Right cardiac involvement in lung diseases: a multimodality approach from diagnosis to prognostication.

Lung diseases are amongst the main healthcare issues in the general population, having a high burden of morbidity and mortality. The cardiovascular system has a key role in patients affected by respiratory disorders. More specifically, the right ventricle (RV) enables the impaired lung function to be overcome in an initial stage of disease process, reducing the severity of dyspnoea. In addition, two of the main causes of death in this setting are RV failure and sudden cardiac death (SCD). Echocardiography is regarded as a useful and easily available tool in assessing RV function. Several noninvasive echocardiographic parameters of elevated pulmonary pressures and RV function have been proposed. The combination of different parameters and imaging methods is paramount and researches regarding RV impairment using these indices has been specifically addressed in relation to the chronic obstructive and restrictive lung disease in order to guide the clinicians in the management of these patients. Cardiac involvement in lung diseases is often observed, and RV changes are reported also in early stages of pulmonary diseases. The role of right ventricle in chronic respiratory disease patients has to be evaluated in detail to describe the response to therapy and the degree of disease progression through multimodality and advanced imaging techniques. The aim of this review is to describe the different pathophysiological mechanisms of cardiac impairment in primary lung disease (such as chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and sarcoidosis) and to summarize the role of cardiac multimodality imaging in the diagnosis and the prognosis of these diseases.

Dynamics and phylogenetic relationships of HIV-1 transmitted drug resistance according to subtype in Italy over the years 2000-14.

Background: Transmitted drug-resistance (TDR) remains a critical aspect for the management of HIV-1-infected individuals. Thus, studying the dynamics of TDR is crucial to optimize HIV care. Methods: In total, 4323 HIV-1 protease/reverse-transcriptase sequences from drug-naive individuals diagnosed in north and central Italy between 2000 and 2014 were analysed. TDR was evaluated over time. Maximum-likelihood and Bayesian phylogenetic trees with bootstrap and Bayesian-probability supports defined transmission clusters. Results: Most individuals were males (80.2%) and Italian (72.1%), with a median (IQR) age of 37 (30-45) years. MSM accounted for 42.2% of cases, followed by heterosexuals (36.4%). Non-B subtype infections accounted for 30.8% of the overall population and increased over time (<2005-14: 19.5%-38.5%, P < 0.0001), particularly among Italians (<2005-14: 6.5%-28.8%, P < 0.0001). TDR prevalence was 8.8% and increased over time in non-B subtypes (<2005-14: 2%-7.1%, P = 0.018). Overall, 467 transmission clusters (involving 1207 individuals; 27.9%) were identified. The prevalence of individuals grouping in transmission clusters increased over time in both B (<2005-14: 12.9%-33.5%, P = 0.001) and non-B subtypes (<2005-14: 18.4%-41.9%, P = 0.006). TDR transmission clusters were 13.3% within the overall cluster observed and dramatically increased in recent years (<2005-14: 14.3%-35.5%, P = 0.005). This recent increase was mainly due to non-B subtype-infected individuals, who were also more frequently involved in large transmission clusters than those infected with a B subtype [median number of individuals in transmission clusters: 7 (IQR 6-19) versus 4 (3-4), P = 0.047]. Conclusions: The epidemiology of HIV transmission changed greatly over time; the increasing number of transmission clusters (sometimes with drug resistance) shows that detection and proper treatment of the multi-transmitters is a major target for controlling HIV spread.

Speckle tracking echocardiography in plasma cell disorders: The role of advanced imaging in the early diagnosis of AL systemic cardiac amyloidosis.

INTRODUCTION: Amyloid light-chain amyloidosis is a rare condition characterized by the abnormal production of immunoglobulin light chain that misshape and form amyloid fibrils. Over time, these amyloid deposits can accumulate slowly, causing dysfunction in organs and tissues. Early identification is crucial to ensure optimal treatment. We aim to identify a better marker of cardiac amyloidosis, using advanced echocardiography, to improve diagnosis and the timing of available treatments. MATERIALS AND METHODS: 108 consecutive hematological patients (32, 30% female and 76, 70% male) with a plasma cell disorder referred to our Cardiological center underwent ECG, first and second-level echocardiography (Speckle Tracking) and complete biochemical profile. The best predictors of ALCA (AUC ≥ 0.8) were included in a further analysis stratified by AL score. RESULTS: At ROC analysis, the best bio-humoral predictors for the diagnosis of ALCA were Nt-pro-BNP (AUC: 0.97; p < 0.01) and Hs-Tn (AUC: 0.87; p < 0.01). Regarding echocardiography, the best diagnostic predictors were left atrial stiffness (LAS) (AUC: 0.83; p < 0.01) for the left atrium; free wall thickness for the right ventricle (AUC: 0.82; <0.01); left ventricular global longitudinal strain (LVGLS) (AUC: 0.92; p < 0.01) and LVMi (AUC 0.80; p < 0.001) for the left ventricle; and AL-score (AUC 0.83 p < 0.01). In patients with AL-SCORE < 1, LAS (AUC 0.86 vs AUC 0.79), LVGLS (AUC 0.92 vs AUC 0.86) and LV mass (AUC 0.91 vs AUC 0.72) had better diagnostic accuracy than patients with higher AL-score (AL SCORE ≥ 1). CONCLUSION: Multi-parametric imaging approach with LVGLS and LAS may be helpful for detecting early cardiac involvement in AL amyloidosis.

[Management of biohazard in health care settings]. / Gestione del rischio biologico in ospedale.

The management of biohazard in health care settings entails multidisciplinarity, valuing the interactions among stakeholders (General Manager, Medical Director, health care workers, prevention and protection units, infection control panels, occupational physicians), with the aim of protecting health and safety of workers, third parties and the health care service. The management issue was tackled within SIMLII guidelines on biohazards, as well as by the SIMLII Section on Preventive Medicine for Health Care Workers, followed by editorial initiatives. This contribution focuses on afield example on the management of data stemming from accidents involving biohazards, highlighting the need of information technology enabling management of enormous amount of health data. This work underlines the primacy of individual risk assessment and management, while combining information on working techniques and procedures with modern health surveillance, on the basis of accredited literature and good medical, organizational and technical practices.

Ageing with HIV: newly diagnosed older adults in Italy.

The prevalence of HIV/AIDS among people in midlife and late adulthood has been increasing in Western countries over the last decade. We analyzed data from a prospective, observational multi-centre study on individuals newly diagnosed with HIV between January 2004 and March 2007 in 10 public counselling and testing sites in Latium, Italy. At diagnosis, routine demographic, epidemiological, clinical and laboratory data are recorded, and patients are asked to complete a questionnaire investigating socio-demographic and psycho-behavioural aspects. To analyze the association of individual characteristics with age, we compared older adults (> or = 50 years) with their younger counterpart (18-49 years). To adjust for potential confounding effect of the epidemiological, clinical and behavioural characteristics, to identify factors associated with older age at HIV diagnosis, multivariate logistic regression analysis was performed. Overall, 1073 individuals were identified, 125 of whom (11.6%) were aged 50 years or above. The questionnaire was completed by 41% (440/1073). Compared with their younger counterparts, a higher proportion of older patients were males, born in Italy, reported heterosexual or unknown HIV risk exposure, were never tested for HIV before and were in a more advanced stage of HIV infection at diagnosis. In addition, older adults had a lower educational level and were more frequently living with their partners or children. With respect to psycho-behavioural characteristics, older patients were more likely to have paid money for sex and have never used recreational drugs. Interestingly, no differences were found regarding condom use, which was poor in both age groups. These findings may have important implications for the management of older adults with HIV, who should be targeted by appropriate public health actions, such as opportunistic screening and easier access to healthcare. Moreover, strategies including information on HIV and prevention of risk behaviours are needed.

Hepatitis B virus, hepatitis C virus and other blood-borne infections in healthcare workers: guidelines for prevention and management in industrialised countries.

The Viral Hepatitis Prevention Board (VHPB) convened a meeting of international experts from the public and private sectors in order to review and evaluate the epidemiology of blood-borne infections in healthcare workers, to evaluate the transmission of hepatitis B and C viruses as an occupational risk, to discuss primary and secondary prevention measures and to review recommendations for infected healthcare workers and (para)medical students. This VHPB meeting outlined a number of recommendations for the prevention and control of viral hepatitis in the following domains: application of standard precautions, panels for counselling infected healthcare workers and patients, hepatitis B vaccination, restrictions on the practice of exposure-prone procedures by infected healthcare workers, ethical and legal issues, assessment of risk and costs, priority setting by individual countries and the role of the VHPB. Participants also identified a number of terms that need harmonization or standardisation in order to facilitate communication between experts.

Long-Term Functional Outcome after Internal Delorme's Procedure for Obstructed Defecation Syndrome, and the Role of Postoperative Rehabilitation.

PURPOSE: To evaluate long-term functional outcomes of Internal Delorme's Procedure (IDP) in patients refractory to conservative treatment for Obstructed Defecation Syndrome (ODS), and to compare those who received postoperative rehabilitation with those who did not. MATERIALS AND METHODS: All patients with ODS refractory to nonoperative therapy were identified across three regional pelvic floor referral hospitals, and IDP was performed. Postoperatively selected patients received biofeedback therapy. Functional outcomes were established using the Cleveland Clinic Constipation (CCC) score and obstructed defecation score (OD score) preoperatively at 12 months and at the last available follow-up. Patient satisfaction was assessed with a visual analogue score. RESULTS: From October 2006 to September 2013, IDP was performed in 170 patients: 77 received postoperative biofeedback and 93 did not. Mean follow-up was 6.3 years (range 1-8 years). CCC and OD scores improved significantly in both groups after 12 months and at the last follow-up (p > 0.05). When comparing two groups while there was no significant difference between CCC and OD scores at 12 months, score was significantly better in the group that received rehabilitation at the last follow-up (p = 0.001). Patient satisfaction was higher in the rehabilitation group (67%) compared with those without rehabilitation (55%). Clinical recurrence was recorded in nine patients who did not have postoperative rehabilitation. CONCLUSIONS: It has been demonstrated that IDP is associated with good long-term functional outcomes. Patients receiving rehabilitation had a better long-term follow-up, a higher overall satisfaction, and lower recurrence rate when compared with the patients who did not receive postoperative rehabilitation.

A curriculum for training healthcare workers in the management of highly infectious diseases.

The SARS epidemic, the threat of bioterrorism, and recent examples of imported highly infectious diseases (HID) in Europe have all highlighted the importance of competent clinical and public health management of infectious disease emergencies. Although the European Union of Medical Specialists in Europe and the Infectious Diseases Society of America have developed curricula for training in infectious disease medicine, neither of those mentions training in the management of HIDs. The European Network for Infectious Diseases (EUNID, http://www.eunid.com) is a European Commission co-funded network of experts in HID management, created to help improve the preparedness for HID emergencies within Europe. One of EUNID's agreed tasks is the development of a curriculum for such a training. Between April 2005 and September 2006, EUNID developed a curriculum and accompanying training course on the basis of a questionnaire that was sent to all country representatives and discussion, followed by amendment of drafts shared through the project website, and a final consensus meeting. The resulting curriculum consists of a two-module course covering the core knowledge and skills that healthcare workers need to safely treat a patient who has, or who may have, an HID. The first module introduces theoretical aspects of HID management, including disease-specific knowledge, infection control, and the public health response, through didactic teaching and class-based discussion. The second module involves a "skill station" and a clinical scenario, and equips trainees with relevant practical skills, including the use of specialised equipment and teamwork practice in patient management. Together, the curriculum and course contribute to the creation of a common framework for training healthcare professionals in Europe, and although they are designed primarily for clinicians that are directly involved in patient care, they are relevant also to public health professionals and others who may be involved in HID management and emergency response.

[Risk factors for hepatitis C virus transmission to Health Care Workers after occupational exposure: a European case-control study]. / Facteurs de risque de transmission accidentelle du VHC au personnel soignant au décours d'un accident exposant au sang: une étude cas-témoins européenne.

BACKGROUND: Factors that influence the risk for HCV infection after occupational exposure to hepatitis C virus (HCV) have not yet been determined. The objective of this study was to assess potential risk factors for Hepatitis C seroconversion after occupational exposure to HCV. METHODS: We conducted a European matched case-control study from 01/01/1991 through 31/12/ 2002. Cases were Health Care Workers (HCWs) who were HCV seronegative at the time of exposure, sustained a documented exposure to HCV, and present documented HCV seroconversion temporally associated with the exposure. Controls-HCWs had a documented exposure to HCV, were HCV seronegative at the time of exposure, and remained so at least 6 months later. Controls were matched to cases for the center and the time period of the exposure occurrence. RESULTS: 60 cases and 204 controls were included. All cases were exposed to HCV-infected materials through percutaneous injuries. Those for whom information was available (61.6%) were exposed to viremic source patients. Multivariate conditional logistic regression analysis, in which HCV viral load was not introduced because of missing values, identified needle placed in the source patient's vein or artery (Odds Ratio [OR]=100.1; 95% Confidence Interval [CI]=7.3-1365.7), deep injury (OR=155.2; 95%CI=7.1-3417.2), and HCW's gender (M vs. F: OR=3.1; 95%CI=1.0-10.0) as risk factors for HCV infection. In univariate unmatched analysis the risk of HCV transmission was increased 11-fold (C195%=1.1-114.1) in HCWs exposed to sources with a viral load>6 log10 copies/mL when compared to sources with a HCV viral load<4 log10 copies/mL. CONCLUSION: The risk of HCV transmission after percutaneous exposure increases with a larger volume of blood, and, a higher titer of HCV in the source patient's blood. The role of HCW's gender need to be further investigated. The results of this study have important implications for counselling and follow-up of HCWs after exposure.

Risk factors for hepatitis C virus transmission to health care workers after occupational exposure: a European case-control study.

BACKGROUND: Additional studies are required to identify risk factors for hepatitis C virus (HCV) transmission to health care workers after occupational exposure to HCV. METHODS: We conducted a matched case-control study in 5 European countries from 1 January 1991 through 31 December 2002. Case patients were health care workers who experienced seroconversion after percutaneous or mucocutaneous exposure to HCV. Control subjects were HCV-exposed health care workers who did not experience seroconversion and were matched with case patients for center and period of exposure. RESULTS: Sixty case patients and 204 control subjects were included in the study. All case patients were exposed to HCV-infected fluids through percutaneous injuries. The 37 case patients for whom information was available were exposed to viremic source patients. As risk factors for HCV infection, multivariate analysis identified needle placement in a source patient's vein or artery (odds ratio [OR], 100.1; 95% confidence interval [CI], 7.3-1365.7), deep injury (OR, 155.2; 95% CI, 7.1-3417.2), and sex of the health care worker (OR for male vs. female, 3.1; 95% CI, 1.0-10.0). Source patient HCV load was not introduced in the multivariate model. In unmatched univariate analysis, the risk of HCV transmission increased 11-fold for health care workers exposed to source patients with a viral load >6 log(10) copies/mL (95% CI, 1.1-114.1), compared with exposures to source patients with a viral load < or =4 log10 copies/mL. CONCLUSION: In this study, HCV occupational transmission was found to occur after percutaneous exposures. The risk of HCV transmission after percutaneous exposure increased with deep injuries and procedures involving hollow-bore needle placement in the source patient's vein or artery. These results highlight the need for widespread adoption of needlestick-prevention devices in health care settings, together with other preventive measures.

The risk of occupational human immunodeficiency virus infection in health care workers. Italian Multicenter Study. The Italian Study Group on Occupational Risk of HIV infection.

BACKGROUND: More than 50 cases of occupationally acquired human immunodeficiency virus (HIV) infection in health care workers (HCWs) have been reported worldwide. Determinants of injuries and of infection are important to investigate to design effective prevention programs. METHODS: In Italy, 29 acute-care public hospitals were enrolled in a multicenter study between 1986 and 1990. At each facility, all HCWs were enrolled who reported percutaneous, mucous-membrane, or nonintact-skin exposure to the body fluids and tissues to which universal precautions apply from an HIV-infected patient. Data were collected at the time of the incident on clinical status of the HIV-infected source, circumstance and type of exposure, and use of infection control precautions. The HCWs were followed up clinically and serologically for HIV infection at 1, 3, 6, and 12 months. RESULTS: A total of 1592 HIV exposures were reported in 1534 HCWs; most exposures (67%) occurred in nurses, followed by physicians and surgeons (17.5%). Needlesticks were the most common source of exposure (58.4%), followed by nonintact-skin and mucous-membrane contamination (22.7% and 11.2%, respectively) and cuts (7.7%). At the time of exposure, 77.5% of the HCWs knew or suspected that the source patient was HIV infected. Two seroconversions were observed among a total of 1488 HCWs followed up for at least 6 months: one occurred in a student nurse who had been stuck with a needle used for an HIV antibody-negative, p24 HIV antigen-positive drug addict; the other was in a nurse who experienced mucous-membrane contamination with a large quantity of blood from an HIV-positive hemophilic patient. The seroconversion rate was 0.10% after percutaneous exposure (1/1003; 95% confidence interval, 0.006% to 0.55%) and 0.63% after mucous-membrane contamination (1/158; 95% confidence interval, 0.018% to 3.47%). CONCLUSIONS: The study demonstrates a small but real risk of HIV infection after percutaneous and mucous-membrane exposure to blood of HIV-infected patients and that transmission can occur during the "window period" of infection. Furthermore, exposures to HIV are not infrequent, and many exposures could be prevented with the use of barrier precautions, appropriate behaviors, and safer devices and techniques.

European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus.

Exposure prevention is the primary strategy to reduce the risk of occupational bloodborne pathogen infections in healthcare workers (HCW). HCWs should be made aware of the medicolegal and clinical relevance of reporting an exposure, and have ready access to expert consultants to receive appropriate counselling, treatment and follow-up. Vaccination against hepatitis B virus (HBV), and demonstration of immunisation before employment are strongly recommended. HCWs with postvaccinal anti-HBs levels, 1-2 months after vaccine completion, >10 mIU/mL are considered as responders. Responders are protected against HBV infection: booster doses of vaccine or periodic antibody concentration testing are not recommended. Alternative strategies to overcome non-response should be adopted. Isolated anti-HBc positive HCWs should be tested for anti-HBc IgM and HBV-DNA: if negative, anti-HBs response to vaccination can distinguish between infection (anti-HBs >50 mUI/ml 30 days after 1st vaccination: anamnestic response) and false positive results(anti-HBs >10 mUI/ml 30 days after 3rd vaccination: primary response); true positive subjects have resistance to re-infection. and do not need vaccination The management of an occupational exposure to HBV differs according to the susceptibility of the exposed HCW and the serostatus of the source. When indicated, post-exposure prophylaxis with HBV vaccine, hepatitis B immunoglobulin or both must be started as soon as possible (within 1-7 days). In the absence of prophylaxis against hepatitis C virus (HCV) infection, follow-up management of HCV exposures depends on whether antiviral treatment during the acute phase is chosen. Test the HCW for HCV-Ab at baseline and after 6 months; up to 12 for HIV-HCV co-infected sources. If treatment is recommended, perform ALT (amino alanine transferase) activity at baseline and monthly for 4 months after exposure, and qualitative HCV-RNA when an increase is detected.

European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus.

Exposure prevention is the primary strategy to reduce the risk of occupational bloodborne pathogen infections in healthcare workers (HCW). HCWs should be made aware of the medicolegal and clinical relevance of reporting an exposure, and have ready access to expert consultants to receive appropriate counselling, treatment and follow-up. Vaccination against hepatitis B virus (HBV), and demonstration of immunisation before employment are strongly recommended. HCWs with postvaccinal anti-HBs levels, 1-2 months after vaccine completion, >or=10 mIU/mL are considered as responders. Responders are protected against HBV infection: booster doses of vaccine or periodic antibody concentration testing are not recommended. Alternative strategies to overcome non-response should be adopted. Isolated anti-HBc positive HCWs should be tested for anti-HBc IgM and HBV-DNA: if negative, anti-HBs response to vaccination can distinguish between infection (anti-HBs >or=50 mUI/ml 30 days after 1st vaccination: anamnestic response) and false positive results(anti-HBs >or=10 mUI/ml 30 days after 3rd vaccination: primary response); true positive subjects have resistance to re-infection. and do not need vaccination The management of an occupational exposure to HBV differs according to the susceptibility of the exposed HCW and the serostatus of the source. When indicated, post-exposure prophylaxis with HBV vaccine, hepatitis B immunoglobulin or both must be started as soon as possible (within 1-7 days). In the absence of prophylaxis against hepatitis C virus (HCV) infection, follow-up management of HCV exposures depends on whether antiviral treatment during the acute phase is chosen. Test the HCW for HCV-Ab at baseline and after 6 months; up to 12 for HIV-HCV co-infected sources. If treatment is recommended, perform ALT (amino alanine transferase) activity at baseline and monthly for 4 months after exposure, and qualitative HCV-RNA when an increase is detected.

A cytopathic effect of Trichomonas vaginalis probably mediated by a mannose/N-acetyl-glucosamine binding lectin.

The pathogenic effect of a highly pathogenic strain of Trichomonas vaginalis on McCoy cell monolayers was investigated. Specific inhibition of the cytopathic effect by monosaccharides, such as N-acetyl-glucosamine (GlcNAc) and mannose (Man), was observed. Our preliminary results suggest that the pathogenicity of T. vaginalis depends on a lectin specifically sensitive to GlcNAc and to a lesser extent to Man. Although N-acetyl-mannosamine was found to be the most efficient inhibitor, this effect seems to be unrelated to the natural biological behaviour of the infested host.

Characterisation of an ATP diphosphohydrolase (Apyrase, EC 3.6.1.5) activity in Trichomonas vaginalis.

In the present report the enzymatic properties of an ATP diphosphohydrolase (apyrase, EC 3.6.1.5) in Trichomonas vaginalis were determined. The enzyme hydrolyses purine and pyrimidine nucleoside 5'-di- and 5'-triphosphates in an optimum pH range of 6.0--8.0. It is Ca(2+)-dependent and is insensitive to classical ATPase inhibitors, such as ouabain (1 mM), N-ethylmaleimide (0.1 mM), orthovanadate (0.1 mM) and sodium azide (5 mM). A significant inhibition of ADP hydrolysis (37%) was observed in the presence of 20 mM sodium azide, an inhibitor of ATP diphosphohydrolase. Levamisole, a specific inhibitor of alkaline phosphatase, and P(1), P(5)-di (adenosine 5'-) pentaphosphate, a specific inhibitor of adenylate kinase, did not inhibit the enzyme activity. The enzyme has apparent K(m) (Michaelis Constant) values of 49.2+/-2.8 and 49.9+/-10.4 microM and V(max) (maximum velocity) values of 49.4+/-7.1 and 48.3+/-6.9 nmol of inorganic phosphate x min(-1) x mg of protein(-1) for ATP and ADP, respectively. The parallel behaviour of ATPase and ADPase activities and the competition plot suggest that ATP and ADP hydrolysis occur at the same active site. The presence of an ATP diphosphohydrolase activity in T. vaginalis may be important for the modulation of nucleotide concentration in the extracellular space, protecting the parasite from the cytolytic effects of the nucleotides, mainly ATP.

Risk of exposure to bloodborne infection for Italian healthcare workers, by job category and work area. Studio Italiano Rischio Occupazionale da HIV Group.

OBJECTIVE: To analyze the rate of occupational exposure to blood and body fluids from all sources and specifically from human immunodeficiency virus (HIV)-infected sources among hospital workers, by job category and work area. DESIGN: Multicenter prospective study. Occupational exposure data (numerator) and full-time equivalents ([FTEs] denominator) were collected over a 5-year period (1994-1998) and analyzed. SETTING: 18 Italian urban acute-care hospitals with infectious disease units. RESULTS: A total of 10,988 percutaneous and 3,361 mucocutaneous exposures were reported. The highest rate of percutaneous exposure per 100 FTEs was observed among general surgery (11%) and general medicine (10.6%) nurses, the lowest among infectious diseases (1.1%) and laboratory (1%) physicians. The highest rates of mucocutaneous exposure were observed among midwives (5.3%) and dialysis nurses (4.7%), the lowest among pathologists (0%). Inadequate sharps disposal and the prevalence of sharps in the working unit influence the risk to housekeepers. The highest combined HIV exposure rates were observed among nurses (7.8%) and physicians (1.9%) working in infectious disease units. The highest rates of high-risk percutaneous exposures per 100 FTE were again observed in nurses regardless of work area, but this risk was higher in medical areas than in surgery (odds ratio, 2.1; 95% confidence interval, 1.9-2.5; P<.0001). CONCLUSION: Exposure risk is related to job tasks, as well as to the type and complexity of care provided in different areas, whereas HIV exposure risk mainly relates to the prevalence of HIV-infected patients in a specific area. The number of accident-prone procedures, especially those involving the use of hollow-bore needles, performed by job category influence the rate of exposure with high risk of infection. Job- and area-specific exposure rates permit monitoring of the effectiveness of targeted interventions and control measures over time.

Risk of HIV and other blood-borne infections in the cardiac setting: patient-to-provider and provider-to-patient transmission.

Health care workers (HCWs) face a well-recognized risk of acquiring blood-borne pathogens in their workplace, in particular hepatitis B and C viruses (HBV/HBC) and human immunodeficiency virus (HIV). Additionally, infected HCWs performing invasive exposure-prone procedures, including in the cardiac setting, represent a potential risk for patients. An increasing number of infected persons could need specific cardiac diagnostic procedures and surgical treatment in the future, regardless of their sex or age. The risk of acquiring HIV, HCV, HBV infection after a single at-risk exposure averages 0.5%, and 1-2%, and 4-30%, respectively. The frequency of percutaneous exposure ranges from 1 to 15 per 100 surgical interventions, with cardiothoracic surgery reporting the highest rates of exposures; mucocutaneous contamination by blood-splash occurs in 50% of cardiothoracic operations. In the Italian Surveillance (SIROH), a total of 987 percutaneous and 255 mucocutaneous exposures were reported in the cardiac setting; most occurred in cardiology units (46%), and in cardiovascular surgery (44%). Overall, 257 source patients were anti-HCV+, 54 HBsAg+, and 14 HIV+. No seroconversions were observed. In the literature, 14 outbreaks were reported documenting transmission of HBV from 12 infected HCWs to 107 patients, and 2 cases of HCV to 6 patients, during cardiothoracic surgery, especially related to sternotomy and its suturing. The transmission rate was estimated to be 5% to 13% for HBV, and 0.36% to 2.25% for HCV. Strategies in risk reduction include adequate surveillance, education, effective sharps disposal, personal protective equipment, safety devices, and innovative technology-based intraoperative procedures.

Metabolic and morphologic disorders in patients treated with highly active antiretroviral therapy since primary HIV infection.

UNLABELLED: Our objective was to describe morphologic and metabolic disorders in patients treated with highly active antiretroviral therapy (HAART) since primary HIV infection (PHI). Our method was prospective evaluation of patients with PHI initiating HAART at the time of diagnosis. Outcome measures were: development of hyperglycemia, hypercholesterolemia, hypertriglyceridemia, and of body shape abnormalities indicative of lipodystrophy, assessed through self-reported questionnaires and physical examination. RESULTS: From May 1997 to April 2001, 41 patients (35 males) with PHI presented at the National Institute for Infectious Diseases "Lazzaro Spallanzani" in Rome, Italy. A protease inhibitor-including regimen was started in 30 patients, and a nonnucleoside reverse transcriptase-inhibitor in 11. Median interval between enrollment and treatment initiation was 30 days (mean 39, range 10-150). Median HAART duration was 19 months (mean 21.2, range 3-47). Thirty-eight patients had undetectable (less than 80 cp/mL) HIV RNA after a median of 3 months (mean 4.1, range 1-15). Mean CD4 cells count increased from 632/mmc at baseline to 936/mmc at the last follow up. No cases of hyperglycemia (glucose level greater than 110 mg/dL) were observed. After a median of 6 months on HAART, 10 patients developed beyond grade 2 (greater than 240 mg/dL) hypercholesterolemia, 5 developed beyond grade 2 (greater than 400 mg/dL) hypertrygliceridemia, and two developed both. Body mass index did not change significantly. Five patients (12.2%) developed lipodystrophy after a median of 14.5 months (mean 15.3, range 2-30), with an incidence of 7.3 per 100 patient-years. CONCLUSIONS: Dyslipidemia and lipodystrophy can occur in patients treated with HAART since PHI. This risk of should be taken into account when considering this early antiretroviral treatment of HIV infection.

Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval.

Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: (i) identify diseases or drugs for which formal HR-QOL assessment is recommended; (ii) identify measures and methods recommended; and (iii) evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts.