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Original Investigation
February 16, 2017

Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials

Author Affiliations
  • 1Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill
  • 2Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York
  • 3Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona
  • 4Division of Cancer Prevention, National Cancer Institute (NCI), Rockville, Maryland
  • 5Department of Medical Oncology and Urology, Division of Solid Tumor, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania
  • 6Clinical Research and Prostate Cancer Program, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania
  • 7Division of Cancer Treatment and Diagnosis, NCI, Rockville, Maryland
  • 8Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
  • 9Division of Cancer Prevention and Control, Department of Internal Medicine, Division of Epidemiology, College of Public Health, The Ohio State University, Columbus
  • 10Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
  • 11Department of Thoracic Oncology, Harvard Medical School, Massachusetts General Hospital, Boston
  • 12Delaware/Christiana Care NCI Community Oncology Research Program (NCORP), Helen F. Graham Cancer Center & Research Institute, Newark
  • 13Department of Medicine, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco
  • 14Program in Women’s Oncology, Department of Obstetrics & Gynecology, Women and Infants Hospital of Rhode Island, Providence
  • 15Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island
  • 16Thoracic Oncology Program, Florida Hospital Cancer Institute, Orlando
  • 17New Hampshire Oncology Hematology, Hooksett
  • 18Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute, Boston, Massachusetts
  • 19Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina
  • 20Hematology Oncology Associates of Central New York, East Syracuse
  • 21Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts
JAMA Oncol. Published online February 16, 2017. doi:10.1001/jamaoncol.2016.6749
Key Points

Question  Is it feasible to collect patient-reported symptomatic adverse events in large multicenter oncology clinical trials?

Findings  Among 285 patients enrolled in 9 US multicenter cancer treatment trials, symptomatic adverse events were successfully self-reported by paients at 93.9% of expected times. Most patients believed that the system was easy to use and useful, and investigators thought that the patient-reported adverse event data were useful and accurate.

Meaning  Participants in multicenter cancer trials can report their own symptomatic adverse events, which may improve the efficiency and accuracy of safety monitoring in clinical research.

Abstract

Importance  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.

Design, Setting, and Participants  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 and Relevance  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.

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