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Sample records for case-management prevention trial

  1. Is Case Management Effective for Long-Lasting Suicide Prevention?

    Science.gov (United States)

    Wang, Liang-Jen; Wu, Ya-Wen; Chen, Chih-Ken

    2015-01-01

    Case management services have been implemented in suicide prevention programs. To investigate whether case management is an effective strategy for reducing the risks of repeated suicide attempts and completed suicides in a city with high suicide rates in northern Taiwan. The Suicide Prevention Center of Keelung City (KSPC) was established in April 2005. Subjects included a consecutive sample of individuals (N = 2,496) registered in KSPC databases between January 1, 2006, and December 31, 2011, with at least one episode of nonfatal self-harm. Subjects were tracked for the duration of the study. Of all the subjects, 1,013 (40.6%) received case management services; 416 (16.7%) had at least one other deliberate self-harm episode and 52 (2.1%) eventually died by suicide. No significant differences were found in the risks of repeated self-harm and completed suicides between suicide survivors who received case management and those who refused the services. However, a significant reduction in suicide rates was found after KSPC was established. Findings suggest that case management services might not reduce the risks of suicide repetition among suicide survivors during long-term follow-up. Future investigation is warranted to determine factors impacting the downward trend of suicide rates.

  2. Cost-effectiveness of preventive case management for parents with a mental illness: A randomized controlled trial from three economic perspectives

    NARCIS (Netherlands)

    Wansink, H.J.; Drost, R.M.W.A.; Paulus, A.T.G.; Ruwaard, D.; Hosman, C.M.H.; Janssens, J.M.A.M.; Evers, S.M.A.A.

    2016-01-01

    Background: The children of parents with a mental illness (COPMI) are at increased risk for developing costly psychiatric disorders because of multiple risk factors which threaten parenting quality and thereby child development. Preventive basic care management (PBCM) is an intervention aimed at

  3. Effects of a case management program on patients with oral precancerous lesions: a randomized controlled trial.

    Science.gov (United States)

    Lin, Hsiu-Ying; Chen, Shu-Ching; Peng, Hsi-Ling; Chen, Mu-Kuan

    2016-01-01

    The aim of this study is to identify the effects of a case management program on knowledge about oral cancer, preventive behavior for oral cancer, and level of uncertainty for patients with oral precancerous lesions. A randomized controlled trial was conducted with two groups, using a pre- and posttest design. The experimental group received a case management program and telephone follow-up sessions; the control group received routine care. Patients were assessed at three time points: first visit to the otolaryngology clinic for biopsy examination (T0), and then at 2 weeks (T1) and 4 weeks (T2) after the biopsy examination. Patients in both groups had significantly higher levels of knowledge about oral cancer, preventive behavior for oral cancer, and lower level of uncertainty at T2 compared to T0. At T2, participants in the experimental group had significantly greater knowledge about oral cancer, more preventive behavior for oral cancer, and less uncertainty compared to those in the control group. The case management program with telephone counseling effectively improved knowledge about oral cancer, preventive behavior for oral cancer, and uncertainty levels in patients with oral precancerous lesions in the four weeks after receiving a biopsy examination. The case management program can be applied with positive results to patients receiving different types of cancer screening, including colorectal, breast, and cervical screening.

  4. Feasibility trial of GP and case-managed support for workplace sickness absence.

    Science.gov (United States)

    Rannard, Anne; Gabbay, Mark; Sen, Dil; Riley, Richard; Britt, David

    2014-07-01

    Aim Our aim was to compare the return-to-work rates between individuals supported by their GP plus workplace health advisers (intervention group) and those supported by their GP alone. Workplace sickness absence places a significant cost burden on individuals and the wider economy. Previous research shows better outcomes for individuals if they are supported while still in employment, or have been on sick leave for four weeks or less. Those helped back to work at an early stage are more likely to remain at work. A non-medicalised case-managed approach appears to have the best outcomes and can prevent or reduce the slide onto out-of-work benefits, but UK literature on its effectiveness is sparse. The design was a feasibility-controlled trial in which participants were sickness absentees, or presentees in employment with work-related health problems. Individuals completed health status measures (SF-36; EQ-5D) and a Job Content Questionnaire at baseline and again at four-month follow-up. Findings In the intervention group, 29/60 participants completed both phases of the trial. GP practices referred two control patients, and, despite various attempts by the research team, GPs failed to engage with the trial. This finding is of concern, although not unique in primary care research. In earlier studies, GPs reported a lack of knowledge and confidence in dealing with workplace health issues. Despite this, we report interesting findings from the case-managed group, the majority of whom returned to work within a month. Age and length of sickness absence at recruitment were better predictors of return-to-work rates than the number of case-managed contacts. The traditional randomised controlled trial approach was unsuitable for this study. GPs showed low interest in workplace sickness absence, despite their pivotal role in the process. This study informed a larger Department for Work and Pensions study of case-managed support.

  5. Case management helps prevent criminal justice recidivism for people with serious mental illness.

    Science.gov (United States)

    Leutwyler, Heather; Hubbard, Erin; Zahnd, Elaine

    2017-09-11

    Purpose The purpose of this paper is to discuss how case management can decrease recidivism for people with serious mental illness (SMI) because people with SMI are at high risk for incarceration and recidivism. Design/methodology/approach Examples of successful case management models for formerly incarcerated individuals with SMI found through a secondary analysis of qualitative data and an analysis of the literature are presented. Findings Currently, no international, national, or statewide guidelines exist to ensure that formerly incarcerated individuals with SMI receive case management upon community reentry despite evidence that such services can prevent further criminal justice involvement. Recommendations include establishment of and evaluation of best practices for case management. In addition, the authors recommend additional funding for case management with the goal of greatly increasing the number of individuals with SMI leaving the criminal justice system in their ability to access adequate case management. Originality/value Providing effective case management tailored to the needs of formerly incarcerated people with SMI improves their quality of life and reduces their involvement in the criminal justice system with clear positive outcomes for public safety and public health.

  6. Case management for frequent users of the emergency department: study protocol of a randomised controlled trial.

    Science.gov (United States)

    Bodenmann, Patrick; Velonaki, Venetia-Sofia; Ruggeri, Ornella; Hugli, Olivier; Burnand, Bernard; Wasserfallen, Jean-Blaise; Moschetti, Karine; Iglesias, Katia; Baggio, Stéphanie; Daeppen, Jean-Bernard

    2014-06-17

    We devised a randomised controlled trial to evaluate the effectiveness and efficiency of an intervention based on case management care for frequent emergency department users. The aim of the intervention is to reduce such patients' emergency department use, to improve their quality of life, and to reduce costs consequent on frequent use. The intervention consists of a combination of comprehensive case management care and standard emergency care. It uses a clinical case management model that is patient-identified, patient-directed, and developed to provide high intensity services. It provides a continuum of hospital- and community-based patient services, which include clinical assessment, outreach referral, and coordination and communication with other service providers. We aim to recruit, during the first year of the study, 250 patients who visit the emergency department of the University Hospital of Lausanne, Switzerland. Eligible patients will have visited the emergency department 5 or more times during the previous 12 months. Randomisation of the participants to the intervention or control groups will be computer generated and concealed. The statistician and each patient will be blinded to the patient's allocation. Participants in the intervention group (N = 125), additionally to standard emergency care, will receive case management from a team, 1 (ambulatory care) to 3 (hospitalization) times during their stay and after 1, 3, and 5 months, at their residence, in the hospital or in the ambulatory care setting. In between the consultations provided, the patients will have the opportunity to contact, at any moment, the case management team. Participants in the control group (N = 125) will receive standard emergency care only. Data will be collected at baseline and 2, 5.5, 9, and 12 months later, including: number of emergency department visits, quality of life (EuroQOL and WHOQOL), health services use, and relevant costs. Data on feelings of discrimination

  7. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    Science.gov (United States)

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha; Davis, Thomas; Marsh, Cheryl

    2008-01-01

    This paper reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to either PCM (n=92) or standard probation (n=91), and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support and service utilization. Arrest data were collected from administrative datasets. The sample (N=183) included mostly African American (57%) and White (20%) women, with a mean age of 34.7 (SD = 9.2) and mean education of 11.6 years (SD = 2.1). Cocaine and heroin were the most frequently reported drugs of abuse, 86% reported prior history of incarceration, and 74% had children. Women assigned to both PCM and standard probation showed change over time in the direction of clinical improvement on 7 of 10 outcomes measured. However, changes observed for the PCM group were no different than those observed for the standard probation group. Higher levels of case management, drug abuse treatment, and probationary supervision may be required to achieve improved outcomes in this population. PMID:21464888

  8. Get Connected: an HIV prevention case management program for men and women leaving California prisons.

    Science.gov (United States)

    Myers, Janet; Zack, Barry; Kramer, Katie; Gardner, Mick; Rucobo, Gonzalo; Costa-Taylor, Stacy

    2005-10-01

    Individuals leaving prison face challenges to establishing healthy lives in the community, including opportunities to engage in behavior that puts them at risk for HIV transmission. HIV prevention case management (PCM) can facilitate linkages to services, which in turn can help remove barriers to healthy behavior. As part of a federally funded demonstration project, the community-based organization Centerforce provided 5 months of PCM to individuals leaving 3 state prisons in California. Program effects were measured by assessing changes in risk behavior, access to services, reincarnation, and program completion. Although response rates preclude definitive conclusions, HIV risk behavior did decrease. Regardless of race, age, or gender, those receiving comprehensive health services were significantly more likely to complete the program. PCM appears to facilitate healthy behavior for individuals leaving prison.

  9. A Randomized Controlled Trial of Hospital-based Case Management in Cancer Care

    DEFF Research Database (Denmark)

    Wulff, Christian; Vedsted, Peter; Søndergaard, Jens

    2013-01-01

    BACKGROUND: Case management (CM) models based on experienced nurses are increasingly used to improve coordination and continuity of care for patients with complex health care needs. Anyway, little is known about the effects of hospital-based CM in cancer care.Aim.To analyse the effects of hospital......-based CM on (i) GPs' evaluation of information from the hospital and collaboration with the hospital staff and (ii) patients' contacts with GPs during daytime and out of hours. DESIGN: A randomized controlled trial allocated 280 colorectal cancer patients 1:1 to either a control group or CM intervention...... of CM patients reported contacting the hospital. CM did not affect the number of patient contacts with the GPs during the daytime, but CM patients showed a tendency towards more contacts to the out-of-hours GP services than non-CM patients. CONCLUSIONS: CM was appreciated by the GPs and reduced...

  10. Indicated Prevention of Fetal Alcohol Spectrum Disorders in South Africa: Effectiveness of Case Management

    Directory of Open Access Journals (Sweden)

    Marlene M. de Vries

    2015-12-01

    Full Text Available In the Western Cape Province of South Africa (ZA a subculture of binge drinking produces the highest global documented prevalence of fetal alcohol spectrum disorders (FASD. FASD prevention research activities in ZA use the Comprehensive Prevention approach from the United States Institute of Medicine. Case management (CM was delivered as a method of indicated prevention to empower heavy drinking pregnant women to achieve cessation or a reduction in drinking. CM activities incorporated life management, Motivational Interviewing (MI techniques and the Community Reinforcement Approach (CRA. Data were collected at baseline, 6, 12 and 18 months. Mean drinking decreases 6 months into CM; but overall alcohol consumption rose significantly over time to levels higher than baseline at 12 and 18 months. Alcohol consumption drops significantly from before pregnancy to the second and third trimesters. AUDIT scores indicate that problematic drinking decreases significantly even after the vulnerable fetus/baby was born. CM significantly increases client happiness, which correlates with reduced weekend drinking. CM was successful for women with high-risk drinking behaviour, and was effective in helping women stop drinking, or drink less, while pregnant, reducing the risk of FASD.

  11. A sense of security: Spouses’ experiences of participating in an orthopaedic case management intervention (the SICAM-trial)

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Kristensson, Jimmie

    2017-01-01

    The aim of the study was to explore and describe spouses' experiences of participating in a case management intervention during older patients' fast-track programme having total hip replacement as well as which intervention elements they found useful. Data were collected through qualitative...... interviews with 10 spouses from the intervention group of the SICAM-trial, directed by predetermined codes based on elements of the intervention. Data were analysed by both authors using directed content analysis. The results showed that the spouses were very pleased about being a part of the case management...... intervention. They enjoyed being active participants even though problems sometimes occurred such as coordination difficulties between the case manager and other healthcare professionals and their feeling of being burdened. The spouses experienced the contact with the case manager as the most meaningful part...

  12. Community-dwelling patients with dementia and their informal caregivers with and without case management: 2-year outcomes of a pragmatic trial

    NARCIS (Netherlands)

    Macneil Vroomen, Janet; Bosmans, Judith E.; van de Ven, Peter M.; Joling, Karlijn J.; van Mierlo, Lisa D.; Meiland, Franka J. M.; Moll van Charante, Eric P.; van Hout, Hein P. J.; de Rooij, Sophia E.

    2015-01-01

    To evaluate outcomes for persons with dementia and primary informal caregivers of 2 types of implemented case management (intensive case management [ICMM] and linkage [LM] models) with no case management (control group). A pragmatic trial using a prospective, observational, controlled, cohort study.

  13. Community-Dwelling Patients With Dementia and Their Informal Caregivers With and Without Case Management : 2-Year Outcomes of a Pragmatic Trial

    NARCIS (Netherlands)

    Vroomen, Janet MacNeil; Bosmans, Judith E.; van de Ven, Peter M.; Joling, Karlijn J.; van Mierlo, Lisa D.; Meiland, Franka J. M.; van Charante, Eric P. Moll; van Hout, Hein P. J.; de Rooij, Sophia E.

    2015-01-01

    Objective: To evaluate outcomes for persons with dementia and primary informal caregivers of 2 types of implemented case management (intensive case management [ICMM] and linkage [LM] models) with no case management (control group). Design: A pragmatic trial using a prospective, observational,

  14. Protective efficacy of malaria case management and intermittent preventive treatment for preventing malaria mortality in children: a systematic review for the Lives Saved Tool

    Directory of Open Access Journals (Sweden)

    Steketee Richard W

    2011-04-01

    Full Text Available Abstract Background The Lives Saved Tool (LiST model was developed to estimate the impact of the scale-up of child survival interventions on child mortality. New advances in antimalarials have improved their efficacy of treating uncomplicated and severe malaria. Artemisinin-based combination therapies (ACTs for uncomplicated Plasmodium falciparum malaria and parenteral or rectal artemisinin or quinine for severe malaria syndromes have been shown to be very effective for the treatment of malaria in children. These interventions are now being considered for inclusion in the LiST model. However, for obvious ethical reasons, their protective efficacy (PE compared to placebo is unknown and their impact on reducing malaria-attributable mortality has not been quantified. Methods We performed systematic literature reviews of published studies in P. falciparum endemic settings to determine the protective efficacy (PE of ACT treatment against malaria deaths among children with uncomplicated malaria, as well as the PE of effective case management including parenteral quinine against malaria deaths among all hospitalized children. As no randomized placebo-controlled trials of malaria treatment have been conducted, we used multiple data sources to ascertain estimates of PE, including a previously performed Delphi estimate for treatment of uncomplicated malaria. Results Based on multiple data sources, we estimate the PE of ACT treatment of uncomplicated P. falciparum malaria on reducing malaria mortality in children 1–23 months to be 99% (range: 94-100%, and in children 24-59 months to be 97% (range: 86-99%. We estimate the PE of treatment of severe P. falciparum malaria with effective case management including intravenous quinine on reducing malaria mortality in children 1-59 months to be 82% (range: 63-94% compared to no treatment. Conclusions This systematic review quantifies the PE of ACT used for treating uncomplicated malaria and effective case

  15. Work Incapacity and Treatment Costs After Severe Accidents: Standard Versus Intensive Case Management in a 6-Year Randomized Controlled Trial.

    Science.gov (United States)

    Scholz, Stefan M; Andermatt, Peter; Tobler, Benno L; Spinnler, Dieter

    2016-09-01

    Purpose Case management is widely accepted as an effective method to support medical rehabilitation and vocational reintegration of accident victims with musculoskeletal injuries. This study investigates whether more intensive case management improves outcomes such as work incapacity and treatment costs for severely injured patients. Methods 8,050 patients were randomly allocated either to standard case management (SCM, administered by claims specialists) or intensive case management (ICM, administered by case managers). These study groups differ mainly by caseload, which was approximately 100 cases in SCM and 35 in ICM. The setting is equivalent to a prospective randomized controlled trial. A 6-year follow-up period was chosen in order to encompass both short-term insurance benefits and permanent disability costs. All data were extracted from administrative insurance databases. Results Average work incapacity over the 6-year follow-up, including contributions from daily allowances and permanent losses from disability, was slightly but insignificantly higher under ICM than under SCM (21.6 vs. 21.3 % of pre-accident work capacity). Remaining work incapacity after 6 years of follow-up showed no difference between ICM and SCM (8.9 vs. 8.8 % of pre-accident work incapacity). Treatment costs were 43,500 Swiss Francs (CHF) in ICM compared to 39,800 in SCM (+9.4 %, p = 0.01). The number of care providers involved in ICM was 10.5 compared to 10.0 in ICM (+5.0 %, p work incapacity as compared to SCM, but did increase healthcare consumption and treatment costs. It is concluded that the intensity of case management alone is not sufficient to improve rehabilitation and vocational reintegration of accident victims.

  16. Case management.

    Science.gov (United States)

    Woodward, Judy; Rice, Eve

    2015-03-01

    Health care in the United States is changing rapidly under pressure from both political and professional stakeholders, and one area on the front line of required change is the discipline of case management. Historically, case management has worked to defragment the health care delivery system for clients and increase access to health care. Case management will have an expanded role resulting from Affordable Care Act initiatives to improve health care. This article includes definitions of case management, current issues related to case management, case management standards of practice, and a case study of the management of pediatric chronic disease. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Effectiveness of case management in the prevention of COPD re-admissions: a pilot study.

    Science.gov (United States)

    van Eeden, Annelies E; van de Poll, Ingrid; van Vulpen, Gertrud; Roldaan, Tim; Wagenaar, Wies; Boland, Melinde R S; Wolterbeek, Ron; Chavannes, Niels H

    2017-11-25

    Chronic obstructive pulmonary disease (COPD) exacerbations are associated with high disease burden and costs, especially in the case of hospitalizations. The overall number of hospital admissions due to exacerbations of COPD has increased. It is remarkable that re-admissions account for a substantial part of these hospitalizations. This pilot study investigates the use of case management to reduce re-admissions due to COPD. COPD patients with more than one hospitalization per year due to an exacerbation were included. The participants (n = 10) were closely monitored and intensively coached for 20 weeks after hospitalization. The case manager provided care in a person-focused manner. The case manager informed and supported the patient, took action when relapse threatened, coordinated and connected primary and secondary care. Data of 12 months before and after start of the intervention were compared. Primary outcome was the difference in number of hospitalizations. Secondary outcomes were health-related quality of life (measured by the Clinical COPD Questionnaire, CCQ) and dyspnoea (measured by the MRC Dyspnoea Scale). The incidence rate of hospitalizations was found to be 2.25 times higher (95% confidence interval [CI] 1.3-3.9; P = 0.004) 12 months before compared with 12 months after the start of case management. COPD patients had a mean CCQ score of 3.3 (95% CI 2.8-3.8) before and 2.4 (95% CI 1.9-2.8) after 20 weeks of case management; a difference of 1.0 (95% CI 0.4-1.6; P = 0.001). The mean MRC scores showed no significant differences before (4.3; 95% CI 3.7-4.9) and after the case management period (3.9; 95% CI 3.2-4.6); a difference of 0.4 (95% CI - 0.1 to 0.9; P = 0.114). This pilot study shows that the number of COPD hospital re-admissions decreased significantly after the introduction of a case manager. Moreover, there was an improvement in patient-reported health-related quality of life.

  18. Effectiveness of post-discharge case management in general-medical outpatients: a randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  19. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour-Delfgaauw, C.H.M.; Vos, R.; Huyse, F.J.; de Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  20. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, C.H.M.; de Vos, R.; Huyse, F.J.; De Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  1. Effectiveness of post-discharge case management in general-medical outpatients : A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  2. Reductions in Transmission Risk Behaviors in HIV-Positive Clients Receiving Prevention Case Management Services: Findings from a Community Demonstration Project

    Science.gov (United States)

    Gasiorowicz, Mari; Llanas, Michelle R.; DiFranceisco, Wayne; Benotsch, Eric G.; Brondino, Michael J.; Catz, Sheryl L.; Hoxie, Neil J.; Reiser, William J.; Vergeront, James M.

    2005-01-01

    Prevention case management (PCM) for HIV-infected persons is an HIV risk reduction intervention designed to assist clients who are aware of their HIV infection and who continue to engage in risk transmission behaviors. PCM combines individual risk reduction counseling with case management to address the psychosocial factors affecting HIV…

  3. Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial.

    Science.gov (United States)

    Peters-Klimm, Frank; Campbell, Stephen; Hermann, Katja; Kunz, Cornelia U; Müller-Tasch, Thomas; Szecsenyi, Joachim

    2010-05-17

    Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs). This patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models. Baseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]). In this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case

  4. [Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

    Science.gov (United States)

    Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

    2014-01-01

    Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

  5. Effects on leisure activities and social participation of a case management intervention for frail older people living at home: a randomised controlled trial.

    Science.gov (United States)

    Granbom, Marianne; Kristensson, Jimmie; Sandberg, Magnus

    2017-07-01

    Frailty causes disability and restrictions on older people's ability to engage in leisure activities and for social participation. The objective of this study was to evaluate the effects of a 1-year case management intervention for frail older people living at home in Sweden in terms of social participation and leisure activities. The study was a randomised controlled trial with repeated follow-ups. The sample (n = 153) was consecutively and randomly assigned to intervention (n = 80) or control groups (n = 73). The intervention group received monthly home visits over the course of a year by nurses and physiotherapists working as case managers, using a multifactorial preventive approach. Data collections on social participation, leisure activities and rating of important leisure activities were performed at baseline, 3, 6, 9 and 12 months, with recruitment between October 2006 and April 2011. The results did not show any differences in favour of the intervention on social participation. However, the intervention group performed leisure activities in general, and important physical leisure activities, to a greater extent than the control group at the 3-month follow-up (median 13 vs. 11, P = 0.034 and median 3 vs. 3, P = 0.031 respectively). A statistically significantly greater proportion of participants from the intervention group had an increased or unchanged number of important social leisure activities that they performed for the periods from baseline to 3 months (93.2% vs. 75.4%, OR = 4.48, 95% CI: 1.37-14.58). Even though statistically significant findings in favour of the intervention were found, more research on activity-focused case management interventions is needed to achieve clear effects on social participation and leisure activities. © 2017 John Wiley & Sons Ltd.

  6. Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wende Rupert

    2010-05-01

    Full Text Available Abstract Background Aged patients with coronary heart disease (CHD have a high prevalence of co-morbidity associated with poor quality of life, high health care costs, and increased risk for adverse outcomes. These patients are often lacking an optimal home care which may result in subsequent readmissions. However, a specific case management programme for elderly patients with myocardial infarction (MI is not yet available. The objective of this trial is to examine the effectiveness of a nurse-based case management in patients aged 65 years and older discharged after treatment of an acute MI in hospital. The programme is expected to influence patient readmission, mortality and quality of life, and thus to reduce health care costs compared with usual care. In this paper the study protocol is described. Methods/design The KORINNA (Koronarinfarkt Nachbehandlung im Alter study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg. Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost

  7. Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Li, Danni; Elliott, Tom; Klein, Gerri; Ur, Ehud; Tang, Tricia S

    2017-06-01

    To examine the effects of a 6-month nurse case manager (NCM) intervention compared to standard care (SC) on glycemic control and diabetes distress in a Canadian tertiary-care setting. We recruited 140 adults with type 2 diabetes and glycated hemoglobin (A1C) levels >8% (64 mmol/mol) from 2 tertiary care facilities and randomized them to: 1) a 6-month NCM intervention in addition to SC or 2) SC by the primary endocrinologists. Assessments were conducted at baseline and at 6 months. Primary outcomes included A1C levels and diabetes distress scores (DDS). Secondary outcomes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symptoms, self-motivation and perception of support. At the 6-month follow up, the NCM group experienced larger reductions in A1C levels of -0.73% compared to the SC group (p=0.027; n=134). The NCM group also showed an additional reduction of -0.40 (26% reduction) in DDS compared to those in the SC group (p=0.001; n=134). The NCM group had lower blood pressure, ate more fruit and vegetables, exercised more, checked their feet more frequently, were more motivated, were less depressed and perceived more support. There were no changes and no group differences in terms of body mass index, medication compliance or frequency of testing. Compared to SC, NCM intervention was more effective in improving glycemic control and reducing diabetes distress. It is, therefore, a viable adjunct to standard diabetes care in the tertiary care setting, particularly for patients at high risk and with poor control. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  8. Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Kirchberger, Inge; Meisinger, Christa; Seidl, Hildegard; Wende, Rupert; Kuch, Bernhard; Holle, Rolf

    2010-05-27

    Aged patients with coronary heart disease (CHD) have a high prevalence of co-morbidity associated with poor quality of life, high health care costs, and increased risk for adverse outcomes. These patients are often lacking an optimal home care which may result in subsequent readmissions. However, a specific case management programme for elderly patients with myocardial infarction (MI) is not yet available. The objective of this trial is to examine the effectiveness of a nurse-based case management in patients aged 65 years and older discharged after treatment of an acute MI in hospital. The programme is expected to influence patient readmission, mortality and quality of life, and thus to reduce health care costs compared with usual care. In this paper the study protocol is described. The KORINNA (Koronarinfarkt Nachbehandlung im Alter) study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg). Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost-effectiveness ratio (ICER) will be calculated. The KORINNA study

  9. Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Stafford Randall S

    2006-09-01

    Full Text Available Abstract Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD. However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. Methods The Stanford and San Mateo Heart to Heart (HTH project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. Results We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or

  10. Design of a Randomised Controlled Trial (RCT on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    Directory of Open Access Journals (Sweden)

    Annema Coby

    2010-05-01

    Full Text Available Abstract Background Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little evidence about the effectiveness of the patient advocacy case management model in clinical practice. Therefore, the objective of our study was to examine the effects of the Dutch patient advocacy case management model for severely disabled Multiple Sclerosis (MS patients and their caregivers compared to usual care. Methods/design In this randomized controlled trial the effectiveness of casemanagement on quality of life of patients and their caregivers, quality of care, service use and economic aspects were evaluated. The primary outcomes of this study were quality of life of MS-patients and caregiver burden of caregivers. Furthermore, we examined quality of life of caregivers, quality of care, service use and costs. Discussion This is a unique trial in which we examined the effectiveness of case management from a broad perspective. We meticulously prepared this study and applied important features and created important conditions for both intervention and research protocol to increase the likelihood of finding evidence for the effectiveness of patient advocacy case management. Concerning the intervention we anticipated to five important conditions: 1 the contrast between the case management intervention compared to the usual care seems to be large enough to detect intervention effects; 2 we included patients with complex care situations and/or were at risk for critical situations; 3 the case managers were familiar with disease specific health-problems and a broad spectrum of solutions; 4 case managers were competent and authorized to perform a medical neurological examination and worked closely with neurologists specialized in MS; and 5 the

  11. Spouses’ involvement in older patients’ fast-track programmes during total hip replacement using case management intervention. A study protocol of the SICAM-trial

    DEFF Research Database (Denmark)

    Berthelsen, Connie Bøttcher; Kristensson, Jimmie

    2015-01-01

    Aim To present the protocol of a two-group quasi-experimental study of spouses’ involvement through case management (The SICAM-trial) in older patients’ fast-track programmes during total hip replacement. Background Patients in fast-track programmes are required to take an active part...... and subsequently include the intervention group to avoid contamination of the control group. A case manager will be recruited to perform the case management intervention. Data will be collected from both groups at baseline, 2 weeks and 3 months after surgery. Outcome measures for patients include: functional...... to education of the health professionals in their need to include relatives in fast-track programmes. The study was funded by the Novo Nordisk Foundation and the Regional Health Scientific Foundation of Sealand....

  12. Design and participant enrollment of a randomized controlled trial evaluating effectiveness and cost effectiveness of a community based case management intervention for patients suffering from COPD

    DEFF Research Database (Denmark)

    Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller

    2015-01-01

    patients were randomized into two groups: the case-managed group and the usual-care group. Participant characteristics were obtained at baseline, and measures on effectiveness and costs were obtained through questionnaires and registries within a 12-month follow-up period. In the forthcoming analysis......Background: Case management interventions are recommended to improve quality of care and reduce costs in chronic care, but further evidence on effectiveness and cost-effectiveness is needed. The objective of this study is the reporting of the design and participant enrollment of a randomized...... controlled trial, conducted to evaluate the effectiveness and cost-effectiveness of a community-based case management model for patients suffering from chronic obstructive pulmonary disease (COPD). With a focus on support for self-care and care coordination, the intervention was hypothesized to result...

  13. A randomized controlled trial of hospital-based case management in cancer care: a general practitioner perspective.

    Science.gov (United States)

    Wulff, Christian N; Vedsted, Peter; Søndergaard, Jens

    2013-02-01

    Case management (CM) models based on experienced nurses are increasingly used to improve coordination and continuity of care for patients with complex health care needs. Anyway, little is known about the effects of hospital-based CM in cancer care. Aim. To analyse the effects of hospital-based CM on (i) GPs' evaluation of information from the hospital and collaboration with the hospital staff and (ii) patients' contacts with GPs during daytime and out of hours. A randomized controlled trial allocated 280 colorectal cancer patients 1:1 to either a control group or CM intervention. Patients were recruited at a Danish surgical department. An ad hoc piloted questionnaire was sent to all patients' GPs 30 weeks after patients' recruitment and the responses from the two groups of GPs were compared. Registry data on patients' contacts with general practice during daytime and out of hours were collected 9 months after recruitment and the data from the two groups were compared quarterly. CM was associated with an overall tendency towards more positive GP evaluations, which for 3 of 20 items reached statistical significance. Statistically significantly fewer GPs of CM patients reported contacting the hospital. CM did not affect the number of patient contacts with the GPs during the daytime, but CM patients showed a tendency towards more contacts to the out-of-hours GP services than non-CM patients. CM was appreciated by the GPs and reduced their need for subsequent hospital contact. CM increased the number of patient contacts to the out-of-hours GP services.

  14. Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Strom Joni L

    2011-10-01

    Full Text Available Abstract Background An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for Methods We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200 male and female participants, 18 years of age or older and with an HbA1c ≥ 8%, will be randomized into one of two groups: (1 an intervention arm employing the innovative FORA system coupled with nurse case management or (2 a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care. Discussion Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's. Trial Registration National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489

  15. Nursing case management, peer coaching, and hepatitis a and B vaccine completion among homeless men recently released on parole: randomized clinical trial.

    Science.gov (United States)

    Nyamathi, Adeline; Salem, Benissa E; Zhang, Sheldon; Farabee, David; Hall, Betsy; Khalilifard, Farinaz; Leake, Barbara

    2015-01-01

    Although hepatitis A virus (HAV) and hepatitis B virus (HBV) infections are vaccine-preventable diseases, few homeless parolees coming out of prisons and jails have received the hepatitis A and B vaccination series. The study focused on completion of the HAV and HBV vaccine series among homeless men on parole. The efficacy of three levels of peer coaching (PC) and nurse-delivered interventions was compared at 12-month follow-up: (a) intensive peer coaching and nurse case management (PC-NCM); (b) intensive PC intervention condition, with minimal nurse involvement; and (c) usual care (UC) intervention condition, which included minimal PC and nurse involvement. Furthermore, we assessed predictors of vaccine completion among this targeted sample. A randomized control trial was conducted with 600 recently paroled men to assess the impact of the three intervention conditions (PC-NCM vs. PC vs. UC) on reducing drug use and recidivism; of these, 345 seronegative, vaccine-eligible subjects were included in this analysis of completion of the Twinrix HAV/HBV vaccine. Logistic regression was added to assess predictors of completion of the HAV/HBV vaccine series and chi-square analysis to compare completion rates across the three levels of intervention. Vaccine completion rate for the intervention conditions were 75.4% (PC-NCM), 71.8% (PC), and 71.9% (UC; p = .78). Predictors of vaccine noncompletion included being Asian and Pacific Islander, experiencing high levels of hostility, positive social support, reporting a history of injection drug use, being released early from California prisons, and being admitted for psychiatric illness. Predictors of vaccine series completion included reporting having six or more friends, recent cocaine use, and staying in drug treatment for at least 90 days. Findings allow greater understanding of factors affecting vaccination completion in order to design more effective programs among the high-risk population of men recently released from

  16. Using evidence-integrated e-learning to enhance case management continuing education for psychiatric nurses: a randomised controlled trial with follow-up.

    Science.gov (United States)

    Liu, Wen-I; Rong, Jiin-Ru; Liu, Chieh-Yu

    2014-11-01

    E-learning is a flexible strategy to improve nurses' knowledge of case management, but there are methodological limitations in previous research into the effectiveness of such programs. To describe the development and effectiveness of an evidence-integrated e-learning program in case management continuing education for Taiwanese psychiatric nurses. Multiple methods were adopted to develop the program and a randomised controlled trial with repeated measures was employed to evaluate it. The e-learning program was developed in four stages: (1) systematic review of literature; (2) needs assessment through a national survey and focus group; (3) development of learning materials; and (4) pilot test. Following program development, psychiatric nurses were recruited and randomly allocated into an experimental or comparison group. The experimental group participated in an e-learning continuing education program. The case management knowledge index with sufficient reliability and validity and a satisfaction survey were used to determine the outcomes. A generalised estimating equation was used to assess the difference between the 2 groups before, after, and at 3 months follow-up. The learning material comprised 5 simulated learning modules, self-assessment questions, learning cases, sharing experiences, and learning resources. A total of 200 participants completed the 3 measurements. Knowledge scores in the experimental group significantly exceeded those in the comparison group after the program and at the 3-month follow-up. Participants reported positive learning perceptions. The program provides an evidence-based educational resource for nursing continuing education in case management. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel)

    Science.gov (United States)

    Shea, Steven; Starren, Justin; Teresi, Jeanne A; Ganz, Michael L; Burton, Tanya M; Pashos, Chris L; Blustein, Jan; Field, Lesley; Morin, Philip C; Izquierdo, Roberto E; Silver, Stephanie; Eimicke, Joseph P; Lantigua, Rafael A; Weinstock, Ruth S

    2010-01-01

    Objective To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention. Design We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State. Measurements We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000– February 27, 2006). Results Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month. Conclusion Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used. PMID:20190064

  18. Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial.

    Science.gov (United States)

    Malte, Carol A; Cox, Koriann; Saxon, Andrew J

    2017-05-01

    This study sought to determine whether homeless veterans entering Veterans Affairs (VA) substance use treatment randomized to intensive addiction/housing case management (AHCM) had improved housing, substance use, mental health, and functional outcomes and lower acute health care utilization, compared to a housing support group (HSG) control. Homeless veterans (n = 181) entering outpatient VA substance use treatment were randomized to AHCM and HSG and received treatment for 12 months. AHCM provided individualized housing, substance use and mental health case management, life skills training, and community outreach. The control condition was a weekly drop-in housing support group. Adjusted longitudinal analyses compared groups on baseline to month 12 change in percentage of days housed and functional status, substance use, and mental health outcomes (36-Item Short-Form Health Survey; Addiction Severity Index [ASI]). Negative binomial regression models compared groups on health care utilization. Both conditions significantly increased percentage of days housed, with no differences detected between conditions. In total, 74 (81.3%) AHCM and 64 (71.1%) HSG participants entered long-term housing (odds ratio = 1.9, 95% confidence interval [0.9, 4.0], p = .088). HSG participants experienced a greater decrease in emergency department visits than AHCM (p = .037), whereas AHCM participants remained in substance use treatment 52.7 days longer (p = .005) and had greater study treatment participation (p housing and substance use care. For those veterans not entering or losing long-term housing, different approaches to outreach and ongoing intervention are required. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Cost-effectiveness of a nurse-led case management intervention in general medical outpatients compared with usual care: An economic evaluation alongside a randomized controlled trial

    DEFF Research Database (Denmark)

    Latour, C.H.; Bosmans, J.E.; van Tulder, M.W.

    2007-01-01

    of life, and psychological functioning. There was a substantial difference in total costs between the NHI group and the control group (€4286; 95% CI, -41; 8026), but this difference was not statistically significant. Conclusion: NHI is not a cost-effective intervention. We do not recommend......Objective: The objective of this study was to evaluate the cost-effectiveness of a nurse-led, home-based, case-management intervention (NHI) after hospital discharge in addition to usual care. Methods: Economic evaluation alongside a randomized controlled trial after being discharged home with 24...... weeks of follow-up. Patients discharged to their home from a general hospital were randomly assigned to NHI or usual care. Clinical outcomes were frequency of emergency readmissions, quality of life, and psychological functioning. Direct costs were measured by means of cost diaries kept by the patients...

  20. (Cost-effectiveness of case-management by district nurses among primary informal caregivers of older adults with dementia symptoms and the older adults who receive informal care: design of a randomized controlled trial [ISCRTN83135728

    Directory of Open Access Journals (Sweden)

    Nijpels Giel

    2005-12-01

    Full Text Available Abstract Background Dementia is an incurable disease with devastating consequences for both patients and their relatives. The objective of this study is to describe the study protocol of a randomized controlled trial with assignment to either usual care or case-management by district nurses, among informal caregivers of older adults with dementia symptoms who live at home and the older adults who receive informal care. Methods/design In this randomized controlled trial, effectiveness as well as cost-effectiveness of case-management is evaluated. It concerns case-management in early-detected patients with dementia symptoms and their primary informal caregivers. Participants are followed up to twelve months after baseline assessment. The main outcome measure of the effect evaluation is the caregiver's sense of competence to care for the older person with dementia symptoms. The economic evaluation is performed from a societal perspective. Discussion This is one of the first trials on case-management that includes an economic evaluation. In addition, it concerns a tailor-made intervention in early-detected patients with dementia symptoms and their caregivers. The results of this randomized controlled trial will provide valuable information for health professionals and policy makers on effectiveness and cost-effectiveness of early tailor-made case-management for patients and their informal caregivers. Moreover, positive effects will challenge current health care systems to move to more pro-active approaches for this group.

  1. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

    Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.

  2. Effect of a housing and case management program on emergency department visits and hospitalizations among chronically ill homeless adults: a randomized trial.

    Science.gov (United States)

    Sadowski, Laura S; Kee, Romina A; VanderWeele, Tyler J; Buchanan, David

    2009-05-06

    Homeless adults, especially those with chronic medical illnesses, are frequent users of costly medical services, especially emergency department and hospital services. To assess the effectiveness of a case management and housing program in reducing use of urgent medical services among homeless adults with chronic medical illnesses. Randomized controlled trial conducted at a public teaching hospital and a private, nonprofit hospital in Chicago, Illinois. Participants were 407 social worker-referred homeless adults with chronic medical illnesses (89% of referrals) from September 2003 until May 2006, with follow-up through December 2007. Analysis was by intention-to-treat. Housing offered as transitional housing after hospitalization discharge, followed by placement in long-term housing; case management offered on-site at primary study sites, transitional housing, and stable housing sites. Usual care participants received standard discharge planning from hospital social workers. Hospitalizations, hospital days, and emergency department visits measured using electronic surveillance, medical records, and interviews. Models were adjusted for baseline differences in demographics, insurance status, prior hospitalization or emergency department visit, human immunodeficiency virus infection, current use of alcohol or other drugs, mental health symptoms, and other factors. The analytic sample (n = 405 [n = 201 for the intervention group, n = 204 for the usual care group]) was 78% men and 78% African American, with a median duration of homelessness of 30 months. After 18 months, 73% of participants had at least 1 hospitalization or emergency department visit. Compared with the usual care group, the intervention group had unadjusted annualized mean reductions of 0.5 hospitalizations (95% confidence interval [CI], -1.2 to 0.2), 2.7 fewer hospital days (95% CI, -5.6 to 0.2), and 1.2 fewer emergency department visits (95% CI, -2.4 to 0.03). Adjusting for baseline covariates

  3. NEURAPRO-E study protocol: a multicentre randomized controlled trial of omega-3 fatty acids and cognitive-behavioural case management for patients at ultra high risk of schizophrenia and other psychotic disorders.

    Science.gov (United States)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby; Yuen, Hok Pan; Schaefer, Miriam; Yung, Alison R; Thompson, Andrew; Berger, Gregor; Mossaheb, Nilufar; Schlögelhofer, Monika; Smesny, Stefan; de Haan, Lieuwe; Riecher-Rössler, Anita; Nordentoft, Merete; Chen, Eric Yu Hai; Verma, Swapna; Hickie, Ian; Amminger, G Paul

    2017-10-01

    Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3 polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study will provide important information with regard to the use of omega-3 PUFAs in the UHR group. This trial is a 6-month, double-blind, randomized placebo-controlled trial of 1.4 g day -1 omega-3 PUFAs in UHR patients aged between 13 and 40 years. The primary hypothesis is that UHR patients receiving omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict response to omega-3 PUFA treatment in the UHR group. This is the protocol of the NeuraproE study. Utilizing a large sample, results from this study will be important in informing indicated prevention strategies for schizophrenia and other psychotic disorders, which may be the strongest avenue for reducing the burden, stigmatization, disability and economic consequences of these disorders. © 2015 Wiley Publishing Asia Pty Ltd.

  4. Effectiveness and efficiency of primary care based case management for chronic diseases: rationale and design of a systematic review and meta-analysis of randomized and non-randomized trials [CRD32009100316].

    NARCIS (Netherlands)

    Freund, T.; Kayling, F.; Miksch, A.; Szecsenyi, J.; Wensing, M.J.P.

    2010-01-01

    BACKGROUND: Case management is an important component of structured and evidence-based primary care for chronically ill patients. Its effectiveness and efficiency has been evaluated in numerous clinical trials. This protocol describes aims and methods of a systematic review of research on the

  5. Building African Capacity for HIV/AIDS Prevention Trials

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

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

  6. Canada-Africa Prevention Trials Network : Building African Capacity ...

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

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

  7. Achieving Drug and Alcohol Abstinence Among Recently Incarcerated Homeless Women: A Randomized Controlled Trial Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program.

    Science.gov (United States)

    Nyamathi, Adeline M; Shin, Sanghyuk S; Smeltzer, Jolene; Salem, Benissa E; Yadav, Kartik; Ekstrand, Maria L; Turner, Susan F; Faucette, Mark

    Homeless female ex-offenders (homeless female offenders) exiting jail and prison are at a critical juncture during reentry and transitioning into the community setting. The purpose of the study was to compare the effect of a dialectical behavioral therapy-case management (DBT-CM) program with a health promotion (HP) program on achieving drug and alcohol abstinence among female parolees/probationers residing in the community. We conducted a multicenter parallel randomized controlled trial with 130 female parolees/probationers (aged 19-64 years) residing in the community randomly assigned to either DBT-CM (n = 65) or HP (n = 65). The trial was conducted in four community-based partner sites in Los Angeles and Pomona, California, from February 2015 to November 2016. Treatment assignment was carried out using a computer-based urn randomization program. The primary outcome was drug and alcohol use abstinence at 6-month follow up. Analysis was based on data from 116 participants with complete outcome data. Multivariable logistic regression revealed that the DBT-CM program remained an independent positive predictor of decrease in drug use among the DBT-CM participants at 6 months (p = .01) as compared with the HP program participants. Being non-White (p < .05) and having higher depressive symptom scores (p < .05) were associated with lower odds of drug use abstinence (i.e., increased the odds of drug use) at 6 months. DBT-CM increased drug and alcohol abstinence at 6-month follow-up, compared to an HP program.

  8. Prevention of hospital payment errors and implications for case management: a study of nine hospitals with a high proportion of short-term admissions over time.

    Science.gov (United States)

    Hightower, Rebecca E

    2008-01-01

    medical advice) occurring during the baseline and remeasurement time frames was examined. The baseline period consisted of 1 month's claims-the complete month just prior to the start of approved project activities. Remeasurement was performed by each hospital and reported to the Quality Improvement Organization on a monthly basis following implementation of the hospital's quality improvement plan. Each hospital was required to provide a monthly remeasurement report by indicator until it had met its stated goal(s) for improvement for 2 consecutive months; therefore, each hospital completed its required monthly reporting for a specific indicator in a different month. Results were calculated for the following indicators: INDICATOR 1: Proportion of unnecessary short-term admissions = number of unnecessary short-term inpatient admissions/total short-term inpatient admissions in time frame. INDICATOR 2: Proportion of errors in billed treatment setting, that is, outpatient observation billed as inpatient = number of errors in billed treatment setting/total short-term admissions in time frame.Six of the 9 hospitals were able to accomplish reduction of their error rates within 6 months from the beginning of the study. The seventh hospital reached its goals in the 7th month, with the 2 remaining hospitals making progress toward their goals by the conclusion of the study. 1 Case managers must be up-to-date with payor requirements regarding medical record documentation for medical necessity of services and timing of inpatient admission, e.g., for Medicare, the date and time of the written physician's order for admission to the inpatient care setting is the date and time of inpatient admission. 2 The balancing of clinical decisions and financial considerations required of case managers in hospital settings remains an ongoing challenge. 3 Senior leadership must be engaged in ensuring the success of the case management program by providing the resources required. 4 Managers of case

  9. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  10. Effectiveness of telephone-based aftercare case management for adult patients with unipolar depression compared to usual care: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Laura Kivelitz

    Full Text Available Patients with depression often have limited access to outpatient psychotherapy following inpatient treatment. The objective of the study was to evaluate the long-term effectiveness of a telephone-based aftercare case management (ACM intervention for patients with depression.We performed a prospective randomized controlled trial in four psychotherapeutic inpatient care units with N = 199 patients with major depression or dysthymia (F32.x, F33.x, F34.1, according to the ICD-10. The ACM consisted of six phone contacts at two-week intervals performed by trained and certified psychotherapists. The control group received usual care (UC. The primary outcome was depressive symptom severity (BDI-II at 9-month follow-up, and secondary outcomes were health-related quality of life (SF-8, EQ-5D, self-efficacy (SWE, and the proportion of patients initiating outpatient psychotherapy. Mixed model analyses were conducted to compare improvements between treatment groups.Regarding the primary outcome of symptom severity, the groups did not significantly differ after 3 months (p = .132; ES = -0.23 or at the 9-month follow-up (p = .284; ES = -0.20. No significant differences in health-related quality of life or self-efficacy were found between groups. Patients receiving ACM were more likely to be in outpatient psychotherapy after 3 months (OR: 3.00[1.12-8.07]; p = .029 and 9 months (OR: 4.78 [1.55-14.74]; p = .006 than those receiving UC.Although telephone-based ACM did not significantly improve symptom severity, it seems to be a valuable approach for overcoming treatment barriers to the clinical pathways of patients with depression regarding their access to outpatient psychotherapy.

  11. Case manager satisfaction in public health.

    Science.gov (United States)

    Schutt, Russell K; Fawcett, Jacqueline; Gall, Gail B; Harrow, Brooke; Woodford, Mary Lou

    2010-01-01

    The purpose of this study was to examine correlates of case managers' satisfaction with their work, services, and service network and to identify connections to service performance and service costs. A decentralized public health program that exemplifies the trend toward more diverse clients and networked services. A mixed method design with 34 case managers. As hypothesized, the case managers' experiences with clients and the service network, and their service effectiveness, were associated with their satisfaction with their jobs and the services they provide. Satisfaction was also positively associated with more timely service delivery. These associations were explained in part by case managers' education and training. Case managers can achieve high levels of job and service satisfaction in outreach programs serving a diverse client population in a decentralized service network. Case managers' job and service satisfaction improves with reduced service problems and service delays and when case managers can devise work-arounds for persistent service problems. Using advanced practice nurses (APN) and providing more on-the-job training may increase case manager satisfaction with their jobs and the services they provide. Special efforts may be needed to prevent a decline in job satisfaction with years of experience.

  12. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial

    Science.gov (United States)

    Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Connelly, Jo; Sarang, Aseefa; Whisler, Adam; Hwang, Stephen W.; O’Campo, Patricia; McKenzie, Kwame

    2015-01-01

    Housing First (HF) is being widely disseminated in efforts to end homelessness among homeless adults with psychiatric disabilities. This study evaluates the effectiveness of HF with Intensive Case Management (ICM) among ethnically diverse homeless adults in an urban setting. 378 participants were randomized to HF with ICM or treatment-as-usual (TAU) in Toronto (Canada), and followed for 24 months. Measures of effectiveness included housing stability, physical (EQ5D-VAS) and mental (CSI, GAIN-SS) health, social functioning (MCAS), quality of life (QoLI20), and health service use. Two-thirds of the sample (63%) was from racialized groups and half (50%) were born outside Canada. Over the 24 months of follow-up, HF participants spent a significantly greater percentage of time in stable residences compared to TAU participants (75.1% 95% CI 70.5 to 79.7 vs. 39.3% 95% CI 34.3 to 44.2, respectively). Similarly, community functioning (MCAS) improved significantly from baseline in HF compared to TAU participants (change in mean difference = +1.67 95% CI 0.04 to 3.30). There was a significant reduction in the number of days spent experiencing alcohol problems among the HF compared to TAU participants at 24 months (ratio of rate ratios = 0.47 95% CI 0.22 to 0.99) relative to baseline, a reduction of 53%. Although the number of emergency department visits and days in hospital over 24 months did not differ significantly between HF and TAU participants, fewer HF participants compared to TAU participants had 1 or more hospitalizations during this period (70.4% vs. 81.1%, respectively; P=0.044). Compared to non-racialized HF participants, racialized HF participants saw an increase in the amount of money spent on alcohol (change in mean difference = $112.90 95% CI 5.84 to 219.96) and a reduction in physical community integration (ratio of rate ratios = 0.67 95% CI 0.47 to 0.96) from baseline to 24 months. Secondary analyses found a significant reduction in the number of days

  13. Prevention and intervention trials for colorectal cancer.

    Science.gov (United States)

    Komiya, Masami; Fujii, Gen; Takahashi, Mami; Iigo, Masaaki; Mutoh, Michihiro

    2013-07-01

    There have been a number of candidates for chemopreventive agents from synthetic drugs and natural compounds suggested to prevent colorectal cancer. However, they have shown modest efficacy in humans. The reason for this could be partly explained by the use of inappropriate models in vitro and in vivo, and the limitation of chemoprevention trials. In Japan, there are no cancer chemopreventive medicines, and few cancer chemoprevention trials to date. In contrast, an increase in the prevalence of colorectal cancer in Japan has forced us to develop more efficient chemopreventive strategies. It is now a good time to review in detail the current status and future prospects for chemoprevention of colorectal cancer with respect to the future development of chemopreventive medicines, particularly using synthetic drugs and natural compounds in Asian populations. The role and mode of action of available synthetic drugs, mainly aspirin and metformin, are reviewed. In addition, the possible impact of natural compounds with anti-inflammatory/immunosuppressive properties, such as ω3 polyunsaturated fatty acid and lactoferrin, are also reviewed.

  14. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial.

    Science.gov (United States)

    Stergiopoulos, Vicky; Gozdzik, Agnes; Misir, Vachan; Skosireva, Anna; Connelly, Jo; Sarang, Aseefa; Whisler, Adam; Hwang, Stephen W; O'Campo, Patricia; McKenzie, Kwame

    2015-01-01

    Housing First (HF) is being widely disseminated in efforts to end homelessness among homeless adults with psychiatric disabilities. This study evaluates the effectiveness of HF with Intensive Case Management (ICM) among ethnically diverse homeless adults in an urban setting. 378 participants were randomized to HF with ICM or treatment-as-usual (TAU) in Toronto (Canada), and followed for 24 months. Measures of effectiveness included housing stability, physical (EQ5D-VAS) and mental (CSI, GAIN-SS) health, social functioning (MCAS), quality of life (QoLI20), and health service use. Two-thirds of the sample (63%) was from racialized groups and half (50%) were born outside Canada. Over the 24 months of follow-up, HF participants spent a significantly greater percentage of time in stable residences compared to TAU participants (75.1% 95% CI 70.5 to 79.7 vs. 39.3% 95% CI 34.3 to 44.2, respectively). Similarly, community functioning (MCAS) improved significantly from baseline in HF compared to TAU participants (change in mean difference = +1.67 95% CI 0.04 to 3.30). There was a significant reduction in the number of days spent experiencing alcohol problems among the HF compared to TAU participants at 24 months (ratio of rate ratios = 0.47 95% CI 0.22 to 0.99) relative to baseline, a reduction of 53%. Although the number of emergency department visits and days in hospital over 24 months did not differ significantly between HF and TAU participants, fewer HF participants compared to TAU participants had 1 or more hospitalizations during this period (70.4% vs. 81.1%, respectively; P=0.044). Compared to non-racialized HF participants, racialized HF participants saw an increase in the amount of money spent on alcohol (change in mean difference = $112.90 95% CI 5.84 to 219.96) and a reduction in physical community integration (ratio of rate ratios = 0.67 95% CI 0.47 to 0.96) from baseline to 24 months. Secondary analyses found a significant reduction in the number of days

  15. Effect of scattered-site housing using rent supplements and intensive case management on housing stability among homeless adults with mental illness: a randomized trial.

    Science.gov (United States)

    Stergiopoulos, Vicky; Hwang, Stephen W; Gozdzik, Agnes; Nisenbaum, Rosane; Latimer, Eric; Rabouin, Daniel; Adair, Carol E; Bourque, Jimmy; Connelly, Jo; Frankish, James; Katz, Laurence Y; Mason, Kate; Misir, Vachan; O'Brien, Kristen; Sareen, Jitender; Schütz, Christian G; Singer, Arielle; Streiner, David L; Vasiliadis, Helen-Maria; Goering, Paula N

    2015-03-03

    Scattered-site housing with Intensive Case Management (ICM) may be an appropriate and less-costly option for homeless adults with mental illness who do not require the treatment intensity of Assertive Community Treatment. To examine the effect of scattered-site housing with ICM services on housing stability and generic quality of life among homeless adults with mental illness and moderate support needs for mental health services. The At Home/Chez Soi project was an unblinded, randomized trial. From October 2009 to July 2011, participants (N = 1198) were recruited in 4 Canadian cities (Vancouver, Winnipeg, Toronto, and Montreal), randomized to the intervention group (n = 689) or usual care group (n = 509), and followed up for 24 months. The intervention consisted of scattered-site housing (using rent supplements) and off-site ICM services. The usual care group had access to existing housing and support services in their communities. The primary outcome was the percentage of days stably housed during the 24-month period following randomization. The secondary outcome was generic quality of life, assessed by a EuroQoL 5 Dimensions (EQ-5D) health questionnaire. During the 24 months after randomization, the adjusted percentage of days stably housed was higher among the intervention group than the usual care group, although adjusted mean differences varied across sites. [table: see text] The mean change in EQ-5D score from baseline to 24 months among the intervention group was not statistically different from the usual care group (60.5 [95%CI, 58.6 to 62.5] at baseline and 67.2 [95%CI, 65.2 to 69.1] at 24 months for the intervention group vs 62.1 [95% CI, 59.9 to 64.4] at baseline and 68.6 [95%CI, 66.3 to 71.0] at 24 months for the usual care group, difference in mean changes, 0.10 [95%CI, −2.92 to 3.13], P=.95). Among homeless adults with mental illness in 4 Canadian cities, scattered site housing with ICM services compared with usual access to existing housing and

  16. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Vicky Stergiopoulos

    Full Text Available Housing First (HF is being widely disseminated in efforts to end homelessness among homeless adults with psychiatric disabilities. This study evaluates the effectiveness of HF with Intensive Case Management (ICM among ethnically diverse homeless adults in an urban setting. 378 participants were randomized to HF with ICM or treatment-as-usual (TAU in Toronto (Canada, and followed for 24 months. Measures of effectiveness included housing stability, physical (EQ5D-VAS and mental (CSI, GAIN-SS health, social functioning (MCAS, quality of life (QoLI20, and health service use. Two-thirds of the sample (63% was from racialized groups and half (50% were born outside Canada. Over the 24 months of follow-up, HF participants spent a significantly greater percentage of time in stable residences compared to TAU participants (75.1% 95% CI 70.5 to 79.7 vs. 39.3% 95% CI 34.3 to 44.2, respectively. Similarly, community functioning (MCAS improved significantly from baseline in HF compared to TAU participants (change in mean difference = +1.67 95% CI 0.04 to 3.30. There was a significant reduction in the number of days spent experiencing alcohol problems among the HF compared to TAU participants at 24 months (ratio of rate ratios = 0.47 95% CI 0.22 to 0.99 relative to baseline, a reduction of 53%. Although the number of emergency department visits and days in hospital over 24 months did not differ significantly between HF and TAU participants, fewer HF participants compared to TAU participants had 1 or more hospitalizations during this period (70.4% vs. 81.1%, respectively; P=0.044. Compared to non-racialized HF participants, racialized HF participants saw an increase in the amount of money spent on alcohol (change in mean difference = $112.90 95% CI 5.84 to 219.96 and a reduction in physical community integration (ratio of rate ratios = 0.67 95% CI 0.47 to 0.96 from baseline to 24 months. Secondary analyses found a significant reduction in the number of days

  17. African Development of AIDS Prevention Trials (ADAPT2) | CRDI ...

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

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

  18. African Development of AIDS Prevention Trials (ADAPT2) | IDRC ...

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

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

  19. Design of a Randomised Controlled Trial (RCT) on the effectiveness of a Dutch patient advocacy case management intervention among severely disabled Multiple Sclerosis patients

    NARCIS (Netherlands)

    Wynia, Klaske; Annema, Coby; Nissen, Hans; De Keyser, Jacques; Middel, Berry

    2010-01-01

    Background: Case management has been suggested as an innovative strategy that facilitates the improvement of a patient's quality of life, reduction of hospital length of stay, optimization of self-care and improvement of satisfaction of patients and professionals involved. However, there is little

  20. The challenge of defining standards of prevention in HIV prevention trials

    NARCIS (Netherlands)

    Philpott, Sean; Heise, Lori; McGrory, Elizabeth; Paxton, Lynn; Hankins, Catherine; Alexander, Lorraine; Apuuli, David Kihumuro; Baeten, Jared; Birx, Deborah; de Bruyn, Guy; Bukusi, Elizabeth; Burns, David; Calazans, Gabriela; Campbell, James; Caswell, Georgina; Coutinho, Alex; Dawson, Liza; Dhai, Amaboo; Dube, Samukeliso; Ecuru, Julius; Essack, Zaynab; Farley, Timothy; Gafos, Mitzy; Irungu, Pauline; Kaleebu, Pontiano; Kamali, Anatoli; Kestelyn, Evelyne; Kublin, James; Lohse, Nicolai; Lutalo, Tom; Macklin, Ruth; Mâsse, Benôıt; Mauney, Chris; McCormack, Sheena; Miller, Lori; Mfutso-Bengo, Joseph; Misra, Rajender; Muganwa, Margaret; Ndase, Patrick; Nel, Annalene; Nielsen, Leslie; Nkala, Busisiwe; O'Reilly, Kevin; Okware, Sam; Paicheler, Geneviève; Rees, Helen; Rerks-Ngarm, Supachai; Ridzon, Renee; Rosenberg, Zeda; Singh, Jerome; Sugarman, Jeremy; Taylor, Douglas; Tusubira, Evans; Ukpong, Morenike; Umulisa, Marie-Michèle; Warren, Mitchell; Slevin, Katherine West; van de Wijgert, Janneke

    2011-01-01

    As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on

  1. Biorepository for Selenium and Vitamin E Cancer Prevention Trial (SELECT) | Division of Cancer Prevention

    Science.gov (United States)

    As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial (SELECT) has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group are developing a plan for prostate cancer biology and nutritional science and micronutrient studies. |

  2. Preventive misconception and adolescents' knowledge about HIV vaccine trials.

    Science.gov (United States)

    Ott, Mary A; Alexander, Andreia B; Lally, Michelle; Steever, John B; Zimet, Gregory D

    2013-12-01

    Adolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry a possibility of harm, requiring investigators to take additional precautions. Of particular concern is preventive misconception, or the overestimation of personal protection that is afforded by enrolment in a prevention intervention trial. As part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16-19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their understanding and opinions related to enrolment in a HIV vaccine trial. A grounded theory analysis looked for shared concepts, and focused on the content and process of adolescent participants' understanding of HIV vaccination and the components of preventive misconception, including experiment, placebo and randomisation. Across interviews, adolescents demonstrated active processing of information, in which they questioned the interviewer, verbally worked out their answers based upon information provided, and corrected themselves. We observed a wide variety of understanding of research concepts. While most understood experiment and placebo, fewer understood randomisation. All understood the need for safer sex even if they did not understand the more basic concepts. Education about basic concepts related to clinical trials, time to absorb materials and assessment of understanding may be necessary in future biomedical prevention trials.

  3. Evaluation of DEM-DISC, customized e-advice on health and social support services for informal carers and case managers of people with dementia; a cluster randomized trial.

    Science.gov (United States)

    Van Mierlo, Lisa D; Meiland, Franka J M; Van de Ven, Peter M; Van Hout, Hein P J; Dröes, Rose-Marie

    2015-08-01

    Few personalized e-interventions are available for informal and professional caregivers of people with dementia. The DEMentia Digital Interactive Social Chart (DEM-DISC) is an ICT tool to support customized disease management in dementia. The aim of this study was to improve and evaluate DEM-DISC, its user-friendliness and usefulness and to investigate the future implementation. A cluster randomized controlled trial (RCT) design was used with measurements at baseline, 6 and 12 months. A total of 73 informal caregivers of people with dementia, supported by 19 randomized case managers participated in the study. In the intervention group, both carers (n = 41) and case managers (n = 13) could access DEM-DISC during twelve months. The control group, 32 carers and 14 case managers, had no access to DEM-DISC. Semi-structured interviews were conducted with ten stakeholders. Informal caregivers who used DEM-DISC for twelve months reported an increased sense of competence than controls. A subgroup of users who frequently accessed DEM-DISC reported more met needs after six months than controls. Overall informal caregivers and case managers judged DEM-DISC as easy to learn and user-friendly. This study demonstrates that using DEM-DISC had a positive effect on the sense of competence and experienced (met) needs of informal carers. This shows the importance of user-friendly ICT solutions to assist carers in finding appropriate care services tailored to their specific situation and needs. For further implementation of DEM-DISC methods to keep the information updated is of great importance.

  4. Capacity Building for HIV/AIDS Prevention Trials | IDRC ...

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

    The Canadian International Development Agency (CIDA) is funding the Africa HIV/AIDS Prevention Trials Capacity Building Program under the umbrella of the Global Health Research Initiative (GHRI). The aim of the program is to build the capacity of African researchers and institutions to conduct anticipated clinical trials ...

  5. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...... for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment...... element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have...

  6. Research findings are catalyst to nationwide HIV prevention trial in ...

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

    2017-12-20

    Dec 20, 2017 ... New research into HIV prevention among the “choice disabled” — vulnerable groups who are less able to make the right choices to protect themselves — has led to a groundbreaking national trial for HIV prevention in Botswana. Three years of research in southern Africa revealed important pointers for ...

  7. Blood pressure lowering-based prevention and the POWER trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov

    2013-01-01

    Full Text Available Arterial hypertension is regarded as an independent and most important risk factor for stroke and its most effective prevention is to lower elevated blood pressure (BP. International guidelines on and the results of large randomized placebo-controlled trials of different antihypertensive drugs used to prevent stroke are given. How to optimize the outpatient prevention of stroke is discussed. The preliminary results of the POWER trial evaluating the safety and efficacy of eprosartan, an angiotensin receptor blocker, in reducing BP are presented.

  8. Methodological challenges in designing dementia prevention trials - The European Dementia Prevention Initiative (EDPI)

    NARCIS (Netherlands)

    Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P.; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A.; Kivipelto, Miia

    2012-01-01

    Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing

  9. Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial.

    Science.gov (United States)

    Chouinard, Maud-Christine; Hudon, Catherine; Dubois, Marie-France; Roberge, Pasquale; Loignon, Christine; Tchouaket, Eric; Fortin, Martin; Couture, Eva-Marjorie; Sasseville, Maxime

    2013-02-07

    Chronic diseases represent a major challenge for health care and social services. A number of people with chronic diseases require more services due to characteristics that increase their vulnerability. Given the burden of increasingly vulnerable patients on primary care, a pragmatic intervention in four Family Medicine Groups (primary care practices in Quebec, Canada) has been proposed for individuals with chronic diseases (diabetes, cardiovascular diseases, respiratory diseases, musculoskeletal diseases and/or chronic pain) who are frequent users of hospital services. The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program. The goals of this study are to: (1) analyze the implementation of the intervention in the participating practices in order to determine how the various contexts have influenced the implementation and the observed effects; (2) evaluate the proximal (self-efficacy, self-management, health habits, activation and psychological distress) and intermediate (empowerment, quality of life and health care use) effects of the intervention on patients; (3) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention. The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders (Family Medicine Group and health centre management, Family Medicine Group practitioners, patients and their families, health centre or community partners). The data will be obtained through individual and group interviews, project documentation reviews and by documenting the intervention. Evaluation of the effects on patients will be based on a pragmatic randomized before-after experimental design with a delayed intervention control group (six months). Economic analysis will include cost-effectiveness and cost-benefit analysis. The integration of a case

  10. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  11. Implementing post-trial access plans for HIV prevention research.

    Science.gov (United States)

    Paul, Amy; Merritt, Maria W; Sugarman, Jeremy

    2018-02-27

    Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Methodological Issues in Primary Prevention Trials for Neurodegenerative Dementia

    NARCIS (Netherlands)

    Andrieu, S.; Coley, N.; Aisen, P.; Carrillo, M.C.; DeKosky, S.; Durga, J.; Fillit, H.; Frisoni, G.B.; Froelich, L.; Gauthier, S.; Jones, R.; Jonsson, L.; Khachaturian, Z.; Morris, J.C.; Orgogozo, J.M.; Ousset, P.J.; Robert, P.; Salmon, E.; Sampaio, C.; Verhey, F.; Wilcock, G.; Vellas, B.

    2009-01-01

    The prevention of neurodegenerative dementias, such as Alzheimer's disease, is a public health priority. Due to the large numbers of affected patients, even interventions bringing about a relatively small delay in disease onset could have large public health effects. Randomized controlled trials

  13. HIV/AIDS Prevention Trials Capacity Building Grants

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

    work involve Canadian researchers collaborating with researchers and decision- makers in Asia, Africa, Eastern Europe, the Middle East, Latin America, and the. Caribbean. About this booklet. This booklet presents projects being carried out with grants from GHRI's HIV/AIDS. Prevention Trials Capacity Building Grants ...

  14. Building Capacity for HIV/AIDS Prevention Trials Research and ...

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

    A relatively small number of African sites have the clinical and laboratory capacity to design, manage and carry out HIV/AIDS prevention trials. This project is based on the premise that many of the required skills are already present at additional locations, but need further development. The grant will facilitate interaction ...

  15. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    Science.gov (United States)

    Taylor, Holly A; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patients. Seven patients were women and all but one white. The mean age was 48 years. During the 4‐month enrolment period, only three patients with EIA were identified; six patients with longer duration of symptoms were also interviewed. Most patients were able to express the primary aim of a hypothetical prevention trial presented. Factors cited by patients favouring enrolment were potential for direct medical benefit and knowledge that they would be withdrawn from the trial if they developed symptoms. Factors cited by patients against enrolment were the inclusion of a placebo and general uncertainty regarding treatment required by the RCT design. Pending larger‐scale empirical projects to explore patients' attitudes about prevention trials, small‐scale formative research in advance of such trials ought to be conducted. PMID:16984939

  16. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management

    Directory of Open Access Journals (Sweden)

    Muth Christiane

    2007-08-01

    Full Text Available Abstract Background Chronic congestive heart failure (CHF is a complex disease with rising prevalence, compromised quality of life (QoL, unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (nonpharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation. Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ, depression and anxiety disorders (PHQ-9, GAD-7, adherence (EHFScBS and SANA, quality of care measured by an adapted

  17. Electronic case management with homeless youth.

    Science.gov (United States)

    Bender, Kimberly; Schau, Nicholas; Begun, Stephanie; Haffejee, Badiah; Barman-Adhikari, Anamika; Hathaway, Jessica

    2015-06-01

    Case management, a widely practiced form of service brokerage, is associated with a variety of positive outcomes for homeless youth, but it may be difficult to implement, as youth face logistical barriers to attending in-person meetings. As part of a larger clinical trial, the current study investigates the feasibility of providing electronic case management (ECM) to homeless youth, using cell-phones, texts, email, and Facebook. Youth were given prepaid cell-phones and a case manager who provided four ECM sessions every 2-3 weeks over a 3-month period. Contact logs were used to record how many youth engaged in ECM, how many attempts were necessary to elicit engagement, and youths' preferred technology methods for engaging. Although engagement in the number of ECM sessions varied, the majority of youth (87.5%) engaged in at least one ECM session. Youth (41%) most commonly needed one contact before they engaged in an ECM session, and the majority responded by the third attempt. While youth most commonly answered calls directly, their chosen method of returning calls was texting. The majority of youth (80%) described ECM positively, reporting themes of convenience, connection, and accountability. The use of ECM, particularly of texting, offers promising implications for providing services to homeless youth. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Improving pediatric prevention via the internet: a randomized, controlled trial.

    Science.gov (United States)

    Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth

    2006-09-01

    Innovations to improve the delivery of pediatric preventive care are needed. We enrolled children, 0 to 11 years of age, into a factorial, randomized, controlled trial of a tailored, evidence-based, Web site (MyHealthyChild) that provided information on prevention topics before a scheduled well-child visit. There were 2 components of the intervention, namely, parental Web content and provider notification. Parental Web content provided information to parents about prevention topics; provider notification communicated to physicians topics that were of interest to parents. We assigned 887 children randomly to 4 groups (usual care, content only, content and notification, or notification only). Outcomes were determined with telephone follow-up surveys conducted 2 to 4 weeks after the visit. Poisson regression analysis was used to determine the independent effects of each intervention on the number of topics discussed and the number of preventive practices implemented. Parents in the notification/content group and in the notification-only group reported discussing more MyHealthyChild topics with their provider. Parents in the notification/content group and in the content-only group reported implementing more MyHealthyChild topic suggestions (such as use of a safety device). A Web-based intervention can activate parents to discuss prevention topics with their child's provider. Delivery of tailored content can promote preventive practices.

  19. The effect of heterogeneity on HIV prevention trials.

    Science.gov (United States)

    Auvert, Bertran; Sitta, Rémi; Zarca, Kevin; Mahiane, Séverin Guy; Pretorius, Carel; Lissouba, Pascale

    2011-04-01

    Randomized controlled trials (RCTs) for the prevention of HIV heterosexual acquisition are usually conducted among adult African populations with high heterogeneity in individual risk of infection. The objectives were to (a) review how this heterogeneity has been considered when designing and interpreting such RCTs, (b) evaluate its effect on the findings and the statistical power of these trials, and (c) assess the potential advantages of using the crossover design with single failure-time endpoint. Individual-level HIV prevention RCTs conducted in Africa and published in the period 1998-2008 were reviewed. Using Monte Carlo simulations and statistical calculations, we assessed the effect of heterogeneity on the findings and the statistical power of HIV prevention RCTs. All reviewed RCTs used the parallel design. The heterogeneity in individual risk of infection within study sites was not used for stratification nor generally considered in the design and interpretation of RCTs. Simulations showed that in the context of high HIV incidence, high heterogeneity can lead to a substantial underestimation of the impact of an intervention and reduced statistical power. Calculations demonstrated that the crossover design allowed for similar or better estimation and statistical power. The crossover design has the ethical advantage of sharing the potential benefits and risks of the intervention between participants. Only trials with two treatment arms and two follow-up periods were modeled. The baseline risk of infection of each participant was assumed to be constant over time and HIV status was assessed at the end of each follow-up period. The heterogeneity in individual risk of HIV infection is an underestimated problem which should be taken into account when designing and interpreting RCTs that test prevention methods of HIV heterosexual acquisition in adult African populations with high HIV incidence. When the effects of tested interventions are rapidly reversible, the

  20. Methodological challenges in designing dementia prevention trials - the European Dementia Prevention Initiative (EDPI).

    Science.gov (United States)

    Richard, Edo; Andrieu, Sandrine; Solomon, Alina; Mangialasche, Francesca; Ahtiluoto, Satu; Moll van Charante, Eric P; Coley, Nicola; Fratiglioni, Laura; Neely, Anna Stigsdotter; Vellas, Bruno; van Gool, Willem A; Kivipelto, Miia

    2012-11-15

    Recent epidemiological studies have indicated numerous associations between vascular and lifestyle related risk factors and incident dementia. However, evidence from randomised controlled trials (RCT) showing effectiveness of interventions aimed at these risk factors in preventing or postponing dementia onset is still lacking. Three large RCTs on multi-component interventions to prevent dementia (preDIVA, FINGER, MAPT) have been initiated in Europe to address these issues. Irrespective of some methodological differences, all three studies target cardiovascular and lifestyle related risk factors. Collaboration within the newly founded 'European Dementia Prevention Initiative' (EDPI) will allow for a comprehensive exploration of optimal target population, intervention and outcome measures, which are currently unknown. Combining data of the ongoing studies and running simulation analyses will facilitate determining the optimal design including accurate sample-size calculations for future multi-national clinical trials on dementia prevention. Interventions aiming at dementia prevention should be pragmatic and easy to implement on a large scale in different health care systems, without generating high additional costs or burden on participants or physicians. As the optimal age for intervention precedes the optimal age for outcome assessment, traditional trial designs might lead to suboptimal timing of either of the two. Separation of intervention and outcome assessment in time is a potential solution, but requires studies with very long follow-up. International collaboration of research groups with experience in dementia prevention studies and well-organised logistics for these major projects is pivotal to success for future large-scale dementia prevention studies. Founding of EDPI is an important first step in this direction. Copyright © 2012 Elsevier B.V. All rights reserved.

  1. Effectiveness of case management for homeless persons: a systematic review.

    Science.gov (United States)

    de Vet, Renée; van Luijtelaar, Maurice J A; Brilleslijper-Kater, Sonja N; Vanderplasschen, Wouter; Beijersbergen, Mariëlle D; Wolf, Judith R L M

    2013-10-01

    We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized controlled trials or quasi-experimental studies comparing case management to other services. We found little evidence for the effectiveness of ICM. SCM improved housing stability, reduced substance use, and removed employment barriers for substance users. ACT improved housing stability and was cost-effective for mentally ill and dually diagnosed persons. CTI showed promise for housing, psychopathology, and substance use and was cost-effective for mentally ill persons. More research is needed on how case management can most effectively support rapid-rehousing approaches to homelessness.

  2. Effectiveness of Case Management for Homeless Persons: A Systematic Review

    Science.gov (United States)

    de Vet, Renée; van Luijtelaar, Maurice J. A.; Brilleslijper-Kater, Sonja N.; Vanderplasschen, Wouter; Beijersbergen, Mariëlle D.

    2013-01-01

    We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized controlled trials or quasi-experimental studies comparing case management to other services. We found little evidence for the effectiveness of ICM. SCM improved housing stability, reduced substance use, and removed employment barriers for substance users. ACT improved housing stability and was cost-effective for mentally ill and dually diagnosed persons. CTI showed promise for housing, psychopathology, and substance use and was cost-effective for mentally ill persons. More research is needed on how case management can most effectively support rapid-rehousing approaches to homelessness. PMID:23947309

  3. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

    Directory of Open Access Journals (Sweden)

    Neto José

    2011-03-01

    Full Text Available Abstract Background Blood pressure (BP within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe

  4. The impact of staff case manager-case management supervisor relationship on job satisfaction and retention of RN case managers.

    Science.gov (United States)

    Hogan, Tierney D

    2005-01-01

    A positive relationship between staff RN case managers and their case management supervisor significantly impacts job satisfaction and retention in case managers. Literature review supports the premise that staff need to trust their supervisor and that there is a connection between this trust and job satisfaction. Staff case managers need to have a voice at work and feel empowered, and a supervisor's leadership style can influence job satisfaction and retention in their staff.

  5. Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial.

    Science.gov (United States)

    Oakeshott, Pippa; Kerry, Sally; Aghaizu, Adamma; Atherton, Helen; Hay, Sima; Taylor-Robinson, David; Simms, Ian; Hay, Phillip

    2010-04-08

    To determine whether screening and treating women for chlamydial infection reduces the incidence of pelvic inflammatory disease over the subsequent 12 months. Randomised controlled trial. Common rooms, lecture theatres, and student bars at universities and further education colleges in London. 2529 sexually active female students, mean age 21 years (range 16-27). Participants completed a questionnaire and provided self taken vaginal swabs, with follow-up after one year. Samples were randomly allocated to immediate testing and treatment for chlamydial infection, or storage and analysis after a year (deferred screening controls). Incidence of clinical pelvic inflammatory disease over 12 months. Baseline prevalence of chlamydia was 5.4% (68/1254) in screened women and 5.9% (75/1265) in controls. 94% (2377/2529) of women were followed up after 12 months. The incidence of pelvic inflammatory disease was 1.3% (15/1191) in screened women compared with 1.9% (23/1186) in controls (relative risk 0.65, 95% confidence interval 0.34 to 1.22). Seven of 74 control women (9.5%, 95% confidence interval 4.7% to 18.3%) who tested positive for chlamydial infection at baseline developed pelvic inflammatory disease over 12 months compared with one of 63 (1.6%) screened women (relative risk 0.17, 0.03 to 1.01). However, most episodes of pelvic inflammatory disease occurred in women who tested negative for chlamydia at baseline (79%, 30/38). 22% (527/2377) of women reported being tested independently for chlamydia during the trial. Although some evidence suggests that screening for chlamydia reduces rates of pelvic inflammatory disease, especially in women with chlamydial infection at baseline, the effectiveness of a single chlamydia test in preventing pelvic inflammatory disease over 12 months may have been overestimated. Trial registration ClinicalTrials.gov NCT00115388.

  6. Case management with homeless mentally ill people.

    Science.gov (United States)

    Rife, J C; First, R J; Greenlee, R W; Miller, L D; Feichter, M A

    1991-02-01

    This article reports the findings of a National Institute of Mental Health (NIMH) services demonstration project that used a mobile case management team to serve homeless mentally ill clients. The project examined three issues: (1) factors associated with client engagement in case management, (2) clients' perceptions of how case management affected their quality of life, and (3) significant differences between clients who remained engaged in case management services and those who discontinued involvement. The results indicated that clients who received more frequent case management contact, had higher assessed independent living skills, were older, were less likely to be substance abusers, and had experienced fewer periods of homelessness and fewer prior psychiatric hospitalizations were more likely to remain engaged in case management services. After six months of case management, clients perceived significant improvement in their global well-being, living situation, use of leisure time, finances, and physical health. Implications for providing case management services to homeless mentally ill people are presented.

  7. Factors Determining Correct Case Management of Acute ...

    African Journals Online (AJOL)

    ARIs) is one of the factors responsible for the high ARI mortality in developing countries. Identification of factors which influence ARI case management by health workers is key for interventions to improve Quality of case management. Objective: ...

  8. Feasibility trial for primary stroke prevention in children with sickle cell anemia in Nigeria (SPIN trial).

    Science.gov (United States)

    Galadanci, Najibah A; Umar Abdullahi, Shehu; Vance, Leah D; Musa Tabari, Abdulkadir; Ali, Shehi; Belonwu, Raymond; Salihu, Auwal; Amal Galadanci, Aisha; Wudil Jibir, Binta; Bello-Manga, Halima; Neville, Kathleen; Kirkham, Fenella J; Shyr, Yu; Phillips, Sharon; Covert, Brittany V; Kassim, Adetola A; Jordan, Lori C; Aliyu, Muktar H; DeBaun, Michael R

    2017-08-01

    The vast majority of children with sickle cell anemia (SCA) live in Africa, where evidence-based guidelines for primary stroke prevention are lacking. In Kano, Nigeria, we conducted a feasibility trial to determine the acceptability of hydroxyurea therapy for primary stroke prevention in children with abnormal transcranial Doppler (TCD) measurements. Children with SCA and abnormal non-imaging TCD measurements (≥200 cm/s) received moderate fixed-dose hydroxyurea therapy (∼20 mg/kg/day). A comparison group of children with TCD measurements hydroxyurea. The comparison group consisted of initially 210 children, of which four developed abnormal TCD measurements, and were started on hydroxyurea. None of the monthly research visits were missed (n = total 603 visits). Two and 10 deaths occurred in the treatment and comparison groups, with mortality rates of 2.69 and 1.81 per 100 patient-years, respectively (P = .67). Our results provide strong evidence, for high family recruitment, retention, and adherence rates, to undertake the first randomized controlled trial with hydroxyurea therapy for primary stroke prevention in children with SCA living in Africa. © 2017 Wiley Periodicals, Inc.

  9. A Randomized Controlled Trial of Caries Prevention in Dental Practice.

    Science.gov (United States)

    Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V

    2017-07-01

    We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once

  10. Is employment-focused case management effective for patients with substance use disorders? Results from a controlled multi-site trial in Germany covering a 2-years-period after inpatient rehabilitation.

    Science.gov (United States)

    Saal, Susanne; Forschner, Lukas; Kemmann, Dietmar; Zlatosch, Jacqueline; Kallert, Thomas W

    2016-08-05

    Substance use disorders are associated with unemployment. An employment-focused case management (CMRE) has been conceptualised as a specific intervention to help substance use disorder patients return to competitive employment immediately after inpatient rehabilitation. This study investigated the effect of the intervention on return to work of persons with substance use disorders. The study was conducted in four German inpatient rehabilitation departments, and included unemployed patients (aged between 18 and 63 years) with a main clinical diagnosis of ICD-10 F10-19 disorders. Six weeks before discharge, patients were randomly allocated to CMRE or standard care (SC) using a quasi-randomised approach. The primary outcome measure was integration into competitive employment 24 months after discharge from rehabilitation. Secondary outcome domains were abstinence, duration of employment, proportion of publicly funded employment, satisfaction with life, precarious housing situation and precarious financial situation, and use of follow-up services. Outcome measures were assessed 6 weeks and 1-2 days prior to discharge, and 12 and 24 months after discharge from rehabilitation. One hundred sixty patients were allocated into the CMRE group and 160 patients into the control group. 267 resp. 179 participants could be included in the analyses performed for the 12-, and the 24-months follow-up assessments. At the study endpoint the rate of integration into the primary labour market was 35.6 % in the CMRE group and 41.2 % in the control group, respectively (Relative Risk 0.92, 95 % CI, 0.47; 1.79). There was a significantly higher proportion in the CMRE group, however, which immediately after discharge linked with services of the Federal Employment Agency or Job Centres. There were no statistically significant differences in other outcomes between the groups. Compared to SC, the additional specific CMRE intervention did not result in superior effects on return to work

  11. Atrophy rates in asymptomatic amyloidosis: implications for Alzheimer prevention trials.

    Directory of Open Access Journals (Sweden)

    K Abigail Andrews

    Full Text Available There is considerable interest in designing therapeutic studies of individuals at risk of Alzheimer disease (AD to prevent the onset of symptoms. Cortical β-amyloid plaques, the first stage of AD pathology, can be detected in vivo using positron emission tomography (PET, and several studies have shown that ~1/3 of healthy elderly have significant β-amyloid deposition. Here we assessed whether asymptomatic amyloid-PET-positive controls have increased rates of brain atrophy, which could be harnessed as an outcome measure for AD prevention trials. We assessed 66 control subjects (age = 73.5±7.3 yrs; MMSE = 29±1.3 from the Australian Imaging Biomarkers & Lifestyle study who had a baseline Pittsburgh Compound B (PiB PET scan and two 3T MRI scans ~18-months apart. We calculated PET standard uptake value ratios (SUVR, and classified individuals as amyloid-positive/negative. Baseline and 18-month MRI scans were registered, and brain, hippocampal, and ventricular volumes and annualized volume changes calculated. Increasing baseline PiB-PET measures of β-amyloid load correlated with hippocampal atrophy rate independent of age (p = 0.014. Twenty-two (1/3 were PiB-positive (SUVR>1.40, the remaining 44 PiB-negative (SUVR≤1.31. Compared to PiB-negatives, PiB-positive individuals were older (76.8±7.5 vs. 71.7±7.5, p<0.05 and more were APOE4 positive (63.6% vs. 19.2%, p<0.01 but there were no differences in baseline brain, ventricle or hippocampal volumes, either with or without correction for total intracranial volume, once age and gender were accounted for. The PiB-positive group had greater total hippocampal loss (0.06±0.08 vs. 0.02±0.05 ml/yr, p = 0.02, independent of age and gender, with non-significantly higher rates of whole brain (7.1±9.4 vs. 4.7±5.5 ml/yr and ventricular (2.0±3.0 vs. 1.1±1.0 ml/yr change. Based on the observed effect size, recruiting 384 (95%CI 195-1080 amyloid-positive subjects/arm will provide 80% power to detect 25

  12. Selenium and Prostate Cancer Prevention: Insights from the Selenium and Vitamin E Cancer Prevention Trial (SELECT

    Directory of Open Access Journals (Sweden)

    Holly L. Nicastro

    2013-04-01

    Full Text Available The Selenium and Vitamin E Cancer Prevention Trial (SELECT was conducted to assess the efficacy of selenium and vitamin E alone, and in combination, on the incidence of prostate cancer. This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was surprising given the strong preclinical and clinical evidence suggesting chemopreventive activity of selenium. Potential explanations for the null findings include the agent formulation and dose, the characteristics of the cohort, and the study design. It is likely that only specific subpopulations may benefit from selenium supplementation; therefore, future studies should consider the baseline selenium status of the participants, age of the cohort, and genotype of specific selenoproteins, among other characteristics, in order to determine the activity of selenium in cancer prevention.

  13. Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial

    NARCIS (Netherlands)

    Beishuizen, Cathrien R. L.; Coley, Nicola; Moll van Charante, Eric P.; van Gool, Willem A.; Richard, Edo; Andrieu, Sandrine

    2017-01-01

    To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. Secondary analysis.

  14. Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial

    NARCIS (Netherlands)

    Beishuizen, C.R.; Coley, N.; Charante, E.P.M. van; Gool, W.A. van; Richard, E.; Andrieu, S.

    2017-01-01

    OBJECTIVES: To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. DESIGN:

  15. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

    Science.gov (United States)

    Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

    2013-01-01

    To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30

  16. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: a pilot trial.

    Science.gov (United States)

    Cook, Deborah J; Johnstone, Jennie; Marshall, John C; Lauzier, Francois; Thabane, Lehana; Mehta, Sangeeta; Dodek, Peter M; McIntyre, Lauralyn; Pagliarello, Joe; Henderson, William; Taylor, Robert W; Cartin-Ceba, Rodrigo; Golan, Eyal; Herridge, Margaret; Wood, Gordon; Ovakim, Daniel; Karachi, Tim; Surette, Michael G; Bowdish, Dawn M E; Lamarche, Daphnee; Verschoor, Chris P; Duan, Erick H; Heels-Ansdell, Diane; Arabi, Yaseen; Meade, Maureen

    2016-08-02

    Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the overall incidence of infection in critically ill patients. However, these studies are small, largely single-center, and at risk of bias. The aim of the PROSPECT pilot trial was to determine the feasibility of conducting a larger trial of probiotics to prevent VAP in mechanically ventilated patients in the intensive care unit (ICU). In a randomized blinded trial, patients expected to be mechanically ventilated for ≥72 hours were allocated to receive either 1 × 10(10) colony-forming units of Lactobacillus rhamnosus GG or placebo, twice daily. Patients were excluded if they were at increased risk of L. rhamnosus GG infection or had contraindications to enteral medication. Feasibility objectives were: (1) timely recruitment; (2) maximal protocol adherence; (3) minimal contamination; and (4) estimated VAP rate ≥10 %. We also measured other infections, diarrhea, ICU and hospital length of stay, and mortality. Overall, in 14 centers in Canada and the USA, all feasibility goals were met: (1) 150 patients were randomized in 1 year; (2) protocol adherence was 97 %; (3) no patients received open-label probiotics; and (4) the VAP rate was 19 %. Other infections included: bloodstream infection (19.3 %), urinary tract infections (12.7 %), and skin and soft tissue infections (4.0 %). Diarrhea, defined as Bristol type 6 or 7 stools, occurred in 133 (88.7 %) of patients, the median length of stay in ICU was 12 days (quartile 1 to quartile 3, 7-18 days), and in hospital was 26 days (quartile 1 to quartile 3, 14-44 days); 23 patients (15.3 %) died in the ICU. The PROSPECT pilot trial supports the feasibility of a larger trial to investigate the effect of L. rhamnosus GG on VAP and other nosocomial infections in critically ill patients. Clinicaltrials

  17. Moving from Efficacy to Effectiveness Trials in Prevention Research

    OpenAIRE

    Marchand, Erica; Stice, Eric; Rohde, Paul; Becker, Carolyn Black

    2010-01-01

    Efficacy trials test whether interventions work under optimal, highly controlled conditions whereas effectiveness trials test whether interventions work with typical clients and providers in real-world settings. Researchers, providers, and funding bodies have called for more effectiveness trials to understand whether interventions produce effects under ecologically valid conditions, which factors predict program effectiveness, and what strategies are needed to successfully implement programs ...

  18. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Directory of Open Access Journals (Sweden)

    Dan Allman

    Full Text Available BACKGROUND: This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. METHODS: In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP guided this work. RESULTS: Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs. Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. DISCUSSION: Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical

  19. Improving ethical and participatory practice for marginalized populations in biomedical HIV prevention trials: lessons from Thailand.

    Science.gov (United States)

    Allman, Dan; Ditmore, Melissa Hope; Kaplan, Karyn

    2014-01-01

    This paper presents findings from a qualitative investigation of ethical and participatory issues related to the conduct of biomedical HIV prevention trials among marginalized populations in Thailand. This research was deemed important to conduct, as several large-scale biomedical HIV prevention trials among marginalized populations had closed prematurely in other countries, and a better understanding of how to prevent similar trial closures from occurring in the future was desired. In-depth key informant interviews were held in Bangkok and Chiang Mai, Thailand. Interviews were audio recorded, transcribed, translated and thematically analyzed. The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP) guided this work. Fourteen interviews were conducted: 10 with policymakers, academic and community-based researchers and trial staff and four with representatives of non-governmental organizations (NGOs). Suggested ways to improve ethical and participatory practice centered on standards of HIV prevention, informed consent, communication and human rights. In particular, the need to overcome language and literacy differences was identified. Key informants felt communication was the basis of ethical understanding and trust within biomedical HIV prevention trial contexts, and thus fundamental to trial participants' ability to exercise free will. Biomedical HIV prevention trials present opportunities for inclusive and productive ethical and participatory practice. Key informants suggested that efforts to improve practice could result in better relationships between research stakeholders and research investigative teams and by extension, better, more ethical participatory trials. This research took place in Thailand and its findings apply primarily to Thailand. However, given the universality of many ethical considerations, the results of this study can inform the improvement of ethical and participatory practice in other parts of the world where

  20. Recruitment of Underrepresented Minority Researchers into HIV Prevention Research: The HIV Prevention Trials Network Scholars Program

    Science.gov (United States)

    Hamilton, Erica L.; Griffith, Sam B.; Jennings, Larissa; Dyer, Typhanye V.; Mayer, Kenneth; Wheeler, Darrell

    2018-01-01

    Abstract Most U.S. investigators in the HIV Prevention Trials Network (HPTN) have been of majority race/ethnicity and sexual orientation. Research participants, in contrast, have been disproportionately from racial/ethnic minorities and men who have sex with men (MSM), reflecting the U.S. epidemic. We initiated and subsequently evaluated the HPTN Scholars Program that mentors early career investigators from underrepresented minority groups. Scholars were affiliated with the HPTN for 12–18 months, mentored by a senior researcher to analyze HPTN study data. Participation in scientific committees, trainings, protocol teams, and advisory groups was facilitated, followed by evaluative exit surveys. Twenty-six trainees have produced 17 peer-reviewed articles to date. Research topics typically explored health disparities and HIV prevention among black and Hispanic MSM and at-risk black women. Most scholars (81% in the first five cohorts) continued HIV research after program completion. Alumni reported program-related career benefits and subsequent funding successes. Their feedback also suggested that we must improve the scholars' abilities to engage new research protocols that are developed within the network. Mentored engagement can nurture the professional development of young researchers from racial/ethnic and sexual minority communities. Minority scientists can benefit from training and mentoring within research consortia, whereas the network research benefits from perspectives of underrepresented minority scientists. PMID:29145745

  1. The managerial nature of case management.

    Science.gov (United States)

    Wolk, J L; Sullivan, W P; Hartmann, D J

    1994-03-01

    Case managers have been viewed as engaging in direct practice, community practice, or both. This article offers a third view: Case managers also engage in the practice of management. Employing Mintzberg's seminal research on chief executive behavior, the authors argue that case managers' work is similarly characterized by brevity, variety, and fragmentation. Case managers perform the 10 roles developed in Mintzberg's original study. These roles are divided into three groups: interpersonal, including figurehead, leader, and liaison; informational, including monitor, disseminator, and spokesperson; and decision-making, including entrepreneur, disturbance handler, resource allocator, and negotiator. Case managers' tasks associated with each role are presented. Considering their work as managerial in nature will help case managers more effectively assist clients in goal achievement.

  2. Disaster case management and individuals with disabilities.

    Science.gov (United States)

    Stough, Laura M; Sharp, Amy N; Decker, Curt; Wilker, Nachama

    2010-08-01

    To examine the case management and disaster recovery needs of individuals with disabilities following Hurricane Katrina. The case managers and supervisors in this study provided case management to individuals with disabilities as part of the largest coordinated disaster case management program in U.S. history, the Katrina Aid Today consortium. This study provides an account of the disaster case management needs of individuals with disabilities as well as a picture of their long-term recovery process two years following the disaster. Forty-two case managers and 12 case management supervisors from this program provided services to a collective caseload of 2,047 individuals with disabilities and their families. Interviews and telephone surveys were conducted with these participants 20-24 months after the disaster. The qualitative data were analyzed using grounded theory methodology, and descriptive statistics summarize the demographic data. Findings suggest that the disaster recovery process is typically more complex and lengthy for individuals with disabilities and requires negotiation of a service system sometimes unprepared for disability-related needs. Barriers to disaster recovery for individuals with disabilities included a lack of accessible housing, transportation, and disaster services. Supports to disaster recovery included the individual effort and advocacy of a case manager, connecting with needed resources, collaboration with other agencies, and client motivation and persistence. Results suggest that disaster recovery is facilitated by case managers with disability expertise, including knowledge about the needs of individuals with disabilities and about disability-related services.

  3. Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy

    Science.gov (United States)

    Cohen, Jessica A.; Mastroianni, Anna C.; Macklin, Ruth

    2014-01-01

    Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously. PMID:25113651

  4. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations

    Science.gov (United States)

    Gewandter, Jennifer S.; Dworkin, Robert H.; Turk, Dennis C.; Farrar, John T.; Fillingim, Roger B.; Gilron, Ian; Markman, John D.; Oaklander, Anne Louise; Polydefkis, Michael J.; Raja, Srinivasa N.; Robinson, James P.; Woolf, Clifford J.; Ziegler, Dan; Ashburn, Michael A.; Burke, Laurie B.; Cowan, Penney; George, Steven Z.; Goli, Veeraindar; Graff, Ole X.; Iyengar, Smriti; Jay, Gary W.; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A.; Kopecky, Ernest A.; Malamut, Richard; McDermott, Michael P.; Palmer, Pamela; Rappaport, Bob A.; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A.

    2018-01-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (i.e., chronic post-surgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (i.e., surgery, viral infection, injury, and toxic/noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials. PMID:25887465

  5. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  6. Willingness to participate in future HIV prevention trials in Beira ...

    African Journals Online (AJOL)

    Among women, WTP was highest for trials evaluating daily oral pre-exposure prophylaxis (PrEP; 84.4% reporting very likely to participate), followed by vaccination (77.8%), daily vaginal gel use (67.7%), coital vaginal gel use (67.1%) and monthly vaginal ring use (47.7%). Among men, WTP was highest for trials evaluating ...

  7. Iowa Case Management for Rural Drug Abuse

    Science.gov (United States)

    Hall, James A.; Vaughan Sarrazin, Mary S.; Huber, Diane L.; Vaughn, Thomas; Block, Robert I.; Reedy, Amanda R.; Jang, MiJin

    2009-01-01

    Objective: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. Method: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual…

  8. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way m

  9. Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

    Science.gov (United States)

    Newman, Peter A; Rubincam, Clara

    2014-12-01

    Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

  10. Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers

    Science.gov (United States)

    ... Prostate Cancer Prostate Cancer Screening Research Selenium and Vitamin E Cancer Prevention Trial (SELECT): Questions and Answers On ... of prostate cancer mean to men who take vitamin E but who were not SELECT participants? The incidence ...

  11. Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial.

    Science.gov (United States)

    Beishuizen, Cathrien R L; Coley, Nicola; Moll van Charante, Eric P; van Gool, Willem A; Richard, Edo; Andrieu, Sandrine

    2017-07-01

    To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. Secondary analysis. One hundred sixteen general practices in the Netherlands. Community-dwelling individuals aged 70 to 78 (N = 2,994). Nurse-led multidomain intervention targeting cardiovascular risk factors to prevent dementia. The associations between participant baseline sociodemographic (age, sex, education), clinical (medical history, disability, cardiovascular risk), neuropsychiatric (depressive symptoms (Geriatric Depression Scale-15), and cognitive (Mini-Mental State Examination)) characteristics and dropout from the trial and nonadherence to the trial intervention were explored using multilevel logistic regression models. Older age, poorer cognitive function, more symptoms of depression, and greater disability were the most important determinants of dropout of older people. The presence of cardiovascular risk factors was not associated with dropout but was associated with nonadherence. Being overweight was a risk factor for nonadherence, whereas people with high blood pressure or a low level of physical exercise adhered better to the intervention. The association between poorer cognitive function and symptoms of depression and dropout was stronger in the control group than in the intervention group, and vice versa for increased disability. In a large dementia prevention trial with 6-year follow-up, dropout was associated with older age, poorer cognitive function, symptoms of depression, and disability at baseline. These findings can help to guide the design of future dementia prevention trials in older adults. The associations found between cardiovascular risk factors and nonadherence need to be confirmed in other older populations receiving cardiovascular prevention interventions

  12. Long-term survival of participants in the prostate cancer prevention trial

    OpenAIRE

    Silberstein, Jonathan L; Sartor, Oliver

    2014-01-01

    The Prostate Cancer Prevention Trial (PCPT) is a seminal study in the field of urology. More than 10 years after its initial publication, updated data from this trial continue to shape our understanding of prostate cancer. Among the major findings from the PCPT has been the demonstration that prostate cancer is common in men with prostate-specific antigen (PSA) once thought to be in the normal range, [1] finasteride prevents the development of benign prostatic hypertrophy, [2] it increases th...

  13. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-03-07

    interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.

  14. Prevention of epilepsy: Should we be avoiding clinical trials?

    Science.gov (United States)

    Klein, Pavel; Tyrlikova, Ivana

    2017-07-01

    Epilepsy prevention is one of the great unmet needs in epilepsy. Approximately 15% of all epilepsy is caused by an acute acquired CNS insult such as traumatic brain injury (TBI), stroke or encephalitis. There is a latent period between the insult and epilepsy onset that presents an opportunity to intervene with preventive treatment that is unique in neurology. Yet no phase 3 epilepsy prevention studies, and only 2 phase 2 studies have been initiated in the last 16years. Current prevailing opinion is that the research community is not ready for clinical preventive epilepsy studies, and that animal models should first be refined and biomarkers of epileptogenesis and of epilepsy discovered before clinical studies are embarked upon. We review data to suggest that there is basis to do epilepsy prevention studies now with the current knowledge and available drugs, and that those studies are feasible with currently available tools. We suggest that a different approach is needed from the past in order to maximize chances of success, minimize the cost, and set up platform for future preventive treatment development. That approach should include close coordination of preclinical and clinical development programs in a combined PTE prevention strategy, consideration of polytherapy, and simultaneous, combined clinical development of preventive treatment and of biomarker discovery. We argue that the currently favored approach of eschewing clinical studies until biomarkers are available will delay the discovery of epilepsy prevention treatment by at least 10 years and significantly increase the cost of such discovery. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for primary prevention of osteoarthritis by joint injury prevention in sport and recreation

    NARCIS (Netherlands)

    Emery, C.A.; Roos, E.M.; Verhagen, E.A.L.M.; Finch, C.F.; Bennell, K.L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L.S.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform

  16. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S

    2014-11-01

    To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry

  17. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

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

  18. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  19. Participant verification: Prevention of co‑enrolment in clinical trials in ...

    African Journals Online (AJOL)

    The Medical Research Council (MRC) HIV Prevention Research Unit (HPRU) developed the Biometric Co-enrolment Prevention System (BCEPS), which uses fingerprint-based biometric technology to identify participants. A trial website was used to determine the robustness and usability of the system. After successful ...

  20. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for primary prevention of osteoarthritis by joint injury prevention in sport and recreation.

    Science.gov (United States)

    Emery, C A; Roos, E M; Verhagen, E; Finch, C F; Bennell, K L; Story, B; Spindler, K; Kemp, J; Lohmander, L S

    2015-05-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for injury prevention RCTs are critical to informing evidence-based practice and policy decisions in health care, public health and the community. Recommendations regarding the interpretation and conduct of injury prevention RCTs will inform the highest level of evidence in the field. These recommendations will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  1. A service manager model: instituting case management.

    Science.gov (United States)

    Eckett, K; Vassallo, L M; Flett, M

    1996-02-01

    Using a service manager model as opposed to a traditional nurse case manager archetype fosters multidisciplinary team interaction. Benefits of this approach to the hospital, the staff and the patients are identified.

  2. New association formed for hospital case managers.

    Science.gov (United States)

    1999-09-01

    A national board of case management professionals has established the Little Rock, AR-based American Case Management Association (ACMA), the first case management association specifically designed to address the needs and concerns of hospital and health system-based case managers. The formation of ACMA was motivated in part by the desire to foster closer cooperation between nurses and social workers in the acute care setting. The association's board and officers have equal representation from the nursing and social work professions. Members of ACMA will be able to take advantage of the following services: a job opportunities network, an information resource center, a director's forum, and a mentoring service. Annual membership dues are $135.

  3. Nutritional intervention trials for preventing and treating pressure ulcer.

    OpenAIRE

    Bourdel-Marchasson, Isabelle; Rondeau, Virginie

    2001-01-01

    The purpose of this study was to assess the effect of nutritional supplementation on dietary intake and on pressure ulcer development in critically ill older patients. The multi-center trial involved 19 wards stratified according to specialty and recruitment for critically ill older patients; 9 wards were randomly selected for nutritional intervention (nutritional intervention group), consisting of the daily distribution of two oral supplements, with each supplement containg 200 kcal, for 15 ...

  4. Prevention of eating disorders: A systematic review of randomized, controlled trials.

    Science.gov (United States)

    Watson, Hunna J; Joyce, Tara; French, Elizabeth; Willan, Vivienne; Kane, Robert T; Tanner-Smith, Emily E; McCormack, Julie; Dawkins, Hayley; Hoiles, Kimberley J; Egan, Sarah J

    2016-09-01

    This systematic review evaluated the efficacy of universal, selective, and indicated eating disorder prevention. A systematic literature search was conducted in Medline, PsycINFO, Embase, Scopus, and the Cochrane Collaboration Library databases to January 2016. Studies were included if they were randomized, controlled trials (RCT) and tested an eating disorder prevention program. We retrieved 13 RCTs of universal prevention (N = 3,989 participants, 55% female, M age = 13.0 years), 85 RCTs of selective prevention (N = 11,949 participants, 99% female, M age = 17.6 years), and 8 RCTs of indicated prevention (N = 510 participants, 100% female, M age = 20.1 years). Meta-analysis was performed with selective prevention trials. As there were a limited number of universal and indicated trials, narrative synthesis was conducted. Media literacy had the most support for universal prevention. Most universal approaches showed significant modest effects on risk factors. Dissonance-based was the best supported approach for selective prevention. Cognitive-behavior therapy (CBT), a healthy weight program, media literacy, and psychoeducation, were also effective for selective prevention and effects were maintained at follow-up. CBT was supported for indicated prevention and effects were maintained at follow-up. The modest effects for universal prevention were likely due to floor effects. The evidence for selective prevention suggests that empirically supported approaches should be disseminated on a wider basis. Our findings suggest CBT should be offered for indicated populations. Overall, results suggest efficacy of several prevention programs for reducing risk for eating disorders, and that wider dissemination is required. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  5. HIV/AIDS Prevention Trials Capacity Building Grants - Phase II ...

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

    Canada's international response to the HIV/AIDS epidemic is largely built around the work of the Canadian HIV Vaccine Initiative (CHVI). CHVI proposes to increase the capacity of Canada and low- and middle-income countries to respond to the HIV/AIDS pandemic by developing new HIV vaccines and other preventive ...

  6. Nutritional Science Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  7. HIV prevention responsibilities in HIV vaccine trials: Complexities ...

    African Journals Online (AJOL)

    implement, and we know very little about what prevention services researchers are currently providing to participants or their successes, best practices and challenges. We recommend that current normative guidance be systematically reviewed and actual practice at vaccine sites be documented. Adding new tools to the ...

  8. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial

    OpenAIRE

    Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.

    2015-01-01

    Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...

  9. Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review

    OpenAIRE

    Levey, Colin; Innes, Nicola; Schwendicke, Falk; Lamont, Thomas; Göstemeyer, Gerd

    2017-01-01

    Background Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations. Methods PubMed, Embase, Web of Knowledge and Cochrane CENT...

  10. Case management approaches to home support for people with dementia.

    Science.gov (United States)

    Reilly, Siobhan; Miranda-Castillo, Claudia; Malouf, Reem; Hoe, Juanita; Toot, Sandeep; Challis, David; Orrell, Martin

    2015-01-05

    Over 35 million people are estimated to be living with dementia in the world and the societal costs are very high. Case management is a widely used and strongly promoted complex intervention for organising and co-ordinating care at the level of the individual, with the aim of providing long-term care for people with dementia in the community as an alternative to early admission to a care home or hospital. To evaluate the effectiveness of case management approaches to home support for people with dementia, from the perspective of the different people involved (patients, carers, and staff) compared with other forms of treatment, including 'treatment as usual', standard community treatment and other non-case management interventions. We searched the following databases up to 31 December 2013: ALOIS, the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group,The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS, Web of Science (including Science Citation Index Expanded (SCI-EXPANDED) and Social Science Citation Index), Campbell Collaboration/SORO database and the Specialised Register of the Cochrane Effective Practice and Organisation of Care Group. We updated this search in March 2014 but results have not yet been incorporated. We include randomised controlled trials (RCTs) of case management interventions for people with dementia living in the community and their carers. We screened interventions to ensure that they focused on planning and co-ordination of care. We used standard methodological procedures as required by The Cochrane Collaboration. Two review authors independently extracted data and made 'Risk of bias' assessments using Cochrane criteria. For continuous outcomes, we used the mean difference (MD) or standardised mean difference (SMD) between groups along with its confidence interval (95% CI). We applied a fixed- or random-effects model as appropriate. For binary or dichotomous data, we generated the corresponding odds

  11. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    Science.gov (United States)

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

    2016-07-01

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

  12. Early-Life Obesity Prevention: Critique of Intervention Trials During the First One Thousand Days.

    Science.gov (United States)

    Reilly, John J; Martin, Anne; Hughes, Adrienne R

    2017-06-01

    To critique the evidence from recent and ongoing obesity prevention interventions in the first 1000 days in order to identify evidence gaps and weaknesses, and to make suggestions for more informative future intervention trials. Completed and ongoing intervention trials have had fairly modest effects, have been limited largely to high-income countries, and have used relatively short-term interventions and outcomes. Comparison of the evidence from completed prevention trials with the evidence from systematic reviews of behavioral risk factors shows that some life-course stages have been neglected (pre-conception and toddlerhood), and that interventions have neglected to target some important behavioral risk factors (maternal smoking during pregnancy, infant and child sleep). Finally, while obesity prevention interventions aim to modify body composition, few intervention trials have used body composition measures as outcomes, and this has limited their sensitivity to detect intervention effects. The new WHO Healthy Lifestyles Trajectory (HeLTI) initiative should address some of these weaknesses. Future early obesity prevention trials should be much more ambitious. They should, ideally: extend their interventions over the first 1000 days; have longer-term (childhood) outcomes, and improved outcome measures (body composition measures in addition to proxies for body composition such as the BMI for age); have greater emphasis on maternal smoking and child sleep; be global.

  13. The Swedish six-community alcohol and drug prevention trial: effects on youth drinking.

    Science.gov (United States)

    Hallgren, Mats; Andréasson, Sven

    2013-09-01

    Local communities are increasingly targeted for alcohol and drug prevention campaigns. This study describes some of the key findings from the Swedish six-community alcohol and drug prevention trial (2003-2007) and lessons learned following an evaluation of the trial's effectiveness. The paper focuses mainly on changes in youth drinking and related harms. This was a pre- to post-intervention effect study comparing six trial communities that received added training and technical support with six control communities where regular prevention efforts were supported by national alcohol and drug action plans. A repeated, cross-sectional survey of 8092 youths aged 15-19 years assessed changes in alcohol consumption, binge drinking, perceived alcohol availability, access to alcohol via parents and adult attitudes towards the supply of alcohol to youths. National registry data were used to assess changes in hospital admissions due to alcohol intoxication. Overall, there were few significant improvements in the six trial communities compared with the control communities. The absence of program effects was largely attributable to the selection of strategies (in particular, school and parental programs) lacking evidence of effectiveness in reducing alcohol consumption at the aggregate level. Prevention programs based on efficacy studies need to be tested in community-based effectiveness trials before being disseminated. © 2013 Australasian Professional Society on Alcohol and other Drugs.

  14. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

    Science.gov (United States)

    Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O'Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R; Hillier, Sharon L; Beigi, Richard

    2018-02-01

    Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

  15. Recruitment and retention of participants for an international type 1 diabetes prevention trial

    DEFF Research Database (Denmark)

    Franciscus, Margaret; Nucci, Anita; Bradley, Brenda

    2014-01-01

    BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns...... privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful...

  16. Fall prevention in acute care hospitals: a randomized trial.

    Science.gov (United States)

    Dykes, Patricia C; Carroll, Diane L; Hurley, Ann; Lipsitz, Stuart; Benoit, Angela; Chang, Frank; Meltzer, Seth; Tsurikova, Ruslana; Zuyov, Lyubov; Middleton, Blackford

    2010-11-03

    Falls cause injury and death for persons of all ages, but risk of falls increases markedly with age. Hospitalization further increases risk, yet no evidence exists to support short-stay hospital-based fall prevention strategies to reduce patient falls. To investigate whether a fall prevention tool kit (FPTK) using health information technology (HIT) decreases patient falls in hospitals. Cluster randomized study conducted January 1, 2009, through June 30, 2009, comparing patient fall rates in 4 urban US hospitals in units that received usual care (4 units and 5104 patients) or the intervention (4 units and 5160 patients). The FPTK integrated existing communication and workflow patterns into the HIT application. Based on a valid fall risk assessment scale completed by a nurse, the FPTK software tailored fall prevention interventions to address patients' specific determinants of fall risk. The FPTK produced bed posters composed of brief text with an accompanying icon, patient education handouts, and plans of care, all communicating patient-specific alerts to key stakeholders. The primary outcome was patient falls per 1000 patient-days adjusted for site and patient care unit. A secondary outcome was fall-related injuries. During the 6-month intervention period, the number of patients with falls differed between control (n = 87) and intervention (n = 67) units (P=.02). Site-adjusted fall rates were significantly higher in control units (4.18 [95% confidence interval {CI}, 3.45-5.06] per 1000 patient-days) than in intervention units (3.15 [95% CI, 2.54-3.90] per 1000 patient-days; P = .04). The FPTK was found to be particularly effective with patients aged 65 years or older (adjusted rate difference, 2.08 [95% CI, 0.61-3.56] per 1000 patient-days; P = .003). No significant effect was noted in fall-related injuries. The use of a fall prevention tool kit in hospital units compared with usual care significantly reduced rate of falls. clinicaltrials.gov Identifier: NCT

  17. Stepped-care prevention of anxiety and depression in late life. A randomized controlled trial

    OpenAIRE

    van 't Veer-Tazelaar, P.J.; van Marwijk, H.W.J.; van Oppen, P.C.; van Hout, H.P.J.; van der Horst, H.E.; Cuijpers, P.; Smit, H.F.E.; Beekman, A.T.F.

    2009-01-01

    Centext: Given the public health significance of latelife depression and anxiety, and the limited capacity of treatment, there is an urgent need to develop effective strategies to prevent these disorders. Objectjve: To determine the effectiveness of an indicated stepped-care prevention program for depression and anxiety disorders in the elderly. Design: Randomized controlled trial with recruitment between October 1, 2004, and October 1, 2005. Setting: Thirty-three primary care practices in th...

  18. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  19. Impact of the JUPITER trial on statin prescribing for primary prevention.

    Science.gov (United States)

    Teng, Jennifer F T; Gomes, Tara; Camacho, Ximena; Grundy, Scott; Juurlink, David N; Mamdani, Muhammad M

    2014-01-01

    As the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial identified a new population of individuals with cholesterol levels below traditional treatment thresholds but with elevated high-sensitivity C-reactive protein (hs-CRP) levels who may benefit from primary prevention with statin therapy, we sought to evaluate the impact of this trial on the incident prescription rates of rosuvastatin alone as well as all statins in a primary prevention population. Population-based, cross-sectional time-series analysis. Administrative health care databases in Ontario, Canada. A total of 299,809 incident statin users 66 years or older were identified during the study period, from January 1, 2003, to March 31, 2011, who were prescribed statin therapy for primary prevention. We evaluated the incident rate of rosuvastatin and all statin use during each quarter of the study period. Overall, no significant trends in all incident statin use were observed (p=0.99). Furthermore, no significant differences were observed in incident rates of rosuvastatin (p=0.21) or all statin (p=0.41) use after the publication of the JUPITER trial. Despite the lack of impact of the JUPITER trial on rosuvastatin or all statin utilization, the relative market share of rosuvastatin increased from 9% to 65% over the study period. The publication of the JUPITER trial did not significantly affect trends in overall statin and rosuvastatin prescribing patterns for primary prevention in this study. Increases in the relative market share of rosuvastatin may be attributed to the impact of the pharmaceutical industry on prescribing patterns. Our results highlight the need to further improve the integration of evidence-based prescribing into cost-effective clinical practice. © 2013 Pharmacotherapy Publications, Inc.

  20. HIV Epidemic in Asia: Implications for HIV Vaccine and Other Prevention Trials

    Science.gov (United States)

    Phanuphak, Nittaya; Lo, Ying-Ru; Shao, Yiming; Solomon, Sunil Suhas; O'Connell, Robert J.; Tovanabutra, Sodsai; Chang, David; Kim, Jerome H.

    2015-01-01

    Abstract An overall decrease of HIV prevalence is now observed in several key Asian countries due to effective prevention programs. The decrease in HIV prevalence and incidence may further improve with the scale-up of combination prevention interventions. The implementation of future prevention trials then faces important challenges. The opportunity to identify heterosexual populations at high risk such as female sex workers may rapidly wane. With unabating HIV epidemics among men who have sex with men (MSM) and transgender (TG) populations, an effective vaccine would likely be the only option to turn the epidemic. It is more likely that efficacy trials will occur among MSM and TG because their higher HIV incidence permits smaller and less costly trials. The constantly evolving patterns of HIV-1 diversity in the region suggest close monitoring of the molecular HIV epidemic in potential target populations for HIV vaccine efficacy trials. CRF01_AE remains predominant in southeast Asian countries and MSM populations in China. This relatively steady pattern is conducive to regional efficacy trials, and as efficacy warrants, to regional licensure. While vaccines inducing nonneutralizing antibodies have promise against HIV acquisition, vaccines designed to induce broadly neutralizing antibodies and cell-mediated immune responses of greater breadth and depth in the mucosal compartments should be considered for testing in MSM and TG. The rationale and design of efficacy trials of combination prevention modalities such as HIV vaccine and preexposure prophylaxis (PrEP) remain hypothetical, require high adherence to PrEP, are more costly, and present new regulatory challenges. The prioritization of prevention interventions should be driven by the HIV epidemic and decided by the country-specific health and regulatory authorities. Modeling the impact and cost–benefit may help this decision process. PMID:26107771

  1. Nurse Case Managers' Experiences on Case Management for Long-term Hospitalization in Korea.

    Science.gov (United States)

    Oh, Jinjoo; Oh, Seieun

    2017-12-01

    The implementation of case management for long-term hospitalization use has been approved for controlling medical cost increases in other countries. But, introduction of the case management in Korea has created issues that hinder its effective operation. This qualitative study aimed to obtain further understanding of the issues surrounding the management of Medical Aid beneficiaries' use of long-term hospitalization from the case managers' perspectives and to provide suggestions for successful case management. Thematic analysis was employed to analyze the data. Medical Aid case managers with 3 or more years of case management experience were recruited from urban, suburban, and rural regions. Data were collected through in-depth interviews: 12 nurse case managers participated in focus group interviews and 11 participated in individual one-on-one interviews. Four major themes emerged: on-site obstacles that hinder work progress; going in an opposite direction; ambiguous position of case managers; and work-related emotions. Eleven subthemes were discovered: chasing potential candidates; becoming an enemy; discharging patients who have nowhere to go; welfare-centered national policies increasing medical costs; Medical Aid Program that encourages hospitalization; misuse of hospitalization; feeling limited; working without authority; fulfilling the expected role; fretting about social criticism; and feeling neglected and unprotected. The findings highlight the complexity and ambiguity of the issues faced by case managers. Successful management of Medical Aid resources requires the orchestrated efforts and collaboration of multiple stakeholders. More systematized support and resources for nurse case managers are essential to fully implement this nursing innovation in Korea. Copyright © 2017. Published by Elsevier B.V.

  2. TRIAL OF ASPIRIN AND CALCIUM ON PREVENTION OF PREECLAMPSIA

    Directory of Open Access Journals (Sweden)

    ALI AKBA TAHERIAN

    2002-06-01

    Full Text Available ntroduction. Preelampsia is a common and serious complication of pregnancy that affects both mother and newborn. This study designed to determine whether low-dose aspirin or calcium supplements taken throughout pregnancy reduce the incidence of preeclampsia. Methods. The present study was a randomized controlled clinical trial. 990 healthy nulliparous women, who were pregnant for 13 to 20 weeks were chosen to receive daily treatment with low dose of aspirin 75 mg (330 patients, aspirin group, calcium D 500 mg (330 Patients, calcium group and no medication (330 patients, control group for remainder of theirs pregnancies. Data included demographic, obstetric, prenatal care, hospital records and final diagnosis were collected. Statistical analysis was performed using Chi-Squre, ANOVA and Duncan test at significance level of 0.05. Results. Preeclampsia occurred in 15 of 330 women in the aspirin group (4.6%, 13 of 330 women in the calcium group (4% and in 33 of 330 women in control group (10.1%. There were significant differences between aspirin and control groups (4.6% vs. 10.1% P < 0.05 also between calcium and control group (4% vs. 10.1% P < 0.05. Discussion. These results suggest that low dose of aspirin or calcium D during pregnancy in healthy nulliparous women is effective to reduce the prevalence of preeclampsia.

  3. Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis.

    Science.gov (United States)

    Jordan, J M; Sowers, M F; Messier, S P; Bradley, J; Arangio, G; Katz, J N; Losina, E; Rovati, L; Bachtell, N; Cooper, C; Spector, T; Zhang, W; Gardiner, J; Wahba, M

    2011-05-01

    The design and execution of prevention trials for OA have methodological issues that are distinct from trials designed to impact prevalent disease. Disease definitions and their precise and sensitive measurement, identification of high-risk populations, the nature of the intervention (pharmaceutical, nutraceutical, behavioral) and its potential pleiotropic impacts on other organ systems are critical to consider. Because prevention trials may be prolonged, close attention to concomitant life changes and co-morbidities, adherence and participant retention in the trial is of primary importance, as is recognition of the potential for "preventive misconception" and "behavioral disinhibition" to affect the ability of the trial to show an effect of the intervention under study. None of these potential pitfalls precludes a successful and scientifically rigorous process and outcome. As technology improves the means to measure and predict the OA process and its clinical consequences, it will be increasingly possible to screen individuals for high-risk phenotypes, combining clinical factors with information from imaging, genetic, metabolic and other biomarkers and to impact this high-risk condition to avoid or delay OA both structurally and symptomatically. Copyright © 2011. Published by Elsevier Ltd.

  4. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials.

    Science.gov (United States)

    Raskin, Jeffrey B; Kamm, Michael A; Jamal, M Mazen; Márquez, Juan; Melzer, Ehud; Schoen, Robert E; Szalóki, Tibor; Barrett, Karen; Streck, Paul

    2014-10-01

    No therapy has been proven to prevent the recurrence of diverticulitis. Mesalamine has shown efficacy in preventing relapse in inflammatory bowel disease, and there is preliminary evidence that it might be effective for diverticular disease. We investigated the efficacy of mesalamine in preventing recurrence of diverticulitis in 2 identical but separate phase 3, randomized, double-blind, placebo-controlled, multicenter trials (identical confirmatory trials were conducted for regulatory reasons). We evaluated the efficacy and safety of multimatrix mesalamine vs placebo in the prevention of recurrent diverticulitis in 590 (PREVENT1) and 592 (PREVENT2) adult patients with ≥1 episodes of acute diverticulitis in the previous 24 months that resolved without surgery. Patients received mesalamine (1.2 g, 2.4 g, or 4.8 g) or placebo once daily for 104 weeks. The primary end point was the proportion of recurrence-free patients at week 104. Diverticulitis recurrence was defined as surgical intervention at any time for diverticular disease or presence of computed tomography scan results demonstrating bowel wall thickening (>5 mm) and/or fat stranding consistent with diverticulitis. For a portion of the study, recurrence also required the presence of abdominal pain and an increase in white blood cells. Mesalamine did not reduce the rate of diverticulitis recurrence at week 104. Among patients in PREVENT1, 53%-63% did not have disease recurrence, compared with 65% of those given placebo. Among patients in PREVENT2, 59%-69% of patients did not have disease recurrence, compared with 68% of those given placebo. Mesalamine did not reduce time to recurrence, and the proportions of patients requiring surgery were comparable among treatment groups. No new adverse events were identified with mesalamine administration. Mesalamine was not superior to placebo in preventing recurrent diverticulitis. Mesalamine is not recommended for this indication. ClinicalTrials.gov ID: NCT00545740 and

  5. A worksite prevention program for construction workers: Design of a randomized controlled trial

    NARCIS (Netherlands)

    Oude Hengel, K.M.; Joling, C.I.; Proper, K.I.; Blatter, B.M.; Bongers, P.M.

    2010-01-01

    Background. A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program

  6. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  7. Randomized Trials on Consider This, a Tailored, Internet-Delivered Smoking Prevention Program for Adolescents

    Science.gov (United States)

    Buller, David B.; Borland, Ron; Woodall, W. Gill; Hall, John R.; Hines, Joan M.; Burris-Woodall, Patricia; Cutter, Gary R.; Miller, Caroline; Balmford, James; Starling, Randall; Ax, Bryan; Saba, Laura

    2008-01-01

    The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools…

  8. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...

  9. Effectiveness of Peer-Led Eating Disorders Prevention: A Replication Trial

    Science.gov (United States)

    Becker, Carolyn Black; Bull, Stephanie; Schaumberg, Katherine; Cauble, Adele; Franco, Amanda

    2008-01-01

    The aim of this study was to replicate and extend results of a previous trial that investigated the effectiveness of 2 peer-led eating disorders prevention interventions in reducing eating disorder risk factors in undergraduate women (C. B. Becker, L. M. Smith, & A. C. Ciao, 2006). To extend findings from the previous study by allowing for…

  10. Clinical trials of antioxidants as cancer prevention agents: past, present, and future.

    Science.gov (United States)

    Goodman, Michael; Bostick, Roberd M; Kucuk, Omer; Jones, Dean P

    2011-09-01

    The purpose of this review is to summarize the most important human clinical trials of antioxidants as cancer prevention agents conducted to date, provide an overview of currently ongoing studies, and discuss future steps needed to advance research in this field. To date there have been several large (at least 7000 participants) trials testing the efficacy of antioxidant supplements in preventing cancer. The specific agents (diet-derived direct antioxidants and essential components of antioxidant enzymes) tested in those trials included β-carotene, vitamin E, vitamin C, selenium, retinol, zinc, riboflavin, and molybdenum. None of the completed trials produced convincing evidence to justify the use of traditional antioxidant-related vitamins or minerals for cancer prevention. Our search of ongoing trials identified six projects at various stages of completion. Five of those six trials use selenium as the intervention of interest delivered either alone or in combination with other agents. The lack of success to date can be explained by a variety of factors that need to be considered in the next generation research. These factors include lack of good biological rationale for selecting specific agents of interest; limited number of agents tested to date; use of pharmacological, rather than dietary, doses; and insufficient duration of intervention and follow-up. The latter consideration underscores the need for alternative endpoints that are associated with increased risk of neoplasia (i.e., biomarkers of risk), but are detectable prior to tumor occurrence. Although dietary antioxidants are a large and diverse group of compounds, only a small proportion of candidate agents have been tested. In summary, the strategy of focusing on large high-budget studies using cancer incidence as the endpoint and testing a relatively limited number of antioxidant agents has been largely unsuccessful. This lack of success in previous trials should not preclude us from seeking novel

  11. Case Management of Adolescents with Chronic Disease.

    Science.gov (United States)

    Lankard, Bettina A.

    This training guide presents a model for optimum delivery of the primary duties, tasks, and steps required in the comprehensive case management of adolescents with chronic disease. Using a team approach to coordinated health care, the guide involves the patient and family as key members of the care team along with the physician, nurse, dietitian,…

  12. 75 FR 27375 - Postal Rate Case Management

    Science.gov (United States)

    2010-05-14

    ... POSTAL REGULATORY COMMISSION [Docket No. PI2010-3; Order No. 456] Postal Rate Case Management AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is seeking comments relevant to management of an anticipated exigent postal rate case. It has scheduled a technical conference...

  13. Does perioperative ketamine have a role in the prevention of chronic postsurgical pain: the ROCKet trial.

    Science.gov (United States)

    Schug, Stephan A; Peyton, Philip

    2017-11-01

    Identifying operations and individuals with an increased risk of chronic postsurgical pain (CPSP) has led to significant interest in interventions with the potential to achieve primary prevention of this condition. Pharmacological prevention remains controversial with a Cochrane review identifying perioperative ketamine administration as the only intervention with possible benefit although, with only small, heterogeneous studies, the authors called for a large randomised controlled trial (RCT) to confirm the validity of this result. In response to these data, a group of researchers from Australia and Hong Kong designed the ROCKet trial - Reduction Of Chronic Post-surgical Pain with Ketamine, endorsed by the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network (CTN).

  14. The Midwest Exercise Trial for the Prevention of Weight Regain: MET POWeR

    Science.gov (United States)

    Donnelly, Joseph E.; Washburn, Richard A.; Sullivan, Debra K.; Honas, Jeffery J.; Mayo, Matthew S.; Goetz, Jeannine; Lee, Jaehoon; Szabo, Amanda N.

    2013-01-01

    Weight reduction in overweight and obese individual’s results in physiological and behavioral changes that make the prevention of weight regain more difficult than either initial weight loss or the prevention of weight gain. Exercise is recommended for the prevention of weight regain by both governmental agencies and professional organizations. To date, the effectiveness of exercise recommendations for the prevention of weight regain has not been evaluated in a properly designed, adequately powered trial. Therefore, we will conduct a randomized trial to evaluate the effectiveness of 3 levels of exercise on the prevention of weight regain, in initially overweight and obese sedentary men and women. Participants will complete a 3 month weight loss intervention of decreased energy intake (EI) and increased exercise (100 minutes/week). Participants achieving clinically significant weight loss (≥ 5% of initial weight), will then be randomly assigned to 12 months of verified exercise at 3 levels (150, 225 or 300 minutes/week). This study will evaluate: 1) the effectiveness of 3 levels of exercise on the prevention of weight regain over 12 months subsequent to clinically significant weight loss (≥ 5%); 2) gender differences in weight regain in response to 3 levels of exercise; and 3) potential compensatory changes in daily physical activity (PA) and EI on weight regain in response to 3 levels of exercise. Results of this investigation will provide information to develop evidenced based recommendations for the level of exercise associated with the prevention of weight regain. PMID:24012915

  15. Compliance with Sport Injury Prevention Interventions in Randomised Controlled Trials: A Systematic Review.

    Science.gov (United States)

    van Reijen, Miriam; Vriend, Ingrid; van Mechelen, Willem; Finch, Caroline F; Verhagen, Evert A

    2016-08-01

    Sport injury prevention studies vary in the way compliance with an intervention is defined, measured and adjusted for. The objective of this systematic review was to assess the extent to which sport injury prevention randomised controlled trials (RCTs) have defined, measured and adjusted results for compliance with an injury prevention intervention. An electronic search was performed in MEDLINE, PubMed, the Cochrane Center of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database) and SPORTDiscus. English RCTs, quasi-RCTs and cluster-RCTs were considered eligible. Trials that involved physically active individuals or examined the effects of an intervention aimed at the prevention of sport- or physical activity-related injuries were included. Of the total of 100 studies included, 71.6 % mentioned compliance or a related term, 68.8 % provided details on compliance measurement and 51.4 % provided compliance data. Only 19.3 % analysed the effect of compliance rates on study outcomes. While studies used heterogeneous methods, pooled effects could not be presented. Studies that account for compliance demonstrated that compliance significant affects study outcomes. The way compliance is dealt with in preventions studies is subject to a large degree of heterogeneity. Valid and reliable tools to measure and report compliance are needed and should be matched to a uniform definition of compliance.

  16. PREBIOUS trial: a multicenter randomized controlled trial of PREventive midline laparotomy closure with a BIOabsorbable mesh for the prevention of incisional hernia: rationale and design.

    Science.gov (United States)

    López-Cano, Manuel; Pereira, José A; Lozoya, Roberto; Feliu, Xavier; Villalobos, Rafael; Navarro, Salvador; Arbós, Maria Antonia; Armengol-Carrasco, Manuel

    2014-11-01

    Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect......Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...

  18. Prevention of Preterm Birth with Pessary in Singletons (PoPPS): a randomized controlled trial.

    Science.gov (United States)

    Dugoff, Lorraine; Berghella, Vincenzo; Sehdev, Harish; Mackeen, A Dhanya; Goetzl, Laura; Ludmir, Jack

    2017-09-20

    To determine if pessary use prevents preterm birth in singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth. In this open-label multicenter randomized trial we enrolled asymptomatic women with singleton gestations with a transvaginal ultrasound cervical length ≤ 25 mm at 18 0 -23 6 weeks and no prior spontaneous preterm birth. Subjects were randomized to receive the Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal fetal medicine staff.. Vaginal progesterone was recommended to women with a cervical length ≤20mm. The primary outcome was preterm birth preterm birth preterm birth preterm birth preterm birth in women with singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth in this small underpowered randomized controlled trial. This trial was registered on ClinicalTrials.gov, number NCT 02056652. This article is protected by copyright. All rights reserved.

  19. A systematic review of core implementation components in team ball sport injury prevention trials.

    Science.gov (United States)

    O'Brien, James; Finch, Caroline F

    2014-10-01

    Recently, the use of specific exercise programmes to prevent musculoskeletal injuries in team ball sports has gained considerable attention, and the results of large-scale, randomised controlled trials have supported their efficacy. To enhance the translation of these interventions into widespread use, research trials must be reported in a way that allows the players, staff and policymakers associated with sports teams to implement these interventions effectively. In particular, information is needed on core implementation components, which represent the essential and indispensable aspects of successful implementation. To assess the extent to which team ball sport injury prevention trial reports have reported the core implementation components of the intervention, the intervention target and the use of any delivery agents (ie, staff or other personnel delivering the intervention). To summarise which specific types of intervention, intervention target and delivery agents are reported. To develop consensus between reviewers on the reporting of these components. Six electronic databases were systematically searched for English-language, peer-reviewed papers on injury prevention exercise programme (IPEP) trials in team ball sports. The reporting of all eligible trials was assessed by two independent reviewers. The reporting of the three core implementation components were coded as 'yes', 'no' or 'unclear'. For cases coded as 'yes', the specific types of interventions, intervention targets and delivery agents were extracted and summarised. The search strategy identified 52 eligible trials. The intervention and the intervention target were reported in all 52 trials. The reporting of 25 trials (48%) specified the use of delivery agents, the reporting of three trials (6%) specified not using delivery agents, and in the reporting of the remaining 24 trials (46%) the use of delivery agents was unclear. The reported intervention type was an IPEP alone in 43 trials (83

  20. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial

    OpenAIRE

    Wing, Rena R; Tate, Deborah; Espeland, Mark; Gorin, Amy; LaRose, Jessica Gokee; Robichaud, Erica Ferguson; Erickson, Karen; Perdue, Letitia; Bahnson, Judy; Lewis, Cora E

    2013-01-01

    Background Weight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young a...

  1. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

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

  2. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

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

  3. Sharing the trousers: gender roles and relationships in an HIV-prevention trial in Zimbabwe.

    Science.gov (United States)

    Montgomery, Elizabeth T; Chidanyika, Agnes; Chipato, Tsungai; van der Straten, Ariane

    2012-01-01

    Male and female gender roles and inequalities are important in contributing to the disproportionate burden of HIV experienced by women in sub-Saharan Africa. Within the context of an HIV prevention trial, we aimed to describe and understand male partner influence on women's use of HIV-prevention methods. Our presumption was not that regressive gender norms prevailed - rather, that a wide range of gendered attitudes and dynamics would be expressed among couples. Data from 16 focus groups with Zimbabwean female trial participants and their male partners and 4 in-depth couples interviews were collected, and form the basis of the analysis. Findings offer descriptions of how couples have adapted techniques for negotiating modern household economies and sexual decision-making in a manner that both preserves traditional gender roles, while accommodating women's entrance into new domains such as the workforce or an HIV-prevention trial. Women's agency to introduce novel female-initiated-method use into her intimate relationships is described. Men and women's accounts of method introduction and use suggest different perceptions about the locus of sexual decision making. The study provides unique insight into a gendered context that is dynamic yet sensitive to change, which in turn can provide useful information to more appropriately guide HIV-prevention activities in this setting.

  4. 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.

  5. Nurse-led case management for ambulatory complex patients in general health care: A systematic review

    NARCIS (Netherlands)

    Latour-Delfgaauw, C.H.M.; van der Windt, D.A.W.M.; de Jonge, P.; Riphagen, II; Vos, R.; Huyse, F.J.; Stalman, W.A.B.

    2007-01-01

    Objective: The aim of this study was to summarize the available literature on the effectiveness of ambulatory nurse-led case management for complex patients in general health care. Method: We searched MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and Cinahl. We included randomized

  6. Combination implementation for HIV prevention: moving from clinical trial evidence to population-level effects.

    Science.gov (United States)

    Chang, Larry W; Serwadda, David; Quinn, Thomas C; Wawer, Maria J; Gray, Ronald H; Reynolds, Steven J

    2013-01-01

    The promise of combination HIV prevention-the application of multiple HIV prevention interventions to maximise population-level effects-has never been greater. However, to succeed in achieving significant reductions in HIV incidence, an additional concept needs to be considered: combination implementation. Combination implementation for HIV prevention is the pragmatic, localised application of evidence-based strategies to enable high sustained uptake and quality of interventions for prevention of HIV. In this Review, we explore diverse implementation strategies including HIV testing and counselling models, task shifting, linkage to and retention in care, antiretroviral therapy support, behaviour change, demand creation, and structural interventions, and discusses how they could be used to complement HIV prevention efforts such as medical male circumcision and treatment as prevention. HIV prevention and treatment have arrived at a pivotal moment when combination efforts might result in substantial enough population-level effects to reverse the epidemic and drive towards elimination of HIV. Only through careful consideration of how to implement and operationalise HIV prevention interventions will the HIV community be able to move from clinical trial evidence to population-level effects. Copyright © 2013 Elsevier Ltd. All rights reserved.

  7. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.

    Science.gov (United States)

    Greene, Nicholas D E; Leung, Kit-Yi; Gay, Victoria; Burren, Katie; Mills, Kevin; Chitty, Lyn S; Copp, Andrew J

    2016-03-28

    Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised.

  8. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

    Science.gov (United States)

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

    2011-10-10

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

  9. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... of the intervention (HR=0.69, 95% CI 0.40-1.19). The risk of a groin injury was reduced by 31%, but this reduction was not significant. A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk...

  10. Estimating effectiveness in HIV prevention trials with a Bayesian hierarchical compound Poisson frailty model

    Science.gov (United States)

    Coley, Rebecca Yates; Browna, Elizabeth R.

    2016-01-01

    Inconsistent results in recent HIV prevention trials of pre-exposure prophylactic interventions may be due to heterogeneity in risk among study participants. Intervention effectiveness is most commonly estimated with the Cox model, which compares event times between populations. When heterogeneity is present, this population-level measure underestimates intervention effectiveness for individuals who are at risk. We propose a likelihood-based Bayesian hierarchical model that estimates the individual-level effectiveness of candidate interventions by accounting for heterogeneity in risk with a compound Poisson-distributed frailty term. This model reflects the mechanisms of HIV risk and allows that some participants are not exposed to HIV and, therefore, have no risk of seroconversion during the study. We assess model performance via simulation and apply the model to data from an HIV prevention trial. PMID:26869051

  11. Long-term survival of participants in the prostate cancer prevention trial

    Directory of Open Access Journals (Sweden)

    Jonathan L Silberstein

    2014-06-01

    Full Text Available The Prostate Cancer Prevention Trial (PCPT is a seminal study in the field of urology. More than 10 years after its initial publication, updated data from this trial continue to shape our understanding of prostate cancer. Among the major findings from the PCPT has been the demonstration that prostate cancer is common in men with prostate-specific antigen (PSA once thought to be in the normal range, [1] finasteride prevents the development of benign prostatic hypertrophy, [2] it increases the sensitivity of PSA [3] and digital rectal examination. [4] Furthermore the PCPT helped to establish the link between erectile dysfunction and cardiovascular disease, [5] and perhaps most importantly finasteride demonstrated a 25% relative risk reduction in the diagnosis of prostate cancer compared with placebo. [6

  12. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  13. HIV-1 transmission linkage in an HIV-1 prevention clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Leitner, Thomas [Los Alamos National Laboratory; Campbell, Mary S [UNIV OF WASHINGTON; Mullins, James I [UNIV OF WASHINGTON; Hughes, James P [UNIV OF WASHINGTON; Wong, Kim G [UNIV OF WASHINGTON; Raugi, Dana N [UNIV OF WASHINGTON; Scrensen, Stefanie [UNIV OF WASHINGTON

    2009-01-01

    HIV-1 sequencing has been used extensively in epidemiologic and forensic studies to investigate patterns of HIV-1 transmission. However, the criteria for establishing genetic linkage between HIV-1 strains in HIV-1 prevention trials have not been formalized. The Partners in Prevention HSV/HIV Transmission Study (ClinicaITrials.gov NCT00194519) enrolled 3408 HIV-1 serodiscordant heterosexual African couples to determine the efficacy of genital herpes suppression with acyclovir in reducing HIV-1 transmission. The trial analysis required laboratory confirmation of HIV-1 linkage between enrolled partners in couples in which seroconversion occurred. Here we describe the process and results from HIV-1 sequencing studies used to perform transmission linkage determination in this clinical trial. Consensus Sanger sequencing of env (C2-V3-C3) and gag (p17-p24) genes was performed on plasma HIV-1 RNA from both partners within 3 months of seroconversion; env single molecule or pyrosequencing was also performed in some cases. For linkage, we required monophyletic clustering between HIV-1 sequences in the transmitting and seroconverting partners, and developed a Bayesian algorithm using genetic distances to evaluate the posterior probability of linkage of participants sequences. Adjudicators classified transmissions as linked, unlinked, or indeterminate. Among 151 seroconversion events, we found 108 (71.5%) linked, 40 (26.5%) unlinked, and 3 (2.0%) to have indeterminate transmissions. Nine (8.3%) were linked by consensus gag sequencing only and 8 (7.4%) required deep sequencing of env. In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner, illustrating the relevance of these methods in the design of future HIV-1 prevention trials in serodiscordant couples. A hierarchy of sequencing techniques, analysis methods, and expert adjudication contributed to the linkage

  14. Viral linkage in HIV-1 seroconverters and their partners in an HIV-1 prevention clinical trial.

    Directory of Open Access Journals (Sweden)

    Mary S Campbell

    2011-03-01

    Full Text Available Characterization of viruses in HIV-1 transmission pairs will help identify biological determinants of infectiousness and evaluate candidate interventions to reduce transmission. Although HIV-1 sequencing is frequently used to substantiate linkage between newly HIV-1 infected individuals and their sexual partners in epidemiologic and forensic studies, viral sequencing is seldom applied in HIV-1 prevention trials. The Partners in Prevention HSV/HIV Transmission Study (ClinicalTrials.gov #NCT00194519 was a prospective randomized placebo-controlled trial that enrolled serodiscordant heterosexual couples to determine the efficacy of genital herpes suppression in reducing HIV-1 transmission; as part of the study analysis, HIV-1 sequences were examined for genetic linkage between seroconverters and their enrolled partners.We obtained partial consensus HIV-1 env and gag sequences from blood plasma for 151 transmission pairs and performed deep sequencing of env in some cases. We analyzed sequences with phylogenetic techniques and developed a Bayesian algorithm to evaluate the probability of linkage. For linkage, we required monophyletic clustering between enrolled partners' sequences and a Bayesian posterior probability of ≥ 50%. Adjudicators classified each seroconversion, finding 108 (71.5% linked, 40 (26.5% unlinked, and 3 (2.0% indeterminate transmissions, with linkage determined by consensus env sequencing in 91 (84%. Male seroconverters had a higher frequency of unlinked transmissions than female seroconverters. The likelihood of transmission from the enrolled partner was related to time on study, with increasing numbers of unlinked transmissions occurring after longer observation periods. Finally, baseline viral load was found to be significantly higher among linked transmitters.In this first use of HIV-1 sequencing to establish endpoints in a large clinical trial, more than one-fourth of transmissions were unlinked to the enrolled partner

  15. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  16. Vitamin D for treatment and prevention of infectious diseases: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Yamshchikov, Alexandra V; Desai, Nirali S; Blumberg, Henry M; Ziegler, Thomas R; Tangpricha, Vin

    2009-01-01

    To review the existing human controlled intervention studies of vitamin D as adjunctive therapy in settings of infection and provide recommendations for design and implementation of future studies in this field on the basis of the evidence reviewed. We conducted a systematic review of randomized controlled clinical trials that studied vitamin D for treatment or prevention of infectious diseases in humans. Studies from 1948 through 2009 were identified through search terms in PubMed and Ovid MEDLINE. Thirteen published controlled trials were identified by our search criteria. Ten trials were placebo controlled, and 9 of the 10 were conducted in a rigorous double-blind design. The selected clinical trials demonstrated substantial heterogeneity in baseline patient demographics, sample size, and vitamin D intervention strategies. Serious adverse events attributable to vitamin D supplementation were rare across all studies. On the basis of studies reviewed to date, the strongest evidence supports further research into adjunctive vitamin D therapy for tuberculosis, influenza, and viral upper respiratory tract illnesses. In the selected studies, certain aspects of study design are highlighted to help guide future clinical research in the field. More rigorously designed clinical trials are needed for further evaluation of the relationship between vitamin D status and the immune response to infection as well as for delineation of necessary changes in clinical practice and medical care of patients with vitamin D deficiency in infectious disease settings.

  17. An effectiveness trial of a new enhanced dissonance eating disorder prevention program among female college students.

    Science.gov (United States)

    Stice, Eric; Butryn, Meghan L; Rohde, Paul; Shaw, Heather; Marti, C Nathan

    2013-12-01

    Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians. Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition. Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced health care utilization or unhealthy weight gain. This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

    Directory of Open Access Journals (Sweden)

    Hiscock Harriet

    2011-01-01

    Full Text Available Abstract Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500 with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively to compare outcomes

  19. Economic evaluation of community-based case management of patients suffering from chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Sørensen, Sabrina S; Pedersen, Kjeld Møller; Weinreich, Ulla M

    2017-01-01

    was the incremental cost-effectiveness ratio (ICER) as cost per quality-adjusted life year (QALY) from the perspective of the healthcare sector. Costs were valued in British Pounds (£) at price level 2016. Scenario analyses and probabilistic sensitivity analyses were conducted in order to assess uncertainty......Objectives: To analyse the cost effectiveness of community-based case management for patients suffering from chronic obstructive pulmonary disease (COPD). Methods: The study took place in the third largest municipality in Denmark and was conducted as a randomised controlled trial with 12 months...... of follow-up. A total of 150 patients with COPD were randomised into two groups receiving usual care and case management in addition to usual care. Case management included among other things self care proficiency, medicine compliance, and care coordination. Outcome measure for the analysis...

  20. Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial

    Directory of Open Access Journals (Sweden)

    Scheepers Hubertina CJ

    2007-06-01

    Full Text Available Abstract Background 15% of multiple pregnancies ends in a preterm delivery, which can lead to mortality and severe long term neonatal morbidity. At present, no generally accepted strategy for the prevention of preterm birth in multiple pregnancies exists. Prophylactic administration of 17-alpha hydroxyprogesterone caproate (17OHPC has proven to be effective in the prevention of preterm birth in women with singleton pregnancies with a previous preterm delivery. At present, there are no data on the effectiveness of progesterone in the prevention of preterm birth in multiple pregnancies. Methods/Design We aim to investigate the hypothesis that 17OHPC will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in multiple pregnancies. Women with a multiple pregnancy at a gestational age between 15 and 20 weeks of gestation will be entered in a placebo-controlled, double blinded randomised study comparing weekly 250 mg 17OHPC intramuscular injections from 16–20 weeks up to 36 weeks of gestation versus placebo. At study entry, cervical length will be measured. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity. Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 15% to 8%. Analysis will be by intention to treat. We will also analyse whether the treatment effect is dependent on cervical length. Discussion This trial will provide evidence as to whether or not 17OHPC-treatment is an effective means of preventing bad neonatal outcome due to preterm birth in multiple pregnancies. Trial registration Current Controlled Trials ISRCTN40512715

  1. Nefopam for the prevention of perioperative shivering: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lv, Meng; Wang, Xuetao; Qu, Wendong; Liu, Mengjie; Wang, Yuelan

    2015-06-09

    Shivering is a frequent complication following surgery and anaesthesia. A large variety of studies have been reported that nefopam may be efficacious for the prevention and treatment of perioperative shivering. Regrettably, there is still no conclusion of the efficacy and safety of nefopam for the prevention of perioperative shivering. The aim of this analysis is to evaluate the efficacy of nefopam for the prevention of perioperative shivering in patients undergoing different types of anaesthesia compared with placebo group and other active interventions. PubMed, EMBASE, Cochrane Central Register of Control Trials were systematically searched for potentially relevant trials. Trial quality and extracted data were evaluated by two authors independently. Dichotomous data on the absence of shivering was extracted and analysed by using relative risk (RR) with 95% confidence interval (CI). Continuous outcome was abstracted and analysed by using weighted mean difference (WMD) with 95% confidence interval (CI). Outcome data was analysed by using random effect model or fixed effect model in accordance with heterogeneity. Compared with placebo, prophylactic administration of nefopam significantly reduced the risk of perioperative shivering not only in the patients under general anaesthesia but also neuraxial anaesthesia (RR 0.08; 95% CI 0.05-0.13). As compared with clonidine, nefopam was more efficacious in the prevention of perioperative shivering (RR 0.34; 95% CI 0.17-0.70). Nefopam has no influence on the extubation time (WMD 0.92; 95% CI -0.15-1.99). Our analysis has demonstrated that nefopam is associated with the decrease of risk of perioperative shivering following anaesthesia without influencing the extubation time.

  2. Rationale for the prevention of syncope trial IV: assessment of midodrine.

    Science.gov (United States)

    Raj, Satish R; Faris, Peter D; McRae, Maureen; Sheldon, Robert S

    2012-12-01

    Vasovagal syncope is a common problem associated with a poor quality of life, which improves when the frequency of syncope is reduced. Effective pharmacological therapies for vasovagal syncope have been elusive. Midodrine is a pro-drug whose primary metabolite is an alpha-1 adrenoreceptor agonist. A few studies have suggested that it may be beneficial in syncope, but all have had significant methodological limitations. A placebo-controlled clinical trial of midodrine for the prevention of vasovagal syncope is needed. The prevention of syncope trial IV (POST 4) is a multicenter, international, randomized, placebo-controlled study of midodrine in the prevention of vasovagal syncope. The primary end point is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive midodrine 10-30 mg/day or matching placebo, and followed for 1 year. Secondary end points include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention-to-treat approach, with a secondary on-treatment analysis. A total sample size of 112, split equally between the two groups, achieves 85 % power to detect a 50 % relative risk reduction when the event rates are 55 and 27.5 % in the placebo and midodrine arms. Allowing for 20 % dropout, we propose to enroll 140 patients. POST 4 is registered with http://www.clinicaltrials.gov (NCT01456481). This study will be the first adequately powered trial to determine whether midodrine is effective in preventing vasovagal syncope. If it is effective, then midodrine may become the first-line pharmacological therapy for this condition.

  3. Rosuvastatin and the JUPITER trial: critical appraisal of a lifeless planet in the galaxy of primary prevention.

    Science.gov (United States)

    López, Antonio; Wright, James M

    2012-01-01

    In November 2008, the JUPITER trial was published in the New England Journal of Medicine. JUPITER is an acronym for Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. It was an AstraZeneca sponsored randomized double-blind trial comparing rosuvastatin 20 mg with placebo in 17,802 apparently healthy men and women with LDL cholesterol JUPITER trial have been widely publicized, and based on the trial, the main regulatory agencies have approved rosuvastatin for the indication of primary prevention of vascular events. However, the interpretation and clinical implications of the JUPITER trial have been questioned and remain controversial. The objective of this commentary is to evaluate the relevance, design, results, and conclusions of the JUPITER study.

  4. Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

    Science.gov (United States)

    Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

    2014-09-02

    Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months

  5. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-21

    In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

  6. Essentials of Advocacy in Case Management: Part 2: Client Advocacy Model and Case Manager's Advocacy Strategies and Competencies.

    Science.gov (United States)

    Tahan, Hussein M

    2016-01-01

    This article describes a client advocacy model for use by case managers. It delineates necessary competencies for the case manager and shares important strategies for effective client advocacy. All practice settings across the continuum of health and human services and case managers of diverse professional backgrounds. Advocacy is a primary role and necessary competency of professional case managers functioning in various care settings. It is rooted in ethical theory and principles. Successful case managers apply ethical principles of advocacy at every step of the case management process and in the decisions they make. Part II of this two-part article presents a client advocacy model for case managers to apply in their practice, describes the role of advocacy in client engagement, and identifies important strategies and a set of essential competencies for effective case management advocacy. Part I already explored the ethical theories and principles of advocacy, the perception of case management-related professional organizations of advocacy, and the common types of advocacy based on scope, complexity, impact, and reach. Acquiring foundational knowledge, skills, and competencies in what advocacy is and how to effectively enact its related behaviors is essential for success of case managers and for achieving desired outcomes for both the clients and health care agencies/providers alike. Case management leaders are urged to use the knowledge shared in this article to develop advocacy training and competency management programs for their case managers.

  7. Case managers' experiences of personal growth: learning from consumers.

    Science.gov (United States)

    Stein, Catherine H; Craft, Scott A

    2007-04-01

    This study examines aspects of case managers' perceived personal growth in their work with consumers. Using a sample of 98 case managers, the psychometric properties of a brief self-report measure of personal growth of case managers were examined. The Case Manager Personal Growth Scale (CMPG) showed good reliability and construct validity as evidenced by negative correlations with scores on professional burnout and positive correlations with personal accomplishment and job satisfaction scores. CMPG scores were unrelated to social desirability scores or caseload size and positively related to age and tenure in the mental health system. Results suggest the strong relevance of the construct of personal growth for case managers.

  8. Methodological Overview of an African American Couple-Based HIV/STD Prevention Trial

    Science.gov (United States)

    2010-01-01

    Objective To provide an overview of the NIMH Multisite HIV/STD Prevention Trial for African American Couples conducted in four urban areas: Atlanta, Los Angeles, New York, and Philadelphia. The rationale, study design methods, proposed data analyses, and study management are described. Design This is a two arm randomized Trial, implementing a modified randomized block design, to evaluate the efficacy of a couples based intervention designed for HIV serodiscordant African American couples. Methods The study phases consisted of formative work, pilot studies, and a randomized clinical trial. The sample is 535 HIV serodiscordant heterosexual African American couples. There are two theoretically derived behavioral interventions with eight group and individual sessions: the Eban HIV/STD Risk Reduction Intervention (treatment) versus the Eban Health Promotion Intervention (control). The treatment intervention was couples based and focused on HIV/STD risk reduction while the control was individual based and focused on health promotion. The two study conditions were structurally similar in length and types of activities. At baseline, participants completed an Audio Computer-assisted Self Interview (ACASI) interview as well as interviewer-administered questionnaire, and provided biological specimens to assess for STDs. Similar follow-up assessments were conducted immediately after the intervention, at 6 months, and at 12 months. Results The Trial results will be analyzed across the four sites by randomization assignment. Generalized estimating equations (GEE) and mixed effects modeling (MEM) are planned to test: (1) the effects of the intervention on STD incidence and condom use as well as on mediator variables of these outcomes, and (2) whether the effects of the intervention differ depending on key moderator variables (e.g., gender of the HIV-seropositive partners, length of relationship, psychological distress, sexual abuse history, and substance abuse history

  9. Interim data monitoring to enroll higher-risk participants in HIV prevention trials

    Directory of Open Access Journals (Sweden)

    Umo-Otong John

    2009-06-01

    Full Text Available Abstract Background Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. Methods We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. Results A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. Conclusion Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. Trial Registration The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770

  10. Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

    Science.gov (United States)

    Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

    2015-01-01

    Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

  11. An Effectiveness Trial of a Dissonance-Based Eating Disorder Prevention Program for High-Risk Adolescent Girls

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff; Shaw, Heather

    2009-01-01

    Efficacy trials indicate that an eating disorder prevention program involving dissonance-inducing activities that decrease thin-ideal internalization reduces risk for current and future eating pathology, yet it is unclear whether this program produces effects under real-world conditions. The present effectiveness trial tested whether this program…

  12. Leadership development and succession planning in case management.

    Science.gov (United States)

    Miodonski, Kathleen; Hines, Patricia

    2013-01-01

    The director of case management is one of health care's leadership positions most frequently in demand. The lack of qualified and effective case management leaders will continue to be an issue for organizations for years to come, influenced by increasing pressures on health care reimbursement and the aging case management workforce. Organizations have an opportunity to create a program to develop future case management leaders from their internal talent. The proposed strategies are designed for the acute care hospital but also have applicability in other health care settings where there are case managers and a need for case management leadership. The business community offers leadership research and leadership development models with relevance to case management. Identifying and developing internal talent for leadership roles has been proven to be effective in preparation for advanced responsibilities, has a positive effect on staff morale, and minimizes the impact of vacant leadership positions during recruitment and onboarding activities. Creating a case management leadership development program for an organization can be an alternative to the process of external recruitment for case management department leaders. Such a program can be undertaken even in today's budget conscious environment by accessing existing resources in an organization in a creative and organized manner. The authors outline an approach for case management leaders to accept responsibility for succession planning and for case managers to accept responsibility for promoting their own career development through creation of a leadership development program.

  13. A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

    Directory of Open Access Journals (Sweden)

    Suzuki Yuriko

    2008-09-01

    Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

  14. Exercise program for prevention of groin pain in football players: a cluster-randomized trial.

    Science.gov (United States)

    Hölmich, P; Larsen, K; Krogsgaard, K; Gluud, C

    2010-12-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect of the intervention (HR=0.69, 95% CI 0.40-1.19). The risk of a groin injury was reduced by 31%, but this reduction was not significant. A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk of developing a groin injury. © 2009 John Wiley & Sons A/S.

  15. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  16. A conceptual framework and ethics analysis for prevention trials of Alzheimer Disease.

    Science.gov (United States)

    Peters, Kevin R; Lynn Beattie, B; Feldman, Howard H; Illes, Judy

    2013-11-01

    As our understanding of the neurobiology of Alzheimer Disease deepens, it has become evident that early intervention is critical to achieving successful therapeutic impact. The availability of diagnostic criteria for preclinical Alzheimer Disease adds momentum to research directed at this goal and even to prevention. The landscape of therapeutic research is thus poised to undergo a dramatic shift in the next 5-10 years, with clinical trials involving subjects at risk for Alzheimer Disease who have few or no symptoms. These trials will also likely rely heavily on genetics, biomarkers, and or risk factor stratification to identify individuals at risk for Alzheimer Disease. Here, we propose a conceptual framework to guide this next generation of pharmacological and non-pharmacological clinical pursuit, and discuss some of the foreseeable ethical considerations that may accompany them. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Characterization of Black Raspberry Functional Food Products for Cancer Prevention Human Clinical Trials

    Science.gov (United States)

    Gu, Junnan; Ahn-Jarvis, Jennifer H.; Riedl, Kenneth M.; Schwartz, Steven J.; Clinton, Steven K.; Vodovotz, Yael

    2014-01-01

    Our team is designing and fully characterizing black raspberry (BRB) food products suitable for long-term cancer prevention studies. The processing, scale-up, and storage effects on the consistency, quality, bioactive stability, and sensory acceptability of two BRB delivery systems of various matrices are presented. BRB dosage, pH, water activity, and texture were consistent in the scale-up production. Confections retained >90% of anthocyanins and ellagitannin after processing. Nectars had >69% of anthocyanins and >66% of ellagitannin retention, which varied with BRB dosage due to the processing difference. Texture remained unchanged during storage. BRB products consumed in a prostate cancer clinical trial were well accepted in sensory tests. Thus, this study demonstrates that two different BRB foods can be formulated to meet quality standards with a consistent bioactive pattern and successfully scaled up for a large human clinical trial focusing on cancer risk and other health outcomes. PMID:24345009

  18. Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial.

    Science.gov (United States)

    Akello, Carolyne A; Bunge, Katherine E; Nakabiito, Clemensia; Mirembe, Brenda G; Fowler, Mary Glenn; Mishra, Anupam; Marrazzo, Jeanne; Chirenje, Zvavahera M; Celum, Connie; Balkus, Jennifer E

    2017-06-01

    Recent HIV prevention trials required use of effective contraceptive methods to fulfill eligibility for enrollment. We compared pregnancy rates in a subset of participants enrolled in the Microbicide Trials Network protocol (MTN-003), a randomized trial of chemoprophylaxis to prevent HIV acquisition among women aged 18-45 years who initiated depot medroxyprogesterone acetate (DMPA) or combined oral contraceptives (COCs) at enrollment, relative to those already using DMPA or COCs. Data were analyzed from MTN-003 participants from Uganda. Before enrollment, information on contraceptive type and initiation date was obtained. Urine pregnancy tests were performed at monthly follow-up visits. Cox proportional hazards models were used to compare pregnancy incidence among new users (initiated ≤60 days before enrollment) and established users (initiated >60 days before enrollment). Of 322 women enrolled, 296 were COC or DMPA users, 82 (28%) were new users, and 214 (72%) were established users. Pregnancy incidence was higher among new contraceptive users compared to established users (20.70% vs. 10.55%; adjusted hazard ratio [HR] = 1.66; 95% confidence interval [95% CI] 0.93-2.96). Among DMPA users, pregnancy incidence was 10.20% in new users versus 3.48% in established users (HR = 2.56; 95% CI 0.86-7.65). Among new COC users, pregnancy incidence was 42.67% in new users versus 23.67% in established COC users (adjusted HR = 1.74; 95% CI 0.87-3.48). New contraceptive users, regardless of method, at the Uganda MTN-003 site had an increased pregnancy risk compared to established users, which may be due to contraceptive initiation primarily for trial eligibility. New users may benefit from intensive contraceptive counseling and additional contraceptive options, including longer acting reversible contraceptives.

  19. A worksite prevention program for construction workers: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Proper Karin I

    2010-06-01

    Full Text Available Abstract Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1 two individual training sessions of a physical therapist to lower the physical workload, (2 a Rest-Break tool to improve the balance between work and recovery, and (3 two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278

  20. Prevention of acute mountain sickness by acetazolamide in Nepali porters: a double-blind controlled trial.

    Science.gov (United States)

    Hillenbrand, Peter; Pahari, Anil K; Soon, Yuen; Subedi, Deepak; Bajracharya, Rajan; Gurung, Puncho; Lal, Barun K; Marahatta, Ramesh; Pradhan, Santosh; Rai, Dilip; Sharma, Shailendra

    2006-01-01

    This study aimed to determine the efficacy, tolerability, and practicality of acetazolamide for the prevention of acute mountain sickness (AMS) in Nepali trekking porters early in the trekking season. This study was a randomized, double-blind controlled trial with 400 male Nepali porters in the Mount Everest region of Nepal, trekking from Namche Bazaar (3440 m) to Lobuche (4930 m), the study endpoint. Participants were randomized to receive 250 mg acetazolamide daily or placebo, and AMS symptom scores (Lake Louise) were compared in highlanders vs lowlanders. Only 109 (27.2%) of the 400 porters completed the trial (28 highlanders, 81 lowlanders). The rest either dropped out (275/400 porters, 68.8%) or were excluded (16/400 porters, 4%). Acute mountain sickness occurred in 13 (11.9%) of 109 porters; all were lowlanders; 7 were taking acetazolamide, 6 taking placebo. Birthplace, acclimatization in the week before the trial, ascent rate, and rest days were the most important variables affecting the incidence of AMS. No highlanders, but 13 (16.1%) of 81 lowlanders had AMS (P = .016). Acclimatization in the pretrial week reduced AMS incidence (P = .013), as did a slower ascent rate (P = .0126), but rest days were the most potent prophylactic variable (P = .0001). Side effects were more frequent in porters taking acetazolamide than in the placebo group (P = .0001), but there were no serious side effects. Acetazolamide was tolerable, but impractical for the routine prevention of AMS in Nepali porters. A good trekking schedule and adequate acclimatization remain the most effective preventive measures. This study identified lowland porters as a high-risk group for developing AMS.

  1. Cognitive Behavioural Suicide Prevention for Male Prisoners: A pilot randomised controlled trial

    Science.gov (United States)

    Pratt, D.; Tarrier, N.; Dunn, G.; Awenat, Y.; Shaw, J.; Ulph, F.; Gooding, P.

    2015-01-01

    Background Prisoners have an exceptional risk of suicide. Cognitive behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualised cognitive behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. Methods A pilot randomised controlled trial of CBSP in addition to treatment as usual (CBSP; n=31) compared to treatment as usual alone (TAU; n=31), was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past six months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Results Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect (Cohen’s d=−0.72, 95%CI: −1.71 to 0.09; baseline mean [SD], TAU: 1.39[3.28] vs CBSP: 1.06[2.10], 6 months mean [SD], TAU: 1.48[3.23] vs CBSP: 0.58[1.52]). Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared to a quarter of the TAU group. Conclusions The delivery and evaluation of cognitive behavioural suicide prevention therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomised controlled trial is warranted. PMID:26165919

  2. The design and development of a complex multifactorial falls assessment intervention for falls prevention: The Prevention of Falls Injury Trial (PreFIT).

    Science.gov (United States)

    Bruce, Julie; Ralhan, Shvaita; Sheridan, Ray; Westacott, Katharine; Withers, Emma; Finnegan, Susanne; Davison, John; Martin, Finbarr C; Lamb, Sarah E

    2017-06-01

    This paper describes the design and development of a complex multifactorial falls prevention (MFFP) intervention for implementation and testing within the framework of a large UK-based falls prevention randomised controlled trial (RCT). A complex intervention was developed for inclusion within the Prevention of Falls Injury Trial (PreFIT), a multicentre pragmatic RCT. PreFIT aims to compare the clinical and cost-effectiveness of three alternative primary care falls prevention interventions (advice, exercise and MFFP), on outcomes of fractures and falls. Community-dwelling adults, aged 70 years and older, were recruited from primary care in the National Health Service (NHS), England. Development of the PreFIT MFFP intervention was informed by the existing evidence base and clinical guidelines for the assessment and management of falls in older adults. After piloting and modification, the final MFFP intervention includes seven falls risk factors: a detailed falls history interview with consideration of 'red flags'; assessment of balance and gait; vision; medication screen; cardiac screen; feet and footwear screen and home environment assessment. This complex intervention has been fully manualised with clear, documented assessment and treatment pathways for each risk factor. Each risk factor is assessed in every trial participant referred for MFFP. Referral for assessment is based upon a screening survey to identify those with a history of falling or balance problems. Intervention delivery can be adapted to the local setting. This complex falls prevention intervention is currently being tested within the framework of a large clinical trial. This paper adheres to TIDieR and CONSORT recommendations for the comprehensive and explicit reporting of trial interventions. Results from the PreFIT study will be published in due course. The effectiveness and cost-effectiveness of the PreFIT MFFP intervention, compared to advice and exercise, on the prevention of falls and

  3. Transformational leadership: the development of a model of nursing case management by the army nurse corps.

    Science.gov (United States)

    Hocker, Susan M; Trofino, Joan

    2003-01-01

    Management philosophy and culture of any organization must match the nursing professions' core value of caring. Organizational conflict symptomology includes communication barriers and widely differing values. Employment of accountability based systems and bringing nurses into governance prevents conflict and improves job satisfaction. This article identifies the barriers to case management program development and discusses strategies for its successful implementation. Today's most successful organizations will implement an institution-wide commitment to a culture within which excellence flourishes. Creative staffing models and professional practice partnerships such as nursing case management will be supported and encouraged by executive leadership; they work as a team and will be jointly accountable for positive outcomes The United States Army Nurse Corps has the framework necessary to develop a premiere nursing organization. Case management departments may adopt these techniques to improve working relationships and leadership capacity within their organizations.

  4. Analyzing Proportion Scores as Outcomes for Prevention Trials: A Statistical Primer

    Science.gov (United States)

    Chen, Kehui; Cheng, Yu; Berkout, Olga; Lindhiem, Oliver

    2018-01-01

    In prevention trials, outcomes of interest frequently include data that are best quantified as proportion scores. In some cases, however, proportion scores may violate the statistical assumptions underlying common analytic methods. In this paper, we provide guidelines for analyzing frequency and proportion data as primary outcomes. We describe standard methods including generalized linear regression models to compare mean proportion scores, and examine tools for testing normality and other assumptions for each model. Recommendations are made for instances when the assumptions are not met, including transformations for proportions scores that are non-normal. We also discuss more sophisticated analytical tools to model change in proportion scores over time. The guidelines provide ready-to-use analytical strategies for frequency and proportion data that are commonly encountered in prevention science. PMID:26960687

  5. Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

    Science.gov (United States)

    Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

    2014-06-01

    Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

  6. Clinical Trial Design for Testing the Stem Cell Model for the Prevention and Treatment of Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Reddy, Rishindra M., E-mail: reddyrm@med.umich.edu [Medical Center, University of Michigan, 1500 E. Medical Center Drive, 2120 Taubman Center, Ann Arbor, MI 48109 (United States); Kakarala, Madhuri; Wicha, Max S. [Comprehensive Cancer Center, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109 (United States)

    2011-06-20

    The cancer stem cell model introduces new strategies for the prevention and treatment of cancers. In cancers that appear to follow the stem cell model, pathways such as Wnt, Notch and Hedgehog may be targeted with natural compounds such as curcumin or drugs to reduce the risk of initiation of new tumors. Disease progression of established tumors could also potentially be inhibited by targeting the tumorigenic stem cells alone, rather than aiming to reduce overall tumor size. These new approaches mandate a change in the design of clinical trials and biomarkers chosen for efficacy assessment for preventative, neoadjuvant, adjuvant, and palliative treatments. Cancer treatments could be evaluated by assessing stem cell markers before and after treatment. Targeted stem cell specific treatment of cancers may not result in “complete” or “partial” responses radiologically, as stem cell targeting may not reduce the tumor bulk, but eliminate further tumorigenic potential. These changes are discussed using breast, pancreatic, and lung cancer as examples.

  7. Psychosocial Predictors of Physical Activity Change Among College Students in an Obesity Prevention Trial.

    Science.gov (United States)

    Arigo, Danielle; Rohde, Paul; Shaw, Heather; Stice, Eric

    2017-07-01

    Moderate-to-vigorous physical activity (MVPA) is critical for maintaining a healthy weight, although little is known about psychological barriers to maintaining MVPA in at-risk groups. Identifying characteristics associated with poor MVPA maintenance in obesity prevention programs could improve participant outcomes. Toward this end, we examined predictors of MVPA in an obesity prevention trial for college students at risk for weight gain (n = 333; 72% female, mean BMI = 23.4 kg/m 2 ). Participants engaged in 1 of 3 weight control interventions and in 4 assessments over 12-month follow-up (ie, measured height/weight, self-reports of psychosocial characteristics, 4 days of accelerometer wear). Multilevel modeling analyses showed that across conditions, participants decreased total MVPA minutes per week over 12 months (B = -5.48, P students who show elevated impulsiveness and cognitive dissonance may improve both MVPA and weight control outcomes for these individuals.

  8. Racial preferences for participation in a depression prevention trial involving problem-solving therapy.

    Science.gov (United States)

    Kasckow, John; Brown, Charlotte; Morse, Jennifer Q; Karpov, Irina; Bensasi, Salem; Thomas, Stephen B; Ford, Angela; Reynolds, Charles

    2010-07-01

    This study compared African Americans' and Caucasians' willingness to participate in an indicated intervention to prevent depression with problem-solving therapy. It also examined participants' problem-solving skills. Hypotheses stated that there would be no racial differences in consent rates and that social problem-solving coping skills would be lower among African Americans than Caucasians. Proportions of African Americans and Caucasians who consented were compared, as were Social Problem Solving Inventory scores between the groups. Of 2,788 individuals approached, 82 (4%) of 1,970 Caucasians and 46 (6%) of 818 African Americans signed consent, and the difference was not significant (p=.09). Racial differences were observed in neither Social Problem Solving Inventory scores nor in the relationship between problem-solving skills and depressive symptoms. African Americans with depression demonstrated a willingness to participate in an indicated trial of depression prevention. Furthermore, both groups would appear to benefit from the problem-solving process.

  9. The Prevention of Gestational Diabetes Mellitus With Antenatal Oral Inositol Supplementation: A Randomized Controlled Trial.

    Science.gov (United States)

    Farren, Maria; Daly, Niamh; McKeating, Aoife; Kinsley, Brendan; Turner, Michael J; Daly, Sean

    2017-06-01

    This study investigated if inositol in a combination of myo -inositol and D -chiro-inositol would prevent gestational diabetes mellitus (GDM) in women with a family history of diabetes. This was a randomized controlled trial that examined whether inositol from the first antenatal visit prevents GDM. The trial was carried out in a single-center tertiary referral center. Women with a family history of diabetes were enrolled at the first antenatal visit. They were randomized to the intervention group, which received a combination of 1,100 mg myo -inositol, 27.6 mg D -chiro-inositol, and 400 μg folic acid, or to the control group, which received 400 μg folic acid only. All women had an oral glucose tolerance test between 24 and 28 weeks' gestation. The primary end point was the incidence of GDM. Statistical analysis was carried out using SPSS Statistical Package version 20. Two hundred forty women, 120 in each arm, were recruited between January 2014 and July 2015. There were no differences in characteristics between the groups. The incidence of GDM was 23.3% ( n = 28) in the intervention group compared with 18.3% ( n = 22) in the control group ( P = 0.34). The mean fasting plasma glucose at the glucose tolerance test was 81 mg/dL in both groups. Commencing an inositol combination in early pregnancy did not prevent GDM in women with a family history of diabetes. Further studies are required to examine whether inositol supplements at varying doses may prevent GDM. © 2017 by the American Diabetes Association.

  10. Mixing nulliparous and multiparous women in randomised controlled trials of preeclampsia prevention is debatable: evidence from a systematic review.

    Science.gov (United States)

    Simon, Emmanuel; Caille, Agnès; Perrotin, Franck; Giraudeau, Bruno

    2013-01-01

    Nulliparity is a major risk factor of preeclampsia investigated in numerous trials of its prevention. We aimed to assess whether these trials considered nulliparity in subject selection or analysis of results. 01 April 2013 search of MEDLINE via PubMed, EMBASE and the Cochrane Library. 01 April 2013 search of trials registered in Clinicaltrials.gov. Randomised controlled trials and metaanalyses of preeclampsia prevention with no restriction to period of publication or language. Metaanalyses were selected to fully identify relevant trials. One reader appraised each selected article/registered protocol using a pretested, standardized data abstraction form developed in a pilot test. For each article, he recorded whether both nulliparous and multiparous were included and, in case of mixed populations, whether randomisation was stratified, and whether subgroup analyses had been reported. For registered protocols, he only assessed whether it was planned to include mixed populations. 88 randomised controlled trials were identified, representing 83,396 included women. In 58 of the 88 articles identified (65.9%), preeclampsia was the primary outcome. In 31 of these (53.4%), the investigation combined nulliparous and multiparous women; only two reports in 31 (6.5%) stated that randomisation was stratified on parity and only four (12.9%) described a subgroup analysis by parity. Of the 30 registered trials, 20 (66.6%) planned to include both nulliparous and multiparous women. Parity is largely ignored in randomised controlled trials of preeclampsia prevention, which raises difficulties in interpreting the results.

  11. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane.

    Science.gov (United States)

    Ivanic, Gerd M; Pink, Peter T; Schneider, Frank; Stuecker, Markus; Homann, Nicolaus C; Preidler, Klaus W

    2006-09-01

    A randomized clinical trial compared two materials used to prevent epidural scarring after microdiscectomy. To determine whether ADCON-L Gel (ALG) or Preclude Spinal Membrane (PSM) was more effective in preventing scarring, reducing pain, and improving quality of life postoperatively. Postdiscectomy syndrome may result from epidural scarring. Various materials have been used in attempts to prevent this problem, but none have provided optimal results. Previous laboratory and clinical studies have found ALG and PSM to be effective, but none compared the two materials. Thirty-one patients undergoing primary microdiscectomy were randomly assigned to receive either ALG or PSM. Postoperatively, patients were evaluated by magnetic resonance imaging (MRI), with contrast, for volume and rostral-caudal extent of scar tissue and nerve root involvement. Back and leg pain and quality of life were assessed by neurologic examinations and standardized patient surveys. Findings at any reoperations were recorded. Results in the PSM (n = 18) and ALG (n = 13) groups were compared statistically. No operative or postoperative complications occurred. Two patients in each group required reoperation. MRI at 6 months showed no, mild or mild-moderate scarring in most patients, with no significant differences between the ALG and PSM groups in scar volume and extent or nerve root involvement. Neurologic examinations and patient surveys showed substantial reductions in pain over time in both groups but no significant differences between groups. PSM was easy to see and remove at reoperation. PSM and ALG are equally effective in preventing epidural scarring associated with postdiscectomy syndrome.

  12. Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial.

    Science.gov (United States)

    Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M

    2015-07-01

    We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.

  13. Involvement of Fathers in Pediatric Obesity Treatment and Prevention Trials: A Systematic Review.

    Science.gov (United States)

    Morgan, Philip J; Young, Myles D; Lloyd, Adam B; Wang, Monica L; Eather, Narelle; Miller, Andrew; Murtagh, Elaine M; Barnes, Alyce T; Pagoto, Sherry L

    2017-02-01

    Despite their important influence on child health, it is assumed that fathers are less likely than mothers to participate in pediatric obesity treatment and prevention research. This review investigated the involvement of fathers in obesity treatment and prevention programs targeting children and adolescents (0-18 years). A systematic review of English, peer-reviewed articles across 7 databases. Retrieved records included at least 1 search term from 2 groups: "participants" (eg, child*, parent*) and "outcomes": (eg, obes*, diet*). Randomized controlled trials (RCTs) assessing behavioral interventions to prevent or treat obesity in pediatric samples were eligible. Parents must have "actively participated" in the study. Two authors independently extracted data using a predefined template. The search retrieved 213 eligible RCTs. Of the RCTs that limited participation to 1 parent only (n = 80), fathers represented only 6% of parents. In RCTs in which participation was open to both parents (n = 133), 92% did not report objective data on father involvement. No study characteristics moderated the level of father involvement, with fathers underrepresented across all study types. Only 4 studies (2%) suggested that a lack of fathers was a possible limitation. Two studies (1%) reported explicit attempts to increase father involvement. The review was limited to RCTs published in English peer-reviewed journals over a 10-year period. Existing pediatric obesity treatment or prevention programs with parent involvement have not engaged fathers. Innovative strategies are needed to make participation more accessible and engaging for fathers. Copyright © 2017 by the American Academy of Pediatrics.

  14. Preventing Obesity in the Military Community (POMC): The Development of a Clinical Trials Research Network

    Science.gov (United States)

    Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.

    2015-01-01

    Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176

  15. Preventing Obesity in the Military Community (POMC: The Development of a Clinical Trials Research Network

    Directory of Open Access Journals (Sweden)

    Elena A. Spieker

    2015-01-01

    Full Text Available Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC is a comprehensive research program within Patient Centered Medical Homes (PCMHs in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1 pregnancy and early infancy (POMC-Mother-Baby, (2 adolescence (POMC-Adolescent, and (3 the first tour of duty after boot camp (POMC-Early Career. Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities.

  16. A computerized harm minimization prevention program for alcohol misuse and related harms: randomized controlled trial.

    Science.gov (United States)

    Vogl, Laura; Teesson, Maree; Andrews, Gavin; Bird, Kevin; Steadman, Bronwyn; Dillon, Paul

    2009-04-01

    Hazardous alcohol use is a leading cause of death among adolescents and young adults world-wide, yet few effective prevention interventions exist. This study was the first to examine a computerized harm minimization intervention to reduce alcohol misuse and related harms in adolescents. Cluster randomized controlled trial of a six-session curriculum-integrated harm minimization prevention program. The intervention was delivered by computer in the form of a teenage drama, which provided education through alcohol-related scenarios to which young people could relate. Schools in Australia. A total of 1466 year 8 students (13 years) from 16 high schools in Australia were allocated randomly to a computerized prevention program (n = 611, eight schools) or usual classes (n = 855, eight schools). Change in knowledge, alcohol use, alcohol-related harms and alcohol expectancies. A computerized prevention program was more effective than usual classes in increasing alcohol-related knowledge of facts that would inform safer drinking choices and decreasing the positive social expectations which students believed alcohol may afford. For females it was effective in decreasing average alcohol consumption, alcohol-related harms and the frequency of drinking to excess (more than four standard drinks; 10 g ethanol). For males the behavioural effects were not significant. A harm minimization approach is effective in educating young people about alcohol-related risks and is effective in reducing risky drinking and harms among girls. Reduction of problems among boys remains a challenge.

  17. Randomised controlled trial of prevention of falls in people aged ≥75 with severe visual impairment: the VIP trial

    Science.gov (United States)

    Campbell, A John; Robertson, M Clare; La Grow, Steven J; Kerse, Ngaire M; Sanderson, Gordon F; Jacobs, Robert J; Sharp, Dianne M; Hale, Leigh A

    2005-01-01

    Objectives To assess the efficacy and cost effectiveness of a home safety programme and a home exercise programme to reduce falls and injuries in older people with low vision. Design Randomised controlled trial. Setting Dunedin and Auckland, New Zealand. Participants 391 women and men aged ≥75 with visual acuity of 6/24 or worse who were living in the community; 92% (361 of 391) completed one year of follow-up. Interventions Participants received a home safety assessment and modification programme delivered by an occupational therapist (n = 100), an exercise programme prescribed at home by a physiotherapist plus vitamin D supplementation (n = 97), both interventions (n = 98), or social visits (n = 96). Main outcome measures Numbers of falls and injuries resulting from falls, costs of implementing the home safety programme. Results Fewer falls occurred in the group randomised to the home safety programme but not in the exercise programme (incidence rate ratios 0.59 (95% confidence interval 0.42 to 0.83) and 1.15 (0.82 to 1.61), respectively). However, within the exercise programme, stricter adherence was associated with fewer falls (P = 0.001). A conservative analysis showed neither intervention was effective in reducing injuries from falls. Delivering the home safety programme cost $NZ650 (£234, 344 euros, $US432) (at 2004 prices) per fall prevented. Conclusion The home safety programme reduced falls and was more cost effective than an exercise programme in this group of elderly people with poor vision. The Otago exercise programme with vitamin D supplementation was not effective in reducing falls or injuries in this group, possibly due to low levels of adherence. Trial registration number ISRCTN15342873. PMID:16183652

  18. Randomised controlled trial of prevention of falls in people aged > or =75 with severe visual impairment: the VIP trial.

    Science.gov (United States)

    Campbell, A John; Robertson, M Clare; La Grow, Steven J; Kerse, Ngaire M; Sanderson, Gordon F; Jacobs, Robert J; Sharp, Dianne M; Hale, Leigh A

    2005-10-08

    To assess the efficacy and cost effectiveness of a home safety programme and a home exercise programme to reduce falls and injuries in older people with low vision. Randomised controlled trial. Dunedin and Auckland, New Zealand. 391 women and men aged > or =75 with visual acuity of 6/24 or worse who were living in the community; 92% (361 of 391) completed one year of follow-up. Participants received a home safety assessment and modification programme delivered by an occupational therapist (n = 100), an exercise programme prescribed at home by a physiotherapist plus vitamin D supplementation (n = 97), both interventions (n = 98), or social visits (n = 96). Numbers of falls and injuries resulting from falls, costs of implementing the home safety programme. Fewer falls occurred in the group randomised to the home safety programme but not in the exercise programme (incidence rate ratios 0.59 (95% confidence interval 0.42 to 0.83) and 1.15 (0.82 to 1.61), respectively). However, within the exercise programme, stricter adherence was associated with fewer falls (P = 0.001). A conservative analysis showed neither intervention was effective in reducing injuries from falls. Delivering the home safety programme cost NZ650 dollars (234 pounds sterling, 344 euros, US432 dollars) (at 2004 prices) per fall prevented. The home safety programme reduced falls and was more cost effective than an exercise programme in this group of elderly people with poor vision. The Otago exercise programme with vitamin D supplementation was not effective in reducing falls or injuries in this group, possibly due to low levels of adherence. Trial registration number ISRCTN15342873.

  19. Seasonal intermittent preventive treatment for the prevention of anaemia and malaria in Ghanaian children: a randomized, placebo controlled trial.

    Directory of Open Access Journals (Sweden)

    Margaret Kweku

    Full Text Available Malaria and anaemia are the leading causes of morbidity and mortality in children in sub-Saharan Africa. We have investigated the effect of intermittent preventive treatment with sulphadoxine-pyrimethamine or artesunate plus amodiaquine on anaemia and malaria in children in an area of intense, prolonged, seasonal malaria transmission in Ghana.2451 children aged 3-59 months from 30 villages were individually randomised to receive placebo or artesunate plus amodiaquine (AS+AQ monthly or bimonthly, or sulphadoxine-pyrimethamine (SP bimonthly over a period of six months. The primary outcome measures were episodes of anaemia (Hb1 year old when they received IPTc compared to the placebo group. However the incidence of malaria in the post intervention period was higher in children who were <1 year old when they received AS+AQ monthly compared to the placebo group.IPTc is safe and efficacious in reducing the burden of malaria in an area of Ghana with a prolonged, intense malaria transmission season.ClinicalTrials.gov NCT00119132.

  20. Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

    Science.gov (United States)

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

    2013-01-01

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

  1. Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: postintervention results.

    Science.gov (United States)

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

    2011-05-01

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

  2. Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.

    Science.gov (United States)

    Deem, Steven; Yanez, David; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam

    2016-01-01

    Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP. A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP

  3. Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.

    Science.gov (United States)

    Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J

    2014-06-16

    To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies

  4. Developing dementia prevention trials: baseline report of the Home-Based Assessment study.

    Science.gov (United States)

    Sano, Mary; Egelko, Susan; Donohue, Michael; Ferris, Steven; Kaye, Jeffrey; Hayes, Tamara L; Mundt, James C; Sun, Chung-Kai; Paparello, Silvia; Aisen, Paul S

    2013-01-01

    This report describes the baseline experience of the multicenter, Home-Based Assessment study, designed to develop methods for dementia prevention trials using novel technologies for test administration and data collection. Nondemented individuals of 75 years of age or more were recruited and evaluated in-person using established clinical trial outcomes of cognition and function, and randomized to one of 3 assessment methodologies: (1) mail-in questionnaire/live telephone interviews [mail-in/phone (MIP)]; (2) automated telephone with interactive voice recognition; and (3) internet-based computer Kiosk. Brief versions of cognitive and noncognitive outcomes were adapted to each methodology and administered at baseline and repeatedly over a 4-year period. "Efficiency" measures assessed the time from screening to baseline, and staff time required for each methodology. A total of 713 individuals signed consent and were screened; 640 met eligibility and were randomized to one of 3 assessment arms; and 581 completed baseline. Dropout, time from screening to baseline, and total staff time were highest among those assigned to internet-based computer Kiosk. However, efficiency measures were driven by nonrecurring start-up activities suggesting that differences may be mitigated over a long trial. Performance among Home-Based Assessment instruments collected through different technologies will be compared with established outcomes over this 4-year study.

  5. Facebook Advertising to Recruit Young, Urban Women into an HIV Prevention Clinical Trial.

    Science.gov (United States)

    Jones, Rachel; Lacroix, Lorraine J; Porcher, Eloni

    2017-11-01

    Advertising via Facebook to elicit involvement in clinical trials has demonstrated promise in expanding geographic reach while maintaining confidentiality. The purpose of this study is to evaluate Facebook advertising to reach at-risk, predominately African American or Black women in higher HIV prevalence communities for an HIV prevention clinical trial, and to compare baseline characteristics to those recruited on-the-ground. Maintaining confidentiality and the practical aspects of creating and posting ads on Facebook are described. The advertising strategy targeted multicultural affinities, gender, age, interest terms, and zip codes. We report on results during 205 days. A total of 516,498 Facebook users viewed the ads an average of four times, resulting in 37,133 clicks to the study website. Compared to 495 screened on-the-ground, 940 were screened via Facebook ads, of these, half (n = 477, 50.74%) were high risk, and of those at risk, 154 were randomized into the 6-month clinical trial. Black women comprised 71.60% (n = 673) of the total screened online. Roughly twice as many Black women screened via Facebook compared to on-the-ground, yet, the percentage at high risk was similar. Preliminary data suggest that the extent to which ad headlines and photos tap into authentic social experience, advertising on Facebook can extend geographic reach and provide a comparative sample to women recruited on-the-ground.

  6. The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277

    Directory of Open Access Journals (Sweden)

    Hurley Susan

    2004-03-01

    Full Text Available Abstract Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i oral lactobacillus versus placebo and (ii vaginal lactobacillus versus placebo.

  7. The PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277].

    Science.gov (United States)

    Pirotta, Marie; Gunn, Jane; Chondros, Patty; Grover, Sonia; Hurley, Susan; Garland, Suzanne

    2004-03-28

    Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. A randomised placebo-controlled blinded 2 x 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18-50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496--124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.

  8. Prophylactic magnesium sulphate in prevention of eclampsia in women with severe preeclampsia: randomised controlled trial (PIPES trial).

    Science.gov (United States)

    Keepanasseril, Anish; Maurya, Dilip Kumar; Manikandan, K; Suriya J, Yavana; Habeebullah, Syed; Raghavan, S Soundara

    2017-10-03

    Optimum dose, route and duration of use of prophylactic magnesium sulphate in women with severe pre-eclampsia is still controversial. We compared the efficacy and safety of 'low-dose Dhaka' regime with 'Loading dose only' regime for seizure prophylaxis in severe preeclampsia using a randomised controlled trial in 402 women. The incidence of eclampsia in the 'low-dose Dhaka' regime group was 1.49% and that in the 'Loading dose only regime' was 2.98% (p = .321). In the low-dose Dhaka regime, injection site abscess and respiratory depression occurred in one woman each. Neonatal outcomes such as Apgar score at 5 minutes (5.0% vs. 8.05% p = .251) and perinatal mortality (20.4% vs. 21.9%, p = .724) were similar in both groups. Loading dose only regime may be considered an effective alternative regime for the prevention of eclampsia in women with severe preeclampsia. Impact statement What is already known on this subject: Efficacy of therapeutic short regime magnesium sulphate in eclampsia has already been reported. Data regarding prophylactic short regime in women with preeclampsia is sparse. What the results of this study add: We have shown that short regime of magnesium sulphate using only the loading dose in the prevention of seizure in preeclampsia is an effective alternative to the low-dose Dhaka regime. What the implications are of these findings for clinical practice and/or further research: The short regime is less resource-intensive. Further larger studies are needed to confirm the efficacy of this short regime and to establish its cost-effectiveness.

  9. Examining End-of-Life Case Management: Systematic Review

    Directory of Open Access Journals (Sweden)

    Roger E. Thomas

    2014-01-01

    Full Text Available Case management was initiated in the 1970s to reduce care discontinuity. A literature review focused on end-of-life (EOL case management identified 17 research articles, with content analysis revealing two themes: (a seeking to determine or establish the value of EOL case management and (b identifying ways to improve EOL case management. The evidence, although limited, suggests that EOL case management is helpful to dying individuals and their families. Research is needed to more clearly illustrate its usefulness or outcomes and the extent of need for it and actual availability. Among other benefits, EOL case management may help reduce hospital utilization, a major concern with the high cost of hospital-based care and the increased desire for home-based EOL care.

  10. Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity

    Directory of Open Access Journals (Sweden)

    Steven Allender

    2016-11-01

    Full Text Available Background: Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives: To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1 strengthen community action for childhood obesity prevention, and (2 measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1 to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7–8 y, grade four (9–10 y and grade six (11–12 y students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools. An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion: This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.

  11. Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity.

    Science.gov (United States)

    Allender, Steven; Millar, Lynne; Hovmand, Peter; Bell, Colin; Moodie, Marj; Carter, Rob; Swinburn, Boyd; Strugnell, Claudia; Lowe, Janette; de la Haye, Kayla; Orellana, Liliana; Morgan, Sue

    2016-11-16

    Background : Community-based initiatives show promise for preventing childhood obesity. They are characterized by community leaders and members working together to address complex local drivers of energy balance. Objectives : To present a protocol for a stepped wedge cluster randomized trial in ten communities in the Great South Coast Region of Victoria, Australia to test whether it is possible to: (1) strengthen community action for childhood obesity prevention, and (2) measure the impact of increased action on risk factors for childhood obesity. Methods: The WHO STOPS intervention involves a facilitated community engagement process that: creates an agreed systems map of childhood obesity causes for a community; identifies intervention opportunities through leveraging the dynamic aspects of the system; and, converts these understandings into community-built, systems-oriented action plans. Ten communities will be randomized (1:1) to intervention or control in year one and all communities will be included by year three. The primary outcome is childhood obesity prevalence among grade two (ages 7-8 y), grade four (9-10 y) and grade six (11-12 y) students measured using our established community-led monitoring system (69% school and 93% student participation rate in government and independent schools). An additional group of 13 external communities from other regions of Victoria with no specific interventions will provide an external comparison. These communities will also allow us to assess diffusion of the intervention to control communities during the first three years of the trial. Conclusion : This trial will test effectiveness, over a five-year period, of community-owned, -supported and -led strategies designed to address complex and dynamic causes of childhood obesity.

  12. Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

    Science.gov (United States)

    Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

    2015-12-01

    Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

  13. Case management to reduce risk of cardiovascular disease in a county health care system.

    Science.gov (United States)

    Ma, Jun; Berra, Kathy; Haskell, William L; Klieman, Linda; Hyde, Shauna; Smith, Mark W; Xiao, Lan; Stafford, Randall S

    2009-11-23

    Case management (CM) is a systematic approach to supplement physician-centered efforts to prevent cardiovascular disease (CVD). Research is limited on its implementation and efficacy in low-income, ethnic minority populations. We conducted a randomized clinical trial to evaluate a nurse- and dietitian-led CM program for reducing major CVD risk factors in low-income, primarily ethnic minority patients in a county health care system, 63.0% of whom had type 2 diabetes mellitus. The primary outcome was the Framingham risk score (FRS). A total of 419 patients at elevated risk of CVD events were randomized and followed up for a mean of 16 months (81.4% retention). The mean FRS was significantly lower for the CM vs usual care group at follow-up (7.80 [95% confidence interval, 7.21-8.38] vs 8.93 [8.36-9.49]; P = .001) after adjusting for baseline FRS. This is equivalent to 5 fewer heart disease events per 1000 individuals per year attributable to the intervention or to 200 individuals receiving the intervention to prevent 1 event per year. The pattern of group differences in the FRS was similar in subgroups defined a priori by sex and ethnicity. The main driver of these differences was lowering the mean (SD) systolic (-4.2 [18.5] vs 2.6 [22.7] mm Hg; P = .003) and diastolic (-6.0 [11.6] vs -3.0 [11.7] mm Hg; P = .02) blood pressures for the CM vs usual care group. Nurse and dietitian CM targeting multifactor risk reduction can lead to modest improvements in CVD risk factors among high-risk patients in low-income, ethnic minority populations receiving care in county health clinics. clinicaltrials.gov Identifier: NCT00128687.

  14. Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.

    Science.gov (United States)

    Gilbert, Peter B; Juraska, Michal; deCamp, Allan C; Karuna, Shelly; Edupuganti, Srilatha; Mgodi, Nyaradzo; Donnell, Deborah J; Bentley, Carter; Sista, Nirupama; Andrew, Philip; Isaacs, Abby; Huang, Yunda; Zhang, Lily; Capparelli, Edmund; Kochar, Nidhi; Wang, Jing; Eshleman, Susan H; Mayer, Kenneth H; Magaret, Craig A; Hural, John; Kublin, James G; Gray, Glenda; Montefiori, David C; Gomez, Margarita M; Burns, David N; McElrath, Julie; Ledgerwood, Julie; Graham, Barney S; Mascola, John R; Cohen, Myron; Corey, Lawrence

    2017-01-01

    Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans. The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa. Participants are randomized 1:1:1 to receive an intravenous infusion of 10 mg/kg VRC01, 30 mg/kg VRC01, or a control preparation every 8 weeks for a total of 10 infusions. Each trial is designed (1) to assess overall prevention efficacy (PE) pooled over the two VRC01 dose groups vs. control and (2) to assess VRC01 dose and laboratory markers as correlates of protection (CoPs) against overall and genotype- and phenotype-specific infection. Each AMP trial is designed to have 90% power to detect PE > 0% if PE is ≥ 60%. The AMP trials are also designed to identify VRC01 properties (i.e., concentration and effector functions) that correlate with protection and to provide insight into mechanistic CoPs. CoPs are assessed using data from breakthrough HIV-1 infections, including genetic sequences and sensitivities to VRC01-mediated neutralization and Fc effector functions. The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high-level protection, setting a benchmark

  15. The IDEFICS intervention trial to prevent childhood obesity: design and study methods.

    Science.gov (United States)

    Pigeot, I; Baranowski, T; De Henauw, S

    2015-12-01

    One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.

  16. Rivaroxaban for stroke prevention in East Asian patients from the ROCKET AF trial.

    Science.gov (United States)

    Wong, Ka Sing Lawrence; Hu, Dai Yi; Oomman, Abraham; Tan, Ru-San; Patel, Manesh R; Singer, Daniel E; Breithardt, Günter; Mahaffey, Kenneth W; Becker, Richard C; Califf, Robert; Fox, Keith A A; Berkowitz, Scott D; Hacke, Werner; Hankey, Graeme J

    2014-06-01

    In Rivaroxaban Once Daily Oral Direct Factor Xa Inhibitor Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban was noninferior to dose-adjusted warfarin in preventing stroke or systemic embolism among patients with nonvalvular atrial fibrillation at moderate to high stroke risk. Because of differences in patient demographics, epidemiology, and stroke risk management in East Asia, outcomes and relative effects of rivaroxaban versus warfarin were assessed to determine consistency among East Asians versus other ROCKET AF participants. Baseline demographics and interaction of treatment effects of rivaroxaban and warfarin among patients within East Asia and outside were assessed. A total of 932 (6.5%) ROCKET AF participants resided in East Asia. At baseline, East Asians had lower weight, creatinine clearance, and prior vitamin K antagonist use; higher prevalence of prior stroke; and less congestive heart failure and prior myocardial infarction than other participants. Despite higher absolute event rates for efficacy and safety outcomes in East Asians, the relative efficacy of rivaroxaban (20 mg once daily; 15 mg once daily for creatinine clearance of 30-49 mL/min) versus warfarin with respect to the primary efficacy end point (stroke/systemic embolism) was consistent among East Asians and non-East Asians (interaction P=0.666). Relative event rates for the major or nonmajor clinically relevant bleeding in patients treated with rivaroxaban and warfarin were consistent among East Asians and non-East Asians (interaction P=0.867). Observed relative efficacy and safety of rivaroxaban versus warfarin were similar among patients within and outside East Asia. Rivaroxaban, 20 mg once daily, is an alternative to warfarin for stroke prevention in East Asians with nonvalvular atrial fibrillation. © 2014 American Heart Association, Inc.

  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. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  19. Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa.

    Directory of Open Access Journals (Sweden)

    Hannah Kibuuka

    Full Text Available HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania and factors that may have influenced their use during the trial.Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit.Overall, 103 (31.8% of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2, married (49.5% and had less than high school education (62.1%. Hormonal contraceptives were the most common method of contraception (58.3% followed by condom use (22.3%. The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4% reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions.Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials.ClinicalTrials.gov NCT00123968.

  20. Delivering prostate cancer prevention messages to the public: how the National Cancer Institute (NCI) effectively spread the word about the Prostate Cancer Prevention Trial (PCPT) results.

    Science.gov (United States)

    Croker, Kara Smigel; Ryan, Anne; Morzenti, Thuy; Cave, Lynn; Maze-Gallman, Tamara; Ford, Leslie

    2004-01-01

    The Prostate Cancer Prevention Trial was the first clinical trial to show that a direct intervention (5 mg of finasteride daily for 7 years) could reduce a man's risk of developing prostate cancer. Initial results also suggested that men taking finasteride had an increased risk of developing what appeared to be higher-grade disease (Gleason score 7-10). The National Cancer Institute has a congressional mandate to communicate health information to the public and has established methods to reach the public directly and to reach information intermediaries in the media, professional societies, and advocacy groups. The groundbreaking yet complicated results of the Prostate Cancer Prevention Trial were widely disseminated by National Cancer Institute using the social marketing and public-relations strategies and tactics detailed here. Copyright 2004 Elsevier Inc.

  1. Applying e-health to case management.

    Science.gov (United States)

    Adams, J M

    2000-01-01

    The healthcare industry is only beginning to understand e-health. E-health can be defined as the use of technology to directly improve healthcare delivery-affording patients the opportunity to participate in their own healthcare management, provider, and institution. The market is changing rapidly, and innovations, partnerships, and mergers are taking place daily. For healthcare institutions, setting a long-term, yet adaptable e-health strategy is of vital importance for the continued success of the organization. For clinicians, an understanding of and familiarity with technologies can significantly improve workflow, organization, and patient interaction. For the patient, technology can be leveraged as a means to take initiative and responsibility for his/her own health. This article defines e-health and explains the implications and benefits of e-health to nurses and their patients. The article also identifies unique opportunities e-health/e-commerce can provide case managers in promoting patient connectivity, care management, and economy in cost of care.

  2. Randomized Controlled Trial of Sildenafil for Preventing Recurrent Ischemic Priapism in Sickle Cell Disease

    Science.gov (United States)

    Burnett, Arthur L.; Anele, Uzoma A.; Trueheart, Irene N.; Strouse, John J.; Casella, James F.

    2014-01-01

    BACKGROUND Successful preventive therapy for ischemic priapism, a disorder of penile erection with major physical and psychologic consequences, is limited. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease. METHODS Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily, unassociated with sleep or sexual activity, for 8 weeks, followed by open-label use of this sildenafil regimen for an additional 8 weeks. RESULTS Priapism frequency reduction by 50% did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses (P = 1.0). However, during open-label assessment, 5 of 8 patients (62.5%) by intention-to-treat analysis and 2 of 3 patients (66.7%) by per protocol analysis met this primary efficacy outcome. No significant differences were found between study groups in rates of adverse effects, although major priapism episodes were decreased 4-fold in patients monitored “on-treatment.” CONCLUSIONS Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease. PMID:24680796

  3. The Training Effectiveness of Prevention Disability Package in High School Girls; a Community Intervention Trial

    Directory of Open Access Journals (Sweden)

    Abolfazl Mohammadbeigi

    2016-11-01

    Full Text Available Background: Training programs and providing essential information such as preborn educational programs for women, unmarried girls are essential as the most important prevention methods for control and prevention of health outcomes and disability. The current study conducted to assess the training effectiveness of Prevention Disability Package in high school girls in a community trail.Materials and Methods: A community trial executed among 1,339 high school girls in Qom, Iran. Subjects were the students that training in 10th and 11th years of education. All of students in each class from all majors were included in the study. According to sampling framework, 55 classes selected randomly assigned to lecture (1264 girls [94.4%], 4 (3% girls to CD-based group and 35 (2.6% girls to control group. Data collection was conducted by a standard and valid questionnaire. Analysis of variance test was used to compare the mean of knowledge score among three groups. Analysis of covariance (ANCOVA used to control the confounding variables.Results: There were significant differences among three groups according to the total score of awareness of disability. Therefore, the mean score of in handicap, musculoskeletal diseases, pregnancy dimensions, and total knowledge about disability causes was higher than in lecture group than CD-based and control groups (P

  4. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

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    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  5. Direct oral anticoagulants in the prevention of venous thromboembolism: evidence from major clinical trials.

    Science.gov (United States)

    Prandoni, Paolo; Temraz, Sally; Taher, Ali

    2014-04-01

    Hospitalized medical and surgical patients encompass a group of patients in whom venous thromboembolism (VTE) poses a major concern on morbidity and mortality. Recently, direct oral anticoagulants for the prevention of VTE have been developed to overcome the drawbacks of the food/drug interactions and the need for frequent laboratory monitoring and dose adjustments associated with the use of vitamin K antagonists and the inconvenience of the subcutaneous administration of low-molecular-weight heparins and fondaparinux. The novel oral anticoagulants that have been tested in major clinical trials for VTE prevention in medical and surgical patients are the thrombin inhibitor dabigatran and the factor Xa inhibitors apixaban, rivaroxaban, and edoxaban, which will be the focus of this review. While the new drugs proved to be highly effective and safe in the prevention of VTE following major orthopedic surgery, they failed to show a favorable benefit-to-risk profile in hospitalized medical patients receiving extended anticoagulation beyond the hospital stay. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Preventing facial pressure ulcers in patients under non-invasive mechanical ventilation: a randomised control trial.

    Science.gov (United States)

    Otero, D Peña; Domínguez, D Vazquez; Fernández, L Hernanz; Magariño, A Santano; González, V Jimenez; Klepzing, J V García; Montesinos, J V Beneit

    2017-03-02

    To comparatively assess the efficacy of four different therapeutic strategies to prevent the development of facial pressure ulcers (FPUs) related to the use of non-invasive mechanical ventilation (NIV) with oro-nasal masks in critically ill hospitalised patients. This randomised control trial was performed at the high dependency unit in the University General Hospital Gregorio Marañón in Madrid, Spain. Overall, 152 patients with acute respiratory failure were recruited. All patients were hospitalised and received NIV through oro-nasal masks. The Norton tool was used to evaluate the general risk of developing pressure ulcers (PUs). Subjects were divided into four groups, each of them receiving a different treatment. Tissue assessment and preventive care were performed by a member of the research team. The incidence of FPUs was significantly lower in the group receiving a solution of hyperoxygenated fatty acids (HOFA) when compared with each of the other therapeutic strategies: direct mask (p=0.055), adhesive thin dressing (p=0.03) and adhesive foam dressing (pfacial skin in contact with the oro-nasal masks showed the highest efficacy in the prevention of NIV-related FPUs.

  7. Delivering prevention for alcohol and cannabis using the Internet: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Teesson, Maree; Vogl, Laura E

    2009-06-01

    To establish the efficacy of an internet based prevention program to reduce alcohol and cannabis use in adolescents. A cluster randomised controlled trial was conducted with 764 13-year olds from ten Australian secondary schools in 2007-2008. Half the schools were randomly allocated to the computerised prevention program (n=397), and half to their usual health classes (n=367). The Climate Schools: Alcohol and Cannabis prevention course is facilitated by the internet and consists of novel, evidence-based, curriculum consistent lessons aimed at reducing alcohol and cannabis use. Participants were assessed at baseline, immediately post, and at six months following the intervention. Compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge at the end of the course and the six month follow-up. In addition, the intervention group showed a reduction in average weekly alcohol consumption and frequency of cannabis use at the six month follow-up. No differences between groups were found on alcohol expectancies, cannabis attitudes, or alcohol and cannabis related harms. The course is acceptable, scalable and fidelity is assured. It increased knowledge regarding alcohol and cannabis, and decreased use of these drugs.

  8. Childhood obesity prevention interventions in childcare settings: systematic review of randomized and nonrandomized controlled trials.

    Science.gov (United States)

    Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C

    2014-01-01

    Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.

  9. Synbiotic for Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial

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    Seyed Ali Jafari

    2014-01-01

    Full Text Available Introduction Antibiotic- associated diarrhea is a common problem in pediatric population. There is growing interest in probiotics, probiotics and synbiotics for prevention of this complication because of their worldwide availability as dietary supplements. The aim of this study was to assess the efficacy of a synbiotic mixture in prevention of antibiotic- associated diarrhea.   Materials and Methods:  In this randomized controlled  trial,  218 patients ( 111 in the synbiotic and 107 in the placebo group aged 6 months to 14 years with respiratory tract infection and/ or otitis media who needed antibiotic treatment in outpatient setting, were enrolled. They received 1 billion Colony Forming Unit of seven probiotics species plus Fructooligosaccharide in form of powder  or placebo ( matched for size, shape, and volume for 7 days. Amoxicillin, Amoxicillin-clavalanic acid, cefixim and Azithromicin were the most common drugs used by physcicians Mothers recorded stool frequency and consistency daily for 7 days.   Results: We found no significant difference (P>0.05 in occurrence of diarrhea between synbiotic and placebo groups.   Conclusion: This synbiotic mixture did not appear to reduce antibiotic- associated diarrhea in children. Further studies are needed to investigate the potential benefits of Synbiotics in prevention of this disease.  

  10. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

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    Toity Deave

    Full Text Available Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB, which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation.We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+, IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre.1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20. However, significantly more

  11. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

    Science.gov (United States)

    Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

    2017-01-01

    Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre. 1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in

  12. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial

    Science.gov (United States)

    Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

    2017-01-01

    Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2

  13. Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials.

    Science.gov (United States)

    Sugarman, Jeremy; Seils, Damon M; Watson-Ormond, J Kemp; Weinfurt, Kevin P

    2016-01-01

    We describe our use of cognitive interviews in developing a measure of "preventive misconception" to demonstrate the importance of this approach to researchers developing surveys in empirical bioethics. The preventive misconception involves research participants' false beliefs about a prevention trial, including beliefs that the interventions being tested will certainly be effective. We developed and refined a measure of the preventive misconception using qualitative interviews that focused on cognitive testing of proposed survey items with HIV prevention trial participants. Two main problems emerged during initial interviews. First, the phrase "reduce your risk," used to elicit beliefs about risk reduction from the use of study medications, was interpreted as relating to a reduction of risky behaviors. Second, the phrase "participating in this study," intended to elicit beliefs about trial group assignment, was interpreted as relating to personal behavior changes associated with study participation. Additional interviews using a revised measure were no longer problematic in these ways, and participants felt the response options were appropriate for conveying their answers. These findings underscore the importance of cognitive testing in developing surveys for empirical bioethics.

  14. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

    Science.gov (United States)

    Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas

    2015-01-01

    Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted

  15. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial

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    Erica G. Soltero

    2017-03-01

    Full Text Available Abstract Background Obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. However, to date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, we propose a randomized-controlled trial to test the short-term (6-month and long-term (12-month efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Methods Participants will be randomized to a lifestyle intervention or usual care group. Participants in the intervention group will attend weekly nutrition and wellness sessions and physical activity sessions twice a week for six months, followed by three months of booster sessions. The overall approach of the intervention is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence. The intervention is also guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. We will test intervention effects on quality of life, explore the potential mediating effects of changes in body composition, total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost effectiveness of the intervention as compared with usual care for improving glucose tolerance. Discussion The proposed trial builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes

  16. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Fisker, Annette; Langberg, Henning; Petersen, Tom; Mortensen, Ole Steen

    2013-03-13

    -statement in designing and reporting RCTs. This large RCT is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the municipal sickness benefit office participating in team meetings. The study has the potential to contribute to the knowledge about how to target the challenges in the treatment of LBP. The aim is to prevent sickness absence and labour market exclusion--both on the individual level and economic costs at community level. Short term results will be available in 2014.This study is approved by the Danish Regional Ethics Committee (J.nr: H-C-2008-112) and is registered at ClinicalTrials.gov: NCT01690234.

  17. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

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    Orton Jane

    2009-12-01

    Full Text Available Abstract Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm ( Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651

  18. Assessing Adherence in the CAPRISA 004 Tenofovir Gel HIV Prevention Trial: Results of a Nested Case–Control Study

    OpenAIRE

    MacQueen, Kathleen M.; Weaver, Mark A.; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-01-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case–control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence a...

  19. Meta-analysis of randomized controlled trials on the efficacy and safety of ondansetron in preventing postanesthesia shivering.

    Science.gov (United States)

    Li, Min; Hu, Xiaolan; Tan, Yuan; Yang, Baoping; Li, Kun; Tang, Zhenyu

    2016-11-01

    Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled trials to examine the controversy. Randomized controlled trials assessing the effect of ondansetron on the prevention of PAS were identified from electronic databases (PubMed and EMBASE). The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity. Twelve trials randomized clinical trials met the inclusion criteria including 1205 subjects. Compared with placebo (saline), ondansetron was associated with a significant reduction of PAS (relative risk 0.33; 95% confidence interval, 0.21-0.51), Substantial heterogeneity was observed between trials (P = 0.0002; I 2  = 71%). Trial sequential analysis showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit establishing sufficient and conclusive evidence. Meta-analysis with all five studies using a fixed-effects model suggested that ondansetron and meperidine have similar effects on the prevention of PAS (relative risk, 0.86; 95% confidence interval, 0.66-1.11), the heterogeneity was not significant (P = 0.34; I 2  = 11%). No significant association of ondansetron with bradycardia was found both comparison with placebo and meperidine. Treat with ondansetron is safe, and may reduce PAS. This finding encourages the use of ondansetron to prevent PAS, but, more high quality randomized clinical trials are still warranted to confirm the effects of different doses of ondansetron on PAS. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  20. Improving Self-Regulation for Obesity Prevention in Head Start: A Randomized Controlled Trial.

    Science.gov (United States)

    Lumeng, Julie C; Miller, Alison L; Horodynski, Mildred A; Brophy-Herb, Holly E; Contreras, Dawn; Lee, Hannah; Sturza, Julie; Kaciroti, Niko; Peterson, Karen E

    2017-05-01

    To determine the effect of an intervention to improve emotional and behavioral self-regulation in combination with an obesity-prevention program on the prevalence of obesity and obesity-related behaviors in preschoolers. This was a cluster-randomized intervention trial in Head Start (HS) classrooms conducted in each of 4 academic years from 2011 to 2015. Participants (697 children; 49% boys; mean age: 4.1 ± 0.5 years; 48% white, 30% African American, 12% Hispanic) were randomly assigned by classroom to 1 of 3 intervention arms: (1) HS + Preschool Obesity Prevention Series (POPS) + Incredible Years Series (IYS) (HS enhanced by the POPS [program targeting evidence-based obesity-prevention behaviors] and the IYS [program to improve children's self-regulation]), (2) HS+POPS, or (3) HS. Primary outcomes were changes in prevalence of obesity, overweight/obesity, BMI z score, and teacher-reported child emotional and behavioral self-regulation; secondary outcomes were dietary intake, outdoor play, screen time, and parent nutrition knowledge and nutrition self-efficacy. HS+POPS+IYS improved teacher-reported self-regulation compared with HS+POPS ( P obesity (16.4% preintervention to 14.3% postintervention in HS+POPS+IYS versus 17.3% to 14.4% in HS+POPS [ P = .54] versus 12.2% to 13.0% in HS [ P = .33]). There was no effect of HS+POPS compared with HS alone ( P = .16). There was no effect on other outcomes except for sugar-sweetened beverage intake (HS+POPS+IYS resulted in a greater decline than HS; P = .005). An intervention for parents and children to improve HS preschoolers' emotional and behavioral self-regulation in combination with an obesity-prevention curriculum did not reduce obesity prevalence or most obesity-related behaviors. Copyright © 2017 by the American Academy of Pediatrics.

  1. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    Science.gov (United States)

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Objective Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Method Adolescents (N=14; 13–18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths’ clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Results Regarding feasibility, 86% of the adolescents completed the intervention (M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Conclusions Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed. PMID:27857509

  2. Excess weight gain prevention in adolescents: Three-year outcome following a randomized controlled trial.

    Science.gov (United States)

    Tanofsky-Kraff, Marian; Shomaker, Lauren B; Wilfley, Denise E; Young, Jami F; Sbrocco, Tracy; Stephens, Mark; Brady, Sheila M; Galescu, Ovidiu; Demidowich, Andrew; Olsen, Cara H; Kozlosky, Merel; Reynolds, James C; Yanovski, Jack A

    2017-03-01

    Interpersonal psychotherapy (IPT) prevents weight gain in adults with obesity and binge-eating-disorder, and is especially effective among those with increased psychosocial problems. However, IPT was not superior to health education (HE) to prevent excess weight gain at 1-year follow-up in 113 adolescent girls at high-risk for excess weight gain because of loss-of-control eating and high body mass index (BMI; kg/m2; Tanofsky-Kraff et al., 2014). Participants from the original trial were recontacted 3 years later for assessment. At baseline, adolescent- and parent-reported social-adjustment problems and trait anxiety were evaluated. At baseline and follow-ups, BMIz and adiposity by dual-energy x-ray absorptiometry were obtained. Nearly 60% were reassessed at 3 years, with no group differences in participation (ps ≥ .70). Consistent with 1 year, there was no main effect of group on change in BMIz/adiposity (ps ≥ .18). In exploratory analyses, baseline social-adjustment problems and trait-anxiety moderated outcome (ps obesity-prone adolescent girls, IPT was not superior to HE in preventing excess weight gain at 3 years. Consistent with theory, exploratory analyses suggested that IPT was associated with improvements in BMIz over 3 years among youth with high social-adjustment problems or trait anxiety. Future studies should test the efficacy of IPT for obesity prevention among at-risk girls with social-adjustment problems and/or anxiety. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Excess Weight Gain Prevention in Adolescents: Three-year Outcome following a Randomized-Controlled Trial

    Science.gov (United States)

    Tanofsky-Kraff, Marian; Shomaker, Lauren B.; Wilfley, Denise E.; Young, Jami F.; Sbrocco, Tracy; Stephens, Mark; Brady, Sheila M.; Galescu, Ovidiu; Demidowich, Andrew; Olsen, Cara H.; Kozlosky, Merel; Reynolds, James C.; Yanovski, Jack A.

    2016-01-01

    Objective Interpersonal psychotherapy (IPT) prevents weight gain in adults with obesity and binge-eating-disorder, and is especially effective among those with increased psychosocial problems. However, IPT was not superior to health-education (HE) to prevent excess weight gain at 1-year follow-up in 113 adolescent girls at high-risk for excess weight gain because of loss-of-control (LOC)-eating and high BMI (kg/m2) (Tanofsky-Kraff et al., 2014). Method Participants from the original trial were re-contacted 3-years later for assessment. At baseline, adolescent- and parent-reported social-adjustment problems and trait-anxiety were evaluated. At baseline and follow-ups, BMIz and adiposity by dual-energy X-ray absorptiometry were obtained. Results Nearly 60% were re-assessed at 3-years, with no group differences in participation (ps≥.70). Consistent with 1-year, there was no main effect of group on change in BMIz/adiposity (ps≥.18). In exploratory analyses, baseline social-adjustment problems and trait-anxiety moderated outcome (psobesity-prone adolescent girls, IPT was not superior to HE in preventing excess weight gain at 3-years. Consistent with theory, exploratory analyses suggested that IPT was associated with improvements in BMIz over 3-years among youth with high social-adjustment problems or trait-anxiety. Future studies should test the efficacy of IPT for obesity prevention among at-risk girls with social-adjustment problems and/or anxiety. PMID:27808536

  4. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial.

    Science.gov (United States)

    La Greca, Annette M; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-12-01

    Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Adolescents (N=14; 13-18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths' clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Regarding feasibility, 86% of the adolescents completed the intervention ( M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed.

  5. Efficacy of a prevention program for eating disorders in schools: a cluster-randomized controlled trial.

    Science.gov (United States)

    Gumz, Antje; Weigel, Angelika; Daubmann, Anne; Wegscheider, Karl; Romer, Georg; Löwe, Bernd

    2017-08-11

    Previous prevention programs in the school context have not addressed both genders, have been time-consuming, or have had deficits in the evaluation method. The aim of the present study was to evaluate the impact of a universal prevention program for female and male adolescents on eating disorder pathology and related risk factors. Between February 2012 and July 2014, 2515 students in 23 schools from 8th or 11th grade were assessed for eligibility in this longitudinal cluster-randomized controlled trial with a six months follow-up. Of those students, 2342 were cluster-randomized to the intervention condition which received a six school hours universal prevention program or to the no treatment control condition. The complete case population comprised 724 students in the intervention (54.3% female, M = 14.3 years, SD = 1.61) and 728 in the control condition (57.0% female, M = 14.7 years, SD = 1.63). Random-effects analysis of covariance on the primary outcome showed no significant differences between the intervention and control groups in their eating disorder pathology change scores six months after the intervention. Regarding secondary outcomes, participants in the intervention group showed a greater increase in knowledge about eating disorders both after the intervention (p < .001, ES = 1.06) and six months later (p = .01, ES = 0.40). Greater reductions in anxiety severity were observed in the intervention group post-intervention (p = .02, ES = 0.22) which was not maintained at the six months follow-up. Results differed between participants from grade 8 and 11. The present universal prevention program can be particularly recommended for adolescents from grade 11. ISRCTN 97989348.

  6. Declining stroke and vascular event recurrence rates in secondary prevention trials over the past 50 years and consequences for current trial design.

    Science.gov (United States)

    Hong, Keun-Sik; Yegiaian, Sharon; Lee, Meng; Lee, Juneyoung; Saver, Jeffrey L

    2011-05-17

    It is widely supposed, but not well-demonstrated, that cumulative advances in standard care have reduced recurrent stroke and cardiovascular events in secondary prevention trials. Systematic search identified all randomized, controlled trials of medical secondary stroke prevention therapies published from 1960 to 2009. Randomized, controlled trials narrowly focused on single stroke mechanisms, including atrial fibrillation, cervical carotid stenosis, and intracranial stenosis, were excluded. From control arms of individual trials, we extracted data for baseline characteristics and annual event rates for recurrent stroke, fatal stroke, and major vascular events and analyzed trends over time. Fifty-nine randomized controlled trials were identified, enrolling 66 157 patients in control arms. Over the 5 decade periods, annual event rates declined, per decade, for recurrent stroke by 0.996% (P=0.001), fatal stroke by 0.282% (P=0.003), and major vascular events by 1.331% (P=0.001). Multiple regression analyses identified increasing antithrombotic use and lower blood pressures as major contributors to the decline in recurrent stroke. For recurrent stroke, annual rates fell from 8.71% in trials launched in the 1960s to 6.10% in the 1970s, 5.41% in the 1980s, 4.04% in the 1990s, and 4.98% in the 2000s. The sample size required for a trial to have adequate power to detect a 20% reduction in recurrent stroke increased 2.2-fold during this period. Recurrent stroke and vascular event rates have declined substantially over the last 5 decades, with improved blood pressure control and more frequent use of antiplatelet therapy as the leading causes. Considerably larger sample sizes are now needed to demonstrate incremental improvements in medical secondary prevention.

  7. 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

  8. Utility of electronic patient records in primary care for stroke secondary prevention trials

    Directory of Open Access Journals (Sweden)

    Ashworth Mark

    2011-02-01

    Full Text Available Abstract Background This study aimed to inform the design of a pragmatic trial of stroke prevention in primary care by evaluating data recorded in electronic patient records (EPRs as potential outcome measures. The study also evaluated achievement of recommended standards of care; variation between family practices; and changes in risk factor values from before to after stroke. Methods Data from the UK General Practice Research Database (GPRD were analysed for 22,730 participants with an index first stroke between 2003 and 2006 from 414 family practices. For each subject, the EPR was evaluated for the 12 months before and after stroke. Measures relevant to stroke secondary prevention were analysed including blood pressure (BP, cholesterol, smoking, alcohol use, body mass index (BMI, atrial fibrillation, utilisation of antihypertensive, antiplatelet and cholesterol lowering drugs. Intraclass correlation coefficients (ICC were estimated by family practice. Random effects models were fitted to evaluate changes in risk factor values over time. Results In the 12 months following stroke, BP was recorded for 90%, cholesterol for 70% and body mass index (BMI for 47%. ICCs by family practice ranged from 0.02 for BP and BMI to 0.05 for LDL and HDL cholesterol. For subjects with records available both before and after stroke, the mean reductions from before to after stroke were: mean systolic BP, 6.02 mm Hg; diastolic BP, 2.78 mm Hg; total cholesterol, 0.60 mmol/l; BMI, 0.34 Kg/m2. There was an absolute reduction in smokers of 5% and heavy drinkers of 4%. The proportion of stroke patients within the recommended guidelines varied from less than a third (29% for systolic BP, just over half for BMI (54%, and over 90% (92% on alcohol consumption. Conclusions Electronic patient records have potential for evaluation of outcomes in pragmatic trials of stroke secondary prevention. Stroke prevention interventions in primary care remain suboptimal but important

  9. Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial.

    Directory of Open Access Journals (Sweden)

    Sarah Cockayne

    Full Text Available Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.In the primary analysis were 484 (98.2% intervention and 507 (98.1% control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16. The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05 as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01. There was an increase (p = 0.02 in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY difference 0.0129, 95% CI -0.0050 to 0.0314 and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.There was a small reduction in falls. The intervention may be cost-effective.ISRCTN ISRCTN68240461.

  10. Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

    Science.gov (United States)

    Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J

    2017-01-01

    Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.

  11. Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Hansen, Baiba Hedegaard; Hanash, Jamal Abed

    2015-01-01

    AIM: Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self-reported health and to identify subgroups with higher efficacy. METHODS: This is a secondary analysis of a 12-month double-blind clinical trial randomizing non......-depressed acute coronary syndrome patients to escitalopram (n = 120) or matching placebo (n = 120). The main outcomes were mean scores on Short Form 36 Health Survey (SF-36) domains, and diagnosis of depression was adjusted for baseline SF-36 scores. RESULTS: Escitalopram did not yield different SF-36...... trajectories on any scale compared with placebo (P > 0.28). Efficacy of escitalopram may have been better among those scoring at least the normative score on general health perceptions (hazard ratio (HR) for depression 0.17 (95% confidence interval 0.02-1.42) ) or social functioning (HR = 0.12 (0...

  12. Pharmacological relapse prevention in alcohol dependence: from animal models to clinical trials.

    Science.gov (United States)

    Boening, J A; Lesch, O M; Spanagel, R; Wolffgramm, J; Narita, M; Sinclair, D; Mason, B J; Wiesbeck, G A

    2001-05-01

    This article represents the proceedings of a symposium at the 2000 ISBRA Meeting in Yokohama, Japan. The chairs were Jobst August-Ludwig Boening and Otto Michel Lesch. The presentations were (1) Pharmacological validation of a new animal model of alcoholism, by Rainer Spanagel; (2) Persisting loss of control as main criterion for alcohol addiction in rats and mice, by Jochen Wolffgramm; (3) Role of NMDA receptor subunits associated with protein kinase C in the prevention of alcohol dependence, by Minoru Narita; (4) Long-term follow up of continued naltrexone treatment, by David Sinclair; (5) Pharmacological treatment trials with dopaminergic and serotonergic substances: Myths or facts? by Gerhard A. Wiesbeck; and (6) Methodology and behavioral therapy of the U.S. acamprosate study, by Barbara J. Mason.

  13. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    DEFF Research Database (Denmark)

    Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine

    2008-01-01

    PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes......: Compliance was highest in SRT but generally decreased over time. SRT and APE caused increased shoulder elevation strength, were more effective than REF to decrease neck pain among those with symptoms at baseline, and prevent development of shoulder pain in those without symptoms at baseline....

  14. Effectiveness of case management for homeless persons: a systematic review

    NARCIS (Netherlands)

    Vet, R. de; Luijtelaar, M.J.A. van; Brilleslijper-Kater, S.N.; Vanderplasschen, W.; Beijersbergen, M.D.; Wolf, J.R.L.M.

    2013-01-01

    We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized

  15. Effectiveness of Case Management for Homeless Persons: A Systematic Review

    NARCIS (Netherlands)

    de Vet, Renée; van Luijtelaar, Maurice J. A.; Brilleslijper-Kater, Sonja N.; Vanderplasschen, Wouter; Beijersbergen, Mariëlle D.; Wolf, Judith R. L. M.

    2013-01-01

    We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized

  16. The #Tamojunto Drug Prevention Program in Brazilian Schools: a Randomized Controlled Trial.

    Science.gov (United States)

    Sanchez, Zila M; Valente, Juliana Y; Sanudo, Adriana; Pereira, Ana Paula D; Cruz, Joselaine I; Schneider, Daniela; Andreoni, Solange

    2017-10-01

    A randomized controlled trial was conducted in 2014 with 7th and 8th grade students from 72 public schools in 6 Brazilian cities. This trial aimed to evaluate the effects of an adapted European school-based drug prevention program Unplugged, called #Tamojunto in Brazil, which was implemented by the Ministry of Health as part of public policy. The experimental group (n = 3340) attended 12 classes in the #Tamojunto program, and the control group (n = 3318) did not receive a school prevention program. Baseline data were collected prior to program implementation, and follow-up data were collected 9 months later, allowing a matching of 4213 adolescents in both waves. The substances examined were alcohol, tobacco, marijuana, inhalants, cocaine, and crack. Multilevel analyses were used to evaluate the changes in consumption of each drug between time points and between groups. The intervention and control groups had similar baseline characteristics. The mean age of the adolescents was 12.5 ± 0.7 years, and 51.3% were female. The program seemed to increase alcohol use initiation (first alcohol use); students in the experimental group had a 30% increased risk of initiating alcohol use during the 9-month follow-up (aRR = 1.30, 95% confidence interval (95%CI) 1.13-1.49, p program suggest that the content and lessons regarding alcohol may enhance curiosity about its use among adolescents. We suggest a re-evaluation of the expansion of the #Tamojunto program in schools while analyzing why the program's effects were inconsistent with those of previous European studies.

  17. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

    Science.gov (United States)

    Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

    2015-12-15

    Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

  18. Strategies for prevention of postoperative delirium: a systematic review and meta-analysis of randomized trials

    Science.gov (United States)

    2013-01-01

    Introduction The ideal measures to prevent postoperative delirium remain unestablished. We conducted this systematic review and meta-analysis to clarify the significance of potential interventions. Methods The PRISMA statement guidelines were followed. Two researchers searched MEDLINE, EMBASE, CINAHL and the Cochrane Library for articles published in English before August 2012. Additional sources included reference lists from reviews and related articles from 'Google Scholar'. Randomized clinical trials (RCTs) on interventions seeking to prevent postoperative delirium in adult patients were included. Data extraction and methodological quality assessment were performed using predefined data fields and scoring system. Meta-analysis was accomplished for studies that used similar strategies. The primary outcome measure was the incidence of postoperative delirium. We further tested whether interventions effective in preventing postoperative delirium shortened the length of hospital stay. Results We identified 38 RCTs with interventions ranging from perioperative managements to pharmacological, psychological or multicomponent interventions. Meta-analysis showed dexmedetomidine sedation was associated with less delirium compared to sedation produced by other drugs (two RCTs with 415 patients, pooled risk ratio (RR) = 0.39; 95% confidence interval (CI) = 0.16 to 0.95). Both typical (three RCTs with 965 patients, RR = 0.71; 95% CI = 0.54 to 0.93) and atypical antipsychotics (three RCTs with 627 patients, RR = 0.36; 95% CI = 0.26 to 0.50) decreased delirium occurrence when compared to placebos. Multicomponent interventions (two RCTs with 325 patients, RR = 0.71; 95% CI = 0.58 to 0.86) were effective in preventing delirium. No difference in the incidences of delirium was found between: neuraxial and general anesthesia (four RCTs with 511 patients, RR = 0.99; 95% CI = 0.65 to 1.50); epidural and intravenous analgesia (three RCTs with 167 patients, RR = 0.93; 95% CI = 0.61 to 1

  19. FTO genotype, dietary protein, and change in appetite: the Preventing Overweight Using Novel Dietary Strategies trial.

    Science.gov (United States)

    Huang, Tao; Qi, Qibin; Li, Yanping; Hu, Frank B; Bray, George A; Sacks, Frank M; Williamson, Donald A; Qi, Lu

    2014-05-01

    A common obesity-risk variant rs9939609 in the fat mass- and obesity-associated (FTO) gene was recently shown to affect appetite, and the gene is sensitive to the regulation of amino acids. We examined the interaction between FTO genotype and protein intake on the long-term changes in appetite in a randomized controlled trial. We genotyped FTO rs9939609 in 737 overweight adults in the 2-y Preventing Overweight Using Novel Dietary Strategies trial and assessed 4 appetite-related traits including cravings, fullness, hunger, and prospective consumption. We showed that dietary protein significantly modified genetic effects on changes in food cravings and appetite scores at 6 mo after adjustment for age, sex, ethnicity, baseline body mass index, weight change, and baseline value for respective outcomes (P-interaction = 0.027 and 0.048, respectively). The A allele was associated with a greater decrease in food cravings and appetite scores in participants with high-protein-diet intake (P = 0.027 and 0.047, respectively) but not in subjects in the low-protein-diet group (P = 0.384 and 0.078, respectively). The weight regain from 6 to 24 mo attenuated gene-protein interactions. Protein intakes did not modify FTO genotype effects on other appetite measures. Our data suggest that individuals with the FTO rs9939609 A allele might obtain more benefits in a reduction of food cravings and appetite by choosing a hypocaloric and higher-protein weight-loss diet. This trial was registered at clinicaltrials.gov as NCT00072995.

  20. Preventing musculoskeletal injuries among recreational adult volleyball players: design of a randomised prospective controlled trial.

    Science.gov (United States)

    Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

    2017-08-02

    Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational volleyball players. This article describes the design of a study evaluating the effectiveness of the developed intervention on the one-season occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational adult volleyball players. A randomized prospective controlled trial with a follow-up period of one volleyball season will be conducted. Participants will be healthy recreational adult volleyball players (18 years of age or older) practicing volleyball (training and/or match) at least twice a week. The intervention ('VolleyVeilig') consists of a warm-up program based on more than 50 distinct exercises (with different variations and levels). The effect of the intervention programme on the occurrence of injuries will be compared to volleyball as usual. Outcome measures will be incidence of acute injury (expressed as number of injuries per 1000 h of play) and prevalence of overuse injuries (expressed as percentage). This study will be one of the first randomized prospective controlled trials evaluating the effectiveness of an intervention on the occurrence of both acute and overuse injuries among recreational adult volleyball players. Outcome of this study could possibly lead to the nationwide implementation of the intervention in all volleyball clubs in The Netherlands, ultimately resulting in less injuries. Dutch Trial Registration NTR6202 , registered February 1st 2017. Version 3, February 2017.

  1. Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Traeger, Adrian C; Moseley, G Lorimer; Hübscher, Markus; Lee, Hopin; Skinner, Ian W; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; McAuley, James H

    2014-06-02

    Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in 'at-risk' individuals. Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18-75 years, with acute LBP (free period and at-risk of developing chronic LBP. Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded. Eligible participants who agree to take part will be randomly allocated to receive 2×1 h sessions of pain biology education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset. Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808. 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. Prevention of diabetes with Mediterranean diets: a subgroup analysis of a randomized trial.

    Science.gov (United States)

    Salas-Salvadó, Jordi; Bulló, Mònica; Estruch, Ramón; Ros, Emilio; Covas, Maria-Isabel; Ibarrola-Jurado, Núria; Corella, Dolores; Arós, Fernando; Gómez-Gracia, Enrique; Ruiz-Gutiérrez, Valentina; Romaguera, Dora; Lapetra, José; Lamuela-Raventós, Rosa Maria; Serra-Majem, Lluís; Pintó, Xavier; Basora, Josep; Muñoz, Miguel Angel; Sorlí, José V; Martínez-González, Miguel A

    2014-01-07

    Interventions promoting weight loss can reduce the incidence of type 2 diabetes mellitus. Whether dietary changes without calorie restriction also protect from diabetes has not been evaluated. To assess the efficacy of Mediterranean diets for the primary prevention of diabetes in the Prevención con Dieta Mediterránea trial, from October 2003 to December 2010 (median follow-up, 4.1 years). Subgroup analysis of a multicenter, randomized trial. (Current Controlled Trials: ISRCTN35739639) SETTING: Primary care centers in Spain. Men and women without diabetes (3541 patients aged 55 to 80 years) at high cardiovascular risk. Participants were randomly assigned and stratified by site, sex, and age but not diabetes status to receive 1 of 3 diets: Mediterranean diet supplemented with extra-virgin olive oil (EVOO), Mediterranean diet supplemented with nuts, or a control diet (advice on a low-fat diet). No intervention to increase physical activity or lose weight was included. Incidence of new-onset type 2 diabetes mellitus (prespecified secondary outcome). During follow-up, 80, 92, and 101 new-onset cases of diabetes occurred in the Mediterranean diet supplemented with EVOO, Mediterranean diet supplemented with mixed nuts, and control diet groups, respectively, corresponding to rates of 16.0, 18.7, and 23.6 cases per 1000 person-years. Multivariate-adjusted hazard ratios were 0.60 (95% CI, 0.43 to 0.85) for the Mediterranean diet supplemented with EVOO and 0.82 (CI, 0.61 to 1.10) for the Mediterranean diet supplemented with nuts compared with the control diet. Randomization was not stratified by diabetes status. Withdrawals were greater in the control group. A Mediterranean diet enriched with EVOO but without energy restrictions reduced diabetes risk among persons with high cardiovascular risk. Instituto de Salud Carlos III.

  3. Young Women Living with HIV: Outcomes from a Targeted Secondary Prevention Empowerment Pilot Trial.

    Science.gov (United States)

    Brothers, Jennifer; Hotton, Anna L; Hosek, Sybil G; Harper, Gary W; Fernandez, M Isabel

    2016-05-01

    Women account for 1 in 5 new HIV infections in the US, make up 24% of people living with HIV, and represent a quarter of AIDS diagnoses. Despite the need for continued prevention among young women living with HIV, there is very little in the literature on how best to reduce sexual risk and increase the health and well-being of young women living with HIV. This article explores the primary and secondary outcomes of a randomized controlled pilot trial of an intervention entitled Young Women Taking Charge and Growing Stronger. This behavioral intervention aimed to decrease sexual risk and empower young women living with HIV by enhancing young women's knowledge and skills pertaining to HIV risk reduction as well as to the factors that increase women's vulnerability, such as sexual inequality, gender, and power imbalances. Findings from this trial demonstrate that group-based behavioral interventions for young women living with HIV have promise to reduce the total number of sexual partners and reduce unprotected vaginal and anal intercourse. However, more work is needed to understand how best to address the challenges young women face in their day to day lives that impact their sexual risk as well as their overall health and access to care and treatment.

  4. Home-based alcohol prevention program for parents and children: A randomized controlled trial.

    Science.gov (United States)

    Mares, S H W; Lichtwarck-Aschoff, A; Verdurmen, J; Schulten, I; Engels, R C M E

    2016-07-01

    Objective To evaluate the effectiveness of a home-based alcohol prevention program to delay initiation of alcohol use in children. Methods In 2011, a total of 1349 sixth-grade children (M=12.15, SD=0.47) and their mothers who could read and write Dutch were recruited from primary schools in the northern part of the Netherlands. They participated in a cluster randomized controlled trial with two conditions; (1) intervention group (5 modules which families received by mail every 4weeks over 5months), (2) control group (a factsheet information brochure). An independent statistician allocated the schools to the conditions (allocation ratio (1:1)). Participants and data-analyst were blind to randomization. The primary outcome was alcohol initiation. Results Of the participants, 680 were randomized to the intervention and 669 to the control condition. In the intervention condition (N=540) 5.4% of the children drank alcohol compared to 7.1% in the control condition (N=601). The difference was not significant (OR=.99, 95% CI=.96-1.02, p=52). Conclusion The present study showed no effects of 'In control: No alcohol!' on alcohol initiation. A critical evaluation of program design and content, and future studies in different target groups, are suggested. The trial is registered at trialregister.nl, number NTR2474. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Vaccines licensed and in clinical trials for the prevention of dengue.

    Science.gov (United States)

    Torresi, J; Ebert, G; Pellegrini, M

    2017-05-04

    Dengue has become a major global public health threat with almost half of the world's population living in at-risk areas. Vaccination would likely represent an effective strategy for the management of dengue disease in endemic regions, however to date there is only one licensed preventative vaccine for dengue infection. The development of a vaccine against dengue virus (DENV) has been hampered by an incomplete understanding of protective immune responses against DENV. The most clinically advanced dengue vaccine is the chimeric yellow fever-dengue vaccine (CYD) that employs the yellow fever virus 17D strain as the replication backbone (Chimerivax-DEN; CYD-TDV). This vaccine had an overall pooled protective efficacy of 65.6% but was substantially more effective against severe dengue and dengue hemorrhagic fever. Several other vaccine approaches have been developed including live attenuated chimeric dengue vaccines (DENVax and LAV Delta 30), DEN protein subunit V180 vaccine (DEN1-80E) and DENV DNA vaccines. These vaccines have been shown to be immunogenic in animals and also safe and immunogenic in humans. However, these vaccines are yet to progress to phase III trials to determine their protective efficacy against dengue. This review will summarize the details of vaccines that have progressed to clinical trials in humans.

  6. Creating effective partnerships for HIV prevention trials: report of a UNAIDS Consultation, Geneva 20-21 June 2005.

    Science.gov (United States)

    2006-04-04

    With an estimated 5 million adults and children newly infected worldwide in 2005, research into new HIV prevention technologies and approaches is urgently needed. Prompted by the heated debate in 2004 about trials of tenofovir for HIV pre-exposure prophylaxis, UNAIDS initiated a year-long process to promote effective partnerships between researchers and civil society in HIV prevention trials, culminating in the 'Creating effective partnerships for HIV prevention trials' consultation in June 2005. Key stakeholders, including researchers, activists, ethicists, government officials, international agencies, civil society, trial participants, sponsors and funders addressed a wide range of issues concerning the rapidly evolving and sometimes tense dynamics of HIV prevention research partnerships. Implementation of the technical and procedural recommendations from this consultation requires collaboration, commitment and a willingness to experiment with new approaches and work with new partners. Researchers, donors, governments, community groups and activists must all be willing to define responsibilities and be held accountable for their contributions to HIV prevention research partnerships, weighing and balancing gains against the costs of time, money, and capacity as the HIV epidemic progresses.

  7. Case management for persons with substance use disorders

    DEFF Research Database (Denmark)

    Hesse, Morten; Vanderplasschen, Wouter; Rapp, Richard

    2007-01-01

    Background Patients with alcohol and other drug use disorders (AOD) frequently have multiple social, physical, and mental health treatment needs, yet have difficulty accessing community services, including drug abuse treatment.  One strategy for linking patients with AOD with relevant services...... is case management, where a single case manager is responsible for linking patients with multiple relevant services. Objectives To conduct a systematic review  of all RCTs on the use of case management for helping drug abusers in or out of treatment. Outcome criteria included successful linkage with other......). Reference searching; personal communication; conference abstracts; book chapters on case management. Selection criteria Randomized controlled studies that compared a specific model of case management with either treatment as usual or another treatment model, included only patients with at least one alcohol...

  8. Cost-Effectiveness of Caries Prevention in Practice: A Randomized Controlled Trial.

    Science.gov (United States)

    O'Neill, C; Worthington, H V; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Tickle, M

    2017-07-01

    A 2-arm parallel-group randomized controlled trial measured the cost-effectiveness of caries prevention in caries-free children aged 2 to 3 y attending general practice. The setting was 22 dental practices in Northern Ireland. Participants were centrally randomized into intervention (22,600 ppm fluoride varnish, toothbrush, a 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized prevention advice) and control (advice only), both provided at 6-monthly intervals during a 3-y follow-up. The primary outcome measure was conversion from caries-free to caries-active states assessed by calibrated and blinded examiners; secondary outcome measures included decayed, missing, or filled teeth surfaces (dmfs); pain; and extraction. Cumulative costs were related to each of the trial's outcomes in a series of incremental cost effectiveness ratios (ICERs). Sensitivity analyses examined the impact of using dentist's time as measured by observation rather than that reported by the dentist. The costs of applying topical fluoride were also estimated assuming the work was undertaken by dental nurses or hygienists rather than dentists. A total of 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 in the intervention group and 547 in the control group) were included in the final analyses. The mean difference in direct health care costs between groups was £107.53 (£155.74 intervention, £48.21 control, P < 0.05) per child. When all health care costs were compared, the intervention group's mean cost was £212.56 more than the control group (£987.53 intervention, £774.97 control, P < 0.05). Statistically significant differences in outcomes were only detected with respect to carious surfaces. The mean cost per carious surface avoided was estimated at £251 (95% confidence interval, £454.39-£79.52). Sensitivity analyses did not materially affect the study's findings. This trial raises concerns about the cost-effectiveness of a fluoride-based intervention

  9. Saline Alone vs Saline plus Mannitol Hydration for the Prevention of Acute Cisplatin Nephrotoxicity: A Randomized Trial

    Science.gov (United States)

    2017-10-15

    REPORT TYPE 10/15/2017 Presentation 4. TITLE AND SUBTITLE Saline Alone vs Saline plus Mannitol Hydration for the Prevention of Acute Cisplatin ...Saline plus Mannitol Hydration for the Prevention of Acute Cisplatin Nephrotoxicity: A Randomized Trial Wilfred Dela Cruz, Frederick Flynt, Sandra...America Background Cisplatin is widely used as an effective chemotherapy in diverse neoplasms and is associated with renal toxicity. Several studies

  10. A parenting programme to prevent abuse of adolescents in South Africa: study protocol for a randomized controlled trial

    OpenAIRE

    Cluver, L; Meinck, F; Shenderovich, Y; Ward, CL; Herrero Romero, R; Lombard, C; Doubt, JS; Steinert, J; Catanho, R; Wittesaele, C; DeStone, S; Salah, N; Mpimilashe, P; Lachman, J; Loening, H

    2016-01-01

    Background An estimated one billion children experience child abuse each year, with the highest rates in low- and middle-income countries. The Sinovuyo Teen programme is part of Parenting for Lifelong Health, a WHO/UNICEF initiative to develop and test violence-prevention programmes for implementation in low-resource contexts. The objectives of this parenting support programme are to prevent the abuse of adolescents, improve parenting and reduce adolescent behavioural problems. This trial aim...

  11. Randomized trial of four noise-induced hearing loss and tinnitus prevention interventions for children.

    Science.gov (United States)

    Martin, William Hal; Griest, Susan E; Sobel, Judith L; Howarth, Linda C

    2013-02-01

    To evaluate the effectiveness of four NIHL prevention interventions at improving knowledge, attitudes, and intended behaviors regarding sound exposure and appropriate use of hearing protective strategies in children. A randomized trial of the four interventions with a non-intervention comparison group. Questionnaires were completed prior to, immediately after, and three months after each intervention. Interventions included: (1) A classroom presentation by older-peer educators, (2) A classroom presentation by health professionals, (3). Exploration of a museum exhibition, and (4). Exploration of an internet-based virtual museum. A comparison group received no intervention. Fifty-three fourth grade classrooms (1120 students) participated in the study. All interventions produced significant improvements but the number of improvements decreased over time. In terms of effectiveness, the classroom programs were more effective than the internet-based virtual exhibit, which was more effective than the visit to the museum exhibition. Self-reported exposures indicated that as many as 94.5% of participants were at risk for NIHL. Interpersonal, interactive educational interventions such as the classroom program are more effective and have longer impact than self-directed learning experiences for NIHL and tinnitus prevention, however each may have an important role in promoting hearing health in elementary school students.

  12. Acupuncture for Preventing Complications after Radical Hysterectomy: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Wei-min Yi

    2014-01-01

    Full Text Available We aimed to investigate the preventive effects of acupuncture for complications after radical hysterectomy. A single-center randomized controlled single-blinded trial was performed in a western-style hospital in China. One hundred and twenty patients after radical hysterectomy were randomly allocated to two groups and started acupuncture from sixth postoperative day for five consecutive days. Sanyinjiao (SP6, Shuidao (ST28, and Epangxian III (MS4 were selected with electrical stimulation and Zusanli (ST36 without electrical stimulation for thirty minutes in treatment group. Binao (LI14 was selected as sham acupuncture point without any stimulation in control group. The main outcome measures were bladder function and prevalence of postoperative complications. Compared with control group, treatment group reported significantly improved bladder function in terms of maximal cystometric capacity, first voiding desire, maximal flow rate, residual urine, and bladder compliance, and decreased bladder sensory loss, incontinence, and urinary retention on fifteenth and thirtieth postoperative days. Treatment group showed significant advantage in reduction of urinary tract infection on thirtieth postoperative day. But no significant difference between groups was observed for lymphocyst formation. By improving postoperative bladder function, early intervention of acupuncture may provide a valuable alternative method to prevent bladder dysfunctional disorders and urinary tract infection after radical hysterectomy.

  13. Pilot trial of a dissonance-based cognitive-behavioral group depression prevention with college students.

    Science.gov (United States)

    Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M

    2016-07-01

    Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = 0.64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming

    Science.gov (United States)

    Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen

    2014-01-01

    Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868

  15. [Personality traits of women participating in a breast cancer prevention trial].

    Science.gov (United States)

    Martino, Gemma; Bellati, Cristina; Cola, Alberto; Galperti, Gabriella; Krogh, Vittorio; Luci, Simona; Raimondi, Milena

    2002-01-01

    We have evaluated the psycho-social factors in women--during menopause with different biological characteristics--who participated in two extensive trials of breast cancer prevention: Diana1 and Tamoxifen. Through the use of a recognized personality test (MMPI, Minnesota Multiphasic Personality Inventory), we observed 500 healthy women who agreed to or refused the health care proposal. The findings show that the women who accept chemical preparations or to modify their dietary habits present different personality traits from those who refuse to adhere. One should ask oneself if the lack of homogeneity of the samples with a different concentration of psycho-social factors can alter the efficacy of a cancer prevention program. During chemoprevention studies, in which a high compliance could bring about a redundancy of experience of sickness, in coherence with our goal of health protection, we think it is necessary to supply psycho-social support which tempers any experience of physical, psychological and inter-personal discomfort in the healthy women. The cognitive model of the personality traits could be programmed also for the compliance of mammographical screening. This model requires the training of health care professionals.

  16. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients.

    Science.gov (United States)

    Bai, Yu; Chen, Dong-Feng; Wang, Rong-Quan; Chen, You-Xiang; Shi, Rui-Hua; Tian, De-An; Chen, Huifang; Eklund, Stefan; Li, Zhao-Shen

    2015-11-01

    High-dose intravenous esomeprazole is the only approved pharmacological treatment for the prevention of peptic ulcer rebleeding (currently approved in over 100 countries worldwide), but has not yet been approved in China. This study aimed to evaluate a high-dose esomeprazole intravenous regimen vs. an active control (cimetidine) for the prevention of rebleeding in Chinese patients with a high risk of peptic ulcer rebleeding who had undergone primary endoscopic hemostatic treatment. This was a parallel-group study conducted at 20 centers in China. The study comprised a randomized, double-blind, intravenous treatment phase of 72 h in which 215 patients received either high-dose esomeprazole (80 mg + 8 mg/h) or cimetidine (200 mg + 60 mg/h), followed by an open-label oral treatment phase in which all patients received esomeprazole 40 mg tablets once daily for 27 days. The primary outcome was the rate of clinically significant rebleeding within the first 72 h after initial endoscopic hemostatic therapy. Secondary outcomes included the rates of clinically significant rebleeding within 7 and 30 days; proportions of patients who had endoscopic retreatment and other surgery due to rebleeding; and number of blood units transfused. The rate of clinically significant rebleeding within 72 h was low overall (3.3%) and numerically lower in patients treated with esomeprazole compared with cimetidine (0.9% vs. 5.6%). Overall, the results of the secondary outcomes also showed a numerical trend towards superiority of esomeprazole over cimetidine. All treatments were well tolerated. In this phase 3, multicenter, randomized trial conducted in China, esomeprazole showed a numerical trend towards superior clinical benefit over cimetidine in the prevention of rebleeding in patients who had successfully undergone initial hemostatic therapy of a bleeding peptic ulcer, with a similar safety and tolerability profile. These findings suggest that esomeprazole may be an

  17. Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss: A Randomized Clinical Trial.

    Science.gov (United States)

    Ramakers, Geerte G J; Kraaijenga, Véronique J C; Cattani, Guido; van Zanten, Gijsbert A; Grolman, Wilko

    2016-06-01

    The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants' intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis. Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit. The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments. Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04). Newly induced tinnitus following sound exposure occurred in 3 of

  18. Can improving working memory prevent academic difficulties? A school based randomised controlled trial.

    Science.gov (United States)

    Roberts, Gehan; Quach, Jon; Gold, Lisa; Anderson, Peter; Rickards, Field; Mensah, Fiona; Ainley, John; Gathercole, Susan; Wake, Melissa

    2011-06-20

    Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If this preventive intervention can be shown to be efficacious, then

  19. Can improving working memory prevent academic difficulties? a school based randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Anderson Peter

    2011-06-01

    Full Text Available Abstract Background Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. Methods/Design This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. Discussion A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If

  20. Process evaluation results of a cluster randomised controlled childhood obesity prevention trial: the WAVES study

    Directory of Open Access Journals (Sweden)

    T. L. Griffin

    2017-08-01

    component was identified as the most challenging, VV the least. Median implementation score across schools was 56/75 (IQR, 51.0 - 60.8. Agreement between teacher logbooks and researcher observations was generally high, the main discrepancies occurred in session duration reporting where in some cases teachers’ estimations tended to be higher than researchers’. Conclusions The WAVES study model provides a rigorous and replicable approach to undertaking and analysing a multi-component process evaluation. Challenges to implementing school-based obesity prevention interventions have been identified which can be used to inform future trials. Trial registration ISRCTN97000586 . 19 May 2010.

  1. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  2. Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial.

    Science.gov (United States)

    Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda

    2013-08-13

    Posttraumatic stress disorder (PTSD) develops in 10-20% of injury patients. We developed a novel, self-guided Internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT) to prevent the onset of PTSD symptoms. To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients. Adult, level 1 trauma center patients were randomly assigned to receive the fully automated Trauma TIPS Internet intervention (n=151) or to receive no early intervention (n=149). Trauma TIPS consisted of psychoeducation, in vivo exposure, and stress management techniques. Both groups were free to use care as usual (nonprotocolized talks with hospital staff). PTSD symptom severity was assessed at 1, 3, 6, and 12 months post injury with a clinical interview (Clinician-Administered PTSD Scale) by blinded trained interviewers and self-report instrument (Impact of Event Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), self-reported depressive and anxiety symptoms (Hospital Anxiety and Depression Scale), and mental health care utilization. Intervention usage was documented. The mean number of intervention logins was 1.7, SD 2.5, median 1, interquartile range (IQR) 1-2. Thirty-four patients in the intervention group did not log in (22.5%), 63 (41.7%) logged in once, and 54 (35.8%) logged in multiple times (mean 3.6, SD 3.5, median 3, IQR 2-4). On clinician-assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (PInternet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high

  3. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  4. Mixing nulliparous and multiparous women in randomised controlled trials of preeclampsia prevention is debatable: evidence from a systematic review.

    Directory of Open Access Journals (Sweden)

    Emmanuel Simon

    Full Text Available BACKGROUND: Nulliparity is a major risk factor of preeclampsia investigated in numerous trials of its prevention. OBJECTIVE: We aimed to assess whether these trials considered nulliparity in subject selection or analysis of results. SEARCH STRATEGY: 01 April 2013 search of MEDLINE via PubMed, EMBASE and the Cochrane Library. 01 April 2013 search of trials registered in Clinicaltrials.gov. SELECTION CRITERIA: Randomised controlled trials and metaanalyses of preeclampsia prevention with no restriction to period of publication or language. Metaanalyses were selected to fully identify relevant trials. DATA COLLECTION AND ANALYSIS: One reader appraised each selected article/registered protocol using a pretested, standardized data abstraction form developed in a pilot test. For each article, he recorded whether both nulliparous and multiparous were included and, in case of mixed populations, whether randomisation was stratified, and whether subgroup analyses had been reported. For registered protocols, he only assessed whether it was planned to include mixed populations. MAIN RESULTS: 88 randomised controlled trials were identified, representing 83,396 included women. In 58 of the 88 articles identified (65.9%, preeclampsia was the primary outcome. In 31 of these (53.4%, the investigation combined nulliparous and multiparous women; only two reports in 31 (6.5% stated that randomisation was stratified on parity and only four (12.9% described a subgroup analysis by parity. Of the 30 registered trials, 20 (66.6% planned to include both nulliparous and multiparous women. CONCLUSION: Parity is largely ignored in randomised controlled trials of preeclampsia prevention, which raises difficulties in interpreting the results.

  5. Randomized clinical trial comparing 2 support surfaces: results of the Prevention of Pressure Ulcers Study.

    Science.gov (United States)

    Russell, Linda J; Reynolds, Tim M; Park, Carol; Rithalia, Shyam; Gonsalkorale, M; Birch, Jan; Torgerson, David; Iglesias, Cynthia

    2003-11-01

    To determine whether a viscoelastic polymer (energy absorbing) foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost-effectiveness in comparison with standard hospital mattresses. Unblinded, randomized, prospective trial. Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom. 1168 patients at risk of developing pressure ulcers (Waterlow score, 15 to 20), with a median age of 83 years (25th to 75th percentile range, 79-87). Participants were allocated to either the experimental equipment (CONFOR-Med mattress/cushion combination) or a standard mattress/cushion combination; all were given standard nursing care. Pressure areas were observed daily. Development of nonblanching erythema. A significant decrease in the incidence of blanching erythema (26.3% to 19.9%; P =.004) and a nonsignificant decrease in the incidence of nonblanching erythema occurred in participants allocated to the experimental equipment. However, when the survival curve plots were analyzed at 7 days, both categories showed statistically significant decreases (P =.0015 and P =.042, respectively). Participants on standard equipment had a relative odds ratio of 1.36 (95% confidence interval [CI], 1.10-1.69) for developing blanching erythema or worse and 1.46 (95% CI, 0.90-1.82) for developing nonblanching erythema or worse. To prevent nonblanching erythema, the number needed to treat (NNT) was 41.9 (95% CI, -82.6-15.3). To prevent any erythema (blanching or nonblanching), the NNT was 11.5 (95% CI, 41.6-9.3). Participants with blanching or nonblanching erythema were significantly less mobile than participants with normal skin and more likely to have worsening mobility (P pressure ulcer status, mattress type was not associated with difference in mobility. Regardless of prevention routine, pressure ulcers occur. In this study, the experimental equipment showed statistical significance to standard equipment

  6. Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence.

    Science.gov (United States)

    Kruis, W; Kardalinos, V; Eisenbach, T; Lukas, M; Vich, T; Bunganic, I; Pokrotnieks, J; Derova, J; Kondrackiene, J; Safadi, R; Tuculanu, D; Tulassay, Z; Banai, J; Curtin, A; Dorofeyev, A E; Zakko, S F; Ferreira, N; Björck, S; Diez Alonso, M M; Mäkelä, J; Talley, N J; Dilger, K; Greinwald, R; Mohrbacher, R; Spiller, R

    2017-08-01

    Previous studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis. To investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis. Two phase 3, randomised, placebo-controlled, double-blind multicentre trials (SAG-37 and SAG-51) investigated mesalazine granules in patients with prior episodes (diverticulitis. Patients were randomised to receive either 3 g mesalazine once daily or placebo (SAG-37, n=345) or to receive either 1.5 g mesalazine once daily, 3 g once daily or placebo for 96 weeks (SAG-51, n=330). The primary endpoint was the proportion of recurrence-free patients during 48 weeks (SAG-37 and SAG-51) or 96 weeks (SAG-51) of treatment. Mesalazine did not increase the proportion of recurrence-free patients over 48 or 96 weeks compared to placebo. In SAG-37, the proportion of recurrence-free patients during 48 weeks was 67.9% with mesalazine and 74.4% with placebo (P=.226). In SAG-51, the proportion of recurrence-free patients over 48 weeks was 46.0% with 1.5 g mesalazine, 52.0% with 3 g mesalazine and 58.0% with placebo (P=.860 for 3 g mesalazine vs placebo) and over 96 weeks 6.9%, 9.8% and 23.1% respectively (P=.980 for 3 g mesalazine vs placebo). Patients with only one diverticulitis episode in the year prior to study entry had a lower recurrence risk compared to >1 episode. Safety data revealed no new adverse events. Mesalazine was not superior to placebo in preventing recurrence of diverticulitis. © 2017 The Authors. Alimentary Pharmacology and Therapeutics published by John Wiley & Sons Ltd.

  7. The effects of a tailored intensive care unit delirium prevention protocol: A randomized controlled trial.

    Science.gov (United States)

    Moon, Kyoung-Ja; Lee, Sun-Mi

    2015-09-01

    A decreased incidence of delirium following the application of non-pharmacologic intervention protocols to several patient populations has been previously reported. However, few studies have been conducted to examine the effects of their application to intensive care unit (ICU) patients. To examine the effects of applying a tailored delirium preventive protocol, developed by the authors, to ICU patients by analyzing its effects on delirium incidence, in-hospital mortality, ICU readmission, and length of ICU stay in a Korean hospital. A single-blind randomized controlled trial. A 1049-bed general hospital with a 105-bed ICU. Sixty and 63 ICU patients were randomly assigned to the intervention and control groups, respectively. The researchers applied the delirium prevention protocol to the intervention group every day for the first 7 days of ICU hospitalization. Delirium incidence, mortality, and re-admission to the ICU during the same hospitalization period were analyzed by logistic regression analysis; the 7- and 30-day in-hospital mortality by Kaplan-Meier survival and Cox proportional hazard regression analysis; and length of ICU stay was assessed by linear regression analysis. Application of the protocol had no significant effect on delirium incidence, in-hospital mortality, re-admission to the ICU, or length of ICU stay. Whereas the risk of 30-day in-hospital mortality was not significantly lower in the intervention than in the control group (OR: 0.33; 95% CI: 0.10-1.09), we found a significantly decreased 7-day in-hospital mortality in the intervention group after protocol application (HR: 0.09; 95% CI: 0.01-0.72). Application of a tailored delirium prevention protocol to acute stage patients during the first 7 days of ICU hospitalization appeared to reduce the 7-day in-hospital risk of mortality only for this patient population. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. The effectiveness of collaborative care for people with memory problems in primary care: results of the CAREDEM case management modelling and feasibility study.

    Science.gov (United States)

    Iliffe, Steve; Waugh, Amy; Poole, Marie; Bamford, Claire; Brittain, Katie; Chew-Graham, Carolyn; Fox, Chris; Katona, Cornelius; Livingston, Gill; Manthorpe, Jill; Steen, Nick; Stephens, Barbara; Hogan, Vanessa; Robinson, Louise

    2014-08-01

    only 60% of the expected number of people, most living in care homes. All stakeholders were positive about the potential of case management; however, only one of the four practices achieved a level of case management activity that might have influenced patient and carer outcomes. Case managers' activity levels were not related solely to time available for case management. Delivery of case management was hindered by limited clarity about the role, poor integration with existing services and a lack of embeddedness within primary care. There were discrepancies between case manager and researcher judgements about need, and evidence of a high threshold for acting on unmet need. The practice nurses experienced difficulties in ring-fencing case management time. The model of case management developed and evaluated in this feasibility study is unlikely to be sustainable in general practice under current conditions and in our view it would not be appropriate to attempt a definitive trial of this model. This study could inform the development of a case management role with a greater likelihood of impact. Different approaches to recruiting and training case managers, and identifying people with dementia who might benefit from case management, are needed, as is exploration of the scale of need for this type of working. Current Controlled Trials ISRCTN74015152. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 52. See the NIHR Journals Library website for further project information.

  9. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  10. Caseload management, work-related stress and case manager self-efficacy among Victorian mental health case managers.

    Science.gov (United States)

    King, Robert

    2009-05-01

    In Australia and comparable countries, case management has become the dominant process by which public mental health services provide outpatient clinical services to people with severe mental illness. There is recognition that caseload size impacts on service provision and that management of caseloads is an important dimension of overall service management. There has been little empirical investigation, however, of caseload and its management. The present study was undertaken in the context of an industrial agreement in Victoria, Australia that required services to introduce standardized approaches to caseload management. The aims of the present study were therefore to (i) investigate caseload size and approaches to caseload management in Victoria's mental health services; and (ii) determine whether caseload size and/or approach to caseload management is associated with work-related stress or case manager self-efficacy among community mental health professionals employed in Victoria's mental health services. A total of 188 case managers responded to an online cross-sectional survey with both purpose-developed items investigating methods of case allocation and caseload monitoring, and standard measures of work-related stress and case manager personal efficacy. The mean caseload size was 20 per full-time case manager. Both work-related stress scores and case manager personal efficacy scores were broadly comparable with those reported in previous studies. Higher caseloads were associated with higher levels of work-related stress and lower levels of case manager personal efficacy. Active monitoring of caseload was associated with lower scores for work-related stress and higher scores for case manager personal efficacy, regardless of size of caseload. Although caseloads were most frequently monitored by the case manager, there was evidence that monitoring by a supervisor was more beneficial than self-monitoring. Routine monitoring of caseload, especially by a workplace

  11. Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

    Science.gov (United States)

    Andrasik, Michele Peake; Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

    2014-06-01

    Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

  12. What is Case Management? A Scoping and Mapping Review

    Directory of Open Access Journals (Sweden)

    Sue Lukersmith

    2016-10-01

    Full Text Available The description of case management in research and clinical practice is highly variable which impedes quality analysis, policy and planning. Case management makes a unique contribution towards the integration of health care, social services and other sector services and supports for people with complex health conditions. There are multiple components and variations of case management depending on the context and client population. This paper aims to scope and map case management in the literature to identify how case management is described in the literature for key complex health conditions (e.g., brain injury, diabetes, mental health, spinal cord injury. Following literature searches in multiple databases, grey literature and exclusion by health condition, community-based and adequate description, there were 661 potential papers for data extraction. Data from 79 papers (1988–2013 were analysed to the point of saturation (no new information and mapped to the model, components and activities. The results included 22 definitions, five models, with 69 activities or tasks of case managers mapped to 17 key components (interventions. The results confirm the significant terminological variance in case management which produces role confusion, ambiguity and hinders comparability across different health conditions and contexts. There is an urgent need for an internationally agreed taxonomy for the coordination, navigation and management of care.

  13. Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section

    NARCIS (Netherlands)

    A. Herdan; R. Roth; D. Grass; M. Klimek (Markus); S. Will; B. Schauf; R. Rossaint; M. Heesen

    2011-01-01

    textabstractHypotension is a frequent complication of spinal anaesthesia for caesarean section and can threaten the well-being of the unborn child. Numerous randomised controlled trials (RCTs) dealt with measures to prevent hypotension. The aim of this study was to determine the reporting quality of

  14. Preventing heavy alcohol use in adolescents (PAS): cluster randomized trial of a parent and student intervention offered separately and simultaneously

    NARCIS (Netherlands)

    Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.

    2009-01-01

    Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19

  15. Cranberries vs antibiotics to prevent urinary tract infections: a randomized double-blind noninferiority trial in premenopausal women

    NARCIS (Netherlands)

    Beerepoot, Mariëlle A. J.; ter Riet, Gerben; Nys, Sita; van der Wal, Willem M.; de Borgie, Corianne A. J. M.; de Reijke, Theo M.; Prins, Jan M.; Koeijers, Jeanne; Verbon, Annelies; Stobberingh, Ellen; Geerlings, Suzanne E.

    2011-01-01

    The increasing prevalence of uropathogens resistant to antimicrobial agents has stimulated interest in cranberries to prevent recurrent urinary tract infections (UTIs). In a double-blind, double-dummy noninferiority trial, 221 premenopausal women with recurrent UTIs were randomized to 12-month

  16. A Meta-Analysis of Trials Evaluating Patient Education and Counseling for Three Groups of Preventive Health Behaviors.

    Science.gov (United States)

    Mullen, Patricia Dolan; Simons-Morton, Denise G.; Ramirez, Gilbert; Frankowski, Ralph F.; Green, Lawrence W.; Mains, Douglas A.

    1997-01-01

    The overall effectiveness of patient education and counseling on preventive health behaviors was examined across published clinical trials, 1971-1994. The effectiveness of various approaches for modifying specific types of behaviors among patients without diagnosed disease was assessed. Multiple regression models indicated differences among…

  17. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no

  18. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial.

    Science.gov (United States)

    Bourgeois, Florence T; Simons, William W; Olson, Karen; Brownstein, John S; Mandl, Kenneth D

    2008-03-14

    Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues. The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention. We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees. The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did

  19. Aspirin for Evidence-Based Preeclampsia Prevention trial: influence of compliance on beneficial effect of aspirin in prevention of preterm preeclampsia.

    Science.gov (United States)

    Wright, David; Poon, Liona C; Rolnik, Daniel L; Syngelaki, Argyro; Delgado, Juan Luis; Vojtassakova, Denisa; de Alvarado, Mercedes; Kapeti, Evgenia; Rehal, Anoop; Pazos, Andrea; Carbone, Ilma Floriana; Dutemeyer, Vivien; Plasencia, Walter; Papantoniou, Nikos; Nicolaides, Kypros H

    2017-12-01

    The Aspirin for Evidence-Based Preeclampsia Prevention trial was a multicenter study in women with singleton pregnancies. Screening was carried out at 11-13 weeks' gestation with an algorithm that combines maternal factors and biomarkers (mean arterial pressure, uterine artery pulsatility index, and maternal serum pregnancy-associated plasma protein A and placental growth factor). Those with an estimated risk for preterm preeclampsia of >1 in 100 were invited to participate in a double-blind trial of aspirin (150 mg/d) vs placebo from 11-14 until 36 weeks' gestation. Preterm preeclampsia with delivery at aspirin group, as compared with 4.3% (35/822) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 to 0.74). We sought to examine the influence of compliance on the beneficial effect of aspirin in prevention of preterm preeclampsia in the Aspirin for Evidence-Based Preeclampsia Prevention trial. This was a secondary analysis of data from the trial. The proportion of prescribed tablets taken was used as an overall measure of compliance. Logistic regression analysis was used to estimate the effect of aspirin on the incidence of preterm preeclampsia according to compliance of aspirin group with compliance ≥90%, in 8/243 (3.3%) of participants in the aspirin group with compliance aspirin group for preterm preeclampsia was 0.24 (95% confidence interval, 0.09-0.65) for compliance ≥90% and 0.59 (95% confidence interval, 0.23-1.53) for compliance aspirin in the prevention of preterm preeclampsia appears to depend on compliance. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

    2015-03-08

    Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

  1. Pressure mapping to prevent pressure ulcers in a hospital setting: A pragmatic randomised controlled trial.

    Science.gov (United States)

    Gunningberg, Lena; Sedin, Inga-Maj; Andersson, Sara; Pingel, Ronnie

    2017-07-01

    Pressure ulcers cause suffering to patients and costs to society. Reducing pressure at the interface between the patient's body and the support surface is a valid clinical intervention for reducing the risk of pressure ulcers. However, studies have shown that knowledge of how to reduce pressure and shear and to prevent pressure ulcers is lacking. To evaluate the effect of a pressure mapping system on pressure ulcer prevalence and incidence in a hospital setting. Pragmatic randomised controlled trial. A geriatric/internal medical ward with 26 beds in a Swedish university hospital. 190 patients were recruited (intervention: n=91; control: n=99) over a period of 9 months. Patients were eligible if they were over 50 years old, admitted to the ward between Sunday 4pm and Friday 4pm, and expected to stay in the ward ≥3 days. The continuous bedside pressure mapping system displays the patient's pressure points in real-time colour imagery showing how pressure is distributed at the body-mat interface. The system gives immediate feedback to staff about the patient's pressure points, facilitating preventive interventions related to repositioning. It was used from admittance to discharge from the ward (or 14 days at most). Both intervention and control groups received standard pressure ulcer prevention care. No significant difference in the prevalence and incidence of pressure ulcers was shown between intervention and control groups. The prevalence of pressure ulcers in the intervention group was 24.2% on day 1 and 28.2% on day 14. In the control group the corresponding numbers were 18.2% and 23.8%. Seven of 69 patients (10.1%) in the intervention group and seven of 81 patients (8.6%) in the control group who had no pressure ulcers on admission developed category 1 and category 2 ulcers during their hospital stay. The incidence rate ratio between the intervention and control groups was 1.13 (95% CI: 0.34-3.79). This study failed to demonstrate a beneficial effect of a

  2. The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

    Science.gov (United States)

    Williams, Lauren T; Hollis, Jenna L; Collins, Clare E; Morgan, Philip J

    2013-10-25

    Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition. The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44-50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25-29.9 kg/m²) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months). The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led

  3. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

    Science.gov (United States)

    Wasserman, Danuta; Hoven, Christina W; Wasserman, Camilla; Wall, Melanie; Eisenberg, Ruth; Hadlaczky, Gergö; Kelleher, Ian; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Iosue, Miriam; Kaess, Michael; Kahn, Jean-Pierre; Keeley, Helen; Musa, George J; Nemes, Bogdan; Postuvan, Vita; Saiz, Pilar; Reiter-Theil, Stella; Varnik, Airi; Varnik, Peeter; Carli, Vladimir

    2015-04-18

    Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025

  4. Universal parenting programme to prevent early childhood behavioural problems: cluster randomised trial.

    Science.gov (United States)

    Hiscock, Harriet; Bayer, Jordana K; Price, Anna; Ukoumunne, Obioha C; Rogers, Susan; Wake, Melissa

    2008-02-09

    To determine whether a parenting programme, offered universally in primary care, can prevent behavioural problems in children and improve parenting and maternal mental health. Cluster randomised trial. 40 primary care nursing centres (clusters) in Victoria, Australia. 733 English speaking mothers of 8 month old children sequentially recruited from well child appointments; 656 retained at 24 months. Structured three session programme at age 8-15 months, co-led by well child providers and a parenting expert. The programme covered normal development and behaviour, strategies to increase desired behaviour, and strategies to reduce unwanted behaviour. Maternal report of child externalising behaviour (child behavior checklist 1(1/2)-5 year old), parenting (parent behavior checklist), and maternal mental health (depression anxiety stress scales) at 18 and 24 months. At 18 months, child behaviour and parenting scores were similar in the two groups. At 24 months, externalising scores in the intervention and control groups were similar (mean 11.9 (SD 7.2) v 12.9 (7.4)); however, on the parent behavior checklist subscale scores, intervention group parents were less likely to report harsh/abusive parenting (mean 38.9 (SD 7.7) v 40.5 (8.8); adjusted mean difference -1.83, 95% confidence interval -3.12 to -0.55) and unreasonable expectations of child development (40.9 (9.9) v 42.7 (9.6); -2.18, -3.74 to -0.62). Mean scores for nurturing parenting and maternal mental health were similar in the two groups at both times. A universal parenting programme resulted in modest improvement in parenting factors that predict behavioural problems in children but did not reduce externalising behavioural problems or affect maternal mental health at 2 years. Trial registration ISRCTN 77531789.

  5. Intravenous amoxicillin/clavulanate for the prevention of bacteraemia following dental procedures: a randomized clinical trial.

    Science.gov (United States)

    Limeres Posse, J; Álvarez Fernández, M; Fernández Feijoo, J; Medina Henríquez, J; Lockhart, P B; Chu, V H; Diz Dios, P

    2016-07-01

    Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antibiotic prophylaxis regimens. This study aimed to evaluate the efficacy of four antimicrobial regimens for the prevention of bacteraemia following dental extractions. The study population included 266 adults requiring dental extractions who were randomly assigned to the following five groups: control (no prophylaxis); 1000/200 mg of amoxicillin/clavulanate intravenously; 2 g of amoxicillin by mouth; 600 mg of clindamycin by mouth; and 600 mg of azithromycin by mouth. Venous blood samples were collected from each patient at baseline and at 30 s, 15 min and 1 h after dental extractions. Samples were inoculated into BACTEC Plus culture bottles and processed in the BACTEC 9240. Conventional microbiological techniques were used for subcultures and further identification of the isolated bacteria. The trial was registered at ClinicalTrials.gov with ID number NCT02115776. The incidence of bacteraemia in the control, amoxicillin/clavulanate, amoxicillin, clindamycin and azithromycin groups was: 96%, 0%, 50%, 87% and 81%, respectively, at 30 s; 65%, 0%, 10%, 65% and 49% at 15 min; and 18%, 0%, 4%, 19% and 18% at 1 h. Streptococci were the most frequently identified bacteria. The percentage of positive blood cultures at 30 s post-extraction was lower in the amoxicillin/clavulanate group than in the amoxicillin group (P dental extractions was undetectable with amoxicillin/clavulanate prophylaxis. Alternative antimicrobial regimens should be sought for patients allergic to the β-lactams. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  6. Regular Exercise to Prevent the Recurrence of Gestational Diabetes Mellitus: A Randomized Controlled Trial.

    Science.gov (United States)

    Guelfi, Kym J; Ong, Ming Jing; Crisp, Nicole A; Fournier, Paul A; Wallman, Karen E; Grove, J Robert; Doherty, Dorota A; Newnham, John P

    2016-10-01

    To investigate the effect of a supervised home-based exercise program on the recurrence and severity of gestational diabetes mellitus (GDM) together with other aspects of maternal health and obstetric and neonatal outcomes. This randomized controlled trial allocated women with a history of GDM to an exercise intervention (14-week supervised home-based stationary cycling program) or to a control group (standard care) at 13±1 weeks of gestation. The primary outcome was a diagnosis of GDM. Secondary outcomes included maternal fitness, psychological well-being, and obstetric and neonatal outcomes. A sample size of 180 (90 in each group) was required to attain 80% power to detect a 40% reduction in the incidence of GDM. Between June 2011 and July 2014, 205 women provided written consent and completed baseline assessments. Of these, 33 (16%) were subsequently excluded as a result of an elevated baseline oral glucose tolerance test (OGTT), leaving 172 randomized to exercise (n=85) or control (n=87). Three women miscarried before the assessment of outcome measures (control=2; exercise=1). All remaining women completed the postintervention OGTT. The recurrence rate of GDM was similar between groups (control 40% [n=34]; exercise 40.5% [n=34]; P=.95) and the severity of GDM at diagnosis was unaffected by the exercise program with similar glucose and insulin responses to the OGTT (glucose 2 hours post-OGTT 7.7±1.5 compared with 7.6±1.6 mmol/L; P>.05). Maternal fitness was improved by the exercise program (P.05). Supervised home-based exercise started at 14 weeks of gestation did not prevent the recurrence of GDM; however, it was associated with important benefits for maternal fitness and psychological well-being. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01283854.

  7. Surgical mask to prevent influenza transmission in households: a cluster randomized trial.

    Directory of Open Access Journals (Sweden)

    Laetitia Canini

    2010-11-01

    Full Text Available Facemasks and respirators have been stockpiled during pandemic preparedness. However, data on their effectiveness for limiting transmission are scarce. We evaluated the effectiveness of facemask use by index cases for limiting influenza transmission by large droplets produced during coughing in households.A cluster randomized intervention trial was conducted in France during the 2008-2009 influenza season. Households were recruited during a medical visit of a household member with a positive rapid influenza A test and symptoms lasting less than 48 hours. Households were randomized either to the mask or control group for 7 days. In the intervention arm, the index case had to wear a surgical mask from the medical visit and for a period of 5 days. The trial was initially intended to include 372 households but was prematurely interrupted after the inclusion of 105 households (306 contacts following the advice of an independent steering committee. We used generalized estimating equations to test the association between the intervention and the proportion of household contacts who developed an influenza-like illness during the 7 days following the inclusion. Influenza-like illness was reported in 24/148 (16.2% of the contacts in the intervention arm and in 25/158 (15.8% of the contacts in the control arm and the difference between arms was 0.40% (95%CI: -10% to 11%, P = 1.00. We observed a good adherence to the intervention. In various sensitivity analyses, we did not identify any trend in the results suggesting effectiveness of facemasks.This study should be interpreted with caution since the lack of statistical power prevents us to draw formal conclusion regarding effectiveness of facemasks in the context of a seasonal epidemic.clinicaltrials.gov NCT00774774.

  8. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

    Science.gov (United States)

    Bellad, M B; Tara, D; Ganachari, M S; Mallapur, M D; Goudar, S S; Kodkany, B S; Sloan, N L; Derman, R

    2012-07-01

    Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Double-blind randomised controlled trial. A teaching hospital: J N Medical College, Belgaum, India. A cohort of 652 consenting eligible pregnant women admitted to the labour room. Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  9. Cluster-randomized xylitol toothpaste trial for early childhood caries prevention

    Science.gov (United States)

    Chi, Donald L.; Tut, Ohnmar K.; Milgrom, Peter

    2013-01-01

    Purpose We assessed the efficacy of supervised toothbrushing with xylitol toothpaste to prevent early childhood caries (ECC) and to reduce mutans streptococci (MS). Methods In this cluster-randomized efficacy trial, 4 Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400ppm/31% fluoride-xylitol (Epic Dental, Provo, UT) or 1,450ppm fluoride-sorbitol toothpaste (Colgate-Palmolive, New York, NY) (N=196 children, ages 4–5 yrs). We hypothesized no difference in efficacy between the two types of toothpaste. The primary outcome was primary molar d2-3mfs increment after 6 mos. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children) and 2 classrooms to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. Results There was no difference between the two groups in baseline or end-of-trial mean d2-3mfs. The mean d2-3mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d2-3mfs, respectively), but the difference was not significant (95% CI:−0.17, 2.37;P=0.07). No adverse effects were reported. Conclusion After 6 mos, brushing with a low strength xylitol/fluoride toothpaste is no more efficacious in reducing ECC than a fluoride only toothpaste in a high caries risk child population. PMID:24709430

  10. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    Science.gov (United States)

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.

    2009-01-01

    BACKGROUND AND PURPOSE: Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces...... strokes in subjects with recent stroke or transient ischemic attack (n=4731). We analyzed SPARCL trial data to determine whether treatment favorably shifts the distribution of severities of ischemic cerebrovascular outcomes. METHODS: Severity was assessed with the National Institutes of Health Stroke...... Scale, Barthel Index, and modified Rankin Scale score at enrollment (1 to 6 months after the index event) and 90 days poststroke in subjects having a stroke during the trial. RESULTS: Over 4.9 years, strokes occurred in 576 subjects. There were reductions in fatal, severe (modified Rankin Scale score 5...

  12. A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Hull, Mark A; Sandell, Anna C; Montgomery, Alan A; Logan, Richard F A; Clifford, Gayle M; Rees, Colin J; Loadman, Paul M; Whitham, Diane

    2013-07-29

    The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials. The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2×2 factorial 'efficacy' study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55-73 year-old patients, who have been identified as 'high risk' (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and 'advanced') per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as 'intermediate risk' for future surveillance. Exploratory end-points include levels of

  13. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Xuelong Zhou

    Full Text Available Dezocine is considered to be an alternative medication for managing postoperative pain. The aim of this study was to assess the efficacy and safety of this drug in this regard.Medline, EMBASE and the Cochrane Central Register of Control Trials (CENTRAL were searched to identify all randomized controlled trials (RCTs that compare dezocine with placebo or dezocine with morphine on postoperative pain. The data were extracted and pooled using Mantel-Haenszel random effects model. Heterogeneity was tested using the I2 statistic with values >50% and Chi2 test with P ≤ 0.05 indicating obvious heterogeneity between the studies.Seven trials evaluating 665 patients were included. The number of patients with at least 50% pain relief was increased (N = 234; RR 3.04, 95% CI 2.27 to 4.08 and physician (N = 465; RR 2.84, 95% CI 1.66 to 4.84 and patient satisfaction (N = 390; RR 2.81, 95% CI 1.85 to 4.26 were improved following the administration of dezocine compared with the placebo. The effects of dezocine were similar to those of morphine in terms of the number of patients reporting at least 50% pain relief within 2-6 h after surgery (N = 235; RR 1.29, 95% CI 1.15 to 1.46 and physician (N = 234; RR 1.18, 95% CI 0.93 to 1.49 and patient (N = 158; RR 1.33, 95% CI 0.93 to 1.92 satisfaction. While, the number of patients with at least 50% pain relief within 0-1 h after surgery increased following dezocine compared with morphine treatment (N = 79; RR 1.45, 95% CI 1.18 to 1.77. There was no difference in the incidence of postoperative nausea and vomiting (PONV following dezocine treatment compared with the placebo (N = 391; RR 1.06, 95% CI 0.42 to 2.68 or morphine treatment (N = 235; RR 0.65, 95% CI 0.14 to 2.93.Dezocine is a promising analgesic for preventing postoperative pain, but further studies are required to evaluate its safety.

  14. Experiences in conducting multiple community-based HIV prevention trials among women in KwaZulu-Natal, South Africa

    Directory of Open Access Journals (Sweden)

    Moodley Jothi

    2010-04-01

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

  15. A prostaglandin E2 receptor antagonist prevents pregnancies during a preclinical contraceptive trial with female macaques.

    Science.gov (United States)

    Peluffo, M C; Stanley, J; Braeuer, N; Rotgeri, A; Fritzemeier, K-H; Fuhrmann, U; Buchmann, B; Adevai, T; Murphy, M J; Zelinski, M B; Lindenthal, B; Hennebold, J D; Stouffer, R L

    2014-07-01

    Can administration of a prostaglandin (PG) E2 receptor 2 (PTGER2) antagonist prevent pregnancy in adult female monkeys by blocking periovulatory events in the follicle without altering menstrual cyclicity or general health? This is the first study to demonstrate that a PTGER2 antagonist can serve as an effective non-hormonal contraceptive in primates. The requirement for PGE2 in ovulation and the release of an oocyte surrounded by expanded cumulus cells (cumulus-oocyte expansion; C-OE) was established through the generation of PTGS2 and PTGER2 null-mutant mice. A critical role for PGE2 in primate ovulation is supported by evidence that intrafollicular injection of indomethacin in rhesus monkeys suppressed follicle rupture, whereas co-injection of PGE2 with indomethacin resulted in ovulation. First, controlled ovulation protocols were performed in adult, female rhesus monkeys to analyze the mRNA levels for genes encoding PGE2 synthesis and signaling components in the naturally selected pre-ovulatory follicle at different times after the ovulatory hCG stimulus (0, 12, 24, 36 h pre-ovulation; 36 h post-ovulation, n = 3-4/time point). Second, controlled ovarian stimulation cycles were utilized to obtain multiple cumulus-oocyte complexes (COCs) from rhesus monkeys to evaluate the role of PGE2 in C-OE in vitro (n = 3-4 animals/treatment; ≥3 COCs/animal/treatment). Third, adult cycling female cynomolgus macaques were randomly assigned (n = 10/group) to vehicle (control) or PTGER2 antagonist (BAY06) groups to perform a contraceptive trial. After the first treatment cycle, a male of proven fertility was introduced into each group and they remained housed together for the duration of the 5-month contraceptive trial that was followed by a post-treatment reversibility trial. Quantitative real-time PCR, COC culture and expansion, immunofluorescence/confocal microscopy, enzyme immunoassay, contraceptive trial, ultrasonography, complete blood counts, serum biochemistry tests

  16. Obesity weight management and bariatric surgery case management programs: a review of literature.

    Science.gov (United States)

    Echols, Jennie

    2010-01-01

    The proportion of Americans with clinically severe obesity has vast implications for the nation's healthcare system since this population have twice as many chronic medical conditions as people with normal weight. Through the use of review of literature, this article (a) describes the types of weight loss programs; (b) reviews the results from studies on effectiveness of bariatric surgery; and (c) identifies recommendations for obesity and bariatric surgery case management programs. Disease management companies appear to be concentrating on general weight loss strategies associated with wellness and other condition-specific disease management products, whereas larger national healthcare companies with at-risk and insurance products offer specific bariatric surgery management products. Case management programs within healthcare systems, health management organizations, and insurance companies are frequently faced with the management of individuals with morbid obesity and, increasingly, those who are requesting or have undergone bariatric surgery. Research shows that morbid obesity is a disease that remains generally unresponsive to diet and drug therapy but appears to respond well to bariatric surgery. Research findings suggest that surgical treatment is more effective than pharmacological treatment of weight loss and the control of some comorbidities associated with obesity. The number of Americans having weight loss surgery increased by 804% between 1998 and 2004, which appears to be a driver for the recent development of obesity disease management and bariatric surgery case management programs. Although the immaturity and lack of studies citing outcomes of obesity disease and case management programs limit the identification of best practices based on outcomes, emerging practices can be identified and recommendations for case management can be formulated. In addition to primary prevention and treatment programs for obesity, this article describes program

  17. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions.

    Science.gov (United States)

    Brienza, David; Kelsey, Sheryl; Karg, Patricia; Allegretti, Ana; Olson, Marian; Schmeler, Mark; Zanca, Jeanne; Geyer, Mary Jo; Kusturiss, Marybeth; Holm, Margo

    2010-12-01

    To determine the efficacy of skin protection wheelchair seat cushions in preventing pressure ulcers in the elderly nursing home population. Clinical trial with participants assigned at random to a skin protection or segmented foam cushion. Two hundred thirty-two participants were recruited between June 2004 and May 2008 and followed for 6 months or until pressure ulcer incidence. Twelve nursing homes. Nursing home residents aged 65 and older who were using wheelchairs for 6 or more hours per day and had a Braden score of 18 or less and a combined Braden activity and mobility score of 5 or less. Participants were recruited from a referred sample. All participants were provided with a fitted wheelchair and randomized into skin protection (SPC, n=113) or segmented foam (SFC, n=119) cushion groups. The SPC group received an air, viscous fluid and foam, or gel and foam cushion. The SFC group received a 7.6-cm crosscut foam cushion. Pressure ulcer incidence over 6 months for wounds near the ischial tuberosities (IT ulcers) were measured. Secondary analysis was performed on combined IT ulcers and ulcers over the sacrum and coccyx (sacral ulcers). One hundred eighty participants reached a study end point, and 42 were lost to follow-up. Ten did not receive the intervention. There were eight (6.7%) IT ulcers in the SFC group and one (0.9%) in the SPC group (P=.04). There were 21 (17.6%) combined IT and sacral ulcers in the SFC group and 12 (10.6%) in the SPC group (P=.14). Skin protection cushions used with fitted wheelchairs lower pressure ulcer incidence for elderly nursing home residents and should be used to help prevent pressure ulcers. © 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.

  18. Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial.

    Science.gov (United States)

    Kemper, Alex R; Barnett, Elizabeth D; Walter, Emmanuel B; Hornik, Christoph; Pierre-Joseph, Natalie; Broder, Karen R; Silverstein, Michael; Harrington, Theresa

    2017-11-01

    Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduces postvaccination presyncope, a potential syncope precursor. We conducted a randomized trial of subjects aged 11 to 21 years receiving ≥1 intramuscular vaccine in primary care clinics. Intervention subjects were encouraged to drink 500 mL of water, with vaccination recommended 10 to 60 minutes later. Control subjects received usual care. Presyncope symptoms were assessed with a 12-item survey during the 20-minutes postvaccination. Symptoms were classified with a primary cutoff sensitive for presyncope, and a secondary, more restrictive cutoff requiring greater symptoms. Results were adjusted for clustering by recruitment center. There were 906 subjects randomly assigned to the control group and 901 subjects randomly assigned to the intervention group. None had syncope. Presyncope occurred in 36.2% of subjects by using the primary definition, and in 8.0% of subjects by using the restrictive definition. There were no significant differences in presyncope by intervention group for the primary (1-sided test, P = .24) or restrictive outcome (1-sided test, P = .17). Among intervention subjects vaccinated within 10 to 60 minutes after drinking all 500 mL of water ( n = 519), no reduction in presyncope was observed for the primary or restrictive outcome (1-sided tests, P = .13, P = .17). In multivariable regression analysis, presyncope was associated with younger age, history of passing out or nearly passing out after a shot or blood draw, prevaccination anxiety, receiving >1 injected vaccine, and greater postvaccination pain. Drinking water before vaccination did not prevent postvaccination presyncope. Predictors of postvaccination presyncope suggest opportunities for presyncope and syncope prevention interventions. Copyright © 2017 by the

  19. Preventing Preschool Mental Health Problems: Population-Based Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Hiscock, Harriet; Gulenc, Alisha; Ukoumunne, Obioha C; Gold, Lisa; Bayer, Jordana; Shaw, Daniel; Le, Ha; Wake, Melissa

    2018-01-01

    Prevention of child behavior problems may reduce later mental health problems. We compared the effectiveness, at the population level, of an efficacious targeted prevention program alone or following a universal parenting program. Three-arm, cluster randomized controlled trial. One thousand three hundred fifty-three primary caregivers and healthy 8-month-old babies recruited from July 2010 to January 2011 from well-child centers (randomization unit). Child Behavior Checklist (CBCL) externalizing and internalizing scales* at child ages 3 and 4.5 years. Parenting Behavior Checklist* and over-involved/protective parenting (primary caregiver report). Secondary caregivers completed starred measures at age 3. Retention was 76% and 77% at ages 3 and 4.5 years, respectively. At 3 years, intention-to-treat analyses found no statistically significant differences (adjusted mean difference [95% confidence interval (CI); p-value]) for externalizing (targeted vs usual care -0.2 [-1.7 to 1.2; p = .76]; combined vs usual care 0.4 [-1.1 to 1.9; p = .60]) or internalizing behavior problems (targeted vs usual care 0.2 [-1.2 to 1.6; p = .76]; combined vs usual care 0.4 [-1.1 to 2.0; p = .58]). Primary outcomes were similar at 4.5 years. At 3 years, primary and secondary caregivers reported less over-involved/protective parenting in both the combined and targeted versus usual care arm; secondary caregivers also reported less harsh discipline in the combined and targeted versus usual care arm. Mean program costs per family were A$218 (targeted arm) and A$682 (combined arm). When translated to the population level by existing staff, pre-existing programs seemed ineffective in improving child behavior, alone or in combination, but improved parenting.

  20. Short stick exercises for fall prevention among older adults: a cluster randomized trial.

    Science.gov (United States)

    Yokoi, Katsushi; Yoshimasu, Kouichi; Takemura, Shigeki; Fukumoto, Jin; Kurasawa, Shigeki; Miyashita, Kazuhisa

    2015-01-01

    To investigate the effects of short stick exercise (SSEs) on fall prevention and improvement of physical function in older adults. A cluster randomized trial was conducted in five residential care facilities. The intervention group (n = 51) practiced SSEs for six months, followed by routine care for six more months. The control group (n = 54) received ordinary care for 12 months. The primary outcome measure was the number of fallers, taking into account the time to first fall using the Kaplan-Meier method. The secondary outcome measures were physical and mental functions. The number of fallers was significantly lower in the intervention group (n = 6) than in the control group (n = 16) during the 12 months. The adjusted hazard ratio for a first fall in the intervention group compared with the control group was 0.15 (CI, 0.03 to 0.74, p = 0.02). The fall-free period was significantly longer in the intervention group than in controls (mean ± SD, 10.1 ± 3.0 versus 9.0 ± 4.1 months, p = 0.027). The functional reach and sit and reach tests were significantly improved at three and six months. The SSEs appeared effective for fall prevention and improvement of physical function in older adults. Implications for Rehabilitation The newly developed short stick exercises appear an effective means of reducing falls among older adults in residential care facilities. The short stick exercises seem to have an immediate effect on improving physical functions. Effects gained by performing the short stick exercises, such as static balance, flexibility and agility may last for six months. The short stick exercises were found to be easy for older adults to practice continuously in residential care facilities.

  1. A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor.

    Science.gov (United States)

    Boulware, David R

    2006-01-01

    Jellyfish stings are a common occurrence among ocean goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. The objective is to evaluate the field efficacy of the jellyfish sting inhibitor, Safe Sea. A double-blind, randomized, placebo-controlled trial occurred at the Dry Tortugas National Park, FL, USA and Sapodilla Cayes, Belize. Participants were healthy volunteers planning to snorkel for 30 to 45 minutes. Ten minutes prior to swimming, each participant was directly observed applying a blinded sample of Safe Sea (Nidaria Technology Ltd, Jordan Valley, Israel) to one side of their body and a blinded sample of Coppertone (Schering-Plough, Kenilworth, NJ, USA) to the contralateral side as placebo control. Masked 26 g samples of both Safe Sea SPF15 and Coppertone SPF15 were provided in identical containers to achieve 2 mg/cm(2) coverage. Sides were randomly chosen by participants. The incidence of jellyfish stings was the main outcome measure. This was assessed by participant interview and examination as subjects exited the water. A total of 82 observed water exposures occurred. Thirteen jellyfish stings occurred during the study period for a 16% incidence. Eleven jellyfish stings occurred with placebo, two with the sting inhibitor, resulting in a relative risk reduction of 82% (95% confidence interval: 21%-96%; p= 0.02). No seabather's eruption or side effects occurred. Safe Sea is a topical barrier cream effective at preventing >80% jellyfish stings under real-world conditions.

  2. Options for the delivery of intermittent preventive treatment for malaria to children: a community randomised trial.

    Directory of Open Access Journals (Sweden)

    Margaret Kweku

    2009-09-01

    Full Text Available Intermittent preventive treatment for malaria in children (IPTc is a promising new intervention for the prevention of malaria but its delivery is a challenge. We have evaluated the coverage of IPTc that can be achieved by two different delivery systems in Ghana.IPTc was delivered by volunteers in six villages (community-based arm and by health workers at health centres or at Expanded Programme on Immunisation outreach clinics (facility based in another six communities. The villages were selected randomly and drugs were administered in May, June, September and October 2006. The first dose of a three-dose regimen of amodiaquine plus sulphadoxine-pyrimethamine was administered under supervision to 3-59 month-old children (n = 964 in the 12 study villages; doses for days 2 and 3 were given to parents/guardians to administer at home.The proportion of children who received at least the first dose of 3 or more courses of IPTc was slightly higher in the community based arm (90.5% vs 86.6%; p = 0.059. Completion of the three dose regimen was high and similar with both delivery systems (91.6% and 91.7% respectively.Seasonal IPTc delivered through community-based or facility-based systems can achieve a high coverage rate with the support and supervision of the district health management team. However, in order to maximise the impact of IPTc, both delivery systems may be needed in some settings.ClinicalTrials.gov NCT00119132.

  3. Schizophrenia, violence, and case management: being supportive and overwhelmed.

    Science.gov (United States)

    Rice, Elizabeth I

    2009-01-01

    The aim of this study is to understand the experiences of case managers as they delivered care to women who were diagnosed with schizophrenia and live with histories of violence. Interpretive phenomenology. Providers valued their relationships with women, yet felt overwhelmed and frustrated with aspects of the case management role. Case managers at times blamed women for the violence in their lives and lacked clarity with regard to their role assisting women in recovery. The violence and poverty that is common for these women is a key factor that increased providers' alienation and confusion as to their role in the provision of care. The educational and supportive needs of case managers must be addressed to uphold recovery-oriented services.

  4. Case Management of Dengue: Lessons Learned.

    Science.gov (United States)

    Kalayanarooj, Siripen; Rothman, Alan L; Srikiatkhachorn, Anon

    2017-03-01

    The global burden of dengue and its geographic distribution have increased over the past several decades. The introduction of dengue in new areas has often been accompanied by high case-fatality rates. Drawing on the experience in managing dengue cases at the Queen Sirikit National Institute of Child Health in Bangkok, Thailand, this article provides the authors' perspectives on key clinical lessons to improve dengue-related outcomes. Parallels between this clinical experience and outcomes reported in randomized controlled trials, results of efforts to disseminate practice recommendations, and suggestions for areas for further research are also discussed. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  5. Secondary Prevention of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus: International Insights From the TECOS Trial (Trial Evaluating Cardiovascular Outcomes With Sitagliptin).

    Science.gov (United States)

    Pagidipati, Neha J; Navar, Ann Marie; Pieper, Karen S; Green, Jennifer B; Bethel, M Angelyn; Armstrong, Paul W; Josse, Robert G; McGuire, Darren K; Lokhnygina, Yuliya; Cornel, Jan H; Halvorsen, Sigrun; Strandberg, Timo E; Delibasi, Tuncay; Holman, Rury R; Peterson, Eric D

    2017-09-26

    Intensive risk factor modification significantly improves outcomes for patients with diabetes mellitus and cardiovascular disease. However, the degree to which secondary prevention treatment goals are achieved in international clinical practice is unknown. Attainment of 5 secondary prevention parameters-aspirin use, lipid control (low-density lipoprotein cholesterol diabetes mellitus and known cardiovascular disease at entry into TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin). Logistic regression was used to evaluate the association between individual and regional factors and secondary prevention achievement at baseline. Cox proportional hazards regression analysis was used to determine the association between baseline secondary prevention achievement and cardiovascular death, myocardial infarction, or stroke. Overall, 29.9% of patients with diabetes mellitus and cardiovascular disease achieved all 5 secondary prevention parameters at baseline, although 71.8% achieved at least 4 parameters. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of ≈25%. Individually, blood pressure control (57.9%) had the lowest overall attainment, whereas nonsmoking status had the highest (89%). Over a median 3.0 years of follow-up, a higher baseline secondary prevention score was associated with improved outcomes in a step-wise graded relationship (adjusted hazard ratio, 0.60; 95% confidence interval, 0.47-0.77 for those patients achieving all 5 measures versus those achieving ≤2). In an international trial population, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes mellitus and cardiovascular disease, which in turn could lead to reduced risk of downstream cardiovascular events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00790205. © 2017 American Heart Association, Inc.

  6. Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling.

    Science.gov (United States)

    Tolley, Elizabeth E; Guthrie, Kate Morrow; Zissette, Seth; Fava, Joseph L; Gill, Katherine; Louw, Cheryl E; Kotze, Philip; Reddy, Krishnaveni; MacQueen, Kathleen

    2018-01-01

    Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research. Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4

  7. Dynamic Condition Response Graphs for Trustworthy Adaptive Case Management

    DEFF Research Database (Denmark)

    Mukkamala, Raghava Rao; Hildebrandt, Thomas; Slaats, Tijs

    2013-01-01

    semantics that supports both run time changes and formal verification. We show how these techniques are being implemented in industry as a component of the Exformatics case management tools. Finally we discuss the planned future work, which will aim to allow changes to be tested for conformance wrt policies...... specified either as linear time logic (LTL) or DCR Graphs, extend the language with time and data and offer extended support for cross-organizational case management systems....

  8. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

    Directory of Open Access Journals (Sweden)

    Alain Brunet

    2013-08-01

    Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.

  9. Transvaginal cervical length scans to prevent prematurity in twins: a randomized controlled trial.

    Science.gov (United States)

    Gordon, Michael C; McKenna, David S; Stewart, Theresa L; Howard, Bobby C; Foster, Kimberly F; Higby, Kenneth; Cypher, Rebecca L; Barth, William H

    2016-02-01

    Twin pregnancies are associated with an increased risk of perinatal morbidity and mortality primarily due to spontaneous preterm deliveries. The mean gestational age for delivery is 35.3 weeks and twins account for 23% of preterm births twin pregnancies. It follows that TVCL assessment may allow identification of a subset of twin pregnancies that re better candidates for interventions intended to prevent prematurity. We sought to determine whether use of TVCL prolongs gestation in twin pregnancies. This is a multicenter, randomized, controlled trial of 125 dichorionic or monochorionic/diamniotic twin pregnancies without prior preterm birth digital exams monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage. The control group (n = 62) had monthly digital cervical examinations but no routine TVCL ultrasound examinations. The primary outcome was gestational age at delivery. Secondary outcomes included percentage of deliveries twin gestations managed with TVCL and digital exams monthly from 16-28 weeks with a standard algorithm for activity restriction and cerclage and controls who had monthly digital cervical examinations but no routine TVCL. Routine second-trimester transvaginal ultrasound assessment of cervical length is not associated with improved outcomes when incorporated into the standard management of otherwise low-risk twin pregnancies. Published by Elsevier Inc.

  10. Impact of implementation and conduct of the HEALTHY primary prevention trial on student performance.

    Science.gov (United States)

    Hernandez, Arthur E; Marcus, Marsha D; Hirst, Kathryn; Faith, Myles S; Goldberg, Linn; Treviño, Roberto P

    2014-01-01

    To determine whether a school-wide intervention program to reduce risk factors for type 2 diabetes (T2D) affected student achievement, rates of disciplinary actions, and attendance rates. The HEALTHY primary prevention trial was designed to evaluate a comprehensive school-based intervention to reduce factors for T2D, especially overweight and obesity. Students were followed up from beginning of sixth grade (Fall 2006) through end of eighth grade (Spring 2009). Forty-two middle schools at seven U.S. sites. Schools were randomized in equal numbers at each site to intervention (21 schools, 2307 students) or control (21 schools, 2296 students). Intervention . An integrated school-wide program that focused on (1) foods and beverages, (2) physical education, (3) classroom-based behavior change and education, and (4) social marketing communication and promotional campaigns. Aggregate (grade- and school-wide) test performance (passing rate), attendance, and referrals for disciplinary actions. Descriptive statistics and tests of intervention versus control using mixed linear models methods to adjust for the clustering of students within schools. There were no differences between intervention and control schools in test performance for mathematics (p = .7835) or reading (p = .6387), attendance (p = .5819), or referrals for disciplinary action (p = .8671). The comprehensive HEALTHY intervention and associated research procedures did not negatively impact student achievement test scores, attendance, or referrals for disciplinary action.

  11. Self-determination theory and weight loss in a Diabetes Prevention Program translation trial.

    Science.gov (United States)

    Trief, Paula M; Cibula, Donald; Delahanty, Linda M; Weinstock, Ruth S

    2017-06-01

    We examined self-determination theory (SDT) and weight loss, and hypothesized that the Diabetes Prevention Program's (DPP) intervention would result in an increase in autonomous regulation of motivation (AR) in participants. Further, that those with higher AR, and those who perceived educators as supporting SDT-defined needs, would lose more weight. Support, Health Information, Nutrition and Exercise (SHINE) Study data (N = 257) were analyzed. SHINE was a randomized, controlled DPP translation trial (2-years, telephonic, primary care staff). Autonomous motivation in males increased significantly, while females showed no change. Males with high AR, but not females, lost more weight. However, the significance of these relationships varied over time. Participants who perceived educators as more supportive of psychological needs lost more weight (especially males). However, effect of support on weight loss was not mediated by AR change. Autonomous motivation and educator support are relevant to male weight loss. Future research might develop interventions to enhance autonomous motivation and educator support, and understand change pathways.

  12. Work, Weight, and Wellness: the 3W Program: a worksite obesity prevention and intervention trial.

    Science.gov (United States)

    Williams, Andrew E; Vogt, Thomas M; Stevens, Victor J; Albright, Cheryl A; Nigg, Claudio R; Meenan, Richard T; Finucane, Melissa L

    2007-11-01

    In this paper, we describe the aims, intervention, and design of the Work, Weight, and Wellness program, a group-randomized worksite obesity prevention and intervention trial being conducted at 31 hotels with 11,559 employees on the island of Oahu in Hawaii. We report baseline prevalence of overweight and obesity, and the distribution of BMI (kilograms per meter squared) across sex, race, and job categories. We also describe factors that have influenced intervention adoption and employee participation. The study's primary outcome is change in BMI among hotel employees over a 2-year intervention period. The intervention includes environmental and group components that target diet, physical activity, and weight management. Men, Pacific Islanders, and individuals employed in managerial or facility maintenance roles had higher prevalence of obesity and higher mean BMI than women and individuals from other races or in other occupational categories. These results may be helpful in guiding choices about the adoption or design of future worksite and community interventions addressing at-risk ethnically diverse populations and are especially relevant to the hotel industry and similar industries.

  13. Mycophenolate mofetil for prevention of liver allograft rejection: initial results of a controlled clinical trial.

    Science.gov (United States)

    Sterneck, M; Fischer, L; Gahlemann, C; Gundlach, M; Rogiers, X; Broelsch, C

    2000-01-01

    Mycophenolate Mofetil (M MF) is a new immunosuppressive agent with proven efficacy for the prevention of kidney allograft rejection. However, only little experience is available with the use of MMF in liver transplant recipients. In this prospective, controlled trial the efficacy and safety of MMF and Azathioprine (AZA) were compared in a Neoral based quadruple immunosuppressive regimen after orthotopic liver transplantation. Between 12/96 and 12/98 57 adult patients were enrolled in the study at the University of Hamburg. 28 patients were randomised to MMF, 29 patients to AZA in combination with equivalent doses of lymphocyte antibodies, Neoral and methylprednisolone. After a median follow-up of 10+/-3.2 months patient or graft survival did not differ significantly between the MMF and AZA group. However, MMF treated patients experienced less frequently acute rejection episodes (MMF: 6/28; 21.4% versus AZA: 13/29; 44.8%) (p=0.06). Furthermore, thrombocytopenia (MMF: 6/28; 21.4% versus AZA: 14/29; 48.3%) (ppreliminary data suggest that after liver transplantation primary immunosuppression with MMF is advantageous over AZA with regard to safety and efficacy.

  14. Does mindfulness have potential in eating disorders prevention? A preliminary controlled trial with young adult women.

    Science.gov (United States)

    Atkinson, Melissa J; Wade, Tracey D

    2016-06-01

    This preliminary randomized controlled trial assessed the feasibility of a pilot mindfulness-based intervention with respect to reducing the risk of eating disorders in young women. Forty-four young adult women with body image concerns (Mage  = 20.57, SD = 3.22) were randomly allocated to a mindfulness-based or a dissonance-based intervention (3 × 1 h weekly sessions), or to assessment-only control. Self-report measures of eating disorder risk factors, symptoms and related psychosocial impairment were compared at baseline, post-intervention, and at 1- and 6-month follow up. At post-intervention, acceptability ratings for both interventions were high. Mindfulness participants demonstrated statistically significant improvements relative to control at post-intervention for weight and shape concern, dietary restraint, thin ideal internalization, eating disorder symptoms and related psychosocial impairment; however, these gains were largely lost over follow up. Dissonance participants did not show statistically significant improvements relative to control on any outcomes, despite small to moderate effect sizes. These preliminary findings demonstrate the acceptability and short-term efficacy of a mindfulness-based approach to reducing the risk of disordered eating in young women. This provides support for the continued evaluation of mindfulness in the prevention and early intervention of eating disorders, with increased efforts to produce maintenance of intervention gains. © 2014 Wiley Publishing Asia Pty Ltd.

  15. Preventing childhood obesity by reducing consumption of carbonated drinks: cluster randomised controlled trial.

    Science.gov (United States)

    James, Janet; Thomas, Peter; Cavan, David; Kerr, David

    2004-05-22

    To determine if a school based educational programme aimed at reducing consumption of carbonated drinks can prevent excessive weight gain in children. Cluster randomised controlled trial. Six primary schools in southwest England. 644 children aged 7-11 years. Focused educational programme on nutrition over one school year. Drink consumption and number of overweight and obese children. Consumption of carbonated drinks over three days decreased by 0.6 glasses (average glass size 250 ml) in the intervention group but increased by 0.2 glasses in the control group (mean difference 0.7, 95% confidence interval 0.1 to 1.3). At 12 months the percentage of overweight and obese children increased in the control group by 7.5%, compared with a decrease in the intervention group of 0.2% (mean difference 7.7%, 2.2% to 13.1%). A targeted, school based education programme produced a modest reduction in the number of carbonated drinks consumed, which was associated with a reduction in the number of overweight and obese children.

  16. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. (c) 2015 APA, all rights reserved).

  17. Effect of probiotic preparation in preventing antibiotic associated diarrhea and colitis: a Clinical trial

    Directory of Open Access Journals (Sweden)

    Nader Zarinfar

    2014-08-01

    Full Text Available Background: Clostridium Difficile is the most common cause of antibiotic- associated diarrhea (AAD and antibiotic associated colitis (AAC in the hospital setting. In this Study, the preventive effect of Lactobacillus coagulance probiotic preparation was investigated on AAD and AAC. Material and Methods: In this double blind randomized clinical trial study, 300 patients under antibiotics treatment according to our inclusion and exclusion criteria were enrolled to the study and randomly divided into two groups, case (tab probiotic, 100mg/day and control group (placebo from initial antibiotic administration till one week after termination of antibiotic consumption. All patients were trained about the signs of diarrhea and colitis. Colitis signs, incidence of diarrhea and its culture findings for the presence of the toxin of Clostridium difficile were recorded and compared between groups. Data were analyzed with appropriate statistical tests and using version 16 of SPSS statistical software. Results: Antibiotic associated diarrhea (AAD was seen in 10 (6.6% and 16 (%10.6 patients of case and control group respectively. There was no significant difference between groups in AAD incidence and positive stool exam regarding the presence of Clostridium difficile toxin. Colitis syndrome were develop in 34 (22.8% and 86 (57% patients of the probiotic and placebo group respectively that was significantly low in case group (p<0.001. Conclusion: There was no statistically significant difference between probiotic group and placebo group in reducing AAD. But, consumption of Lactobacillus coagulance probiotic can reduce the incidence of antibiotic associated colitis.

  18. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

    Science.gov (United States)

    Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark; Livant, Edward; Palanee-Phillips, Thesla; Hendrix, Craig W; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Soto-Torres, Lydia E; Schwartz, Katie; Hillier, Sharon L; Baeten, Jared M

    2017-11-01

    Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. An upward trend in adherence was observed (P 95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.

  19. Process evaluation results of a cluster randomised controlled childhood obesity prevention trial: the WAVES study.

    Science.gov (United States)

    Griffin, T L; Clarke, J L; Lancashire, E R; Pallan, M J; Adab, P

    2017-08-29

    challenging, VV the least. Median implementation score across schools was 56/75 (IQR, 51.0 - 60.8). Agreement between teacher logbooks and researcher observations was generally high, the main discrepancies occurred in session duration reporting where in some cases teachers' estimations tended to be higher than researchers'. The WAVES study model provides a rigorous and replicable approach to undertaking and analysing a multi-component process evaluation. Challenges to implementing school-based obesity prevention interventions have been identified which can be used to inform future trials. ISRCTN97000586 . 19 May 2010.

  20. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial.

    Science.gov (United States)

    Brown, Gregory K; Ten Have, Thomas; Henriques, Gregg R; Xie, Sharon X; Hollander, Judd E; Beck, Aaron T

    2005-08-03

    Suicide attempts constitute a major risk factor for completed suicide, yet few interventions specifically designed to prevent suicide attempts have been evaluated. To determine the effectiveness of a 10-session cognitive therapy intervention designed to prevent repeat suicide attempts in adults who recently attempted suicide. Randomized controlled trial of adults (N = 120) who attempted suicide and were evaluated at a hospital emergency department within 48 hours of the attempt. Potential participants (N = 350) were consecutively recruited from October 1999 to September 2002; 66 refused to participate and 164 were ineligible. Participants were followed up for 18 months. Cognitive therapy or enhanced usual care with tracking and referral services. Incidence of repeat suicide attempts and number of days until a repeat suicide attempt. Suicide ideation (dichotomized), hopelessness, and depression severity at 1, 3, 6, 12, and 18 months. From baseline to the 18-month assessment, 13 participants (24.1%) in the cognitive therapy group and 23 participants (41.6%) in the usual care group made at least 1 subsequent suicide attempt (asymptotic z score, 1.97; P = .049). Using the Kaplan-Meier method, the estimated 18-month reattempt-free probability in the cognitive therapy group was 0.76 (95% confidence interval [CI], 0.62-0.85) and in the usual care group was 0.58 (95% CI, 0.44-0.70). Participants in the cognitive therapy group had a significantly lower reattempt rate (Wald chi2(1) = 3.9; P = .049) and were 50% less likely to reattempt suicide than participants in the usual care group (hazard ratio, 0.51; 95% CI, 0.26-0.997). The severity of self-reported depression was significantly lower for the cognitive therapy group than for the usual care group at 6 months (P= .02), 12 months (P = .009), and 18 months (P = .046). The cognitive therapy group reported significantly less hopelessness than the usual care group at 6 months (P = .045). There were no significant differences

  1. Go!: results from a quasi-experimental obesity prevention trial with hospital employees

    Directory of Open Access Journals (Sweden)

    Lara J. LaCaille

    2016-02-01

    other worksite obesity prevention studies using ecological approaches. Implementing low-impact physical activity (e.g., walking, stair use may be more readily incorporated into the worksite setting than more challenging behaviors of altering dietary habits and increasing more vigorous forms of physical activity. Trial Registration This study was registered with clinicaltrials.gov ( NCT01585480 on April 24, 2012.

  2. Low Vision Depression Prevention Trial in Age-Related Macular Degeneration

    Science.gov (United States)

    Rovner, Barry W.; Casten, Robin J.; Hegel, Mark T.; Massof, Robert W.; Leiby, Benjamin E.; Ho, Allen C.; Tasman, William S.

    2014-01-01

    Purpose To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Design Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Participants Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Interventions Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Main Outcome Measures The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire–25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). Results At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27–1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27–0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. Conclusions An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid

  3. Fall prevention by nursing assistants among community-living elderly people. A randomised controlled trial.

    Science.gov (United States)

    Fahlström, Gunilla; Kamwendo, Kitty; Forsberg, Jenny; Bodin, Lennart

    2017-08-29

    Falls among elderly are a major public health issue in Sweden. The aim was to determine whether nursing assistants can prevent falls by supervising community-living elderly individuals with a history of falling in performing individually designed home exercise programmes. A randomised controlled trial was performed in Sweden, in eight municipalities in the county of Örebro, during 2007-2009. Community-living persons 65 years or older having experienced at least one fall during the last 12 months were included. The intervention group consisted of 76 participants, and there were 72 in the control group. The interventions were free of charge and were shared between a physiotherapist and a nursing assistant. The former designed a programme aiming to improve balance, leg strength and walking ability. The nursing assistant supervised the performance of activities during eight home visits during a 5-month intervention period. The measures and instruments used were health-related quality of life (SF-36), activity of daily living (ADL-staircase), balance, (Falls Efficacy Scale, and Berg Balance Scale), walking ability (Timed Up and Go and the 3-metre walking test), leg strength, (chair stand test). All participants were asked to keep a structured calendar of their physical exercise, walks and occurrence of falls during their 12-month study period. Hospital healthcare consumption data were collected. Although the 5-month intervention did not significantly decrease the risk for days with falls, RR 1.10 (95% CI 0.58, 2.07), p = 0.77, significant changes in favour of the intervention group were noted for balance (p = 0.03), ADL (p = 0.035), bodily pain (p = 0.003) and reported health transition over time (p = 0.008) as well as less hospital care due to fractures (p = 0.025). Additional studies with more participants are needed to establish whether or not falls can be significantly prevented with this model which is workable in home-based fall prevention. © 2017

  4. Nursing case management in the millennium. Two perspectives.

    Science.gov (United States)

    Coile, R C; Matthews, P

    1999-01-01

    To prepare case managers for the next millennium, Russell Coile, a noted healthcare futurist, and Pamela Matthews, a respected clinician and consultant, participate in a dialogue. Coile takes a broad view of millennial issues, while Matthews responds to those issues with her clinician's perspective. Case management will face challenges and opportunities as a result of internal and external pressures to the healthcare community. These pressures, both near- and far-term, will simultaneously strengthen and tax the case manager's responsibilities. Developments in technology and demands for more and better access to high-quality patient information will require nursing case managers to expand their knowledge of, and influence over, the application of technology and information systems. Case managers will need to participate in advocating, planning, and deploying these systems. Technological challenges will not change case managers' fundamental roles within an organization, but they will strengthen and support those roles by harnessing the information necessary to allow more efficient outcomes, create standards of care, and increase patient satisfaction.

  5. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial: a multi-centred, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thompson Kara

    2010-12-01

    Full Text Available Abstract Background Despite lack of outward signs, most individuals after non-disabling stroke (NDS and transient ischemic attack (TIA have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress. In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity. Methods/Design A single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE. Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be

  6. The Value of Pre-Screening in the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease Trial.

    Science.gov (United States)

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

    2018-01-01

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

  7. Community-based trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection trial

    Directory of Open Access Journals (Sweden)

    Taylor-Robinson David

    2008-12-01

    Full Text Available Abstract Background Pelvic inflammatory disease (PID is common and can lead to tubal factor infertility, ectopic pregnancy or chronic pelvic pain. Despite major UK government investment in the National Chlamydia Screening Programme, evidence of benefit remains controversial. The main aim of this trial was to investigate whether screening and treatment of chlamydial infection reduced the incidence of PID over 12 months. Secondary aims were to conduct exploratory studies of the role of bacterial vaginosis (BV in the development of PID and of the natural history of chlamydial infection. Design Randomised controlled trial with follow up after 12 months. Setting non-healthcare Common rooms and lecture theatres at 20 universities and further education colleges in Greater London. Participants 2500 sexually active female students were asked to complete a questionnaire on sexual health and provide self-administered vaginal swabs and smears. Intervention Vaginal swabs from intervention women were tested for chlamydia by polymerase chain reaction (PCR and those infected referred for treatment. Vaginal swabs from control women were stored and analysed after a year. Vaginal smears were Gram stained and analysed for BV. Main outcome measure Incidence of clinical PID over 12 months in intervention and control groups. Possible cases of PID will be identified from questionnaires and record searches. Confirmation of the diagnosis will be done by detailed review of medical records by three independent researchers blind to whether the woman is in intervention or control group. Trial registration Clinical Trials NCT 00115388

  8. Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: a multicenter randomized placebo controlled trial.

    Science.gov (United States)

    Visser, Laura; de Boer, Marjon A; de Groot, Christianne J M; Nijman, Tobias A J; Hemels, Marieke A C; Bloemenkamp, Kitty W M; Bosmans, Judith E; Kok, Marjolein; van Laar, Judith O; Sueters, Marieke; Scheepers, Hubertina; van Drongelen, Joris; Franssen, Maureen T M; Sikkema, J Marko; Duvekot, Hans J J; Bekker, Mireille N; van der Post, Joris A M; Naaktgeboren, Christiana; Mol, Ben W J; Oudijk, Martijn A

    2017-07-14

    Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial. Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo. This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. Clinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.

  9. Improving preventive service delivery at adult complete health check-ups: the Preventive health Evidence-based Recommendation Form (PERFORM cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Moineddin Rahim

    2006-07-01

    Full Text Available Abstract Background To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting. Methods A prospective cluster randomized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto. Preventive Care Checklist Forms© were created to be used by family physicians at adult health check-ups over a five-month period. The sex-specific forms incorporate evidence-based recommendations on preventive health services and documentation space for routine procedures such as physical examination. The forms were used in two intervention clinics and two control clinics. Rates and relative risks (RR of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups. Results Randomly-selected charts were reviewed at baseline (n = 509 and post-intervention (n = 608. Baseline rates for provision of preventive health services ranged from 3% (fecal occult blood testing to 93% (blood pressure measurement, similar to other settings. The percentage of up-to-date preventive health services delivered per patient at the end of the intervention was 48.9% in the control group and 71.7% in the intervention group. This is an overall 22.8% absolute increase (p = 0.0001, and 46.6% relative increase in the delivery of preventive health services per patient in the intervention group compared to controls. Eight of thirteen preventive health services showed a statistically significant change (p Conclusion This simple, low cost, clinically relevant intervention improves the delivery of preventive health services by prompting physicians of evidence-based recommendations in a checklist format that incorporates existing practice patterns. Periodic updates

  10. Prevention

    Science.gov (United States)

    ... Error processing SSI file About Heart Disease & Stroke Prevention Heart disease and stroke are an epidemic in ... secondhand smoke. Barriers to Effective Heart Disease & Stroke Prevention Many people with key risk factors for heart ...

  11. Efficacy and safety of ondansetron in preventing postanesthesia shivering: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Tie, Hong-Tao; Su, Guang-Zhu; He, Kun; Liang, Shao-Rong; Yuan, Hao-Wei; Mou, Jun-Huan

    2014-03-03

    Shivering is a very common complication in the postanesthesia period. Increasing studies have reported ondansetron may be effective in prevention of postanesthesia shivering (PAS). However, the results remained controversial; hence we conducted a meta-analysis of randomized controlled trials to evaluate the efficacy and safety of ondansetron on the prevention of postanesthesia shivering. PubMed and Embase databases were searched to identify the eligible randomized controlled trials assessing the effect of ondansetron on the prevention of PAS. Results were expressed as risk ratios (RRs) with accompanying 95% confidence intervals (CIs). The meta-analysis was performed with fixed-effect model or random-effect model according to the heterogeneity. Six trials including 533 subjects were included. Compared with placebo, ondansetron was associated with a significant reduction of PAS (RR 0.43, 95% CI, 0.27-0.70), without an increased risk of bradycardia (RR 0.37, 95% CI, 0.12-1.15). Compared with meperidine, no difference was observed in the incidence of PAS (RR 0.68, 95% CI, 0.39-1.19) and bradycardia (RR 2.0, 95% CI, 0.38-10.64). Ondansetron has a preventive effect on PAS without a paralleled side effect of bradycardia.

  12. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial.

    Science.gov (United States)

    Wing, Rena R; Tate, Deborah; Espeland, Mark; Gorin, Amy; LaRose, Jessica Gokee; Robichaud, Erica Ferguson; Erickson, Karen; Perdue, Letitia; Bahnson, Judy; Lewis, Cora E

    2013-04-04

    Weight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young adults compared to a minimal treatment control. The interventions focus on either small, consistent changes in eating and exercise behaviors, or larger, periodic changes to buffer against expected weight gains. SNAP targets recruitment of six hundred young adults (18-35 years) with a body mass index between 21.0-30.0 kg/m2, who will be randomly assigned with equal probability to: (1) minimal intervention control; (2) self-regulation with Small Changes; or (3) self-regulation with Large Changes. Both interventions receive 8 weekly face-to-face group sessions, followed by 2 monthly sessions, with two 4-week refresher courses in each of subsequent years. Participants are instructed to report weight via web at least monthly thereafter, and receive monthly email feedback. Participants in Small Changes are taught to make small daily changes (~100 calorie changes) in how much or what they eat and to accumulate 2000 additional steps per day. Participants in Large Changes are taught to create a weight loss buffer of 5-10 pounds once per year to protect against anticipated weight gains. Both groups are encouraged to self-weigh daily and taught a self-regulation color zone system that specifies action depending on weight gain prevention success. Individualized treatment contact is offered to participants who report weight gains. Participants are assessed at baseline, 4 months, and then annually. The primary outcome is weight gain over an average of 3 years of follow-up; secondary outcomes include

  13. Integrating Behavioral HIV Interventions into Biomedical Prevention Trials with Youth: Lessons from Chicago’s Project PrEPare

    Science.gov (United States)

    Hosek, Sybil G.; Green, Keith R.; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A.; Kapogiannis, Bill

    2013-01-01

    On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM. PMID:24223514

  14. Antifungal Prevention of Systemic Candidiasis in Immunocompetent ICU Adults: Systematic Review and Meta-Analysis of Clinical Trials.

    Science.gov (United States)

    Dupont, Hervé; Mahjoub, Yazine; Chouaki, Taieb; Lorne, Emmanuel; Zogheib, Elie

    2017-11-01

    The aim of this study was to identify the impact of antifungal prevention in critically ill immunocompetent adult patients on mortality and subsequent infection. A systematic review and meta-analysis of randomized controlled trials comparing any antifungal use versus placebo to prevent candidiasis in ICU patients were performed. Searches were performed on PubMed, Embase, Scopus, main conference proceedings, and ClinicalTrials.gov, as well as reference lists. The primary outcomes were mortality and invasive candidiasis. The secondary outcome was the rate of Candida albicans and nonalbicans strains after treatment. A random effect model was used, and sensitivity analysis was performed for both outcomes. Results are expressed as risk ratios and their 95% CIs. Nineteen trials (10 with fluconazole, four with ketoconazole, one with itraconazole, three with micafungin, and one with caspofungin) including 2,792 patients were identified. No individual trial showed a decreased mortality rate. Combined analysis showed that preventive antifungal did not decrease mortality (risk ratio, 0.88; 95% CI, 0.74-1.04; p = 0.14) but significantly decreased secondary fungal infections by 50% (risk ratio, 0.49; 95% CI, 0.35-0.68; p = 0.0001). No shift across nonalbicans strains was observed during treatment (risk ratio, 0.62; 95% CI, 0.19-1.97; p = 0.42). However, publication biases preclude any definite conclusions for prevention of infection. Antifungal prevention of systemic candidiasis in immunocompetent critically ill adults did not reduce mortality and may have decreased secondary fungal infection rates. However, significant publication bias was present.

  15. Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding".

    Science.gov (United States)

    Montgomery, Elizabeth T; van der Straten, Ariane; Stadler, Jonathan; Hartmann, Miriam; Magazi, Busisiwe; Mathebula, Florence; Laborde, Nicole; Soto-Torres, Lydia

    2015-05-01

    There is widespread evidence that male partners influence women's ability and willingness to join HIV prevention trials and to use female-controlled prevention strategies such as microbicide gels. VOICE-C was an ancillary study to the Microbicide Trials Network's VOICE trial at the Johannesburg site that explored social and structural factors influencing women's use of study tablets and vaginal gel. Qualitative data were analyzed from 102 randomly-selected VOICE participants interviewed through in-depth interviews (IDI, n = 41); ethnographic interviews (n = 21) or focus group discussions (FGD, n = 40) and 22 male partners interviewed in 14 IDI and 2 FGD. Male partners' "understanding" pervaded as a central explanation for how male partners directly and indirectly influenced their female partners' trial participation and product use, irrespective of assignment to the gel or tablet study groups. The meaning behind "understanding" in this context was described by both men and women in two important and complementary ways: (1) "comprehension" of the study purpose including biological properties or effects of the products, and (2) "support/agreeability" for female partners being study participants or using products. During analysis a third dimension of "understanding" emerged as men's acceptance of larger shifts in gender roles and relationship power, and the potential implications of women's increased access to biomedical knowledge, services and prevention methods. Despite displays of some female agency to negotiate and use HIV prevention methods, male partners still have a critical influence on women's ability and willingness to do so. Efforts to increase their understanding of research goals, study design and products' mechanisms of action could ameliorate distrust, empower men to serve as product advocates, adherence buddies, and foster greater adherence support for women in situations where it is needed. Strategies to address gender norms and the broader

  16. Cost effectiveness of patient education for the prevention of falls in hospital: economic evaluation from a randomized controlled trial.

    Science.gov (United States)

    Haines, Terry P; Hill, Anne-Marie; Hill, Keith D; Brauer, Sandra G; Hoffmann, Tammy; Etherton-Beer, Christopher; McPhail, Steven M

    2013-05-22

    Falls are one of the most frequently occurring adverse events that impact upon the recovery of older hospital inpatients. Falls can threaten both immediate and longer-term health and independence. There is need to identify cost-effective means for preventing falls in hospitals. Hospital-based falls prevention interventions tested in randomized trials have not yet been subjected to economic evaluation. Incremental cost-effectiveness analysis was undertaken from the health service provider perspective, over the period of hospitalization (time horizon) using the Australian Dollar (A$) at 2008 values. Analyses were based on data from a randomized trial among n = 1,206 acute and rehabilitation inpatients. Decision tree modeling with three-way sensitivity analyses were conducted using burden of disease estimates developed from trial data and previous research. The intervention was a multimedia patient education program provided with trained health professional follow-up shown to reduce falls among cognitively intact hospital patients. The short-term cost to a health service of one cognitively intact patient being a faller could be as high as A$14,591 (2008). The education program cost A$526 (2008) to prevent one cognitively intact patient becoming a faller and A$294 (2008) to prevent one fall based on primary trial data. These estimates were unstable due to high variability in the hospital costs accrued by individual patients involved in the trial. There was a 52% probability the complete program was both more effective and less costly (from the health service perspective) than providing usual care alone. Decision tree modeling sensitivity analyses identified that when provided in real life contexts, the program would be both more effective in preventing falls among cognitively intact inpatients and cost saving where the proportion of these patients who would otherwise fall under usual care conditions is at least 4.0%. This economic evaluation was designed to assist

  17. Zika virus infections in pregnancy: epidemics and case management

    Directory of Open Access Journals (Sweden)

    Fatih sahiner

    2016-03-01

    Full Text Available Zika virus is an RNA virus belonging to the Flaviviridae family, and is primarily transmitted by Aedes mosquitoes. Only a small number of cases had been described until 2007 when the first major Zika virus outbreak occurred on Yap Island, Micronesia. Approximately 80% of people infected with Zika virus do not exhibit any symptoms. Symptomatic infections are generally moderate and characterized by acute onset of fever, maculopapular rash, arthralgia, or conjunctivitis. The virus has recently attracted a broad interest due to the emerging cases of microcephaly that are possibly associated with mothers infected by the Zika virus during pregnancy, and the regional increases in the incidence of Guillain-Barre syndrome during the epidemic periods. Although the relationship between Zika virus infection and these abnormalities is not obviously understood yet, Zika virus testing is recommended for infants with microcephaly or intracranial calcifications whose mothers were potentially infected with the Zika virus during pregnancy. Every day, new reports are being published about the outbreaks associated with this virus; nevertheless, no new cases of this virus have been reported in Turkey. Despite this, we cannot currently exclude the possibility of the encounter with the virus because of the presence of Aedes mosquitoes, which are responsible for the spread of the virus, are prevalent in Turkey, and an increasing number of travel-related cases are being reported from different countries. In the light of the current knowledge on this virus, this review aims to discuss the course of Zika virus infections in detail, especially congenital infection, and presenting current information about the case management and preventive measures. [Cukurova Med J 2016; 41(1.000: 143-151

  18. A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

    Science.gov (United States)

    Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

    2016-01-01

    Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  19. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial.

    Science.gov (United States)

    Silverstein, Michael; Diaz-Linhart, Yaminette; Cabral, Howard; Beardslee, William; Hegel, Mark; Haile, Winta; Sander, Jenna; Patts, Gregory; Feinberg, Emily

    2017-08-01

    Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy. To determine the efficacy of a depression prevention strategy embedded in Head Start. This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016. Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119). Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders. Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants

  20. A Phase II Clinical Trial Evaluating the Preventive Effectiveness of Lactobacillus Vaginal Suppositories in Patients with Recurrent Cystitis.

    Science.gov (United States)

    Wada, Koichiro; Uehara, Shinya; Ishii, Ayano; Sadahira, Takuya; Yamamoto, Masumi; Mitsuhata, Ritsuko; Takamoto, Atsushi; Araki, Motoo; Kobayashi, Yasuyuki; Watanabe, Masami; Watanabe, Toyohiko; Hotta, Katsuyuki; Nasu, Yasutomo

    2016-08-01

    Urinary tract infections (UTIs) are the most common bacterial infections in women, and many patients experience frequent recurrence. The aim of this report is to introduce an on-going prospective phase II clinical trial performed to evaluate the preventive effectiveness of Lactobacillus vaginal suppositories for prevention of recurrent cystitis. Patients enrolled in this study are administered vaginal suppositories containing the GAI 98322 strain of Lactobacillus crispatus every 2 days or 3 times a week for one year. The primary endpoint is recurrence of cystitis and the secondary endpoints are adverse events. Recruitment began in December 2013 and target sample size is 20 participants.

  1. 'It looks like you just want them when things get rough': civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials.

    Science.gov (United States)

    Koen, Jennifer; Essack, Zaynab; Slack, Catherine; Lindegger, Graham; Newman, Peter A

    2013-12-01

    Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised. © 2012 John Wiley & Sons Ltd.

  2. Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history - an open-label randomised trial (the EPPI trial): study protocol.

    Science.gov (United States)

    Groom, K M; McCowan, L M; Stone, P R; Chamley, L C; McLintock, C

    2016-11-22

    Preeclampsia and intrauterine fetal growth restriction (IUGR) are two of the most common causes of maternal and perinatal morbidity and mortality. Current methods of predicting those at most risk of these conditions remain relatively poor, and in clinical practice past obstetric history remains the most commonly used tool. Aspirin and, in women at risk of preeclampsia only, calcium have been demonstrated to have a modest effect on risk reduction. Several observational studies and randomised trials suggest that low molecular weight heparin (LMWH) therapy may confer some benefit. This is a multicentre open label randomised controlled trial to determine the effect of the LMWH, enoxaparin, on the prevention of recurrence of preeclampsia and/or IUGR in women at high risk due to their past obstetric history in addition to standard high risk care for all participants. A singleton pregnancy >6 +0 and 12 weeks having; (1) preeclampsia delivered preeclampsia). The primary outcome is preeclampsia and/or SGA prevention of placental mediated conditions. ACTRN12609000699268 Australian New Zealand Clinical Trials Registry. Date registered 13/Aug/2009 (prospective registration).

  3. Health coaching to prevent excessive gestational weight gain: A randomized-controlled trial.

    Science.gov (United States)

    Skouteris, Helen; McPhie, Skye; Hill, Briony; McCabe, Marita; Milgrom, Jeannette; Kent, Bridie; Bruce, Lauren; Herring, Sharon; Gale, Janette; Mihalopoulos, Cathrine; Shih, Sophy; Teale, Glyn; Lachal, Jennifer

    2016-02-01

    The objectives of this study were to evaluate the efficacy of a health coaching (HC) intervention designed to prevent excessive gestational weight gain (GWG), and promote positive psychosocial and motivational outcomes in comparison with an Education Alone (EA) group. Randomized-controlled trial. Two hundred and sixty-one women who were <18 weeks pregnant consented to take part. Those allocated to the HC group received a tailored HC intervention delivered by a Health Coach, whilst those in the EA group attended two education sessions. Women completed measures, including motivation, psychosocial variables, sleep quality, and knowledge, beliefs and expectations concerning GWG, at 15 weeks of gestation (Time 1) and 33 weeks of gestation (Time 2). Post-birth data were also collected at 2 months post-partum (Time 3). There was no intervention effect in relation to weight gained during pregnancy, rate of excessive GWG or birth outcomes. The only differences between HC and EA women were higher readiness (b = 0.29, 95% CIs = 0.03-0.55, p < .05) and the importance to achieve a healthy GWG (b = 0.27, 95% CIs = 0.02-0.52, p < .05), improved sleep quality (b = -0.22, 95% CIs = -0.44 to -0.03, p < .05), and increased knowledge for an appropriate amount of GWG that would be best for their baby's health (b = -1.75, 95% CI = -3.26 to -0.24, p < .05) reported by the HC at Time 2. Whilst the HC intervention was not successful in preventing excessive GWG, several implications for the design of future GWG interventions were identified, including the burden of the intervention commitment and the use of weight monitoring. What is already known on the subject? Designing interventions to address gestational weight gain (GWG) continues to be a challenge. To date, health behaviour change factors have not been the focus of GWG interventions. What does this study add? Our health coaching (HC) intervention did not reduce GWG more so than education alone (EA). There was an intervention effect

  4. Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Franciane Schneider

    2015-04-01

    Full Text Available OBJECTIVE To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. METHOD This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27 and experimental (24. RESULTS There is statistically significant evidence (p-value = 0.0120 that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402. CONCLUSION Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  5. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    Science.gov (United States)

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  6. Pharmacologic Prevention of Incident Atrial Fibrillation: Long-Term Results From the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).

    Science.gov (United States)

    Dewland, Thomas A; Soliman, Elsayed Z; Yamal, Jose-Miguel; Davis, Barry R; Alonso, Alvaro; Albert, Christine M; Simpson, Lara M; Haywood, L Julian; Marcus, Gregory M

    2017-12-01

    Although atrial fibrillation (AF) guidelines indicate that pharmacological blockade of the renin-angiotensin system may be considered for primary AF prevention in hypertensive patients, previous studies have yielded conflicting results. We sought to determine whether randomization to lisinopril reduces incident AF or atrial flutter (AFL) compared with chlorthalidone in a large clinical trial cohort with extended post-trial surveillance. We performed a secondary analysis of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial), a randomized, double-blind, active-controlled clinical trial that enrolled hypertensive individuals ≥55 years of age with at least one other cardiovascular risk factor. Participants were randomly assigned to receive amlodipine, lisinopril, or chlorthalidone. Individuals with elevated fasting low-density lipoprotein cholesterol levels were also randomized to pravastatin versus usual care. The primary outcome was the development of either AF or AFL as diagnosed by serial study ECGs or by Medicare claims data. Among 14 837 participants without prevalent AF or AFL, 2514 developed AF/AFL during a mean 7.5±3.2 years of follow-up. Compared with chlorthalidone, randomization to either lisinopril (hazard ratio, 1.04; 95% confidence interval, 0.94-1.15; P =0.46) or amlodipine (hazard ratio, 0.93; 95% confidence interval, 0.84-1.03; P =0.16) was not associated with a significant reduction in incident AF/AFL. Compared with chlorthalidone, treatment with lisinopril is not associated with a meaningful reduction in incident AF or AFL among older adults with a history of hypertension. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542. © 2017 American Heart Association, Inc.

  7. Towards eliminating malaria in high endemic countries: the roles of community health workers and related cadres and their challenges in integrated community case management for malaria: a systematic review.

    Science.gov (United States)

    Sunguya, Bruno F; Mlunde, Linda B; Ayer, Rakesh; Jimba, Masamine

    2017-01-03

    Human resource for health crisis has impaired global efforts against malaria in highly endemic countries. To address this, the World Health Organization (WHO) recommended scaling-up of community health workers (CHWs) and related cadres owing to their documented success in malaria and other disease prevention and management. Evidence is inconsistent on the roles and challenges they encounter in malaria interventions. This systematic review aims to summarize evidence on roles and challenges of CHWs and related cadres in integrated community case management for malaria (iCCM). This systematic review retrieved evidence from PubMed, CINAHL, ISI Web of Knowledge, and WHO regional databases. Terms extracted from the Boolean phrase used for PubMed were also used in other databases. The review included studies with Randomized Control Trial, Quasi-experimental, Pre-post interventional, Longitudinal and cohort, Cross-sectional, Case study, and Secondary data analysis. Because of heterogeneity, only narrative synthesis was conducted for this review. A total of 66 articles were eligible for analysis out of 1380 studies retrieved. CHWs and related cadre roles in malaria interventions included: malaria case management, prevention including health surveillance and health promotion specific to malaria. Despite their documented success, CHWs and related cadres succumb to health system challenges. These are poor and unsustainable finance for iCCM, workforce related challenges, lack of and unsustainable supply of medicines and diagnostics, lack of information and research, service delivery and leadership challenges. Community health workers and related cadres had important preventive, case management and promotive roles in malaria interventions. To enable their effective integration into the health systems, the identified challenges should be addressed. They include: introducing sustainable financing on iCCM programmes, tailoring their training to address the identified gaps

  8. Ankles back in randomized controlled trial (ABrCt: braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Verhagen Evert ALM

    2011-09-01

    Full Text Available Abstract Background Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. Methods/Design This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. Discussion The ABrCt is the first randomized controlled trial to directly compare the secondary preventive

  9. Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial.

    Science.gov (United States)

    1975-07-12

    The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospective randomised trial. 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial; 2076 of these were in the control group and 2045 patients received heparin. The two groups were well matched for age, sex, weight, blood-group, and other factors which could predispose to the development of venous thromboembolism. 180 (4-4 %) patients died during the postoperative period, 100 in the control and 80 in the heparin group: 72% of deaths in the control and 66% in the heparin group had necropsy examination. 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism (P smaller than 0-005). In addition, emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes. Taking all pulmonary emboli together, the findings were again significant (P smaller than 0-005). Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis (D.V.T.) 667 were in the control group and 625 in the heparin group. The frequency of isotopic D.V.T. was reduced from 24-6% in the control group 7-7% in the heparin group (P smaller 0-005). In 30 patients D.V.T. was detected at necropsy; 24 in the control and 6 in the heparin group (P smaller 0-005). 32 patients in the control group and 11 in the heparin group developed clinically diagnosed D.V.T. which was confirmed by venography (P smaller than 0-005). In addition, 24 patients in the control and 8 in the heparin group were treated for clinically suspected pulmonary emoblism. The difference in the number of patients requiring treatment for D.V.T. and/or pulmonary embolism in the two groups was

  10. Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia.

    Science.gov (United States)

    Kennedy, Stephen B; Bolay, Fatorma; Kieh, Mark; Grandits, Greg; Badio, Moses; Ballou, Ripley; Eckes, Risa; Feinberg, Mark; Follmann, Dean; Grund, Birgit; Gupta, Swati; Hensley, Lisa; Higgs, Elizabeth; Janosko, Krisztina; Johnson, Melvin; Kateh, Francis; Logue, James; Marchand, Jonathan; Monath, Thomas; Nason, Martha; Nyenswah, Tolbert; Roman, François; Stavale, Eric; Wolfson, Julian; Neaton, James D; Lane, H Clifford

    2017-10-12

    The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia. We initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated. A total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons). A

  11. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Ferrazzi, Paolo; Pullara, Alberto; Adler, Yehuda; Barosi, Alberto; Caforio, Alida L; Cemin, Roberto; Chirillo, Fabio; Comoglio, Chiara; Cugola, Diego; Cumetti, Davide; Dyrda, Oleksandr; Ferrua, Stefania; Finkelstein, Yaron; Flocco, Roberto; Gandino, Anna; Hoit, Brian; Innocente, Francesco; Maestroni, Silvia; Musumeci, Francesco; Oh, Jae; Pergolini, Amedeo; Polizzi, Vincenzo; Ristic, Arsen; Simon, Caterina; Spodick, David H; Tarzia, Vincenzo; Trimboli, Stefania; Valenti, Anna; Belli, Riccardo; Gaita, Fiorenzo

    2014-09-10

    Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients ≥70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in

  12. Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Wang, J; Yao, M; Xu, J-h; Shu, B; Wang, Y-j; Cui, X-j

    2016-05-01

    We conducted a systematic review of randomized controlled trials (RCTs) of bisphosphonates for the prevention of osteopenia in kidney-transplant recipients. Bisphosphonates improved bone mineral density at the lumbar spine and femoral neck after 12 months. However, additional well-designed RCTs are required to determine the optimal treatment strategy. Osteopenic-osteoporotic syndrome is a bone complication of renal transplantation. Bisphosphonates, calcitonin, and vitamin D analogs may be used to prevent or treat osteoporosis or bone loss after renal transplantation. However, there is currently no widely recognized strategy for the prevention of corticosteroid-induced osteoporosis. This study aims to assess the available evidence to guide the targeted use of bisphosphonates for reducing osteoporosis and bone loss in renal-transplant recipients. We searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE for randomized controlled trials of bisphosphonates for osteoporosis or bone loss after renal transplantation. A total of 352 abstracts were identified, of which 55 were considered for evaluation and 9 were included in the final analysis. The primary outcome measure was change in the bone mineral density (BMD) of the lumbar spine and femoral neck after 12 months. Data extraction was performed independently by two investigators. BMD at the lumbar spine was improved after treatment with bisphosphonates [9 trials; 418 patients; weighted mean difference (WMD), 0.61; 95 % confidence interval (CI), 0.16-1.06]. Eight trials (406 patients) that reported changes in BMD at the femoral neck also showed improved outcomes after treatment with bisphosphonates (WMD, 0.06; 95 % CI, 0.03-0.09). Bisphosphonates improve BMD at the lumbar spine and femoral neck after 12 months in renal-transplant recipients.

  13. A typology of practice narratives during the implementation of a preventive, community intervention trial.

    Science.gov (United States)

    Riley, Therese; Hawe, Penelope

    2009-12-14

    Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.

  14. Brief motivational feedback and cognitive behavioral interventions for prevention of disordered gambling: a randomized clinical trial.

    Science.gov (United States)

    Larimer, Mary E; Neighbors, Clayton; Lostutter, Ty W; Whiteside, Ursula; Cronce, Jessica M; Kaysen, Debra; Walker, Denise D

    2012-06-01

    The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Randomized clinical trial with assignment to a personalized feedback intervention (PFI), cognitive-behavioral intervention (CBI) or assessment-only control (AOC). PFI was delivered individually in a single session and included feedback regarding gambling behavior, norms, consequences and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over four to six sessions and included functional analysis and brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. College campus. At-risk or probable pathological gamblers (n = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions and beliefs. Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = 0.48; CBI d = 0.39) and DSM-IV criteria (PFI d = 0.60; CBI d = 0.48), reductions in frequency for PFI (d = 0.48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. A single-session personalized feedback intervention and a multi-session cognitive-behavioral intervention may be helpful in reducing disordered gambling in US college students. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  15. Evaluation of the Prostate Cancer Prevention Trial Risk calculator in a high-risk screening population.

    Science.gov (United States)

    Kaplan, David J; Boorjian, Stephen A; Ruth, Karen; Egleston, Brian L; Chen, David Y T; Viterbo, Rosalia; Uzzo, Robert G; Buyyounouski, Mark K; Raysor, Susan; Giri, Veda N

    2010-02-01

    Diagnostic (exploratory cohort). 2b. To evaluate the Prostate Cancer Prevention Trial (PCPT) risk calculator in a screening cohort of young, racially diverse, high-risk men with a low baseline prostate-specific antigen (PSA) level and enrolled in the Prostate Cancer Risk Assessment Program (PRAP). The PCPT calculator provides an assessment of prostate cancer risk based on age, PSA level, race, previous biopsy, and family history. Eligibility for PRAP includes men aged 35-69 years who are African-American, have a family history of prostate cancer, or have a known BRCA1/2 mutation. PCPT risk scores were determined for PRAP participants, and were compared to observed prostate cancer rates. In all, 624 participants were evaluated, including 382 (61.2%) African-American men and 242 (38.7%) men with a family history of prostate cancer; the median (range) age was 49.0 (34.0-69.0) years and the median PSA level 0.9 (0.1-27.2) ng/mL. The PCPT risk score correlated with prostate cancer diagnosis, as the median baseline risk score in patients diagnosed with prostate cancer was 31.3%, vs 14.2% in patients not diagnosed with prostate cancer (P calculator similarly stratified the risk of diagnosis of Gleason score > or =7 disease, as the median risk score was 36.2% in patients diagnosed with Gleason > or =7 prostate cancer vs 15.2% in all other participants (P calculator score was found to stratify prostate cancer risk in a cohort of young, primarily African-American men with a low baseline PSA level. These results support further evaluation of this predictive tool for assessing the risk of prostate cancer in high-risk men.

  16. A typology of practice narratives during the implementation of a preventive, community intervention trial

    Science.gov (United States)

    2009-01-01

    Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions. PMID:20003399

  17. Aspirin plus calcium supplementation to prevent superimposed preeclampsia: a randomized trial

    Directory of Open Access Journals (Sweden)

    E.V. Souza

    2014-05-01

    Full Text Available Preeclampsia is an important cause of maternal and perinatal morbidity and mortality. Previous studies have tested calcium supplementation and aspirin separately to reduce the incidence of preeclampsia but not the effects of combined supplementation. The objective of this study was to investigate the effectiveness of aspirin combined with calcium supplementation to prevent preeclampsia in women with chronic hypertension. A double-blind, placebo-controlled randomized clinical trial was carried out at the antenatal clinic of a large university hospital in São Paulo, SP, Brazil. A total of 49 women with chronic hypertension and abnormal uterine artery Doppler at 20-27 weeks gestation were randomly assigned to receive placebo (N = 26 or 100 mg aspirin plus 2 g calcium (N = 23 daily until delivery. The main outcome of this pilot study was development of superimposed preeclampsia. Secondary outcomes were fetal growth restriction and preterm birth. The rate of superimposed preeclampsia was 28.6% lower among women receiving aspirin plus calcium than in the placebo group (52.2 vs 73.1%, respectively, P=0.112. The rate of fetal growth restriction was reduced by 80.8% in the supplemented group (25 vs 4.8% in the placebo vs supplemented groups, respectively; P=0.073. The rate of preterm birth was 33.3% in both groups. The combined supplementation of aspirin and calcium starting at 20-27 weeks of gestation produced a nonsignificant decrease in the incidence of superimposed preeclampsia and fetal growth restriction in hypertensive women with abnormal uterine artery Doppler.

  18. Group Music Therapy as a Preventive Intervention for Young People at Risk: Cluster-Randomized Trial.

    Science.gov (United States)

    Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes

    2017-07-01

    Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  19. Mindfulness Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Glasner-Edwards, Suzette; Mooney, Larissa J; Ang, Alfonso; Garneau, Hélène Chokron; Hartwell, Emily; Brecht, Mary-Lynn; Rawson, Richard A

    2017-02-01

    In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.

  20. Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial.

    Science.gov (United States)

    Comper, Maria Luiza Caires; Dennerlein, Jack Tigh; Evangelista, Gabriela Dos Santos; Rodrigues da Silva, Patricia; Padula, Rosimeire Simprini

    2017-08-01

    Job rotation is an organisational strategy widely used on assembly lines in manufacturing industries to mitigate workers' exposure so as to prevent musculoskeletal disorders. This study aimed to evaluate the effectiveness of job rotation for reducing working hours lost due to sick leave resulting from musculoskeletal diseases. The design consisted of a 1-year cluster randomised controlled trial with a blinded assessor. Production sectors of the textile industry were randomised to intervention and control groups. Both groups received ergonomic training. The intervention group performed a job rotation programme. The primary outcome measure was number of working hours lost due to sick leave as a result of musculoskeletal disease (ICD-10). The secondary outcome measures were musculoskeletal symptoms (Yes/No), risk factors for musculoskeletal diseases (0-10), psychosocial factors and fatigue (0-100), general health (0-100), and productivity (0-10). All secondary outcomes were measured at baseline and 12-month follow-up. At the 12-month follow-up, both groups showed an increase in the number of working hours lost due to sick leave for musculoskeletal disease. There was no significant difference between the job rotation intervention group (mean deviation -5.6 hours, 95% CI -25.0 to 13.8) at the 12-month follow-up and the control group. There were no significant differences between groups for the secondary outcomes (p>0.05). The job rotation programme was not effective in reducing the number of working hours lost due to sick leave, decreasing the prevalence of musculoskeletal symptoms, or improving perception of musculoskeletal pain and workplace risk factors, psychosocial risk factors and productivity. NCT01979731. 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/.

  1. School-based eating disorder prevention: a pilot effectiveness trial of teacher-delivered Media Smart.

    Science.gov (United States)

    Wilksch, Simon M

    2015-02-01

    This pilot study tested teacher-delivered Media Smart, a school-based eating disorder prevention program that has achieved significant benefits when delivered by health professionals. Two Grade 7 classes (N = 51; M age = 12.43 years) participated, with one randomly allocated to Media Smart (n = 27; 67% girls) and the other to a control condition of usual lessons (n = 24; 37% girls). Program feasibility was assessed by teacher self-report, whereas student self-report of shape and weight concern (primary outcome variable) and seven additional risk factors were measured at baseline, post-program and 6-month follow up. Teacher ratings of program feasibility revealed that 25 of the 29 (86.2%) program activities were taught with 96% of activities rated as either highly (19 activities) or moderately (5 activities) valuable for students. Mixed model analyses were conducted using a 2 (group: Media Smart, control) × 2 (time: post-program, 6-month follow up) × 2 (gender: girls, boys) design, with baseline scores as a covariate. A not-significant trend for group favouring Media Smart was observed for shape and weight concern (Cohen's d effect size [d] = 0.32), whereas significant effects were found for feelings of ineffectiveness (d = 0.52) and weight-related peer teasing (d = 0.68). The program was feasible for teacher delivery and showed some promising results, supporting a more substantial randomized-controlled effectiveness trial. © 2013 Wiley Publishing Asia Pty Ltd.

  2. Falls prevention and balance rehabilitation in multiple sclerosis: a bi-centre randomised controlled trial.

    Science.gov (United States)

    Cattaneo, Davide; Rasova, Kamila; Gervasoni, Elisa; Dobrovodská, Gabriela; Montesano, Angelo; Jonsdottir, Johanna

    2018-03-01

    People with Multiple Sclerosis (PwMS) have a high incidence of accidental falls that have a potentially detrimental effect on their daily life participation. The effect of balance specific rehabilitation on clinical balance measures and frequency of falls in PwMS was studied. A bi-centre randomised rater-blinded controlled trial. Participants in both groups received 20 treatment sessions. Participants in the intervention group received treatment aimed at improving balance and mobility. Participants in the control group received treatments to reduce limitations at activity and body function level. Primary measures were frequency of fallers (>1 fall in two months) and responders (>3 points improvement) at the Berg Balance Scale (BBS). Data was analysed according to an intention to treat approach. One hundred and nineteen participants were randomised. Following treatment frequency of fallers was 22% in the intervention group and 23% in the control group, odds ratio (OR) and (confidence limits): 1.05 (0.41 to 2.77). Responders on the BBS were 28% in the intervention group and 33% in the control group, OR = 0.75 (0.30 to 1.91). At follow up ORs for fallers and responders at BBS were 0.98 (0.48 to 2.01) and 0.79 (0.26 to 2.42), respectively. Twenty sessions 2-3 times/week of balance specific rehabilitation did not reduce fall frequency nor improve balance suggesting the need for more frequent and challenging interventions. Implications for Rehabilitation Programs for balance rehabilitation can improve balance but their effects in fall prevention are unclear. Twenty treatments sessions 2/3 times per week did not reduced frequency of falls in MS. The comparison with similar studies suggests that higher intensity of practice of highly challenging balance activities appears to be critical to maximizing effectiveness.

  3. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial.

    Science.gov (United States)

    Ngai, Ivan M; Van Arsdale, Anne; Govindappagari, Shravya; Judge, Nancy E; Neto, Nicole K; Bernstein, Jeffrey; Bernstein, Peter S; Garry, David J

    2015-12-01

    To compare chlorhexidine with alcohol, povidone-iodine with alcohol, and both applied sequentially to estimate their relative effectiveness in prevention of surgical site infections after cesarean delivery. Women undergoing nonemergent cesarean birth at greater than 37 0/7 weeks of gestation were randomly allocated to one of three antiseptic skin preparations: povidone-iodine with alcohol, chlorhexidine with alcohol, or the sequential combination of both solutions. The primary outcome was surgical site infection reported within the first 30 days postpartum. Based on a surgical site infection rate of 12%, an anticipated 50% reduction for the combination group relative to either single skin preparation group, with a power of 0.90 and an α of 0.05, 430 women per group were needed to detect a difference. From January 2013 to July 2014, 1,404 women were randomly assigned to one of three groups: povidone-iodine with alcohol (n=463), chlorhexidine with alcohol (n=474), or both (n=467). The groups were similar with respect to demographics, medical disorders, indication for cesarean delivery, operative time, and blood loss. The overall rate of surgical site infection-4.3%-was lower than anticipated. The skin preparation groups had similar surgical site infection rates: povidone-iodine 4.6%, chlorhexidine with alcohol 4.5%, and sequential 3.9% (P=.85). The skin preparation techniques resulted in similar rates of surgical site infections. Our study provides no support for any particular method of skin preparation before cesarean delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01870583. I.

  4. Milk Sweetened with Xylitol: A Proof-of-Principle Caries Prevention Randomized Clinical Trial.

    Science.gov (United States)

    Chi, Donald L; Zegarra, Graciela; Vasquez Huerta, Elsa C; Castillo, Jorge L; Milgrom, Peter; Roberts, Marilyn C; Cabrera-Matta, Ailin R; Merino, Ana P

    2016-09-15

    To evaluate the efficacy of xylitol-sweetened milk as a caries-preventive strategy. In this nine-month prospective proof-of-principle trial, Peruvian schoolchildren were randomized to one of five different milk groups: (1) eight g of xylitol per 200 mL milk once per day; (2) four g of xylitol per 100 mL milk twice per day; (3) eight g of sorbitol per 200 mL milk once per day; (4) four g of sorbitol per 100 mL milk twice per day; or (5) eight g of sucrose per 200 mL milk once per day. The primary outcome was plaque mutans streptococci (MS) at nine months. A secondary outcome was caries incidence. We hypothesized that children in the xylitol groups would have a greater MS decline and lower caries incidence. One hundred fifty-three children were randomized in the intent-to-treat analyses. Children receiving xylitol had a greater decline in MS than children receiving sucrose (P=0.02) but were not different from children receiving sorbitol (P=0.07). Dental caries incidence for xylitol once per day or twice per day was 5.3±3.4 and 4.3±4.0 surfaces, respectively, compared to sorbitol once per day, sorbitol twice per day, or sucrose (4.1±2.8, 3.7±4.2, and 3.2±3.4 surfaces, respectively). There were no differences in caries incidence between xylitol and sucrose (rate ratio [RR] = 1.51; 95 percent confidence interval [CI] = 0.88, 2.59; P=0.13) or between xylitol and sorbitol (RR = 1.28; 95 percent CI = 0.90, 1.83; P=0.16). Xylitol-sweetened milk significantly reduced mutans streptococci levels compared to sucrose-sweetened milk, but differences in caries incidence were not detected.

  5. An interdisciplinary framework for measuring and supporting adherence in HIV prevention trials of ARV-based vaginal rings.

    Science.gov (United States)

    MacQueen, Kathleen M; Tolley, Elizabeth E; Owen, Derek H; Amico, K Rivet; Morrow, Kathleen M; Moench, Thomas; Friend, David R; Friedland, Barbara

    2014-01-01

    Product adherence and its measurement have emerged as a critical challenge in the evaluation of new HIV prevention technologies. Long-acting ARV-based vaginal rings may simplify use instructions and require less user behaviour, thereby facilitating adherence. One ARV-based ring is in efficacy trials and others, including multipurpose rings, are in the pipeline. Participant motivations, counselling support and measurement challenges during ring trials must still be addressed. In previous HIV prevention trials, this has been done largely using descriptive and post-hoc methods that are highly variable and minimally evaluated. We outline an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence, and to measure adherence in the context of randomized, blinded clinical trials. The interdisciplinary framework highlights the dual use of adherence measurement (i.e. to provide feedback during trial implementation and to inform interpretation of trial findings) and underscores the complex pathways that connect measurement, adherence support and enacted adherence behaviour. Three inter-related approaches are highlighted: 1) adherence support - sequential efforts to define motivators of study product adherence and to develop, test, refine and evaluate adherence support messages; 2) self-reported psychometric measures - creation of valid and generalizable measures based in easily administered scales that capture vaginal ring use with improved predictive ability at screening, baseline and follow-up that better engage participants in reporting adherence; and 3) more objective measurement of adherence - real-time adherence monitoring and cumulative measurement to correlate adherence with overall product effectiveness through innovative designs, models and prototypes using electronic and biometric technologies to detect ring insertion and/or removal or expulsion. Coordinating research along these three pathways will

  6. Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women

    OpenAIRE

    McMurdo, Marion E. T.; Argo, Ishbel; Phillips, Gabby; Daly, Fergus; Davey, Peter

    2008-01-01

    Objectives To compare the effectiveness of cranberry extract with low-dose trimethoprim in the prevention of recurrent urinary tract infections (UTIs) in older women. Patients and methods One hundred and thirty-seven women with two or more antibiotic-treated UTIs in the previous 12 months were randomized to receive either 500 mg of cranberry extract or 100 mg of trimethoprim for 6 months. Trial registration: ISRCTN80031108. Results Thirty-nine of 137 participants (28%) had an antibiotic-treat...

  7. Sodium bicarbonate for the prevention of contrast induced nephropathy: A meta-analysis of published clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Kunadian, Vijayalakshmi, E-mail: kunadianvijay@aol.com [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Zaman, Azfar, E-mail: Azfar.Zaman@nuth.nhs.uk [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne (United Kingdom); Spyridopoulos, Ioakim [Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals, NHS Foundation Trust/Newcastle University, Newcastle upon Tyne (United Kingdom); Institute of Human Genetics, Newcastle University, Newcastle upon Tyne (United Kingdom); Qiu, Weiliang [Channing Laboratory, Department of Medicine, Brigham and Women' s Hospital/Harvard Medical School, Boston, MA, United States of America (United States)

    2011-07-15

    Background: Contrast induced nephropathy (CIN) is a serious but rare complication following contrast based procedures. Sodium bicarbonate (NaHCO{sub 3}) has been postulated to prevent CIN by various mechanisms. However, the outcomes following sodium bicarbonate administration to prevent CIN have been inconsistent. Methods: A meta-analysis of published randomized clinical trials to determine if the administration of sodium bicarbonate is superior to sodium chloride among patients with chronic renal failure undergoing catheterization and interventional procedures in preventing CIN was performed. Results: Data were combined across seven published clinical trials consisting of 1734 patients. There were no significant differences in the baseline characteristics between the NaHCO{sub 3} and NaCl groups except patients in the bicarbonate group were heavier (P = 0.04). The odds ratio (OR) for the development of contrast nephropathy for NaHCO{sub 3} versus NaCl was 0.33 (95% confidence interval [CI] 0.16-0.69; P = 0.003). Heterogeneity and publication bias were detectable with P-values 0.01 and 0.0005 respectively. There was no difference between the NaHCO{sub 3} group and the NaCl group in the occurrence of death [OR 0.6; 95% CI (0.26-1.41); P = 0.24], congestive heart failure [OR 0.85; 95% CI (0.32-2.24); P = 0.74] and the requirement for renal replacement therapy [OR 0.56; 95% CI (0.22-1.41); P = 0.22]. Conclusion: This meta-analysis demonstrates that based on currently available randomized trials, the administration of NaHCO{sub 3} is superior to the administration of NaCl alone in the prevention of CIN among patients with moderate to severe chronic kidney disease. However, further controlled clinical trials are needed due to significant study heterogeneity and publication bias.

  8. Sodium bicarbonate for the prevention of contrast induced nephropathy: A meta-analysis of published clinical trials

    International Nuclear Information System (INIS)

    Kunadian, Vijayalakshmi; Zaman, Azfar; Spyridopoulos, Ioakim; Qiu, Weiliang

    2011-01-01

    Background: Contrast induced nephropathy (CIN) is a serious but rare complication following contrast based procedures. Sodium bicarbonate (NaHCO 3 ) has been postulated to prevent CIN by various mechanisms. However, the outcomes following sodium bicarbonate administration to prevent CIN have been inconsistent. Methods: A meta-analysis of published randomized clinical trials to determine if the administration of sodium bicarbonate is superior to sodium chloride among patients with chronic renal failure undergoing catheterization and interventional procedures in preventing CIN was performed. Results: Data were combined across seven published clinical trials consisting of 1734 patients. There were no significant differences in the baseline characteristics between the NaHCO 3 and NaCl groups except patients in the bicarbonate group were heavier (P = 0.04). The odds ratio (OR) for the development of contrast nephropathy for NaHCO 3 versus NaCl was 0.33 (95% confidence interval [CI] 0.16-0.69; P = 0.003). Heterogeneity and publication bias were detectable with P-values 0.01 and 0.0005 respectively. There was no difference between the NaHCO 3 group and the NaCl group in the occurrence of death [OR 0.6; 95% CI (0.26-1.41); P = 0.24], congestive heart failure [OR 0.85; 95% CI (0.32-2.24); P = 0.74] and the requirement for renal replacement therapy [OR 0.56; 95% CI (0.22-1.41); P = 0.22]. Conclusion: This meta-analysis demonstrates that based on currently available randomized trials, the administration of NaHCO 3 is superior to the administration of NaCl alone in the prevention of CIN among patients with moderate to severe chronic kidney disease. However, further controlled clinical trials are needed due to significant study heterogeneity and publication bias.

  9. Adverse Effects of Carbetocin versus Oxytocin in the Prevention of Postpartum Haemorrhage after Caesarean Section: A Randomized Controlled Trial

    OpenAIRE

    D. Mannaerts; L. Van der Veeken; H. Coppejans; Y. Jacquemyn

    2018-01-01

    Purpose. To compare the incidence of nausea, vomiting, and arterial hypotension between carbetocin and oxytocin to prevent haemorrhage after caesarean section (CS). Methods. A randomized controlled trial in term pregnant women undergoing planned CS. Groups were randomized to carbetocin or oxytocin. Blood pressure (BP), heart rate, presence of nausea/vomitus, and need for vasopressors were evaluated throughout surgery. Preoperative and postoperative haemoglobin and haematocrit levels were comp...

  10. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria.

    Directory of Open Access Journals (Sweden)

    Vera Halpern

    Full Text Available This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection.This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1:1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events.The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10 than on placebo (13, a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3-1.8; p = 0.56. Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5-1.1; p = 0.19 for the combined STI outcome. Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported.Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV.ClinicalTrials.gov NCT00120770.

  11. Case management considerations of progressive dementia in a home setting.

    Science.gov (United States)

    Pierce, Mary Ellen

    2010-01-01

    Nursing theory, research, and best practice guidelines contribute substantially to the field of dementia care. Interventional plans are challenged most by those dementias considered progressive and deteriorative in nature, requiring ongoing reassessment and modification of care practices as the clinical course changes. The purpose of this article is to provide guidelines for case managers in the development of effective, individualized care plans for clients with progressive dementia residing in a home setting. The application of these guidelines is illustrated through the presentation of an actual case. The practice setting is a private home in the Pacific Northwest. Geriatric case management is provided by an RN case manager. Progressive dementia presents challenges to home care. Professional case management using comprehensive, holistic assessment, collaborative approaches, and best practice fundamentals serve to create an effective, individualized plan of care. The increasing geriatric population presents great opportunities for case managers in strategic management for creating successful home care models in clients with progressive dementia. Use of nursing diagnoses, dementia research, and collaborative approaches with families and other medical providers creates a viable alternative for clients with progressive dementia.

  12. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  13. Rationale, design, and protocol for the prevention of low back pain in the military (POLM trial (NCT00373009

    Directory of Open Access Journals (Sweden)

    Dugan Jessica L

    2007-09-01

    Full Text Available Abstract Background There are few effective strategies reported for the primary prevention of low back pain (LBP. Core stabilization exercises targeting the deep abdominal and trunk musculature and psychosocial education programs addressing patient beliefs and coping styles represent the current best evidence for secondary prevention of low back pain. However, these programs have not been widely tested to determine if they are effective at preventing the primary onset and/or severity of LBP. The purpose of this cluster randomized clinical trial is to determine if a combined core stabilization exercise and education program is effective in preventing the onset and/or severity of LBP. The effect of the combined program will be compared to three other standard programs. Methods/Design Consecutive Soldiers participating in advanced individual training (AIT will be screened for eligibility requirements and consented to study participation, as appropriate. Companies of Soldiers will be randomly assigned to receive the following standard prevention programs; a core stabilization exercise program (CSEP alone, a CSEP with a psychosocial education (PSEP, a traditional exercise (TEP, or a TEP with a PSEP. Proximal outcome measures will be assessed at the conclusion of AIT (a 12 week training period and include imaging of deep lumbar musculature using real-time ultrasound imaging and beliefs about LBP by self-report questionnaire. We are hypothesizing that Soldiers receiving the CSEP will have improved thickness of selected deep lumbar musculature (transversus abdominus, multifidi, and erector spinae muscles. We are also hypothesizing that Soldiers receiving the PSEP will have improved beliefs about the management of LBP. After AIT, Soldiers will be followed monthly to measure the distal outcomes of LBP occurrence and severity. This information will be collected during the subsequent 2 years following completion of AIT using a web-based data entry system

  14. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

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

    2016-12-01

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

  15. Primary prevention of cardiovascular events with low-dose aspirin and vitamin E in type 2 diabetic patients: results of the Primary Prevention Project (PPP) trial.

    Science.gov (United States)

    Sacco, Michele; Pellegrini, Fabio; Roncaglioni, Maria C; Avanzini, Fausto; Tognoni, Gianni; Nicolucci, Antonio

    2003-12-01

    We investigated in general practice the efficacy of antiplatelets and antioxidants in primary prevention of cardiovascular events in people with type 2 diabetes. The Primary Prevention Project (PPP) is a randomized, open trial with a two-by-two factorial design aimed to investigate low-dose aspirin (100 mg/day) and vitamin E (300 mg/day) in the prevention of cardiovascular events in patients with one or more cardiovascular risk factors. The primary end point was a composite end point of cardiovascular death, stroke, or myocardial infarction. A total of 1,031 people with diabetes in the PPP, aged >/=50 years, without a previous cardiovascular event were enrolled by 316 general practitioners and 14 diabetes outpatient clinics. The PPP trial was prematurely stopped (after a median of 3.7 years) by the independent data safety and monitoring board because of a consistent benefit of aspirin compared with the control group in a population of 4,495 patients with one or more major cardiovascular risk factors. In diabetic patients, aspirin treatment was associated with a nonsignificant reduction in the main end point (relative risk [RR] = 0.90, 95% CI 0.50-1.62) and in total cardiovascular events (0.89, 0.62-1.26) and with a nonsignificant increase in cardiovascular deaths (1.23, 0.69-2.19). In nondiabetic subjects, RRs for the main end point, total cardiovascular events, and cardiovascular deaths were 0.59 (0.37-0.94), 0.69 (0.53-0.90), and 0.32 (0.14-0.72), respectively. No significant reduction in any of the end points considered could be found with vitamin E in either diabetic or nondiabetic subjects. Our data suggest a lower effect of primary prevention of cardiovascular disease (CVD) with low-dose aspirin in diabetic patients as opposed to subjects with other cardiovascular risk factors. If confirmed, these findings might indicate that the antiplatelet effects of aspirin in diabetic patients are overwhelmed by aspirin-insensitive mechanisms of platelet activation and

  16. Case management and adherence to an online disease management system.

    Science.gov (United States)

    Robertson, Lucy; Smith, Michael; Tannenbaum, Dennis

    2005-01-01

    Non-adherence to treatment presents a significant obstacle to achieving favourable health outcomes. We have studied consumers' adherence to an online disease management system for depression, called Recovery Road. Recovery Road was implemented on a pilot basis for mental health care in Western Australia. Recovery Road was available for use by consumers and clinicians to augment usual treatment. One hundred and thirty consumers who had been diagnosed with major depression were enrolled. Consumers who used Recovery Road (n = 98) were provided with education, progress monitoring, e-consultation, e-diary and online evidenced-based therapy. Consumers received either standard, automated adherence reminders by email (n = 69), or case management, which included personalized email and telephone follow-up in response to non-adherence (n = 29). After the first eight sessions, the adherence was 84% in the case management group and 55% in the automatic reminders group. The results suggest that case management increases adherence to online disease management systems.

  17. Comparison of methods for estimating the intraclass correlation coefficient for binary responses in cancer prevention cluster randomized trials.

    Science.gov (United States)

    Wu, Sheng; Crespi, Catherine M; Wong, Weng Kee

    2012-09-01

    The intraclass correlation coefficient (ICC) is a fundamental parameter of interest in cluster randomized trials as it can greatly affect statistical power. We compare common methods of estimating the ICC in cluster randomized trials with binary outcomes, with a specific focus on their application to community-based cancer prevention trials with primary outcome of self-reported cancer screening. Using three real data sets from cancer screening intervention trials with different numbers and types of clusters and cluster sizes, we obtained point estimates and 95% confidence intervals for the ICC using five methods: the analysis of variance estimator, the Fleiss-Cuzick estimator, the Pearson estimator, an estimator based on generalized estimating equations and an estimator from a random intercept logistic regression model. We compared estimates of the ICC for the overall sample and by study condition. Our results show that ICC estimates from different methods can be quite different, although confidence intervals generally overlap. The ICC varied substantially by study condition in two studies, suggesting that the common practice of assuming a common ICC across all clusters in the trial is questionable. A simulation study confirmed pitfalls of erroneously assuming a common ICC. Investigators should consider using sample size and analysis methods that allow the ICC to vary by study condition. Copyright © 2012. Published by Elsevier Inc.

  18. The "wins" of change: evaluating the impact of predicted changes on case management practice.

    Science.gov (United States)

    Stanton, Marietta P; Barnett Lammon, Carol Ann

    2008-01-01

    A variety of strategies were employed to identify current and future trends that would impact the practice of case management. Historical review, consultation with case management experts, literature review, and environmental scanning by practicing case managers were strategies employed to determine the impact of current and future trends on case management. The trends identified in this article have implications for case managers in a variety of settings. Case managers participating in the environmental scanning process to evaluate the impact of the identified trends on their organization included representation from acute care, home care, behavioral health, workers' compensation, and private insurance settings. The top 7 trends identified by experts in the field of case management included pay for performance, recovery audit contractors, Medicare demonstration projects, transitions of care, informatics in healthcare and case management, metrics for case management, and the impact of an aging population in case management. Practicing case managers were asked to react to these trends in terms of likelihood of occurrence in their organization and impact of these trends on their case management practice. Case management will ultimately have a higher degree of accountability for its practice if metrics to evaluate and reimbursement for case management become a reality. A multitude of performance measures exist that will be monitored and be tied to reimbursement. To ensure that agencies are accomplishing these performance measures, case management will potentially have a growing importance. Case managers perceive that these trends have a predominantly positive impact on case management.

  19. Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

    Science.gov (United States)

    Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy

    2017-02-13

    As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures

  20. Interatrial septum versus right atrial appendage pacing for prevention of atrial fibrillation : A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, L; Jiang, H; Wang, W; Bai, J; Liang, Y; Su, Y; Ge, J

    2017-07-28

    Interatrial septum (IAS) pacing seems to be a promising strategy for the prevention of atrial fibrillation (AF); however, studies have yielded conflicting results. This meta-analysis was to compare IAS with right atrial appendage (RAA) pacing on the prevention of postpacing AF occurrence. Pubmed, MEDLINE, EMBASE and Web of Science databases were searched through October 2016 for randomized controlled trials comparing IAS with RAA pacing on the prevention of AF. Data concerning study design, patient characteristics and outcomes were extracted. Risk ratio (RR), weighted mean differences (WMD) or standardized mean differences (SMD) were calculated using fixed or random effects models. A total of 12 trials involving 1146 patients with dual-chamber pacing were included. Although IAS was superior to RAA pacing in terms of reducing the number of AF episodes (SMD = -0.29, P = 0.05), AF burden (SMD = -0.41, P = 0.008) and P -wave duration (WMD = -34.45 ms, P IAS pacing. Nevertheless, no differences were observed concerning all-cause death (RR = 1.04, P = 0.88), procedure-related events (RR = 1.17, P = 0.69) and pacing parameters between IAS and RAA pacing in the follow-up period. IAS pacing is safe and as well tolerated as RAA pacing. Although IAS pacing may fail to prevent permanent AF occurrence and recurrences of AF, it is able to not only improve interatrial conduction, but also reduce AF burden.

  1. Prevention of groin injuries in sports: a systematic review with meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Esteve, E; Rathleff, M S; Bagur-Calafat, C; Urrútia, G; Thorborg, K

    2015-06-01

    Groin injuries are common in football and ice hockey, and previous groin injury is a strong risk factor for future groin injuries, which calls for primary prevention. The aim of this systematic review was to evaluate the effect of specific groin-injury prevention programmes in sports. A comprehensive search was performed in May 2014 yielding 1747 potentially relevant references. Two independent assessors evaluated randomised controlled trials for inclusion, extracted data and performed quality assessments using Cochrane's risk of bias tool. Quantitative analyses were performed in Review Manager 5.3. Seven trials were included: six on football players (four male and two female populations) and one on male handball players. In total there were 4191 participants with a total of 157 injuries. The primary analysis, including all participants, did not show a significant reduction in the number of groin injuries after completing a groin injury prevention programme (relative risk (RR) 0.81; 95% CI 0.60 to 1.09). Subgroup analysis based on type of sports, gender and type of prevention programme showed similar non-significant estimates with RR ranging from 0.48 to 0.81. Meta-analysis revealed a potential clinically meaningful groin injury reduction of 19%, even though no statistical significant reduction in sport-related groin injuries could be documented. PROSPERO registration ID CRD42014009614. 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. Behavioral counseling to prevent childhood obesity--study protocol of a pragmatic trial in maternity and child health care.

    Science.gov (United States)

    Mustila, Taina; Keskinen, Päivi; Luoto, Riitta

    2012-07-03

    Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring's age of five years. An option to participate a group counseling at child's age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice.

  3. Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians

    Directory of Open Access Journals (Sweden)

    Tuomilehto Jaakko

    2011-10-01

    Full Text Available Abstract Background Despite the growing emphasis on the inclusion of ethnic minority patients in research, there is little published on the recruitment of these populations especially to randomised, community based, lifestyle intervention trials in the UK. Methods We share our experience of recruitment to screening in the PODOSA (Prevention of Diabetes and Obesity in South Asians trial, which screened 1319 recruits (target 1800 for trial eligibility. A multi-pronged recruitment approach was used. Enrolment via the National Health Service included direct referrals from health care professionals and written invitations via general practices. Recruitment within the community was carried out by both the research team and through our partnerships with local South Asian groups and organisations. Participants were encouraged to refer friends and family throughout the recruitment period. Results Health care professionals referred only 55 potential participants. The response to written invitations via general practitioners was 5.2%, lower than reported in other general populations. Community orientated, personal approaches for recruitment were comparatively effective yielding 1728 referrals (82% to the screening stage. Conclusions The PODOSA experience shows that a community orientated, personal approach for recruiting South Asian ethnic minority populations can be successful in a trial setting. We recommend that consideration is given to cover recruitment costs associated with community engagement and other personalised approaches. Researchers should consider prioritising approaches that minimise interference with professionals' work and, particularly in the current economic climate, keep costs to a minimum. The lessons learned in PODOSA should contribute to future community based trials in South Asians. Trial Registration Current Controlled Trials ISRCTN25729565

  4. Prevention of colonic neoplasia with polyethylene glycol: A short term randomized placebo-controlled double-blinded trial.

    Science.gov (United States)

    Wali, Ramesh K; Bianchi, Laura; Kupfer, Sonia; De La Cruz, Mart; Jovanovic, Borko; Weber, Christopher; Goldberg, Michael J; Rodriguez, L M; Bergan, Raymond; Rubin, David; Tull, Mary Beth; Richmond, Ellen; Parker, Beth; Khan, Seema; Roy, Hemant K

    2018-01-01

    Chemoprevention represents an attractive modality against colorectal cancer (CRC) although widespread clinical implementation of promising agents (e.g. aspirin/NSAIDS) have been stymied by both suboptimal efficacy and concerns over toxicity. This highlights the need for better agents. Several groups, including our own, have reported that the over-the-counter laxative polyethylene glycol (PEG) has remarkable efficacy in rodent models of colon carcinogenesis. In this study, we undertook the first randomized human trial to address the role of PEG in prevention of human colonic neoplasia. This was a double-blind, placebo-controlled, three-arm trial where eligible subjects were randomized to 8g PEG-3350 (n = 27) or 17g PEG-3350 (n = 24), or placebo (n = 24; maltodextrin) orally for a duration of six months. Our initial primary endpoint was rectal aberrant crypt foci (ACF) but this was changed during protocol period to rectal mucosal epidermal growth factor receptor (EGFR). Of the 87 patients randomized, 48 completed study primary endpoints and rectal EGFR unchanged PEG treatment. Rectal ACF had a trend suggesting potentially reduction with PEG treatment (pre-post change 1.7 in placebo versus -0.3 in PEG 8+ 17g doses, p = 0.108). Other endpoints (proliferation, apoptosis, expression of SNAIL and E-cadherin), previously noted to be modulated in rodent models, appeared unchanged with PEG treatment in this clinical trial. We conclude that PEG was generally well tolerated with the trial failing to meet primary efficacy endpoints. However, rectal ACFs demonstrated a trend (albeit statistically insignificant) for suppression with PEG. Moreover, all molecular assays including EGFR were unaltered with PEG underscoring issues with lack of translatability of biomarkers from preclinical to clinical trials. This data may provide the impetus for future clinical trials on PEG using more robust biomarkers of chemoprevention. ClinicalTrials.gov NCT00828984.

  5. Stress Prevention@Work: a study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Rianne J. A. Hoek

    2017-07-01

    Full Text Available Abstract Background Adequate implementation of work-related stress management interventions can reduce or prevent work-related stress and sick leave in organizations. We developed a multifaceted integral stress-prevention strategy for organizations from several sectors that includes a digital platform and collaborative learning network. The digital platform contains a stepwise protocol to implement work-related stress-management interventions. It includes stress screeners, interventions and intervention providers to facilitate access to and the selection of matching work-related stress-management interventions. The collaborative learning network, including stakeholders from various organizations, plans meetings focussing on an exchange of experiences and good practices among organizations for the implementation of stress prevention measures. This paper describes the design of an integral stress-prevention strategy, Stress Prevention@Work, and the protocol for the evaluation of: 1 the effects of the strategy on perceived stress and work-related outcomes, and 2 the barriers and facilitators for implementation of the strategy. Methods The effectiveness of Stress Prevention@Work will be evaluated in a cluster controlled trial, in a large healthcare organization in the Netherlands, at six and 12 months. An independent researcher will match teams on working conditions and size and allocate the teams to the intervention or control group. Teams in the intervention group will be offered Stress Prevention@Work. For each intervention team, one employee is responsible for applying the strategy within his/her team using the digital platform and visiting the collaborative learning network. Using a waiting list design, the control group will be given access to the strategy after 12 months. The primary outcome is the employees’ perceived stress measured by the stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21. Secondary outcome measures

  6. Microbicide trials for preventing HIV/AIDS in South Africa: Phase II ...

    African Journals Online (AJOL)

    Some recommended that the study staff improve their professionalism and punctuality. They suggested the formation of participant support groups, and expressed a preference to remain involved in the trial. Some participants appeared to have become dependent on services provided during the trial. We have taken the ...

  7. The cost-effectiveness of a patient centred pressure ulcer prevention care bundle: Findings from the INTACT cluster randomised trial.

    Science.gov (United States)

    Whitty, Jennifer A; McInnes, Elizabeth; Bucknall, Tracey; Webster, Joan; Gillespie, Brigid M; Banks, Merrilyn; Thalib, Lukman; Wallis, Marianne; Cumsille, Jose; Roberts, Shelley; Chaboyer, Wendy

    2017-10-01

    Pressure ulcers are serious, avoidable, costly and common adverse outcomes of healthcare. To evaluate the cost-effectiveness of a patient-centred pressure ulcer prevention care bundle compared to standard care. Cost-effectiveness and cost-benefit analyses of pressure ulcer prevention performed from the health system perspective using data collected alongside a cluster-randomised trial. Eight tertiary hospitals in Australia. Adult patients receiving either a patient-centred pressure ulcer prevention care bundle (n=799) or standard care (n=799). Direct costs related to the intervention and preventative strategies were collected from trial data and supplemented by micro-costing data on patient turning and skin care from a 4-week substudy (n=317). The time horizon for the economic evaluation matched the trial duration, with the endpoint being diagnosis of a new pressure ulcer, hospital discharge/transfer or 28days; whichever occurred first. For the cost-effectiveness analysis, the primary outcome was the incremental costs of prevention per additional hospital acquired pressure ulcer case avoided, estimated using a two-stage cluster-adjusted non-parametric bootstrap method. The cost-benefit analysis estimated net monetary benefit, which considered both the costs of prevention and any difference in length of stay. All costs are reported in AU$(2015). The care bundle cost AU$144.91 (95%CI: $74.96 to $246.08) more per patient than standard care. The largest contributors to cost were clinical nurse time for repositioning and skin inspection. In the cost-effectiveness analysis, the care bundle was estimated to cost an additional $3296 (95%CI: dominant to $144,525) per pressure ulcer avoided. This estimate is highly uncertain. Length of stay was unexpectedly higher in the care bundle group. In a cost-benefit analysis which considered length of stay, the net monetary benefit for the care bundle was estimated to be -$2320 (95%CI -$3900, -$1175) per patient, suggesting the care

  8. Care for the case manager: balancing your wheel of life.

    Science.gov (United States)

    Crowell, D M

    1998-01-01

    The case manager's role in our complex health care system is demanding and draining without some self-reflective attention. The Wheel of Life is a key tool for individuals to assess how well they are leading a fully balanced life. The eight aspects of a balanced life--values, self-care, work, relationships, leisure, relaxation, exercise, and centering--are explained and discussed. A self-reflective activity is presented that encourages readers to assess their current life balance. This focused clarification of personal and professional life will facilitate a more fully balanced life with rewards for case managers as individuals, and for their family, clients, and the health care organization.

  9. Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tiedemann, A; Sturnieks, D L; Hill, A-M; Lovitt, L; Clemson, L; Lord, S R; Harvey, L; Sherrington, C

    2014-11-19

    Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people. A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial. The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters. Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number

  10. Lumbar supports to prevent recurrent low back pain among home care workers: a randomized trial

    NARCIS (Netherlands)

    Roelofs, Pepijn D. D. M.; Bierma-Zeinstra, Sita M. A.; van Poppel, Mireille N. M.; Jellema, Petra; Willemsen, Sten P.; van Tulder, Maurits W.; van Mechelen, Willem; Koes, Bart W.

    2007-01-01

    People use lumbar supports to prevent low back pain. Secondary analyses from primary preventive studies suggest benefit among workers with previous low back pain, but definitive studies on the effectiveness of supports for the secondary prevention of low back pain are lacking. To determine the

  11. Improving linkage with substance abuse treatment using brief case management and motivational interviewing.

    Science.gov (United States)

    Rapp, Richard C; Otto, Amy L; Lane, D Timothy; Redko, Cristina; McGatha, Sue; Carlson, Robert G

    2008-04-01

    Poor linkage with substance abuse treatment remains a problem, negating the benefits that can accrue to both substance abusers and the larger society. Numerous behavioral interventions have been tested to determine their potential role in improving linkage. A randomized clinical trial of 678 substance abusers compared the linkage effect of two brief interventions with the referral standard of care (SOC) at a centralized intake unit (CIU). Interventions included five sessions of strengths-based case management (SBCM) or one session of motivational interviewing (MI). A priori hypotheses predicted that both interventions would be better than the standard of care in predicting linkage and that SBCM would be more effective than MI. We analyzed the effect of the two interventions on overall treatment linkage rates and by treatment modality. Logistic regression analysis examined predictors of treatment linkage for the sample and each group. Two hypotheses were confirmed in that SBCM (n=222) was effective in improving linkage compared to the SOC (n=230), 55.0% vs. 38.7% (pMotivational interviewing (n=226) was not significantly more effective in improving linkage than the standard of care (44.7% vs. 38.7%; p>.05). The three trial groups differed only slightly on the client characteristics that predicted linkage with treatment. The results of this study confirm a body of literature that supports the effectiveness of case management in improving linkage with treatment. The role of motivational interviewing in improving linkage was not supported. Results are discussed in the context of other case management and motivational interviewing linkage studies.

  12. Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial.

    Science.gov (United States)

    Janssen, Kasper W; van Mechelen, Willem; Verhagen, Evert Alm

    2011-09-27

    Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care. This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention. The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training

  13. Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

    Directory of Open Access Journals (Sweden)

    Peter A Newman

    Full Text Available Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations.From 2008-2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement.Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of "community"; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted.This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as

  14. Towards a