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Table 3 PRO Consortium Translation Process Steps

From: Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices

Step Number Step Name Universal Approach Country-specific Approach for New Language
1 Preparation Obtain permission to translate, decide on approach, and Item Definition Table provided. Translation consultants identified for each of the target countries. In-country affiliates identified or back-up option if necessary. Plan for final review and proofreading in the mode to be used in the clinical trial and whether additional text (e.g., error messages, navigational terms) needs translation in addition to the measure itself. Obtain permission to translate, decide on approach, and Item Definition Table provided. “Mother”a country selected and translation consultants identified for “Mother” country and for adaptations if required. In-country affiliates identified or back-up option if necessary. Plan for final review and proofreading in the mode to be used in the clinical trial and whether additional text (e.g., error messages, navigational terms) needs translation in addition to the measure itself.
2 Forward Translation Minimum of 2 forward translations by translators from different target countries if applicable. Minimum of 2 forward translations by translators from “Mother” language.
3 Reconciliation Forward translations are reconciled into one translation, with several options to accommodate translation company practices. Universal approach seeks to find a solution that works across target countries. Rationale documented. Forward translations are reconciled into one translation in “Mother” language, with several options to accommodate translation company practices. Rationale documented.
4 Back-translation Conduct at least one back-translation of the reconciled forward translation. (Back-translator to be kept blind to source questionnaire and Item Definition Table.) Conduct at least one back-translation of the reconciled “Mother” forward translation. (Back-translator to be kept blind to source questionnaire and Item Definition Table.)
5 Revision of Reconciled Forward Translation Evaluate back-translation to assess semantic equivalence [14] and identify issues in the reconciled translation, agree on revisions needed, taking into consideration feedback from multiple target countries, and implement changes. Evaluate back-translation to assess semantic equivalence [14] and identify issues in the reconciled translation, agree on revisions needed, and implement changes.
5A Adaptation of “mother” target language for other countries (country-specific only) Not applicable. Two parallel reviewers from each target country review “Mother” language version and propose changes to suit their country. Reconciliation of the two adaptations as in Step 3, back-translation of adapted items and evaluation of issues, and revision as needed based on back-translation evaluation.
6 International Harmonization All languages in the project are reviewed for consistency and conceptual equivalence with each other and the original language version. All languages in the project are reviewed for consistency and conceptual equivalence with each other and the original language version.
7 Proofreading Two or more proofreaders from different target countries check translation, and correct any remaining spelling, diacritical, grammatical or other errors; clinician review is optional. In-country affiliate(s) review translation separately. Two or more proofreaders for “Mother” language and adaptations check translation, and correct any remaining spelling, diacritical, grammatical or other errors; clinician review is optional. In-country affiliate(s) review translation separately.
8 Cognitive Interviewing Pilot testing and cognitive interviewing conducted in each target country, with a minimum of 5 participants per language/country who match the target population for as many criteria as reasonably practical. In-person where possible. Testing to be done for target language in each target country in the study associated with that language (e.g., for German, conduct pilot testing in both Germany and Austria). If another relevant country is added in the future, additional cognitive interviews with the universal version in the new country (e.g., Switzerland) need to be conducted. Pilot testing and cognitive interviewing conducted in each target country, with a minimum of 5 participants per language/country who match the target population for as many criteria as reasonably practical. In-person where possible.
9 Post-Cognitive Interview Review
(Analysis/Revisions)
Review cognitive interview results and compile feedback for translation team resolution. Agree on any revisions to reconciled forward translation identified during cognitive interviews. Review cognitive interview results and compile feedback for translation team resolution. Agree on any revisions to reconciled forward translation or adaptations identified during cognitive interviews.
10 Final Review and Documentation (Proofreading) Ensure proposed revision maintains conceptual equivalence and does not threaten international harmonization for future data pooling purposes, implement revisions, proofread revised translations, and document any relevant alternatives in the Item Definition Table. Conduct final proofreading of measure translations (format/layout) for mode(s) of implementation (e.g., screen shots, paper) to identify any mistakes or errors that may impact integrity of data collection. Ensure proposed revision maintains conceptual equivalence and does not threaten international harmonization for future data pooling purposes, implement revisions, proofread revised translations or adaptations, and document any relevant alternatives in the Item Definition Table. Conduct final proofreading of measure translations (format/layout) for mode(s) of implementation (e.g., screen shots, paper) to identify any mistakes or errors that may impact integrity of data collection.
11 Report Prepare final summary report documenting development of each translation and providing description of all translation and cultural adaptation decisions. Prepare final summary report documenting development of each translation or adaptation and providing description of all translation and cultural adaptation decisions.
12 Archiving/Record-keeping Documentation to be archived:
• Qualifications and experience of translation team
• Documentation of changes made throughout the translation work and rationale for changes
• Translation certificates
• Translation report including results of cognitive interviews
Same as Universal approach.
  1. aIn a country-specific translation situation where many countries using that language may need to be included in a study, one of the languages referred to as the “Mother” language is chosen to undergo the initial steps of forward translation, reconciliation, and back-translation. At that point, the “Mother” language version can be adapted for use in other countries without having to start from the beginning. An example would be German, where Germany would be chosen as the “Mother” language, and used as the basis for German adaptations for Austria and Switzerland