Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program: Bariatric Surgical Risk/Benefit Calculator: 1-year comorbidity remission.

BACKGROUND: Clinical calculators can provide patient-personalized estimates of treatment risks and health outcomes. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) set out to create a publicly available tool to assess both short-term postoperative risk and long-term benefits for prospective adult patients eligible for 1 of 4 primary bariatric procedures. The calculator is comprised of multiple prediction elements: (1) 30-day postoperative risk, (2) 1-year body mass index projections, and (3) 1-year comorbidity remission. OBJECTIVES: To assess the performance of the 1-year comorbidity remission prediction feature of the calculator. SETTING: Not-for-profit organization clinical data registry. METHODS: MBSAQIP data across 4.5 years from 240,227 total patients indicating at least 1 comorbidity of interest present preoperatively and who had a 1-year follow-up record documenting their comorbidity status were included. Six models were constructed, stratified by the presence of the respective preoperative comorbidity: hypertension, hyperlipidemia, gastroesophageal reflux disease, sleep apnea, non-insulin-dependent diabetes, and insulin-dependent diabetes. A multinomial logistic regression model was used to predict 1-year remission (total, partial, or no remission) of insulin-dependent diabetes. All other outcomes were binary (yes or no at 1 yr), and ordinary logistic regression models were used. RESULTS: All models showed adequate discrimination (C statistics ranging from .58 to .68). Plots of observed versus predicted remission (%) showed excellent calibration across all models. CONCLUSION: All remission models were well calibrated with sufficient discrimination. The MBSAQIP Bariatric Surgical Risk/Benefit Calculator is a publicly available tool intended for integration into clinical practice to enhance patient-clinician discussions and informed consent.

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Bariatric Surgical Risk/Benefit Calculator: 1-year weight.

BACKGROUND: Data-driven tools can be designed to provide patient-personalized estimates of health outcomes. Clinical calculators are commonly built to assess risk, but potential benefits of treatment should be equally considered. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) sought to create a risk and benefit calculator for adult patients considering primary metabolic and bariatric surgery with multiple prediction features: (1) 30-day risk, (2) 1-year body mass index (BMI) projections, and (3) 1-year co-morbidity remission. OBJECTIVE: To assess the performance of the 1-year BMI projections feature of this tool. SETTING: Not-for-profit organization, clinical data registry. METHODS: MBSAQIP data from 596,024 cases across 4.5 years from 882 centers with ∼2.5 million records through 18 months postoperatively were included. A generalized estimating equation model was used to estimate BMI over time for 4 primary procedures: laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass, and biliopancreatic diversion with duodenal switch. RESULTS: The mean absolute error (MAE) in BMI predictions through postoperative month 12 was 1.68 units; overall correlation of actual and predicted BMI was .94. MAE of postoperative BMI estimates (1-12 mo) was lowest for laparoscopic sleeve gastrectomy (1.64) and highest for biliopancreatic diversion with duodenal switch (1.99). BMI predictions at 12 months showed MAE = 2.99 units. CONCLUSIONS: Predicted BMI closely aligned with actual BMI values across the 12-month postoperative period. The MBSAQIP Bariatric Surgical Risk/Benefit Calculator is publicly available with the intent to facilitate patient-clinician communication and guide surgical decision making. This tool can aid in evaluating postoperative risk as well as benefits and long-term expectations.

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program bariatric surgical risk/benefit calculator: 30-day risk.

BACKGROUND: There is increasing demand for data-driven tools that provide accurate and clearly communicated patient-specific information. These can aid discussions between practitioners and patients, promote shared decision-making, and enhance informed consent. The American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) sought to create a risk calculator for adult patients considering primary metabolic and bariatric surgery, with multiple prediction features: (1) 30-day risk; (2) 1-year body mass index projections; and (3) 1-year co-morbidity remission. OBJECTIVES: To evaluate the 30-day risk estimation feature of this tool. SETTING: Not-for-profit organization, international bariatric surgery clinical data registry. METHODS: MBSAQIP data across 5.5 years, 925 hospitals, and 775,291 cases were used to develop the 30-day risk feature. Logistic regression models were employed to estimate postoperative risks for 9 outcomes across 4 procedures: laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, laparoscopic adjustable gastric band, and biliopancreatic diversion with duodenal switch. RESULTS: The tool showed good discrimination for mortality and surgical site infection models (c-statistics, .80 and .70, respectively), and was slightly less accurate for the 7 other complications (.62-.69). Graphical representations showed excellent calibration for all 9 outcomes. CONCLUSIONS: Overall, the 30-day risk models were accurate and well calibrated, with acceptable discrimination. The MBSAQIP bariatric surgical risk/benefit calculator is publicly available, with the intent to be integrated into healthcare practice to guide bariatric surgical decision-making and care planning, and to enhance communication between patients and their surgical care team.

Effects of coronavirus disease 2019 on the Society for Vascular Surgery Vascular Quality Initiative arterial procedure registry.

In the present report, we have described the abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures in response to the coronavirus disease 2019 (COVID-19) pandemic. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020 to discern the effects of the COVID-19 pandemic. Approximately three fourths of physicians (74%) had adopted a restrictive operating policy for urgent and emergent cases only. However, one half had considered "time sensitive" elective cases as urgent. Data manager case entry was affected by both low case volumes and low staffing resulting from reassignment or furlough. A sevenfold reduction in arterial Vascular Quality Initiative case volume entry was noted in the first quarter of 2020 compared with the same period in 2019. The downstream consequences of delaying vascular procedures for carotid artery stenosis, aortic aneurysm repair, vascular access, and chronic limb ischemia remain undetermined. Further ramifications of the COVID-19 pandemic shutdown will likely be amplified if resumption of elective vascular care is delayed beyond a short window of time.

Impact of COVID-19 on the Society for Vascular Surgery Vascular Quality Initiative Venous Procedure Registries (varicose vein and inferior vena cava filter).

In response to the pandemic, an abrupt pivot of Vascular Quality Initiative physician members away from standard clinical practice to a restrictive phase of emergent and urgent vascular procedures occurred. The Society for Vascular Surgery Patient Safety Organization queried both data managers and physicians in May 2020. Approximately three-fourths (74%) of physicians adopted restrictive operating policies for urgent and emergent cases only, whereas one-half proceeded with "time sensitive" elective cases as urgent. Data manager case entry was negatively affected by both low case volumes and staffing due to reassignment or furlough. Venous registry volumes were reduced fivefold in the first quarter of 2020 compared with a similar period in 2019. The consequences of delaying vascular procedures for ambulatory venous practice remain unknown with increased morbidity likely. Challenges to determine venous thromboembolism mortality impact exist given difficulty in verifying "in home and extended care facility" deaths. Further ramifications of a pandemic shutdown will likely be amplified if postponement of elective vascular care extends beyond a short window of time. It will be important to monitor disease progression and case severity as a result of policy shifts adopted locally in response to pandemic surges.

Prevalence and Risk Factors for Bariatric Surgery Readmissions: Findings From 130,007 Admissions in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

OBJECTIVE: To evaluate readmissions following laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB). BACKGROUND: Few studies have evaluated national readmission rates for primary bariatric surgery with national, bariatric-specific data. METHODS: Patients undergoing primary LAGB, LSG, or LRYGB from January 1, 2014 to December 31, 2014, at 698 centers were identified based upon Current Procedural Terminology codes. The primary outcome was 30-day readmission from date of initial operation. RESULTS: A total of 130,007 patients who underwent primary bariatric surgery were identified: 7378 LAGB (5.7%), 80,646 LSG (62.0%), and 41,983 LRYGB (32.3%). A total of 5663 (4.4%) patients were readmitted within 30 days for all causes. Patients undergoing LAGB had the lowest related readmission rate of 1.4%, followed by LSG (2.8%), and LRYGB (4.9%). Of patients who had a complication, 17.9% (n = 785) were readmitted, whereas those without readmission had a complication 1.9% of the time (P < 0.001). The most common cause of a related readmission was nausea, vomiting, fluid, electrolyte, and nutritional depletion (35.4%), followed by abdominal pain (13.5%), anastomotic leak (6.4%), and bleeding (5.8%), accounting for more than 61% of readmissions. When compared with LAGB, LSG, and LRYGB had significantly higher rates of readmission (LSG: odds ratio 1.89; 95% confidence interval 1.52-2.33; LRYGB: odds ratio 3.06; 95% confidence interval 2.46-3.81). CONCLUSIONS: National bariatric readmissions after primary procedures were closely associated with complications, varied based on the type of procedure, and were most commonly due to nausea, vomiting, electrolyte, and nutritional depletion.

Concurrent bariatric operations and association with perioperative outcomes: registry based cohort study.

Objective To determine whether perioperative outcomes differ between patients undergoing concurrent compared with non-concurrent bariatric operations in the USA.Design Retrospective, propensity score matched cohort study.Setting Hospitals in the US accredited by the American College of Surgeons' metabolic and bariatric surgery accreditation and quality improvement program.Participants 513 167 patients undergoing bariatric operations between 1 January 2014 and 31 December 2016.Main outcome measures The primary outcome measure was a composite of 30 day death, morbidity, readmission, reoperation, anastomotic or staple line leak, and bleeding events. Operative duration and lengths of stay were also assessed. Operations were defined as concurrent if they overlapped by 60 or more minutes or in their entirety.Results In this study of 513 167 operations, 739 (29.5%) surgeons at 483 (57.8%) hospitals performed 6087 (1.2%) concurrent operations. The most frequently performed concurrent bariatric operations were sleeve gastrectomy (n=3250, 53.4%) and Roux-en-Y gastric bypass (n=1601, 26.3%). Concurrent operations were more often performed at large academic medical centers with higher operative volumes and numbers of trainees and by higher volume surgeons. Compared with non-concurrent operations, concurrent operations lasted a median of 34 minutes longer (P<0.001) and resulted in 0.3 days longer average length of stay (P<0.001). Perioperative adverse events were not observed to more likely occur in concurrent compared with non-concurrent operations (7.5% v 7.4%; relative risk 1.02, 95% confidence interval 0.90 to 1.15; P=0.84).Conclusions Concurrent bariatric operations occurred infrequently, but when they did, there was no observable increased risk for adverse perioperative outcomes compared with non-concurrent operations. These results, however, do not argue against improved and more meaningful disclosure of concurrent surgery practices.

Reliability of the American College of Surgeons Commission on Cancer's Quality of Care Measures for Hospital and Surgeon Profiling.

BACKGROUND: Efforts to improve healthcare quality involve profiling hospitals and providers. Whether cancer-specific measures can be used reliably for profiling purposes has not been reported. STUDY DESIGN: Hospitals and surgeons were profiled with 3 measures assessing the adequacy of lymphadenectomy for colon (ie at least 12 regional lymph nodes [12RLN] are removed and pathologically examined for resected colon cancer), gastric (ie at least 15 regional lymph nodes [G15RLN] are removed and pathologically examined for resected gastric cancer), and non-small cell lung (ie at least 10 regional lymph nodes [10RLN] are removed and pathologically examined for American Joint Committee on Cancer stage IA, IB, IIA, and IIB resected non-small cell lung cancer) cancers using hierarchical models. National Cancer Data Base cases spanning 2010 to 2013 were included if they met measure eligibility. Reliability estimates for hospital and surgeon performance across cumulative years of data (2013, 2012 to 2013, 2011 to 2013, and 2010 to 2013) were calculated with and without risk adjustment. Surgeon caseload minimums were projected to achieve reliabilities of 0.40 and 0.70. RESULTS: Reliability estimates tended to increase with longer periods of data collection but at different rates, depending on measure, level of aggregation, and performance outlier status. Profiling hospitals using 12RLN with 2 years of data yielded a median reliability of 0.72 (interquartile range [IQR] 0.55 to 0.83); however, 4 years of data yielded a median reliability of only 0.31 (IQR 0.14 to 0.54) for surgeons. The G15RLN performance was poor overall; 10RLN had high reliability at both hospital (0.74; IQR 0.50 to 0.86) and surgeon (0.61; IQR 0.34 to 0.80) levels using 1 year of data, but the literature questions this measure's validity. Few surgeons could achieve appropriate levels of reliability regardless of increased data collection duration. CONCLUSIONS: Profiling hospitals based on measures such as these can achieve acceptable reliability in reasonable timeframes, but does not always. Either lower levels of reliability should be accepted to profile surgeons with these measures or longer timeframes should be used.

The Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: The First Report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).

OBJECTIVE: Questions remain regarding best surgical techniques to use for a laparoscopic sleeve gastrectomy (LSG) including the use of staple line reinforcement (SLR), bougie size (BS), and distance from the pylorus (DP) where the staple line is initiated. Our objectives were to assess the impact of these techniques on 30-day outcomes and to evaluate the impact of these techniques on weight loss and comorbidities at 1 year. METHODS: Using the MBSAQIP data registry, univariate analyses and hierarchical logistical regression models were developed to analyze outcomes for techniques of LSG at patient and surgeon-level. RESULTS: A total of 189,477 LSG operations were performed by 1634 surgeons at 720 centers from 2012 to 2014. Eighty percent of surgeons used SLR, 20% did not. SLR cases were associated with higher leak rates (0.96% vs 0.65%, odds ratio [OR] 1.20 95% confidence interval [CI] 1.00-1.43) and lower bleed rates (0.75% vs 1.00%, OR 0.74 95% CI 0.63-0.86) compared to no SLR at patient level. At the surgeon level, leak rates remained significant, but bleeding events became nonsignificant. BS ≥38 was associated with significantly lower leak rates compared to BS <38 at patient and surgeon level (patient level: 0.80% vs 0.96%, OR 0.72, 95% CI 0.62-0.94; surgeon level: 0.84% vs 0.95%, OR 0.90, 95% CI 0.80-0.99). BS ≥40 was associated with increased weight loss. DP had no impact on leaks or bleeds but showed an increase in weight loss with increasing DP. CONCLUSION: LSG is a safe procedure with a low morbidity rate. SLR is associated with increased leak rates. A surgeon should consider risks, benefits, and costs of these surgical techniques when performing a LSG and selectively utilize those that, in their hands, minimize morbidity while maximizing clinical effectiveness.

On-demand Reporting of Risk-adjusted and Smoothed Rates for Quality Profiling in ACS NSQIP.

BACKGROUND: Surgical quality improvement depends on hospitals having accurate and timely information about comparative performance. Profiling accuracy is improved by risk adjustment and shrinkage adjustment to stabilize estimates. These adjustments are included in ACS NSQIP reports, where hospital odds ratios (OR) are estimated using hierarchical models built on contemporaneous data. However, the timeliness of feedback remains an issue. STUDY DESIGN: We describe an alternative, nonhierarchical approach, which yields risk- and shrinkage-adjusted rates. In contrast to our "Traditional" NSQIP method, this approach uses preexisting equations, built on historical data, which permits hospitals to have near immediate access to profiling results. We compared our traditional method to this new "on-demand" approach with respect to outlier determinations, kappa statistics, and correlations between logged OR and standardized rates, for 12 models (4 surgical groups by 3 outcomes). RESULTS: When both methods used the same contemporaneous data, there were similar numbers of hospital outliers and correlations between logged OR and standardized rates were high. However, larger differences were observed when the effect of contemporaneous versus historical data was added to differences in statistical methodology. CONCLUSIONS: The on-demand, nonhierarchical approach provides results similar to the traditional hierarchical method and offers immediacy, an "over-time" perspective, application to a broader range of models and data subsets, and reporting of more easily understood rates. Although the nonhierarchical method results are now available "on-demand" in a web-based application, the hierarchical approach has advantages, which support its continued periodic publication as the gold standard for hospital profiling in the program.

Profiling Individual Surgeon Performance Using Information from a High-Quality Clinical Registry: Opportunities and Limitations.

BACKGROUND: There is increasing interest in profiling the quality of individual medical providers. Valid assessment of individuals should highlight improvement opportunities, but must be considered in the context of limitations. STUDY DESIGN: High quality clinical data from the American College of Surgeons NSQIP, gathered in accordance with strict policies and specifications, was used to construct individual surgeon-level assessments. There were 39,976 cases evaluated, performed by 197 surgeons across 9 hospitals. Both 2-level (cases by surgeon) and 3-level (cases by surgeon by hospital) risk-adjusted, hierarchical regression analyses were performed. Outcomes were 30-day postoperative morbidity, surgical site infection, and mortality. Surgeon performance was compared in both absolute and relative terms. "Signal-to-noise" reliability was calculated for surgeons and models. Projected case requirements for reliability levels were generated. RESULTS: Surgeon performances could be distinguished to different degrees: morbidity distinguished best, mortality least. Outliers could be identified for morbidity and infection, but not mortality. Reliability was also highest for morbidity and lowest for mortality. Even models with high overall reliability did not assess all providers reliably. Incorporating institutional effects had predictable effects: penalizing providers at "good" institutions, benefiting providers at "poor" institutions. CONCLUSIONS: Individual surgeon profiles can, at times, be distinguished with moderate or good reliability, but to different degrees in different models. Absolute and relative comparisons are feasible. Incorporating institutional level effects in individual provider modeling presents an interesting policy dilemma, appearing to benefit providers at "poor-performing" institutions, but penalizing those at "high-performing" ones. No portrayal of individual medical provider quality should be accepted without consideration of modeling rationale and, critically, reliability.

A Comprehensive Evaluation of Statistical Reliability in ACS NSQIP Profiling Models.

OBJECTIVE: To assess statistical reliability of hospital profiling models in ACS NSQIP (American College of Surgeons' National Surgical Quality Improvement Program). BACKGROUND: The ACS NSQIP January 2013 Semiannual Report provided risk-adjusted hospital quality assessments for 137 models. METHODS: Median reliability and percentage of hospitals achieving acceptable reliability were computed for each model. Average median reliability was computed across models with common outcomes. RESULTS: Median reliability varied across the 137 models, from a high of 0.91 for "All Cases Morbidity" to a low of 0.005 for "Procedure-Targeted Total Hip Arthroplasty Surgical Site Infection." Generally, reliability was greatest for models with larger sample sizes and higher outcome event rates. Among "Essentials" models, 72% attained a median reliability of 0.40 or more, and 24% of 0.70 or more. Among "Procedure-Targeted" models, 29% attained a median reliability of 0.40 or more, and 3% of 0.70 or more. Percentage of hospitals achieving an acceptable reliability of 0.40 ranged from 98% for "All Cases Morbidity" to 0% for "Procedure-Targeted Pancreatectomy Mortality." For Essentials models, average median reliability for each outcome, except mortality, was more than 0.40. However, for Procedure-Targeted models the average median was less than 0.40. CONCLUSIONS: For a large proportion of ACS NSQIP Essentials models, statistical reliability is adequate for assessing surgical quality and differentiating hospital performance. The Procedure-Targeted program is evolving in terms of statistical reliability, with promising results to date. These results also argue for broader discussions of statistical reliability in performance assessments for the profession.

Risk-adjusted hospital outcomes for children's surgery.

UNLABELLED: BACKGROUND The American College of Surgeons National Surgical Quality Improvement Program-Pediatric was initiated in 2008 to drive quality improvement in children's surgery. Low mortality and morbidity in previous analyses limited differentiation of hospital performance. METHODS: Participating institutions included children's units within general hospitals and free-standing children's hospitals. Cases selected by Current Procedural Terminology codes encompassed procedures within pediatric general, otolaryngologic, orthopedic, urologic, plastic, neurologic, thoracic, and gynecologic surgery. Trained personnel abstracted demographic, surgical profile, preoperative, intraoperative, and postoperative variables. Incorporating procedure-specific risk, hierarchical models for 30-day mortality and morbidities were developed with significant predictors identified by stepwise logistic regression. Reliability was estimated to assess the balance of information versus error within models. RESULTS: In 2011, 46 281 patients from 43 hospitals were accrued; 1467 codes were aggregated into 226 groupings. Overall mortality was 0.3%, composite morbidity 5.8%, and surgical site infection (SSI) 1.8%. Hierarchical models revealed outlier hospitals with above or below expected performance for composite morbidity in the entire cohort, pediatric abdominal subgroup, and spine subgroup; SSI in the entire cohort and pediatric abdominal subgroup; and urinary tract infection in the entire cohort. Based on reliability estimates, mortality discriminates performance poorly due to very low event rate; however, reliable model construction for composite morbidity and SSI that differentiate institutions is feasible. CONCLUSIONS: The National Surgical Quality Improvement Program-Pediatric expansion has yielded risk-adjusted models to differentiate hospital performance in composite and specific morbidities. However, mortality has low utility as a children's surgery performance indicator. Programmatic improvements have resulted in actionable data.

Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and surgical focus.

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) collects detailed clinical data from participating hospitals using standardized data definitions, analyzes these data, and provides participating hospitals with reports that permit risk-adjusted comparisons with a surgical quality standard. Since its inception, the ACS NSQIP has worked to refine surgical outcomes measurements and enhance statistical methods to improve the reliability and validity of this hospital profiling. From an original focus on controlling for between-hospital differences in patient risk factors with logistic regression, ACS NSQIP has added a variable to better adjust for the complexity and risk profile of surgical procedures (procedure mix adjustment) and stabilized estimates derived from small samples by using a hierarchical model with shrinkage adjustment. New models have been developed focusing on specific surgical procedures (eg, "Procedure Targeted" models), which provide opportunities to incorporate indication and other procedure-specific variables and outcomes to improve risk adjustment. In addition, comparative benchmark reports given to participating hospitals have been expanded considerably to allow more detailed evaluations of performance. Finally, procedures have been developed to estimate surgical risk for individual patients. This article describes the development of, and justification for, these new statistical methods and reporting strategies in ACS NSQIP.