A third of systematic reviews changed or did not specify the primary outcome: A PROSPERO register study

Andrea C Tricco, Elise Cogo, Matthew J Page, Julie Polisena, Alison Booth, Kerry Dwan, Heather MacDonald, Tammy J Clifford, Lesley A Stewart, Sharon E Straus, David Moher

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVES: To examine outcome reporting bias of systematic reviews registered in PROSPERO.

STUDY DESIGN AND SETTING: Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions or downgrades. Relative risks (RR) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favourable and statistically significant.

RESULTS: 96 systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR 2.14, 95% CI 0.53 to 8.63) or decreased risk of downgrading (RR 0.76, 0.27-2.17) an outcome when the meta-analysis result was favourable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR 0.89, 0.31-2.53) or decreased risk of downgrading (RR 0.56, 0.29-1.08) an outcome when the conclusion was positive.

CONCLUSIONS: We recommend review authors carefully consider primary outcome selection and journals are encouraged to focus acceptance on registered systematic reviews.

Original languageEnglish
Pages (from-to)46–54
Number of pages9
JournalJournal of Clinical Epidemiology
Volume79
Early online date11 Apr 2016
DOIs
Publication statusE-pub ahead of print - 11 Apr 2016

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