Purpose:Speed of clinical response to a new therapeutic intervention is a critical determinant of the overall treatment outcomes, but tools focused on asthma response speed are currently unavailable. This study aimed to validate the psychometric properties of a new questionnaire initially written in Italian, the Speed of Change in Feeling of Health (SCFH), in patients with asthma. Patients and Methods:Two hundred and seventy subjects with not-well- or poorly controlled asthma, enrolled in the Italian sites of the NEWTON real-world study, were asked to complete the provisional version of SCFH and three validated questionnaires, the Stanford Expectation of Treatment Scale (SETS), the 5-item version of the Asthma Control Questionnaire (ACQ-5), and the Global Rating Scale (GRS). Internal consistency and validity were determined. Moreover, we assessed the minimal clinically important difference (MCID) using anchor-based method. Results:One hundred and ninety-six patients completed the questionnaire at least once at 7 (±1), 14 (±2), or 30 (±3) days after starting BDP/FF NEXThaler® 100/6 μg treatment. We started from SCFH provisional questionnaire of 30 items, the internal consistency of which revealed a high redundancy (Cronbach's alpha of 0.98), prompting its reduction to an 8-item questionnaire (SCFH-8; Cronbach's alpha = 0.90). Known-group validity indicated significant differences in SCFH-8 scores (p = 0.0003) at 30 (±3) days after enrollment between improved and non-improved subjects, as defined by changes in ACQ-5 scores. The study confirmed the convergent validity through comparisons with the SETS and the ACQ-5 questionnaires. A clinically relevant change in feeling of health was observed in 43.3% of participants at 7 days, while the cumulative frequency of patients reporting a clinically relevant change in their feeling of health at 30 days after enrollment was 70.4%. Conclusion:The Italian version of SCFH-8 is a valid, short tool with good psychometric properties for determining the speed of change in health perception after starting treatment.

INTRODUCTION:The recent guideline from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) on observational studies prompts a broader reflection on the impact of regulations on clinical research and real-world evidence. While regulations are necessary to ensure ethical and scientific standards, their effectiveness in improving research quality is unclear. It is also uncertain whether these regulations strengthen clinical research or create bureaucratic obstacles. This quantitative, "before and after" study investigates the impact of the 2008 AIFA guideline and the 2018 General Data Protection Regulation (GDPR) on the complexity of ethical evaluation processes. As a secondary outcome, we also aimed to investigate whether the duration and probability of suspensions were influenced by intrinsic study characteristics (study design, rare disease, genetic data, post-authorization safety study). MATERIALS:The study analyzed the ethical evaluation process of 112 observational multicenter studies with 2,875 submissions from 2002 to 2022, included in the database of Medineos srl. The number of suspensions observed in each evaluation process was a surrogate endpoint of complexity of evaluation process. METHODS:Descriptive analyses and survival analysis were used to evaluate the total evaluation time, and a logistic model was applied to assess the probability of receiving a suspension. RESULTS:The median (and interquartile range) evaluation time for "pre-AIFA" submissions was 70 (41-133) days, whereas it was 75 (45-122) days for "post-AIFA" submissions. The median evaluation time was 68 (41-113) days without suspension and 127 (84-180) days with suspension. Post-AIFA submissions had a higher likelihood of suspension. The median evaluation time for "pre-GDPR" submissions was 70 (42-123) days, whereas it was 90 (63-140) days for "post-GDPR" submissions. AIFA guidelines slightly increased evaluation time and the likelihood of suspension, suggesting improved quality control. GDPR increased evaluation time due to privacy evaluations but did not affect suspension probability. Intrinsic study factors did not impact evaluation duration or suspension probability. CONCLUSIONS:Although more extensive analyses are necessary, this study suggests that past changes in Italian regulations have affected the evaluation by the Ethics Committee (EC) and have also impacted the conduct of the observational studies. The data generated can be useful for monitoring the future impact of the recently published new AIFA guideline.

Introduction Major depressive disorder (MDD), especially in case of suicidal risk, is a psychiatric emergency, associated with high patient burden and healthcare resource utilization. Although active and urgent treatment is crucial, little is known on comprehensive care management of this condition in Italy. Objectives Here we report the ARIANNA study [NCT04463108] interim results to primarily describe the treatment utilization pathways of patients with MDD and active suicidal ideation with intent in the current clinical practice in Italy. Methods This observational prospective cohort study included adult patients with a moderate-to-severe major depressive episode (MDE) and active suicidality from 24 Italian sites. Real-world data on patient characteristics, treatments, clinical outcomes, and healthcare utilization were collected during a 90-day follow-up. Data collection is still ongoing. Results Sixty-four evaluable patients were considered for this interim analysis: 41 (64.1%) females, mean [SD] age 46.0 [15.4] years, a concomitant psychiatric diagnosis in 7 (10.9%), and other comorbidities in 26 (40.6%). The baseline mean [SD] MADRS total score was 37.5 [7.2], with severe MDE and prior suicidal behavior in 30 (46.9%) and 21 (32.8%) patients, respectively. Median [25th;75th percentiles] duration of current MDE was 1.1 [0.3;2.1] months. Acute inpatient hospitalization was provided for 43 (67.2%) patients. Antidepressant augmentation with mood stabilizers and/or antipsychotic drugs and optimization were the most frequent early standard-of-care treatment regimens in 32 (53.3%) and 24 (40.0%) patients with available data (N=60), respectively. Conclusions Our preliminary results suggest that initial treatment approaches in this critical population are mostly polypharmacological and delivered as inpatient care, with consequent intensive resource utilization. Disclosure The ARIANNA study was sponsored by Janssen-Cilag SpA, Italy. DD and MA are employees of Janssen-Cilag SpA. DA and BR are employees of MediNeos S.U.R.L., a company subject to the direction and coordination of IQVIA Solutions HQ Ltd.