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      Patient-reported outcome measures in arthroplasty registries : Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part I. Overview and rationale for patient-reported outcome measures

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          Abstract

          The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population.

          A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).

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          Most cited references8

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            The use of the Oxford hip and knee scores.

            The Oxford hip and knee scores have been extensively used since they were first described in 1996 and 1998. During this time, they have been modified and used for many different purposes. This paper describes how they should be used and seeks to clarify areas of confusion.
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              Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life.

              This study used the standard error of measurement (SEM) to evaluate intra-individual change on both the Chronic Respiratory Disease Questionnaire (CRQ) and the SF-36. After analyzing the reliability and validity of both instruments at baseline among 471 COPD outpatients, the SEM was compared to established minimal clinically important difference (MCID) standards for three CRQ dimensions. A value of one SEM closely approximated the MCID standards for all CRQ dimensions. This SEM-based criterion was then validated by cross-classifying the change status (improved, stable, or declined) of 393 follow-up outpatients using the one-SEM criterion and the MCID standard. Excellent agreement was achieved for all three CRQ dimensions. Although MCID standards have not been established for the SF-36, the one-SEM criterion was explored in these change scores. Among SF-36 scales demonstrating acceptable reliability and reasonable variance, the percent of individuals within each change category was consistent with those seen in the CRQ dimensions. These results replicate previous findings where a value of one SEM also closely approximated MCIDs for all dimensions of the Chronic Heart Disease Questionnaire among cardiovascular outpatients. The one-SEM criterion should be explored in other health-related quality of life instruments with established MCIDs.
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                Author and article information

                Journal
                Acta Orthop
                Acta Orthop
                IORT
                Acta Orthopaedica
                Taylor & Francis
                1745-3674
                1745-3682
                July 2016
                05 May 2016
                : 87
                : Suppl 1 , Acta Orthopaedica Supplementum no 362: ISAR meeting Gothenburg 2015
                : 3-8
                Affiliations
                [1 ]Swedish Hip Arthroplasty Register and Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
                [2 ]California Joint Replacement Registry, San Francisco, CA, USA
                [3 ]Canadian Joint Replacement Registry and University of Manitoba, Winnipeg, Manitoba, Canada
                [4 ]Geneva Arthroplasty Registry, Division of Orthopaedic Surgery, Geneva University Hospitals, Geneva, Switzerland
                [5 ]Dutch Arthroplasty Register, Hertogenbosch, the Netherlands
                [6 ]New Zealand Joint Registry and University of Otago, Christchurch, New Zealand
                [7 ]Hospital for Special Surgery and Weill Cornell Medical College, New York, NY, USA
                [8 ]FORCE-TJR and University of Massachusetts Medical School, Worcester, MA, USA
                [9 ]Canadian Joint Replacement Registry and Dalhousie University, Halifax, Nova Scotia, Canada
                [10 ]Danish Hip Arthroplasty Register and University of Southern Denmark, Odense, Denmark
                [11 ]Nuffield Department of Population Health and University of Oxford, Oxford, UK
                Author notes
                Article
                iort-87-3
                10.1080/17453674.2016.1181815
                4937773
                27168175
                6631315c-b35e-414e-af63-0c6ea7047fc8
                © 2016 The Author(s). Published by Taylor & Francis on behalf of the Nordic Orthopedic Federation.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License ( https://creativecommons.org/licenses/by-nc/3.0)

                History
                : 15 August 2015
                : 17 September 2015
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                Orthopedics
                Orthopedics

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