Oncology patient preferences in reporting on symptoms

Background:Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriatefrequency of PRO administration in oncology trials. The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.Methods:166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.Results:When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”. Conclusions: PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer

Errors in answering migraine patient-reported outcome measure questions: patients consider training necessary in clinical trials

Background:In migraine clinical trials, patients’ understanding of the terminology used in patient-reported outcome (PRO) measures is important as variability in completing PRO measures can reduce the power to detect treatment efficacy. This study examines patients’ understanding of how to complete PRO measures in the absence of training, if minimal training can improve the accuracy of answering PRO items, and patients’ opinion on the necessity of training and their preference for the method of training.Methods:Participants reporting a diagnosis of migraine completed online surveys. Participants were given scenarios of how to report headache days and pain severity. Respondents were asked about their opinions on the necessity of training, and their preference for the method of training. In a second study, participants were given a hypothetical scenario on how to report pain severity before and after a short training.Results:The majority of participants had different criteria to interpret PRO questions and provided incorrect answers to our scenarios. In the second study, with minimal training, errors were reduced by 7.5%. Over 90% of participants viewed educational materials and training as necessary and preferred electronic modes of training with the ability to review training materials as needed for the duration of the trial. Conclusions: Patient training may improve data quality and inter-rater reliability in clinical trials. Electronic interactive training could be used as an approach to reduce inconsistencies in PRO measures and improve data quality