Transparent reporting of hypotheses and analyses in behavioral medicine research: An audit of publications in 2018 and 2008.
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ABSTRACT: Objective
We aimed to document the use of transparent reporting of hypotheses and analyses in behavioral medicine journals in 2018 and 2008.Design
We examined a randomly selected portion of articles published in 2018 and 2008 by behavioral medicine journals with the highest impact factor, excluding manuscripts that were reviews or purely descriptive.Main outcome measures
We coded whether articles explicitly stated if the hypotheses/outcomes/analyses were primary or secondary; if study was registered/pre-registered; if "exploratory" or a related term was used to describe analyses/aims; and if power analyses were reported.Results
We coded 162 manuscripts published in 2018 (87% observational and 12% experimental). Sixteen percent were explicit in describing hypotheses/outcomes/analyses as primary or secondary, 51% appeared to report secondary hypotheses/outcomes/analyses but did not use term "secondary," and 33% were unclear. Registration occurred in 14% of studies, but 91% did not report which analyses were registered. "Exploratory" or related term was used in 31% of studies. Power analyses were reported in 8% of studies. Compared to 2008 (n=120), studies published in 2018 were more likely to be registered and less likely to have explicitly stated if outcomes were primary or secondary.Conclusions
Behavioral medicine stakeholders should consider strategies to increase clarity of reporting, and particularly details that will inform readers if analyses were pre-planned or post-hoc.
SUBMITTER: McVay MA
PROVIDER: S-EPMC8145985 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Importance:Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care. Objective:To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals. Design, Setting, and Participants:Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute-Surveillance, Epidemiology, and End Results and US Census databases. Main Outcomes and Measures:Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and ?2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported. Results:Among 230 trials with a total of 112?293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR, 1.63; 95% CI, 0.93-2.87; P?=?.09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR, 2.26, 95% CI, 1.16-4.67; P?=?.03) changed minimally and varied across races. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial participants, respectively, and the proportion for each race enrolled over time changed nominally (blacks, 3.6% vs 2.9% and Hispanics, 5.3% vs 6.7%) from July 2008 to June 2013 vs July 2013 to June 2018. Compared with their proportion of US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented compared with whites (98% of expected) and Asians (438% of expected). Conclusions and Relevance:Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.
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Project description: Not available
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