Men with newly diagnosed prostate cancer (PCa) can reliably report their comorbidities, and participants in cancer clinical trials “are willing and able” to report symptomatic adverse events (AEs), according to the findings of separate studies published in JAMA Oncology.
The new findings could have implications for therapeutic decision making, cutting study-related data collection costs, and improving reporting of toxic events in clinical trials.
In a study of a population-based cohort of 881 men with newly diagnosed localized PCa, Fan Ye, MD, MPH, and colleagues at the University of North Carolina at Chapel Hill compared the presence or absence of 20 medical conditions based on patient reports versus medical records. For 16 of the 20 conditions, patient reports agreed with medical records for more than 90% of patients. Agreement was lowest for arthritis (66%) and hyperlipidemia (68%). Nonwhite race and lower educational level were not associated with lower patient versus physician report agreement.
On multivariate analysis, researchers found that older age was associated with lower overall agreement for multiple conditions. For example, compared with patients younger than 60 years, those older than 70 years had significantly lower overall agreement for myocardial infarction, cerebrovascular disease, kidney disease, coronary artery disease, and arrhythmia.
“Patient reporting provides information similar to medical record abstraction and may be a less costly method for assessing comorbid conditions for observational comparative effectiveness research,” Dr Ye and colleagues wrote.
Accurate assessment of comorbidities is important, they researchers noted, because patients’ baseline comorbidities directly affect PCa treatment decision making. “In the United States, younger and healthier patients commonly undergo prostatectomy, whereas older patients and those with more comorbid conditions receive radiation or conservative management.”
The study cohort was part of the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study. Patients had a median age of 65 years (range 41–80 years). Of the 881 men, 633 (71.9%) were white. Investigators assessed conditions by patient report via telephone survey and by medical record abstraction at the time of study enrollment.
For the other study, Ethan Basch, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues examined patient reporting of symptomatic AEs in 9 US multicenter cancer clinical trials. The study enrolled 285 patients with a median age of 57 years. Of these, 151 (53%) had breast cancer, 16 (5.6%) had colorectal cancer, 10 (3.5%) had lung cancer, 14 (4.9%) had PCa, and 94 (33%) were receiving supportive care.
Patients completed self-reports at 1202 (93.9%) of 1280 visits during which they had an opportunity to self-report. Patient-investigator agreement was moderate or worse for most symptoms, with investigators reporting fewer AEs than patients across symptoms, Dr Basch’s team stated. The study also showed that 93% of patients found the reporting system easy to use and useful; 94% and 83.2% of investigators considered patient-reported AEs to be useful and accurate, respectively.
“Participants in multicenter clinical trials are willing and able to report their own symptomatic AEs at most clinic visits and report more AEs than investigators,” Dr Basch and his colleagues concluded. “This approach may improve the precision of AE reporting in cancer trials.”
In an editorial accompanying both studies, Zaina P. Qureshi, PhD, MPH, MS, of the University of South Carolina in Columbia, and coauthors said the studies “take important first steps in showing us that it is feasible to obtain expanded information about patient experiences, comorbid conditions, and toxic effects that occur among patients with cancer.”
The editorial writers commented that the study by Dr Ye and colleagues “provides support for the reliability of reported comorbid illnesses by men with localized prostate cancer when compared with the medical record. Furthermore, hypothesized factors of race and education were not relevant predictors of the accuracy of self-report. The feasibility of this approach has implications for evaluating patterns of care and outcomes for men with localized prostate cancer.”
In addition, they stated that an important consequence of the findings by Dr Basch’s group “may be that patients may bridge the gap and be an important source of adverse event information in a wide range of clinical trials, facilitating more complete reporting of toxic effects during clinical trials.”
Qureshi ZP, Ganz PA, Bennett CL. Improving the evidence base for delivery of high-quality cancer care. JAMA Oncol 2017;3(8):1029-1031. doi:10.1001/jamaoncol.2016.6722
Ye F, Moon DH, Carpenter WR, et al. Comparison of patient report and medical records of comorbidities: Results from a population-based cohort of patients with prostate cancer. JAMA Oncol 2017; 3(8):1035-1042. doi:10.1001/jamaoncol.2016.6744
Basch E, Dueck AC, Rogak LJ, et al. Feasibility assessment of patient reporting of symptomatic adverse events in multicenter cancer clinical trials. JAMA Oncol 2017;3:1043-1050. doi:10.1001/jamaoncol.2016.6749