[Validation of the 13-30ARAMAV assessment, a new quality of life and autonomy questionnaire adapted to visually impaired patients]. / Validation du bilan 13­30ARAMAV, un nouveau questionnaire de qualité de vie et d'autonomie adapté aux patients déficients visuels.

PURPOSE: To evaluate the ARAMAV 13-30 questionnaire, a new autonomy and quality of life questionnaire developed for visually impaired patients. METHODS: We carried out a single-center prospective study at the ARAMAV institute in collaboration with the University Hospital of Nîmes. The patients included were admitted for low vision rehabilitation. Each patient received an occupational therapy assessment, the Short Forms 36 (SF36) quality of life questionnaire and the ARAMAV 13-30 questionnaire at the start and at the end of rehabilitation. We verified the reproducibility, the sensitivity to change, and internal and external consistency of the questionnaire. RESULTS: We included 231 patients over a period of 4 years. All the patients were blind or visually impaired. We observed excellent intra- and interuser reproducibility of the questionnaire, with a Lin coefficient>0.9 (0.99 and 0.91, respectively). By comparing the variations of the different scores between before and after low vision rehabilitation, we observed excellent sensitivity to change for both the autonomy and quality of life portions of the questionnaire. Finally, we observed excellent internal and external consistency. CONCLUSION: We therefore propose the ARAMAV 13-30 questionnaire as a new tool in evaluating autonomy and quality of life specifically in visually impaired patients, which may also be used to assess the effect of low vision rehabilitation.

The current risk of retroviral infections transmitted by transfusion in patients who have undergone multiple transfusions. Cooleycare Cooperative Group.

BACKGROUND: To conduct a multicenter, prospective survey within the program of the Cooleycare Cooperative Group to evaluate the rate of transfusion-transmitted infections with human immunodeficiency virus (HIV) and human T-lymphotropic virus (HTLV) in a cohort of patients who were homozygous for beta thalassemia and underwent multiple transfusions during the 6-year follow-up. PATIENTS AND METHODS: One thousand three hundred eighty-four patients with beta thalassemia from 36 centers were enrolled from December 1989 to March 1990. Serum samples were tested at regular intervals during the period from December 1989 to March 1996 for anti-HIV and anti-HTLV antibodies in 1 laboratory. Samples from 1073 and 1001 of the 1384 patients were available for evaluation also during the periods from December 1992 to March 1993 and December 1995 to March 1996, respectively. The risk of acquiring infection was calculated by the ratio between the number of patients who experienced seroconversion and the number of red blood cell units administered to the patients during the study period. RESULTS: The prevalence of HIV infection found in the period from December 1989 to March 1990 was 2.9% (40 of 1384 patients). During follow-up, 1 of 1001 patients showed anti-HIV seroconversion. The incidence of HIV infection was 1.7 per 10,000 person-years (upper boundary of the 95% confidence interval, 5 per 10,000). The risk of HIV infection was 1 in 190,000 U (upper boundary of the 95% confidence interval, 1 in 67,000). At baseline, 4 patients were infected with HTLV (3 with HTLV-1 and 1 with HTLV-2). No seroconversions were observed during follow-up; the risk of HTLV infection was less than 1 in 190,000 U. CONCLUSION: The application of reliable screening procedures for donor selection reduced the transmission of transfusion-associated HIV infection in 1989-1995 to fewer than 2 cases in 10,000 person-years or 1 case per 190,000 units of red blood cells.

The incidence and risk factors of community-acquired hepatitis C in a cohort of Italian blood donors.

To assess the incidence and source of community-acquired hepatitis C virus (HCV) infection among subjects at low risk for blood-borne diseases, we prospectively studied a cohort of 16,515 repeat blood donors over a mean follow-up time of 36 months. Second- and third-generation methods were used for hepatitis C virus antibody (anti-HCV) testing. HCV RNA was determined in the serum of anti-HCV-positive donors by reverse-transcription polymerase chain reaction. Liver biopsy was performed in the viremic subjects. Risk factors for HCV infection were identified by a psychosocial questionnaire in the whole cohort. During follow-up, 5 donors became infected with HCV. The incidence was 1 per 10,000 person-years (95% confidence interval, 0.3-2.4 per 10,000). During the 6 months before seroconversion, four subjects (80%) underwent medical or surgical percutaneous procedures, compared with 26.5% in the entire donor cohort (difference between frequencies, 53.5%; CI: 18.9-89.1). One seroconverting donor had sexual intercourse with an infected subject. Only 1 infected donor developed clinically evident acute hepatitis. HCV RNA remained detectable in 4 of 5 subjects for 8 to 36 months after seroconversion, and liver biopsy showed chronic hepatitis in all cases. Thus, new cases of hepatitis C occur among individuals without a history of known risk factors, some of which may be caused by nosocomial exposure.

Sexual transmission of hepatitis C virus to a repeat blood donor.

BACKGROUND: Sexual transmission of hepatitis C virus (HCV) can occur, albeit inefficiently, and this represents a possible cause of community-acquired infections. This study describes a case of asymptomatic HCV infection acquired by a repeat blood donor from her sexual partner. CASE REPORT: A female repeat blood donor showed anti-HCV seroconversion and a slight elevation in alanine aminotransferase. She had a normal physical examination and no clinical symptoms. She admitted a sexual partnership with a man with chronic HCV infection. Genotyping showed subtype 3a infection in both. Nucleotide sequence analysis of the hypervariable region of the viral envelope was performed on five clones obtained from the donor and the partner. Five blood donors with subtype 3a infection were analyzed as controls. The mean homology among clones was 99.3 percent (95% CI, 98.9-99.7) in the donor and 96.8 percent (95% CI, 94.4-99.2) in the partner, which suggests a more recent infection in the woman. The mean homology between donor and partner was 93.4 percent (95% CI, 93.1-93.8), which is different from that between donor and controls (76.2%; 95% CI, 73.3-79.1; difference between means, 17.2%; 95% CI, 16.0-18.4). This suggests that the infection was transmitted to the donor from her sexual partner. Sexual intercourse is the most probable route of transmission, because parenteral risk factors were absent. CONCLUSION: Heterosexual transmission of HCV can occur in the absence of a long-lasting contact, and the infection can be asymptomatic. It remains to be determined whether the sexual partners of HCV-infected subjects should be deferred from blood donation.

The incidence and natural course of transfusion-associated GB virus C/hepatitis G virus infection in a cohort of thalassemic patients. The Cooleycare Cooperative Group.

To evaluate the risk of transmitting blood-borne GB virus C/hepatitis G virus (GBV-C/HGV) and to define the natural course of infection, we performed a prospective study in a cohort of multitransfused beta-thalassemics during a 6-year follow-up period. We analyzed serum samples of 150 patients collected at 3-year intervals from 1990 to 1996. GBV-C/HGV RNA was determined by reverse transcriptase-polymerase chain reaction and antibodies to E2-protein by an enzyme immunoassay. At baseline, 14.5% of patients had viremia and 18.5% anti-E2. None of the patients with anti-E2 in 1990 subsequently became viremic. Of the 100 GBV-C/HGV RNA-, anti-E2- patients, 10 acquired infection during follow-up, as indicated by positivity of GBV-C/HGV RNA (n = 2), anti-E2 (n = 7), or both markers (n = 1) in 1996. The incidence was 1.7 per 100 person-years (95% confidence interval [CI], 0.8 to 3). Since approximately 19,000 blood units were transfused to these patients during follow-up, the risk of infection was 5.3 in 10,000 units (95% CI, 2 to 8.5). Six of 22 viremic patients cleared the virus during follow-up; 4 of them became anti-E2+. Twelve of 28 patients lost anti-E2 reactivity during follow-up. In conclusion, more than 25% of infections resolve within 6 years; the presence of anti-E2 seems to be protective against infection. Anti-E2 reactivity may decrease with time.

Asymptomatic hepatitis G virus infection in blood donors.

BACKGROUND: Hepatitis G virus (HGV) has been reported in patients with fulminant hepatitis and aplastic anemia, but HGV RNA has also been found in healthy individuals. The possible associations of HGV with liver function and hematologic abnormalities in asymptomatic blood donors were investigated. STUDY DESIGN AND METHODS: Serum HGV RNA was determined in 200 repeat donors (Group A), 44 subjects with elevated alanine aminotransferase (Group B), and 54 hepatitis C virus carriers (Group C). Liver histology was evaluated in Group C by using the histologic activity index. RESULTS: HGV RNA was detected in three subjects of Group A (1.5%; 95% CI: 0.3-4.3), two of Group B (4.5%; 95% CI: 0.6-15.5%), and six of Group C (11.1%; 95% CI: 4.2-22.6). The prevalence of leukopenia and elevated gamma-glutamyl transpeptidase was higher in the 11 viremic donors than in 88 nonviremic subjects (36% vs. 2.3%, and 55% vs. 22%, respectively; p < 0.05), matched for clinical and demographic characteristics. The mean histologic activity index score +/- standard error was 4 +/- 0.7 in the HGV RNA-positive donors and 3.4 +/- 0.3 in the HGV RNA-negative donors. CONCLUSION: HGV is endemic in Italian blood donors, although it has a limited role in causing liver damage. Further studies are needed to clarify its role in inducing transfusion-associated disease in myelosuppression.

Multicenter study on hepatitis C virus infection in patients with dilated cardiomyopathy. North Italy Transplant Program (NITP).

Preliminary epidemiological and histological studies from Japan suggested that hepatitis C virus (HCV) infection has a role in the development of dilated cardiomyopathy (DCM). This multicenter study was conducted to verify this hypothesis on a large cohort of Italian patients with end-stage heart failure. Antibodies to HCV were determined in the 752 consecutive patients (608 males and 144 females; age, 53 +/- 13 years) who entered the waiting list for cardiac transplantation from 1995 to 1997 at the six cardiac surgery centers participating in the North Italy Transplant program. Three hundred and nine patients (41%) had dilated, 9 (1%) restrictive, and 4 (0.5%) hypertrophic cardiomyopathy; 284 patients (38%) had ischemic, 65 (9%) valvular, and 22 (3%) congenital heart disease; 5 patients (0.5%) had primary pulmonary hypertension; 54 patients (7%) had other or nonspecified heart disease. Overall, 41 of 752 patients (5.4%) resulted anti-HCV-reactive. Serological evidence of HCV infection was found in 12 of 309 patients with DCM (3.9%; 95% CI, 1.7-6.0), and in 29 of 443 without DCM (6.5%; 95% CI, 4.2-8.8), without statistical difference (difference of prevalence rate: 2.6%; 95% CI, -4.9 to 5.8). In conclusion, HCV does not seem to have a primary role in the pathogenesis of DCM. However, since our findings are in disagreement with those obtained in smaller series of patients of other ethnicity, large studies from different countries should be conducted.

A prospective study on TT virus infection in transfusion-dependent patients with beta-thalassemia.

A novel DNA virus designated TT virus (TTV) has been reported to be involved in the development of posttransfusion non-A-C hepatitis. We evaluated the frequency and natural course of TTV infection in a cohort of transfusion-dependent thalassemic patients in a 3-year follow-up study. Ninety-three serum hepatitis C virus (HCV) antibody-negative patients (median age of 8 years; range, 0 to 25) from eight centers were studied. Of them, 34 (37%) had an abnormal alanine-aminotransferase (ALT) baseline pattern, and the other 12 (13%) showed ALT flare-ups during the follow-up. TTV DNA in patient sera collected at the time of enrollment and at the end of follow-up was determined by polymerase chain reaction (PCR). In parallel, serum samples from 100 healthy blood donors were also tested. At baseline, 87 patient sera (93.5%) tested positive for the TTV DNA. Of these TTV DNA-positive patients, 84 (96.5%) remained viremic at the end of the study period. Of the 6 TTV DNA-negative patients, 3 acquired TTV infection during follow-up. However, no definite relation was observed between the results of TTV DNA determination and ALT patterns. TTV viremia was also detectable in 22% of blood donors. In conclusion, TTV infection is frequent and persistent among Italian transfusion-dependent patients. The high rate of viremia observed in healthy donors indicates that the parenteral route is not the only mode of TTV spread.

A multicenter prospective study on the risk of acquiring liver disease in anti-hepatitis C virus negative patients affected from homozygous beta-thalassemia.

Although the risk of transfusion-transmitted hepatitis has been recently reduced, transfusion-dependent beta-thalassemia patients may still develop liver disease due to viral infection or iron overload. We assessed the frequency and causes of liver dysfunction in a cohort of anti-hepatitis C virus (HCV) negative thalassemics. Of 1,481 thalassemics enrolled in 31 centers, 219 (14.8%) tested anti-HCV- by second-generation assays; 181 completed a 3-year follow-up program consisting of alanine-aminotransferase (ALT) measurement at each transfusion and anti-HCV determination by third-generation enzyme-immunoassay (EIA-3) at the end of study. Serum ferritin levels were determined at baseline and at the end of follow-up. Ten patients were anti-HCV+ by EIA-3 at the end of follow-up. Of them, seven were already positive in 1992 to 1993 when the initial sera were retested by EIA-3, one tested indeterminate by confirmatory assay, and two had true seroconversion (incidence, 4. 27/1,000 person years; risk of infection, 1/7,100 blood units, 95% confidence interval [CI], 1 in 2,000-1 in 71,000 units). At baseline, 67 of 174 thalassemics had abnormal ALT. Of those with normal ALT, seven subsequently developed at least one episode of moderate ALT increase (incidence, 24.6/1,000 person-years). All of the 20 patients with ferritin values >/=3,000 ng/mL had clinically relevant ALT abnormalities, as compared with 53 of 151 with <3,000 ng/mL (P < .005). Hepatic dysfunction is still frequent in thalassemics. Although it is mainly attributable to siderosis and primary HCV infection, the role of undiscovered transmissible agents cannot be excluded.