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Biomedical subjects

M Pappalettera

Publications and source records attributed to M Pappalettera.

At least 19 recordsLinked to original sources

Practices and attitudes towards quality assurance, inspection and accreditation in blood collection establishments in the European community.

In the framework of a European Community (EC)-supported project, a survey of practices and attitudes towards quality assurance, inspection and accreditation in Blood Collection Establishments (BCEs) in the EC member states was carried out. Analysis of 352 responses to a structured questionnaire revealed a preference for national standards over international, and an introspective and reactive view to quality management. Four broad categories of operational performance in relation to safety were formed: initial, repeatable, managed and optimising, with the majority of responses (209) being characterized as initial. Although a direct relationship between the size of the BCE and the range and level of quality management practices is apparent in the data, further analysis shows that small BCEs have much higher ratio of personnel per blood unit collected/processed than large BCEs and thus seem to have an inherent potential for improvement. Overall, a clear preference for inspection and accreditation by professional peers at the national level was indicated.

Accreditation↗

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.

Adult↗

Use of SERVQUAL to assess clinicians' satisfaction with the blood transfusion service.

BACKGROUND AND OBJECTIVES: Limited information is available on the level of satisfaction of clinicians with services delivered by blood banks. The purpose of this study was to evaluate the satisfaction of clinicians with our blood transfusion service. MATERIALS AND METHODS: We prepared a questionnaire based on SERVQUAL, a method used to measure customers' appreciation of quality of service, by assessing the gap between perceived and expected quality. The questionnaire consisted of 14 items grouped according to five dimensions of quality of service: assurance, empathy, responsiveness, reliability, tangibles. Clinicians were asked to give two scores on a scale from 1 to 7 for each item, score (e) representing what they expected from an 'excellent' service, score (r) how they graded the service received. We considered wide differences in scores of service expectation and receipt for a question to be indicative of either service above expected levels (r > e) or service below expectation (r < e); similar scores for both expected and received service (within 1 point on the grading scale) were taken to indicate that the service received was that which was expected. RESULTS: A total of 184 questionnaires (49%) were returned. For the 14 items considered, the proportion of clinicians expressing levels of satisfaction similar to or above expectation ranged from 67 to 96%. Three critical areas, which clinicians considered important (expectation scores 6-7) were associated with satisfaction below expectation in more than 20% of responders. They were: clarity of procedures, clarity of blood request forms, and convenience of blood request and issuing times, which were rated as important by 77, 80 and 72% of clinicians, respectively. CONCLUSION: SERVQUAL was useful to gather information on the level of clinicians' satisfaction with our transfusion service.

Ancillary Services, Hospital↗

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.

Adult↗

Relationship of the time of storage and transfusion reactions to platelet concentrates from buffy coats.

BACKGROUND: Transfusion reactions to platelet concentrates prepared from buffy coats (BC-PCs) were reviewed to determine the effect of some variables of BC-PC preparation and storage: time of BC storage before BC-PC preparation (1-2 days); time of BC-PC storage before transfusion (1-5 days); no white cell reduction versus laboratory and bedside BC-PC white cell reduction. STUDY DESIGN AND METHODS: A multiple linear logistic regression model was used by which the relative effect of one variable is expressed as the relative risk of transfusion reaction against a baseline level (1-day storage, no white cell reduction). RESULTS: During the 14 months of study, a total of 2707 BC-PC transfusions were given to 192 patients; 37 reactions (1.4%) were reported in 25 patients (13%). The transfusion reactions were febrile, nonhemolytic in 23 cases; allergic in 5; febrile and allergic in 2; and other in 7. The relative risk of transfusion reaction to BC-PCs prepared from BCs stored for 2 days was 1.98 times that to BC-PCs prepared from BCs stored for 1 day (p = 0.07). The relative risk of transfusion reaction of 5-day-old BC-PCs was 10.7 times that of 1-day-old BC-PCs (p = 0.001). The relative risk of transfusion reactions of BC-PCs white cell-reduced in the laboratory and at the bedside were 0.65 (p = 0.3) and 1.87 (p = 0.1) times, respectively, that of non-white cell-reduced BC-PCs. CONCLUSION: Time of storage seems to be an important variable associated with BC-PC transfusion reaction.

Blood Component Transfusion↗

Thyroid vascularization by color doppler ultrasonography in Graves' disease. Changes related to different phases and to the long-term outcome of the disease.

To investigate possible correlations between thyroid vascularization and activity of Graves' disease, we measured blood flow (TBF) at the inferior thyroid artery and intraparenchymal vascularization (number of vessels per square centimeter) by color Doppler ultrasonography (CDU) on Graves' patients at different phases of the disease. We studied 88 patients cross sectionally: 22 untreated; 17 euthyroid after 6 months of methimazole; 49 euthyroid at drug withdrawal after 12 to 24 months of treatment. The patients of the latter group were followed up for 29.1 +/- 6.3 months after discontinuation of treatment. On the day of CDU examination, free triiodothyronine (FT3), free thyroxine (FT4), thyrotropin (TSH), antiperoxidase and anti-TSH receptor (TRAb) antibodies were measured. Vascularization indices were significantly higher in the Graves' patients than in controls. In the patients euthyroid under treatment, vascularization was not significantly lower than in the untreated group, but TBF and vessel number both appeared clearly reduced in the patients tested at drug withdrawal. The vascularization indices at drug withdrawal were significantly higher in the patients who relapsed than in those in stable remission: TBF (mL/min) 50.6 +/- 36.8 vs. 23.8 +/- 17.5, p = 0.001; vessel number/cm2 1.8 +/- 0.8 vs. 0.8 +/- 0.5, p = 0.002. A multivariate analysis, evaluating the predictive value of vascularization, hormonal and immunological parameters for relapse, demonstrated a significant predictive value for TRAb (RR 8.2; p = 0.001) and a weak predictive value for TBF (RR 1.1; p = 0.02). In conclusion, CDU examination confirms that thyroid hypervascularization in Graves' disease is not related to thyroid hormone circulating levels. The association of increased TBF and high levels of TRAb in the relapsing forms of disease suggests that thyroid hypervascularization is probably related to the activity of the underlying autoimmune processes.

Adult↗

Influence of different hepatitis C virus genotypes on the course of asymptomatic hepatitis C virus infection.

BACKGROUND & AIMS: The association of liver disease with hepatitis C virus (HCV) genotypes mainly refers to patients with serious liver damage; little information is available on symptomless carriers. The aim of this study was to investigate the correlation of genotypes with clinical course, risk factors for infection, and antibody to HCV reactivity in asymptomatic subjects. METHODS: One hundred nine viremic blood donors with at least 1 year of follow-up were studied; 41 underwent liver biopsy. Genotypes were determined by line-probe assay. RESULTS: Genotype 1 was found in 47 (43.1%), genotype 2 in 48 (44%), genotype 3 in 8 (7.3%), genotype 4 in 2 (1.8%), and coinfections in 4 (3.7%). The relative risk (RR) for a raised pattern of alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyltranspeptidase was 2.1 (confidence interval [CI], 1.4-3.2), 1.7 (CI, 1.2-2.4), and 2.8 (CI, 1.6-4.9) in subjects with genotype 1 vs. 0.4 (CI, 0.2-0.7), 0.4 (CI, 0.3-0.7), and 0.4 (CI, 0.2-0.8) in subjects with genotype 2. Chronic hepatitis was found in 68%; the RR of chronic hepatitis was similar for genotypes 1 and 2 (RR, 1.1 [CI, 0.8-1.7] vs. RR, 1.0 [CI, 0.7-1.6]). Reactivity to NS4-derived antigens was infrequent in type 2-infected subjects. CONCLUSIONS: Genotype 2 was as frequent as genotype 1 but associated with less liver function impairment. The high prevalence of chronic hepatitis should be considered in counseling viremic asymptomatic donors.

Adult↗

HLA-DRB1 compatibility in cadaver kidney transplantation: correlation with graft survival and function.

The introduction of genomic HLA-DR typing has stimulated a re-evaluation of the role of HLA-DR compatibility on cadaver kidney transplantation. We retrospectively studied the influence of HLA-DRB1 matching on the survival of 416 patients using univariate and Cox regression analysis as well as its influence on the occurrence of rejection episodes and on creatinine level at the 3rd month in the 198 recipients for whom these data were available. The following parameters were also considered: HLA-A,B compatibility, donor and recipient age, graft number, pre-transplant blood transfusions and panel reactive antibodies (PRA). Twenty-four month graft survival was 100% for transplants with zero mismatches (n = 47), 87.9% for those with one mismatch (n = 191) and 81.3% for those with two mismatches (n = 178). In the Cox model, HLA-DRB1 matching was the most significant variable influencing graft survival (47% of chi 2 P = 0.001), followed by HLA-A,B matching (23%, P = 0.02) and donor age (19%, P = 0.04). Ninety-two percent of the patients with zero mismatches experienced no rejection episodes in the first 3 posttransplant months compared with 62% and 41% of patients with one and two mismatches, respectively. Mean creatinine level (mg/dl) was 1.2, 1.4, and 1.5 in patients with zero, one, and two mismatches, respectively. Should these results be confirmed by prospective studies, HLA-DRB1 compatibility will have to be considered as an organ allocation criterion.

Adolescent↗

Human lymphocyte antigens in Graves' disease: correlation with persistent course of disease.

Graves' disease is a thyroid autoimmune disorder associated with specific human lymphocyte antigen (HLA) alleles, characterized by an unpredictable long-term course. To investigate possible relations between HLA phenotype and outcome of the disease, the authors typed for HLA antigens in 105 patients with Graves' disease with different course of disease. All patients were treated with antithyroid drugs for at least 12 months; 29 patients had stable remission 24 or more months after withdrawal of treatment; 76 patients had persistent disease--66 unremitting/relapsing hyperthyroidism, 10 stable hypothyroidism--36 or more months after onset of disease. The following findings emerged from this study: 1) HLA B8 and DR3 were increased significantly in Graves' patients versus 6,682 control subjects from the same geographic area (23.80% vs 12.01%, odds ratio [OR] 1.98, and 31.43% vs 18.00%, OR 1.75, respectively); the antigen combinations B8-DR3, B8-Cw7-DR3, and A1-B8-Cw7-DR3 were significantly more frequent in Graves' patients vs control subjects; in addition, these combinations were present exclusively in patients with persistent disease (B8-DR3 28.95%, OR 7.14, B8-Cw7-DR3 27.63%, OR 11.24, and A1-B8-Cw7-DR3 18.42%, OR 11.29). These data provide evidence that not only susceptibility to Graves' disease, but also persistent activity of the autoimmune process, producing either hyperthyroidism or stable hypothyroidism, is associated with specific HLA antigen phenotypes.

Adolescent↗

Hepatitis C virus RNA and liver histology in blood donors reactive to a single antigen by second-generation recombinant immunoblot assay.

The clinical significance of single band reactivity (indeterminate pattern) at anti-hepatitis C virus (HCV) second-generation recombinant immunoblot assay (RIBA-2) was investigated in symptomless subjects with normal liver function tests to obtain data for their counseling and clinical management. Serum and hepatic HCV RNA were determined by the nested polymerase chain reaction, and liver histology was evaluated in 40 symptomless blood donors with stable indeterminate RIBA-2 pattern, including 38 reactive to c22-3. All but one had normal alanine aminotransferase (ALT) levels. Two new immunoblot tests, RIBA-3 and INNO-LIA HCV Ab III (LIA-III), which incorporate additional HCV antigens, were also done to assess whether they could identify the viremic subjects. Ten cases (25%, confidence interval 12 to 38) were HCV RNA positive. Three of the HCV RNA-positive and none of the HCV RNA-negative subjects had chronic hepatitis. RIBA-2 strong intensity of reaction (score > 2+) was observed in all the HCV RNA-positive and in 12 HCV RNA-negative subjects. RIBA-3 and LIA-III gave positive results in 9 of 10 and 10 of 10 HCV RNA-positive, but also in 8 of 30 and 24 of 30 HCV RNA-negative subjects. A c-22-3 reactivity score of 4+ by RIBA-3 and E2/NS1 reactivity by LIA-III were both strongly associated with HCV RNA (P < .001). Based on relatively high prevalence of chronic hepatitis in our series (30%), apparently healthy subjects with stable indeterminate RIBA-2 pattern and HCV RNA positivity should be considered for liver biopsy independently of ALT profile.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Cadaver kidney transplantation in the north Italy transplant program in the nineties.

The most relevant changes which have taken place in the NITp in the nineties include the introduction of HLA-DRB1 matching, the extension of both recipient and donor selection criteria, and an increase in donor procurement and consequently, in transplantation activity. Some of the changes in policy resulted from extensive analysis of our previous experience. For the future years, the NITp has set the following priorities: Consolidate the increase of donor procurement activity registered in the past 15 months by educational campaigns for health workers and the public, and organizational measures aimed at strengthening ICUs, nominating transplant coordinators and introducing a system of reimbursement for organs procured. Improve the quality of results in terms of patient rehabilitation and cost-benefit through: continued evaluation of protocols for patient admission on the waiting lists and careful selection of donors; and prospective use of genomic HLA Class II matching and also consider genomic typing for HLA Class I which is almost a reality. Establish a single pool of patients on the waiting list evaluated according to common protocols with the possibility of performing the transplant in each of the authorized centers in turn, respecting the best HLA match and the local use of organs. Finally, standards for donor treatment, organ procurement, histocompatibility testing and transplantation must be established. For this purpose, accreditation programs which have begun to be applied in Europe seem to be the adequate tool.

Adolescent↗

Platelet concentrates from buffy coats: improved conditions for preparation and evaluation in routine clinical use.

Since 1990, platelet concentrates prepared by soft centrifugation of buffy-coat pools diluted with a glucose-free, commercially available crystalloid solution (BC-PC) are the first choice product for all platelet recipients in our institution. Numerous in vitro and in vivo observations from our own and other laboratories indicate that BC-PC compare favorably to PC prepared from platelet-rich plasma (PRP). In the present in vitro study we evaluated traditional and bottom-and-top bags and modified centrifugation conditions with the aim of increasing in vitro platelet yield in BC-PC. This was 14-18% higher compared with our previous protocol when prolonged centrifugation and bottom-and-top bags were used. In addition, we evaluated post-transfusion platelet count increments in 42 unselected adult hematological patients routinely transfused with 703 1-5 day-old BC-PC pools. Transfusion data were managed with PLATELET, an MS-DOS compatible program which includes automated calculation of transfusion efficacy and periodic patient reports. Mean pre-, 1 h and 24 h post-transfusion platelet counts were 16, 38 and 28x10 9/L, respectively. Mean 1 h and 24 h post-transfusion platelet count increments, expressed as percentage of expected, were 40 and 24%, respectively. These data were similar to those obtained previously in 189 unselected hematological patients given 2432 PRP-PC transfusions (mean 1 h post-transfusion increment 46% of expected). The present in vitro study confirms that similar platelet yields can be obtained with the BC and PRP methods. In vivo findings show that also in routine conditions post-transfusion increments of PRP-PC and BC-PC are similar.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

White cell-reduced red cells prepared by filtration: a critical evaluation of current filters and methods for counting residual white cells.

White cell (WBC) reduction, red cell (RBC) recovery, and filtration time were determined in 1-day-old standard and buffy coat-depleted RBCs filtered in the laboratory through six commercial filters for WBC reduction. Residual WBCs were counted with a Bürker chamber (BC), with a Nageotte chamber (NC), and by flow cytometry (FC). Results show that BC counts were 0 in several cases in which WBCs were detected with NC and FC, which indicated that the traditional BC method is too insensitive in use with currently available filters. Calibration curves performed by FC and with NC with samples containing known concentrations of WBCs from 1000 to 1 per microL showed that both FC and NC detected, on average, 67 percent of WBCs present in the samples (efficiency). However, the efficiency of FC showed small variability (61-70%) at different WBC levels, whereas the variability with NC was large (39-91%). This greater variability prevented the correction of NC counts by using a single factor and indicated difficulty in NC standardization. Therefore, because our main aim was to compare different filters rather than to define absolute levels of WBC contamination, uncorrected FC and NC counts were chosen to be reported. True WBC counts per unit should not exceed values that can be obtained by dividing uncorrected counts by the lowest efficiencies (61% for FC and 39% for NC). Uncorrected NC and FC counts were below 2 x 10(6) per unit in all units processed through three of the filters and below 5 x 10(6) per unit in all units processed through the other three.(ABSTRACT TRUNCATED AT 250 WORDS)

Erythrocytes↗