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Introduction: Standard concentration (100 units/mL) mealtime insulin is frequently used to treat patients with type 1 (T1D) and type 2 diabetes (T2D). A more concentrated version of the medication (200 units/mL) has been available in Italy since 2016. This concentrated version is bioequivalent to the standard version and delivers the same amount of medication but in half the volume of liquid. The purpose of this study was to examine patient preferences and estimate health state utilities associated with standard and concentrated rapid-acting mealtime analog insulin., Methods: Participants with T1D and T2D in Italy valued two health states in time trade-off interviews. The descriptions of diabetes and treatment in the two health states were identical, differing only in terms of insulin concentration (e.g., half as much liquid for the same dose, less effort needed to press the injection button, and fewer injection pens required with concentrated insulin). To ensure participants understood the health states, they were shown a short video illustrating the differences between concentrations., Results: A total of 217 participants completed the interviews (49.8% male; mean age 56.1 years; 109 from Milan; 108 from Rome; 12.0% T1D; 88.0% T2D). When asked which health state they preferred, 98.2% responded the concentrated version, 0.9% said the standard version, and 0.9% had no preference. Mean [standard deviation (SD)] utilities rounded to three decimals were 0.892 (0.099) for the concentrated version and 0.884 (0.101) for the standard version. The mean (SD; p value) utility difference between the standard and concentrated rapid-acting insulin was 0.007 (0.019; p < 0.0001)., Conclusions: Findings from this study provide insight into patient preferences associated with concentration of rapid-acting insulin. Although the difference in utility is small, patients consistently preferred the concentrated formulation over the standard insulin, and for some patients this difference had an impact on utility valuations. These results suggest that the concentration of rapid-acting insulin should be considered because it could affect treatment preference and quality of life., Funding: Eli Lilly and Company.

Background: We recently reported that self-evaluation of the incidence and severity of treatment-related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0-based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self- and doctor-evaluated day of onset and duration of TSEs in the same population., Patients and Methods: Six hundred and four patients were enrolled at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity of nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third chemotherapy cycles. At each time-point, information on TSEs was extracted from the medical charts and compared to patient questionnaires., Results: A total of 594 and 573 paired patient and doctor questionnaires were collected after cycles one and three, respectively. TSE duration was significantly longer when reported by patients compared to doctors for six and seven of ten items after cycles one and three, respectively. Due to the combined effect of doctor underreporting of TSE incidence and duration, the mean percentages of cycle days with TSEs were significantly higher for all ten items when based on patient reports. Day of onset could not be evaluated because of insufficient numbers of complete records., Conclusions: Self-reporting TSE duration is feasible using a CTCAE-derived questionnaire. As doctors tend to underestimate TSE incidence and duration, patient-reported outcomes should be incorporated into clinical practice, perhaps using eHealth technologies, to harness their potential to better estimate total TSE burden., (© 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Importance: Patient perspective on chemotherapy-related adverse effects is being increasingly acknowledged both in experimental clinical trials and in clinical practice., Objective: To evaluate a 10-item, paper questionnaire derived from the US National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for patient-reported chemotherapy-related adverse effects., Design, Setting, and Participants: Prospective, single-arm study of 604 women with breast cancer receiving standard adjuvant chemotherapy conducted at 11 outpatient oncology clinics at academic and nonacademic Italian hospitals between January 2011 and October 2013. The CTCAE version 4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third cycle of chemotherapy. Adverse effect information was also extracted from the medical records to compare with patient-reported data., Main Outcomes and Measures: Differences in adverse effect-reporting between paired questionnaires and agreement between patient and physician adverse effect-reporting (grade 0 vs grade ≥1) were studied. Linear regression was used to study the effect of the number of patients enrolled at each institution on the magnitude of discrepancy in adverse effect-reporting between patients and physicians., Results: A total of 604 women (median age, 53.4 years; interquartile range, 45.0-62.7 years) were enrolled. The number of patients enrolled at each site varied between 6 and 236. Three patients withdrew consent prior to starting the first cycle of adjuvant chemotherapy. After cycle 1 of adjuvant chemotherapy, 596 patient questionnaires were collected, and 581 patient questionnaires were collected after cycle 3. Of the questionnaires collected, 594 and 573 had corresponding questionnaire results extracted from medical records at the same time point. The median (interquartile range) percentage of completed questionnaire fields was 82% (80%-88%) for both the first and third cycle questionnaires, and the results of the 2 patient questionnaires showed a reduction in vomiting (severity), diarrhea (both incidence and severity), and pain (both incidence and severity), as well as a statistically significant increase in dysgeusia (both incidence and severity) and dyspnea (both incidence and severity) in the second patient-completed questionnaire. The frequency and severity of chemotherapy-related adverse effects were consistently greater in patient-reported data than physician-reported data. As a result, interrater agreement was low for most adverse effects, ranging from 0.10 for anorexia to 0.54 for vomiting (Cohen κ statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting adverse effects and the number of patients enrolled at each site., Conclusions and Relevance: Adherence to reporting adjuvant chemotherapy-related adverse effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the physician-patient relationship.