Inadequate Reporting of Cointerventions, Other Methodological Factors, and Treatment Estimates in Cardiovascular Trials: A Meta-Epidemiological Study.

Objective: To assess how inadequate reporting of cointerventions influences estimated treatment effects in recent cardiovascular trials.

Methods: Medline/Embase were systematically searched from January 1, 2011 to July 1, 2021 for trials evaluating pharmacologic interventions on clinical cardiovascular outcomes published in 5 high-impact journals. Information on adequate vs inadequate reporting of cointerventions, blinding, risk of bias due to deviations of intended interventions (low vs high/some concerns), funding (nonindustry vs industry), design (superiority vs noninferiority), and results were assessed by 2 reviewers.

Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations.

Pragmatic trials testing the effectiveness of interventions under "real world" conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice.

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

Objectives: To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications.

Study Design And Setting: Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records.