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Sökning: onr:"swepub:oai:DiVA.org:mdh-62347" > An overview of crit...

  • 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 ...

  • Elsevier BV,2020
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:mdh-62347
  • https://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-62347URI
  • https://doi.org/10.1016/j.healthpol.2020.07.007DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-417785URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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 och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Schölin Bywall, KarinUppsala universitet,Centrum för forsknings- och bioetik(Swepub:uu)karsc514 (författare)
  • Mauer, JonathanPfizer, Inc., 500 Arcola Road, 19426 Collegeville, PA, USA (författare)
  • Watt, StephenPfizer Inc., 235 East 42ndStreet, 10017 New York, NY, USA (författare)
  • Cleemput, IrinaBelgian Health Care Knowledge Centre (KCE), Doorbuilding (10th floor), Kruidtuinlaan 55, 1000 Brussels, Belgium (författare)
  • Pinto, Cathy AnneMerck & Co., Inc., Kenilworth, NJ, USA (författare)
  • van Overbeeke, ElineClincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium (författare)
  • Huys, IsabelleClincial Pharmacology and Pharmacotherapy, University of Leuven, Herestraat 49 - Box 521, 3000 Leuven, Belgium (författare)
  • 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)
  • Hermann, RichardAstraZeneca Pharmaceuticals L.P, One MedImmune Way, 20878 Gaithersburg, MD, USA (författare)
  • Veldwijk, JorienErasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, P.O. Box 1738, 3000DR Rotterdam,The Netherlands (författare)
  • 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)

Sammanhörande titlar

  • Ingår i:Health Policy: Elsevier BV124:12, s. 1325-13320168-85101872-6054

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