors with a pVL at ATI week 49, only three maintained pVL <3.0 log(10 copies/ml. HIV-1 Gag-specific CD4+ interferon-γ responses were not associated with initial virologic suppression and no evidence of vaccine-driven HIV sequence evolution was detected. Participants with initial virologic suppression were found to have a lower percentage of CD4+ CTLA-4+ cells prior to treatment interruption, but a greater proportion of HIV-1 Gag-reactive CD4+ TNF-α+ cells expressing either CTLA-4 or PD-1. CONCLUSIONS: Among individuals participating in a rAd5 therapeutic HIV-1 gag vaccine trial, initial viral suppression was found in a subset of patients, but this response was not sustained. The association between CTLA-4 and PD-1 expression on CD4+ T cells and virologic outcome warrants further study in trials of other

  6. 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...

  7. 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...

  8. Interactive Environments: Opportunities for Social Innovation and Public Health Initiatives

    Directory of Open Access Journals (Sweden)

    Predrag K. Nikolic

    2016-05-01

    Full Text Available How to keep people in a “good health”, longer and healthier life is more than just a phrase listed in a sustainable strategies it became crucial issue for any future social innovation initiative and community needs. New technologies and its application in everyday living surrounding are affecting a way we are interacting between each other and with services around us. As a result, we are facing huge psychological and cultural shift in human behavior and raising of new social practices. We are in need of using new approaches and models in order to provoke human behavior change which is more than ever depending on content and context users can reach in interactive environments they are approaching through their devices or in a physical space. New powerful playground for social innovations is born.

  9. [A framework for evaluating ethical issues of public health initiatives: practical aspects and theoretical implications].

    Science.gov (United States)

    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.

  10. Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.

    Science.gov (United States)

    Sampson, Mario R; Benjamin, Daniel K; Cohen-Wolkowiez, Michael

    2012-09-01

    Clinical trials in children are challenging and filled with important ethical considerations that differ from adults. Given difficulties associated with pediatric clinical trials, off-label prescribing is a common practice in pediatrics, which can lead to adverse safety events and efficacy failures. To overcome these consequences, in the past 15 years, legislation in the USA and Europe has provided incentives to industry and increased government funding to conduct pediatric trials. Pediatric trial networks have also been formed to decrease the knowledge gap. However, challenges to performing pediatric trials and lack of standardization and guidelines regarding studies in children still exist. Standards for Research (StaR) in Child Health, begun in 2009, aims to improve the design, conduct and reporting of pediatric trials. This organization uses a consensus guideline approach involving academic, government and industry stakeholders to identify and disseminate best practices for pediatric trials. Six out of 11 planned standards are currently published.

  11. 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

  12. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    Science.gov (United States)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  13. Why prudence is needed when interpreting articles reporting clinical trial results in mental health.

    Science.gov (United States)

    Dal-Ré, Rafael; Bobes, Julio; Cuijpers, Pim

    2017-03-28

    Clinical trial results' reliability is impacted by reporting bias. This is primarily manifested as publication bias and outcome reporting bias. Mental health trials are prone to two methodological deficiencies: (1) using small numbers of participants that facilitates false positive findings and exaggerated size effects, and (2) the obligatory use of psychometric scales that require subjective assessments. These two deficiencies contribute to the publication of unreliable results. Considerable reporting bias has been found in safety and efficacy findings in psychotherapy and pharmacotherapy trials. Reporting bias can be carried forward to meta-analyses, a key source for clinical practice guidelines. The final result is the frequent overestimation of treatment effects that could impact patients and clinician-informed decisions. Prospective registration of trials and publication of results are the two major methods to reduce reporting bias. Prospective trial registration will allow checking whether they are published (so it will help to prevent publication bias) and, if published, whether those outcomes and analyses that were deemed as appropriate before trial commencement are actually published (hence helping to find out selective reporting of outcomes). Unfortunately, the rate of registered trials in mental health interventions is low and, frequently, of poor quality. Clinicians should be prudent when interpreting the results of published trials and some meta-analyses - such as those conducted by scientists working for the sponsor company or those that only include published trials. Prescribers, however, should be confident when prescribing drugs following the summary of product characteristics, since regulatory agencies have access to all clinical trial results.

  14. Community health and medical provision: impact on neonates (the CHAMPION trial

    Directory of Open Access Journals (Sweden)

    Frost Chris

    2007-07-01

    Full Text Available Abstract Background The trial aims to evaluate whether neonatal mortality can be reduced through systemic changes to the provision and promotion of healthcare. Neonatal mortality rates in India are high compared to other low income countries, and there is a wide variation of rates across regions. There is evidence that relatively inexpensive interventions may be able to prevent up to 75% of these deaths. One area with a particularly high rate is Mahabubnagar District in Andhra Pradesh, where neonatal mortality is estimated to be in the region of 4–9%. The area suffers from a vicious cycle of both poor supply of and small demand for health care services. The trial will assess whether a package of interventions to facilitate systemic changes to the provision and promotion of healthcare may be able to substantially reduce neonatal mortality in this area and be cost-effective. If successful, the trial is designed so that it should be possible to substantially scale up the project in regions with similarly high neonatal mortality throughout Andhra Pradesh and elsewhere. Methods/Design This trial will be a cluster-randomised controlled trial involving 464 villages in Mahabubnagar District. The package of interventions will first be introduced in half of the villages with the others serving as controls. The trial will run for a period of three years. The intervention in the trial has two key elements: a community health promotion campaign and a system to contract out healthcare to non-public institutions. The health promotion campaign will include a health education campaign, participatory discussion groups, training of village health workers and midwives, and improved coordination of antenatal services. The intervention group will also have subsidised access to pregnancy-related healthcare services at non-public lth centres (NPHCs. The primary outcome of the trial will be neonatal mortality. Secondary outcomes will include age at and cause of

  15. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  16. Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial.

    Science.gov (United States)

    Mendelow, A David; Gregson, Barbara A; Rowan, Elise N; Francis, Richard; McColl, Elaine; McNamee, Paul; Chambers, Iain R; Unterberg, Andreas; Boyers, Dwayne; Mitchell, Patrick M

    2015-09-01

    Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, -4.4-25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.

  17. [Public Health initiative for improved vaccination for asylum seekers].

    Science.gov (United States)

    Brockmann, Stefan O; Wjst, Stephanie; Zelmer, Ursula; Carollo, Stefanie; Schmid, Mirjam; Roller, Gottfried; Eichner, Martin

    2016-05-01

    The number of asylum seekers in Germany has increased dramatically in 2015. Their medical care includes the officially recommended vaccinations; yet, no detailed information on this is yet available in Germany. In light of the rising number of asylum seekers, we have developed a concept to facilitate their vaccination. This concept includes the coordination of different partners, the supply of vaccines and other materials through the local health office, and the cooperation with the local physicians' association. To evaluate and accelerate progress, we compared the number of vaccinations conducted by physicians independently of the vaccination concept with those conducted within the new concept. For the period of investigation, 2,256 new asylum seekers were temporarily accommodated in the facilities. The vaccination concept was applied in only some of the facilities. Twenty-eight percent of all asylum seekers (642) were vaccinated at least once; 89 % of the vaccinees (571) were vaccinated within the newly developed concept. In the facilities that were not included in this concept, only 6 % of the refugees were vaccinated, whereas in the facilities that were included up to 58 % were vaccinated. Even though the new concept has started successfully, further innovations are required to reach sufficient vaccination coverage among asylum seekers. In view of the large number of new asylum seekers expected, the adjustment and expansion of the new concept requires professional planning and coordination. Furthermore, additional resources are required.

  18. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial.

    Science.gov (United States)

    Ohel, Gonen; Gonen, Roni; Vaida, Sonia; Barak, Shlomi; Gaitini, Luis

    2006-03-01

    To determine whether early initiation of epidural analgesia in nulliparous women affects the rate of cesarean sections and other obstetric outcome measures. A randomized trial in which 449 at term nulliparous women in early labor, at less than 3 cm of cervical dilatation, were assigned to either immediate initiation of epidural analgesia at first request (221 women), or delay of epidural until the cervix dilated to at least 4 cm (228 women). At initiation of the epidural the mean cervical dilatation was 2.4 cm in the early epidural group and 4.6 cm in the late group (P labor, the women indicated a preference for early epidural. Initiation of epidural analgesia in early labor, following the first request for epidural, did not result in increased cesarean deliveries, instrumental vaginal deliveries, and other adverse effects; furthermore, it was associated with shorter duration of the first stage of labor and was clearly preferred by the women.

  19. Teeth Tales: a community-based child oral health promotion trial with migrant families in Australia

    OpenAIRE

    Gibbs, L.; Waters, E; Christian, B.; Gold, L.; Young, D.; Silva, A; Calache, H.; Gussy, M.; Watt, R.; Riggs, E; Tadic, M.; Hall, M.; Gondal, I.; Pradel, V.; Moore, L.

    2015-01-01

    Objectives The Teeth Tales trial aimed to establish a model for child oral health promotion for culturally diverse communities in Australia. Design An exploratory trial implementing a community-based child oral health promotion intervention for Australian families from migrant backgrounds. Mixed method, longitudinal evaluation. Setting The intervention was based in Moreland, a culturally diverse locality in Melbourne, Australia. Participants Families with 1–4-year-old children, self-identifie...

  20. 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.

  1. The effect of family policies and public health initiatives on breastfeeding initiation among 18 high-income countries: a qualitative comparative analysis research design

    National Research Council Canada - National Science Library

    Amanda Marie Lubold

    2017-01-01

    Background The objective of this study is to examine the effects of macro-level factors - welfare state policies and public health initiatives - on breastfeeding initiation among eighteen high-income countries...

  2. 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

  3. 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...

  4. Initiation of health-behaviour change among employees participating in a web-based health risk assessment with tailored feedback

    Directory of Open Access Journals (Sweden)

    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

  5. The Ghana community-based health planning and services initiative for scaling up service delivery innovation.

    Science.gov (United States)

    Nyonator, Frank K; Awoonor-Williams, J Koku; Phillips, James F; Jones, Tanya C; Miller, Robert A

    2005-01-01

    Research projects demonstrating ways to improve health services often fail to have an impact on what national health programmes actually do. An approach to evidence-based policy development has been launched in Ghana which bridges the gap between research and programme implementation. After nearly two decades of national debate and investigation into appropriate strategies for service delivery at the periphery, the Community-based Health Planning and Services (CHPS) Initiative has employed strategies tested in the successful Navrongo experiment to guide national health reforms that mobilize volunteerism, resources and cultural institutions for supporting community-based primary health care. Over a 2-year period, 104 out of the 110 districts in Ghana started CHPS. This paper reviews the development of the CHPS initiative, describes the processes of implementation and relates the initiative to the principles of scaling up organizational change which it embraces. Evidence from the national monitoring and evaluation programme provides insights into CHPS' success and identifies constraints on future progress.

  6. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.

    Directory of Open Access Journals (Sweden)

    Serena P Koenig

    2017-07-01

    Full Text Available Attrition during the period from HIV testing to antiretroviral therapy (ART initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.We conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic infections (GHESKIO Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1 to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44% participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52% had <1,000 copies/ml; 20 participants (6% died. In the same-day ART group, 184 (53% participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61% had <1,000 copies/ml; 10 (3% participants died. The unadjusted risk ratio (RR of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015 for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p

  7. In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study

    Science.gov (United States)

    Badano, Aldo; Badal, Andreu; Glick, Stephen; Graff, Christian G.; Samuelson, Frank; Sharma, Diksha; Zeng, Rongping

    2017-03-01

    Expensive and lengthy clinical trials can delay regulatory evaluation and add significant burden that stifles innovation affecting patient access to novel, high-quality imaging technologies. In silico imaging holds promise for evaluating the safety and effectiveness of imaging technologies with much less burden than clinical trials. We define in silico imaging as a computer simulation of an entire imaging system (including source, object, task, and observer components) used for research, development, optimization, technology assessment, and regulatory evaluation of new technology. In this work we describe VICTRE (our study of virtual imaging clinical trials for regulatory evaluation) and the considerations for building an entire imaging pipeline in silico including device (physics), patient (anatomy, disease), and image interpretation models for regulatory evaluation using open-source tools.

  8. A cluster randomised controlled trial and process evaluation of a training programme for mental health professionals to enhance user involvement in care planning in service users with severe mental health issues (EQUIP): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bower, Peter; Roberts, Chris; O'Leary, Neil; Callaghan, Patrick; Bee, Penny; Fraser, Claire; Gibbons, Chris; Olleveant, Nicola; Rogers, Anne; Davies, Linda; Drake, Richard; Sanders, Caroline; Meade, Oonagh; Grundy, Andrew; Walker, Lauren; Cree, Lindsey; Berzins, Kathryn; Brooks, Helen; Beatty, Susan; Cahoon, Patrick; Rolfe, Anita; Lovell, Karina

    2015-08-13

    Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their own care, there is substantial empirical evidence that the majority of users are not fully involved in the care planning process. Our aim is to evaluate the effectiveness and cost-effectiveness of training for mental health professionals in improving user involvement with the care planning processes. This is a cluster randomised controlled trial of community mental health teams in NHS Trusts in England allocated either to a training intervention to improve user and carer involvement in care planning or control (no training and care planning as usual). We will evaluate the effectiveness of the training intervention using a mixed design, including a 'cluster cohort' sample, a 'cluster cross-sectional' sample and process evaluation. Service users will be recruited from the caseloads of care co-ordinators. The primary outcome will be change in self-reported involvement in care planning as measured by the validated Health Care Climate Questionnaire. Secondary outcomes include involvement in care planning, satisfaction with services, medication side-effects, recovery and hope, mental health symptoms, alliance/engagement, well-being and quality of life. Cost- effectiveness will also be measured. A process evaluation informed by implementation theory will be undertaken to assess the extent to which the training was implemented and to gauge sustainability beyond the time-frame of the trial. It is hoped that the trial will generate data to inform mental health care policy and practice on care planning. ISRCTN16488358 (14 May 2014).

  9. A digital intake approach in specialized mental health care: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    Metz, Margot J; Elfeddali, Iman; Krol, David G H; Veerbeek, Marjolein A; de Beurs, Edwin; Beekman, Aartjan T F; van der Feltz-Cornelis, Christina M

    2017-03-07

    Enhancing patient participation is becoming increasingly important in mental health care as patients use to have a dependent, inactive role and nonadherence to treatment is a regular problem. Research shows promising results of initiatives stimulating patient participation in partnership with their clinicians. However, few initiatives targeting both patients' and clinicians' behaviour have been evaluated in randomised trials (RCT). Therefore, in GGz Breburg, a specialized mental health institution, a digital intake approach was developed aimed at exploring treatment needs, expectations and preferences of patients intended to prepare patients for the intake consultations. Subsequently, patients and clinicians discuss this information during intake consultations and make shared decisions about options in treatment. The aim of this trial is to test the efficacy of this new digital intake approach facilitated by Routine Outcome Monitoring (ROM), peer support and training of clinicians as compared to the intake as usual. The primary outcome is decisional conflict about choices in treatment. Secondary outcomes focus on patient participation, shared decision making, working alliance, adherence to treatment and clinical outcomes. This article presents the study protocol of a cluster-randomised controlled trial in four outpatient departments for adults with depression, anxiety and personality disorders, working in two different regions. Randomisation is done between two similar intake-teams within each department. In the four intervention teams the new intake approach is implemented. The four control teams apply the intake as usual and will implement the new approach after the completion of the study. In total 176 patients are projected to participate in the study. Data collection will be at baseline, and at two weeks and two months after the intake. This study will potentially demonstrate the efficacy of the new digital intake approach in mental health care in terms of the

  10. Social determinants of health in Canada: Are healthy living initiatives there yet? A policy analysis

    Directory of Open Access Journals (Sweden)

    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

  11. The Delaware Geography-Health Initiative: Lessons Learned in Designing a GIS-Based Curriculum

    Science.gov (United States)

    Rees, Peter W.; Silberman, Jordan A.

    2010-01-01

    The Delaware Geography-Health Initiative is a Web- and GIS-based set of lesson units for teaching geographic concepts and research methods within the context of the state's high school geography standards. Each unit follows a research-based, inquiry-centered model addressing questions of health because of Delaware's high incidence of cancer,…

  12. The Delaware Geography-Health Initiative: Lessons Learned in Designing a GIS-Based Curriculum

    Science.gov (United States)

    Rees, Peter W.; Silberman, Jordan A.

    2010-01-01

    The Delaware Geography-Health Initiative is a Web- and GIS-based set of lesson units for teaching geographic concepts and research methods within the context of the state's high school geography standards. Each unit follows a research-based, inquiry-centered model addressing questions of health because of Delaware's high incidence of cancer,…

  13. Initial benzodiazepine use and improved health-related quality of life.

    NARCIS (Netherlands)

    van Hulten, Rolf; Teeuw, Bart; Bakker, Albert; Leufkens, Hubert G

    2005-01-01

    OBJECTIVE: The health-related quality of life (HRQOL) of initial benzodiazepine users was measured over time. Furthermore, benzodiazepine usage characteristics as determinants of change in mental and physical health status of the benzodiazepine users were examined. METHODS: In the only pharmacy of a

  14. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    Science.gov (United States)

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  15. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management : a randomized trial

    NARCIS (Netherlands)

    Graziosi, GCM; Mol, BWJ; Reuwer, PJH; Drogtrop, A; Bruinse, HW

    2004-01-01

    BACKGROUND: Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject. METHODS: Women with early pregnancy failure, who had been managed expectantly for at least

  16. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    Science.gov (United States)

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  17. 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....

  18. Incorporating Preliminary Mental Health Assessment in the Initial Healthcare for Refugees in New Jersey.

    Science.gov (United States)

    Al-Obaidi, AbdulKareem; West, Bernadette; Fox, Anne; Savin, Daniel

    2015-07-01

    The study aims to assess the feasibility of introducing a mental health screening tool into the initial health care assessment for refugees in New Jersey, US. A semi-structured interview was conducted with a convenience sample of professionals providing refugee health care in New Jersey and in a number of other states. There is a widespread appreciation of the need to consider the mental and emotional issues of the refugees as a priority in healthcare services. A mental health screening tool is required for practice in NJ. Community resources should be coupled with early screening for better refugee mental health outcomes.

  19. Analysis of Developing Public Health Service Sector with Private Finance Initiative in Guangxi

    Institute of Scientific and Technical Information of China (English)

    王宇

    2006-01-01

    In Guangxi Public Health Service Sector (GPHSS), because lack of budget, it has caused a number of problems, such as weakened public health service in rural areas, poor professional quality of medical personnel in public health units at village and township levels, current urban public health service could not meet the health demand for urban residents. This paper is a secondary research. Through analysis of the financial problem and both of the advantages and disadvantages of using the Private Finance Initiative (PFI), it intend to demonstrate that using the PFI could be considered as a good way for the Guangxi government.

  20. Age at Time of Initial Sexual Intercourse and Health of Adolescent Girls.

    Science.gov (United States)

    Lara, Lúcia A S; Abdo, Carmita H N

    2016-10-01

    Adolescence is characterized by marked changes in the body, psychology, and sexual behavior due to increasing production of hormones. In this review we aimed to assess the effect of age at the time of first sexual intercourse (sexarche) on the health of adolescent girls, and identify factors that might protect against early initiation of sexual relations in girls. The PubMed, Lilacs, and Google Scholar databases were searched for clinical trials, comparative studies, case-control studies, cross-sectional studies, cohort studies, multicenter studies, observational studies, meta-analyses, and systematic reviews published up to December 2014 on this theme. The search terms were: "sexual debut," "coitarche," "sexarche," and "young people," "adolescent," "unplanned pregnancy," "adolescent contraception," and "STDs." Data were extracted from 28 studies and 41 references were used to introduce the theme and to support the discussion. Sexarche has been occurring in increasingly younger girls. A young age at sexarche can lead to subsequent risky sexual behavior. Girls who have sexarche when they are 14 years old or younger are less likely to use contraception on this occasion, take more time before they start using contraception in subsequent sexual relations, are more likely to have several sex partners, have a higher risk for depression, have lower self-esteem and more episodes of repentance, and have a higher risk for a sexually transmitted disease and cervical cancer. Girls with low educational, socioeconomic, and cultural status, little parental monitoring, parental separation, and absence of religiosity tend to experience sexarche at a younger age. Adolescent girls who postpone sexarche until they are 16 years old are physically and psychologically healthier than those who have sexarche at a younger age. This suggests that providing adolescent girls with appropriate education about sexual relations might reduce the negative effect of sexual relations at a young age.

  1. High glycemic index diet as a risk factor for depression: analyses from the Women's Health Initiative.

    Science.gov (United States)

    Gangwisch, James E; Hale, Lauren; Garcia, Lorena; Malaspina, Dolores; Opler, Mark G; Payne, Martha E; Rossom, Rebecca C; Lane, Dorothy

    2015-08-01

    The consumption of sweetened beverages, refined foods, and pastries has been shown to be associated with an increased risk of depression in longitudinal studies. However, any influence that refined carbohydrates has on mood could be commensurate with their proportion in the overall diet; studies are therefore needed that measure overall intakes of carbohydrate and sugar, glycemic index (GI), and glycemic load. We hypothesized that higher dietary GI and glycemic load would be associated with greater odds of the prevalence and incidence of depression. This was a prospective cohort study to investigate the relations between dietary GI, glycemic load, and other carbohydrate measures (added sugars, total sugars, glucose, sucrose, lactose, fructose, starch, carbohydrate) and depression in postmenopausal women who participated in the Women's Health Initiative Observational Study at baseline between 1994 and 1998 (n = 87,618) and at the 3-y follow-up (n = 69,954). We found a progressively higher dietary GI to be associated with increasing odds of incident depression in fully adjusted models (OR for the fifth compared with first quintile: 1.22; 95% CI: 1.09, 1.37), with the trend being statistically significant (P = 0.0032). Progressively higher consumption of dietary added sugars was also associated with increasing odds of incident depression (OR for the fifth compared with first quintile: 1.23; 95% CI: 1.07, 1.41; P-trend = 0.0029). Higher consumption of lactose, fiber, nonjuice fruit, and vegetables was significantly associated with lower odds of incident depression, and nonwhole/refined grain consumption was associated with increased odds of depression. The results from this study suggest that high-GI diets could be a risk factor for depression in postmenopausal women. Randomized trials should be undertaken to examine the question of whether diets rich in low-GI foods could serve as treatments and primary preventive measures for depression in postmenopausal women.

  2. Health research ethics in malaria vector trials in Africa.

    Science.gov (United States)

    Kilama, Wen L

    2010-12-13

    Malaria mosquito research in Africa as elsewhere is just over a century old. Early trials for development of mosquito control tools were driven by colonial enterprises and war efforts; they were, therefore, tested in military or colonial settings. The failure of those tools and environmental concerns, coupled with the desperate need for integrated malaria control strategies, has necessitated the development of new malaria mosquito control tools, which are to be tested on humans, their environment and mosquito habitats. Ethical concerns start with phase 2 trials, which pose limited ethical dilemmas. Phase 3 trials, which are undertaken on vulnerable civilian populations, pose ethical dilemmas ranging from individual to community concerns. It is argued that such trials must abide by established ethical principles especially safety, which is mainly enshrined in the principle of non-maleficence. As there is total lack of experience with many of the promising candidate tools (eg genetically modified mosquitoes, entomopathogenic fungi, and biocontrol agents), great caution must be exercised before they are introduced in the field. Since malaria vector trials, especially phase 3 are intrusive and in large populations, individual and community respect is mandatory, and must give great priority to community engagement. It is concluded that new tools must be safe, beneficial, efficacious, effective, and acceptable to large populations in the short and long-term, and that research benefits should be equitably distributed to all who bear the brunt of the research burdens. It is further concluded that individual and institutional capacity strengthening should be provided, in order to undertake essential research, carry out scientific and ethical review, and establish competent regulatory frameworks.

  3. A RIGHT DIRECTION OF e-CLINICAL TRIALS IN HEALTH INDUSTRY THROUGH IT

    Directory of Open Access Journals (Sweden)

    Gupta Sumeet

    2010-08-01

    Full Text Available Objective: Clinical trial is an inextricable link between advances in medical research technology and improved health care. It is a component of medical health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness and promoting health, the present study investigated the facts of clinical trials and to highlight the features of e-clinical trials through information technology system. Methodology: The study has been carried out using secondary data from different sources which includes official website of the clinical trial gov and ublished articles. Results: Challenges encountered by the harmaceutical industry in the research and development of clinical trial process include design of clinical trial, lack of pidemiological data in specific time, problems in assessing clinicalrelevance and cost-effectiveness, lack of knowledge and training, and high prices. Conclusion: This paper puts forward certain suggestion in order to strengthen the e-clinical trials. Under the eclinicaltrial process the pharmaceutical industry has to achieve a great success in development of clinical data in the patients of various diseases and has brought them a great relief.

  4. A RIGHT DIRECTION OF e-CLINICAL TRIALS IN HEALTH INDUSTRY THROUGH IT

    Directory of Open Access Journals (Sweden)

    Gupta Sumeet,

    2010-10-01

    Full Text Available Objective: Clinical trial is an inextricable link between advances in medical research technology and improved health care. It is a component of medical health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness and promoting health, the present study investigated the facts of clinical trials and to highlight the features of e-clinical trials through information technology system. Methodology: The study has been carried out using secondary data from different sources which includes official website of the clinical trial gov and published articles. Results: Challenges encountered by the pharmaceutical industry in the research and development of clinical trial process include design of clinical trial, lack of pidemiological data in specific time, problems in assessing clinicalrelevance and cost-effectiveness, lack of knowledge and training, and high prices. Conclusion: This paper puts forward certain suggestion in order to strengthen the e-clinical trials. Under the eclinicaltrial process the pharmaceutical industry has to achieve a great success in development of clinical data in the patients of various diseases and has brought them a great relief.

  5. A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

    Science.gov (United States)

    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…

  6. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  7. Initiation of home mechanical ventilation at home: A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A.; Kerstjens, H.A.M.; Prins, S.C.L.; Vermeulen, K.M.; Wijkstra, P.J.

    2014-01-01

    Introduction Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  8. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-01-01

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-in

  9. Cost effectiveness of arthrocentesis as initial treatment for temporomandibular joint arthralgia: A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L.M.; Stant, A.D.; Quik, E.H.; Huddleston Slater, J.J.R.; Stegenga, B.

    2013-01-01

    Objective: To determine the cost effectiveness of arthrocentesis as initial treatment compared to care as usual (CAU) for temporomandibular joint (TMJ) arthralgia. Materials and methods: 80 patients were randomly allocated to arthrocentesis as initial treatment (n = 40) or CAU (n = 40). Arthrocentes

  10. 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.

  11. The Genesis, Implementation and Impact of the Better Access Mental Health Initiative Introducing Medicare-Funded Psychology Services

    Science.gov (United States)

    Littlefield, Lyn; Giese, Jill

    2008-01-01

    The Australian Government's Better Access to Mental Health Care initiative introduced mental health reforms that included the availability of Medicare-funded psychology services. The mental health initiative has resulted in a huge uptake of these services, demonstrating the strong community demand for psychological treatment. The initiative has…

  12. International Society of Nephrology-Hydration and Kidney Health Initiative - Expanding Research and Knowledge.

    Science.gov (United States)

    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.

  13. A survey of local health promotion initiatives for older people in Wales

    Directory of Open Access Journals (Sweden)

    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

  14. [The initial trial of the clinical use of FK-1 glue in surgical interventions].

    Science.gov (United States)

    Abzhueva, O V; Rusanov, V M; Zhidkov, I L

    2000-01-01

    The article presents results of a comparative clinical trial of the preparation "fibrinous glue" (FK-1) and "Beriplast" in operations on the lungs for hermetization of the wound and the lung as well as in reconstructive plastic gynecological operations. Intraoperative hermetization in operations on the lungs was obtained in 67% of the cases when using "FK-1" and in 64% with "Beriplast". In all the cases the lung was spread during 12 hours after operation. The visual intraoperative assessment of using "FK-1" and control laparoscopy on the 4th-5th days after operation showed its good effect in gynecological procedures. Clinical trials of the new domestic fibrinous glue "FK-1" in surgical and gynecological clinics confirmed its high medical effectiveness.

  15. 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

  16. Development and initial validation of the Therapeutic Misunderstanding Scale for use with clinical trials research participants.

    Science.gov (United States)

    Chou, Pak Hei Benedito; O'Rourke, Norm

    2012-01-01

    Therapeutic misconception is evident when clinical trials participants conflate research and treatment, erroneously believing that every aspect of the research is intended to be for their direct benefit. We developed the 20-item Therapeutic Misunderstanding Scale (TMU) based on responses from 464 community-dwelling adults 50+ years of age (Study 1). A three-factor solution based on Horng and Grady's (2003) three-facets definition was identified using both exploratory and confirmatory factor analyses (EFA and CFA; these analyses were performed on separate samples). CFA results point to a second-order solution where each of Horng and Grady's three facets contribute significantly to the measurement of a higher-order therapeutic misunderstanding latent construct. Internal consistency of TMU responses (full scale) as well as the therapeutic misconception, misestimation, and optimism subscales were calculated as α = 0.88, α = 0.83, α = 0.79, and α = 0.75, respectively. These results were subsequently supported with responses from former clinical trials participants (Study 2). This TMU provides applied researchers a brief measure for use in future studies as well as a screening instrument for clinicians to more fully assess informed consent for participation in clinical trials research.

  17. Interactions between Global Health Initiatives and country health systems: the case of a neglected tropical diseases control program in Mali.

    Science.gov (United States)

    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

  18. Vegetarian diets in the Adventist Health Study 2: a review of initial published findings.

    Science.gov (United States)

    Orlich, Michael J; Fraser, Gary E

    2014-07-01

    The Adventist Health Study 2 is a large cohort that is well suited to the study of the relation of vegetarian dietary patterns to health and disease risk. Here we review initial published findings with regard to vegetarian diets and several health outcomes. Vegetarian dietary patterns were associated with lower body mass index, lower prevalence and incidence of diabetes mellitus, lower prevalence of the metabolic syndrome and its component factors, lower prevalence of hypertension, lower all-cause mortality, and in some instances, lower risk of cancer. Findings with regard to factors related to vegetarian diets and bone health are also reviewed. These initial results show important links between vegetarian dietary patterns and improved health. © 2014 American Society for Nutrition.

  19. Vegetarian diets in the Adventist Health Study 2: a review of initial published findings1234

    Science.gov (United States)

    Orlich, Michael J; Fraser, Gary E

    2014-01-01

    The Adventist Health Study 2 is a large cohort that is well suited to the study of the relation of vegetarian dietary patterns to health and disease risk. Here we review initial published findings with regard to vegetarian diets and several health outcomes. Vegetarian dietary patterns were associated with lower body mass index, lower prevalence and incidence of diabetes mellitus, lower prevalence of the metabolic syndrome and its component factors, lower prevalence of hypertension, lower all-cause mortality, and in some instances, lower risk of cancer. Findings with regard to factors related to vegetarian diets and bone health are also reviewed. These initial results show important links between vegetarian dietary patterns and improved health. PMID:24898223

  20. Nurse-initiated telephone follow-ups of patients with chronic obstructive pulmonary disease do not reduce readmission rates but support disease management: A randomised controlled trial

    DEFF Research Database (Denmark)

    Karlsson, Marie Lavesen; Ladelund, Steen; Just, Addie

    2016-01-01

    of disease management were completed. Readmission and death were recorded on days 30 and 84. Results: There was no significant difference in readmission rates, but significant differences in patients’ assessment of own perception of managing dyspnoea, lung symptoms, ability to react to signs of exacerbation......Introduction: Readmissions reduce quality of life and increase mortality. Furthermore, disease severity and shortened length of stay make it difficult to support disease management during admission. The aim of this study was to explore whether telephone follow-up after discharge may reduce...... readmission rates, lower mortality and improve disease management in patients with chronic obstructive pulmonary disease (COPD). 
Methods: This was a randomised controlled trial (n = 224) with nurse-initiated telephone intervention after discharge. On day 30, questionnaires about health status and perceptions...

  1. 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

  2. Where theory and practice of global health intersect: the developmental history of a Canadian global health initiative

    Directory of Open Access Journals (Sweden)

    Ibrahim Daibes

    2014-07-01

    Full Text Available Objective: 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. Design: 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. Results: 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. Conclusions: 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.

  3. 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

  4. The Smart Health Initiative in China: The Case of Wuhan, Hubei Province.

    Science.gov (United States)

    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.

  5. Enacting sustainable school-based health initiatives: a communication-centered approach to policy and practice.

    Science.gov (United States)

    LeGreco, Marianne; Canary, Heather E

    2011-03-01

    Communication plays an important role in all aspects of the development and use of policy. We present a communication-centered perspective on the processes of enacting public health policies. Our proposed conceptual framework comprises 4 communication frames: orientation, amplification, implementation, and integration. Empirical examples from 2 longitudinal studies of school-based health policies show how each frame includes different communication processes that enable sustainable public health policy practices in school-based health initiatives. These 4 frames provide unique insight into the capacity of school-based public health policy to engage youths, parents, and a broader community of stakeholders. Communication is often included as an element of health policy; however, our framework demonstrates the importance of communication as a pivotal resource in sustaining changes in public health practices.

  6. Labour market initiatives: potential settings for improving the health of people who are unemployed.

    Science.gov (United States)

    Harris, Elizabeth; Rose, Vanessa; Ritchie, Jan; Harris, Neil

    2009-12-01

    Unemployment is detrimental to health. The Unemployment and Health Project in South Western Sydney sought to work with labour market programs to improve the health, particularly, mental health, of unemployed people. This paper describes the experiences of the Project. Phase one commenced in 1995 and involved consultation with the majority of Skillshares (labour market programs under the Labor government) in south-western Sydney to identify potential areas of action. Phase two commenced in 1998 and involved the development of a brief cognitive behaviour therapy intervention that was delivered in Job Network Settings (the next generation of labour market programs under the Liberal government). The cognitive behaviour therapy intervention has been successful in improving mental health in five small scale trials but the intervention has proved difficult to scale up and evaluate comprehensively. Generating more general interest in improving the health of unemployed people through the Job Network has also been difficult. This is related to different understanding and valuing of evidence, a highly volatile context, lack of shared core business by the health and employment sectors, and the changing nature of work in Australia. There are theoretical and practical reasons why it is difficult for labour market programs to be a setting for improving the health of unemployed people. However, the reach of labour market programs into the high risk groups warrants more attention by mental health promotion programs.

  7. Strengthening the Effectiveness of State-Level Community Health Worker Initiatives Through Ambulatory Care Partnerships

    Science.gov (United States)

    Allen, Caitlin; Nell Brownstein, J.; Jayapaul-Philip, Bina; Matos, Sergio; Mirambeau, Alberta

    2017-01-01

    The transformation of the US health care system and the recognition of the effectiveness of community health workers (CHWs) have accelerated national, state, and local efforts to engage CHWs in the support of vulnerable populations. Much can be learned about how to successfully integrate CHWs into health care teams, how to maximize their impact on chronic disease self-management, and how to strengthen their role as emissaries between clinical services and community resources; we share examples of effective strategies. Ambulatory care staff members are key partners in statewide initiatives to build and sustain the CHW workforce and reduce health disparities. PMID:26049655

  8. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    OpenAIRE

    Crichton Georgina E; C Howe Peter R; Buckley Jonathan D; Coates Alison M; Murphy Karen J

    2012-01-01

    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...

  9. Working with Community Health Workers as 'volunteers' in a vaccine trial: practical and ethical experiences and implications.

    Science.gov (United States)

    Angwenyi, Vibian; Kamuya, Dorcas; Mwachiro, Dorothy; Marsh, Vicki; Njuguna, Patricia; Molyneux, Sassy

    2013-04-01

    Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on 'performance'. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

  10. Under the (legal radar screen: global health initiatives and international human rights obligations

    Directory of Open Access Journals (Sweden)

    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

  11. Can a regional government's social inclusion initiative contribute to the quest for health equity?

    Science.gov (United States)

    Baum, Fran; Newman, Lareen; Biedrzycki, Katherine; Patterson, Jan

    2010-12-01

    Despite decades of concern about reducing health inequity, the Commission on the Social Determinants of Health (CSDH) painted a picture of persistent and, in some cases, increasing health inequity. It also made a call for increased evaluation of interventions that might reduce inequities. This paper describes such an intervention-the Social Inclusion Initiative (SII) of the South Australian Government-that was documented for the Social Exclusion Knowledge Network of the CSDH. This initiative is designed to increase social inclusion by addressing key determinants of health inequity-in the study period these were education, homelessness and drug use. Our paper examines evidence from a rapid appraisal to determine whether a social inclusion initiative is a useful aspect of government action to reduce health inequity. It describes achievements in each specific area and the ways they can be expected to affect health equity. Our study highlighted four factors central to the successes achieved by the SII. These were the independent authority and influence of the leadership of the SII, the whole of government approach supported by an overarching strategic plan which sets clear goals for government and the clear and unambiguous support from the highest level of government. We conclude that a social inclusion approach can be valuable in the quest to reduce inequities and that further research on innovative social policy approaches is required to examine their likely impact on health equity.

  12. Telemonitoring increases patient awareness of health and prompts health-related action: initial evaluation of the TELE-ERA study.

    Science.gov (United States)

    Pecina, Jennifer L; Vickers, Kristin S; Finnie, Dawn M; Hathaway, Julie C; Hanson, Gregory J; Takahashi, Paul Y

    2011-01-01

    Telemonitoring is being increasingly used for chronic disease monitoring. Understanding elderly patients' feelings and perspectives toward telemonitoring is important to minimize any barriers to implementation in this population. Twenty Tele-Era Trial participants completed qualitative interviews assessing opinions about their telemonitoring experience. Participants also rated telemonitoring on burden, communication with clinicians, impact on medical condition knowledge, and confidence in using the monitor. On an average, participants rated telemonitoring as minimally burdensome, rated themselves confident in using the monitor, and positively rated telemonitoring for clinical communication. Qualitative analysis revealed a predominant theme that telemonitoring increases patient awareness of their health and also that telemonitoring prompts action. Elderly patients find home telemonitoring to be an acceptable and satisfying experience that can increase their awareness of their health and provide a sense of safety in their home. Home telemonitoring can lead to earlier evaluation of decline in health status.

  13. 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.

  14. 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.

  15. 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.

  16. Ethical review of health-related biotechnology research in Africa: a role for the Pan African Bioethics Initiative (PABIN).

    Science.gov (United States)

    Petros, B

    2007-01-01

    The paper reviews the status of nature and functions of the Pan African Bioethics Initiative (PABIN) a voluntary organization, founded in 2001 by leading members of the African health research and bioethics communities, with the aim of enhancing ethical awareness in Africa, in general, and building ethical clearance capacity in all African countries in particular. PABIN, with a membership drawn from more than 20 African countries is a member of the forum of the WHO/TDR Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). PABIN works closely with its sister forums in Asia, Latin America, Eastern Europe, and North America as well as other continental and international organizations that promote bioethics in health research. PABIN has conducted three conferences and several seminars in collaboration with continental and international partners on subjects of ethical concerns in Africa. Strategically, PABIN aims at assisting in the development of competent in-country bioethics review systems in all African countries. Notable among the contemporary issues that is on the PABIN agenda is addressing the repercussions of the active pursuit by pharmaceutical and other commercial interests from the Western developed countries to conduct all sorts of clinical biomedical trials on African populations before marketing such biotechnological products and services. This drive has brought with it highly controversial ethical issues at a time when both technical and organizational capacity are lacking in much of Africa to address the ethical concerns that are arising from some health-related researches. PABIN seeks to assure that the expected health and social benefits derivable from biotechnology are reaped in accordance with internationally accepted norms.

  17. Demographic and health attributes of the Nahua, initial contact population of the Peruvian Amazon

    Directory of Open Access Journals (Sweden)

    Dante R. Culqui

    2016-01-01

    Full Text Available Abstract We present the case of the Nahua population of Santa Rosa de Serjali, Peruvian Amazon's population, considered of initial contact. This population consists of human groups that for a long time decided to live in isolation, but lately have begun living a more sedentary lifestyle and in contact with Western populations. There are two fully identified initial contact groups in Peru: the Nahua and the Nanti. The health statistics of the Nahua are scarce. This study offers an interpretation of demographic and epidemiological indicators of the Nahua people, trying to identify if a certain degree of health vulnerability exists. We performed a cross sectional study, and after analyzing their health indicators, as well as the supplemental qualitative analysis of the population, brought us to conclude that in 2006, the Nahua, remained in a state of health vulnerability.

  18. Early Initiation of Antenatal Care and Factors Associated with Early Antenatal Care Initiation at Health Facilities in Southern Ethiopia

    Directory of Open Access Journals (Sweden)

    Mengesha Boko Geta

    2017-01-01

    Full Text Available Antenatal care (ANC is care given to pregnant mothers to timely identify and mitigate pregnancy related problems that can harm mother or fetus. Most of Ethiopian mothers present late for ANC. The aim of this paper was to assess determinants of early antenatal care initiation among pregnant women. Mothers attending Shebedino District Health Centers for ANC between January 12 and February 18, 2015, were invited to the study. Multistage sampling technique and structured questionnaire were used to collect data by trained data collectors. Univariate and bivariate analysis were conducted to study the association between explanatory and outcome variable. Out of 608 women, 132 [21.71%] had their first ANC within the recommended time [before or at 3 months]. Media access [AOR = 2.11 95% CI 1.00, 3.22], knowledge about the correct time of ANC booking [AOR = 4.49 95% CI 2.47, 6.16], and having been advised to book within 12 weeks [AOR = 4.14 95% CI 3.80, 5.21] were determinants of first-trimester booking. Health professionals and care providers should provide full information, advice, and appropriate care about early ANC for every eligible mother.

  19. Electrode fusion for the prediction of self-initiated fine movements from single-trial readiness potentials.

    Science.gov (United States)

    Abou Zeid, Elias; Chau, Tom

    2015-06-01

    Current human-machine interfaces (HMIs) for users with severe disabilities often have difficulty distinguishing between intentional and inadvertent activations. Pre-movement neuro-cortical activity may aid in this elusive discrimination task but has not been exploited in HMIs. This work investigates the utility of the readiness potential (RP), a slow negative cortical potential preceding voluntary movement, for detecting the intention of self-initiated fine movements prior to their motoric realization. We recorded electroencephalography from the frontal, central, parietal and occipital lobes of 10 participants using a self-initiated switch activation protocol. Eye movement artifacts were removed by regression and the RP was detected on a single-trial basis, in a narrow frequency range (0.1-1 Hz). Common average reference was applied prior to windowed-averaging for feature extraction. Electrodes were selected according to a separability measure based on Fisher projection. Our findings demonstrate that feature fusion from an optimal number of electrodes achieves a statistically significant lower classification error than the best single classifier. Finally, voluntary fine movement intention was detected on a single-trial basis at above-chance levels approximately 396 ms before physical switch activation. These findings encourage the development of rapid-response, intention-aware HMIs for individuals with severe disabilities who struggle with executing voluntary fine motor movements.

  20. Considerations for community-based mHealth initiatives: insights from three Beacon Communities.

    Science.gov (United States)

    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.

  1. 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

  2. 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.

  3. Functional and psychosocial effects of health qigong in patients with COPD: a randomized controlled trial.

    Science.gov (United States)

    Ng, Bobby H P; Tsang, Hector W H; Jones, Alice Y M; So, C T; Mok, Thomas Y W

    2011-03-01

    The initial gain from a Pulmonary Rehabilitation Program (PRP) among patients with chronic obstructive pulmonary disease (COPD) begins to fade away 6 months after the completion of a rehabilitation program. One possible reason may be due to the poor compliance of the patients to the existing forms of home exercise program (e.g., walking, weight training activities, etc.). This study tested the efficacy of health qigong (HQG), a traditional Chinese exercise, as an adjunct home exercise program in optimizing the gains obtained from PRP until 6 months after discharge. This was a randomized controlled trial (RCT) on a mind-body exercise intervention. Eighty (80) patients with COPD receiving conventional PRP pulmonary rehabilitation program were randomized to the HQG intervention group (n = 40) and control group (n = 40). Assessments were undertaken by blinded assessors at baseline, discharge from training, and follow-up (FU) at 3 and 6 months. Primary outcomes involved functional capacity scales and secondary outcomes involved quality-of-life scales. Intention-to-treat analysis identified trends of improvement in all outcome measures in the HQG group, whereas lesser improvement and trends of deteriorations were identified in the control group. Ancillary analysis using a per-protocol method, however, identified significantly better improvements in functional capacity measures among the HQG at the 6-month FU. This RCT provided some evidence to support the positive effect of HQG as an adjunct home exercise for rehabilitation among people with COPD and to support further related research.

  4. [Perspectives on veterinary public health, food security, and the "One Health" joint initiative].

    Science.gov (United States)

    Cartín-Rojas, Andrés

    2014-09-01

    Veterinarians play a key role in food security. The health of millions of people, stimulation of national economies, development of sustainable livestock production related to this food source, and the different agricultural production systems that compose value chains, and access to more profitable international markets all depend on their efficient and transparent work. Shifting nutritional patterns globally, along with expected population growth, and the increase in marketable food commodity routes and volumes, forecast that demand for animal source food will steadily intensify over the coming decades. To successfully address these challenges, the veterinary profession should establish more practical and up-to-date conceptual and methodological frameworks for academic and professional profiles, focusing the profession on the different public health subject areas, in undergraduate and graduate courses. Furthermore, interdisciplinary alliances should also be developed--such as the "One Health" approach proposed by the United Nations Food and Agriculture Organization (FAO), the World Organization for Animal Health (OIE), and the World Health Organization (WHO)--to establish frameworks for joint work and public policies more in line with the domestic conditions of Latin American countries, using a collaborative, sustainable, and comprehensive approach to animal health, food security, and public health policy.

  5. [Initiatives in urban health communities: Health promotion at work in deprived territories].

    Science.gov (United States)

    Motard, Clémentine; Tessier, Stéphane

    2016-12-19

    The “Urban Health Workshop” [“Atelier santé ville” (Asv)] approach, created in 2000 and interfacing between urban development policies and public health, is implemented in about 250 territories. After more than fifteen years of implementation and development, it appeared useful to review experiences and analyse their effects.Conducted in 2015, this research demonstrates the benefits of Asv, which created health territorial dynamics and local strategies to reduce social and territorial health inequalities. Fifty-one Asv coordinators participated in the study, 30 by answering a survey, 28 (7 of whom had already answered the survey) by a semi-structured interview. The high flexibility of the approach, essential to adapt to a complex reality, justifies a qualitative analysis.Capitalising on these experiences defined the main lessons from implementation of the Asv approach and identified the “good practices” of some of the projects, with the objective of promotion and dissemination of the knowledge acquired. The main consequences observed are territorial dynamics, mobilization of diverse actors and transfer of people’s needs to policy-makers and elected representatives. Health promotion was a central part of all experiences: Asvs implement an approach that is inspired and guided by the five action areas for health promotion identified in the Ottawa Charter.Moreover, the majority of Local Health Contracts (“Contrats locaux de santé”) are based on existing Asvs, indicating the effectiveness of the approach..

  6. Health sector initiatives for disaster risk management in ethiopia: a narrative review.

    Science.gov (United States)

    Tadesse, Luche; Ardalan, Ali

    2014-04-01

    Natural and man-made disasters are prevailing in Ethiopia mainly due to drought, floods, landslides, earthquake, volcanic eruptions, and disease epidemics. Few studies so far have critically reviewed about medical responses to disasters and little information exists pertaining to the initiatives being undertaken by health sector from the perspective of basic disaster management cycle. This article aimed to review emergency health responses to disasters and other related interventions which have been undertaken in the health sector. Relevant documents were identified by searches in the websites of different sectors in Ethiopian and international non-governmental organizations and United Nations agencies. Using selected keywords, articles were also searched in the data bases of Medline, CINAHL, Scopus, and Google Scholar. In addition, pertinent articles from non-indexed journals were referred to. Disaster management system in Ethiopia focused on response, recovery, and rehabilitation from 1974 to 1988; while the period between 1988 and 1993 marked the transition phase towards a more comprehensive approach. Theoretically, from 1993 onwards, the disaster management system has fully integrated the mitigation, prevention, and preparedness phases into already existing response and recovery approach, particularly for drought. This policy has changed the emergency response practices and the health sector has taken some initiatives in the area of emergency health care. Hence, drought early warning system, therapeutic feeding program in hospitals, health centers and posts in drought prone areas to manage promptly acute malnutrition cases have all been put in place. In addition, public health disease emergencies have been responded to at all levels of health care system. Emergency health responses to drought and its ramifications such as acute malnutrition and epidemics have become more comprehensive in the context of basic disaster management phases; and impacts of drought

  7. A review of health literacy: Definitions, interpretations, and implications for policy initiatives.

    Science.gov (United States)

    Malloy-Weir, Leslie J; Charles, Cathy; Gafni, Amiram; Entwistle, Vikki

    2016-05-19

    Definitions and interpretations of 'health literacy' have important implications for the delivery of health care and for health policy-related initiatives. We conducted a systematic review and critical analysis to determine the extent to which definitions of health literacy differ in the academic literature, the similarities and differences across definitions, and possible interpretations for the most commonly used definitions. We identified 250 different definitions of health literacy and grouped them into three categories: (i) most commonly used definitions (n=6), (ii) modified versions of these most commonly used definitions (n=133), and (iii) 'other' definitions (n=111). We found the most commonly used definitions to be open to multiple interpretations and to reflect underlying assumptions that are not always justifiable. Attention is needed to the ways in which differing definitions and interpretations of health literacy may affect patient care and the delivery of health literacy-related policy initiatives.Journal of Public Health Policy advance online publication, 19 May 2016; doi:10.1057/jphp.2016.18.

  8. Short-term functional health and well-being after marital separation: does initiator status make a difference?

    Science.gov (United States)

    Hewitt, Belinda; Turrell, Gavin

    2011-06-01

    The authors investigated the health consequences of marital separation and whether the partners who initiated the separation had better health than those who did not. The data came from the Households, Income and Labour Dynamics in Australia (HILDA) panel study (2001-2007), comprising an analytic sample of 1,786 men and 2,068 women who were in their first marriages in 2001. For participants who separated, the authors distinguished between self-initiated, partner-initiated, and jointly initiated separations. Using linear random-intercept models, they examined scores on the 8 physical and mental health dimensions of Short Form 36, with scale scores ranging from 0 to 100. The results indicated that in general, men who separated had a decline in health, although this was more pronounced for mental dimensions than for physical dimensions. Among separated men, those whose partner initiated the separation had poorer mental health than those for whom the separation was self-initiated or jointly initiated (-4.61). Women's physical health improved with separation, but their mental health declined. For separated women, those whose partner initiated the separation had lower scores on the general health (-5.39), role-emotional (-11.08), and mental health (-7.18) scales than women who self-initiated separation. The health consequences of separation were less severe for self- or jointly initiated separations, suggesting that not all marital dissolutions are equally bad for health.

  9. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: dschwartz3@nshs.edu [Department of Radiation Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY (United States); Feinstein Institute for Medical Research, Manhasset, NY (United States); Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Garden, Adam S.; Thomas, Jimmy [Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Chen Yipei; Zhang Yongbin [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Lewin, Jan; Chambers, Mark S. [Department of Head and Neck Surgery, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States); Dong, Lei [Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  10. Randomised trial of cord clamping and initial stabilisation at very preterm birth.

    Science.gov (United States)

    Duley, Lelia; Dorling, Jon; Pushpa-Rajah, Angela; Oddie, Sam J; Yoxall, Charles William; Schoonakker, Bernard; Bradshaw, Lucy; Mitchell, Eleanor J; Fawke, Joe Anthony

    2017-09-18

    For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care. Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes. Eight UK tertiary maternity units. 261 women expected to have a live birth before 32 weeks, and their 276 babies. Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping. Intraventricular haemorrhage (IVH), death before discharge. 132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35(+6) weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers. This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed. ISRCTN 21456601. © 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.

  11. A systematic review of factors affecting children's right to health in cluster randomized trials in Kenya.

    Science.gov (United States)

    Oduwo, Elizabeth; Edwards, Sarah J L

    2014-07-16

    Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot' studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children's right to health, and the negative duty on governments not to prevent access to treatment. The applicants challenged a government decision to offer Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply. The government refused to expand access, arguing they needed to collect more information, and citing concerns about long-term hazards, side effects, resistance and inadequate infrastructure. The court ruled this violated children's right to health and asked the government to immediately expand access. Cluster randomized trials involving children are increasingly popular, and are often used to reduce 'contamination': the possibility that members of a cluster adopt behavior of other clusters. However, they raise unique issues insufficiently addressed in literature and ethical guidelines. This case provides additional crucial guidance, based on a common human rights framework, for the Kenyan government and other involved stakeholders. Children possess special rights, often represent a 'captive' group, and so motivate extra consideration. In a systematic review, we therefore investigated whether cluster trial designs are used to prevent or delay children's access to treatment in Kenya or otherwise inconsistently with children's right to health as outlined in the above case. Although we did not find state sponsored cluster trials, most had significant public sector involvement. Core obligations under children's right to health were inadequately addressed across trials. Few cluster trials reported rationale for cluster randomization, offered post- trial access or

  12. Mapping of initiatives to increase membership in mutual health organizations in Benin

    Directory of Open Access Journals (Sweden)

    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

  13. A controlled trial of flumazenil and gabapentin for initial treatment of methylamphetamine dependence.

    Science.gov (United States)

    Urschel, Harold C; Hanselka, Larry L; Baron, Michael

    2011-02-01

    Drug use has been associated with craving, which may be described as a powerful and sometimes overwhelming urge to use the drug. Patients seeking treatment for methylamphetamine dependence must cope with drug cravings as they engage in psychosocial treatments. Changes in brain GABA(A) receptors during substance use and withdrawal provide a neurobiological basis for craving and associated anxiety. Flumazenil (a benzodiazepine antagonist) plus gabapentin (an antiepileptic) were compared with placebo in a randomized, double-blind study to assess the effects on craving during initial treatment for methylamphetamine dependence. Evaluation was conducted over a 30-day period. Craving and drug use were found to be highly correlated. Craving was reduced significantly in the flumazenil plus gabapentin group compared with placebo following the initial treatment period and throughout the 30 days. Decreased methylamphetamine use was also observed, as measured by urine drug screens and self-reports.

  14. 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

  15. The WISHED Trial: implementation of an interactive health communication application for patients with chronic kidney disease.

    Science.gov (United States)

    Harvey, Andrea; Walsh, Michael; Jain, Arsh K; Bosch, Eric; Moreau, Cathy; Garland, Jocelyn; Brimble, K Scott

    2016-01-01

    Despite many advantages over facility-based therapies, less than 25 % of prevalent dialysis patients in Ontario are on a home therapy. Interactive health communication applications, web-based packages for patients, have been shown to have a beneficial effect on knowledge, social support, self-efficacy, and behavioral and clinical outcomes but have not been evaluated in patients with chronic kidney disease (CKD). Web-based tools designed for patients with CKD exist but to our knowledge have not been assessed in their ability to influence dialysis modality decision-making. To determine if a web-based tool increases utilization of a home-based therapy in patients with CKD starting dialysis. This is a multi-centered randomized controlled study. Participants will be recruited from sites in Canada. Two hundred and sixty-four consenting patients with an estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73 m(2) who have received modality education will be enrolled in the study. The primary outcome will be the proportion of participants who are on dialysis using a home-based therapy within 3 months of dialysis initiation. Secondary outcomes will include the proportion of patients intending to perform a home-based modality and measures of dialysis knowledge, decision conflict, and social support. The between-group differences in frequencies will be expressed as either absolute risk differences and/or by calculating the odds ratio and its associated 95 % confidence interval. This study will assess whether access to a website dedicated to supporting and promoting home-based dialysis therapies will increase the proportion of patients with CKD who initiate a home-based dialysis therapy. ClinicalTrials.gov #NCT01403454, registration date: July 21, 2011.

  16. Quarter-dose quadruple combination therapy for initial treatment of hypertension: placebo-controlled, crossover, randomised trial and systematic review.

    Science.gov (United States)

    Chow, Clara K; Thakkar, Jay; Bennett, Alex; Hillis, Graham; Burke, Michael; Usherwood, Tim; Vo, Kha; Rogers, Kris; Atkins, Emily; Webster, Ruth; Chou, Michael; Dehbi, Hakim-Moulay; Salam, Abdul; Patel, Anushka; Neal, Bruce; Peiris, David; Krum, Henry; Chalmers, John; Nelson, Mark; Reid, Christopher M; Woodward, Mark; Hilmer, Sarah; Thom, Simon; Rodgers, Anthony

    2017-03-11

    randomisation and two patients dropped out for administrative reasons. The placebo-corrected reduction in systolic 24-h blood pressure with the quadpill was 19 mm Hg (95% CI 14-23), and office blood pressure was reduced by 22/13 mm Hg (p<0·0001). During quadpill treatment, 18 (100%) of 18 participants achieved office blood pressure less than 140/90 mm Hg, compared with six (33%) of 18 during placebo treatment (p=0·0013). There were no serious adverse events and all patients reported that the quadpill was easy to swallow. Our systematic review identified 36 trials (n=4721 participants) of one drug at quarter-dose and six trials (n=312) of two drugs at quarter-dose, against placebo. The pooled placebo-corrected blood pressure-lowering effects were 5/2 mm Hg and 7/5 mm Hg, respectively (both p<0·0001), and there were no side-effects from either regimen. The findings of our small trial in the context of previous randomised evidence suggest that the benefits of quarter-dose therapy could be additive across classes and might confer a clinically important reduction in blood pressure. Further examination of the quadpill concept is needed to investigate effectiveness against usual treatment options and longer term tolerability. National Heart Foundation, Australia; University of Sydney; and National Health and Medical Research Council of Australia. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Enhancing the sustainability and climate resiliency of health care facilities: a comparison of initiatives and toolkits.

    Science.gov (United States)

    Balbus, John; Berry, Peter; Brettle, Meagan; Jagnarine-Azan, Shalini; Soares, Agnes; Ugarte, Ciro; Varangu, Linda; Prats, Elena Villalobos

    2016-09-01

    Extreme weather events have revealed the vulnerability of health care facilities and the extent of devastation to the community when they fail. With climate change anticipated to increase extreme weather and its impacts worldwide-severe droughts, floods, heat waves, and related vector-borne diseases-health care officials need to understand and address the vulnerabilities of their health care systems and take action to improve resiliency in ways that also meet sustainability goals. Generally, the health sector is among a country's largest consumers of energy and a significant source of greenhouse gas emissions. Now it has the opportunity lead climate mitigation, while reducing energy, water, and other costs. This Special Report summarizes several initiatives and compares three toolkits for implementing sustainability and resiliency measures for health care facilities: the Canadian Health Care Facility Climate Change Resiliency Toolkit, the U.S. Sustainable and Climate Resilient Health Care Facilities Toolkit, and the PAHO SMART Hospitals Toolkit of the World Health Organization/Pan American Health Organization. These tools and the lessons learned can provide a critical starting point for any health system in the Americas.

  18. 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

  19. A Study of Failures of Follow-Through for Initial Mental Health Interviews.

    Science.gov (United States)

    Callister, Sheldon; Berger, Mike

    Mental health center administrators are concerned about persons who contact centers but fail to keep initial appointments. Factors within centers that discourage client follow-through must be identified and changed. Telephone surveys were attempted for 50 such individuals from the youth (N=23) and adult (N=27) team logs of the Weber Mental Health…

  20. Health Promotion and Aging: Educational and Clinical Initiatives by the Federal Government.

    Science.gov (United States)

    Haber, David

    2002-01-01

    Discusses positive and negative effects of five federal health promotion initiatives: Medicare Prevention Benefits, Surgeon General's Reports, Healthy People 2000 and 2001, Guide to Clinical Preventive Services, and Put Prevention into Practice Campaign. Recommends additional research and coordination with state and private sector agencies.…

  1. Dietary patterns are associated with disease risk among participants in the women's health initiative observational study

    Science.gov (United States)

    Coronary heart disease (CHD) is the leading cause of death in women. A nested case-control study tested whether dietary patterns predicted CHD events among 1224 participants in the Women’s Health Initiative-Observational Study (WHI-OS) with centrally confirmed CHD, fatal or nonfatal myocardial infar...

  2. A Study of Failures of Follow-Through for Initial Mental Health Interviews.

    Science.gov (United States)

    Callister, Sheldon; Berger, Mike

    Mental health center administrators are concerned about persons who contact centers but fail to keep initial appointments. Factors within centers that discourage client follow-through must be identified and changed. Telephone surveys were attempted for 50 such individuals from the youth (N=23) and adult (N=27) team logs of the Weber Mental Health…

  3. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.

    Science.gov (United States)

    Sibilitz, Kirstine L; Berg, Selina K; Rasmussen, Trine B; Risom, Signe Stelling; Thygesen, Lau C; Tang, Lars; Hansen, Tina B; Johansen, Pernille Palm; Gluud, Christian; Lindschou, Jane; Schmid, Jean Paul; Hassager, Christian; Køber, Lars; Taylor, Rod S; Zwisler, Ann-Dorthe

    2016-12-15

    The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery. The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36. 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group. NCT01558765, 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/.

  4. 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 BACKGROUND: 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. METHODS AND FINDINGS: 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

  5. Mental health promotion in the health care setting: collaboration and engagement in the development of a mental health promotion capacity-building initiative.

    Science.gov (United States)

    Horn, Michelle A; Rauscher, Alana B; Ardiles, Paola A; Griffin, Shannon L

    2014-01-01

    Health Compass is an innovative, multiphased project that aims to transform health care practice and shift organizational culture by building the capacity of Provincial Health Services Authority (PHSA) health care providers to further promote the mental health and well-being of patients and families accessing PHSA's health care services. Health Compass was developed within a health promotion framework, which involved collaboration and engagement with stakeholders across all partnering PHSA agencies. This approach led to the development of an educational and training resource that contributes to increased capacity for mental health promotion within the health care setting. Based on interviews with Health Compass' internal Project Team and findings from a Stakeholder Engagement Evaluation Report, this article outlines the participatory approach taken to develop the Health Compass Mental Health Promotion Resource and E-Learning Tool. A number of key facilitators for collaboration and engagement are discussed, which may be particularly applicable to the implementation of a mental health promotion program or initiative within a complex health care setting.

  6. Overcoming challenges to initiating cell therapy clinical trials in rapidly developing countries: India as a model.

    Science.gov (United States)

    Viswanathan, Sowmya; Rao, Mahendra; Keating, Armand; Srivastava, Alok

    2013-08-01

    Increasingly, a number of rapidly developing countries, including India, China, Brazil, and others, are becoming global hot spots for the development of regenerative medicine applications, including stem cell-based therapies. Identifying and overcoming regulatory and translational research challenges and promoting scientific and ethical clinical trials with cells will help curb the growth of stem cell tourism for unproven therapies. It will also enable academic investigators, local regulators, and national and international biotechnology and biopharmaceutical companies to accelerate stem cell-based clinical research that could lead to effective innovative treatments in these regions. Using India as a model system and obtaining input from regulators, clinicians, academics, and industry representatives across the stem cell field in India, we reviewed the role of key agencies and processes involved in this field. We have identified areas that need attention and here provide solutions from other established and functioning models in the world to streamline and unify the regulatory and ethics approval processes for cell-based therapies. We also make recommendations to check the growth and functioning of clinics offering unproven treatments. Addressing these issues will remove considerable hurdles to both local and international investigators, accelerate the pace of research and development, and create a quality environment for reliable products to emerge. By doing so, these countries would have taken one important step to move to the forefront of stem cell-based therapeutics.

  7. Submitted for your consideration: potential advantages of a novel clinical trial design and initial patient reaction

    Directory of Open Access Journals (Sweden)

    Matthew Shane Loop

    2012-08-01

    Full Text Available In many circumstances, individuals do not respond identically to the same treatment. This phenomenon, which is called treatment response heterogeneity (TRH, appears to be present in treatments for many conditions, including obesity. Estimating the total amount of TRH, predicting an individual’s response, and identifying the mediators of TRH are of interest to biomedical researchers. Clinical investigators and physicians commonly postulate that some of these mediators could be genetic. Current designs can estimate TRH as a function of specific, measurable observed factors; however, they cannot estimate the total amount of TRH, nor provide reliable estimates of individual persons’ responses. We propose a new repeated randomizations design (RRD, which can be conceived as a generalization of the Balaam design, that would allow estimates of that variability and facilitate estimation of the total amount of TRH, prediction of an individual’s response, and identification of the mediators of TRH. In a pilot study, we asked 118 subjects entering a weight loss trial for their opinion of the RRD, and they stated a preference for the RRD over the conventional 2-arm parallel groups design. Research is needed as to how the RRD will work in practice and its relative statistical properties, and we invite dialogue about it.

  8. Augmented reality system for CT-guided interventions: system description and initial phantom trials

    Science.gov (United States)

    Sauer, Frank; Schoepf, Uwe J.; Khamene, Ali; Vogt, Sebastian; Das, Marco; Silverman, Stuart G.

    2003-05-01

    We are developing an augmented reality (AR) image guidance system, in which information derived from medical images is overlaid onto a video view of the patient. The interventionalist wears a head-mounted display (HMD) that presents him with the augmented stereo view. The HMD is custom fitted with two miniature color video cameras that capture the stereo view of the scene. A third video camera, operating in the near IR, is also attached to the HMD and is used for head tracking. The system achieves real-time performance of 30 frames per second. The graphics appears firmly anchored in the scne, without any noticeable swimming or jitter or time lag. For the application of CT-guided interventions, we extended our original prototype system to include tracking of a biopsy needle to which we attached a set of optical markers. The AR visualization provides very intuitive guidance for planning and placement of the needle and reduces radiation to patient and radiologist. We used an interventional abdominal phantom with simulated liver lesions to perform an inital set of experiments. The users were consistently able to locate the target lesion with the first needle pass. These results provide encouragement to move the system towards clinical trials.

  9. A student-initiated and student-facilitated international health elective for preclinical medical students

    Directory of Open Access Journals (Sweden)

    Nirali Vora

    2010-02-01

    Full Text Available Introduction: Global health education is becoming more important for developing well-rounded physicians and may encourage students toward a career in primary care. Many medical schools, however, lack adequate and structured opportunities for students beginning the curriculum. Methods: Second-year medical students initiated, designed, and facilitated a pass–fail international health elective, providing a curricular framework for preclinical medical students wishing to gain exposure to the clinical and cultural practices of a developing country. Results: All course participants (N=30 completed a post-travel questionnaire within one week of sharing their experiences. Screening reflection essays for common themes that fulfill university core competencies yielded specific global health learning outcomes, including analysis of health care determinants. Conclusion: Medical students successfully implemented a sustainable global health curriculum for preclinical student peers. Financial constraints, language, and organizational burdens limit student participation. In future, long-term studies should analyze career impact and benefits to the host country.

  10. Membrane sweeping at initiation of formal labor induction: a randomized controlled trial.

    Science.gov (United States)

    Tan, Peng Chiong; Jacob, Reena; Omar, Siti Zawiah

    2006-03-01

    To determine the benefit of membrane sweeping at initiation of labor induction in conjunction with formal methods of labor induction. Two hundred seventy-four women at term with a singleton fetus in cephalic presentation and intact membranes were randomly assigned to receive membrane sweeping or no membrane sweeping at initiation of formal labor induction with either dinoprostone pessary or amniotomy. Outcome measures included mode of delivery, induction-to-delivery interval, dinosprostone dose, any oxytocin use and duration of oxytocin use in labor, visual analog score for pain associated with sweeping, and visual analog score for satisfaction with the birth process. Two hundred sixty-four women (136 sweep and 128 no sweep) had their data analyzed. Ten women (4 sweep and 6 no sweep) were excluded because of exclusion criteria infringements. Swept women had higher spontaneous vaginal delivery rate (69% compared with 56%, P = .041), shorter induction to delivery interval (mean 14 compared with 19 hours, P = .003), fewer that required oxytocin use (46% compared with 59%, P = .037), shorter duration of oxytocin infusion (mean 2.6 compared with 4.3 hours, P = .001) and improved visual analog score for birth process satisfaction (mean 4.0 compared with 4.7, P = .015). The reduction in dinoprostone dose used (mean 1.2 compared with 1.3, P = .082) was not significant. Postsweeping visual analog score for pain (mean 4.7 compared with 3.5, P initiation of labor induction increased the spontaneous vaginal delivery rate, reduced oxytocic drug use, shortened induction to delivery interval, and improved patient satisfaction. I.

  11. 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

  12. 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

    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...... regulations in some countries, the safety of the most common types of HIT systems such as EHRs and CPOE without decision support is not being explicitly addressed in most nations. Appropriate mechanisms for safety assurance are required for the full range of HIT systems for health professionals and consumers......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...

  13. Feeding trials in organic food quality and health research

    DEFF Research Database (Denmark)

    Velimirov, Alberta; Huber, Machteld; Lauridsen, Charlotte

    2010-01-01

    Feeding experiments comparing organically and conventionally produced food are performed to assess the overall impact on the animals' health as a model for the effects experienced by the human consumers. These experiments are based on systems research and characterized by their focus on production...... methods, whole food testing and procedures in accordance with the terms of organic farming. A short review of such experiments shows that the majority of these tests revealed effects of the organically produced feed on health parameters such as reproductive performance and immune responses. Systems...... research is not just about simple cause-effect chains, but rather about the pluralism of interactions in biological networks; therefore, the interpretation of the outcome of whole food experiments is difficult. Furthermore, the test diets of organic and conventional origin can be constituted in different...

  14. Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378

    OpenAIRE

    Ewings Paul E; Reeves Barnaby C; Taylor Rod S; Taylor Rebecca J

    2004-01-01

    Abstract Introduction Critical appraisal skills are believed to play a central role in an evidence-based approach to health practice. The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aimed at health care professionals. Methods This prospective controlled trial randomized 145 self-selected general practitioners, hospital physicians, professions allied to medicine, and healthcare managers/administrators from the South West...

  15. A mHealth Application for Chronic Wound Care: Findings of a User Trial

    OpenAIRE

    Friesen, Marcia R; Carole Hamel; McLeod, Robert D.

    2013-01-01

    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 ulti...

  16. Provider-Initiated Late Preterm Births in Brazil: Differences between Public and Private Health Services

    Science.gov (United States)

    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

    Background 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. Methods 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. Results 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. Conclusion 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. PMID:27196102

  17. Provider-Initiated Late Preterm Births in Brazil: Differences between Public and Private Health Services.

    Science.gov (United States)

    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.

  18. Provider-Initiated Late Preterm Births in Brazil: Differences between Public and Private Health Services.

    Directory of Open Access Journals (Sweden)

    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.

  19. Dementia care initiative in primary practice – study protocol of a cluster randomized trial on dementia management in a general practice setting

    Directory of Open Access Journals (Sweden)

    Holle Rolf

    2009-06-01

    Full Text Available Abstract Background Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent as possible and to reduce the burden of caregivers. The objective of the study is to compare a complex intervention including caregiver support groups and counselling against usual care in terms of time to nursing home placement. In this paper the study protocol is described. Methods/Design The IDA (Initiative Demenzversorgung in der Allgemeinmedizin project is designed as a three armed cluster-randomized trial where dementia patients and their informal caregivers are recruited by general practitioners. Patients in the study region of Middle Franconia, Germany, are included if they have mild or moderate dementia, are at least 65 years old, and are members of the German AOK (Allgemeine Ortskrankenkasse sickness fund. In the control group patients receive regular treatment, whereas in the two intervention groups general practitioners participate in a training course in evidence based dementia treatment, recommend support groups and offer counseling to the family caregivers either beginning at baseline or after the 1-year follow-up. The study recruitment and follow-up took place from July 2005 to January 2009. 303 general practitioners were randomized of which 129 recruited a total of 390 patients. Time to nursing home admission within the two year intervention and follow-up period is the primary endpoint. Secondary endpoints are cognitive status, activities of daily living, burden of care giving as well as healthcare costs. For an economic analysis from the societal perspective, data are collected from caregivers as well as

  20. The HAAPI (Home Arm Assistance Progression Initiative) Trial: - A Novel Robotics Delivery Approach in Stroke Rehabilitation

    Science.gov (United States)

    Wolf, Steven L.; Sahu, Komal; Bay, R. Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

    2015-01-01

    Background Geographical location, socioeconomic status and logistics surrounding transportation impede access of post-stroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing for the remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP), was incorporated within a home exercise program (HEP) to improve upper extremity functional capabilities post-stroke. Objective To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months post-stroke and characterized as underserved. Methods In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to upper extremity rehabilitation were randomized to the: 1) experimental group which received combined HEP and HMP for 3 hrs/day x 5 days x 8 weeks; or 2) control group which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl Meyer Assessment (upper extremity) were primary and secondary outcome measures respectively, undertaken before and after the interventions. Results Both groups demonstrated improvement across all upper extremity outcomes. Conclusions Robotic+HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time, additional research is necessary to determine appropriate dosage of HMP and HEP. PMID:25782693

  1. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation.

    Science.gov (United States)

    Wolf, Steven L; Sahu, Komal; Bay, R Curtis; Buchanan, Sharon; Reiss, Aimee; Linder, Susan; Rosenfeldt, Anson; Alberts, Jay

    2015-01-01

    Geographical location, socioeconomic status, and logistics surrounding transportation impede access of poststroke individuals to comprehensive rehabilitative services. Robotic therapy may enhance telerehabilitation by delivering consistent and state-of-the art therapy while allowing remote monitoring and adjusting therapy for underserved populations. The Hand Mentor Pro (HMP) was incorporated within a home exercise program (HEP) to improve upper-extremity (UE) functional capabilities poststroke. To determine the efficacy of a home-based telemonitored robotic-assisted therapy as part of a HEP compared with a dose-matched HEP-only intervention among individuals less than 6 months poststroke and characterized as underserved. In this prospective, single-blinded, multisite, randomized controlled trial, 99 hemiparetic participants with limited access to UE rehabilitation were randomized to either (1) the experimental group, which received combined HEP and HMP for 3 h/d ×5 days ×8 weeks, or (2) the control group, which received HEP only at an identical dosage. Weekly communication between the supervising therapist and participant promoted compliance and progression of the HEP and HMP prescription. The Action Research Arm Test and Wolf Motor Function Test along with the Fugl-Meyer Assessment (UE) were primary and secondary outcome measures, respectively, undertaken before and after the interventions. Both groups demonstrated improvement across all UE outcomes. Robotic + HEP and HEP only were both effectively delivered remotely. There was no difference between groups in change in motor function over time. Additional research is necessary to determine the appropriate dosage of HMP and HEP. © The Author(s) 2015.

  2. 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

  3. Case-based reasoning using electronic health records efficiently identifies eligible patients for clinical trials.

    Science.gov (United States)

    Miotto, Riccardo; Weng, Chunhua

    2015-04-01

    To develop a cost-effective, case-based reasoning framework for clinical research eligibility screening by only reusing the electronic health records (EHRs) of minimal enrolled participants to represent the target patient for each trial under consideration. The EHR data--specifically diagnosis, medications, laboratory results, and clinical notes--of known clinical trial participants were aggregated to profile the "target patient" for a trial, which was used to discover new eligible patients for that trial. The EHR data of unseen patients were matched to this "target patient" to determine their relevance to the trial; the higher the relevance, the more likely the patient was eligible. Relevance scores were a weighted linear combination of cosine similarities computed over individual EHR data types. For evaluation, we identified 262 participants of 13 diversified clinical trials conducted at Columbia University as our gold standard. We ran a 2-fold cross validation with half of the participants used for training and the other half used for testing along with other 30 000 patients selected at random from our clinical database. We performed binary classification and ranking experiments. The overall area under the ROC curve for classification was 0.95, enabling the highlight of eligible patients with good precision. Ranking showed satisfactory results especially at the top of the recommended list, with each trial having at least one eligible patient in the top five positions. This relevance-based method can potentially be used to identify eligible patients for clinical trials by processing patient EHR data alone without parsing free-text eligibility criteria, and shows promise of efficient "case-based reasoning" modeled only on minimal trial participants. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  4. Infidelity, initiation, and the emotional climate of divorce: are there implications for mental health?

    Science.gov (United States)

    Sweeney, M M; Horwitz, A V

    2001-09-01

    A large literature has examined the role of "secondary" stressors, such as problems with finances, social support, residential mobility, and children, in producing the well-documented association between divorce and a variety of psychopathological conditions. Much less attention, however, has been paid to variation in the "primary" disruption experience. We address this omission using data from the National Survey of Families and Households to investigate the interrelationships among depression, initiator status, and spousal infidelity. While we find little evidence of direct effects of initiator status or spousal infidelity on post-divorce depression, the importance of these characteristics emerges when they are considered in an interactive context. Specifically, while divorce initiation is associated with reduced depression among individuals with unfaithful spouses, initiation is associated with increased depression in the absence of spousal infidelity. Taken together, our findings suggest that characteristics of the divorce experience may interact in complex ways to produce variation in mental health outcomes.

  5. Transdiagnostic group behavioral activation and exposure therapy for youth anxiety and depression: Initial randomized controlled trial.

    Science.gov (United States)

    Chu, Brian C; Crocco, Sofia T; Esseling, Petra; Areizaga, Margaret J; Lindner, Alison M; Skriner, Laura C

    2016-01-01

    Anxiety and depression are debilitating and commonly co-occurring in young adolescents, yet few interventions are designed to treat both disorder classes together. Initial efficacy is presented of a school-based transdiagnostic group behavioral activation therapy (GBAT) that emphasizes anti-avoidance in vivo exposure. Youth (N = 35; ages 12-14; 50.9% male) were randomly assigned to either GBAT (n = 21) or WL (n = 14) after completing a double-gated screening process. Multi-reporter, multi-domain outcomes were assessed at pretreatment, posttreatment, and four-month follow-up (FU). GBAT was associated with greater posttreatment remission rates than WL in principal diagnosis (57.1% vs. 28.6%; X1(2) = 2.76, p = .09) and secondary diagnosis (70.6% vs. 10%; X1(2) = 9.26, p = .003), and greater improvement in Clinical Global Impairment - Severity ratings, B = -1.10 (0.42), p = .01. Symptom outcomes were not significantly different at posttreatment. GBAT produced greater posttreatment behavioral activation (large effect size) and fewer negative thoughts (medium effect), two transdiagnostic processes, both at the trend level. Most outcomes showed linear improvement from pretreatment to FU that did not differ depending on initial condition assignment. Sample size was small, but GBAT is a promising transdiagnostic intervention for youth anxiety and unipolar mood disorders that can feasibly and acceptably be applied in school settings.

  6. Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial.

    Science.gov (United States)

    Kaeley, Gurjit S; Evangelisto, Amy M; Nishio, Midori J; Goss, Sandra L; Liu, Shufang; Kalabic, Jasmina; Kupper, Hartmut

    2016-08-01

    To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7.5 mg/week) MTX; all patients received 40 mg open-label ADA every other week for 24 weeks. The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) to test for noninferiority of low-dosage MTX using a 15% margin. US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology, assessing synovial hypertrophy, vascularity, and bony erosions. Rapid improvement in clinical indices was observed in both groups after addition of ADA. The difference in mean DAS28-CRP (0.37, 95% CI 0.07-0.66) comparing low-dosage (4.12, 95% CI 3.88-4.34) versus high-dosage MTX (3.75, 95% CI 3.52-3.97) was statistically significant and non-inferiority was not met. Statistically significant differences were not detected for most clinical, functional, and US outcomes. Pharmacokinetic and safety profiles were similar. In MUSICA, Week 24 mean DAS28-CRP, the primary endpoint, did not meet non-inferiority for the low-dosage MTX group. Although the differences between the 2 MTX dosage groups were small, our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA.

  7. Recruitment and Enrollment of African Americans and Caucasians in a Health Promotion Trial for Persons with Serious Mental Illness

    Science.gov (United States)

    Siddiqui, Mona; Cooper, Lisa A.; Appel, Lawrence J.; Yu, Airong; Charleston, Jeanne; Gennusa, Joseph; Dickerson, Faith; Daumit, Gail L.

    2015-01-01

    African Americans with serious mental illness (SMI) continue to experience inadequate representation in clinical trials. Persons with SMI, regardless of race, have an increased burden of all cardiovascular disease (CVD) risk factors including obesity, hypertension, diabetes mellitus, dyslipidemia, the metabolic syndrome and tobacco smoking. Having SMI and being African American, however, is each associated with an increased risk of CVD mortality compared to the general population. There is a critical need, therefore, to adapt health promotion interventions for African Americans with SMI. We sought to examine overall recruitment into a randomized clinical trial of CVD prevention among persons with SMI, and to examine racial differences in interest, enrollment, and potential barriers to participation. Although similar levels of interest in participation were seen between African Americans and Caucasians in signing screening consent, 9.6% fewer African Americans enrolled due to inability to complete initial data collection. Further work is needed to more fully understand the nature of the barriers encountered by African Americans with SMI who otherwise may be interested in participating within clinical trials. PMID:25812255

  8. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

  9. Relation of initial spacing and relative stand density indices to stand characteristics in a Douglas-fir plantation spacing trial

    Science.gov (United States)

    Curtis, Robert O.; Bansal, Sheel; Harrington, Constance A.

    2016-01-01

    This report presents updated information on a 1981 Douglas-fir (Pseudotsuga menziesii (Mirb.) Franco var. menziesii) plantation spacing trial at 33 years from planting. Stand statistics at the most recent measurement were compared for initial spacing of 1 through 6 meters and associated relative densities. There was no clear relationship of spacing to top height. Diameter, live crown ratio, and percent survival increased with spacing; basal area and relative density decreased with increase in spacing. Volume in trees ≥ 4 cm diameter was greatest at 2 m spacing, while utilizable volume (trees ≥20 cm dbh) was greatest at 4 m spacing. Live crown ratio decreased and total crown projectional area increased with increasing relative density indices. Total crown projectional area was more closely related to relative density than to basal area.

  10. Supplemental vibrational force does not reduce pain experience during initial alignment with fixed orthodontic appliances: a multicenter randomized clinical trial.

    Science.gov (United States)

    Woodhouse, Neil R; DiBiase, Andrew T; Papageorgiou, Spyridon N; Johnson, Nicola; Slipper, Carmel; Grant, James; Alsaleh, Maryam; Cobourne, Martyn T

    2015-11-27

    This prospective randomized trial investigated the effect of supplemental vibrational force on orthodontic pain during alignment with fixed-appliances. Eighty-one subjects analgesics reported slightly higher maximum-pain although this was not significant (P = 0.170). The effect of intervention was independent of analgesia (P = 0.883). At T1 and T2, a statistically and clinically significant increase in mean pain was seen at 4 and 24-hours, declining at 72-hours and becoming insignificant at 1-week. For mean alignment-rate, pain-intensity and use of analgesics, no significant differences existed between groups (P > 0.003). The only significant predictor for mean pain was time. Use of an AcceleDent vibrational device had no significant effect on orthodontic pain or analgesia consumption during initial alignment with fixed appliances.

  11. Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints.

    Science.gov (United States)

    Johnsen, Tone Langjordet; Indahl, Aage; Baste, Valborg; Eriksen, Hege Randi; Tveito, Torill Helene

    2016-08-19

    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. 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. 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, organisational, and individual perspective. Clinicaltrials.gov: NCT02396797

  12. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    Directory of Open Access Journals (Sweden)

    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.

  13. 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.

  14. From the Paralympics to public health: increasing physical activity through legislative and policy initiatives.

    Science.gov (United States)

    Blauwet, Cheri A; Iezzoni, Lisa I

    2014-08-01

    Individuals with disabilities experience a disproportionate rate of chronic disease and are more likely to lead sedentary lifestyles than the general population. Multiple complex factors likely contribute to these disparities, including structural, socioeconomic and attitudinal barriers that impede broad participation of individuals with disabilities in health and wellness promotion programs. Public health initiatives aimed at mitigating these health disparities emphasize improved access to physical activity and sports opportunities. Given its visibility, the Paralympic Movement provides an opportunity to transform how society conceptualizes the relationship of disability to physical fitness. The Paralympics also serve as a catalyst for public health education and program development. Already, public policies and governmental regulations are expanding grassroots sports opportunities for youth and adults with disabilities, thus promoting inclusive opportunities for participation in physical activity.

  15. Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Shahin Lockman

    Full Text Available Nevirapine (NVP is widely used in antiretroviral treatment (ART of HIV-1 globally. The primary objective of the AA5208/OCTANE trial was to compare the efficacy of NVP-based versus lopinavir/ritonavir (LPV/r-based initial ART.In seven African countries (Botswana, Kenya, Malawi, South Africa, Uganda, Zambia, and Zimbabwe, 500 antiretroviral-naïve HIV-infected women with CD4<200 cells/mm(3 were enrolled into a two-arm randomized trial to initiate open-label ART with tenofovir (TDF/emtricitabine (FTC once/day plus either NVP (n = 249 or LPV/r (n = 251 twice/day, and followed for ≥48 weeks. The primary endpoint was time from randomization to death or confirmed virologic failure ([VF] (plasma HIV RNA<1 log(10 below baseline 12 weeks after treatment initiation, or ≥400 copies/ml at or after 24 weeks, with comparison between treatments based on hazard ratios (HRs in intention-to-treat analysis. Equivalence of randomized treatments was defined as finding the 95% CI for HR for virological failure or death in the range 0.5 to 2.0. Baseline characteristics were (median: age = 34 years, CD4 = 121 cells/mm(3, HIV RNA = 5.2 log(10copies/ml. Median follow-up = 118 weeks; 29 (6% women were lost to follow-up. 42 women (37 VFs, five deaths; 17% in the NVP and 50 (43 VFs, seven deaths; 20% in the LPV/r arm reached the primary endpoint (HR 0.85, 95% CI 0.56-1.29. During initial assigned treatment, 14% and 16% of women receiving NVP and LPV/r experienced grade 3/4 signs/symptoms and 26% and 22% experienced grade 3/4 laboratory abnormalities. However, 35 (14% women discontinued NVP because of adverse events, most in the first 8 weeks, versus none for LPV/r (p<0.001. VF, death, or permanent treatment discontinuation occurred in 80 (32% of NVP and 54 (22% of LPV/r arms (HR = 1.7, 95% CI 1.2-2.4, with the difference primarily due to more treatment discontinuation in the NVP arm. 13 (45% of 29 women tested in the NVP versus six (15% of 40

  16. Building cooperation through health initiatives: an Arab and Israeli case study

    Directory of Open Access Journals (Sweden)

    Skinner Harvey A

    2007-07-01

    Full Text Available Abstract Background Ongoing conflict in the Middle East poses a major threat to health and security. A project screening Arab and Israeli newborns for hearing loss provided an opportunity to evaluate ways for building cooperation. The aims of this study were to: a examine what attracted Israeli, Jordanian and Palestinian participants to the project, b describe challenges they faced, and c draw lessons learned for guiding cross-border health initiatives. Methods A case study method was used involving 12 key informants stratified by country (3 Israeli, 3 Jordanian, 3 Palestinian, 3 Canadian. In-depth interviews were tape-recorded, transcribed and analyzed using an inductive qualitative approach to derive key themes. Results Major reasons for getting involved included: concern over an important health problem, curiosity about neighbors and opportunities for professional advancement. Participants were attracted to prospects for opening the dialogue, building relationships and facilitating cooperation in the region. The political situation was a major challenge that delayed implementation of the project and placed participants under social pressure. Among lessons learned, fostering personal relationships was viewed as critical for success of this initiative. Conclusion Arab and Israeli health professionals were prepared to get involved for two types of reasons: a Project Level: opportunity to address a significant health issue (e.g. congenital hearing loss while enhancing their professional careers, and b Meta Level: concern about taking positive steps for building cooperation in the region. We invite discussion about roles that health professionals can play in building "cooperation networks" for underpinning health security, conflict resolution and global health promotion.

  17. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial.

    Science.gov (United States)

    Schneider, Ralph; Lauschke, Joerg; Tischer, Tina; Schneider, Cindy; Voss, Wolfgang; Moehlenkamp, Felix; Glass, Aenne; Diedrich, Doreen; Bänsch, Dietmar

    2015-05-01

    The incidence of atrial fibrillation (AF) after ablation of a cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) is high. The purpose of this study was to test the hypothesis that AFL and AF may be initiated by pulmonary vein triggers. This prospective randomized trial tested the efficacy of a standalone pulmonary vein isolation (PVI) in patients with AFL but without AF. Patients with AFL but without documented AF were randomly assigned to 1 of 3 treatment groups: (1) antiarrhythmic drugs (AAD), (2) CTI ablation, or (3) circumferential PVI. The primary end-point was defined as any recurrent atrial tachyarrhythmia and the secondary end-point as recurrence of AFL. In case of tachyarrhythmia recurrence in the PVI group, a second PVI was performed to close gaps in the ablation lines. Of the 60 patients, 17 were randomized to AAD, 23 to CTI ablation, and 20 to PVI. During follow-up of 1.42 ± 0.83 years, 14 of 17 patients (82.4%) in the AAD group, 14 of 23 patients (60.9%) in the CTI group, and 2 of 20 patients (10%) in the PVI group reached the primary end-point (P PVI procedures per patient. AFL reoccurred in 9 patients (52.9.%) in the AAD group, in 2 patients (8.7%) in the CTI group, and after a single PVI in 3 patients (15%) in the PVI group (P = .003). After closure of gaps, 1 patient (5%) in the PVI group presented with recurrent AFL. Pulmonary vein triggers play an important role in AFL. PVI can prevent the recurrence of AFL, even without CTI ablation. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  18. How to do better health reform: a snapshot of change and improvement initiatives in the health systems of 30 countries.

    Science.gov (United States)

    Braithwaite, Jeffrey; Matsuyama, Yukihiro; Mannion, Russell; Johnson, Julie; Bates, David W; Hughes, Cliff

    2016-09-21

    Health systems are continually being reformed. Why, and how? To answer these questions, we draw on a book we recently contributed, Healthcare Reform, Quality and Safety: Perspectives, Participants, Partnerships and Prospects in 30 Countries We analyse the impact that these health-reform initiatives have had on the quality and safety of care in an international context-that is, in low-, middle- and high-income countries-Argentina, Australia, Brazil, Chile, China, Denmark, England, Ghana, Germany, the Gulf states, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Myanmar, New Zealand, Norway, Oman, Papua New Guinea (PNG), South Africa, the USA, Scotland and Sweden. Popular reforms in less well-off countries include boosting equity, providing infrastructure, and reducing mortality and morbidity in maternal and child health. In countries with higher GDP per capita, the focus is on new IT systems or trialling innovative funding models. Wealthy or less wealthy, countries are embracing ways to enhance quality of care and keep patients safe, via mechanisms such as accreditation, clinical guidelines and hand hygiene campaigns. Two timely reminders are that, first, a population's health is not determined solely by the acute system, but is a product of inter-sectoral effort-that is, measures to alleviate poverty and provide good housing, education, nutrition, running water and sanitation across the population. Second, all reformers and advocates of better-quality of care should include well-designed evaluation in their initiatives. Too often, improvement is assumed, not measured. That is perhaps the key message.

  19. Internet-based search of randomised trials relevant to mental health originating in the Arab world

    Directory of Open Access Journals (Sweden)

    Adams Clive E

    2005-07-01

    Full Text Available Abstract Background The internet is becoming a widely used source of accessing medical research through various on-line databases. This instant access to information is of benefit to busy clinicians and service users around the world. The population of the Arab World is comparable to that of the United States, yet it is widely believed to have a greatly contrasting output of randomised controlled trials related to mental health. This study was designed to investigate the existence of such research in the Arab World and also to investigate the availability of this research on-line. Methods Survey of findings from three internet-based potential sources of randomised trials originating from the Arab world and relevant to mental health care. Results A manual search of an Arabic online current contents service identified 3 studies, MEDLINE, EMBASE, and PsycINFO searches identified only 1 study, and a manual search of a specifically indexed, study-based mental health database, PsiTri, revealed 27 trials. Conclusion There genuinely seem to be few trials from the Arab world and accessing these on-line was problematic. Replication of some studies that guide psychiatric/psychological practice in the Arab world would seem prudent.

  20. 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.

  1. From rhetoric to reality: barriers faced by Health For All initiatives.

    Science.gov (United States)

    Berkeley, Dina; Springett, Jane

    2006-07-01

    The last two decades have witnessed an upsurge in the development and implementation of 'Health For All-type' initiatives in many parts of the world. However, despite the popularity of the approach, barriers and constraints to the fulfillment of their remit still persist, making it difficult for them to achieve the potential originally envisaged. Drawing upon considerable empirical work while evaluating the European Healthy City projects and English Health Action Zones, this paper explores the differences between barriers and constraints and then focuses on barriers as they manifest themselves in England. It distinguishes between cultural barriers, stemming from different philosophical, organisational, and professional/experiential cultures, and political barriers, stemming from both party political and realpolitik concerns. It discusses how these barriers often operate together, compounding their individual impacts, with detrimental effects for Health For All initiatives. Consequently, while the prevailing rhetoric appears to promote an alternative, and more appropriate, vision of how health can be maintained and enhanced, these barriers effectively function to sustain the hegemony of the status quo which was, and is, based on a different and outdated vision. We argue that acknowledging the continuous persistence of these barriers is an essential first step towards turning the prevailing health-related rhetoric into reality.

  2. Political Action Day: A Student-Led Initiative to Increase Health Advocacy Training Among Medical Students

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    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.

  3. Random assignment in clinical trials: issues in planning (Infant Health and Development Program).

    Science.gov (United States)

    Kraemer, H C; Fendt, K H

    1990-01-01

    Various options available for the randomization of subjects into groups in a clinical trial are discussed, emphasizing the issues of logistics given less focus in more mathematical treatments. We discuss advantages and disadvantages of total randomization, of Zelen-type randomization procedures, of Efron-type procedures vs more classical blocking procedures to control the balance between groups, and of Simon-Pocock-type procedures vs more classical stratification for controlling possible biases in prognostic factors. Finally, we discuss issues related to choice and implementation of randomization procedures. The discussion is illustrated with the processes of decision-making in a national collaborative randomized clinical trial, the Infant Health and Development Program.

  4. CHAMP: Cognitive behaviour therapy for health anxiety in medical patients, a randomised controlled trial

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    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

  5. Geographically varying effects of weather on tobacco consumption: implications for health marketing initiatives.

    Science.gov (United States)

    Govind, Rahul; Garg, Nitika; Sun, Wenbin

    2014-01-01

    Weather and its fluctuations have been found to influence the consumption of negative hedonic goods. However, such findings are of limited use to health marketers who cannot control the weather, and hence, its effects. The current research utilizes data obtained at the zip-code level to study geographical variations in the effect of weather on tobacco consumption across the entire continental United States. The results allow health marketers to identify areas that will be most responsive to marketing efforts aimed at curtailing negative hedonic consumption and thus implement more effective, region-specific initiatives.

  6. Exercise for health for early postmenopausal women: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Asikainen, Tuula-Maria; Kukkonen-Harjula, Katriina; Miilunpalo, Seppo

    2004-01-01

    Women who pass menopause face many changes that may lead to loss of health-related fitness (HRF), especially if sedentary. Many exercise recommendations are also relevant for early postmenopausal women; however, these may not meet their specific needs because the recommendations are based mainly on studies on men. We conducted a systematic review for randomised, controlled exercise trials on postmenopausal women (aged 50 to 65 years) on components of HRF. HRF consists of morphological fitness (body composition and bone strength), musculoskeletal fitness (muscle strength and endurance, flexibility), motor fitness (postural control), cardiorespiratory fitness (maximal aerobic power, blood pressure) and metabolic fitness (lipid and carbohydrate metabolism). The outcome variables chosen were: bodyweight; proportion of body fat of total bodyweight (F%); bone mineral density (BMD); bone mineral content (BMC); various tests on muscle performance, flexibility, balance and coordination; maximal oxygen consumption (V-dotO(2max)); resting blood pressure (BP); total cholesterol (TC); high-density lipoprotein-cholesterol; low-density lipoprotein-cholesterol; triglycerides; blood glucose and insulin. The feasibility of the exercise programme was assessed from drop-out, attendance and injury rates. Twenty-eight randomised controlled trials with 2646 participants were assessed. In total, 18 studies reported on the effects of exercise on bodyweight and F%, 16 on BMD or BMC, 11 on muscular strength or endurance, five on flexibility, six on balance or coordination, 18 on V-dotO(2max), seven on BP, nine on lipids and two studies on glucose an one on insulin. Based on these studies, early postmenopausal women could benefit from 30 minutes of daily moderate walking in one to three bouts combined with a resistance training programme twice a week. For a sedentary person, walking is feasible and can be incorporated into everyday life. A feasible way to start resistance training is to

  7. Participation in a mobile health intervention trial to improve retention in HIV care: does gender matter?

    Science.gov (United States)

    van der Kop, Mia L; Muhula, Samuel; Ekström, Anna M; Jongbloed, Kate; Smillie, Kirsten; Abunah, Bonface; Kinagwi, Koki; Kyomuhangi, Lennie B; Gelmon, Lawrence; Ojakaa, David I; Lester, Richard T; Awiti, Patricia O

    2017-02-01

    Background To be consistent with the United Nations' sustainable development goals on gender equality, mobile health (mHealth) programmes should aim to use communications technology to promote the empowerment of women. We conducted a pre-trial analysis of data from the WelTel Retain study on retention in HIV care to assess gender-based differences in phone access, phone sharing and concerns about receiving text messages from a healthcare provider. Methods Between April 2013-June 2015, HIV-positive adults were screened for trial participation at two clinics in urban slums in Nairobi, Kenya. Proportions of men and women excluded from the trial due to phone-related criteria were compared using a chi-square test. Gender-based differences in phone sharing patterns and concerns among trial participants were similarly compared. Results Of 1068 individuals screened, there was no difference in the proportion of men ( n = 39/378, 10.3%) and women ( n = 71/690, 10.3%) excluded because of phone-related criteria ( p-value = 0.989). Among those who shared their phone, women ( n = 52/108, 48.1%) were more likely than men ( n = 6/60, 10.0%) to share with other non-household and household members ( p < 0.001). Few participants had concerns about receiving text messages from their healthcare provider; those with concerns were all women ( n = 6/700). Discussion In this study, men and women were equally able to participate in a trial of an mHealth intervention. Equitable access in these urban slums may indicate the 'gender digital divide' is narrowing in some settings; however, gender-specific phone sharing patterns and concerns regarding privacy must be fully considered in the development and scale-up of mHealth programmes.

  8. 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

  9. The impact of a bodyweight and physical activity intervention (BeWEL) initiated through a national colorectal cancer screening programme: randomised controlled trial.

    Science.gov (United States)

    Anderson, Annie S; Craigie, Angela M; Caswell, Stephen; Treweek, Shaun; Stead, Martine; Macleod, Maureen; Daly, Fergus; Belch, Jill; Rodger, Jackie; Kirk, Alison; Ludbrook, Anne; Rauchhaus, Petra; Norwood, Patricia; Thompson, Joyce; Wardle, Jane; Steele, Robert J C

    2014-03-07

    To evaluate the impact of a diet and physical activity intervention (BeWEL) on weight change in people with a body mass index >25 weight (kg)/height (m)(2) at increased risk of colorectal cancer and other obesity related comorbidities. Multicentre, parallel group, randomised controlled trial. Four Scottish National Health Service health boards. 329 overweight or obese adults (aged 50 to 74 years) who had undergone colonoscopy after a positive faecal occult blood test result, as part of the national bowel screening programme, and had a diagnosis of adenoma confirmed by histopathology. 163 were randomised to intervention and 166 to control. Participants were randomised to a control group (weight loss booklet only) or 12 month intervention group (three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls). A goal of 7% reduction in body weight was set and participants received a personalised energy prescription (2508 kJ (600 kcal) below that required for weight maintenance) and bodyweight scales. Motivational interviewing techniques explored self assessed confidence, ambivalence, and personal values concerning weight. Behavioural strategies included goal setting, identifying intentions of implementation, self monitoring of body weight, and counsellor feedback about reported diet, physical activity, and weight change. The primary outcome was weight change over 12 months. Secondary outcomes included changes in waist circumference, blood pressure, fasting cardiovascular biomarkers, and glucose metabolism variables, physical activity, diet, and alcohol consumption. At 12 months, data on the primary outcome were available for 148 (91%) participants in the intervention group and 157 (95%) in the control group. Mean weight loss was 3.50 kg (SD 4.91) (95% confidence interval 2.70 to 4.30) in the intervention group compared with 0.78 kg (SD 3.77) (0.19 to 1.38) in the control group. The group difference was 2.69 kg (95% confidence interval 1

  10. The legacy of the Child Health and Nutrition Research Initiative (CHNRI

    Directory of Open Access Journals (Sweden)

    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.

  11. 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.

  12. Why is it difficult to implement e-health initiatives? A qualitative study

    Directory of Open Access Journals (Sweden)

    Wallace Paul

    2011-01-01

    Full Text Available Abstract Background The use of information and communication technologies in healthcare is seen as essential for high quality and cost-effective healthcare. However, implementation of e-health initiatives has often been problematic, with many failing to demonstrate predicted benefits. This study aimed to explore and understand the experiences of implementers -- the senior managers and other staff charged with implementing e-health initiatives and their assessment of factors which promote or inhibit the successful implementation, embedding, and integration of e-health initiatives. Methods We used a case study methodology, using semi-structured interviews with implementers for data collection. Case studies were selected to provide a range of healthcare contexts (primary, secondary, community care, e-health initiatives, and degrees of normalization. The initiatives studied were Picture Archiving and Communication System (PACS in secondary care, a Community Nurse Information System (CNIS in community care, and Choose and Book (C&B across the primary-secondary care interface. Implementers were selected to provide a range of seniority, including chief executive officers, middle managers, and staff with 'on the ground' experience. Interview data were analyzed using a framework derived from Normalization Process Theory (NPT. Results Twenty-three interviews were completed across the three case studies. There were wide differences in experiences of implementation and embedding across these case studies; these differences were well explained by collective action components of NPT. New technology was most likely to 'normalize' where implementers perceived that it had a positive impact on interactions between professionals and patients and between different professional groups, and fit well with the organisational goals and skill sets of existing staff. However, where implementers perceived problems in one or more of these areas, they also perceived a lower

  13. Study Protocol - an exploratory trial on health promoting schools at Dutch secondary schools

    Directory of Open Access Journals (Sweden)

    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.

  14. Study Protocol - an exploratory trial on health promoting schools at Dutch secondary schools

    Directory of Open Access Journals (Sweden)

    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.

  15. Pan-Canadian REspiratory STandards INitiative for Electronic Health Records (PRESTINE): 2011 national forum proceedings.

    Science.gov (United States)

    Lougheed, M Diane; Minard, Janice; Dworkin, Shari; Juurlink, Mary-Ann; Temple, Walley J; To, Teresa; Koehn, Marc; Van Dam, Anne; Boulet, Louis-Philippe

    2012-01-01

    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 bring together key

  16. 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

  17. 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.

  18. Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health Initiative

    OpenAIRE

    Nolin, Thomas D.; Aronoff, George R.; Fissell, William H.; Jain, Lokesh; Madabushi, Rajnikanth; Reynolds, Kellie; Zhang, Lei; Huang, Shiew Mei; Mehrotra, Rajnish; Flessner, Michael F.; Leypoldt, John K.; Witcher, Jennifer W.; Zineh, Issam; Archdeacon, Patrick; Roy-Chaudhury, Prabir

    2014-01-01

    The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has asse...

  19. 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.

  20. Obesity and risk of pancreatic cancer among postmenopausal women: the Women's Health Initiative (United States)

    OpenAIRE

    Luo, J.; Margolis, K L.; Adami, H-O; LaCroix, A. (Andrea); Ye, W.

    2008-01-01

    A total of 138 503 women in the Women's Health Initiative in the United States were followed (for an average of 7.7 years) through 12 September 2005 to examine obesity, especially central obesity in relation to pancreatic cancer (n=251). Women in the highest quintile of waist-to-hip ratio had 70% (95% confidence interval 10–160%) excess risk of pancreatic cancer compared with women in the lowest quintile.

  1. First-line nurse leaders' health-care change management initiatives.

    Science.gov (United States)

    Macphee, Maura; Suryaprakash, Nitya

    2012-03-01

    To examine nurse leaders' change management projects within British Columbia, Canada. British Columbia Nursing Leadership Institute 2007-10 attendees worked on year-long change management initiatives/projects of importance to their respective health-care institutions. Most leaders were in first-line positions with Change management, a universal competency, must be included in leadership development programmes. © 2011 Blackwell Publishing Ltd.

  2. ONE Nano: NIEHS’s Strategic Initiative on the Health and Safety Effects of Engineered Nanomaterials

    Science.gov (United States)

    Johnson, Anne F.; Balshaw, David M.; Garantziotis, Stavros; Walker, Nigel J.; Weis, Christopher; Nadadur, Srikanth S.; Birnbaum, Linda S.

    2013-01-01

    Background: The past decade has seen tremendous expansion in the production and application of engineered nanomaterials (ENMs). The unique properties that make ENMs useful in the marketplace also make their interactions with biological systems difficult to anticipate and critically important to explore. Currently, little is known about the health effects of human exposure to these materials. Objectives: As part of its role in supporting the National Nanotechnology Initiative, the National Institute of Environmental Health Sciences (NIEHS) has developed an integrated, strategic research program—“ONE Nano”—to increase our fundamental understanding of how ENMs interact with living systems, to develop predictive models for quantifying ENM exposure and assessing ENM health impacts, and to guide the design of second-generation ENMs to minimize adverse health effects. Discussion: The NIEHS’s research investments in ENM health and safety include extramural grants and grantee consortia, intramural research activities, and toxicological studies being conducted by the National Toxicology Program (NTP). These efforts have enhanced collaboration within the nanotechnology research community and produced toxicological profiles for selected ENMs, as well as improved methods and protocols for conducting in vitro and in vivo studies to assess ENM health effects. Conclusion: By drawing upon the strengths of the NIEHS’s intramural, extramural, and NTP programs and establishing productive partnerships with other institutes and agencies across the federal government, the NIEHS’s strategic ONE Nano program is working toward new advances to improve our understanding of the health impacts of engineered nanomaterials and support the goals of the National Nanotechnology Initiative. PMID:23407114

  3. 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...... with blood bank and image management software which is regulated in the USA. Of the 16 initiatives directed at unregulated software, 11 were aimed at increasing standardisation using guidelines and standards for safe system design, build, implementation and use. Three initiatives for unregulated software...... 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...

  4. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  5. 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.

  6. Are current debt relief initiatives an option for scaling up health financing in beneficiary countries?

    Science.gov (United States)

    Kaddar, M; Furrer, E

    2008-11-01

    One central goal of the enhanced Heavily Indebted Poor Countries (HIPC) Initiative and the more recent Multilateral Debt Relief Initiative (MDRI) is to free up additional resources for public spending on poverty reduction. The health sector was expected to benefit from a considerable share of these funds. The volume of released resources is important enough in certain countries to make a difference for priority programmes that have been underfunded so far. However, the relevance of these initiatives in terms of boosting health expenditure depends essentially, at the global level, on the compliance of donors with their aid commitments and, at the domestic level, on the success of health officials in advocating for an adequate share of the additional fiscal space. Advocacy efforts are often limited by a state of asymmetric information whereby some ministries are not well aware of the economic consequences of debt relief on public finances and of the management systems in place to deal with savings from debt relief. A thorough comprehension of these issues seems essential for health advocates to increase their bargaining power and for a wider public to readjust expectations of what debt relief can realistically achieve and of what can be measured. This paper intends to narrow the information gap by classifying debt relief savings management systems observed in practice. We illustrate some of the major advantages and stated drawbacks and outline the policy implications for health officials operating in the countries concerned. There should be careful monitoring of fungibility (i.e. where untraceable funds risk substitution) and additionality (i.e. the extent to which new inputs add to existing inputs at national and international level).

  7. Predicting initial client engagement with community mental health services by routinely measured data.

    Science.gov (United States)

    Roeg, Diana; van de Goor, Ien; Garretsen, Henk

    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 before the first contact were measured at team entrance with clients (n = 529) of three community mental health teams. Regression analysis was used to predict engagement. Gender, age, referrer, having children, having a partner, and ethnicity showed a minor relationship with engagement. Higher problem severity measured by the team members with the Health of the Nation Outcome Scales, being referred for having psychiatric problems and/or causing severe and long-lasting trouble (as 'assessed' by the often non-professional referrer), and a longer duration between enrollment and the first conversation with a client, were indicative for a lower engagement. The final model explained 19.2 % of the variance in engagement. It can be concluded that initial client engagement with community mental health services can be predicted, in part, by routinely measured data. The findings can be used by community mental healthcare teams to create an awareness system.

  8. Whose place is it anyway? Representational politics in a place-based health initiative.

    Science.gov (United States)

    Rushton, Carole

    2014-03-01

    The association between place and poor health, such as chronic disease, is well documented and in recent years has given rise to public health strategies such as place-based initiatives (PBIs). This article reports on the emergence of one such initiative in Australia, in regions identified as culturally diverse and socially disadvantaged. The study draws on the intellectual resources provided by governmentality and actor-network theory to provide insights into the reasons why community actors were excluded from a new governance body established to represent their interests. Risk-thinking and representational politics determined who represented whom in the PBI partnership. Paradoxically, actors representing 'community', identified as being 'at risk', were excluded from the partnership during its translation because they were also identified as being 'a risk'. As a consequence, contrary to federal government health and social policy in Australia, it was state government interests rather than the interests of community actors that influenced decisions made in relation to local health planning and the allocation of resources.

  9. The role of the architectural environment in community health: an evidence-based initiative.

    Science.gov (United States)

    Verderber, Stephen; Kimbrell, Joseph

    2005-01-01

    This discussion reports the status of a 12-year program administered by a statewide health agency to strategically assess, redevelop, and monitor the architectural and facility management performance of its network of community-based public health care facilities. A protocol, the Strategic Facility Improvement initiative, has directly resulted in significant improvements to the major share of a network of over 100 community clinic and clinical support facilities in the State of Louisiana. The SFI initiative provides oversight with respect to the allocation of public health capital improvement infrastructural resources and has guided completion of 55 facility replacement or renovation projects to date. Its administrative mission, organizational structure, and field methodology is presented as a vehicle to significantly improve the architectural condition of clinical and clinical support environments for underrepresented patient populations. The SFI process is discussed as an evidence-based means to foster greater systemic success in capital improvement efforts within public sector health agencies in the United States and in international contexts.

  10. Applying a global justice lens to health systems research ethics: an initial exploration.

    Science.gov (United States)

    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.

  11. The initial evaluation in the working process of occupational therapists in the mental health system

    Directory of Open Access Journals (Sweden)

    Alana de Paiva Nogueira Fornereto Gozzi

    2013-12-01

    Full Text Available : In the field of mental health, Occupational Therapy uses different references in practice development. It is important to observe how occupational therapists in the mental health system assess users’ demands on their work scenarios. In this research, we aimed to study the assessment process of occupational therapists in different services of the mental health system. A descriptive cross-sectional case study was conducted using a qualitative approach. Data were obtained through interviews with occupational therapists integrated to the mental health services of a specific region. The region studied belongs to a Regional Health Department in the state of São Paulo. The thematic analysis method was applied to the data collected allowing the dentification of categories of analysis. The results obtained from one of these categories (the assessment process of occupational therapists showed that most of the professionals interviewed do perform the initial evaluation. This assessment was carried out informally in every case employing tools built by the professionals themselves during their own practices. In addition, patients with chronic mental illnesses are usually admitted in the Occupational Therapy services studied. These characteristics, obtained from active professionals, are useful in the creation of technical criteria for users’ admission in Occupational Therapy mental health treatment.

  12. The laboratory efficiencies initiative: partnership for building a sustainable national public health laboratory system.

    Science.gov (United States)

    Ridderhof, John C; Moulton, Anthony D; Ned, Renée M; Nicholson, Janet K A; Chu, May C; Becker, Scott J; Blank, Eric C; Breckenridge, Karen J; Waddell, Victor; Brokopp, Charles

    2013-01-01

    Beginning in early 2011, the Centers for Disease Control and Prevention and the Association of Public Health Laboratories launched the Laboratory Efficiencies Initiative (LEI) to help public health laboratories (PHLs) and the nation's entire PHL system achieve and maintain sustainability to continue to conduct vital services in the face of unprecedented financial and other pressures. The LEI focuses on stimulating substantial gains in laboratories' operating efficiency and cost efficiency through the adoption of proven and promising management practices. In its first year, the LEI generated a strategic plan and a number of resources that PHL directors can use toward achieving LEI goals. Additionally, the first year saw the formation of a dynamic community of practitioners committed to implementing the LEI strategic plan in coordination with state and local public health executives, program officials, foundations, and other key partners.

  13. Overview of the Veterans Health Administration (VHA) Quality Enhancement Research Initiative (QUERI)

    Science.gov (United States)

    McQueen, Lynn; Mittman, Brian S.; Demakis, John G.

    2004-01-01

    The U.S. Veterans Health Administration (VHA)'s Quality Enhancement Research Initiative (QUERI) is an innovative integration of health services research, policy, and clinical care delivery designed to improve the quality, outcomes, and efficiency of VHA health care through the identification and implementation of evidence-based practices in routine care settings. A total of eight condition-specific QUERI centers are currently in operation, each pursuing an integrated portfolio of activities designed to identify and correct gaps in clinical quality and performance and to derive generalizable scientific knowledge regarding quality improvement processes and methods and their effectiveness. This overview article describes QUERI's mission, history, structure, and activities and provides a brief summary of key findings and impacts. PMID:15187071

  14. Patient self-management in primary care patients with mild COPD - protocol of a randomised controlled trial of telephone health coaching.

    Science.gov (United States)

    Sidhu, Manbinder S; Daley, Amanda; Jordan, Rachel; Coventry, Peter A; Heneghan, Carl; Jowett, Sue; Singh, Sally; Marsh, Jennifer; Adab, Peymane; Varghese, Jinu; Nunan, David; Blakemore, Amy; Stevens, Jenny; Dowson, Lee; Fitzmaurice, David; Jolly, Kate

    2015-02-22

    The prevalence of diagnosed chronic obstructive pulmonary disease (COPD) in the UK is 1.8%, although it is estimated that this represents less than half of the total disease in the population as much remains undiagnosed. Case finding initiatives in primary care will identify people with mild disease and symptoms. The majority of self-management trials have identified patients from secondary care clinics or following a hospital admission for exacerbation of their condition. This trial will recruit a primary care population with mild symptoms of COPD and use telephone health coaching to encourage self-management. In this study, using a multi-centred randomised controlled trial (RCT) across at least 70 general practices in England, we plan to establish the effectiveness of nurse-led telephone health coaching to support self-management in primary care for people who report only mild symptoms of their COPD (MRC grade 1 and 2) compared to usual care. The intervention focuses on taking up smoking cessation services, increasing physical activity, medication management and action planning and is underpinned by behavioural change theory. In total, we aim to recruit 556 patients with COPD confirmed by spirometry with follow up at six and 12 months. The primary outcome is health related quality of life using the St Georges Respiratory Questionnaire (SGRQ). Spirometry and BMI are measured at baseline. Secondary outcomes include self-reported health behaviours (smoking and physical activity), physical activity measured by accelerometery (at 12 months), psychological morbidity, self-efficacy and cost-effectiveness of the intervention. Longitudinal qualitative interviews will explore how engaged participants were with the intervention and how embedded behaviour change was in every day practices. This trial will provide robust evidence about the effectiveness of a novel telephone health coaching intervention to promote behaviour change and prevent disease progression in patients

  15. The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health.

    Science.gov (United States)

    Flear, Mark L

    2016-03-01

    The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives. 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/

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

    Science.gov (United States)

    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.

  17. The Evolution of World Health Organization's Initiatives for the Strengthening of Nursing and Midwifery.

    Science.gov (United States)

    Ventura, Carla Aparecida Arena; Mendes, Isabel Amélia Costa; Fumincelli, Laís; Trevizan, Maria Auxiliadora

    2015-09-01

    To describe the evolution in the resolutions approved by World Health Organization (WHO)'s World Health Assembly (WHA) to strengthen nursing and midwifery. Qualitative and descriptive study, undertaken through a search of resolutions presented by WHA, on the WHO website, regarding the theme "strengthening of nursing and midwifery." The resolutions on the theme "nursing and midwifery" were included, whose titles were available and whose full texts were accessed, excluding those on general health themes. The key words used were resolutions, strengthening, and nursing and midwifery. Among the 20 resolutions found, 12 were selected, adopted between 1948 and 2013, in accordance with the study inclusion criteria. The data were interpreted using thematic qualitative analysis, identifying and grouping the data in categories related to the study theme. Based on the content analysis of the 12 resolutions studied, three thematic categories were defined: "nursing and midwifery in primary health"; "role of nursing and midwifery in health for all"; and "nurses and midwives' professional training." Based on the categories, the evolution in the strengthening of nursing and midwifery was demonstrated through the initiatives and resolutions approved by WHA, highlighting the importance of nurses and midwives as multiprofessional health team members and their fundamental role in the improvements of the health system. Therefore, in accordance with the needs of each country, the member states can implement strategies presented by the WHA resolutions to strengthen nursing and midwifery services. This study has relevance for the development of health policies considering the relevant contributions of nurses and midwives to healthcare systems and services, based on the analysis of WHO resolutions involving these professions. © 2015 Sigma Theta Tau International.

  18. Implementing health policy: lessons from the Scottish Well Mens policy initiative

    Directory of Open Access Journals (Sweden)

    Flora Douglas

    2015-12-01

    Full Text Available Background: 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. Methods and materials: 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. Results and conclusions: 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.

  19. The Role of Tai Chi in Mental Health Management-Lessons Learned from Clinical Trials.

    Science.gov (United States)

    Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

    2016-01-01

    Many people seek alternative treatments to reduce stress and to manage anxiety. To counsel people appropriately, physicians need to understand current evidence and recognize both the value and defects in the facts. To review the effect of Tai Chi interventions on improvement of mental health and to learn lessons from current evidence through various clinical studies. A literature search was performed to identify research studies that assessed Tai Chi's mental health benefits. Selected studies were classified according to research design, outcome measures, and results. They were qualitatively assessed based on Tai Chi's significant influence on mental health in the areas of mood, stress, and anxiety level. After screening in citations that mentioned Tai Chi as an intervention, we found 21 clinical studies, all of which included at least one outcome measure of mental health or a testing system that included a mental health component. Our results show low evidence of recommending Tai Chi intervention to all patients who seek improvement in mental health despite that many positive effects of Tai Chi practice on mood and anxiety were found in different clinical trials. Considering the fact that Tai Chi is a gentle exercise, well suited for people with various physical capabilities, especially the elderly, health care providers may consider recommending it to people with mental health issues and seek alternative treatment besides routine medical care. Nonetheless, clinicians should be aware of the limitations due to incomplete understanding of Tai Chi as an intervention. Better evidence and stronger clinical trial designs are needed to further investigate Tai Chi's role in improving mental health.

  20. 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.

  1. WIC mothers' social environment and postpartum health on breastfeeding initiation and duration.

    Science.gov (United States)

    Darfour-Oduro, Sandra Asantewaa; Kim, Juhee

    2014-12-01

    A low breastfeeding rate has been a consistent maternal and child health problem in the United States, especially for low-income families. Understanding mothers' social environment and overall well-being is important in determining how mothers will take care of themselves and their infants during the postnatal period in relation to the breastfeeding rate among low-income mothers. In this study, we examined the effects of the social environment of mothers enrolled in a Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program in eastern Illinois and their postpartum health on breastfeeding initiation (n=103) and maintaining breastfeeding for at least 3 months (n=73). Using logistic regression models, a significant positive association (adjusted odds ratio [AOR]=3.47; 95% confidence interval [CI], 1.15-10.47; p=0.03) between marital status and breastfeeding initiation and a significant negative association (AOR=0.23; 95% CI, 0.06-0.88) between receiving food stamps and breastfeeding initiation were found. WIC mothers who were married were 4.1 times as likely to maintain any breastfeeding for at least 3 months than single mothers, and the association was significant (AOR=4.08; 95% CI, 1.36-12.27; p=0.01). The breastfeeding initiation rate was 77.7%, however, the mean±standard deviation age of the child when breastfeeding stopped was 2.2±1.4 months. There was a nonsignificant association between postpartum depression and breastfeeding initiation and maintaining any breastfeeding for 3 months. This study has shown that the familial environment of mothers plays a very important role in improving breastfeeding rates among WIC mothers. In addition, there is a negative relationship between using a food assistance program and breastfeeding among low-income women.

  2. 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.…

  3. 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

  4. An integrated approach to preventing cardiovascular disease: community-based approaches, health system initiatives, and public health policy

    Directory of Open Access Journals (Sweden)

    Tina Karwalajtys

    2010-09-01

    Full Text Available Tina Karwalajtys1, Janusz Kaczorowski2,31Department of Family Medicine, McMaster University, Hamilton, ON, Canada; 2Primary Care & Community Research, Child & Family Research Institute, Vancouver, BC, Canada; 3Department of Family Practice, University of British Columbia, Vancouver, BC, CanadaAbstract: Cardiovascular disease (CVD is largely the product of interactions among modifiable risk factors that are common in developed nations and increasingly of concern in developing countries. Hypertension is an important precursor to the development of CVD, and although detection and treatment rates have improved in recent years in some jurisdictions, effective strategies and policies supporting a shift in distribution of risk factors at the population level remain paramount. Challenges in managing cardiovascular health more effectively include factors at the patient, provider, and system level. Strategies to reduce hypertension and CVD should be population based, incorporate multilevel, multicomponent, and socioenvironmental approaches, and integrate community resources with public health and clinical care. There is an urgent need to improve monitoring and management of risk factors through community-wide, primary care-linked initiatives, increase the evidence base for community-based prevention strategies, further develop and evaluate promising program components, and develop new approaches to support healthy lifestyle behaviors in diverse age, socioeconomic, and ethnocultural groups. Policy and system changes are critical to reduce risk in populations, including legislation and public education to reduce dietary sodium and trans-fatty acids, food pricing policies, and changes to health care delivery systems to explicitly support prevention and management of CVD.Keywords: risk factors, blood pressure determination, community health services, community health planning, public health practice

  5. Does clinical equipoise apply to cluster randomized trials in health research?

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    Brehaut Jamie C

    2011-05-01

    Full Text Available Abstract 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

  6. West African Youth Initiative: outcome of a reproductive health education program.

    Science.gov (United States)

    Brieger, W R; Delano, G E; Lane, C G; Oladepo, O; Oyediran, K A

    2001-12-01

    To describe the implementation and evaluation of an adolescent reproductive health peer education program in West Africa. The program, known as the West African Youth Initiative (WAYI), was developed to improve knowledge of sexuality and reproductive health, and promote safer sex behaviors and contraceptive use among sexually active adolescents in Nigeria and Ghana. Between November 1994 and April 1997, two organizations, the Association for Reproductive and Family Health (ARFH), based in Nigeria, and Advocates for Youth, based in Washington D.C., supported community-based youth-serving organizations in the two countries to implement peer education projects. Consultants from the African Regional Health Education Centre (ARHEC) in Nigeria provided technical assistance in designing and conducting a quasi-experimental process and outcome evaluation of the projects. There were significant differences over time and between intervention and control groups concerning reproductive health knowledge, use of contraceptives in the previous 3 months, willingness to buy contraceptives, and self-efficacy in contraceptive use. Overall, the project provides evidence that peer education is most effective at improving knowledge and promoting attitudinal and behavior change among young people in school settings.

  7. United States-Mexico cross-border health insurance initiatives: Salud Migrante and Medicare in Mexico.

    Science.gov (United States)

    Vargas Bustamante, Arturo; Laugesen, Miriam; Caban, Mabel; Rosenau, Pauline

    2012-01-01

    While U.S. health care reform will most likely reduce the overall number of uninsured Mexican-Americans, it does not address challenges related to health care coverage for undocumented Mexican immigrants, who will remain uninsured under the measures of the reform; documented low-income Mexican immigrants who have not met the five-year waiting period required for Medicaid benefits; or the growing number of retired U.S. citizens living in Mexico, who lack easy access to Medicare-supported services. This article reviews two promising binational initiatives that could help address these challenges-Salud Migrante and Medicare in Mexico; discusses their prospective applications within the context of U.S. health care reform; and identifies potential challenges to their implementation (legal, political, and regulatory), as well as the possible benefits, including coverage of uninsured Mexican immigrants, and their integration into the U.S. health care system (through Salud Migrante), and access to lower-cost Medicare-supported health care for U.S. retirees in Mexico (Medicare in Mexico).

  8. Health education for microcredit clients in Peru: a randomized controlled trial.

    Science.gov (United States)

    Hamad, Rita; Fernald, Lia Ch; Karlan, Dean S

    2011-01-24

    behavior, or that microcredit organizations may not be an appropriate setting for the administration of child health educational interventions of this type. This study is registered with ClinicalTrials.gov, NCT01047033.

  9. Randomised controlled trial of cognitive-motivational therapy program for the initial phase of schizophrenia: a 6-month assessment

    Directory of Open Access Journals (Sweden)

    Carol Palma-Sevillano

    2011-06-01

    Full Text Available Background and Objectives: The aim of this study is to investigate the relative effectiveness of routine care (RC in addition to a specific early intervention program (PIPE compared to routine care alone. Methods: A total of 34 participants in the initial phase of schizophrenia took part in randomized, single-blind controlled trial. Participants were randomized to receive either routine care (RC; n = 13 or routine integrated with Cognitive-Motivational Therapy (PIPE; n = 21. PIPE comprised individual and family Cognitive-Motivational therapy plus routine care for 12 months. In this paper we present preliminary results at 6 months after the beginning of the intervention. Clinical assessments were carried out at pre-treatment, and in this manuscript the results at 3 and 6 months after starting the intervention by external raters are presented, using the Positive and Negative Syndrome Scale, Brief Psychiatry Rating Scale, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, and relapses. Mann-Whitney test and MANOVAs analysis for variance effects were used for the statistical analysis. Results: Significant greater clinical effects were observed in those patients treated in RC+PIPE at three months from baseline assessment and at six months in PANSS scale (Mann-Whitney test; p < 0.000. Other benefits of the program included increase in global activity, reduced relapse rates, and reduction of the pharmacological treatment. Conclusions: These findings show the effectiveness of a program of routine care integrated with cognitive-motivational interventions (individual and family therapy over routine psychiatric care alone for patients who are in the initial phase of schizophrenia.

  10. Result of randomized control trial to increase breast health awareness among young females in Malaysia.

    Science.gov (United States)

    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 (pknowledge on breast self examination (pBreast 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. The ANZCTR clinical trial registry ( ACTRN12616000831482 ), retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.

  11. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  12. Preventing smoking initiation or relapse following 8.5 weeks of involuntary smoking abstinence in basic military training: trial design, interventions, and baseline data.

    Science.gov (United States)

    Brandon, Thomas H; Klesges, Robert C; Ebbert, Jon O; Talcott, Gerald W; Thomas, Fridtjof; Leroy, Karen; Richey, Phyllis A; Colvin, Lauren

    2014-05-01

    Smoking cessation is a primary method of reducing excess mortality and morbidity. Unfortunately, the vast majority of cessation attempts end in eventual relapse. Relapse-prevention interventions have shown some success at improving the long-term maintenance of tobacco abstinence among individuals motivated to abstain. However, involuntary tobacco abstinence (e.g., military training, hospitalization, incarceration) presents another opportunity for intervention to prevent relapse. During basic military training (BMT), tobacco use is strictly forbidden in all service branches, but tobacco relapse (and initiation) following BMT is extremely high. This paper reports on the design, intervention development, and baseline characteristics of a randomized controlled trial testing minimal interventions designed to prevent tobacco relapse among United States Air Force (USAF) personnel following BMT. Participants are randomized by squadron to receive either a standard smoking-cessation booklet, a new motivation-based booklet designed specifically for USAF personal, or the latter booklet combined with a brief, face-to-face motivational session. Primary outcomes will be self-reported tobacco use at 12 and 24month follow-up. Given that the Department of Defense is the world's largest employer, the potential of leveraging involuntary tobacco abstinence during BMT into extended abstinence has substantial public health significance.

  13. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

    OpenAIRE

    Bruland, P; McGilchrist, M.; Zapletal, E.; Acosta, D.; Proeve, J.; Askin, S.; Ganslandt, T.; Doods, J.; Dugas, M.

    2016-01-01

    BACKGROUND: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems...

  14. 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…

  15. Developing sustainable global health technologies: insight from an initiative to address neonatal hypothermia.

    Science.gov (United States)

    Gupta, Rajesh; Patel, Rajan; Murty, Naganand; Panicker, Rahul; Chen, Jane

    2015-02-01

    Relative to drugs, diagnostics, and vaccines, efforts to develop other global health technologies, such as medical devices, are limited and often focus on the short-term goal of prototype development instead of the long-term goal of a sustainable business model. To develop a medical device to address neonatal hypothermia for use in resource-limited settings, we turned to principles of design theory: (1) define the problem with consideration of appropriate integration into relevant health policies, (2) identify the users of the technology and the scenarios in which the technology would be used, and (3) use a highly iterative product design and development process that incorporates the perspective of the user of the technology at the outset and addresses scalability. In contrast to our initial idea, to create a single device, the process guided us to create two separate devices, both strikingly different from current solutions. We offer insights from our initial experience that may be helpful to others engaging in global health technology development.

  16. The Border Environmental Health Initiative-investigating the transboundary Santa Cruz watershed

    Science.gov (United States)

    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.

  17. Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

    Science.gov (United States)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-06-11

    There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis. We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration. Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for

  18. Initiating a participatory action research process in the Agincourt health and socio-demographic surveillance site.

    Science.gov (United States)

    Wariri, Oghenebrume; D'Ambruoso, Lucia; Twine, Rhian; Ngobeni, Sizzy; van der Merwe, Maria; Spies, Barry; Kahn, Kathleen; Tollman, Stephen; Wagner, Ryan G; Byass, Peter

    2017-06-01

    Despite progressive health policy, disease burdens in South Africa remain patterned by deeply entrenched social inequalities. Accounting for the relationships between context, health and risk can provide important information for equitable service delivery. The aims of the research were to initiate a participatory research process with communities in a low income setting and produce evidence of practical relevance. We initiated a participatory action research (PAR) process in the Agincourt health and socio-demographic surveillance site (HDSS) in rural north-east South Africa. Three village-based discussion groups were convened and consulted about conditions to examine, one of which was under-5 mortality. A series of discussions followed in which routine HDSS data were presented and participants' subjective perspectives were elicited and systematized into collective forms of knowledge using ranking, diagramming and participatory photography. The process concluded with a priority setting exercise. Visual and narrative data were thematically analyzed to complement the participants' analysis. A range of social and structural root causes of under-5 mortality were identified: poverty, unemployment, inadequate housing, unsafe environments and shortages of clean water. Despite these constraints, single mothers were often viewed as negligent. A series of mid-level contributory factors in clinics were also identified: overcrowding, poor staffing, delays in treatment and shortages of medications. In a similar sense, pronounced blame and negativity were directed toward clinic nurses in spite of the systems constraints identified. Actions to address these issues were prioritized as: expanding clinics, improving accountability and responsiveness of health workers, improving employment, providing clean water, and expanding community engagement for health promotion. We initiated a PAR process to gain local knowledge and prioritize actions. The process was acceptable to those

  19. Educational attainment, MRI changes, and cognitive function in older postmenopausal women from the Women's Health Initiative Memory Study.

    Science.gov (United States)

    Rapp, Stephen R; Espeland, Mark A; Manson, Joann E; Resnick, Susan M; Bryan, Nick R; Smoller, Sylvia; Coker, Laura H; Phillips, Lawrence S; Stefanick, Marcia L; Sarto, Gloria E

    2013-01-01

    The relationship between neuropathology and clinically manifested functional and cognitive deficits is complex. Clinical observations of individuals with greater neuropathology who function better than some individuals with less neuropathology are common and puzzling. Educational attainment, a proxy for "cognitive reserve," may help to explain this apparent contradiction. The objective of this study is to determine if educational attainment is correlated with cognitive decline, brain lesion volume, and total brain atrophy. One thousand three hundred ninety of the 7,479 community-dwelling women 65 years of age and older enrolled in the Women's Health Initiative Memory Study, two parallel randomized, placebo-controlled clinical trials comparing unopposed and opposed postmenopausal hormone therapy with placebo, were studied. Study participants received annual assessments of global cognitive function with the Modified Mini Mental State exam. One thousand sixty-three participants also received supplemental neurocognitive battery and neuroimaging studies. Magnetic resonance imaging was used to calculate total ischemic lesion and brain volumes. Incident cases of probable dementia and mild cognitive impairment were centrally adjudicated. After adjustment for total lesion and total brain volumes (atrophy), higher educational attainment predicted better cognitive performance (p cognitive function (p < 0.001). Thus, higher educational attainment was associated with a delay in diagnosis of dementia/MCI in the face of a growing neuropathological load.

  20. Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Levenson, Jessica C; Rollman, Bruce L; Ritterband, Lee M; Strollo, Patrick J; Smith, Kenneth J; Yabes, Jonathan G; Moore, Charity G; Harvey, Allison G; Buysse, Daniel J

    2017-06-06

    Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

  1. 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.

  2. Exploring How Knowledge Translation Can Improve Sustainability of Community-Based Health Initiatives for People with Intellectual/Developmental Disabilities

    Science.gov (United States)

    Spassiani, Natasha A.; Parker Harris, Sarah; Hammel, Joy

    2016-01-01

    Community-based health initiatives (CBHI) play an important role in maintaining the health, function and participation of people with intellectual/developmental disabilities (I/DD) living in the community. However, implementation and long-term sustainability of CBHI is challenging. The Promoting Action on Research Implementation in Health Services…

  3. Initial experiences and innovations in supervising community health workers for maternal, newborn, and child health in Morogoro region, Tanzania.

    Science.gov (United States)

    Roberton, Timothy; Applegate, Jennifer; Lefevre, Amnesty E; Mosha, Idda; Cooper, Chelsea M; Silverman, Marissa; Feldhaus, Isabelle; Chebet, Joy J; Mpembeni, Rose; Semu, Helen; Killewo, Japhet; Winch, Peter; Baqui, Abdullah H; George, Asha S

    2015-04-09

    Supervision is meant to improve the performance and motivation of community health workers (CHWs). However, most evidence on supervision relates to facility health workers. The Integrated Maternal, Newborn, and Child Health (MNCH) Program in Morogoro region, Tanzania, implemented a CHW pilot with a cascade supervision model where facility health workers were trained in supportive supervision for volunteer CHWs, supported by regional and district staff, and with village leaders to further support CHWs. We examine the initial experiences of CHWs, their supervisors, and village leaders to understand the strengths and challenges of such a supervision model for CHWs. Quantitative and qualitative data were collected concurrently from CHWs, supervisors, and village leaders. A survey was administered to 228 (96%) of the CHWs in the Integrated MNCH Program and semi-structured interviews were conducted with 15 CHWs, 8 supervisors, and 15 village leaders purposefully sampled to represent different actor perspectives from health centre catchment villages in Morogoro region. Descriptive statistics analysed the frequency and content of CHW supervision, while thematic content analysis explored CHW, supervisor, and village leader experiences with CHW supervision. CHWs meet with their facility-based supervisors an average of 1.2 times per month. CHWs value supervision and appreciate the sense of legitimacy that arises when supervisors visit them in their village. Village leaders and district staff are engaged and committed to supporting CHWs. Despite these successes, facility-based supervisors visit CHWs in their village an average of only once every 2.8 months, CHWs and supervisors still see supervision primarily as an opportunity to check reports, and meetings with district staff are infrequent and not well scheduled. Supervision of CHWs could be strengthened by streamlining supervision protocols to focus less on report checking and more on problem solving and skills development

  4. 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.

  5. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  6. Reducing postpartum weight retention – a pilot trial in primary health care

    Directory of Open Access Journals (Sweden)

    Fogelholm Mikael

    2007-09-01

    Full Text Available Abstract Background Postpartum weight retention may contribute to the development of obesity. We studied whether individual counselling on diet and physical activity from 2 to 10 months postpartum has positive effects on diet and leisure time physical activity and increases the proportion of primiparas returning to their pre-pregnancy weight. Methods A controlled trial including ninety-two postpartum primiparas was conducted in three intervention and three control child health clinics in primary health care in Finland. The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse; the controls received the usual care. Results In total, 50% of the intervention group and 30% of the control group returned to their pre-pregnancy weight (weight retention ≤ 0 kg by 10 months postpartum (p = 0.06. The confounder-adjusted odds ratio for returning to pre-pregnancy weight was 3.89 (95% CI 1.16–13.04, p = 0.028 for the intervention group compared with the controls. The mean proportion of high-fibre bread (of total weekly amount of bread increased by 16.1% (95% CI 4.3–27.9 by 10 months postpartum in the intervention group compared with the controls when adjusted for confounders (p = 0.008. No significant differences were observed in changes in leisure time physical activity between the groups. Conclusion The intervention increased the proportion of primiparas returning to pre-pregnancy weight and the proportion of high-fibre bread in their diet. Larger randomized controlled trials are needed to show whether counselling can improve dietary and leisure time physical activity habits in postpartum women and also to confirm the results concerning the effect on reducing postpartum weight retention. Trial registration Current Controlled Trials ISRCTN21512277

  7. Rethinking Evaluations of Health Equity Initiatives: an introduction to the special issue.

    Science.gov (United States)

    Sridharan, Sanjeev; Tannahill, Carol

    2013-02-01

    This paper is an introduction to a special issue on "Re-thinking Evaluations of Health Equity Initiatives." The papers in this volume aim to build understanding of how evaluations can contribute to addressing inequities and how evaluation design can develop a better understanding and also better respond to: (i) policy maker and practitioner needs; (ii) the systemic and complex nature of the interventions necessary to impact inequities; (iii) an understanding of the processes that generate inequities. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Return to work and occupational physicians' management of common mental health problems - process evaluation of a randomized controlled trial

    National Research Council Canada - National Science Library

    David S Rebergen; David J Bruinvels; Chris M Bos; Allard J van der Beek; Willem van Mechelen

    2010-01-01

    ...) to the Dutch guideline on the management of common mental health problems and its effect on return to work as part of the process evaluation of a trial comparing adherence to the guideline to care as usual...

  9. 10 Jahre Women’s Health Initiative (WHI: Was haben wir gelernt?

    Directory of Open Access Journals (Sweden)

    Birkhäuser M

    2013-01-01

    Full Text Available Bis 2002 galten die Östrogen-Ersatztherapie (ERT und die kombinierte Östrogen-Gestagen-Ersatztherapie (oder Hormonersatztherapie [HRT] als sicher und zuverlässig. Nach allen damaligen Daten aus soliden Beobachtungsstudien wie der Nurses’ Health Study überwog der Nutzen einer ERT/HRT deren Risiken. Dann löste die Erstpublikation zur Women’s Health Initiative zu Unrecht eine panikartige Angst vor jeglicher Hormoneinnahme aus. Die vorliegende Stellungnahme fasst den heutigen evidenzbasierten Wissensstand zu Nutzen und Risken einer HRT (inklusive Tibolon und von SERMs 10 Jahre nach der ersten WHI-Publikation zusammen. Sie kommt zum Schluss, dass innerhalb des „günstigen Fensters“ der Nutzen signifikant über die Risiken überwiegt.

  10. Compliance with guidelines-recommended processes in pneumonia: impact of health status and initial signs.

    Directory of Open Access Journals (Sweden)

    Rosario Menéndez

    Full Text Available Initial care has been associated with improved survival of community-acquired pneumonia (CAP. We aimed to investigate patient comorbidities and health status measured by the Charlson index and clinical signs at diagnosis associated with adherence to recommended processes of care in CAP. We studied 3844 patients hospitalized with CAP. The evaluated recommendations were antibiotic adherence to Spanish guidelines, first antibiotic dose 65 (OR, 1.51 and COPD (OR, 1.80 were protective factors. The combination of antibiotic adherence and timing <6 hours was negatively associated with confusion (OR, 0.69 and a high Charlson score (OR, 0.92 adjusting for severity and hospital effect, whereas age was not an independent factor. Deficient health status and confusion, rather than age, are associated with lower compliance with antibiotic therapy recommendations and timing, thus identifying a subpopulation more prone to receiving lower quality care.

  11. Compliance with Guidelines-Recommended Processes in Pneumonia: Impact of Health Status and Initial Signs

    Science.gov (United States)

    Menéndez, Rosario; Torres, Antoni; Reyes, Soledad; Zalacain, Rafael; Capelastegui, Alberto; Rajas, Olga; Borderías, Luis; Martín-Villasclaras, Juan J.; Bello, Salvador; Alfageme, Inmaculada; de Castro, Felipe Rodríguez; Rello, Jordi; Molinos, Luis; Ruiz-Manzano, Juan

    2012-01-01

    Initial care has been associated with improved survival of community-acquired pneumonia (CAP). We aimed to investigate patient comorbidities and health status measured by the Charlson index and clinical signs at diagnosis associated with adherence to recommended processes of care in CAP. We studied 3844 patients hospitalized with CAP. The evaluated recommendations were antibiotic adherence to Spanish guidelines, first antibiotic dose 65 (OR, 1.51) and COPD (OR, 1.80) were protective factors. The combination of antibiotic adherence and timing <6 hours was negatively associated with confusion (OR, 0.69) and a high Charlson score (OR, 0.92) adjusting for severity and hospital effect, whereas age was not an independent factor. Deficient health status and confusion, rather than age, are associated with lower compliance with antibiotic therapy recommendations and timing, thus identifying a subpopulation more prone to receiving lower quality care. PMID:22629420

  12. Promoting policy and environmental change using photovoice in the Kaiser Permanente Community Health Initiative.

    Science.gov (United States)

    Kramer, Leila; Schwartz, Pamela; Cheadle, Allen; Borton, J Elaine; Wright, Merrick; Chase, Charlie; Lindley, Corina

    2010-05-01

    Creative ways must be found to engage both community residents and political leaders around policy and environmental solutions to public health issues. Photovoice is a community-based, participatory approach to documentary photography that provides people with training on photography, ethics, critical discussion, and policy advocacy. Photovoice projects have been implemented across the nation as part of Kaiser Permanente's Community Health Initiative-a community-based obesity prevention effort. This article focuses on the first Photovoice project implemented in three communities in Colorado. Photovoice themes related to healthy eating and active living include a lack of access to healthy food choices in stores and schools, unsafe street crossings and sidewalks, and the need to redevelop certain areas to encourage safe recreation. The involvement of policy leaders in the project combined with several dissemination activities has contributed to healthier food offerings in schools and neighborhoods and city planning efforts that emphasize walkability and access to healthy food, and park revitalization.

  13. Investigating the health implications of social policy initiatives at the local level: study design and methods

    Directory of Open Access Journals (Sweden)

    Carey Gemma E

    2010-12-01

    Full Text Available Abstract Background In this paper we present the research design and methods of a study that seeks to capture local level responses to an Australian national social policy initiative, aimed at reducing inequalities in the social determinants of health. Methods/Design The study takes a policy-to-practice approach and combines policy and stakeholder interviewing with a comparative case study analysis of two not-for-profit organisations involved in the delivery of federal government policy. Discussion Before the health impacts of broad-scale policies, such as the one described in this study, can be assessed at the population level, we need to understand the implementation process. This is consistent with current thinking in political science and social policy, which has emphasised the importance of investigating how, and if, policies are translated into operational realities.

  14. Ten Years after the International Committee of Medical Journal Editors' Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis.

    Directory of Open Access Journals (Sweden)

    Anette Lampert

    Full Text Available Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy.We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria.Considering studies that were completed before 2014 (N = 99, 75 (76% pediatric phase 3 clinical trials were published but 24 (24% remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated.Ten years after the ICMJE's clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures.

  15. A meta-ethnographic study of health care staff perceptions of the WHO/UNICEF Baby Friendly Health Initiative.

    Science.gov (United States)

    Schmied, Virginia; Thomson, Gillian; Byrom, Anna; Burns, Elaine; Sheehan, Athena; Dykes, Fiona

    2014-12-01

    Implementation of the Baby Friendly Health Initiative (BFHI) is associated with increases in breastfeeding initiation and duration of exclusive breastfeeding and 'any' breastfeeding. However, implementation of the BFHI is challenging. To identify and synthesise health care staff perceptions of the WHO/UNICEF BFHI and identify facilitators and barriers for implementation. Seven qualitative studies, published between 2003 and 2013 were analysed using meta-ethnographic synthesis. Three overarching themes were identified. First the BFHI was viewed variously as a 'desirable innovation or an unfriendly imposition'. Participants were passionate about supporting breastfeeding and improving consistency in the information provided. This view was juxtaposed against the belief that BFHI represents an imposition on women's choices, and is a costly exercise for little gain in breastfeeding rates. The second theme highlighted cultural and organisational constraints and obstacles to BFHI implementation including resource issues, entrenched staff practices and staff rationalisation of non-compliance. Theme three captured a level of optimism and enthusiasm amongst participants who could identify a dedicated and credible leader to lead the BFHI change process. Collaborative engagement with all key stakeholders was crucial. Health care staff hold variant beliefs and attitudes towards BFHI, which can help or hinder the implementation process. The introduction of the BFHI at a local level requires detailed planning, extensive collaboration, and an enthusiastic and committed leader to drive the change process. This synthesis has highlighted the importance of thinking more creatively about the translation of this global policy into effective change at the local level. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  16. The effects of global health initiatives on country health systems: a review of the evidence from HIV/AIDS control.

    Science.gov (United States)

    Biesma, Regien G; Brugha, Ruairí; Harmer, Andrew; Walsh, Aisling; Spicer, Neil; Walt, Gill

    2009-07-01

    This paper reviews country-level evidence about the impact of global health initiatives (GHIs), which have had profound effects on recipient country health systems in middle and low income countries. We have selected three initiatives that account for an estimated two-thirds of external funding earmarked for HIV/AIDS control in resource-poor countries: the Global Fund to Fight AIDS, TB and Malaria, the World Bank Multi-country AIDS Program (MAP) and the US President's Emergency Plan for AIDS Relief (PEPFAR). This paper draws on 31 original country-specific and cross-country articles and reports, based on country-level fieldwork conducted between 2002 and 2007. Positive effects have included a rapid scale-up in HIV/AIDS service delivery, greater stakeholder participation, and channelling of funds to non-governmental stakeholders, mainly NGOs and faith-based bodies. Negative effects include distortion of recipient countries' national policies, notably through distracting governments from coordinated efforts to strengthen health systems and re-verticalization of planning, management and monitoring and evaluation systems. Sub-national and district studies are needed to assess the degree to which GHIs are learning to align with and build the capacities of countries to respond to HIV/AIDS; whether marginalized populations access and benefit from GHI-funded programmes; and about the cost-effectiveness and long-term sustainability of the HIV and AIDS programmes funded by the GHIs. Three multi-country sets of evaluations, which will be reporting in 2009, will answer some of these questions.

  17. Evaluating the sub-national fidelity of national Initiatives in decentralized health systems: Integrated Primary Health Care Governance in Nigeria.

    Science.gov (United States)

    Eboreime, Ejemai Amaize; Abimbola, Seye; Obi, Felix Abrahams; Ebirim, Obinna; Olubajo, Olalekan; Eyles, John; Nxumalo, Nonhlanhla Lynette; Mambulu, Faith Nankasa

    2017-03-21

    Policy making, translation and implementation in politically and administratively decentralized systems can be challenging. Beyond the mere sub-national acceptance of national initiatives, adherence to policy implementation processes is often poor, particularly in low and middle-income countries. In this study, we explore the implementation fidelity of integrated PHC governance policy in Nigeria's decentralized governance system and its implications on closing implementation gaps with respect to other top-down health policies and initiatives. Having engaged policy makers, we identified 9 core components of the policy (Governance, Legislation, Minimum Service Package, Repositioning, Systems Development, Operational Guidelines, Human Resources, Funding Structure, and Office Establishment). We evaluated the level and pattern of implementation at state level as compared to the national guidelines using a scorecard approach. Contrary to national government's assessment of level of compliance, we found that sub-national governments exercised significant discretion with respect to the implementation of core components of the policy. Whereas 35 and 32% of states fully met national criteria for the structural domains of "Office Establishment" and Legislation" respectively, no state was fully compliant to "Human Resource Management" and "Funding" requirements, which are more indicative of functionality. The pattern of implementation suggests that, rather than implementing to improve outcomes, state governments may be more interested in executing low hanging fruits in order to access national incentives. Our study highlights the importance of evaluating implementation fidelity in providing evidence of implementation gaps towards improving policy execution, particularly in decentralized health systems. This approach will help national policy makers identify more effective ways of supporting lower tiers of governance towards improvement of health systems and outcomes.

  18. A European inventory of common electronic health record data elements for clinical trial feasibility

    OpenAIRE

    Doods, J.; Botteri, F. (Florence); Dugas, M.; Fritz, F.

    2014-01-01

    Background: Clinical studies are a necessity for new medications and therapies. Many studies, however, struggle to meet their recruitment numbers in time or have problems in meeting them at all. With increasing numbers of electronic health records (EHRs) in hospitals, huge databanks emerge that could be utilized to support research. The Innovative Medicine Initiative (IMI) funded project ‘Electronic Health Records for Clinical Research’ (EHR4CR) created a standardized and homogenous inventory...

  19. Health care resource utilization before and after natalizumab initiation among patients with multiple sclerosis in Germany

    Directory of Open Access Journals (Sweden)

    Watson C

    2017-02-01

    Full Text Available Crystal Watson,1 Christine Prosser,2 Sebastian Braun,2 Pamela B Landsman-Blumberg,3 Erika Gleissner,4 Sarah Naoshy1 1Health Economics and Outcomes Research, Global Market Access, Biogen, Cambridge, MA, USA; 2Real World Evidence, Xcenda GmbH, Hanover, Germany; 3Applied Data Analytics, Xcenda LLC, Palm Harbor, FL, USA; 4Market Access, Biogen, Ismaning, Germany Background: Multiple sclerosis (MS, a progressive neurodegenerative disease, greatly impacts the quality of life and economic status of people affected by this disease. In Germany, the total annual cost of MS is estimated at €40,000 per person with MS. Natalizumab has shown to slow MS disease progression, reduce relapses, and improve the quality of life of people with MS.Objective: To evaluate MS-related and all-cause health care resource utilization and costs among German MS patients during the 12 months before and after initiation of natalizumab in a real-world setting.Methods: The current analysis was conducted using the Health Risk Institute research database. Identified patients were aged ≥18 years with ≥1 diagnosis of MS and had initiated natalizumab therapy (index, with 12-month pre– and post–index-period data. Patients were stratified by prior disease-modifying therapy (DMT usage or no DMT usage in the pre-index period. Outcome measures included corticosteroid use and number of sick/disability days, inpatient stays, and outpatient visits. Health care costs were calculated separately for pre- and post-index periods on a per-patient basis and adjusted for inflation.Results: In a final sample of 193 natalizumab-treated patients, per-patient MS-related corticosteroid use was reduced by 62.3%, MS-related sick days by 27.6%, and inpatient costs by 78.3% from the pre- to post-index period. Furthermore, the proportion of patients with MS-related hospitalizations decreased from 49.7% to 14.0% (P<0.001; this reduction was seen for patients with and without prior DMT use

  20. 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

  1. Community Asthma Initiative to Improve Health Outcomes and Reduce Disparities Among Children with Asthma.

    Science.gov (United States)

    Woods, Elizabeth R; Bhaumik, Urmi; Sommer, Susan J; Chan, Elaine; Tsopelas, Lindsay; Fleegler, Eric W; Lorenzi, Margarita; Klements, Elizabeth M; Dickerson, Deborah U; Nethersole, Shari; Dulin, Rick

    2016-02-12

    Black and Hispanic children are hospitalized with complications of asthma at much higher rates than white children. The Boston Children's Hospital Community Asthma Initiative (CAI) provides asthma case management and home visits for children from low-income neighborhoods in Boston, Massachusetts, to address racial/ethnic health disparities in pediatric asthma outcomes. CAI objectives were to evaluate 1) case management data by parent/guardian report for health outcomes and 2) hospital administrative data for comparison between intervention and comparison groups. Data from parent/guardian reports indicate that CAI decreased the number of children with any (one or more) asthma-related hospitalizations (decrease of 79% at 12 months) and any asthma-related emergency department visits (decrease of 56% at 12 months) among children served, most of whom were non-Hispanic black or Hispanic. Hospital administrative data also indicate that the number of asthma-related hospitalizations per child significantly decreased among CAI participants compared with a comparison group. The CAI model has been replicated in other cities and states with adaptations to local cultural and systems variations. Health outcome and cost data have been used to contribute to a business case to educate legislators and insurers about outcomes and costs for this enhanced approach to care. Strong partnerships with public health, community, and housing agencies have allowed CAI to leverage its outcomes to expand systemic changes locally and statewide to reduce asthma morbidity.

  2. A Pilot Physical Activity Initiative to Improve Mental Health Status amongst Iranian Institutionalized Older People

    Directory of Open Access Journals (Sweden)

    Hossein Matlabi

    2014-07-01

    Full Text Available Background: Sufficient level of physical activity may promote overall and mental health of old people. This study was carried out to investigate the practicability of a physical activity promotion initiative amongst institutionalized older people in Tabriz, Iran. Methods: Purposive sampling method was used in this semi-experimental study to recruit 31 older people living in a selected residential care in Tabriz. Moderate-intensity aerobic and muscle-strengthening activity was planned for those who had not severe baseline cognitive impairment or were not too frail to undertake the survey. The General Health Questionnaire (GHQ-28 was used to measure mental health status before and after intervention through a face-to-face interview. Descriptive statistics, Wilkcoxon rank-sum, Mann–Whitney U and Chi-Square tests were employed to analyses the data. Results: The applied intervention was significantly improved status of physical health, anxiety and insomnia, social dysfunction and severe depression. Conclusion: Incorporation of physical activity promotion programs into routines of older people residential care homes in Iran is feasible but may need training of physical activity specialists to work with older people based on their physical endurance and limitations.

  3. Participatory GIS in action, a public health initiative from Kerala, India

    Science.gov (United States)

    Soman, B.

    2014-11-01

    Community ownership is essential for sustainable public health initiatives. The advantages of getting active involvement of homebound village women in a public health campaign to establish community health surveillance are being reported in this paper. With the support of the local self government authorities, we had selected 120 village women, and they were given extensive training on various healthcare schemes, home based management of local ailments, leadership skills and survey techniques. Afterwards, they had been asked to share their knowledge with at least 10-15 women in their neighbourhood. This had improved their status in the neighbourhood, as more and more people started getting their advice on healthcare and social services related matters. Subsequently, they had collected the socio-demographic and morbidity details of the entire households, including the geometric coordinates (longitude and latitude) of the households and public offices. In this process, they began to use the geographic position system (GPS) machines, dismissing the myth that women are not that techno savvy, further improving their acceptability in the community. Many among them were seen proudly describing the implications of the thematic maps to the village people and line department staff in the monthly subcentre meetings. Many were offered seats in the local body elections by leading political parties, a few of them did stand in the elections and three of them had won the elections. This experience reinforces our belief that the empowerment of villagers with newer technology could be a public health tool with much wider positive implications.

  4. Correlates of Competency to Stand Trial Among Youths Admitted to a Juvenile Mental Health Court.

    Science.gov (United States)

    Bath, Eraka; Reba-Harrelson, Lauren; Peace, Robyn; Shen, Jie; Liu, Honghu

    2015-09-01

    Competency to stand trial (CST) assessment of juvenile offenders is a relatively recent phenomenon, as are juvenile mental health courts. Factors associated with youths' ability to participate in legal proceedings are not well understood, regardless of the court venue. Using a sample of 324 juveniles participating in the Los Angeles County Juvenile Mental Health Court (LAJMHC), we sought to explore the relationships of age, mental health diagnosis, and history of mental health treatment to CST status. Results suggest youths under the age of 15 were significantly more likely to have been found incompetent to stand trial (IST) when compared with older youths (p = .007). Youths with a diagnosis of a pervasive developmental disorder or intellectual disability were also more likely to be found IST than those without these diagnoses (p = .02 and p = .0001, respectively). Conversely, participants aged 16 or 17 years and diagnosed with a mood, substance abuse, or psychotic disorder were more likely to be found CST than those without these diagnoses (p competency attainment and recidivism prevention services, both within these specialty courts and in juvenile proceedings in general.

  5. Errors in self-reports of health services use: impact on alzheimer disease clinical trial designs.

    Science.gov (United States)

    Callahan, Christopher M; Tu, Wanzhu; Stump, Timothy E; Clark, Daniel O; Unroe, Kathleen T; Hendrie, Hugh C

    2015-01-01

    Most Alzheimer disease clinical trials that compare the use of health services rely on reports of caregivers. The goal of this study was to assess the accuracy of self-reports among older adults with Alzheimer disease and their caregiver proxy respondents. This issue is particularly relevant to Alzheimer disease clinical trials because inaccuracy can lead both to loss of power and increased bias in study outcomes. We compared respondent accuracy in reporting any use and in reporting the frequency of use with actual utilization data as documented in a comprehensive database. We next simulated the impact of underreporting and overreporting on sample size estimates and treatment effect bias for clinical trials comparing utilization between experimental groups. Respondents self-reports have a poor level of accuracy with κ-values often below 0.5. Respondents tend to underreport use even for rare events such as hospitalizations and nursing home stays. In analyses simulating underreporting and overreporting of varying magnitude, we found that errors in self-reports can increase the required sample size by 15% to 30%. In addition, bias in the reported treatment effect ranged from 3% to 18% due to both underreporting and overreporting errors. Use of self-report data in clinical trials of Alzheimer disease treatments may inflate sample size needs. Even when adequate power is achieved by increasing sample size, reporting errors can result in a biased estimate of the true effect size of the intervention.

  6. Web Services-Based Access to Local Clinical Trial Databases: A Standards Initiative of the Association of American Cancer Institutes

    OpenAIRE

    Stahl, Douglas C.; Evans, Richard M.; Afrin, Lawrence B.; DeTeresa, Richard M.; Ko, Dave; Mitchell, Kevin

    2003-01-01

    Electronic discovery of the clinical trials being performed at a specific research center is a challenging task, which presently requires manual review of the center’s locally maintained databases or web pages of protocol listings. Near real-time automated discovery of available trials would increase the efficiency and effectiveness of clinical trial searching, and would facilitate the development of new services for information providers and consumers. Automated discovery efforts to date hav...

  7. An interdisciplinary educational trial for adolescent health and development in urbanising China.

    Science.gov (United States)

    Zang, Yu-Li; Liu, Qian; Pu, Lin-Zhe

    2013-03-01

    To evaluate the effects on master student participants of an intensive interdisciplinary educational programme aiming at improving adolescent health and development services in urbanising China. There is a need for interdisciplinary education and collaborative practice in health, but few educational programmes have been reported. Experimental design including a qualitative component. Purposive sampling was used to identify master students in relevant disciplinary areas for the four-day classroom learning, four-day field learning and a half-day reflection, focusing on key aspects of adolescent health and development in the face of rapid urbanisation. Data about family function, cognitive development, adolescent health and development competency, and difficulties caused by health conditions were collected using quantitative and qualitative methods. Master student participants reported positive outcomes in adolescent health and development competency, and cognitive development. Six themes were identified about the programme and its impact: 'programme evaluation', 'programme characteristics', 'changed views about nursing and nurses', 'lessons learned', 'participation benefits' and 'suggestions for future action'. Interdisciplinary educational programmes are possible and beneficial at masters level but may be very challenging given the need for administrative, financial and human resources. Interdisciplinary educational programmes require to start with small health sector trials to accumulate evidence and skills. Faculty development is a prerequisite for such programmes towards collaborative practice. © 2012 Blackwell Publishing Ltd.

  8. Common data elements for substance use disorders in electronic health records: the NIDA Clinical Trials Network experience.

    Science.gov (United States)

    Ghitza, Udi E; Gore-Langton, Robert E; Lindblad, Robert; Shide, David; Subramaniam, Geetha; Tai, Betty

    2013-01-01

    Electronic health records (EHRs) are essential in improving quality and enhancing efficiency of health-care delivery. By 2015, medical care receiving service reimbursement from US Centers for Medicare and Medicaid Services (CMS) must show 'meaningful use' of EHRs. Substance use disorders (SUD) are grossly under-detected and under-treated in current US medical care settings. Hence, an urgent need exists for improved identification of and clinical intervention for SUD in medical settings. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUD in general medical settings, with the objective of incorporation into US EHRs. Stakeholders were identified and queried for input and consensus on validated screening and assessment for SUD in general medical settings to develop common data elements to serve as shared resources for EHRs on screening, brief intervention and referral to treatment (SBIRT), with the intent of supporting interoperability and data exchange in a developing Nationwide Health Information Network. Through consensus of input from stakeholders, a validated screening and brief assessment instrument, supported by Clinical Decision Support tools, was chosen to be used at out-patient general medical settings. The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and 'meaningful use' of the US Office of the National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

  9. 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

  10. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

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    Rousseau Sally

    2010-10-01

    Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT

  11. World Health Organization guidelines should not change the CD4 count threshold for antiretroviral therapy initiation

    Directory of Open Access Journals (Sweden)

    Nathan Geffen

    2013-03-01

    Full Text Available The World Health Organization (WHO currently recommends that HIV-positive adults start antiretroviral therapy (ART at CD4 counts <350 cells/μl. Several countries have changed their guidelines to recommend ART irrespective of CD4 count or at a threshold of 500 CD4 cells/μl. Consequently, WHO is currently revising its treatment guidelines and considering recommending ART initiation at CD4 counts <500 cells/μl. Such decisions are critically important, as WHO guidelines inform healthcare policies in developing countries and are used by activists in their advocacy work. Changing the CD4 initiation point from 350 to 500 cells/μl would, however, be premature and have profound cost implications on Global Fund, President’s Emergency Plan for AIDS Relief (PEPFAR and developing country health budgets. We should be willing to campaign for such a change in guidelines despite cost implications, if supported by evidence. However, the evidence remains outstanding. S Afr J HIV Med 2013;14(1:6-7. DOI:10.7196/SAJHIVMED.906

  12. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials.

    Science.gov (United States)

    Talbot, Laura A; Brede, Emily; Price, Marquita; Metter, E Jeffrey

    2017-07-25

    Military service members with lower extremity injuries are at risk for compromised health-related quality of life during rehabilitation. The purpose of this secondary data analysis was to examine changes in self-perceived physical and mental health in two clinical trials of military service members during rehabilitation for a lower extremity injury. This study is a secondary analysis of existing data from two cohorts of active duty military service members with lower extremity injuries as they participated in separate randomized controlled trials. A similar pattern for both physical and mental health was observed in both groups of participants. Perceptions of physical health improved significantly in both studies, whereas mental health perceptions may or may not have declined. Increased attention to mental health may be important during rehabilitation after major and minor lower extremity injuries. Although perceptions of physical health improve, corresponding changes may not occur in mental health perceptions. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Establishing a health demographic surveillance site in Bhaktapur district, Nepal: initial experiences and findings

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    Aryal Umesh

    2012-09-01

    Full Text Available Abstract Background A health demographic surveillance system (HDSS provides longitudinal data regarding health and demography in countries with coverage error and poor quality data on vital registration systems due to lack of public awareness, inadequate legal basis and limited use of data in health planning. The health system in Nepal, a low-income country, does not focus primarily on health registration, and does not conduct regular health data collection. This study aimed to initiate and establish the first HDSS in Nepal. Results We conducted a baseline survey in Jhaukhel and Duwakot, two villages in Bhaktapur district. The study surveyed 2,712 households comprising a total population of 13,669. The sex ratio in the study area was 101 males per 100 females and the average household size was 5. The crude birth and death rates were 9.7 and 3.9/1,000 population/year, respectively. About 11% of births occurred at home, and we found no mortality in infants and children less than 5 years of age. Various health problems were found commonly and some of them include respiratory problems (41.9%; headache, vertigo and dizziness (16.7%; bone and joint pain (14.4%; gastrointestinal problems (13.9%; heart disease, including hypertension (8.8%; accidents and injuries (2.9%; and diabetes mellitus (2.6%. The prevalence of non-communicable disease (NCD was 4.3% (95% CI: 3.83; 4.86 among individuals older than 30 years. Age-adjusted odds ratios showed that risk factors, such as sex, ethnic group, occupation and education, associated with NCD. Conclusion Our baseline survey demonstrated that it is possible to collect accurate and reliable data in a village setting in Nepal, and this study successfully established an HDSS site. We determined that both maternal and child health are better in the surveillance site compared to the entire country. Risk factors associated with NCDs dominated morbidity and mortality patterns.

  14. Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial

    DEFF Research Database (Denmark)

    Gehrman, J.; Angenete, E; Björholt, I.

    2016-01-01

    Background: Open surgery with resection and colostomy (Hartmann's procedure) has been the standard treatment for perforated diverticulitis with purulent peritonitis. In recent years laparoscopic lavage has emerged as an alternative, with potential benefits for patients with purulent peritonitis......, Hinchey grade III. The aim of this study was to compare laparoscopic lavage and Hartmann's procedure with health economic evaluation within the framework of the DILALA (DIverticulitis – LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) trial. Methods......), from inclusion in the trial throughout the patient's expected life. Results: The study included 43 patients who underwent laparoscopic lavage and 40 who had Hartmann's procedure in Denmark and Sweden during 2010–2014. In base-case A, the difference in mean cost per patient between laparoscopic lavage...

  15. Susceptibility to transmitting HIV in patients initiating antiretroviral therapy in rural district hospitals in Cameroon (Stratall ANRS 12110/ESTHER Trial.

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    Gilbert Ndziessi

    Full Text Available OBJECTIVES: Using cohort data nested in a randomized trial conducted in Cameroon, this study aimed to investigate time trends and predictors of the susceptibility to transmitting HIV during the first 24 months of treatment. METHODS: The outcome, susceptibility to transmitting HIV, was defined as reporting inconsistent condom use and experiencing incomplete virological suppression. Mixed logistic regressions were performed to identify predictors of this outcome among 250 patients reporting to have had sexual relationships either with HIV-negative or unknown HIV status partner(s. RESULTS: Despite an initial decrease from 76% at M0 to 50% at M6, the rate of inconsistent condom use significantly increased from M12 (59% to M24 (66% (p = 0.017. However, the proportion of patients susceptible to transmitting HIV significantly decreased over follow-up from 76% at M0, to 50% at M6, 31% at M12 and 27% at M24 (p<0.001. After controlling for age, gender and intervention group, we found that perceiving healthcare staff's readiness to listen as poor (adjusted odds ratios (AOR [95% Confidence Interval (CI] = 1.87 [1.01-3.46], reporting to have sexual relationships more than once per week (AOR [95%CI] = 2.52 [1.29-4.93], having more than one sexual partner (AOR [95%CI] = 2.53 [1.21-5.30] and desiring a/another child (AOR [95%CI] = 2.07 [1.10-3.87] were all associated with a higher risk of being susceptible to transmitting HIV. Conversely, time since ART initiation (AOR [95%CI] = 0.66 [0.53-0.83] for an extra 6 months and ART adherence (AOR [95%CI] = 0.33 [0.15-0.72] were significantly associated with a lower risk of being susceptible to transmitting HIV. CONCLUSIONS: The decrease observed in the susceptibility to transmitting HIV suggests that fear of behavioural disinhibition should not be a barrier to universal access to ART. However, developing adequate preventive interventions matching patients' expectations -like the desire to have children- and

  16. Bringing interdisciplinary and multicultural team building to health care education: the downstate team-building initiative.

    Science.gov (United States)

    Hope, Joanie Mayer; Lugassy, Daniel; Meyer, Rina; Jeanty, Freida; Myers, Stephanie; Jones, Sadie; Bradley, Joann; Mitchell, Rena; Cramer, Eva

    2005-01-01

    To evaluate the impact of the Downstate Team-Building Initiative (DTBI), a model multicultural and interdisciplinary health care team-building program for health professions students. A total of 65 students representing seven health disciplines participated in DTBI's first three years (one cohort per year since implementation). During the 18-session curriculum, students self-evaluated their group's progress through Tuckman's four team-development stages (FORMING, STORMING, NORMING, PERFORMING) on an 11-point scale. Students completed matched pre- and postintervention program evaluations assessing five variables: interdisciplinary understanding, interdisciplinary attitudes, teamwork skills, multicultural skills, and team atmosphere. After participation, students completed narrative follow-up questionnaires investigating impact one and two years after program completion. Each year's team development curve followed a similar logarithmic trajectory. Cohort 1 remained in team development stage 3 (NORMING) while Cohorts 2 and 3 advanced into the final stage-PERFORMING. A total of 34 matched pre- and postintervention evaluations showed significant change in all major variables: Team atmosphere and group teamwork skills improved most (48% and 44%, respectively). Interdisciplinary understanding improved 42%. Individual multicultural skills (defined by ability to address racism, homophobia, and sexism) started at the highest baseline and improved the least (13%). Group multicultural skills improved 36%. Of 23 responses to the follow-up surveys, 22 (96%) stated DTBI was a meaningful educational experience applicable to their current clinical surroundings. DTBI successfully united students across health discipline, ethnicity, socioeconomic class, gender, and sexual orientation into functioning teams. The model represents an effective approach to teaching health care team building and demonstrates benefits in both preclinical and clinical years of training.

  17. 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.

  18. Scale refinement and initial evaluation of a behavioral health function measurement tool for work disability evaluation.

    Science.gov (United States)

    Marfeo, Elizabeth E; Ni, Pengsheng; Haley, Stephen M; Bogusz, Kara; Meterko, Mark; McDonough, Christine M; Chan, Leighton; Rasch, Elizabeth K; Brandt, Diane E; Jette, Alan M

    2013-09-01

    To use item response theory (IRT) data simulations to construct and perform initial psychometric testing of a newly developed instrument, the Social Security Administration Behavioral Health Function (SSA-BH) instrument, that aims to assess behavioral health functioning relevant to the context of work. Cross-sectional survey followed by IRT calibration data simulations. Community. Sample of individuals applying for Social Security Administration disability benefits: claimants (n=1015) and a normative comparative sample of U.S. adults (n=1000). None. SSA-BH measurement instrument. IRT analyses supported the unidimensionality of 4 SSA-BH scales: mood and emotions (35 items), self-efficacy (23 items), social interactions (6 items), and behavioral control (15 items). All SSA-BH scales demonstrated strong psychometric properties including reliability, accuracy, and breadth of coverage. High correlations of the simulated 5- or 10-item computer adaptive tests with the full item bank indicated robust ability of the computer adaptive testing approach to comprehensively characterize behavioral health function along 4 distinct dimensions. Initial testing and evaluation of the SSA-BH instrument demonstrated good accuracy, reliability, and content coverage along all 4 scales. Behavioral function profiles of Social Security Administration claimants were generated and compared with age- and sex-matched norms along 4 scales: mood and emotions, behavioral control, social interactions, and self-efficacy. Using the computer adaptive test-based approach offers the ability to collect standardized, comprehensive functional information about claimants in an efficient way, which may prove useful in the context of the Social Security Administration's work disability programs. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. The ethics of testing a test: randomized trials of the health impact of diagnostic tests for infectious diseases.

    Science.gov (United States)

    Dowdy, David W; Gounder, Celine R; Corbett, Elizabeth L; Ngwira, Lucky G; Chaisson, Richard E; Merritt, Maria W

    2012-12-01

    In the last decade, many new rapid diagnostic tests for infectious diseases have been developed. In general, these new tests are developed with the intent to optimize feasibility and population health, not accuracy alone. However, unlike drugs or vaccines, diagnostic tests are evaluated and licensed on the basis of accuracy, not health impact (eg, reduced morbidity or mortality). Thus, these tests are sometimes recommended or scaled up for purposes of improving population health without randomized evidence that they do so. We highlight the importance of randomized trials to evaluate the health impact of novel diagnostics and note that such trials raise distinctive ethical challenges of equipoise, equity, and informed consent. We discuss the distinction between equipoise for patient-important outcomes versus diagnostic accuracy, the equity implications of evaluating health impact of diagnostics under routine conditions, and the importance of offering reasonable choices for informed consent in diagnostic trials.

  20. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  1. Effects of Three Motivationally Targeted Mobile Device Applications on Initial Physical Activity and Sedentary Behavior Change in Midlife and Older Adults: A Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Abby C King

    vs. Control app: d = 1.19,CI = 0.56, 1.81; Affect vs. Analytic app: d = 1.41,CI = 0.74, 2.07.The results provide initial support for the use of a smartphone-delivered social frame in the early induction of both physical activity and sedentary behavior changes. The information obtained also sets the stage for further investigation of subgroups that might particularly benefit from different motivationally framed apps in these two key health promotion areas.ClinicalTrials.gov NCT01516411.

  2. Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

    Directory of Open Access Journals (Sweden)

    Raftery James

    2011-05-01

    Full Text Available Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1 statistically significant in favour of the new treatment, 2 statistically significant in favour of the control treatment 3 true negative, 4 truly inconclusive, 5 inconclusive in favour of new treatment or 6 inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials. Results Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%. The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative. The results were classified as truly inconclusive (i.e. failed to answer the question asked for 24% of comparisons (20/85. HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials. Conclusions The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that

  3. Predictors on delay of initial health-seeking in new pulmonary tuberculosis cases among migrants population in East China.

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    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.

  4. Health Heritage© a web-based tool for the collection and assessment of family health history: initial user experience and analytic validity.

    Science.gov (United States)

    Cohn, W F; Ropka, M E; Pelletier, S L; Barrett, J R; Kinzie, M B; Harrison, M B; Liu, Z; Miesfeldt, S; Tucker, A L; Worrall, B B; Gibson, J; Mullins, I M; Elward, K S; Franko, J; Guterbock, T M; Knaus, W A

    2010-01-01

    A detailed family health history is currently the most potentially useful tool for diagnosis and risk assessment in clinical genetics. We developed and evaluated the usability and analytic validity of a patient-driven web-based family health history collection and analysis tool. Health Heritage(©) guides users through the collection of their family health history by relative, generates a pedigree, completes risk assessment, stratification, and recommendations for 89 conditions. We compared the performance of Health Heritage to that of Usual Care using a nonrandomized cohort trial of 109 volunteers. We contrasted the completeness and sensitivity of family health history collection and risk assessments derived from Health Heritage and Usual Care to those obtained by genetic counselors and genetic assessment teams. Nearly half (42%) of the Health Heritage participants reported discovery of health risks; 63% found the information easy to understand and 56% indicated it would change their health behavior. Health Heritage consistently outperformed Usual Care in the completeness and accuracy of family health history collection, identifying 60% of the elevated risk conditions specified by the genetic team versus 24% identified by Usual Care. Health Heritage also had greater sensitivity than Usual Care when comparing the identification of risks. These results suggest a strong role for automated family health history collection and risk assessment and underscore the potential of these data to serve as the foundation for comprehensive, cost-effective personalized genomic medicine. Copyright © 2010 S. Karger AG, Basel.

  5. A systematic review of randomized controlled trials on curative and health enhancement effects of forest therapy

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    Kamioka H

    2012-07-01

    Full Text Available Hiroharu Kamioka,1 Kiichiro Tsutani,2 Yoshiteru Mutoh,3 Takuya Honda,4 Nobuyoshi Shiozawa,5 Shinpei Okada,6 Sang-Jun Park,6 Jun Kitayuguchi,7 Masamitsu Kamada,8 Hiroyasu Okuizumi,9 Shuichi Handa91Faculty of Regional Environment Science, Tokyo University of Agriculture, Tokyo, 2Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, 3Todai Policy Alternatives Research Institute, The University of Tokyo, Tokyo, 4Japanese Society for the Promotion of Science, Tokyo, 5Food Labeling Division, Consumer Affairs Agency, Cabinet Office, Government of Japan, Tokyo, 6Physical Education and Medicine Research Foundation, Nagano, 7Physical Education and Medicine Research Center Unnan, Shimane, 8Department of Environmental and Preventive Medicine, Shimane University School of Medicine, Shimane, 9Mimaki Onsen (Spa Clinic, Tomi City, Nagano, JapanObjective: To summarize the evidence for curative and health enhancement effects through forest therapy and to assess the quality of studies based on a review of randomized controlled trials (RCTs.Study design: A systematic review based on RCTs.Methods: Studies were eligible if they were RCTs. Studies included one treatment group in which forest therapy was applied. The following databases – from 1990 to November 9, 2010 – were searched: MEDLINE via PubMed, CINAHL, Web of Science, and Ichushi-Web. All Cochrane databases and Campbell Systematic Reviews were also searched up to November 9, 2010.Results: Two trials met all inclusion criteria. No specific diseases were evaluated, and both studies reported significant effectiveness in one or more outcomes for health enhancement. However, the results of evaluations with the CONSORT (Consolidated Standards of Reporting Trials 2010 and CLEAR NPT (A Checklist to Evaluate a Report of a Nonpharmacological Trial checklists generally showed a remarkable lack of description in the studies. Furthermore, there was a

  6. Nutrient supplementation may adversely affect maternal oral health--a randomised controlled trial in rural Malawi.

    Science.gov (United States)

    Harjunmaa, Ulla; Järnstedt, Jorma; Dewey, Kathryn G; Ashorn, Ulla; Maleta, Kenneth; Vosti, Stephen A; Ashorn, Per

    2016-01-01

    Nutritional supplementation during pregnancy is increasingly recommended especially in low-resource settings, but its oral health impacts have not been studied. Our aim was to examine whether supplementation with multiple micronutrients (MMN) or small-quantity lipid-based nutrient supplements affects dental caries development or periodontal health in a rural Malawian population. The study was embedded in a controlled iLiNS-DYAD trial that enrolled 1391 pregnant women groups were similar at baseline in average socio-economic, nutritional and health status. At the end of the intervention, the prevalence of caries was 56.7%, 69.1% and 63.3% (P = 0.004), and periodontitis 34.9%, 29.8% and 31.2% (P = 0.338) in the IFA, MMN and LNS groups, respectively. Compared with the IFA group, women in the MMN group had 0.60 (0.18-1.02) and in the LNS group 0.59 (0.17-1.01) higher mean number of caries lesions. In the absence of baseline oral health data, firm conclusions on causality cannot be drawn. However, although not confirmatory, the findings are consistent with a possibility that provision of MMN or LNS may have increased the caries incidence in this target population. Because of the potential public health impacts, further research on the association between gestational nutrient interventions and oral health in low-income settings is needed.

  7. Teaching emotional intelligence to intensive care unit nurses and their general health: a randomized clinical trial.

    Science.gov (United States)

    Sharif, F; Rezaie, S; Keshavarzi, S; Mansoori, P; Ghadakpoor, S

    2013-07-01

    Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. This randomized clinical trial (registered as IRCT201208022812N9) was conducted on 52 of 200 in intensive care unit nurses affiliated to Shiraz University of Medical Sciences. They were recruited through purposeful convenience sampling and then randomly categorized into two groups. The intervention group members were trained in emotional intelligence. Bar-on emotional intelligence and Goldberg's general health questionnaires were administered to each participant before, immediately after, and one month after the intervention. While the mean score of general health for the intervention group decreased from 25.4 before the intervention, to 18.1 immediately after the intervention and to 14.6 one month later, for the control group, it increased from 22.0, to 24.2 and to 26.5, respectively (pTeaching emotional intelligence improved the general health of intensive care unit nurses.

  8. Teaching Emotional Intelligence to Intensive Care Unit Nurses and their General Health: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    F Sharif

    2013-07-01

    Full Text Available Background: Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. Objective: To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. Methods: This randomized clinical trial (registered as IRCT201208022812N9 was conducted on 52 of 200 in intensive care unit nurses affiliated to Shiraz University of Medical Sciences. They were recruited through purposeful convenience sampling and then randomly categorized into two groups. The intervention group members were trained in emotional intelligence. Bar-on emotional intelligence and Goldberg's general health questionnaires were administered to each participant before, immediately after, and one month after the intervention. Results: While the mean score of general health for the intervention group decreased from 25.4 before the intervention, to 18.1 immediately after the intervention and to 14.6 one month later, for the control group, it increased from 22.0, to 24.2 and to 26.5, respectively (p<0.001. Conclusion: Teaching emotional intelligence improved the general health of intensive care unit nurses.

  9. An assessment of policymakers' engagement initiatives to promote evidence informed health policy making in Nigeria.

    Science.gov (United States)

    Uneke, Chigozie Jesse; Sombie, Issiaka; Keita, Namoudou; Lokossou, Virgil; Johnson, Ermel; Ongolo-Zogo, Pierre

    2017-01-01

    In most developing countries including Nigeria, one of the most challenging issues associated with evidence-to-policy link is the capacity constraints of policymakers to access, synthesize, adapt and utilize available research evidence. The purpose of this review is to assess the efforts and various initiatives that have been undertaken to deliberately engage policymakers and other stakeholders in the health sector in Nigeria for the promotion of evidence informed policymaking. A MEDLINE Entrez Pubmed search was performed and studies that investigated policy making process, evidence to policy link, research to policy mechanism, and researchers/policymakers interaction in Nigeria in relation to health policy were sought. Of the 132 publications found, 14(10.6%) fulfilled the study inclusion criteria and were selected and included in the review. Of the fourteen scientific publications identified, 11 of the studies targeted both researchers and policymakers and the principal tool of intervention was training workshops which focused on various aspects of evidence informed policymaking. All the studies indicated positive outcomes and impacts in relation to quantifiable improvement in policymakers' knowledge and competence in evidence to policy process. Capacity strengthening engagement mechanism is needed for both researchers to generate better evidence and for policymakers and health-care professionals to better use available evidence.

  10. Partnering with public schools: a resident-driven reproductive health education initiative.

    Science.gov (United States)

    Kuo, Kelly; Zhu, Tao Y; Raidoo, Shandhini; Zhao, Lulu X; Sammarco, Anne; Ashby, Karen

    2014-02-01

    To assess the impact of a resident-driven sexual health educational initiative in an inner-city Cleveland middle school. 10 resident physicians and 57 students in 7(th) and 8(th) grade participated in this prospective cohort study. Residents taught 3 sessions on the topics of basic anatomy and physiology, pregnancy, sexually transmitted infections (STI), contraception, and safe relationships. Outcome measures included the percentages of students able to name at least 3 different STIs and contraceptive methods; to name potential complications of STIs; and to correctly identify condoms and abstinence as the only contraceptive methods also protective against STI transmission. Significant improvements were noted in students' baseline knowledge of human anatomy, contraception, and safe sex practices after completion of the curriculum. The percentage of students able to name at least 3 forms of birth control increased from 1.7% to 70.7% (P reproductive health education in schools. The socioeconomic burden of teen pregnancy justifies comprehensive efforts to improve reproductive health education. Copyright © 2014 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  11. Measuring sustainability within the Veterans Administration Mental Health System Redesign initiative.

    Science.gov (United States)

    Ford, James H; Krahn, Dean; Wise, Meg; Oliver, Karen Anderson

    2011-01-01

    To examine how attributes affecting sustainability differ across Veterans Health Administration organizational components and by staff characteristics. Surveys of 870 change team members and 50 staff interviews within the Veterans Affairs' Mental Health System Redesign initiative. A 1-way ANOVA with a Tukey post hoc test examined differences in sustainability by Veteran Integrated Service Networks, job classification, and tenure from staff survey data of the Sustainability Index. Qualitative interviews used an iterative process to identify "a priori" and "in vivo" themes. A simple stepwise linear regression explored predictors of sustainability. Sustainability differed across Veteran Integrated Service Networks and staff tenure. Job classification differences existed for the following: (1) benefits and credibility of the change and (2) staff involvement and attitudes toward change. Sustainability barriers were staff and institutional resistance and nonsupportive leadership. Facilitators were commitment to veterans, strong leadership, and use of quality improvement tools. Sustainability predictors were outcomes tracking, regular reporting, and use of Plan, Do, Study, Adjust cycles. Creating homogeneous implementation and sustainability processes across a national health system is difficult. Despite the Veterans Affairs' best evidence-based implementation efforts, there was significant variance. Locally tailored interventions might better support sustainability than "one-size-fits-all" approaches. Further research is needed to understand how participation in a quality improvement collaborative affects sustainability.

  12. [Mixed design for the evaluation of the Mesoamerica Health 2015 initiative].

    Science.gov (United States)

    Gutiérrez, Juan Pablo; Téllez-Rojo, Marta María; Torres, Pilar; Romero, Martín; Bertozzi, Stefano M

    2011-01-01

    Since the Salud Mesoamerica 2015 initiative (SM-2015) aim is to improve health and nutrition conditions of those most vulnerable in Mesoamerica, the goal of the evaluation is to generate evidence of the joint effectiveness of a package of interventions designed to improve the health conditions. We propose a mix design for the evaluation, which will allow to know the magnitude of changes attributable to the interventions, as well as the meanings of these changes for the target population, taking into account the specificities of each country. The main axis of this design is a locality panel where information about individuals, households, and health facilities (first and second level) will also be collected. The evaluation design described in this paper was developed between June and December, 2009, and it was integrated during workshops in Cuernavaca (Mexico), Managua (Nicaragua), and San Jose (Costa Rica). The proposed design will allow to generate evidence about the joint effectiveness of the package of interventions proposed for the SM-2015. The success of this design rests on the political commitment of countries and donors.

  13. Chapter 4: Assessing the Air Pollution, Greenhouse Gas, Air Quality, and Health Benefits of Clean Energy Initiatives

    Science.gov (United States)

    Chapter 4 of “Assessing the Multiple Benefits of Clean Energy” helps state energy, environmental, and economic policy makers assess the air quality, greenhouse gas, air pollution, and health benefits of clean energy initiatives.

  14. Effect of health risk assessment and counselling on health behaviour and survival in older people: a pragmatic randomised trial.

    Directory of Open Access Journals (Sweden)

    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

  15. High glycemic index diet as a risk factor for depression: analyses from the Women’s Health Initiative1

    Science.gov (United States)

    Gangwisch, James E; Hale, Lauren; Garcia, Lorena; Malaspina, Dolores; Opler, Mark G; Payne, Martha E; Rossom, Rebecca C; Lane, Dorothy

    2015-01-01

    Background: The consumption of sweetened beverages, refined foods, and pastries has been shown to be associated with an increased risk of depression in longitudinal studies. However, any influence that refined carbohydrates has on mood could be commensurate with their proportion in the overall diet; studies are therefore needed that measure overall intakes of carbohydrate and sugar, glycemic index (GI), and glycemic load. Objective: We hypothesized that higher dietary GI and glycemic load would be associated with greater odds of the prevalence and incidence of depression. Design: This was a prospective cohort study to investigate the relations between dietary GI, glycemic load, and other carbohydrate measures (added sugars, total sugars, glucose, sucrose, lactose, fructose, starch, carbohydrate) and depression in postmenopausal women who participated in the Women’s Health Initiative Observational Study at baseline between 1994 and 1998 (n = 87,618) and at the 3-y follow-up (n = 69,954). Results: We found a progressively higher dietary GI to be associated with increasing odds of incident depression in fully adjusted models (OR for the fifth compared with first quintile: 1.22; 95% CI: 1.09, 1.37), with the trend being statistically significant (P = 0.0032). Progressively higher consumption of dietary added sugars was also associated with increasing odds of incident depression (OR for the fifth compared with first quintile: 1.23; 95% CI: 1.07, 1.41; P-trend = 0.0029). Higher consumption of lactose, fiber, nonjuice fruit, and vegetables was significantly associated with lower odds of incident depression, and nonwhole/refined grain consumption was associated with increased odds of depression. Conclusions: The results from this study suggest that high-GI diets could be a risk factor for depression in postmenopausal women. Randomized trials should be undertaken to examine the question of whether diets rich in low-GI foods could serve as treatments and primary preventive

  16. Employees' perception of workplace health promotion initiatives in Taiwan: a cross-sectional survey of 30 worksites.

    Science.gov (United States)

    Hsu, Shang-Wei; Lin, Jin-Ding; Lee, Kuam-Tin; Loh, Ching-Hui; Yen, Chia-Feng; Lin, Lan-Ping; Chu, Cordia M; Chou, Yu-Ching

    2009-10-01

    The present study was to describe the input/process and evaluate the effectiveness of Taiwanese Workplace Health Promotion Initiatives based on employees' perspectives. This study employed a cross-sectional design by a structured questionnaire that was completed by 842 employees in 30 workplaces that participated in the Taiwan Workplace Health Promotion (WHP) Initiatives which supported by Ministry of Health from 2004 to 2006. The results found that the employees generally agreed that WHP improved their personal health skills. There was a lower level of agreement with respect to other input/process domains such as workplace healthy policy, workplace supportive health environments and WHP activities and services and the WHP effectiveness. With regard to the prediction of WHP effectiveness, the domain of workplace health activities/services could only predict 50.5% of the variation of the effectiveness in a regression model. Three domains of workplace - health activities/services, personal health skills and supportive health environments - were significantly correlated to the agree level of health promotion effectiveness. The results suggest that companies that intend initiating health promotion programs need to conduct a detailed assessment of the nature of the workplace settings and the perceptions of employees.

  17. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

    Science.gov (United States)

    Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G; Phillips, Siobhan M; Ritzwoller, Debra P; Roby, Dylan H; Rodriguez, Hector P; Sabo, Roy T; Sheinfeld Gorin, Sherri N; Stange, Kurt C

    2013-06-25

    There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and

  18. When is informed consent required in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Boruch Robert

    2011-09-01

    Full Text Available Abstract 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, we 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 second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a

  19. Insights into the epidemiology of postmenopausal osteoporosis: the Women's Health Initiative.

    Science.gov (United States)

    Jackson, Rebecca D; Mysiw, W Jerry

    2014-11-01

    Osteoporosis and its associated increased risk for fragility fracture is one of the most disabling consequences of aging in women. To successfully reduce the public health burden of this pervasive disease, it is necessary to develop strategies that permit the earlier identification of women at risk for fracture and ensure that preventive interventions to reduce the risk for fracture are both safe and effective. The Women's Health Initiative offers the unprecedented opportunity to systematically address both of these issues. Eleven clinically available risk factors (age, race/ethnicity, self-reported health, weight, height, physical activity, parental hip fracture, fracture history after age 54, current smoking, corticosteroid use, and history of treated diabetes), have been identified to predict 5-year hip fracture risk in white women. Two of these factors (age and fracture history) also predict risk for total fractures in women irrespective of race-ethnicity. Biomarkers including low vitamin D or bioavailable testosterone and/or high cystatin C, pro-inflammatory cytokines, osteoprotegerin and sex hormone-binding globulin also predict risk for hip fracture independent of clinical risk factors. Two cornerstones of therapy for postmenopausal osteoporosis-postmenopausal hormone therapy and calcium plus vitamin D supplementation- were rigorously studied. Estrogen with or without a progestin was effective at preventing bone loss and reducing risk for hip, clinical vertebral and total fractures but the balance of risks and benefits failed to show an overall benefit of taking estrogen-alone or estrogen plus progestin as a preventive strategy for skeletal health. Calcium plus vitamin D supplementation also demonstrated a small but significant favorable effect on hip bone density but in contrast, the modest effect did not translate into a significant reduction in the risk of fractures in intent-to-treat analyses. Data such as these have helped to lay a foundation for the

  20. Initiatives on early detection and intervention to proactively identify health and social problems in older people : Experiences from the Netherlands

    NARCIS (Netherlands)

    Lette, Manon; Baan, C.A.; van den Berg, Matthijs; de Bruin, Simone R.

    2015-01-01

    Background Over the last years, several initiatives on early detection and intervention have been put in place to proactively identify health and social problems in (frail) older people. An overview of the initiatives currently available in the Netherlands is lacking, and it is unknown whether they

  1. Getting Started: Initiating Critical Ethnography and Community-Based Action Research in a Program of Rural Health Studies

    Directory of Open Access Journals (Sweden)

    Jennifer B. Averill

    2006-06-01

    Full Text Available Rural populations experience higher rates of illness, less access to health care resources, and lower rates of health insurance coverage than do urban populations. A need exists to identify and address the health care needs of rural communities and other isolated populations and to contextualize the findings in the larger rural health environment. Critical ethnography combined with community-based action research is a constructive approach for improving the health status of rural elders as well as other members of isolated communities. Detailed guidelines on how to initiate an ethnographic community-based action study, as shown through a study that explores the definitions of health, health care perceptions, and health care issues for rural elders in the southwestern United States, highlight the value of this type of research for the study of the health care issues of rural populations.

  2. Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

    Science.gov (United States)

    Hurst, Frank P; Chianchiano, Dolph; Upchurch, Linda; Fisher, Benjamin R; Flythe, Jennifer E; Castillo Lee, Celeste; Hill, Terri; Neuland, Carolyn Y

    2017-04-27

    New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas. Published by Elsevier Inc.

  3. 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 researc

  4. What are the health benefits of active travel? A systematic review of trials and cohort studies.

    Directory of Open Access Journals (Sweden)

    Lucinda E Saunders

    Full Text Available BACKGROUND: Increasing active travel (primarily walking and cycling has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. METHODS: The study design was a systematic review of (i non-randomised and randomised controlled trials, and (ii prospective observational studies examining either (a the effects of interventions to promote active travel or (b the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. RESULTS: Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. CONCLUSIONS: Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such

  5. Development of a community health inclusion index: an evaluation tool for improving inclusion of people with disabilities in community health initiatives

    OpenAIRE

    Eisenberg, Yochai; Rimmer, James H.; Mehta, Tapan; Fox, Michael H.

    2015-01-01

    Background Community health initiatives often do not provide enough supports for people with disabilities to fully participate in healthy, active living opportunities. The purpose of this study was to design an instrument that focused on integrating disability-related items into a multi-level survey tool that assessed healthy, active living initiatives. Methods The development and testing of the Community Health Inclusion Index (CHII) involved four components: (a) literature review of studies...

  6. Continuation of care following an initial primary care visit with a mental health diagnosis: differences by receipt of VHA Primary Care-Mental Health Integration services.

    Science.gov (United States)

    Bohnert, Kipling M; Pfeiffer, Paul N; Szymanski, Benjamin R; McCarthy, John F

    2013-01-01

    For patients with an initial primary care (PC) encounter in the Veterans Health Administration (VHA) that included a mental health diagnosis, we evaluate whether same-day receipt of Primary Care-Mental Health Integration (PC-MHI) services is associated with the likelihood of receiving a subsequent mental-health-related encounter in the following 90 days. Using VHA administrative data, we identified 9046 patients who received VHA care for the first time in fiscal year 2009, received a PC encounter that included a mental health diagnosis on the first day of their VHA services and initiated care at a VHA facility that provided PC-MHI services. Using multivariable generalized estimating equations logistic regression, we examined whether receipt of same-day PC-MHI was associated with receipt of a subsequent encounter with a mental health diagnosis within 90 days. Analyses adjusted for Operation Enduring Freedom/Operation Iraqi Freedom Veteran status, demographic characteristics, service-connected disability, psychiatric and non-psychiatric diagnoses, and psychotropic medication initiation on the index day of service use. Receipt of same-day PC-MHI services was positively associated with having a mental-health-related encounter in the following 90 days (adjusted odds ratio=2.05; 95% confidence interval=1.66-2.54). PC-MHI services may enhance mental health continuation of care among PC patients with mental health conditions who initiate VHA services. Published by Elsevier Inc.

  7. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme.

    Science.gov (United States)

    Walters, Stephen J; Bonacho Dos Anjos Henriques-Cadby, Inês; Bortolami, Oscar; Flight, Laura; Hind, Daniel; Jacques, Richard M; Knox, Christopher; Nadin, Ben; Rothwell, Joanne; Surtees, Michael; Julious, Steven A

    2017-03-20

    Substantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope. To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed. Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers. Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data). This review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43-2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79-97%). There is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections. 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/.

  8. Optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature Database (LILACS

    Directory of Open Access Journals (Sweden)

    Aldemar Araujo Castro

    Full Text Available OBJECTIVE: To define and disseminate the optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature (LILACS. This strategy was elaborated based on the optimal search strategy for MEDLINE recommended by Cochrane Collaboration for the identification of clinical trials in electronic databases. DESIGN: Technical information. SETTING: Clinical Trials and Meta-Analysis Unit, Federal University of São Paulo, in conjunction with the Brazilian Cochrane Center, São Paulo, Brazil. (http://www.epm.br/cochrane. DATA: LILACS/CD-ROM (Latin American and Caribbean Health Science Information Database, 27th edition, January 1997, edited by BIREME (Latin American and Caribbean Health Science Information Center. LILACS Indexes 670 journals in the region, with abstracts in English, Portuguese or Spanish; only 41 overlap in the MEDLINE-EMBASE. Of the 168.902 citations since 1982, 104,016 are in human trials, and 38,261 citations are potentiality clinical trials. Search strategy was elaborated combining headings with text word in three languages, adapting the interface of the LILACS. We will be working by locating clinical trials in LILACS for Cochrane Controlled Trials Database. This effort is being coordinated by the Brazilian Cochrane Center.

  9. Cluster Randomized-Controlled Trial of Interventions to Improve Health for Adults with Intellectual Disability Who Live in Private Dwellings

    Science.gov (United States)

    Lennox, Nicholas; Bain, Chris; Rey-Conde, Therese; Taylor, Miriam; Boyle, Frances M.; Purdie, David M.; Ware, Robert S.

    2010-01-01

    Background: People with intellectual disability who live in the community often have poor health and healthcare, partly as a consequence of poor communication, recall difficulties and incomplete patient health information. Materials and Methods: A cluster randomized-controlled trial with 2 x 2 factorial design was conducted with adults with…

  10. How do experts define relevance criteria when initiating Health Impact Assessments of national policies?

    DEFF Research Database (Denmark)

    Kraemer, Stella Rj; Gulis, Gabriel

    2014-01-01

    The aim of this article is to present how the Danish Disease Prevention Committee (DDPC) members and HIA-experts understand when HIA is "relevant", which in this context means when there is "presumed to be a direct and documented effect on the health and morbidity of citizens". Method: DDPC members...... that the DDPC recommendation gives rise to a discussion on differing perceptions of relevance. The same definition can be used for both direct and indirect effects depending on interpretation. Documented evidence for an effect is desirable in the form provided by the traditional biomedical evidence hierarchy...... but HIA-experts emphasises use of local knowledge. The primary criteria for initiating a HIA, is whether the outcome of the HIA is expected to be taken into account in the decision-making process. The second criteria, is how do decision-makers perceive or interpret a decision to be relevant for HIA...

  11. Minimum Initial Service Package (MISP) for reproductive health during emergencies: time for a new paradigm?

    Science.gov (United States)

    Onyango, Monica Adhiambo; Hixson, Bretta Lynne; McNally, Siobhan

    2013-01-01

    Reproductive health (RH) has historically received low priority in the hierarchy of humanitarian response. Awareness of RH needs in emergencies began in the mid-1990s and led to the formation of the Inter-Agency Working Group (IAWG) for RH. Subsequently, the Minimum Initial Service Package (MISP), a set of guidelines for RH service delivery in crisis settings, was created. The objectives of the MISP are to facilitate the coordination of RH services, prevent and manage the consequences of sexual violence, reduce HIV transmission, minimize maternal and neonatal morbidity and mortality, and plan for comprehensive RH services in the post-crisis phase. Available documentation on MISP implementation is minimal, and reveals mixed success. Challenges include low MISP awareness, inadequate RH training among humanitarian actors, logistical difficulties and poor coordination. Continued emphasis on advocacy and capacity building, a stronger focus on logistics and coordination and a greater commitment to monitoring and evaluation are essential for improving the MISP's effectiveness in the field.

  12. Developing an instrument for assessing fidelity of motivational care planning: The Aboriginal and Islander Mental health initiative adherence scale.

    Science.gov (United States)

    Prowse, Phuong-Tu; Nagel, Tricia

    2014-01-01

    The aim of this study was to design and trial an Adherence Scale to measure fidelity of Motivational Care Planning (MCP) within a clinical trial. This culturally adapted therapy MCP uses a client centered holistic approach that emphasises family and culture to motivate healthy life style changes. The Motivational Care Planning-Adherence Scale (MCP-AS) was developed through consultation with Aboriginal and Islander Mental Health Initiative (AIMhi) Indigenous and non-Indigenous trainers, and review of MCP training resources. The resultant ten-item scale incorporates a 9-Point Likert Scale with a supporting protocol manual and uses objective, behaviourally anchored criteria for each scale point. A fidelity assessor piloted the tool through analysis of four audio-recordings of MCP (conducted by Indigenous researchers within a study in remote communities in Northern Australia). File audits of the remote therapy sessions were utilised as an additional source of information. A Gold Standard Motivational Care Planning training video was also assessed using the MCP-AS. The Motivational Care Planning-Adherence Scale contains items measuring both process and content of therapy sessions. This scale was used successfully to assess therapy through observation of audio or video-recorded sessions and review of clinical notes. Treatment fidelity measured by the MCP-AS within the pilot study indicated high fidelity ratings. Ratings were high across the three domains of rapport, motivation, and self-management with especially high ratings for positive feedback and engagement, review of stressors and goal setting. The Motivational Care Planning-Adherence Scale has the potential to provide a measure of quality of delivery of Motivation Care Planning. The pilot findings suggest that despite challenges within the remote Indigenous community setting, Indigenous therapists delivered therapy that was of high fidelity. While developed as a research tool, the scale has the potential to

  13. Strengthening capacity for AIDS vaccine research: analysis of the Pfizer Global Health Fellows program and the International AIDS Vaccine Initiative.

    Science.gov (United States)

    Vian, Taryn; Koseki, Sayaka; Feeley, Frank G; Beard, Jennifer

    2013-10-02

    Industry partnerships can help leverage resources to advance HIV/AIDS vaccine research, service delivery, and policy advocacy goals. This often involves capacity building for international and local non-governmental organizations (NGOs). International volunteering is increasingly being used as a capacity building strategy, yet little is known about how corporate volunteers help to improve performance of NGOs in the fight against HIV/AIDS. This case study helps to extend our understanding by analyzing how the Pfizer Global Health Fellows (GHF) program helped develop capacity of the International AIDS Vaccine Initiative (IAVI), looking specifically at Fellowship activities in South Africa, Kenya, and Uganda. From 2005-2009, 8 Pfizer GHF worked with IAVI and local research centers to strengthen capacity to conduct and monitor vaccine trials to meet international standards and expand trial activities. Data collection for the case study included review of Fellow job descriptions, online journals, evaluation reports, and interviews with Fellows and IAVI staff. Qualitative methods were used to analyze factors which influenced the process and outcomes of capacity strengthening. Fellows filled critical short-term expert staffing needs at IAVI as well as providing technical assistance and staff development activities. Capacity building included assistance in establishing operating procedures for the start-up period of research centers; training staff in Good Clinical Practice (GCP); developing monitoring capacity (staff and systems) to assure that centers are audit-ready at all times; and strategic planning for data management systems. Factors key to the success of volunteering partnerships included similarities in mission between the corporate and NGO partners, expertise and experience of Fellows, and attitudes of partner organization staff. By developing standard operating procedures, ensuring that monitoring and regulatory compliance systems were in place, training

  14. Health promotion lifestyle interventions for weight management in psychosis: a systematic review and meta-analysis of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Bonfioli Elena

    2012-07-01

    Full Text Available Abstract Background Psychiatric patients have more physical health problems and much shorter life expectancies compared to the general population, due primarily to premature cardiovascular disease. A multi-causal model which includes a higher prevalence of risk factors has provided a valid explanation. It takes into consideration not only risks such as gender, age, and family history that are inherently non-modifiable, but also those such as obesity, smoking, diabetes, hypertension, and dyslipidemia that are modifiable through behavioural changes and improved care. Thus, it is crucial to focus on factors that increase cardiovascular risk. Obesity in particular has been associated with both the lifestyle habits and the side effects of antipsychotic medications. The present systematic review and meta-analysis aims at collecting and updating available evidence on the efficacy of non-pharmacological health promotion programmes for psychotic patients in randomised clinical trials. Methods We systematically reviewed the randomised controlled trials from 1990 onward, in which psychoeducational and/or cognitive-behavioural interventions aimed at weight loss or prevention of weight gain in patients with psychosis had been compared to treatment as usual. We carried out a meta-analysis and pooled the results of the studies with Body Mass Index as primary outcome. Results The results of the meta-analysis show an effect toward the experimental group. At the end of the intervention phase there is a −0.98 kg/m2 reduction in the mean Body Mass Index of psychotic subjects. Notably, prevention studies with individual psychoeducational programmes that include diet and/or physical activity seem to have the highest impact. Conclusions When compared with treatment as usual in psychotic patients, preventive and individual lifestyle interventions that include diet and physical activity generally prove to be effective in reducing weight. Physical screening and

  15. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Science.gov (United States)

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  16. The Psychology School Mental Health Initiative: An Innovative Approach to the Delivery of School-Based Intervention Services

    Science.gov (United States)

    Millar, Golden M.; Lean, Debra; Sweet, Susan D.; Moraes, Sabrina C.; Nelson, Victoria

    2013-01-01

    Evidence suggests that schools have, by default, become the primary mental health system for students in Canada. The goal of the present study was to design, implement, and evaluate the Psychology School Mental Health Initiative (PSMHI). The PSMHI is an innovative attempt to increase the capacity of school-based psychology staff to deliver…

  17. 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

  18. The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis.

    Science.gov (United States)

    Freeman, Daniel; Sheaves, Bryony; Goodwin, Guy M; Yu, Ly-Mee; Nickless, Alecia; Harrison, Paul J; Emsley, Richard; Luik, Annemarie I; Foster, Russell G; Wadekar, Vanashree; Hinds, Christopher; Gumley, Andrew; Jones, Ray; Lightman, Stafford; Jones, Steve; Bentall, Richard; Kinderman, Peter; Rowse, Georgina; Brugha, Traolach; Blagrove, Mark; Gregory, Alice M; Fleming, Leanne; Walklet, Elaine; Glazebrook, Cris; Davies, E Bethan; Hollis, Chris; Haddock, Gillian; John, Bev; Coulson, Mark; Fowler, David; Pugh, Katherine; Cape, John; Moseley, Peter; Brown, Gary; Hughes, Claire; Obonsawin, Marc; Coker, Sian; Watkins, Edward; Schwannauer, Matthias; MacMahon, Kenneth; Siriwardena, A Niroshan; Espie, Colin A

    2017-10-01

    Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Wellcome Trust. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by

  19. The Refugee Health Nurse Liaison: a nurse led initiative to improve healthcare for asylum seekers and refugees.

    Science.gov (United States)

    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.

  20. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    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.

  1. Comparison of a Commonwealth-initiated regional radiation oncology facility in Toowoomba with a Queensland Health facility.

    Science.gov (United States)

    Poulsen, M; Middleton, M; McQuitty, S; Ramsay, J; Gogna, K; Martin, J; Khoo, E; Wong, W; Fairweather, R; Walpole, E

    2010-08-01

    The aim was to compare a private Commonwealth-initiated regional radiation oncology facility in Toowoomba with a Queensland Health facility (QHF) in Brisbane. The comparison concentrated on staffing, case mix and operational budgets, but was not able to look at changes in access to services. Data were collected from the two facilities from January 2008 to June 2008 inclusive. A number of factors were compared, including case mix, staffing levels, delay times for treatment, research, training and treatment costs. The case mix between the two areas was similar with curative treatments making up just over half the work load in both centres and two-thirds the work being made up of cancers of breast and prostate. Staffing levels were leaner in Toowoomba, especially in the areas of nursing, administration and trial coordinators. Research activity was slightly higher in Toowoomba. The average medicare cost per treatment course was similar in both centres ($5000 per course). Total costs of an average treatment including patient, State and Commonwealth costs, showed a 30% difference in costing favouring Toowoomba. This regional radiation oncology centre has provided state-of-the-art cancer care that is close to home for patients living in the Darling Downs region. Both public and private patients have been treated with modest costs to the patient and significant savings to QH. The case mix is similar to the QHF, and there has been significant activity in clinical research. A paperless working environment is one factor that has allowed staffing levels to be reduced. Ongoing support from Governments are required if private facilities are to participate in important ongoing staff training.

  2. Lay health educators increase colorectal cancer screening among Hmong Americans: A cluster randomized controlled trial.

    Science.gov (United States)

    Tong, Elisa K; Nguyen, Tung T; Lo, Penny; Stewart, Susan L; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Kagawa-Singer, Marjorie L; Sy, Angela U; Cuaresma, Charlene; Lam, Hy T; Wong, Ching; Tran, Mi T; Chen, Moon S

    2017-01-01

    Asian Americans have lower colorectal cancer (CRC) screening rates than non-Hispanic white individuals. Hmong Americans have limited socioeconomic resources and literacy. The current randomized controlled trial was conducted to determine whether bilingual/bicultural lay health educator (LHE) education could increase CRC screening among Hmong Americans. A cluster randomized controlled trial was conducted among Hmong Americans in Sacramento, California. LHEs and recruited participants were randomized to intervention or control groups. The intervention group received CRC education over 3 months delivered by an LHE. The control group received education regarding nutrition and physical activity delivered by a health educator. The outcomes were changes in self-reported ever-screening and up-to-date CRC screening after 6 months. All 329 participants were foreign-born with mostly no formal education, limited English proficiency, and no employment. The majority of the participants were insured and had a regular source of health care. The intervention group experienced greater changes after the intervention than the control group for ever-screening (P = .068) and being up-to-date with screening (Pscreening (adjusted odds ratio, 1.73; 95% confidence interval, 1.07-2.79) and being up-to-date with screening (adjusted odds ratio, 1.71; 95% confidence interval, 1.26-2.32). Individuals who had health insurance were found to have >4 times the odds of receiving screening, both ever-screening and up-to-date screening. A higher CRC knowledge score mediated the intervention effect for both screening outcomes. A culturally and linguistically appropriate educational intervention delivered by trained LHEs was found to increase CRC screening in an immigrant population with low levels of education, employment, English proficiency, and literacy. Cancer 2017;98-106. © 2016 American Cancer Society. © 2016 American Cancer Society.

  3. PS3-05: Electronic Data Collection for a Clinical Trial Conducted within a Health System

    Science.gov (United States)

    Kerby, Tessa; Schneider, Nicole; Asche, Stephen; Loes, Linda; Maciosek, Michael; Meyers, Peter; Michalski, Derek; Margolis, Karen

    2010-01-01

    Background/Aims: Designing a seamless data collection tool for a research study across multiple physical locations within a health care system is challenging. Paper-based data collection is prone to data entry errors, subject to delays in availability of data, and environmentally wasteful. Web-based data collection tools are costly, time consuming to produce, and have security issues. We used Microsoft Access to create an efficient, low-cost electronic data collection tool for a clinical trial that required availability at numerous locations in the HealthPartners system. Methods: The research study required data collection entry points at ten different locations for different types of users, all linked into the HealthPartners computer network. A single Access database with linked modules for recruitment, tracking, eligibility determination and data collection was designed. Results: The recruitment module used at the research department integrated data on recruitment mailings and telephone screening of interested respondents, and used an automated algorithm to perform eligibility checks. The research clinic module for clinic visits was populated with eligible participants as determined by the recruitment module. This clinic module included further eligibility checks, data collection and treatment assignment. Participants then became available in the intervention module to pharmacist case managers located at 8 HealthPartners primary care clinics to collect data for the intervention. Based on study entry date, Access created a visit log to aid the case managers with timely adherence to the trial protocol. The database is stored on a secure server that is accessible only to authorized study team members, with further restrictions on data entry and access determined by study team role. Conclusions: The disadvantages of Microsoft Access (lack of flexibility, “bugginess”, older technology) are counterbalanced by many advantages (ready availability, inexpensiveness

  4. Evaluation of the 'healthy start to pregnancy' early antenatal health promotion workshop: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilkinson Shelley A

    2012-11-01

    Full Text Available Abstract Background Pregnancy is an ideal time to encourage healthy lifestyles as most women access health services and are more receptive to health messages; however few effective interventions exist. The aim of this research was to deliver a low-intensity, dietitian-led behavior change workshop at a Maternity Hospital to influence behaviors with demonstrated health outcomes. Methods Workshop effectiveness was evaluated using an RCT; ‘usual care’ women (n = 182 received a nutrition resource at their first antenatal visit and 'intervention' women also attended a one-hour ‘Healthy Start to Pregnancy’ workshop (n = 178. Dietary intake, physical activity levels, gestational weight gain knowledge, smoking cessation, and intention to breastfeed were assessed at service-entry and 12 weeks later. Intention-to-treat (ITT and per-protocol (PP analyses examined change over time between groups. Results Approximately half (48.3% the intervention women attended the workshop and overall response rate at time 2 was 67.2%. Significantly more women in the intervention met pregnancy fruit guidelines at time 2 (+4.3%, p = 0.011 and had a clinically-relevant increase in physical activity (+27 minutes/week compared with women who only received the resource (ITT. Women who attended the workshop increased their consumption of serves of fruit (+0.4 serves/day, p = 0.004, vegetables (+0.4 serves/day, p = 0.006, met fruit guidelines (+11.9%, p , had a higher diet quality score (p = 0.027 and clinically-relevant increases in physical activity (+21.3 minutes/week compared with those who only received the resource (PP. Conclusions The Healthy Start to Pregnancy workshop attendance facilitates improvements in important health behaviors. Service changes and accessibility issues are required to assist women's workshop attendance to allow more women to benefit from the workshop’s effects. Trial registration Australian New Zealand Clinical Trials Registry ACTRN

  5. White Blood Cell Count and Total and Cause-Specific Mortality in the Women's Health Initiative.

    Science.gov (United States)

    Kabat, Geoffrey C; Kim, Mimi Y; Manson, JoAnn E; Lessin, Lawrence; Lin, Juan; Wassertheil-Smoller, Sylvia; Rohan, Thomas E

    2017-03-22

    White blood cell (WBC) count appears to predict total mortality and coronary heart disease (CHD) mortality, but it is unclear to what extent the association reflects confounding by smoking, underlying illness, or comorbid conditions. We used data from the Women's Health Initiative to examine the associations of WBC count with total mortality, CHD mortality, and cancer mortality. WBC count was measured at baseline in 160,117 postmenopausal women and again in year 3 in 74,375 participants. Participants were followed for a mean of 16 years. Cox proportional hazards models were used to estimate the relative mortality hazards associated with deciles of baseline WBC count and of the mean of baseline + year 3 WBC count. High deciles of both baseline and mean WBC count were positively associated with total mortality and CHD mortality, whereas the association with cancer mortality was weaker. The association of WBC count with mortality was independent of smoking and did not appear to be influenced by previous disease history. The potential clinical utility of this common laboratory test in predicting mortality risk warrants further study. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Collaboration and competition in a children's health initiative coalition: a network analysis.

    Science.gov (United States)

    Valente, Thomas W; Coronges, Kathryn A; Stevens, Gregory D; Cousineau, Michael R

    2008-11-01

    Activating communities to achieve public health change and initiate policy reform usually requires collective action from many entities. This case study analyzes inter-organizational networks among members of a coalition created to expand health insurance coverage to uninsured children in a large metropolitan area. Six networks were measured: collaboration, competition, formal agreements, receive funding from, send funding to, and greater communication. The response rate was 65.8% (50 of the 76 active members). Positive network questions such as "who do you collaborate with" elicited many network choices whereas negative ones such as "who do you compete with" elicited few. The collaboration network had a core-periphery structure and analysis showed that a large network can be reduced to a small set of core organizations one-sixth the size of the whole. Centrality (out- and in-degree) was associated with perceived organizational function and perceived barriers to success. For example, organizations that received many choices as collaboration partners were more likely to perceive the coalition functioned well than those who received few choices. The study suggests that perceptions of organizational performance are associated with position in the network, central members are more likely to perceive the organization performs well than those on the periphery.

  7. Electric Blanket Use and Risk of Thyroid Cancer in the Women's Health Initiative Observational Cohort.

    Science.gov (United States)

    Kato, Ikuko; Young, Alicia; Liu, Jingmin; Abrams, Judith; Bock, Cathryn; Simon, Michael

    2015-01-01

    Thyroid cancer disproportionally affects more women than men. The aim of this study was to assess whether exposure to extremely low frequency electric magnetic fields from electric blankets (EBs) was associated with the development of thyroid cancer. Data were analyzed from 89,527 women who participated in the Women's Health Initiative Observational Study and who responded to questions concerning prior use of EBs. During a mean follow-up of 12.2 years, 190 incident cases of thyroid cancer were identified. We estimated the hazard ratio (HR) and 95 percent confidence interval (CI) of incident thyroid cancer associated with EB use by Cox's proportional hazard model, adjusted for selected covariates. A majority, 57 percent, of the women in the cohort reported the use of EBs while sleeping and/or for warming the bed before sleep. No association was found between use of EBs and subsequent risk of thyroid cancer (HR = 0.98, 95 percent CI 0.72-1.32). Duration of EB use measured in years, months, or hours had no effect on risk. These results did not change when the cases were limited to papillary thyroid cancer, the most frequently occurring histologic type. The results of this study do not support possible health hazards of EBs in regards to thyroid cancer risk.

  8. Urinary cadmium and estimated dietary cadmium in the Women's Health Initiative.

    Science.gov (United States)

    Quraishi, Sabah M; Adams, Scott V; Shafer, Martin; Meliker, Jaymie R; Li, Wenjun; Luo, Juhua; Neuhouser, Marian L; Newcomb, Polly A

    2016-01-01

    Cadmium, a heavy metal dispersed in the environment as a result of industrial and agricultural applications, has been implicated in several human diseases including renal disease, cancers, and compromised bone health. In the general population, the predominant sources of cadmium exposure are tobacco and diet. Urinary cadmium (uCd) reflects long-term exposure and has been frequently used to assess cadmium exposure in epidemiological studies; estimated dietary intake of cadmium (dCd) has also been used in several studies. The validity of dCd in comparison with uCd is unclear. This study aimed to compare dCd, estimated from food frequency questionnaires, to uCd measured in spot urine samples from 1,002 participants of the Women's Health Initiative. Using linear regression, we found that dCd was not statistically significantly associated with uCd (β=0.006, P-value=0.14). When stratified by smoking status, dCd was not significantly associated with uCd both in never smokers (β=0.006, P-value=0.09) and in ever smokers (β=0.003, P-value=0.67). Our results suggest that because of the lack of association between estimated dCd and measured uCd, dietary estimation of cadmium exposure should be used with caution in epidemiologic studies.

  9. The ENRICH Study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: rationale and design of a mixed methods cluster randomized trial.

    Science.gov (United States)

    Howard, Andrea A; Hirsch-Moverman, Yael; Saito, Suzue; Gadisa, Tsigereda; Daftary, Amrita; Melaku, Zenebe

    2017-06-01

    Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6-9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete. The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

  10. The Effects of Bikram Yoga on Health: Critical Review and Clinical Trial Recommendations.

    Science.gov (United States)

    Hewett, Zoe L; Cheema, Birinder S; Pumpa, Kate L; Smith, Caroline A

    2015-01-01

    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.

  11. The Effects of Bikram Yoga on Health: Critical Review and Clinical Trial Recommendations

    Directory of Open Access Journals (Sweden)

    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.

  12. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.

  13. Effect of a primary health-care-based controlled trial for cardiorespiratory fitness in refugee women

    Directory of Open Access Journals (Sweden)

    Johansson Sven-Erik

    2010-08-01

    Full Text Available Abstract Background Refugee women have a high risk of coronary heart disease with low physical activity as one possible mediator. Furthermore, cultural and environmental barriers to increasing physical activity have been demonstrated. The aim of the study was to evaluate the combined effect of an approximate 6-month primary health care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active refugee women. Methods A controlled clinical trial, named "Support for Increased Physical Activity", was executed among 243 refugee women recruited between November 2006 and April 2008 from two deprived geographic areas in southern Stockholm, Sweden. One geographic area provided the intervention group and the other area the control group. The control group was on a higher activity level at both baseline and follow-up, which was taken into consideration in the analysis by applying statistical models that accounted for this. Relative aerobic capacity and fitness level were assessed as the two main outcome measures. Results The intervention group increased their relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml·kg·min-1 to a greater extent than the control group between baseline and the 6-month follow-up, after adjusting for possible confounders (P = 0.020. Conclusions A combined primary health-care and community-based exercise programme (involving non-profit organizations can be an effective strategy to increase cardiorespiratory fitness among low-active refugee women. Trial Registration ClinicalTrials.gov ID: NCT00747942

  14. Collective learning, change and improvement in health care: trialling a facilitated learning initiative with general practice teams.

    Science.gov (United States)

    Bunniss, Suzanne; Gray, Francesca; Kelly, Diane

    2012-06-01

    Many patients, families, health care professionals and politicians desire for quality improvement within the UK National Health Service. One way to achieve this change is for health care teams to work and learn together more effectively. This research aimed to design and trial a facilitated learning programme with the aim of supporting general practice teams in fostering the characteristics of learning organizations. This is an action research study. Qualitative data were captured during and after the trial from 40 participants in two multi-professional general practice teams within different Scottish health boards. Data were gathered using observations, semi-structured interviews and written learning notes. Taking part in the LPP was a positive experience of learning together as a practice and enhanced communication within the team was a particular outcome. External facilitation helped provide focus and reduce inter-professional barriers. Teams found working in small, mixed role discussion groups particularly valuable in understanding each others' perspectives. The active learning style of the LPP could be daunting at times but teams valued the chance to identify their own quality improvement goals. Teams introduced a number of changes to improve the quality of care within their practice as a result of their participation. This trial of the learning practice programme shows that, with facilitation and the appropriate input of resources, general practice teams can successfully apply learning organization principles to produce quality improvement outcomes. The study also demonstrates the value of action research in researching iterative change over time. © 2011 Blackwell Publishing Ltd.

  15. Exploring Health Care Providers' Views About Initiating End-of-Life Care Communication.

    Science.gov (United States)

    Nedjat-Haiem, Frances R; Carrion, Iraida V; Gonzalez, Krystana; Ell, Kathleen; Thompson, Beti; Mishra, Shiraz I

    2017-05-01

    Numerous factors impede effective and timely end-of-life (EOL) care communication. These factors include delays in communication until patients are seriously ill and/or close to death. Gaps in patient-provider communication negatively affect advance care planning and limit referrals to palliative and hospice care. Confusion about the roles of various health care providers also limits communication, especially when providers do not coordinate care with other health care providers in various disciplines. Although providers receive education regarding EOL communication and care coordination, little is known about the roles of all health care providers, including nonphysician support staff working with physicians to discuss the possibility of dying and help patients prepare for death. This study explores the perspectives of physicians, nurses, social workers, and chaplains on engaging seriously ill patients and families in EOL care communication. Qualitative data were from 79 (medical and nonmedical) providers practicing at 2 medical centers in Central Los Angeles. Three themes that describe providers' perceptions of their roles and responsibility in talking with seriously ill patients emerged: (1) providers' roles for engaging in EOL discussions, (2) responsibility of physicians for initiating and leading discussions, and (3) need for team co-management patient care. Providers highlighted the importance of beginning discussions early by having physicians lead them, specifically due to their medical training and need to clarify medical information regarding patients' prognosis. Although physicians are a vital part of leading EOL communication, and are at the center of communication of medical information, an interdisciplinary approach that involves nurses, social workers, and chaplains could significantly improve patient care.

  16. Breckinridge Project, initial effort. Report VII, Volume 4. Safety and health plan

    Energy Technology Data Exchange (ETDEWEB)

    None

    1982-01-01

    The Safety and Health Plan recognizes the potential hazards associated with the Project and has been developed specifically to respond to these risks in a positive manner. Prevention, the primary objective of the Plan, starts with building safety controls into the process design and continues through engineering, construction, start-up, and operation of the Project facilities and equipment. Compliance with applicable federal, state, and local health and safety laws, regulations, and codes throughout all Project phases is required and assured. The Plan requires that each major Project phase be thoroughly reviewed and analyzed to determine that those provisions required to assure the safety and health of all employees and the public, and to prevent property and equipment losses, have been provided. The Plan requires followup on those items or situations where corrective action needs were identified to assure that the action was taken and is effective. Emphasis is placed on loss prevention. Exhibit 1 provides a breakdown of Ashland Synthetic Fuels, Inc.'s (ASFI's) Loss Prevention Program. The Plan recognizes that the varied nature of the work is such as to require the services of skilled, trained, and responsible personnel who are aware of the hazards and know that the work can be done safely, if done correctly. Good operating practice is likewise safe operating practice. Training is provided to familiarize personnel with good operational practice, the general sequence of activities, reporting requirements, and above all, the concept that each step in the operating procedures must be successfully concluded before the following step can be safely initiated. The Plan provides for periodic review and evaluation of all safety and loss prevention activities at the plant and departmental levels.

  17. Impact evaluation of the Urban Health Initiative in urban Uttar Pradesh, India

    Science.gov (United States)

    Achyut, Pranita; Benson, Aimee; Calhoun, Lisa M.; Corroon, Meghan; Guilkey, David K.; Kebede, Essete; Lance, Peter M.; Mishra, Anurag; Nanda, Priya; O'Hara, Rick; Sengupta, Ranajit; Speizer, Ilene S.; Stewart, John F.; Winston, Jennifer

    2016-01-01

    Objectives The Urban Health Initiative (UHI) was initiated in 2009 with the goal of increasing family planning (FP) use among the poor in urban areas of Uttar Pradesh, India. The Measurement, Learning & Evaluation project (MLE) was tasked with rigorous impact evaluation of the UHI. This paper presents the impact evaluation findings of the UHI program. Study design The MLE design includes a longitudinal sample of women and health facilities with baseline (2010) and endline (2014) data collection in six cities in Uttar Pradesh, India. At baseline, samples representative of women in each city were selected with oversampling of the poor. Eighty-four percent of women interviewed at baseline were reinterviewed 4 years later at endline. The longitudinal data support a within/fixed-effects approach to identification of program impact on changes in modern FP use. Results Impact evaluation results show significant effects of exposure to both demand and supply side program activities. In particular, women exposed to brochures (marginal effect: 6.96, p < .001), billboards/posters/wall hangings (marginal effect: 2.09, p < .05), and FP on the television (marginal effect: 2.46, p < .001) were significantly more likely to be using a modern method at endline. In addition, we found borderline significance for being exposed to a community health worker (marginal effect: 1.66, p < .10) and living close to an improved public and private supply environment where UHI undertook activities (marginal effects and p values: 2.48, p < .05 and 1.56, p < .10, respectively). Conclusions UHI program activities were designed to complement the Government of India's strategies aimed at ensuring access to and provision of FP to urban poor populations. The effective demand- and supply-side strategies of the UHI program are therefore likely to be sustainable and scalable to other urban areas in India. Implications statement Findings from this study are important for designing sustainable and

  18. Bioequivalence and Bioavailability Clinical Trials: A Status Report from the National Institutes of Health ClinicalTrials.gov Registry

    OpenAIRE

    Stockmann, Chris; Spigarelli, Michael G.; Ampofo, Krow; Sherwin, Catherine MT

    2013-01-01

    Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a national clinical trials registry. All bioequivalence and bioavailability studies registered in the United...

  19. Web services-based access to local clinical trial databases: a standards initiative of the Association of American Cancer Institutes.

    Science.gov (United States)

    Stahl, Douglas C; Evans, Richard M; Afrin, Lawrence B; DeTeresa, Richard M; Ko, Dave; Mitchell, Kevin

    2003-01-01

    Electronic discovery of the clinical trials being performed at a specific research center is a challenging task, which presently requires manual review of the center's locally maintained databases or web pages of protocol listings. Near real-time automated discovery of available trials would increase the efficiency and effectiveness of clinical trial searching, and would facilitate the development of new services for information providers and consumers. Automated discovery efforts to date have been hindered by issues such as disparate database schemas, vocabularies, and insufficient standards for easy intersystem exchange of high-level data, but adequate infrastructure now exists that make possible the development of applications for near real-time automated discovery of trials. This paper describes the current state (design and implementation) of the Web Services Specification for Publication and Discovery of Clinical Trials as developed by the Technology Task Force of the Association of American Cancer Institutes. The paper then briefly discusses a prototype web service-based application that implements the specification. Directions for evolution of this specification are also discussed.

  20. Development of a practical approach to expert elicitation for randomised controlled trials with missing health outcomes: Application to the IMPROVE trial.

    Science.gov (United States)

    Mason, Alexina J; Gomes, Manuel; Grieve, Richard; Ulug, Pinar; Powell, Janet T; Carpenter, James

    2017-08-01

    The analyses of randomised controlled trials with missing data typically assume that, after conditioning on the observed data, the probability of missing data does not depend on the patient's outcome, and so the data are 'missing at random' . This assumption is usually implausible, for example, because patients in relatively poor health may be more likely to drop out. Methodological guidelines recommend that trials require sensitivity analysis, which is best informed by elicited expert opinion, to assess whether conclusions are robust to alternative assumptions about the missing data. A major barrier to implementing these methods in practice is the lack of relevant practical tools for eliciting expert opinion. We develop a new practical tool for eliciting expert opinion and demonstrate its use for randomised controlled trials with missing data. We develop and illustrate our approach for eliciting expert opinion with the IMPROVE trial (ISRCTN 48334791), an ongoing multi-centre randomised controlled trial which compares an emergency endovascular strategy versus open repair for patients with ruptured abdominal aortic aneurysm. In the IMPROVE trial at 3 months post-randomisation, 21% of surviving patients did not complete health-related quality of life questionnaires (assessed by EQ-5D-3L). We address this problem by developing a web-based tool that provides a practical approach for eliciting expert opinion about quality of life differences between patients with missing versus complete data. We show how this expert opinion can define informative priors within a fully Bayesian framework to perform sensitivity analyses that allow the missing data to depend upon unobserved patient characteristics. A total of 26 experts, of 46 asked to participate, completed the elicitation exercise. The elicited quality of life scores were lower on average for the patients with missing versus complete data, but there was considerable uncertainty in these elicited values. The missing at

  1. Design and implementation of the AIRWAYS-2 trial: A multi-centre cluster randomised controlled trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest.

    Science.gov (United States)

    Taylor, Jodi; Black, Sarah; J Brett, Stephen; Kirby, Kim; Nolan, Jerry P; Reeves, Barnaby C; Robinson, Maria; Rogers, Chris A; Scott, Lauren J; South, Adrian; Stokes, Elizabeth A; Thomas, Matthew; Voss, Sarah; Wordsworth, Sarah; Benger, Jonathan R

    2016-12-01

    Health outcomes after out of hospital cardiac arrest (OHCA) are extremely poor, with only 7-9% of patients in the United Kingdom (UK) surviving to hospital discharge. Currently emergency medical services (EMS) use either tracheal intubation or newer supraglottic airway devices (SGAs) to provide advanced airway management during OHCA. Equipoise between the two techniques has led to calls for a well-designed randomised controlled trial. The primary objective of the AIRWAYS-2 trial is to assess whether the clinical effectiveness of the i-gel, a second-generation SGA, is superior to tracheal intubation in the initial airway management of OHCA patients in the UK. Paramedics recruited to the AIRWAYS-2 trial are randomised to use either tracheal intubation or i-gel as their first advanced airway intervention. Adults who have had a non-traumatic OHCA and are attended by an AIRWAYS-2 paramedic are retrospectively assessed against eligibility criteria for inclusion. The primary outcome is the modified Rankin Scale score at hospital discharge. Secondary objectives are to: (i) estimate differences between groups in outcome measures relating to airway management, hospital stay and recovery at 3 and 6 months; (ii) estimate the cost effectiveness of the i-gel compared to tracheal intubation. Because OHCA patient needs immediate treatment there are several unusual features and challenges to the design and implementation of this trial; these include level of randomisation, the automatic enrolment model, enrolment of patients that lack capacity and minimisation of bias. Patient enrolment began in June 2015. The trial will enrol 9070 patients over two years. The results are expected to influence future resuscitation guidelines. Trial Registration ISRCTN: 08256118. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

  2. Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Manandhar Dharma

    2011-05-01

    Full Text Available Abstract Background Birth attendance by trained health workers is low in rural Nepal. Local participation in improving health services and increased interaction between health systems and communities may stimulate demand for health services. Significant increases in birth attendance by trained health workers may be affected through community mobilisation by local women's groups and health management committee strengthening. We will test the effect of community mobilisation through women's groups, and health management committee strengthening, on institutional deliveries and home deliveries attended by trained health workers in Makwanpur District. Design Cluster randomised controlled trial involving 43 village development committee clusters. 21 clusters will receive the intervention and 22 clusters will serve as control areas. In intervention areas, Female Community Health Volunteers are supported in convening monthly women's groups. The groups work through an action research cycle in which they consider barriers to institutional delivery, plan and implement strategies to address these barriers with their communities, and evaluate their progress. Health management committees participate in three-day workshops that use appreciative inquiry methods to explore and plan ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. Primary outcomes are institutional deliveries and home deliveries conducted by trained health workers. Secondary outcome measures include uptake of antenatal and postnatal care, neonatal mortality and stillbirth rates, and maternal morbidity. Trial registration number ISRCTN99834806

  3. Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378

    Directory of Open Access Journals (Sweden)

    Ewings Paul E

    2004-12-01

    Full Text Available Abstract Introduction Critical appraisal skills are believed to play a central role in an evidence-based approach to health practice. The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aimed at health care professionals. Methods This prospective controlled trial randomized 145 self-selected general practitioners, hospital physicians, professions allied to medicine, and healthcare managers/administrators from the South West of England to a half-day critical appraisal skills training workshop (based on the model of problem-based small group learning or waiting list control. The following outcomes were assessed at 6-months follow up: knowledge of the principles necessary for appraising evidence; attitudes towards the use of evidence about healthcare; evidence seeking behaviour; perceived confidence in appraising evidence; and ability to critically appraise a systematic review article. Results At follow up overall knowledge score [mean difference: 2.6 (95% CI: 0.6 to 4.6] and ability to appraise the results of a systematic review [mean difference: 1.2 (95% CI: 0.01 to 2.4] were higher in the critical skills training group compared to control. No statistical significant differences in overall attitude towards evidence, evidence seeking behaviour, perceived confidence, and other areas of critical appraisal skills ability (methodology or generalizability were observed between groups. Taking into account the workshop provision costs and costs of participants time and expenses of participants, the average cost of providing the critical appraisal workshops was approximately £250 per person. Conclusions The findings of this study challenge the policy of funding 'one-off' educational interventions aimed at enhancing the evidence-based practice of health care professionals. Future evaluations of evidence-based practice interventions need to take in account this trial's negative findings

  4. 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.

  5. The use of international service learning initiatives for global health education: case studies from Rwanda and Mexico.

    Science.gov (United States)

    Plumb, Ellen; Roe, Kathleen; Plumb, James; Sepe, Priscilla; Soin, Komal; Ramirez, Aragon; Baganizi, Edmond; Simmons, Rob; Khubchandani, Jagdish

    2013-05-01

    Global health education and health promotion have the potential to engage students, scholars, and practitioners in ways that go beyond the classroom teaching routine. This engagement in global communities, can range from reflection on continuing deep-seated questions about human rights and civic responsibility to the use of health education and promotion-related theoretical, intellectual, and practical skills. In the arena of global health education and promotion, these skills also range from leadership and advocacy to decision making, critical and creative thinking, teamwork, and problem solving. In recent times, there has been a growing interest in cross-cultural collaborations and educational initiatives to improve stakeholder's understanding of global health principles and practices, to enrich the experiences of health professionals, and to improve the lives of those who are disenfranchised and live across borders. In this article of Health Promotion Practice, we highlight two unique cases of cross-national collaborations and provide a glimpse of the various shapes and forms taken by cross-cultural educational initiatives for global health education and promotion. We summarize the history, philosophy, and current working practices relevant to these collaborations, keeping in view the global health domains, competencies, and activities. In addition, we also compare the key components and activities of these two case studies from Rwanda and Mexico, wherein communities in these two countries collaborated with academic institutions and health professionals in the United States.

  6. The Initiative to extend Medicare into Mexico: a case study in changing U.S. Health Care Policy

    Directory of Open Access Journals (Sweden)

    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.

  7. Development and initial evaluation of blended cognitive behavioural treatment for major depression in routine specialized mental health care

    Directory of Open Access Journals (Sweden)

    Lisa C. Kooistra

    2016-05-01

    Discussion: Although no conclusions can be drawn based on the current study, our observations suggest that a blended CBT approach might shorten treatment duration and has the potential to be a valuable treatment option for patients with severe depression in specialized mental health care settings. Further exploration of the effectiveness of our bCBT protocol by means of a randomized controlled trial is warranted.

  8. 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

  9. A framework for scaling up health interventions: lessons from large-scale improvement initiatives in Africa.

    Science.gov (United States)

    Barker, Pierre M; Reid, Amy; Schall, Marie W

    2016-01-29

    Scaling up complex health interventions to large populations is not a straightforward task. Without intentional, guided efforts to scale up, it can take many years for a new evidence-based intervention to be broadly implemented. For the past decade, researchers and implementers have developed models of scale-up that move beyond earlier paradigms that assumed ideas and practices would successfully spread through a combination of publication, policy, training, and example. Drawing from the previously reported frameworks for scaling up health interventions and our experience in the USA and abroad, we describe a framework for taking health interventions to full scale, and we use two large-scale improvement initiatives in Africa to illustrate the framework in action. We first identified other scale-up approaches for comparison and analysis of common constructs by searching for systematic reviews of scale-up in health care, reviewing those bibliographies, speaking with experts, and reviewing common research databases (PubMed, Google Scholar) for papers in English from peer-reviewed and "gray" sources that discussed models, frameworks, or theories for scale-up from 2000 to 2014. We then analyzed the results of this external review in the context of the models and frameworks developed over the past 20 years by Associates in Process Improvement (API) and the Institute for Healthcare improvement (IHI). Finally, we reflected on two national-scale improvement initiatives that IHI had undertaken in Ghana and South Africa that were testing grounds for early iterations of the framework presented in this paper. The framework describes three core components: a sequence of activities that are required to get a program of work to full scale, the mechanisms that are required to facilitate the adoption of interventions, and the underlying factors and support systems required for successful scale-up. The four steps in the sequence include (1) Set-up, which prepares the ground for

  10. News media coverage of smoking and health is associated with changes in population rates of smoking cessation but not initiation.

    Science.gov (United States)

    Pierce, J P; Gilpin, E A

    2001-06-01

    To determine whether changes in news media coverage of smoking and health issues are associated with changes in smoking behaviour in the USA. Issue importance in the US news media is assessed by the number of articles published annually in major magazines indexed in The Reader's Guide to Periodical Literature. Annual incidence rates for cessation and initiation in the USA were computed from the large, representative National Health Interview Surveys (1965-1992). Patterns in cessation incidence were considered for ages 20-34 years and 35-50 years. Initiation incidence was examined for adolescents (14-17 years) and young adults (18-21 years) of both sexes. From 1950 to the early 1980s, the annual incidence of cessation in the USA mirrored the pattern of news media coverage of smoking and health, particularly for middle aged smokers. Cessation rates in younger adults increased considerably when second hand smoke concerns started to increase in the US population. Incidence of initiation in young adults did not start to decline until the beginning of the public health campaign against smoking in the 1960s. Among adolescents, incidence rates did not start to decline until the 1970s, after the broadcast ban on cigarette advertising. The level of coverage of smoking and health in the news media may play an important role in determining the rate of population smoking cessation, but not initiation. In countries where cessation has lagged, advocates should work to increase the newsworthiness of smoking and health issues.

  11. Research protocol for a randomized controlled trial of the health effects of volunteering for seniors.

    Science.gov (United States)

    Pettigrew, Simone; Jongenelis, Michelle; Newton, Robert U; Warburton, Jeni; Jackson, Ben

    2015-06-04

    A growing evidence base demonstrates that interventions that focus on participation in physical and social activities can assist in preventing and treating both physical and mental health problems. In addition, there is some evidence that engaging in volunteering activities can provide beneficial social, physical, psychological, and cognitive outcomes for older people. This study will use a randomized controlled trial approach to investigate the potential for interventions involving volunteer activities to produce positive physical and psychological outcomes for older people, thereby contributing to the limited evidence relating to the potential for volunteering to provide multiple health effects. This randomized controlled trial will involve 400 retired/non-employed individuals in good health aged 60+ years living in the metropolitan area in Perth, Western Australia. Participants will be recruited from the Perth metropolitan area using a variety of recruitment methods to achieve a diverse sample in terms of age, gender, and socioeconomic status. Consenting and eligible participants will be randomly assigned to an intervention (n = 200) or control group (n = 200). Those in the intervention group will be asked to engage in a minimum 60 min of volunteer activities per week for a period of 6 months, while those in the control group will be asked to maintain their existing lifestyle or take on new activities as they see fit. Physical and psychological outcomes will be assessed. Primary physical outcomes will include physical activity and sedentary time (measured using pedometers and Actigraph monitors) and physical health (measured using a battery of physical functioning tests, resting heart rate, blood pressure, BMI, and girth). Primary psychological outcomes will include psychological well-being, depression, self-esteem, and quality of life (measured using the Warwick-Edinburgh Mental Well-Being Scale, Center for Epidemiologic Studies Depression Scale, the

  12. The French-German initiative for Chernobyl. Programme 3 study of the health effects