Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study

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. Two literatu...

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Veröffentlicht in:Frontiers in Pharmacology Jg. 10; H. 1395; S. 1395
Hauptverfasser: van Overbeeke, Eline, Janssens, Rosanne, Whichello, Chiara, Schölin Bywall, Karin, Sharpe, Jenny, Nikolenko, Nikoletta, Phillips, Berkeley S., Guiddi, Paolo, Pravettoni, Gabriella, Vergani, Laura, Marton, Giulia, Cleemput, Irina, Simoens, Steven, Kübler, Jürgen, Juhaeri, Juhaeri, Levitan, Bennett, de Bekker-Grob, Esther W., Veldwijk, Jorien, Huys, Isabelle
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Switzerland Frontiers Media SA 03.12.2019
Frontiers Media S.A
Schlagworte:
decision-making
Decision-making; Health technology assessment; Marketing authorization; Medical products; Patient preferences
health technology assessment
marketing authorization
medical products
patient preferences
Pharmacology
RM1-950
Samhällsfarmaci och klinisk farmaci
Social and Clinical Pharmacy
Therapeutics. Pharmacology
health technology assessment
marketing authorization
decision-making
patient preferences
medical products
ISSN:1663-9812, 1663-9812
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Zusammenfassung: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. 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. 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. 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.
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Reviewed by: Dušanka Miloša Krajnović, University of Belgrade, Serbia; Hanna Evelina Sidjabat, University of Queensland, Australia
These authors share last authorship
This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology
Edited by: Liset Van Dijk, Netherlands Institute for Health Services Research, Netherlands
ISSN:1663-9812
1663-9812
DOI:10.3389/fphar.2019.01395