Equity in the recovery of elective and oncological surgery volumes after the COVID-19 lockdown: a multicentre cohort study in Italy.

BACKGROUND: The COVID-19 pandemic has had, and still has, a profound impact on national health systems, altering trajectories of care and exacerbating existing inequalities in health. Postponement of surgeries and cancellation of elective surgical procedures have been reported worldwide. In Italy, the lock-down measures following the COVID-19 pandemic caused cancellations of surgical procedures and important backlogs; little is known about potential social inequalities in the recovery process that occurred during the post-lockdown period. This study aims at evaluating whether all population social strata benefited equally from the surgical volumes' recovery in four large Italian regions. METHODS: This multicentre cohort study covers a population of approximately 11 million people. To assess if social inequalities exist in the recovery of eight indicators of elective and oncological surgery, we estimated Risk Ratios (RR) through Poisson models, comparing the incidence proportions of events recorded during COVID-19 (2020-21) with those in pre-pandemic years (2018-19) for each pandemic period and educational level. RESULTS: Compared to 2018-19, volumes of elective surgery showed a U-shape with the most significant drops during the second wave or the vaccination phase. The recovery was socially unequal. At the end of 2021, incidence proportions among highly educated people generally exceeded the expected ones; RRs were 1.31 (95%CI 1.21-1.42), 1.24 (95%CI 1.17-1.23), 1.17 (95%CI 1.08-1.26) for knee and hip replacement and prostatic surgery, respectively. Among low educated patients, RR remained always < 1. Oncological surgery indicators showed a similar social gradient. Whereas volumes were preserved among the highly educated, the low educated were still lagging behind at the end of 2021. CONCLUSIONS: Surgical procedures generally returned to pre-pandemic levels but the low educated experienced the slowest recovery. An equity-oriented appraisal of trends in healthcare provision should be included in pandemic preparedness plans, to ensure that social inequalities are promptly recognised and tackled.

Indirect impact of the COVID-19 pandemic and its containment measures on social inequalities in hospital utilisation in Italy.

BACKGROUND: The pandemic may undermine the equity of access to and utilisation of health services for conditions other than COVID-19. The objective of the study is to evaluate the indirect impact of COVID-19 and lockdown measures on sociodemographic inequalities in healthcare utilisation in seven Italian areas. METHODS: In this multicentre retrospective study, we evaluated whether COVID-19 modified the association between educational level or deprivation and indicators of hospital utilisation and quality of care. We also assessed variations in gradients by sex and age class. We estimated age-standardised rates and prevalence and their relative per cent changes comparing pandemic (2020) and pre-pandemic (2018-2019) periods, and the Relative Index of Inequalities (RIIs) fitting multivariable Poisson models with an interaction between socioeconomic position and period. RESULTS: Compared with 2018-2019, hospital utilisation and, to a lesser extent, timeliness of procedures indicators fell during the first months of 2020. Larger declines were registered among women, the elderly and the low educated resulting in a shrinkage (or widening if RII <1) of the educational gradients for most of the indicators. Timeliness of procedures indicators did not show any educational gradient neither before nor during the pandemic. Inequalities by deprivation were nuanced and did not substantially change in 2020. CONCLUSIONS: The socially patterned reduction of hospital utilisation may lead to a potential exacerbation of health inequalities among groups who were already vulnerable before the pandemic. The healthcare service can contribute to contrast health disparities worsened by COVID-19 through more efficient communication and locally appropriate interventions.

Cost per care of the first year of direct antiviral agents in the Liguria Region: a multicenter analysis.

AIMS: Despite the remarkable efficacy shown in clinical practice, concerns have been raised about the costs associated with direct antiviral agent (DAA) therapy. This article presents the real-life costs for DAA treatment sustained by the Italian National Health Service in the Liguria Region (Northern Italy). METHODS: A retrospective analysis of the cost per care sustained for DAA treatment, relating to the period from January 1 to December 31, 2015 in five centers in Liguria was performed. All patients undergoing DAA-based treatments for hepatitis C virus (HCV) infection were enrolled. On-treatment costs included: HCV treatment, laboratory test, outpatient services, attended visits, drugs used for the management of adverse events (erythropoietin, albumin or red blood cell packs) and inpatient service admissions. RESULTS: In total, 327 patients were enrolled. No difference in terms of sustained virologic response (SVR) rate among different treatments was reported. The majority (85.0%) of patients did not report any side effects and only 15 (4.6%) required hospital admission. Forty-two patients (12.8%) required high-cost drugs for the management of adverse events. The overall cost sustained was €14,744,433. DAA±ribavirin (RBV) accounted for the wide majority of this cost (98.9%; €14,585,123). Genotype (GT) 1, the most commonly treated GT, was associated with an average cost of €43,445 per patient. Detailed analysis of the costs for GT 1 showed the treatment based on ritonavir boosted paritaprevir/ombitasvir + dasabuvir±RBV with an average cost of €24,978 (RBV+) and €25,448 (RBV-) per patient was the most cost-effective. The average cost per SVR was €48,184. Once again, the ritonavir boosted paritaprevir/ombitasvir + dasabuvir regimen was associated with the lowest cost/SVR (€25,448/SVR [GT 1b] and similar results for other GTs). CONCLUSION: Antiviral regimen is the major contributor to costs in the treatment of HCV infection. Appropriate regimen selection could result in a major cost saving, which can be reinvested to allow more patients to be treated.

Efficacy, safety and cost per responder of biologics in the treatment of non-radiographic axial spondyloarthritis.

Anti-tumour necrosis factor (TNF) agents are recommended as second-line therapy for patients with axial spondyloarthropathies. This analysis reviewed data on studies investigating the efficacy and tolerability of anti-TNF agents in patients with non-radiographic axial spondyloarthritis (nr-axSpA) who had failed first-line non-steroidal anti-inflammatory (NSAID) treatment. Efficacy data from RCTs were used to calculate the number needed to treat (NNT) for individual anti-TNFs and then the cost per responder was determined to provide an indication of the value of each therapy. A systematic literature review and analysis of search results over the period January 2008 to September 2014 identified four randomised placebo-controlled trials that were included in the analysis. Adalimumab, etanercept and certolizumab pegol were all effective and well tolerated in patients with nr-axSpA. A patient was more likely to reach ASAS20 or ASAS40 when treated with etanercept or adalimumab, the NNT was lowest for adalimumab, and the risk of adverse events was higher with certolizumab pegol 200 mg every 2 weeks. The cost per responder (NNT) was lowest for adalimumab, followed closely by certolizumab 400 mg every 4 weeks, intermediate for certolizumab 200 mg every 2 weeks and highest for etanercept. Although all anti-TNF agents were associated with clinical improvement in patients with nr-axSpA, adalimumab presented a better cost per responder than etanercept and certolizumab pegol.

Actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia: temporal trends of prescription and hospitalization rates over 5 years in a large population of Italian men.

PURPOSE: The purpose of the study is to estimate the trends in drug prescriptions and the hospitalization rates for lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in real-life clinical practice, using information deriving from administrative databases of the Italian health care system. METHODS: Prescription data on approximately 1,500,000 men over 40 were examined, and prescribed boxes of alpha-blockers (ABs) and/or 5 alpha reductase inhibitors (5ARI) were calculated for 5 consecutive years, from 2004 to 2008. Annual use prevalence and incidence rates for each drug class and for the combination therapy (CT) were calculated according to age for the entire study period. Hospitalization rates for reasons related to LUTS/BPH were also evaluated for the same time period. RESULTS: The overall distribution of drugs for LUTS/BPH, in terms of number of boxes prescribed, increased by 43 %. This increase was accounted for by both classes of drugs although it was greater for 5ARI than for AB (+49 vs +41 %). The prevalence of CT showed a substantial increase to almost 25 % in patients aged ≥75. Hospitalization rate for BPH/LUTS-related reasons decreased during the study period (8 and 3 % per year for non-surgical and surgical reasons, respectively). CONCLUSIONS: The prevalence of the use of drugs prescribed for LUTS/BPH has steadily increased. An increase in terms of prescribed boxes was observed for both classes of drugs, even though the increase was greater for 5ARIs. The reduction in the hospitalization rates needs additional researches.

Clinical effects and economical impact of dutasteride and finasteride therapy in Italian men with LUTS.

OBJECTIVES: To investigate differences in the risk of benign prostatic hyperplasia (BPH)- related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients under dutasteride or finasteride treatment. MATERIAL AND METHODS: A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included. The association of the outcomes was assessed using a multiple Cox proportional hazard model. Propensity score matched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs finasteride in BPH-treated patient was performed. RESULTS: From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The overall hospitalization for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitalization for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgical reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under finasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. finasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 €. CONCLUSIONS: The clinical effects of dutasteride and finasteride are slightly different. The likelihood of hospitalization for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefit for dutasteride. Comparative prospective studies are necessary to confirm these results.

Hospital discharge database as a tool to monitor incidence, survival and burden of cancer in adolescents and young adults.

AIMS AND BACKGROUND: Cancer in young patients (15-39 years) is unique for the distribution of types, therapeutic options and clinical evolution. Administrative databases represent well-documented tools in epidemiology, and in oncology they are very important in those realities without cancer registries. Our study aimed to analyze the occurrence, outcomes and burden of cancer in young patients through the analysis of hospital discharge records. METHODS: Hospital discharge databases and civil registries were analyzed through record linkage technique. Annual incidence rate (AIR), standardized incidence rate (SR), overall survival, hospitalization rate, and mean number of hospitalizations were evaluated. RESULTS: Among 2,330,459 young adults, 1846 new cancer patients had been hospitalized in the analyzed period. The SR was 69.3/100,000/year: 1051, 56.9%, were females (AIR 91.0 and SR 76.0) and 795, 43.1%, were males (AIR 67.6 and SR 62.5). Hematological disease was more frequent in males than females (25.5% vs 14.7%, P <0.0001), whereas solid tumors were more frequent among females (85.3% vs 74.5, P <0.0001). The distribution by diagnostic group showed that among females breast cancer was the most frequent (n = 272, SR 17.2), whereas among males genitourinary tract cancer (n = 245, SR 19.2), especially testicular cancer (n = 187, SR 15.1), was the most frequent. Metastatic disease at diagnosis was already present in 198 patients with a solid cancer (13.3%), whereas 213 (11.5%) developed metastasis in the following years. At 12 months from the diagnosis, 87 of 1488 patients with solid cancers and 35 of 358 patients with hematologic disease failed: overall survival was 94% and 90%, respectively. Patients with a new diagnosis of cancer had produced 6663 hospitalizations, 4640 (69.6%) of which were due to solid tumors, 3992 (59.9%) produced by patients over 29 years old, and 3606 (54.1%) by females. The percentage of day hospital admissions increased proportionally with patient age: 25.7% of all hospitalizations among older adolescents (15-20 years) and 32.9% among young adults of 34-39 years. CONCLUSIONS: Administrative data have clear advantages in terms of availability and large numbers. Comparison of our results with the literature showed that a health care delivery database can provide useful information for clinical-epidemiologic evaluations in oncology as well as for the analysis of health services utilization.

Laparoendoscopic single-site upper urinary tract surgery: assessment of postoperative complications and analysis of risk factors.

BACKGROUND: Laparoendoscopic single-site surgery (LESS) has been developed in an attempt to minimise the morbidity and scarring associated with surgical intervention. OBJECTIVE: To evaluate the incidence of and the risk factors for complications in patients undergoing LESS upper urinary tract surgery. DESIGN, SETTING, AND PARTICIPANTS: Between September 2007 and February 2011, 192 consecutive patients underwent LESS for upper urinary tract diseases at four institutions. MEASUREMENTS: All complications occurring at any time after surgery were captured, including the inpatient stay as well as in the outpatient setting. They were classified as early (onset<30 d), intermediate (onset 31-90 d), or late (onset>90 d) complications, depending on the date of onset. All complications were graded according to the modified Clavien classification. RESULTS AND LIMITATIONS: The patient population was generally young (mean: 55±18 yr of age), nonobese (mean body mass index [BMI]: 26.5±4.8 kg/m2), and healthy (mean preoperative American Society of Anaesthesiologists [ASA] score: 2±1). Forty-six patients had had prior abdominal surgery. Mean operative time was 164±63 min, with a mean estimated blood loss (EBL) of 147±221 ml. In 77 cases (40%), the surgeons required additional ports, with a standard laparoscopy conversion rate of 6%. Mean hospital stay was 3.3±2.3 d, and the mean visual analogue scale (VAS) score at discharge was 1.7±1.43. Thirty-three complications were recorded-30 early, 2 intermediate, and 1 late-for an overall complication rate of 17%. Statistically significant associations were noted between the occurrence of a complication and age, ASA score, EBL, length of stay (LOS), and malignant disease at pathology. Univariable and the multivariable analyses showed that a higher ASA score (incidence rate ratio [IRR]: 1.4; 95% confidence interval [CI], 1.0-2.1; p=0.034) and malignant disease at pathology (IRR: 2.5; 95% CI, 1.3-4.7; p=0.039) represented risk factors for complications. Poisson regression analysis over time showed a 23% non-statistically significant reduction in risk of complications every year (IRR: 0.77; 95% CI, 0.5-1.19; p=0.242). CONCLUSIONS: Malignant disease at pathology and high ASA score represent a predictive factor for complication after LESS for upper urinary tract surgery. Thus, surgeons approaching LESS should start with benign diseases in low-surgical-risk patients to minimise the likelihood of postoperative complications.

[Administrative databases as a basic tool for the epidemiology of cardiovascular diseases]. / Database amministrativi come risorsa accessibile e strumento efficiente per l'epidemiologia cardiovascolare. Metodologia generale e scenari di applicazione ai modelli della cronicità e dello scompenso.

The broader availability of administrative databases, characterized by increasing data reliability, related to the various steps of the healthcare process, has became also in Italy an important resource for epidemiological studies. Specifically, the methodological developments in the handling and analysis of drug prescription files can be seen as the original and highly informative backbone of a comprehensive monitoring of healthcare delivery processes. The area of chronic cardiovascular treatments occupies a privileged space in these developments, which are illustrated in the paper, with a synthetic presentation of the methodology supported by a model analysis of the epidemiology of heart failure in a healthcare district and by a reference list which has been conceived to provide to the reader a comprehensive perspective on an area so far largely unexplored.