Sanofi PRO Questionnaires

Capturing the patient’s perspective through Patient-Reported Outcome questionnaires

Health is more than the absence of disease. It has physical, social and psychological components that can only be understood by asking and listening to those who have ill health and/or require medication. For more than 20 years, Sanofi has explored how diseases and medication impact patients’ daily life through the use of Patient-Reported Outcome (PRO) questionnaires. These questionnaires capture the perspective of those who are living with the disease on many topics of central importance for them, such as disease signs and symptoms, physical functioning, quality of life, satisfaction, or medication side-effects.

We have implemented many existing PRO questionnaires in our clinical programs over the years. When existing questionnaires were inadequate or concepts of importance to patients had not been previously evaluated, we developed new PRO questionnaires. These questionnaires were developed alongside patients in a scientifically rigorous manner to ensure robust and holistic evaluation of things that matter to them. This website presents the PRO questionnaires developed by Sanofi and those currently in development, to all who may be interested: pharmaceutical companies, academics, clinicians, and patients.

Our PRO Questionnaires


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PRO questionnaires

Latest News

Important discussions at the Drug Information Association (DIA) Study Endpoints Community conference, 2018

The 2018 DIA Study Endpoints Community conference was held in September in Bethesda, Maryland. The conference brought together health care professionals involved in the selecting, developing, analysing, and interpreting of study endpoints. The focus was on advancing the scientific development and evaluation of study endpoints and educating other health care professionals about these developments. The congress agenda was broad, but all sessions emphasised patient-centricity, which has afforded significant innovations in how patients can be involved in endpoint development and selection in the past few years. Of particular interest was discussion around whether regulatory, payer and patient perspectives on the value of study endpoints can align, and whether core outcome sets for consistent measurement and analysis would facilitate this alignment. Core outcome sets are being developed by numerous organisations, including the Center for Medical Technology Policy (CMTP) and the International Consortium for Health Outcome Measurement (ICHOM) and recently the FDA send a request for information to facilitate their consideration of the value of core outcome sets in certain disease areas. It will be interesting to see how this develops, and the central role of patient-reported outcome (PRO) measures in these. Another topic discussed in detail – and resonating with the Sanofi team - was the importance of measuring positive well-being; something which is rarely done. Rather we focus on the absence of negative well-being, which of course is not the same thing at all.

02-Oct-2018 17:03 Read more

Webinar on PACT-Q

In collaboration with Mapi Research Trust, Sanofi is organizing a free educational webinar dedicated to the Perception of Anticoagulant Treatment Questionnaire (PACT-Q) on Thursday, September 27, 2018. The PACT-Q is a valid and reliable instrument that allows the assessment of patients' expectations and satisfaction regarding anticoagulant treatment, as well as their opinion about treatment convenience of use. The objective of this webinar is to present the rationale for developing the PACT-Q, its development and validation, and its conditions of use, as well as its description among other PRO questionnaires within the Sanofi PRO questionnaire website. Please register today to this event and join our expert webinar hosts from Sanofi and Mapi to gain insight into how the health research and pharmaceutical community can use the PACT-Q in clinical research studies.

20-Sep-2018 09:13 Read more

Understanding personalised definitions of health

A recent research paper highlights the heterogeneity in peoples opinions about their health status. A small qualitative study, published in Expert Review of Pharmacoeconomics & Outcomes Research, explored the personalised health perspectives of 14 adults with self-reported diagnoses of cardiovascular disease (CVD). People were asked to segment a 0-100 scale (from the EuroQol 5-dimension questionnaire) into sections to show the boundaries between their own definitions of “poor”, “fair”, “good” and “excellent” health.  There was a notable variability in where people drew the boundaries; the poor-fair boundary ranged between 10 and 50; fair-good between 40 and 75; and good-excellent between 60 and 91. Usually, when looking at PRO data, it is inherently assumed that a self-reported health score has the same meaning for all i.e. a score of 40 for three separate respondents would be indicative of the same level of health status. However, the above study suggests that if three respondents provided a rating of 40 on the scale, one may believe that their health was good, another fair, and the third, poor. Similarly, respondents providing a rating of 60 could consider themselves to be in excellent, good, or just fair overall health. This finding underscores the challenges in interpreting self-reported health scores. The article proposes use of a personalised framework for gathering individual definitions of health and using this information to interpret clinical meaning of PRO data for an individual patient. We believe that this is essential if PROs are to provide informative and useful data to researchers, healthcare providers, regulators, and patients.

19-Sep-2018 17:01 Read more