Why do companies want to develop new patient-reported outcomes (PRO)?
How does the process start when we want to develop a new questionnaire?
What are the key areas to look into for understanding the quality of a PRO?
What guidelines exist on developing new PROs?

In today’s episode, Antoine and I answer these questions and more. E.g. we talk about the importance of calibrating the relevance of the existing items in the questionnaire and developing new ones in order to reach more accurate measurements resulting in good PROs.

Stay tuned and listen while we also cover the following points:
  • How do capitalizing on existing instruments while improving them produce good patient-reported outcomes?
  • What is an “Item Bank”?
  • What is the data you need to gather first before developing new instruments and items?

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Antoine Regnault

Ph.D., Global Lead – Statistics; Modus Outcomes, A Division of THREAD

Antoine is a biostatistician with a strong interest in measurement science applied to patient-centered outcomes. As a consultant, he uses his combined skillset in psychometrics and statistics to support pharmaceutical companies with their analyses of patient-centered outcomes data from clinical trials and observational studies in a wide variety of disease areas (oncology, hematology, neurology and rare diseases, among others). Antoine has co-authored more than 40 peer-reviewed papers on analysis of patient-centered outcomes data and has been an active member of the International Society of Quality of Life (ISOQOL), where he currently co-chairs the Statistics Special Interest Group, and of several international research initiatives such as SISAQOL-IMI, SPIRIT-PRO and NeuroMET-2.

Cleanthous 2020 MG Symptoms PRO
Regnault 2021 MDS

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I want to help the community of statisticians, data scientists, programmers and other quantitative scientists to be more influential, innovative, and effective. I believe that as a community we can help our research, our regulatory and payer systems, and ultimately physicians and patients take better decisions based on better evidence.

I work to achieve a future in which everyone can access the right evidence in the right format at the right time to make sound decisions.

When my kids are sick, I want to have good evidence to discuss with the physician about the different therapy choices.

When my mother is sick, I want her to understand the evidence and being able to understand it.

When I get sick, I want to find evidence that I can trust and that helps me to have meaningful discussions with my healthcare professionals.

I want to live in a world, where the media reports correctly about medical evidence and in which society distinguishes between fake evidence and real evidence.

Let’s work together to achieve this.