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Background: Patient-reported outcomes (PROS) are widely accepted measures for evaluating outcomes of surgical interventions. As patient-reported information is stored in electronic health records, it is essential that there are valid electronic PRO (ePRO) instruments available for clinicians and researchers. The aim of this study was to evaluate the validity of electronic versions of five widely used foot and ankle specific PRO instruments. Methods: Altogether 111 consecutive elective foot/ankle surgery patients were invited face-to-face to participate in this study. Patients completed electronic versions of the Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS), the modified Lower Extremity Function Scale (LEFS), the Manchester-Oxford Foot Questionnaire (MOXFQ), and the Visual Analogue Scale Foot and Ankle (VAS-FA) on the day of elective foot and/or ankle surgery. Construct validity, coverage, and targeting of the scales were assessed. Results: Based on general and predefined thresholds, construct validity, coverage, and targeting of the ePRO versions of the FAAM, the FAOS, the MOXFQ, and the VAS-FA were acceptable. Major issues arose with score distribution and convergent validity of the modified LEFS instrument. Conclusions: The ePRO versions of the FAAM, the FAOS, the MOXFQ and the VAS-FA provide valid scores for foot and ankle patients. However, our findings do not support the use of the modified LEFS as an electronic outcome measure for patients with orthopedic foot and/or ankle pathologies. (C) 2020 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Background Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinician-reported outcome measures. While typically included in measures originally developed for pen-and-paper completion, a greater number of clinical trials currently use electronic approaches to their collection. This leads researchers to question whether the measurement properties of the scale have been conserved during the migration to an electronic format, particularly because electronic formats often use a different scale length than the 100 mm paper standard. Methods We performed a review of published studies investigating the measurement comparability of paper and electronic formats of the VAS. Results Our literature search yielded 26 studies published between 1997 and 2018 that reported comparison of paper and electronic formats using the VAS. After excluding 2 publications, 23 of the remaining 24 studies included in this review reported electronic formats of the VAS (eVAS) and paper formats (pVAS) to be equivalent. A further study concluded that eVAS and pVAS were both acceptable but should not be interchanged. eVAS length varied from 21 to 200 mm, indicating that 100 mm length is not a requirement. Conclusions The literature supports the hypothesis that eVAS and pVAS provide comparable results regardless of the VAS length. When implementing a VAS on a screen-based electronic mode, we recommend following industry best practices for faithful migration to minimise the likelihood of non-comparability with pVAS.

Objectives To assess the measurement equivalence of the original paper version of an adapted tablet version of the EuroQol five-dimensional questionnaire (EQ-5D). Methods A randomly selected sample of 509 individuals aged 18 to 64 years from the general population responded to the EQ-5D at two time points separated by a minimum interval of 24 hours and were allocated to one of the following groups: test-retest group (tablet-tablet) or crossover group (paper-tablet and tablet-paper). Agreement between methods was determined using the intraclass correlation coefficient (ICC) and the κ coefficient. Results In the crossover group, the following ICC values were obtained: 0.76 (confidence interval [CI] 0.58–0.89) for EQ-5D scores and 0.77 (CI 0.68–0.84) for visual analogue scale in subjects responding first to the tablet version; 0.83 (CI 0.75–0.89) for EQ-5D scores and 0.75 (CI 0.67–0.85) for visual analogue scale in subjects responding first to the paper version. In the test-retest group, the ICC was 0.85 (CI 0.73–0.91) for EQ-5D scores and 0.79 (CI 0.66–0.87) for visual analogue scale. The κ values were higher than 0.69 in this group. The internal consistencies of the paper and tablet methods were similar. Conclusions The paper and tablet versions of the EQ-5D are equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar among individuals. Objetivos Avaliar a equivalência de medidas da versão original em papel de uma versão adaptada para tablet do questionário de cinco dimensões EuroQol (EQ-5D). Métodos Uma amostra selecionada aleatoriamente de 509 indivíduos com idade entre 18 e 64 anos da população geral respondeu ao EQ-5D em dois momentos separados por um intervalo mínimo de 24 horas e foram alocados em um dos seguintes grupos: grupo teste-reteste (tablet -tablet) ou grupo crossover (papel-tablet e tablet-papel). A concordância entre os métodos foi determinada por meio do coeficiente de correlação intraclasse (ICC) e do coeficiente κ. Resultados No grupo crossover, os seguintes valores de ICC foram obtidos: 0,76 (intervalo de confiança [IC] 0,58–0,89) para escores EQ-5D e 0,77 (IC 0,68–0,84) para escala visual analógica em indivíduos que responderam primeiro à versão tablet; 0,83 (IC 0,75–0,89) para pontuações EQ-5D e 0,75 (IC 0,67–0,85) para escala visual analógica em indivíduos que responderam primeiro à versão em papel. No grupo teste-reteste, o ICC foi de 0,85 (IC 0,73–0,91) para os escores do EQ-5D e 0,79 (IC 0,66–0,87) para a escala visual analógica. Os valores de κ foram superiores a 0,69 neste grupo. As consistências internas dos métodos de papel e tablet foram semelhantes. Conclusões As versões em papel e tablet do EQ-5D são equivalentes. A concordância teste-reteste e crossover foi alta e a aceitabilidade dos métodos foi semelhante entre os indivíduos.

BACKGROUND: The objectives of the study were to develop web-based Spanish and Catalan versions of the EQ-5D-Y, and to compare scores and psychometric properties with the paper version. METHODS: Web-based and paper versions of EQ-5D-Y were included in a cross-sectional study in Palafolls (Barcelona), Spain and administered to students (n = 923) aged 8 to 18 years from 2 primary and 1 secondary school and their parents. All students completed both the web-based and paper versions during school time with an interval of at least 2 h between administrations. The order of administration was randomized. Participants completed EQ-5D-Y, a measure of mental health status (the Strengths and Difficulties Questionnaire), and sociodemographic variables using a self-administered questionnaire. Parents questionnaire included parental level of education and presence of chronic conditions in children. Missing values, and floor and ceiling effects were compared between versions. Mean score differences were computed for the visual analogue scale (VAS). Percentage of agreement, kappa index (k) and intraclass correlation coefficient (ICC) were computed to analyze the level of agreement between web-based and paper versions on EQ-5D-Y dimensions and VAS. Known groups validity was analyzed and compared between the two formats. RESULTS: Participation rate was 77 % (n = 715). Both formats of EQ-5D-Y showed low percentages of missing values (n = 2, and 4 to 9 for web and paper versions respectively), and a high ceiling effect by dimension (range from 79 % to 96 %). Percent agreement for EQ-5D-Y dimensions on the web and paper versions was acceptable (range 89 % to 97 %), and k ranged from 0.55 (0.48-0.61, usual activities dimension) to 0.75 (0.68-0.82, mobility dimension). Mean score difference on the VAS was 0.07, and the ICC for VAS scores on the two formats was 0.84 (0.82-0.86). Both formats showed acceptable ability to discriminate according to self-perceived health, reporting chronic conditions, and mental health status. CONCLUSIONS: The digital EQ-5D-Y showed almost identical VAS scores and acceptable levels of agreement on dimensions. Both formats demonstrated acceptable levels of construct validity. Availability of the Spanish and Catalan web-version will facilitate its use in HRQOL assessment and in economic evaluation. The study was financed by the Spanish Ministry of Health, contract N° PI12/01296.