Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Apr;24(2):491-506.
doi: 10.1111/hex.13191. Epub 2021 Feb 24.

Evaluation of patient engagement in medicine development: A multi-stakeholder framework with metrics

Lidewij Eva Vat  1 , Teresa Finlay  2 , Paul Robinson  3 , Giorgio Barbareschi  4 , Mathieu Boudes  5 , Ana Maria Diaz Ponce  6 , Michaela Dinboeck  7 , Lukas Eichmann  8 , Elisa Ferrer  9 , Sevgi E Fruytier  1 , Claudia Hey  10 , Jacqueline E W Broerse  1 , Tjerk Jan Schuitmaker-Warnaar  1
Affiliations

Evaluation of patient engagement in medicine development: A multi-stakeholder framework with metrics

Lidewij Eva Vat et al. Health Expect. 2021 Apr.

Abstract

Background: Patient engagement is becoming more customary in medicine development. However, embedding it in organizational decision-making remains challenging, partly due to lack of agreement on its value and the means to evaluate it. The objective of this project was to develop a monitoring and evaluation framework, with metrics, to demonstrate impact and enhance learning.

Methods: A consortium of five patient groups, 15 biopharmaceutical companies and two academic groups iteratively created a framework in a multi-phase participatory process, including analysis of its application in 24 cases.

Results: The framework includes six components, with 87 metrics and 15 context factors distributed among (sub)components: (a) Input: expectations, preparations, resources, representativeness of stakeholders; (b) Activities/process: structure, management, interactions, satisfaction; (c) Learnings and changes; (d) Impacts: research relevance, study ethics and inclusiveness, study quality and efficiency, quality of evidence and uptake of products, empowerment, reputation and trust, embedding of patient engagement; (e) Context: policy, institutional, community, decision-making contextual factors. Case study findings show a wide variation in use of metrics. There is no 'one size fits all' set of metrics appropriate for every initiative or organization. Presented sample sets of metrics can be tailored to individual situations.

Conclusion: Introducing change into any process is best done when the value of that change is clear. This framework allows participants to select what metrics they value and assess to what extent patient engagement has contributed.

Patient contribution: Five patient groups were involved in all phases of the study (design, conduct, interpretation of data) and in writing the manuscript.

Keywords: impact; metrics; monitoring and evaluation; patient engagement; patient participation; quality indicators.

PubMed Disclaimer

Conflict of interest statement

None declared.

Figures

FIGURE 1
FIGURE 1
Study design and participatory action research process
FIGURE 2
FIGURE 2
Patient Engagement Monitoring and Evaluation framework
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Crowe S, Fenton M, Hall M, Cowan K, Chalmers I. Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Res Involve Engage. 2015;1(1):2. 10.1186/s40900-015-0003-x - DOI - PMC - PubMed
    1. Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009–13. BMJ. 2017;359:j4530. 10.1136/bmj.j4530 - DOI - PMC - PubMed
    1. Minogue V, Cooke M, Donskoy A‐L, Vicary P, Wells B. Patient and public involvement in reducing health and care research waste. Res Involve Engage. 2018;4(1):5. 10.1186/s40900-018-0087-1 - DOI - PMC - PubMed
    1. Brintnall‐Karabelas J, Sung S, Cadman ME, Squires C, Whorton K, Pao M. Improving recruitment in clinical trials: why eligible participants decline. J Empir Res Hum Res Ethics. 2011;6(1):69‐74. 10.1525/jer.2011.6.1.69 - DOI - PMC - PubMed
    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86‐89. 10.1016/S0140-6736(09)60329-9 - DOI - PubMed

Publication types

LinkOut - more resources