Dataset Information

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980.

ABSTRACT: We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes.We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK)) for cardiovascular disease (dates January 1, 1980 to December 31, 2012). Among 106 grants that potentially met inclusion criteria, 20 studies were not published and 48 publications were excluded, leaving 38 publications for analysis. ClinicalTrials.gov abstracts were used to determine whether outcome measures had been pre-specified.Three fourths of trials were registered in ClinicalTrials.gov and all published pre-specified outcomes. Twenty-six trials reported a behavioral outcome with 81 % reporting significant improvements for the target behavior. Thirty-two trials reported a physiological outcome. All were objectively measured, and 81 % reported significant benefit. Seventeen trials reported morbidity outcomes, and seven reported a significant benefit. Nine trials assessed mortality, and all were null for this outcome.Behavioral trials complied with trial registration standards. Most reported a physiological benefit, but few documented morbidity or mortality benefits.

SUBMITTER: Irvin VL

PROVIDER: S-EPMC4744141 | biostudies-other | 2016 Feb

REPOSITORIES: biostudies-other

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Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980.

Irvin Veronica L VL Kaplan Robert M RM

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20160201 1

<h4>Purpose</h4>We reviewed large-budget, National Institutes of Health (NIH)-supported randomized controlled trials (RCTs) with behavioral interventions to assess (1) publication rates, (2) trial registration, (3) use of objective measures, (4) significant behavior and physiological change, and (5) effect sizes.<h4>Methods</h4>We identified large-budget grants (>$500,000/year) funded by NIH (National Heart Lung and Blood Institute (NHLBI) or National Institute of Diabetes & Digestive and Kidney ...[more]

PMID: 26507906

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Project description:BACKGROUND/AIMS:Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. METHODS:We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. RESULTS:It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. CONCLUSION:New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible.

Project description:BackgroundThe widespread adoption of smartphones provides researchers with expanded opportunities for developing, testing and implementing interventions. National Institutes of Health (NIH) funds competitive, investigator-initiated grant applications. Funded grants represent the state of the science and therefore are expected to anticipate the progression of research in the near future.ObjectiveThe objective of this paper is to provide an analysis of the kinds of smartphone-based intervention apps funded in NIH research grants during the five-year period between 2014 and 2018.MethodsWe queried NIH Reporter to identify candidate funded grants that addressed mHealth and the use of smartphones. From 1524 potential grants, we identified 397 that met the requisites of including an intervention app. Each grant's abstract was analyzed to understand the focus of intervention. The year of funding, type of activity (eg, R01, R34, and so on) and funding were noted.ResultsWe identified 13 categories of strategies employed in funded smartphone intervention apps. Most grants included either one (35.0%) or two (39.0%) intervention approaches. These included artificial intelligence (57 apps), bionic adaptation (33 apps), cognitive and behavioral therapies (68 apps), contingency management (24 apps), education and information (85 apps), enhanced motivation (50 apps), facilitating, reminding and referring (60 apps), gaming and gamification (52 apps), mindfulness training (18 apps), monitoring and feedback (192 apps), norm setting (7 apps), skills training (85 apps) and social support and social networking (59 apps). The most frequently observed grant types included Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants (40.8%) and Research Project Grants (R01s) (26.2%). The number of grants funded increased through the five-year period from 60 in 2014 to 112 in 2018.ConclusionsSmartphone intervention apps are increasingly competitive for NIH funding. They reflect a wide diversity of approaches that have significant potential for use in applied settings.

Dataset Information

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980.

Publications

Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980.

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