Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicenter randomized controlled trial (TOP Study).

BACKGROUND: First-line over-the-scope (OTS) clip treatment has shown higher efficacy than standard endoscopic therapy in acute nonvariceal upper gastrointestinal bleeding (NVUGIB) from different causes. We compared OTS clips with through-the-scope (TTS) clips as first-line mechanical treatment in the specific setting of peptic ulcer bleeding. METHODS: We conducted an international, multicenter randomized controlled trial on consecutive patients with suspected NVUGIB. Patients with Forrest Ia-IIb gastroduodenal peptic ulcer were randomized 1:1 to OTS clip or TTS clip treatment. The primary outcome was the rate of 30-day rebleeding after successful initial hemostasis. Secondary outcomes included the rates of successful initial hemostasis and overall clinical success, defined as the composite of successful initial hemostasis and no evidence of 30-day rebleeding. RESULTS: 251 patients were screened and 112 patients were randomized to OTS (n = 61) or TTS (n = 51) clip treatment. The 30-day rebleeding rates were 1.6% (1/61) and 3.9% (2/51) in patients treated with OTS clips and TTS clips, respectively (Kaplan-Meier log-rank, P = 0.46). Successful initial hemostasis rates were 98.4% (60/61) in the OTS clip group and 78.4% (40/51) in the TTS clip group (P = 0.001). Overall clinical success rates were 96.7% (59/61) with OTS clips and 74.5% (38/51) with TTS clips (P = 0.001). CONCLUSIONS: Low rates of 30-day rebleeding were observed after first-line endoscopic treatment of acute peptic ulcer bleeding with either OTS or TTS clips. However, OTS clips showed higher efficacy than TTS clips in achieving successful initial hemostasis and overall clinical success.

Analysis on a database of ship accidents in port areas.

In the last 15 years, the number of vessels in the world fleet has grown by around 53% and their gross tonnage has increased by 47%, with a consequent significant increment of marine accidents worldwide. Accident database are the basic resource for risk assessment methods to help decision-makers to enact strategies and undergo hazard and vulnerability mitigation measures. Understanding ship accidents distribution in terms of involved GT, typical age of the affected vessels, category of the ships, as well as distribution of underlying causes and consequences is the first necessary step to improve accident mitigation actions to be implemented for future assessments. In the present work, the results of an analysis on a database of vessel accidents in Mediterranean and worldwide port areas developed within the framework of the project ISY PORT (Integrated SYstem for navigation risk mitigation in PORTs) is herein presented. The distribution of accidents was analyzed in terms of relevant vessel characteristics i.e. Grosse Tonnage (GT), age at the time of the accident, ship's category, causality event, weather conditions and number of fatalities/injuries/lost at sea. The database can be used as a basis for maritime risk assessment methods and for calibration of real-time ship collision avoidance scenarios.

Patterns of utilisation of specialist care after SARS-Cov-2 infection: a retrospective cohort study.

OBJECTIVE: To explore the pattern of health services utilisation of people who had had a documented SARS-Cov-2 infection. DESIGN: Retrospective cohort study. SETTING: The Italian province of Reggio Emilia. PARTICIPANTS: 36 036 subjects who recovered from SARS-CoV-2 infection during the period September 2020-May 2021. These were matched for age, sex and Charlson Index with an equal number of subjects never found positive at the SARS-Cov-2 swab test over the study period. MAIN OUTCOME MEASURES: Hospital admissions for all medical conditions and for respiratory or cardiovascular conditions only; access to emergency room (for any cause); outpatient specialist visits (pneumology, cardiology, neurology, endocrinology, gastroenterology, rheumatology, dermatology, mental health) and overall cost of care. RESULTS: Within a median follow-up time of 152 days (range 1-180), previous exposure to SARS-Cov-2 infection was always associated with higher probability of needing access to hospital or ambulatory care, except for dermatology, mental health and gastroenterology specialist visits. Post-COVID subjects with Charlson Index≥1 were hospitalised more frequently for heart disease and for non-surgical reasons than subjects with Charlson index=0, whereas the opposite occurred for hospitalisations for respiratory diseases and pneumology visits. A previous SARS-CoV-2 infection was associated with 27% higher cost of care compared with people never infected. The difference in cost was more evident among those with Charlson Index>1. Subjects who had anti-SARS-CoV-2 vaccination had lower probability of falling in the highest cost quartile. CONCLUSIONS: Our findings reflect the burden of post-COVID sequelae, providing some specific insight on their impact on the extra-use of health services according to patients' characteristics and vaccination status. Vaccination is associated with lower cost of care following SARS-CoV-2 infection, highlighting the favourable impact of vaccines on the use of health services even when they do not prevent infection.

Occurrence of complications in patients restored with implants.

OBJECTIVES: To determine the occurrence and clustering of complications in subjects restored with fixed implant-supported prostheses. METHODS: In the present retrospective case series, 241 subjects treated at one clinical centre and provided with 729 implants were included. A clinical and radiographic examination was performed after a mean follow-up period of 4.8 ± 2.0 years. Additional information on occurrence of technical (chipping, loss of retention, fracture of components) and biological complications (marginal bone loss, implant loss) during follow-up was extracted from patient records. For each type of complication and complications overall, regression analyses were performed to identify potential risk factors. Cox regression analyses were used to evaluate time to event for implant loss and technical complications. RESULTS: In all, 30% of the 241 patients presented with at least one complication of technical and/or biological character during the follow-up period. Technical complications affected 19.5% of subjects, while 14.1% presented with marginal bone loss >2 mm. Implant loss occurred in 4.6% of subjects. While technical complications were noted already early during the maintenance period (<1200 days), implant loss typically occurred during a later phase. A small subgroup of subjects (7.9%) experienced more than one type of complication. CONCLUSIONS: Complications occurred frequently and the most common type of complication was of technical character. Technical and biological complications occurred independently of each other.

Prompt Resumption of Screening Programme Reduced the Impact of COVID-19 on New Breast Cancer Diagnoses in Northern Italy.

The aim of this study is to evaluate the real impact of COVID-19 during the entire 2020 period, compared with 2019. The data comes from a Cancer Registry in Northern Italy and we compared clinical and treatment characteristics of breast cancer by age, stage, treatment, and status screening. In 2020 there was no decrease in invasive tumours nor in in situ (513 vs. 493 and 76 vs. 73, respectively), while there was a significant decrease in surgery and increase in neoadjuvant chemotherapy (p = 0.016). In the screening range (aged 45-74), no change in stage and grading was observed. In the four periods examined there was an increase in new diagnoses during pre-lockdown, a decrease in tumours especially at age 75+ [IRR 0.45; 95%CI 0.25-0.79] during lockdown, a recovery of new diagnoses in women 45+ in the low incidence period while in the last period there was a significant increase only for ages 45-74 [IRR 1.48; 95% CI 1.11-1.98]. Screening activities were suspended from March to May, but over the summer and autumn the backlog was addressed. This suggests that a prompt resumption of programmed screening may have limited the impact of the pandemic on the delay of breast cancer diagnoses.

End-of-life care in cancer patients: how much drug therapy and how much palliative care? Record linkage study in Northern Italy.

OBJECTIVES: Investigating end-of-life use of anticancer drugs and of palliative care services. DESIGN: Population based cohort linked to mortality registry and administrative databases. SETTING: Emilia-Romagna Region (Northern Italy). PARTICIPANTS: 55 625 residents who died of cancer between 2017 and 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: Multivariate analyses were carried out to assess the relationship between cancer drug therapy and palliative care services, and their association with factors related to tumour severity. RESULTS: In the last month of life, 15.3% of study population received anticancer drugs (from 12.5% to 16.9% across the eight Local Health Authorities-LHA) and 40.2% received palliative care services (from 36.2% to 43.7%). Drug therapy was inversely associated with receiving palliative care services within the last 30 days (OR 0.92, 95% CI 0.87 to 0.97), surgery within the last 6 months (OR 0.59, 95% CI 0.52 to 0.67), aggressive tumours (OR 0.88, 95% CI 0.84 to 0.93) and increasing age (OR 0.95, 95% CI 0.95 to 0.95). Drug therapy was more likely among those with haematologic tumours (OR 2.15, 95% CI 2.00 to 2.30) and in case of hospital admissions within the last 6 months (OR 1.63, 95% CI 1.55 to 1.72). Palliative care was less likely among those with haematologic compared with other tumours (OR 0.52, 95% CI 0.49 to 0.56), in case of surgery (OR 0.44, 95% CI 0.39 to 0.49) or hospital admissions (OR 0.70, 95% CI 0.67 to 0.72) within the last 6 months, if receiving anticancer drugs during the last 30 days (OR 0.90, 95% CI 0.85 to 0.94) and for each year of increasing age (OR 0.99, 95% CI 0.99 to 0.99). Palliative care was more likely in the presence of aggressive tumours (OR 1.12, 95% CI 1.08 to 1.16). CONCLUSION: Use of anticancer drugs and palliative care in the last month of life were inversely associated, showing variability across different LHAs. While administrative data have limits, our findings are in line with conclusions of other studies.

The effects of centralizing cancer surgery on postoperative mortality: A systematic review and meta-analysis.

OBJECTIVES: To review the evidence of the effects of centralization of cancer surgery on postoperative mortality. METHODS: We searched Medline, Embase, Cinahl, Cochrane and Scopus (up to November 2019) for studies that (i) assessed the effects of centralization of cancer surgery policies on in-hospital or 30-day mortality, or (ii) described changes in both postoperative mortality for a surgical intervention and degree of centralization using reduction in the number of hospitals or increases in the proportion of patients undergoing cancer surgery at high volume hospitals as proxy. PRISMA guidelines were followed. We estimated pooled odds ratios (OR) and conducted meta-regression to assess the relationship between degree of centralization and mortality. RESULTS: A total of 41 studies met our inclusion criteria of which 15 evaluated the effect of centralization policies on postoperative mortality after cancer surgery and 26 described concurrent changes in the degree of centralization and postoperative mortality. Policy evaluation studies mainly used before-after designs (n = 13) or interrupted time series analysis (n = 2), mainly focusing on pancreatic, oesophageal and gastric cancer. All but one showed some degree of reduction in postoperative mortality, with statistically significant effects demonstrated by six studies. The pooled odds ratio for centralization policy effect was 0.68 (95% Confidence interval: 0.54-0.85; I2 = 80%). Meta-regression analysis of the 26 descriptive studies found that an increase of the proportion of patients treated at high volume hospitals was associated with greater reduction in postoperative mortality. CONCLUSIONS: Centralization of cancer surgery is associated with reduced postoperative mortality. However, existing evidence tends to be of low quality and estimates of the effect size are likely inflated. There is a need for prospective studies using more robust approaches, and for centralization efforts to be accompanied by well-designed evaluations of their effectiveness.

Survival of Hospitalized COVID-19 Patients in Northern Italy: A Population-Based Cohort Study by the ITA-COVID-19 Network.

INTRODUCTION: COVID-19 case fatality rate in hospitalized patients varies across countries and studies. Reliable estimates, specific for age, sex, and comorbidities, are needed to monitor the epidemic, to compare the outcome in different settings, and to correctly design trials for COVID-19 interventions. The aim of this study was to provide population-based survival curves of hospitalized COVID-19 patients. MATERIALS AND METHODS: A cohort study was conducted in three areas of Northern Italy, heavily affected by SARS-CoV-2 infection (Lombardy and Veneto Regions, and Reggio Emilia province), using a loco-regional COVID-19 surveillance system, linked to hospital discharge databases. We included all patients testing positive for SARS-CoV-2 RNA by RT-PCR on nasopharyngeal/throat swab samples who were hospitalized from 21 February to 21 April 2020. Kaplan-Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex, and the Charlson Index. RESULTS: Overall, 42,926 hospitalized COVID-19 patients were identified. Patients' median age was 69 years (IQR: 57-79), 62.6% were males, and 6.0% had a Charlson Index ≥3. Survival curves showed that 22.0% (95% CI 21.6-22.4) of patients died within 14 days and 27.6% (95% CI 27.2-28.1) within 30 days from hospitalization. Survival was higher in younger patients and in females. The negative impact of comorbidities on survival was more pronounced in younger age groups. CONCLUSION: The high fatality rate observed in the study (28% at 30 days) suggests that studies should focus on death as primary endpoint during a follow-up of at least one month.

Association between Exposure to Influenza Vaccination and COVID-19 Diagnosis and Outcomes.

We explored whether influenza vaccination (IV) affects susceptibility to SARS-CoV-2 infection and clinical outcomes in COVID-19 patients in 17,608 residents of the Italian province of Reggio Emilia undergoing a SARS-CoV-2 test. Exposure to IV was ascertained and the strength of the association with SARS-CoV-2 positivity expressed with odds ratios (OR). Rates of hospitalisations and death in those found positive were assessed and hazard ratios (HR) were estimated. The prevalence of IV was 34.3% in the 4885 SARS-CoV-2 positive and 29.5% in the 12,723 negative subjects, but the adjusted OR indicated that vaccinated individuals had a lower probability of testing positive (OR = 0.89; 95% CI 0.80-0.99). Among the 4885 positive individuals, 1676 had received IV. After adjusting for confounding factors, there was no association between IV and hospitalisation (1.00; 95% CI 0.84-1.29) or death (HR = 1.14; 95% CI 0.95-1.37). However, for patients age ≥65 vaccinated close to the SARS-CoV-2 outbreak, HRs were 0.66 (95% CI: 0.44-0.98) and 0.70 (95% CI 0.50-1.00), for hospitalisation and death, respectively. In this study, IV was associated with a lower probability of COVID-19 diagnosis. In COVID-19 patients, overall, IV did not affect outcomes, although a protective effect was observed for the elderly receiving IV almost in parallel with the SARS-CoV-2 outbreak. These findings provide reassurance in planning IV campaigns and underscore the need for exploring further their impact on COVID-19.

Characteristics and outcomes of a cohort of COVID-19 patients in the Province of Reggio Emilia, Italy.

This is a population-based prospective cohort study on archive data describing the age- and sex-specific prevalence of COVID-19 and its prognostic factors. All 2653 symptomatic patients tested positive for SARS-CoV-2 from February 27 to April 2, 2020 in the Reggio Emilia province, Italy, were included. COVID-19 cumulative incidence, hospitalization and death rates, and adjusted hazard ratios (HR) with 95% confidence interval (95% CI) were calculated according to sociodemographic and clinical characteristics. Females had higher prevalence of infection than males below age 50 (2.61 vs. 1.84 ‰), but lower in older ages (16.49 vs. 20.86 ‰ over age 80). Case fatality rate reached 20.7% in cases with more than 4 weeks follow up. After adjusting for age and comorbidities, men had a higher risk of hospitalization (HR 1.4 95% CI 1.2 to 1.6) and of death (HR 1.6, 95% CI 1.2 to 2.1). Patients over age 80 compared to age < 50 had HR 7.1 (95% CI 5.4 to 9.3) and HR 27.8 (95% CI 12.5 to 61.7) for hospitalization and death, respectively. Immigrants had a higher risk of hospitalization (HR 1.3, 95% CI 0.99 to 1.81) than Italians and a similar risk of death. Risk of hospitalization and of death were higher in patients with heart failure, arrhythmia, dementia, coronary heart disease, diabetes, and hypertension, while COPD increased the risk of hospitalization (HR 1.9, 95% CI 1.4 to 2.5) but not of death (HR 1.1, 95% CI 0.7 to 1.7). Previous use of ACE inhibitors had no effect on risk of death (HR 0.97, 95% CI 0.69 to 1.34). Identified susceptible populations and fragile patients should be considered when setting priorities in public health planning and clinical decision making.

Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients.

INTRODUCTION: The epidemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. There are several controversial hypotheses on the potentially harmful or beneficial effects of antihypertensive drugs acting on the renin-angiotensin-aldosterone system (RAAS) in coronavirus disease 2019 (COVID-19). Furthermore, there is accumulating evidence, based on several observational studies, that angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) do not increase the risk of contracting SARS-CoV-2 infection. On the other hand, conflicting findings regarding the role of ACEIs/ARBs as prognosis modifiers in COVID-19 hospitalised patients have been reported. OBJECTIVE: The aim of this large-scale, retrospective cohort study was to investigate whether prior exposure to ACEIs and/or ARBs was associated with all-cause mortality among over 40,000 hospitalised COVID-19 patients compared with calcium channel blockers (CCBs), a potential therapeutic alternative. METHODS: This study was conducted using COVID-19 registries linked to claims databases from Lombardy, Veneto and Reggio Emilia (overall, 25% of Italian population). Overall, 42,926 patients hospitalised between 21 February and 21 April 2020 with a diagnosis of COVID-19 confirmed by real-time polymerase chain reaction tests were included in this study. All-cause mortality occurring in or out of hospital, as reported in the COVID-19 registry, was estimated. Using Cox models, adjusted hazard ratios (HRs) of all-cause mortality (along with 95% confidence intervals [CIs]) were estimated separately for ACEIs/ARBs and other antihypertensives versus CCBs and non-use. RESULTS: Overall, 11,205 in- and out-of-hospital deaths occurred over a median of 24 days of follow-up after hospital admission due to COVID-19. Compared with CCBs, adjusted analyses showed no difference in the risk of death among ACEI (HR 0.97, 95% CI 0.89-1.06) or ARB (HR 0.98, 95% CI 0.89-1.06) users. When non-use of antihypertensives was considered as a comparator, a modest statistically significant increase in mortality risk was observed for any antihypertensive use. However, when restricting to drugs with antihypertensive indications only, these marginal increases disappeared. Sensitivity and subgroup analyses confirmed our main findings. CONCLUSIONS: ACEI/ARB use is not associated with either an increased or decreased risk of all-cause mortality, compared with CCB use, in the largest cohort of hospitalised COVID-19 patients exposed to these drugs studied to date. The use of these drugs therefore does not affect the prognosis of COVID-19. This finding strengthens recommendations of international regulatory agencies about not withdrawing/switching ACEI/ARB treatments to modify COVID-19 prognosis.

Effects on Clinical Outcomes of a 5-Year Surgical Safety Checklist Implementation Experience: A Large-scale Population-Based Difference-in-Differences Study.

The adoption of a surgical checklist is strongly recommended worldwide as an effective practice to improve patient safety; however, several studies have reported mixed results and a number of issues are still unresolved. The main objective of this study was to explore the impact of the first 5-year period of a surgical checklist-based intervention in a large regional health care system in Italy (4 500 000 inhabitants). We conducted a retrospective longitudinal study on 1 166 424 patients who underwent surgery in 48 public hospitals between 2006 and 2014. The adherence to the checklist was measured between 2011 and 2013 through a computerized database. The effects of the intervention were explored through multivariable logistic regression and difference-in-differences (DID) approaches, based on current administrative data sources. In-hospital and 30-days mortality, 30-days readmissions and length-of-stay (LOS) ⩾8 days were the observed outcomes. Adherence to the checklist showed marked variations across hospitals (0%-93.3%). A pre/post analysis detected statistically significant differences between surgical interventions performed in hospitals with higher adherence to the checklist (⩾75% of the surgeries) and those performed in other hospitals, as for the 30-days readmissions rate (odds ratio [OR]: 0.96; 95% confidence interval [CI]: 0.94-0.98) and LOS ⩾ 8 days rate (OR: 0.88; 95% CI: 0.87-0.89). These findings were confirmed after risk adjustment and DID analysis. No association was observed with mortality outcomes. On the whole, our study attained mixed results. Although a protective effect of the surgical checklist use could not be proved over the first 5 years of this regional implementation experience, our research offers some methodological insights for practical use in the evaluation process of large-scale implementation projects.

Bone loss at implants and teeth in the same inter-proximal unit: A radiographic study.

OBJECTIVE: This study was performed to determine whether the distance between an implant and a tooth present in an inter-proximal unit influenced the amount of marginal bone loss that occurred at the two facing (adjacent) surfaces. MATERIALS AND METHODS: One hundred and eighty patients with a total of 278 inter-proximal units were included. Radiographs of implants that also included adjacent (facing) natural tooth/teeth were digitalized, and various linear measurements were performed using a software program. The marginal bone level and the bone level change that had occurred during a mean of 5.8 years were assessed as well as distance between the implant and the adjacent tooth/teeth. RESULTS: The mean amount of additional marginal bone loss that took place during the observation period was about 0.4 mm at both implants and adjacent tooth surfaces. The horizontal distance between an implant and the facing tooth did not influence the amount of marginal bone loss that had occurred. In most inter-proximal units, more advanced bone loss (>1 mm, >2 mm) had ensued either at the implant or at the facing tooth surface. Advanced additional bone loss occurred at both the implant and the tooth in only about 3% of the examined subjects. CONCLUSION: Bone loss at implants and teeth appears to be a site-specific phenomenon and not dependent on the inter-proximal distance.

Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry.

Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

How health service delivery guides the allocation of major trauma patients in the intensive care units of the inclusive (hub and spoke) trauma system of the Emilia Romagna Region (Italy). A cross-sectional study.

OBJECTIVE: To evaluate cross-sectional patient distribution and standardised 30-day mortality in the intensive care units (ICU) of an inclusive hub and spoke trauma system. SETTING: ICUs of the Integrated System for Trauma Patient Care (SIAT) of Emilia-Romagna, an Italian region with a population of approximately 4.5 million. PARTICIPANTS: 5300 patients with an Injury Severity Score (ISS) >15 were admitted to the regional ICUs and recorded in the Regional Severe Trauma Registry between 2007 and 2012. Patients were classified by the Abbreviated Injury Score as follows: (1) traumatic brain injury (2) multiple injuriesand (3) extracranial lesions. The SIATs were divided into those with at least one neurosurgical level II trauma centre (TC) and those with a neurosurgical unit in the level I TC only. RESULTS: A higher proportion of patients (out of all SIAT patients) were admitted to the level I TC at the head of the SIAT with no additional neurosurgical facilities (1083/1472, 73.6%) compared with the level I TCs heading SIATs with neurosurgical level II TCs (1905/3815; 49.9%). A similar percentage of patients were admitted to level I TCs (1905/3815; 49.9%) and neurosurgical level II TCs (1702/3815, 44.6%) in the SIATs with neurosurgical level II TCs. Observed versus expected mortality (OE) was not statistically different among the three types of centre with a neurosurgical unit; however, the best mean OE values were observed in the level I TC in the SIAT with no neurosurgical unit. CONCLUSION: The Hub and Spoke concept was fully applied in the SIAT in which neurosurgical facilities were available in the level I TC only. The performance of this system suggests that competition among level I and level II TCs in the same Trauma System reduces performance in both. The density of neurosurgical centres must be considered by public health system governors before implementing trauma systems.

Diagnosis and treatment of rheumatoid arthritis in the Emilia Romagna region: a prospective population-based study.

OBJECTIVES: To perform a population-based study in rheumatoid arthritis (RA) patients, in order to evaluate the efficacy and safety of pharmacologic treatments. METHODS: 1087 patients with RA were enrolled; inclusion criteria were: newly diagnosed RA, already diagnosed RA with high disease activity (HDA) (DAS28≥4.2) starting biologic DMARDs (bDMARDs), already diagnosed RA with HDA continuing with conventional DMARDs (cDMARDs). The following data were collected: demographics, clinical and laboratory features, imaging and prescribed drugs. All parameters except immunology and imaging (performed yearly) were repeated at each follow-up evaluations (after 3, 6 and 12 months, and thereafter every 12 months). In order to evaluate clinical response, the EULAR response criteria were used as the gold standard. RESULTS: 414 (38.1%) newly diagnosed patients with RA, 477 (43.9%) RA patients who started bDMARDs and 196 (18.0%) RA patients who continued with cDMARDs were enrolled from April 2012 to March 2015 at 12 Rheumatology Centres in the Emilia Romagna Region. Statistical analyses showed a relative risk ratio (RRR) for moderate response of 1.65 in RA patients who started bDMARDs (p=0.16) and 2.49 for newly diagnosed RA (p=0.01). Sex, age and Health Assessment Questionnaire were not statistically significant. A RRR of 2.00 has been confirmed for RA patients who started bDMARDs (p<0.0005) for a good response as well as 2.20 for newly diagnosed RA (p<0.0005). An increase in adverse events among bDMARDs was found, but when looking at infections or neoplasia, no differences were highlighted between RA which started bDMARDs and RA who continued with cDMARDs. CONCLUSIONS: Our results are in line with already published papers from British and Swedish Registries: a greater likelihood to have a good response is demonstrated for not longstanding RA starting cDMARDs or RA with HDA when a bDMARD is started. Also a good safety profile is demonstrated.

Bone loss at implants and teeth in the same segment of the dentition in partially dentate subjects.

BACKGROUND: Some studies have indicated that marginal bone loss at implants and at teeth are similar, while results from other studies showed that implants lost more bone than teeth in the same dentition. AIM: To determine the amount of progressive marginal bone loss that had occurred at implants and teeth in the same segment of the dentition following implant placement in partially dentate subjects. MATERIAL AND METHODS: A total of 217 patients with a total of 573 implants and 318 teeth present in the same segments of the dentition were included. Radiographs were available from 1 year (baseline) and ≥3 years after loading. RESULTS: The mean bone loss that occurred between the two examinations was at implants 0.42 ± 0.68 mm and at teeth 0.44 ± 0.52 mm. Thirty-eight subjects (18%) had ≥1 implant exhibiting >1 mm bone loss. Bone loss at the 148 implants in this category of patients was 1.30 ± 1.04 mm with a corresponding loss at the 69 teeth of 0.53 ± 0.62 mm. Eighteen subjects (8%) had ≥1 tooth that exhibited >1 mm bone loss. The mean amount of bone loss in this sample was 1.37 ± 0.87 mm (38 teeth) and 0.29 ± 0.31 mm (56 implants). CONCLUSIONS: This study showed that marginal bone loss at implants and teeth in many partially dentate subjects might be independent phenomena.

Self-controlled case-series study to verify the effect of adherence to Beta-blockers in secondary prevention of myocardial infarction.

BACKGROUND: Beta-blockers (BB) are recommended in secondary prevention of acute myocardial infarction (AMI), but adherence to prescription medication is a recognized problem. Most literature on the consequences of poor adherence to prescribed BB is limited by the possibility of "healthy adherer bias" and better-designed studies have been advocated. METHODS AND RESULTS: We investigated the association between adherence to BB prescription and risk of subsequent AMIs using the self-controlled case series design, which allows improved control of interpersonal confounding, being based on intrapersonal comparisons. From all the 30 089 patients hospitalized for AMI in the years 2009-2011 in an Italian region we selected those that suffered subsequent AMIs at days 31 to 365 from discharge (1328), and then the 1207 that had at least one BB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to BB and the relative AMI incidence rate ratios (IRR) of BB exposure were estimated by conditional Poisson regression. The IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.69 to 0.90, P=0.001). Various sensitivity analyses confirmed the robustness to possible failure of assumptions, ie, considering only first recurrences (IRR 0.76, 95% CI 0.66 to 0.88, P<0.001), excluding cardiovascular fatalities (IRR 0.76, 95% CI 0.65 to 0.89, P<0.001), and excluding individuals with long hospital admissions (IRR 0.60, 95% CI 0.43 to 0.83, P=0.002). CONCLUSIONS: Adherence to recommended BB therapy was associated with a 20% reduction of recurrent AMIs, consistently with previous research, but with decreased concerns about healthy-adherer bias.

Adherence to agents acting on the renin-angiotensin system in secondary prevention of non-fatal myocardial infarction: a self-controlled case-series study.

AIMS: In accordance with current guidelines, patients discharged after acute myocardial infarction (AMI) are usually prescribed agents acting on the renin-angiotensin system (ACE-I/ARB). However, adherence to prescribing medications is a recognized problem and most studies demonstrating the value of adherence were limited by their non-randomized design and by 'healthy-adherer' bias. Herein we sought to evaluate the relationship between adherence to ACE-I/ARB and risk of subsequent AMIs, by using the self-controlled case-series design which virtually eliminates interpersonal confounding, being based on intrapersonal comparisons. METHODS AND RESULTS: We linked data from three longitudinal registries containing information about hospitalizations, drug prescriptions, and vital status of all residents in an Italian region. From 30 089 patients hospitalized for AMI in the years 2009-11, we enrolled the 978 with non-fatal re-AMIs at Days 31-365 after discharge, receiving at least one ACE-I/ARB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to ACE-I/ARB. The relative re-AMI incidence rate ratios (IRRs) of ACE-I/ARB exposure were estimated by conditional Poisson regression. During drug-covered periods, the risk of AMI recurrence was ∼20% lower, i.e. the IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.66-0.96, P = 0.001). The benefit of ACE-I/ARB was confirmed also by sensitivity analyses considering only first recurrences, excluding cases with AMI within previous 3 years, or with long, not AMI, hospital re-admission. CONCLUSIONS: Poor adherence to ACE-I/ARB prescription medication was associated with a 20% increased risk of recurrent AMI. This was consistent with previous research, but the SCSS study design, even if not randomized, eased previous concerns about healthy-adherer bias.