Linguistic and Cultural Validation of Patient-Reported Outcomes Used in Clinical Trials

INVITED COMMENTARIES Linguistic and Cultural Validation of Patient-Reported Outcomes Used in Clinical Trials Stanley E. Althof, PhD,1 Raymond C. Rosen, PhD,2 and Dennis A. Revicki, PhD3 INTRODUCTION The apparently same language can have variations across geographic regions. For example, Spanish spoken in Spain differs from Spanish spoken in Argentina as does French spoken in France and French spoken in Belgium. In some countries, such as India and China, there can be multiple different dialects and languages spoken. Thus, the language into which the PRO is translated must be adapted to the country and its cultural characteristics. Well-known PROs such as the International Index of Erectile Function (IIEF),3 the Female Sexual Function Index (FSFI),4 and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)5 have been translated to and linguistically and culturally validated in different languages. This commentary discusses the construct of equivalence and reviews the process of linguistic and cultural validation of PROs.2,6e9 We present the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) task force that developed an algorithm for linguistic and cultural validation.9 Because PROs are often the primary outcome assessments in clinical trials, regulatory agencies are carefully scrutinizing the process of translation and validation.6 NOTION OF EQUIVALENCE In translating from a source to a target language, several forms of equivalence are important to recognize.6 These include (i) semantic equivalence, whereby items mean the same thing to PROCESS OF LINGUISTIC AND CULTURAL VALIDATION The ISPOR task force promulgated a framework for the translation and cultural adaptation of PROs.9 Table 1 lists all the society’s recommendations; we highlight the most essential recommendations from their report. Forward Translation The guidelines recommend that at least 2 forward translations be independently completed by native speakers within the specific culture because they possess a greater awareness of the cultural aspects of language than non-native speakers. Using more than 1 translator aids in the detections of errors and an overemphasis on 1 translator’s idiosyncratic style. Reconciliation A reconciliation panel or an individual not involved in the initial forward translation should integrate and resolve conflicts between the 2 forward translations, creating a final forward translation. Received September 27, 2017. Accepted November 21, 2017. 1 Case Western Reserve University School of Medicine, Cleveland, OH, USA; 2 New England Research Institutes, Watertown, MA, USA; 3 Outcomes Research, Evidera, Bethesda, MD, USA Copyright ª 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jsxm.2017.11.017 J Sex Med 2018;15:115e117 Backward Translation Backward translation is a quality control step that insures the same meaning is evident when the forward translation is translated back to the original language. Then, the backward-translated version is compared with the original source language document for conceptual equivalence. 115 Downloaded from https://academic.oup.com/jsm/article/15/2/115/6980257 by guest on 25 January 2023 Clinical trials in sexual medicine depend on patient-reported outcomes (PROs) to efficiently and confidently gather data generated by subjects, their significant others, and/or the clinicians conducting the trials.1 Increasingly, clinical trials for male and female sexual dysfunctions have become more international in scope.2 This necessitates the translation and cultural adaptation of PROs from a source language to at least 1 other target language. In principle, the notion of translating the PRO from 1 language to another appears simple; in reality, it is a complex, sophisticated, and labor-intensive effort. individuals in the target and source language groups; (ii) conceptual equivalence of constructs and items, meaning that the constructs are relevant and are acceptable in the 2 cultures; (iii) operational equivalence to ensure that standardized methods of survey administration are appropriate for the target culture; (iv) psychometric or measurement equivalence, whereby comparable psychometric properties are observed in the source and target language measures; (v) item equivalence, whereby items are not differentially more difficult (eg, biased) in the target culture than in the original, item weights reflect a similar comparative importance of the items between groups, and the meaning of and distance between response choices is similar across cultures; and (vi) criterion equivalence, whereby the interpretation of scores is the same across language and cultural groups and when compared with norms for each group. 116 Althof et al Table 1. International Society for Pharmacoeconomics and Outcomes Research framework for translating patient-reported outcomes9 Preparation Forward translation Reconciliation Backward translation Backward-translation review Harmonization Cognitive debriefing Review of cognitive debriefing and finalization Proofreading Final report Cognitive Debriefing Cognitive debriefing is a process performed by trained qualitative researchers, individually or in groups, to ascertain whether the measure that has been translated into the new language properly conveys the intent of the questions to the subjects (cognitive equivalence). Response scales also are examined for their utility in responding to the individual questions that are appropriate for the target language and culture. Finalization and Testing of the Translation Based on the results of the cognitive debriefing, alterations and modifications can be made to the translated instrument. We recommend that 1 last step be added to the ISPOR recommendation, which is to evaluate the psychometric properties (eg, reliability, validity) of the translated instrument to determine whether the translated scale has similar measurement properties as the original source document. For instance, are the specificity and sensitivity comparable in the source and newly translated instrument versions? This final recommendation can be challenging, but confirmation of acceptable measurement qualities of the translated measures are essential in international clinical trials in which data are combined across multiple different countries. CONCLUSION Given the increase in international clinical trials evaluating new treatments for female or male sexual dysfunction, adherence to recommended guidelines for linguistic translation and cultural adaptation is essential for ensuring the quality of PRO end-point data. Moreover, following these guidelines gives regulatory agencies confidence in data from the translated version of the PRO. The ISPOR guidelines on translation and cultural validation provide a good starting point for organizing the development of language and cultural adaptations of PRO measures of sexual function, activity, and distress for international clinical trials. Careful attention needs to be placed on qualitative research to make certain that different concepts related to sexual function and satisfaction are meaningful across cultures targeted for translation. In most situations, language Corresponding Author: Stanley E. Althof, PhD, Case Western Reserve University School of Medicine, 1515 N Flagler Drive, Suite 540, Cleveland, OH 33401; E-mail: [email protected] Conflicts of Interest: The authors report no conflicts of interest. Funding: None. STATEMENT OF AUTHORSHIP Category 1 (a) Conception and Design Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki (b) Acquisition of Data Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki (c) Analysis and Interpretation of Data Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki Category 2 (a) Drafting the Article Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki (b) Revising It for Intellectual Content Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki Category 3 (a) Final Approval of the Completed Article Stanley E. Althof; Raymond C. Rosen; Dennis A. Revicki REFERENCES 1. Althof S. Patient reported outcomes and clinical trials. J Sex Med 2016;13:1027-1028. 2. Wild D, Eremenco S, Mear I, et al. Multinational trials—recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report. Value Health 2009;12:430-440. 3. Rosen RC, Riley A, Wagner G, et al. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822-830. J Sex Med 2018;15:115e117 Downloaded from https://academic.oup.com/jsm/article/15/2/115/6980257 by guest on 25 January 2023 1 2 3 4 5 6 7 8 9 10 translations focus on completing the cognitive interviewing necessary for ensuring acceptable language and culturally appropriate versions, but few translators conduct research to evaluate the measurement properties of the translated instruments. Evaluation and confirmation of the psychometric characteristics of the newly translated instruments are important and necessary when PRO end-point data are combined across countries in international clinical trials. For example, secondary analyses of clinical trial data can be useful for evaluating the reliability and validity of the translated scales. Given adequately translated, culturally valid, and psychometrically strong PRO end points, the results of international clinical trials can help clinicians and their patients understand the benefits of new treatments for male and female sexual disorders. Patient-Reported Outcomes in Clinical Trials 4. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 2000;26:191-208. 5. Althof S, Corty E, Levine S. EDITS: development of a questionnaire for evaluating satisfaction with treatment for erectile dysfunction. Urology 1999;53:793-799. 6. Acquadro C, Conway C, Hareendran A, et al. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health 2008; 11:509-521. 117 7. Eremenco S, Cella D, Arnold B. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof 2005;28:212-232. 8. Hatzichristou D, Kirana E, Banner L, et al. Diagnosing sexual dysfunction in men and women: sexual history taking and the role of symptom scales and questionnaires. J Sex Med 2016; 13:1166-1182. 9. Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patientreported outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2005;8:94-104. Downloaded from https://academic.oup.com/jsm/article/15/2/115/6980257 by guest on 25 January 2023 J Sex Med 2018;15:115e117