Valuing patient engagement: Reflexive learning in evidence generation practices for health technology assessment

Callum J. Gunn*, Neil Bertelsen, Barbara J. Regeer, Tjerk Jan Schuitmaker-Warnaar

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Much attention in health technology assessment (HTA), a health system governance mechanism used for determining the value of health technologies, is being paid to improving the quality and patient-relevance of the evidence used in assessment pratices. Whilst the direct involvement of patient actors throughout HTA processes has become a more routine element of institutional practice, the ‘impacts’ of patient engagement (PE) initiatives have proven difficult to determine and enhance. In reflexive governance theories, reflexive learning is a critical mechanism of multi-stakeholder arrangements that better handles the complexities of technologies and how they are understood through governance practices. This paper explores how reflexive learning can be used to build a richer conceptualisation of PE in HTA, in order to generate suggestions for enhancing PE practices and their impact. We critically apply reflexive learning insights on qualitative data derived from the co-creation process of a PE evaluation framework, organised through an EU project focused on strengthening PE practices across medicines development (2018–2020), including 24 interactive case studies, 3 multi-stakeholder workshops, and our observations throughout the project. The findings characterise two dimensions of reflexive learning in PE: First, reflexive learning refers to the adaptive reorganisation of evidence generating practices, including the revision of medicines' evaluation criteria and the conditions under which evidence ‘relevant’ to HTA is constructed. Second, reflexive learning spotlights the sociopolitics which shape technology evaluation. Four themes affecting meaningful and sustained PE in medicines development were analysed: institutional boundaries due to established evaluation criteria; timing of engagements; network relations between institutional actors; and the politics of patient representation. Extending beyond discrete PE activities and their reported impacts, reflexive forms of learning are crucial to yielding more ‘meaningful’ PE for HTA and medicines development, facilitating a HTA practice that more meaningfully deals with the complexities of medicines evidence generation.

Original languageEnglish
Article number114048
Pages (from-to)1-9
Number of pages9
JournalSocial Science & Medicine
Volume280
Early online date21 May 2021
DOIs
Publication statusE-pub ahead of print - 21 May 2021

Bibliographical note

Funding Information:
This work has been financed by the IMI-PARADIGM project. PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines) received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777450. We thank the WP3 research team (Lea Darvey, Teresa Finlay, Sevgi Fruytier, Nicole Goedhart, Laiba Husain, and Lidewij Vat) and all WP3 partners for their contributions to the PARADIGM project. We are grateful to Ann Single and Jetske Erisman for their insightful comments on the drafts, and for the efforts taken by three anonymous reviewers and the editors in providing constructive and valuable feedback.

Funding Information:
This research took place in the context of the IMI-PARADIGM (2018–2020) project. PARADIGM (a project funded by the Innovative Medicines Initiative, a public-private partnership between European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations, EFPIA) focused on PE throughout the medicines development lifecycle. Project partners include representatives of the pharmaceutical industry, regulatory/HTA and payers organisations; patient organisations; and academia. PARADIGM aims to develop tools and resources for organisations within medicines development to support PE practices, including monitoring and evaluation. Work Package 3 (WP3), led by a research team including the first and last authors, co-developed a monitoring and evaluation framework of metrics for measuring PE impact ( Vat et al., 2021 ), which aims to facilitate organisations in developing PE (evaluation) strategies. To develop this framework, WP3 collated and analysed a range of PE initiative ‘case studies’ (n = 24) as well as organising two multi-stakeholder workshops (March 2019, April 2020) which focused on PE in three distinct but interlinked ‘stages’ of medicines development – 1) research priority setting, 2) design of clinical trials, and 3) early dialogues between medicines developers and HTA and regulatory agencies.

Funding Information:
This work has been financed by the IMI-PARADIGM project. PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines) received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777450 . We thank the WP3 research team (Lea Darvey, Teresa Finlay, Sevgi Fruytier, Nicole Goedhart, Laiba Husain, and Lidewij Vat) and all WP3 partners for their contributions to the PARADIGM project. We are grateful to Ann Single and Jetske Erisman for their insightful comments on the drafts, and for the efforts taken by three anonymous reviewers and the editors in providing constructive and valuable feedback.

Publisher Copyright:
© 2021 The Authors

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

  • Evidence generation
  • Health technology assessment
  • Medicines evaluation
  • Patient engagement
  • Reflexive learning

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