Cochlear implant in prelingually deafened oralist adults: speech perception outcomes, subjective benefits and quality of life improvement.

The aim of this study is to report our results in a group of prelingually deafened adults, who followed an oralist rehabilitation programme, and submitted to cochlear implant at our institution. We evaluated 30 prelingually deafened adult patients, 18 males and 12 females, median age 35 years, of a group of 36 prelingually deafened adult patients consecutively submitted to unilateral cochlear implantation at the ENT Unit of the University of Pisa. After implantation, patients achieved significant benefits in terms of speech perception skills, including the ability to have telephone conversations in some cases, quality of life and their own perception of disability. According to literature data, the results herein reported are quite variable but generally satisfactory. Procedures other than traditional speech perception measures should be used to evaluate the benefits of cochlear implant in such patients, to compressively evaluate the global benefits, not only in terms of speech perception, but also in terms of quality of life and daily life.

The social cost of chronic kidney disease in Italy.

This study aims to estimate the mean annual social cost per patient with chronic kidney disease (CKD) by stages 4 and 5 pre-dialyses and cost components in Italy. The multicenter cross-sectional study included all adult outpatients in charge of the 14 main Nephrology Centers of Tuscany Region during 7 weeks from 2012 to 2013. Direct medical costs have been estimated using tariffs for laboratory tests, diagnostic exams, visits, hospitalization and prices for drugs. Non-medical costs included expenses of low-protein special foods, travel, and formal and informal care. Patients' and caregivers' losses of productivity have been estimated as indirect costs using the human capital approach. Costs have been expressed in Euros (2016). Totals of 279 patients in stage 4 and 205 patients in stage 5 have been enrolled. The estimated mean annual social cost of a patient with CKD were €7422 (±€6255) for stage 4 and €8971 (±€6503) for stage 5 (p < 0.05). Direct medical costs were higher in stage 5 as compared to stage 4; direct non-medical costs and indirect costs accounted, respectively, for 41 and 5 % of the total social cost of CKD stage 4 and for 33 and 9 % of CKD stage 5. In Italy, the overall annual social cost of CKD was €1,809,552,398 representing 0.11 % of the Gross Domestic Product. Direct non-medical costs and indirect costs were weighted on the social cost of CKD almost as much as the direct medical cost. Patients, their families and the productivity system sustain the burden of the disease almost as much as the healthcare system.

The social cost of rheumatoid arthritis in Italy: the results of an estimation exercise.

The objective of this study is to estimate the mean annual social cost per adult person and the total social cost of rheumatoid arthritis (RA) in Italy. A literature review was performed by searching primary economic studies on adults in order to collect cost data of RA in Italy in the last decade. The review results were merged with data of institutional sources for estimating - following the methodological steps of the cost of illness analysis - the social cost of RA in Italy. The mean annual social cost of RA was € 13,595 per adult patient in Italy. Affecting 259,795 persons, RA determines a social cost of € 3.5 billions in Italy. Non-medical direct cost and indirect cost represent the main cost items (48% and 31%) of the total social cost of RA in Italy. Based on these results, it appears evident that the assessment of the economic burden of RA solely based on direct medical costs evaluation gives a limited view of the phenomenon.

Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in paediatric patients.

The aim of this systematic review of the literature was to summarize the results of scientific publications on the clinical effectiveness of the cochlear implant (CI) procedure in children. The members of the Working Group first examined existing national and international literature and the principal international guidelines on the procedure. They considered as universally-accepted the usefulness/effectiveness of unilateral cochlear implantation in severely-profoundly deaf children. Accordingly, they focused attention on systematic reviews addressing clinical effectiveness and cost/efficacy of the CI procedure, with particular regard to the most controversial issues for which international consensus is lacking. The following aspects were evaluated: post-CI outcomes linked to precocity of CI; bilateral (simultaneous/ sequential) CI vs. unilateral CI and vs. bimodal stimulation; benefits derived from CI in deaf children with associated disabilities. With regard to the outcomes after implantation linked to precocity of intervention, there are few studies comparing post-CI outcomes in children implanted within the first year of life with those of children implanted in the second year. The selected studies suggest that children implanted within the first year of life present hearing and communicative outcomes that are better than those of children implanted after 12 months of age. Concerning children implanted after the first year of life, all studies confirm an advantage with respect to implant precocity, and many document an advantage in children who received cochlear implants under 18 months of age compared to those implanted at a later stage. With regard to bilateral CI, the studies demonstrate that compared to unilateral CI, bilateral CI offers advantages in terms of hearing in noise, sound localization and during hearing in a silent environment. There is, however, a wide range of variability. The studies also document the advantages after sequential bilateral CI. In these cases, a short interval between interventions, precocity of the first CI and precocity of the second CI are considered positive prognostic factors. In deaf children with associated disabilities, the studies analyzed evidence that the CI procedure is also suitable for children with disabilities associated with deafness, and that even these children may benefit from the procedure, even if these may be slower and inferior to those in children with isolated deafness, especially in terms of high communicative and perceptive skills.

Systematic review of the scientific literature on the economic evaluation of cochlear implants in paediatric patients.

The aim of the study consists in a systematic review concerning the economic evaluation of cochlear implant (CI) in children by searching the main international clinical and economic electronic databases. All primary studies published in English from January 2000 to May 2010 were included. The types of studies selected concerned partial economic evaluation, including direct and indirect costs of cochlear implantation; complete economic evaluation, including minimization of costs, cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) performed through observational and experimental studies. A total of 68 articles were obtained from the database research. Of these, 54 did not meet the inclusion criteria and were eliminated. After reading the abstracts of the 14 articles selected, 11 were considered eligible. The articles were then read in full text. Furthermore, 5 articles identified by bibliography research were added manually. After reading 16 of the selected articles, 9 were included in the review. With regard to the studies included, countries examined, objectives, study design, methodology, prospect of analysis adopted, temporal horizon, the cost categories analyzed strongly differ from one study to another. Cost analysis, cost-effectiveness analysis and an analysis of educational costs associated with cochlear implants were performed. Regarding the cost analysis, only two articles reported both direct cost and indirect costs. The direct cost ranged between € 39,507 and € 68,235 (2011 values). The studies related to cost-effectiveness analysis were not easily comparable: one study reported a cost per QALY ranging between $ 5197 and $ 9209; another referred a cost of $ 2154 for QALY if benefits were not discounted, and $ 16,546 if discounted. Educational costs are significant, and increase with the level of hearing loss and type of school attended. This systematic review shows that the healthcare costs are high, but savings in terms of indirect and quality of life costs are also significant. Cochlear implantation in a paediatric age is cost-effective. The exiguity and heterogeneity of studies did not allow detailed comparative analysis of the studies included in the review.

Systematic review of the scientific literature on the economic evaluation of cochlear implants in adult patients.

A systematic review of the economic literature of cochlear implants (CI) was conducted with the aim of summarizing the results of studies on the cost effectiveness of monolateral and bilateral (sequential/simultaneous) CI in adult patients affected by severe to profound prelingual and postlingual hearing impairment. The literature search was performed using "PubMed MEDLINE" and the Centre for Reviews and Dissemination search engines. Inclusion criteria related to economic evaluation included primary studies published in English language from January 2000 to May 2010 and aimed to quantify costs of CI and compare monolateral CI vs. acoustic prosthesis and bilateral (sequential/ simultaneous) CI vs. monolateral CI in terms of cost per unit of effectiveness. Four articles were identified. The mean direct medical cost of the monolateral CI varied from € 30,026 to € 45,770 in postlingually deafened patients, and the cost of device represented the main cost component. Additional median costs of simultaneous and sequential bilateral CI were, respectively, € 21,831 and € 25,459. The mean direct medical cost of monolateral CI was € 31,942 in prelingually deafened patients. The monolateral CI in postlingually deafened patients represented a cost effective intervention as compared with no implant (€ /QALY varied from € 7,930, € 24,983 to € 33,094). Monolateral CI were not a cost effective intervention for traditional patients with more than 40 years of hearing impairment (€ 64,604/QALY ) or for patients with marginal benefits from using acoustic prosthesis with more than 30 years of hearing impairment (€ 106,267/QALY ). The cost effectiveness of monolateral CI worsened with increasing age (€ /QALY from € 23,439 for patients < 30 years old to € 55,369 for patients > 70 years). Bilateral CI in postlingually deafened patients were less cost effective than monolateral CI (from € 91,943/QALY to € 102,640/QALY ). Monolateral CI were cost effective in prelingually deafened patients (€ /QALY : € 8,096). Given the few economic evaluation studies in literature, future researches are needed to support the cost effectiveness results of CI in adults and to evaluate the cost effectiveness of bilateral CI, as well as to estimate the non-medical direct and indirect cost components.

Incidence and timing of infections after liver transplant in Italy.

BACKGROUND: Infections are one of the main complications that cause high morbidity and mortality in transplant recipients. This study sought to estimate the incidence of infections and their main determinants in liver transplant recipients in the first year after transplantation. PATIENTS AND METHODS: A prospective study was conducted on 103 consecutive patients (72% men) who underwent transplantation in three centers in Northern (Bologna) and Central (Rome) Italy in 2005. Person-years (PY) at risk, incidence rates (IR), IR ratios and 95% confidence intervals were computed for viral, fungal, and bacterial infections. RESULTS: The 103 patients (median age 55 years) contributed a total of 78.2 PYs, with a median follow-up of 286 days (interquartile range: 194 to 365 days). Fifty-eight patients (56.3%) experienced one or more infections, namely, 151 events (IR = 193.2 infections/100 PYs). IR for bacterial, fungal, and viral infections were 110.0, 56.3, and 26.9 infections/100 Pys, respectively. Within the first 30 days after transplantation, 37.9% patients (39/103) developed one or more events. Bacterial infections represented the most frequent event (86/151, 57.0%). Risk factors significantly associated with increased IR were gender (female), age (>50 years), prolonged intensive care stay volume of blood transfused during surgery and posttransplant, and need for retransplantation. CONCLUSIONS: These preliminary results showed the relevance of infectious events after liver transplantation especially those of bacterial etiology, and identified factors mainly associated with their occurrence.

Immunosuppression and cancer: A comparison of risks in recipients of organ transplants and in HIV-positive individuals.

The comparison of cancers occurring excessively among HIV-infected and transplanted individuals may help to elucidate the relationship between immune surveillance, viral infections, and cancer. A longitudinal study was conducted on 2002 HIV-infected Italian subjects, 6072 HIV-infected French individuals, and 2878 Italian recipients of solid organ transplants. Standardized incidence ratios (SIR) and 95% confidence intervals (CI) were computed to quantify the risk for cancer, compared with the French and Italian general populations. The SIRs for all cancers were 9.8 (95% CI: 9.0-10.6) for HIV-infected individuals versus 2.2 (95% CI: 1.9-2.5) for transplant recipients. In both groups, most of the excess risk was attributable to virus-related cancers, such as Kaposi's sarcoma (KS; SIR = 451 in HIV-positive individuals, 125 in transplant recipients), non-Hodgkin's lymphoma (NHL; SIR = 62.1 and 11.1, respectively), and liver cancer (SIR = 9.4 and 4.1, respectively). Significantly increased SIRs for anal cancer and Hodgkin's lymphoma were found only among HIV-positive individuals. Among women younger than 40 years of age, a more than 10-fold increase in cervical cancer risk was found in both groups. Among HIV-infected individuals treatment with highly active antiretroviral therapies drastically reduced SIRs for KS and NHL only. These results show that HIV-infected individuals and transplant recipients share a similar pattern of cancer risk, largely due to virus-related cancers.

Risk of Kaposi's sarcoma and of other cancers in Italian renal transplant patients.

A follow-up study of 1844 renal transplant patients in Italy showed a 113-fold increased risk for Kaposi's sarcoma. Kaposi's sarcoma risk was higher in persons born in southern than in northern Italy. Significant increases were also observed for cancers of the lip, liver, kidney and for non-Hodgkin's lymphoma.