Abstract

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies. An annual systematic review update is carried out to maintain the currency of database content.MethodsThe methods used in the fourth update of the systematic review followed the same approach used in the original review and previous updates. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. Searches were carried out in March 2018 to identify studies that had been published or indexed between January 2017 and the end of December 2017.ResultsForty-eight new studies, describing the development of 56 COS, were included. There has been an increase in the number of studies clearly specifying the scope of the COS in terms of the population (n = 43, 90%) and intervention (n = 48, 100%) characteristics. Public participation has continued to rise with over half (n = 27, 56%) of studies in the current review including input from members of the public. The rate of inclusion of all stakeholder groups has increased, in particular participation from non-clinical research experts has risen from 32% (mean average in previous reviews) to 62% (n = 29). Input from participants located in Australasia (n = 17; 41%), Asia (n = 18; 44%), South America (n = 13; 32%) and Africa (n = 7; 17%) have all increased since the previous reviews.ConclusionThis update included a pronounced increase in the number of new COS identified compared to the previous three updates. There was an improvement in the reporting of the scope, stakeholder participants and methods used. Furthermore, there has been an increase in participation from Australasia, Asia, South America and Africa. These advancements are reflective of the efforts made in recent years to raise awareness about the need for COS development and uptake, as well as developments in COS methodology.

Highlights

  • Insufficient consideration of the outcomes measured in clinical trials, and other studies, is increasingly being addressed through the development and use of core outcome sets (COS)

  • There was an improvement in the reporting of the scope, stakeholder participants and methods used

  • There has been an increase in participation from Australasia, Asia, South America and Africa. These advancements are reflective of the efforts made in recent years to raise awareness about the need for COS development and uptake, as well as developments in COS methodology

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Summary

Introduction

Insufficient consideration of the outcomes measured in clinical trials, and other studies, is increasingly being addressed through the development and use of core outcome sets (COS). The Core Outcome Measures in Effectiveness Trials (COMET) Initiative aims to collate and stimulate the development and application of COS, by maintaining a public repository of studies relevant to the development of COS (The COMET database, http://www.comet-initiative.org/studies/search). The review, highlighted a gap in the involvement of stakeholders from a wider range of geographical settings, in particular low and middle income countries (LMIC). This is important to increase the applicability of COS to global health and tackling the global burden of disease [6]. The Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies.

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