title: Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes.
abstract: The objectives of this study were to describe and demonstrate a new model of developing patient reported outcomes (PROs) that are patient-centered, and to test the hypothesis that following this model would result in a qualitatively different PRO than if the typical PRO development model were followed. The typical process of developing PROs begins with an initial list of signs or symptoms originating from clinicians or PRO developers; patient validation of this list ensures that the list (i.e., the new PRO) is interpretable by patients, but not that patient perspectives are central or even represented. The new model begins with elicitation from clinicians and patients independently and separately. These perspectives are formally analyzed qualitatively, and the results are iteratively integrated by researchers, supporting clinical relevance and patient centeredness. We describe the application of this new model to the development of a PRO for urinary signs and symptoms in individuals with neuropathic bladder, and test the hypothesis that the two processes generate qualitatively different instruments using a national validation sample of 300 respondents. Of its 29 items, the new instrument included 13 signs/symptoms derived from existing clinical practice guidelines, with 16 others derived from the patient/focus groups. The three most-endorsed items came from the patients, and the three least-endorsed items came from clinical guidelines. Thematic qualitative analysis of the elicitation process, as well as the results from our national sample, support the conclusion that the new model yields an instrument that is clinically interpretable, but more patient-centered, than the typical model would have done in this context.
authors.affiliation: Collaborative for Research on Outcomes and -Metrics, Georgetown University Medical Center, Washington, D.C., United States of America.|Department of Neurology, Georgetown University Medical Center, Washington, D.C., United States of America.|Department of Biostatistics, Bioinformatics & Biomathematics, Georgetown University Medical Center, Washington, D.C., United States of America.
authors.forename: Rochelle E
authors.identifier: http://orcid.org/0000-0002-1121-2119
authors.initials: RE
authors.lastname: Tractenberg
authors.affiliation: Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C., United States of America.
authors.forename: Amanda
authors.initials: A
authors.lastname: Garver
authors.affiliation: Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C., United States of America.|MedStar National Rehabilitation Hospital, Washington, D.C., United States of America.
authors.forename: Inger H
authors.initials: IH
authors.lastname: Ljungberg
authors.affiliation: Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C., United States of America.|MedStar National Rehabilitation Hospital, Washington, D.C., United States of America.|MedStar Health Research Health Institute, Hyattsville, Maryland, United States of America.
authors.forename: Manon M
authors.initials: MM
authors.lastname: Schladen
authors.affiliation: Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C., United States of America.|MedStar National Rehabilitation Hospital, Washington, D.C., United States of America.
authors.forename: Suzanne L
authors.initials: SL
authors.lastname: Groah
mesh_terms: D017144:Focus Groups; D017408:Guidelines as Topic; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D000071066:Patient Reported Outcome Measures; D010361:Patients / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires