Objective: To describe the validity and reliability of the Italian version of the EUROPEP instrument for patient evaluation of general practice care. Methods: A survey was performed among patients who visited a general practice (n 0983), using the 23-item EUROPEP questionnaire. The scores are aggregated in two dimensions: ''clinical behaviour'' and ''organization of care''. The cultural adaptation of the questionnaire into Italian has been performed by using the formal translation procedures applied in other European countries. Data were analysed with respect to item response rate, item Áscale correlation, internal consistency reliability and construct validity of the instrument. Results: The item response rate was good for 17 items, acceptable for four items and problematic for one item. The item Áscale correlation largely exceeded a value of 0.40 for all items in both scales. The internal consistency of the aggregated scores was also very good, the reliability coefficients being 0.95 for ''clinical behaviour'' and 0.90 for ''organization of care''. As expected, older age and better health status were associated with more positive evaluation of care. Conclusion:Our study confirms that, even in its Italian version, the EUROPEP is a valid and easy-to-use instrument for gathering information on patients' experience with and evaluation of general practice care.

ObjectiveS: Niraparib was recently approved for maintenance treatment of recurrent ovarian cancer patients in response to platinum-based chemotherapy. In the clinical trial, niraparib dose was adjusted to manage adverse events, resulting in a lower average dose intensity (DI) compared to the starting dose of 300mg/day. The objective was to compare the average DI in the clinical trial and real-world settings for niraparib. MethOdS: The average DI in the clinical trial setting was obtained from the Phase 3 NOVA trial. The DI was calculated as the sum of daily doses actually consumed divided by total duration. The real-world DI was derived from data obtained through specialty pharmacies on dispensing and treatment discontinuation. The analysis was performed on patients with a minimum of 4 months (127 days) of follow up. For patients who discontinued treatment, treatment duration was the time between treatment start and treatment discontinuation. For patients who were still on therapy, treatment duration was time between treatment start and analysis date. Sensitivity analysis was conducted by setting the treatment duration for these patients based on either the analysis date or date of last dispense plus 30 days, whichever was later. ReSultS: Among the 367 patients treated with niraparib in the NOVA trial the mean (95% CI) DI was 194.98mg/day (±7.10) and the median was 195.12mg/day. Data was available in the real-world setting for 907 patients. In these patients, the mean (95% CI) DI was 202.43mg/day (±8.08) and median was 186.33mg/day. In the sensitivity analysis, the mean (95% CI) DI was 197.97mg/day (±7.99) and median was 183.67mg/day. CONCLUSIONS The DI in the real-world setting for niraparib is similar to that observed in the clinical trial. Since the cost of niraparib is proportional to dose administered, it is important to consider the actual DI in estimating the real-world cost of niraparib.

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