Annali dell'Istituto Superiore di Sanità
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Publications from International Organizations on Public Health
Full text linkThe Publications from International Organizations on Public Health section includes a wider selection of the most recent publications edited by the main international organizations active in the field of public health, such as: the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations (FAO), the International Labour Organization (ILO), the Organisation for Economic Co-operation and Development (OECD), the United Nations Educational, Scientific and Cultural Organization (UNESCO), the United Nations Environment Programme (UNEP), the United Nations Programme on HIV/AIDS (UNAIDS), and the World Health Organization (WHO)
The authorization process of observational studies in Italy: exploring two decades of Ethics Committee approval data
Full text linkIntroduction. 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
Visual responses in a transplanted eye: reality or chimera?
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Publications from International Organizations on Public Health
Full text linkThe Publications from International Organizations on Public Health section includes a wider selection of the most recent publications edited by the main international organizations active in the field of public health, such as: the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations (FAO), the International Labour Organization (ILO), the Organisation for Economic Co-operation and Development (OECD), the United Nations Educational, Scientific and Cultural Organization (UNESCO), the United Nations Environment Programme (UNEP), the United Nations Programme on HIV/AIDS (UNAIDS), and the World Health Organization (WHO)
Psychological distress and its impact on the onset of lasting neurological symptoms during the pandemic: evidence from the Italian Twin Registry
Full text linkIntroduction. Neurocognitive disorders are typical of older people. Psychological distress increased during the pandemic, particularly in young people. Although often underestimated, the impact of psychological distress on neurological disorders should be considered. As part of a longitudinal study conducted by the Italian Twin Registry (ITR) on the health effects of COVID-19 pandemic, we explored the onset of lasting neurological symptoms in relation with pre-existing psychological symptoms and/or SARSCov-2 infection.Methods. Online surveys on adult subjects of the ITR: in June 2020 we investigated symptoms of depression, anxiety and post-traumatic distress and, in December 2021, the onset of six persisting neurocognitive symptoms. SARS-CoV-2 infection was examined in both surveys. Associations of psychological symptoms and of viral infection with subsequent neurological manifestations were tested through logistic regression analysis.Results. Among 1,784 participants (mean age 46.6), 42.8% reported neurological symptoms and 15.7% SARS-Cov-2 infection. Odds of neurological manifestations increased in participants with depressive or anxiety symptoms (ORs: 1.44 to 3.72), and in those with COVID-19 (ORs: 1.73 to 2.32). Anxiety symptoms explained more cases of cognitive symptoms (26.9% to 37.9%) than COVID-19 (9.1% to 15.5%). Smell/taste changes were strongly associated with viral infection (OR: 43.2).Conclusions. During the pandemic, widespread psychological distress contributed more than COVID-19 to the appearance of some cognitive symptoms in a relatively young population. Our findings indicates that preservation of neurological well-being cannot ignore mental health interventions
Does exceeding maximum waiting times of total hip replacement patients affect resource consumption? Evidence from a highly specialized orthopedic Italian hospital
Full text linkBackground. Long waiting times for elective surgeries are a common issue in publicly funded healthcare systems, raising concerns about their impact on patient outcomes. In Italy, the National Health System assigns priority classes to regulate waiting times, with class C patients expected to undergo surgery within 180 days. This study investigates whether exceeding this threshold affects surgical and hospitalization outcomes for patients undergoing total hip replacement (THR).Methods. We conducted a retrospective observational study on 1,872 class C patients who underwent THR between 2019 and 2022 at the Rizzoli Orthopedic Institute andaffiliated centers. Patients were categorized based on adherence to the 180-day waiting threshold. The study analyzed differences in surgical time, length of hospital stays and touch time. Additional analyses considered patient characteristics such as the American Society of Anesthesiologists (ASA) classification and Body Mass Index (BMI). Independent t-tests were used to assess statistical significance.Results. Patients exceeding the 180-day waiting limit did not show significantly longer hospital stays or surgical times compared to those operated on time (p>0.05). However, ASA classification and BMI influenced hospital stay duration, with high ASA (3-4) patients staying 1.7 days longer on average and obese patients (BMI ≥30) staying 0.4 days longer.Conclusions. The findings suggest that exceeding the maximum waiting time does not negatively impact surgical outcomes or hospital stay duration. However, clinical characteristics such as ASA and BMI play a significant role in postoperative recovery. Further research is needed to refine prioritization criteria to ensure optimal patient outcomes
Exploring the link between cervical cancer screening and COVID-19 vaccination adherence. Evidence from a pilot study in Rome, Italy (2021-2022)
Full text linkIntroduction. Oncological screenings and vaccinations are essential preventive strategies, yet participation in both remains suboptimal and variable.Methods. This pilot study examines the association between cervical cancer screening adherence and COVID-19 vaccination uptake among women aged 25-64 years in a large Local Health Authority in Rome, Italy, during 2021-2022. Analyzing data from 101,302 women, we identified a strong positive association between COVID-19 vaccination status and cervical screening participation, suggesting that common determinants influence both behaviors.Results. Age and area of residence also emerged as predictors of screening adherence, with lower participation observed among younger women and those living in central districts. Conclusions. Our findings highlight the need to foster a broader culture of prevention by integrating vaccination and screening efforts to improve public health outcomes. Enhancing health literacy and addressing shared barriers may increase participation in both programs. However, further research is needed to validate these findings, explore the underlying determinants of preventive behaviors, and develop targeted interventions to boost adherence to prevention programs
Healthcare professionals’ perceptions of caesarean section decision-making and the implementation of Audit&Feedback strategies in the Calabria Region: a qualitative study
Full text linkIntroduction. Calabria Region has one of the highest caesarean section (CS) rate in Italy. To encourage the implementation of Audit&Feedback strategies, this study aimed to explore factors influencing CS decision-making from healthcare professionals’ perspectives.Method. A descriptive qualitative study was conducted through focus groups (FGs) with healthcare professionals (HPs) from 11 Maternity Units and 3 Community Health Services for Families of Calabria, from February to April 2021.Results. Six FGs were carried out, involving 92 HPs. Main determinants influencing high CS rates included medicalization of birth, reported women’s fear of childbirth, family pressure, cultural beliefs, organizational issues, and medico-legal concerns. HPs emphasized teamwork, midwifery-led low-risk pathways, training, and audits to reduce CS rates and improve quality of care.Conclusions. This study identified determinants influencing CS decision-making in Calabria highlighting opportunities to reduce CS through empowering education, shared protocols, and women’s active involvement in decision-making process. Audit&Feedback strategies could improve health outcomes.
Organization and functioning of the Italian Departments of Mental Health in the pandemic and post-pandemic period
Full text linkIntroduction. The pandemic significantly affected mental health, leading to a reorganization of services. This study examines changes in Italy’s Departments of Mental Health (DMHs), comparing surveys from 2021 (during COVID-19) and 2023 (post-pandemic).Methods. The two surveys involved 19 Italian DMHs and covered variables related to mental health care (number of centres, available staff, services provided and intervention methods).Results. Between 2021 and 2023, services show structural stability with a solid territorial network. Organizational changes point to greater flexibility and customization, with a stronger semi-residential hospital offer. Human resources give mixed signals: psychologists and health care social workers are increasing, while social workers and psychiatric rehabilitation technicians are decreasing. Clinically, hospitalizations in General Hospital Psychiatric Units (GHPUs), Emergency Department (ED) visits, and self-harm cases are rising, while psychiatric and psychological visits decline. Remote nursing and psychosocial interventions are increasing. The growth in first psychological consultations and users taken into care suggests a gradual return to in-person access and partial prepandemic normality.Conclusions. The data substantiate the need for continuous attention and adequate support to address post-pandemic mental distress, highlighting the importance of reorganizing services to effectively respond to the new needs of the population