PivNG primers and probes set used in the cobas omni Utility Channel is a reliable supplemental test for detection of Neisseria gonorrhoeae in oropharyngeal, urogenital and rectal specimens collected in cobas PCR Media.

OBJECTIVE: To evaluate the clinical performance of the novel PivNG primers and probes set (PivNG test) used in the cobas omni Utility Channel for supplemental testing of Neisseria gonorrhoeae (NG). METHODS: Oropharyngeal, urogenital and rectal samples were self-collected during routine testing at Barts Health sexual health clinics, London, UK. Samples were tested by the cobas CT/NG test and PivNG cobas omni Utility Channel test on cobas 6800/8800 Systems. Supplemental testing was carried out with the Xpert CT/NG test. PivNG overall percent agreements, positive percent agreements (PPAs)/negative percent agreements (NPAs) and positive/negative predictive values were calculated for each sample type. Microscopy and/or culture data were included for a randomised subset of concordant/discordant results, and a composite reference standard (cobas CT/NG, Xpert CT/NG and culture results) adjusted for partial verification bias was used to determine PivNG PPA and NPA. RESULTS: Of 447 evaluable samples with valid results from all three assays (cobas CT/NG, PivNG and Xpert CT/NG), 288 (64.4%) were NG-positive by both PivNG and cobas CT/NG; 117 (26.2%) were NG-negative in both tests; and 42 (9.4%) had discordant results (with NG-negative supplementary Xpert) CT/NG results in 40/42 instances). Of 19 PivNG/Xpert CT/NG-discordant samples, 11 were confirmed NG-positive by microscopy and/or culture results. PivNG PPA and NPA were 100% and 91% for oropharyngeal swabs, 100% and 100% for vaginal swabs, 100% and 100% for male urine samples, and 100% and 97% for rectal swabs, respectively, compared with the partially adjusted composite reference standard. CONCLUSIONS: PivNG is a reliable supplementary test with high sensitivity for confirming NG infection when used in conjunction with the cobas CT/NG test and samples collected in cobas PCR Media. Moreover, the PivNG test offers a convenient, high-throughput solution for supplemental NG testing of various sample types, with the potential to reduce the number of indeterminate reports.

The prevalence of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) at testing centers in Belgium, Germany, Spain, and the UK using the cobas TV/MG molecular assay.

Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) can lead to long-term sequelae in males and females; however, global prevalence data vary between geographical regions, as these sexually transmitted infections are not included in routine screening. The objective of this study was to use the cobas® TV/MG assay to assess the point prevalence of TV and MG in specimens from men and women over a broad European geographical area. Urine, vaginal, endocervical, and rectal samples were collected from patients aged ≥ 18 years receiving Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) screening as per local standard of care at sites in Belgium, Germany, Spain, and the UK (Wales). Remnant samples were assessed using the cobas TV/MG assay. Analysis of 2795 samples showed that MG prevalence varied slightly across female sample types (range: 1.7-5.8%; p = 0.0042). MG prevalence was higher in male rectal samples (12.5%) than in male urine samples (3.9%; p < 0.0001). TV prevalence was low in male (0.8%; 12/1535) and female (1.3%; 16/1260) samples across all sites. Co-infection of TV/MG with CT or NG was 10.0% (19/190) and 9.6% (7/73), respectively, in both male and female samples. MG and TV prevalence rates were comparable to the published literature in Europe. MG prevalence was highest in male rectal samples; as rectal testing is an off-label use of the cobas TV/MG assay, the clinical utility of this assay for rectal testing should be further investigated.

A multi-center study comparing the analytical sensitivity and clinical concordance of three HIV-1 viral load assays.

BACKGROUND: HIV-1 viral load assays are essential tools for clinical management of people living with HIV-1. OBJECTIVES AND STUDY DESIGN: We evaluated concordance between three assays: the cobas® HIV-1 test for use on the cobas® 6800 and cobas® 8800 systems (cobas HIV-1); the COBAS® TaqMan® HIV-1 Test, v2.0 for use with the High Pure System and the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 test, v2.0. Analytical sensitivity, precision and accuracy of all three methods were assessed using the WHO 2nd International Standard for HIV-1, with concentrations from 5 to 1000 copies/mL. Accuracy and concordance were evaluated using 212 clinical specimens. Overall percent agreement (OPA) was determined using three different thresholds used as medical decision points. RESULTS: The limit of detection was below 20 copies/mL for each assay. The hit rate for each assay was 100 % for concentrations ≥ 50 copies/mL. Only the cobas HIV-1 test generated quantifiable data for all replicates at 50 copies/mL. Between 50 and 400 copies/mL, results for all assays were accurate within 0.09 log10 copies/mL, with standard deviation less than 0.14 log10 copies/mL. The mean difference between paired results in clinical specimens ranged from -0.050 to 0.107 log10 copies/mL across all assay comparisons. The OPA between pairs of assays ranged from 94.8 to 98.1% at the 50 copies/mL cutoff, and improved to a range of 97.6-99.0% at the 200 copies/mL cutoff. At the 1000 copies/mL cutoff, OPA between assays was 98.5-99.0%. CONCLUSIONS: The cobas HIV-1 assay is highly sensitive, accurate and suitable for use in clinical practice.

Evaluation of the Roche cobas MTB and MTB-RIF/INH Assays in Samples from Germany and Sierra Leone.

The Roche cobas MTB and MTB-RIF/INH assays allow for detection of Mycobacterium tuberculosis complex (MTBC) nucleic acid and rifampicin (RIF) and isoniazid (INH) resistance-associated mutations in an automated, high-throughput workflow. In this study, we evaluated the performance of these assays, employing samples from settings of low and high tuberculosis (TB) burdens. A total of 325 frozen, leftover respiratory samples collected from treatment-naive patients with presumptive TB in Germany (n = 280) and presumptive RIF-resistant TB in Sierra Leone (n = 45) were used in this study. cobas MTB results for detection of MTBC DNA from N-acetyl-l-cysteine-sodium hydroxide (NALC-NaOH)-treated samples were compared to culture results. Predictions of RIF and INH resistance by the cobas MTB-RIF/INH assay were compared to a composite reference standard (phenotypic drug susceptibility testing and line probe assay). Whole-genome sequencing was used to resolve discordances. The overall sensitivity of cobas MTB for detection of MTBC DNA in culture-positive samples (n = 102) was 89.2% (95% confidence interval [CI], 81.7 to 93.9%). The specificity of cobas MTB was 98.6% (95% CI, 96.1 to 99.5%). Sensitivity and specificity for detection of RIF and INH resistance were 88.4% (95% CI, 75.5 to 94.9%) and 97.6% (95% CI, 87.4 to 99.6%) and 76.6% (95% CI, 62.8 to 86.4%) and 100.0% (95% CI, 90.8 to 100.0%), respectively. Discordant results for RIF and INH resistance were mainly due to uncommon mutations in samples from Sierra Leone that were not covered by the cobas MTB-RIF/INH assay. In conclusion, cobas MTB and MTB-RIF/INH assays provide accurate detection of MTBC DNA and resistance-associated mutations in respiratory samples. The influence of regional variations in the prevalence of resistance-conferring mutations requires further investigation.

Commutability and concordance of four hepatitis B virus DNA assays in an international multicenter study.

BACKGROUND: HBV DNA is the most important molecular marker in hepatitis B, used to determine treatment indication and monitoring. Most patients require lifelong hepatitis B virus (HBV) management, thus viral load (VL) monitoring may be performed at different laboratories, with different HBV assays, which may result in different VL results. This multicenter study compares the commutability and concordance of results from four different HBV DNA assays: CAP/CTM HBVv2, HPS/CTM HBVv2 and the new cobas 6800/8800 HBV and cobas 4800 HBV assays. METHODS: Across all four assays, HBV limit of detection (LoD) and linearity at lower concentrations were assessed using panels traceable to the World Health Organization international standard, and concordance was investigated at the important medical decision cutoffs 2000 and 20,000 IU/ml, using specimens from HBV-positive patients. RESULTS: The calculated LoD via a probit curve was 2.7 IU/ml for cobas 6800/8800 HBV, 2.8 IU/ml for cobas 4800 HBV, 9.6 IU/ml for CAP/CTM HBVv2, and 6.2 IU/ml for HPS/CTM HBVv2. The average accuracy was comparable between cobas 6800/8800 HBV, cobas 4800 HBV and CAP/CTM HBVv2 (0.04-0.05 log10 IU/ml), while a slightly lower accuracy was documented for HPS/CTM HBVv2 (-0.16 log10 IU/ml). A total of 211-245 clinical samples were used for a pairwise comparison. Mean paired log differences ranged from -0.17 log10 IU/ml to -0.01 log10 IU/ml. Coefficient of determination was over 98% for all pairs with high overall percent agreement at the 2000 and 20,000 IU/ml cutoffs (from 91.7% to 96.3%). In a subset of samples with VL±0.5 log10 to the 2000 and 20,000 IU/ml thresholds, concordance was still 72% and 82%, respectively. CONCLUSIONS: The new cobas 6800/8800 HBV and 4800 HBV assays show high accuracy in samples with low-level viremia and a high concordance with the established HBV tests, CAP/CTM HBVv2 and HPS/CTM HBVv2, at 2000 and 20,000 IU/ml. Thus, all four HBV assays have high commutability and may be used interchangeably in routine clinical practice.

Decision making in family medicine: randomized trial of the effects of the InfoClinique and Trip database search engines.

OBJECTIVE: To compare the ability of users of 2 medical search engines, InfoClinique and the Trip database, to provide correct answers to clinical questions and to explore the perceived effects of the tools on the clinical decision-making process. DESIGN: Randomized trial. SETTING: Three family medicine units of the family medicine program of the Faculty of Medicine at Laval University in Quebec city, Que. PARTICIPANTS: Fifteen second-year family medicine residents. INTERVENTION: Residents generated 30 structured questions about therapy or preventive treatment (2 questions per resident) based on clinical encounters. Using an Internet platform designed for the trial, each resident answered 20 of these questions (their own 2, plus 18 of the questions formulated by other residents, selected randomly) before and after searching for information with 1 of the 2 search engines. For each question, 5 residents were randomly assigned to begin their search with InfoClinique and 5 with the Trip database. MAIN OUTCOME MEASURES: The ability of residents to provide correct answers to clinical questions using the search engines, as determined by third-party evaluation. After answering each question, participants completed a questionnaire to assess their perception of the engine's effect on the decision-making process in clinical practice. RESULTS: Of 300 possible pairs of answers (1 answer before and 1 after the initial search), 254 (85%) were produced by 14 residents. Of these, 132 (52%) and 122 (48%) pairs of answers concerned questions that had been assigned an initial search with InfoClinique and the Trip database, respectively. Both engines produced an important and similar absolute increase in the proportion of correct answers after searching (26% to 62% for InfoClinique, for an increase of 36%; 24% to 63% for the Trip database, for an increase of 39%; P = .68). For all 30 clinical questions, at least 1 resident produced the correct answer after searching with either search engine. The mean (SD) time of the initial search for each question was 23.5 (7.6) minutes with InfoClinique and 22.3 (7.8) minutes with the Trip database (P = .30). Participants' perceptions of each engine's effect on the decision-making process were very positive and similar for both search engines. CONCLUSION: Family medicine residents' ability to provide correct answers to clinical questions increased dramatically and similarly with the use of both InfoClinique and the Trip database. These tools have strong potential to increase the quality of medical care.

The impact of blended teaching on knowledge, satisfaction, and self-directed learning in nursing undergraduates: a randomized, controlled trial.

AIM: This study aimed to assess the effectiveness of a blended-teaching intervention using Internet-based tutorials coupled with traditional lectures in an introduction to research undergraduate nursing course. Effects of the intervention were compared with conventional, face-to-face classroom teaching on three outcomes: knowledge, satisfaction, and self-learning readiness. METHOD: A two-group, randomized, controlled design was used, involving 112 participants. Descriptive statistics and analysis of covariance (ANCOVA) were performed. RESULTS: The teaching method was found to have no direct impact on knowledge acquisition, satisfaction, and self-learning readiness. However, motivation and teaching method had an interaction effect on knowledge acquisition by students. Among less motivated students, those in the intervention group performed better than those who received traditional training. CONCLUSION: These findings suggest that this blended-teaching method could better suit some students, depending on their degree of motivation and level of self-directed learning readiness.

Development of PRIDe: a tool to assess physicians' preference of role in clinical decision making.

OBJECTIVE: To develop and evaluate items for inclusion in PRIDe (Preferred Role in Decision Making), a new tool to assess changes of role preference among professionals exposed to training in shared decision making (SDM). METHODS: This study was part of a pilot trial to evaluate the effectiveness of SDM training on the doctors' prescription of antibiotics for acute respiratory infections. Thirty-nine family physicians were randomized to immediate exposure to training or to delayed exposure. Potential items for PRIDe and a questionnaire about physicians' intention to engage in SDM were administered at baseline and at follow-up. RESULTS: Following analysis, we retained five items that captured a change in physicians' preference. The items' scores were pooled and the resulting tool showed limited internal consistency (Cronbach's alpha = 0.41) but significant test-retest reliability (immediate group: P = 0.03; delayed group: P = 0.008) and acceptable discriminant validity, with patients involved in decision making more actively after training than before (Fisher's test, P = .02). CONCLUSION: This initial step to develop an evaluation tool to assess changes in doctors' preference of role in decision making following SDM training shows promising results. The next step is to develop more clinical vignettes followed by questions inspired from this analysis. PRACTICE IMPLICATIONS: The PRIDe instrument can be used in the assessment of health professionals' attitude towards shared decision making after training in shared decision making. Additional research is needed to evaluate its validity before it can be recommended for use.

Mind-body interventions during pregnancy for preventing or treating women's anxiety.

BACKGROUND: Anxiety during pregnancy is a common problem. Anxiety and stress could have consequences on the course of the pregnancy and the later development of the child. Anxiety responds well to treatments such as cognitive behavioral therapy and/or medication. Non-pharmacological interventions such as mind-body interventions, known to decrease anxiety in several clinical situations, might be offered for treating and preventing anxiety during pregnancy. OBJECTIVES: To assess the benefits of mind-body interventions during pregnancy in preventing or treating women's anxiety and in influencing perinatal outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010), MEDLINE (1950 to 30 November 2010), EMBASE (1974 to 30 November 2010), the National Center for Complementary and Alternative Medicine (NCCAM) (1 December 2010), ClinicalTrials.gov (December 2010) and Current Controlled Trials (1 December 2010), searched the reference lists of selected studies and contacted professionals and authors in the field. SELECTION CRITERIA: Randomized controlled trials, involving pregnant women of any age at any time from conception to one month after birth, comparing mind-body interventions with a control group. Mind-body interventions include: autogenic training, biofeedback, hypnotherapy, imagery, meditation, prayer, auto-suggestion, tai-chi and yoga. Control group includes: standard care, other pharmacological or non-pharmacological interventions, other types of mind-body interventions or no treatment at all. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion all assessed risk of bias for each included study. We extracted data independently using an agreed form and checked it for accuracy. MAIN RESULTS: We included eight trials (556 participants), evaluating hypnotherapy (one trial), imagery (five trials), autogenic training (one trial) and yoga (one trial). Due to the small number of studies per intervention and to the diversity of outcome measurements, we performed no meta-analysis, and have reported results individually for each study. Compared with usual care, in one study (133 women), imagery may have a positive effect on anxiety during labor decreasing anxiety at the early and middle stages of labor (MD -1.46; 95% CI -2.43 to -0.49; one study, 133 women) and (MD -1.24; 95% CI -2.18 to -0.30). Another study showed that imagery had a positive effect on anxiety and depression in the immediate postpartum period. Autogenic training might be effective for decreasing women's anxiety before delivering. AUTHORS' CONCLUSIONS: Mind-body interventions might benefit women's anxiety during pregnancy. Based on individual studies, there is some but no strong evidence for the effectiveness of mind-body interventions for the management of anxiety during pregnancy. The main limitations of the studies were the lack of blinding and insufficient details on the methods used for randomization.

Prenatal screening for Down syndrome: a survey of willingness in women and family physicians to engage in shared decision-making.

OBJECTIVE: To assess the willingness of women and their family physicians (FPs) to engage in shared decision-making (SDM) as regards prenatal Down-syndrome screening and the factors that might influence their willingness to do so. METHODS: We conducted a survey of participants in Québec City, Canada, using the theory of planned behavior. We used a general linear model and multilevel approach that took the fact that some women consulted the same FP into account. RESULTS: This study comprised 109 pregnant women and 41 FPs. On a scale of - 3 to + 3, the pregnant women's and FPs' response scores were, respectively, 2.11 ± 1.38 and 2.66 ± 0.40. In women, attitude, significant others, self-efficacy, perceived moral correctness, and their FP's attitude influenced their willingness to engage in SDM. However, women without a post-secondary education were less likely to engage in SDM than women with a post-secondary education, mostly because the former lacked a sense of self-efficacy. In FPs, only attitude and significant others influenced their willingness to engage in SDM. CONCLUSION: Overall, the women and their FPs wished to engage in SDM as regards prenatal Down-syndrome screening. Only a few factors influenced this desire which therefore may be modifiable.

Training family physicians in shared decision making for the use of antibiotics for acute respiratory infections: a pilot clustered randomized controlled trial.

BACKGROUND: Experts estimate that the prevalence of antibiotics use exceeds the prevalence of bacterial acute respiratory infections (ARIs). OBJECTIVE: To develop, adapt and validate DECISION+ and estimate its impact on the decision of family physicians (FPs) and their patients on whether to use antibiotics for ARIs. DESIGN: Two-arm parallel clustered pilot randomized controlled trial. SETTING AND PARTICIPANTS: Four family medicine groups were randomized to immediate DECISION+ participation (the experimental group) or delayed DECISION+ participation (the control group). Thirty-three FPs and 459 patients participated. INTERVENTION: DECISION+ is a multiple-component, continuing professional development program in shared decision making that addresses the use of antibiotics for ARIs. MAIN OUTCOME MEASURES: Throughout the pilot trial, DECISION+ was adapted in response to participant feedback. After the consultation, patients and FPs independently self-reported the decision (immediate use, delayed use, or no use of antibiotics) and its quality. Agreement between their decisional conflict was assessed. Two weeks later, patients assessed their decisional regret and health status. RESULTS: Compared to the control group, the experimental group reduced its immediate use of antibiotics (49 vs. 33% absolute difference = 16%; P = 0.08). Decisional conflict agreement was stronger in the experimental group (absolute difference of Pearson's r = 0.26; P = 0.06). Decisional regret and perceptions of the quality of the decision and of health status in the two groups were similar. DISCUSSION AND CONCLUSIONS: DECISION+ was developed successfully and appears to reduce the use of antibiotics for ARIs without affecting patients' outcomes. A larger trial is needed to confirm this observation.

Minimizing pain during vasectomy: the mini-needle anesthetic technique.

PURPOSE: We describe pain scores for a modified anesthesia technique for no-scalpel vasectomy using a 1-inch 30 gauge mini-needle. MATERIALS AND METHODS: A prospective study was performed in 277 patients who received anesthesia using a 3 cc syringe filled with approximately 2 cc 2% lidocaine without epinephrine and a 1-inch 30 gauge needle. Local anesthesia was given directly to the vas at the expected surgical site on each side. RESULTS: Mean +/- SD pain intensity score on the 10 cm visual analog scale was 1.5 +/- 1.6 (95% CI 1.3-1.7) during the anesthesia and 0.6 +/- 1.0 (95% CI 0.5-0.7) during the procedure. Patients experienced less pain during anesthesia and the procedure than they expected before vasectomy (average 3.1 +/- 1.8, 95% CI 2.8-3.3). CONCLUSIONS: The mini-needle technique provides excellent anesthesia for no-scalpel vasectomy. It compares favorably to the standard vasal block and other anesthetic alternatives with the additional benefit of minimal equipment and less anesthesia.

How much do family physicians involve pregnant women in decisions about prenatal screening for Down syndrome?

OBJECTIVE: To assess the extent to which family physicians (FPs) involve women in decisions about prenatal screening for Down syndrome. METHODS: Based on transcripts of consultations between 41 FPs and 128 women, two raters independently assessed clinician's efforts to involve women in decisions about prenatal screening for Down syndrome using the French-language version of OPTION. Descriptive statistics of OPTION scores were calculated. Construct validity was assessed by performing a principal factor analysis and by measuring association with consultation duration and FPs sociodemograhics. Internal consistency was assessed with Cronbach's alpha and inter-rater reliability with the intraclass correlation coefficient. RESULTS: The overall mean OPTION score was low: 19 +/- 7 (range = 0 [no involvement] to 100 [high involvement]). One factor accounted for 80% of the variance. Both internal consistency and inter-rater reliability were very good (Cronbach's alpha = 0.73; ICC = 0.76). OPTION scores were lower for residents than for licensed FPs (17 +/- 5 vs 21 +/- 4; p = 0.02) and were positively associated with duration of consultation (r = 0.56; p < 0.001). CONCLUSION: Based on the French-language version of OPTION, which showed satisfactory psychometric properties, FPs studied put minimal efforts to involve women in decisions about prenatal screening for Down syndrome.