Core Outcome Measures in Effectiveness Trials

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

General Information

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

Authors:
Young, A. E. Brookes, S. T. Avery, K. N. L. Davies, A. Metcalfe, C. Blazeby, J. M.

Publication

Journal:
Journal of Clinical Epidemiology
Volume:
115
Issue:
Pages:
14 - 24
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):
This work was supported by a National Institute for Health Research (NIHR), United Kingdom Doctoral Research Fellowship DRF-2016-09-031. This work was undertaken with the support of the Medical Research Council ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures—MR/K025643/1) and Royal College of Surgeons of England Bristol Surgical Trials Centre. KNLA and JMB were supported by the NIHR Biomedical Research Centre (BRC) at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.

Health Area

Disease Category
Other

Disease Name
N/A

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any

Method(s)

Systematic review

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.


Stakeholders Involved

None

Study Type

Systematic review of core outcome sets

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