[A new scale for measuring the psycho-physical effects of work-related stress in a perspective of methods integration]. / Una nuova scala di misura degli effetti psico-fisici dello stress lavoro-correlato in una prospettiva d'integrazione di metodi.

BACKGROUND: This study fits into a perspective of integrated work-related stress assessment, in response to the need to limit the common method variance and the role played by individual variables in subjective measures. OBJECTIVES: The goal of this study was to check the metric properties of a new scale of mental and physical strain developed for the evaluation of stress symptoms by the physician and to detect the antecedents of psycho-physical symptoms, in terms of both individual and work characteristics, through an integrated approach. METHOD: The study was conducted on 409 workers involved in health surveillance activities, to whom the new scale and a subjective assessment tool were administered. RESULTS: Confirmatory factor analysis showed that the scale is a reliable tool for hetero-evaluation of psycho-physical symptoms attributable to stress at work. Moreover, specific individual characteristics, such as the presence of prior health disorders and the female gender, and organizational features, such as the pathological work/life conflict and the workload, were found to be risk factors in relation to psychological and physical strain. Age, consumption of alcoholic beverages between meals, relationships with colleagues, and the characteristics of the workplace were instead found to be important protective factors. DISCUSSION: The adoption of an integrated approach made it possible to improve and study in depth the ways of work-related stress assessment, highlighting the pivotal role of the occupational health physician making the evaluation.

[The surveillance of occupational risks. Problems and perspectives of the recent legislative framework after the national preliminary survey]. / I dati sanitari aggregati e di rischio dei lavoratori sottoposti a sorveglianza sanitaria. Risultati preliminari dello studio pilota nazionale sulle comunicazioni ex art. 40. D.lgs 81/2008.

BACKGROUND: Legislation in Italy concerning health, safety and prevention at the workplace recently established a new data communication standard OBJECTIVES: The findings are reported of a specific survey on 18 Local Health Units (ASL) over the entire Italian territory, aimed at identifying the critical points in data management and analyze the available information. METHODS: The occupational health physician for each company must collect and transmit information on the number of workers submitted to health surveillance protocols to the Local Health Unit. Information must be divided by risk factor and gender Local health Units then transmit the data to the Regions and finally to the Italian National Institute for Occupational Safety and Prevention (ISPESL). RESULTS: A sample of 22.977 companies was studied, providing information on about 410,009 workers undergoing health surveillance protocols. Carrying or moving heavy loads, exposure to noise, VDU and chemical substances were the most frequent risk factors. The difference between genders was significant in risk allocation, with exposures to VDU and biological agents prevalently among females. CONCLUSIONS: The information thus collected suffered from a lack of data organization and completeness in the sample under study, but nevertheless provides preliminary evidence of a map of occupational risks on a national basis, confirming the potential for the new law (D.Lgs 81/2008) to investigate health safety and prevention at the workplace.

Blood donors with 'medium' or 'minor' risk factors for human immunodeficiency virus infection: are they eligible for donation?

BACKGROUND AND OBJECTIVES: We conducted a longitudinal prospective study to assess the eligibility to blood donation of donors with 'minor' risk factors (i.e. minor surgery, professional exposure, cohabitation with 'high risk' people, occasional use of light drugs) or 'medium' risk factors for human immuno-deficiency virus (HIV) infection (i.e. casual sexual relationship, multiple heterosexual exposure, sexual partnership with subjects at risk, regular use of light drugs). DESIGN AND METHODS: During a 4-year period we administered a psychosocial questionnaire to all donors attending our Center. In addition we determined anti-HIV, anti-hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and syphilis serology (TPHA) at entry to the study and at 6-month intervals. RESULTS: Of 25,367 donors, 1,535 (6%) reported medium and 8,761 (34%) minor risk. At enrollment into the study, 4 medium risk donors were anti-HIV positive and there was a significantly higher rate of positivity for TPHA (0.33% vs 0.07%) and anti-HCV (1.17% vs 0.63%) in this group than in donors reporting no risk. No anti-HIV positivity was observed in minor or no risk donors. During a median follow-up of 18 months, none of 24,404 donors undergoing 106,503 visits seroconverted to HIV. The incidences of novel HCV and syphilis infections were almost one log greater in donors at medium risk (3 and 1x10-4/yr, respectively) than in no risk donors (0.4 and 0.1x10-4/yr, respectively). Medium risk donors were more frequently males (Odds Ratio=3.2, 95% confidence interval= 2.8-3.7), aged 26-35 yrs (1.52; 1.3-1.78), single (1.4; 1.2-1.6), divorced (2; 1.4-2.8), freelance workers (1.43; 1.1-1.9) and first-time donors (1.8; 1.6-2.1) than no risk donors. INTERPRETATION AND CONCLUSIONS: The only 4 HIV positive subjects of the cohort were medium risk donors picked up at enrollment. No HIV seroconversion was observed during the study. On the basis of this study we will continue to defer 'medium' risk donors.

Sustained response to interferon-alpha2a monotherapy of young blood donors with minimal-to-mild chronic hepatitis C. The Donor Surveillance Study Group.

Subjects with minimal-to-mild chronic hepatitis C may suffer long-term consequences of hepatitis C virus (HCV) infection. Nonetheless, they are not candidates for antiviral treatment, mainly because little data are available concerning the efficacy and safety of therapy. Thirty-two HCV RNA positive individuals aged 18-45 years, who had a histological activity index score < or = 8 and alanine aminotransferase (ALT) levels < or = 1.5 times lower than the normal limit for at least 1 year, were prospectively enrolled among a cohort of 35358 candidate blood donors, and treated with 4.5 mega units (MU) of recombinant interferon-alpha2a (IFN-alpha2a) thrice weekly for 6 months, and for an additional 6 months if a virological response was observed. Twelve months after the completion of treatment, 13 of 31 evaluable patients were HCV RNA negative, accounting for a sustained response rate of 42%. Patients without fibrosis had a lower response rate than those with mild fibrosis (two of 14 vs 11 of 17; P=0.012). In responders, median aminotransferase levels were significantly lower after therapy than before (11.04 +/- 3.98 vs 27.3 +/- 12.32 U l-1, respectively; P < 0. 005). When the analysis was limited to the six responders whose pretreatment aminotransferase levels were consistently normal, this difference was still significant (9.33 +/- 4.12 vs 20.58 +/- 6.73 U l-1; P=0.002). In conclusion, a durable suppression of viraemia can be obtained by IFN monotherapy in a relatively high proportion of young subjects with minimal-to-mild chronic hepatitis C, especially when portal fibrosis is found on liver biopsy. The disappearance of viraemia always leads to a reduction in the degree of hepatocellular necrosis.

Clinical evaluation of percent free prostate-specific antigen using the AxSYM system in the best analytical scenario.

OBJECTIVE: Percent free prostate-specific antigen (PSA) is a promising tool for prostate cancer (CaP) diagnosis. However, its diagnostic performances have not yet been established. The present study was carried out with the aim of evaluating percent free PSA in the most favourable analytical conditions. MATERIALS AND METHODS: Eighty-eight patients affected by newly diagnosed, untreated, primary CaP, and 169 cases with biopsy-confirmed, untreated, benign prostatic hypertrophy (BPH) were prospectively enrolled. Abbott AxSYM total and free PSA were measured by the same technician using the same instrument and the same reagent batch. RESULTS: Percent free PSA was more effective than total PSA in differential diagnosis between CaP and BPH in every evaluated dose range of total PSA. In cases with total PSA >4 microg/l, percent free PSA could have reduced by about 50% the rate of unnecessary biopsies with a probably still acceptable 93% cancer detection rate. The likelihood of CaP after the determination of percent free PSA was in fact higher than 50% using cut-off points which provide low sensitivity values (i.e. 58% in men aged 50-59 years). CONCLUSIONS: Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 microg/l and in reducing the rate of unnecessary biopsies in men with total PSA higher than 4 microg/l. However, percent free PSA should be cautiously interpreted in decision making in individual patients since post-test probability is relatively low in men aged 50-70 years.

Percent free prostate-specific antigen in assessing the probability of prostate cancer under optimal analytical conditions.

Although general consensus exists that percent free prostate-specific antigen (PSA) is superior to total immunoreactive PSA for prostate cancer (CaP) detection, its diagnostic performance is not yet well established. Analytical problems may account for difficulties in evaluating percent free PSA because the free PSA concentration is substantially lower than that of total PSA. The aim of the present study was to establish the diagnostic performances of the IMMULITE percent free PSA assay from Diagnostics Products Corp. under experimental conditions optimized to minimize analytical variability. Eighty-five patients with untreated primary CaP and 261 with untreated benign prostate hypertrophy (BPH) were prospectively enrolled. The Diagnostics Products IMMULITE total (Third Generation) and free PSA were measured by the same technician, using the same instrument and the same reagent batch. We calculated the post-test probability to express how the likelihood of the diagnosis of CaP changed after the percent free PSA was determined. Areas under the ROC curves of percent free PSA were better than those of total PSA in every evaluated range of total PSA. The percent free PSA could have reduced the rate of unnecessary biopsies by 47% in patients with total PSA >/=4 microg/L with only 3.8% false-negative results. The post-test probability of percent free PSA was, however, <50% in men 50-70 years of age, using cutoff points providing sensitivity from 99% to 80%. Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 microg/L. In men with low total PSA, the diagnostic performance of the percent free PSA assay may be optimized by controlling methodological variability. The percent free PSA assay is effective in reducing the rate of unnecessary biopsies in men with total PSA >4 microg/L. However, the post-test probability provided by percent free PSA is relatively low in asymptomatic patients 50-70 years of age.

Prostate cancer probability after total PSA and percent free PSA determination.

UNLABELLED: The percent free PSA value is a promising diagnostic tool for prostate cancer. However, its actual role has not yet been established because of the widely diverging sensitivity and specificity values. This could depend at least in part on analytical difficulties, since the free PSA concentration is much lower than that of total PSA. The present investigation was designed to evaluate the diagnostic performance of the percent free PSA in the most favorable analytical conditions. MATERIALS AND METHODS: 81 patients affected by newly diagnosed, untreated primary prostate cancer (CaP) and 239 patients with untreated benign prostatic hyperplasia (BPH) were prospectively enrolled. Hybritech total and free PSA were measured by the same technician using the same reagent batch. RESULTS: The percent free PSA was not significantly associated with age, tumor stage, gland volume, Gleason score, and total PSA, nor was it significantly affected by concomitant prostatic complications either in CaP or BPH. Percent free PSA was more effective than total PSA in the differential diagnosis between CaP and BPH in every evaluated dose range of total PSA. Percent free PSA determination could have reduced the rate of unnecessary biopsies in cases with total PSA > or = 4 ng/mL and > or = 10 ng/mL (avoided biopsies 61% and 63%, respectively). The post-test probability of the disease, which represents the proportion of patients with a positive percent free PSA value who have the disease, was, however, relatively low in younger patients with total PSA within the normal range. CONCLUSIONS: The diagnostic performance of the percent free PSA value is enhanced when the methodological variability is reduced, particularly in men with low total PSA. Percent free PSA is superior to total PSA in distinguishing primary CaP from BPH in patients with total PSA between 2 and 30 ng/mL. The percent free PSA value is effective in reducing the rate of unnecessary biopsies in men with total PSA higher than 4 or 10 ng/mL. However, due to its relatively low post-test probability, the percent free PSA value should be interpreted with caution in the decision-making related to individual patients and should be used in association with clinical and instrumental evaluation of the patient.

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.

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)

CA 15-3 value and neoplastic disease predictivity in the follow-up for breast cancer.

The role of CA 15-3 in breast cancer has been widely studied by several authors. This study was designed to describe the predictivity of CA 15-3 determinations for the metastasis or second primary tumor in patients subjected to follow-up for breast cancer. All the 1,123 determinations of CA 15-3 carried out during 1991 in a hospital laboratory were analyzed. By cross-matching anagraphic items of patients with clinical data from different hospital databases, it was possible to reconstruct the clinical history. At the cutoff point of 40 U/ml, the positive predictive value of the CA 15-3 was 99.4%. This study shows the very close association between CA 15-3 > or = 40.0 U/ml and disease, suggesting a careful restaging when the marker increases without clinical evidence of metastases. Hormonal treatment should also be considered.

Controlled trial of desmopressin in liver cirrhosis and other conditions associated with a prolonged bleeding time.

The synthetic vasopressin derivative desmopressin (DDAVP) shortens a prolonged bleeding time (BT) in patients with uremia, congenital platelet dysfunction, and von Willebrand disease. To establish the limits of the clinical usefulness of DDAVP, a controlled randomized study was carried out in 53 patients and ten volunteers with different conditions that have in common a prolonged BT. DDAVP significantly shortened the BT in 21 cirrhotics (P less than .01), in eight patients with unclassified prolonged BT (P less than .05) and in ten volunteers taking the antiplatelet drugs aspirin (P less than .05) and ticlopidine. The BT changes were not statistically significant in 15 patients with severe thrombocytopenia nor in nine with congenital platelet dysfunction, even though a few patients with storage pool deficiency responded with a marked BT shortening. Our findings indicate that DDAVP might be given when biopsies or other surgical procedures must be carried out in patients with prolonged BT. However, the compound is often ineffective in patients with thrombocytopenia or congenital platelet dysfunction.

Heterogeneity of type I von Willebrand disease: evidence for a subgroup with an abnormal von Willebrand factor.

Type I von Willebrand disease (vWD) is characterized by equally low plasma concentrations of von Willebrand factor antigen (vWF:Ag) and ristocetin cofactor (RiCof) and by the presence of all vWF multimers in sodium dodecyl sulfate (SDS)-agarose gel electrophoresis. For 17 patients (13 kindreds) diagnosed with these criteria, we have studied the platelet contents of vWF:Ag and RiCof and the changes of these in plasma after DDAVP infusion. Platelet vWF:Ag and RiCof were normal in four kindreds (called "platelet normal" subgroup); following 1-deamino-8-D-arginine vasopressin; plasma vWF:Ag, RiCof and the bleeding time (BT) became normal. In six kindreds, platelet vWF:Ag and RiCof were equally low (platelet low); after DDAVP, plasma vWF:Ag and RiCof remained low, and the BT was prolonged. In three additional kindreds, platelets contained normal concentrations of vWF:Ag, but RiCof was very low (platelet discordant); even though a complete set of multimers was found in plasma and platelets, there was a relatively small amount of large multimers. After DDAVP, plasma vWF:Ag became normal, but RiCof remained low and the BT was very prolonged. These findings demonstrated that there can be an abnormal vWF (RiCof less than vWF:Ag) even in type I vWD, coexisting with a complete set of vWF multimers (platelet discordant); that the abnormal vWF can be shown more clearly in platelets than in plasma or else in plasma after DDAVP infusion; and that DDAVP normalizes the BT only in those patients with normal platelet levels of both vWF:Ag and RiCof (platelet normal).