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      Are validated outcome measures used in distal radial fractures truly valid? : A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist

      research-article
      , MD 1 , , , MD 2 , , FRCSC, MD, PhD 3 , , MD, PhD 4 , , MD, PhD 5 , , PhD 5
      Bone & Joint Research
      PROM, Distal radius fracture, COSMIN, Validation study

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          Abstract

          Objectives

          Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property.

          Methods

          A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies.

          Results

          In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties.

          Conclusion

          According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties.

          Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462.

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          Most cited references38

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          Epidemiology of adult fractures: A review.

          The epidemiology of adult fractures is changing quickly. An analysis of 5953 fractures reviewed in a single orthopaedic trauma unit in 2000 showed that there are eight different fracture distribution curves into which all fractures can be placed. Only two fracture curves involve predominantly young patients; the other six show an increased incidence of fractures in older patients. It is popularly assumed that osteoporotic fractures are mainly seen in the thoracolumbar spine, proximal femur, proximal humerus and distal radius, but analysis of the data indicates that 14 different fractures should now be considered to be potentially osteoporotic. About 30% of fractures in men, 66% of fractures in women and 70% of inpatient fractures are potentially osteoporotic.
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            Reliability and validity testing of the Michigan Hand Outcomes Questionnaire.

            In this study, psychometric principles were used to develop an outcomes questionnaire capable of measuring health state domains important to patients with hand disorders. These domains were hypothesized to include (1) overall hand function, (2) activities of daily living (ADL), (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with hand function. An initial pool of 100 questions was pilot-tested for clarity in 20 patients; following factor analysis, the number of questions was reduced to a 37-item Michigan Hand Outcomes Questionnaire (MHQ). The MHQ, along with the Short Form-12, a generic health status outcomes questionnaire, was then administered to 200 consecutive patients at a university-based hand surgery clinic and was subjected to reliability and validity testing. The mean time required to complete the questionnaire was 10 minutes (range, 7-20 minutes). Factor analysis supported the 6 hypothesized scales. Test-retest reliability using Spearman's correlation demonstrated substantial agreement, ranging from 0.81 for the aesthetics scale to 0.97 for the ADL scale. In testing for internal consistency, Cronbach's alphas ranged from 0.86 for the pain scale to 0.97 for the ADL scale (values >0.7 for Cronbach's alpha are considered a good internal consistency). Correlation between scales gave evidence of construct validity. In comparing similar scales in the MHQ and the Short Form-12, a moderate correlation (range, 0.54-0.79) for the ADL, work performance, and pain scales was found. In evaluating the discriminate validity of the aesthetics scale, a significant difference (p = .0012) was found between the aesthetics scores for patients with carpal tunnel syndrome and patients with rheumatoid arthritis. The MHQ is a reliable and valid instrument for measuring hand outcomes. It can be used in a clinic setting with minimal burden to patients. The questions in the MHQ have undergone rigorous psychometric testing, and the MHQ is a promising instrument for evaluation of outcomes following hand surgery.
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              Patient rating of wrist pain and disability: a reliable and valid measurement tool.

              The goal of this study was to develop a reliable and valid tool for quantifying patient-rated wrist pain and disability. Survey, tool development, reliability, and validity study. Upper extremity unit. One hundred members of the International Wrist Investigators were surveyed by mail to assist in development of the scale. Patients with distal radius (n = 64) or scaphoid (n = 35) fractures were enrolled in a reliability study, and 101 patients with distal radius fractures were enrolled in a validity study. Information from the expert survey, biomechanical literature, and patient interviews was used as a basis for item generation and definition of structural limitations for a scale that would be practical in the clinic. Patients with distal radius or scaphoid fractures completed the Patient-Rated Wrist Evaluation (PRWE) on two occasions to determine test-retest reliability. Patients with distal radius fractures (n = 101) completed the PRWE and the SF-36 and were tested with traditional impairment measures at baseline and at two, three, and six months after fracture to determine construct and criterion validity. Reliability coefficients (ICCs) and validity correlations (Pearson product moment correlations). Patient opinions on pain and on ability to do activities of daily living and work were thought to be the most important dimensions to include in subjective outcome tools. Brevity and simplicity were seen as essential in the clinic environment. A fifteen-item questionnaire (the PRWE) was designed to measure wrist pain and disability. Test-retest reliability was excellent (ICCs > 0.90). Validity assessment demonstrated that the instrument detected significant differences over time (p < 0.01) and was appropriately correlated with alternate forms of assessing parameters of pain and disability. The PRWE provides a brief, reliable, and valid measure of patient-rated pain and disability.
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                Author and article information

                Contributors
                Role: Orthopaedic Surgeon
                Role: Orthopaedic Resident
                Role: Orthopaedic Surgeon, Professor
                Role: Trauma Surgeon, Professor
                Role: Orthopaedic Surgeon
                Role: Program Manager
                Journal
                Bone Joint Res
                Bone & Joint Research
                2046-3758
                April 2016
                25 June 2016
                : 5
                : 4
                : 153-161
                Affiliations
                [1 ]Department of Orthopaedic and Trauma Surgery, Deventer Ziekenhuis, Nico Bolkesteinlaan 75 7416 SEDeventer, The Netherlands
                [2 ]Department of Orthopaedic and Trauma Surgery, Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands
                [3 ]Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada
                [4 ]Trauma Unit, Department of Surgery, Academic Medical Center, University of Amsterdam, P.O. Box 22660, 1100, DD, Amsterdam, The Netherlands
                [5 ]Department of Orthopaedic and Trauma Surgery, JointResearch OLVG East, Oosterpark 9, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands
                Author notes
                [*]Dr Y. V. Kleinlugtenbelt; e-mail: ijdoklb@ 123456hotmail.com
                Article
                10.1302_2046-3758.54.2000462
                10.1302/2046-3758.54.2000462
                4921040
                27132246
                138b614f-f103-4dd4-8b0d-92c9a0ad75f1
                © 2016 Kleinlugtenbelt et al.

                This is an open-access article distributed under the terms of the Creative Commons Attributions licence (CC -BY-NC), which permits unrestricted use, distribution, and reproduction in any medium, but not for commercial gain, provided the original author and source are credited.

                History
                : 20 July 2015
                : 2 February 2016
                Categories
                Trauma
                6
                Prom
                Distal Radius Fracture
                Cosmin
                Validation Study

                prom,distal radius fracture,cosmin,validation study
                prom, distal radius fracture, cosmin, validation study

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