Identifying Common Core Outcome Domains from Core Outcome Sets of Musculoskeletal Conditions: Protocol for a Systematic Review

Overview

Journal Syst Rev

Publisher Biomed Central

Date 2022 Nov 19

PMID 36403060

Authors

Tamer S Sabet

David B Anderson

Peter W Stubbs

Rachelle Buchbinder

Caroline B Terwee

Alessandro Chiarotto

Joel Gagnier

Arianne P Verhagen

Affiliations

Soon will be listed here.

Abstract

Background: Core outcome sets (COSs) aim to reduce outcome heterogeneity in clinical practice and research by suggesting a minimum number of agreed-upon outcomes in clinical trials. Most COSs in the musculoskeletal field are developed for specific conditions. We propose that there are likely to be common core domains within existing musculoskeletal COSs that may be used as a starting point in the development of future COSs. We aim to identify common core domains from existing COSs and to facilitate the development of new COSs for musculoskeletal conditions. As a secondary aim, we will assess the development quality of these COSs.

Methods: A systematic review including musculoskeletal COSs. We will search Core Outcome Measures in Effectiveness Trials (COMET) database, MEDLINE, EMBASE, Scopus, Cochrane Methodology Register and International Consortium for Health Outcome Measurement (ICHOM). Studies will be included if related to the development of a COS in adults with musculoskeletal conditions and for any type of intervention. Quality will be assessed using the Core Outcome Set-Standards for Development (COS-STAD) recommendations. Data extracted will include scope of the COS, health condition, interventions and outcome domains. Primary outcomes will be all core domains recommended within each COS. We define a common core outcome domain as one present in at least 67% of all COSs. All findings will be summarized and presented using descriptive statistics.

Discussion: This systematic review of COSs will describe the core domains recommended within each musculoskeletal COS. Common domains found may be used in the initial stages of development of future musculoskeletal COSs.

Systematic Review Registration: PROSPERO CRD42021239141.

Citing Articles

Effectiveness of Telemedicine for Musculoskeletal Disorders: Umbrella Review.

Bargeri S, Castellini G, Vitale J, Guida S, Banfi G, Gianola S J Med Internet Res. 2024; 26:e50090.

PMID: 38306156 PMC: 10873802. DOI: 10.2196/50090.

References

Williamson P, Altman D, Blazeby J, Clarke M, Devane D, Gargon E . Developing core outcome sets for clinical trials: issues to consider. Trials. 2012; 13:132. PMC: 3472231. DOI: 10.1186/1745-6215-13-132. View

Glasziou P, Altman D, Bossuyt P, Boutron I, Clarke M, Julious S . Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014; 383(9913):267-76. DOI: 10.1016/S0140-6736(13)62228-X. View

Kirkham J, Davis K, Altman D, Blazeby J, Clarke M, Tunis S . Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med. 2017; 14(11):e1002447. PMC: 5689835. DOI: 10.1371/journal.pmed.1002447. View

Page M, McKenzie J, Green S, Beaton D, Jain N, Lenza M . Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials. J Clin Epidemiol. 2015; 68(11):1270-81. PMC: 4711903. DOI: 10.1016/j.jclinepi.2015.06.006. View

Boers M, Kirwan J, Wells G, Beaton D, Gossec L, DAgostino M . Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014; 67(7):745-53. DOI: 10.1016/j.jclinepi.2013.11.013. View

Kirkham J, Gargon E, Clarke M, Williamson P . Can a core outcome set improve the quality of systematic reviews?--a survey of the Co-ordinating Editors of Cochrane Review Groups. Trials. 2013; 14:21. PMC: 3575292. DOI: 10.1186/1745-6215-14-21. View

Chiarotto A, Terwee C, Deyo R, Boers M, Lin C, Buchbinder R . A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014; 15:511. PMC: 4308079. DOI: 10.1186/1745-6215-15-511. View

Clarke M, Williamson P . Core outcome sets and systematic reviews. Syst Rev. 2016; 5:11. PMC: 4719739. DOI: 10.1186/s13643-016-0188-6. View

Gargon E, Gurung B, Medley N, Altman D, Blazeby J, Clarke M . Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014; 9(6):e99111. PMC: 4059640. DOI: 10.1371/journal.pone.0099111. View

10.

Williamson P, Altman D, Bagley H, Barnes K, Blazeby J, Brookes S . The COMET Handbook: version 1.0. Trials. 2017; 18(Suppl 3):280. PMC: 5499094. DOI: 10.1186/s13063-017-1978-4. View

11.

. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020; 396(10258):1204-1222. PMC: 7567026. DOI: 10.1016/S0140-6736(20)30925-9. View

12.

Ramiro S, Page M, Whittle S, Huang H, Verhagen A, Beaton D . The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders. J Rheumatol. 2019; 46(8):969-975. DOI: 10.3899/jrheum.181070. View

13.

Buchbinder R, Page M, Huang H, Verhagen A, Beaton D, Kopkow C . A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group. J Rheumatol. 2017; 44(12):1880-1883. DOI: 10.3899/jrheum.161123. View

14.

Porter M . A strategy for health care reform--toward a value-based system. N Engl J Med. 2009; 361(2):109-12. DOI: 10.1056/NEJMp0904131. View

15.

Britt H, Harrison C, Miller G, Knox S . Prevalence and patterns of multimorbidity in Australia. Med J Aust. 2008; 189(2):72-7. DOI: 10.5694/j.1326-5377.2008.tb01919.x. View

16.

Page M, McKenzie J, Kirkham J, Dwan K, Kramer S, Green S . Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database Syst Rev. 2014; (10):MR000035. PMC: 8191366. DOI: 10.1002/14651858.MR000035.pub2. View

17.

Safiri S, Kolahi A, Hoy D, Buchbinder R, Mansournia M, Bettampadi D . Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020; 368:m791. PMC: 7249252. DOI: 10.1136/bmj.m791. View

18.

Boers M, Kirwan J, Gossec L, Conaghan P, DAgostino M, Bingham 3rd C . How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0. J Rheumatol. 2014; 41(5):1025-30. DOI: 10.3899/jrheum.131314. View

19.

Maxwell L, Beaton D, Shea B, Wells G, Boers M, Grosskleg S . Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology. J Rheumatol. 2019; 46(8):1014-1020. DOI: 10.3899/jrheum.181097. View

20.

Smith T, Hawker G, Hunter D, March L, Boers M, Shea B . The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis. J Rheumatol. 2019; 46(8):981-989. PMC: 10753652. DOI: 10.3899/jrheum.181194. View