ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research

被引：622

作者：

Reeve, Bryce B. ^{[1
,2
]}

Wyrwich, Kathleen W. ^{[3
]}

Wu, Albert W. ^{[4
]}

Velikova, Galina ^{[5
]}

Terwee, Caroline B. ^{[6
]}

Snyder, Claire F. ^{[4
]}

Schwartz, Carolyn ^{[7
]}

Revicki, Dennis A. ^{[3
]}

Moinpour, Carol M. ^{[8
]}

McLeod, Lori D. ^{[9
]}

Lyons, Jessica C. ^{[2
]}

Lenderking, William R. ^{[3
]}

Hinds, Pamela S. ^{[10
,11
]}

Hays, Ron D. ^{[12
]}

Greenhalgh, Joanne ^{[5
]}

Gershon, Richard ^{[13
]}

Feeny, David ^{[14
]}

Fayers, Peter M. ^{[15
,16
]}

Cella, David ^{[13
]}

Brundage, Michael ^{[17
]}

Ahmed, Sara ^{[18
]}

Aaronson, Neil K. ^{[19
,20
]}

Butt, Zeeshan ^{[13
]}

机构：

[1] Univ N Carolina, Gillings Sch Global Publ Hlth, Dept Hlth Policy & Management, Chapel Hill, NC 27599 USA

[2] Univ N Carolina, Lineberger Comprehens Canc Ctr, Chapel Hill, NC 27599 USA

[3] United BioSource Corp, Bethesda, MD USA

[4] Johns Hopkins Sch Med, Baltimore, MD USA

[5] Univ Leeds, Leeds, W Yorkshire, England

[6] Vrije Univ Amsterdam Med Ctr, Amsterdam, Netherlands

[7] DeltaQuest Fdn Inc, Concord, MA USA

[8] Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA

[9] Res Triangle Inst Hlth Solut, Durham, NC USA

[10] Childrens Natl Med Ctr, Washington, DC 20010 USA

[11] George Washington Univ, Sch Med, Washington, DC USA

[12] Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA

[13] NW Univ Feinberg, Sch Med, Chicago, IL USA

[14] Univ Alberta, Alberta, AB, Canada

[15] Univ Aberdeen, Aberdeen, Scotland

[16] Norwegian Univ Sci & Technol NTNU, Trondheim, Norway

[17] Queens Univ, Kingston, ON, Canada

[18] McGill Univ, Montreal, PQ, Canada

[19] Netherlands Canc Inst, Amsterdam, Netherlands

[20] Univ Amsterdam, Amsterdam, Netherlands

来源：

QUALITY OF LIFE RESEARCH | 2013年 / 22卷 / 08期

基金：

美国国家卫生研究院;

关键词：

Patient-reported outcomes; Comparative effectiveness; Patient-centered outcomes research; Psychometrics; Questionnaire; QUALITY-OF-LIFE; STATUS MEASUREMENT INSTRUMENTS; TASK-FORCE; METHODOLOGICAL QUALITY; PROMOTIONAL CLAIMS; MEANINGFUL CHANGE; COSMIN CHECKLIST; LABELING CLAIMS; PRO MEASURES; RELIABILITY;

D O I：

10.1007/s11136-012-0344-y

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：

An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative's goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER. We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as "recommended" when > 50 % respondents endorsed it as "required as a minimum standard." The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden. The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

引用

页码：1889 / 1905

页数：17

共 56 条

[1]

Aaronson N, 2002, QUAL LIFE RES, V11, P193

[2] Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials [J].

Acquadro, Catherine ;

Conway, Katrin ;

Hareendran, Asha ;

Aaronson, Neil .

VALUE IN HEALTH, 2008, 11 (03) :509-521

[3] The Use of Patient-reported Outcomes (PRO) Within Comparative Effectiveness Research Implications for Clinical Practice and Health Care Policy [J].

Ahmed, Sara ;

Berzon, Richard A. ;

Revicki, Dennis A. ;

Lenderking, William R. ;

Moinpour, Carol M. ;

Basch, Ethan ;

Reeve, Bryce B. ;

Wu, Albert W. .

MEDICAL CARE, 2012, 50 (12) :1060-1070

[4] The new COSMIN guidelines confront traditional concepts of responsiveness [J].

Angst, Felix .

BMC MEDICAL RESEARCH METHODOLOGY, 2011, 11

[5] Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research The PCORI Perspective [J].

Basch, Ethan ;

Aronson, Naomi ;

Berg, Alfred ;

Flum, David ;

Gabriel, Sherine ;

Goodman, Steven N. ;

Helfand, Mark ;

Ioannidis, John P. A. ;

Lauer, Michael ;

Meltzer, David ;

Mittman, Brian ;

Newhouse, Robin ;

Normand, Sharon-Lise ;

Schneeweiss, Sebastian ;

Slutsky, Jean ;

Tinetti, Mary ;

Yancy, Clyde .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 307 (15) :1636-1640

[6] Electronic Toxicity Monitoring and Patient-Reported Outcomes [J].

Basch, Ethan M. ;

Reeve, Bryce B. ;

Mitchell, Sandra A. ;

Clauser, Stephen B. ;

Minasian, Lori ;

Sit, Laura ;

Chilukuri, Ram ;

Baumgartner, Paul ;

Rogak, Lauren ;

Blauel, Emily ;

Abernethy, Amy P. ;

Bruner, Deborah .

CANCER JOURNAL, 2011, 17 (04) :231-234

[7] How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure [J].

Brozek, Jan L. ;

Guyatt, Gordon H. ;

Schuenemann, Holger J. .

HEALTH AND QUALITY OF LIFE OUTCOMES, 2006, 4 (1)

[8]

Cella D., 1997, MANUAL FUNCTIONAL AS

[9] Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report [J].

Coons, Stephen Joel ;

Gwaltney, Chad J. ;

Hays, Ron D. ;

Lundy, J. Jason ;

Sloan, Jeff A. ;

Revicki, Dennis A. ;

Lenderking, William R. ;

Cella, David ;

Basch, Ethan .

VALUE IN HEALTH, 2009, 12 (04) :419-429

[10] Defining clinically meaningful change in health-related quality of life [J].

Crosby, RD ;

Kolotkin, RL ;

Williams, GR .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2003, 56 (05) :395-407

← 1 2 3 4 5 6 →