WorldWideScience

Sample records for prevention trial methods

  1. 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.

  2. 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.

  3. 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

  4. Preventing cognitive decline in older African Americans with mild cognitive impairment: design and methods of a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Leiby, Benjamin E

    2012-07-01

    Mild Cognitive Impairment (MCI) affects 25% of older African Americans and predicts progression to Alzheimer's disease. An extensive epidemiologic literature suggests that cognitive, physical, and/or social activities may prevent cognitive decline. We describe the methods of a randomized clinical trial to test the efficacy of Behavior Activation to prevent cognitive decline in older African Americans with the amnestic multiple domain subtype of MCI. Community Health Workers deliver 6 initial in-home treatment sessions over 2-3 months and then 6 subsequent in-home booster sessions using language, materials, and concepts that are culturally relevant to older African Americans during this 24 month clinical trial. We are randomizing 200 subjects who are recruited from churches, senior centers, and medical clinics to Behavior Activation or Supportive Therapy, which controls for attention. The primary outcome is episodic memory as measured by the Hopkins Verbal Learning Test-Revised at baseline and at months 3, 12, 18, and 24. The secondary outcomes are general and domain-specific neuropsychological function, activities of daily living, depression, and quality-of-life. The negative results of recent clinical trials of drug treatments for MCI and Alzheimer's disease suggest that behavioral interventions may provide an alternative treatment approach to preserve cognition in an aging society. Copyright © 2012 Elsevier Inc. All rights reserved.

  5. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Schwenk Michael

    2012-04-01

    Full Text Available Abstract Background The standardisation of the assessment methodology and case definition represents a major precondition for the comparison of study results and the conduction of meta-analyses. International guidelines provide recommendations for the standardisation of falls methodology; however, injurious falls have not been targeted. The aim of the present article was to review systematically the range of case definitions and methods used to measure and report on injurious falls in randomised controlled trials (RCTs on fall prevention. Methods An electronic literature search of selected comprehensive databases was performed to identify injurious falls definitions in published trials. Inclusion criteria were: RCTs on falls prevention published in English, study population ≥ 65 years, definition of injurious falls as a study endpoint by using the terms "injuries" and "falls". Results The search yielded 2089 articles, 2048 were excluded according to defined inclusion criteria. Forty-one articles were included. The systematic analysis of the methodology applied in RCTs disclosed substantial variations in the definition and methods used to measure and document injurious falls. The limited standardisation hampered comparability of study results. Our results also highlight that studies which used a similar, standardised definition of injurious falls showed comparable outcomes. Conclusions No standard for defining, measuring, and documenting injurious falls could be identified among published RCTs. A standardised injurious falls definition enhances the comparability of study results as demonstrated by a subgroup of RCTs used a similar definition. Recommendations for standardising the methodology are given in the present review.

  6. A Pilot Randomised Controlled Trial of a School-Based Resilience Intervention to Prevent Depressive Symptoms for Young Adolescents with Autism Spectrum Disorder: A Mixed Methods Analysis

    Science.gov (United States)

    Mackay, Bethany A.; Shochet, Ian M.; Orr, Jayne A.

    2017-01-01

    Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in…

  7. Preventing Peer Violence Against Children: Methods and Baseline Data of a Cluster Randomized Controlled Trial in Pakistan.

    Science.gov (United States)

    McFarlane, Judith; Karmaliani, Rozina; Maqbool Ahmed Khuwaja, Hussain; Gulzar, Saleema; Somani, Rozina; Saeed Ali, Tazeen; Somani, Yasmeen H; Shehzad Bhamani, Shireen; Krone, Ryan D; Paulson, Rene M; Muhammad, Atta; Jewkes, Rachel

    2017-03-24

    Violence against and among children is a global public health problem that annually affects 50% of youth worldwide with major impacts on child development, education, and health including increased probability of major causes of morbidity and mortality in adulthood. It is also associated with the experience of and perpetration of later violence against women. The aim of this article is to describe the intervention, study design, methods, and baseline findings of a cluster randomized controlled trial underway in Pakistan to evaluate a school-based play intervention aiming to reduce peer violence and enhance mental health. A cluster randomized controlled design is being conducted with boys and girls in grade 6 in 40 schools in Hyderabad, Pakistan, over a period of 2 years. The Multidimensional Peer-Victimization and Peer Perpetration Scales and the Children's Depression Inventory 2 (CDI 2) are being used to measure the primary outcomes while investigator-derived scales are being used to assess domestic violence within the family. Specifics of the intervention, field logistics, ethical, and fidelity management issues employed to test the program's impact on school age youth in a volatile and politically unstable country form this report. A total of 1,752 school-age youth were enrolled and interviewed at baseline. Over the preceding 4 weeks, 94% of the boys and 85% of the girls reported 1 or more occurrences of victimization, and 85% of the boys and 66% of the girls reported 1 or more acts of perpetration. Boys reported more depression compared with girls, as well as higher negative mood and self-esteem scores and more interpersonal and emotional problems. Globally, prevalence of youth violence perpetration and victimization is high and associated with poor physical and emotional health. Applying a randomized controlled design to evaluate a peer violence prevention program built on a firm infrastructure and that is ready for scale-up and sustainability will make an

  8. A Pilot Randomised Controlled Trial of a School-Based Resilience Intervention to Prevent Depressive Symptoms for Young Adolescents with Autism Spectrum Disorder: A Mixed Methods Analysis.

    Science.gov (United States)

    Mackay, Bethany A; Shochet, Ian M; Orr, Jayne A

    2017-11-01

    Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in schools with adolescents with ASD in years 6 and 7. Quantitative results showed significant intervention effects on parent reports of adolescent coping self-efficacy (maintained at 6 month follow-up) but no effect on depressive symptoms or mental health. Qualitative outcomes reflected perceived improvements from the intervention for adolescents' coping self-efficacy, self-confidence, social skills, and affect regulation. Converging results remain encouraging given this population's difficulties coping with adversity, managing emotions and interacting socially which strongly influence developmental outcomes.

  9. A randomized controlled trial of the Arctic Sun Temperature Management System versus conventional methods for preventing hypothermia during off-pump cardiac surgery.

    Science.gov (United States)

    Grocott, Hilary P; Mathew, Joseph P; Carver, Elizabeth H; Phillips-Bute, Barbara; Landolfo, Kevin P; Newman, Mark F

    2004-02-01

    In this trial we compared the hypothermia avoidance abilities of the Arctic Sun Temperature Management System (a servo-regulated system that circulates temperature-controlled water through unique energy transfer pads adherent to the patient's body) with conventional temperature control methods. Patients undergoing off-pump coronary artery bypass (OPCAB) surgery were randomized to either the Arctic Sun System alone (AS group) or conventional methods (control group; increased room temperature, heated IV fluids, convective forced air warming system) for the prevention of hypothermia (defined by a temperature temperature servo-regulated to a target of 36.8 degrees C. Temperature was recorded throughout the operative period and comparisons were made between groups for both the time and area under the curve (AUC) for a temperature control group = 15) were studied. The AS group had significantly less hypothermia than the control group, both for duration of time control group; P = 0.0008) as well as for AUCcontrol group; P = 0.002). The Arctic Sun Temperature Management System significantly reduced intraoperative hypothermia during OPCAB surgery. Importantly, this was achieved in the absence of any other temperature modulating techniques, including the use of IV fluid warming or increases in the ambient operating room temperature. The Arctic Sun Temperature Management System was more effective than conventional methods in preventing hypothermia during off-pump coronary artery bypass graft surgery.

  10. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  11. Effectiveness of McKenzie Method-Based Self-Management Approach for the Secondary Prevention of a Recurrence of Low Back Pain (SAFE Trial): Protocol for a Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    de Campos, Tarcisio F; Maher, Chris G; Clare, Helen A; da Silva, Tatiane M; Hancock, Mark J

    2017-08-01

    Although many people recover quickly from an episode of low back pain (LBP), recurrence is very common. There is limited evidence on effective prevention strategies for recurrences of LBP. The purpose of this study was to determine the effectiveness of a McKenzie method-based self-management approach in the secondary prevention of LBP. This will be a pragmatic randomized controlled trial. Participants will be recruited from the community and primary care, with the intervention delivered in a number of physical therapist practices in Sydney, Australia. The study will have 396 participants, all of whom are at least 18 years old. Participants will be randomly assigned to either the McKenzie method-based self-management approach group or a minimal intervention control group. The primary outcome will be days to first self-reported recurrence of an episode of activity-limiting LBP. The secondary outcomes will include: days to first self-reported recurrence of an episode of LBP, days to first self-reported recurrence of an episode of LBP leading to care seeking, and the impact of LBP over a 12-month period. All participants will be followed up monthly for a minimum of 12 months or until they have a recurrence of activity-limiting LBP. All participants will also be followed-up at 3, 6, 9, and 12 months to assess the impact of back pain, physical activity levels, study program adherence, credibility, and adverse events. Participants and therapists will not be masked to the interventions. To our knowledge, this will be the first large, high-quality randomized controlled trial investigating the effectiveness of a McKenzie method-based self-management approach for preventing recurrences of LBP. If this approach is found to be effective, it will offer a low-cost, simple method for reducing the personal and societal burdens of LBP. © 2017 American Physical Therapy Association

  12. Healthy Habits, Happy Homes: methods and baseline data of a randomized controlled trial to improve household routines for obesity prevention.

    Science.gov (United States)

    Taveras, Elsie M; McDonald, Julia; O'Brien, Ashley; Haines, Jess; Sherry, Bettylou; Bottino, Clement J; Troncoso, Karen; Schmidt, Marie Evans; Koziol, Renata

    2012-11-01

    To develop a home-based intervention for parents of 2-5 year old children to promote household routines to prevent overweight/obesity. We recruited 121 children from health centers in Boston between 2011 and 2012 and randomized 62 to intervention and 59 to the control condition. The 6-month intervention included 1) motivational coaching at home and by phone with a health educator, 2) mailed educational materials, and 3) weekly text messages. The intervention promoted three household routines: eating meals as a family, obtaining adequate sleep, and limiting screen time. Of the 121 children, mean (SD) age was 4.0 (1.1) years; 52% were Hispanic, 34% Black, and 14% White/Other. Nearly 60% of the sample had annual household incomes ≤ $20,000. Approximately 64% of families reported eating together ≥ 7 times per week, however, many meals were eaten in front of a TV. Over half of the children slept less than the recommended 11h/night and 78% viewed ≥ 2 h/day of screen time. Household routines that increase obesity risk were prevalent among low-income families in this study. If proven to be effective, promotion of household routines related to family meals, sleep, and screen time may prevent young children from becoming overweight/obese. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. A randomized comparative trial of combinational methods for preventing post-spinal hypotension at elective cesarean delivery

    Directory of Open Access Journals (Sweden)

    Mitra Jabalameli

    2011-01-01

    Conclusions: Among the three studied methods, administration of ephedrine plus bandage of the lower extremities was the most effective one in reducing the incidence of post-spinal hypotension. The groups were not clinically different concerning the effect of treatment on newborn health.

  14. 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.

  15. Evaluation Methods for Prevention Education.

    Science.gov (United States)

    Blue, Amy V.; Barnette, J. Jackson; Ferguson, Kristi J.; Garr, David R.

    2000-01-01

    Discusses the importance of assessing medical students' competence in prevention knowledge, skills, and attitudes. Provides general guidance for programs interested in evaluating their prevention instructional efforts, and gives specific examples of possible methods for evaluating prevention education. Stresses the need to tailor assessment…

  16. 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.

  17. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

    Science.gov (United States)

    Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

    2017-07-18

    Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop

  18. Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers.

    Science.gov (United States)

    Martínez-Vizcaino, Vicente; Mota, Jorge; Solera-Martínez, Montserrat; Notario-Pacheco, Blanca; Arias-Palencia, Natalia; García-Prieto, Jorge Cañete; González-García, Alberto; Álvarez-Bueno, Celia; Sánchez-López, Mairena

    2015-02-22

    Childhood obesity has become an alarming worldwide increasing public health problem. The earlier adiposity rebound occurs, the greater the risk of becoming obese during puberty and adolescence. It has been speculated about the potential influence of vigorous physical activity on modifying the age of onset of adiposity rebound. Moreover, studies aimed to evaluate the effectiveness of physical activity interventions programs on reducing adiposity and other cardiovascular risk factors in children younger than 6 years are scarce. This paper describes the rationale and methods of a study aimed to test the effectiveness of a two-years multidimensional pre-school intervention on preventing obesity and improving physical fitness during the adiposity rebound period. Twenty-one schools from the provinces of Cuenca and Ciudad Real, Spain, were randomised to an intervention and a control arm. In the first academic year, children in third grade of pre-school and first grade of primary school in the intervention group received the physical activity intervention (MOVI-KIDS). After an academic year schools were crossed over to the alternative arm. According to the socio-ecological model, the intervention included children, their parents and teachers, and the school environment where MOVI-KIDS was conducted. MOVI-KIDS consisted of: i) three-h/week sessions of recreational non-competitive physical activity in after-school time; ii) educational materials to parents and teachers about physical activity benefits and sedentary lifestyle risks; and iii) modifications in the playground to promote physical activity during recess. Baseline and post-intervention outcomes are going to be measured in both arms three times, at the beginning and at the end of first academic year, and at the end of the second academic year. Primary outcomes included body mass index, waist circumference, triceps skinfold thickness, percentage of both body fat and fat-free mass, and blood pressure. Secondary end

  19. 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, ...

  20. 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, ...

  1. SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation

    NARCIS (Netherlands)

    Duijzer, G.; Haveman-Nies, A.; Jansen, S.C.; Beek, ter J.; Hiddink, G.J.; Feskens, E.J.M.

    2014-01-01

    Background - Implementation of interventions in real-life settings requires a comprehensive evaluation approach. The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting. Methods/Design - The SLIMMER study is a

  2. The Road Ahead to Cure Alzheimer’s Disease: Development of Biological Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target Populations

    Science.gov (United States)

    Cavedo, E.; Lista, S.; Khachaturian, Z.; Aisen, P.; Amouyel, P.; Herholz, K.; Jack, C.R.; Sperling, R.; Cummings, J.; Blennow, K.; O’Bryant, S.; Frisoni, G.B.; Khachaturian, A.; Kivipelto, M.; Klunk, W.; Broich, K.; Andrieu, S.; de Schotten, M. Thiebaut; Mangin, J.-F.; Lammertsma, A.A.; Johnson, K.; Teipel, S.; Drzezga, A.; Bokde, A.; Colliot, O.; Bakardjian, H.; Zetterberg, H.; Dubois, B.; Vellas, B.; Schneider, L.S.; Hampel, H.

    2015-01-01

    Alzheimer’s disease (AD) is a slowly progressing non-linear dynamic brain disease in which pathophysiological abnormalities, detectable in vivo by biological markers, precede overt clinical symptoms by many years to decades. Use of these biomarkers for the detection of early and preclinical AD has become of central importance following publication of two international expert working group’s revised criteria for the diagnosis of AD dementia, mild cognitive impairment (MCI) due to AD, prodromal AD and preclinical AD. As a consequence of matured research evidence six AD biomarkers are sufficiently validated and partly qualified to be incorporated into operationalized clinical diagnostic criteria and use in primary and secondary prevention trials. These biomarkers fall into two molecular categories: biomarkers of amyloid-beta (Aβ) deposition and plaque formation as well as of tau-protein related hyperphosphorylation and neurodegeneration. Three of the six gold-standard (“core feasible) biomarkers are neuroimaging measures and three are cerebrospinal fluid (CSF) analytes. CSF Aβ1-42 (Aβ1-42), also expressed as Aβ1-42 : Aβ1-40 ratio, T-tau, and P-tau Thr181 & Thr231 proteins have proven diagnostic accuracy and risk enhancement in prodromal MCI and AD dementia. Conversely, having all three biomarkers in the normal range rules out AD. Intermediate conditions require further patient follow-up. Magnetic resonance imaging (MRI) at increasing field strength and resolution allows detecting the evolution of distinct types of structural and functional abnormality pattern throughout early to late AD stages. Anatomical or volumetric MRI is the most widely used technique and provides local and global measures of atrophy. The revised diagnostic criteria for “prodromal AD” and “mild cognitive impairment due to AD” include hippocampal atrophy (as the fourth validated biomarker), which is considered an indicator of regional neuronal injury. Advanced image analysis

  3. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial.

    Science.gov (United States)

    Simons, Monique; Chinapaw, Mai J M; van de Bovenkamp, Maaike; de Boer, Michiel R; Seidell, Jacob C; Brug, Johannes; de Vet, Emely

    2014-03-24

    Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games--i.e. active games--may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12-16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents' measured BMI-SDS (SDS=adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents' self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in adolescents. Dutch Trial register NTR3228.

  4. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

    Science.gov (United States)

    Grangeiro, Alexandre; Couto, Márcia Thereza; Peres, Maria Fernanda; Luiz, Olinda; Zucchi, Eliana Miura; de Castilho, Euclides Ayres; Estevam, Denize Lotufo; Alencar, Rosa; Wolffenbüttel, Karina; Escuder, Maria Mercedes; Calazans, Gabriela; Ferraz, Dulce; Arruda, Érico; Corrêa, Maria da Gloria; Amaral, Fabiana Rezende; Santos, Juliane Cardoso Villela; Alvarez, Vivian Salles; Kietzmann, Tiago

    2015-08-25

    Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals

  5. Skills methods to prevent smoking.

    Science.gov (United States)

    Schinke, S P; Gilchrist, L D; Schilling, R F; Snow, W H; Bobo, J K

    1986-01-01

    School health educators have devoted much attention to cigarette smoking. Recent years have seen the testing of interventions to prevent smoking. To date, controlled studies have not evaluated the added value of skills methods for preventing smoking. This article describes such an evaluation with sixth-grade students from two schools. Subjects were pretested and randomly assigned to receive conventional health education methods or to receive skills intervention. Both conditions included films, peer testimonials, discussions, and homework. Health education condition subjects additionally participated in oral quizzes, games, and debates. Skills condition subjects additionally learned problem-solving, self-instruction, and interpersonal communication methods. At postintervention, skills condition subjects, more than health education condition subjects, had better scores on measures of smoking-related knowledge, attitudes, and intentions. In addition, reported cigarette use, validated by biochemical data collection, was lower in the skills condition than in the health education condition at all postintervention measurements, including a 24-month follow-up. The article discusses the strengths, limits, and implications of the study for other smoking prevention efforts in schools.

  6. 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.

  7. 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 ...

  8. 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 ...

  9. The Vitamin D Antenatal Asthma Reduction Trial (VDAART): rationale, design, and methods of a randomized, controlled trial of vitamin D supplementation in pregnancy for the primary prevention of asthma and allergies in children.

    Science.gov (United States)

    Litonjua, Augusto A; Lange, Nancy E; Carey, Vincent J; Brown, Stacey; Laranjo, Nancy; Harshfield, Benjamin J; O'Connor, George T; Sandel, Megan; Strunk, Robert C; Bacharier, Leonard B; Zeiger, Robert S; Schatz, Michael; Hollis, Bruce W; Weiss, Scott T

    2014-05-01

    There is intense interest in the role of vitamin D in the development of asthma and allergies. However, studies differ on whether a higher vitamin D intake or status in pregnancy or at birth is protective against asthma and allergies. To address this uncertainty, the Vitamin D Antenatal Asthma Reduction Trial (VDAART) was developed. VDAART is a randomized, double-blind, placebo-controlled trial of vitamin D supplementation in pregnant women to determine whether prenatal supplementation can prevent the development of asthma and allergies in women's offspring. A secondary aim is to determine whether vitamin D supplementation can prevent the development of pregnancy complications, such as preeclampsia, preterm birth, and gestational diabetes. Women were randomized to the treatment arm of 4000IU/day of vitamin D3 plus a daily multivitamin that contained 400IU of vitamin D3 or the placebo arm of placebo plus a multivitamin that contained 400IU daily of vitamin D3. Women who were between the gestational ages of 10 and 18 weeks were randomized from three clinical centers across the United States - Boston Medical Center, Washington University in St. Louis, and Kaiser Permanente Southern California Region (San Diego, CA). Supplementation took place throughout pregnancy. Monthly monitoring of urinary calcium to creatinine ratio was performed in addition to medical record review for adverse events. Offspring are being evaluated quarterly through questionnaires and yearly during in-person visits until the 3rd birthday of the child. Ancillary studies will investigate neonatal T-regulatory cell function, maternal vaginal flora, and maternal and child intestinal flora. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. 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

  11. 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…

  12. 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

  13. 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

  14. 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. |

  15. 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.

  16. 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

  17. 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 ...

  18. 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...

  19. Trial Sequential Methods for Meta-Analysis

    Science.gov (United States)

    Kulinskaya, Elena; Wood, John

    2014-01-01

    Statistical methods for sequential meta-analysis have applications also for the design of new trials. Existing methods are based on group sequential methods developed for single trials and start with the calculation of a required information size. This works satisfactorily within the framework of fixed effects meta-analysis, but conceptual…

  20. Collaborative Evaluation of a High School Prevention Curriculum: How Methods of Collaborative Evaluation Enhanced a Randomized Control Trial to Inform Program Improvement

    Science.gov (United States)

    Orsini, Muhsin Michael; Wyrick, David L.; Milroy, Jeffrey J.

    2012-01-01

    Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome…

  1. 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 ...

  2. 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.

  3. 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

  4. Bayesian adaptive methods for clinical trials

    CERN Document Server

    Berry, Scott M; Muller, Peter

    2010-01-01

    Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISP...

  5. 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.

  6. 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...

  7. 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...

  8. 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

  9. 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 ...

  10. 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 ...

  11. 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

  12. 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

  13. 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…

  14. Early Prevention Method for Power Systems Instability

    DEFF Research Database (Denmark)

    Dmitrova, Evgenia

    a given operational conditions and predicts the resulting stability margins for the new steady state, while avoiding time consuming time domain simulations. The method has been validated on the Western Danish power system model, containing 464 buses. The case study of aperiodic small signal angular....... The predicted effect of the suggested countermeasure application is in a good agreement with the results obtained by RMS dynamic simulation. Developed method enables adaptive preventive control for near real-time stability maintenance. The achieved results are opening promising perspective for power system’s......In the scope of this work, a method capable of fast identification of the proper countermeasure, that prevents emerging instability, has been developed. The focus is placed on the prevention of aperiodic small signal angular instability by means of manipulations applied to load nodes (nodes...

  15. 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.

  16. 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…

  17. 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.

  18. 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.

  19. PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mikael Fogelholm

    2017-06-01

    Full Text Available Type-2 diabetes (T2D is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand. Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6 years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.

  20. PREVIEW: Prevention of Diabetes through Lifestyle Intervention and Population Studies in Europe and around the World. Design, Methods, and Baseline Participant Description of an Adult Cohort Enrolled into a Three-Year Randomised Clinical Trial.

    Science.gov (United States)

    Fogelholm, Mikael; Larsen, Thomas Meinert; Westerterp-Plantenga, Margriet; Macdonald, Ian; Martinez, J Alfredo; Boyadjieva, Nadka; Poppitt, Sally; Schlicht, Wolfgang; Stratton, Gareth; Sundvall, Jouko; Lam, Tony; Jalo, Elli; Christensen, Pia; Drummen, Mathijs; Simpson, Elizabeth; Navas-Carretero, Santiago; Handjieva-Darlenska, Teodora; Muirhead, Roslyn; Silvestre, Marta P; Kahlert, Daniela; Pastor-Sanz, Laura; Brand-Miller, Jennie; Raben, Anne

    2017-06-20

    Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated. The intervention started with a two-month weight reduction using a low-calorie diet, followed by a randomised 34-month weight maintenance phase comprising four treatment arms. Eight intervention centres are participating (Denmark, Finland, United Kingdom, The Netherlands, Spain, Bulgaria, Australia, and New Zealand). Data from blood specimens, urine, faeces, questionnaires, diaries, body composition assessments, and accelerometers are collected at months 0, 2, 6, 12, 18, 24, and 36. In total, 2326 adults were recruited. The mean age was 51.6 (SD 11.6) years, 67% were women. PREVIEW is, to date, the largest multinational trial to address the prevention of T2D in pre-diabetic adults through diet and exercise intervention. Participants will complete the final intervention in March, 2018.

  1. 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.

  2. 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.

  3. The Monte Carlo method the method of statistical trials

    CERN Document Server

    Shreider, YuA

    1966-01-01

    The Monte Carlo Method: The Method of Statistical Trials is a systematic account of the fundamental concepts and techniques of the Monte Carlo method, together with its range of applications. Some of these applications include the computation of definite integrals, neutron physics, and in the investigation of servicing processes. This volume is comprised of seven chapters and begins with an overview of the basic features of the Monte Carlo method and typical examples of its application to simple problems in computational mathematics. The next chapter examines the computation of multi-dimensio

  4. 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.

  5. 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

  6. 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

  7. Application of the trial equation method for solving some nonlinear ...

    Indian Academy of Sciences (India)

    the trial equation method. Also a more general trial equation method is proposed. Keywords. Trial equation method; KdV equation; K(m, n) equation; dual-power law; soliton solution. PACS Nos 02.30.Jr; 02.70.Wz; 04.20.Jb. 1. Introduction. Nonlinear phenomena exist in all the fields such as fluid mechanics, plasma physics, ...

  8. 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.

  9. 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.

  10. 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

  11. 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

    , 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 determination process.

  12. 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.

  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

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    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. 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

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

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    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

  16. 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.

  17. 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

  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. 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.

  20. 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:

  1. 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

  2. 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

  3. 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

  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. The study of technological prevention method of road accident ...

    African Journals Online (AJOL)

    The study of technological prevention method of road accident related to driver and vehicle. ... road accident prevention method based on the factors studied. The study of this paper can provide forceful data analysis support for the road traffic safety related research. Keywords: road accident; accident prevention; road safety.

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

    Directory of Open Access Journals (Sweden)

    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

  7. 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

  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. 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

  11. 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.

  12. 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 ...

  13. Effective Methods to Improve Recruitment and Retention in School-Based Substance Use Prevention Studies

    Science.gov (United States)

    Bruzzese, Jean-Marie; Gallagher, Richard; McCann-Doyle, Sharon; Reiss, Philip T.; Wijetunga, Neil A.

    2009-01-01

    Background: Poor recruitment and high attrition may invalidate results of research studies. This paper describes successful recruitment and retention strategies in a school-based substance use prevention trial and explores factors associated with intervention attendance and retention. Methods: A total of 384 parent-child dyads from 15 schools in…

  14. 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

  15. 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

  16. 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

  17. 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

  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. 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

  20. Utilization of malaria prevention methods by pregnant women in ...

    African Journals Online (AJOL)

    The most used method was mosquito bednet, 82.5%. Some of the women 17.5% did not use any of the prevention methods. Conclusion: Use of malaria prevention methods in combination is not considered a priority by pregnant women. Sensitization campaigns by governments and NGOs should give that a priority position.

  1. 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

  2. Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.

    Directory of Open Access Journals (Sweden)

    Philippe Flandre

    Full Text Available In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statistical methods have been introduced to provide confidence intervals for that difference. The main objective is to investigate whether the choice of the statistical method changes the conclusion of the trials.We presented 11 trials published in 2010 using a difference in proportions as the primary endpoint. In these trials, 5 different statistical methods have been used to estimate such confidence intervals. The five methods are described and applied to data from the 11 trials. The noninferiority of the new treatment is not demonstrated if the prespecified noninferiority margin it includes in the confidence interval of the treatment difference.Results indicated that confidence intervals can be quite different according to the method used. In many situations, however, conclusions of the trials are not altered because point estimates of the treatment difference were too far from the prespecified noninferiority margins. Nevertheless, in few trials the use of different statistical methods led to different conclusions. In particular the use of "exact" methods can be very confusing.Statistical methods used to estimate confidence intervals in noninferiority trials have a strong impact on the conclusion of such trials.

  3. 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

  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

    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.

  5. Application of the trial equation method for solving some nonlinear ...

    Indian Academy of Sciences (India)

    In this paper some exact solutions including soliton solutions for the KdV equation with dual power law nonlinearity and the (, ) equation with generalized evolution are obtained using the trial equation method. Also a more general trial equation method is proposed.

  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. 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

  8. 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

  9. 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.

  10. 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.

  11. 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 ...

  12. 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

  13. Method for preventing micromechanical structures from adhering to another object

    Science.gov (United States)

    Smith, J.H.; Ricco, A.J.

    1998-06-16

    A method for preventing micromechanical structures from adhering to another object includes the step of immersing a micromechanical structure and its associated substrate in a chemical species that does not stick to itself. The method can be employed during the manufacture of micromechanical structures to prevent micromechanical parts from sticking or adhering to one another and their associated substrate surface. 3 figs.

  14. 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

  15. 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...

  16. Utilization of malaria prevention methods by pregnant women in Yaounde

    OpenAIRE

    Bisong, Calvin Ebai; Dongmo, Clemence Meli

    2013-01-01

    Introduction Malaria prevention methods are diverse. Their availability sometimes does not guarantee effective usage and the use of each method in isolation may not provide the necessary results for the fight against malaria. Pregnant women are relatively more vulnerable and so it is recommended that they should be protected against malaria. Proper protection will require malaria prevention methods in combination. This study seeks to find out what methods pregnant women use and how many of th...

  17. Early Prevention Method for Power System Instability

    DEFF Research Database (Denmark)

    Dmitrova, Evgenia; Wittrock, Martin Lindholm; Jóhannsson, Hjörtur

    2015-01-01

    are then determined, using a grid transformation coefficient (GTC) and a numerical, iterative solution to an equation system. The stability criteriacan then be assessed to evaluate the sufficiency of a suggested counter measure. The method is demonstrated on a synthetic 8-bus network and a 464-bus model...... of the Western Denm ark transmission grid. The method successfully demonstrates its ability to efficiently identify and evaluate counter measures for a large, practical system....

  18. 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.

  19. 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.

  20. 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

  1. 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

  2. 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

  3. 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.

  4. 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...

  5. Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

    2010-01-01

    Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

  6. The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Andrea A. Howard

    2017-06-01

    Discussion: The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

  7. Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich...

    Science.gov (United States)

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secon...

  8. 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 ...

  9. Sparsity Prevention Pivoting Method for Linear Programming

    DEFF Research Database (Denmark)

    Li, Peiqiang; Li, Qiyuan; Li, Canbing

    2018-01-01

    . The principle of this method is avoided choosing the row which the value of the element in the b vector is zero as the row of the pivot element to make the matrix in linear programming density and ensure that most subsequent steps will improve the value of the objective function. One step following......When the simplex algorithm is used to calculate a linear programming problem, if the matrix is a sparse matrix, it will be possible to lead to many zero-length calculation steps, and even iterative cycle will appear. To deal with the problem, a new pivoting method is proposed in this paper...... this principle is inserted to reselect the pivot element in the existing linear programming algorithm. Both the conditions for inserting this step and the maximum number of allowed insertion steps are determined. In the case study, taking several numbers of linear programming problems as examples, the results...

  10. Advances in Statistical Methods for Substance Abuse Prevention Research

    Science.gov (United States)

    MacKinnon, David P.; Lockwood, Chondra M.

    2010-01-01

    The paper describes advances in statistical methods for prevention research with a particular focus on substance abuse prevention. Standard analysis methods are extended to the typical research designs and characteristics of the data collected in prevention research. Prevention research often includes longitudinal measurement, clustering of data in units such as schools or clinics, missing data, and categorical as well as continuous outcome variables. Statistical methods to handle these features of prevention data are outlined. Developments in mediation, moderation, and implementation analysis allow for the extraction of more detailed information from a prevention study. Advancements in the interpretation of prevention research results include more widespread calculation of effect size and statistical power, the use of confidence intervals as well as hypothesis testing, detailed causal analysis of research findings, and meta-analysis. The increased availability of statistical software has contributed greatly to the use of new methods in prevention research. It is likely that the Internet will continue to stimulate the development and application of new methods. PMID:12940467

  11. 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.

  12. 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.

  13. 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.

  14. Use of quality management methods in the transition from efficacious prevention programs to effective prevention services.

    Science.gov (United States)

    Daniels, Vicki-Smith; Sandler, Irwin; Wolchik, Sharlene

    2008-06-01

    This paper applies concepts and methods developed in management to translate efficacious prevention programs into effective prevention services. The paper describes Quality Function Deployment (QFD) as a method for structured planning and development that connects the needs and wants of the consumer with the design of the product or service. The paper describes basic tools used in quality management, and discusses how they might be applied to prepare a prevention program for implementation by community agencies. Prevention programs are conceptualized as having multiple consumers (i.e., stakeholders), including the participants who receive the service, the service providers, the organizations that deliver the program, and the researchers who evaluate the programs. As an illustration of one step in the application of QFD to translate efficacious prevention programs into effective prevention services, analysis of the needs and preferences of Family Courts for the implementation of an the New Beginnings Program is presented.

  15. 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.

  16. Methods employed in the prevention and treatment of malaria ...

    African Journals Online (AJOL)

    onasoga olayinka

    Therefore, there is need to concentrate on health education of these women on the hazards associated with the crude methods as well as importance of intermittent preventive treatment (IPT) during pregnancy so as to achieve effective control of malaria among pregnant women. Key words: Malaria prevention, Malaria ...

  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. 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

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.  

  1. An irrational trial equation method and its applications

    Indian Academy of Sciences (India)

    Finally, we also discuss a more general irrational trial equation method, and use it to give a number of exact solutions to the Fujimoto–Watanabe equation [17] ut = u3uxxx + 3u2uxuxx + 3αu2ux. (3). 2. Irrational trial equation method. We consider the following nonlinear partial differential equation: N(u, ut,utt,...,ux,uxx,...,utx,.

  2. 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...

  3. 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...

  4. Methods to prevent turbogenerators design elements defects

    Directory of Open Access Journals (Sweden)

    Валентина Володимирівна Шевченко

    2016-11-01

    Full Text Available The paper shows that the determination of a failure probability due to the design, technological and operational drawbacks, as well as due to the turbogenerators working time exceeding from statistics data is inaccurate. Machine park of turbogenerators being rather limited in number, the classification and the distribution of generators into groups is random. It can not be used in practice to identify the pre-emergency state of turbogenerators and their timely stop. Analysis and classification of most frequent defects of turbogenerators has been performed. Methods for assessing such defects and reduction of their development have been offered. The article notes that expenses should be taken into account when setting up a monitoring system to assess the state and to identify defects. Reduction of expenditures on both operating and new turbogenerators must be justified. Rapid return of investments must be ensured. The list of additional tests has been proposed: measurement of infrared radiation outside the body of the turbogenerator for the estimation of the thermal field distribution and the defects of gas coolers identification; vibroacoustic inspection of the stator core and casing to find out the defects in the suspension of the core in the stator casing; analysis of the impurities in the cooling gas and in the dry remains of the drainage products to detect the products of the steel core and the winding insulation wear; value measurement and establishment of the partial discharges formation position; research of vibrations to reveal the cracks in the shaft, circuiting in the rotor windings and defects in the bearings. The paper notes that at upgrading as power grows overall and mounting dimensions must be preserved so that the existing foundation could be used as well as the existing security systems. Therefore, when designing or upgrading turbogenerators with an increase in power it is necessary to introduce new design decisions

  5. Adaptive design methods in clinical trials – a review

    Directory of Open Access Journals (Sweden)

    Chang Mark

    2008-05-01

    Full Text Available Abstract In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc, and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments, challenges in by design (prospective adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed.

  6. 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

  7. 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...

  8. 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....

  9. 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 ...

  10. 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.

  11. 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

  12. 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 ...

  13. 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.

  14. 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 ...

  15. 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.

  16. 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

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

    Directory of Open Access Journals (Sweden)

    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

  18. 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

  19. 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

  20. 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.

  1. 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.

  2. 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.

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

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    T. L. Griffin

    2017-08-01

    Full Text Available Abstract Background Increasing prevalence of childhood obesity and its related consequences emphasises the importance of developing and evaluating interventions aimed at prevention. The importance of process evaluation in health intervention research is increasingly recognised, assessing implementation and participant response, and how these may relate to intervention success or failure. A comprehensive process evaluation was designed and undertaken for the West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES study that tested the effectiveness of an obesity prevention programme for children aged 6-7 years, delivered in 24 UK schools. The four intervention components were: additional daily school-time physical activity (PA; cooking workshops for children and parents; Villa Vitality (VV, a 6-week healthy lifestyle promotion programme run by a local football club; and signposting to local PA opportunities. Methods Data relating to six dimensions (Fidelity, Reach, Recruitment, Quality, Participant Responsiveness, Context were collected via questionnaires, logbooks, direct observations, focus groups and interviews. Multiple data collection methods allowed for data triangulation and validation of methods, comparing research observations with teacher records. The 6-stage WAVES study model ((i Data collection, (ii Collation, (iii Tabulation, (iv Score allocation and discussion, (v Consultation, (vi Final score allocation was developed to guide the collection, assimilation and analysis of process evaluation data. Two researchers independently allocated school scores on a 5-point Likert scale for each process evaluation dimension. Researchers then discussed school score allocations and reached a consensus. Schools were ranked by total score, and grouped to reflect low, medium or high intervention implementation. Results The intervention was predominantly well-implemented and well-received by teachers, parents and children. The PA

  4. Suicide Methods in Asia: Implications in Suicide Prevention

    Science.gov (United States)

    Wu, Kevin Chien-Chang; Chen, Ying-Yeh; Yip, Paul S. F.

    2012-01-01

    As the largest continent in the World, Asia accounts for about 60% of World suicides. Preventing suicide by restricting access to suicide methods is one of the few evidence-based suicide prevention strategies. However, there has been a lack of systematic exploration of suicide methods in Asian countries. To amend this shortage, the current review examines the leading suicide methods in different Asian countries, their trend, their age- and sex- specific characteristics, and their implications for suicide prevention. In total, 42 articles with leading suicide methods data in 17 Asian countries/regions were retrieved. The epidemiologic characteristics and recent trends of common suicide methods reflect specific socio-cultural, economic, and religious situations in the region. Common suicide methods shift with the introduction of technologies and constructions, and have specific age- or sex-characteristics that may render the restriction of suicide methods not equally effective for all sex and age sub-groups. Charcoal burning, pesticide poisoning, native plant poisoning, self-immolation, and jumping are all prominent examples. In the information society, suicide prevention that focuses on suicide methods must monitor and control the innovation and spread of knowledge and practices of suicide “technologies”. It may be more cost-effective to design safety into technologies as a way of suicide prevention while there is no rash of suicides yet by the new technologies. Further research on suicide methods is important for public health approaches to suicide prevention with sensitivity to socio-cultural, economic, and religious factors in different countries. PMID:22690187

  5. Suicide Methods in Asia: Implications in Suicide Prevention

    Directory of Open Access Journals (Sweden)

    Paul S. F. Yip

    2012-03-01

    Full Text Available As the largest continent in the World, Asia accounts for about 60% of World suicides. Preventing suicide by restricting access to suicide methods is one of the few evidence-based suicide prevention strategies. However, there has been a lack of systematic exploration of suicide methods in Asian countries. To amend this shortage, the current review examines the leading suicide methods in different Asian countries, their trend, their age- and sex- specific characteristics, and their implications for suicide prevention. In total, 42 articles with leading suicide methods data in 17 Asian countries/regions were retrieved. The epidemiologic characteristics and recent trends of common suicide methods reflect specific socio-cultural, economic, and religious situations in the region. Common suicide methods shift with the introduction of technologies and constructions, and have specific age- or sex-characteristics that may render the restriction of suicide methods not equally effective for all sex and age sub-groups. Charcoal burning, pesticide poisoning, native plant poisoning, self-immolation, and jumping are all prominent examples. In the information society, suicide prevention that focuses on suicide methods must monitor and control the innovation and spread of knowledge and practices of suicide “technologies”. It may be more cost-effective to design safety into technologies as a way of suicide prevention while there is no rash of suicides yet by the new technologies. Further research on suicide methods is important for public health approaches to suicide prevention with sensitivity to socio-cultural, economic, and religious factors in different countries.

  6. 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.

  7. 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.

  8. 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.

  9. Dental caries and periodontal disease (prevention and control methods).

    Science.gov (United States)

    Juan, S P

    1999-01-01

    There is a compelling need to apply preventive programs in both private and community practice of dentistry. This is to maintain improvements in oral health in developed and industrialized countries, and to stem increases in oral diseases in underserved and developing ones. At the outset, the terms prevention and control must be understood. The former is considered to mean a procedure or course of action that prevents the onset of disease, whereas the latter, implies reversing or stabilizing disease conditions. To be more precise, prevention will refer to the pre-pathologic or pre-clinical stage encompassing the promotive and specific protection levels--primary prevention stage. On the other hand, control will encompass early diagnosis and prompt treatment, disability limitation and rehabilitation levels-termed also collectively, as pathologic, clinical and final stages, or secondary and tertiary prevention. Community-based programs are usually structured to compliment therapeutic interventions of oral diseases, as well as prevention. In this era, and towards the next millennium, preventive and control programs are given high priorities in order to minimize the need for curative, restorative and therapeutic management of oral diseases. This review of the literature will give emphasis on established methods and programs for the prevention and control of the two most common oral diseases, dental caries and periodontal disease. The problems, background, and oral health objectives for the year 2000 as proposed by the World Health Organization (WHO) and the Federation Dentaire Internationale (FDI), as well as the recent advances in oral health relative to these diseases will be discussed. Finally, to better improve the efficacy of existing prevention and control methods, research needs and areas of concern relative to these diseases will be given consideration.

  10. 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

  11. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

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    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  12. 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...

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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...

  19. 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

  20. 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.

  1. 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

  2. Methods to improve patient recruitment and retention in stroke trials

    DEFF Research Database (Denmark)

    Berge, Eivind; Stapf, Christian; Al-Shahi Salman, Rustam

    2016-01-01

    by health services only when delivered within clinical trials. The literature review revealed that few methods have been formally evaluated. The top five priorities for evaluation identified in the workshop were as follows: short and illustrated patient information leaflets, nonwritten consent......Background: The success of randomized-controlled stroke trials is dependent on the recruitment and retention of a sufficient number of patients, but fewer than half of all trials meet their target number of patients. Methods: We performed a search and review of the literature, and conducted...... a survey and workshop among 56 European stroke trialists, to identify barriers, suggest methods to improve recruitment and retention, and make a priority list of interventions that merit further evaluation. Results: The survey and workshop identified a number of barriers to patient recruitment...

  3. 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.

  4. Methods to monitor and evaluate household waste prevention.

    Science.gov (United States)

    Sharp, Veronica; Giorgi, Sara; Wilson, David C

    2010-03-01

    This paper presents one strand of the findings from a comprehensive synthesis review of the policy-relevant evidence on household waste prevention. The focus herein is on how to measure waste prevention: it is always difficult to measure what is not there. Yet reliable and robust monitoring and evaluation of household waste prevention interventions is essential, to enable policy makers, local authorities and practitioners to: (a) collect robust and high quality data; (b) ensure robust decisions are made about where to prioritize resources; and (c) ensure that waste prevention initiatives are being effective and delivering behaviour change. The evidence reveals a range of methods for monitoring and evaluation, including self-weighing; pre- and post-intervention surveys, focusing on attitudes and behaviours and/or on participation rates; tracking waste arisings via collection data and/or compositional analysis; and estimation/modelling. There appears to be an emerging consensus that no single approach is sufficient on its own, rather a 'hybrid' method using a suite of monitoring approaches - usually including surveys, waste tonnage data and monitoring of campaigns - is recommended. The evidence concurs that there is no benefit in trying to further collate evidence from past waste prevention projects, other than to establish, in a few selected cases, if waste prevention behaviour has been sustained beyond cessation of the active intervention campaign. A more promising way forward is to ensure that new intervention campaigns are properly evaluated and that the evidence is captured and collated into a common resource.

  5. 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

  6. 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.

  7. 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.

  8. Purpose and methods of a Pollution Prevention Awareness Program

    Energy Technology Data Exchange (ETDEWEB)

    Flowers, P.A.; Irwin, E.F.; Poligone, S.E.

    1994-08-15

    The purpose of the Pollution Prevention Awareness Program (PPAP), which is required by DOE Order 5400.1, is to foster the philosophy that prevention is superior to remediation. The goal of the program is to incorporate pollution prevention into the decision-making process at every level throughout the organization. The objectives are to instill awareness, disseminate information, provide training and rewards for identifying the true source or cause of wastes, and encourage employee participation in solving environmental issues and preventing pollution. PPAP at the Oak Ridge Y-12 Plant was created several years ago and continues to grow. We believe that we have implemented several unique methods of communicating environmental awareness to promote a more active work force in identifying ways of reducing pollution.

  9. 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.

  10. 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

  11. Nurse-led telephone-based follow-up of secondary prevention after acute coronary syndrome: One-year results from the randomized controlled NAILED-ACS trial

    OpenAIRE

    Huber, Daniel; Henriksson, Robin; Jakobsson, Stina; Mooe, Thomas

    2017-01-01

    Background. Secondary prevention after acute coronary syndrome (ACS) could reduce morbidity and mortality, but guideline targets are seldom reached. We hypothesized that nurse-led telephone- based intervention would increase adherence. Methods. The NAILED ACS trial is a prospective, controlled, randomized trial. Patients admitted for ACS at Ostersund hospital, Sweden, were randomized to usual follow-up by a general practitioner or a nurse-led intervention. The intervention comprised telephone...

  12. Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting

    Science.gov (United States)

    2013-01-01

    Background Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention randomized trial in the child care setting. Methods/design A randomized, controlled obesity prevention trial is currently being conducted over a three year period (2010-present). The sample consists of 28 low-income, ethnically diverse child care centers with 1105 children (sample is 60% Hispanic, 15% Haitian, 12% Black, 2% non-Hispanic White and 71% of caregivers were born outside of the US). The purpose is to test the efficacy of a parent and teacher role-modelpan>ing intervention on children’s nutrition and physical activity behaviors. . The Healthy Caregivers-Healthy Children (HC2) intervention arm schools received a combination of (1) implementing a daily curricula for teachers/parents (the nutritional gatekeepers); (2) implementing a daily curricula for children; (3) technical assistance with meal and snack menu modifications such as including more fresh and less canned produce; and (4) creation of a center policy for dietary requirements for meals and snacks, physical activity and screen time. Control arm schools received an attention control safety curriculum. Major outcome measures include pre-post changes in child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, amount of physical activity, and parental nutrition and physical activity knowledge, attitudes, and beliefs, defined by intentions and behaviors. All measures were administered at the beginning and end of the school year for year one and year two of the study for a total of 4 longitudinal time points for assessment. Discussion Although few

  13. Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting

    Directory of Open Access Journals (Sweden)

    Natale Ruby

    2013-01-01

    Full Text Available Abstract Background Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention randomized trial in the child care setting. Methods/design A randomized, controlled obesity prevention trial is currently being conducted over a three year period (2010-present. The sample consists of 28 low-income, ethnically diverse child care centers with 1105 children (sample is 60% Hispanic, 15% Haitian, 12% Black, 2% non-Hispanic White and 71% of caregivers were born outside of the US. The purpose is to test the efficacy of a parent and teacher role-modeling intervention on children’s nutrition and physical activity behaviors. . The Healthy Caregivers-Healthy Children (HC2 intervention arm schools received a combination of (1 implementing a daily curricula for teachers/parents (the nutritional gatekeepers; (2 implementing a daily curricula for children; (3 technical assistance with meal and snack menu modifications such as including more fresh and less canned produce; and (4 creation of a center policy for dietary requirements for meals and snacks, physical activity and screen time. Control arm schools received an attention control safety curriculum. Major outcome measures include pre-post changes in child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, amount of physical activity, and parental nutrition and physical activity knowledge, attitudes, and beliefs, defined by intentions and behaviors. All measures were administered at the beginning and end of the school year for year one and year two of the study for a total of 4 longitudinal time points for assessment

  14. 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

  15. 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…

  16. 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...

  17. 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…

  18. 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).

  19. 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

  20. 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

  1. 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).

  2. 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

  3. 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

  4. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Maas Josina C

    2012-03-01

    Full Text Available Abstract Background Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP. Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. Methods A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching. Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i ankle and knee flexion during gait and ii gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. Discussion This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Trial Registration Number

  5. 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

  6. 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

  7. 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.

  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

    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...

  9. Methods employed in the prevention and treatment of malaria ...

    African Journals Online (AJOL)

    Background: Malaria remains a major public health problem in Nigeria and is the most common cause of hospital attendance in all age groups, of which children and pregnant women are the major risk groups; therefore this study was designed to explore various methods of prevention and treatment of malaria among ...

  10. Materials and methods for preventing and treating anastomotic leaks

    Energy Technology Data Exchange (ETDEWEB)

    Alverdy, John C.

    2018-04-10

    Materials and methods for preventing and treating anastomotic leaks are disclosed. Data establishes that pathogenic microbes interfere with establishing epithelial cell barriers in anastomoses and, more generally, with the reconnection of any two portions of like or different tissues comprising epithelia. Suitable prophylactic and therapeutic composition comprise, e.g., a phosphorylated high molecular weight polyethylene glycol compound.

  11. 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.

  12. Application of the trial equation method for solving some nonlinear ...

    Indian Academy of Sciences (India)

    Their key idea is to expand solutions of given differential equations as functions of solutions of solvable differential equations, in particular, polynomial and rational func- tions. This idea is so good that many types of nonlinear differential equations can be solved by it. Also, Liu proposed the trial equation method and applied ...

  13. The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme

    Directory of Open Access Journals (Sweden)

    Jacobs Nele

    2007-09-01

    Full Text Available Abstract Background Cardiovascular diseases (CVD are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterol, hyperglycemia, overweight and obesity as well as behavioural risk factors (sedentary lifestyle, high fat intake and low fruit and vegetable intake, smoking. The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors. Methods/Design In a randomized controlled trial, one group will receive a maximal intervention (= intervention group. The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician. The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback. Discussion This trial incorporates interventions by GPs and other health professionals aiming at a reduction of

  14. Methods of Preventives to keep Birth Control in the Quran

    Directory of Open Access Journals (Sweden)

    Ahmad Yunus Mohd Noor

    2017-12-01

    Full Text Available This research is mainly concerned about the methods set by the Quran for preserving the human breeding, which is regarded the main pillar not only for the future survival of the humankind, but also for assuring its permanence and continuity. Taking this into consideration, the Quran has addressed this issue by setting solid preventive tools that ensure the continuity and prosperity of the human offspring in a normal manner. The objective of the research is to shed light on the importance of protecting the human offspring in the Quran, since neglecting its importance could lead to the corruption of the whole society and its members. The research attempts also to tackle the various preventive tools that the Quran has adopted for protecting the normal continuity and prosperity of the human offspring. The research proposes to study the Quranic verses that address the protection of the human offspring and the various preventive tools that should be adopted, along with the accredited analysis and statements of purpose of the Quranic verses, with reference to the approved sources of interpretation. Apart of the findings are that the Quran has set two main methods for protecting the human offspring that is; the preventive tools for protecting the amount of birth control, and the preventive tools for maintaining the quality of birth control. The preventive tools for protecting the amount of birth control include the forbidding of being monastic, the prohibiting of killing children for fear of poverty, and the forbidding of falling into immorality, either outwardly or inwardly. They also include the establishment of prayer, giving charity, reciting Dhikr (remembrance and asking of forgiveness. The preventive tools for maintaining the quality of birth control, however, include not approaching adultery, prohibiting adoption, and forbidding incest, the people of shirk and immorality and blasphemy.

  15. 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

  16. 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

  17. 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

  18. Bayesian methods in clinical trials: a Bayesian analysis of ECOG trials E1684 and E1690

    Directory of Open Access Journals (Sweden)

    Ibrahim Joseph G

    2012-11-01

    Full Text Available Abstract Background E1684 was the pivotal adjuvant melanoma trial for establishment of high-dose interferon (IFN as effective therapy of high-risk melanoma patients. E1690 was an intriguing effort to corroborate E1684, and the differences between the outcomes of these trials have embroiled the field in controversy over the past several years. The analyses of E1684 and E1690 were carried out separately when the results were published, and there were no further analyses trying to perform a single analysis of the combined trials. Method In this paper, we consider such a joint analysis by carrying out a Bayesian analysis of these two trials, thus providing us with a consistent and coherent methodology for combining the results from these two trials. Results The Bayesian analysis using power priors provided a more coherent flexible and potentially more accurate analysis than a separate analysis of these data or a frequentist analysis of these data. The methodology provides a consistent framework for carrying out a single unified analysis by combining data from two or more studies. Conclusions Such Bayesian analyses can be crucial in situations where the results from two theoretically identical trials yield somewhat conflicting or inconsistent results.

  19. 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

  20. 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

  1. 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...

  2. Evaluation method of radon preventing effect in underground construction

    International Nuclear Information System (INIS)

    Luo Shaodong; Deng Yuequan; Dong Faqin; Qu Ruixue; Xie Zhonglei

    2014-01-01

    Background: It's difficult to evaluate the radon prevention effect because of the short operating time of measuring instrument under the circumstances of high humidity in underground construction. Purpose: A new rapid method to evaluate the radon prevention efficiency of underground construction was introduced. Methods: The radon concentrations before and after shielding operation were determined, and according to the regularity of radon decay, the shielding rate can be calculated. Results: The results showed that radon shielding rate in underground construction remains generally stable with variation of time, and the actual relatively standard deviation was 3.95%. So the rapid determination and evaluation of radon preventing effect under special conditions in underground construction can be realized by taking shielding rate in a short time for the final shielding rate. Compared with those by the local static method in ground lab, the results were similar. Conclusion: This paper provided a prompt, accurate and practicable way for the evaluation of radon prevention in underground construction, having a certain reference value. (authors)

  3. 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

  4. Evaluation of the Prevention and Reactivation Care Program (PReCaP) for the hospitalized elderly: A prospective nonrandomized controlled trial

    OpenAIRE

    Asmus-Szepesi, Kirsten; Flinterman, Linda; Koopmanschap, Marc; Nieboer, Anna; Bakker, Ton; Mackenbach, Johan; Steyerberg, Ewout

    2015-01-01

    textabstractBackground: The hospitalized elderly are at risk of functional decline. We evaluated the effects and care costs of a specialized geriatric rehabilitation program aimed at preventing functional decline among at-risk hospitalized elderly. Methods: The prospective nonrandomized controlled trial reported here was performed in three hospitals in the Netherlands. One hospital implemented the Prevention and Reactivation Care Program (PReCaP), while two other hospitals providing usual car...

  5. Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marnitz Ulf

    2010-01-01

    Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910

  6. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; van Charente, Eric P. Moll; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  7. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people: Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; Moll van Charante, Eric P.; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  8. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J; MacNeil-Vroomen, Janet L; van Rijn, Marjon; Buurman, Bianca M; de Rooij, Sophia E; Moll van Charante, Eric P; Bosmans, Judith E

    2017-01-01

    OBJECTIVE: To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. METHODS: We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  9. One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

    Science.gov (United States)

    Knowlden, Adam; Sharma, Manoj

    2016-01-01

    Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

  10. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

    2016-01-01

    Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

  11. 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

  12. 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.

  13. 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

    Increasing prevalence of childhood obesity and its related consequences emphasises the importance of developing and evaluating interventions aimed at prevention. The importance of process evaluation in health intervention research is increasingly recognised, assessing implementation and participant response, and how these may relate to intervention success or failure. A comprehensive process evaluation was designed and undertaken for the West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study that tested the effectiveness of an obesity prevention programme for children aged 6-7 years, delivered in 24 UK schools. The four intervention components were: additional daily school-time physical activity (PA); cooking workshops for children and parents; Villa Vitality (VV), a 6-week healthy lifestyle promotion programme run by a local football club; and signposting to local PA opportunities. Data relating to six dimensions (Fidelity, Reach, Recruitment, Quality, Participant Responsiveness, Context) were collected via questionnaires, logbooks, direct observations, focus groups and interviews. Multiple data collection methods allowed for data triangulation and validation of methods, comparing research observations with teacher records. The 6-stage WAVES study model ((i) Data collection, (ii) Collation, (iii) Tabulation, (iv) Score allocation and discussion, (v) Consultation, (vi) Final score allocation) was developed to guide the collection, assimilation and analysis of process evaluation data. Two researchers independently allocated school scores on a 5-point Likert scale for each process evaluation dimension. Researchers then discussed school score allocations and reached a consensus. Schools were ranked by total score, and grouped to reflect low, medium or high intervention implementation. The intervention was predominantly well-implemented and well-received by teachers, parents and children. The PA component was identified as the most

  14. Economic Evaluation of PRIMROSE—A Trial-Based Analysis of an Early Childhood Intervention to Prevent Obesity

    Directory of Open Access Journals (Sweden)

    Nora Döring

    2018-03-01

    Full Text Available BackgroundChildhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden.MethodsThe economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9–48 months of age through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty.ResultsThe estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348 per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents’ absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented.ConclusionWe cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Deposit and scale prevention methods in thermal sea water desalination

    International Nuclear Information System (INIS)

    Froehner, K.R.

    1977-01-01

    Introductory remarks deal with the 'fouling factor' and its influence on the overall heat transfer coefficient of msf evaporators. The composition of the matter dissolved in sea water and the thermal and chemical properties lead to formation of alkaline scale or even hard, sulphate scale on the heat exchanger tube walls and can hamper plant operation and economics seriously. Among the scale prevention methods are 1) pH control by acid dosing (decarbonation), 2) 'threshold treatment' by dosing of inhibitors of different kind, 3) mechanical cleaning by sponge rubber balls guided through the heat exchanger tubes, in general combined with methods no. 1 or 2, and 4) application of a scale crystals germ slurry (seeding). Mention is made of several other scale prevention proposals. The problems encountered with marine life (suspension, deposit, growth) in desalination plants are touched. (orig.) [de

  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.

    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

  2. Applying probabilistic methods for assessments and calculations for accident prevention

    International Nuclear Information System (INIS)

    Anon.

    1984-01-01

    The guidelines for the prevention of accidents require plant design-specific and radioecological calculations to be made in order to show that maximum acceptable expsoure values will not be exceeded in case of an accident. For this purpose, main parameters affecting the accident scenario have to be determined by probabilistic methods. This offers the advantage that parameters can be quantified on the basis of unambigious and realistic criteria, and final results can be defined in terms of conservativity. (DG) [de

  3. 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...

  4. Automated patient and medication payment method for clinical trials

    Directory of Open Access Journals (Sweden)

    Yawn BP

    2013-01-01

    Full Text Available Barbara P Yawn,1 Suzanne Madison,1 Susan Bertram,1 Wilson D Pace,2 Anne Fuhlbrigge,3 Elliot Israel,3 Dawn Littlefield,1 Margary Kurland,1 Michael E Wechsler41Olmsted Medical Center, Department of Research, Rochester, MN, 2UCDHSC, Department of Family Medicine, University of Colorado Health Science Centre, Aurora, CO, 3Brigham and Women's Hospital, Pulmonary and Critical Care Division, Boston, MA, 4National Jewish Medical Center, Division of Pulmonology, Denver, CO, USABackground: Published reports and studies related to patient compensation for clinical trials focus primarily on the ethical issues related to appropriate amounts to reimburse for patient's time and risk burden. Little has been published regarding the method of payment for patient participation. As clinical trials move into widely dispersed community practices and more complex designs, the method of payment also becomes more complex. Here we review the decision process and payment method selected for a primary care-based randomized clinical trial of asthma management in Black Americans.Methods: The method selected is a credit card system designed specifically for clinical trials that allows both fixed and variable real-time payments. We operationalized the study design by providing each patient with two cards, one for reimbursement for study visits and one for payment of medication costs directly to the pharmacies.Results: Of the 1015 patients enrolled, only two refused use of the ClinCard, requesting cash payments for visits and only rarely a weekend or fill-in pharmacist refused to use the card system for payment directly to the pharmacy. Overall, the system has been well accepted by patients and local study teams. The ClinCard administrative system facilitates the fiscal accounting and medication adherence record-keeping by the central teams. Monthly fees are modest, and all 12 study institutional review boards approved use of the system without concern for patient

  5. 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

  6. 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

  7. Sham-controlled, randomized, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

    Science.gov (United States)

    Meng, Zhiqiang; Garcia, M. Kay; Hu, Chaosu; Chiang, Joseph; Chambers, Mark; Rosenthal, David I.; Peng, Huiting; Wu, Caijun; Zhao, Qi; Zhao, Genming; Liu, Luming; Spelman, Amy; Palmer, J. Lynn; Wei, Qi; Cohen, Lorenzo

    2013-01-01

    Background Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy. Methods A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy. To determine feasibility of a sham procedure, 23 patients were randomized to real acupuncture (N = 11) or to sham acupuncture (N = 12). Patients were treated 3 times/week during their course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy. Results XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P’s xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-center, randomized, placebo-controlled trials are now needed. PMID:22285177

  8. Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

    Directory of Open Access Journals (Sweden)

    Babalwa Zani

    Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

  9. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial

    Directory of Open Access Journals (Sweden)

    Alperstein Garth

    2007-05-01

    Full Text Available Abstract Background Studies have shown that a proportion of children as young as two years are already overweight. This indicates that obesity prevention programs that commence as early as possible and are family-focused are needed. This Healthy Beginnings Trial aims to determine the efficacy of a community-based randomized controlled trial (RCT of a home visiting intervention in preventing the early onset of childhood overweight and obesity. The intervention will be conducted over the first two years of life to increase healthy feeding behaviours and physical activity, decrease physical inactivity, enhance parent-child interaction, and hence reduce overweight and obesity among children at 2 and 5 years of age in the most socially and economically disadvantaged areas of Sydney, Australia. Methods/design This RCT will be conducted with a consecutive sample of 782 first time mothers with their newborn children. Pregnant women who are expecting their first child, and who are between weeks 24 and 34 of their pregnancy, will be invited to participate in the trial at the antenatal clinic. Informed consent will be obtained and participants will then be randomly allocated to the intervention or the control group. The allocation will be concealed by sequentially numbered, sealed opaque envelopes containing a computer generated random number. The intervention comprises eight home visits from a specially trained community nurse over two years and pro-active telephone support between the visits. Main outcomes include a duration of breastfeeding measured at 6 and 12 months, b introduction of solids measured at 4 and 6 months, c nutrition, physical activity and television viewing measured at 24 months, and d overweight/obesity status at age 2 and 5 years. Discussion The results of this trial will ascertain whether the home based early intervention is effective in preventing the early onset of childhood overweight and obesity. If proved to be effective, it

  10. Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP 10–14 UK)

    Science.gov (United States)

    2014-01-01

    Background Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10–14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10–14 (SFP 10–14 UK). Methods/Design The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10–14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as ‘never’ and ‘1-2 times or more’. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. Discussion The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. Trial registration Current Controlled Trials ISRCTN63550893. PMID:24438460

  11. 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

  12. Go!: results from a quasi-experimental obesity prevention trial with hospital employees

    Directory of Open Access Journals (Sweden)

    Lara J. LaCaille

    2016-02-01

    Full Text Available Abstract Background Worksite obesity prevention interventions using an ecological approach may hold promise for reducing typical weight gain. The purpose of this study was to examine the effectiveness of Go!, an innovative 12-month multi-component worksite obesity prevention intervention. Methods A quasi-experimental non-equivalent control group design was utilized; 407 eligible hospital employees (intervention arm and 93 eligible clinic employees (comparison arm participated. The intervention involved pedometer distribution, labeling of all foods in the worksite cafeteria and vending machines (with calories, step equivalent, and a traffic light based on energy density signaling recommended portion, persuasive messaging throughout the hospital, and the integration of influential employees to reinforce healthy social norms. Changes in weight, BMI, waist circumference, physical activity, and dietary behavior after 6 months and 1 year were primary outcomes. Secondary outcomes included knowledge, perceptions of employer commitment to employee health, availability of information about diet, exercise, and weight loss, perceptions of coworker support and frequency of health discussions with coworkers. A process evaluation was conducted as part of the study. Results Repeated measures ANCOVA indicated that neither group showed significant increases in weight, BMI, or waist circumference over 12 months. The intervention group showed a modest increase in physical activity in the form of walking, but decreases in fruit and vegetable servings and fiber intake. They also reported significant increases in knowledge, information, perceptions of employer commitment, and health discussions with peers. Employees expressed positive attitudes towards all components of the Go! intervention. Conclusions This low-intensity intervention was well-received by employees but had little effect on their weight over the course of 12 months. Such results are consistent with

  13. 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

  14. 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.

  15. 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.

  16. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

    Directory of Open Access Journals (Sweden)

    Hayes Rachel

    2010-10-01

    Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

  17. Postpartum Depression Prevention for Reservation-Based American Indians: Results from a Pilot Randomized Controlled Trial

    Science.gov (United States)

    Ginsburg, Golda S.; Barlow, Allison; Goklish, Novalene; Hastings, Ranelda; Baker, Elena Varipatis; Mullany, Britta; Tein, Jenn-Yun; Walkup, John

    2012-01-01

    Background: Postpartum depression is a devastating condition that affects a significant number of women and their offspring. Few preventive interventions have targeted high risk youth, such as American Indians (AIs). Objective: To evaluate the feasibility of a depression prevention program for AI adolescents and young adults. Methods: Expectant AI…

  18. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies

    Directory of Open Access Journals (Sweden)

    Sheridan Stacey L

    2011-12-01

    Full Text Available Abstract Background Efficacious strategies for the primary prevention of coronary heart disease (CHD are underused, and, when used, have low adherence. Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice. Methods We conducted a randomized trial of a CHD prevention intervention (including a computerized decision aid and automated tailored adherence messages at one university general internal medicine practice. After obtaining informed consent and collecting baseline data, we randomized patients (men and women age 40-79 with no prior history of cardiovascular disease to either the intervention or usual care. We then saw them for two additional study visits over 3 months. For intervention participants, we administered the decision aid at the primary study visit (1 week after baseline visit and then mailed 3 tailored adherence reminders at 2, 4, and 6 weeks. We assessed our outcomes (including the predicted likelihood of angina, myocardial infarction, and CHD death over 10 years (CHD risk and self-reported adherence between groups at 3 month follow-up. Data collection occurred from June 2007 through December 2009. All study procedures were IRB approved. Results We randomized 160 eligible patients (81 intervention; 79 control and followed 96% to study conclusion. Mean predicted CHD risk at baseline was 11.3%. The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points (95% CI 8% to 42%, with the biggest effect for aspirin. It also changed predicted CHD risk by -1.1% (95% CI -0.16% to -2%, with a larger effect in a pre-specified subgroup of high risk patients. Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk. Clinical trials registration number ClinicalTrials

  19. Rationale and protocol of a trial for prevention of diabetic atherosclerosis by using antiplatelet drugs: study of Diabetic Atherosclerosis Prevention by Cilostazol (DAPC study

    Directory of Open Access Journals (Sweden)

    Kawamori Ryuzo

    2006-08-01

    Full Text Available Abstract Background Secondary treatment of arteriosclerosis may be applicable for the primary prevention of atherosclerosis in diabetic patients. This prospective, 2-year follow-up study was designed to determine the efficacy and safety of antiplatelet therapy in the prevention of atherosclerosis of diabetic subjects. Methods Patients with type 2 diabetes and arteriosclerosis obliterans from the Eastern Asian countries were registered online and randomly assigned either to the aspirin group (81–100 mg/day or the cilostazol group (100–200 mg/day in this international, 2-year, prospective follow-up interventional study. Results The primary study endpoint was changes in right and left maximum intima-media thickness of the common carotid artery. Secondary endpoints include changes in right and left maximum intima-media thickness of the internal carotid artery; semiquantitative evaluation of cerebral infarction by magnetic resonance imaging; cardiovascular events including sudden death, stroke, transient cerebral ischemic attacks, acute myocardial infarction, angina, and progression of arteriosclerosis obliterans; overall death; withdrawal; and change in ankle-brachial pressure index. Conclusion This is the first study to use an online system that was developed in Asian countries for pooling data from an international clinical trial. These findings are expected to help in the prevention of diabetic atherosclerosis and subsequent cardiovascular and cerebrovascular disease.

  20. Effectiveness of the home-based alcohol prevention program "In control: No alcohol!": study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Verdurmen Jacqueline EE

    2011-08-01

    Full Text Available Abstract Background In the Netherlands, children start to drink at an early age; of the Dutch 12-year olds, 40% reports lifetime alcohol use, while 9.7% reports last-month drinking. Starting to drink at an early age puts youth at risk of developing several alcohol-related problems later in life. Recently, a home-based prevention program called "In control: No alcohol!" was developed to delay the age of alcohol onset in children. The main aim of this project is to conduct a Randomized Controlled Trial (RCT to evaluate the effectiveness of the program. Methods/Design The prevention program will be tested with an RCT among mothers and their 6 grade primary school children (11-12 years old, randomly assigned to the prevention or control condition. The program consists of five printed magazines and an activity book designed to improve parental alcohol-specific socialization. Parent-child dyads in the control group receive a factsheet information brochure, which is the standard alcohol brochure of the Trimbos Institute (the Netherlands Institute for Mental Health and Addiction. Outcome measures are initiation of alcohol use (have been drinking at least one glass of alcohol, alcohol-specific parenting, susceptibility to drinking alcohol, alcohol expectancies, self-efficacy, and frequency and intensity of child alcohol use. Questionnaires will be administered online on secured Internet webpages, with personal login codes for both mothers and children. Mothers and children in both the experimental and control condition will be surveyed at baseline and after 6, 12, and 18 months (follow-ups. Discussion The present study protocol presents the design of an RCT evaluating the effectiveness of the home-based "In control: No alcohol!" program for 6 grade primary school children (11-12 years old. It is hypothesized that children in the prevention condition will be less likely to have their first glass of alcohol, compared to the control condition. When the

  1. Is it possible to prevent sports injuries? Review of controlled clinical trials and recommendations for future work.

    Science.gov (United States)

    Parkkari, J; Kujala, U M; Kannus, P

    2001-01-01

    Sports injuries are one of the most common injuries in modern western societies. Treating sports injuries is often difficult, expensive and time consuming, and thus, preventive strategies and activities are justified on medical as well as economic grounds. A successful injury surveillance and prevention requires valid pre- and post-intervention data on the extent of the problem. The aetiology, risk factors and exact mechanisms of injuries need to be identified before initiating a measure or programme for preventing sports injuries, and measurement of the outcome (injury) must include a standardised definition of the injury and its severity, as well as a systematic method of collecting the information. Valid and reliable measurement of the exposure includes exact information about the population at risk and exposure time. The true efficacy of a preventive measure or programme can be best evaluated through a well-planned randomised trial. Until now, 16 randomised, controlled trials (RCT) have been published on prevention of sports injuries. According to these RCT, the general injury rate can be reduced by a multifactorial injury prevention programme in soccer (relative risk 0.25, p ankle disk training, combined with a thorough warm-up, in European team handball [odds ratio 0.17; 95% confidence interval (CI) 0.09 to 0.32, p Ankle sprains can be prevented by ankle supports (i.e. semirigid orthoses or air-cast braces) in high-risk sporting activities, such as soccer and basketball (Peto odds ratio 0.49; 95% CI 0.37 to 0.66), and stress fractures of the lower limb by the use of shock-absorbing insoles in footwear (Peto odds ratio 0.47; 95% CI 0.30 to 0.76). In future studies, it is extremely important for researches to seek consultation with epidemiologists and statisticians to be certain that the study hypothesis is appropriate and that the methodology can lead to reliable and valid information. Further well-designed randomised studies are needed on preventive actions

  2. Applying sample survey methods to clinical trials data.

    Science.gov (United States)

    LaVange, L M; Koch, G G; Schwartz, T A

    This paper outlines the utility of statistical methods for sample surveys in analysing clinical trials data. Sample survey statisticians face a variety of complex data analysis issues deriving from the use of multi-stage probability sampling from finite populations. One such issue is that of clustering of observations at the various stages of sampling. Survey data analysis approaches developed to accommodate clustering in the sample design have more general application to clinical studies in which repeated measures structures are encountered. Situations where these methods are of interest include multi-visit studies where responses are observed at two or more time points for each patient, multi-period cross-over studies, and epidemiological studies for repeated occurrences of adverse events or illnesses. We describe statistical procedures for fitting multiple regression models to sample survey data that are more effective for repeated measures studies with complicated data structures than the more traditional approaches of multivariate repeated measures analysis. In this setting, one can specify a primary sampling unit within which repeated measures have intraclass correlation. This intraclass correlation is taken into account by sample survey regression methods through robust estimates of the standard errors of the regression coefficients. Regression estimates are obtained from model fitting estimation equations which ignore the correlation structure of the data (that is, computing procedures which assume that all observational units are independent or are from simple random samples). The analytic approach is straightforward to apply with logistic models for dichotomous data, proportional odds models for ordinal data, and linear models for continuously scaled data, and results are interpretable in terms of population average parameters. Through the features summarized here, the sample survey regression methods have many similarities to the broader family of

  3. Surgical method for prevention of scaring in conducting sinustrabeculectomy

    Directory of Open Access Journals (Sweden)

    Zhuravleva A.N.

    2017-06-01

    Full Text Available Prolonged hypotensive effect in the postoperative period is one of the main tasks of modern glaucoma surgery. In connection with this, the aim of our study is to develop a surgical method of prevention of scarring during the classical sinustrabeculectomy. Material and Methods. The operation was performed in 13 patients (13 eyes with primary open angle glaucoma (POAG ll-lll (B-C in steps aged 50-70 years. The duration of observation up of 2 year. Results. After 9-12 months of hypotensive efficacy was 100% (13 eyes in 20-24 months — 98% (12 of 13 eyes. The result was confirmed using standard methods of examination (visometry, tonometry, computerized perimetry, tonography et al., in the early postoperative period was performed optical coherence tomography of the anterior segment, then — ultrasound biomicroscopy. Conclusions. Developed a new version of the surgical treatment of glaucoma a long-acting hypotensive effect.

  4. Caries clinical trial methods for the assessment of oral care products in the 21st century.

    Science.gov (United States)

    Ellwood, R P; Gomez, J; Goma, J; Pretty, I A

    2012-09-01

    Traditionally, caries clinical trials of oral care products have focused on the prevention of caries in children and adolescents at the "cavitation" level. Because of a general reduction in caries incidence and the use of positive control comparators, studies have grown both in size and duration to improve statistical power. Currently, they tend to be of 2 to 3 years' duration, with up to 2,000 high-risk individuals per group. During the past decade, there has been a shift in emphasis from a restorative approach to the treatment of dental caries to a therapeutic approach focused on the remineralization of early caries lesions. However, caries clinical trials of oral care products have not often reflected this paradigm change. This manuscript reviews alternative caries clinical trial methods for oral care products. It is concluded that methods focused on the detection and monitoring of enamel caries and root caries, by visual approaches such as ICDAS and instrumental methods such as QLF, Diagnodent, and Electrical Caries Monitors, provide viable alternatives to traditional methods. In particular, such approaches more accurately reflect the modes of action of many therapeutic agents and formulations and may reduce the cost and duration of product innovation.

  5. Randomized clinical trial of prevention of seroma formation after mastectomy by local methylprednisolone injection

    DEFF Research Database (Denmark)

    Qvamme, G; Axelsson, C. K.; Lanng, C

    2015-01-01

    BACKGROUND: Seroma formation, the most prevalent postoperative complication after mastectomy, is an inflammatory process that is potentially preventable via local steroid administration. This study investigated the effect of local steroid administration on seroma formation. METHODS: This was a do...

  6. 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.

  7. 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.

  8. A method for prevention of radioactive material release

    International Nuclear Information System (INIS)

    Uchida, Shunsuke; Sato, Chikara; Kitamura, Masao.

    1975-01-01

    Object: To provide a method for preventing an underwater radioactive material from being released in a simple and highly reliable manner, which can decrease an amount of radioactive materials discharged into open air from reactor water containing a large amount of radioactive materials such as a reactor core pool. Structure: Pure warm water higher in temperature than that of reactor water is poured from the top of a water surface of a water tank which stores reactor water containing radioactive materials such as radioactive iodine, and water is drawn through an outlet located downwardly of the pure warm water inlet to form a layer of pure warm water at the upper part of the water tank while preventing diffusion of the reactor water into the pure warm water by the difference in density between the reactor water and the pure warm water and downward movement of the pure warm water, thereby preventing contact of the reactor water with the atmosphere and diffusion of the radioactive material into the atmosphere. (Kamimura, M.)

  9. Method of Preventing Shrinkage of Aluminum Foam Using Carbonates

    Directory of Open Access Journals (Sweden)

    Takashi Nakamura

    2011-12-01

    Full Text Available Metallic foams are commonly produced using titanium hydride as a foaming agent. Carbonates produce aluminum foam with a fine and homogenous cell structure. However, foams produced using carbonates show marked shrinkage, which is clearly different from those produced using titanium hydride. It is essential for practical applications to clarify foam shrinkage and establish a method of preventing it. In this research, cell structures were observed to study the shrinkage of aluminum foam produced using carbonates. The cells of foam produced using dolomite as a foaming agent connected to each other with maximum expansion. It was estimated that foaming gas was released through connected cells to the outside. It was assumed that cell formation at different sites is effective in preventing shrinkage induced by cell connection. The multiple additions of dolomite and magnesium carbonate, which have different decomposition temperatures, were applied. The foam in the case with multiple additions maintained a density of 0.66 up to 973 K, at which the foam produced using dolomite shrank. It was verified that the multiple additions of carbonates are effective in preventing shrinkage.

  10. Method of preventing stress corrosion cracks of reactor pipelines

    International Nuclear Information System (INIS)

    Oonaka, Noriyuki; Shoji, Saburo; Kikuchi, Eiji; Tanno, Kazuo.

    1979-01-01

    Purpose: In a case where, at the time of the transient operation of the reactor, the pH in reactor water and the concentration of oxidants are monitored, and the monitoring signals depart from the reference values or the welding heat affected portions of the pipeline are monitored by a non-destructive detector, and stress corrosion cracks are detected, these portions are protected from corrosion by a cathode current, and the generation and development of cracks are prevented. Method: The concentrations of dissolved oxygen and hydrogen peroxide in reactor water are monitored by a sensitized SUS 304 stainless steel electrode and a silver/silver chloride electrode. When monitoring signals depart from the reference values at temperatures with respect to the natural potential of stainless steel, memorized in the control system, a cathod current is caused to flow to the welding heat affected portions thereby to protect the same from corroding. Furthermore, the welding heat affected portions are monitored by the non-destructive detector, and even when stress corrosion cracks have been detected, the welding heat affected portions are prevented from corroding by a cathode current, thereby to prevent the development of stress corrosion cracks of the primary pipeline system. (Sekiya, K.)

  11. Weight-training injuries. Common injuries and preventative methods.

    Science.gov (United States)

    Mazur, L J; Yetman, R J; Risser, W L

    1993-07-01

    The use of weights is an increasingly popular conditioning technique, competitive sport and recreational activity among children, adolescents and young adults. Weight-training can cause significant musculoskeletal injuries such as fractures, dislocations, spondylolysis, spondylolisthesis, intervertebral disk herniation, and meniscal injuries of the knee. Although injuries can occur during the use of weight machines, most apparently happen during the aggressive use of free weights. Prepubescent and older athletes who are well trained and supervised appear to have low injury rates in strength training programmes. Good coaching and proper weightlifting techniques and other injury prevention methods are likely to minimise the number of musculoskeletal problems caused by weight-training.

  12. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    Directory of Open Access Journals (Sweden)

    Waldén Markus

    2009-06-01

    Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to

  13. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

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    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  14. 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.

  15. Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

    Directory of Open Access Journals (Sweden)

    Parker C

    2014-12-01

    Full Text Available Caleb Parker,1 Amy Corneli,1 Kawango Agot,2 Jacob Odhiambo,2 Jesse Asewe,2 Khatija Ahmed,3 Joseph Skhosana,3 Malebo Ratlhagana,3 Michele Lanham,1 Christina Wong,1 Jennifer Deese,1 Rachel Manongi,4 Lut Van Damme,1On behalf of the FEM-PrEP recruitment group 1FHI 360, Global Health, Population and Nutrition, Durham, NC, USA; 2Impact Research and Development Organization, Kisumu, Kenya; 3Setshaba Research Centre, Soshanguve, Pretoria, South Africa; 4Kilimanjaro Christian Medical Centre, Moshi, Tanzania Abstract: We implemented an empirically informed, geographically based recruitment approach for FEM-PrEP, a human immunodeficiency virus (HIV prevention clinical trial of daily oral emtricitabine (FTC and tenofovir disoproxil fumarate (TDF for HIV prevention. During the formative research phase, we conducted a modification of the Priorities for Local AIDS Control Efforts (PLACE method and used those data and staff experiences to identify and prioritize for recruitment geographic areas where HIV incidence might be high. During the clinical trial, we implemented a routinely monitored and flexible recruitment plan in the geographical areas identified in the formative research. We describe three lessons learnt from implementing this approach: 1 the PLACE data were critical in identifying places presumed to be high risk; 2 staff experiences, in combination with PLACE data, were needed to inform a practical recruitment strategy; and 3 recruiting in establishments in priority areas identified by the PLACE data led to screening many HIV-positive women at the Bondo site (Kenya, placing additional burden on clinic staff. These lessons learnt highlight the critical importance of having a flexible and monitored recruitment strategy. Although we successfully recruited a study population at higher risk for HIV, FEM-PrEP was unable to determine the effectiveness of FTC/TDF for HIV prevention, due to low adherence to the study product among participants. We must

  16. 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

  17. 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

  18. Dissonance-Based Prevention of Eating Disorder Risk Factors in Middle School Girls: Results from Two Pilot Trials

    Science.gov (United States)

    Rohde, Paul; Auslander, Beth A.; Shaw, Heather; Raineri, Kate M.; Gau, Jeff M.; Stice, Eric

    2014-01-01

    Objective Although several eating disorder prevention programs reduce eating disorder risk factors and symptoms for female high school and college students, few efficacious prevention programs exist for female middle school students, despite the fact that body image and eating disturbances often emerge then. Two pilot trials evaluated a new dissonance-based eating disorder prevention program for middle school girls with body image concerns. Methods Female middle school students with body dissatisfaction from two sites (Study 1: N = 81, M age = 12.1, SD = 0.9; Study 2: N = 52, M age = 12.5, SD = 0.8) were randomized to a dissonance intervention (MS Body Project) or educational brochure control; Study 2 included a 3-month follow-up. Results Intervention participants showed significant posttest reductions in only one of six variables with both Studies 1 and 2 (i.e., pressure to be thin and negative affect, respectively), though posttest effect sizes suggested medium reductions in eating disorder risk factors and symptoms (Study 1 M d = 0.40; Study 2 M d = 0.65); reductions at 3-month follow-up in Study 2 were not evident (M d = 0.19). Conclusions Results suggest that this new middle school version of the Body Project is producing medium magnitude reductions in eating disorder risk factors at posttest but that effects are showing limited persistence. Continued refinement and evaluation of this intervention appears warranted to develop more effective prevention programs for this age group. PMID:24590419

  19. Efficacy of aprepitant for prevention of postoperative nausea and vomiting. Systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Berrío Valencia, Marta Inés

    2014-10-01

    Full Text Available Objective: To evaluate the efficacy of aprepitant compared with other antiemetics for the prevention of postoperative nausea and vomiting in adults who underwent general anesthesia. Methods: Systematic review of randomized clinical trials with meta-analysis, that evaluated the efficacy of aprepitant in comparatison with other antiemetics for the prevention of postoperative nausea and vomiting, antiemetic rescue and adverse effects. The search was done in The Cochrane Library, EBSCO, EMBASE, LILACS, OVID, PubMed, SciELO, ScienceDirect, Scopus and Google Scholar. Heterogeneity was defined with the Cochran Q and I2 statistic, the model fixed and random effects were used, the Mantel-Haenszel for relative risk of each outcome and its respective confidence interval 95% were used. Results: There was significant difference in favor of aprepitant for the prevention of vomiting at 24 (RR 0.52; 95% CI: 0.38-0.7 and at 48 hours (RR 0.51; 95% CI: 0.39 to 0.67 but not for nausea at 24 hours (RR 1.16; 95% CI: 0.85-1.6. Conclusions: Aprepitant prevents postoperative vomiting, but not nausea, at 24 and 48 hours.

  20. Are dual-method messages undermining STI/HIV prevention?

    Science.gov (United States)

    O'Leary, Ann

    2011-01-01

    Adolescent girls and young women who are at risk for unplanned pregnancy and sexually transmitted infection (STI), including HIV, are frequently counseled to use a hormonal contraceptive to protect against the former and condoms to protect against the latter, for example, American College of Obstetricians and Gynecologists, 2011. The present paper reviews the literature on multiple risk messages, compliance with this dual-use recommendation, predictors of dual use, and interventions developed to encourage dual use. Data indicate that simultaneous use of these two methods is not common, and that efforts to encourage dual use have not yielded promising results. An alternative is to recommend condom use alone, since condoms protect very well against STI and HIV, and quite well against pregnancy when used consistently and correctly. The availability of emergency contraception is relevant here. Research utilizing a randomized controlled trial is recommended.

  1. Are Dual-Method Messages Undermining STI/HIV Prevention?

    Directory of Open Access Journals (Sweden)

    Ann O'Leary

    2011-01-01

    Full Text Available Adolescent girls and young women who are at risk for unplanned pregnancy and sexually transmitted infection (STI, including HIV, are frequently counseled to use a hormonal contraceptive to protect against the former and condoms to protect against the latter, for exampe, American College of Obstetricians and Gynecologists, 2011. The present paper reviews the literature on multiple risk messages, compliance with this dual-use recommendation, predictors of dual use, and interventions developed to encourage dual use. Data indicate that simultaneous use of these two methods is not common, and that efforts to encourage dual use have not yielded promising results. An alternative is to recommend condom use alone, since condoms protect very well against STI and HIV, and quite well against pregnancy when used consistently and correctly. The availability of emergency contraception is relevant here. Research utilizing a randomized controlled trial is recommended.

  2. Clustering Methods with Qualitative Data: A Mixed Methods Approach for Prevention Research with Small Samples

    Science.gov (United States)

    Henry, David; Dymnicki, Allison B.; Mohatt, Nathaniel; Allen, James; Kelly, James G.

    2016-01-01

    Qualitative methods potentially add depth to prevention research, but can produce large amounts of complex data even with small samples. Studies conducted with culturally distinct samples often produce voluminous qualitative data, but may lack sufficient sample sizes for sophisticated quantitative analysis. Currently lacking in mixed methods research are methods allowing for more fully integrating qualitative and quantitative analysis techniques. Cluster analysis can be applied to coded qualitative data to clarify the findings of prevention studies by aiding efforts to reveal such things as the motives of participants for their actions and the reasons behind counterintuitive findings. By clustering groups of participants with similar profiles of codes in a quantitative analysis, cluster analysis can serve as a key component in mixed methods research. This article reports two studies. In the first study, we conduct simulations to test the accuracy of cluster assignment using three different clustering methods with binary data as produced when coding qualitative interviews. Results indicated that hierarchical clustering, K-Means clustering, and latent class analysis produced similar levels of accuracy with binary data, and that the accuracy of these methods did not decrease with samples as small as 50. Whereas the first study explores the feasibility of using common clustering methods with binary data, the second study provides a “real-world” example using data from a qualitative study of community leadership connected with a drug abuse prevention project. We discuss the implications of this approach for conducting prevention research, especially with small samples and culturally distinct communities. PMID:25946969

  3. Clustering Methods with Qualitative Data: a Mixed-Methods Approach for Prevention Research with Small Samples.

    Science.gov (United States)

    Henry, David; Dymnicki, Allison B; Mohatt, Nathaniel; Allen, James; Kelly, James G

    2015-10-01

    Qualitative methods potentially add depth to prevention research but can produce large amounts of complex data even with small samples. Studies conducted with culturally distinct samples often produce voluminous qualitative data but may lack sufficient sample sizes for sophisticated quantitative analysis. Currently lacking in mixed-methods research are methods allowing for more fully integrating qualitative and quantitative analysis techniques. Cluster analysis can be applied to coded qualitative data to clarify the findings of prevention studies by aiding efforts to reveal such things as the motives of participants for their actions and the reasons behind counterintuitive findings. By clustering groups of participants with similar profiles of codes in a quantitative analysis, cluster analysis can serve as a key component in mixed-methods research. This article reports two studies. In the first study, we conduct simulations to test the accuracy of cluster assignment using three different clustering methods with binary data as produced when coding qualitative interviews. Results indicated that hierarchical clustering, K-means clustering, and latent class analysis produced similar levels of accuracy with binary data and that the accuracy of these methods did not decrease with samples as small as 50. Whereas the first study explores the feasibility of using common clustering methods with binary data, the second study provides a "real-world" example using data from a qualitative study of community leadership connected with a drug abuse prevention project. We discuss the implications of this approach for conducting prevention research, especially with small samples and culturally distinct communities.

  4. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Giovancarli, Camille; Malbos, Eric; Baumstarck, Karine; Parola, Nathalie; Pélissier, Marie-Florence; Lançon, Christophe; Auquier, Pascal; Boyer, Laurent

    2016-02-19

    Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program. The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included. This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy. ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014).

  5. 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.

  6. 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.

  7. Economic Evaluation of Obesity Prevention in Early Childhood: Methods, Limitations and Recommendations.

    Science.gov (United States)

    Döring, Nora; Mayer, Susanne; Rasmussen, Finn; Sonntag, Diana

    2016-09-13

    Despite methodological advances in the field of economic evaluations of interventions, economic evaluations of obesity prevention programmes in early childhood are seldom conducted. The aim of the present study was to explore existing methods and applications of economic evaluations, examining their limitations and making recommendations for future cost-effectiveness assessments. A systematic literature search was conducted using PubMed, Cochrane Library, the British National Health Service Economic Evaluation Databases and EconLit. Eligible studies included trial-based or simulation-based cost-effectiveness analyses of obesity prevention programmes targeting preschool children and/or their parents. The quality of included studies was assessed. Of the six studies included, five were intervention studies and one was based on a simulation approach conducted on secondary data. We identified three main conceptual and methodological limitations of their economic evaluations: Insufficient conceptual approach considering the complexity of childhood obesity, inadequate measurement of effects of interventions, and lack of valid instruments to measure child-related quality of life and costs. Despite the need for economic evaluations of obesity prevention programmes in early childhood, only a few studies of varying quality have been conducted. Moreover, due to methodological and conceptual weaknesses, they offer only limited information for policy makers and intervention providers. We elaborate reasons for the limitations of these studies and offer guidance for designing better economic evaluations of early obesity prevention.

  8. 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…

  9. 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.

  10. Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial.

    Science.gov (United States)

    Merom, Dafna; Cumming, Robert; Mathieu, Erin; Anstey, Kaarin J; Rissel, Chris; Simpson, Judy M; Morton, Rachael L; Cerin, Ester; Sherrington, Catherine; Lord, Stephen R

    2013-05-15

    Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the 'holistic' approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people. A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed. This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting

  11. Ineffectiveness of probiotics in preventing recurrence after curative resection for Crohn's disease: a randomised controlled trial with Lactobacillus GG

    Science.gov (United States)

    Prantera, C; Scribano, M L; Falasco, G; Andreoli, A; Luzi, C

    2002-01-01

    Background and aims: Experimental studies have shown that luminal bacteria may be involved in Crohn's disease. Probiotics are a possible alternative to antibiotics. The aim of this randomised placebo controlled study was to determine if Lactobacillus GG, given by mouth for one year, could prevent Crohn's recurrent lesions after surgery or to reduce their severity. Methods: Patients operated on for Crohn's disease in whom all of the diseased gut had been removed were randomly allocated to receive 12 billion colony forming units of Lactobacillus or identical placebo for one year. Ileocolonoscopy was performed at the end of the trial or at the onset of symptoms. Endoscopic recurrence was defined as grade 2 or higher of Rutgeerts scoring system. Results: Eight of 45 patients were excluded from the trial (three for non-compliance and five for protocol violations). Clinical recurrence was ascertained in three (16.6%) patients who received Lactobacillus and in two (10.5%) who received placebo. Nine of 15 patients in clinical remission on Lactobacillus (60%) had endoscopic recurrence compared with six of 17 (35.3%) on placebo (p=0.297). There were no significant differences in the severity of the lesions between the two groups. Conclusions: Lactobacillus GG seems neither to prevent endoscopic recurrence at one year nor reduce the severity of recurrent lesions. PMID:12171964

  12. Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting.

    Science.gov (United States)

    Natale, Ruby; Scott, Stephanie Hapeman; Messiah, Sarah E; Schrack, Maria Mesa; Uhlhorn, Susan B; Delamater, Alan

    2013-01-28

    Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention randomized trial in the child care setting. A randomized, controlled obesity prevention trial is currently being conducted over a three year period (2010-present). The sample consists of 28 low-income, ethnically diverse child care centers with 1105 children (sample is 60% Hispanic, 15% Haitian, 12% Black, 2% non-Hispanic White and 71% of caregivers were born outside of the US). The purpose is to test the efficacy of a parent and teacher role-modeling intervention on children's nutrition and physical activity behaviors. . The Healthy Caregivers-Healthy Children (HC2) intervention arm schools received a combination of (1) implementing a daily curricula for teachers/parents (the nutritional gatekeepers); (2) implementing a daily curricula for children; (3) technical assistance with meal and snack menu modifications such as including more fresh and less canned produce; and (4) creation of a center policy for dietary requirements for meals and snacks, physical activity and screen time. Control arm schools received an attention control safety curriculum. Major outcome measures include pre-post changes in child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, amount of physical activity, and parental nutrition and physical activity knowledge, attitudes, and beliefs, defined by intentions and behaviors. All measures were administered at the beginning and end of the school year for year one and year two of the study for a total of 4 longitudinal time points for assessment. Although few attempts have been made to prevent obesity

  13. 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.

  14. 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

  15. Randomized Controlled Trial of Mindfulness Meditation and Exercise for the Prevention of Acute Respiratory Infection: Possible Mechanisms of Action

    Directory of Open Access Journals (Sweden)

    Aleksandra Zgierska

    2013-01-01

    Full Text Available Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI. This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N=51, moderate-intensity exercise (N=51, or wait-list control (N=52. Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey. Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months. A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old. Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale at 3 months may mediate intervention effects on ARI severity and duration (P<0.05; 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2–9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

  16. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

    Directory of Open Access Journals (Sweden)

    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  17. Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Schuit Ewoud

    2012-03-01

    Full Text Available Abstract Background Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix or to determine adverse effects for rare outcomes such as intrauterine death. Methods/design We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity. Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. Discussion Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.

  18. A non-inferiority, individually randomized trial of intermittent screening and treatment versus intermittent preventive treatment in the control of malaria in pregnancy

    DEFF Research Database (Denmark)

    Tagbor, Harry; Cairns, Matthew; Bojang, Kalifa

    2015-01-01

    BACKGROUND: The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive wom...... receiving cotrimoxazole prophylaxis in whom SP is contraindicated. TRIAL REGISTRATION: ClinicalTrials.gov NCT01084213 Pan African Clinical trials Registry PACT201202000272122....... (ISTp) is an alternative approach. METHODS AND FINDINGS: An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana...

  19. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records

    NARCIS (Netherlands)

    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

    BACKGROUND AND PURPOSE: 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

  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. 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

  2. Comparison of interdental cleaning methods: a randomized controlled trial.

    Science.gov (United States)

    Jackson, Margaret A; Kellett, Margaret; Worthington, Helen V; Clerehugh, Valerie

    2006-08-01

    Although interdental cleaning is an integral component of home plaque control for periodontally involved patients, limited data exist on the periodontal benefits of commonly used interdental cleaning methods before definitive root surface debridement is undertaken. Therefore, the aim of this study was to compare the effects of a customized interdental brushing technique and a customized flossing technique on clinical periodontal outcomes prior to root surface debridement in chronic periodontitis cases. This was a single-blind, randomized controlled clinical trial. Seventy-seven patients with chronic periodontitis were measured for plaque, relative interdental papillae level, Eastman interdental bleeding index, probing depths, and bleeding on probing at interdental sites and underwent a 10-minute hand scaling to remove easily accessible calculus deposits. Before group allocation, patients were advised on toothbrushing and instructed in two customized methods of interdental cleaning involving dental floss and precurved interdental brushes. Materials were supplied after random allocation. Participants were recalled at 6 and 12 weeks for clinical measurements, reinforcement of instructions, and fresh materials. There were significant reductions from baseline for all indices in both groups (P floss group in every parameter (P floss group (P <0.01). This trial demonstrated that patients were able to improve clinical periodontal outcomes by interdental cleaning, particularly with interdental brushes, even before thorough root surface debridement was undertaken.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Randomized controlled trial of the effect of medical audit on AIDS prevention in general practice

    DEFF Research Database (Denmark)

    Sandbæk, Annelli

    1999-01-01

    OBJECTIVE: We aimed to evaluate the effect of a medical audit on AIDS prevention in general practice. METHODS: We conducted a prospective randomized controlled study performed as 'lagged intervention'. At the time of comparison, the intervention group had completed 6 months of audit including a p...... of such consultations initiated by the GPs. CONCLUSIONS: Medical audit had no observed effect on AIDS prevention in general practice. Udgivelsesdato: 1999-Oct......OBJECTIVE: We aimed to evaluate the effect of a medical audit on AIDS prevention in general practice. METHODS: We conducted a prospective randomized controlled study performed as 'lagged intervention'. At the time of comparison, the intervention group had completed 6 months of audit including....... One hundred and thirty-three GPs completed the project. The main outcome measures were the number of consultations involving AIDS prevention and the number of talks about AIDS initiated by the GP, and some elements of the content were registered on a chart. RESULTS: No statistically significant...

  8. 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.

  9. Randomized trial of piperaquine with sulfadoxine-pyrimethamine or dihydroartemisinin for malaria intermittent preventive treatment in children.

    Directory of Open Access Journals (Sweden)

    Badara Cisse

    Full Text Available BACKGROUND: The long terminal half life of piperaquine makes it suitable for intermittent preventive treatment for malaria but no studies of its use for prevention have been done in Africa. We did a cluster randomized trial to determine whether piperaquine in combination with either dihydroartemisin (DHA or sulfadoxine-pyrimethamine (SP is as effective, and better tolerated, than SP plus amodiaquine (AQ, when used for intermittent preventive treatment in children delivered by community health workers in a rural area of Senegal. METHODS: Treatments were delivered to children 3-59 months of age in their homes once per month during the transmission season by community health workers. 33 health workers, each covering about 60 children, were randomized to deliver either SP+AQ, DHA+PQ or SP+PQ. Primary endpoints were the incidence of attacks of clinical malaria, and the incidence of adverse events. RESULTS: 1893 children were enrolled. Coverage of monthly rounds and compliance with daily doses was similar in all groups; 90% of children received at least 2 monthly doses. Piperaquine combinations were better tolerated than SP+AQ with a significantly lower risk of common, mild adverse events. 103 episodes of clinical malaria were recorded during the course of the trial. 68 children had malaria with parasitaemia >3000/microL, 29/671 (4.3% in the SP+AQ group, compared with 22/604 (3.6% in the DHA+PQ group (risk difference 0.47%, 95%CI -2.3%,+3.3%, and 17/618 (2.8% in the SP+PQ group (risk difference 1.2%, 95%CI -1.3%,+3.6%. Prevalences of parasitaemia and the proportion of children carrying Pfdhfr and Pfdhps mutations associated with resistance to SP were very low in all groups at the end of the transmission season. CONCLUSIONS: Seasonal IPT with SP+PQ in children is highly effective and well tolerated; the combination of two long-acting drugs is likely to impede the emergence of resistant parasites. TRIAL REGISTRATION: ClinicalTrials.gov NCT00529620.

  10. Atorvastatin reduces the risk of cardiovascular events in patients with carotid atherosclerosis: a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Sillesen, H.; Amarenco, P.; Hennerici, M.G.

    2008-01-01

    BACKGROUND AND PURPOSE: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found that treatment with atorvastatin 80 mg per day reduced the risk of stroke and cardiovascular events in patients with a recent transient ischemic attack (TIA) or stroke. We hypothesized...... this benefit would be greatest in the subgroup of patients with carotid stenosis. METHODS: The SPARCL trial randomized patients with TIA or stroke within 1 to 6 months without known coronary heart disease (CHD) and low-density lipoprotein cholesterol 100 to 190 mg/dL to treatment with atorvastatin 80 mg per...

  11. 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.

  12. Method of preventing contaminations in radioactive material handling facilities

    International Nuclear Information System (INIS)

    Inoue, Shunji.

    1986-01-01

    Purpose: To prevent the contamination on the floor surface of working places by laying polyvinyl butyral sheets over the floor surface, replacing when the sheets are contaminated, followed by burning. Method: Polyvinyl butyral sheets comprising 50 - 70 mol% of butyral component are laid in a radioactive material handling facility, radioactive materials are handled on the polyvinyl butyral sheets and the sheets are replaced when contaminated. The polyvinyl butyral sheets used contain 62 - 68 mol% of butyral component and has 0.03 - 0.2 mm thickness. The contaminated sheets are subjected to burning processing. This can surely collect radioactive materials and the sheets have favorable burnability, releasing no corrosive or deleterious gases. In addition, they are inexpensive and give no hindrance to the workers walking. (Takahashi, M.)

  13. The Open Method of Coordination - Effectively preventing welfare state retrenchment?

    Directory of Open Access Journals (Sweden)

    Milena Büchs

    2009-11-01

    Full Text Available This article re-examines the division between 'optimists' and 'pessimists' within the literature on the Open Method of Coordination’s (OMC effectiveness. Each of those 'camps' tends to focus on a different question. 'Optimists' are more concerned with the question of whether the OMC exerts an influence on the national level and through which mechanisms, whilst 'pessimists' concentrate on the question of whether the OMC can 'strengthen' EU social policy and therefore European welfare states. This article combines these two perspectives and argues that the OMC is indeed capable of influencing national policies through the dissemination of ideas and 'learning' as the 'optimists' stress. However, policy 'learning' at the member state level is shaped and constrained by a variety of internal and external pressures. Against the hopes of most of the OMC 'optimists', this makes the OMC largely ineffective in preventing welfare state retrenchment.

  14. Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials

    Directory of Open Access Journals (Sweden)

    Monika Doshi

    2017-05-01

    Full Text Available Abstract Background The HIV epidemic among men who have sex with men (MSM continues to expand globally. The addition of an efficacious, prophylactic vaccine to combination prevention offers immense hope, particularly in low- and middle- income countries which bear the greatest global impact. However, in these settings, there is a paucity of vaccine preparedness studies that specifically pertain to MSM. Our study is the first vaccine preparedness study among MSM and female sex workers (FSWs in Kenya. In this paper, we explore willingness of Kenyan MSM to participate in HIV vaccine efficacy trials. In addition to individual and socio-cultural motivators and barriers that influence willingness to participate (WTP, we explore the associations or linkages that participants draw between their experiences with or knowledge of medical research both generally and within the context of HIV/AIDS, their perceptions of a future HIV vaccine and their willingness to participate in HIV vaccine trials. Methods Using a social network-based approach, we employed snowball sampling to recruit MSM into the study from Kisumu, Mombasa, and Nairobi. A field team consisting of seven community researchers conducted in-depth interviews with a total of 70 study participants. A coding scheme for transcribed and translated data was developed and the data was then analysed thematically. Results Most participants felt that an HIV vaccine would bring a number of benefits to self, as well as to MSM communities, including quelling personal fears related to HIV acquisition and reducing/eliminating stigma and discrimination shouldered by their community. Willingness to participate in HIV vaccine efficacy trials was highly motivated by various forms of altruism. Specific researcher responsibilities centred on safe-guarding the rights and well-being of participants were also found to govern WTP, as were reflections on the acceptability of a future preventive HIV vaccine. Conclusion

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. Oral Administration to Nursing Women of Lactobacillus fermentum CECT5716 Prevents Lactational Mastitis Development: A Randomized Controlled Trial

    Science.gov (United States)

    Hurtado, José A.; Maldonado-Lobón, Jose A.; Díaz-Ropero, M. Paz; Flores-Rojas, Katherine; Uberos, José; Leante, José L.; Affumicato, Laura; Couce, María Luz; Garrido, José M.; Olivares, Mónica

    2017-01-01

    Abstract Objective: The objective of this study is to evaluate the preventive effect of oral administration of Lactobacillus fermentum CECT5716 on mastitis incidence in lactating women. Methods: A randomized double-blinded controlled trial that included 625 women was conducted. Women who received preventive dose of antibiotic in the context of delivery were recruited 1–6 days after childbirth and randomly assigned to a group. Probiotic group received 1 capsule/day containing L. fermentum 3 × 109 CFU, control group received 1 placebo capsule/day containing maltodextrin. The intervention period was 16 weeks. The primary outcome of the study was the incidence of clinical mastitis defined as at least two out of the three breast symptoms (pain, redness, and lump) and at least one of fever or flu-like symptoms (shivering, hot sweats, or aches). Results: Two hundred ninety-one women completed 16 weeks of treatment. Sixteen women in the probiotic group developed mastitis versus 30 women in the control group (odds ratio = 0.531; p = 0.058). Incidence rate of mastitis in the probiotic group was significantly lower than that in the control group (IR = 0.130 in the probiotic group versus IR = 0.263 in the control group; p = 0.021). Therefore, the oral administration of L. fermentum CECT5716 during lactation decreased by 51% the incidence rate of clinical mastitis. Staphylococcus spp. load at the end of intervention was significantly lower in breast milk of women in the probiotic group than in breast milk of women in the control group (p = 0.025). Conclusion: Consumption of the probiotic strain L. fermentum CECT5716 might be used during breastfeeding as an efficient strategy to prevent development of lactational mastitis in women. Trial registration: NCT02203877.

  5. HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention

    Directory of Open Access Journals (Sweden)

    Linde Jennifer A

    2012-02-01

    Full Text Available Abstract Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1 measured height and weight; 2 online surveys of individual dietary intake and physical activity behaviors; and 3 detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75, 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2. A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36. Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461

  6. Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care

    Directory of Open Access Journals (Sweden)

    Weiderpass Elisabete

    2008-08-01

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

  7. Folic acid supplementation in pregnancy to prevent preterm birth: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Saccone, Gabriele; Berghella, Vincenzo

    2016-04-01

    Folic acid (FA) may have a role in the prevention of pregnancy complications. However, the efficacy of FA supplementation in reducing the risk of preterm birth (PTB) is still unclear. The aim of this systematic review with meta-analysis was to evaluate the efficacy of folic acid supplementation during pregnancy to prevent preterm birth (PTB). The research protocol was designed a priori, defining methods for searching the literature in electronic databases, including and examining articles, and extracting and analyzing data. We included all randomized trials (RCTs) of asymptomatic singleton gestations without prior PTB who were randomized to prophylactic treatment with either FA supplementation or control (placebo or no treatment). The primary outcome was the incidence of PTB supplementation had a similar rate of PTB birth weight (mean difference 85.58g, 95% CI -55.17-226.34), low birth weight (21.0% vs 15.1%; RR 0.79, 95% CI 0.49 to 1.28) and perinatal death (2.9% vs 2.4%; RR 0.90, 95% CI 0.60-1.34). In summary, FA supplementation during pregnancy does not prevent PTB supplementation remains the most important intervention to reduce the risk of neural tube defects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. Multiple imputation methods for bivariate outcomes in cluster randomised trials.

    Science.gov (United States)

    DiazOrdaz, K; Kenward, M G; Gomes, M; Grieve, R

    2016-09-10

    Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis, single-level multiple imputation that ignores the clustering, multiple imputation with a fixed effect for each cluster and multilevel multiple imputation. We contrasted the alternative approaches to handling missing data in a cost-effectiveness analysis that uses data from a cluster randomised trial to evaluate an exercise intervention for care home residents. We then conducted a simulation study to assess the performance of these approaches on bivariate continuous outcomes, in terms of confidence interval coverage and empirical bias in the estimated treatment effects. Missing-at-random clustered data scenarios were simulated following a full-factorial design. Across all the missing data mechanisms considered, the multiple imputation methods provided estimators with negligible bias, while complete case analysis resulted in biased treatment effect estimates in scenarios where the randomised treatment arm was associated with missingness. Confidence interval coverage was generally in excess of nominal levels (up to 99.8%) following fixed-effects multiple imputation and too low following single-level multiple imputation. Multilevel multiple imputation led to coverage levels of approximately 95% throughout. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  13. 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.

  14. 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.

  15. Three randomized trials of maternal influenza immunization in Mali, Nepal, and South Africa: Methods and expectations.

    Science.gov (United States)

    Omer, Saad B; Richards, Jennifer L; Madhi, Shabir A; Tapia, Milagritos D; Steinhoff, Mark C; Aqil, Anushka R; Wairagkar, Niteen

    2015-07-31

    Influenza infection in pregnancy can have adverse impacts on maternal, fetal, and infant outcomes. Influenza vaccination in pregnancy is an appealing strategy to protect pregnant women and their infants. The Bill & Melinda Gates Foundation is supporting three large, randomized trials in Nepal, Mali, and South Africa evaluating the efficacy and safety of maternal immunization to prevent influenza disease in pregnant women and their infants <6 months of age. Results from these individual studies are expected in 2014 and 2015. While the results from the three maternal immunization trials are likely to strengthen the evidence base regarding the impact of influenza immunization in pregnancy, expectations for these results should be realistic. For example, evidence from previous influenza vaccine studies - conducted in general, non-pregnant populations - suggests substantial geographic and year-to-year variability in influenza incidence and vaccine efficacy/effectiveness. Since the evidence generated from the three maternal influenza immunization trials will be complementary, in this paper we present a side-by-side description of the three studies as well as the similarities and differences between these trials in terms of study location, design, outcome evaluation, and laboratory and epidemiological methods. We also describe the likely remaining knowledge gap after the results from these trials become available along with a description of the analyses that will be conducted when the results from these individual data are pooled. Moreover, we highlight that additional research on logistics of seasonal influenza vaccine supply, surveillance and strain matching, and optimal delivery strategies for pregnant women will be important for informing global policy related to maternal influenza immunization. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness.

    Science.gov (United States)

    Guthrie, Kate M; Rosen, Rochelle K; Vargas, Sara E; Guillen, Melissa; Steger, Arielle L; Getz, Melissa L; Smith, Kelley A; Ramirez, Jaime J; Kojic, Erna M

    2017-10-01

    The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user-their sensory perceptions, their judgements of those experiences, and their willingness to use a product-is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.

  17. Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

    Science.gov (United States)

    Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

    2014-01-01

    Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord

  18. 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.

  19. Impact on the Quality of Life of an Educational Program for the Prevention of Work-Related Musculoskeletal Disorders: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Amantéa Vinicius A

    2011-01-01

    Full Text Available Abstract Background Work-related musculoskeletal disorders (WMSD are a major cause for concern in public health and the main causes of sick leave. Treatments for WMSD have given disappointing results; prevention is the best strategy, but results of preventive measures have not been consistent. To the best of our knowledge there are few studies in literature that evaluated the impact of a specific program aimed at preventing WMSD on the quality of life of employed persons. Methods One hundred and one clerical and production workers in a steel trading company were enrolled in an open-label randomized controlled clinical trial (parallel groups to compare the efficacy of an educational program for primary prevention of WMSD with control intervention. The primary outcome was a change in the physical functioning domain of the quality of life (QL measured by Medical Outcomes Study Short Form 36 Health Survey (SF-36. The intervention group underwent six consecutive weekly sessions concerning specific orientations for the prevention of WMSD, while the control group received general health education in an identical schedule. The SF-36 and theses Work Limitation Questionnaire (WLQ were evaluated at weeks zero, five and 26. Results Baseline characteristics of the interventions groups were comparable, and both groups comprised predominantly young healthy individuals. No significant differences in the variation of the SF-36 and WLQ between the groups were observed at weeks five and 26. However, both groups demonstrated improvement in some aspects of SF-36, suggesting that both educational interventions have beneficial impacts on QL. Conclusions A specific educational program aimed at the preventing of WMSD was comparable with general health orientation for the improvement of QL and work capacity in a sample of healthy workers during a six month period. Trial Registration ClinicalTrials.gov: NCT00874718 Trial Registration

  20. Blending Qualitative and Computational Linguistics Methods for Fidelity Assessment: Experience with the Familias Unidas Preventive Intervention.

    Science.gov (United States)

    Gallo, Carlos; Pantin, Hilda; Villamar, Juan; Prado, Guillermo; Tapia, Maria; Ogihara, Mitsunori; Cruden, Gracelyn; Brown, C Hendricks

    2015-09-01

    Careful fidelity monitoring and feedback are critical to implementing effective interventions. A wide range of procedures exist to assess fidelity; most are derived from observational assessments (Schoenwald and Garland, Psycholog Assess 25:146-156, 2013). However, these fidelity measures are resource intensive for research teams in efficacy/effectiveness trials, and are often unattainable or unmanageable for the host organization to rate when the program is implemented on a large scale. We present a first step towards automated processing of linguistic patterns in fidelity monitoring of a behavioral intervention using an innovative mixed methods approach to fidelity assessment that uses rule-based, computational linguistics to overcome major resource burdens. Data come from an effectiveness trial of the Familias Unidas intervention, an evidence-based, family-centered preventive intervention found to be efficacious in reducing conduct problems, substance use and HIV sexual risk behaviors among Hispanic youth. This computational approach focuses on "joining," which measures the quality of the working alliance of the facilitator with the family. Quantitative assessments of reliability are provided. Kappa scores between a human rater and a machine rater for the new method for measuring joining reached 0.83. Early findings suggest that this approach can reduce the high cost of fidelity measurement and the time delay between fidelity assessment and feedback to facilitators; it also has the potential for improving the quality of intervention fidelity ratings.

  1. Phase I Trial of a Lactobacillus crispatus Vaginal Suppository for Prevention of Recurrent Urinary Tract Infection in Women

    Science.gov (United States)

    Czaja, Christopher A.; Stapleton, Ann E.; Yarova-Yarovaya, Yuliya; Stamm, Walter E.

    2007-01-01

    Objectives: We performed a phase I trial to assess the safety and tolerance of a Lactobacillus vaginal suppository for prevention of recurrent UTI. Methods: Premenopausal women with a history of recurrent UTI were randomized to use L. crispatus CTV-05 or placebo vaginal suppositories daily for five days. Results: 30 women were randomized (15 to L. crispatus CTV-05). No severe adverse events occurred. Mild to moderate vaginal discharge and genital irritation were reported by women in both study arms. Seven women randomized to L. crispatus CTV-05 developed pyuria without associated symptoms. Most women had high concentrations of vaginal H202-producing lactobacilli before randomization. L. crispatus, L. jensenii, and L. gasseri were the most common Lactobacillus species identified, with stable prevalence over time. Conclusions: L. crispatus CTV-05 can be given as a vaginal suppository with minimal sideeffects to healthy women with a history of recurrent UTI. Mild inflammation of the urinary tract was noted in some women. PMID:18288237

  2. Preventing blood transfusion failures: FMEA, an effective assessment method.

    Science.gov (United States)

    Najafpour, Zhila; Hasoumi, Mojtaba; Behzadi, Faranak; Mohamadi, Efat; Jafary, Mohamadreza; Saeedi, Morteza

    2017-06-30

    Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. A structured FMEA was recruited in our study performed in 2014, and corrective actions were implemented and re-evaluated after 6 months. Sixteen 2-h sessions were held to perform FMEA in the blood transfusion process, including five steps: establishing the context, selecting team members, analysis of the processes, hazard analysis, and developing a risk reduction protocol for blood transfusion. Failure modes with the highest risk priority numbers (RPNs) were identified. The overall RPN scores ranged from 5 to 100 among which, four failure modes were associated with RPNs over 75. The data analysis indicated that failures with the highest RPNs were: labelling (RPN: 100), transfusion of blood or the component (RPN: 100), patient identification (RPN: 80) and sampling (RPN: 75). The results demonstrated that mis-transfusion of blood or blood component is the most important error, which can lead to serious morbidity or mortality. Provision of training to the personnel on blood transfusion, knowledge raising on hazards and appropriate preventative measures, as well as developing standard safety guidelines are essential, and must be implemented during all steps of blood and blood component transfusion.

  3. The effect of cardiorespiratory fitness assessment in preventive health checks: a randomised controlled trial

    DEFF Research Database (Denmark)

    Høj, Kirsten; Skriver, Mette Vinther; Maindal, Helle Terkildsen

    2018-01-01

    Background: Poor cardiorespiratory fitness (CRF) increases morbidity and mortality risks. Routine CRF assessment in clinical practice has thus been advocated, but little is known about the effect. In this study, we investigated the effect of CRF assessment on CRF in a preventive health check...... programme. Methods: We used a randomised design, in which we invited 4153 middle-aged adults and included 2201 participants who received a preventive health check with CRF assessment (intervention) or without CRF assessment (control). After 1 year, participants were examined. The primary outcomes were....... Conclusion: Preventive health checks with CRF assessment did not provide higher CRF levels at 1-year follow-up than preventive health checks without CRF assessment....

  4. 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

  5. Humidification policies for mechanically ventilated intensive care patients and prevention of ventilator-associated pneumonia: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Niël-Weise, B S; Wille, J C; van den Broek, P J

    2007-04-01

    The Dutch Working Party on Infection Prevention (WIP) aimed to determine whether certain humidification policies are better than others in terms of prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated intensive care unit (ICU) patients. Publications were retrieved by a systematic search of Medline and the Cochrane Library up to February 2006. All (quasi-) randomized trials and systematic reviews/meta-analyses comparing humidification methods in ventilated ICU patients were selected. Two reviewers independently assessed trial quality and extracted data. If the data was incomplete, clarification was sought from original authors and used to calculate the relative risk of VAP. Data for VAP were combined in the analysis, where appropriate, using a random-effects model. Ten trials were included in the review. In general, the quality of the trials and the way they were reported were unsatisfactory. The results did not show any benefit from specific humidification techniques in terms of reducing VAP. WIP do not recommend either passive or active humidifiers to prevent VAP, nor the type of passive humidifiers to be used. Regarding active humidification, WIP recommends using heated wire circuits. This is due to the theoretical consideration that less condensate reduces colonization and subsequent risk of spread throughout an ICU when condensate is removed.

  6. 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.

  7. 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

  8. Assessing Odor Level when Using PrePex for HIV Prevention: A Prospective, Randomized, Open Label, Blinded Assessor Trial to Improve Uptake of Male Circumcision.

    Directory of Open Access Journals (Sweden)

    Vincent Mutabazi

    Full Text Available The PrePex is a WHO--prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex device and acts as the leading center of excellence providing training and formal guidelines. As part of the Government's efforts to improve PrePex implementation, it made efforts to improve the psychological acceptability of device by men, thus increasing uptake with VMMC in sub-Saharan Africa. Some men who underwent the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it was placed. This complaint was identified as potential risk for uptake of the device. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor and patient foreskin hygiene technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a trial to test different hygiene-cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern. The main objective of the trial was to compare odor levels between three arms, having identical personal hygiene but different foreskin hygiene techniques using either clear water with soap during a daily shower, soapy water using a syringe, or chlorhexidine using a syringe. One hundred and one subjects were enrolled to the trial and randomly allocated into three trial arms. Using chlorhexidine solution daily almost completely eliminated odor, and was statistically significant more effective that the other two arms. The trial results suggest that odor from the foreskin, while wearing the PrePex device, could be related to the growth of anaerobic bacteria, which can be prevented by a chlorhexidine cleaning method. This finding can be used to increase acceptability by men when considering PrePex as one of the leading methods for HIV prevention in VMMC programs.

  9. Reduction of claustrophobia during magnetic resonance imaging: methods and design of the "CLAUSTRO" randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Teichgräber Ulf

    2011-02-01

    Full Text Available Abstract Background Magnetic resonance (MR imaging has been described as the most important medical innovation in the last 25 years. Over 80 million MR procedures are now performed each year and on average 2.3% (95% confidence interval: 2.0 to 2.5% of all patients scheduled for MR imaging suffer from claustrophobia. Thus, prevention of MR imaging by claustrophobia is a common problem and approximately 2,000,000 MR procedures worldwide cannot be completed due to this situation. Patients with claustrophobic anxiety are more likely to be frightened and experience a feeling of confinement or being closed in during MR imaging. In these patients, conscious sedation and additional sequences (after sedation may be necessary to complete the examinations. Further improvements in MR design appear to be essential to alleviate this situation and broaden the applicability of MR imaging. A more open scanner configuration might help reduce claustrophobic reactions while maintaining image quality and diagnostic accuracy. Methods/Design We propose to analyze the rate of claustrophobic reactions, clinical utility, image quality, patient acceptance, and cost-effectiveness of an open MR scanner in a randomized comparison with a recently designed short-bore but closed scanner with 97% noise reduction. The primary aim of this study is thus to determine whether an open MR scanner can reduce claustrophobic reactions, thereby enabling more examinations of claustrophobic patients without incurring the safety issues associated with conscious sedation. In this manuscript we detail the methods and design of the prospective "CLAUSTRO" trial. Discussion This randomized controlled trial will be the first direct comparison of open vertical and closed short-bore MR systems in regards to claustrophobia and image quality as well as diagnostic utility. Trial Registration ClinicalTrials.gov: NCT00715806

  10. Trends in the application of dynamic allocation methods in multi-arm cancer clinical trials.

    Science.gov (United States)

    Pond, Gregory R; Tang, Patricia A; Welch, Stephen A; Chen, Eric X

    2010-06-01

    Dynamic allocation (DA) methods which attempt to balance baseline prognostic factors between treatment arms, can be used in multi-arm clinical trials to sequentially allocate patients to treatment. Although some experts express concern regarding the validity of inference from trials using DA, others believe DA methods produce more credible results. A review of published multi-arm cancer clinical trials was conducted to explore the frequency of DA use in oncology. Multi-arm phase III clinical trials of at least 100 patients per arm, published in 13 major oncology journals from 1995-2005 were manually reviewed. Information about reported use of DA methods, or randomization via random permuted blocks (PB), was extracted along with trial characteristics. Of 476 published clinical trials, 112 (23.5%) reported using some form of DA method, while 103 (21.6%) reported using PB methods. Most trials (403 or 84.7%) reported stratifying on at least one baseline factor. The mean number of stratification factors was 2.70 per trial, and 78.6% of DA trials reported 3 or more stratification factors compared with 30.2% of non-DA trials (p complete details of the allocation method used, thus it is possible some manuscripts reported incorrect allocation methods. Journals were selected which were assumed to publish most large, multi-arm clinical trials in cancer from 1995-2005, however, some trials were likely reported in journals other than what was reviewed. DA methods are frequently used in multi-arm cancer clinical trials. The use of DA appears to becoming more common over time and are used more frequently when an academic cooperative group is involved. No relationship between industry funded trials or geographic region and allocation method was observed. Clinical Trials 2010; 7: 227-234. http://ctj.sagepub.com.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  16. 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

  17. 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.

  18. A Randomized Controlled Trial of an Online Relapse Prevention Program for Adolescents in Substance Abuse Treatment

    Science.gov (United States)

    Trudeau, Kimberlee J.; Black, Ryan A.; Kamon, Jody L.; Sussman, Steve

    2017-01-01

    Background: An Internet-based relapse prevention supplement to adolescent substance abuse treatment programming is a promising modality to reinforce treatment gains and enhance recovery; however, an evidence base is lacking. Objective: To assess the efficacy of the online Navigating my Journey (NmJ) program. Methods: 129 adolescent-aged…

  19. A Randomized Placebo-Controlled Trial of a School-Based Depression Prevention Program.

    Science.gov (United States)

    Merry, Sally; McDowell, Heather; Wild, Chris J.; Bir, Julliet; Cunliffe, Rachel

    2004-01-01

    Objective: To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program. Method: Three hundred ninety-two students age 13 to 15 from two schools were randomized to intervention (RAP-Kiwi) and placebo programs run by teachers. RAP-Kiwi was an 11-session manual-based program derived from…

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

    NARCIS (Netherlands)

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

    2016-01-01

    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

  1. Prevention of Low Back Pain in the Military: A Randomized Clinical Trial

    Science.gov (United States)

    2009-06-01

    low back pain (LBP). Direct assessment of trunk muscle function is not...FL PURPOSE/HYPOTHESIS: Trunk muscle endurance may have an important role in the prevention and treatment of low back pain (LBP). Direct as- sessment...TX without a history of LBP were enrolled. Materials/Methods Ultrasound images were obtained bilaterally at rest for the following trunk muscles

  2. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  3. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

    Science.gov (United States)

    Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

    2014-04-01

    Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we

  4. The women made it work: fuzzy transitive closure of the results chain in a dengue prevention trial in Mexico

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    Neil Andersson

    2017-05-01

    Full Text Available Abstract Background A modified theory of planned behaviour (acronym CASCADA proposes that Conscious knowledge precedes a change in Attitude, which in turn precedes positive deviations from negative Subjective norms, intention to Change, perception of Agency to change, Discussion of possible action, and Action itself. We used this as a results chain to investigate gender-specific behaviour dynamics in chemical-free dengue prevention. Methods Secondary analysis of the Mexican arm of a cluster randomised controlled trial used household survey data on intermediate outcomes of dengue prevention behaviour. We used a matrix of odds ratios between outcomes, transformed to a symmetrical range (−1, 1, to compute fuzzy transitive closure of the results chain for control and intervention clusters, then for male and female respondents separately in each group. Transitive closure of a map computes the influence of each factor on each other factor, taking account of all influences in the system. Cumulative net influence was the sum of influences across the results chain. Results Responses of 5042 women and 1143 men in 45 intervention clusters contrasted with those of 5025 women and 1179 men in 45 control clusters. Control clusters showed a distal block (negative influence in the results chain with a cumulative net influence of 0.88; intervention clusters showed no such block and a cumulative net influence of 1.92. Female control respondents, like the overall control picture, showed a distal block, whereas female intervention responses showed no such blocks (cumulative net influence 0.78 and 1.73 respectively. Male control respondents showed weak distal blocks. Male intervention responses showed several new negative influences and a reduction of cumulative net influence (1.38 in control and 1.11 in intervention clusters. Conclusions The overall influence of the intervention across the results chain fits with the trial findings, but is different for women and

  5. Vertical transmission of HIV from mother to child in sub-Saharan Africa: modes of transmission and methods for prevention.

    Science.gov (United States)

    Santmyire, B R

    2001-05-01

    The impact of the human immunodeficiency virus (HIV) epidemic in sub-Saharan Africa on future mortality rates of infants, children, and mothers, life expectancy, and economic growth is profound. Vertical transmission of HIV, transmission from mother to child, is a major factor in the increasing rates of HIV infection in sub-Saharan Africa. Vertical transmission of HIV occurs in utero, intrapartum during labor and delivery, and postpartum during breast-feeding. Because of the large numbers of HIV-infected mothers in developing countries, the majority trials regarding prevention of vertical transmission of HIV have been conducted in sub-Saharan Africa. Thus, sub-Saharan Africa has become a human laboratory, which demonstrates both the successes and failures of preventative methods to reduce vertical transmission of HIV. This review summarizes the body of research dedicated to understanding the pathophysiology of vertical transmission of HIV and pharmacology of inhibition of vertical transmission of HIV. While many debate the ethics of conducting trials in developing countries where effective prevention modalities have been slow to be implemented for economic, social and political reasons, studies continue and researchers continue to discover therapies and preventative methods, which may reduce the future devastation of HIV both in sub-Saharan Africa and throughout the world.

  6. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain

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    Descarreaux Martin

    2011-02-01

    Full Text Available Abstract Background Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP. The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. Methods Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29, a SMT group (n = 36 or a SMT + exercise group (n = 33. The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group, 1 monthly SMT session (SMT group or 1 monthly SMT session combined with a home exercise program (SMT + exercise group. The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS, active cervical ranges of motion (cROM, the neck disability index (NDI and the Bournemouth questionnaire (BQ. Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ and the SF-12 Questionnaire. Results Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL was associated with the preventive phase. Conclusions This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the

  7. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain

    Science.gov (United States)

    2011-01-01

    Background Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. Methods Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Results Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. Conclusions This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase

  8. Resource costing for multinational neurologic clinical trials: methods and results.

    Science.gov (United States)

    Schulman, K; Burke, J; Drummond, M; Davies, L; Carlsson, P; Gruger, J; Harris, A; Lucioni, C; Gisbert, R; Llana, T; Tom, E; Bloom, B; Willke, R; Glick, H

    1998-11-01

    We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

  9. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

    Science.gov (United States)

    Meng, Zhiqiang; Garcia, M. Kay; Hu, Chaosu; Chiang, Joseph; Chambers, Mark; Rosenthal, David I.; Peng, Huiting; Zhang, Ying; Zhao, Qi; Zhao, Genming; Liu, Luming; Spelman, Amy; Palmer, J. Lynn; Wei, Qi; Cohen, Lorenzo

    2011-01-01

    Background Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients and available treatments are of little benefit. The objective of this trial was to determine if acupuncture can prevent xerostomia among head/neck patients undergoing radiotherapy. Methods A randomized, controlled trial among patients with nasopharyngeal carcinoma was conducted comparing acupuncture to standard care. Participants were treated at Fudan University Shanghai Cancer Center, Shanghai, China. Forty patients were randomized to acupuncture treatment and 46 to standard care. Patients were treated 3 times/week on the same days they received radiotherapy. Subjective measures included the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head/Neck (MDASI-HN). Objective measures were unstimulated and stimulated whole salivary flow rates (UWSFR; SSFR). Patients were followed for 6 months after the end of radiotherapy. Results XQ scores for acupuncture were statistically significantly lower than controls starting in week 3 through the 6-months(P=0.003 at week3, all other P’s xerostomia and improved QOL. PMID:22072272

  10. Adverse Effects of Carbetocin versus Oxytocin in the Prevention of Postpartum Haemorrhage after Caesarean Section: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    D. Mannaerts

    2018-01-01

    Full Text Available 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 compared. Results. Fifty-eight women were randomized (carbetocin n=32; oxytocin n=26. Both medications had hypotensive effect, difference in BP for carbetocin versus oxytocin: systolic (14.4 ± 2.4 mmHg versus 8.5 ± 1.8 mmHg; diastolic (7.8 ± 1.6 mmHg versus 8.9 ± 3.0 mmHg without significant difference between the drugs (p=0.1 and p=0.7. Both groups had similar needs for vasopressors. The presence of nausea was not rare, but the difference was not statistically significant (p=0.4. Average blood loss was slightly lower in the carbetocin group but not statistically significant (p=0.8. Conclusion. In planned CS, a possible clinical significant lower incidence of nausea after carbetocin was noted but this was not statistically significant. There were no differences regarding BP, heart rate, the need for vasopressor, and blood loss. The study was registered in the International Journal of Clinical Trials (ISRCTN 95504420, 2/2017.

  11. 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...

  12. 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.

  13. 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.

  14. 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).

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. Effectiveness of the Strengthening Families Programme 10–14 in Poland for the prevention of alcohol and drug misuse: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Okulicz-Kozaryn Katarzyna

    2012-06-01

    Full Text Available Abstract Background Alcohol and other drug use and misuse is a significant problem amongst Polish youth. The SFP10-14 is a family-based prevention intervention that has positive results in US trials, but questions remain about the generalizability of these results to other countries and settings. Methods/Design A cluster randomized controlled trial in community settings across Poland. Communities will be randomized to a SFP10-14 trial arm or to a control arm. Recruitment and consent of families, and delivery of the SFP10-14, will be undertaken by community workers. The primary outcomes are alcohol and other drug use and misuse. Secondary (or intermediate outcomes include parenting practices, parent–child relations, and child problem behaviour. Interview-based questionnaires will be administered at baseline, 12 and 24 months. Discussion The trial will provide information about the effectiveness of the SFP10-14 in Poland. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN89673828

  2. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  3. 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.

  4. 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.

  5. Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trials: public health implications

    Directory of Open Access Journals (Sweden)

    Sanz Sergi

    2007-09-01

    Full Text Available Abstract Background Intermittent preventive treatment (IPTi with sulphadoxine-pyrimethamine (SP in infants resulted in different estimates of clinical malaria protection in two trials that used the same protocol in Ifakara, Tanzania, and Manhiça, Mozambique. Understanding the reasons for the discrepant results will help to elucidate the action mechanism of this intervention, which is essential for rational policy formulation. Methods A comparative analysis of two IPTi trials that used the same study design, follow-up, intervention, procedures and assessment of outcomes, in Tanzania and Mozambique was undertaken. Children were randomised to receive either SP or placebo administered 3 times alongside routine vaccinations delivered through the Expanded Program on Immunisation (EPI. Characteristics of the two areas and efficacy on clinical malaria after each dose were compared. Results The most relevant difference was in ITN's use ; 68% in Ifakara and zero in Manhiça. In Ifakara, IPTi was associated with a 53% (95% CI 14.0; 74.1 reduction in the risk of clinical malaria between the second and the third dose; during the same period there was no significant effect in Manhiça. Similarly, protection against malaria episodes was maintained in Ifakara during 6 months after dose 3, but no effect of IPTi was observed in Manhiça. Conclusion The high ITN coverage in Ifakara is the most likely explanation for the difference in IPTi efficacy on clinical malaria. Combination of IPTi and ITNs may be the most cost-effective tool for malaria control currently available, and needs to be explored in current and future studies. Trial Registration Manhiça study registration number: NCT00209795 Ifakara study registration number: NCT88523834

  6. Exercise intervention to prevent falls and enhance mobility in community dwellers after stroke: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Barker Ruth N

    2009-07-01

    Full Text Available Abstract Background Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. Methods and design Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. Discussion This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Method for preventing plugging in the pyrolysis of agglomerative coals

    Science.gov (United States)

    Green, Norman W.

    1979-01-23

    To prevent plugging in a pyrolysis operation where an agglomerative coal in a nondeleteriously reactive carrier gas is injected as a turbulent jet from an opening into an elongate pyrolysis reactor, the coal is comminuted to a size where the particles under operating conditions will detackify prior to contact with internal reactor surfaces while a secondary flow of fluid is introduced along the peripheral inner surface of the reactor to prevent backflow of the coal particles. The pyrolysis operation is depicted by two equations which enable preselection of conditions which insure prevention of reactor plugging.

  15. The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study.

    Science.gov (United States)

    Shingler, Ellie; Hackshaw-McGeagh, Lucy; Robles, Luke; Persad, Raj; Koupparis, Anthony; Rowe, Edward; Shiridzinomwa, Constance; Bahl, Amit; Martin, Richard M; Lane, J Athene

    2017-03-07

    There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. The Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) aimed to assess a diet and physical activity intervention in men undergoing radical prostatectomy for localized prostate cancer. The trial included a qualitative component to explore the experiences of men participating in the trial in order to understand the acceptability of the intervention and data collection methods. We report the qualitative findings of the trial and consider how these can be used to inform future research. PrEvENT involved randomizing men to either a dietary and/or physical activity intervention. Semi-structured interviews were conducted with a purposive sample of 17 men on completion of the 6 month trial. Interviews took place in clinic or as telephone interviews, if requested by the participant, and were audio recorded, transcribed, and analyzed using the thematic-based framework approach. Analysis was conducted throughout the data collection process to allow emergent themes to be further explored in subsequent interviews. Three overarching themes were identified: acceptability of the intervention, acceptability of the data collection methods and trial logistics. Participants were predominantly positive about both the dietary and physical activity interventions and most men found the methods of data collection appropriate. Recommendations for future trials include consideration of alternative physical activity options, such as cycling or gym sessions, increased information on portion sizes, the potential importance of including wives or partners in the dietary change process and the possibility of using the pedometer or other wearable technology as part of the physical activity intervention. We provide insight into the opinions and experiences of the acceptability of the PrEvENT

  16. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco smoke exposure on infant lung function and respiratory health.

    Science.gov (United States)

    McEvoy, Cindy T; Milner, Kristin F; Scherman, Ashley J; Schilling, Diane G; Tiller, Christina J; Vuylsteke, Brittany; Shorey-Kendrick, Lyndsey E; Spindel, Eliot R; Schuff, Robert; Mitchell, Julie; Peters, Dawn; Metz, Jill; Haas, David; Jackson, Keith; Tepper, Robert S; Morris, Cynthia D

    2017-07-01

    Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective effect of vitamin C supplementation on the lung function of offspring exposed to in utero smoke in a non-human primate model and an initial human trial. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) is a randomized, double-blind, placebo-controlled trial to evaluate pulmonary function at 3months of age in infants delivered to pregnant smokers randomized to 500mg/day of vitamin C versus placebo during pregnancy. Secondary aims evaluate the incidence of wheezing through 12months and pulmonary function testing at 12months of age. Women are randomized between 13 and 23weeks gestation from clinical sites in Portland, Oregon at Oregon Health & Science University and PeaceHealth Southwest Medical Center and in Indianapolis, Indiana at Indiana University and Wishard Hospital. Vitamin C supplementation occurs from randomization to delivery. Monthly contact with participants and monitoring of medical records is performed to document medication adherence, changes in smoking and medical history, and adverse events. Pulmonary function testing of offspring occurs at 3 and 12months of age and incidence of wheezing and respiratory illness through 12months is captured via at least quarterly questionnaires. Ancillary studies are investigating the impact of vitamin C on placental blood flow and DNA methylation. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Can custom-made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts.

    Science.gov (United States)

    Larsen, Kristian; Weidich, Flemming; Leboeuf-Yde, Charlotte

    2002-06-01

    Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems. One review concludes that the former is clinically effective in relation to prevention, whereas the latter has been tested in only 1 randomized clinical trial, concluding that stress fractures could be prevented. To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible. Prospective, randomized, controlled intervention trial. One female and 145 male military conscripts (aged 18 to 24 years), representing 25% of all new conscripts in a Danish regiment. Health data were collected by questionnaires at initiation of the study and 3 months later. Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period. No intervention was provided for the control group. Differences between the 2 groups were tested with the chi-square test, and statistical significance was accepted at P biomechanic shoe orthoses. However, because care-seeking for lower extremity problems is rare, using this method of prevention in military conscripts would be too costly. We also noted that the choice of statistical approach determined the outcome.

  18. Role of APOE and Age at Enrollment in the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT

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    Lea T. Drye

    2012-08-01

    Full Text Available Background: The Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT tested whether non-steroidal anti-inflammatory drugs (NSAIDs can prevent Alzheimer’s disease (AD. The results were null. We analyzed ADAPT data to examine if the effects of NSAIDs on AD risk differed depending upon APOE genotype or age as has been suggested by previous observational studies. Methods: ADAPT randomized 2,528 cognitively intact older adults to either celecoxib, naproxen sodium or placebo; 2,388 participants provided blood samples for APOE genotyping. Proportional hazards regression was used to estimate the effects of naproxen or celecoxib versus placebo on incident AD by age at enrollment and APOE genotype. Results: The proportion of subjects providing a biological sample did not differ between the treatment groups. In models of AD risk, none of the tests for 2-way interactions between either NSAID and age or APOE genotype were significant (p > 0.05. Conclusions: The data did not support the hypothesis that the association between NSAIDs and AD risk differed by age or APOE genotype.

  19. PHYSIOTHERAPY METHODS IN PREVENTION OF FALLS IN ELDERLY PEOPLE

    Directory of Open Access Journals (Sweden)

    MAŁGORZATA GAJOS

    2016-06-01

    Full Text Available The process of population ageing is observed not only in Poland but also in other European countries. Physiological processes of ageing reduces the functional capacity. In particular, associated diseases, progressive weakness and failure of the motor system increases the risk of collapse in seniors. Dangerous consequences of falls, inter alia, injuries, can often cause death, what justifies its classification as a so-called geriatric giant. Health and psychosocial consequences of falls should be noted. Therefore, there is a great need for induction of preventive measures. Many results of studies constantly show, that an effective intervention in preventing falls in seniors should include, first and foremost, multidirectional rehabilitation, which aims to improve balance and increase postural strength muscle. In addition, prevention should include: patient education, pharmacotherapy prescribed by a medical specialist, eyesight improvement, elimination of potential risks surrounding the patient. The introduction of multi-directional prevention of falls can reduce the risk of their occurrence up to 50%.

  20. Net Gain: A New Method for Preventing Malaria Deaths | CRDI ...

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

    Christian Lengeler is currently Senior Scientist in the Department of Public Health and Epidemiology of the Swiss Tropical Institute in Basel, Switzerland. He was previously a research fellow at the London School of Hygiene and Tropical Medicine where he facilitated coordination of the net trial network. Jacqueline Cattani is ...

  1. Net Gain: A New Method for Preventing Malaria Deaths | IDRC ...

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

    He was previously a research fellow at the London School of Hygiene and Tropical Medicine where he facilitated coordination of the net trial network. Jacqueline Cattani is Manager of the Task Force on Insecticide-Impregnated Bednets and Other Materials with the UNDP/World Bank/WHO Special Programme for Research ...

  2. 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

  3. 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

  4. 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...

  5. 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.

  6. [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.

  7. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. Pregnancy incidence and risk factors among women participating in vaginal microbicide trials for HIV prevention: systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Alfred Musekiwa

    Full Text Available INTRODUCTION: Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors. METHODS: A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively. RESULTS: Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants were included. A total of 4,107 participants (15.0% fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551 yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96 pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy. CONCLUSIONS: The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.

  18. 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).

  19. A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol

    Science.gov (United States)

    2012-01-01

    Background Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is C. difficile associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of C. difficile has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora. Methods This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and C. difficile diarrhoea during 8–12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of C. difficile diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK. Discussion Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control C. difficile diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals. Trial registration International Standard Randomised Controlled

  20. A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol

    Directory of Open Access Journals (Sweden)

    Allen Stephen J

    2012-05-01

    Full Text Available Abstract Background Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is C. difficile associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of C. difficile has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora. Methods This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and C. difficile diarrhoea during 8–12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of C. difficile diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK. Discussion Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control C. difficile diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals. Trial registration International

  1. 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.

  2. Internet-based prevention of posttraumatic stress symptoms in injured trauma patients: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Joanne Mouthaan

    2011-11-01

    Full Text Available Background: Injured trauma victims are at risk of developing Posttraumatic Stress Disorder (PTSD and other post-trauma psychopathology. So far, interventions using cognitive behavioral techniques (CBT have proven most efficacious in treating early PTSD in highly symptomatic individuals. No early intervention for the prevention of PTSD for all victims has yet proven effective. In the acute psychosocial care for trauma victims, there is a clear need for easily applicable, accessible, cost-efficient early interventions. Objective: To describe the design of a randomized controlled trial (RCT evaluating the effectiveness of a brief Internet-based early intervention that incorporates CBT techniques with the aim of reducing acute psychological distress and preventing long-term PTSD symptoms in injured trauma victims. Method: In a two armed RCT, 300 injured trauma victims from two Level-1 trauma centers in Amsterdam, the Netherlands, will be assigned to an intervention or a control group. Inclusion criteria are: being 18 years of age or older, having experienced a traumatic event according to the diagnostic criteria of the DSM-IV and understanding the Dutch language. The intervention group will be given access to the intervention's website (www.traumatips.nl, and are specifically requested to login within the first month postinjury. The primary clinical study outcome is PTSD symptom severity. Secondary outcomes include symptoms of depression and anxiety, quality of life, and social support. In addition, a cost-effectiveness analysis of the intervention will be performed. Data are collected at one week post-injury, prior to first login (baseline, and at 1, 3, 6 and 12 months. Analyses will be on an intention-to-treat basis. Discussion: The results will provide more insight into the effects of preventive interventions in general, and Internet-based early interventions specifically, on acute stress reactions and PTSD, in an injured population, during the

  3. Comparison of Two Methods of Direct and Indirect Education on Osteoporosis Preventive Behaviors among Female Students

    Directory of Open Access Journals (Sweden)

    Leila Darabi

    2017-08-01

    Full Text Available Background Osteoporosis is the most common metabolic bone disease that decreases bone mass, causes destruction and eventually friability. This disease is preventable, and because adolescent females are the high-risk population, teaching this age group is of the utmost importance. The aim of this study was to compare the effects of the two educational methods (Lecture and Pamphlet on osteoporosis preventive behaviors among female students. Materials and Methods: This was a randomized clinical trial (RCT. To collect data, demographic questionnaire, food frequency questionnaire (FFQ, and physical activity questionnaire were used. Subjects were 205 seventh-grade girls who were selected by multistage random method and allocated in two experimental (Lecture = 68, Pamphlet = 67 and 70 for control group. In the Lecture group, there were 5 sessions of training, each of which lasted 60 minutes. In the Pamphlet group, only educational pamphlets were given, and no interventions were performed in the control group. Data were analyzed through statistical software SPSS version 21.0. Descriptive statistics, chi-square tests, t-test and ANOVA were applied to analyze the data. Results: The mean age of the students was 13 + 0.856 years old and there was no difference in terms of demographic variables between intervention and control groups. The results identified the mean scores of physical activity behaviors significantly improved two mounts after the intervention in the lecture group (P=0.001.While, the men scores of the pamphlet group had no significant changes after two months, but the differences of the both group compared to the control group were significant. Considering the significant decreased in the control group (P= 001. The mean scores of calcium intake in the two lecture and pamphlet groups significantly increased (P

  4. 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

  5. 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

  6. 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

  7. 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…

  8. Methods for therapeutic trials in COPD: lessons from the TORCH trial

    DEFF Research Database (Denmark)

    Keene, O N; Vestbo, J; Anderson, J A

    2009-01-01

    The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect of inclus......The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect...... to be combined with careful analysis of withdrawal patterns across treatments. The negative binomial model is currently the best approach to statistical analysis of exacerbation rates, while analysis of time to exacerbation can supplement this approach. In the TORCH trial, exacerbation rates were higher among...

  9. Long-Term Follow-up of Participants with Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

    Science.gov (United States)

    Piller, Linda B.; Baraniuk, Sarah; Simpson, Lara M.; Cushman, William C.; Massie, Barry M.; Einhorn, Paula T.; Oparil, Suzanne; Ford, Charles E.; Graumlich, James F.; Dart, Richard A.; Parish, David C.; Retta, Tamrat M.; Cuyjet, Aloysius B.; Jafri, Syed Z.; Furberg, Curt D.; Saklayen, Mohammad G.; Thadani, Udho; Probstfield, Jeffrey L.; Davis, Barry R.

    2011-01-01

    Background In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, practice-based, active-control, comparative effectiveness trial in high-risk hypertensive participants, risk of new-onset heart failure (HF) was higher in the amlodipine (2.5-10 mg/day) and lisinopril (10-40 mg/day) arms compared with the chlorthalidone (12.5-25 mg/day) arm . Similar to other studies, mortality rates following new-onset HF were very high (≥50% at 5 years), and were similar across randomized treatment arms. After the randomized phase of the trial ended in 2002, outcomes were determined from administrative databases. Methods and Results Using national databases, post-trial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized (in-trial) phase of ALLHAT. Mean follow-up for the entire period was 8.9 years. Of 1761 participants with incident HF in-trial, 1348 died. Post-HF all-cause mortality was similar across treatment groups with adjusted hazard ratios (95% confidence intervals) of 0.95 (0.81-1.12) and 1.05 (0.89-1.25), respectively, for amlodipine and lisinopril compared with chlorthalidone, and 10-year adjusted rates of 86%, 87%, and 83%, respectively. All-cause mortality rates were also similar among those with reduced ejection fractions (84%) and preserved ejection fractions (81%) with no significant differences by randomized treatment arm. Conclusions Once HF develops, risk of death is high and consistent across randomized treatment groups. Measures to prevent the development of HF, especially blood pressure control, must be a priority if mortality associated with development of HF is to be addressed. PMID:21969009

  10. 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

  11. 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.

  12. Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP trial

    Directory of Open Access Journals (Sweden)

    Jenny Lloyd

    2017-04-01

    Full Text Available Abstract Background We have developed a healthy lifestyles programme (HeLP for primary school aged children (9–10 years, currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity by gender, cluster level socio-economic status, school size and time of recruitment into the trial. Methods Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP or control (usual practice stratified by the proportion of children eligible for free school meals (FSM, 1 Year 5 class. The primary outcome is change in body mass index standard deviation score (BMI sds at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample and food intake at 18 months. Results At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8% and children from schools in FSM category 2 (28.2% vs 23.2% were overweight or obese. Children were consuming a mean (range of 4.15 (0–13 energy dense snacks (EDS and 3.23 (0–9 healthy snacks (HS per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8 in MVPA and thirteen hours (779.3 min per day (11 h to 15 h doing less than ‘light’ intensity activity. Less than 5% of children achieved the Departments of Health’s recommendation of 60 min of MVPA every day. Conclusion We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not

  13. 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.

  14. DIABRISK - SL Prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's - study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Viberti Giancarlo

    2011-09-01

    Full Text Available Abstract Background Urban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM and cardiovascular disease (CVD. There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly lifestyle modification advice is superior to a less-intensive (12 monthly; control group lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years. Methods/Design This is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53% healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines. Discussion DIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio

  15. Method for preventing and/or treating insulin resistance

    NARCIS (Netherlands)

    Nieuwdorp, M.; Vos, de W.M.

    2013-01-01

    The present invention describes use of Eubacterium hallii et rel. and/or Alcaligenes faecalis et rel., as well as pharmaceutical, food, or feed compositions comprising these bacteria, as a medicament, in particular for preventing and/or treating insulin resistance and/or insulin resistance-related

  16. Ethical and Unethical Methods of Plagiarism Prevention in Academic Writing

    Science.gov (United States)

    Bakhtiyari, Kaveh; Salehi, Hadi; Embi, Mohamed Amin; Shakiba, Masoud; Zavvari, Azam; Shahbazi-Moghadam, Masoomeh; Ebrahim, Nader Ale; Mohammadjafari, Marjan

    2014-01-01

    This paper discusses plagiarism origins, and the ethical solutions to prevent it. It also reviews some unethical approaches, which may be used to decrease the plagiarism rate in academic writings. We propose eight ethical techniques to avoid unconscious and accidental plagiarism in manuscripts without using online systems such as Turnitin and/or…

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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