Successful models in organ procurement.
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Biomedical subjects
Publications and source records attributed to A Ghirardini.
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BACKGROUND AND OBJECTIVES: The characterization of lymphocyte subsets in blood donors has been utilized to determine the normal ranges that can be related to race. A study was performed in blood donors from two racial groups - Caucasian (Italians) and Asian (Philippinos) - to define respective T-lymphocyte subsets and levels of cytokines. MATERIALS AND METHODS: Ninety-two blood donors (46 Italians and 46 Philippinos) were enrolled. Blood count and immunophenotyping of lymphocytes by flow cytometry were carried out, and cytokine production was tested in six blood donors of each group. RESULTS: Philippino blood donors showed a significantly higher mean value of leucocytes (P = 0.01) and lymphocytes (P < 0.001) than Italians. The mean absolute count of lymphocyte subsets CD3- CD16+ CD56+ and CD3+ CD8+ were both significantly higher in Philippino than in Italian subjects, respectively, P < 0.01 and P < 0.0001. Philippinos showed a statistically significant higher frequency of lymphocytes producing interferon-gamma (IFN-gamma) compared to Italians (P = 0.02). CONCLUSIONS: T-lymphocyte subsets in Italian and Philippino blood donors seem to be correlated to ethnic background. The higher levels of CD3+ CD8+ T cells, natural killer (NK) cells and IFN-gamma-producing cells found in Philippinos suggest leucoreduction in Asian blood donors.
UNLABELLED: The role of hospital staff in the organ procurement process is crucial. Nevertheless, there is little literature about their attitudes toward donation. The Donor Action Hospital Attitude Survey (HAS) comprises a series of questions to assess hospital staff's attitudes, beliefs, and knowledge on organ donation and transplantation. Further analysis of the data will help identify any weak areas in the staff viewpoint and information, highlight potential needs for more education on specific issues, and establish a baseline to monitor future improvements. We used the Donor Action HAS in the Emilia-Romagna region, Italy. The aim of this paper is to assess and better understand the personnel's viewpoint in the 12 main hospitals of the region. The survey was carried out among hospital staff involved in organ donation. 1576 responses were collected (52 % of distributed questionnaires), of which 1024 came from nurses, 475 from physicians, and 77 from other backgrounds. Questions were subdivided into categories, and for every point an overall mark (maximum 3/3) was calculated. RESULTS: 1. Involvement in donation process during the past year: 1.24 /3, 2. Attitudes to organ donation (OD): 2.51 /3, 3. Skills / Self-confidence in donation practices: 1.36 /3, 4. Satisfaction with local transplant coordinator (TC) services: 2.31 /3. The attitude towards organ donation was positive, 1386 respondents support organ donation. A high percentage (93.6 % of respondents) is of the opinion that transplantation helps save other people's lives. Most uncertainty arises on the question whether donation helps families with grief. It is remarkable that only 53 % of those prepared to donate organs have informed the family of their wish. Many respondents do not feel comfortable performing key tasks close to donation. Major difficulties were observed in explaining to a family the concept of brain death (0.98 /3). Knowledge on the concept of brain-death was one of the most requested subjects for improvement. Emilia-Romagna is the region with one of the highest donation rates in Italy (29.9 pmp in 2000). Nevertheless, more profound knowledge of the local situation could help further improve donation.
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The number of donations per million population (pmp) per year and the number of transplants pmp/year enables one to compare donation or transplant programs made in different years in the same area or made the same year in different areas. These pmp indexes may be integrated with an evaluation system by which each organ is evaluated separately in terms of the efficiency of its procurement and transplant systems using the procurement index (percentage in terms of number of organs utilized/number of organs procurable from donors utilized in a single area during 1 year) and the transplant index (percentage in terms of number of transplants performed/number of organs harvested in a single area during 1 year). We have called them Caldes I (procurement) and Caldes II (transplant) indexes. The harvest index evaluates the efficiency of utilization of organs retrieved from suitable donors. It usually ranges between 80-90% for the kidney, 70-95% for the liver, 40-50% for the heart, and 5-15% for the lungs. The transplant index evaluates for each organ the transplant team capacity to use available organs which can be harvested locally or in different areas. It usually ranges between 60-120%. Index determination did not require information different from the standard data available. Both the harvest and transplant indexes could be used to compare the efficiency of donation and transplant programs and policies in the same area during different years or at the same time in different areas. They can be critical in evaluating: (a) marginal donor utilization, (b) marginal organ utilization, and (c) dishomogeneity of organ retrieval and organ transplantation in different regions belonging to the same area. They also enable to evaluate if organs considered not available in a single area are offered to other areas or are not retrieved at all from available donors.
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Organ donation and transplantation activity in Italy have been always characterised by two contrasting features: first the constant positive trend in the improvement of the number of organ donors and transplants which allowed the country to exceed the value of 12 donors per million population in 1998; second the difficult situation in southern regions, so that the national distribution of the activity is highly and steadily non homogeneous. Herein we report the data regarding donation, retrievals and transplant activity in Italy in the years 1994-98, focusing on the activity of each region and the three interregional centres which encompass the majority of the national territory.
Spain was the first European country adopting a strategy of organ procurement based on a specific health professional named transplant coordinator, who was first established in Catalunya in the middle eighties. In principle, the transplant coordinator is a doctor with hospital experience who is involved full time in organ procurement. The transplant coordination activity is available without interruption, due to a team work. Transplant coordination is based on four main functions: clinical, research, training and communication, management. The principles of transplant coordination according to the Spanish model are reported in the recently approved Italian law on transplantation (law 91/1999), indicating the coordinator's specific functions: a) communication to the regional reference centre of the data concerning the possible organ donors, b) preparation of the documents needed, c) relationship with the donors' family, d) information and education of the population on transplantation issues.
This study presents the final report of a long-term psychological assessment of men with haemophilia and HIV infection. The knowledge, emotional impact regarding HIV infection and prospective changes over time and the need for psychological support were evaluated. The study group comprised 118 men with haemophilia, 66 HIV seropositive and 52 seronegative, from the Haemophilia Centres in Bari, Florence, Milan and Naples. All subjects performed psychological tests (STAI: state and trait anxiety inventory; SDS: self-rating depression scale) and completed questionnaires to ascertain their knowledge and the emotional impact of AIDS. After enrollment (1992-93) the assessment was repeated twice over a 2-year period. A high percentage of subjects in both groups answered the questionnaire on knowledge correctly and, more specifically, all (100%) admitted knowing that sexual intercourse was a risk factor for HIV infection, adding that sexual partners of haemophiliacs with HIV should be regularly tested. The percentage, however, decreased for seropositives who admitted to always using a condom during sexual intercourse (86%) and for those who declared that partners were periodically tested for HIV (60%). The most important feature of the study is that, contrary to predicted expectations, seropositive and seronegative subjects presented the same degree of emotional involvement: there are no statistically significant differences in average scores between groups either on the anxiety or depression scales. Moreover, for certain aspects, seronegatives revealed greater emotional involvement: at baseline evaluation, they felt more fear and unhappiness with statistically significant differences compared to asymptomatics. Furthermore, seronegatives more than seropositives continue to feel reluctance towards infusion and avoid blood products after learning of AIDS. These results emphasize the importance of paying due attention to the emotional status of seronegatives. Their reluctance towards the use of blood products (despite present safety) is a very important issue for the possible consequences of treatment with the risk of worsening the clinical condition. In conclusion, we believe that counselling on HIV infection/AIDS needs to address every person with haemophilia regardless of HIV status.
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OBJECTIVES: To estimate survival trends for persons with haemophilia and HIV/AIDS. DESIGN AND METHODS: Survival analysis conducted among the cohort of HIV-positive haemophiliacs with AIDS at the Italian Haemophilia Registry. Kaplan-Meier method was used to estimate survival times, stratifying for demographic and clinical covariates. Cox proportional hazards model was applied in order to identify factors independently associated with survival. RESULTS: Median survival from the first AIDS diagnosis to death was estimated to be 17.0 months for 176 individuals with AIDS. Median survival after AIDS diagnosis increased from 12.0 months in December 1983-December 1988 to 17.0 months in January 1989-May 1990 and to 25.0 months in June 1990-December 1991. Median survival times were significantly (P < 0.001) lower for individuals diagnosed with non-infective AIDS indicator diseases (lymphoma, AIDS-associated neurological disease, Kaposi's sarcoma, wasting syndrome: 4.0 months), in comparison with haemophiliacs diagnosed with Pneumocystis carinii pneumonia (PCP; 18.0 months) or other infections (35.0 months). Antiretroviral treatment after AIDS diagnosis was associated with a longer survival than that estimated for individuals with no treatment after AIDS; the same was true for PCP prophylaxis. Younger age at HIV seroconversion and at AIDS diagnosis were associated with a longer survival. Multivariate analysis showed that factors independently associated with survival were type of AIDS indicator disease and antiretroviral administration after AIDS diagnosis. CONCLUSIONS: This study indicates an increasing survival from AIDS diagnosis to death over time, also as a result of the introduction of antiretroviral therapy. Survival trends are similar to those reported among homosexual men and intravenous drug users with AIDS, suggesting a similar access to the health-care system for individuals with AIDS. Survival studies may improve our understanding of the natural history of HIV infection and may indicate the impact of preventive measures.
The purpose of this study was to estimate the median incubation time between human immunodeficiency virus (HIV) infection and onset of acquired immunodeficiency syndrome (AIDS), using three parametric models and six estimates of seroconversion time. Study subjects were 732 HIV-positive haemophiliacs enrolled in the Italian Registry of patients with congenital coagulation disorders. Seroconversion time was estimated for each subject according to six different criteria, based on three distributions of seroconversion (uniform, uniform on three sub-intervals and truncated Weibull) and two indices synthesizing each distribution (median and median of three random values). The estimated seroconversion times were subsequently used as starting points in the analysis of incubation. This was performed applying Kaplan-Meier non-parametric survival analysis, and fitting to incubation data three probability density functions, representing three different situations with respect to the hazard of developing AIDS following seroconversion (namely Weibull (WE), generalized exponential (GE) and log-logistic (LL)). The cumulative incidence over an 8-year period ranged from 14.9 to 17.8 per cent when applying the Kaplan-Meier method, from 14.1 to 17.2 per cent when using the WE function, from 14.5 to 17.3 per cent when using the GE function and from 14.4 to 17.3 per cent when using the LL function, depending on the estimate of seroconversion time used. Similarly, the median incubation times ranged from 12.6 to 15.0 years with the WE function, from 14.0 to 16.5 years with the GE function, and from 13.4 to 16.1 years with the LL function. The presence of a bound on the increase of the hazard function seems to affect the incubation more strongly than the eventual decrease following the attainment of the maximum risk. This may be due to the decrease in the hazard beginning when most of the seropositive subjects have already developed AIDS.
To evaluate the incidence and prevalence of hemophilia in Italy and the impact of HIV infection on the Italian hemophiliac population, data from a computerized national registry of patients from 95% of the hemophilia care centers in Italy were analyzed. A total of 4643 patients were included in the registry. The prevalence of hemophilia A was 8.2 per 100,000 males, with no significant regional differences; for hemophilia B the corresponding figure was 1.5 per 100,000. Temporal trends in hemophilia incidence suggest that the diagnosis of mild and moderate hemophilia has improved. The overall HIV prevalence was 26% and was significantly (p < 0.001) higher in patients with hemophilia B (47.1%) compared to those with hemophilia A (26.8%) or other diseases (16.5%). The highest rate of HIV seropositivity was among patients 20-29 years of age. The annual amount of clotting factor concentrates received was significantly (p < 0.001) higher in HIV seropositive patients than in those who were seronegative. Antibody testing was never performed on 10.1% of severely affected patients. The number of patients in the Italian registry was similar to the number that would have been expected based on prevalence estimates from other countries. In comparison with other countries, the prevalence of HIV infection recorded in Italy was lower in persons with hemophilia A, but higher in those with hemophilia B. Our study demonstrates the usefulness of a registry in delineating the epidemiology of hemophilia and in studying risk factors for HIV infection. It also underlines the need for continuing surveillance of this population.
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40 Hemophilia Centers from the USA, Canada, Europe and Japan referred to the International Registry 204 patients with haemophilia A, treated by Immune Tolerance (IT) Protocols over the past two decades because of the presence of an inhibitor to FVIII. 82% of the patients were high responders, while IT was started with low levels of inhibitor (< 10 BU) in most (57.3%) of the cases. 69 patients (33.8%) were given the highest FVIII dosage (> or = 200 IU/kg/day), 71 (34.8%) intermediate dosages (50- < 200) and 64 (31.4%) the lowest dosages (< 50). Of 158 patients persevering with treatment long enough to judge the outcome thereof, 107 (67.7%) achieved tolerance, 12 (7.6%) had a partial response, while 39 (24.7%) did not respond. Multivariate logistic regression analysis showed that two variables were independently associated with the highest probability of success: the use of high dose protocols (> or = 100 IU/kg/day) (p < .0001) and the presence of low levels of inhibitor (< 10 BU) at enrollment (p = .004). The Kaplan-Meier inhibitor-free survival curve showed that tolerance is longlasting: only 1 out of 107 patients relapsed and the longest documented tolerant patient has been inhibitor-free for 16 years. 129 hemophiliacs were HIV Ab-negative at enrollment; of the 118 HIV-screened after the treatment, 18 (13.9%) were found to be HIV Ab-positive. IT can indeed modify the natural history of inhibitors to FVIII in hemophilia.
To determine whether an outbreak of hepatitis A that occurred in 52 Italian hemophiliacs was acquired through the infusion of contaminated factor VIII or through environmental enteric transmission, a case-control study of the first 29 infected patients was carried out. Case patients were neither more nor less likely than controls (hemophiliacs without HAV infection) to have traveled to high-risk countries, consumed raw shellfish or had contact with persons with jaundice. The case patients, however, were more likely than controls to have received a factor VIII concentrate treated with solvent-detergent and to have had larger infusions of the concentrate during the presumed HAV incubation period. In the PCR analysis of HAV sequences from implicated lots of factor VIII, HAV sequences were found in 5 of 12 lots of factor VIII implicated in the outbreak. Three different strains of HAV were recovered, suggesting that lots were not contaminated from the same plasmapheresis donor. To obtain molecular evidence that the HAV detected in the factor VIII preparations was responsible for transmission of HAV, serial serum samples from two patients were tested for HAV gene sequences and compared with those of the implicated lots. The genomic sequences of HAV obtained for two matched sets of factor VIII and recipient serum samples were identical within each set, but different for the two sets.