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A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes.

Abstract：

OBJECTIVES:Core outcome set (COS) development often begins with a systematic review to identify outcomes. Reviews frequently show heterogeneity in numbers of outcomes reported across trials. Contributing to this is a lack of a uniform definition for an outcome. This study proposes a first working definition for a unique trial outcome to support reporting a quantitative assessment of outcome reporting heterogeneity (ORH). STUDY DESIGN AND SETTING:Eligible COS literature (development papers, protocols, and reviews) were identified using the COMET database, Ovid MEDLINE, and PubMed. Outcome numbers, definitions, timing, and grouping methodology were examined. RESULTS:One hundred and thirty two studies were included. 82 (88.1%) studies (excluding protocols) reported a total number of unique outcomes (median, 82; range, 12-5776; IQR, 261). Timing of assessment was reported in 32 (31.4%) studies. Methods to group similar outcomes were reported in 8 (7.8%) articles. No study defined how outcomes were agreed as different and how final numbers of unique outcomes were determined. It is proposed that a unique outcome requires original meaning and context. Thus ORH is suggested to be the reporting of multiple unique outcomes across trials related to one health care condition. CONCLUSION:This review identified inconsistencies in how authors define, extract, group, and count trial outcomes. Further work is needed to refine our proposed definitions to optimize COS development and allow a quantifiable measure of ORH.

journal_name

J Clin Epidemiol

journal_title

Journal of clinical epidemiology

authors

Young AE,Brookes ST,Avery KNL,Davies A,Metcalfe C,Blazeby JM

doi

10.1016/j.jclinepi.2019.06.016

subject

Has Abstract

pub_date

2019-11-01 00:00:00

pages

14-24

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(19)30287-2

journal_volume

115

pub_type

杂志文章

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