scholarly journals Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Shawn McKown ◽  
Catherine Acquadro ◽  
Caroline Anfray ◽  
Benjamin Arnold ◽  
Sonya Eremenco ◽  
...  
Keyword(s):  
Cultural Adaptation ◽  
Patient Reported Outcome ◽  
Validation Process ◽  
Linguistic Validation ◽  
Performance Outcome ◽  
Industry Standard ◽  
Patient Reported ◽  
And Performance ◽  
Clinical Outcome Assessments ◽  
Translation And Cultural Adaptation

Abstract Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. The recommended process utilized to translate ObsRO, ClinRO and PerfO measures from one language to another aligns closely with the industry standard process for PRO measures. The substantial differences between respondent categories across COA types require targeted approaches to the cognitive interviewing procedures utilized within the linguistic validation process, including the use of patients for patient-facing text in ClinRO measures, and the need to interview the targeted observers for ObsROs measures.

scholarly journals Translation and Cultural Adaptation of the Pectus Excavatum Evaluation Questionnaire From English to Catalan and Spanish

2021 ◽  
Author(s):  
Irene de Haro Jorge ◽  
Xavier Tarrado ◽  
Asteria Albert Cazalla ◽  
Natalie Garcia-Smith ◽  
Alba Fernandez-Candial ◽  
...  
Keyword(s):  
Cultural Adaptation ◽  
Pectus Excavatum ◽  
Patient Reported Outcome ◽  
Cognitive Debriefing ◽  
Life Changes ◽  
Evaluation Questionnaire ◽  
Patient Reported ◽  
Back Translation ◽  
Negative Effect ◽  
Translation And Cultural Adaptation

Abstract Background:Pectus excavatum is the most common congenital chest wall deformity. It can have a negative effect in exercise tolerance. However, cosmetic features are the most frequent concerns in these patients. The pectus excavatum evaluation questionnaire is a patient-reported outcome (PRO) tool to measure the physical and psychosocial quality of life changes after surgical repair of pectus excavatum. No specific tool has been developed in our languages to evaluate PRO in pectus excavatum patients. Our aim is to translate and culturally adapt the pectus excavatum evaluation questionnaire to European Spanish and Catalan.Methods:Guidelines for translation of PRO were followed. The pectus excavatum evaluation questionnaire, consisting of 34 items, was translated from English to Spanish and to Catalan. Three forward translations and one back translation were performed for each language. Cognitive debriefing interviews were developed.Results:The reconciliation of the forward translations revealed a 14.7% of inconsistencies for each language. The Spanish back translation showed a 64.7% of disagreement with the source, the Catalan 58.8%. Changes in each reconciled version were made to amend the diverting items. 10 patients and their parents participate in the cognitive debriefing for each language, 5 patients had been operated and 5 had not. 4 patients out of 10, for each language, showed difficulties for understanding one of the pectus excavatum evaluation questionnaire items, thus also resulted in a modification of the reconciled version.Conclusion:The translation and cultural adaptation process resulted in the development of a European Spanish and a Catalan version of the pectus excavatum evaluation questionnaire for application in Spanish and Catalan pectus excavatum patients.

scholarly journals Best Practices in the Development, Translation, and Cultural Adaptation of Patient-Reported Outcome Measures for Adults With Hearing Impairment: Lessons From the Cochlear Implant Quality of Life Instruments

2021 ◽  
Vol 15 ◽  
Author(s):  
Ariane Laplante-Lévesque ◽  
Judy R. Dubno ◽  
Isabelle Mosnier ◽  
Evelyne Ferrary ◽  
Theodore R. McRackan
Keyword(s):  
Quality Of Life ◽  
Best Practices ◽  
Cochlear Implant ◽  
Hearing Impairment ◽  
Cultural Adaptation ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Translation And Cultural Adaptation

This manuscript summarizes available evidence-based best practices in the development, translation, and cultural adaptation of one type of outcome measure for adults with hearing impairment, patient-reported outcome measures (PROMs). It presents the development of the Cochlear Implant Quality of Life (CIQOL) instruments and the ongoing translation and cultural adaptation of the CIQOL-35 Profile from English to French as case studies and discusses useful lessons for selecting, developing, translating, culturally adapting, and using PROMs. Relevant best practice guides are introduced, described and their steps are illustrated with examples. Future trends in hearing-related PROMs, including computerized adaptive testing, patient-reported experience measures (PREMs), economic evaluation and allocation of scarce resources, and PROMs in low-resource settings, are discussed. The manuscript concludes on the lessons that can be learned from implementation science for the successful and sustainable integration of PROMs in clinical practice.

The Performance and Association Between Patient-reported and Performance-based Measures of Physical Functioning in Research on Individuals with Arthritis

2015 ◽  
Vol 43 (1) ◽  
pp. 131-137 ◽  
Author(s):  
Laura C. Pinheiro ◽  
Leigh F. Callahan ◽  
Rebecca J. Cleveland ◽  
Lloyd J. Edwards ◽  
Bryce B. Reeve
Keyword(s):  
Physical Activity ◽  
Physical Functioning ◽  
Physical Activity Intervention ◽  
Secondary Data ◽  
Patient Reported Outcome ◽  
Surrogate Endpoints ◽  
Accurate Representation ◽  
Patient Reported ◽  
And Performance ◽  
Community Trial

Objective.To evaluate the association between patient-reported outcome (PRO) and performance-based (PB) measures of physical functioning (PF) among individuals with self-identified arthritis to inform decisions of which to use when evaluating the effectiveness of a physical activity intervention.Methods.Secondary data analysis of a nonrandomized 2-arm pre-post community trial of 462 individuals who self-identified as having arthritis and participated in the Walk with Ease (WWE) intervention. Two PRO and 8 PB assessments were collected at baseline (preintervention) and at 6-week followup. We calculated correlations between PB and PRO measures, assessed how measures identified changes in PF from baseline to followup, and compared PRO and PB measures to arthritis symptoms of pain, stiffness, and fatigue.Results.Strength of correlations between PB and PRO measures varied depending on the PB measure, ranging from 0.21 to 0.54. PRO and PB measures identified PF improvements from baseline to followup, but none showed significant differences between the 2 WWE modalities (instructor-led or self-directed groups). Correlations with arthritis symptoms were stronger for PRO (0.30–0.46) than PB measures (0.03–0.31).Conclusion.PRO measures may provide us with insights into aspects of PF that are not identified by PB measures alone. Use of PRO measures allows patients to communicate their perceptions of PF, which may provide a more accurate representation of overall PF. Our study does not suggest abandoning the use of PB measures to characterize PF in patients with self-identified arthritis, but recommends that PRO measures may serve as complementary or surrogate endpoints for some studies.

scholarly journals Translation and Cultural Adaptation of adult PROMIS Physical Function Short Forms into Simplified Chinese

2021 ◽  
Author(s):  
Yueshi Huang ◽  
Xiaoju Zhang ◽  
Yang Yang ◽  
Tingting Cai ◽  
Wen Zhang ◽  
...  
Keyword(s):  
Physical Function ◽  
Cultural Adaptation ◽  
Patient Reported Outcomes ◽  
Measurement Information ◽  
Linguistic Validation ◽  
Outcomes Measurement ◽  
Short Forms ◽  
Simplified Chinese ◽  
Patient Reported ◽  
Measurement Information System

Abstract Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) has been proven to be an effective and efficient measurement tool and has entered its global promotion phase. Our research team was authorized by the PROMIS Health Organization to translate five adult Patient-Reported Outcomes Measurement Information System (PROMIS) physical function short forms (4a, 6b, 8b, 8c, and 8c 7-Day) to ensure the conceptual and semantical equivalence to the source and pretest them in a Chinese population for cultural adaptation.Methods: The translation was conducted following the Functional Assessment of Chronic Illness Therapy (FACIT) methodology, which mainly includes forward translation, reconciliation, back-translation, expert reviews, cognitive testing, and linguistic validation, etc. And cognitive interview was used to pretest the translated items in Chinese patients with cancer and a healthy population.Results: The translation process was relatively smooth, except for some translated versions that slightly altered some word choices or sentence structures. Subsequent pre-testing of the Simplified Chinese short forms showed that clarifying or laying emphasis on the time frame in the instructions was needful, and two sets of response categories and one item stem needed some slight revisions due to cultural or language discrepancies.Conclusion: The translation and linguistic validation of five adult PROMIS physical function short forms into Simplified Chinese have been completed, and field testing, calibration, and psychometric testing are pending.

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