title: Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.
abstract: Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings.
authors.affiliation: Nursing Department, National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: lwehrlen@nih.gov.
authors.forename: Leslie
authors.initials: L
authors.lastname: Wehrlen
authors.affiliation: Nursing Department, National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: krumlaum@cc.nih.gov.
authors.forename: Mike
authors.initials: M
authors.lastname: Krumlauf
authors.affiliation: Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA. Electronic address: nesse@mail.nih.gov.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ness
authors.affiliation: Newton-Wellesley Hospital, Newton, MA 02462, USA. Electronic address: dmaloof@partners.org.
authors.forename: Damiana
authors.initials: D
authors.lastname: Maloof
authors.affiliation: Nursing Department, National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: mbevans@cc.nih.gov.
authors.forename: Margaret
authors.initials: M
authors.lastname: Bevans
mesh_terms: D035843:Biomedical Research; D057189:Checklist; D002986:Clinical Trials as Topic; D003625:Data Collection / Q000592:standards*; D006801:Humans; D000071066:Patient Reported Outcome Measures; D012108:Research Personnel; D057566:Self Report
keywords: Clinical trials; Guidance; Patient diary; Patient reported outcome; Questionnaire; Self-reported data