Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases

Abstract

Including target populations in the design and implementation of research trials has been one response to the growing health disparities endemic to our health care system, as well as an aid to study generalizability. One type of community-based participatory research is "Patient Centered-Research", in which patient perspectives on the germane research questions and methodologies are incorporated into the study. The Patient-Centered Outcomes Research Institute (PCORI) has mandated that meaningful patient and stakeholder engagement be incorporated into all applications. As of March 2015, PCORI funded seven clinically-focused studies of patients with kidney disease. The goal of this paper is to synthesize the experiences of these studies to gain an understanding of how meaningful patient and stakeholder engagement can occur in clinical research of kidney diseases, and what the key barriers are to its implementation. Our collective experience suggests that successful implementation of a patient- and stakeholder-engaged research paradigm involves: (1) defining the roles and process for the incorporation of input; (2) identifying the particular patients and other stakeholders; (3) engaging patients and other stakeholders so they appreciate the value of their own participation and have personal investment in the research process; and (4) overcoming barriers and challenges that arise and threaten the productivity of the collaboration. It is our hope that the experiences of these studies will further interest and capacity for incorporating patient and stakeholder perspectives in research of kidney diseases.

Research co-design in health: a rapid overview of reviews

“…Certain approaches restricted their focus to specific types of co-design collaborations, for example, between academic researchers and end-user organisations [28] or to collect research data [29]. Approaches also differed in the extent to which they emphasised intensity of engagement.…”

“…Co-design activities were typically used to facilitate (1) prioritisation and research agenda-setting [5,10,12]; (2) review of research proposals [8,29] and (3) contribution to study design, outcomes and materials [33]. For example, Schilling and Gerhardus [12] describe a prioritisation process that included an initial survey of older adults with dementia followed by a group workshop.…”

“…In one review, Yoshida et al [13] investigated a specific method for prioritisation, exploring how a research prioritisation technique designed to incorporate stakeholder contributions, the Child Health and Nutrition Research Institute method, had been used. Cukor [29] described how a community advisory board drawn from patients with kidney disease and their caregivers reviewed and provided feedback on initial proposals (i.e. research questions) for funded research.…”

“…The frequency and intensity of research co-design activities varied greatly across the included reviewsfrom seeking occasional contributions from end-users to seeking daily involvement and from relatively lowintensity activities such as seeking end-user feedback on research materials to intensely collaborative powersharing arrangements in end-user-led research (e.g. [10,23,29]). Oliver et al ( [10], summary on p. 96) provide a particularly detailed examination of how different activities performed across different levels of researcher and end-user engagement.…”

Patient‐Engaged Research: Choosing the “Right” Patients to Avoid Pitfalls

“…Patient engagement requires commitment from both the researchers and the engaged patients to maintain contact and participation, and trust has been described as a key factor in sustaining engagement over time. 17 Thus, it is not surprising that PIs would turn to individuals with whom they have preexisting relationships or who are referred to them via their professional networks. Longstanding relationships are likely to be based on some degree of trust and to allow PIs insight into the potential quality of a working relationship.…”