Performance of an antigen assay for diagnosing acute hepatitis E virus genotype 3 infection

BackgroundHepatitis E virus (HEV) is a major cause of hepatitis worldwide. Its diagnosis is based on the detection of anti-HEV IgM and/or HEV-RNA.ObjectiveTo evaluate the performance of the Wantaï HEV-antigen (Ag) ELISA^Plus assay for diagnosing acute HEV infections.Study designSpecificity was assessed using 100 blood samples containing no anti-HEV IgM, anti-HEV IgG, or HEV-RNA. Cross reactivity was assessed using samples positive for hepatitis C virus RNA (n = 10), Epstein-Barr virus DNA (n = 10) and cytomegalovirus DNA (n = 10). Serial dilutions of 4 HEV RNA positive samples were used to estimate the corresponding viremia detected with the Ag assay. Blood samples from 33 immunocompetent and 31 immunocompromised patients with an acute HEV genotype 3 infection, HEV-RNA positive, were tested to assess diagnostic sensitivity.ResultsThe HEV-Ag assay was 100% specific, with no cross-reactivity. The lower viremias detected ranged from 10³ copies/ml to 10⁵ copies/ml (800–80,000 UI/ml). Diagnostic sensitivity for an acute HEV infection was 91%, with no significant difference between immunocompetent (88%) and immunocompromised (94%) patients. The HEV-Ag assay was more frequently positive in immunocompromised patients at the acute phase (94%) than was the anti-HEV IgM test (71%; p = 0.04). The HEV-Ag assay ratio was correlated with HEV-RNA viral load (ρ = 0.54; p < 0.0001).ConclusionThe HEV-Ag assay performed well and could be suitable for laboratories with no molecular diagnosic facilities.     

Evaluation of two VIDAS ®prototypes for detecting anti-HEV IgG

BackgroundHigh performance anti-hepatitis E virus (HEV) IgG assays are crucial for epidemiology.ObjectiveTo evaluate the performance of 2 prototypes developed for the VIDAS^® automatic system for detecting anti-HEV IgG, one based on the ORF2 antigen (ORF2 prototype) and the other on the ORF2 and ORF3 antigens (ORF2/3 prototype), with reference to the Wantai anti-HEV IgG assay.Study designThe sensitivity of each assay was determined by testing 113 blood samples, 63 from immunocompetent and 50 from immunocompromised patients, with a proven HEV infection defined by detecting HEV RNA. Their specificity was assessed with 103 blood samples that the Wantai assay indicated was negative for anti-HEV IgM and IgG, and negative for HEV-RNA. Cross reactivity was assessed using samples that were positive for hepatitis A virus IgG (n = 16), hepatitis C virus antibodies (n = 15), hepatitis B virus antigen and anti-HBc antibodies (n = 16), rheumatoid factor (n = 14), and negative for anti-HEV IgG with the Wantai assay.ResultsThe sensitivities in immunocompetent patients were: 95.2% (ORF2), 96.8% (ORF2/3), and 93.6% (Wantai); in immunocompromised patients they were: 66% (ORF2), 72% (ORF2/3), and 68% (Wantai). Both VIDAS prototypes detected low concentrations of anti-HEV IgG. The overall specificity was 100% (ORF2 prototype) and 98.1% (ORF2/3 prototype). Both VIDAS prototypes cross-reacted in five samples (9.6%), mainly those containing HCV antibodies or rheumatoid factor.ConclusionBoth VIDAS^® prototypes performed very well and appear to be suitable for routine detection of anti-HEV IgG.     

Discrepancy between anti-hepatitis E virus immunoglobulin G prevalence assessed by two assays in kidney and liver transplant recipients

BackgroundHepatitis E virus (HEV) is an emerging clinical threat in Europe among kidney and liver-transplant recipients. The incidence and prevalence of HEV infection in this special population are poorly known. False-negative results have been observed for anti-HEV IgG detection in severely immunocompromized persons. Moreover, large discrepancies have been reported between rates of anti-HEV IgG detection in blood donors and hepatitis E cases.ObjectivesTo compare anti-HEV IgG and IgM prevalence using two different commercial microplate enzyme-immuno assays (MEIAs) (Adaltis and Wantai) in 64 kidney-/liver-transplant recipients.Study designSerum samples tested in our routine clinical practice over the 12/2009–12/2011 period with Adaltis MEIAs were retrospectively tested using Wantai MEIAs. IgG-positive sera were further tested by an immunoblot while those found IgM-positive were further tested with an immunochromatography rapid test and for the presence of HEV RNA.ResultsPositive results on anti-HEV IgG testing were obtained for seven (10.9%) compared to 20 (31.3%) serum samples with Adaltis and Wantai assays, respectively (p = 0.005). Then, 6/7 (86%) of the serum samples positive with Adaltis and 16/20 (80%) of those positive with Wantai were positive with the immunoblot. One patient with chronic HEV infection was IgG-negative with both MEIAs. Regarding anti-HEV IgM, Adaltis and Wantai assays were concordant for 97% of the serum samples, prevalence being 8% with both MEIAs.ConclusionsThe accuracy of currently available commercial or in-house anti-HEV IgG MEIAs should be tested comparatively on a panel of serum samples collected from solid organ-transplant recipients, including some who experienced PCR-documented HEV infection.     

Low frequency of acute hepatitis E virus (HEV) infections but high past HEV exposure in subjects from Cambodia with mild liver enzyme elevations,unexplained fever or immunodeficiency due to HIV-1 infection

BackgroundIn Cambodia, previous studies conducted on hepatitis E virus (HEV) infection are scant, sometimes old, and showed inconsistent results. Moreover, there is no data about HEV infection in Cambodian HIV-1-infected patients.ObjectivesTo assess the occurrence of acute HEV infections and the level of past HEV exposure in one Mekong country.Study designUsing anti-HEV IgM and HEV RNA detection, we retrospectively investigated the presence of acute HEV infection in 825 individuals, including 350 subjects with or without fever, 300 subjects with or without liver enzyme elevations (LEE) and 175 antiretroviral treatment (ART)-naïve, severely immunocompromised HIV-1-infected patients. The detection of anti-HEV IgG was also performed to assess ancient HEV exposure.ResultsNine individuals tested positive for anti-HEV IgM yielding an overall rate of 1.1% (95% confidence interval (CI), 0.5–2.0). We did not find significant differences for anti-HEV IgM rates between subjects with unexplained fevers (1.5%) and those with malaria or dengue-associated fever (1.7%) or non-febrile individuals (0%) (P = 0.49), and between subjects with (1.5%) and without (2.0%) LEE (P = 0.87). No HIV-infected patient tested positive for anti-HEV IgM. HEV RNA was not detected in all tested plasma specimens (n = 578). Overall, the anti-HEV IgG prevalence rate was 30.1% (95% CI, 27.0–33.2).ConclusionsThe scarcity of recent HEV infection contrasted with the high level of past HEV exposure. The role of HEV in liver disease is likely minor in Cambodia since no HEV RNA was detected in our studied populations, including HIV-positive patients with severe immunodepression.     

Seroprevalence of hepatitis E antibodies in a population of recyclable waste pickers in Brazil

BackgroundHepatitis E virus (HEV) infection represents an important cause of acute viral hepatitis. Selective waste collection is a widespread activity carried out by the urban poor, and recyclable waste pickers have a lifestyle that makes this group highly vulnerable to unfavorable socio-economic and environmental factors. To date, the epidemiology of HEV infection in this population remains unknown.ObjectivesTo assess the seroprevalence of hepatitis E-specific antibodies in a population of recyclable waste pickers in Brazil.Study designBetween April 2010 and May 2011, a cross-sectional study was conducted among recyclable waste pickers from all 15 recycling cooperatives in Goiânia City, Central Brazil. The participants were tested for serological markers indicative of HEV infection.ResultsOf 432 individuals asked to participate in the survey, 431 (99.8%) agreed to participate. Twenty-four of 431 participants were anti-HEV IgG positive by ELISA. Of these, 22 were confirmed positive by immunoblot, resulting in an anti-HEV IgG prevalence of 5.1% (95% CI: 3.4–7.6). In addition, four individuals were anti-HEV IgM positive by ELISA. Of these, three (0.7%; 95% CI: 0.4–2.4) were confirmed anti-HEV IgM positive by immunoblot, but were HEV RNA negative. One was concurrently positive for anti-HEV IgG. Only age > 40 years was independently associated with the presence of anti-HEV.ConclusionsThese findings demonstrated that the prevalence of HEV antibodies among recyclable waste pickers in Central Brazil is relatively low and increased with age.     

High seroprevalence against hepatitis E virus in patients with chronic hepatitis C virus infection

BackgroundHepatitis E virus (HEV) genotype 3 is endemic in Europe. Superinfection with HEV in patients with underlying chronic liver disease can cause hepatic decompensation leading to increased morbidity and mortality.ObjectivesThe prevalence of anti-HEV antibodies was investigated in 204 patients with chronic hepatitis C virus (HCV) infection and different stages of fibrosis.Study designSera were analyzed for anti-HEV IgG, IgM and HEV RNA.ResultsThe median age of the patients was 55 years (IQR 40–62 years); 126 (62%) were men. Ninety-eight (48%) patients had a METAVIR fibrosis stage F2 or higher. The prevalence of anti-HEV IgG was 30% (62/204), which was significantly higher than among Swedish blood donors (17%, p < 0.01). The prevalence of anti-HEV antibodies was associated with higher age (OR 1.08 (1.05–1.11); p < 0.01). It was also higher for patients with a prior history of blood transfusion (48%) as compared to intravenous drug use (IDU; 26%) as the risk factor for acquisition of the HCV infection (OR 2.72 (1.2–6.19); p < 0.02). The prevalence of anti-HEV IgG was also significantly higher in patients with significant fibrosis, i.e. ≥F2 (38%; OR 2.04 (1.11–3.76); p = 0.02) and/or neoplasm (72%; OR 7.27 (2.46–21.44); p < 0.01).ConclusionsWhen adjusted for age, the prevalence of anti-HEV antibodies was significantly higher in patients with previous or current malignant liver disease compared to blood donors. The lack of significant correlation between HCV and HEV infections indicate low level of transmission of HEV by IDU. HEV infections warrant more attention, especially in patients with preexisting liver disease.     

Evaluation of rapid tests for diagnosis of acute hepatitis E

BackgroundHepatitis E virus diagnosis still presents difficulties due to discordant results among diagnostic tests.ObjectivesThe aim of this study was to evaluate the performance of two rapid tests for detection of anti-HEV IgM antibodies.Study designThe rapid tests were compared with three commercial anti-HEV ELISA assays and one Real-Time PCR assay on 59 sera from patients with acute viral non-AC hepatitis.ResultsThe presence of anti-HEV IgM antibodies was evaluated by two rapid tests (Wantai and Assure) on 25 HEV RNA positive samples. Anti-HEV IgM antibodies were detected in 24/25 and 23/25 samples respectively. The sensitivity and specificity of Wantai and Assure Rapid tests were evaluated using the 25 HEV RNA positive samples and 50 HEV RNA negative samples (including sera from acute-phase HAV and HBV infections and blood donors). Overall, the sensitivity of Wantai Rapid and Assure Rapid tests was 96.1% and 92.6% respectively; the specificity of the 2 tests was 100%.ConclusionOur data suggest the potential use of anti-HEV IgM rapid assays as a first line test in primary health care settings, particularly useful for patients with chronic liver disease or pregnant women who urgently need an antiviral treatment.     

Hepatitis E virus seroprevalence in three hyperendemic areas: Nepal,Bangladesh and southwest France

BackgroundHepatitis E causes a significant burden of disease in developing countries and has recently been increasingly recognized in developed countries. Comparing population anti-hepatitis E virus (HEV) seroprevalence across populations has been difficult.ObjectivesThe aim of this study was to compare the anti-HEV IgG seroprevalence in both adults and children in three hyper-endemic areas (Nepal, Bangladesh and southwest France) using a sensitive, commercial anti-HEV IgG assay.Study DesignSerum or plasma from adults and children in Nepal (n=498), Bangladesh (n = 1,009) and Southwest France (n = 1031) were tested for anti-HEV IgG using the Wantai assay.ResultsAfter age-standardization, anti-HEV IgG seroprevalence was 47.1%, 49.8% and 34.0% in Nepal, Bangladesh and southwest France, respectively. There was no difference in seroprevalence by gender in any of the countries. A paucity of infections in children 1–10 years-old was consistently observed (less than 15%) at all 3 locations.ConclusionsSurprisingly similar high rates of anti-HEV antibodies were detected using a common, sensitive assay. Despite differences in the epidemiology and circulating genotype of HEV in Nepal, Bangladesh and southwest France, this study found more similarities in population seroprevalence than expected.     

Incidence and seroprevalence of hepatitis E virus infection in pregnant women infected with hepatitis B virus and antibody placental transfer in infants

BackgroundHepatitis E has poor outcomes in pregnant women. Superinfection of hepatitis E virus (HEV) in patients infected with hepatitis B virus (HBV) may worsen liver disease.ObjectivesTo estimate the incidence and seroprevalence of HEV infection among HBV-infected pregnant women, to investigate the transplacental transfer of maternal anti-HEV IgG, and to compare the maternal and neonatal outcomes in anti-HEV positive and negative pregnant women.Study designTotally 391 HBV-infected pregnant women were recruited from April 2012 to October 2014. Paired mothers and infants were followed up at an average 9.8 months postpartum. Anti-HEV IgG and IgM were tested by ELISA.ResultsOf the pregnant women, none was anti-HEV IgM positive and 42 (10.7%) were IgG positive. At the follow-up, 3 seronegative women converted to anti-HEV IgG positive, with an estimated incidence of 17 per 1000 person-years. No significant differences of gestational age, preterm birth rate, Apgar score and birthweight were observed between newborns of anti-HEV IgG positive and negative mothers. Of the 42 neonates born to anti-HEV IgG positive mothers, 38 (90.5%) had anti-HEV IgG in their cord blood. The neonatal and maternal anti-HEV IgG levels were positively correlated (r = 0.827, p < 0.05). All infants were negative for both anti-HEV IgM and IgG at the follow-up.ConclusionsHBV-infected pregnant women rarely have novel HEV infection during late pregnancy in Jiangsu, China. Maternal anti-HEV IgG efficiently transfers into the fetuses, and disappears in infants before 10 months old.     

Prevalence of antibodies and RNA genome of hepatitis E virus in a cohort of French immunocompromised

BackgroundRecently, cases of chronic hepatitis E have been identified in immunocompromised patients.ObjectivesTo evaluate the prevalence of anti-HEV IgG antibodies and the persistence of HEV-RNA in sera of immunocompromised patients with regular follow-up at Saint-Louis Hospital in Paris, France.Study design307 samples collected from 261 HIV-infected patients and 46 kidney transplant (KT)-patients were retrospectively tested for the presence of the following hepatitis E virus (HEV) infection markers: anti-HEV IgM antibodies, anti-HEV IgG antibodies, anti-HEV IgG avidity index, and HEV-RNA.ResultsAnti-HEV IgG positive serology was found in 4 HIV-infected patients (1.5%) and 3 KT-patients (6.5%), leading to an overall seroprevalence of 2.3%. HEV-RNA detection was not observed among 55 HIV-patients at higher risk of chronic HEV (<200 CD4 cells/mm³, elevated alanine aminotransferase (ALT) levels, and/or positive anti-HEV antibodies) and among 44 KT-patients. None of the seven patients had anti-HEV IgM antibodies, thereby excluding any acute infection. The IgG avidity index confirmed past HEV infection among tested patients.ConclusionsThe low seroprevalence observed in the Paris region does not warrant a systematic evaluation of HEV infection in immunocompromised patients. However, HEV infection must be examined as a possibility if unexplained increases in ALT should occur and after more common viral hepatitis infections are excluded.     

Hepatitis E virus infections in children age 0–15, Uganda outbreak, 2007

BackgroundThe epidemiology of hepatitis E virus (HEV) infections among children is not well understood, with some studies reporting that hepatitis E infections do not affect children.ObjectivesWe analyzed seroepidemiologic data collected during a hepatitis E outbreak in Uganda to determine prevalence of past and recent HEV infections among children aged 0–15 years.Study designIndividuals were randomly selected from a household census to participate in a seroprevalence survey. We analyzed data on IgM and IgG antibody to HEV among children aged 0–15 years. We categorized the study population by age group [aged 0–5, 6–10, and 11–15 years], and further stratified the youngest children [aged 0–1, 2–3, and 4–5 years]. Presence of IgG anti-HEV alone indicated past HEV infection, whereas recent infection was defined as presence of IgM anti-HEV with or without IgG anti-HEV.ResultsAmong children aged 0–15 years (N = 244), prevalence of past HEV infection was 25.4% (62/244) and was highest among children aged 0–5 years [31.0% (27/87)]. Evidence of recent HEV infection was detected in 37.3% (91/244) of children aged 0–15 years. Among younger children, recent HEV infection increased with age from 4.3% (1/23) in children aged 0–1 year to 36.7% (11/30) in children aged 4–5 years.ConclusionThese data show that children are not spared from HEV infections. Illness during childhood in developing countries is common and HEV infections may be misdiagnosed as another acute illness, or under diagnosed. The lack of clinical care, HEV diagnostics, and surveillance in developing countries limit our full understanding of hepatitis E epidemiology.     

The diagnostic and prognostic significance of soluble urokinase plasminogen activator receptor in Crimean-Congo hemorrhagic fever

BackgroundCrimean-Congo hemorrhagic fever (CCHF) is a potentially fatal disease caused by a tick-borne virus from the Bunyaviridae family. It has recently been reported that soluble urokinase-type plasminogen activator receptor (suPAR), secreted from endothelial cells and the mononuclear phagocyte system, one of the main targets of the CCHF virus, is a potential biomarker for several bacterial and viral infection diseases.ObjectivesThis study was intended to determine the diagnostic and prognostic significance of suPAR levels in CCHF.Study designThis retrospective study was conducted between June 2006 and August 2009 using plasma from patients monitored with a diagnosis of CCHF and from healthy blood donors. Levels of plasma suPAR were determined using an enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.ResultsOne hundred CCHF patients were enrolled in the study. The control group was made up of 53 healthy blood donors. suPAR values of 6.2 ± 4.2 were determined in the CCHF patients and of 2.3 ± 0.6 in the control group (p < 0.0001). A suPAR level optimum diagnostic cut-off point of 3.06 ng/mL was determined, with an area underneath the ROC (AUROC) curve of 0.94 (95% CI: 0.89–0.97), sensitivity of 87% (95% CI: 79–93%), specificity of 92% (95% CI: 82–98%), PPV of 95% and NPV of 79%. Five of the patients died. suPAR was 18.4 ± 9.1 in the patients that died and 5.6 ± 2.6 in the survivors (p = 0.034). In terms of mortality, suPAR level had an optimum diagnostic cut-off point of 10.6 ng/mL, AUROC of 0.97 (95% CI: 0.94–0.99), sensitivity of 100% (95% CI: 48–100%), specificity of 96% (95% CI: 90–99%), PPV of 50% and NPV of 100%.ConclusionsPlasma suPAR level, a new biomarker, is a test that can be used in the differential diagnosis and monitoring of CCHF in patients admitted to hospital with suspected infection. The test is at the same time important in being a possible predictor of mortality.     

Sporadic cases of acute autochthonous hepatitis E virus infection in Southwest Germany

Hepatitis E infection is usually a self-limiting disease and an important cause of acute hepatitis in tropical and subtropical regions where the virus is endemic. In industrialized countries, sporadic cases of acute hepatitis E virus (HEV) infections have been described and the number of documented autochthonous infections seems to be increasing. We report three sporadic cases of autochthonous hepatitis E infections in Southwestern Germany which presented at our university hospital within two years. All cases were men who presented with acute hepatitis, icterus and elevated liver. In case 1 and case 2, liver biopsy revealed acute hepatitis, both patients were positive for anti-HEV antibodies, case 1 was also positive for HEV RNA with a viral load of 3.0 × 10³ copies/ml in serum. In case 3, anti-HEV antibodies were detectable and HEV RNA was detected in serum (4.3 × 10³ copies/ml) and stool (1.4 × 10⁶ copies/ml). None of the patients had a recent travel history outside Germany and close contact to animals has been denied. HEV sequence analysis of two patients revealed genotype 3 with homologies to other European isolates and isolates from swine. Thus the source of infection remains unclear. Hepatitis E should be considered in differential diagnosis in patients with unexplained hepatitis and patients with acute hepatitis, whatever their age or travel history might be, should be tested for HEV.     

Clinical evaluation of a multi-parameter customized respiratory TaqMan® array card compared to conventional methods in immunocompromised patients

BackgroundRespiratory viral infections can cause significant morbidity and mortality in immunocompromised patients. Conventional tests routinely available at most institutions are limited by the number of detectable pathogens, by a poor sensitivity and/or a long turnaround time.ObjectivesTo compare the performance of routine conventional testing with direct fluorescent antibody assays and viral culture to a customized TaqMan® array card (TAC) real-time PCR method, targeting 24 viruses, 8 bacteria and 2 fungi simultaneously.Study designWe collected 143 respiratory samples from 120 symptomatic immunocompromised patients. Samples for which conventional and TAC results were discordant underwent further verification testing.ResultsThe TAC assay identified viral pathogens in more samples than did conventional testing (77/143 versus 27/143; McNemar P < 0.0001), even when TAC results for viruses that could not be detected by conventional testing were excluded from analysis (59/143 versus 26/143; P < 0.0001). In addition, the TAC assay identified 18 samples with non-viral pathogens. Verification testing confirmed positive TAC results for 50 out of 55 samples for which conventional testing was negative. Two out of three samples with a positive conventional test but negative TAC result were confirmed positive. A viral and a total pathogen co-infection rate of 5.6% and 11.8% were found, respectively.ConclusionsThe customized TAC assay resulted in a significantly increased identification of respiratory viruses. This study provides a practical real-life assessment of the performance of the TAC assay in a population for whom rapid and accurate diagnosis of viral and atypical pathogens is crucial for appropriate clinical management.     

Human enterovirus and rhinovirus infections are associated with otitis media in a prospective birth cohort study

BackgroundHuman enteroviruses (HEVs) and rhinoviruses (HRVs) have been linked to acute otitis media (AOM).ObjectivesThe present study evaluates the aforementioned association in a birth cohort setting.Study designThe cohort included 286 healthy infants (191 boys) followed from birth up to the age of 2 years in the Type 1 Diabetes Prediction and Prevention study in Finland. Stool samples were collected monthly and analyzed for the presence of HRV and HEV RNA using RT-PCR. Clinical symptoms were recorded by a questionnaire every 3–6 months.ResultsAltogether 610 AOM episodes were reported during the follow-up. 9.8% of the stool samples were positive for HRV and 6.8% for HEV. HRV positivity peaked at the age of 3–6 months declining gradually after this age, whereas HEV positivity peaked later, at the age of 12–24 months. The risk of AOM was increased in children who were HEV positive at least once at the age of 6–12 months (OR 2.2 [95%CI 1.1–4.2], P = 0.023) or who were HRV positive at least once at the age of 18–24 months (OR 2.3 [95%CI 1.0–5.2], P = 0.042). Having an older sibling, short breast-feeding and maternal smoking during pregnancy were also significantly associated with AOM.ConclusionsHRV and HEV infections are frequent during the first months of life. The observed trend for increased risk of AOM in HRV and HEV positive children is in line with the results from hospital series suggesting that these viruses may play an independent role in the pathogenesis of AOM.     

Providing prenatal care to pregnant women with overweight or obesity: Differences in provider communication and ratings of the patient-provider relationship by patient body weight

ObjectiveTo examine the association of women’s body weight with provider communication during prenatal care.MethodsWe coded audio recordings of prenatal visits between 22 providers and 117 of their patients using the Roter Interaction Analysis System. Multivariate, multilevel Poisson models were used to examine the relationship between patient pre-pregnancy body mass index and provider communication.ResultsCompared to women with normal weight, providers asked fewer lifestyle questions (IRR 0.66, 95% CI 0.44–0.99, p = 0.04) and gave less lifestyle information (IRR 0.51, 95% CI 0.32–0.82, p = 0.01) to women with overweight and obesity, respectively. Providers used fewer approval (IRR 0.68, 95% CI 0.51–0.91, p = 0.01) and concern statements (IRR 0.68, 95% CI 0.53–0.86, p = 0.002) when caring for women with overweight and fewer self-disclosure statements caring for women with obesity (IRR 0.40, 95% CI 0.19–0.84 p = 0.02).ConclusionLess lifestyle and rapport building communication for women with obesity may weaken patient-provider relationship during routine prenatal care.Practice implicationsInterventions to increase use of patient-centered communication – especially for women with overweight and obesity – may improve prenatal care quality.     

Detecting the effects of physician training in self-care interviewing skills: Coding of standardized patient (SP) visit recordings versus SP post-visit ratings

ObjectiveTo compare how coder ratings of standardized patient (SP) visit recordings and SP ratings of the visits detect primary care physician (PCP) training in self-efficacy enhancing interviewing techniques (SEE IT).MethodsAnalyses of data from 50 PCPs who participated in a randomized controlled trial of SEE IT training, which led to increased SEE IT use during three SP visits 1–3 months post-intervention. Untrained SPs rated SEE IT use post-visit. Subsequently, three trained coders generated a consensus SEE IT rating from visit audio recordings. SPs and coders were blinded to provider study arm, and coders to SP ratings.ResultsSP and coder ratings were correlated (r = 0.62). In detecting the intervention effect, the areas under the receiver operating characteristic curve were 0.80 (95% CI 0.74–0.87) and 0.76 (95% CI 0.69–0.84) for consensus coder and SP ratings, respectively (difference 0.04, 95% CI −0.04–0.11; z = 1.04, p = 0.30).ConclusionSP ratings were not significantly different from coder ratings of SP visit recordings in detecting PCP SEE IT training.Practice implicationsIf similar findings are observed in larger studies, it would suggest a greater role for SP ratings in detecting provider interviewing skills training, given the relative simplicity, low cost, and non-intrusiveness of the approach.     

Comparison the effect of lateral wedge insole and acupuncture in medial compartment knee osteoarthritis: A randomized controlled trial

BackgroundThere is lack of well-designed trials evaluating structural benefits of non-pharmacologic therapies in knee osteoarthritis (OA). In this parallel-group randomized controlled trial, we aim to compare the possible advantages of lateral wedge insole and acupuncture in patients with medial knee OA.MethodPatients with grade two or three of medial knee OA were randomly allocated to group one who received an in shoe lateral wedge and group two who underwent acupuncture. We assessed patients' pain, function and knee joint cartilage thickness before and after intervention. Paired t-test and independent samples t-test were used for in group and between group analyses. (Level of evidence: 2.)ResultsTwenty patients in each group were recruited in the study. Pain significantly decreased after therapy in both groups one and two (paired t test, P < 0.001, 95% CI: 1.62–3.25 and 1.58–3.20 respectively). Function improved in each group (paired t test, P = 0.001, 95% CI of 0.94–2.38 in group one and 0.97–2.43 in group two). A non-clinically statistically significant difference regarding the femoral and tibial cartilage thickness was obtained in both groups one (P = 0.005, CI: − 0.43–0.82 and P = 0.037, CI: − 0.44–0.80 respectively) and two (P = 0.025, CI: − 0.45–0.79 and P = 0.035, CI: − 0.29–0.96 respectively). Between groups analysis showed no significant difference regarding abovementioned measures.ConclusionBoth lateral wedge insole and acupuncture can be effective in the treatment of medial knee osteoarthritis without any superiority of one over the other.Iranian Registry of Clinical Trials: IRCT201201108235N1.URL: http://irct.ir/searchen.php     

Investigating an outbreak of acute viral hepatitis caused by hepatitis E virus variants in Karachi, South Pakistan

Hepatitis E is a classic water-borne disease in developing countries. Detection of anti-HEV IgM and IgG antibodies, in addition to HEV RNA are useful epidemiological markers in diagnosis of hepatitis E. This study was conducted to investigate an outbreak of acute viral hepatitis in South-Pakistan. Anti-HEV IgM and IgG were assessed comparatively with serological kits manufactured by Abbott, Cosmic, TGH, and Wantai, selecting HEV RNA as reference assay. Molecular evolutionary analysis was performed by phylogeny and HEV spread time analysis by Bayesian Coalescent Theory approach. Of the 89 patients, 24 (26.9%) did not have acute hepatitis viral marker. Of the remaining 65 cases, 4 (6.1%) were positive for anti-HAV IgM, one (1.5%) for anti-HBc IgM, 2 (3%) for HCV, 53 (81.5%) for anti-HEV IgM, and 5 (7.7%) were hepatitis-negative. The Wantai test was 100% sensitive and specific followed by Cosmic (98.1% and 100%), TGH (98.1% and 97.2%) and Abbott (79.2% and 83.3%). Two HEV variant strains were detected by phylogeny responsible for this acute hepatitis outbreak. Estimates on demographic history of HEV showed that HEV in Pakistan has remained at a steady nonexpanding phase from around 1970 to the year 2005, in which it expanded explosively with the emergence of new HEV variants. In conclusion, the limited sensitivity of available assay (Abbott anti-HEV EIA) may be a concern in HEV diagnosis in Pakistan. This study cautions that the dissemination of the variant strains to other areas of Pakistan may lead to explosive HEV outbreaks.