Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research

Abstract

Background An annual update to a systematic review of core outcome sets (COS) for research ensures that the COMET database is up-to-date. The aims of this study were to: (i) identify COS that were published or indexed in 2019 and to describe the methodological approaches used in these studies; (ii) investigate whether children have been included as participants in published COS development studies, and which methods have been used to facilitate their participation; iii) update a previous exercise to identify COS relevant to the most burdensome global diseases and injuries. Methods MEDLINE and SCOPUS were searched to identify studies published or indexed between (and inclusive of) January 2019 and December 2019. Automated screening methods were used to rank the citations in order of relevance; the top 25% in ranked priority order were screened for eligibility. COS were assessed against each of the Core Outcome Set-STAndards for Development (COS-STAD). A search of the COMET database was undertaken to identify COS relevant to the 25 leading causes of disease burden. Results Thirty-three studies, describing the development of 37 COS, were included in this update. These studies have been added to the COMET database, which now contains 370 published (1981–2019) COS studies for clinical research. Six (18%) of the 33 studies in this update were deemed to have met all of the minimum standards for COS development (range = 4 to 12 criteria, median = 9 criteria). Of the 370 COS studies published to date, 82 COS have been developed for paediatric health conditions and children would have been eligible to participate in 68/82 of these studies. Eleven of these 68 (16%) COS studies have included children as participants within the development process, most commonly through participation in Delphi surveys. Relevant COS were identified for 22/25 leading causes of global disease burden. Conclusion There has been a demonstrated increase in COS developed for both research and routine practice, and consistently high inclusion of patient participants. COS developed for paediatric conditions need to further incorporate the perspectives of children, alongside parents and other adults, and adopt research methods fit for this purpose. COS developers should consider the gaps identified in this update as priorities for COS development.

More than half of systematic reviews have relevant core outcome sets

“…For each relevant COS, we used an existing database of previously extracted information regarding participating stakeholder groups and recommended core outcomes. This database includes details of all published COS and was compiled using the data extracted for an annually updated SR of published COS [8] , [9] , [10] , [11] , [12] , [13] .…”

Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

“…The sixth annual update of a systematic review of COS showed that there were 370 published (1981-2019) COS studies documenting clinical research (9). A research assessed the uptake of COS in RCTs or systematic reviews, and the results showed that the uptake rates reported for RCTs varied from 0% RCTs (gout) to 82% RCTs (rheumatoid arthritis) (10).…”

Patient participation in Delphi surveys to develop core outcome sets: systematic review

“…Patient participation in COS studies has increased over recent years, with Gargon et al 5 reporting 77% of published COS studies included patients or their representatives (eg, carers or patient advocates). While this paper focuses largely on patient participation in COS, it is important to distinguish between this and patient involvement in COS studies.…”