title: Toward a generalized framework of core measurement areas in clinical trials: a position paper for OMERACT 11.
abstract: OBJECTIVE
  The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference.
  
  
  METHODS
  We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology.
  
  
  RESULTS
  The draft framework comprises 4 core "areas": death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed.
  
  
  CONCLUSIONS
  In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.
authors.affiliation: From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children's Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Leanne
authors.initials: L
authors.lastname: Idzerda
authors.forename: John R
authors.initials: JR
authors.lastname: Kirwan
authors.forename: Dorcas
authors.initials: D
authors.lastname: Beaton
authors.forename: Reuben
authors.initials: R
authors.lastname: Escorpizo
authors.forename: Annelies
authors.initials: A
authors.lastname: Boonen
authors.forename: Susan
authors.initials: S
authors.lastname: Magasi
authors.forename: Ian
authors.initials: I
authors.lastname: Sinha
authors.forename: Gerold
authors.initials: G
authors.lastname: Stucki
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012216:Rheumatic Diseases / Q000628:therapy*; D012219:Rheumatology / Q000592:standards*
keywords: CLINICAL TRIALS; CORE MEASUREMENT; OMERACT 11; OUTCOME AND PROCESS ASSESSMENT