Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853

A national perspective on the decline of abdominoperineal resection for rectal cancer

Objective: To assess rates of abdominoperineal excision of the rectum (APER) for rectal cancer between centers and over time, and to evaluate the influence of patient characteristics, including social deprivation, on,APER rate. Methods: Data on patients undergoing APER or anterior resection (AR) in England were extracted from a national administrative database for the years 1996 to 2004. The primary outcome was the proportion of patients presenting with rectal cancer undergoing APER. Hierarchical logistic regression was used to identify independent factors associated with a nonrestorative resection. Results: Data on 52,643 patients were analyzed, 13,109(24.9%) of whom underwent APER. The APER rate significantly reduced over the study period from 29.4% to 21.2% (P < 0.001). Operative mortality following AR decreased significantly during the period of study (5. 1 % to 4.2%, P = 0.002), while that following APER did not (P = 0.075). Male patients were more likely to undergo APER (P < 0.001), whereas those with an emergency presentation more commonly underwent AR (P < 0.00 1). Independent predictors of increased APER rate were male gender (odds ratio [OR] = 1.239, P < 0.001) and social deprivation (most vs. least deprived; OR 1.589, P < 0.001), whereas increasing patient age (OR = 0.977, P = 0.027 per 10-year increase), year of study (2003/4 vs. 1996/7; OR = 0.646, P < 0.001) and initial presentation as an emergency (OR = 0.713, P < 0.001) were associated with lower APER rates. After accounting for case-mix, there was significant between-center variability in APER rates. Conclusion: Socially deprived patients were more likely to undergo abdominoperineal resection. Significant improvements in rates of nonrestorative resection were seen over time but although short-term outcomes following AR have improved, those following APER have not. Permanent stoma rates following rectal cancer surgery may be considered a surrogate marker of surgical qualit

Proving the effectiveness of the fundamentals of robotic surgery (FRS) skills curriculum: A single-blinded, multispecialty, multi-institutional randomized control trial

Objective: To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform. Summary Background Data: There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills. Methods: Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n ¼ 29), dV-Trainer (n ¼ 30), and DVSS (n ¼ 32) that trained to benchmarks and control (n ¼ 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores. Results: All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67). Conclusions: We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved

Recombinant activated factor VII: a solution to refractory haemorrhage in vascular surgery?

ObjectivesPost-operative haemorrhage is a recognised complication and independent predictor of outcome in complex vascular surgery. The off-license administration of activated Recombinant Factor VII (rFVIIa) to treat haemorrhage in other surgical settings has been investigated, but concerns over potential adverse events have limited its use in vascular surgery. This article reports rFVIIa's method of action and systematically reviews rFVIIa's role in complex vascular surgery.MethodsA systematic literature search identified articles reporting on rFVIIa administration within vascular surgery patients. Patient-specific data regarding transfusion requirements was extracted and pooled statistical analysis performed.Results15 articles reporting 43 patients were identified. RFVIIa has been administered in open and endovascular procedures and in both elective and emergency settings. Major aortic surgery accounted for 75% of cases. The range of rFVIIa administered as a cumulative dose was large, as was the variation in initial dose. Transfusion data from 9 patients was pooled and analysed. Significant differences were found between pre- and post- rFVIIa for packed red cell transfusions (mean 29.2 vs. 8.2, p=0.015). Intra-arterial thrombosis was reported in 3 cases.ConclusionsRFVIIa may reduce haemorrhage in selected vascular surgical patients. Randomized controlled trials are justified to definitively investigate its role within this setting