Delayed treatment in breast cancer patients during the COVID-19 pandemic: a population health information research infrastructure (PHIRI) case study.

BACKGROUND: The indirect impact of the coronavirus disease 2019 pandemic on healthcare services was studied by assessing changes in the trend of the time to first treatment for women 18 or older who were diagnosed and treated for breast cancer between 2017 and 2021. METHODS: An observational retrospective longitudinal study based on aggregated data from four European Union (EU) countries/regions investigating the time it took to receive breast cancer treatment. We compiled outputs from a federated analysis to detect structural breakpoints, confirming the empirical breakpoints by differences between the trends observed and forecasted after March 2020. Finally, we built several segmented regressions to explore the association of contextual factors with the observed changes in treatment delays. RESULTS: We observed empirical structural breakpoints on the monthly median time to surgery trend in Aragon (ranging from 9.20 to 17.38 days), Marche (from 37.17 to 42.04 days) and Wales (from 28.67 to 35.08 days). On the contrary, no empirical structural breakpoints were observed in Belgium (ranging from 21.25 to 23.95 days) after the pandemic's beginning. Furthermore, we confirmed statistically significant differences between the observed trend and the forecasts for Aragon and Wales. Finally, we found the interaction between the region and the pandemic's start (before/after March 2020) significantly associated with the trend of delayed breast cancer treatment at the population level. CONCLUSIONS: Although they were not clinically relevant, only Aragon and Wales showed significant differences with expected delays after March 2020. However, experiences differed between countries/regions, pointing to structural factors other than the pandemic.

Trends and cyclic variation in the incidence of childhood type 1 diabetes in two Italian regions over 33 years and during the COVID-19 pandemic.

AIM: There is conflicting evidence about the impact of the COVID-19 pandemic on the incidence of type 1 diabetes. Here, we analysed long-term trends in the incidence of type 1 diabetes in Italian children and adolescents from 1989 to 2019 and compared the incidence observed during the COVID-19 pandemic with that estimated from long-term data. MATERIALS AND METHODS: This was a population-based incidence study using longitudinal data from two diabetes registries in mainland Italy. Trends in the incidence of type 1 diabetes from 1 January 1989 to 31 December 2019 were estimated using Poisson and segmented regression models. RESULTS: There was a significant increasing trend in the incidence of type 1 diabetes of 3.6% per year [95% confidence interval (CI): 2.4-4.8] between 1989 and 2003, a breakpoint in 2003, and then a constant incidence until 2019 (0.5%, 95% CI: -1.3 to 2.4). There was a significant 4-year cycle in incidence over the entire study period. The rate observed in 2021 (26.7, 95% CI: 23.0-30.9) was significantly higher than expected (19.5, 95% CI: 17.6-21.4; p = .010). CONCLUSION: Long-term incidence analysis showed an unexpected increase in new cases of type 1 diabetes in 2021. The incidence of type 1 diabetes now needs continuous monitoring using population registries to understand better the impact of COVID-19 on new-onset type 1 diabetes in children.

The quality of mental health care for people with bipolar disorders in the Italian mental health system: the QUADIM project.

BACKGROUND: The assessment of the quality of care pathways delivered to people with severe mental disorders in a community-based system remains uncommon, especially using healthcare utilization databases. The aim of the study was to evaluate the quality of care provided to people with bipolar disorders taken-in-care by mental health services of four Italian areas (Lombardy, Emilia-Romagna, Lazio, province of Palermo). METHODS: Thirty-six quality indicators were implemented to assess quality of mental health care for patients with bipolar disorders, according to three dimensions (accessibility and appropriateness, continuity, and safety). Data were retrieved from healthcare utilization (HCU) databases, which contain data on mental health treatments, hospital admissions, outpatient interventions, laboratory tests and drug prescriptions. RESULTS: 29,242 prevalent and 752 incident cases taken-in-care by regional mental health services with a diagnosis of bipolar disorder in 2015 were identified. Age-standardized treated prevalence rate was 16.2 (per 10,000 adult residents) and treated incidence rate 1.3. In the year of evaluation, 97% of prevalent cases had ≥ 1 outpatient/day-care contacts and 88% had ≥ 1 psychiatric visits. The median of outpatient/day-care contacts was 9.3 interventions per-year. Psychoeducation was provided to 3.5% of patients and psychotherapy to 11.5%, with low intensity. 63% prevalent cases were treated with antipsychotics, 71.5% with mood stabilizers, 46.6% with antidepressants. Appropriate laboratory tests were conducted in less than one-third of prevalent patients with a prescription of antipsychotics; three quarters of those with a prescription of lithium. Lower proportions were observed for incident patients. In prevalent patients, the Standardized Mortality Ratio was 1.35 (95% CI: 1.26-1.44): 1.18 (1.07-1.29) in females, 1.60 (1.45-1.77) in males. Heterogeneity across areas was considerable in both cohorts. CONCLUSIONS: We found a meaningful treatment gap in bipolar disorders in Italian mental health services, suggesting that the fact they are entirely community-based does not assure sufficient coverage by itself. Continuity of contacts was sufficient, but intensity of care was low, suggesting the risk of suboptimal treatment and low effectiveness. Care pathways were monitored and evaluated using administrative healthcare databases, adding evidence that such data may contribute to assess the quality of clinical pathways in mental health.

Detecting early signals of COVID-19 outbreaks in 2020 in small areas by monitoring healthcare utilisation databases: first lessons learned from the Italian Alert_CoV project.

BackgroundDuring the COVID-19 pandemic, large-scale diagnostic testing and contact tracing have proven insufficient to promptly monitor the spread of infections.AimTo develop and retrospectively evaluate a system identifying aberrations in the use of selected healthcare services to timely detect COVID-19 outbreaks in small areas.MethodsData were retrieved from the healthcare utilisation (HCU) databases of the Lombardy Region, Italy. We identified eight services suggesting a respiratory infection (syndromic proxies). Count time series reporting the weekly occurrence of each proxy from 2015 to 2020 were generated considering small administrative areas (i.e. census units of Cremona and Mantua provinces). The ability to uncover aberrations during 2020 was tested for two algorithms: the improved Farrington algorithm and the generalised likelihood ratio-based procedure for negative binomial counts. To evaluate these algorithms' performance in detecting outbreaks earlier than the standard surveillance, confirmed outbreaks, defined according to the weekly number of confirmed COVID-19 cases, were used as reference. Performances were assessed separately for the first and second semester of the year. Proxies positively impacting performance were identified.ResultsWe estimated that 70% of outbreaks could be detected early using the proposed approach, with a corresponding false positive rate of ca 20%. Performance did not substantially differ either between algorithms or semesters. The best proxies included emergency calls for respiratory or infectious disease causes and emergency room visits.ConclusionImplementing HCU-based monitoring systems in small areas deserves further investigations as it could facilitate the containment of COVID-19 and other unknown infectious diseases in the future.

Does the mental health system provide effective coverage to people with schizophrenic disorder? A self-controlled case series study in Italy.

PURPOSE: To measure indicators of timeliness and continuity of treatments on patients with schizophrenic disorder in 'real-life' practice, and to validate them through their relationship with relapse occurrences. METHODS: The target population was from four Italian regions overall covering 22 million beneficiaries of the NHS (37% of the entire Italian population). The cohort included 12,054 patients newly taken into care for schizophrenic disorder between January 2015 and June 2016. The self-controlled case series (SCCS) design was used to estimate the incidence rate ratio of relapse occurrences according to mental healthcare coverage. RESULTS: Poor timeliness (82% and 33% of cohort members had not yet started treatment with psychosocial interventions and antipsychotic drug therapy within the first year after they were taken into care) and continuity (27% and 23% of patients were persistent with psychosocial interventions, and antipsychotic drug therapy within the first 2 years after starting the specific treatment) were observed. According to SCCS design, 4794 relapses occurred during 9430 PY (with incidence rate of 50.8 every 100 PY). Compared with periods not covered by mental healthcare, those covered by psychosocial intervention alone, antipsychotic drugs alone and by psychosocial intervention and antipsychotic drugs together were, respectively, associated with relapse rate reductions of 28% (95% CI 4-46%), 24% (17-30%) and 44% (32-53%). CONCLUSION: Healthcare administrative data may contribute to monitor and to assess the effectiveness of a mental health system. Persistent use of both psychosocial intervention and antipsychotic drugs reduces risk of severe relapse.

Laparoscopic transperitoneal adrenalectomy: a comparative study of different techniques for vessel sealing.

BACKGROUND: Laparoscopic adrenalectomy is the standard surgical approach to adrenal lesions. Adrenal vessel sealing is the critical surgical phase of laparoscopic adrenalectomy. This study aimed at comparing perioperative outcomes of laparoscopic transperitoneal adrenalectomy by means of radiofrequency energy-based device (LARFD) to those performed with traditional clipping device (LACD), while focusing on the different adrenal vessel control techniques. METHODS: Patients who underwent adrenalectomy for adrenal disease between January 1994 and April 2019 at the Surgical Clinic, Polytechnic University of Marche were included in the study. Overall, 414 patients met inclusion criteria for study eligibility: 211 and 203 patients underwent LARFD and LACD, respectively. Multiple models of quantile regression, logistic regression and Poisson finite mixture regression were used to assess the relationship between operative time, conversion to open procedure, length of stay (LoS), surgical procedure and patient characteristics, respectively. RESULTS: LARFD reduced operative time of about 12 min compared to LACD. Additional operative time-related factors were surgery side, surgery approach, conversion to open procedure and trocar number. The probability of conversion to open procedure decreased by about 76% for each added trocar, whereas it increased by about 49% for each added centimeter of adrenal lesion and by about 25% for each added year of surgery. Two patient clusters were identified based on the LoS: long-stay and short-stay. In the long-stay cluster, LoS decreased of about 30% in LARFD group and it was significantly associated with conversion to open procedure and postoperative complications, whereas in short-stay cluster only postoperative complications had a significant effect on LoS. CONCLUSION: Laparoscopic transperitoneal adrenalectomy performed by means of radiofrequency energy-based device for the sealing of adrenal vessels is an effective procedure reducing operative time with potentially improved postoperative outcomes.

Cost-effectiveness of the adherence with recommendations for clinical monitoring of patients with diabetes.

BACKGROUND AND AIMS: To validate a set of indicators for monitoring the quality of care of patients with diabetes in 'real-life' practice through its relationship with measurable clinical outcomes and healthcare costs. METHODS AND RESULTS: A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, -2 to 27) and 23 days (9-38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed. CONCLUSION: Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Measuring multimorbidity inequality across Italy through the multisource comorbidity score: a nationwide study.

BACKGROUND: Multimorbidity is a growing concern for healthcare systems, with many countries experiencing demographic transition to older population profiles. A simple multisource comorbidity score (MCS) has been recently developed and validated. A very large real-world investigation was conducted with the aim of measuring inequalities in the MCS distribution across Italy. METHODS: Beneficiaries of the Italian National Health Service aged 50-85 years who in 2018 were resident in one of the 10 participant regions formed the study population (15.7 million of the 24.9 million overall resident in Italy). MCS was assigned to each beneficiary by categorizing the individual sum of the comorbid values (i.e. the weights corresponding to the comorbid conditions of which the individual suffered) into one of the six categories denoting a progressive worsening comorbidity status. MCS distributions in women and men across geographic partitions were compared. RESULTS: Compared with beneficiaries from northern Italy, those from centre and south showed worse comorbidity profile for both women and men. MCS median age (i.e. the age above which half of the beneficiaries suffered at least one comorbidity) ranged from 60 (centre and south) to 68 years (north) in women and from 63 (centre and south) to 68 years (north) in men. The percentage of comorbid population was lower than 50% for northern population, whereas it was around 60% for central and southern ones. CONCLUSION: MCS allowed of capturing geographic variability of multimorbidity prevalence, thus showing up its value for addressing health policy in order to guide national health planning.

Effect of national and local lockdowns on the control of COVID-19 pandemic: a rapid review.

OBJECTIVES: to describe and compare the effectiveness of national and local lockdowns in controlling the spread of COVID-19. METHODS: a rapid review of published and grey literature on COVID-19 pandemic was conducted following predefined eligibility criteria by searching electronic databases, repositories of pre-print articles, websites and databases of international health, and research related institutions and organisations. RESULTS: of 584 initially identified records up to 5 July 2020, 19 articles met the inclusion criteria and were included in the review. Most of the studies (No. 11) used the reproduction  number (Rt) as a measure of effect and in all of them areduction of the estimated value at post-intervention period was found. The implementation of lockdown in 11 European countries was associated with an average 82% reduction of Rt, ranging from a  posterior Rt of 0.44 (95%CI 0.26-0.61) for Norway to a posterior Rt of 0.82 (95%CI 0.73- 0.93) for  Belgium. Changes in infection rates and transmission rates were estimated in 8 studies. Daily changes in infection rates ranged from -0.6% (Sweden) to -11.3% (Hubei and Guangdong provinces). Additionally, other studies reported a change in the trend of hospitalizations (Italy, Spain) and positive effects on the  doubling time of cases (Hubei, China) after lockdown. CONCLUSIONS: results of this rapid review suggest a positive effect of the containment measures on the spread of COVID-19 pandemic, with a major effect in  countries where lockdown started early and was more restrictive. Rigorous research is warranted to evaluate which approach is the most effective in each stage of the epidemic and in specific social contexts, in particular addressing if these approaches should be implemented on the whole population or target specific risk groups.

Effectiveness of adherence to recommended clinical examinations of diabetic patients in preventing diabetes-related hospitalizations.

OBJECTIVE: To validate a set of indicators for quality of diabetes care through their relationship with measurable clinical outcomes. DESIGN: A retrospective cohort study was carried out from 2010 to 2015. SETTING: Population-based study. Data were retrieved from healthcare utilization databases of three Italian regions (Lombardy, Emilia Romagna and Lazio) on the whole covering 20 million citizens. PARTICIPANTS: The 77 285 individuals who were newly taken in care for diabetes during 2010 entered into the cohort. INTERVENTIONS: Exposure to selected clinical recommendations (i.e. periodic controls for glycated hemoglobin, lipid profile, urine albumin excretion, serum creatinine and dilated eye exams) was recorded. MAIN OUTCOMES MEASURES: A composite outcome was employed taking into account hospitalizations for brief-term diabetes complications, uncontrolled diabetes, long-term vascular outcomes and no traumatic lower limb amputation. A multivariable proportional hazards model was fitted to estimate hazard ratio, and 95% confidence intervals (CI), for the exposure-outcome association. RESULTS: Among the newly taken in care patients with diabetes, those who adhered to almost none (0 or 1), just some (2 or 3) or almost all (4 or 5) recommendations during the first year after diagnosis were 44%, 36% and 20%, respectively. Compared patients who adhered to almost none recommendation, significant risk reductions of 16% (95% CI, 6-24%) and 20% (7-28%) were observed for those who adhered to just some and almost all recommendations, respectively. CONCLUSIONS: Tight control of patients with diabetes through regular clinical examinations must to be considered the cornerstone of national guidance, national audits and quality improvement incentives schemes.

Segmented Bayesian calibration approach for estimating age in forensic science.

Forensic age estimation is receiving growing attention from researchers in the last few years. Accurate estimates of age are needed both for identifying real age in individuals without any identity document and assessing it for human remains. The methods applied in such context are mostly based on radiological analysis of some anatomical districts and entail the use of a regression model. However, estimating chronological age by regression models leads to overestimated ages in younger subjects and underestimated ages in older ones. We introduced a full Bayesian calibration method combined with a segmented function for age estimation that relied on a Normal distribution as a density model to mitigate this bias. In this way, we were also able to model the decreasing growth rate in juveniles. We compared our new Bayesian-segmented model with other existing approaches. The proposed method helped producing more robust and precise forecasts of age than compared models while exhibited comparable accuracy in terms of forecasting measures. Our method seemed to overcome the estimation bias also when applied to a real data set of South-African juvenile subjects.

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial.

OBJECTIVE: To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease. STUDY DESIGN: This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic. RESULTS: After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089). CONCLUSIONS: Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00808301.

Disordered eating behaviors in adolescents with type 1 diabetes: A cross-sectional population-based study in Italy.

OBJECTIVE: To evaluate the association of clinical, metabolic and socioeconomic factors with disordered eating behaviors (DEB) among adolescents with type 1 diabetes screened using the Diabetes Eating Problem Survey-Revised (DEPS-R). METHODS: A cross-sectional, population-based study involved 163 adolescents with type 1 diabetes, aged 11-20 years, recruited from the registry for type 1 diabetes of Marche Region, Italy, who completed the DEPS-R (response rate 74.4%). Clinical characteristics, lipid profile, HbA1c , family profile of education and occupation were evaluated. The Italian version of DEPS-R was validated, and the prevalence of DEB estimated. The association of demographic, socioeconomic, and clinical factors with DEB was evaluated by multiple correspondence analysis and multiple logistic regression. RESULTS: The prevalence of DEPS-R-positive (score ≥20) was 27% (95% CI 17-38) in boys and 42% (95% CI 31-53) in girls. A clinical profile of DEPS-R-positive was identified: overweight, little time spent in physical activity, low socioeconomic status, poor metabolic control, skipping insulin injections. Furthermore, the probability of DEPS-R-positive increased 63% for every added unit of HbA1c , 36% for every added number of insulin injections skipped in a week and decreased about 20% for every added hour/week spent in physical activity. Overweight youth were six times more likely to be DEPS-R-positive. DISCUSSION: A specific clinical profile of DEPS-R-positive was identified. A multidisciplinary clinical approach aimed to normalize eating behaviors and enhance self-esteem should be used to prevent the onset of these behaviors, and continuous educational programs are needed to promote healthy behaviors and lifestyles.

The role of socio-economic and clinical factors on HbA1c in children and adolescents with type 1 diabetes: an Italian multicentre survey.

OBJECTIVE: To identify the role of the family's socio-economic and clinical characteristics on metabolic control in children and adolescents with type 1 diabetes. METHODS: In this cross-sectional, multicentre study, 768 subjects with type 1 diabetes under 18 years of age were consecutively recruited from January 2008 to February 2009. Target condition was considered for HbA1c values <7.5% (<58 mmol/mol). A multiple correspondence analysis (MCA) was performed to analyze the association between the socio-economic and clinical characteristics of the participants. A logistic regression analysis was performed to identify factors associated with the subjects metabolic control. In both analyses, the family's socio-economic status was represented, measured by the Hollingshead Four-Factor Index of Social Status (SES) or by parental years of education. RESULTS: A total of 28.1% of subjects reached target HbA1c values. The MCA identified a strong association between at-target condition and several factors: high levels of SES or high levels of parental education, the use of the carbohydrate counting system, the use of insulin pumps, the use of the insulin delivery system over a short period of time, a normal body mass index. The logistic regression analysis showed that SES and the mother's years of education were significantly associated with the target condition [odds ratio (OR): 1.01, 95% confidence interval (CI): 1.01-1.03, p = 0.029; OR: 1.05, 95% CI: 1.01-1.10, p = 0.027, respectively). CONCLUSIONS: Personal, clinical, and family characteristics were found to be associated with HbA1c target. Their identification can be crucial in addressing strategies to optimize metabolic control and improve diabetes management.

Overuse of surgery in patients with pancreatic cancer. A nationwide analysis in Italy.

BACKGROUND: According to current guidelines, pancreatic cancer patients should be strictly selected for surgery, either palliative or resective. METHODS: Population-based study, including all patients undergoing surgery for pancreatic cancer in Italy between 2010 and 2012. Hospitals were divided into five volume groups (quintiles), to search for differences among volume categories. RESULTS: There were 544 hospitals performing 10 936 pancreatic cancer operations. The probability of undergoing palliative/explorative surgery was inversely related to volume, being 24.4% in very high-volume hospitals and 62.5% in very low-volume centres (adjusted OR 5.175). Contrarily, the resection rate in patients without metastases decreased from 86.9% to 46.1% (adjusted OR 7.429). As for resections, the mortality of non-resective surgery was inversely related to volume (p < 0.001). Surprisingly, mortality of non-resective surgery was higher than that for resections (8.2% vs. 6.7%; p < 0.01). Approximately 9% of all resections were performed on patients with distant metastases, irrespective of hospital volume group. The excess cost for the National Health System from surgery overuse was estimated at 12.5 million euro. DISCUSSION: Discrepancies between guidelines on pancreatic cancer treatment and surgical practice were observed. An overuse of surgery was detected, with serious clinical and economic consequences.

AHRQ prevention quality indicators to assess the quality of primary care of local providers: a pilot study from Italy.

BACKGROUND: Outside the USA, Agency for Healthcare Research and Quality (AHRQ) prevention quality indicators (PQIs) have been used to compare the quality of primary care services only at a national or regional level. However, in several national health systems, primary care is not directly managed by the regions but is in charge of smaller territorial entities. We evaluated whether PQIs might be used to compare the performance of local providers such as Italian local health authorities (LHAs) and health districts. METHODS: We analysed the hospital discharge abstracts of 44 LHAs (and 11 health districts) of five Italian regions (including ≈18 million residents) in 2008-10. Age-standardized PQI rates were computed following AHRQ specifications. Potential predictors were investigated using multilevel modelling. RESULTS: We analysed 11 470 722 hospitalizations. The overall rates of preventable hospitalizations (composite PQI 90) were 1012, 889 and 988 (×100 000 inhabitants) in 2008, 2009 and 2010, respectively. Composite PQIs were able to differentiate LHAs and health districts and showed small variation in the performance ranking over years. CONCLUSION: Although further research is required, our findings support the use of composite PQIs to evaluate the performance of relatively small primary health care providers (50 000-60 000 enrollees) in countries with universal health care coverage. Achieving high precision may be crucial for a structured quality assessment system to align hospitalization rate indicators with measures of other contexts of care (cost, clinical management, satisfaction/experience) that are typically computed at a local level.

Perforator flaps in late-stage pressure sore treatment: outcome analysis of 11-year-long experience with 143 patients.

BACKGROUND: In the last decade, perforator flaps have been introduced for the treatment of pressure ulcers as alternative to the more popular myocutaneous local flaps. We reviewed our single-team 11-year experience in order to define whether real advantages could be achieved. METHODS: We analyzed 143 patients undergoing perforator flap surgery for a single late-stage pressure sore. All patients underwent the same protocol treatment. Data regarding associated pathologies, demographics, complications, healing, and hospitalization times were collected. RESULTS: Ninety-three percent of 143 patients were white Caucasian, and 61% were men, with median age of 51 years. Of 143 stage 4 ulcers, 46.2% were ischial, 42.7% sacral, and 11.2% trochanteric. The most common diagnosis was traumatic paraplegia/tetraplegia (74.9%); no significant difference was found in diagnosis distribution and in ulcer location between recurrent and nonrecurrent patients. We performed 44 S-GAP, 78 I-GAP, 3 PFAP-am, and 18 PFAP-1 flaps. At 2 years' follow-up, the overall recurrence was 22.4% and new ulcer occurrence was 4.2%. Mean hospital stay was 16 days. The overall complication percentage was 22.4%, mostly due to suture-line dehiscence (14%) and distal flap necrosis (6.3%). PFAP flaps had a significant higher risk of developing recurrence than I-GAP flaps. The recurrence risk was significantly higher for subjects suffering from coronary artery disease. CONCLUSIONS: Late-stage pressure sore treatment with local perforator flaps can achieve reliable long-term outcomes in terms of recurrences and complications. When compared to previously published data, perforator flaps surgery decreased postoperative hospital stay (by an average of nearly 1 week), reoperations (5.6%), and occurrences.

Understanding Patterns of Adherence to Antifibrotic Treatment in Idiopathic Pulmonary Fibrosis: Insights from an Italian Prospective Cohort Study.

Background: Pirfenidone and Nintedanib have significantly improved the prognosis of patients with idiopathic pulmonary fibrosis (IPF), reducing mortality risk and exacerbations. This study aimed to analyze antifibrotic treatment utilization and its association with clinical outcomes (i.e., acute exacerbation or death) during 2014-2021 in newly diagnosed IPF patients, using Healthcare Utilization Databases of the Marche Region, Italy. Methods: The first 12-month adherence to antifibrotic was estimated using the Proportion of Days Covered (PDC), defining adherence as PDC ≥ 75%. State Sequence Analysis over the initial 52 weeks of treatment was used to identify adherence patterns. The role of adherence patterns on acute exacerbations/death, adjusted by demographic, clinical features, and monthly adherence after the 52-week period (time-dependent variable), was assessed with Cox regression. Results: Among 667 new IPF cases, 296 received antifibrotic prescriptions, with 62.8% being adherent in the first year. Three antifibrotic utilization patterns emerged-high adherence (37.2%), medium adherence (42.5%), and low adherence (20.3%)-with median PDCs of 95.3%, 79.5%, and 18.6%, respectively. These patterns did not directly influence three-year mortality/exacerbation probability, but sustained adherence reduced risk over time. Conclusions: Good adherence was observed in in this population-based study, emphasizing the importance of continuous antifibrotics therapy over time to mitigate adverse outcomes.

Incidence of amyotrophic lateral sclerosis before and during the COVID-19 pandemic: evidence from an 8-year population-based study in Central Italy based on healthcare utilization databases.

BACKGROUND: Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder with a high multidimensional burden, with an obscure etiopathogenesis. METHODS: We designed a longitudinal, population-based study of people residing in Central Italy (Marche Region) who were beneficiaries of the National Health System. People with an unprecedented ALS hospitalization (335.20 ICD-9 CM) or tagged with an ALS exemption between 2014 and 2021 were considered incident cases. ALS cases residing in the region for <3 years or with an active ALS exemption or hospitalized for ALS before 2014 were excluded. We used secondary sources to identify new ALS diagnoses. The regional referral center for ALS's database was used to test the accuracy of secondary sources in detecting cases. ALS mean incidence was compared to that reported in similar studies conducted in Italy. The incidence rate trend adjusted by sex and age was evaluated using the Poisson regression model. RESULTS: We detected 425 new ALS cases (median age: 70y) in the 2014-2021 period, with a mean incidence of 3.5:100,000 py (95%CI: 3.2-3.8; M:F = 1.2), similar to that reported in similar studies conducted in Italy. No trend was observed during 2014-2019. After including 2020-2021 in the model, we observed a mean decrease in incidence of 5.8% (95% CI 2.0%; 9.5%, p = 0.003). CONCLUSION: We show a decrease in the incidence rate of ALS in Marche, during the 2014-2021 period, as a possible outcome of a delayed neurological assessment and diagnosis during the pandemic. An ad hoc developed identification algorithm, based on healthcare utilization databases, is a valuable tool to assess the health impact of global contingencies.

Role of viable but non culturable cells in patients with cystic fibrosis in the era of highly effective modulator therapy.

BACKGROUND: Lung infections antibiotic treatment in Cystic Fibrosis patients (pwCF) is often complicated by bacterial persisters, including the so-called Viable but Non Culturable (VBNC) forms, live cells undetected by the routine cultural microbiological methods. This study investigated the occurrence of VBNC cells of five CF bacterial pathogens in 94 pwCF over one year and the possible associations with the patients' clinical features. METHODS: Sputum samples, recovered at routine visits and during exacerbation episodes, were analyzed for the presence of the five pathogens by both routine culture-based assays and species-specific qPCR. VBNC cells were estimated as the difference between molecular and cultural counts and their presence was matched with the clinical data in particular the therapeutic regimens. RESULTS: All but ten pwCF showed the presence of VBNC cells at least once during the study. Pseudomonas aeruginosa and methicillin-susceptible Staphylococcus aureus were the species most frequently found in the VBNC state. Only the former showed a significant association between chronic infection and VBNC cells presence; VBNC-MSSA positive patients significantly increased overtime. The presence of non culturable bacteria was generally concurrent with poor lung functionality and more frequent pulmonary exacerbations. No significant association with modulator treatment was evidenced. CONCLUSIONS: The obtained data demonstrated the overwhelming occurrence of bacterial VBNC cells in CF lung infections, warranting a constant monitoring of pwCF and underlining the need of implementing the routine culture-based assays with culture-independent techniques. This is pivotal to understand the CF bacterial population dynamics and to efficiently contrast the lung infection progression and worsening.