By Jessica Robinson-Papp, MD MS
Every Thursday afternoon, I meet with my collaborator and friend, Dr. Monica Rivera Mindt. Dr. Monica Rivera Mindt. Dr. Rivera Mindt is a community engaged researcher who has spent decades living and working in the Harlem neighborhood of New York City focusing on brain health, specifically the mechanisms underlying racial and ethnic disparities in cognitive decline. Last week we got to talking about the different ways we have engaged with communities and how successful it has been in supporting many of our studies, particularly those focused on brain health. Today it’s the norm to include people with lived experience in the design, execution, and reporting of all kinds of clinical research. But like many things that we start to take for granted, if we don’t periodically stop to reflect on why we do something, we risk losing purpose and authenticity. Following our conversation, I wanted to remind myself of the fundamental reasons for community engagement in research. Why do we think it’s a good idea and what do we know about its effects on outcomes? I also wanted to think more specifically about community engagement in the context of pain research. So I indulged myself in little reading.
I found a comprehensive chapter on ResearchGate (published in 2008) describing the evolution of Community Based Participatory Research (CBPR) titled: “The theoretical, historical, and practice roots of CBPR,” by Bonnie Duran DrPH of the University of Washington in Seattle. Dr. Duran traces the history of CBPR back to the 1940s when the term “action research” was coined to describe a self-reflective and collaborative quality improvement method. She also draws a lineage to CBPR from the social justice movements of the 1960s and 1970s which sought to reduce inequities between researchers and study participants, including providing greater access to and control over study results and their dissemination. This historical context suggests that diverse stakeholders were originally included in research both for their unique insights and also for ethical reasons.
Many years later, patient-engaged research got a boost from the Affordable Care Act (aka Obamacare) which led to the establishment of the Patient-Centered Outcomes Research Institute (PCORI) in 2010. PCORI’s mission is to “fund research that helps people make better-informed healthcare decisions based on their needs and preferences.” As a funder of research, PCORI is unique in that it requires researchers to include patient input in their research process. This was still pretty novel at the time of PCORI’s founding; a Pubmed search of the term “patient engagement” shows a inflection point right around 2010 with increasing numbers of publications in years since. Requiring patient input for studies of healthcare delivery, such as those funded by PCORI, seem like common sense. If your goal is to help a group of patients make informed choices it seems obvious that you’d need to involve those very people in your study design. But it would still be nice to prove that patient engagement improves these studies. PCORI set out to do just that in an article published in 2019. Since all PCORI studies require patient engagement, a formal comparison of studies with and without patient engagement wasn’t possible. Instead, the authors reviewed 126 articles describing PCORI-funded research and performed a qualitative analysis of text pertaining to patient engagement. They concluded that “…findings suggest that engagement contributes to research that is better aligned with patients’ and clinicians’ needs.” This is encouraging, although a cynic might wonder about the likelihood of PCORI-funded researchers including negative statements about patient engagement in their publications.
So too in the field of pain research has patient engagement become a popular idea. The International Association for the Study of Pain (IASP) published a fact sheet on the topic last year. The Helping to End Addition Long Term (HEAL) initiative, the body within the National Institutes of Health (NIH) that funds pain research has also emphasized the importance of patient engagement. But does it really make sense to seek the patient perspective in all forms of pain research?
It feels slightly scandalous to suggest, but is it possible that patient engagement has gone too far, and that by extending it past its original purpose we are diluting its power? This question may be particularly relevant to tightly regulated areas of research, such as early drug development, in which study design may be mostly dictated by budgetary limitations and the requirements of regulatory bodies such as the Food and Drug Administration (FDA). The needs of patients must still guide such research, but what if the perspective of the clinician-scientist on these needs is enough? Clinicians interact extensively with patients absorbing their perspectives over hundreds and thousands of encounters. This is effectively qualitative research, albeit informal. The idea of the clinician as patient proxy is unpleasant, it sounds authoritative and paternalistic. But is the engagement of a handful of people with lived experience really likely to be less biased, or is it just something that’s become accepted as a “best practice” without strong rationale? If it’s the latter, we should be brave and acknowledge own our own expertise as clinician-scientists, while respecting the time and wisdom of community members by engaging with them only when their input really matters and when we can engage whole-heartedly.
It’s quite likely that there will never be strong quantitative evidence that patient engagement improves research. That doesn’t mean we shouldn’t do it, rather we should strive to engage patients in research areas where common sense and the historical origins of CBPR indicate it’s important, particularly research involving ethical and/or value-based decisions.