Transparency enhancement for reports of randomized controlled trials in behavioral medicine

Article type
Authors
Falzon L, Trudeau K, Davidson K
Abstract
Background: As presented at last year's Colloquium, the now registered Cochrane Behavioral Medicine Field advocates for the inclusion of study details (participants, provider, setting) of interventions. These details are important in addressing the generalizability of a particular randomized trial and have implications for summarizing across randomized trials when conducting a systematic review on a particular topic. Therefore, within our Field register, we are coding for these details.

Objectives: The purpose of this study is to identify how often details for these categories are reported in the abstracts of behavioral medicine randomized controlled trials.

Methods: Abstracts for 42% (n=2944) of the randomized controlled trials in our current register of behavioral medicine trials included in PubMed (n=7589) were reviewed for transparency of participant group (e.g. ethnicity, age), provider of intervention (e.g. physician, nurse, counselor, teacher), and setting of intervention (e.g. community, inpatient, specialty care such as substance abuse clinic) for each study.

Results: Details for at least one of these categories was reported in the abstracts for 68% (or 1887/2944) of our sample. Details for all three categories were reported in the abstracts for 4% (or 138/2944) of our sample.

Conclusions: Although behavioral medicine has made great strides in improving the transparency of reports of randomized controlled trials (e.g. the adoption of CONSORT (Consolidated Standards of Reporting Trials) by leading journals in this field), additional changes are recommended: 1) increasing awareness of variables in intervention studies that may predict outcomes in behavioral medicine trials and 2) requiring structured abstracts with specific categories for participant, provider, and setting.