Guillemin et al 1993 [1] | Bullinger et al 1998 [3] | Beaton et al 2002 [2] | Modified process for KIT | |
---|---|---|---|---|
Background and methods | Linguistic translation alone is insufficient for cross-cultural application of measures. | International Society for Quality of Life Assessment project group recommendations. | Based on Guillemin et al 1993. | Published guidelines too rigorous for a small cohort of children with a rare disease. |
Systematic literature review of the methodology of cross-cultural adaptation. | Focused primarily on the SF36, EORTC and Nottingham Health Profile experiences. | Guidelines Currently Used by the American Academy of Orthopedic Surgeons Outcomes Committee. | ||
Proposed standardized guide-lines based on the review. | ||||
Forward translation | ≥ 2 Professional translators NSTL* and culturally representative. | ≥ 2 Professional translators NSTL. | 2 Professional translators (NSTL). | Single forward translation by bilingual clinical expert in target country. |
Both naive and informed translators are required. | Translators naïve to SF36. | Both naive and informed translators are required. | ||
≥ 2 Independent translations. | Translators NSTL rate the difficulty of the translation. | 2 Independent translations. | ||
Consensus after forward translation | No specific process outlined. | Within-country reconciliation of problematic items and response options with local PI and translators. | 2 Translators and a facilitator synthesize a translated version of the questionnaire from the 2 forward translations. | Not part of the process. |
Back translation(final language into source language) | ≥ 2 Professional, naïve translators NSE.# | 2 Professional translators NSE. | 2 Professional, naïve translators NSE. | 1 Professional, naïve translator for each of the target languages. |
Translate independently. | Health Assessment Lab compared back translations to initial version for "conceptual equivalence." Discrepancies discussed with local PI. | Translators should not have a clinical background. | Single back translation. | |
Must have as many back translations as forward translations. | Must have as many back as forward translations. | |||
Consensus/Synthesis | A multi-disciplinary committee including, experts in concepts and the disease, to compare English versions. | International investigators meeting. | Expert committee consolidates all translations and produces a questionnaire for field-testing. | A multi-disciplinary expert committee compares English back-translated versions. |
Structured techniques are used to resolve discrepancies. | Expert committee consists of methodologists, health care professionals, language experts and translators. | Local bilingual clinical expert adjudicates any discrepancies with committee. | ||
Inclusion of bilingual members is ideal. | Consensus meeting to form reconciled versions. | |||
Testing with participants | The translated questionnaire may be administered to a group of patients using a probe technique. | Focus groups with up to 50 respondents and translations revised as needed. | The translated version is administered to 30-40 people using a probe technique. | Training provided for cognitive debriefing skills by operations group. |
or | Testing done in individual countries. | Cognitive debriefing in individual countries. | ||
Both the English and translated questionnaires are administered to bilingual lay people. | Modified EORTC debriefing questionnaire used. | |||
Total number of formal translations | At least 2 forward and 2 back translations. | At least 2 forward translations and a consensus version, i.e. 3. | At least 2 forward translations and consensus version, i.e. 3. | Single forward and back translation. |
2 Back translations. | At least 2 back translations. | |||
Number of consensus meetings | After forward and back translations. | Between forward and back translations. | Between forward and back translations. | After forward and back translations. |
After pre-testing. | After difficulty ratings. | After back translations. | After pre-testing. | |
After back translation. | ||||
Role of patients | To ensure face validity of the translation. | Lay panel made up of general public was used to achieve consensus when translators could not. | To ensure translated version retains equivalence to original version. | To ensure face validity of the translation. |
Patients and lay people pilot tested final forward translation. | ||||
Number of patients | Specific requirement is not Stipulated. | 50 | 30-40 | 10 Children and their parents per country. |