Beta-human chorionic gonadotrophin point of care testing for the management of pregnancy of unknown location.

RESEARCH QUESTION: Does a commercially available quantitative beta-human chorionic gonadotrophin (BHCG) point of care testing (POCT) device improve workflow management in early pregnancy by performing comparably to gold standard laboratory methods, and is the performance of a validated pregnancy of unknown location (PUL) triage strategy maintained using POCT BHCG results? DESIGN: Women classified with a PUL between 2018 and 2021 at three early pregnancy units were included. The linear relationship of untreated whole-blood POCT and serum laboratory BHCG values was defined using coefficients and regression. Paired serial BHCG values were then incorporated into the validated M6 multinomial logistic regression model to stratify the PUL as at high risk or at low risk of clinical complications. The sensitivity and negative predictive value were assessed. The timings required for equivocal POCT and laboratory care pathways were compared. RESULTS: A total of 462 PUL were included. The discrepancy between 571 laboratory and POCT BHCG values was -5.2% (-6.2 IU/l), with a correlation coefficient of 0.96. The 133 PUL with paired 0 and 48 h BHCG values were compared using the M6 model. The sensitivity for high-risk outcomes (96.2%) and negative predictive values (98.5%) was excellent for both. Sample receipt and laboratory processing took 135 min (421 timings), compared with 12 min (91 timings) when using POCT (P < 0.0001). CONCLUSIONS: POCT BHCG values correlated well with laboratory testing measurements. The M6 model retained its performance when using POCT BHCG values. Using the model with POCT may improve workflow and patient care without compromising on effective PUL triage.

Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices.

OBJECTIVES: Quantitative human chorionic gonadotropin (hCG) measurements are used to manage women classified with a pregnancy of unknown location (PUL). Two point of care testing (POCT) devices that quantify hCG are commercially available. We verified the i-STAT 1 (Abbott) and the AQT 90 FLEX (Radiometer) prior to use in PUL triage. METHODS: Tests for precision, external quality assurance (EQA), correlation, hook effect and recovery were undertaken alongside a POCT usability assessment during this prospective multi-center verification. RESULTS: Coefficients of variation ranged between 4.0 and 5.1 % for the three i-STAT 1 internal quality control (IQC) solutions and between 6.8 and 7.3 % for the two AQT IQC solutions. Symmetric differences in POCT EQA results when compared with laboratory and EQA stock values ranged between 3.2 and 24.5 % for the i-STAT 1 and between 3.3 and 36.9 % for the AQT. Correlation coefficients (i-STAT 1: 0.96, AQT: 0.99) and goodness of fit curves (i-STAT 1: 0.92, AQT: 0.99) were excellent when using suitable whole blood samples. An hCG hook effect was noted with the i-STAT 1 between 572,194 and 799,089 IU/L, lower than the hook effect noted with the AQT, which was between 799,089 and 1,619,309 IU/L. When hematocrit concentration was considered in sample types validated for use with each device, hCG recovery was 108 % with the i-STAT 1 and 98 % with the AQT. The i-STAT 1 scored lower on usability overall (90/130) than the AQT (121/130, p<0.001, Mann-Whitney). CONCLUSIONS: Both hCG POCT devices were verified for use in clinical practice. Practical factors must also be considered when choosing which device to use in each unit.

Validation of a virtual reality simulator for the use of transvaginal ultrasonography in gynaecology and early pregnancy.

INTRODUCTION: The objective was to validate a virtual reality simulation ultrasound model as a tool for training in the use of transvaginal ultrasonography in gynaecology and early pregnancy. METHODS: Three separate groups consisting of novice and intermediate level residents as well as expert ultrasound examiners were recruited to the study. All were asked to answer a questionnaire regarding demographic data and ultrasound experience. They subsequently completed two modules: basic gynaecology and early pregnancy, followed by corresponding assessments using a high-fidelity simulator (Scantrainer; Medaphor™, Cardiff, UK). Finally, the expert group completed an additional questionnaire about various elements of the simulator using a 5-point Likert scale. RESULTS: Each group consisted of eight participants. Overall, the participants agreed that simulation played a role in training (Novices: 75% (n = 6); Intermediates: 100% (n = 8); Experts: 75% (n = 6)). For the degree of realism of the target objects in the gynaecology and early pregnancy module environments compared to a real-patient environment, the simulator was rated satisfactory or very satisfactory by 88% (n = 7) and 75% (n = 6) of experts, respectively. All experts rated the overall usefulness of the content of the simulator for learning fundamental ultrasound technical skills compared to current training methods to be at least satisfactory. When reviewing the assessment scores, experts scored higher than non-experts in gynaecology (P = 0.002) and early pregnancy modules (P = 0.03). DISCUSSION: Face, content and construct validity were demonstrated by the virtual reality ultrasound simulator, suggesting it may be an effective method for training ultrasound skills in gynaecology and early pregnancy to non-expert residents.

Heparin for assisted reproduction: summary of a Cochrane review.

It is suggested that heparin given in the peri-implantation period may improve clinical outcomes in women undergoing assisted reproduction techniques (ART). This systematic review evaluates the use of heparin in subfertile women undergoing ART.

The characteristic ultrasound features of specific types of ovarian pathology (review).

Characterizing ovarian masses enables patients with malignancy to be appropriately triaged for treatment by subspecialist gynecological oncologists, which has been shown to optimize care and improve survival. Furthermore, correctly classifying benign masses facilitates the selection of patients with ovarian pathology that may either not require intervention, or be suitable for minimal access surgery if intervention is required. However, predicting whether a mass is benign or malignant is not the only clinically relevant information that we need to know before deciding on appropriate treatment. Knowing the specific histology of a mass is becoming of increasing importance as management options become more tailored to the individual patient. For example predicting a mucinous borderline tumor gives the opportunity for fertility sparing surgery, and will highlight the need for further gastrointestinal assessment. For benign disease, predicting the presence of an endometrioma and possible deeply infiltrating endometriosis is important when considering both who should perform and the extent of surgery. An examiner's subjective assessment of the morphological and vascular features of a mass using ultrasonography has been shown to be highly effective for predicting whether a mass is benign or malignant. Many masses also have features that enable a reliable diagnosis of the specific pathology of a particular mass to be made. In this narrative review we aim to describe the typical morphological features seen on ultrasound of different adnexal masses and illustrate these by showing representative ultrasound images.

Heparin for assisted reproduction.

BACKGROUND: Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after egg collection or at embryo transfer during assisted reproduction. Heparin has been advocated to improve embryo implantation and clinical outcomes.  It has been proposed that heparin enhances the intra-uterine environment by improving decidualisation with an associated activation of growth factors and a cytokine expression profile in the endometrium that is favourable to pregnancy. OBJECTIVES: To investigate whether the administration of heparin around the time of implantation (peri-implantation heparin) improves clinical outcomes in subfertile women undergoing assisted reproduction. SEARCH METHODS: A comprehensive and exhaustive search strategy was developed in consultation with the Trials Search Co-ordinator of the Cochrane Menstrual Disorders and Subfertility Group (MDSG). The strategy was used in an attempt to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress). Relevant trials were identified from both electronic databases and other resources (last search 6 May 2013). SELECTION CRITERIA: All randomised controlled trials (RCTs) were included where peri-implantation heparin was given during assisted reproduction. Peri-implantation low molecular weight heparin (LMWH) during IVF/ICSI was given at or after egg collection or at embryo transfer in the included studies. Live birth rate was the primary outcome. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility and quality of trials and extracted relevant data. The quality of the evidence was evaluated using GRADE methods. MAIN RESULTS: Three RCTs (involving 386 women) were included in the review.Peri-implantation LMWH administration during assisted reproduction was associated with a significant improvement in live birth rate compared with placebo or no LMWH (odds ratio (OR) 1.77, 95% confidence interval (CI) 1.07 to 2.90, three studies, 386 women, I(2) = 51%, very low quality evidence with high heterogeneity). There was also a significant improvement in the clinical pregnancy rate with use of LMWH (OR 1.61, 95% CI 1.03 to 2.53, three studies, 386 women, I(2) = 29%, very low quality evidence with low heterogeneity).However these findings should be interpreted with extreme caution as they were dependent upon the choice of statistical method: they were no longer statistically significant when a random-effects model was used.Adverse events were poorly reported in all included studies, with no comparative data available. However, LMWH did cause adverse effects including bruising, ecchymosis, bleeding, thrombocytopenia and allergic reactions. It appeared that these adverse effects were increased if heparin therapy was used over a longer duration. AUTHORS' CONCLUSIONS: The results of this Cochrane review of three randomised controlled trials with a total of 386 women suggested that peri-implantation LMWH in assisted reproduction treatment (ART) cycles may improve the live birth rate in women undergoing assisted reproduction. However, these results were dependent on small low quality studies with substantial heterogeneity, and were sensitive to the choice of statistical model. There were side effects reported with use of heparin, including bruising and bleeding, and no reliable data on long-term effects. The results do not justify this use of heparin outside well-conducted research trials.These findings need to be further investigated with well-designed, adequately powered, double-blind, randomised, placebo-controlled, multicentre trials. Further investigations could also focus on the effects of the local (uterine) and not systemic application of heparin during ART.

A novel technique for the semi-automated measurement of embryo volume: an intraobserver reliability study.

The aim was to assess intraobserver reliability of a new semi-automated technique of embryo volumetry. Power calculations suggested 46 subjects with viable, singleton pregnancies were required for reliability analysis. Crown rump length (CRL) of each embryo was analyzed using 2-D and a 3-D dataset acquired using transvaginal ultrasound. Virtual organ computer-aided analysis (VOCAL) was used to calculate volume of gestation sac (GSV) and yolk sac (YSV) and SonoAVC (sonography-based automated volume count) was used to quantify fluid volume (FV). Embryo volume was calculated by subtracting FV and YSV from GSV. Each dataset was measured twice. Reliability was assessed using Bland-Altman plots and intraclass correlation coefficients (ICCs). Fifty-two datasets were analyzed. Median embryo volume was 1.8 cm(3) (0.1 to 8.1 cm(3)); median gestational age 7 + 4 weeks; median CRL 13 mm (2 to 29 mm). Mean difference of embryo volume measurements was 0.1cm(3) (limits of agreement [LOA] -0.3 to 0.4 cm(3)); multiples of mean (MoM) 0.38; mean difference of CRL measurements 0.3 mm (LOA -1.4 to 2.0 mm), MoM = 0.26. ICC for embryo volume was 0.999 (95%CI 0.998 to 0.999), confirming excellent intraobserver agreement. ICC for CRL was 0.996 (95%CI 0.991 to 0.998). Regression analysis showed good correlation between embryo volume and CRL (R(2) = 0.60). The new semi-automated 3-D technique provides reliable measures of embryo volume. Further work is required to assess the validity of this technique.

The management of miscarriage.

Women diagnosed with incomplete and delayed miscarriage are faced with three options for their subsequent management: expectant, medical or surgical. Health-care practitioners must empower patients to make educated decisions about their own management by providing them with sufficient information in a readily understandable format. This can be difficult both for the patient and the staff in what is often an understandably, highly emotional situation. Detailed counselling is an essential part of the process as psychological outcomes have been shown to be improved when women feel in control of the decision-making process. In this article, we discuss each of the treatment options in detail, and explore how the type of miscarriage influences their relative success rates. We also consider the comparative risks of bleeding, infection, side effects of drugs, pain scores and quality-of-life scores associated with each method through evidence derived from systematic reviews, meta-analyses and randomised controlled trials.

How good are emergency department Senior House Officers at interpreting X-rays following radiographers' triage?

OBJECTIVE: To assess the accuracy of Senior House Officers at interpreting plain X-rays following their triage by radiographers in an emergency department. METHOD: We collected 2593 patients' records by systematic sampling of all those seen by emergency physicians between January 2002 and April 2002 (ca 10 000 patients) in a UK emergency department. The variables recorded included evidence of X-ray investigations and, when present, the Senior House Officer's diagnosis, the presence (abnormal) or absence of a radiographers red dot and the reference standard diagnosis. A separate category of uncertain (inconclusive) was applied to the Senior House Officer and reference standard diagnosis where appropriate. Diagnostic performance was measured by likelihood ratios with associated pre-test and post-test probabilities. RESULTS: Including the uncertain category as abnormal gave the following results: there were 967 X-rays and those with a red dot had a probability of an abnormality of 80%. Although a further opinion of abnormal by a Senior House Officer increased this probability to 89% when they overrode the red dot opinion of the radiographer, it was incorrect in 26% of cases. CONCLUSION: Currently, the Senior House Officer contributes to the red dot system by improving on the radiographer in rates of diagnosis of both abnormal and normal X-rays. Further reductions in error rates, however, are unlikely to be achieved until there is a change to the existing system. This may ultimately involve removing some of the responsibility of X-ray interpretation from the Senior House Officer. Any future research should consider the methodological issues highlighted by this study.

Does discussion of possible scar rupture influence preferred mode of delivery after a caesarean section?

Using retrospective and prospective analyses of antenatal records, it was found that by 2003, discussions about the options for delivery after one lower segment caesarean section (LSCS) were almost always documented in antenatal notes, compared with only rare entries in 1993; specific mention of the risks of scar rupture were made in just under 50% in 2003. There was a considerable reduction in the proportion of women whose preference was to labour in 2003 compared with 1993 and also in the number who ultimately delivered vaginally. There was, however, no evidence that those women with whom possible scar rupture had been discussed were discouraged from attempting vaginal delivery. These data suggest that, contrary to expectations, increasing patients' involvement in their management in this situation does not result in fewer caesarean sections.