Appraising patient preference methods for decision-making in the medical product lifecycle: an empirical comparison

Author:

Whichello ChiaraORCID,Levitan Bennett,Juhaeri Juhaeri,Patadia Vaishali,DiSantostefano Rachael,Pinto Cathy Anne,de Bekker-Grob Esther W.

Abstract

Abstract Background Incorporating patient preference (PP) information into decision-making has become increasingly important to many stakeholders. However, there is little guidance on which patient preference assessment methods, including preference exploration (qualitative) and elicitation (quantitative) methods, are most suitable for decision-making at different stages in the medical product lifecycle (MPLC). This study aimed to use an empirical approach to assess which attributes of PP assessment methods are most important, and to identify which methods are most suitable, for decision-makers’ needs during different stages in the MPLC. Methods A four-step cumulative approach was taken: 1) Identify important criteria to appraise methods through a Q-methodology exercise, 2) Determine numerical weights to ascertain the relative importance of each criterion through an analytical hierarchy process, 3) Assess the performance of 33 PP methods by applying these weights, consulting international health preference research experts and review of literature, and 4) Compare and rank the methods within taxonomy groups reflecting their similar techniques to identify the most promising methods. Results The Q-methodology exercise was completed by 54 stakeholders with PP study experience, and the analytical hierarchy process was completed by 85 stakeholders with PP study experience. Additionally, 17 health preference research experts were consulted to assess the performance of the PP methods. Thirteen promising preference exploration and elicitation methods were identified as likely to meet decision-makers’ needs. Additionally, eight other methods that decision-makers might consider were identified, although they appeared appropriate only for some stages of the MPLC. Conclusions This transparent, weighted approach to the comparison of methods supports decision-makers and researchers in selecting PP methods most appropriate for a given application.

Funder

Innovative Medicines Initiative

Publisher

Springer Science and Business Media LLC

Subject

Health Informatics,Health Policy,Computer Science Applications

Reference43 articles.

1. Meredith Y, Tarek A, Marilyn M, Bennett L, Rebecca N, Anne M, et al. Patient engagement at a tipping point—the need for cultural change across patient, sponsor, and regulator stakeholders: insights from the DIA conference. Thrapeutic Innov Regul Sci. 2016;50(5):546–53.

2. FDA, “Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling;” 2016. Docket Number: FDA-2015-D-1580, 2016.

3. Center for Devices and Radiological Health (CDRH), “Guidance for Industry and Food and Drug Administration Staff: Factors to Conider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” Food and Drug Administration (FDA); 2016. Docket No. FDA-2011-D-0577, 2012.

4. Center for Devices and Radiological Health (CDRH), “Factors to consider when making benefit-risk determinations for medical device investigational device exemptions,” Food and Drug Administration (FDA); 2017. Docket No. FDA-2015-D-1777, 2017.

5. Center for Devices and Radiological Health (CDRH), “Factors to Consider Regarding BenefitRisk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” Food and Drug Administration (FDA); 2016. Docket No. FDA-2016-D-1495, 2016.

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