title: 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.
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material .
authors.forename: Daniel
authors.initials: D
authors.lastname: Cukor
authors.forename: Lewis M
authors.initials: LM
authors.lastname: Cohen
authors.forename: Elizabeth L
authors.initials: EL
authors.lastname: Cope
authors.forename: Nasrollah
authors.initials: N
authors.lastname: Ghahramani
authors.forename: S Susan
authors.initials: SS
authors.lastname: Hedayati
authors.forename: Denise M
authors.initials: DM
authors.lastname: Hynes
authors.forename: Vallabh O
authors.initials: VO
authors.lastname: Shah
authors.forename: Francesca
authors.initials: F
authors.lastname: Tentori
authors.forename: Mark
authors.initials: M
authors.lastname: Unruh
authors.forename: Jeanette
authors.initials: J
authors.lastname: Bobelu
authors.forename: Scott
authors.initials: S
authors.lastname: Cohen
authors.forename: Laura M
authors.initials: LM
authors.lastname: Dember
authors.forename: Thomas
authors.initials: T
authors.lastname: Faber
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Fischer
authors.forename: Rani
authors.initials: R
authors.lastname: Gallardo
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Germain
authors.forename: Donica
authors.initials: D
authors.lastname: Ghahate
authors.forename: Nancy
authors.initials: N
authors.lastname: Grote
authors.forename: Lori
authors.initials: L
authors.lastname: Hartwell
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.forename: Paul L
authors.initials: PL
authors.lastname: Kimmel
authors.forename: Nancy
authors.initials: N
authors.lastname: Kutner
authors.forename: Susan
authors.initials: S
authors.lastname: Lawson
authors.forename: Lisa
authors.initials: L
authors.lastname: Marr
authors.forename: Robert G
authors.initials: RG
authors.lastname: Nelson
authors.forename: Anna C
authors.initials: AC
authors.lastname: Porter
authors.forename: Phillip
authors.initials: P
authors.lastname: Sandy
authors.forename: Bruce B
authors.initials: BB
authors.lastname: Struminger
authors.forename: Lalita
authors.initials: L
authors.lastname: Subramanian
authors.forename: Steve
authors.initials: S
authors.lastname: Weisbord
authors.forename: Bessie
authors.initials: B
authors.lastname: Young
authors.forename: Rajnish
authors.initials: R
authors.lastname: Mehrotra
mesh_terms: D055812:Community-Based Participatory Research; D006801:Humans; D007674:Kidney Diseases; D063868:Patient Outcome Assessment; D010358:Patient Participation; D018579:Patient Selection; D000073597:Stakeholder Participation
keywords: Community-Based Participatory Research; Humans; Patient Outcome Assessment; chronic kidney disease; clinical nephrology; depression; diabetic nephropathy; dialysis; end-stage renal disease; kidney disease; nephrotic syndrome; randomized controlled trials