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Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0
被引：615
|作者：
Boers, Maarten
[1
]
Kirwan, John R.
[2
]
Wells, George
[3
]
Beaton, Dorcas
[4
]
Gossec, Laure
[5
,6
]
d'Agostino, Maria-Antonietta
[7
]
Conaghan, Philip G.
[8
]
Bingham, Clifton O., III
[9
]
Brooks, Peter
[10
]
Landewe, Robert
[11
]
March, Lyn
[12
,13
]
Simon, Lee S.
[14
]
Singh, Jasvinder A.
[15
,16
]
Strand, Vibeke
[17
]
Tugwell, Peter
[18
]
机构：
[1] Vrije Univ Amsterdam Med Ctr, Dept Epidemiol & Biostat, NL-1007 MB Amsterdam, Netherlands
[2] Univ Bristol, Acad Rheumatol Unit, Bristol Royal Infirm, Bristol, Avon, England
[3] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada
[4] Univ Toronto, Dept Occupat Sci & Occupat Therapy, Toronto, ON, Canada
[5] Univ Paris 06, Dept Rheumatol, GRC UMPC EEMOIS 08, Paris, France
[6] Hop La Pitie Salpetriere, AP HP, Paris, France
[7] Univ Versailles St Quentin Yvelines, Dept Rheumatol, Ambroise Pare Hosp, Boulogne, France
[8] Univ Leeds, NIHR Leeds Musculoskeletal Biomed Res Unit, Leeds, W Yorkshire, England
[9] Johns Hopkins Univ, Div Rheumatol, Baltimore, MD 21224 USA
[10] Univ Melbourne, Sch Populat & Global Hlth, Melbourne, Vic, Australia
[11] Univ Amsterdam, Acad Med Ctr, Dept Clin Immunol & Rheumatol, NL-1105 AZ Amsterdam, Netherlands
[12] Univ Sydney, Kolling Inst Med Res, Inst Bone & Joint Res, Sydney, NSW 2006, Australia
[13] Royal N Shore Hosp, Dept Rheumatol, St Leonards, NSW 2065, Australia
[14] SDG LLC, Cambridge, MA 02138 USA
[15] Univ Alabama Birmingham, Div Rheumatol, Birmingham, AL 35294 USA
[16] Vet Affairs Med Ctr, Birmingham, AL 35294 USA
[17] Stanford Univ, School Med, Div Immunol Rheumatol, Palo Alto, CA 94028 USA
[18] Univ Ottawa, Dept Med, Ottawa, ON, Canada
关键词：
Outcome assessment (health care);
Clinical trial;
Rheumatology;
Research design;
Biological markers;
Reference Standards;
RHEUMATOID-ARTHRITIS;
PATIENT PERSPECTIVE;
QUALITY;
CONSENSUS;
INSTRUMENTS;
FRAMEWORK;
COSMIN;
AREAS;
LIFE;
D O I：
10.1016/j.jclinepi.2013.11.013
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
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. (C) 2014 The Authors. Published by Elsevier Inc. All rights reserved.
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页码：745 / 753
页数：9
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