Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980
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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.
KeywordsBehavior Intervention Cardiovascular Trial registration Publication statistics Effect sizes Periodicals as topics/statistics Randomized controlled trials as topics/statistics
Conflict of Interest and Ethical Adherence
Manuscript submitted to Annals of Behavioral Medicine
Study authors: Veronica L. Irvin & Robert M. Kaplan
Study title: Effect Sizes and Primary Outcomes in Large Behavioral Randomized-Controlled Trials Funded by NIH Since 1980
This research was conducted while both authors were affiliated with the Intramural Research Program of the National Institutes of Health, Clinical Center, Department of Rehabilitation Medicine. Dr. Irvin was a post-doctoral fellow with the National Institutes of Health. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the National Institutes of Health or the US government.
Conflict of Interest
Both authors were with National Institutes of Health at the time of data analysis—Dr. Kaplan as an employee and Dr. Irvin as a post-doctoral fellow. There was no official grant funded by NIH to conduct these analyses. Dr. Irvin is now Assistant Professor at Oregon State University and Dr. Kaplan is now Chief Scientific Officer at the Agency for Healthcare Research and Quality. There are no other conflicts of interests to report.
This study was determined exempt from review by the National Institute of Health, Office of Human Subjects Research (NIH OHSRP no. 11648 PI: Kaplan).
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