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Abstract Rationale Screening for lung cancer with low-dose spiral computed tomography (LDCT) has been shown to reduce lung cancer mortality by 20% compared with screening with chest X-ray (CXR) in the National Lung Screening Trial, but uncertainty remains concerning the efficacy of LDCT screening in a community setting. Objectives To explore the effect of LDCT screening on lung cancer mortality compared with no screening. Secondary endpoints included incidence, stage, and resectability rates. Methods Male smokers of 20+ pack-years, aged 60 to 74 years, underwent a baseline CXR and sputum cytology examination and received five screening rounds with LDCT or a yearly clinical review only in a randomized fashion. Measurements and Main Results A total of 1,264 subjects were enrolled in the LDCT arm and 1,186 in the control arm. Their median age was 64.0 years (interquartile range, 5), and median smoking exposure was 45.0 pack-years. The median follow-up was 8.35 years. One hundred four patients (8.23%) were diagnosed with lung cancer in the screening arm (66 by CT), 47 of whom (3.71%) had stage I disease; 72 control patients (6.07%) were diagnosed with lung cancer, with 16 (1.35%) being stage I cases. Lung cancer mortality was 543 per 100,000 person-years (95% confidence interval, 413–700) in the LDCT arm versus 544 per 100,000 person-years (95% CI, 410–709) in the control arm (hazard ratio, 0.993; 95% confidence interval, 0.688–1.433). Conclusions Because of its limited statistical power, the results of the DANTE (Detection And screening of early lung cancer with Novel imaging TEchnology) trial do not allow us to make a definitive statement about the efficacy of LDCT screening. However, they underline the importance of obtaining additional data from randomized trials with intervention-free reference arms before the implementation of population screening.

Screening for lung cancer with modern imaging technology may decrease lung cancer mortality, but encouraging results have only been obtained in uncontrolled studies. To explore the effect of screening with low-dose spiral computed tomography (LDCT) on lung cancer mortality. Secondary endpoints are incidence, stage at diagnosis, and resectability. Male subjects, aged 60 to 75 years, smokers of 20 or more pack-years, were randomized to screening with LDCT or control groups. All participants underwent a baseline, once-only chest X-ray and sputum cytology examination. Screening-arm subjects had LDCT upon accrual to be repeated every year for 4 years, whereas controls had a yearly medical examination only. A total of 2,811 subjects were randomized and 2,472 were enrolled (LDCT, 1,276; control, 1,196). After a median follow-up of 33 months, lung cancer was detected in 60 (4.7%) patients receiving LDCT and 34 (2.8%) control subjects (P = 0.016). Resectability rates were similar in both groups. More patients with stage I disease were detected by LDCT (54 vs. 34%; P = 0.06) and fewer cases were detected in the screening arm due to intercurrent symptoms. However, the number of advanced lung cancer cases was the same as in the control arm. Twenty patients in the LDCT group (1.6%) and 20 controls (1.7%) died of lung cancer, whereas 26 and 25 died of other causes, respectively. The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated.

Hereditary breast/ovarian cancer (HBOC) syndrome is caused by the inheritance of monoallelic germline BRCA1/2 gene mutations. If BRCA1/2 mutation carriers are identified before the disease develops, effective actions against HBOC can be taken, including intensive screening, risk-reducing mastectomy and salpingo-oophorectomy, and risk-reducing medications. The Italian National Prevention Plan mandates the creation of regional BRCA genetic testing programmes. So far, however, only informal data have been reported on their implementation. We have designed a study aimed at evaluating the results of a population-based programme for risk assessment and genetic counselling and testing for BRCA1/2-related HBOC that is underway in the Emilia-Romagna region (northern Italy). The programme—which is entirely free—includes basic screening with an estimate of the likelihood of carrying a BRCA1/2 mutation using a familial risk assessment tool, a closer examination of women with suspected risk increase, an assessment of the need for further genetic counselling and, if needed, genetic testing and risk-reducing interventions. In this paper, the design of the programme and the protocol of the study are presented. The study has an observational, historical cohort design. Eligible are the women found to be at an increased risk of HBOC (profile 3 women). The main objectives are (i) to determine the precision of the programme in measuring the level of risk of HBOC for profile 3 women; (ii) to determine the characteristics of profile 3 women and their association with the risk management strategy chosen; (iii) to compare the age at onset, histologic type, tumour stage, molecular subtype, and prognosis of breast/ovarian cancers observed in the cohort of profile 3 women with the features of sporadic cancers observed in the general female population; (iv) to determine the level and the determinants of adherence to recommendations; and (v) to determine the appropriateness and timing of risk-reducing surgery and medications. Investigating the quality and results of the programme is necessary because the best practices in risk assessment and genetic counselling and testing for BRCA1/2-related cancer and the challenges they encounter should be identified and shared. The study has the potential to provide sound empirical evidence for the factors affecting the effectiveness of this type of service.

Background Regular physical activity (PA) is a key factor of lifestyle behavior enhancing general health and fitness, especially in people after total hip or knee replacement (THR and TKR). Orthopaedic surgeons can play a primary role in advocating the benefits of an active lifestyle. Aim of the study was 1) to assess the attitude of orthopaedic surgeons towards PA for people after THR/TKR and 2) to compare the attitude between a Northern European (the Netherlands) and a Southern European (Italy) country and analyze which factors influence the attitude towards PA. Methods A cross-cultural study. An (online) survey was distributed among orthopaedic surgeons in Italy and the Netherlands. Chi-square and Mann–Whitney tests were used to compare surgeons’ and clinics’ characteristics, and questionnaires’ scores, respectively. A linear regression analysis was conducted to assess which surgeon characteristics influence attitude towards PA. Results A cohort of 159 surgeons (103 Italians and 56 Dutch) was analyzed. The median score of overall orthopaedic surgeons’ attitude towards PA was positive (57 out of 72). Dutch surgeons showed a more positive attitude compared to Italian surgeons ( p  < 0.01). Main difference was found in the “Physical activity concern” factor, where Italian surgeons showed more concern about the negative effects of PA on the survival of the prosthesis. The regression analyses showed that “Country” and “Type of clinic” were associated with the surgeons’ attitude. Conclusions Overall, the orthopaedic surgeons’ attitude towards PA for people with THR and TKR was positive. However, Dutch surgeons seem to be more positive compared to the Italian. The country of residence was the item that most influenced attitude. Further investigations are needed to untangle specific factors, such as cultural, socioeconomic, or contextual differences within the variable “country” that may influence orthopaedic surgeons’ attitudes towards PA.

Background: Hantavirus cardiopulmonary syndrome (HCPS) has a mortality up to 35–40% and its treatment is mainly supportive. A variable to predict progression from mild to severe disease is unavailable. This study was performed in patients with documented infection by Andes orthohantavirus, and the aim was to find a simple variable to predict progression to moderate/severe HCPS in patients with mild disease at admission. Methods: We performed a retrospective analysis of 175 patients between 2001 and 2018. Patients were categorized into mild, moderate, and severe disease according to organ failure and advanced support need at hospital admission (e.g., mechanical ventilation, vasopressors). Progression to moderate/severe disease was defined accordingly. Clinical and laboratory variables associated with progression were explored. Results: Forty patients with mild disease were identified; 14 of them progressed to moderate/severe disease. Only platelet count was different between those who progressed versus those that did not (37 (34–58) vs. 83 (64–177) K/mm3, p < 0.001). A ROC curve analysis showed an AUC = 0.889 (0.78–1.0) p < 0.001, with a platelet count greater than 115K /mm3 ruling out progression to moderate/severe disease. Conclusions: In patients with mild disease at presentation, platelet count could help to define priority of evacuation to tertiary care centers.

We externally validated the fatty liver index (FLI), the lipid accumulation product (LAP), the hepatic steatosis index (HSI), and the Zhejiang University index (ZJU) for the diagnosis of fatty liver (FL) and non-alcoholic fatty liver disease (NAFLD) in the general population. The validation was performed on 2159 citizens of the town of Bagnacavallo (Ravenna, Italy). Calibration was evaluated by calculating the calibration slope and intercept and by inspecting calibration plots; discrimination was evaluated using the c-statistic. The average calibration slope was 1 and the average intercept was 0 for all combinations of outcomes and indices. For the diagnosis of FL, the c-statistic was 0.85 for FLI, 0.83 for ZJU, 0.82 for HSI, and 0.80 for LAP; for the diagnosis of NAFLD, the c-statistic was 0.77 for FLI, 0.76 for ZJU, 0.75 for HSI, and 0.74 for LAP. All indices were strongly correlated with each other. In conclusion, FLI, LAP, HSI, and ZJU perform similarly well to diagnose FL and NAFLD in the Bagnacavallo population, even if FLI has a small advantage as discrimination is concerned.

Total hip replacement (THR) and total knee replacement (TKR) are among the most common elective surgical procedures. There is a large consensus on the importance of physical activity promotion for an active lifestyle in persons who underwent THR or TKR to prevent or mitigate disability and improve the quality of life (QoL) in the long term. However, there is no best practice in exercise and physical activity specifically designed for these persons. The present protocol aims to evaluate the efficacy and safety of an exercise program (6 month duration) designed for improving quality of life in people who had undergone THR or TKR. This paper describes a randomized controlled trial protocol that involves persons with THR or TKR. The participant will be randomly assigned to an intervention group or a control group. The intervention group will perform post-rehabilitation supervised training; the control group will be requested to follow the usual care. The primary outcome is QoL, measured with the Short-Form Health Survey (SF-36); Secondary outcomes are clinical, functional and lifestyle measures that may influence QoL. The results of this study could provide evidence for clinicians, exercise trainers, and policymakers toward a strategy that ensures safe and effective exercise physical activity after surgery.

Health-related quality of life predicts outcomes but is not affected by peritoneal clearance: The ADEMEX trial. We hypothesized that increasing small solute clearance in peritoneal dialysis (PD) would lead to improvements in patient health-related quality of life (HRQOL). Patients were randomized to a control group [standard 4×2L continuous ambulatory peritoneal dialysis (CAPD)] and an intervention group (CAPD with a target creatinine clearance ≥60L/week/1.73m2). The Kidney Disease Quality of Life Short Form was obtained at baseline and at 6, 12, and 24 months. Physical (PCS), mental (MCS), and kidney disease component summary (KDCS) scores were computed. The two groups were comparable at baseline with respect to HRQOL. Baseline variables highly predictive of better QOL included absence of diabetes, younger age, higher starting GFR, and serum albumin. Baseline values of QOL were highly predictive of survival and hospitalizations. An unadjusted comparison revealed that patients in the intervention group had significantly higher PCS and KDCS scores at six months. However, there were no significant differences between the intervention and control patients at 12 or 24 months. When similar analyses were carried out adjusting for different patterns of patient dropout, there were no significant differences between the two groups at any time point in terms of PCS, MCS, and KDCS scores. We found no evidence of a long-term benefit in HRQOL of CAPD patients by increasing peritoneal small-solute clearances when HRQOL parameters were adjusted for patient dropout. Measures of HRQOL have a significant predictive value for patient survival and hospitalizations.

Background Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study is proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use. Methods/design Information will be provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics will be also available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists will get specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians will be trained in patient counselling strategies. The information campaign will be implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample. Discussion While the campaign messages will be mainly directed to the general population, doctors' prescribing will be assessed. The main rationale for this apparent discrepancy lies in the influence patients may have on physicians' prescribing behaviour (directly or indirectly) and in physicians' endorsement of the campaign goals, considering their participation in its design. This study could observe a reduction lower than 5% in the prescribing rate of antibiotics. Such a reduction would be of public health relevance and would determine average savings of almost twice as much as the campaign costs.

Eighty-eight immunocompetent patients with deep mycoses from eight countries were evaluated with the same protocol for efficacy of fluconazole monotherapy. Entry doses were raised from 100 to 400 mg as safety was shown in initial cohorts, and dosages up to 2,400 mg daily and durations up to 44 months were studied. Results were very similar in different countries. Twenty-seven of 28 evaluable patients with paracoccidioidomycosis, 13 of 19 with sporotrichosis, 14 of 16 with coccidioidomycosis, and eight of eight with histoplasmosis demonstrated objective responses to therapy, as did one patient each with zygomycosis and alternariosis. For these patients, relapses have been unusual thus far. In contrast, one patient with chromoblastomycosis responded but relapsed, and six did not respond; one patient with mycetoma responded but relapsed, and two did not respond. The drug was well tolerated by patients, including six who received intravenous therapy. In vitro susceptibility tests suggested that clinical response was correlated with susceptibility but that resistance did not preclude clinical response. Fluconazole therapy appears efficacious for several deep mycoses; dosages of >200 mg daily may be needed for some diseases. The further evaluation of fluconazole for these entities is warranted.