ArticleBMJ open2022
Proportionate translation of study materials and measures in a multinational global health trial: methodology development and implementation.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Implementation of peer support for people with severe mental health conditions in high-, middle- and low-income-countries: a theory of change approach.BMC health services research · 2024Trial
- Translation and interpreting services must be considered across the lifecycle of clinical trials.Trials · 2026Article
- Experiences of service users receiving peer support in mental health services: Qualitative findings from the international UPSIDES trial.Global mental health (Cambridge, England) · 2026Article
- Development and evaluation of a mental health recovery priority measure for cross-cultural research: global INSPIRE.Social psychiatry and psychiatric epidemiology · 2025Article
- Beyond symptom improvement: transdiagnostic and disorder-specific ways to assess functional and quality of life outcomes across mental disorders in adults.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2025Article
- A comparison of the costs and patterns of expenditure for care for severe mental illness in five countries with different levels of economic development.Epidemiology and psychiatric sciences · 2025Article
- Measuring fidelity to manualised peer support for people with severe mental health conditions: development and psychometric evaluation of the UPSIDES fidelity scale.BMC psychiatry · 2024Article
- 28-country global study on associations between cultural characteristics and Recovery College fidelity.Npj mental health research · 2024Article
- Article
- Perspectives of key informants before and after implementing UPSIDES peer support in mental health services: qualitative findings from an international multi-site study.BMC health services research · 2024Article
- Article
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Authors and funding
17 authors.
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Abstract
objectivesCurrent translation guidelines do not include sufficiently flexible translation approaches for different study materials. We aimed to develop a proportionate methodology to inform translation of all types of study materials in global health trials.
designThe design included three stages: (1) categorisation of study materials, (2) integration of existing translation frameworks and (3) methodology implementation (Germany, India, Israel, Tanzania and Uganda) and refinement.
participantsThe study population comprised 27 mental health service users and 27 mental health workers who were fluent in the local language in stage 7 (pretesting), and 54 bilingual mental health service users, aged 18 years or over, and able to give consent as judged by a clinician for step 9 (psychometric evaluation).
settingThe study took place in preparation for the Using Peer Support in Developing Empowering Mental Health Services (UPSIDES) randomised controlled trial (ISRCTN26008944). PRIMARY OUTCOME MEASURE: The primary outcome measure was the Social Inclusion Scale (SIS).
resultsThe typology identifies four categories of study materials: local text, study-generated text, secondary measures and primary measure. The UPSIDES Proportionate Translation Methodology comprises ten steps: preparation, forward translation, reconciliation, back translation, review, harmonisation, pretesting, finalisation, psychometric evaluation and dissemination. The translated primary outcome measure for the UPSIDES Trial (SIS) demonstrated adequate content validity (49.3 vs 48.5, p=0.08), convergent validity and internal consistency (0.73), with minimal floor/ceiling effects.
conclusionThis methodology can be recommended for translating, cross-culturally adapting and validating all study materials, including standardised measures, in future multisite global trials. The methodology is particularly applicable to multi-national studies involving sites with differing resource levels. The robustness of the psychometric findings is limited by the sample sizes for each site. However, making this limitation explicit is preferable to the typical practice of not reporting adequate details about measure translation and validation. TRAIL REGISTRATION NUMBER: ISRCTN26008944.
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