Epidemiological and molecular characterization of HBV and HCV infections in HIV-1-infected inmate population in Italy: a 2017-2019 multicenter cross-sectional study.

HBV/HCV co-infection is common in HIV-1-infected prisoners. To investigate the characteristics of HIV co-infections, and to evaluate the molecular heterogeneity of HIV, HBV and HCV in prisoners, we carried-out a multicenter cross-sectional study, including 65 HIV-1-infected inmates enrolled in 5 Italian detention centers during the period 2017-2019. HIV-1 subtyping showed that 77.1% of inmates were infected with B subtype and 22.9% with non-B subtypes. Italian nationals were all infected with subtype B (93.1%), except two individuals, one infected with the recombinant form CRF72_BF1, and the other with the HIV-1 sub-subtype A6, both previously not identified in inmates of Italian nationality. Non-Italian nationals were infected with subtype B (52.6%), CRFs (36.8%) and sub-subtypes A1 and A3 (5.2%). HIV variants carrying resistance mutations to NRTI, NNRTI, PI and InSTI were found in 7 inmates, 4 of which were never exposed to the relevant classes of drugs associated with these mutations. HBV and/or HCV co-infections markers were found in 49/65 (75.4%) inmates, while 27/65 (41.5%) showed markers of both HBV and HCV coinfection. Further, Italian nationals showed a significant higher presence of HCV markers as compared to non-Italian nationals (p = 0.0001). Finally, HCV phylogenetic analysis performed in 18 inmates revealed the presence of HCV subtypes 1a, 3a, 4d (66.6%, 16.7% and 16.7%, respectively). Our data suggest the need to monitor HIV, HBV and HCV infections in prisons in order to prevent spreading of these viruses both in jails and in the general population, and to implement effective public health programs that limit the circulation of different genetic forms as well as of viral variants with mutations conferring resistance to treatment.

A multicenter clinical study with myo-inositol and alpha-lactalbumin in Mexican and Italian PCOS patients.

OBJECTIVE: This open-label non-randomized clinical study aimed at evaluating the effects of myo-inositol plus alpha-lactalbumin in two groups of PCOS women, treated in Mexico and Italy. Alpha-lactalbumin was used being effective in increasing myo-inositol intestinal absorption. This effect is very useful in greatly reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects). PATIENTS AND METHODS: The study involved 34 normal weight or overweight patients (14 in Mexico and 20 in Italy), aged 18 to 40 years, with anovulation and infertility > 1 year and insulin resistance diagnosed by HOMA-Index. Patients were administered orally with 2 g myo-inositol, 50 mg alpha-lactalbumin, and 200 µg of folic acid twice a day for 6 months. Controls were the same patients at t0 (baseline). The primary outcome was HOMA-index decrease after 3 and 6 months of treatment. Other parameters monitored were BMI, progesterone, LH, FSH, total testosterone, free testosterone, androstenedione, total cholesterol, HDL, LDL, triglycerides. RESULTS: Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results were obtained with insulin, HOMA-index, LH, and androstenedione. No significant adverse effects were detected in both groups of patients. CONCLUSIONS: This clinical trial demonstrated for the first time that myo-inositol and alpha-lactalbumin improve important parameters in PCOS patients characterized by different metabolic profiles.

Safety of oral alpha-lipoic acid treatment in pregnant women: a retrospective observational study.

OBJECTIVE: Alpha-lipoic acid is a natural molecule, which directly or by means of its reduced form, dihydrolipoic acid, exerts antioxidant, anti-inflammatory and immunomodulatory activities, very helpful also in preventing miscarriage and preterm delivery. Used as dietary supplement alpha-lipoic acid was demonstrated to be safe for living organisms even when administered at high doses. However, no study was made so far to verify the safety of its continuous administration on a substantial number of pregnant women. The present investigation was performed to answer this issue. PATIENTS AND METHODS: An observational retrospective study was carried out analyzing 610 expectant mothers. They had been treated daily by oral route with 600 mg alpha-lipoic acid, for at least 7 weeks during gestation. The primary outcome was to verify alpha-lipoic acid safety in the mother and infant. Maternal safety was assessed by monitoring for adverse reactions, physical and clinical examination, including a morbidity assessment. Laboratory and clinical examinations were performed monthly. Neonatal safety was assessed by the evaluation of birth weight, gestational age, Apgar scores, neonatal death with the related cause of death. Data collected from the Birth Registry of Campania Region were used as control. RESULTS: This study provided a very clear and reassuring picture about the safety of alpha-lipoic acid oral treatment during pregnancy. No adverse effect was noticed in mothers or newborns. The two sets of monitored data, from treated and controls, were completely superimposable or, in some cases, better in alpha-lipoic acid group. CONCLUSIONS: Our results open a reassuring scenario regarding the administration of alpha-lipoic acid during pregnancy.

Quality of life, depression and fatigue in mildly disabled patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: 3-year results from the COGIMUS (COGnitive Impairment in MUltiple Sclerosis) study.

BACKGROUND: The precise relationships among quality of life, depression, fatigue and cognitive impairment in multiple sclerosis (MS) are complex and poorly understood. OBJECTIVE: To assess the effects of subcutaneous interferon beta-1a on quality of life, depression and fatigue over 3 years in the COGIMUS study, and to examine the relationship between these outcomes and baseline cognitive status. METHODS: COGIMUS was an observational 3-year trial assessing cognitive function in 459 patients with relapsing-remitting MS treated with subcutaneous interferon beta-1a. RESULTS: In total, 331 patients completed the study (168 received interferon beta-1a, 44 µg subcutaneously three times weekly, and 163 received interferon beta-1a, 22 µg subcutaneously three times weekly). Mean MS Quality of Life-54 (MSQoL-54) composite scores did not change over time. There were no significant differences between groups in MSQoL-54 composite scores when patients were grouped by treatment dose and baseline cognitive status. Mean (standard deviation) Hamilton Depression Rating Scale score decreased from 6.8 (4.9) at baseline to 5.8 (5.9) at year 3. Mean total Fatigue Impact Scale scores were low (<30) at all time points. CONCLUSION: Quality of life, depression and fatigue remained largely stable over 3 years; no effects of treatment dose or baseline cognitive status were found.

BDNF Val66Met polymorphism and brain volumes in multiple sclerosis.

Brain derived neurotrophic factor (BDNF) regulates several CNS physiological and pathological processes. To investigate in multiple sclerosis (MS) patients, the relationship between the Val66Met polymorphism of BDNF and clinical markers of disease activity and MRI markers of focal and diffuse brain pathologies. 45 MS patients and 34 healthy controls (HCs) were genotyped and subjected to clinical-MRI examination. Global white matter fraction (gWM-f), gray matter-f (GM-f), cerebrospinal fluid-f (CSF-f), and abnormal WM-f were measured. We studied 26 Val/Val and 19 Val/Met patients and 23 Val/Val and 11 Val/Met HCs. We found that Val/Val patients had lower GM-f and higher CSF-f than Val/Val HCs; such differences were not statistically significant comparing Val/Met patients to HCs. The regression analysis showed that both Val/Met genotype and relapse number were associated with lower CSF-f. Our data suggest that Met allele might be a protective factor against MS as it is associated to a lower brain atrophy.

Effects of immunomodulatory treatment with subcutaneous interferon beta-1a on cognitive decline in mildly disabled patients with relapsing-remitting multiple sclerosis.

The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNbeta-1a) on cognition in mildly disabled patients with relapsing-remitting multiple sclerosis (RRMS). Patients aged 18-50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score

Cognitive impairment and its relation with disease measures in mildly disabled patients with relapsing-remitting multiple sclerosis: baseline results from the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study.

BACKGROUND: Cognitive impairment is a common symptom of multiple sclerosis (MS), but the association between cognitive impairment and magnetic resonance imaging (MRI) disease measures in patients with relapsing-remitting (RR) MS is unclear. OBJECTIVES: To study the prevalence of cognitive impairment and its relation with MRI disease measures in mildly disabled patients with RRMS. METHODS: Patients aged 18-50 years with RRMS (McDonald criteria) and an Expanded Disability Status Scale (EDSS) score or=3 cognitive tests) was present in approximately 20% of all patients and in the subgroup who underwent MRI. T2 hyperintense and T1 hypointense lesion volumes were significantly higher in patients with cognitive impairment (defined as impaired performance on at least three tests of the Rao's battery) than those without. EDSS score was also significantly higher in cognitively impaired than in cognitively preserved patients. Disease duration, depression, and years in formal education did not differ significantly between cognitively impaired and cognitively preserved patients. T2 lesion volume, performance intelligence quotient, and age were significant predictors of cognitive impairment in this population. Weak correlations were found between performance on individual cognitive tests and specific MRI measures, with T1 and T2 lesion volumes correlating with performance on most cognitive tests. CONCLUSIONS: Cognitive impairment occurs in approximately one-fifth of mildly disabled patients with MS and is associated with specific MRI disease measures. Assessment of cognitive function at diagnosis could facilitate the identification of patients who may benefit from therapeutic intervention with disease-modifying therapies to prevent further lesion development.

[Outcomes of hip replacement: a hospital-based longitudinal study in Lazio region (Italy)]. / Esiti degli interventi di protesi d'anca: uno studio longitudinale su base ospedaliera nel Lazio.

Hip replacement (HR) is a very effective procedure for chronic hip diseases especially in elderly. The aims of this study were: 1) to describe the typology of HRs; 2) to assess short and long term outcomes; 3) to evaluate the relationship between both individual and hospital characteristics with the outcomes. Regional hospital discharge data and mortality register were used. The study population included residents of the Lazio region, over 17 years of age, who underwent HR in any private or public hospital in Italy. We used logistic regression analysis to examine in-hospital mortality, 30-day mortality, 90-day mortality. Cox regression analysis was run to investigate revision and 3-5 year mortality. Out of 8159 HRs, 69.5% were total hip replacements (THR) conducted predominantly on females over 70 years of age. We observed 262 in-hospital deaths (7.4% endoprothesis, 1.4% THR). Thirty and 90-day mortality also showed a different pattern among the two procedures (endoprothesis 8.0% and 15.8%, THR 1.3% and 2.2%). At the end of the follow-up, 21% of patients had died and 204 revisions had been carried out (1.4% endoprothesis, 3.0% THR). Overall, 1898 patients (23.3%) had a revision or died. The main short and long term mortality risk factors were: age, male gender and comorbidities. Hospital volume was not associated with a significant mortality risk. For endoprothesis, waiting time before surgery longer than 7 days was associated with a 30-day mortality risk of 2.83. The present study prompted us to test methodologies to evaluate quality levels in orthopaedic surgery units throughout the region using information systems. Further studies are needed to better understand the variability in the characteristics of care that emerged in Lazio hospitals.

[Epidemiology of femur fracture and characteristics of hospital care in Lazio]. / Epidemiologia della frattura del femore e fattori correlati alla mortalità intraospedaliera nel Lazio.

UNLABELLED: We aimed at describing the epidemiology of femur fracture in elderly hospitalized for femur fracture in Lazio (Italy), and evaluating the association between patient's and hospital characteristics on in-hospital mortality. We conducted a population- and hospital-based study (Lazio region: 5.233.233 inhabitants) among people 65+ years aged. SOURCE OF DATA: regional hospital register 2002-2003; ICD-9-CM codes for patients' selection 820 e 821. Direct standardization (rate x 1000) and logistic regression analysis (OR, 95% CI) were performed. Overall hospitalization rate in elderly was 7.5%o (10.l%o females vs. 3.9%0 males). 12.033 patients with femur fractures were enrolled in the study period; 21,6% were not treated surgically: in comparison with those who underwent surgery, they were males, residents out of Rome, older and with worst health status. In-hospital mortality rate was 7,97%. In-hospital mortality determinants were: male gender (OR=0.56), older age (85+, OR=3.30), living out of Rome (OR=0.50), comorbidities (Charlson 'index 3: OR=4.44), "others and unspecified parts of femur" as site of fracture (OR=1.84), admission to a private hospital (OR=O. 79) and a surgical treatment (OR=0.20). In conclusion, this study showed the effect of selected individual characteristics on in hospital mortality and suggested a role of early surgical treatment and access to private sector. Regional hospital information systems represent useful tools to address epidemiological impact of hip fracture and its health care resources utilization.

[Factors related to in-hospital mortality after stroke in Lazio region, Italy]. / Determinanti della mortalità intra-ospedaliera in seguito a ictus cerebrale nel Lazio.

The use of hospital discharge abstracts in estimating the outcome of hospital care represents an ongoing interest in public health. However standardized methodologies are still not available. We carried out a retrospective study to estimate the association between demographic and clinical characteristics and in-hospital mortality after stroke by using administrative data from the Hospital Information System in Lazio Region. We also assessed the relationship between the presence of neurology services and the outcome. We found 12,781 incident episodes of stroke (main diagnosis ICD-9: 430-431-434-436) (49.3% male, mean age = 74 years) admitted in 126 hospitals in the Lazio region for the period 1999-2000. From the hospital discharge abstracts we collected patient demographic and clinical data. The hospitals were classified in centres with and without neurology services. Admissions to hospitals with neurology services were evaluated as predictors of in-hospital mortality after adjustment for gender, age, residence, education, source of admission, type of stroke, heart disease, kidney disease and history of atrial fibrillation. In-hospital mortality (within 30 day) was 25.1%. Female gender, advanced age, residence in Rome, urgent transport, kidney disease and history of atrial fibrillation were associated with an increased risk. Hemorrhagic stroke (ICD-9 = 430-431) had a worse outcome than ischemic stroke (ICD-9 = 434) and acute undefined cerebrovascular disease (ICD-9 = 436). Patients admitted to hospitals with neurology services showed a significantly decreased risk (OR = 0.88, IC95% = 0.79-0.98), particularly in occlusion of cerebral artery (ICD-9 = 434) and in undefined cerebrovascular disease (ICD-9 = 436). Demographic and clinical variables are associated with the outcome of hospitalised stroke patients. Admissions of acute stroke patients in specialized hospitals seem to play a role in reducing the risk of in-hospital mortality.

Implementation of a surveillance system for stroke based on administrative and clinical data in the Lazio region (Italy): methodological aspects.

Stroke is the third leading cause of death and the most important cause of long-term disability in Italy and other developed countries, heavily influencing quality of life and costs of health care. In spite of the widespread occurrence of the disease and its relevant impact in Italy, there is neither a national nor a regional surveillance system of cerebrovascular diseases. A regional surveillance system for stroke has two important aims: to help to interpret the geographical and temporal trends of the disease for health care planning and resource allocation and to allow close monitoring of the quality of stroke services. Age-standardized mortality rates for cerebrovascular diseases in the Lazio region (5,242,709 inhabitants) in the period 1998-99 were 69.4 for males and 59.4 for females per 100,000 inhabitants. In the year 2000, about 3% of all hospital discharges were for cerebrovascular diseases with a hospitalisation rate of 4.36 per 1000 inhabitants. The mean length of stay is 12 days (median of 9 days) and in-hospital death is 15.4%. The admission rate for cerebrovascular diseases to emergency departments is 3.40 per 1000 inhabitants. The goal of the Lazio Regional Health Authority is to implement a surveillance system for stroke based both on current data (mortality and discharge data) and on information collected in a registry for quality assessment of stroke care. The first step of the study is to develop a regional register of acute stroke using an 'ad hoc' data sheet integrated in the computer-based patient record system of clinical and administrative data (GIPSE) operating in all emergency departments in the region.

[The quality of medical records: a retrospective study in Lazio Region, Italy]. / La qualità della cartella clinica negli ospedali del Lazio.

INTRODUCTION: Medical records have an important role in the communication among different care providers and in forensic medicine. In Italy, information on completeness and correctness of medical records is scanty, whereas future hospital accreditation could take into account their quality as a proxy of good medical practice. PURPOSE: We performed a retrospective study in order to assess the quality of medical records in the Lazio region. METHODS: From all 37009 hospital discharges for five different diseases in 123 hospitals (acute myocardial infarction (AMI), coronary artery bypass surgery, pneumonia, cerebrovascular disorders, breast surgery), registered in the Regional Hospital Information System, we selected a random sample of 2022 (5.5% of the total). Ten physicians, previously trained, reviewed the relative medical charts and filled in "ad hoc" questionnaires. RESULTS: A total of 1960 (97% of the target) charts were reviewed. Organization and structure of data recording strongly varied. Important differences were found across the diseases for various items: presence of anamnesis 98.1% (range: from 95.6% for breast surgery to 100% for AMI); presence of physical examination 92.7% (range: from 88.1% for breast surgery to 98.5% for AMI), completeness of the daily medical records was good in 70.8% (range: from 34.2% for pneumonia to 93.9% for cerebrovascular disorders). Variability among different type of hospitals was also observed, being teaching hospitals and some private hospitals more accurate. CONCLUSIONS: Quality of medical records tended to vary across different type of hospitals and different diseases. Actions for improving the quality should be undertaken as a priority. Efforts have to be done in restructuring charts, creating guidelines and training caregivers. The development and application of computer based health information systems should help solving these problems.