PMID- 28208174 OWN - NLM STAT- MEDLINE DCOM- 20170907 LR - 20220310 IS - 2374-2445 (Electronic) IS - 2374-2437 (Print) IS - 2374-2437 (Linking) VI - 3 IP - 8 DP - 2017 Aug 1 TI - Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials. PG - 1043-1050 LID - 10.1001/jamaoncol.2016.6749 [doi] AB - 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 kappa 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 kappa < 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. FAU - Basch, Ethan AU - Basch E AD - Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill. AD - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York. FAU - Dueck, Amylou C AU - Dueck AC AD - Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona. FAU - Rogak, Lauren J AU - Rogak LJ AD - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York. FAU - Minasian, Lori M AU - Minasian LM AD - Division of Cancer Prevention, National Cancer Institute (NCI), Rockville, Maryland. FAU - Kelly, William Kevin AU - Kelly WK AD - Department of Medical Oncology and Urology, Division of Solid Tumor, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania. AD - Clinical Research and Prostate Cancer Program, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania. FAU - O'Mara, Ann M AU - O'Mara AM AD - Division of Cancer Treatment and Diagnosis, NCI, Rockville, Maryland. FAU - Denicoff, Andrea M AU - Denicoff AM AD - Division of Cancer Treatment and Diagnosis, NCI, Rockville, Maryland. FAU - Seisler, Drew AU - Seisler D AD - Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. FAU - Atherton, Pamela J AU - Atherton PJ AD - Alliance Statistics and Data Center, Division of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. FAU - Paskett, Electra AU - Paskett E AD - Division of Cancer Prevention and Control, Department of Internal Medicine, Division of Epidemiology, College of Public Health, The Ohio State University, Columbus. FAU - Carey, Lisa AU - Carey L AD - Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill. FAU - Dickler, Maura AU - Dickler M AD - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. FAU - Heist, Rebecca S AU - Heist RS AD - Department of Thoracic Oncology, Harvard Medical School, Massachusetts General Hospital, Boston. FAU - Himelstein, Andrew AU - Himelstein A AD - Delaware/Christiana Care NCI Community Oncology Research Program (NCORP), Helen F. Graham Cancer Center & Research Institute, Newark. FAU - Rugo, Hope S AU - Rugo HS AD - Department of Medicine, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco. FAU - Sikov, William M AU - Sikov WM AD - Program in Women's Oncology, Department of Obstetrics & Gynecology, Women and Infants Hospital of Rhode Island, Providence. AD - Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island. FAU - Socinski, Mark A AU - Socinski MA AD - Thoracic Oncology Program, Florida Hospital Cancer Institute, Orlando. FAU - Venook, Alan P AU - Venook AP AD - Department of Medicine, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco. FAU - Weckstein, Douglas J AU - Weckstein DJ AD - New Hampshire Oncology Hematology, Hooksett. FAU - Lake, Diana E AU - Lake DE AD - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. FAU - Biggs, David D AU - Biggs DD AD - Delaware/Christiana Care NCI Community Oncology Research Program (NCORP), Helen F. Graham Cancer Center & Research Institute, Newark. FAU - Freedman, Rachel A AU - Freedman RA AD - Department of Medical Oncology, Harvard Medical School, Dana-Farber Cancer Institute, Boston, Massachusetts. FAU - Kuzma, Charles AU - Kuzma C AD - Southeast Clinical Oncology Research Consortium, Winston-Salem, North Carolina. FAU - Kirshner, Jeffrey J AU - Kirshner JJ AD - Hematology Oncology Associates of Central New York, East Syracuse. FAU - Schrag, Deborah AU - Schrag D AD - Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts. LA - eng GR - UG1 CA189829/CA/NCI NIH HHS/United States GR - U10 CA032291/CA/NCI NIH HHS/United States GR - U10 CA077658/CA/NCI NIH HHS/United States GR - U10 CA086726/CA/NCI NIH HHS/United States GR - U10 CA035279/CA/NCI NIH HHS/United States GR - U10 CA045808/CA/NCI NIH HHS/United States GR - U10 CA031946/CA/NCI NIH HHS/United States GR - U10 CA033601/CA/NCI NIH HHS/United States GR - U10 CA045389/CA/NCI NIH HHS/United States GR - U10 CA180854/CA/NCI NIH HHS/United States GR - U10 CA021060/CA/NCI NIH HHS/United States GR - U10 CA180821/CA/NCI NIH HHS/United States GR - P30 CA016086/CA/NCI NIH HHS/United States GR - U10 CA035421/CA/NCI NIH HHS/United States GR - U10 CA114558/CA/NCI NIH HHS/United States GR - U10 CA045418/CA/NCI NIH HHS/United States GR - U10 CA180836/CA/NCI NIH HHS/United States GR - UG1 CA189858/CA/NCI NIH HHS/United States GR - U10 CA180791/CA/NCI NIH HHS/United States GR - U10 CA037447/CA/NCI NIH HHS/United States GR - U10 CA180850/CA/NCI NIH HHS/United States GR - UG1 CA189817/CA/NCI NIH HHS/United States GR - UG1 CA189850/CA/NCI NIH HHS/United States GR - UG1 CA189830/CA/NCI NIH HHS/United States GR - U10 CA041287/CA/NCI NIH HHS/United States GR - UG1 CA189823/CA/NCI NIH HHS/United States GR - U10 CA047559/CA/NCI NIH HHS/United States GR - U10 CA077651/CA/NCI NIH HHS/United States GR - U10 CA180790/CA/NCI NIH HHS/United States GR - UG1 CA189972/CA/NCI NIH HHS/United States GR - U10 CA180882/CA/NCI NIH HHS/United States GR - UG1 CA189853/CA/NCI NIH HHS/United States GR - UG1 CA189819/CA/NCI NIH HHS/United States GR - P30 CA016359/CA/NCI NIH HHS/United States GR - U10 CA180867/CA/NCI NIH HHS/United States GR - U10 CA180838/CA/NCI NIH HHS/United States GR - U10 CA047642/CA/NCI NIH HHS/United States GR - U10 CA180844/CA/NCI NIH HHS/United States GR - U10 CA003927/CA/NCI NIH HHS/United States GR - U10 CA138561/CA/NCI NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Multicenter Study PL - United States TA - JAMA Oncol JT - JAMA oncology JID - 101652861 RN - 0 (Antineoplastic Agents) SB - IM CIN - JAMA Oncol. 2017 Aug 1;3(8):1029-1031. PMID: 28208180 MH - Adult MH - *Adverse Drug Reaction Reporting Systems MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*adverse effects/therapeutic use MH - Feasibility Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - Patient Reported Outcome Measures MH - *Self Report MH - Young Adult PMC - PMC5553624 MID - NIHMS871610 COIS- Conflict of Interest Disclosures: None reported. EDAT- 2017/02/17 06:00 MHDA- 2017/09/08 06:00 PMCR- 2018/08/01 CRDT- 2017/02/17 06:00 PHST- 2017/02/17 06:00 [pubmed] PHST- 2017/09/08 06:00 [medline] PHST- 2017/02/17 06:00 [entrez] PHST- 2018/08/01 00:00 [pmc-release] AID - 2603225 [pii] AID - 10.1001/jamaoncol.2016.6749 [doi] PST - ppublish SO - JAMA Oncol. 2017 Aug 1;3(8):1043-1050. doi: 10.1001/jamaoncol.2016.6749.