http://www.hrainc.net/publications/pdfs/2005%20Wild%20VIH%20-%20PRO-SIG.pdf

Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting Diagnostic Accuracy (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

https://www.bmj.com/content/bmj/351/bmj.h5527.full.pdf

STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies

Condition-specific health status measures are commonly used as outcome measures in clinical trials and to assess patient progress in routine clinical practice. The expert panel that met to discuss this special issue of Spine recommended that, when possible, a condition-specific measure for back pain should be chosen from two widely used measures, the Roland–Morris Disability Questionnaire (RDQ) or the Oswestry Disability Index (ODI). These two measures have been used in a wide variety of situations over many years, and each is available in a number of languages. In this article, the authors describe these two instruments and provide evidence of their validity and reliability and some comparative results obtained with the use of the two questionnaires. The instruments themselves are included in the appendixes. When used in the forms reproduced in the appendixes, no permission is required from the authors or from Spine. Other back pain–specific health status measures are described by Kopec elsewhere in this edition of Spine.

The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire.

Rationale, aims and objectives The diversity of the population worldwide suggests a great need for cross-culturally validated research instruments or scales. Researchers and clinicians must have access to reliable and valid measures of concepts of interest in their own cultures and languages to conduct cross-cultural research and/or provide quality patient care. Although there are well-established methodological approaches for translating, adapting and validating instruments or scales for use in cross-cultural health care research, a great variation in the use of these approaches continues to prevail in the health care literature. Therefore, the objectives of this scholarly paper were to review published recommendations of cross-cultural validation of instruments and scales, and to propose and present a clear and user-friendly guideline for the translation, adaptation and validation of instruments or scales for cross-cultural health care research. Methods A review of highly recommended methodological approaches to translation, adaptation and cross-cultural validation of research instruments or scales was performed. Recommendations were summarized and incorporated into a seven-step guideline. Each one of the steps was described and key points were highlighted. Example of a project using the proposed steps of the guideline was fully described. Conclusions Translation, adaptation and validation of instruments or scales for crosscultural research is very time-consuming and requires careful planning and the adoption of rigorous methodological approaches to derive a reliable and valid measure of the concept of interest in the target population.

Translation, adaptation and validation of instruments or scales for use in cross‐cultural health care research: a clear and user‐friendly guideline

1. Introduction 2. Concepts, theories and models, and types of measurements 3. The development of a measurement instrument 4. Field testing - item reduction and data structure 5. Reliability 6. Validity 7. Responsiveness 8. Interpretation 9. Systematic reviews of measurement properties Index.

Measurement in Medicine: A Practical Guide

With the increase in the number of multinational and multicultural research projects, the need to adapt health status measures for use in other than the source language has also grown rapidly. 1,4,27 Most questionnaires were developed in English-speaking countries, 11 but even within these countries, researchers must consider immigrant populations in studies of health, especially when their exclusion could lead to a systematic bias in studies of health care utilization or quality of life. 9,11 The cross-cultural adaptation of a health status selfadministered questionnaire for use in a new country, culture, and/or language necessitates use of a unique method, to reach equivalence between the original source and target versions of the questionnaire. It is now recognized that if measures are to be used across cultures, the items must not only be translated well linguistically, but also must be adapted culturally to maintain the content validity of the instrument at a conceptual level across different cultures. 6,11‐13,15,24 Attention to this level of detail allows increased confidence that the impact of a disease or its treatment is described in a similar manner in multinational trials or outcome evaluations. The term “cross-cultural adaptation” is used to encompass a process that looks at both language (translation) and cultural adaptation issues in the process of preparing a questionnaire for use in another setting. Cross-cultural adaptations should be considered for several different scenarios. In some cases, this is more obvious than in others. Guillemin et al 11 suggest five different examples of when attention should be paid to this adaptation by comparing the target (where it is going to be used) and source (where it was developed) language and culture. The first scenario is that it is to be used in the same language and culture in which it was developed. No adaptation is necessary. The last scenario is the opposite extreme, the application of a questionnaire in a different culture, language and country—moving the Short Form 36-item questionnaire from the United States (source) to Japan (target) 7 which would necessitate translation and cultural adaptation. The other scenarios are summarized in Table 1 and reflect situations when some translation and/or adaptation is needed. The guidelines described in this document are based on a review of cross-cultural adaptation in the medical, sociological, and psychological literature. This review led to the description of a thorough adaptation process designed to maximize the attainment of semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires. 13 . Further experience in cross-cultural adaptation of generic and diseasespecific instruments and alternative strategies driven by different research groups 18 have led to some refinements

Guidelines for the process of cross-cultural adaptation of self-report measures.

(1995). Cross-cultural Adaptation and Validation of Heatth Status Measures. Scandinavian Journal of Rheumatology: Vol. 24, No. 2, pp. 61-63.

Cross-cultural adaptation and validation of health status measures.

Objective. To determine whether the frequency of cancer is increased among patients with systemic sclerosis (SSc).



Methods. A retrospective chart review of 248 patients who were followed up prospectively was conducted.



Results. Cancers developed in 18 patients (7.3%) during 2,001 patient-years at risk. The most frequent types were cancers of the lung (7 patients) and breast (5 patients). Older age at diagnosis of SSc was a significant risk factor for cancer. Lung cancer was associated with the presence of pulmonary fibrosis. The age-standardized incidence rate for all cancers (7.9/1,000) was 2.1 times the overall rate in the Ontario population (P > 0.0001).



Conclusion. The frequency of cancer is increased in patients with SSc.

Cancer in systemic sclerosis.

Objective. To develop a short form of the Arthritis Impact Measurement Scales 2 (AIMS2) questionnaire, preserving content validity as the priority criterion.



Methods. A 2-step reduction procedure was used: 1) Delphi technique, with 1 panel of patients and 1 panel of experts each selecting 1 set of items independently; and 2) nominal group technique, where members of both panels reached consensus on the final selection of items, using information derived from item analysis. Psychometric properties of the AIMS2-Short Form (AIMS2-SF) and AIMS2 were compared using data from a cohort of 127 rheumatoid arthritis patients who completed the AIMS2 twice prior to the initiation of methotrexate (MTX) treatment and 3 months post-initiation of MTX treatment.



Results. The 2 panels reached consensus on a 26-item AIMS2-SF (54.4% reduction from the AIMS2). Factor analysis showed preservation of the 5-component structure. Convergent validity (Physical and Symptom components with clinical variables: r = 0.24-0.59), test-retest reproducibility (intraclass correlation coefficient >0.7), and sensitivity to change at 3 months (standardized response mean 0.36-0.8, except Social Interaction component [0.08]) were very close to the values for the original AIMS2.



Conclusion. The AIMS2-SF is a shorter version of the AIMS2 (i.e., available in 2-page format) and has psychometric properties similar to those of the AIMS2.

/pdf/the-aims2-sf-a-short-form-of-the-arthritis-impact-jpw3zfkumb.pdf

THE AIMS2-SF A Short Form of the Arthritis Impact Measurement Scales 2

https://orbilu.uni.lu/bitstream/10993/1673/1/RAT%20et%20al.%20Int%20J%20Clin%20Epidemio%202005.pdf

Francis Guillemin

Papers

Guidelines for the process of cross-cultural adaptation of self-report measures.

Cross-cultural adaptation and validation of health status measures.

Cancer in systemic sclerosis.

THE AIMS2-SF A Short Form of the Arthritis Impact Measurement Scales 2

OAKHQOL: a new instrument to measure quality of life in knee and hip osteoarthritis.