Primary outcome reporting in adolescent depression clinical trials needs standardization

Abstract

Background: Evidence-based health care is informed by results of randomized clinical trials (RCTs) and their syntheses in meta-analyses. When the trial outcomes measured are not clearly described in trial publications, knowledge synthesis, translation, and decision-making may be impeded. While heterogeneity in outcomes measured in adolescent major depressive disorder (MDD) RCTs has been described, the comprehensiveness of outcome reporting is unknown. This study aimed to assess the reporting of primary outcomes in RCTs evaluating treatments for adolescent MDD. Methods: RCTs evaluating treatment interventions in adolescents with a diagnosis of MDD published between 2008 and 2017 specifying a single primary outcome were eligible for outcome reporting assessment. Outcome reporting assessment was done independently in duplicate using a comprehensive checklist of 58 reporting items. Primary outcome information provided in each RCT publication was scored as “fully reported”, “partially reported”, or “not reported” for each checklist item, as applicable. Results: Eighteen of 42 identified articles were found to have a discernable single primary outcome and were included for outcome reporting assessment. Most trials (72%) did not fully report on over half of the 58 checklist items. Items describing masking of outcome assessors, timing and frequency of outcome assessment, and outcome analyses were fully reported in over 70% of trials. Items less frequently reported included outcome measurement instrument properties (ranging from 6-17%), justification of timing and frequency of outcome assessment (6%), and justification of criteria used for clinically significant differences (17%). The overall comprehensiveness of reporting appeared stable over time. Conclusions: Heterogeneous reporting exists in published adolescent MDD RCTs, with frequent omissions of key details about their primary outcomes. These omissions may impair interpretability, replicability, and synthesis of RCTs that inform clinical guidelines and decision-making in this field. Consensus on the minimal criteria for outcome reporting in adolescent MDD RCTs is needed. Trial registration: Not applicable

Revisiting the theoretical and methodological foundations of depression measurement

“…In intervention trials published in clinical psychology journals, only one in seven studies preregister their measures 157 , leaving these studies vulnerable to selecting which measures to report post hoc, a practice especially prevalent in studies with industry funding 158 . Similarly, only 18 of 32 reviewed randomized controlled trials of adolescent depression featured an identifiable, single, primary outcome 159 . This lack of transparency when administering instruments creates fertile ground for questionable measurement practices, and muddies the inferences that can be drawn.…”

Selecting and collecting outcomes for clinical trials: an international qualitative study exploring stakeholder perspectives

“…Most studies of outcomes have focused on outcome selection 19 and adherence to reporting guidance 20,21 . Our study is different.…”

Primary outcome reporting in adolescent depression clinical trials needs standardization

“…Assessments of the comprehensiveness of outcome reporting in the published trials made using the resultant 58 item checklist were conducted independently and in duplicate by two reviewers (SP and AC) trained in clinical trial reporting methodology. A standardized data charting form (available online [34]) developed using Research Electronic Data Capture (REDCap) data management software [35] was used during assessment.…”