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      Translation and Linguistic Validation of the Patient's Knee Implant Performance (PKIP) into Japanese

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          Abstract

          Objective

          The patient's knee implant performance (PKIP) is a patient-reported outcome measure, developed in the USA in English that evaluates knee functional performance before and after primary total knee arthroplasty (TKA). The PKIP assesses the level of satisfaction, confidence, and stability, while performing various activities, as well as the need for changing ways of doing activities. It comprises 24 items. The objective of this study was to present the methodology of the linguistic validation of the PKIP.

          Methods

          The Japanese version of the PKIP was developed using a standard linguistic validation (LV) process. The LV involved the following steps: (1) conceptual analysis of the original version; (2) translation into Japanese using a dual forward/backward translation process; (3) review by an orthopaedics surgeon; (4) test on five respondents; and (5) proofreading.

          Results

          The translation itself did not reveal major translatability issues, either cultural, semantic, or syntactic. Most of the activities listed (e.g., going up stairs, getting in/out of a car, and walking up a hill/ramp/incline) were easily translated. Only one activity was culturally sensitive and raised some discussion, i.e., “sitting down on a toilet,” since the style of Japanese toilets is different from the western style. Overall, the respondents well understood the questionnaire. However, the expression “how your knee is working with your body” used in the opening sentence was an issue for both the clinician and the respondents. A compromise was found by using a Japanese equivalent of “how your knee functions with your legs.”

          Conclusion

          The rigorous translation process, which involved the collaboration of a minimum of thirteen people (sponsor, four translators, two coordinators (one in Japan and one in Europe), one clinician, and five respondents) enabled the production of a Japanese version of the PKIP conceptually equivalent to the USA English original.

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          Most cited references27

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          Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

          In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.
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            Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.

            Within the context of a double blind randomized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs, we validated WOMAC, a new multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The pain, stiffness and physical function subscales fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency. WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials.
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              Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.

              There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.
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                Author and article information

                Contributors
                Journal
                Adv Orthop
                Adv Orthop
                AORTH
                Advances in Orthopedics
                Hindawi
                2090-3464
                2090-3472
                2024
                30 April 2024
                : 2024
                : 6645361
                Affiliations
                1Johnson and Johnson K.K., 5-2, Nishi-Kanda 3-Chome, Chiyoda-Ku, Tokyo 101-0065, Japan
                2Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, 1, 4-3 Asahi-Cho, Abeno-Ku, Osaka City 545-8585, Japan
                3DePuy Synthes Joint Reconstruction Inc., 700 Orthopaedic Drive, Warsaw, Indiana, USA
                Author notes

                Academic Editor: Raffaele Vitiello

                Author information
                https://orcid.org/0000-0002-9573-3885
                Article
                10.1155/2024/6645361
                11074845
                38715703
                dc1f84a8-57ef-45f9-a926-645e3f7ed9d7
                Copyright © 2024 Fumiya Ohmasa et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 20 June 2023
                : 25 March 2024
                : 9 April 2024
                Categories
                Research Article

                Orthopedics
                Orthopedics

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