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BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 1/2019

Open Access 01-12-2019 | Research article

Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review

Authors: Rosanne Janssens, Isabelle Huys, Eline van Overbeeke, Chiara Whichello, Sarah Harding, Jürgen Kübler, Juhaeri Juhaeri, Antonio Ciaglia, Steven Simoens, Hilde Stevens, Meredith Smith, Bennett Levitan, Irina Cleemput, Esther de Bekker-Grob, Jorien Veldwijk

Published in: BMC Medical Informatics and Decision Making | Issue 1/2019

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Abstract

Background

The inclusion of patient preferences (PP) in the medical product life cycle is a topic of growing interest to stakeholders such as academics, Health Technology Assessment (HTA) bodies, reimbursement agencies, industry, patients, physicians and regulators. This review aimed to understand the potential roles, reasons for using PP and the expectations, concerns and requirements associated with PP in industry processes, regulatory benefit-risk assessment (BRA) and marketing authorization (MA), and HTA and reimbursement decision-making.

Methods

A systematic review of peer-reviewed and grey literature published between January 2011 and March 2018 was performed. Consulted databases were EconLit, Embase, Guidelines International Network, PsycINFO and PubMed. A two-step strategy was used to select literature. Literature was analyzed using NVivo (QSR international).

Results

From 1015 initially identified documents, 72 were included. Most were written from an academic perspective (61%) and focused on PP in BRA/MA and/or HTA/reimbursement (73%). Using PP to improve understanding of patients’ valuations of treatment outcomes, patients’ benefit-risk trade-offs and preference heterogeneity were roles identified in all three decision-making contexts. Reasons for using PP relate to the unique insights and position of patients and the positive effect of including PP on the quality of the decision-making process. Concerns shared across decision-making contexts included methodological questions concerning the validity, reliability and cognitive burden of preference methods. In order to use PP, general, operational and quality requirements were identified, including recognition of the importance of PP and ensuring patient understanding in PP studies.

Conclusions

Despite the array of opportunities and added value of using PP throughout the different steps of the MPLC identified in this review, their inclusion in decision-making is hampered by methodological challenges and lack of specific guidance on how to tackle these challenges when undertaking PP studies. To support the development of such guidance, more best practice PP studies and PP studies investigating the methodological issues identified in this review are critically needed.
Appendix
Available only for authorised users
Footnotes
1
Synonyms for attributes in literature are “characteristics”, “features”, “objects” or “criteria”.
 
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Metadata
Title
Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review
Authors
Rosanne Janssens
Isabelle Huys
Eline van Overbeeke
Chiara Whichello
Sarah Harding
Jürgen Kübler
Juhaeri Juhaeri
Antonio Ciaglia
Steven Simoens
Hilde Stevens
Meredith Smith
Bennett Levitan
Irina Cleemput
Esther de Bekker-Grob
Jorien Veldwijk
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2019
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-019-0875-z

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