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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 to 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.

journal_name

BMC Med Res Methodol

journal_title

BMC medical research methodology

authors

Monsour A,Mew EJ,Patel S,Chee-A-Tow A,Saeed L,Santos L,Courtney DB,Watson PN,Monga S,Szatmari P,Offringa M,Butcher NJ

doi

10.1186/s12874-020-01019-6

subject

Has Abstract

pub_date

2020-05-25 00:00:00

pages

129

issue

issn

1471-2288

pii

10.1186/s12874-020-01019-6

journal_volume

pub_type

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Primary outcome reporting in adolescent depression clinical trials needs standardization.