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An overview of crit...
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Whichello, ChiaraErasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
(författare)
An overview of critical decision-points in the medical product lifecycle : Where to include patient preference information in the decision-making process?
- Artikel/kapitelEngelska2020
Förlag, utgivningsår, omfång ...
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Elsevier BV,2020
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:mdh-62347
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https://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-62347URI
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https://doi.org/10.1016/j.healthpol.2020.07.007DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-417785URI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:art swepub-publicationtype
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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.
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Biuppslag (personer, institutioner, konferenser, titlar ...)
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Schölin Bywall, KarinUppsala universitet,Centrum för forsknings- och bioetik(Swepub:uu)karsc514
(författare)
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Mauer, JonathanPfizer, Inc., 500 Arcola Road, 19426 Collegeville, PA, USA
(författare)
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Watt, StephenPfizer Inc., 235 East 42ndStreet, 10017 New York, NY, USA
(författare)
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Cleemput, IrinaBelgian Health Care Knowledge Centre (KCE), Doorbuilding (10th floor), Kruidtuinlaan 55, 1000 Brussels, Belgium
(författare)
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Pinto, Cathy AnneMerck & Co., Inc., Kenilworth, NJ, USA
(författare)
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van Overbeeke, ElineClincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium
(författare)
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Huys, IsabelleClincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium
(författare)
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de Bekker-Grob, Esther W.Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
(författare)
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Hermann, RichardAstraZeneca Pharmaceuticals L.P, One MedImmune Way, 20878 Gaithersburg, MD, USA
(författare)
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Veldwijk, JorienErasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands
(författare)
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Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The NetherlandsCentrum för forsknings- och bioetik
(creator_code:org_t)
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Ingår i:Health Policy: Elsevier BV124:12, s. 1325-13320168-85101872-6054
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