title: Patient-Reported Outcome Assessments as Endpoints in Studies in Infectious Diseases.
abstract: The goal of administering medical interventions is to help patients live longer or live better. In keeping with this goal, there has been increasing interest in taking the "voice" of the patient into account during the development process, specifically in the evaluation of treatment benefits of medical interventions, and use of patient-centered outcome data to justify reimbursement. Patient-reported outcomes (PROs) are outcome assessments (OAs) used to define endpoints that can provide direct evidence of treatment benefit on how patients feel or function. When PROs are appropriately developed, they can increase the efficiency and clinical relevance of clinical trials. Several PROs have been developed for OA in specific infectious diseases indications, and more are under development. PROs also hold promise for use in evaluating adherence, adverse effects, satisfaction with care, and routine clinical practice.
authors.affiliation: George Washington University School of Medicine.
authors.forename: John H
authors.initials: JH
authors.lastname: Powers
authors.affiliation: ICON PLC, San Francisco, California.
authors.forename: Kellee
authors.initials: K
authors.lastname: Howard
authors.affiliation: ICON PLC, San Francisco, California.
authors.forename: Todd
authors.initials: T
authors.lastname: Saretsky
authors.affiliation: ICON PLC, San Francisco, California.
authors.forename: Sarah
authors.initials: S
authors.lastname: Clifford
authors.affiliation: Foundation for the National Institutes of Health, Bethesda, Maryland.
authors.forename: Steve
authors.initials: S
authors.lastname: Hoffmann
authors.affiliation: Llorens Consulting, Bay Village, Ohio.
authors.forename: Lily
authors.initials: L
authors.lastname: Llorens
authors.affiliation: Talbot Advisors, LLC, Anna Maria, Florida.
authors.forename: George
authors.initials: G
authors.lastname: Talbot
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003141:Communicable Diseases / Q000188:drug therapy*; D006801:Humans; D063868:Patient Outcome Assessment; D017410:Practice Guidelines as Topic
chemical_list: D000900:Anti-Bacterial Agents
keywords: clinical practice; clinical trials; endpoints; infectious diseases; patient-reported outcomes