Sanofi PRO Questionnaires

F.A.Q

Discover frequently asked questions about Sanofi's questionnaires.

Last update: February 2017

A PRO  questionnaire comprises one or several questions for the patients to describe how they feel and/or function. It could evaluate sleep, mood, physical activities, satisfaction with treatment or a multitude of other aspects of patients’ disease and/or medication. Disease symptoms such as pain or nausea can only be measured by PRO questionnaires as they cannot be observed by someone else and are only known by patients.

PRO questionnaires are developed with the help of patients and are phrased using patients’ own words.

Used in clinical trials, they are considered as a direct measure of patients’ disease and/or medication. They can also be used in clinical practice to help patients communicate with clinicians about their disease or medication.

They have to be completed by patients themselves, without any input from someone else. For patients who cannot respond for themselves (e.g. infants or cognitively impaired), we generally ask a parent, spouse or a non-clinical caregiver to evaluate events or behaviors that can be observed. In this case, we use observer-reported outcome (ObsRO) questionnaires.

As recommended by health regulatory authorities, these questionnaires should be well-defined, reliable and valid measures. With this in mind, Sanofi has used high levels of scientific standards and best practices to develop their questionnaires.

For consistency and interpretation of results, you should not modify a Sanofi PRO  questionnaire, unless you have received written authorization from Sanofi. By deleting or adding an item, modifying the response choices, the ordering of items, the recall period, or making any other modifications, you will alter the content and substance of the questionnaire which is considered well-defined, reliable and valid in its current form.

A PRO  questionnaire is a way to measure something. Any measure should show good measurement properties (also called psychometric properties) to give confidence in the data derived by that measure. In PRO science these measurement properties are often referred to as “psychometric validation”, and include assessments of reliability, validity, sensitivity to disease severity, and sensitivity to change. A PRO questionnaire that has undergone a psychometric validation with good results is considered well-defined, reliable and valid.

All Sanofi PRO  questionnaires were psychometrically validated. They are therefore considered well-defined, reliable and valid. For details on their validation, please refer to the corresponding page of each questionnaire on this website. You may also find more detailed information on psychometric validation in ePROVIDE™ (link provided on each questionnaire page) or within the validation references provided on each questionnaire page.

Each Sanofi PRO questionnaire has a specific scoring algorithm. Scoring instructions are provided with the Sanofi PRO questionnaire once the User Agreement is submitted. You may also find detailed information on scoring of the questionnaires in ePROVIDE™ (link provided on each questionnaire page) or within the validation references provided on each questionnaire page.

In order to use PRO  questionnaires in clinical trials, they should be available to all participants according to the languages commonly spoken in the participating countries. This is not a simple case of translating the questionnaires verbatim as the aim is to obtain a new language version that is:

  • conceptually equivalent to the original and comparable across languages;
  • culturally relevant to the context of the target country;
  • easily understood by the people to whom the translated instrument is administered.

 

A detailed linguistic validation process consists of the following steps:

  • A forward translation (by 2 translators from target country with reconciliation)
  • A backward translation (by one translator from original country)
  • Cognitive interviews  (testing of the new language version with 5 people (patients or healthy subjects))
  • Proofreading and finalization of the new language version
  • Production of a linguistic validation certificate

Sanofi has undertaken a rigorous conceptual translation and linguistic validation of its PRO questionnaires into many languages using the methodology described above (“What is a linguistic validation process?”). For additional information on available language versions for each instrument, please refer to the specific PRO questionnaire page.

To ensure similarly high levels of rigor in translating Sanofi’s PRO questionnaires, any agreement for use will insist on similar level of translation and linguistic validation to ensure the production of harmonized and consistent new languages.

For any information on electronic version availability of Sanofi PRO questionnaires please contact Mapi Research Trust. Mapi Research Trust is in charge of distribution of the Sanofi PRO questionnaires.

Sanofi PRO questionnaires and translations are protected by copyright with all rights reserved to Sanofi, and its development partners where relevant. The Sanofi PRO questionnaires are internationally distributed by Mapi Research Trust. Any user who wishes to use and/or translate the Sanofi PRO questionnaires must complete a User Agreement with Mapi Research Trust.