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"Cohen, Mark E"
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National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training
In this randomized trial comparing ACGME duty-hour policies with more flexible policies for surgical residents, the flexible policies resulted in noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality.
In response to concerns about patient safety and resident well-being, the Accreditation Council for Graduate Medical Education (ACGME) introduced national regulations in 2003 that limited resident duty periods to 80 hours per week, capped overnight shift lengths, and mandated minimum time off between shifts.
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Concerns persisted,
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and in 2011, the ACGME implemented further restrictions to shorten maximum shift lengths for interns and increase time off after overnight on-call duty for residents.
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Although most observers agree that some duty-hour regulation was necessary, critics cite a weak evidence base for the 2003 and 2011 reforms.
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Several retrospective . . .
Journal Article
Risk of Morbidity and Mortality Following Hepato-Pancreato-Biliary Surgery
Introduction
Hepatic, pancreatic, and complex biliary (HPB) surgery can be associated with major morbidity and significant mortality. For the past 5 years, the American College of Surgeons–National Surgical Quality Improvement Program (ACS–NSQIP) has gathered robust data on patients undergoing HPB surgery. We sought to use the ACS–NSQIP data to determine which preoperative variables were predictive of adverse outcomes in patients undergoing HPB surgery.
Methods
Data collected from ACS–NSQIP on patients undergoing hepatic, pancreatic, or complex biliary surgery between 2005 and 2009 were analyzed (
n
= 13,558). Diagnoses and surgical procedures were categorized into 10 and eight groups, respectively. Seventeen preoperative clinical variables were assessed for prediction of 30-day postoperative morbidity and mortality. Multivariate logistic regression was utilized to develop a risk model.
Results
Of the 13,558 patients who underwent an HPB procedure, 7,321 (54%) had pancreatic, 4,881 (36%) hepatic, and 1,356 (10%) biliary surgery. Overall, 70.3% of patients had a cancer diagnosis. Post-operative complications occurred in 3,850 patients for an overall morbidity of 28.4%. Serious complications occurred in 2,522 (18.6%) patients; 366 patients died for an overall peri-operative mortality of 2.7%. Peri-operative outcome was associated with diagnosis and type of procedure. Hepatic trisectionectomy (5.8%) and total pancreatectomy (5.4%) had the highest 30-day mortality. Of the preoperative variables examined, age >74, dyspnea with moderate exertion, steroid use, prior cardiac procedure, ascites, and pre-operative sepsis were associated with morbidity and mortality (all
P
< 0.05).
Conclusions
While overall morbidity and mortality for HPB surgery are low, peri-operative outcomes are heterogeneous and depend on diagnosis, procedure type, and key clinical factors. By combining these factors, an ACS–NSQIP “HPB Risk Calculator” may be developed in the future to help better risk-stratify patients being considered for complex HPB surgery.
Journal Article
Validation study of the ACS NSQIP surgical risk calculator for two procedures in Japan
The ACS NSQIP Surgical Risk Calculator (SRC) assesses risk to support goal-concordant care. While it accurately predicts US outcomes, its performance internationally is unknown. This study evaluates SRC accuracy in predicting mortality following low anterior resection (LAR) and pancreaticoduodenectomy (PD) in NSQIP patients and accuracy retention when applied to native Japanese patients (National Clinical Database, NCD).
NSQIP (41,260 LAR; 15,114 PD) and NCD cases (61,220 LAR; 27,901 PD) from 2015 to 2017 were processed through the SRC mortality model. Country-specific calibration and discrimination were assessed with and without an intercept correction applied to the Japanese data.
The SRC exhibited acceptable calibration for LAR and PD when applied to NSQIP data but miscalibration for NCD data. A simple correction to the model intercept, motivated by lower mortality rates in the Japanese data, successfully remediated the miscalibration.
The SRC may inaccurately predict surgical risk when applied to the native Japanese population. An intercept correction method is suggested when miscalibration is encountered; it is simple to implement and may permit effective international use of the SRC.
•ACS NSQIP Surgical Risk Calculator (SRC) is a widely-used risk-assessment tool.•Intercept correction can permit effective international use of the ACS NSQIP SRC.•Intercept correction facilitates the benchmarking of surgical quality worldwide.
Journal Article
Post Hepatectomy Liver Failure Risk Calculator for Preoperative and Early Postoperative Period Following Major Hepatectomy
Background
Post hepatectomy liver failure (PHLF) is associated with significant perioperative morbidity and mortality. A tool to identify patients at risk for PHLF may allow for earlier intervention to mitigate its severity and help clinicians when counseling patients. Our objective was to develop a PHLF risk calculator.
Study Design
Patients who underwent hepatectomy for any indication from 2014 to 2017 were identified from ACS NSQIP. A multivariable logistic regression model was developed that included preoperative and intraoperative variables. Model fit was assessed for discrimination using the C-statistic, and calibration using Hosmer and Lemeshow (HL) Chi square. Validation of the calculator was performed utilizing tenfold cross validation.
Results
Among 15,636 hepatectomy patients analyzed, the overall incidence of clinically significant PHLF was 2.8%. Preoperative patient factors associated with increased PHLF were male gender, preoperative ascites within 30 days of surgery, higher ASA class, preoperative total bilirubin greater than 1.2 mg/dl, and AST greater than 40 units/l. Disease related factors associated with PHLF included histology, and use of neoadjuvant therapy. Intraoperative factors associated with PHLF were extent of resection, open surgical approach, abnormal liver texture, and biliary reconstruction. The calculator’s C-statistic was 0.83 and the HL Chi square was 10.9 (
p
= 0.21) demonstrating excellent discrimination and calibration. On tenfold cross validation, the mean test group C-statistic was 0.82 and the HL
p
value was 0.26.
Conclusion
We present a multi-institutional preoperative and early postoperative PHLF risk calculator, which demonstrated excellent discrimination and calibration. This tool can be used to help identify high-risk patients to facilitate earlier interventions.
Journal Article
Impact of Hepatectomy Surgical Complexity on Outcomes and Hospital Quality Rankings
Background
There is substantial variation in the surgical complexity of hepatectomy. Currently, the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk adjusts for hospital quality comparisons using only the primary procedure code. Our objectives were to (1) assess the association between secondary procedures and complications; (2) assess model performance with inclusion of surgical complexity adjustment; and (3) examine whether secondary procedures affect hospital quality rankings.
Methods
Using ACS NSQIP (2007–2012), patients undergoing hepatectomy were identified. Secondary procedure codes and total work relative value units (RVUs) were used to approximate procedural complexity. The effect of procedural complexity variables on outcomes and hospital quality rankings were examined using hierarchical models.
Results
Among 11,826 patients who underwent hepatectomy at 261 hospitals, 32.8 % underwent at least one secondary procedure. Serious morbidity occurred in 18.0 % of patients. Seven of nine secondary procedures were significantly associated with death or serious morbidity on multivariable analysis. Model performance improved when secondary procedure categories were included, and secondary procedure categories outperformed total RVUs. The C-statistic for death or serious morbidity was 0.689 in the standard NSQIP model, 0.703 when total RVU was included, and 0.718 when secondary procedure categories were included. Of the 26 hospitals that were poor performers for death or serious morbidity using the standard ACS NSQIP model, three became average performers when secondary procedure categories were included in the model.
Conclusions
Secondary procedures are associated with an increased risk of postoperative complications. Inclusion of secondary procedure code categories in research and risk prediction models should be considered for hepatectomy.
Journal Article
Surgical quality improvement programs in Japan and USA: Report from the collaborative projects between Japanese Society of Gastroenterological Surgery and American College of Surgeons National Surgical Quality Improvement Program
The Japanese Society of Gastroenterological Surgery (JSGS) and the American College of Surgeons National Surgical Quality Improvement Program (ACS‐NSQIP) have collaboratively developed several clinical projects since 2011 using two nationwide clinical registries with the goal of achieving further improvement of surgical quality in both countries. In this review, the historical viewpoints and the collaboration between JSGS and ACS and their use of nationwide registries [National Clinical Database (NCD) and NSQIP] for research are reviewed. We have carried out a joint project, the 30‐day Mortality Risk Model Study and, currently, we are working on several joint projects such as the Morbidity‐Mortality Study, Japan‐USA Calibration Study, Geriatric Study, and Safety Culture Study as well as Auditing in JSGS/NCD with reference to the NSQIP method. These joint projects will continue to provide us with important information and data to drive improvements in surgical care in both countries. This will also help us to identify any unknown weaknesses in the health‐care systems of the USA and Japan.
The Japanese Society of Gastroenterological Surgery (JSGS) and the American College of Surgeons National Surgical Quality Improvement Program (ACS‐NSQIP) have collaboratively developed several clinical projects since 2011 using two nationwide clinical registries with the goal of achieving further improvement of surgical quality in both countries.
Journal Article
Does Comanagement of Patients With Hip Fracture Influence 30-Day Outcomes
Introduction:
Comanagement of hip fractures is thought to optimize outcomes for these high-risk patients, but this practice is not universal. We aimed to determine whether comanagement of patients with hip fracture affects 30-day outcomes.
Methods:
The American College of Surgeons National Surgical Quality Improvement Program database was queried for all hip fractures between January 2015 and January 2017, totaling 15 461 patients (144 hospitals). Patients were divided into 3 cohorts: 11 233 comanaged throughout stay (CM), 2537 partially comanaged during stay (PCM), or 1691 not comanaged (NCM), by orthopedic surgeons with medicine physicians or geriatricians. Data collected included demographics, hip fracture type, postoperative outcomes, and length of stay (LOS). Logistic regression and linear regression analyses were performed.
Results:
Both CM and PCM patients were older, with more dementia, poorer mobility, and more comorbidities than NCM patients. Mortality rates were 4.55%, 0.81%, and 0.33% for CM, PCM, and NCM, respectively, and risk-adjusted odds ratios (ORs) were 1.63 (95% confidence interval = 1.22-2.23) and 1.22 (0.87-1.74) for CM and PCM, respectively, compared to NCM. Morbidity rates were 11.06%, 15.45%, and 7.63% for CM, PCM, and NCM, respectively, and ORs were 1.74 (1.41-2.16) and 1.94 (1.57-2.41) for CM and PCM, respectively, compared to NCM. Risk-adjusted mean square LOS was 6.38, 8.80, and 7.23 for CM, PCM, and NC, respectively (P < .01).
Conclusions:
Comanaged patients with hip fracture had poorer cognition, function, and general health, with the shortest LOS. Surprisingly, NCM was associated with reduced morbidity and mortality, which may relate to them being the healthiest patients. Overall, our findings still support orthogeriatric comanagement in this high-risk group to maximize outcomes.
Journal Article
Surgical Outcomes in Canada and the United States: An Analysis of the ACS-NSQIP Clinical Registry
Background
There has been longstanding uncertainty over whether lower healthcare spending in Canada might be associated with inferior outcomes for hospital-based care. We hypothesized that mortality and surgical complication rates would be higher for patients who underwent four common surgical procedures in Canada as compared to the US.
Design, Setting, and Participants
We conducted a retrospective cohort study of all adults who underwent hip fracture repair, colectomy, pancreatectomy, or spine surgery in 96 Canadian and 585 US hospitals participating in the American College of Surgeons National Surgical Quality Improvement Project (ACS-NSQIP) between January 1, 2015 and December 31, 2019. We compared patients with respect to demographic characteristics and comorbidity. We then compared unadjusted and adjusted outcomes within 30-days of surgery for patients in Canada and the US including: (1) Mortality; (2) A composite constituting 1-or-more of the following complications (cardiac arrest; myocardial infarction; pneumonia; renal failure/; return to operating room; surgical site infection; sepsis; unplanned intubation).
Results
Our hip fracture cohort consisted of 21,166 patients in Canada (22.3%) and 73,817 in the US (77.7%), for colectomy 21,279 patients in Canada (8.9%) and 218,307 (91.1%), for pancreatectomy 873 (7.8%) in Canada and 12,078 (92.2%) in the US, and for spine surgery 14,088 (5.3%) and 252,029 (94.7%). Patient sociodemographics and comorbidity were clinically similar between jurisdictions. In adjusted analyses odds of death was significantly higher in Canada for two procedures (colectomy (OR 1.22; 95% CI 1.044–1.424;
P
= .012) and pancreatectomy (OR 2.11; 95% CI 1.26–3.56;
P
= .005)) and similar for hip fracture and spine surgery. Odds of the composite outcome were significantly higher in Canada for all 4 procedures, largely driven by higher risk of cardiac events and post-operative infections.
Conclusions
We found evidence of higher rates of mortality and surgical complications within 30-days of surgery for patients in Canada as compared to the US.
Journal Article