Ethan Basch|Lauren J. Rogak|Amylou C. Dueck
Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials
University of North Carolina at Chapel Hill|Memorial Sloan Kettering Cancer Center|Memorial Sloan Kettering Cancer Center|Mayo Clinic in Arizona
purposethere increasing interest use patientreported outcome pro measures evaluate symptomatic adverse events aes cancer treatment trials however currently standard recommended approaches integrating patientreported ae measures trialsmethodsapproaches identified previous trials selecting aes solicited patient reporting administering patientreported ae measures analyzing reporting resultsfindingsapproaches integrating patientreported ae measures cancer trials generally combine current standard methods clinicianreported aes established best practices using pro measures specific aes selected pro questionnaire based common expected reactions given trial context derived literature review qualitativemixedmethods evaluations set administered across arms trial mechanism collecting unsolicited patientreported aes also ideally included patients preferably report baseline end active treatment well frequent standardized schedule active treatment weekly home recall period corresponding frequency reporting eg past 7 days less frequent reporting may considered initial intensive monitoring period trials prolonged treatments longterm followup electronic pro data collection preferred backup data collection missed pro reports advisable boost response rates analysis use combination approaches ae pro data high proportion patients experiencing baseline symptoms systematic subtraction onstudy aes considered improve reporting symptoms related treatment granular longitudinal analyses individual symptoms also usefulimplicationsmethods evolving integrating patientreported symptomatic aes cancer trials methods expected evolve data trials become available