The process of reconciliation: evaluation of guidelines for translating quality-of-life questionnaires.

Reconciliation refers to the process through which two or more independent forward translations are merged into one single translation. This critical step in the translation process is difficult to formalize. The purpose of this review is to analyze how reconciliation is specified in leading guidelines for the translation of quality-of-life questionnaires and other patient-reported outcome forms with regard to the number and qualifications of individuals involved, the processes followed, as well as the criteria applied. In general, relatively little attention has been paid to characterizing the process in detail. Based on these findings, we specify criteria to be followed.

Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients.

BACKGROUND: Multinational clinical trials commonly include different language versions of patient-reported outcomes (PRO) instruments without considering the question of their cross-cultural validity. The inclusion of a PRO instrument, the Adult AIDS Clinical Trial Group Symptom Distress Module (SDM), in an multinational clinical trial in HIV-1 antiretroviral-naive patients offered an opportunity to explore the methods to assess cross-cultural validity of PRO instruments in the context of clinical trials. PURPOSE: To assess the cross-cultural validity of the SDM across seven cultural groups in the setting of a multinational HIV clinical trial. METHODS: Twenty-five language versions of the SDM were included in a Phase IIb/III trial comparing maraviroc with efavirenz (each in combination with zidovudine/ lamivudine) conducted in 12 countries to assess symptoms perceived by HIV-1-infected antiretroviral-naive patients. Differential item functioning (DIF) detection and the STATIS method were combined in a pragmatic approach to assess the cross-cultural validity of the SDM using pre-antiretroviral treatment data from 759 patients. RESULTS: Statistically significant DIF between cultural groups was observed for four items: fatigue; fevers; anxiety; and headache. However, examination of these items by linguists did not lead to meaningful explanations for the statistical differences. With the STATIS approach, the Bantu and European Germanic groups were the furthest from the Occidental English group. LIMITATIONS: The assessment of cross-cultural validity had to be performed on some very small samples and on data aggregated by cultural groups, which suggests the need for a cautious interpretation of the results. CONCLUSIONS: Given the heterogeneity of cultures considered, the absence of meaningful explanations for statistically significant differences between cultural groups supports the cross-cultural validity of the SDM versions included in this trial. Thus, this study demonstrated that it is feasible to conduct assessment of crosscultural validity of PRO instruments using data collected in the setting of multinational clinical trials.

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.

OBJECTIVES: With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and 3) the assessment of measurement equivalence to support the aggregation of data from different countries. METHODS: The task force addressed these three areas, reviewed the available literature, and had multiple discussions to develop this report. RESULTS: Decision aid tools have also been developed and presented for the selection of languages and the approaches suggested for the use of the same language in different countries. CONCLUSION: It is hoped that this report and the decision tools proposed will assist those involved with multinational trials to 1) decide on the translations required for each country; 2) choose the approach to use when the same language is spoken in more than one country; and 3) choose methods to gather evidence to support the pooling of data collected using different language versions of the same tool.

Quality of life in multiple sclerosis: translation in French Canadian of the MSQoL-54.

BACKGROUND: Multiple Sclerosis (MS) is a neurodegenerative disease which runs its course for the remainder of the patient's life frequently causing disability of varying degrees. Negative effects on Health-related quality of life (HRQOL) are well documented and a subject of clinical study. The Multiple Sclerosis QOL 54 (MSQOL-54) questionnaire was developed to measure HRQOL in patients with MS. It is composed of 54 items, and is a combination of the SF-36 and 18 disease-specific items. OBJECTIVE: The objective of this project was to translate the MSQOL-54 into French Canadian, and to make it available to the Canadian scientific community for clinical research and clinical practice. METHODS: Across all French speaking regions, there are occurrences of variation. They include the pronunciation, sentence structure, and the lexicon, where the differences are most marked. For this reason, it was decided to translate the US original MSQOL-54 into French Canadian instead of adapting the existing French version. The SF-36 has been previously validated and published in French Canadian, therefore the translation work was performed solely on the 18 MS specific items. The translation followed an internationally accepted methodology into 3 steps: forward translation, backward translation, and patients' cognitive debriefing. RESULTS: Instructions and Items 38, 43, 45 and 49 were the most debated. Problematic issues mainly resided in the field of semantics. Patients' testing (n = 5) did not reveal conceptual problems. The questionnaire was well accepted, with an average time for completion of 19 minutes. CONCLUSION: The French Canadian MSQOL-54 is now available to the Canadian scientific community and will be a useful tool for health-care providers to assess HRQOL of patients with MS as a routine part of clinical practice. The next step in the cultural adaptation of the MSQOL-54 in French Canadian will be the evaluation of its psychometric properties.

A new approach to multicultural item generation in the development of two obesity-specific measures: the Obesity and Weight Loss Quality of Life (OWLQOL) questionnaire and the Weight-Related Symptom Measure (WRSM).

BACKGROUND: Being overweight or obese has substantial effects on individuals' perceptions of their health and quality of life (QoL). Generic measures often miss important QoL information, and existing obesity-specific instruments have shortcomings with respect to cross-cultural input, application to differing levels of severity, conceptual clarity, and patient burden. OBJECTIVE: This study aimed to develop culturally sensitive measures of QoL and symptoms in overweight or obese persons, both those trying to lose weight and those not trying to lose weight. METHODS: Currently accepted criteria and guidelines for questionnaire development were streamlined and augmented to include cross-cultural input from 5 European countries and the United States. The preliminary pool of items was created based on qualitative interviews conducted in the United States, followed by an early check of item translatability and preharmonization across all languages. Ten additional qualitative in-country interviews were then conducted to produce further culture-specific items. This was followed by 2 forward and 1 backward translation, plus cognitive debriefing interviews in each country. Finally, an expanded international harmonization meeting was held to ensure inclusion of appropriate new items and their acceptability across all 6 cultures. RESULTS: The procedures described resulted in development of the 41-item Obesity and Weight Loss Quality of Life questionnaire and the 20-item Weight-Related Symptom Measure. These questionnaires are subject to further psychometric validation. CONCLUSIONS: Augmentation of the initial item-generation and international harmonization steps of questionnaire development through integration of cross-cultural input allowed greater validity of cross-cultural content while meeting time, budget, and resource constraints.