Table 1.
Summary of Wound Healing Questionnaire adaptation methodology
| Methodology | Yes | No | Details |
|---|---|---|---|
| Concept definition (protocol) | Y | Protocol agreed between international Study Management Group, developers, community, and patient partners. Preregistered and published in Trials 20 and in SWAT store registry (ID126) | |
| Qualitative phase: cross-cultural and cross-contextual adaptation (in source language, English) | |||
| ȃConsultant identified | Y | An in-country consultant was identified in each target country who was fluent in both the source and target language(s). This was typically the national principal investigator (a surgeon involved directly in wound assessment) for the study, or else a clinical nominee | |
| ȃStructured interviews (expert review) | Y | Structured interviews were designed to review the instrument validity, items, and scaling. The topic guide was directed item by item, learning from cognitive theory. In each country, 2–3 interviews were conducted with site investigators directly involved in wound assessment | |
| ȃFocus groups (reconciliation and translatability assessment) | Y | A focus group was held with each country to review coding and analysis from the expert review phase (member checking). This included several investigators fluent in both the source and target language. An item-by-item translatability assessment was made in parallel. Any further iterative modifications were made before moving into the harmonization meeting | |
| ȃCommunity and patient partner review | Y | Patient advisory group meeting with representation from 4 of the target countries (Nigeria, South Africa, India, Ghana) was convened to review the recommendations for adaptation of the instrument item by item, and to co-design the cohort study including co-production of the telephone follow-up pathway and supporting documentation | |
| ȃHarmonization meeting | Y | Virtual meeting on Zoom platform with national principal investigators to sign off final adaptation of the adapted English language WHQ to move into cross-language translation | |
| Cross-language translation (performed for each target language) | |||
| ȃDual forward translations | Y | Performed by translators fluent in both the source and target language, and native to the target country | |
| ȃForward translation reconciliation | Y | Comparison of translations with any discrepancies resolved with discussion between translators and in-country consultant | |
| ȃBack translation × 1 | Y | Performed by translator fluent in both the source and target language, and native to the target country | |
| ȃBack translation reconciliation | Y | Comparison of back-translated source language questionnaire with original. Discussion within in-country consultant to review and resolve any consistencies | |
| ȃDeveloper’s review | Y | Developers collaborated as members of the Study Management Group and co-authors of this manuscript | |
| ȃCognitive interviewing (replaced with data review) | N | Cognitive interviewing with patients was not possible during SARS-CoV-2. Qualitative data from the expert review and transability assessment were used instead to inform translation, led by the consultant | |
| ȃClinician review and proofreading | Y | Clinicians involved in wound care embedded in the adaptation and translation process. Two native speaking clinicians provided the final review and proofreading | |
| ȃPilot testing | Y | Target language delivery tested during follow-up with 5–10 patients to test comprehension, phrasing, and delivery. A monitoring call was held with the investigators to review feedback before progression to the quantitative study | |
| ȃHarmonization meeting | Y | Virtual meeting on Zoom platform with national principal investigators to act as a final quality check and share review lessons learnt during translation | |
| ȃPublished | Y | Final version published included in Table 3 (source language) and supplementary material (target languages) | |
| Quantitative phase: cohort study of adapted and translated WHQ (source and target languages) | |||
| ȃCohort study | Y | Study within a trial within the FALCON RCT to test feasibility, acceptability, and measurement properties of WHQ. Minimum sample size target of 100 patients per country | |
| ȃRasch analysis of cohort study data | Y | Rasch unidimensional measurement modelling in data used to evaluate scaling, measurement properties, and differential item functioning across key subgroups | |
| Reconciliation and reporting | |||
| ȃTriangulation | Y | Triangulation of qualitative and quantitative data to inform final recommendations for WHQ adaptation | |
| ȃCommunity and patient partner review | Y | Presentation of findings of cohort study to patient advisory group to co-interpret patterns in data and share insight on final recommendations for WHQ adaptation. Co-production of a lay abstract summary of the research findings for dissemination to the public | |
| ȃFinal harmonization meeting | Y | Virtual meeting on Zoom platform with national principal investigators | |
| ȃValidation report | Y | A full prospective validation study for the adapted global WHQ in the target languages in 7 low- and middle-income countries is reported elsewhere. | |
Adapted from Oxford University Innovation outcomes centre checklist, and Mapi process for cross-cultural and cross-language adaptation. SWAT, study within a trial; WHQ, Wound Healing Questionnaire.