Safety profile of recombinant adjuvanted anti-herpes zoster vaccine (RZV) in high-risk groups: Data from active surveillance program. Puglia (Italy), 2021-23.

BACKGROUND: Since 2021 a recombinant adjuvanted anti-Herpes Zoster vaccine(Recombinant Zoster Vaccine, RZV) is offered in Italy to high-risk patients. Few real-life data about RZV safety are available in target populations. OBJECTIVES: This study investigates Adverse Events Following Immunization(AEFIs), baseline disease flare-ups, and Herpes Zoster (HZ) episodes occurring after RZV administration in a heterogeneous population of fragile patients to design its safety profile. METHODS: This is a retrospective population-based study. RZV-vaccinated patients at Bari Policlinico General Hospital vaccination clinic from October 1st, 2021, to March 31st, 2023, were enrolled. Subjects were screened for reason of RZV eligibility and baseline chronic pathologies. AEFIs occurred in the first 7-days post-vaccination period were collected, and baseline disease flare-ups and post-vaccination HZ episodes were assessed via a 3-month follow-up. RESULTS: Five-hundred-thirty-eight patients were included and total of 1,031 doses were administered. Most patients were vaccinated due to ongoing immunosuppressive therapy(54.65 %); onco-hematological and cardiovascular conditions were the most common chronic baseline pathologies. Out of 1,031 follow-ups, 441 AEFI cases were reported(42.7/100). The most common symptoms were injection site pain/itching(35.60/100), asthenia/malaise(11.44/100), and fever (10.09/100). Four serious AEFIs occurred(0.38/100). Older age, male sex, and history of cardiovascular diseases(OR:0.71; 95CI:0.52-0.98; p-value <0.05) were found to decrease AEFIs risk, while endocrine-metabolic illnesses(OR:1.61; 95CI:1.15-2.26; p-value <0.05) increased it. Twelve patients(2.23 %) reported a flare-up/worsening of their baseline chronic condition within the first three months after vaccination(mean interval 31.75 days, range 0-68 days). Patients with rheumatological illnesses had a higher risk of relapse(OR:16.56; 95CI:3.58-76.56; p-value <0.001), while male sex behaved as a protective factor. Twelve patients who completed the vaccination cycle(2.43%) had at least one HZ episode by the long-term follow-up. CONCLUSIONS: The study demonstrates RZV safety in a significant number of high-risk patients. Hence, RZV should be actively offered as part of tailored vaccination programs to decrease the burden of HZ in fragile populations.

The Effects of the COVID-19 Pandemic on Vaccination Hesitancy: A Viewpoint.

Vaccination hesitancy is considered by the World Health Organization as a danger to global health. In recent years, vaccine hesitancy rates to COVID-19 have been studied worldwide. In our study, we aim to provide an overview of the concept of vaccine hesitancy, with regard to the post-COVID era, and to provide prevention and management strategies. A search of the international literature until March 2023 was conducted in the PubMed database. The 5723 papers found were divided into two groups: prior to the COVID-19 era and from 2021 onward. Papers about the vaccine hesitation phenomenon are becoming more common during the SARS-CoV-2 pandemic and following the marketing that the vaccine companies have carried out on the different types of COVID-19 vaccines. It is advisable that healthcare authorities, at the national and international level, as well as healthcare professionals, at the local level, should promote a series of activities to reduce the vaccine hesitancy rate.

Vaccine coverage for recommended vaccines among splenectomised patients in Apulia, South Italy: a retrospective cohort study.

OBJECTIVE: Splenectomised/asplenic patients have a 10-50 fold higher risk than the general population of developing overwhelming postsplenectomy infection. To control this risk, these patients have to receive a specific immunisation schedule, before or in the 2 weeks after the surgical intervention. The study aims to estimate vaccine coverage (VC) for recommended vaccines among splenectomised patients in Apulia (South Italy), and to define the determinants of vaccination uptake in this population. DESIGN: Retrospective cohort study. SETTING: Apulia, Southern Italy. PARTICIPANTS: 1576 splenectomised patients. METHODS: The Apulian regional archive of hospital discharge forms (SDOs) was used to define the splenectomised Apulian inhabitants. The study period went from 2015 to 2020. The vaccination status for Streptococcus pneumoniae (13-valent conjugate anti-pneumococcal vaccine+PPSV23), Haemophilus influenzae type b (Hib; one dose), Neisseria meningitidis ACYW135 (two doses), Neisseria meningitidis B (two doses) and influenza (at least one dose of influenza vaccine before an influenza season after splenectomy) was assessed via data collected from the Regional Immunisation Database (GIAVA). In order to define a subject as fully immunised, we considered the Centers for Diseases Control and Prevention guidelines to define the optimal immunisation status. RESULTS: Since 2015, 1576 Apulian inhabitants have undergone splenectomy; the VC for anti-Neisseria meningitidis B vaccine was 30.9%, for anti-Neisseria meningitidis ACYW135 was 27.7%, for anti-Streptococcus pneumoniae was 27.0%, for anti-Hib was 30.1%, and 49.2% received at least one dose of influenza vaccine before an influenza season after splenectomy. None of the patients splenectomised in 2015 and 2016 had received the recommended MenACYW135 and PPSV23 booster doses 5 years after completing the basal cycles. CONCLUSIONS: The results of our study highlight low VC values among Apulian splenectomised patients. The task of public health institutions is to implement new strategies aimed at increasing VC in this population, implementing educational measures for patients and families, training for general practitioners and specialists, and ad hoc communication campaigns.

Influenza vaccine coverage in 6months-64 years-old patients affected by chronic diseases: A retrospective cohort study in Italy.

At the beginning of each flu season, the Italian Ministry of Health defines the categories at higher risk of influenza complications, for which vaccination is actively and freely offered. The vaccine coverage (VC) of the influenza vaccine in subjects from 6 months to 64 years of age suffering from diseases that increase the risk of complications from influenza during the 2020-2021 season was evaluated. Our study wants to evaluate the VCs of the influenza vaccine in these subjects during the 2020/2021 season in Apulia. The digital archives relative to the Apulian population were used. A retrospective cohort study design was performed. 484,636 Apulian residents aged between 6 months and 64 years suffered from at least one chronic disease; 139,222 of 484,636 subjects received the influenza vaccine (VC: 28.7%) from October 2020 to January 2021. Considering the single comorbidities, the greatest values are found for pathologies for which major surgical interventions are planned and chronic renal failure/adrenal insufficiency patients, while the worst for chronic liver diseases and pathologies for which major surgical interventions are planned. In any case, it would seem that better VC is achieved in subjects with more than one chronic condition. Influenza vaccination must be promoted as a central public health measure, also because by reducing the burden on hospitals, it can greatly benefit the management of COVID-19 patients. Greater efforts by public health institutions must be implemented in order to achieve better VC in the target categories, including chronic patients.

COVID-19 vaccination hesitancy among Italian parents: A systematic review and meta-analysis.

In May 2021, the Italian government extended the COVID-19 vaccination campaign to 12- to 18-year-old subjects and, starting December 2021, vaccines were also offered to children between 5 and 11 years-old. Despite these efforts, suboptimal vaccination coverages are reported. The purpose of this review is to estimate the proportion of parents/caregivers of children and adolescents expressing COVID-19 vaccine hesitancy in Italy. The vaccine hesitation rate among parents of minors was 55.1% (95%CI: 43.8-66.1%). A higher value was evidenced in studies focusing on children (59.9%; 95%CI = 43.7-75.1%) compared to the ones focusing on adolescents (51.3%; 95%CI = 34.5-68.0%). The main reasons for unwillingness were the belief that the vaccine was unsafe or ineffective, fear of adverse events, and considering COVID-19 a non-threatening disease. The implementation of effective communication campaigns and health educational programs on safe pediatric vaccinations is essential to support strategies to bolster vaccination confidence.

Prevalence of healthcare workers fully vaccinated against hepatitis B without circulating antibodies in Italy and role of age at baseline cycle vaccination: a systematic review and meta-analysis.

INTRODUCTION: Healthcare workers (HCWs) susceptible to hepatitis B represent an important public health concern. National and international guidelines recommend assessing the hepatitis B immune status of all HCWs and possibly vaccinating those found to be seronegative (non-responders). We conducted a meta-analysis to estimate the rate of hepatitis B sero-susceptibility among HCWs in Italy and to explore possible options for the management of non-responders. AREAS COVERED: Nineteen studies, selected from scientific articles available in the Scopus, MEDLINE/PubMed and ISI Web of Knowledge databases between 1 January 2016 and 22 April 2022, were included. The prevalence of HBV-susceptible HCWs was 27.1% (95%CI = 23.2-31.7%). In a comparison by sex (males vs. females) the RR was 1.16 (95%CI = 1.03-1.31), and by full-cycle vaccination period (adolescence vs. infancy) the RR was 0.30 (95%CI = 0.25-0.37). Occupational health screenings for hepatitis B, with subsequent vaccination of non-responders, and exclusion of susceptible HCWs from high-risk settings have been common management strategies. EXPERT OPINION: It is highly probable that a proportion of the next generation of medical students and HCWs will not show circulating IgG on serologic evaluation. Therefore, more targeted efforts are needed to identify these individuals and actively immunize them.

Long-Term Immunogenicity of Inactivated and Oral Polio Vaccines: An Italian Retrospective Cohort Study.

Oral and inactivated poliovirus (PV) vaccines have contributed toward the global eradication of wild PV2 and PV3, as well as the elimination of PV1 in most countries. While the long-term (>5−10 years) persistence of protective antibodies in ≥80% of the population vaccinated with ≥3−4 doses of oral poliovirus vaccine (OPV) has been demonstrated, the duration of immunity in people vaccinated with the inactivated poliovirus vaccine (IPV) is still unclear. This study evaluated the seroprevalence of anti-PV neutralizing antibodies and the long-term immunogenicity conferred by OPV and IPV in a sample of medical students from the University of Bari (April 2014−October 2020). The levels of neutralizing PV1, PV2, and PV3 antibodies in blood samples taken during the assessments were evaluated. Neutralizing antibodies against PV1, PV2, and PV3 were present in >90% of the study participants, with rates of >99%, >98%, and ~92−99%, respectively. IPV resulted in a higher immunological response than OPV against PV3. Protective antibodies against all three viruses persisted for at least 18 years after administration of the last vaccine dose. Until PV1 is completely eradicated, maximum vigilance from public health institutions must be maintained.

Medium-to-Long-Term Immunogenicity of BNT162b2 mRNA COVID-19 Vaccine: A Retrospective Cohort Study.

To deal with the COVID-19 pandemic, a mass vaccination campaign was started in European countries on 27 December 2020. The first vaccine available to immunize healthcare workers (HCWs) was the BNT162b2 mRNA COVID-19 vaccine. While many studies have shown a high antibody response after the second vaccine dose, antibody persistence over the medium-to-long term has yet to be evaluated. The medium-to-long-term persistence of anti-SARS-CoV-2 antibodies was determined in a sample of fully vaccinated HCWs at Bari Policlinico General Hospital, Italy. This is a observational cohort study. HCWs who completed the immunization basal cycle were screened for anti-SARS-CoV-2 IgG on days 15, 30, 60, 90, and 120 after the second vaccine dose. At each time point, >99% of the screened HCWs were seroprotected. While the geometric mean titer initially declined over time, by 60 days the titer had stabilized. Older subjects seem to lose IgG faster than younger ones. The immunogenicity conferred by the vaccine provides further evidence that it is an essential weapon in efforts to bring the COVID-19 pandemic under control. Accordingly, strict measures should be implemented, ranging from the mandatory vaccination of HCWs to strong incentives aimed at achieving vaccination of the large majority of the overall population.

Immune response to one dose of BNT162b2 mRNA Covid-19 vaccine followed by SARS-CoV-2 infection: An Italian prospective observational study.

INTRODUCTION: A mass vaccination campaign against SARS-CoV-2 was initiated in European countries on December 27, 2020. This study compared the antibody response in a sample of healthcare workers (HCWs) who, after the first dose of the BNT162b2 mRNA vaccine, were infected with SARS-CoV-2 (infection group) with the response in a control group of HCWs immunized with two doses (vaccine group). METHODS: This two-arm observational cohort study was carried out using routine health surveillance data obtained from HCWs at Bari Policlinico General Hospital (Italy). The antibody response was determined infection group and vaccine group. RESULTS: Among the 100 HCWs, 25 (25.0%) were in the infection group and 75 (75.0%) in the full-vaccine group. At the serological evaluation, all of the HCWs tested positive, with a geometric mean titer (GMT) of 7106.8 (95 %CI = 5628.5-8973.4) and a statistically significant difference (p < 0.0001) between the infection group (GMT = 2139.7; 95 %CI = 1310.4-3493.6) and the vaccine group (GMT = 10603.6; 95 %CI = 8698.0-12926.8). DISCUSSION: Our results shed light on the vaccine response of individuals in different risk categories. It also emphasizes the need for the continued use by HCWs of PPE and good practices during the window between the first and second anti-SARS-CoV-2 vaccinations.

Attitude for vaccination prophylaxis among pregnant women: a cross-sectional study.

Pregnant women and newborns are considered a subgroup of population at increased risk for several infectious diseases, some of which are vaccine-preventable. Anti-diphtheria-tetanus-pertussis vaccine (dTpa) and influenza vaccine are recommended for pregnant women. We carried out a study to evaluate the knowledge of new mothers toward the main vaccine-preventable diseases and to assess their compliance with recommended vaccinations. Using the Hospital Discharge Forms (SDO), the list of women who gave birth in 2018 was generated. Women were interviewed by a questionnaire administered by telephone. The study sample consisted of 145 subjects, with an average age of 35.0 ± 5.9 years (range = 18.0-47.0). 5/145 (3.4%; 95% CI = 1.1-7.9%) subjects were advised during pregnancy to have the flu shot; only 1/145 (0.7%; 95% CI = 0.5-71.6%) reported the flu vaccine during the last pregnancy. 94/145 (64.8%; 95% CI = 57.2-73.2%) respondents declared that they had carried out the TORCH panel exams before pregnancy; of these 18/94 (19.2%; 95% C = 11.8-28.6%) were susceptible for rubella. Of these subjects, for 7/18 (38.9%; 95% CI = 17.3-64.3%) rubella vaccination was offered and 5/7 (71.4%; 95% CI = 29.0-96.3%) decided to carry out the vaccination. Only 1/145 (0.7%; 95% CI = 0.0-3.8%) of the interviewed woman underwent anti-dTap vaccination. Greater efforts must be made by public health institutions to raise awareness and improve vaccination compliance in this population.

BNT162b2 mRNA COVID-19 Vaccine Effectiveness in the Prevention of SARS-CoV-2 Infection: A Preliminary Report.

In the preregistration trial, data on efficacy of BNT162b2 mRNA vaccine against SARS-CoV-2 infection were not collected. This study aimed to evaluate vaccine effectiveness (VE) against documented infection. Bari Policlinico University Hospital health care workers (HCWs) who completed the vaccination schedule were matched with HCWs who had refused vaccination. VE for documented infection was 61.9% (95% confidence interval [CI], 19.2%-82.0%) 14-20 days after first dose, 87.9% (95% CI, 51.7%-97.0%) 21-27 days after first dose, and 96.0% (95% CI, 82.2%-99.1%) 7 or more days after second dose. Unvaccinated HCWs remain a concern in the context of the pandemic emergency.

Long -term persistence of antibodies against varicella in fully immunized healthcare workers: an Italian retrospective cohort study.

BACKGROUND: Chickenpox is a highly contagious disease caused by the varicella zoster virus (VZV), and in infants, adolescents, adults, pregnant women, and the immunocompromised it can be serious. The best way to prevent chickenpox is immunization with the varicella vaccine. Protective levels of antibodies induced by the varicella vaccine decline over time, but there is currently no formal recommendation for testing anti-varicella zoster virus (VZV) IgG levels in immunized healthcare workers (HCWs). METHODS: The aims of this study were to evaluate the seroprevalence of circulating anti-VZV IgG in a sample a sample of students and residents of the medical school of the University of Bari, the long-term immunogenicity of the varicella vaccine, and the effectiveness of a strategy consisting of a third vaccine booster dose. The study population was screened as part of a biological risk assessment conducted between April 2014 and October 2020. A strategy for the management of non-responders was also examined. RESULTS: The 182 students and residents included in the study had a documented history of immunization (two doses of varicella vaccine). The absence of anti-VZV IgG was determined in 34% (62/182; 95%CI = 27.2-41.4%), with serosusceptibility more common among males than females (p < 0.05). After a third varicella dose, seroconversion was achieved in 100% of this previously seronegative group. No serious adverse events were recorded. CONCLUSIONS: One-third of the study population immunized against VZV lacked a protective antibody titer, but a third dose of vaccine restored protection. Since it is highly unlikely that VZV will be eliminated in the immediate future, the loss of immunity in a substantial portion of the population implies a risk of varicella outbreaks in the coming years. Screening for varicella immunity in routine assessments of the biological risk of medical students and HCWs may help to prevent nosocomial VZV infections.

Long-term persistence of poliovirus neutralizing antibodies in the era of polio elimination: An Italian retrospective cohort study.

INTRODUCTION: The extensive use of oral and inactivated poliovirus (PV) vaccines has driven progress toward the global eradication of wild PV2 and PV3 and the elimination of PV1 in most countries, including Italy. Although the persistence of circulating neutralizing antibodies among the vaccinated is unclear, it is estimated that > 99% of the population vaccinated according to the recommended protocol should be protected for at least 18 years. METHODS: This study evaluated the seroprevalence of anti-PV neutralizing antibodies and the long-term immunogenicity of the oral poliovirus vaccine (OPV) in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for a biological risk assessment between April 2014 and October 2020. RESULTS: The prevalence of protected vaccinated individuals was > 90% for PV1, PV2, and PV3. Specifically, >99% of the study group was protected against PV1, > 98% against PV2, and almost 93% against PV3. Protective antibodies against all three viruses persisted for at least up to 18 years after administration of the last OPV dose, with PV1 and PV2 antibodies detected in > 95% of the participants > 30 years after the last OPV dose. CONCLUSIONS: The childhood series of four doses of OPV guarantees a long duration of protection, despite the elimination of the virus and therefore the absence of a natural booster. However, until PV1 is completely eradicated, maximum vigilance on the part of public health institutions must be maintained.

Prevalence and management of measles susceptibility in healthcare workers in Italy: a systematic review and meta-analysis.

INTRODUCTION: The national and international guidelines recommend evaluating all healthcare workers (HCWs) for their measles immune status and possibly vaccinating those who are seronegative. AREAS COVERED: We conducted a systematic review and meta-analysis in order to estimate the rate of measles susceptibility among HCWs in Italy and to explore possible options for the management of those found to be susceptible. Twenty-three studies were included in the meta-analysis. The prevalence of HCWs susceptible to measles was 11.5% (95%CI = 8.1-15.4%) and was higher in studies in which prevalence was evaluated by survey (16.7%; 95%CI = 8.9-26.3) than by the direct evaluation of blood specimens (9.1%; 95%CI = 6.2-12.5%). Occupational medicine examinations for measles screening with possible subsequent vaccination of seronegatives and the exclusion of susceptible HCWs from high-risk settings were common management strategies. EXPERT OPINION: HCWs susceptible to measles are an important epidemiological concern in Italy, and efforts to identify and actively offer the vaccine to this population should be increased.

Long time persistence of antibodies against Mumps in fully MMR immunized young adults: an Italian retrospective cohort study.

Protective levels of antibodies induced by the MMR vaccine have been shown to decline over time, but actually there is not a formal recommendation about the opportunity of testing immunized HCWs to investigate the persistence of anti-Mumps IgG. This study aims to evaluate the long-time immunogenicity of MMR vaccination in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for the biological risk assessment (April 2014-June 2018). A strategy for the management of non-responder subjects has been experimented and described. Two thousand students and residents, with documented immunization status (two doses of MMR vaccine), have been tested. 120/2,000 (6%; 95%CI = 5.0-7.1%) subjects did not show anti-Mumps IgG. This percentage was similar among males and females. After a third MMR dose, we noted a seroconversion of 90% of seronegative participants. No serious adverse events were recorded. An important proportion of subjects immunized for MMR do not show an antibodies protective titer. The immunogenicity and the safety of the third dose seem confirmed by our data. Including the screening model described in the routine assessment of the biological risk of medical students and HCWs may be a winning strategy in preventing Mumps nosocomial infection.

Immunity to rubella: an Italian retrospective cohort study.

BACKGROUND: International guidelines recommend that healthcare workers (HCWs) have presumptive evidence of immunity to rubella and that susceptible HCWs and doubt cases receive two doses of the MMR vaccine. However, a small percentage of the fully immunized will remain unprotected against wild viruses. Moreover, protective levels of antibodies induced by the vaccine have been shown to decline over time, but a formal recommendation regarding the testing of immunized HCWs for the persistence of IgG against rubella is lacking. METHODS: The aim of this study was to evaluate the long-term immunogenicity conferred by rubella vaccination and the effectiveness of a strategy for the management of immunized individuals in whom IgG against rubella could not be demonstrated (non-responders). The study enrolled students and medical residents who attended the Hygiene Department of Bari Policlinico University Hospital for biological risk assessment (April 2014 to June 2018). RESULTS: Two thousand students and residents with documented immunization (≥2 doses of rubella or MMR vaccine) were tested. In 181 (9%), IgG against rubella was not detectable. The seronegative rate was higher among participants vaccinated at age < 2 years (89.6%) and lower among those immunized at age ≥ 2 years (93.6%; p < 0.0001). The administration of a single MMR booster dose resulted in a seroconversion rate of 98% in the seronegative group. The seroconversion rate after a second booster dose was 100%. No serious adverse events in the re-immunized were recorded. CONCLUSIONS: An important proportion of individuals immunized for rubella or MMR do not have a protective titer for the disease(s). Our management strategy (booster followed by re-test and, for those who are still negative, a second booster and re-test) is consistent with the goal of achieving immunological memory.

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017-2018.

Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

Serum sarcosine is a risk factor for progression and survival in patients with metastatic castration-resistant prostate cancer.

AIM: Sarcosine has been identified as a differential metabolite that is greatly increased during progression from normal tissue to prostate cancer and metastatic disease. In this study we assessed the role of serum sarcosine in metastatic castration-resistant prostate cancer (mCRPC) patients. PATIENTS & METHODS: Data from 52 mCRPC patients treated with docetaxel-based chemotherapy were retrospectively analyzed. Receiver operating characteristic curves, and Kaplan-Meier and Cox multivariate analyses were performed. RESULTS: Median sarcosine values were significantly higher in mCRPC versus non-mCRPC patients (0.81 vs 0.52 nmol/µl; p < 0.0001). A significant correlation resulted between serum sarcosine levels and the duration of hormone sensitivity (Spearman's correlation coefficient: -0.51; p = 0.001). At multivariate analysis sarcosine was an independent prognostic factor of outcome in terms of overall and progression-free survival. CONCLUSION: Serum sarcosine values were significantly increased in patients with metastatic disease. Moreover, this biomarker is a risk factor for progression and survival in chemotherapy-treated mCRPC patients.

Serum sarcosine increases the accuracy of prostate cancer detection in patients with total serum PSA less than 4.0 ng/ml.

BACKGROUND: Sarcosine is reported to be a differential metabolite that is greatly increased during prostate cancer (PCa) progression. In this study, we assessed the role of serum sarcosine as a biomarker for PCa, as well as any association between sarcosine levels and clinical-pathological parameters. METHODS: Sarcosine was measured by fluorometric assay in serum samples from 290 PCa patients and 312 patients with no evidence of malignancy (NEM), confirmed by 8-12 core prostate biopsies. Nonparametric statistical tests and receiver operating characteristics (ROC) analyses were performed to assess the diagnostic performance of sarcosine in different (prostate-specific antigen) PSA ranges. RESULTS: ROC analyses in subjects with PSA < 4 ng/ml showed a higher predictive value of sarcosine (AUC = 0.668) versus total PSA (AUC = 0.535) (P = 0.03), whereas for the other two PSA ranges (4-10 ng/ml and >10 ng/ml), percent ratio of free to total PSA (%fPSA) showed a predictive superiority over sarcosine. Moreover, in patients with a PSA < 4 ng/ml, the percentage of low/intermediate-grade cancers was positively associated with sarcosine levels (P = 0.005). The specificities for serum sarcosine, %fPSA, PSA, and the logistic regression model at 95% sensitivity were 24.4, 3.41, 2.22, and 28.4%, respectively. CONCLUSIONS: We provide evidence that serum sarcosine has a higher predictive value than tPSA and %fPSA in patients with PSA < 4 ng/ml. Moreover, sarcosine levels were significantly different in low grade versus high grade cancers in this subset of patients, suggesting that this marker may be a further tool not only for diagnosing PCa in normal PSA and abnormal DRE/TRUS patients but also for selecting candidates for non-aggressive therapies and active surveillance.

The perception of healthcare quality of elderly in the city of Bari, South Italy.

BACKGROUND: In recent decades in Italy, as in all the industrialized nations, the proportion of elderly subjects in the total population is constantly on the increase. However the increased life expectancy is not always paralleled by a true improvement in the quality of life. In this context, it is essential to analyze elderly real health needs and the responses to these needs, especially in terms of healthcare, that the territorial services are perceived to offer. METHODS: In the period from June to September 2006 we selected randomly one General Practitioner (GP) for each district of the Bari Municipal Area and, form each GP, we randomly chose 25 patients over 65 years old (YO). We conducted phone interviews using a standard data collection questionnaire and, for each of the recruited subjects, the GP filled a data collection sheet. RESULTS: Although the mean age (73.6 years) of the population under study was quite high, the general state of health was judged good both by the G P- and by their elderly patients (>75%).Notably, the great majority of elderly patients considered the healthcare they receive to be satisfactory (>60%): in particular, the GP was the true point of reference for this slice of the population for strictly medical problems as well as for advice. On the contrary, the patients attributed little value to social services, which were poorly known and scarcely used (8.5%). Public hospital facilities played a central role in second level healthcare in more than 30% of cases; private facilities covered by public health insurance were also very important. As possible solutions to the problem of loneliness, 36.6% of the patients declared that they approved of nursing homes. CONCLUSION: Decision makers need to create services supporting the key role played by General Practitioners, who are well aware that their assistance is not sufficient to satisfy the health needs of the elderly.