title: Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials.
abstract: OBJECTIVE
  In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials.
  
  
  OBJECTIVE
  To examine whether patients are willing and able to report their symptomatic AEs in multicenter trials.
  
  
  METHODS
  A total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers at 5 successive clinic visits. Patient adherence was tracked with reasons for missed self-reports. Agreement with clinician AE reports was analyzed with weighted κ statistics. Patient and investigator perspectives were elicited by survey. The study was conducted from March 15, 2007, to August 11, 2011. Data analysis was performed from August 9, 2013, to March 21, 2014.
  
  
  RESULTS
  Of the 361 patients invited to participate, 285 individuals enrolled, with a median age of 57 years (range, 24-88), 202 (74.3%) female, 241 (85.5%) white, 73 (26.8%) with a high school education or less, and 176 (64.7%) who reported regular internet use (denominators varied owing to missing data). Across all patients and trials, there were 1280 visits during which patients had an opportunity to self-report (ie, patients were alive and enrolled in a treatment trial at the time of the visit). Self-reports were completed at 1202 visits (93.9% overall adherence). Adherence was highest at baseline and declined over time (visit 1, 100%; visit 2, 96%; visit 3, 95%; visit 4, 91%; and visit 5, 85%). Reasons for missing PROs included institutional errors in 27 of 48 (56.3%) of the cases (eg, staff forgetting to bring computers to patients at visits), patients feeling "too ill" in 8 (16.7%), patient refusal in 8 (16.7%), and internet connectivity problems in 5 (10.4%). Patient-investigator CTCAE agreement was moderate or worse for most symptoms (most κ < 0.05), with investigators reporting fewer AEs than patients across symptoms. Most patients believed that the system was easy to use (234 [93.2%]) and useful (230 [93.1%]), and investigators thought that the patient-reported AEs were useful (133 [94.3%]) and accurate (119 [83.2%]).
  
  
  CONCLUSIONS
  Participants in multicenter cancer trials are willing and able to report their own symptomatic AEs at most clinic visits and report more AEs than investigators. This approach may improve the precision of AE reporting in cancer trials.
authors.affiliation: Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill.|Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.affiliation: Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Lauren J
authors.initials: LJ
authors.lastname: Rogak
authors.affiliation: Division of Cancer Prevention, National Cancer Institute (NCI), Rockville, Maryland.
authors.forename: Lori M
authors.initials: LM
authors.lastname: Minasian
authors.affiliation: Department of Medical Oncology and Urology, Division of Solid Tumor, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.|Clinical Research and Prostate Cancer Program, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania.
authors.forename: William Kevin
authors.initials: WK
authors.lastname: Kelly
authors.affiliation: Division of Cancer Treatment and Diagnosis, NCI, Rockville, Maryland.
authors.forename: Ann M
authors.initials: AM
authors.lastname: O'Mara
authors.affiliation: Division of Cancer Treatment and Diagnosis, NCI, Rockville, Maryland.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Denicoff
authors.affiliation: Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Drew
authors.initials: D
authors.lastname: Seisler
authors.affiliation: Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.affiliation: Division of Cancer Prevention and Control, Department of Internal Medicine, Division of Epidemiology, College of Public Health, The Ohio State University, Columbus.
authors.forename: Electra
authors.initials: E
authors.lastname: Paskett
authors.affiliation: Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill.
authors.forename: Lisa
authors.initials: L
authors.lastname: Carey
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Maura
authors.initials: M
authors.lastname: Dickler
authors.affiliation: Department of Thoracic Oncology, Harvard Medical School, Massachusetts General Hospital, Boston.
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Heist
authors.affiliation: Delaware/Christiana Care NCI Community Oncology Research Program (NCORP), Helen F. Graham Cancer Center & Research Institute, Newark.
authors.forename: Andrew
authors.initials: A
authors.lastname: Himelstein
authors.affiliation: Department of Medicine, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco.
authors.forename: Hope S
authors.initials: HS
authors.lastname: Rugo
authors.affiliation: Program in Women's Oncology, Department of Obstetrics & Gynecology, Women and Infants Hospital of Rhode Island, Providence.|Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
authors.forename: William M
authors.initials: WM
authors.lastname: Sikov
authors.affiliation: Thoracic Oncology Program, Florida Hospital Cancer Institute, Orlando.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.affiliation: Department of Medicine, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco.
authors.forename: Alan P
authors.initials: AP
authors.lastname: Venook
authors.affiliation: New Hampshire Oncology Hematology, Hooksett.
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Weckstein
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Diana E
authors.initials: DE
authors.lastname: Lake
authors.affiliation: Delaware/Christiana Care NCI Community Oncology Research Program (NCORP), Helen F. Graham Cancer Center & Research Institute, Newark.
authors.forename: David D
authors.initials: DD
authors.lastname: Biggs
authors.affiliation: Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Freedman
authors.affiliation: Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina.
authors.forename: Charles
authors.initials: C
authors.lastname: Kuzma
authors.affiliation: Hematology Oncology Associates of Central New York, East Syracuse.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Kirshner
authors.affiliation: Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D057566:Self Report; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents