mpü process –
linguistic validation and cognitive debriefing of PRO

Since clinical trials/clinical studies are increasingly being conducted at an international level, there is also a growing need for translation, harmonisation and cultural adaptation of patient-reported outcome measures (PROM) and for linguistic validation of the PROMs.

For PROMs, you can select a complete package for linguistic validation including cognitive debriefing or just select individual steps.

mpü – your expert for linguistic validation with cognitive debriefing of PROM

Translations + patient recruitment + testing under one roof

• Process BEFORE the start of the study to ensure that the study participants understand the content of the questionnaires properly
  
  
• Translations, where appropriate with back translations, of all questionnaires that will need to be completed by the study participants during the study
  
  
• Translations and cultural adaptation in all languages of the study countries
  
  
• Patient recruitment in all languages of the study countries
  
  
• Implementation of the tests (cognitive debriefing) in the study countries
  
  
• Patients interpret and evaluate the study questionnaires translated into their mother tongue to determine how easy they are to understand with no interference by the interviewer 
  
  
• Depending on the result, the source text or the translation into individual languages may potentially need to be revised

mpü expertise

• mpü will support you with the development of strategies from the first steps of linguistic validation including the cognitive debriefing of PROMs.
   
• mpü will provide reliable PRO instruments which enable the successful implementation of your global studies.
  
  
• The mpü processes guarantee official acceptance.

Our network – your success

The global mpü network of

• Medical translators
• Subject experts
• Doctors
• In-country reviewers and interviewers
• Linguistic validators

means we have the option to carry out both the patient recruitment and the cognitive debriefing in the target country. Through this mpü procedure, we can ensure the scientific accuracy of the PROMs.

The cognitive debriefing of the translated document is a step that is critical to the results. This process allows us to ensure that all patients understand the PROMs correctly and in the same way and are able to complete them in all target languages at a subsequent stage in the study.

From a linguistic perspective, each mpü project is equivalent in all languages. You can rely on your data from all countries being able to be pooled for the statistical analyses.

The quality standard for linguistic validation processes and the cognitive debriefing of PRO

The mpü expertise in the field of the translation and harmonisation of paper-based or electronic PRO instruments is based on our focus on translations of documents for globally active pharmaceutical companies and CROs.

The mpü processes and quality standard for the linguistic validation and the cognitive debriefing of PROMs follow all important guidelines: 

• PRO guideline of the American Food and Drug Administration (FDA) 
• Regulations of the European Medicines Agency (EMA)
• ICH-GCP standards
• Guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).