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      The Achilles tendon Total Rupture Score is a responsive primary outcome measure: an evaluation of the Dutch version including minimally important change

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          Abstract

          Purpose

          Aim of this study was to evaluate the responsiveness of the Dutch version of the Achilles tendon Total Rupture Score (ATRS-NL).

          Methods

          Patients ( N = 47) completed the ATRS-NL at 3 and 6 months after Achilles tendon rupture (ATR). Additionally, they filled out the Euroqol-5D-5L (EQ-5D-5L) and Global Rating of Change Score (GRoC). Effect sizes (ES) and standardized response means (SRM) were calculated. The anchor-based method for determining the minimally important change (MIC) was used. GRoC and improvement on the items mobility and usual activities on the EQ-5D-5L served as external criteria. The scores on these anchors were used to categorize patients’ physical functioning as improved or unchanged between 3 and 6 months after ATR. Receiver operating curve (ROC) analysis was performed, with the calculation of the area under the ROC curve (AUC) and the estimation of MIC values using the optimal cut-off points.

          Results

          There was a large change (ES: 1.58) and good responsiveness (SRM: 1.19) of the ATRS-NL between 3 and 6 months after ATR. Using ROC analysis, the MIC values ranged from 13.5 to 28.5 for reporting improvement on EQ-5D-5L mobility and GRoC, respectively. The AUC of improvement on mobility and improvement on GRoC were > 0.70.

          Conclusion

          The ATRS-NL showed good responsiveness in ATR patients between 3 and 6 months after injury. Use of this questionnaire is recommended in clinical follow-up and longitudinal research of ATR patients. MIC values of 13.5 and 28.5 are recommended to consider ATR patients as improved and greatly improved between 3 and 6 months after ATR.

          Level of evidence

          II.

          Related collections

          Most cited references43

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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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            Methods for assessing responsiveness: a critical review and recommendations.

            A review of the literature suggests there are two major aspects of responsiveness. We define the first as "internal responsiveness," which characterizes the ability of a measure to change over a prespecified time frame, and the second as "external responsiveness, " which reflects the extent to which change in a measure relates to corresponding change in a reference measure of clinical or health status. The properties and interpretation of commonly used internal and external responsiveness statistics are examined. It is from the interpretation point of view that external responsiveness statistics are considered particularly attractive. The usefulness of regression models for assessing external responsiveness is also highlighted.
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              [Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff].

              To value EQ-5D health states by a general Dutch public. EQ-5D is a standardised questionnaire that is used to calculate quality-adjusted life-years for cost-utility analysis. Descriptive. A sample of 309 Dutch adults from Rotterdam and surroundings was asked to value 17 EQ-5D health states using the time trade-off method. Regression analysis was applied to the valuations of these 17 health states. By means of the estimated regression coefficients, which together constitute the so-called Dutch tariff, valuations can be determined for all possible EQ-5D health states. These values reflect the relative desirability of health states on a scale where 1 refers to full health and 0 refers to death. Societal valuations are necessary in order to correct life-years for the quality of life. Complete data were obtained from 298 persons. Theywere representative for the Dutch population as far as age, gender and subjective health were concerned, but had a somewhat higher educational level. The estimated Dutch EQ-5D tariff revealed that the respondents assigned the most weight to (preventing) pain and anxiety or depression, followed by mobility, self-care and the activities of daily living. The Dutch tariff differed from the UK ('Measurement and Valuation of Health') tariff, which is currently used in Dutch cost-utility analyses. Compared to UK respondents, Dutch respondents assigned more weight to anxiety and depression and less weight to the other dimensions. Conclusion. The valuation of health states by this representative Dutch study group differed from the valuation that is currently used in Dutch cost-utility analyses.
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                Author and article information

                Contributors
                O.C.Dams@umcg.nl
                Journal
                Knee Surg Sports Traumatol Arthrosc
                Knee Surg Sports Traumatol Arthrosc
                Knee Surgery, Sports Traumatology, Arthroscopy
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0942-2056
                1433-7347
                7 March 2020
                7 March 2020
                2020
                : 28
                : 10
                : 3330-3338
                Affiliations
                [1 ]GRID grid.4494.d, ISNI 0000 0000 9558 4598, Department of Orthopaedic Surgery, , University of Groningen, University Medical Center Groningen, ; Hanzeplein 1, 9713 GZ Groningen, The Netherlands
                [2 ]GRID grid.4494.d, ISNI 0000 0000 9558 4598, Department of Trauma Surgery, , University of Groningen, University Medical Center Groningen, ; Hanzeplein 1, 9713 GZ Groningen, The Netherlands
                [3 ]GRID grid.4494.d, ISNI 0000 0000 9558 4598, Department of Human Movement Sciences, , University of Groningen, University Medical Center Groningen, ; Hanzeplein 1, 9713 GZ Groningen, The Netherlands
                [4 ]GRID grid.415351.7, ISNI 0000 0004 0398 026X, Sports Valley, Gelderse Vallei Hospital, ; Willy Brandtlaan 10, 6716 RP Ede, The Netherlands
                Article
                5924
                10.1007/s00167-020-05924-7
                7511458
                32146524
                3bd5763b-ae72-424a-8542-b0eed829efc2
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 22 October 2019
                : 25 February 2020
                Categories
                Ankle
                Custom metadata
                © European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2020

                Surgery
                achilles tendon rupture,prom,questionnaire,epidemiology,atrs,dutch,responsiveness,minimally important change,follow-up

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