The OMERACT core domain set for clinical trials of shoulder disorders

Sofia Ramiro, Matthew J. Page, Samuel L. Whittle, Hsiaomin Huang, Arianne P. Verhagen, Dorcas E. Beaton, Pamela Richards, Marieke Voshaar, Beverley Shea, Danielle A. Van Der Windt, Christian Kopkow, Mario Lenza, Nitin B. Jain, Bethan Richards, Catherine Hill, Tiffany K. Gill, Bart Koes, Nadine E. Foster, Philip G. Conaghan, Toby Smith & 4 others Peter Malliaras, Yngve Roe, Joel J. Gagnier, Rachelle Buchbinder

Research output: Contribution to journalArticleResearchpeer-review

4 Citations (Scopus)

Abstract

Objective. To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. Methods. At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. Results. The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. Conclusion. OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

Original languageEnglish
Pages (from-to)969-975
Number of pages7
JournalJournal of Rheumatology
Volume46
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

Keywords

  • Core outcome set
  • OMERACT
  • Outcome measurement
  • Shoulder
  • Trials

Cite this

Ramiro, Sofia ; Page, Matthew J. ; Whittle, Samuel L. ; Huang, Hsiaomin ; Verhagen, Arianne P. ; Beaton, Dorcas E. ; Richards, Pamela ; Voshaar, Marieke ; Shea, Beverley ; Van Der Windt, Danielle A. ; Kopkow, Christian ; Lenza, Mario ; Jain, Nitin B. ; Richards, Bethan ; Hill, Catherine ; Gill, Tiffany K. ; Koes, Bart ; Foster, Nadine E. ; Conaghan, Philip G. ; Smith, Toby ; Malliaras, Peter ; Roe, Yngve ; Gagnier, Joel J. ; Buchbinder, Rachelle. / The OMERACT core domain set for clinical trials of shoulder disorders. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 8. pp. 969-975.
@article{b52707eb480840a3bfba89f4031700b5,
title = "The OMERACT core domain set for clinical trials of shoulder disorders",
abstract = "Objective. To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. Methods. At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. Results. The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71{\%} agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. Conclusion. OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.",
keywords = "Core outcome set, OMERACT, Outcome measurement, Shoulder, Trials",
author = "Sofia Ramiro and Page, {Matthew J.} and Whittle, {Samuel L.} and Hsiaomin Huang and Verhagen, {Arianne P.} and Beaton, {Dorcas E.} and Pamela Richards and Marieke Voshaar and Beverley Shea and {Van Der Windt}, {Danielle A.} and Christian Kopkow and Mario Lenza and Jain, {Nitin B.} and Bethan Richards and Catherine Hill and Gill, {Tiffany K.} and Bart Koes and Foster, {Nadine E.} and Conaghan, {Philip G.} and Toby Smith and Peter Malliaras and Yngve Roe and Gagnier, {Joel J.} and Rachelle Buchbinder",
year = "2019",
month = "8",
day = "1",
doi = "10.3899/jrheum.181070",
language = "English",
volume = "46",
pages = "969--975",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "8",

}

Ramiro, S, Page, MJ, Whittle, SL, Huang, H, Verhagen, AP, Beaton, DE, Richards, P, Voshaar, M, Shea, B, Van Der Windt, DA, Kopkow, C, Lenza, M, Jain, NB, Richards, B, Hill, C, Gill, TK, Koes, B, Foster, NE, Conaghan, PG, Smith, T, Malliaras, P, Roe, Y, Gagnier, JJ & Buchbinder, R 2019, 'The OMERACT core domain set for clinical trials of shoulder disorders', Journal of Rheumatology, vol. 46, no. 8, pp. 969-975. https://doi.org/10.3899/jrheum.181070

The OMERACT core domain set for clinical trials of shoulder disorders. / Ramiro, Sofia; Page, Matthew J.; Whittle, Samuel L.; Huang, Hsiaomin; Verhagen, Arianne P.; Beaton, Dorcas E.; Richards, Pamela; Voshaar, Marieke; Shea, Beverley; Van Der Windt, Danielle A.; Kopkow, Christian; Lenza, Mario; Jain, Nitin B.; Richards, Bethan; Hill, Catherine; Gill, Tiffany K.; Koes, Bart; Foster, Nadine E.; Conaghan, Philip G.; Smith, Toby; Malliaras, Peter; Roe, Yngve; Gagnier, Joel J.; Buchbinder, Rachelle.

In: Journal of Rheumatology, Vol. 46, No. 8, 01.08.2019, p. 969-975.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - The OMERACT core domain set for clinical trials of shoulder disorders

AU - Ramiro, Sofia

AU - Page, Matthew J.

AU - Whittle, Samuel L.

AU - Huang, Hsiaomin

AU - Verhagen, Arianne P.

AU - Beaton, Dorcas E.

AU - Richards, Pamela

AU - Voshaar, Marieke

AU - Shea, Beverley

AU - Van Der Windt, Danielle A.

AU - Kopkow, Christian

AU - Lenza, Mario

AU - Jain, Nitin B.

AU - Richards, Bethan

AU - Hill, Catherine

AU - Gill, Tiffany K.

AU - Koes, Bart

AU - Foster, Nadine E.

AU - Conaghan, Philip G.

AU - Smith, Toby

AU - Malliaras, Peter

AU - Roe, Yngve

AU - Gagnier, Joel J.

AU - Buchbinder, Rachelle

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objective. To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. Methods. At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. Results. The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. Conclusion. OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

AB - Objective. To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process. Methods. At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants. Results. The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set. Conclusion. OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

KW - Core outcome set

KW - OMERACT

KW - Outcome measurement

KW - Shoulder

KW - Trials

UR - http://www.scopus.com/inward/record.url?scp=85070227022&partnerID=8YFLogxK

U2 - 10.3899/jrheum.181070

DO - 10.3899/jrheum.181070

M3 - Article

VL - 46

SP - 969

EP - 975

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 8

ER -