Budget Impact of RefluxStop™ as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom.

Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett's esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

A systematic review of patient reported outcome measures (PROMs) and quality of life reporting in patients undergoing laparoscopic cholecystectomy.

Patient reported outcome measures (PROMs) provide a valuable means of measuring outcomes subjectively from a patient's perspective, facilitating the assessment of service quality across healthcare providers, and assisting patients and clinicians in shared decision making. The primary aim of this systematic review was to critically appraise all historic studies evaluating patient reported quality of life, in adult patients undergoing laparoscopic cholecystectomy for symptomatic gallstones. The secondary aim was to perform a quality assessment of cholecystectomy-specific PROM-validation studies. A literature review was performed in PubMed, Google ScholarTM, the Cochrane Library, Medline, CINAHL, EMBASE and PsychINFO databases up to September 2017. Study characteristics, PROM-specific details and a bias assessment were summarised for non-validation studies. A COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) analysis was performed to assess the methodological quality of identified PROM-validation studies. Fifty one studies were found to evaluate health-related quality of life (HRQoL) after laparoscopic cholecystectomy. Although 94.1% of these studies included PROMs as a primary outcome measure, <20% provided level 1 evidence through randomised controlled trials (RCTs). There was significant variation in the selection and reporting of PROMs, with no studies declaring patient involvement in PROM selection, and 88.2% of studies failing to document the management of missing data points, or non-returned surveys (33.3%). In the 6 PROM-validation studies identified, only 5 psychometric properties were evaluated, the findings of which were limited due to the small number of studies. This systematic review identifies a lack in consistency of study design and PRO reporting in clinical trials. Whilst an increasing number of studies are being performed to evaluate PROs, a lack of adherence to existing PRO administration and reporting guidelines is continuing to negatively affect study quality. We recommend that future clinical trials utilizing PROs should adhere to established comprehensive guidelines as described.

Carbon dioxide narcosis and grand mal seizure complicating laparoscopic herniorrhaphy.

A 60-year-old man without comorbidity underwent a totally extraperitoneal repair of bilateral inguinal hernias under general anesthesia. Forty minutes after the procedure he developed a slow, shallow respiratory pattern with a respiratory rate of 5/min and a self-limiting grand mal seizure lasting 30 seconds. Arterial blood gas analysis indicated significant hypercarbia and acidosis. The total dose of morphine administered was 20 mg intravenously. Naloxone was administered and the respiratory rate improved. The patient was discharged after 24 hours after making a good recovery and has had no further seizures a year after surgery. Although hypercarbia is a well-known complication of laparoscopic surgery when CO2 is used for insufflation, this, to the best of our knowledge, is the first reported case of a patient sustaining a grand mal seizure resulting from CO2 narcosis after laparoscopic surgery. The possible mechanisms are discussed.

Colorectal cancer: current care, future innovations and economic considerations.

For those involved in colorectal cancer management, the present day is an exciting time. There is a multitude of new techniques to be considered for early detection (screening). National population screening for 60-69-year olds in England is due to start this year. Also, minimally invasive surgical techniques and multimodal pathways of care are aiding faster recovery, and there are increasing options for both adjuvant and palliative therapies. This article summarizes how colorectal cancer is currently managed in the UK and discusses the developments that are in the early stages of clinical use or on the horizon. Current management is discussed in detail in the hope that innovators reading the article may identify areas for improvement and allow comparison of new interventions with what are currently the gold standards. As changes are moving so fast, this review will probably only relate to the next 10 years at most. It does not provide a detailed reference list to support all therapies but indicates the key publications that will enable more detailed reading.