期刊
JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 115, 期 -, 页码 14-24出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2019.06.016
关键词
Outcomes; Research methodology; Core outcome set; Clinical trials; Systematic review; COMET
资金
- National Institute for Health Research (NIHR), United Kingdom Doctoral Research Fellowship [DRF-2016-09-031]
- Medical Research Council ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) [MR/K025643/1]
- Royal College of Surgeons of England Bristol Surgical Trials Centre
- NIHR Biomedical Research Centre (BRC) at the University Hospitals Bristol NHS Foundation Trust
- University of Bristol
- MRC [MR/K025643/1] Funding Source: UKRI
- National Institutes of Health Research (NIHR) [DRF-2016-09-031] Funding Source: National Institutes of Health Research (NIHR)
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. Crown Copyright (C) 2019 Published by Elsevier Inc.
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