An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?
Health Policy
; 124(12): 1325-1332, 2020 Dec.
Article
em En
| MEDLINE
| ID: mdl-32839011
ABSTRACT
BACKGROUND:
Patient 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.OBJECTIVES:
The 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.METHODS:
A 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.RESULTS:
Six 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.CONCLUSION:
Currently, 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Avaliação da Tecnologia Biomédica
/
Preferência do Paciente
Tipo de estudo:
Health_technology_assessment
/
Prognostic_studies
/
Qualitative_research
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Health Policy
Assunto da revista:
PESQUISA EM SERVICOS DE SAUDE
/
SAUDE PUBLICA
Ano de publicação:
2020
Tipo de documento:
Article