Which value aspects are relevant for the evaluation of medical devices? Exploring stakeholders’ views through a Web-Delphi process

BMC Health Services Research

Research

Liliana Freitas¹  Ana C. L. Vieira¹  Carlos A. Bana e Costa²  Mónica D. Oliveira³  Helena Monteiro⁴ 

[1] CEG-IST, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001, Lisbon, Portugal;CEG-IST, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001, Lisbon, Portugal;LSE Health-Medical Technology Research Group (MTRG), London School of Economics, Houghton St, WC2A 2AE, London, UK;CEG-IST, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1049-001, Lisbon, Portugal;iBB- Institute for Bioengineering and Biosciences and i4HB- Associate Laboratory Institute for Health and Bioeconomy, Instituto Superior Técnico, Universidade de Lisboa, Av. Rovisco Pais, 1, 1049-001, Lisbon, Portugal;Infarmed, I. P., Lisbon, Portugal;

关键词: Medical devices;    Health technology assessment;    Web-Delphi;    Health stakeholders;    Implantable medical devices;    In vitro tests based on biomarkers;   

DOI  :  10.1186/s12913-023-09550-0

 received in 2022-12-15, accepted in 2023-05-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundImplementation and uptake of health technology assessment for evaluating medical devices require including aspects that different stakeholders consider relevant, beyond cost and effectiveness. However, the involvement of stakeholders in sharing their views still needs to be improved.ObjectiveThis article explores the relevance of distinct value aspects for evaluating different types of medical devices according to stakeholders' views.MethodsThirty-four value aspects collected through literature review and expert validation were the input for a 2-round Web-Delphi process. In the Web-Delphi, a panel of participants from five stakeholders’ groups (healthcare professionals, buyers and policymakers, academics, industry, and patients and citizens) judged the relevance of each aspect, by assigning a relevance-level (‘Critical’, ‘Fundamental’, ‘Complementary’, or ‘Irrelevant’), for two types of medical devices separately: ‘Implantable’ and ‘In vitro tests based on biomarkers’. Opinions were analysed at the panel and group level, and similarities across devices were identified.ResultsOne hundred thirty-four participants completed the process. No aspects were considered ‘Irrelevant’, neither for the panel nor for stakeholder groups, in both types of devices. The panel considered effectiveness and safety-related aspects ‘Critical’ (e.g., ‘Adverse events for the patient’), and costs-related aspects ‘Fundamental’ (e.g., ‘Cost of the medical device’). Several additional aspects not included in existing frameworks’ literature, e.g., related to environmental impact and devices’ usage by the healthcare professional, were deemed as relevant by the panel. A moderate to substantial agreement across and within groups was observed.ConclusionDifferent stakeholders agree on the relevance of including multiple aspects in medical devices’ evaluation. This study produces key information to inform the development of frameworks for valuing medical devices, and to guide evidence collection.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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