Implementing a pragmatic framework for authentic patient–researcher partnerships in clinical research
Abstract
In response to the creation of the Patient-Centered Outcomes Research Institute in 2010, researchers have begun to incorporate patient and family stakeholders into the research process as equal partners, bringing their unique perspectives and experiences to the table. Nonetheless, there is a dearth of literature around how best to engage patients and families and many barriers to doing so effectively. This paper outlines a pragmatic framework of collaborative engagement and partnership between research investigators and patient and family advisors from existing patient and family advisory councils (PFACs) at an academic medical center. This framework includes the role for each party throughout the clinical research process (launch, hypothesis, specific aims, measures/methods, results, interpretations/recommendation and dissemination).
Supplementary Material
File (suppl_data.docx)
- Download
- 29.34 KB
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Frank L, Basch E, Selby JV. The PCORI perspective on patient-centered outcomes research. JAMA 312(15), 1513–1514 (2014).
•• This perspective piece outlines the philosophy behind the Patient-Centered Outcomes Research Institutes (PCORI's) requirement for patient engagement in research, its added value and the work PCORI is doing to further explore and understand methods of patient engagement that uphold scientific rigor and increase effectiveness of research undertaken.
2.
Coelho T. A patient advocate's perspective on patient-centered comparative effectiveness research. Health. Aff. (Millwood) 29(10), 1885–1890 (2010).
• Coelho shares his personal experience as a patient and long-time advocate, explaining the importance of patient-centered comparative effectiveness research that engages patient stakeholders and his belief that comparative effectiveness research will lead to significant improvements in patient care and education.
3.
Institute of Medicine. Crossing the Quality Chasm: a New Health System for the 21st Century. The National Academies Press, Washington, DC, USA (2001).
4.
Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA 307(15), 1583–1584 (2012).
5.
Selby JV. The Patient-Centered Outcomes Research Institute: a 2013 agenda for “research done differently”. Popul. Health Manag. 16(2), 69–70 (2013).
6.
Domecq JP, Prutsky G, Elraiyah T et al. Patient engagement in research: a systematic review. BMC Health Serv. Res. 14, 89 (2014).
•• This systematic literature review found that patient engagement in research is feasible in practice but that gaps exist as to the best methods to ensure sustained, legitimate engagement throughout the process.
7.
Shalowitz MU, Isacco A, Barquin N et al. Community-based participatory research: a review of the literature with strategies for community engagement. J. Dev. Behav. Pediatr. 30(4), 350–361 (2009).
8.
Bogart LM, Uyeda K. Community-based participatory research: partnering with communities for effective and sustainable behavioral health interventions. Health Psychol. 28(4), 391–393 (2009).
9.
Devine EB, Alfonso-Cristancho R, Devlin A et al. A model for incorporating patient and stakeholder voices in a learning health care network: Washington State's Comparative Effectiveness Research Translation Network. J. Clin. Epidemiol. 66(8 Suppl.), S122–S129 (2013).
10.
Forsythe LP, Ellis LE, Edmundson L et al. Patient and stakeholder engagement in the PCORI pilot projects: description and lessons learned. J. Gen. Intern. Med. 31(1), 13–21 (2016).
•• Details lessons learned from early PCORI pilot studies, providing insight into the stakeholders engaged and how, stakeholder contributions and facilitators and challenges.
11.
Concannon TW, Meissner P, Grunbaum JA et al. A new taxonomy for stakeholder engagement in patient-centered outcomes research. J. Gen. Intern. Med. 27(8), 985–991 (2012).
• Concannon et al. propose a taxonomy to identify stakeholders to engage in research, clarify roles and responsibilities at each stage of research and recommend steps for researchers to take to begin engaging stakeholders.
12.
Deverka PA, Lavallee DC, Desai PJ et al. Stakeholder participation in comparative effectiveness research: defining a framework for effective engagement. J. Comp. Eff. Res. 1(2), 181–194 (2012).
13.
Hoffman A, Montgomery R, Aubry W, Tunis SR. How best to engage patients, doctors, and other stakeholders in designing comparative effectiveness studies. Health Aff. (Millwood) 29(10), 1834–1841 (2010).
14.
Frank L, Forsythe L, Ellis L et al. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Qual. Life Res. 24(5), 1033–1041 (2015).
15.
de Wit MP, Elberse JE, Broerse JE, Abma TA. Do not forget the professional - the value of the FIRST model for guiding the structural involvement of patients in rheumatology research. Health Expect. 18(4), 489–503 (2015).
16.
Wu AW, Snyder C, Clancy CM, Steinwachs DM. Adding the patient perspective to comparative effectiveness research. Health Aff. (Millwood) 29(10), 1863–1871 (2010).
17.
Mullins CD, Abdulhalim AM, Lavallee DC. Continuous patient engagement in comparative effectiveness research. JAMA 307(15), 1587–1588 (2012).
18.
Nass P, Levine S, Yancy C. Methods for involving patients in topic generation for patient-centered comparative effectiveness research: an international perspective. Research Priorities White Paper (PCORI-SOL-RPWG-001) for the Patient-Centered Outcomes Research Institute, Washington, DC, USA (2012). www.pcori.org/assets/Methods-for-Involving-Patients-in-Topic-Generation-for-Patient-Centered-Comparative-Effectiveness-Research-%E2%80%93-An-International-Perspective.pdf.
•• Nass et al. describe the importance of and process for engaging the public in research, proposing a patient-centered typology of engagement and outlining specific protocols for engaging the public at various levels.
19.
Herrin J, Harris KG, Kenward K, Hines S, Joshi MS, Frosch DL. Patient and family engagement: a survey of US hospital practices. BMJ Qual. Saf. 25, 182–189 (2016).
20.
Patient-Centered Outcomes Research Institute. PCORI compensation framework for engaged research partners (2015). www.pcori.org/sites/default/files/PCORI-Compensation-Framework-for-Engaged-Research-Partners.pdf.
• PCORI details a framework for financial compensation for patients as engaged partners in research, providing the rationale for and guidance on fair compensation.
21.
Agency for Healthcare Research and Quality. Supporting patient and consumer involvement in patient-centered outcomes research. AHRQ Community Forum (2011). www.effectivehealthcare.ahrq.gov/tasks/sites/ehc/assets/File/Consumer-Involvement-in-Patient-Centered-Outcomes-Research.pdf.
22.
Tunis SR, Benner J, McClellan M. Comparative effectiveness research: policy context, methods development and research infrastructure. Stat. Med. 29(19), 1963–1976 (2010).
23.
Bill-Axelson A, Holmberg L, Ruutu M et al. Radical prostatectomy versus watchful waiting in early prostate cancer. N. Engl. J. Med. 352(19), 1977–1984 (2005).
24.
Lavallee DC, Williams CJ, Tambor ES, Deverka PA. Stakeholder engagement in comparative effectiveness research: how will we measure success? J. Comp. Eff. Res. 1(5), 397–407 (2012).
• Highlights the importance of and need for evaluative measures for stakeholder engagement and proposes six meta criteria for measuring its success.
25.
Lewis B. PFACs: where's the money? patient experience research report. The Beryl Institute, Bedford, TX, USA (2014). www.ipfcc.org/advance/topics/beryl-inst-patient-exp-research-rpt.pdf.
26.
2015 PFAC Summary Report. Health Care for All, Boston, MA, USA (2015). www.ipfcc.org/advance/topics/Review-of-PFAC-2014-Reports.pdf.
27.
PCORnet, The National Patient-Centered Clinical Research Network (2015). www.pcornet.org.
28.
Anise A. Our new evidence to action networks - helping awardees share knowledge. Patient-Centered Outcomes Research Institute, Washington DC, USA (2015). www.pcori.org/blog/our-new-evidence-action-networks-helping-awardees-share-knowledge.
Information & Authors
Information
Published In
Copyright
© Future Medicine Ltd.
History
Published online: 4 May 2016
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Implementing a pragmatic framework for authentic patient–researcher partnerships in clinical research. (2016) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2015-0023
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Patricia Mortenson, Homira Osman, Erin Beattie, Corinne Kagan, Victoria Larocca, Claudia Maltais, Linda Niksic, Margo Thompson, Kathryn Selby, Building capacity for patient-engagement in neuromuscular disease research: A network project, Journal of Neuromuscular Diseases, 10.1177/22143602251405819, (2025).
- Eugenie Evelynne Johnson, Sean Gill, Madeleine Still, Daisy Trenchard, Debbie Smith, Rebecca Harmston, Jane McDermott, Fiona Pearson, Understanding the Scope, Intent and Extent of Published Conceptual Frameworks of Frameworks for Patient and Public Involvement in Health and Social Care Research: A Rapid Scoping Review, Health Expectations, 10.1111/hex.70425, 28, 5, (2025).
- Theresa Haugen, Jennifer L. Gallop, Hélène Doerflinger, Lowe Syndrome and Me: a co-creation video series connecting patients, caregivers, and researchers, Frontiers in Cell and Developmental Biology, 10.3389/fcell.2025.1610207, 13, (2025).
- Sally-Anne Dews, Rachel Daley, Akhil Bansal, Jennifer Preston, Natalie Bohm, The power of language: how to bridge the gap between healthcare research and patients – a scoping review, Current Medical Research and Opinion, 10.1080/03007995.2023.2295984, 40, 2, (279-291), (2024).
- Madeleine Huwe, Becky Woolf, Jennie David, Michael Seid, Shehzad Saeed, Peter Margolis, Conceptualizing and redefining successful patient engagement in patient advisory councils in learning health networks, Learning Health Systems, 10.1002/lrh2.10377, 8, 1, (2023).
- Sanae Kishimoto, Norio Watanabe, Yosuke Yamamoto, Takumi Imai, Rei Aida, Christopher Germer, Risa Tamagawa-Mineoka, Ryosuke Shimizu, Steven Hickman, Yujiro Nakayama, Takafumi Etoh, Ethan Sahker, Martha B. Carnie, Toshi A. Furukawa, Efficacy of Integrated Online Mindfulness and Self-compassion Training for Adults With Atopic Dermatitis, JAMA Dermatology, 10.1001/jamadermatol.2023.0975, 159, 6, (628), (2023).
- Francine Buchanan, Amy Peasgood, Megan Easton, Karen Haas, Unni Narayanan, The Research Family Advisory Committee: the patient and family view of implementing a research-focused patient engagement strategy, Research Involvement and Engagement, 10.1186/s40900-022-00335-z, 8, 1, (2022).
- Dana Ketcher, Anne Bidelman, Liem Q. Le, Amy K. Otto, Daniel K. Lester, Kim K. Amtmann-Beuttner, Brian D. Gonzalez, Kenneth L. Wright, Susan T. Vadaparampil, Maija Reblin, Eric K. Lau, Partnering patients, caregivers, and basic scientists: an engagement model that fosters patient- and family-centered research culture, Translational Research, 10.1016/j.trsl.2020.07.013, 227, (64-74), (2021).
- Sabina B. Gesell, Sylvia W. Coleman, Laurie H. Mettam, Anna M. Johnson, Mysha E. Sissine, Pamela W. Duncan, How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study, Journal of Clinical and Translational Science, 10.1017/cts.2020.552, 5, 1, (2020).
- David B. Reuben, Thomas M. Gill, Alan Stevens, Jeff Williamson, Elena Volpi, Maya Lichtenstein, Lee A. Jennings, Zaldy Tan, Leslie Evertson, David Bass, Lisa Weitzman, Martie Carnie, Nancy Wilson, Katy Araujo, Peter Charpentier, Can Meng, Erich J. Greene, James Dziura, Jodi Liu, Erin Unger, Mia Yang, Katherine Currie, Kristin M. Lenoir, Aval‐NaʼRee S. Green, Sitara Abraham, Ashley Vernon, Rafael Samper‐Ternent, Mukaila Raji, Roxana M. Hirst, Rebecca Galloway, Glen R. Finney, Ilene Ladd, Alanna Kulchak Rahm, Pamela Borek, Peter Peduzzi, D‐CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System–Based Versus Community‐Based Dementia Care Versus Usual Dementia Care , Journal of the American Geriatrics Society, 10.1111/jgs.16862, 68, 11, (2492-2499), (2020).