Primary outcome reporting in adolescent depression clinical trials needs standardization

Area of Science:

• Clinical Trials Methodology
• Adolescent Psychiatry
• Evidence-Based Medicine

Background:

• Randomized clinical trials (RCTs) and meta-analyses are crucial for evidence-based health care.
• Incomplete reporting of trial outcomes impedes knowledge synthesis and clinical decision-making.
• Previous research noted outcome heterogeneity in adolescent major depressive disorder (MDD) RCTs, but reporting comprehensiveness was unknown.

Purpose of the Study:

• To assess the comprehensiveness of primary outcome reporting in RCTs for adolescent MDD.

Main Methods:

• A systematic review of RCTs published between 2008-2017 evaluating treatments for adolescent MDD.
• Included trials specified a single primary outcome.
• Outcome reporting was assessed independently in duplicate using a 58-item checklist, scoring items as fully, partially, or not reported.

Main Results:

• Eighteen trials met inclusion criteria.
• Most trials (72%) failed to fully report over half of the 58 checklist items.
• Reporting was consistently poor for outcome measurement properties (6-17%) and justification of clinically significant differences (17%).

Conclusions:

• Published RCTs for adolescent MDD exhibit heterogeneous and incomplete primary outcome reporting.
• Omissions of key details hinder interpretability, replicability, and synthesis of trial findings.
• There is a need for consensus on minimal criteria for outcome reporting in adolescent MDD RCTs.