Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II–III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial

Aim Haemorrhoids are a common condition, with nearly 30,000 procedures carried out in England in 2014/15, and result in a significant quality-of-life burden to patients and a financial burden to the healthcare system. This study examined the cost effectiveness of haemorrhoidal artery ligation (HAL) compared with rubber band ligation (RBL) in the treatment of grade II–III haemorrhoids. Method This analyses used data from the HubBLe study, a multicentre, open-label, parallel group, randomised controlled trial conducted in 17 acute UK hospitals between September 2012 and August 2015. A full economic evaluation, including long-term cost effectiveness, was conducted from the UK National Health Service (NHS) perspective. Main outcomes included healthcare costs, quality-adjusted life-years (QALYs) and recurrence. Costeffectiveness results were presented in terms of incremental cost per QALY gained and cost per recurrence avoided. Extrapolation analysis for 3 years beyond the trial follow-up, two subgroup analyses (by grade of haemorrhoids and recurrence following RBL at baseline), and various sensitivity analyses were undertaken. Results In the primary base-case within-trial analysis, the incremental total mean cost per patient for HAL compared with RBL was £1027 (95% confidence interval [CI] £782– £1272, p\0.001). The incremental QALYs were 0.01 QALYs (95% CI -0.02 to 0.04, p = 0.49). This generated an incremental cost-effectiveness ratio (ICER) of £104,427 per QALY. In the extrapolation analysis, the estimated probabilistic ICER was £21,798 per QALY. Results from all subgroup and sensitivity analyses did not materially change the base-case result. Conclusions Under all assessed scenarios, the HAL procedure was not cost effective compared with RBL for the treatment of grade II-III haemorrhoids at a cost-effectiveness threshold of £20,000 per QALY; therefore

Simulation research to enhance patient safety and outcomes: recommendations of the Simnovate Patient Safety Domain Group

The use of simulation-based training has established itself in healthcare but its implementation has been varied and mostly limited to technical and non-technical skills training. This article discusses the possibilities of the use of simulation as part of an overarching approach to improving patient safety, and represents the views of the Simnovate Patient Safety Domain Group, an international multidisciplinary expert group dedicated to the improvement of patient safety. The application and integration of simulation into the various facets of a learning healthcare system is discussed, with reference to relevant literature and the different modalities of simulation which may be employed. The selection and standardisation of outcomes is highlighted as a key goal if the evidence base for simulation-based patient safety interventions is to be strengthened. This may be achieved through the establishment of standardised reporting criteria. If such safety interventions can be proven to be effective, financial incentives are likely to be necessary to promote their uptake, with the intention that up-front cost to payers or insurers be recouped in the longer term but reductions in complications and lengths of stay.This research was funded through an unrestricted donation from the Blema and Arnold Steinberg Foundation. NS's research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London at King's College Hospital NHS Foundation Trust. NS is a member of King's Improvement Science, which is part of the NIHR CLAHRC South London and comprises a specialist team of improvement scientists and senior researchers based at King's College London. Its work is funded by King's Health Partners (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust, King's College London and South London and Maudsley NHS Foundation Trust), Guy's and St Thomas' Charity, the Maudsley Charity and the Health Foundation. RT's research is supported by the Canadian Institutes of Health Research (CIHR) and the Canadian Foundation for Innovation (CFI)

Risk factors, complications and survival after upper abdominal surgery:a prospective cohort study

Background: Preoperative weight loss and abnormal serum-albumin have traditionally been associated with reduced survival. More recently, a correlation between postoperative complications and reduced long-term survival has been reported and the significance of the relative proportion of skeletal muscle, visceral and subcutaneous adipose tissue has been examined with conflicting results. We investigated how preoperative body composition and major non-fatal complications related to overall survival and compared this to established predictors in a large cohort undergoing upper abdominal surgery. Methods: From 2001 to 2006, 447 patients were included in a Norwegian multicenter randomized controlled trial in major upper abdominal surgery. Patients were now, six years later, analyzed as a single prospective cohort and overall survival was retrieved from the National Population Registry. Body composition indices were calculated from CT images taken within three months preoperatively. Results: Preoperative serum-albumin 5 % (HR = 1.38, p = 0.023) were independently associated with reduced survival. There was no association between any of the preoperative body composition indices and reduced survival. Major postoperative complications were independently associated with reduced survival but only as long as patients who died within 90 days were included in the analysis. Conclusions: Our study has confirmed the robust significance of the traditional indicators, preoperative serum-albumin and weight loss. The body composition indices did not prove beneficial as global indicators of poor prognosis in upper abdominal surgery. We found no association between non-fatal postoperative complications and long-term survival

Development of an evidence-based curriculum for training of ward-based surgical care

Background Ward-based care of surgical patients is a complex and variable process, centered on the surgical ward round (WR). The authors describe the development of an evidence-based curriculum to improve ward-based care in the form of surgical WRs. Methods A modular, simulation-based curriculum was developed according to validated methods, incorporating the most recent evidence in the design of each educational module. Results A predevelopmental analysis questionnaire identified themes of patient assessment and management, communication skills, and teamwork as areas to be addressed. Curricular development incorporated knowledge and confidence assessment, lecture-based teaching, and simulated WR, followed by individualized assessment, debriefing, and feedback. Each module is evidence based and assesses trainees using validated tools. Conclusions A comprehensive and cost-effective simulation-based curriculum, developed according to a validated framework, has been developed for surgical WRs and ward-based care. This may improve trainees' WR performance, improving patient care and surgical outcomes in turn

Surgical ward round quality and impact on variable patient outcomes

Objective: To investigate the relationship between variability in surgical ward round (WR) quality and clinical outcomes. Background: Evidence increasingly suggests that ward-based care plays a key role in surgical outcomes. The WR is the focal point of surgical inpatient care. Assimilating various sources of clinical information is necessary for thorough patient assessment during the WR; whether this relates to outcomes has not previously been examined. Methods: WRs were observed for patients on a surgical high-dependency unit in a tertiary academic surgical unit. All sources of clinical information (SCI) were considered. Thoroughness of assessment, defined as the percentage of SCI assessed by the clinician, was recorded as a marker of WR quality. Complications were recorded from patient records; preventability was based on Agency for Healthcare and Research Quality guidelines. The relationship between WR quality and incidence of preventable complications was analyzed. Results: Sixty-nine WRs were observed over 37 days for 50 patients receiving care in the high-dependency unit. Observed morbidity rate was 60% (30/50). Seventy-four percent of all complications (35/46) occurred on the high-dependency unit. There was significant variability in WR quality: clinicians assessed 9% to 91% (mean = 55% ± 17%) of SCI (analysis of variance P = 0.025). Low-quality (% SCI assessed less than the mean) WRs resulted in a greater incidence of patients experiencing preventable complications [83% (10/12) vs 39% (7/18)] (P = 0.034), odds ratio = 6.43 (95% confidence interval = 1.05–39.3). Forty-one percent of complications (19/46) could have been diagnosed earlier or possibly prevented. Conclusions: Patient assessment during WRs is variable. Less thorough WRs result in delayed diagnoses and preventable complications, and they negatively affect outcomes. Focusing on WR quality and training may improve patient care

Validation of the simulated ward environment for assessment of ward-based surgical care

Objective: To assess the feasibility of developing a simulated ward environment in which to assess the ward-based care of surgical patients by clinicians of varying levels of experience (construct validation). Background: Increasing evidence points to the importance of the postoperative or ward-based phase of surgical care in determining patient outcomes. Ward-based care is determined by the clinician ward round, with the simulated ward environment potentially providing a safe environment for training and assessment. Methods: A high-fidelity surgical ward environment was developed. Junior and senior trainees conducted ward rounds of 3 standardized surgical patients and were assessed using a checklist of assessment and management care processes, modified NOTECHS score, and fidelity questionnaire. Results: Nine senior and 9 junior trainees were observed. There was no significant difference in time taken to conduct the round (37.6 ± 2.7 vs 32.6 ± 1.9 minutes, P = 0.16). Senior trainees performed significantly more assessment processes (73% ± 2.8% vs 63% ± 2.5%, P = 0.016) and completed more management tasks (73% ± 4.5% vs 59.4% ± 5%, P = 0.058). Fifteen adverse events were committed by junior trainees versus 8 by seniors (P < 0.001). Seniors scored higher on nontechnical ability (NOTECHS score 21.8 ± 0.61 vs 18.1 ± 1.12, P = 0.017). All of subjects felt the ward, patients, and scenarios were realistic. Conclusions: A high-fidelity, immersive, construct-valid ward simulator has been developed in which to observe and assess ward-based processes of surgical care

Surgical care checklists to optimize patient care following postoperative complications

Background: Postoperative complications are common. Inconsistency in the care of complications is reflected in variable rates of failure to rescue. This study aims to develop and validate checklists for treatment of common postoperative complications. Methods: Initial checklists were based on best evidence, with expert clinician review. Casenote review was performed, comparing checklist item completion with outcomes. Logistic regression was performed for risk of further morbidity, considering American Society of Anesthesiology grade, age, sex, and checklist compliance. Checklists were finalized through end user multidisciplinary review. Results: Evidence-based checklists were developed. Retrospective casenote review revealed management of 86% (31/37) of these complications to be noncompliant with checklist-mandated care. This resulted in delays and errors in 65% (24/37) of cases, with median treatment delay of 6 hours (interquartile range 5.4 hours). Regression analysis revealed poor checklist compliance to be to only significant factor (odds ratio 6.75, 95% confidence interval 1.11 to 41.00, P = .038) for developing further morbidity. Conclusions: Management of complications is highly variable, with failure to adhere to best practice principles significantly associated with an increased risk of further morbidity. This study presents an evidence-based framework for the development of checklists to standardize care