Gefitinib and Methotrexate to Treat Ectopic Pregnancies with a Pre-Treatment Serum hCG 1000–10,000 IU/L: Phase II Open Label, Single Arm Multi-Centre Trial

This work was supported by an NHMRC Grant (#1008276) to ST, TJ and EW, and an MRC Centenary Award (G0802808) to AH. The funders had no role study design, collection, analysis, and interpretation of data; in the writing of the report or in the decision to submit the paper.Peer reviewedPublisher PD

Vacuum aspiration for induced abortion could be safely and legally performed by nurses and midwives

Background: Some 40% of abortions carried out in England and Wales are done by vacuum aspiration. It is widely assumed that, in order to be lawful, these procedures must be performed by doctors. Aim and design: This study aimed to provide a detailed reassessment of the relevant law and the clinical evidence that supports this assumption. Conclusions: A close reading of relevant law reveals that this assumption is unfounded. On the contrary, it would be lawful for appropriately trained nurses or midwives, acting as part of a multidisciplinary team, to carry out vacuum aspiration procedures. This interpretation of the law offers the potential for developing more streamlined, cost-effective abortion services, which would be both safe and highly acceptable to patients

Outcomes of delivering a fertility preservation service for women with cancer over a 12-year period at a UK assisted conception unit.

This service evaluation aimed to appraise the delivery of a fertility preservation service for women with cancer which was established in 2005 as part of an Assisted Conception Unit. First, the ACU-database was interrogated between 08/2005 and 01/2017; revealing 174 women received referrals over the 12-year period with a steady referral increase each year. Demographic analyses revealed factors, such as being partnered, to be strong indicators of whether women would seek FP or not. To improve service provision, women who had consented to be contacted for audit, administrative and research purposes, received questionnaires to ascertain their perspectives on the FP decision-making process, their outcomes and ACU after-care. The majority perceived their experience as excellent due to the care they received from ACU staff, speed and efficiency in service delivery. The increasing number of referrals since 2005 is reassuring. However, this audit also highlighted shortcomings of the service, such as limited awareness of the fertility counselling service and lack of after-care. IMPACT STATEMENT What is already known on this subject? There has been an increase in women diagnosed with cancer undergoing fertility preservation (FP) before starting potential gonadotoxic treatment. Offering FP to these women is essential as the ability to have future children is often perceived as equally as important as survivorship, and a source of hope for the future. What do the results of this study add? This study presents a service evaluation, across a 12-year period, of delivering FP services to women with cancer in one UK Assisted Conception Unit (ACU). Women's experiences of the service were evaluated to enhance service delivery and make recommendations for clinical practice. What are the implications of these findings for clinical practice and/or future research? The current service evaluation demonstrated increased rates of FP referral over a 12-year period for women with cancer. While this increasing number is reassuring and reflecting increased awareness among professionals and patients; shortcomings in the care pathway were also found: women reported limited opportunity to see fertility counsellors and desired better after care. This information may also be of benefit to other ACUs seeking to enhance and improve service provision in the care of women with cancer, contemplating fertility preservation

Reasonable expectations of privacy in non-disclosure of familial genetic risk: What is it reasonable to expect?

Where there is conflict between a patient's interests in non-disclosure of their genetic information to relatives and the relative's interest in knowing the information because it indicates their genetic risk, clinicians have customarily been able to protect themselves against legal action by maintaining confidence even if, professionally, they did not consider this to be the right thing to do. In ABC v St Georges Healthcare NHS Trust ([2017] EWCA Civ 336) the healthcare team recorded their concern about the wisdom of the patient's decision to withhold genetic risk information from his relative, but chose to respect what they considered to be an unwise choice. Even though professional guidance considers that clinicians have the discretion to breach confidence where they believe this to be justified, (Royal College of Physicians, Royal College of Pathologists and the British Society of Human Genetics, 2006; GMC, 2017) clinicians find it difficult to exercise this discretion in line with their convictions against the backdrop of the legal prioritisation of the duty to maintain confidence. Thus, the professional discretion is not being freely exercised because of doubts about the legal protection available in the event of disclosure. The reliance on consent as the legal basis for setting aside the duty of confidence often vetoes sharing information with relatives. This paper argues that an objective approach based on privacy, rather than a subjective consent-based approach, would give greater freedom to clinicians to exercise the discretion which their professional guidance affords

Developing criteria for Cesarean Section using the RAND appropriateness method

<p>Abstract</p> <p>Background</p> <p>Cesarean section rates are increasing worldwide, and a rapid increase has been observed in Iran. Disagreement exists between clinicians about when to use cesarean section. We aimed to identify the appropriateness criteria for the use of cesarean section in Iran.</p> <p>Method</p> <p>A consensus development study using a modified version of the RAND Appropriateness Method (RAM). We generated scenarios from valid clinical guidelines and expert opinions. A panel of experts participated in consensus development: first round via mail (12 members), second round face-to-face (9 members). We followed the RAM recommendations for the development of the scenario lists, rating scales, and statistical analyses.</p> <p>Results</p> <p>294 scenarios relevant to cesarean section were identified. 191 scenarios were considered appropriate, of which 125 scenarios were agreed upon. The panel found cesarean inappropriate for 21% of scenarios, and 'equivocal' for 14% of scenarios.</p> <p>Conclusion</p> <p>RAM is useful for identifying stakeholder views in settings with limited resources. The participants' views on appropriateness of certain indications differed with available evidence. A large number of scenarios without agreement may partly explain why it has been difficult to curb the growth in cesarean section rate.</p

A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial

Background Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking. Objectives To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use. Design Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded. Setting A total of 26 UK obstetric units. Participants Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated. Interventions Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed. Main outcome measures Primary – donor blood transfusion. Secondary – units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer–Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes – costs of resources and service provision taking the UK NHS perspective. Results We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at £8110 per donor blood transfusion avoided. Conclusions The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective. Future work Research into risk of alloimmunisation among women exposed to cell salvage is needed. Trial registration Current Controlled Trials ISRCTN66118656. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information

Demographics of infertility and management of unexplained infertility

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Treating symptomatic uterine fibroids with myomectomy: current practice and views of UK consultants

Background: The demand for uterus-sparing treatments is increasing as more women postpone childbirth to their 30–40s, when fibroids are more symptomatic. With an increasing choice of treatment options and changing care-provider profiles, now is an opportune time to survey current practices and opinions. Using a 25-stem questionnaire, a web-based survey was used to capture the practices and opinions of UK consultant gynecologists on the treatment of symptomatic fibroids, including the types of procedure most frequently used, methods used to reduce blood loss, and awareness and acceptability of treatment options, and to assess the impact of gender and experience of the treating gynecologist. Results: The response rate was 22%. Laparascopic myomectomy is used least frequently, with 80% of the respondents using GnRHa preoperatively to minimize blood loss and correct anemia, while vasopressin is most frequently used to reduce intraoperative blood loss. Female consultants operate significantly less frequently than males. Those with more than 10 years consultant experience are more likely to perform an open myomectomy compared to those with less than 10 years experience. Conclusions: Compared to a similar survey performed 10 years ago, surgical methods remain to be the most common treatments, but use of less invasive treatments such as UAE has increased. Consultants’ attitudes appear to be responding to the patient demand for less radical treatments. However, it is yet to be seen if the changing consultant demographics will keep up with this demand. The low response rate warrants cautious interpretation of the results, but they provide an interesting snapshot of current views and practices