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Design, Conduct, an...
Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle : A Multi-Method Study
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- van Overbeeke, Eline (författare)
- Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
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- Janssens, Rosanne (författare)
- Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
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- Whichello, Chiara (författare)
- School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands
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- Schölin Bywall, Karin (författare)
- Uppsala universitet,Centrum för forsknings- och bioetik
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- Sharpe, Jenny (författare)
- Muscular Dystrophy UK, London, United Kingdom
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- Nikolenko, Nikoletta (författare)
- John Walton Muscular Dystrophy Research Centre, Newcastle University, Newcastle, United Kingdom
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- Philips, Berkeley S. (författare)
- Pfizer, Tadworth, United Kingdom,Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
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- Guiddi, Paolo (författare)
- Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy
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- Pravettoni, Gabriella (författare)
- Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
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- Vergani, Laura (författare)
- Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
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- Marton, Giulia (författare)
- Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
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- Cleemput, Irina (författare)
- Belgian Health Care Knowledge Centre, Brussels, Belgium
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- Simoens, Steven (författare)
- Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
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- Kübler, Jürgen (författare)
- Quantitative Scientific Consulting, Marburg, Germany
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- Juhaeri, Juhaeri (författare)
- Sanofi, Bridgewater, NJ, United States
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- Levitan, Bennet (författare)
- Janssen Research & Development, Titusville, NJ, United States
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- de Bekker-Grob, Esther W. (författare)
- School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands
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- Veldwijk, Jorien (författare)
- School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands
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- Huys, Isabelle (författare)
- Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium
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(creator_code:org_t)
- 2019-12-03
- 2019
- Engelska.
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Ingår i: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 10:1395
- Relaterad länk:
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https://doi.org/10.3...
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https://doi.org/10.3...
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https://www.frontier...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.3...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Samhällsfarmaci och klinisk farmaci (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Social and Clinical Pharmacy (hsv//eng)
Nyckelord
- patient preferences
- medical products
- decision-making
- health technology assessment
- marketing authorization
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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van Overbeeke, E ...
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Janssens, Rosann ...
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Whichello, Chiar ...
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Schölin Bywall, ...
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Sharpe, Jenny
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Nikolenko, Nikol ...
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visa fler...
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Philips, Berkele ...
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Guiddi, Paolo
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Pravettoni, Gabr ...
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Vergani, Laura
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Marton, Giulia
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Cleemput, Irina
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Simoens, Steven
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Kübler, Jürgen
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Juhaeri, Juhaeri
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Levitan, Bennet
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de Bekker-Grob, ...
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Veldwijk, Jorien
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Huys, Isabelle
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Medicinska och f ...
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och Samhällsfarmaci ...
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Frontiers in Pha ...
- Av lärosätet
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Mälardalens universitet
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Uppsala universitet