Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries

Abstract

BackgroundCore outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process.MethodsThis review employed the same, multifaceted approach that was used in the original review and the previous two updates. This approach has identified studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. This update includes an analysis of the inclusion of participants from low and middle income countries (LMICs) as identified by the OECD, in these COS.ResultsEighteen publications, relating to 15 new studies describing the development of 15 COS, were eligible for inclusion in the review. Results show an increase in the use of mixed methods, including Delphi surveys. Clinical experts remain the most common stakeholder group involved. Overall, only 16% of the 259 COS studies published up to the end of 2016 have included participants from LMICs.ConclusionThis review highlights opportunities for greater public participation in COS development and the involvement of stakeholders from a wider range of geographical settings, in particular LMICs.

Pediatric perioperative outcomes: Protocol for a systematic literature review and identification of a core outcome set for infants, children, and young people requiring anesthesia and surgery

“…In addition, standardized and clearly defined endpoints should be of significance to key stakeholders, relevant to the patient, clinically important, and valid to ensure subsequent impact on healthcare delivery or policy . COMET resources include details of standardized methodology, a database of current and completed projects, and updated reviews …”

“…Diverse international involvement in core outcome set development helps ensure identification of outcomes that are broadly valid and applicable for use in pediatric populations in different countries around the globe. Consensus requires an international collaboration as usual practice and limited resources may influence clinical indicators and the relative importance of different outcomes. Ideally, the validity, reliability, and sensitivity to change of measurement tools is confirmed in different populations to ensure accurate translation of instructions for observers (eg, FLACC score for pain) and child understanding (eg, pictorial representations for self‐report of PONV or pain).…”

Navigating the landscape of core outcome set development in dermatology

“…16 The development of COS in healthcare research has rapidly grown over recent years with 299 published COS up to 2017. 18,19 Developing standards for Core Outcome Set development Furthermore, COMET maintains an international database for existing and ongoing work on COS development in healthcare that helps to reduce duplication of effort. 24 To date, the focus of COMET has been to encourage groups to identify the most important outcome domains for clinical trials.…”

Defining patient value in haemophilia care

“…8 no doubt that these are important, but as O'Mahony and colleagues point out, implementation of the framework will require further review and validation of these outcomes by patient groups, including those from low and middle-income countries. 12 Then, these outcomes should be measured appropriately. Already, an abundance of tools exists to measure a variety of outcomes, such as joint health status, 13 QoL, 14 activities and participation, 13,15 as well as outcomes specifically for people with inhibitors.…”

“…O'Mahony and colleagues suggest outcomes relevant for individuals with haemophilia, including mortality, QoL and pain in tier 1, time to recovery from a bleed and time missed from school or work in tier 2 and joint preservation and lifelong productivity in tier 3. There is no doubt that these are important, but as O'Mahony and colleagues point out, implementation of the framework will require further review and validation of these outcomes by patient groups, including those from low and middle‐income countries . Then, these outcomes should be measured appropriately.…”