Table 1 A comparison of cross-cultural adaptations of quality of life measures.

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.