Introduction to Patient-Reported Outcomes

Presentation
Teaching
Organisation
Courses concerned

Learning outcomes

Introduction to Patient reported outcomes

Goals

Become familiar with the added value, development, validation of patient-reported outcomes and their role in clinical trials

Content

Part I: Introduction to patient centered medicine development and PRO

Part II : PRO development and validation

Part III: Implementation of PRO in clinical trials

Part IV: Interpretation of PROs

Part V: multicultural context

Exercices

Assessment method

course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 10 pages reflection about a theme discussed during the courses).

The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.

Sources, references and any support material

ISPOR PRO Task Forces (http://www.ispor.org/taskforces/tfindex.asp.) examples below:
- Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force. http://www.ispor.org/workpaper/PROchildrenadolescents/Matza_et_al_2013_…
- Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation http://www.ispor.org/workpaper/research_practices/PROTranslation_Adapta…
- Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification:TheISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PROTaskForce Report http://www.ispor.org/taskforces/documents/Rothman.pdf
- Clinical Outcomes Assessment –Emerging Good Practices Task Force. http://www.ispor.org/TaskForces/Clinical-Outcomes-Assessment.asp
- Liu, Eggleston, HU. Emerging Health Economics and Outcomes Research in the Asia-Pacific Region. Values in Health 11 suppl. 1 2008 S1-SS2
- Draft and Final Guidance to Industry (FDA) http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf
- EMA Reflections Paper http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf
- de Vet, H. C., C. B. Terwee, et al. (2006). "Minimal changes in health status questionnaires: distinction between minimally detectable change and minimallyimportant change." Health QualLife Outcomes4: 54.
- Deyo, R. A., P. Diehr, et al. (1991). "Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation." Control ClinTrials12(4 Suppl): 142S-158S.

Language of instruction

French

Training	Study programme	Block	Credits
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique	Standard	0	2
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique	Standard	0	2
Master 120 en sciences biomédicales à finalité spécialisée en recherche préclinique	Standard	2	2
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique	Standard	2	2