Learning from the report of the independent medicines and medical devices safety review: “first do no harm”

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review, 1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the “healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate”. We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conducted Overarching themes and missed opportunities to prevent avoidable harm Three clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - Primodos The anti-epileptic drug - sodium valproate Surgical mesh for prolapse & incontinence The recommendations made by the review and implementation guidance Responses to the review, such as apologies issued by BSUG 2 /BAUS 3 /RCOG, 4 and compensations schemes such as the Scottish scheme as recommended by the review

The Relationship Between Urinary Symptom Severity And Functional Status İn Patients With Stroke

Background Lower Urinary Tract Dysfunction (LUTD) is a condition that is common in stroke patients and affects their quality of life and psychological state. Aim To determine the factors affecting LUTD severity in stroke patients and to evaluate its relationship with functional status. Method 77 stroke patients were included in our study. Demographic and stroke characteristics of all patients were recorded. Functional Ambulation Scale (FAS), Functional Independence Measure (FIM), the Core Lower Urinary Tract Symptom Score (CLSS) Questionnaire, Beck Depression Scale were administered to the patient. 33 of 77 patients had urodynamic study and these patients constituted the subgroup of the study. Patients were grouped according to type of disorder, type of detrusor and detrusor sphincter dyssynergia (DSD) using urodynamic study findings. Result The mean CLSS of men was significantly higher than women ( P = 0.017). A significant positive correlation was found between age and CLSS ( P = 0.035 r = 0.24) and negative correlation was found between total FIM and all sub-parameter scores and mean of CLSS ( P = 0.001 r = -0.467). Conclusion LUTD is common in stroke patients and the presence of urinary symptoms is associated with poor functional status. No significant relationship was observed between urodynamic data except maximum flow rate and CLSS.

A clinical trial comparing BiVap (Richard Wolf®) saline vaporization of the prostate vs. TwisterTM Diode Laser System in the treatment of benign prostatic obstruction between prostate volume 90 to 150 ml

Introduction To evaluate the efficacy, safety and postoperative outcomes of the BiVap and Twister systems with benign prostatic obstruction (BPO) in prostate volüm between 90–150 ml. Methods In total, we included 131 patients treated with BiVap system (n = 68) and Twister system (n = 63). Postoperative complications including urinary tract infection, transient hematuria, severe dysuria and fever >38° C, urinary incontinence and urethral stricture were also noted. All patients were evaluated at the postoperative 1st, 3rd, 6th and 12th month and preoperative and postoperative values of IPSS score, QoL score, total PSA, IIEF 15, PVR, Qmax and Qave were compared. Results Preoperative demographic characteristics were similar in the 2 groups. There was observed significant improvement for IPSS, Qmax, Qave, PVR, and QoL score by the postoperative first month compared to the preoperative values in both groups. Maximum improvement in the IPSS, Qmax, Qave, QoL score and PVR were achieved at postoperative 6, 3, 12, 3 and 12th months respectively in group 1. In group 2 maximum improvement in the same parameters were achieved at postoperative 6, 3, 6, 6 and 12th months, respectively. Conclusions BiVap and Twister systems are safe, effective, and useful technique, which can be used in the surgical treatment of BPO between 90–150 ml.

Extra-peritoneal Laparoscopic Resection of Benign Prostate Adenoma >150 CC with preservation of posterior wall of prostatic urethra: Dundee Technique and early outcomes

Background There are limited options for men with large benign prostates (>150cc) and bladder outflow obstruction due to benign prostatic hyperplasia (BPH). Management options include surgery (open or minimal access) and endoscopic procedures. There is a paucity of literature on outcomes for prostates >150cc. Methods In this case series we describe a step-by-step, illustrated, modified extra-peritoneal technique of laparoscopic prostatectomy with preservation of the posterior prostatic urethra. This involves creation of extra-peritoneal space, transverse incision of prostate capsule, progressive adenoma dissection, resection, and closure of the capsule. Results Ten patients underwent this procedure between 2015 and 2019. The mean age was 72.4 years and mean prostate size was 215.5cc. Mean procedure duration was 200 min and there were no intraoperative complications. Most patients were discharged on postoperative day 1. Mean intraoperative blood loss was 120 ml with no patient requiring blood transfusion. At follow up (mean 37 months) no patients had residual symptoms of BPH. Conclusion We describe a novel extraperitoneal laparoscopic technique for benign prostates of >150cc with very good outcomes. The transferability of this technique to centres with laparoscopic expertise at minimal extra cost and future adaptability in the robotic setting are some of the advantages of this technique.

Editorial – Medical litigation in the 21st century

The possibility of a medical negligence claim lies at the back of many doctors’ minds. But which specialties see the greatest and fewest claims, and what are the potential costs to the NHS of a successful claim? In their article, Dr Lane et al. analyse 10 years’ NHS litigation data, broken down by specialty, number of claims, and the attendant cost of those claims which were successful. Litigation in the ‘post Montgomery’ era is considered along with some of the common factors which may lead to a patient or their family taking legal action.

National trends and cost of litigation in UK National Health Service (NHS): a specialty-specific analysis from the past decade

Background and aims Medical litigation claim and costs in UK are rising. This study aims to analyse the 10-year trend in litigation costs for individual clinical specialties in the UK from 2009/10 to 2018/19. Methods Data were procured from National Health Service (NHS) Resolution. Number of claims, total litigation costs and cost per claim were ascertained for each financial year. The data collected also includes the number of claims and average amount per claim per speciality during the years 2009–2019 (2009/2010 to 2018/2019 financial years). Results The total annual cost of NHS litigation is currently £3.6 billion(2018/2019). Damages make up the greatest proportion of costs(£1.5 billion). Surgical specialties have the greatest number of claims annually(2847) but Obstetrics has the greatest total litigation(£1.9 billion) and cost per claim(£2.6 million). Number of claims, total costs and cost per claim are significantly greater in 2018/2019 than in 2009/2010. Conclusions Addressing the issue of litigations is complex. Medically there are speciality specific issues that require attention, whilst some general measures are common to all: effective communication, setting realistic targets and maintaining a motivated, adequately staffed workforce. These, alongside legal reforms, may reduce the financial burden of increasing litigation on the NHS.

Waist circumference, hip circumference, arm span, and waist-to-hip ratio high risk of polycystic ovarian syndrome

Background and Aims Polycystic ovarian syndrome is a reproductive problem of women with high prevalence cases accompanied by obesity conditions. Obesity condition can be seen from the size of waist circumference, hip circumference, arm span, and waist-to-hip ratio. This study aims to find out the risk factors between waist circumference size, hip circumference, arm span, and waist-to-hip ratio with polycystic ovarian syndrome. Methods This research is an analytical observation using a case-control approach conducted at Sekar Fertility Clinic and Poly Obgyn Dr Moewardi General Hospital Surakarta. Subjects were 150 consisting of 75 polycystic ovarian syndrome women and 75 normal fertile women. Sampling techniques used in this study are purposive sampling, researchers doing anthropometric measurements in the form of waist circumference, hip circumference, arm span, and waist-to-hip ratio simultaneously. The results were analyzed using Statistic Product and Service Solution 25. Results The results of the study obtained waist circumference with polycystic ovarian syndrome ( b = 3.002; CI 95% = 3.41–123.5; p = 0.001), hip circumference ( b = −2.671; CI 95% = 0.01–0.37; p = 0.002), arm span ( b = 5.318; CI 95% = 32.23–129.58; p < 0.001) and waist-to-hip ratio ( b = 1.761; CI 95% = 1.02–33.01; p = 0.047). Conclusion Waist circumference size, hip circumference, arm span, and waist-to-hip ratio correlate to a high risk of polycystic ovarian syndrome. Arm span is more dominant as an indicator of high risk to polycystic ovarian syndrome compared to waist circumference, hip circumference, and waist-to-hip ratio.