Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0

Maarten Boers, John R. Kirwan, George Wells, Dorcas Beaton, Laure Gossec, Maria-Antonietta d'Agostino, Philip G. Conaghan, Clifton O. Bingham III, Peter Brooks, Robert Landewé, Lyn March, Lee S. Simon, Jasvinder A. Singh, Vibeke Strand, Peter Tugwell

Research output: Contribution to journalArticleResearchpeer-review

371 Citations (Scopus)

Abstract

Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.

Original languageEnglish
Pages (from-to)745-753
Number of pages9
JournalJournal of Clinical Epidemiology
Volume67
Issue number7
DOIs
Publication statusPublished - Jul 2014
Externally publishedYes

Keywords

  • Biological markers
  • Clinical trial
  • Outcome assessment (health care)
  • Reference Standards
  • Research design
  • Rheumatology

Cite this

Boers, M., Kirwan, J. R., Wells, G., Beaton, D., Gossec, L., d'Agostino, M-A., ... Tugwell, P. (2014). Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. Journal of Clinical Epidemiology, 67(7), 745-753. https://doi.org/10.1016/j.jclinepi.2013.11.013
Boers, Maarten ; Kirwan, John R. ; Wells, George ; Beaton, Dorcas ; Gossec, Laure ; d'Agostino, Maria-Antonietta ; Conaghan, Philip G. ; Bingham III, Clifton O. ; Brooks, Peter ; Landewé, Robert ; March, Lyn ; Simon, Lee S. ; Singh, Jasvinder A. ; Strand, Vibeke ; Tugwell, Peter. / Developing core outcome measurement sets for clinical trials : OMERACT filter 2.0. In: Journal of Clinical Epidemiology. 2014 ; Vol. 67, No. 7. pp. 745-753.
@article{02d1dc3f8fde4371a0971868bd9e331a,
title = "Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0",
abstract = "Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core {"}Areas,{"} namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core {"}Domain{"} within each of the Areas to formulate the {"}Core Domain Set.{"} Next, at least one applicable measurement instrument for each core Domain is identified to formulate a {"}Core Outcome Measurement Set.{"} Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96{\%} of the voting participants (n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.",
keywords = "Biological markers, Clinical trial, Outcome assessment (health care), Reference Standards, Research design, Rheumatology",
author = "Maarten Boers and Kirwan, {John R.} and George Wells and Dorcas Beaton and Laure Gossec and Maria-Antonietta d'Agostino and Conaghan, {Philip G.} and {Bingham III}, {Clifton O.} and Peter Brooks and Robert Landew{\'e} and Lyn March and Simon, {Lee S.} and Singh, {Jasvinder A.} and Vibeke Strand and Peter Tugwell",
year = "2014",
month = "7",
doi = "10.1016/j.jclinepi.2013.11.013",
language = "English",
volume = "67",
pages = "745--753",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier",
number = "7",

}

Boers, M, Kirwan, JR, Wells, G, Beaton, D, Gossec, L, d'Agostino, M-A, Conaghan, PG, Bingham III, CO, Brooks, P, Landewé, R, March, L, Simon, LS, Singh, JA, Strand, V & Tugwell, P 2014, 'Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0', Journal of Clinical Epidemiology, vol. 67, no. 7, pp. 745-753. https://doi.org/10.1016/j.jclinepi.2013.11.013

Developing core outcome measurement sets for clinical trials : OMERACT filter 2.0. / Boers, Maarten; Kirwan, John R.; Wells, George; Beaton, Dorcas; Gossec, Laure; d'Agostino, Maria-Antonietta; Conaghan, Philip G.; Bingham III, Clifton O.; Brooks, Peter; Landewé, Robert ; March, Lyn; Simon, Lee S.; Singh, Jasvinder A.; Strand, Vibeke; Tugwell, Peter.

In: Journal of Clinical Epidemiology, Vol. 67, No. 7, 07.2014, p. 745-753.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Developing core outcome measurement sets for clinical trials

T2 - OMERACT filter 2.0

AU - Boers, Maarten

AU - Kirwan, John R.

AU - Wells, George

AU - Beaton, Dorcas

AU - Gossec, Laure

AU - d'Agostino, Maria-Antonietta

AU - Conaghan, Philip G.

AU - Bingham III, Clifton O.

AU - Brooks, Peter

AU - Landewé, Robert

AU - March, Lyn

AU - Simon, Lee S.

AU - Singh, Jasvinder A.

AU - Strand, Vibeke

AU - Tugwell, Peter

PY - 2014/7

Y1 - 2014/7

N2 - Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.

AB - Background Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Methods Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. Results To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n = 125) at the OMERACT 11 consensus conference endorsed this model and process. Conclusion The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care.

KW - Biological markers

KW - Clinical trial

KW - Outcome assessment (health care)

KW - Reference Standards

KW - Research design

KW - Rheumatology

UR - http://www.scopus.com/inward/record.url?scp=84902549977&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2013.11.013

DO - 10.1016/j.jclinepi.2013.11.013

M3 - Article

AN - SCOPUS:84902549977

VL - 67

SP - 745

EP - 753

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

IS - 7

ER -