Needs of breast cancer survivors: a systematic review of quantitative data.

This systematic review aimed to update the perceived needs of individuals with breast cancer (BC). Databases were searched for studies reporting quantitative data collected through validated assessment tools. Needs of adults with BC were reported by survivorship phase. The post-diagnosis and the post-surgery phases revealed the most needs; health system and information needs represented the greatest concern, with average Supportive Care Needs Survey-Short Form (SCNS-SF34) scores ranging from 62.0 to 75.8 post-diagnosis and from 45.0 to 67.8 post-surgery. Needs then seemed to decrease or remain stable up to within one year from diagnosis, when needs in all domains increased again; health system and information needs remained a priority. Younger age, side effects, type of treatment, and advanced stage were associated with the occurrence of unmet needs. The needs of BC survivors vary over the course of their cancer experience. This knowledge can assist the planning of appropriate assessments.

Tobacco vs. electronic cigarettes: absence of harm reduction after six years of follow-up.

OBJECTIVE: Information on the long-term safety of electronic cigarettes (e-cig) is still limited. We report the results after six years of follow-up of the first observational study assessing e-cig long-term effectiveness and safety. PATIENTS AND METHODS: Participants were adults who smoked ≥1 tobacco cigarette/day (tobacco smokers); or used any type of e-cig inhaling ≥50 puffs weekly (e-cig users); or used both (dual users). Participants were contacted directly or by phone and/or internet interviews. Hospital discharge abstract data and carbon monoxide level tests were also used. RESULTS: Data were available for 228 e-cig users (all ex-smokers), 469 tobacco smokers, 215 dual users. A possibly smoking-related disease (PSRD) was recorded in 90 subjects (9.9%); 11 deceased (1.2%). No differences were observed across groups in PSRD rates, with minor changes in self-reported health. Among e-cig users, 64.0% remained tobacco abstinent. Dual users and tobacco smokers did not significantly differ in the rate of cessation of tobacco (38.6% vs. 33.9%, respectively) and all products (23.7% vs. 26.4%). A comparable decrease in daily cigarettes was also observed. 39.5% of the sample switched at least once (tobacco smokers: 15.1%; dual users: 83.3%). CONCLUSIONS: After six years, no evidence of harm reduction was found among e-cig or dual users. The complete switch to e-cig might support tobacco quitters remain abstinent, but the use of e-cig in addition to tobacco did not improve smoking cessation or reduction.

Costs of irritable bowel syndrome in European countries with universal healthcare coverage: a meta-analysis.

OBJECTIVE: To provide an overall estimate of the direct, indirect and total costs of irritable bowel syndrome (IBS) for the adult population of the European countries with universal healthcare coverage. MATERIALS AND METHODS: We searched MedLine and Scopus databases (up to September 2018) to identify the European studies that evaluated the economic impact of IBS. Mean annual direct, indirect and total per-capita IBS costs were estimated using random-effect single-group meta-analyses of continuous data. All analyses were stratified by payer category (governments, insurance, societal), and the results were expressed as summary mean and 95% CI. RESULTS: A total of 24 studies were included in the meta-analyses. Only two studies evaluated IBS costs in Italy. The pooled summary of direct IBS per-capita cost, obtained from 23 European datasets (n=15,157), was €1837/year (95% CI: 1480-2195), with large differences across payers (from €1183 to €3358, in countries with publicly-funded and insurance-based health systems, respectively). The mean indirect cost, extracted from 13 datasets (n=3978), was €2314/year (95% CI: 1811-2817), again with wide differences across payers. Finally, the meta-analysis estimating the total annual cost, based upon 11 European datasets (n=2757), yielded a summary estimate of €2889/year (95% CI: 2318-3460) per patient, ranging from €1602 (insurance-based health systems) to €3909 (studies adopting a societal perspective). CONCLUSIONS: Considering a conservative estimate of 2,736,700 Italian adults affected by the syndrome, the minimum costs due to IBS in Italy - likely underestimated - range from 6 to 8 billion euro per year. Given the substantial economic burden for patients, healthcare systems and society, IBS should be included among the priorities of the public health agenda.

Mediterranean diet and the risk of poor semen quality: cross-sectional analysis of men referring to an Italian Fertility Clinic.

BACKGROUND: Several diet patterns have been suggested as involved in processes of spermatogenesis and thus in male subfertility. To study the relation between Mediterranean diet and abnormal sperm parameters in men of subfertile couples, we performed a cross-sectional analysis of baseline data from a prospective cohort study. METHODS: Patients were enrolled in an Italian Fertility Clinic. Couples undergoing assisted reproduction techniques (ART) were interviewed to obtain information on personal and health history, lifestyle habits, and diet, on the day of oocyte retrieval. On the same day, a semen sample was also collected and analyzed to proceed with ART. Adherence to Mediterranean diet was evaluated using a Mediterranean Diet Score (MDS). Odds ratios (OR) and 95% confidence intervals (CI) were calculated for semen volume <1.5 mL, sperm concentration <15 mil/mL, and total count <39 mil. RESULTS: Three hundred nine men, age range 27-60, were enrolled: 19.3% had semen volume < 1.5 mL, 30.5% sperm concentration <15 mil/mL, and 32.1% total count <39 mil. MDS was low (0-3) in 86 men (27.8%), intermediate (4-5) in 131 (42.4%), and high (6-9) in 92 (29.8%). Semen volume was not associated with MDS. Compared to the highest MDS category (6-9), the ORs for low sperm concentration were 1.34 (95% CI 0.69-2.50) for MDS 4-5 and 2.42 (95% CI 1.21-4.83) for MDS 0-3, with significant trend (p = 0.011). The corresponding estimates for total count were 1.26 (95% CI 0.66-2.42) and 2.08 (95% CI 1.05-4.12), with significant trend (p = 0.034). These findings were consistent in strata of history of reproductive organ diseases. CONCLUSIONS: Mediterranean Diet Score was positively associated with normal sperm concentration and total count, but not with semen volume.

Cohort study of electronic cigarette use: safety and effectiveness after 4 years of follow-up.

OBJECTIVE: More than a decade after e-cigarette (e-cig) market launch, limited information are available on their safety after 24 months of use. In 2013, we started the first observational study assessing e-cig long-term effectiveness and safety, directly comparing tobacco smokers and e-cig users. Here we report the results after four years of follow-up. PATIENTS AND METHODS: Adults (30-75 years) were included if: smokers of ≥1 tobacco cigarette/day (tobacco smokers); users of any type of e-cig inhaling ≥50 puffs weekly (e-cig users); users of both tobacco and e-cig (dual users). Data were collected by phone and/or internet, and carbon monoxide levels tested in 50% of those declaring tobacco abstinence. Main outcomes were: possibly smoking-related diseases (PSRD; validated through hospital discharge data or visit in 62.6% of the sample); 4-year tobacco abstinence; number of tobacco cigarettes/day. RESULTS: Data were available for 228 e-cig users (all ex-smokers), 471 tobacco smokers, 216 dual users. A PSRD was observed in 73 subjects (8.0%). No differences emerged across groups in PSRD rates, with negligible variations in self-reported health. Of e-cig users, 63.6% remained tobacco abstinent; dual users and tobacco smokers showed non-significantly different rates of tobacco (33.8% vs. 26.8%) and all-product (20.2% vs. 19.4%) cessation, and a similar decrease in cigarettes/day. Almost 40% of the sample switched at least once (tobacco smokers: 17.2%; dual users: 81.9%). CONCLUSIONS: After four years, a scarce, non-significant harm reduction was observed among e-cig or dual users. Given the long-lasting health effects of tobacco smoking, the benefits of e-cig use may start being detectable at the next follow-up (six years). The complete switch to e-cig may help tobacco quitters remain abstinent, but e-cig use in addition to tobacco did not increase the likelihood of smoking cessation or reduction.

Nutrient-based dietary patterns and nasopharyngeal cancer: evidence from an exploratory factor analysis.

BACKGROUND: To our knowledge, no study assessed the association between dietary patterns and nasopharyngeal carcinoma (NPC) in low-incidence areas. METHODS: We examined this association in a hospital-based case-control study carried out in Italy between 1992 and 2008, including 198 incident NPC cases and 594 controls. A posteriori dietary patterns were identified through principal component factor analysis performed on 28 nutrients and minerals derived from a 78-item food-frequency questionnaire. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated using unconditional multiple logistic regression models on tertiles of factor scores. RESULTS: We identified five dietary patterns named Animal products, Starch-rich, Vitamins and fibre, Animal unsaturated fatty acids (AUFAs), and Vegetable unsaturated fatty acids (VUFAs). The Animal product (OR=2.62, 95% CI=1.67-4.13, for the highest vs lowest score tertile), Starch-rich (OR=2.05, 95% CI=1.27-3.33), and VUFA (OR=1.90, 95% CI=1.22-2.96) patterns were positively associated with NPC. The AUFA pattern showed a positive association of borderline significance, whereas the Vitamins and fibre pattern was nonsignificantly but inversely associated with NPC. CONCLUSIONS: These findings suggest that diets rich in animal products, starch, and fats are positively related to NPC risk in this low-incidence country.

Continuity of care of cancer patients. Analysis of theoretical models and survey tools of continuity of care in people with a cancer diagnosis.

BACKGROUND: The Italian Ministry of Health declared oncology a priority and stressed the importance of ensuring continuity and integration in cancer care pathways. In order to monitor the quality of cancer care pathways, we need to explore patients' experience of the continuity of care, identifying the dimensions that define continuity. METHODS: We found 886 relevant articles in the Pubmed database from 1987 to 5 November 2013. The search strategy for the electronic database was defined using the Population, Intervention, Comparison and Outcome(s) framework (PICO) to identify keywords. Two researchers independently reviewed records identified through the search strategy, analyzing continuity dimensions, specificity and/or transversal domains. RESULTS: We selected 20 articles that measure the patients' experience of continuity of care: 7 articles including 5 questionnaires [Questionnaire by King et al. 2008; Cancer care coordination Questionnaire (Cccq); Patient Continuity of Care Questionnaire (Pccq); Medical Care Questionnaire (Mcq); Continuity and Coordination of Care Questionnaire (CCCQ)]; 6 articles evaluating the relationship between patient and his/her physician (the same across the care pathway) in terms of frequency and/or dispersion; 6 articles considering one subscale of larger scales designed to evaluate the generic cancer care service patient experience; 1 revealing four organizational indicators of care pathway continuity / discontinuity. CONCLUSIONS: We traced 3 transversal dimensions across the individual analyses: informational, organizational, relational continuity. It follows that in order to cater to the needs of cancer patients, we need to simultaneously focus on these three dimensions along the cancer care pathway. In line with these results, we promoted the "R.In.Cu.ORAM.i" study (Networks for Integrated Treatment of colorectal and breast cancer), in Area Vasta Romagna Area (Italy), and developed a continuity of care patient-experience continuity tool.

Foods, nutrients and the risk of oral and pharyngeal cancer.

BACKGROUND: Besides tobacco and alcohol, dietary habits may have a relevant role in oral cavity and pharyngeal (OCP) cancer. METHODS: We analysed the role of selected food groups and nutrients on OCP cancer in a case-control study carried out between 1997 and 2009 in Italy and Switzerland. This included 768 incident, histologically confirmed squamous cell carcinoma cases and 2078 hospital controls. Odds ratios (ORs) were estimated using logistic regression models including terms for tobacco, alcohol and other relevant covariates. RESULTS: Significant inverse trends in risk were observed for all vegetables (OR=0.19, for the highest vs the lowest consumption) and all fruits (OR=0.39), whereas significant direct associations were found for milk and dairy products (OR=1.50), eggs (OR=1.71), red meat (OR=1.55), potatoes (OR=1.85) and desserts (OR=1.68), although trends in risk were significant only for potatoes and desserts. With reference to nutrients, significant inverse relations were observed for vegetable protein (OR=0.45, for the highest vs the lowest quintile), vegetable fat (OR=0.54), polyunsaturated fatty acids (OR=0.53), α-carotene (OR=0.51), ß-carotene (OR=0.28), ß-cryptoxanthin (OR=0.37), lutein and zeazanthin (OR=0.34), vitamin E (OR=0.26), vitamin C (OR=0.40) and total folate (OR=0.34), whereas direct ones were observed for animal protein (OR=1.57), animal fat (OR=2.47), saturated fatty acids (OR=2.18), cholesterol (OR=2.29) and retinol (OR=1.88). Combinations of low consumption of fruits and vegetables, and high consumption of meat with high tobacco and alcohol, led to 10- to over 20-fold excess risk of OCP cancer. CONCLUSION: Our study confirms and further quantifies that a diet rich in fruits and vegetables and poor in meat and products of animal origin has a favourable role against OCP cancer.

Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients.

BACKGROUND: Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM). AIM: The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters. SUBJECTS AND METHODS: This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA1c) levels between 6-8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis. RESULTS: Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl vs 3.0 mg/dl; p<0.01) in addition to a greater reduction in the extent of MS (-13.2 vs -4.9; p=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA1c (6.41±0.65 vs 6.96±0.74%; p<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88±1.95 vs 4.68±3.63; p=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (-5.7%). CONCLUSIONS: The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability.

Hospital network performance: a survey of hospital stakeholders' perspectives.

Hospital networks are an emerging organizational form designed to face the new challenges of public health systems. Although the benefits introduced by network models in terms of rationalization of resources are known, evidence about stakeholders' perspectives on hospital network performance from the literature is scanty. Using the Competing Values Framework of organizational effectiveness and its subsequent adaptation by Minvielle et al., we conducted in 2009 a survey in five hospitals of an Italian network for oncological care to examine and compare the views on hospital network performance of internal stakeholders (physicians, nurses and the administrative staff). 329 questionnaires exploring stakeholders' perspectives were completed, with a response rate of 65.8%. Using exploratory factor analysis of the 66 items of the questionnaire, we identified 4 factors, i.e. Centrality of relationships, Quality of care, Attractiveness/Reputation and Staff empowerment and Protection of workers' rights. 42 items were retained in the analysis. Factor scores proved to be high (mean score>8 on a 10-item scale), except for Attractiveness/Reputation (mean score 6.79), indicating that stakeholders attach a higher importance to relational and health care aspects. Comparison of factor scores among stakeholders did not reveal significant differences, suggesting a broadly shared view on hospital network performance.

Dietary patterns and upper aerodigestive tract cancers: an overview and review.

BACKGROUND: The relationship between diet and cancers of the upper aerodigestive tract (UADT) has been investigated through dietary patterns. DESIGN: Published studies on the relationship between a priori and a posteriori dietary patterns and UADT cancers were selected through a Medline search. RESULTS: Twenty-four case-control studies were identified. Most of them identified a posteriori dietary patterns, mainly using principal component factor analysis, and a few used a priori dietary patterns, based on the available evidence on known effects of dietary habits on UADT cancers. In one study, no association was found between the identified patterns and UADT cancers. All the remaining 23 papers reported at least one favorable or unfavorable dietary pattern related to UADT cancers. The most consistent findings are the beneficial role of a dietary pattern based on fruit and vegetables or nutrients mostly contained in such foods, and the unfavorable role of an alcohol drinker pattern. A possible unfavorable role of patterns based on meats and animal products emerged as well. CONCLUSION: The consistency of results among populations indicates that diets rich in fruit and vegetables, and poor in alcohol and animal products are favorable for UADT cancers.

Adherence to the European food safety authority's dietary recommendations and colorectal cancer risk.

BACKGROUND/OBJECTIVE: The European Food Safety Authority (EFSA) recently published dietary guidelines for the intakes of carbohydrates, fiber, fats and water. We evaluated their role on the risk of a specific disease, known to be related to diet. SUBJECTS/METHODS: We used data from an Italian case-control study including 1953 colorectal cancer (CRC) cases and 4154 controls. We developed a so-called EFSA index summing up 1 point for adherence to each EFSA guideline. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) of CRC and its subsites were derived from unconditional multiple logistic regression models, for both the index and its components. RESULTS: When each EFSA index component was analyzed separately, we found significant increased risks of CRC for non adherence to the guidelines on linoleic (OR=1.20, 95% CI, 1.07-1.36) and alpha-linolenic fatty acids (OR=1.19, 95% CI, 1.06-1.34). When all the guidelines were included in the same model, no significant association emerged. Compared with minimal adherence, the ORs of CRC for subsequent EFSA index scores were 1.03 (95% CI, 0.72-1.47), 1.05 (95% CI, 0.75-1.48), 1.04 (95% CI, 0.81-1.60), 0.99 (95% CI, 0.69-1.43), and 1.04 (95% CI, 0.67-1.61). No significant association emerged for colon and rectal cancer separately, and for males and females. CONCLUSIONS: Overall adherence to the EFSA dietary guidelines is not associated to colorectal, colon and rectal cancer risk in our population. Adherence to guidelines on linoleic and alpha-linolenic fatty acids may have a modest beneficial role on CRC risk.

Nutrient-based dietary patterns and the risk of head and neck cancer: a pooled analysis in the International Head and Neck Cancer Epidemiology consortium.

BACKGROUND: The association between dietary patterns and head and neck cancer has rarely been addressed. PATIENTS AND METHODS: We used individual-level pooled data from five case-control studies (2452 cases and 5013 controls) participating in the International Head and Neck Cancer Epidemiology consortium. A posteriori dietary patterns were identified through a principal component factor analysis carried out on 24 nutrients derived from study-specific food-frequency questionnaires. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were estimated using unconditional logistic regression models on quintiles of factor scores. RESULTS: We identified three major dietary patterns named 'animal products and cereals', 'antioxidant vitamins and fiber', and 'fats'. The 'antioxidant vitamins and fiber' pattern was inversely related to oral and pharyngeal cancer (OR=0.57, 95% CI 0.43-0.76 for the highest versus the lowest score quintile). The 'animal products and cereals' pattern was positively associated with laryngeal cancer (OR=1.54, 95% CI 1.12-2.11), whereas the 'fats' pattern was inversely associated with oral and pharyngeal cancer (OR=0.78, 95% CI 0.63-0.97) and positively associated with laryngeal cancer (OR=1.69, 95% CI 1.22-2.34). CONCLUSIONS: These findings suggest that diets rich in animal products, cereals, and fats are positively related to laryngeal cancer, and those rich in fruit and vegetables inversely related to oral and pharyngeal cancer.

Dietary patterns and the risk of esophageal cancer.

BACKGROUND: The role of dietary habits on esophageal cancer risk has been rarely considered in terms of dietary patterns. PATIENTS AND METHODS: We analyzed data from an Italian case-control study, including 304 cases with squamous cell carcinoma of the esophagus and 743 hospital controls. Dietary habits were evaluated using a food frequency questionnaire. A posteriori dietary patterns were identified through principal component factor analysis performed on 28 selected nutrients. Odds ratios (ORs) and 95% confidence intervals (CIs) were obtained from multiple logistic regression models applied on quartiles of factor scores, adjusting for potential confounding variables. RESULTS: We identified five major dietary patterns, named 'animal products and related components', 'vitamins and fiber', 'starch-rich', 'other polyunsaturated fatty acids and vitamin D', and 'other fats'. The 'animal products and related components' pattern was positively related to esophageal cancer (OR = 1.64, 95% CI:1.06-2.55, for the highest versus the lowest quartile of factor scores category). The 'vitamins and fiber' (OR = 0.50, 95% CI: 0.32-0.78) and the 'other polyunsaturated fatty acids and vitamin D' (OR = 0.48, 95% CI: 0.31-0.74) were inversely related to esophageal cancer. No significant association was observed for the other patterns. CONCLUSION: Our findings suggest that a diet rich in foods from animal origin and poor in foods containing vitamins and fiber increase esophageal cancer risk.

Dietary intake of selected micronutrients and the risk of pancreatic cancer: an Italian case-control study.

OBJECTIVE: several studies have shown an inverse relation between vegetable and fruit intake and pancreatic cancer, but no specific beneficial component of such foods has been consistently identified. We considered the role of 15 selected vitamins and carotenoids and 6 minerals on pancreatic cancer risk in an Italian case-control study. METHODS: subjects were 326 patients with incident pancreatic cancer and 652 controls, admitted to the same hospitals as cases for acute conditions. Micronutrient computation was based on a validated and reproducible food-frequency questionnaire. We estimated the odds ratios (OR) and confidence intervals (CI) using conditional logistic regression models, adjusted for various confounding factors and for energy intake, according to the residual model. RESULTS: comparing the highest to the lowest quintile of intake, the OR were 0.60 (95% CI 0.36-0.98) for vitamin E, 0.44 (95% CI 0.27-0.73) for vitamin C, 0.56 (95% CI 0.34-0.93) for folate, and 0.57 (95% CI 0.35-0.92) for potassium. No significant inverse associations were observed for α-carotene (OR = 0.69, 95% CI 0.43-1.12), ß-carotene (OR = 0.64, 95% CI 0.39-1.06), and ß-cryptoxanthin (OR = 0.66, 95% CI 0.39-1.09). No relation was found for other micronutrients considered. CONCLUSION: our findings support a favorable role of vitamins E and C, selected carotenoids, and folate on pancreatic carcinogenesis.

Observational study on the performance of the Narhinel method (nasal aspirator and physiological saline solution) versus physiological saline solution in the prevention of recurrences of viral rhinitis and associated complications of the upper respiratory tract infections (URTI), with a special focus on acute rhinosinusitis and acute otitis of the middle ear.

AIM: The aim of this study was to assess the validity of Narhinel method in the prevention of recurrences of viral rhinitis and of any associated sequelae, in particular acute otitis of the middle ear (AOM) and acute rhinosinusitis (AR). METHODS: This was a prospective observational study, in children aged from two months to two years, observed for five months during the cold season and carried out by family pediatricians (FIMP association) in Friuli Venezia Giulia, Italy. The study enrolled 435 patients. The observed population consisted of two groups: the first one of 238 children treated with Narhinel method and the second one of 197 patients treated only with the physiological saline solution. In compliance with the guidelines of an observational trial, the children were prescribed the therapeutic treatments used as a routine. The patients were recruited for the trial after the responsible parent had signed the informed consent form. The study protocol had been approved by the Ethics Committee of the area of Pordenone. In order to be recruited, patients had to comply with the following criteria: symptoms suggestive of the common cold; age > or =2 months < or =2 years; male and female. Patients presenting one or more of the following characteristics were not included: systemic diseases; congenital nasal obstruction (choanal atresia); infections of the upper and lower respiratory tracts other than common cold; systemic and/or topical use of antibiotics and/or corticosteroids at the moment of recruitment. During the five months of the observation period, all the therapies that the investigators had decided it was necessary to administer had been included and recorded in the CRF. Patients evaluations were carried out for five months. The clinical assessment was performed at baseline (B), in the first week (Fw) and monthly and described as M1 to 5; several clinical parameters were analyzed (anterior and posterior rhinorrhoea, oral respiration, noisy nasal respiration, and nasally transmitted thoracic sounds) and measured by the pediatrician at all examinations from B to M5. Other parameters were derived from the parents' daily observations, recorded in a diary and made note of the quality of sleep, diet and respiration, and the use of any drug during any relapse of acute rhinitis (common cold episode). Recurrence of AOM and AR was assessed by the pediatrician at M1-2-3-4-5. Safety of use was determined using the Italian Health Ministry incident/near incident report sheets for Medical Device and based on diaries where the parents took note of any events which occurred during the observation period. Parental satisfaction and compliance were assessed through a questionnaire given to the parents at the end of the last visit (M5). RESULTS: In the Narhinel group, the mean age was inferior (statistically significant): 8.9 compared to 11.4 months in the physiological saline solution group. The frequency of recurrences from viral rhinitis was very similar in the two groups and a decrease (statistical significant) was observed from M3 through M5 in both groups. Rhinorrhea, oral breathing, and other upper respiratory symptoms, improved in the two groups even if in the Narhinel one the improvement was more prominent during the first two months of observation. There was no difference in the frequency of AR between the groups: at M4 and M5, there was a statistically significant decrease in the frequency of episodes. The frequency of AOM varied in the two groups considering a comparison intra-groups: at M5 the decrease of episodes was statistically significant in the Narhinel group. In Narhinel group, AR and acute AOM seem to be more markedly controlled (frequency) especially for AOM. The frequency of adverse events (AEs) did not vary in the two groups: in the Narhinel one there was a difference (not statistically significant and not clinically relevant) in the number of patients with AEs, especially crying and nasal bleeding. One serious AE was reported in the physiological saline solution group. A 14-month-old child developed laryngospasm which recovered completely after hospital treatment with adrenaline. This event was not related to treatment with saline solution and causality was assessed as "unlikely" by the investigator. In the Narhinel group, one serious event of moderate convulsion febrile in a male patient (age of 0.9) was reported. The causality relationship was assessed by the investigator as improbable. Parents' satisfaction was higher (statistically significant) in the Narhinel group compared to the physiological saline solution alone group. CONCLUSION: In acute rhinites (common cold) both medical devices are effective nevertheless Narhinel method is valid and shows better results in AOM and AR. Moreover Narhinel method was also more appreciated by parents than physiological saline solution. According to authors' experience, the Narhinel method is safe and its performance is valid in the prevention of AOM and AR in children.

Meta-analysis of determinants for pet ownership in 12 European birth cohorts on asthma and allergies: a GA2LEN initiative.

BACKGROUND: Studies on pet ownership as a risk or protective factor for asthma and allergy show inconsistent results. This may be on account of insufficient adjustment of confounding factors. AIM: The objective of this study was to describe determinants of cat and dog ownership in European families with and without allergies. METHODS: Within the EU-funded network of excellence GA(2)LEN, we performed meta-analyses with data from 12 ongoing European birth cohort studies on asthma and allergy. Each of the birth cohort studies enrolled between 485 and 4089 children. Pet ownership, allergic status (asthma, allergic rhinitis, eczema) of parents and siblings, parental education, access to ground floor, and number of people living at home were assessed by questionnaires. RESULTS: Among the 25 056 families from seven European countries cats (14.9%) were more common than dogs (12.0%). Allergic family history significantly reduced the odds to own a cat (adjusted combined random-effect OR 0.91; 95% CI 0.85-0.99), or dog (0.90; 0.86-0.94). A higher parental educational level had even more pronounced effects on cat (0.84; 0.71-0.98), and dog ownership (0.61; 0.54-0.70). Elder siblings reduced the odds to own cats, but not dogs. Convenient ground access significantly increased the odds, whereas crowding at home was not associated with cat or dog ownership. CONCLUSIONS: The chances to own a cat or dog were significantly reduced in allergic families, in parents with a higher educational level, and in homes without convenient ground access. In addition to parental allergies, social and housing factors should be considered as potential confounders in studies on pet exposure and allergic diseases.

Self-reported history of hypercholesterolaemia and gallstones and the risk of prostate cancer.

BACKGROUND: Although prostate cancer is one of the most common male cancers, its aetiology-and particularly the role of comorbidity-remains poorly understood. PATIENTS AND METHODS: Between 1991 and 2002, a case-control study on prostate cancer was conducted in Italy. This included 1294 men under the age of 75 years with incident, histologically confirmed prostate cancer, and 1451 controls, admitted to the same hospitals as cases for a wide spectrum of acute, non-neoplastic diseases. The subjects' self-reported history of selected medical conditions was assessed through a structured and satisfactorily reproducible questionnaire. Multivariate odds ratios (ORs) and 95% confidence intervals (CIs) were obtained after allowance for major potential confounding factors. RESULTS: A significant direct relation was observed between hypercholesterolaemia and prostate cancer (OR = 1.51, 95% CI 1.23-1.85). This association was stronger (OR = 1.80) in older subjects (age > or =65) than in younger ones (OR = 1.32). A non-significant excess risk of prostate cancer was also observed for gallstones (OR = 1.26, 95% CI 0.93-1.70) and the relation was apparently stronger in patients with lower body mass index (OR = 1.59). CONCLUSIONS: This study suggests a possible relation between hypercholesterolaemia and prostate cancer.

Concentrations of major elements and mercury in unstimulated human saliva.

The aim of this study was a preliminary assessment of a possible role of human saliva in the diagnosis of some physiological and pathological changes in oral and body functions. Reliable procedures for collection and analysis of samples were established in order to assess total concentrations of Ca, K, Mg, Na, P, and Hg in whole unstimulated saliva. Possible relationships between element concentrations and sex, age, smoking, illness conditions, or side effects resulting from the use of drugs were investigated. The effects of stimulated or unstimulated collection procedures, dental prosthesis, and amalgam fillings were also evaluated. Total concentrations of major cations and Hg in whole saliva from 33 healthy adults living in the Siena district showed a coefficient of variation ranging from 11% (P) to 53% (Na) and average values were in the same range of those previously reported for unstimulated saliva. Healthy males had significantly higher concentrations of K, Na, P, and Na/K, Na/Ca, Na/Mg, and Na/P values than females. Age, smoking, dental prosthesis, and amalgam fillings had no significant effects on the concentrations of major elements. On the contrary, concentrations of Hg were positively correlated to the number of amalgam fillings and increased at a rate of about 1.9 microg/L for each filling. No correlations were found between Hg concentrations and those of major elements. Comparisons with literature data showed a different composition (particularly for Na and Hg concentrations) between unstimulated and stimulated saliva. Samples from patients affected by idiopathic pulmonary fibrosis had significantly higher concentrations of K and the maximum value was measured in a patient affected by acute pulmonary edema. This increase was likely the result of pharmacological treatments with tricyclic antidepressants and/or saline solutions. Data reported in this study, although preliminary, contribute to the assessment of levels of major cations (some of them very little investigated) and Hg in whole unstimulated human saliva and provides consistent support for further research on the possible use of this easy accessible matrix as a diagnostic tool of body function changes.

Mosses and lichens as biomonitors of trace metals. A comparison study on Hypnum cupressiforme and Parmelia caperata in a former mining district in Italy.

Samples of the moss Hypnum cupressiforme and the epiphytic lichen Parmelia, caperata were collected during the summer of 1999 in an area (Colline Metallifere, central Italy) intensively exploited in the past for metals (Cu, Fe, Pb, Zn) and currently for geothermal resources. Lichens were more sensitive than mosses to emissions of S compounds near geothermal fields and abandoned sulphide ore smelting plants. Comparison of elemental compositions of the two cryptogamic species from the same sampling sites showed significantly higher concentrations of lithophile elements (Al, Cr, Fe, Mn, Ni, Ti) in the moss and atmophile elements (Hg, Cd. Pb, Cu, V, Zn) in the lichen. Patterns of bioaccumulation of elements throughout the study area were quite similar for widespread pollutants such as S, B, As, Zn, Cr and Ni, but the lichen and the moss showed different distribution patterns of Hg, Cd and other elements subject to long-range atmospheric transport. These results are due to differences in the morphology and ecophysiology of mosses and lichens and indicate that these organisms cannot be used interchangeably as biomonitors of metals in areas with mineral deposits.