Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action

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Abstract

Background

There is increased recognition that incorporating patients’ perspectives and insights into the medicines development process results in better health outcomes and benefits for all involved stakeholders. Despite the increased interest and the existence of frameworks and practical recommendations, patient engagement (PE) is not yet considered standard practice. The objective of this work was to provide a roadmap to support systematic change in all stakeholder organisations involved in medicines development across Europe, patients and patient organisations, medicines developers, academia, regulatory authorities, Health Technology Assessment bodies, payers, policy-makers and public research funders, to sustain PE practices.

Methods

A mixed-methods approach was used by the EU-funded Innovative Medicines Initiative PARADIGM Consortium to co-develop the sustainability roadmap including background work to identify success factors and scenarios for sustainable PE. The roadmap development was based on the Theory of Change concept and populated with findings from (1) interviews with national/ and international institutions with the potential to increase PE uptake by other stakeholders; (2) multi-stakeholder workshops and webinars; and (3) consultations with specific stakeholder groups, Consortium members and a consultative body formed by international PE initiatives.

Results

This roadmap sets strategic goals for the PE community to achieve meaningful and systematic PE through changes in the culture, processes and resources of stakeholder organisations. It brings in key PARADIGM outputs to work in a coordinated fashion with existing frameworks and mechanisms to achieve system-wide sustained PE.

Conclusions

The roadmap provides a framework for all stakeholders to take collective action within their organisations and across Europe to implement PE in a sustainable manner.

Supplementary Information

The online version contains supplementary material available at 10.1007/s43441-021-00282-z.

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Most cited references 39

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Technology roadmapping—A planning framework for evolution and revolution

David Probert, Clare J.P. Farrukh, Robert Phaal (2004)

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The PCORI Engagement Rubric: Promising Practices for Partnering in Research

Susan Sheridan, Suzanne Schrandt, Laura Forsythe … (2017)

Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric).

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Is Open Access

Patient and public engagement in priority setting: A systematic rapid review of the literature

Elizabeth Manafo, Lisa Petermann, Virginia Vandall-Walker … (2018)

Background Current research suggests that while patients are becoming more engaged across the health delivery spectrum, this involvement occurs most often at the pre-preparation stage to identify ‘high-level’ priorities in health ecosystem priority setting, and at the preparation phase for health research. Objective The purpose of this systematic rapid review of the literature is to describe the evidence that does exist in relation to patient and public engagement priority setting in both health ecosystem and health research. Data sources HealthStar (via OVID); CINAHL; Proquest Databases; and Scholar’s Portal. Study eligibility criteria i) published in English; ii) published within the timeframe of 2007—Current (10 years) unless the report/article was formative in synthesizing key considerations of patient engagement in health ecosystem and health research priority setting; iii) conducted in Canada, the US, Europe, UK, Australia/New Zealand, or Scandinavian countries. Study appraisal and synthesis i) Is the research valid, sound, and applicable?; ii) what outcomes can we potentially expect if we implement the findings from this research?; iii) will the target population (i.e., health researchers and practitioners) be able to use this research?. A summary of findings from each of the respective processes was synthesized to highlight key information that would support decision-making for researchers when determining the best priority setting process to apply for their specific patient-oriented research. Results Seventy articles from the UK, US, Canada, Netherlands and Australia were selected for review. Results were organized into two tiers of public and patient engagement in prioritization: Tier 1—Deliberative and Tier 2—Consultative. Highly structured patient and public engagement planning activities include the James Lind Alliance Priority Setting Partnerships (UK), Dialogue Method (Netherlands), Global Evidence Mapping (Australia), and the Deep Inclusion Method/CHoosing All Together (US). Limitations The critical study limitations include challenges in comprehensively identifying the patient engagement literature for review, bias in article selection due to the identified scope, missed information due to a more limited use of exhaustive search strategies (e.g., in-depth hand searching), and the heterogeneity of reported study findings. Conclusion The four public and patient engagement priority setting processes identified were successful in setting priorities that are inclusive and objectively based, specific to the priorities of stakeholders engaged in the process. The processes were robust, strategic and aimed to promote equity in patient voices. Key limitations identified a lack of evaluation data on the success and extent in which patients were engaged. Issues pertaining to feasibility of stakeholder engagement, coordination, communication and limited resources were also considered.

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Author and article information

Contributors

Elisa Ferrer:

ORCID: http://orcid.org/0000-0001-9345-8659

ferrer.elisa@gmail.com

Journal

Journal ID (nlm-ta): Ther Innov Regul Sci

Journal ID (iso-abbrev): Ther Innov Regul Sci

Title: Therapeutic Innovation & Regulatory Science

Publisher: Springer International Publishing (Cham )

ISSN (Print): 2168-4790

ISSN (Electronic): 2168-4804

Publication date (Electronic): 10 May 2021

Publication date PMC-release: 10 May 2021

Pages: 1-18

Affiliations

[1 ]GRID grid.433753.5, EURORDIS-Rare Diseases Europe, ; Paris, France

[2 ]Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Rd, Oxford, OX2 6GG UK

[3 ]European AIDS Treatment Group (EATG), Düsseldorf, Germany

[4 ]GRID grid.475319.d, European Patients’ Forum (EPF), ; Chaussée d’Etterbeek, Brussels, Belgium

[5 ]Teamit Research S.L., Barcelona, Spain

[6 ]The Synergist, Brussels, Belgium

[7 ]Novartis International AG, Basel, Switzerland

[8 ]GRID grid.410513.2, ISNI 0000 0000 8800 7493, Pfizer Inc, ; San Diego, CA USA

[9 ]GRID grid.419040.8, ISNI 0000 0004 1795 1427, Aragón Health Sciences Institute, , Instituto Aragonés de Ciencias de la Salud (IACS), ; Zaragoza, Spain

[10 ]Health Technology Assessment International (HTAi)-Patient and Citizen Involvement Interest Group, Berlin, Germany

[11 ]GRID grid.452397.e, European Medicines Agency (EMA), ; Amsterdam, The Netherlands

[12 ]Sanofi-Genzyme, Brussels, Belgium

[13 ]GRID grid.484123.8, ISNI 0000 0000 9246 8110, European Federation of Pharmaceutical Industries and Associations (EFPIA), ; Brussels, Belgium

Author information

Stuart D. Faulkner http://orcid.org/0000-0002-6345-5323

Elisa Ferrer http://orcid.org/0000-0001-9345-8659

Article

Publisher ID: 282

DOI: 10.1007/s43441-021-00282-z

PMC ID: 8108434

PubMed ID: 33970465

SO-VID: e17c17dd-e880-4fde-8cc1-f6fe2170d608

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 9 December 2020

Date accepted : 17 March 2021

Funding

Funded by: Innovative Medicines Initiative 2 Joint Undertaking

Award ID: Grant Agreement 777450

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Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action

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Abstract

Background

Methods

Results

Conclusions

Supplementary Information

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SDG 13: Climate Action

Most cited references 39

Technology roadmapping—A planning framework for evolution and revolution

The PCORI Engagement Rubric: Promising Practices for Partnering in Research

Patient and public engagement in priority setting: A systematic rapid review of the literature

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Cited by 13

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