Updating M6 pregnancy of unknown location risk-prediction model including evaluation of clinical factors.

OBJECTIVES: Ectopic pregnancy (EP) is a major high-risk outcome following a pregnancy of unknown location (PUL) classification. Biochemical markers are used to triage PUL as high vs low risk to guide appropriate follow-up. The M6 model is currently the best risk-prediction model. We aimed to update the M6 model and evaluate whether performance can be improved by including clinical factors. METHODS: This prospective cohort study recruited consecutive PUL between January 2015 and January 2017 at eight units (Phase 1), with two centers continuing recruitment between January 2017 and March 2021 (Phase 2). Serum samples were collected routinely and sent for ß-human chorionic gonadotropin (ß-hCG) and progesterone measurement. Clinical factors recorded were maternal age, pain score, bleeding score and history of EP. Based on transvaginal ultrasonography and/or biochemical confirmation during follow-up, PUL were classified subsequently as failed PUL (FPUL), intrauterine pregnancy (IUP) or EP (including persistent PUL (PPUL)). The M6 models with (M6P ) and without (M6NP ) progesterone were refitted and extended with clinical factors. Model validation was performed using internal-external cross-validation (IECV) (Phase 1) and temporal external validation (EV) (Phase 2). Missing values were handled using multiple imputation. RESULTS: Overall, 5473 PUL were recruited over both phases. A total of 709 PUL were excluded because maternal age was < 16 years or initial ß-hCG was ≤ 25 IU/L, leaving 4764 (87%) PUL for analysis (2894 in Phase 1 and 1870 in Phase 2). For the refitted M6P model, the area under the receiver-operating-characteristics curve (AUC) for EP/PPUL vs IUP/FPUL was 0.89 for IECV and 0.84-0.88 for EV, with respective sensitivities of 94% and 92-93%. For the refitted M6NP model, the AUCs were 0.85 for IECV and 0.82-0.86 for EV, with respective sensitivities of 92% and 93-94%. Calibration performance was good overall, but with heterogeneity between centers. Net Benefit confirmed clinical utility. The change in AUC when M6P was extended to include maternal age, bleeding score and history of EP was between -0.02 and 0.01, depending on center and phase. The corresponding change in AUC when M6NP was extended was between -0.01 and 0.03. At the 5% threshold to define high risk of EP/PPUL, extending M6P altered sensitivity by -0.02 to -0.01, specificity by 0.03 to 0.04 and Net Benefit by -0.005 to 0.006. Extending M6NP altered sensitivity by -0.03 to -0.01, specificity by 0.05 to 0.07 and Net Benefit by -0.005 to 0.006. CONCLUSIONS: The updated M6 model offers accurate diagnostic performance, with excellent sensitivity for EP. Adding clinical factors to the model improved performance in some centers, especially when progesterone levels were not suitable or unavailable. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Time-effectiveness and convenience of transvaginal ultrasound probe disinfection using ultraviolet vs chlorine dioxide multistep wipe system: prospective survey study.

OBJECTIVES: To compare the efficiency, ease of use and user satisfaction of two methods of transvaginal ultrasound probe high-level disinfection: ultraviolet-C radiation (UV-C) and a chlorine dioxide multistep wipe system. METHODS: This was a prospective survey study. UV-C units were introduced into a busy early pregnancy assessment service and compared with a multiwipe system for disinfection. Before seeing each patient, healthcare professionals (HCPs) measured with a stopwatch the time taken to complete a cycle of disinfection using either UV-C or chlorine dioxide multistep wipes and responded to a quick-response (QR) code-linked survey. Additional essential tasks that could be completed before seeing the next patient during probe disinfection were also documented. Using another QR code-linked survey, data on ease of use, satisfaction with the system used and preferred system were collected. The ease of use and satisfaction with the system were rated on a 0 to 10 Likert scale (0 poor, 10 excellent). A free-text section for comments was then completed. RESULTS: Disinfection using UV-C (n = 331) was 60% faster than the chlorine dioxide multiwipe system (n = 332) (101 vs 250 s; P < 0.0001). A greater number of tasks were completed during probe disinfection when using UV-C, saving a further 74 s per patient (P < 0.0001). The HCPs using UV-C (n = 71) reported greater ease of use (median Likert score, 10 vs 3; P < 0.0001) and satisfaction (median Likert score, 10 vs 2; P < 0.0001) compared with those using the multiwipe system (n = 43). HCPs reported that the chlorine dioxide system was time-consuming and environmentally unfriendly, while the UV-C system was efficient and easy to use. Overall, 98% of the HCPs preferred using the UV-C system. CONCLUSIONS: UV-C technology is more time-efficient and allows more essential tasks to be completed during disinfection. For a 4-h ultrasound list of 15 patients, the use of UV-C would save 55 min 45 s. HCPs found UV-C preferable and easier to use. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

A national survey of skin health in nursing personnel.

BACKGROUND: Hand dermatitis is a well-established occupational risk in nursing staff. AIMS: To explore skin health in nursing staff and to develop resources and recommendations to promote good skincare at work. METHODS: Cross-sectional survey. RESULTS: We analysed data from 1,545 surveys. Forty-six percent reported 'poor' skin health and the majority (93%) experienced at least one skin problem over the previous 12 months, with only 22% seeking help from their employer. Only 2% took time off work due to skin problems, with many expressing concerns that taking sick leave would be viewed negatively by others. Over half (53%) had reduced or stopped using antibacterial rubs and soap, and 18% had reduced the use of gloves. Most respondents used hand cream and over half used products they had purchased themselves. Only 42% received skin health care information from employers, with fewer (26%) receiving training on how to identify early signs of skin disease. Only 16% had access to skin surveillance in line with regulatory requirements. Only 26% of respondents were aware of the support offered by their professional nursing association. Suggestions for improving skin health included increasing publicity concerning the importance of skin health in healthcare settings, improving access to hand creams, better quality products, enhanced education and training and more involvement from Occupational Health (OH). CONCLUSIONS: Results confirm that poor skin health remains a persistent problem for nurses. Employers could do more to promote skin health and nurses need to be made more aware of the support and guidance offered by professional bodies.

External validation of models to predict the outcome of pregnancies of unknown location: a multicentre cohort study.

OBJECTIVE: To validate externally five approaches to predict ectopic pregnancy (EP) in pregnancies of unknown location (PUL): the M6P and M6NP risk models, the two-step triage strategy (2ST, which incorporates M6P), the M4 risk model, and beta human chorionic gonadotropin ratio cut-offs (BhCG-RC). DESIGN: Secondary analysis of a prospective cohort study. SETTING: Eight UK early pregnancy assessment units. POPULATION: Women presenting with a PUL and BhCG >25 IU/l. METHODS: Women were managed using the 2ST protocol: PUL were classified as low risk of EP if presenting progesterone ≤2 nmol/l; the remaining cases returned 2 days later for triage based on M6P. EP risk ≥5% was used to classify PUL as high risk. Missing values were imputed, and predictions for the five approaches were calculated post hoc. We meta-analysed centre-specific results. MAIN OUTCOME MEASURES: Discrimination, calibration and clinical utility (decision curve analysis) for predicting EP. RESULTS: Of 2899 eligible women, the primary analysis excluded 297 (10%) women who were lost to follow up. The area under the ROC curve for EP was 0.89 (95% CI 0.86-0.91) for M6P, 0.88 (0.86-0.90) for 2ST, 0.86 (0.83-0.88) for M6NP and 0.82 (0.78-0.85) for M4. Sensitivities for EP were 96% (M6P), 94% (2ST), 92% (N6NP), 80% (M4) and 58% (BhCG-RC); false-positive rates were 35%, 33%, 39%, 24% and 13%. M6P and 2ST had the best clinical utility and good overall calibration, with modest variability between centres. CONCLUSIONS: 2ST and M6P performed best for prediction and triage in PUL. TWEETABLE ABSTRACT: The M6 model, as part of a two-step triage strategy, is the best approach to characterise and triage PULs.

Ultrasound characteristics, serum biochemistry and outcome of ectopic pregnancies presenting during COVID-19 pandemic.

OBJECTIVE: To describe and compare the characteristics of ectopic pregnancies (EPs) in the year prior to vs during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: This was a retrospective analysis of women diagnosed with an EP on transvaginal sonography conducted at a center in London, UK, providing early-pregnancy assessment, between 1 January 2019 and 31 December 2020. Women were identified via the Astraia ultrasound reporting system using coded and non-coded outcomes of EP or pregnancy outside the uterine cavity. Data related to predefined outcomes were collected using Astraia and Cerner electronic reporting systems. Main outcome measures included clinical, ultrasound and biochemical features of EP, in addition to reported complications and management. RESULTS: There were 22 683 consultations over the 2-year period. Following consultation, a similar number and proportion of EPs were diagnosed in 2019 (141/12 657 (1%)) and 2020 (134/10 026 (1%)). Both cohorts were comparable in age, ethnicity, weight and method of conception. Gestational age at the first transvaginal sonography scan and at diagnosis were similar, and no difference in location, size or morphology of EP was found between the two cohorts. Serum human chorionic gonadotropin (hCG) levels at the time of EP diagnosis were higher in 2020 than in 2019 (1005 IU/L vs 665 IU/L; P = 0.03). The proportions of women according to type of final EP management were similar, but the rate of failed first-line management was higher during vs before the pandemic (16% vs 6%; P = 0.01). The rates of blood detected in the pelvis (hemoperitoneum) on ultrasound (23% vs 26%; P = 0.58) and of ruptured EP confirmed surgically (9% vs 3%; P = 0.07) were similar in 2019 vs 2020. CONCLUSIONS: No difference was observed in the location, size, morphology or gestational age at the first ultrasound examination or at diagnosis of EP between women diagnosed before vs during the COVID-19 pandemic. Complication rates and final management strategy were also unchanged. However, hCG levels and the failure rate of first-line conservative management measures were higher during the pandemic. Our findings suggest that women continued to access appropriate care for EP during the COVID-19 pandemic, with no evidence of diagnostic delay or an increase in adverse outcome in our population. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study.

OBJECTIVE: The M6 risk-prediction model was published as part of a two-step protocol using an initial progesterone level of ≤ 2 nmol/L to identify probable failing pregnancies (Step 1) followed by the M6 model (Step 2). The M6 model has been shown to have good triage performance for stratifying women with a pregnancy of unknown location (PUL) as being at low or high risk of harboring an ectopic pregnancy (EP). This study validated the triage performance of the two-step protocol in clinical practice by evaluating the number of protocol-related adverse events and how effectively patients were triaged. METHODS: This was a prospective multicenter interventional study of 3272 women with a PUL, carried out between January 2015 and January 2017 in four district general hospitals and four university teaching hospitals in the UK. The final pregnancy outcome was defined as: a failed PUL (FPUL), an intrauterine pregnancy (IUP) or an EP (including persistent PUL (PPUL)). FPUL and IUP were grouped as low-risk and EP/PPUL as high-risk PUL. Serum progesterone and human chorionic gonadotropin (hCG) levels were measured at presentation in all patients. If the initial progesterone level was ≤ 2 nmol/L, patients were discharged and were asked to have a follow-up urine pregnancy test in 2 weeks to confirm a negative result. If the progesterone level was > 2 nmol/L or a measurement had not been taken, hCG level was measured again at 48 h and results were entered into the M6 model. Patients were managed according to the outcome predicted by the protocol. Those classified as 'low risk, probable FPUL' were advised to perform a urine pregnancy test in 2 weeks and those classified as 'low risk, probable IUP' were invited for a scan a week later. When a woman with a PUL was classified as high risk (i.e. risk of EP ≥ 5%) she was reviewed clinically within 48 h. One center used a progesterone cut-off of ≤ 10 nmol/L and its data were analyzed separately. If the recommended management protocol was not adhered to, this was recorded as a protocol deviation and classified as: unscheduled visit for clinician reason, unscheduled visit for patient reason or incorrect timing of blood test or ultrasound scan. The classifications outlined in the UK Good Clinical Practice (GCP) guidelines were used to evaluate the incidence of adverse events. Data were analyzed using descriptive statistics. RESULTS: Of the 3272 women with a PUL, 2625 were included in the final analysis (317 met the exclusion criteria or were lost to follow-up, while 330 were evaluated using a progesterone cut-off of ≤ 10 nmol/L). Initial progesterone results were available for 2392 (91.1%) patients. In Step 1, 407 (15.5%) patients were classified as low risk (progesterone ≤ 2 nmol/L), of whom seven (1.7%) were ultimately diagnosed with an EP. In 279 of the remaining 2218 women with a PUL, the M6 model was not applied owing to protocol deviation or because the outcome was already known (usually on the basis of an ultrasound scan) before a second hCG reading was taken; of these patients, 30 were diagnosed with an EP. In Step 2, 1038 women with a PUL were classified as low risk, of whom eight (0.8%) had a final outcome of EP. Of 901 women classified as high risk at Step 2, 275 (30.5%) had an EP. Therefore, 275/320 (85.9%) EPs were correctly classified as high risk. Overall, 1445/2625 PUL (55.0%) were classified as low risk, of which 15 (1.0%) were EP. None of these cases resulted in a ruptured EP or significant clinical harm. Sixty-two women participating in the study had an adverse event, but no woman had a serious adverse event as defined in the UK GCP guidelines. CONCLUSIONS: This study has shown that the two-step protocol incorporating the M6 model effectively triaged the majority of women with a PUL as being at low risk of an EP, minimizing the follow-up required for these patients after just two visits. There were few misclassified EPs and none of these women came to significant clinical harm or suffered a serious adverse clinical event. The two-step protocol incorporating the M6 model is an effective and clinically safe way of rationalizing the management of women with a PUL. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Squeezed vacuum phase control at 2 µm.

We demonstrate phase control for vacuum-squeezed light at a 2 µm wavelength, which is a necessary technology for proposed future gravitational wave observatories. The control scheme allowed examination of noise behavior at frequencies below 1 kHz and indicated that squeezing below this frequency was limited by dark noise and scattered light. We directly measure 3.9±0.2 dB of squeezing from 2 kHz to 80 kHz and 14.2±0.3 dB of antisqueezing relative to the shot noise level. The observed maximum level of squeezing is currently limited by photodetector quantum efficiency and laser instabilities at this new wavelength for squeezed light. Accounting for all losses, we conclude the generation of 11.3 dB of squeezing at the optical parametric oscillator.

Can risk factors, clinical history and symptoms be used to predict risk of ectopic pregnancy in women attending an early pregnancy assessment unit?

OBJECTIVE: To examine whether risk factors and symptoms may be used to predict the likelihood of ectopic pregnancy (EP) in women attending early pregnancy assessment units in the UK. METHODS: This was an observational cohort study of pregnant women under 12 weeks' gestation who were recruited from three London university hospitals between August 2012 and April 2013. One hospital continued recruitment between January and June 2015. A standardized information sheet incorporating patient demographics, medical history and symptoms was completed by patients and confirmed by examining clinicians. The outcome measure was final pregnancy location. RESULTS: There were 1320 eligible patients included in the analysis, with a total of 72 EPs (rate of 6%). Pelvic pain and diarrhea > three times in the previous 24 h were independent symptoms that increased the risk of EP, with relative risks of 2.4 (95% CI, 1.4-4.0; P = 0.002) and 2.2 (95% CI, 1.08-4.5; P = 0.03), respectively. The only other independent marker of risk of EP was duration of vaginal bleeding; the risk of EP increased by 20% (95% CI, 14%-27%) for every 1-day increment in duration (P < 0.001). A logistic regression model incorporating these factors demonstrated an area under the receiver-operating characteristics curve of 0.73 (95% CI, 0.67-0.79). The prevalence of EP was low when there was no pelvic pain, no diarrhea and the duration of bleeding was ≤ 3 days, with an EP rate of 2% (6/391). In the presence of a single risk factor, the EP rate increased to 5% (29/631) when only pelvic pain was present, 8% (1/12) when only diarrhea > three times in the previous 24 h was reported and 9% (9/103) when there was only vaginal bleeding with a duration > 3 days. Women with pelvic pain and vaginal bleeding of any severity for > 3 days had a high EP rate of 16% (23/146). In the nine women who also reported diarrhea > three times in the previous 24 h, two had EP. CONCLUSIONS: Only the presence of pelvic pain, diarrhea > three times in the previous 24 h and duration of bleeding were symptoms that significantly increased the risk for EP in women attending early pregnancy assessment units. Risk factors and symptoms alone could not be used to predict reliably an EP. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Renal Autotransplantation in Lynch Syndrome: A Viable Option in a Patient With Contralateral Metachronous Ureteral Cancer.

The success of human kidney allotransplantation was realized over six decades ago. First described 50 years ago, renal autotransplantation has been utilized sparingly as a salvage procedure for patients at risk of losing renal function, either from a benign or malignant condition. While classically associated with colorectal malignancies, Lynch syndrome also carries a small yet significant risk for the development of ureteral carcinoma. For these patients who develop chronic kidney disease, allotransplantation may not be an option due to the lifelong risk of several malignancies. We report the first known case of renal autotransplantation in a patient with metachronous ureteral cancer due to Lynch syndrome.

The management of cytotoxic chemotherapy extravasation: a systematic review of the literature to evaluate the evidence underpinning contemporary practice.

Management of cytotoxic drug extravasation remains contentious, with differing views on the most effective management strategy. With the increasing drive to provide effective, evidence-based healthcare, while ensuring the patient experience of the treatment provided plays a significant part in the development of clinical practice guidelines, the purpose of this literature review was to both critically analyse the quality of evidence that underpins contemporary practice and to determine if the patient experience is taken into account. A literature search was undertaken sourcing publications from the 1960s to July 2014 identifying all studies detailing strategies aimed at preventing the need for surgical debridement and all studies evaluating extravasation management from the patient's perspective. No conclusive evidence was found to suggest one clinical strategy as more effective than the other. No studies were identified that evaluated outcome from the patient's perspective. It is therefore suggested that outcomes-based research should underpin contemporary extravasation management guidelines to determine what the final outcome or 'end result' is and how this impacts on the patient and that the current lack of research into the patient experience of extravasation management is an area that needs to be addressed.

Should automated electronic hand-hygiene monitoring systems be implemented in routine patient care? Systematic review and appraisal with Medical Research Council Framework for Complex Interventions.

Manual hand-hygiene audit is time-consuming, labour-intensive and inaccurate. Automated hand-hygiene monitoring systems (AHHMSs) offer advantages (generation of standardized data, avoidance of the Hawthorne effect). World Health Organization Guidelines for Hand Hygiene published in 2009 suggest that AHHMSs are a possible alternative. The objective of this review was to assess the current state of the literature for AHHMSs and offer recommendations for use in real-world settings. This was a systematic literature review, and publications included were from the time that PubMed commenced until 19th November 2023. Forty-three publications met the criteria. Using the Medical Research Council's Framework for Developing and Evaluating Complex Interventions, two were categorized as intervention development studies. Thirty-nine were evaluations. Two described implementation in real-world settings. Most were small scale and short duration. AHHMSs in conjunction with additional intervention (visual or auditory cue, performance feedback) could increase hand hygiene compliance in the short term. Impact on infection rates was difficult to determine. In the few publications where costs and resources were considered, time devoted to improving hand hygiene compliance increased when an AHHMS was in use. Health workers' opinions about AHHMSs were mixed. In conclusion, at present too little is known about the longer-term advantages of AHHMSs to recommend uptake in routine patient care. Until more longer-term accounts of implementation (over 12 months) become available, efforts should be made to improve direct observation of hand hygiene compliance to improve its accuracy and credibility. The Medical Research Council Framework could be used to categorize other complex interventions involving use of technology to prevent infection to help establish readiness for implementation.

The efficacy of saline washout technique in the management of exfoliant and vesicant chemotherapy extravasation: a historical case series report.

This report presents the results from a historical case series of cytotoxic drug extravasations managed by saline washout; its purpose is to assess the efficacy of the procedure based on patient outcome. Eighty-nine patients were identified as having experienced a vesicant or exfoliant extravasation from incident reports filed over a 10-year period, from 1 April 2001 to 31 March 2011. Outcome was measured against the need for further surgical treatment being required. Of the 89 cases assessed for efficacy of saline washout one patient experienced a wound infection, which was treated effectively with oral antibiotics. There were no other complications reported and no patients required further treatment with surgical debridement. The majority of patients had no deferral of treatment as chemotherapy could be continued in their unaffected arm immediately following saline washout procedure. For patients where cannulation in their opposite arm for continuation of treatment was not advisable chemotherapy was delayed between 3 and 7 days. Hospitalisation as a result of the extravasation or subsequent treatment was not required in any of the 89 cases. Results indicate that saline washout technique is a safe and effective management strategy for the treatment of both vesicant and exfoliant chemotherapy extravasation.

What techniques are recommended to undertake procedures that require asepsis? Content and cluster analysis of information supplied in international guidance.

BACKGROUND: Health professionals frequently conduct procedures requiring asepsis but there is no definitive evidence-based guidance on how aseptic technique should be undertaken. OBJECTIVE: To undertake content and cluster analysis to compare and contrast information relating to the conduct of aseptic technique in national and international guidance. METHODS: Content and hierarchical cluster analysis. RESULTS: We identified 16 sources of information from: organizations that generate infection prevention guidelines, provide advice about infection prevention in addition to other topics, generate guidance for procedures (e.g., wound care); practice manuals; MeSH and Wikipedia. Content related to: theory underpinning aseptic technique; terminology used; how and when it should be undertaken; and equipment. The nature and amount of information varied widely. Most frequently stated information related to: environment or equipment (N = 13), followed by the absolute nature of asepsis and the importance of hand hygiene (N = 10); general personal protective equipment, the significance of pathogens, and no-touch techniques (N = 8); that it is risk-based (N = 7); the existence of key parts or sites, and that there are different types of aseptic technique (N = 6). The most comprehensive sources were a wound care organization in the USA, and a British internationally used textbook. Least information was provided in some general infection prevention guidelines. CONCLUSION: Progress with research and practice in relation to aseptic technique suffers through lack of common goals and understanding. This study is one step towards establishing what constitutes aseptic technique, how and when it should be conducted, and the equipment necessary. This is required to support practice, policy and education, and may improve sustainability of healthcare resources.

Challenges undertaking procedures requiring asepsis: a qualitative interview study with nurses.

BACKGROUND: Invasive devices and breaches to skin and mucous membranes increase susceptibility to infection. Nurses frequently undertake procedures requiring asepsis (PRAs), but report challenges and unwarranted variations in practice. OBJECTIVE: To explore nurses' experiences, perceived gaps in information and support needed to conduct PRAs. METHODS: Qualitative interviews were undertaken with 20 nurses in the UK National Health Service between September 2021 and January 2022 employing approaches to sampling and data collection adopted in grounded theory. RESULTS: Informants were employed in diverse clinical settings. They thought that outside operating theatres, attempts to maintain asepsis would inevitably be compromised, but that much could still be done to contain the risk of contaminating susceptible sites irrespective of circumstances. Suboptimal practice was reported, and informants were unclear whether asepsis was needed to perform routine procedures (e.g. dressing chronic wounds, manipulating indwelling intravascular lines). Problems were attributed to inadequacies in nursing education, poor access to continuing professional development, and carelessness of junior nurses and medical staff. Informants wanted more detailed guidelines to conduct PRAs. Senior nurses wanted procedures to be conducted in the same way regardless of circumstance. Nurses who undertook PRAs regularly suggested that guidelines should be flexible. CONCLUSION: There is a need for detailed guidelines to inform PRAs, better access to clinical updating, and improvements in pre-registration nursing education. To meet contemporary standards, guideline generation should adopt recognized methodology. Student nurses should be introduced to the knowledge and skills required to undertake and adjust PRAs according to circumstance during simulated practice before contact with real patients.

Off label use of devices and drugs in interventional radiology.

AIM: To establish how often off-label device and drug use occurs in interventional radiology (IR) in a UK tertiary referral hospital and consider the wider implications for the interventional radiologist. MATERIALS AND METHODS: Prospective data were collected during interventional procedures for 1 working week in a university hospital. Out-of-hours procedures and procedures outside the department were excluded. Operators were asked to record the drugs and devices used, the indication, and method of use. The instructions for use/summary of product characteristics were then studied for each device/drug used to assess if the use was on or off-label. RESULTS: During the study period 52 cases were performed and data were available on 26 cases (50%). In 22 of the 26 cases (84%) there was evidence of off-label use of devices or drugs. Off-label use of drugs included treatment of venous malformations with Fibrovein(©) (sodium tetradecyl sulphate), which is licensed for the treatment of varicose veins in the leg, and intra-arterial injection of heparin, which is licensed for intravenous and subcutaneous use. Off-label device use included placing vascular sheaths in the urinary tract, using angiographic catheters to guide wires in the urinary tract, using sheaths for thrombosuction, reshaping of the tip of most guidewires, and using angioplasty balloons to dislodge the arterial plug at fistula thrombectomy. CONCLUSION: Off-label device and drugs use is common in a UK tertiary hospital IR department and literature suggests this is common in the wider IR community. There are important clinical and legal implications for off-label use for patients and physicians.

Causes, prevention and management of surgical site infection.

Superficial surgical site infection (SSI) usually resolves quickly causing only short-term discomfort. However, SSI involving deeper tissues is a leading cause of morbidity and mortality and increases the overall cost of care. Although SSI commonly originates in the operating theatre, signs and symptoms of infection often do not appear until patients have been discharged from hospital. Nurses in a range of clinical settings are involved in the care of patients who either develop or are at risk of developing SSI and therefore need to know how to advise and manage these patients.

Delivery of antimicrobial stewardship competencies in UK pre-registration nurse education programmes: a national cross-sectional survey.

BACKGROUND: Registered nurses perform numerous functions critical to the success of antimicrobial stewardship, but only 63% of pre-registration nursing programmes include any teaching about stewardship. Updated nursing standards indicate that nurses require antimicrobial stewardship knowledge and skills. AIM: To explore the delivery of key antimicrobial stewardship competencies within updated pre-registration nursing programmes. METHODS: This study had a cross-sectional survey design. Data were collected between March and June 2021. FINDINGS: Lecturers from 35 UK universities responsible for teaching antimicrobial stewardship participated in this study. The provision of antimicrobial stewardship teaching and learning was inconsistent across programmes, with competencies in infection prevention and control, patient-centred care and interprofessional collaborative practice taking precedent over competencies pertaining to the use, management and monitoring of antimicrobials. Online learning and teaching surrounding hand hygiene, personal protective equipment and immunization theory was reported to have increased during the pandemic. Only a small number of respondents reported that students shared taught learning with other healthcare professional groups. CONCLUSION: There is a need to ensure consistency in antimicrobial stewardship across programmes, and greater knowledge pertaining to the use, management and monitoring of antimicrobials should be included. Programmes need to adopt teaching strategies and methods that allow nurses to develop interprofessional skills in order to practice collaboratively.

Limitations of current definitions of miscarriage using mean gestational sac diameter and crown-rump length measurements: a multicenter observational study.

OBJECTIVES: There is significant variation in cut-off values for mean gestational sac diameter (MSD) and embryo crown-rump length (CRL) used to define miscarriage, values suggested in the literature ranging from 13 to 25 mm for MSD and from 3 to 8 mm for CRL. We aimed to define the false-positive rate (FPR) for the diagnosis of miscarriage associated with different CRL and MSD measurements with or without a yolk sac in a large study population of patients attending early pregnancy clinics. We also aimed to define cut-off values for CRL and MSD that, on the basis of a single measurement, can definitively diagnose a miscarriage and so exclude possible inadvertent termination of pregnancy. METHODS: This was an observational cross-sectional study. Data were collected prospectively according to a predefined protocol. Intrauterine pregnancy of uncertain viability (IPUV) was defined as an empty gestational sac or sac with a yolk sac but no embryo seen with MSD < 20 or < 30 mm or an embryo with an absent heartbeat and CRL < 6 mm or < 8 mm. We recruited to the study 1060 consecutive women with IPUV. The endpoint was presence or absence of a viable pregnancy at the time of first-trimester screening ultrasonography between 11 and 14 weeks. The sensitivity, specificity, positive and negative predictive values were calculated for potential cut-off values to define miscarriage from MSD 8 to 30 mm with or without a yolk sac and from CRL 3 to 8 mm. RESULTS: Of the 1060 women with a diagnosis of IPUV, 473 remained viable and 587 were non-viable by the time of the 11-14-week scan. In the absence of both embryo and yolk sac, the FPR for miscarriage was 4.4% when an MSD cut-off of 16 mm was used and 0.5% for a cut-off of 20 mm. There were no false-positive test results for miscarriage when a cut-off of MSD ≥ 21 mm was used. If a yolk sac was present but an embryo was not, the FPR for miscarriage was 2.6% for an MSD cut-off of 16 mm and 0.4% for a cut-off of 20 mm, with no false-positive results when a cut-off of MSD ≥ 21 mm was used. When an embryo was visible with an absent heartbeat, using a CRL cut-off of 4 mm the FPR for miscarriage was 8.3%, and for a CRL cut-off of 5 mm it was also 8.3%. There were no false-positive results using a CRL cut-off of ≥ 5.3 mm. CONCLUSIONS: These data show that some current definitions used to diagnose miscarriage are potentially unsafe. Current national guidelines should be reviewed to avoid inadvertent termination of wanted pregnancies. An MSD cut-off of > 25 mm and a CRL cut-off of > 7 mm could be introduced to minimize the risk of a false-positive diagnosis of miscarriage.

Gestational sac and embryonic growth are not useful as criteria to define miscarriage: a multicenter observational study.

OBJECTIVES: We studied changes in mean gestational sac diameter (MSD) and embryonic crown-rump length (CRL) in intrauterine pregnancies of uncertain viability (IPUVs). We aimed to establish cut-off values for MSD and CRL growth that could be definitively associated with either viability or miscarriage, and to establish the relationship between growth in MSD and appearance of embryonic structures in the gestational sac. METHODS: One thousand and sixty consecutive IPUVs were recruited prospectively from four London University hospitals: 462 with no yolk sac or embryo, 419 with a yolk sac but no embryo, and 179 with an embryo but no heartbeat visible. IPUV was defined as an empty gestational sac with or without a yolk sac but no embryo seen with MSD < 20 or < 30 mm (depending on center) or an embryo with no heartbeat and CRL < 6 mm or < 8 mm (depending on center). Scans were repeated 7-14 days later. The endpoint was viability at first-trimester screening ultrasonography between 11 and 14 weeks. Change in MSD and CRL between the first and second scans of each pregnancy was compared with respect to viability and appearance of embryonic structures using the two-sample t-test. RESULTS: The study included 359 pregnancies in which a gestational sac with or without embryo was identified at the follow-up scan 7-14 days later. Of these, 192 were viable and 167 non-viable at the 11-14-week scan. MSD growth was significantly higher in viable than non-viable pregnancies (mean 1.003 vs. 0.503 mm/day; P < 0.001, 95% CI of difference 0.403-0.596). A difference in CRL growth was found between the two groups (mean 0.673 vs. 0.148 mm/day; P < 0.001, 95% CI of difference 0.345-0.703). MSD growth of 0.6 mm/day was associated with a specificity for diagnosing miscarriage of 90.1%, a sensitivity of 61.7% and 19 false-positive test results. A cut-off of CRL growth rate of 0.2 mm/day gave a sensitivity of 76.3% and there were no false-positive test results for miscarriage. On repeat scan the failure of either a yolk sac or embryo to be visualized was always associated with miscarriage. CONCLUSION: There is an overlap in MSD growth rates between viable and non-viable IPUV. No cut-off exists for MSD growth below which a viable pregnancy could be safely excluded. A cut-off value for CRL growth of 0.2 mm/day was always associated with miscarriage. These data suggest that criteria to diagnose miscarriage based on growth in MSD and CRL are potentially unsafe. However, finding an empty gestational sac on two scans more than 7 days apart is highly likely to indicate miscarriage, irrespective of growth.