TY - JOUR
T1 - Validity and reliability of the Dutch translation of the OPUS' client satisfaction with device module in chronic users of hand orthoses
AU - Oud, Tanja
AU - Tuijtelaars, Jana
AU - Schenk, Jimmy
AU - Nollet, Frans
AU - Brehm, Merel-Anne
N1 - Funding Information: As part of a feasibility study on 3D-printed hand orthoses, this study was supported by ZonMW, The Netherlands Organisation for Health Research and Development [grant number: 10310012110002]. The funders had no role in the design of the study, and collection, analyses, interpretation of the data, or decision to submit results. Funding Information: The authors would like to express gratitude to Professor Allen Heinemann (one of the developers of the CSD) and Professor Caroline Terwee, for their assistance and cooperation in the translation process. Also, Néomée Alain (NA), Jenny Nunn (JN), Ruben de Jong (RdJ), Hans Bogaards and Tessa Busch are thanked for their contribution to translating the CSD. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12
Y1 - 2023/12
N2 - BACKGROUND: Orthosis satisfaction is an important outcome in assessing quality of care. However, no measurement specifically assessing orthosis satisfaction is available in the Dutch language. Therefore, the aim of this study was to translate the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics Users' Survey (OPUS) into Dutch, and to assess its content validity, structural validity and reliability in persons with chronic hand conditions. METHODS: The CSD was translated and cross-cultural adapted according to respective guidelines. To determine content validity, 10 chronic hand orthotic users and two professionals judged the relevance, comprehensibility, and comprehensiveness of the Dutch CSD (D-CSD). Thereafter, in a cross-sectional study, 76 persons were asked to complete the D-CSD twice, with a 2-week interval. Dimensionality of the D-CSD was examined by principal component analysis (PCA), and factor model fit was assessed by confirmatory factor analysis (CFA). Reliability was assessed as internal consistency and test-retest reliability, including the 95% limits of agreement (LoA), the standard error of measurement (SEM) and smallest detectable change (SDC). RESULTS: The D-CSD items and response options were deemed relevant and comprehensible. After adding an item on cleaning the orthosis, content validity was judged sufficient. PCA indicated a one-factor model, which was confirmed by CFA. We found good internal consistency (Cronbach's alpha = 0.82; 95%CI 0.75-0.87), and moderate to good test-retest reliability (ICC = 0.81; 95%CI 0.71-0.87). There was no difference between the mean D-CSD score at test (26.8 points) and retest (25.9 points) (mean (SD) difference: 0.86 points (4.00); 95%CI -0.06-1.79; p = 0.07). The 95% LoA were -6.99 to 8.71, and the SEM and SDC were 2.88 and 7.98 points, respectively. CONCLUSIONS: Based on sufficient content and structural validity, and good reliability, we consider the D-CSD a useful tool to evaluate orthosis satisfaction in persons with chronic hand conditions on group level. Because of a relatively high SDC, sensitivity to detect changes over time on individual level is limited. STUDY REGISTRATION NUMBER: NCT05320211.
AB - BACKGROUND: Orthosis satisfaction is an important outcome in assessing quality of care. However, no measurement specifically assessing orthosis satisfaction is available in the Dutch language. Therefore, the aim of this study was to translate the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics Users' Survey (OPUS) into Dutch, and to assess its content validity, structural validity and reliability in persons with chronic hand conditions. METHODS: The CSD was translated and cross-cultural adapted according to respective guidelines. To determine content validity, 10 chronic hand orthotic users and two professionals judged the relevance, comprehensibility, and comprehensiveness of the Dutch CSD (D-CSD). Thereafter, in a cross-sectional study, 76 persons were asked to complete the D-CSD twice, with a 2-week interval. Dimensionality of the D-CSD was examined by principal component analysis (PCA), and factor model fit was assessed by confirmatory factor analysis (CFA). Reliability was assessed as internal consistency and test-retest reliability, including the 95% limits of agreement (LoA), the standard error of measurement (SEM) and smallest detectable change (SDC). RESULTS: The D-CSD items and response options were deemed relevant and comprehensible. After adding an item on cleaning the orthosis, content validity was judged sufficient. PCA indicated a one-factor model, which was confirmed by CFA. We found good internal consistency (Cronbach's alpha = 0.82; 95%CI 0.75-0.87), and moderate to good test-retest reliability (ICC = 0.81; 95%CI 0.71-0.87). There was no difference between the mean D-CSD score at test (26.8 points) and retest (25.9 points) (mean (SD) difference: 0.86 points (4.00); 95%CI -0.06-1.79; p = 0.07). The 95% LoA were -6.99 to 8.71, and the SEM and SDC were 2.88 and 7.98 points, respectively. CONCLUSIONS: Based on sufficient content and structural validity, and good reliability, we consider the D-CSD a useful tool to evaluate orthosis satisfaction in persons with chronic hand conditions on group level. Because of a relatively high SDC, sensitivity to detect changes over time on individual level is limited. STUDY REGISTRATION NUMBER: NCT05320211.
KW - Hand
KW - OPUS-CSD
KW - Orthotic Devices
KW - Patient reported outcome measures
KW - Reliability and validity
UR - http://www.scopus.com/inward/record.url?scp=85168452498&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12955-023-02181-3
DO - https://doi.org/10.1186/s12955-023-02181-3
M3 - Article
C2 - 37605151
SN - 1477-7525
VL - 21
SP - 93
JO - Health and quality of life outcomes
JF - Health and quality of life outcomes
IS - 1
M1 - 93
ER -