As the longstanding practice of patient and stakeholder engagement in research becomes better defined, and its value comes further into public awareness, efforts to study and formalize engaged research approaches increasingly garner attention and support. As described in previous posts in this series, the primary goal of these efforts is to infuse and inform research activities with aspects of valuable lived experience – informed by representatives of the target community, or by other relevant non-traditional research partners. In the specific case of patient-centered biomedical research, substantive engagement helps to align research activities with the goals, needs, preferences, and values of patients or otherwise affected communities (including caregivers and at-risk individuals). This ultimately renders research findings more impactful and more likely to support improvement of health outcomes; it increases the likelihood that resultant evidence will be truly responsive to patient needs and reflective of patient experiences. Incorporating engagement into biomedical research constitutes one strategy of a multi-pronged approach for addressing complications associated with the slow research-to-treatment pipeline (currently evidenced by the sluggish improvement in observed health outcomes, despite the relatively large amount of resources allocated to biomedical research). According to the literature and existing canon of work, people in patient-centered research also feel that this engaged approach strengthens project design, increases patient participation, and increases transparency and patient trust in the research community. Ultimately, it helps to ensure that the health research enterprise is driven by, or at least acknowledging of, the topics and questions that matter most – to patients, stakeholders, and the broader public.

Practiced and studied approaches to patient engagement have gained traction and recognition across the field. Funders play a pivotal role in accelerating adoption of these practices; they increasingly encourage, or require, applicants to utilize an “engaged” methodology for studies – or even to conduct a formal evaluation of engagement activities. Targeted funding is often made available through explicit allocations (e.g. PCORI Engagement Awards), delineated requirements for proposal elements, or incentivized engagement through increased likelihood of funding. PCORI, AHRQ, and RWJF are leaders in this space, with funders like the NIH and FDA quickly following their lead.

Communications describing initiatives of PCORI and PCORnet identify the promotion and practice of engagement as central to the project work, thus increasing the visibility and acceptance of engagement in biomedical research spaces. Their organizational efforts – and the bodies of work produced by their grantees and research network partners – have also resulted in a proliferation of tools and resources to facilitate engagement, as well as diverse approaches to executing engagement activities. Similarly, other institutions are working to establish policies that support engagement models for research and promote non-traditional research partnerships. For example, the FDA developed a Patient Council in 2016 to “better coordinate and integrate the role of patient perspectives in regulatory decision-making,” and has launched a series of initiatives related to patient-focused drug development and patient experience data – adhering to the statutory requirement of the 21st Century Cures Act and PDUFA VI. Those activities include engaging patients, caregivers, and advocates, and stakeholders extensively – throughout drug development and regulatory review processes.

Mirroring the notion that diverse perspectives should be accounted for, in designing and conducting research, engagement science helps to demonstrate that a “one size fits all” approach to inclusion is ineffective. More attention needs to be paid to evaluating both the quality and the outcomes that engagement produces. The question now is: Are we making research more responsive to the needs of patients, producing results that positively impact outcomes, and ensuring that our stakeholder engagement approaches prove equitable and effective? If evidence from the fields of action research or community engaged research serves as any indication, patient engagement in biomedical research will continue to emerge as a promising practice. The growth of this field will necessitate that greater attention be paid to understanding and shaping (1) the ways we put this work into practice, and (2) the ways engagement can be formalized via policy mechanisms.

Leaders must continue to implement both big and small “P” policies, in order to create environments truly conducive of the incubation and sustenance of engagement practice. This suggests that changes need to be made and regulated at both the state and national levels of policymaking, and within the context of localized efforts or individual organizations. Ideally, such policies would demonstrate emphasis on equity and would promote use of evidence-based and engagement-centric approaches in both health research and delivery settings.

In response to the climate of demand for this work, there has been growing interest in studying and refining best practices for conducting engaged research. Engagement science has arisen from the need for evaluating engagement approaches and methodologies, and for empirically demonstrating the importance of continued research engagement efforts. Early findings, emergent from this body of work (as reviewed in the upcoming post), have created the foundation for an important evidence base that will be increasingly referenced to inform the trajectory of future research engagement activities. 

The Engagement Science blog series includes the following six posts. Links will be made available as each post is published:

  1. Introducing Inclusive Research Practices & Potential Impacts
  2. An Overview of the Landscape of Engaged Research
  3. Factors Fueling the Need for Better Defined Engagement
  4. A Look at Existing Evidence
  5. Where to Focus & the Future of the Field
  6. Where Do We Go from Here?
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Author, Member

Holly Peay, PhD

Senior Researcher - RTI International

Dr. Peay is a social scientist, genetic counselor, and bioethicist at RTI International. Read Bio

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Rachel Dungan, M.S.S.P.

Senior Manager - AcademyHealth

As Senior Manager, Rachel develops and applies strategies for translating and disseminating public health syst... Read Bio

Rebekah Angove, Ph.D.

Vice President, Director - Patient Advocate Foundation, REACHnet

Dr. Angove is the Vice President of Patient Experience and Program Evaluation at Patient Advocate Foundation a... Read Bio

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Elizabeth Cope, Ph.D., M.P.H.

Senior Director, Public and Population Health - AcademyHealth

Elizabeth Cope is Senior Director of Public and Population Health at AcademyHealth, bringing experience in the... Read Bio

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