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Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study
Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0002-5865-5590
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2019 (English)In: Frontiers in Pharmacology, ISSN 1663-9812, E-ISSN 1663-9812, Vol. 10, no 1395Article in journal (Refereed) Published
Abstract [en]

Objectives: To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed and conducted to allow for inclusion of patient preferences in decision-making along the medical product life cycle (MPLC), and how patient preferences can be used in such decision-making.

Methods: Two literature reviews and semi-structured interviews (n = 143) with healthcare stakeholders in Europe and the US were conducted; results of these informed the design of focus group guides. Eight focus groups were conducted with European patients, industry representatives and regulators, and with US regulators and European/Canadian health technology assessment (HTA) representatives. Focus groups were analyzed thematically using NVivo.

Results: Stakeholder perspectives on how PPS should be designed and conducted were as follows: 1) study design should be informed by the research questions and patient population; 2) preferred treatment attributes and levels, as well as trade-offs among attributes and levels should be investigated; 3) the patient sample and method should match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from PPS should be shared with relevant stakeholders. The value of patient preferences in decision-making was found to increase with the level of patient preference sensitivity of decisions on medical products. Stakeholders mentioned that patient preferences are hardly used in current decision-making. Potential applications for patient preferences across industry, regulatory and HTA processes were identified. Four applications seemed most promising for systematic integration of patient preferences: 1) benefit-risk assessment by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4) multi criteria decision analysis in HTA.

Conclusions: The value of patient preferences for decision-making depends on the level of collaboration across stakeholders; the match between the research question, MPLC phase, sample, and preference method used in PPS; and the sensitivity of the decision regarding a medical product to patient preferences. Promising applications for patient preferences should be further explored with stakeholders to optimize their inclusion in decision-making.

Place, publisher, year, edition, pages
2019. Vol. 10, no 1395
Keywords [en]
patient preferences, medical products, decision-making, health technology assessment, marketing authorization
National Category
Social and Clinical Pharmacy
Identifiers
URN: urn:nbn:se:uu:diva-398215DOI: 10.3389/fphar.2019.01395ISI: 000505681700001PubMedID: 31849657OAI: oai:DiVA.org:uu-398215DiVA, id: diva2:1374936
Projects
IMI-PREFER
Note

Jorien Veldwijk and Isabelle Huys share last authorship.

Available from: 2019-12-03 Created: 2019-12-03 Last updated: 2020-01-28Bibliographically approved

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