The Italian pertussis vaccine trial: ethical issues.
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Biomedical subjects
Publications and source records attributed to D Greco.
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To evaluate the completeness and accuracy in the reporting of AIDS-associated Kaposi's sarcoma (KS) and non-Hodgkin's lymphomas (NHL) in Italy, a linkage study of the notifications to the Italian AIDS Registry (RAIDS--the national compulsory AIDS surveillance system) and the clinical and pathological records of the Italian Cooperative Group on AIDS-related tumors (GICAT--a nationwide voluntary reporting system for HIV-infected individuals who develop cancer) was carried out. A total of 288 cases of KS and 258 cases of NHL fulfilling the AIDS definition criteria, histologically diagnosed by the GICAT centers between January 1987 and March 1992, were matched with the 16,860 AIDS cases reported to the RAIDS up to March 1993. The linkage procedure, based on name, gender, and date of birth, identified 276 cases of KS (96%) and 241 cases of NHL (93%) present in both files ("linked" cases). The diagnosis of KS did not appear among the clinical manifestations of AIDS in the RAIDS file in 67 out of the 276 linked KS (24%), either with coincident dates of KS diagnosis and of case notification (19 cases) or when the KS diagnosis followed by > or = 2 months the case notification to RAIDS (48 cases). Of the 241 linked NHL, 84 (33%) had no such neoplastic complications of AIDS listed in the RAIDS file, 23 with coincident dates of NHL diagnosis and of case notification and 61 with the NHL diagnosis made > or = 2 months after the notification. A noteworthy discrepancy in the classification of the three histologic subtypes of NHL emerged between the GICAT and the RAIDS. The degree of underreporting of AIDS-associated cancers that emerged from the present study suggests that augmentation with other sources of oncological information is important to better estimate the burden of AIDS-related tumors and to study the interaction between HIV infection and cancer.
Social networks and daily activities of children and adolescents living and/or working on the streets of a large Brazilian city were examined. Drawing on data collected through structured surveys, in-depth interviews, focus group discussions, and field observations, we described street youths' family situation, social resources, institutional experiences, survival activities, and problem behaviors and investigated differences attributable to age, gender, and living situation (at home or on the street). Youngsters who lived at home and worked on the street appeared to be experiencing orderly development despite their impoverished circumstances. Youngsters who lived on the street showed hallmarks of psychological and physical risk, including parental loss, diminished social support, substance abuse, and early onset of sexual activity. Possible implications of these contextual differences for development are discussed, and directions for future research are suggested.
A sample of 393 Albanian refugees, including both children and adults, was tested for serological HAV, HBV, HDV and HCV markers. A high prevalence of infection with both the hepatitis A and B viruses was found, while HDV and HCV infections were uncommon. The overall prevalence of anti-HAV was 96%; it was very high in children 0-10 years, suggesting that HAV infection is largely acquired during childhood and that poor ambiental conditions influence the spreading of this viral infection. One or more serological markers of HBV infection were found in 295 Albanians (75%), confirming the endemic nature of this virus in the Albanian community. The overall prevalence of HBsAg was 19%, and the carrier rate was higher in males than in females. The high HBsAg prevalence among children suggests that HBV infection is usually acquired in early childhood. The serological data obtained in the Albanian sample examined clearly indicate the urgent need for measures to reduce the incidence of HAV and HBV infections and to avoid the further spread of HDV and HCV infections. Finally, the high prevalence of type B hepatitis indicates the necessity of vaccination against HBV for all risk groups and for all children at birth.
Street youth are at risk of HIV infection worldwide. To develop effective prevention strategies, information about the meanings and functions of sexual activity for street youth is needed. In this paper, data from structured questionnaires, focus group discussions, in-depth interviews and field observations are used to build up a picture of the sexual culture of 9-to-18-year-olds living and/or working on the streets of a large Brazilian city. The findings reveal that these children and adolescents engage in sexual behavior that puts them at risk of sexually transmitted diseases, including HIV/AIDS, and reinforce that sex is a multi-determined and entrenched behavior in this population. Interventions must take into account the fact that for street youth, sex is used as a means of ensuring survival, seeking comfort, finding pleasure, and dealing with psychological issues that arise during adolescence.
A cohort of 69 children born to HIV-1 positive women was studied to evaluate types, prevalences and relationships to clinical stages of HIV-1-related oral lesions. In addition, relationships among C. albicans biotypes, clinical features of oral candidiasis and HIV-1 disease were investigated. C. albicans biotypes did not correlate with clinical features of oral lesions, disease stages and CD4+ lymphocyte count. Of 8 patients with recurrent oral candidiasis, 4 changed clinical features and 5 changed biotype. Our study pointed out the high frequency (28.9%) of oral lesions, especially caused by fungi and the importance of the examination of the oral cavity in children born to HIV-1 positive women.
A course for regional trainers was organized by the Working Group for HIV training (PFH) and held in Rome. This course has motivated the participants and has given them the ability to organize similar training activities at local level. The training methodology, the evaluation methods and the objectives used in the course are described. An investigation has been carried out by the Working Group of PFH to evaluate the training activity of the participants at the regional level. The results show that 17 out of the 25 participants have been able to organize a total number of 53 peripheral courses and train 2144 health workers. The training methodology and the evaluation method utilized at the different local levels have followed the ones used in the central course.
Dopamine beta-hydroxylase, the enzyme which converts dopamine to norepinephrine, is expressed in a cell type-restricted pattern in neuroendocrine tissue. A segment of the rat gene containing 395 bases of 5'-flanking sequence regulates expression of a reporter gene in a cell type-selective pattern in mammalian cell cultures. Using deletion mutants of the 5'-flanking sequence, we have identified a 30-base genetic regulatory element, designated DB1, which enhances transcription from a heterologous promoter 5-20-fold in neuroendocrine cell lines. DB1-specific DNA-protein complexes are found in nuclear extracts from all cell lines examined, but the migration pattern differs between cell lines. The 5'-flanking region of the dopamine beta-hydroxylase gene is also responsive to cyclic AMP and phorbol ester treatment of SHSY-5Y neuroblastoma cells. The simultaneous presence of both effectors results in synergistic increases in DBH1 mRNA and reporter gene activity. The second messenger regulatory element was localized to the region containing the DB1 element, and reporter plasmids containing multiple copies of the DB1 element are responsive to treatment with inducers. The results of this study identify a cis-acting regulatory element which influences both cell type selectivity and second messenger responsiveness of the rat dopamine beta-hydroxylase gene.
OBJECTIVE: To assess the long-term effectiveness of zidovudine (AZT) in patients with acquired immunodeficiency syndrome (AIDS). This assessment has never been adequately done because controlled clinical trials were stopped early and survival comparisons were made with historical controls. DESIGN: Nonrandomized contemporary observational study of patients treated and not treated with zidovudine. SETTING: Twenty-three AIDS treatment centers throughout Italy that reported cases to the National Registry of AIDS Cases between July 1987 and March 1988. PATIENTS: One hundred fifty-nine zidovudine-treated and 112 untreated patients with AIDS, the majority of whom had acquired human immunodeficiency virus (HIV) infection through intravenous drug use. OUTCOME MEASURES: Median survival and 1- and 2-year survival for treated and untreated groups, as estimated using the Kaplan-Meier method. Cox proportional hazards regression analysis was also used to identify independent predictors of survival among the variables studied. RESULTS: Patients were similar with respect to CD4/CD8 ratio, age, sex, clinical and immunological status at diagnosis, and source of HIV infection. After 24 months, survival was 45.9% (95% confidence interval [CI], 36.1% to 55.7%) in the treated group and 20.5% (95% CI, 12.6% to 28.3%) in the untreated group, with median survival of 21.2 and 9.6 months, respectively. CONCLUSIONS: Possible biases of this study include imperfect matching for clinical status and better overall medical care of treated patients. Nevertheless, we believe that the observed differences in survival were primarily due to zidovudine treatment.
The immunity against poliomyelitis in a representative sample of the Albanian population recently immigrant to Italy was evaluated. A significant number of the subjects examined lacked protective antibodies against one or more polioviruses. The most prevalent seronegativity related to poliovirus type 3 (41.3%), followed by poliovirus type 1 (21.5%). This result was more consistent in the younger age groups. Our data suggest the hypothesis that this problem arises from the use of a vaccine of discontinuous efficacy caused by defective preservation. A poliovaccine booster dose for all emigree subjects aged less than 15 years is suggested.
OBJECTIVE: To describe the epidemiology of AIDS-associated Kaposi's sarcoma (KS) in Italy between January 1982 and September 1991. DESIGN: To make this study comparable with previous research from other countries, statistical analysis of data from the Italian AIDS surveillance system was performed. METHODS: Odds ratios (OR) and 95% confidence intervals (CI) were used to examine the association between several characteristics of AIDS cases and the presence of KS as the presenting clinical manifestation of AIDS. Trends in the frequency of AIDS-associated KS were also estimated. RESULTS: Of the 10,584 Italian AIDS cases reported up to September 1991, 720 (6.8%) had KS as the presenting clinical manifestation. In comparison with intravenous drug users (IVDU), of whom 2.6% had KS, homosexual or bisexual men had a nearly 10-fold higher risk of KS (OR, 10.2; 95% CI, 8.2-12.8), homosexual men who were also IVDU a nearly fourfold increased risk (OR, 4.4; 95% CI, 3.0-6.6) and heterosexuals a 2.6-fold risk (95% CI, 1.7-3.7). Men were more likely to have KS than women. The percentage of new AIDS cases with KS recorded each year in Italy declined from 12.0% in 1982-1986 to 5.8% in 1990-1991, a significant relative decrease of 19.0% per year (95% CI, 14.1-23.6%). The decline was observed among both IVDU (20% per year) and homosexual or bisexual men (11.4% per year). The frequency of KS was similar across age groups within each transmission category, whereas geographical differences emerged in the prevalence of AIDS-associated KS, especially among IVDU. CONCLUSIONS: Our data on the epidemiology of AIDS-associated KS in Italy are similar to reports from North America and Europe, which show that KS is more common among individuals who acquired HIV infection by sexual transmission rather than parenterally, and that the incidence of this neoplasm is declining over time. The still poorly understood aetiology of AIDS-associated KS needs to be investigated further.
In Italy pertussis vaccination is optional. Fewer than 40% of children younger than 5 years of age are vaccinated, and pertussis remains a common childhood disease. We use data from a variety of sources to examine trends and characteristics of Italian children with pertussis and reasons behind the low vaccine coverage. Approximately 25% of Italian children have experienced clinical pertussis by their fifth birthday. The disease is most severe in those less than 1 year of age; in this group an estimated 1 in 14 cases are hospitalized and 1 in 850 die. The incidence appears to be increasing in the 1- to 4-year age group despite increased vaccination coverage. The low vaccine coverage appears to be caused by the ambivalence of the Italian pediatric community about the vaccine rather than parental concerns about vaccine safety. Legislation is being considered to make pertussis vaccination mandatory.
From 1987 to 1989, the National Health Institute carried out a before and after intervention study in order to evaluate the effectiveness of active surveillance and of modification of patient care practices in reducing the incidence of postoperative infections. The initial study population consisted of 20 general and thoracic surgical wards in 12 hospitals; 11 wards were not able to complete the study and were therefore excluded from the analysis. In December 1988, after a 13-month period in which baseline infection rates were assessed in 4,096 patients, written protocols regarding modification of patient care practices were defined and applied. Effectiveness of intervention was evaluated comparing infection rates measured in a 6-month period in 1989 on 1,638 operated patients with those of the previous period. In the overall population, a reduction of 19% of nosocomial infections was observed after the intervention. When individual infection sites were considered, pneumonia rates were statistically significantly reduced by 39%; for the other infection sites the observed differences were not significant. Effectiveness of intervention varied by subgroups of wards. In three of the studied wards, surgical wound infections were significantly reduced by 72%, whereas in the remaining wards the intervention seemed to have no positive impact on infection rates. Nevertheless, the intervention seemed to have been effective in increasing the awareness of infection problems in two other wards. Results of the study suggest that a consistent reduction of postoperative infections can be achieved in surgical wards where usual patient-care practices differ from standard of patient care policies. Nevertheless, the observed variation in effectiveness of intervention by individual wards suggests that differences in structural and behavioral characteristics can affect the compliance with recommended standards.
We report on mosaic 46,XY/46,XY,del(5)(p15) cri du chat syndrome. The clinical findings are compared with those compiled from a literature survey. A phoniatric evaluation was performed and compared with that of a cri du chat patient without mosaicism previously observed by the authors.
To assess the magnitude of the AIDS epidemic in the Italian adolescent (13-19 years) and young adult (20-24 years) age groups, data on AIDS cases notified to the AIDS Operational Centre as of 31 March 1990 were used. Of the 6068 reported AIDS cases, 0.7% occurred among adolescents and 15.7% among young adults. Among adolescents most cases were haemophiliacs (45.4%), while among young adults, drug use was the most frequently reported mode of transmission (87.5%). Females were more likely than males to contract the disease through the heterosexual contact in both the adolescent (20.0% vs 0%) and in young adult (15.1% vs 0.7%) age groups. Among young adults a geographical trend was present with a decrease in case rates from north to south, while for adolescents the rates were higher in northern and southern than in central Italy. If the incidence of AIDS is to be reduced in Italy, further efforts should be made to target the adolescent age group, since many of the young adult cases are likely to have resulted from HIV infection during adolescence.
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