Clinical trials play an important role in getting new drugs, treatments and medical devices to market. During these trials, patient-reported outcomes (PROs) are common instruments used to gather patient perspectives. The importance of accurate translation and cultural adaptation of PROs for international clinical trials cannot be overestimated.

To get the most accurate patient-reported outcome (PRO) translations for your clinical trial, follow these 10 steps:

1. Prepare

Get permission to translate the patient-reported outcome. Involve the instrument developer if possible. Clarify information used in the instrument to help establish conceptual equivalence. Bring an in-country expert for each target language you need a translation for on board.

2. Translate

Now is where the fun begins! Recruit translators who are native speakers of the target language and who have previous experience translating patient-reported outcomes. Instruct the translators with everything they need to know, including background information, clear explanations of the concepts used in the PRO and any required preferences. Have two or more translators create independent translations.

3. Reconcile

Decide who should be involved with the translation reconciliation process. One example is a qualified translator who did not translate the PRO. A second example is a committee of the in-country expert, the project manager and the original translators. Reconcile the original independent translations into a single unified translation.

4. Back Translate

Make sure the back translators are native speakers of the PRO’s source language. Depending on the type of content, instruct them to do a literal back translation or a conceptual one. Then have the translators back translate the reconciled translation. This helps with quality control.  

5. Review the Back Translation

For each language, the project manager and the in-country expert review the back translation and compare it to the original patient-reported outcome. They identify any problem areas and have the translation corrected.

6. Harmonize

Harmonization helps ensure conceptual equivalence among the original patient-reported outcome and all translations. However, it can be achieved in a number of ways. One example is a harmonization conference that involves in-country experts and back translators. Another example is a review and resolution process involving the project manager and the in-country experts.

7. Perform Cognitive Debriefing

Does the translation do what it’s supposed to do? Now it’s time to test that. For each language, the in-country expert should test the translation for cognitive equivalence and comprehensibility with patients or groups who represent the PRO’s target population.

8. Review Cognitive Debriefing

What happened in the cognitive debriefing? Did the translation stand up in the field? The project manager reviews the results and identifies any issues that arose. If so, the in-country expert and the project manager have the translation modified.

9. Proofread

A proofreader performs a final quality check and corrects any errors in grammar, spelling, etc.  that may have been missed.

10. Finalize

The project manager creates a final report to document the translation process. He or she describes the methodology used to create the translations as well as explains the thought process behind different translation decisions. This is an important step in reporting requirements.

11. Celebrate

Now that your accurately translated patient-reported outcome is ready to be used in the field, it’s time to celebrate. Your clinical trial is one step closer to the finish line!