How to choose core outcome measurement sets for clinical trials

OMERACT 11 approves filter 2.0

Maarten Boers, John R. Kirwan, Laure Gossec, Philip G. Conaghan, Maria Antonietta D'Agostino, Clifton Bingham, Peter M. Brooks, Robert Landewé, Lyn March, Lee Simon, Jasvinder A. Singh, Vibeke Strand, George A. Wells, Peter Tugwell

Research output: Contribution to journalArticle

Abstract

Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.

Original languageEnglish (US)
Pages (from-to)1025-1030
Number of pages6
JournalJournal of Rheumatology
Volume41
Issue number5
DOIs
StatePublished - 2014

Fingerprint

Rheumatology
Clinical Trials
Outcome Assessment (Health Care)
Internet
Observational Studies
Costs and Cost Analysis
Health

Keywords

  • Clinical trials
  • Core outcome sets
  • Omeract filter
  • Outcome and process assessment

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy
  • Medicine(all)

Cite this

Boers, M., Kirwan, J. R., Gossec, L., Conaghan, P. G., D'Agostino, M. A., Bingham, C., ... Tugwell, P. (2014). How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0. Journal of Rheumatology, 41(5), 1025-1030. https://doi.org/10.3899/jrheum.131314

How to choose core outcome measurement sets for clinical trials : OMERACT 11 approves filter 2.0. / Boers, Maarten; Kirwan, John R.; Gossec, Laure; Conaghan, Philip G.; D'Agostino, Maria Antonietta; Bingham, Clifton; Brooks, Peter M.; Landewé, Robert; March, Lyn; Simon, Lee; Singh, Jasvinder A.; Strand, Vibeke; Wells, George A.; Tugwell, Peter.

In: Journal of Rheumatology, Vol. 41, No. 5, 2014, p. 1025-1030.

Research output: Contribution to journalArticle

Boers, M, Kirwan, JR, Gossec, L, Conaghan, PG, D'Agostino, MA, Bingham, C, Brooks, PM, Landewé, R, March, L, Simon, L, Singh, JA, Strand, V, Wells, GA & Tugwell, P 2014, 'How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0', Journal of Rheumatology, vol. 41, no. 5, pp. 1025-1030. https://doi.org/10.3899/jrheum.131314
Boers, Maarten ; Kirwan, John R. ; Gossec, Laure ; Conaghan, Philip G. ; D'Agostino, Maria Antonietta ; Bingham, Clifton ; Brooks, Peter M. ; Landewé, Robert ; March, Lyn ; Simon, Lee ; Singh, Jasvinder A. ; Strand, Vibeke ; Wells, George A. ; Tugwell, Peter. / How to choose core outcome measurement sets for clinical trials : OMERACT 11 approves filter 2.0. In: Journal of Rheumatology. 2014 ; Vol. 41, No. 5. pp. 1025-1030.
@article{a7a7fdf2cc1b407db774ab2366ec486d,
title = "How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0",
abstract = "Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed {"}OMERACT Filter 2.0.{"} Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ({"}core domain set{"}). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final {"}core outcome measurement set.{"} At final vote, 96{\%} of participants agreed {"}The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook.{"} Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.",
keywords = "Clinical trials, Core outcome sets, Omeract filter, Outcome and process assessment",
author = "Maarten Boers and Kirwan, {John R.} and Laure Gossec and Conaghan, {Philip G.} and D'Agostino, {Maria Antonietta} and Clifton Bingham and Brooks, {Peter M.} and Robert Landew{\'e} and Lyn March and Lee Simon and Singh, {Jasvinder A.} and Vibeke Strand and Wells, {George A.} and Peter Tugwell",
year = "2014",
doi = "10.3899/jrheum.131314",
language = "English (US)",
volume = "41",
pages = "1025--1030",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "5",

}

TY - JOUR

T1 - How to choose core outcome measurement sets for clinical trials

T2 - OMERACT 11 approves filter 2.0

AU - Boers, Maarten

AU - Kirwan, John R.

AU - Gossec, Laure

AU - Conaghan, Philip G.

AU - D'Agostino, Maria Antonietta

AU - Bingham, Clifton

AU - Brooks, Peter M.

AU - Landewé, Robert

AU - March, Lyn

AU - Simon, Lee

AU - Singh, Jasvinder A.

AU - Strand, Vibeke

AU - Wells, George A.

AU - Tugwell, Peter

PY - 2014

Y1 - 2014

N2 - Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.

AB - Objective. The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Methods. Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. Results. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Conclusion. Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.

KW - Clinical trials

KW - Core outcome sets

KW - Omeract filter

KW - Outcome and process assessment

UR - http://www.scopus.com/inward/record.url?scp=84895444749&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84895444749&partnerID=8YFLogxK

U2 - 10.3899/jrheum.131314

DO - 10.3899/jrheum.131314

M3 - Article

VL - 41

SP - 1025

EP - 1030

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 5

ER -