A systematic review finds Core Outcome Set uptake varies widely across different areas of health

Karen L Hughes,Mike Clarke,Paula R Williamson

doi:10.1016/j.jclinepi.2020.09.029

Karen L Hughes, Mike Clarke + Show 1 more

Open Access

https://doi.org/10.1016/j.jclinepi.2020.09.029

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Abstract

ObjectiveThe aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health. Study Design and SettingWe examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomized controlled trials (RCTs) or systematic reviews (SRs). ResultsWe identified 24 studies that had assessed uptake in RCTs and two studies that had assessed uptake in SRs. The studies covered a total of 17/337 (5%) COS. Uptake rates reported for RCTs varied from 0% of RCTs (gout) to 82% RCTs (rheumatoid arthritis) measuring the full COS. Studies that assessed uptake of individual core outcomes showed a wide variation in uptake between the outcomes. Suggested barriers to uptake included lack of validated measures, lack of patient and other key stakeholder involvement in COS development, and lack of awareness of the COS. ConclusionsFew studies have been undertaken to assess the uptake of COS in RCTs and SRs. Further studies are needed to assess whether COS have been implemented across a wider range of disease categories and to explore the barriers and facilitators to COS uptake.

Highlights

In 2014 Gargon et al, under the auspices of the COMET (Core Outcome Measures for Effectiveness Trials) Initiative, published a systematic review bringing together studies that had made recommendations about which outcomes to measure in clinical trials of specific health conditions [1]
Four studies were excluded because they did not assess the uptake of all outcomes that were recommended by the Core Outcome Sets (COS)
A third study focused on measurement instruments and included an assessment of uptake of some, but not all, COS outcomes and the final study assessed the uptake of a selection of outcomes from a COS that is made up of 48 recommendations

Summary

Introduction

In 2014 Gargon et al, under the auspices of the COMET (Core Outcome Measures for Effectiveness Trials) Initiative, published a systematic review bringing together studies that had made recommendations about which outcomes to measure in clinical trials of specific health conditions [1]. Known as Core Outcome Sets (COS), are defined by the COMET Initiative as ‘‘an agreed standardized set of outcomes that should be measured and reported, as a minimum, in all clinical trials

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