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      Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs)

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          Abstract

          Background

          There is a need for better interpretation of orthopedic treatment effects. Patient-reported outcome measures (PROMs) are already commonly used for patient evaluation. PROMs can be used to determine treatment effects in research as well as in clinical settings by calculating change scores, with pre- and post-treatment evaluation. The smallest detectable change (SDC) and minimal important change (MIC) are two important benchmarks for interpreting these change scores. The purpose was to determine the SDC and the MIC for four commonly used shoulder-related PROMs: Simple Shoulder Test (SST), Disabilities of the Arm, Shoulder and Hand (DASH and QuickDASH), and the Oxford Shoulder Score (OSS).

          Methods

          A cohort of 164 consecutive patients with shoulder problems visiting an orthopedic outpatient clinic completed the SST, DASH, and the OSS at their first visit and 6 months after operative or non-operative treatment. The SDC was calculated with a test re-test protocol (0–2 weeks). For the MIC, change scores (0–6 months of evaluation) were calculated in seven subgroups of patients, according to an additional self-administered ranking of change over time (anchor-based mean change technique). The MIC is defined as the average score of the ‘slightly improved’ group according to the anchor. The QuickDASH was computed from the DASH.

          Results

          The SDC of the SST was 2.8, DASH 16.3, QuickDASH 17.1, and OSS 6.0. The MIC change score for the SST was 2.2, DASH 12.4, QuickDASH 13.4, and OSS 6.0.

          Conclusion

          This study shows that on an individual patient-based level, when taking into account SDC and MIC, the change score should exceed 2.8 points for the SST, 16.3 points for the DASH, 17.1 points for the QuickDASH, and 6.0 points for the OSS to have a clinically relevant change on a PROM, which is not due to measurement error.

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          Most cited references25

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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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            Development of the QuickDASH: comparison of three item-reduction approaches.

            The purpose of this study was to develop a short, reliable, and valid measure of physical function and symptoms related to upper-limb musculoskeletal disorders by shortening the full, thirty-item DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure. Three item-reduction techniques were used on the cross-sectional field-testing data derived from a study of 407 patients with various upper-limb conditions. These techniques were the concept-retention method, the equidiscriminative item-total correlation, and the item response theory (Rasch modeling). Three eleven-item scales were created. Data from a longitudinal cohort study in which the DASH questionnaire was administered to 200 patients with shoulder and wrist/hand disorders were then used to assess the reliability (Cronbach alpha and test-retest reliability) and validity (cross-sectional and longitudinal construct) of the three scales. Results were compared with those derived with the full DASH. The three versions were comparable with regard to their measurement properties. All had a Cronbach alpha of > or = 0.92 and an intraclass correlation coefficient of > or = 0.94. Evidence of construct validity was established (r > or = 0.64 with single-item indices of pain and function). The concept-retention method, the most subjective of the approaches to item reduction, ranked highest in terms of its similarity to the original DASH. The concept-retention version is named the QuickDASH. It contains eleven items and is similar with regard to scores and properties to the full DASH. A comparison of item-reduction approaches suggested that the retention of clinically sensible and important content produced a comparable, if not slightly better, instrument than did more statistically driven approaches.
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              Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change

              Changes in scores on health status questionnaires are difficult to interpret. Several methods to determine minimally important changes (MICs) have been proposed which can broadly be divided in distribution-based and anchor-based methods. Comparisons of these methods have led to insight into essential differences between these approaches. Some authors have tried to come to a uniform measure for the MIC, such as 0.5 standard deviation and the value of one standard error of measurement (SEM). Others have emphasized the diversity of MIC values, depending on the type of anchor, the definition of minimal importance on the anchor, and characteristics of the disease under study. A closer look makes clear that some distribution-based methods have been merely focused on minimally detectable changes. For assessing minimally important changes, anchor-based methods are preferred, as they include a definition of what is minimally important. Acknowledging the distinction between minimally detectable and minimally important changes is useful, not only to avoid confusion among MIC methods, but also to gain information on two important benchmarks on the scale of a health status measurement instrument. Appreciating the distinction, it becomes possible to judge whether the minimally detectable change of a measurement instrument is sufficiently small to detect minimally important changes.
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                Author and article information

                Journal
                J Orthop Surg Res
                J Orthop Surg Res
                Journal of Orthopaedic Surgery and Research
                BioMed Central
                1749-799X
                2013
                14 November 2013
                : 8
                : 40
                Affiliations
                [1 ]Department of Orthopaedic Surgery and Traumatology, Waterland Hospital, Waterlandlaan 250, Purmerend 1441 RN, The Netherlands
                [2 ]Department of Orthopaedic Surgery and Traumatology, OLVG Hospital, Amsterdam 1091, AC, The Netherlands
                [3 ]Department of Orthopaedic Surgery and Traumatology, University Medical Center Utrecht, Utrecht 3584, CX, The Netherlands
                [4 ]Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam 1081, BT, The Netherlands
                Article
                1749-799X-8-40
                10.1186/1749-799X-8-40
                3842665
                24225254
                9e4d6517-c092-42a1-b8f4-2f6a2a1cca48
                Copyright © 2013 van Kampen et al.; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 April 2013
                : 4 November 2013
                Categories
                Research Article

                Surgery
                shoulder,prom,interpretation,mic,sdc,dash,simple shoulder test,oxford shoulder score
                Surgery
                shoulder, prom, interpretation, mic, sdc, dash, simple shoulder test, oxford shoulder score

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