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An overview of crit...
An overview of critical decision-points in the medical product lifecycle : Where to include patient preference information in the decision-making process?
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- Whichello, Chiara (författare)
- Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
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- Schölin Bywall, Karin (författare)
- Uppsala universitet,Centrum för forsknings- och bioetik
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- Mauer, Jonathan (författare)
- Pfizer, Inc., 500 Arcola Road, 19426 Collegeville, PA, USA
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- Watt, Stephen (författare)
- Pfizer Inc., 235 East 42ndStreet, 10017 New York, NY, USA
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- Cleemput, Irina (författare)
- Belgian Health Care Knowledge Centre (KCE), Doorbuilding (10th floor), Kruidtuinlaan 55, 1000 Brussels, Belgium
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- Pinto, Cathy Anne (författare)
- Merck & Co., Inc., Kenilworth, NJ, USA
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- van Overbeeke, Eline (författare)
- Clincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium
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- Huys, Isabelle (författare)
- Clincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium
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- de Bekker-Grob, Esther W. (författare)
- Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
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- Hermann, Richard (författare)
- AstraZeneca Pharmaceuticals L.P, One MedImmune Way, 20878 Gaithersburg, MD, USA
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- Veldwijk, Jorien (författare)
- Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
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Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, PO. Box 1738, 3000DR Rotterdam,The Netherlands Centrum för forsknings- och bioetik (creator_code:org_t)
- Elsevier BV, 2020
- 2020
- Engelska.
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Ingår i: Health Policy. - : Elsevier BV. - 0168-8510 .- 1872-6054. ; 124:12, s. 1325-1332
- Relaterad länk:
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https://doi.org/10.1...
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https://doi.org/10.1...
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https://doi.org/10.1...
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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/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- BackgroundPatient preference (PP) information is not effectively integrated in decision-making throughout the medical product lifecycle (MPLC), despite having the potential to improve patients’ healthcare options. A first step requires an understanding of existing processes and decision-points to know how to incorporate PP information in order to improve patient-centric decision-making.ObjectivesThe aims were to: 1) identify the decision-making processes and decision-points throughout the MPLC for industry, regulatory authorities, and reimbursement/HTA, and 2) determine which decision-points can potentially include PP information.MethodsA scoping literature review was conducted using five scientific databases. Semi-structured interviews were conducted with representatives from seven European countries and the US, including industry (n = 24), regulatory authorities (n = 23), reimbursement/HTA (n = 23). Finally, validation meetings with key stakeholders (n = 11) were conducted.ResultsSix critical decision-points were identified for industry decision-making, three for regulatory decision-making, and six for reimbursement/HTA decision-making. Stakeholder groups agreed that PP information is not systematically integrated, either as obligatory information or pre-set criteria, but would benefit all the listed decision-points in the future.ConclusionCurrently, PP information is not considered as obligatory information to submit for any of the MPLC decision-points. However, PP information is considered an important component by most stakeholders to inform future decision-making across the MPLC. The integration of PP information into 15 identified decision-points needs continued discussion and collaboration between stakeholders.
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)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Medicinsk etik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Medical Ethics (hsv//eng)
Nyckelord
- Patient preferences
- Patient preference information
- Decision-Making
- HTA decision-making
- Regulatory decision-making
- Industry decision-making
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- ref (ämneskategori)
- art (ämneskategori)
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Whichello, Chiar ...
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Schölin Bywall, ...
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Mauer, Jonathan
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Watt, Stephen
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Cleemput, Irina
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Pinto, Cathy Ann ...
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van Overbeeke, E ...
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Huys, Isabelle
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de Bekker-Grob, ...
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Hermann, Richard
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Veldwijk, Jorien
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