Adverse event self-reporting feasible in oncology clinical trials
medwireNews: Clinical trial participants are willing and able to report their own symptomatic adverse events (AEs) at chemotherapy clinic visits, a study among oncology patients shows.
Furthermore, the patients reported more AEs than investigators, which suggests the self-reporting approach “may improve the efficiency and accuracy of safety monitoring in clinical research,” Ethan Basch (University of North Carolina, Chapel Hill, USA) and colleagues remark.
The feasibility study invited patients enrolled in nine multicenter cancer treatment trials, to self-report 13 common symptomatic AEs using a patient-reported outcome (PRO) questionnaire that included plain language items based on the US National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE).
The participants used tablet computers at five consecutive chemotherapy cycle clinic visits to answer questions about anorexia, constipation, cough, diarrhea, dyspnea, fatigue, hand or foot reaction or rash, mucositis, nausea, neuropathy, pain, vomiting, and watery eyes.
Of the 361 patients invited to participate in the study, 285 (median age of 57 years, 74.3% female) enrolled, with around two-thirds describing themselves as regular internet users. Reasons for not enrolling included lack of interest (n=29), anxiety (n=6), being too ill (n=2), not wanting to use a computer (n=1), being too busy (n=1), and a dislike of research (n=1).
The researchers report in JAMA Oncology that PROs were completed on 1202 (93.9%) of 1280 possible occasions. Adherence was 100% baseline and declined over time to 85% at visit 5. This level, however, still exceeded the predetermined feasibility threshold of 80% or higher adherence, they point out.
Institutional error (eg, staff forgetting to bring computers to patients at visits) accounted for more than half (56.3%) of the missing PROs. Patients feeling too ill (16.7%), patient refusal (16.7%), and internet connectivity problems (10.4%) also played a part.
“These findings suggest that adherence rates could be boosted through standardized mechanisms to support staff and technology,” Basch and co-authors write.
They note that patient-investigator CTCAE agreement was generally fair (κ statistic 0.21–0.40), but ranged from being slight (κ=0.03) for hand or foot reaction or rash to substantial for vomiting (κ=0.82).
Anorexia, fatigue, nausea, and pain were the AEs most commonly underreported by clinicians compared with patients.
Despite these discrepancies, most clinicians reported that they viewed (91.6%) and discussed (76.4%) the PROs at clinic visits and found the reports to be useful (94.3%) and accurate (83.2%).
Most patients said that the system was easy to use (93.2%), useful (93.1%), and improved discussions with clinicians (85.4%).
Basch et al conclude: “This study demonstrates the feasibility of patient self-reporting of AEs in multicenter cancer clinical trials, elucidates areas for further refinement, and paves the way for a more patient-centered and accurate approach to symptomatic AE reporting in cancer clinical research.”
By Laura Cowen
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