ABSTRACT
Technology and artificial intelligence, alongside the COVID-19 pandemic vastly increasing technology use in health care, have precipitated an escalation of big data. Although real-world data (RWD) and real-world evidence (RWE) have contributed to determining outcomes outside the scope of randomized clinical trials (RCTs), RWD and RWE are underutilized in demonstrating drug effectiveness. Utilizing RWD may enhance the ability of regulatory agencies to approve drugs, provide drug effectiveness insight to payers, and improve personalized medicine. Additionally, RWD and RWE may assist in overcoming the limitations of RCT data such as treatment adherence and underrepresented patient subgroups and may support and expedite drug repositioning. Even though the limitations of using RWE and RWD include fragmented data context, poor data quality, and information governance, healthcare analytics hubs such as the European Health Data Space are designed to foster synergy among private and public healthcare players and may assist in overcoming these potential limitations. Such healthcare analytics hubs may enhance the utilization of RWE and/or RWD, which could ultimately result in better patient outcomes. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.
ABSTRACT
Background: At present few data have clearly showed an increased frequency of idiopathic central precocious puberty (CPP) in females during the COVID-19 pandemic. The role of environmental factors is not fully understood and various hypotheses have been formulated. Aims of the Study: To evaluate retrospectively the incidence of newly diagnosed CPP and other pubertal disorders (premature thelarche, early puberty, fast puberty and precocious menarche) in two regions of Italy (Tuscany and Emilia-Romagna) during and after the lockdown for COVID-19. Patients and Methods: The study included 440 females evaluated for pubertal disorders into the Centres of Florence, Parma, Reggio Emilia and Modena between the 1 January 2020 into the 31 December 2021. Subjects with endocrine or chronic diseases were excluded. Monthly incidence rates and clinical features were compared with a control group of patients evaluated for the same problems into 2019. Result(s): Our data confirmed a higher frequency of CPP in females (261 patients, mean age 7.6 +/- 0.6 years, without significant differences between the diagnoses carried out in 2020 and 2021) compared to 2019 (52 cases, mean age 7.5 +/- 0.7 years, p < 0.0001). Interestingly, CPP cases were significantly higher also in the first two months of 2020, so before the start of Italian lockdown and just before the Sars-COV-2 pandemic was declared (21 cases vs. 7 in the same period of 2019;p < 0.0001). Our preliminar data seem also to suggest an increased frequency of the diagnoses of premature thelarche (54 patients in 2021 and 31 patients in 2020 vs 21 patients in 2019, respectively p < 0.0001 and < 0.05;between 2020 and 2021: p < 0.0001), early puberty (31 patients in 2021 and 25 patients in 2020 vs 16 patients in 2019, respectively p < 0.0001 and p < 0.05), fast puberty (20 patients in 2020 vs 5 patients in 2019 and 2021;respectively, p < 0.0001) and precocious menarche (9 patients in 2021 vs 3 patients in 2019 and 4 patients in 2020;p < 0.0001). Conclusion(s): Our data, on the one hand, confirm an increase in the frequency of new cases of CPP during and after the lockdown for COVID-19 pandemic, but also show an increase, albeit differently distributed in these 2 years of epidemic, in other pubertal development disorders. Interestingly, this could delineate different factors involved in the genesis of these disorders. Further studies and insights appear necessary to better explain these aspects.