We recently talked about back translations, first from the perspective of how/if they add value and then taking a look at how to tackle issues of discrepancy in meaning. Both posts generated good comments, most of them of the "back translations are not a good way to assess quality" type.
When translating health-related quality of life documents (HRQoL) or patient reported outcome (PRO) measures such as patient diaries, not only are back translations non-negotiable, they are also much more involved than a simple "backwards translation".
A group of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in 2005 evaluated a dozen guidelines concerning the translation of PROs. The group concluded that poorly translated measures threaten the validity of clinical research. ISPOR then set out to rectify the situation by proposing a robust and standardized process for producing translated measures and instruments that are fully validated.
ISPOR's Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures (PDF link) outlines this ten-step process:
- Forward Translation;
- Back Translation;
- Back Translation Review;
- Cognitive Debriefing;
- Review of Cognitive Debriefing Results and Finalization;
- Proofreading; and
- Final Report.
While this process might seem like overkill, it is, in fact, the only standardized means to produce fully validated translations. And in the case of clinical trials where hundreds of millions of dollars may be at stake, $20,000 in additional translation costs is nothing compared to potentially invalid research findings.
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Categories: clinical research