External validation of the Codman score in colorectal surgery: a pragmatic tool to drive quality improvement.

AIM: The simple six-variable Codman score is a tool designed to reduce the complexity of contemporary risk-adjusted postoperative mortality rate predictions. We sought to externally validate the Codman score in colorectal surgery. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant user file and colectomy targeted dataset of 2020 were merged. A Codman score (composed of six variables: age, American Society of Anesthesiologists score, emergency status, degree of sepsis, functional status and preoperative blood transfusion) was assigned to every patient. The primary outcome was in-hospital mortality and secondary outcome was morbidity at 30 days. Logistic regression analyses were performed using the Codman score and the ACS NSQIP mortality and morbidity algorithms as independent variables for the primary and secondary outcomes. The predictive performance of discrimination area under receiver operating curve (AUC) and calibration of the Codman score and these algorithms were compared. RESULTS: A total of 40 589 patients were included and a Codman score was generated for 40 557 (99.02%) patients. The median Codman score was 3 (interquartile range 1-4). To predict mortality, the Codman score had an AUC of 0.92 (95% CI 0.91-0.93) compared to the NSQIP mortality score 0.93 (95% CI 0.92-0.94). To predict morbidity, the Codman score had an AUC of 0.68 (95% CI 0.66-0.68) compared to the NSQIP morbidity score 0.72 (95% CI 0.71-0.73). When body mass index and surgical approach was added to the Codman score, the performance was no different to the NSQIP morbidity score. The calibration of observed versus expected predictions was almost perfect for both the morbidity and mortality NSQIP predictions, and only well fitted for Codman scores of less than 4 and greater than 7. CONCLUSION: We propose that the six-variable Codman score is an efficient and actionable method for generating validated risk-adjusted outcome predictions and comparative benchmarks to drive quality improvement in colorectal surgery.

ADAMTSL2 protein and a soluble biomarker signature identify at-risk non-alcoholic steatohepatitis and fibrosis in adults with NAFLD.

BACKGROUND & AIMS: Identifying fibrosis in non-alcoholic fatty liver disease (NAFLD) is essential to predict liver-related outcomes and guide treatment decisions. A protein-based signature of fibrosis could serve as a valuable, non-invasive diagnostic tool. This study sought to identify circulating proteins associated with fibrosis in NAFLD. METHODS: We used aptamer-based proteomics to measure 4,783 proteins in 2 cohorts (Cohort A and B). Targeted, quantitative assays coupling aptamer-based protein pull down and mass spectrometry (SPMS) validated the profiling results in a bariatric and NAFLD cohort (Cohort C and D, respectively). Generalized linear modeling-logistic regression assessed the ability of candidate proteins to classify fibrosis. RESULTS: From the multiplex profiling, 16 proteins differed significantly by fibrosis in cohorts A (n = 62) and B (n = 98). Quantitative and robust SPMS assays were developed for 8 proteins and validated in Cohorts C (n = 71) and D (n = 84). The A disintegrin and metalloproteinase with thrombospondin motifs like 2 (ADAMTSL2) protein accurately distinguished non-alcoholic fatty liver (NAFL)/non-alcoholic steatohepatitis (NASH) with fibrosis stage 0-1 (F0-1) from at-risk NASH with fibrosis stage 2-4, with AUROCs of 0.83 and 0.86 in Cohorts C and D, respectively, and from NASH with significant fibrosis (F2-3), with AUROCs of 0.80 and 0.83 in Cohorts C and D, respectively. An 8-protein panel distinguished NAFL/NASH F0-1 from at-risk NASH (AUROCs 0.90 and 0.87 in Cohort C and D, respectively) and NASH F2-3 (AUROCs 0.89 and 0.83 in Cohorts C and D, respectively). The 8-protein panel and ADAMTSL2 protein had superior performance to the NAFLD fibrosis score and fibrosis-4 score. CONCLUSION: The ADAMTSL2 protein and an 8-protein soluble biomarker panel are highly associated with at-risk NASH and significant fibrosis; they exhibited superior diagnostic performance compared to standard of care fibrosis scores. LAY SUMMARY: Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of liver disease worldwide. Diagnosing NAFLD and identifying fibrosis (scarring of the liver) currently requires a liver biopsy. Our study identified novel proteins found in the blood which may identify fibrosis without the need for a liver biopsy.

Intraoperative leak test is associated with lower postoperative bleed rate in primary sleeve gastrectomy: a propensity matched analysis of primary and revision bariatric surgery using the MBSAQIP database.

BACKGROUND: Gastrointestinal leaks after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) occur infrequently but lead to clinical and socioeconomic burden on patients. Surgeons perform intraoperative leak test (IOLT) via gastric tube or endoscopy to help prevent postoperative leaks. However, there is knowledge gap in the literature on effectiveness of IOLT during bariatric surgery. METHODS: In this observational cohort study using the 2015-2017 MBSAQIP database, we compared the outcomes in patients who received IOLT with those who did not during primary or revision RYGB and SG. The primary outcome was 30-day postoperative leak. Secondary outcomes were procedure duration and the rates of 30-day postoperative bleed, readmission, reoperation and intervention. Propensity score matching was used to assemble cohorts of patients with similar baseline characteristics. RESULTS: Among 363,042 patients, 82% underwent IOLT. Four subgroups of patients who underwent operations with or without IOLT during primary RYGB (n = 13,756), primary SG (n = 110,810), revision RYGB (n = 1140), and revision SG (n = 5576) had similar propensity scores and were matched 1:1. Patients who underwent IOLT had similar postoperative leak rates compared to those who did not (Primary RYGB with IOLT 0.7% v. without IOLT 0.6%; Primary SG 0.4% v. 0.3%; Revision RYGB 2.3% v. 1.0%; Revision SG 1.1% v. 0.7%). In primary SG subgroup, patients who underwent IOLT had lower postoperative bleed rates (0.6% v. 0.8%, p = 0.002). In primary RYGB and SG subgroups, operations with IOLT were slightly longer. CONCLUSION: Postoperative leak rates after primary and revision bariatric surgery were low and similar irrespective of IOLT. Patients who had IOLT during primary SG had lower postoperative bleed rates. Current judgment as to whether to perform an IOLT leads to excellent outcomes, and thus, current practices should continue. However, one should consider an IOLT during primary SG, not necessarily to reduce leak rates but to help reduce postoperative bleeding occurrences.

Description and Impact of a Comprehensive Multispecialty Multidisciplinary Intervention to Decrease Opioid Prescribing in Surgery.

INTRODUCTION: Diversion of excess prescription opioids contributes to the opioid epidemic. We sought to describe and study the impact of a comprehensive departmental initiative to decrease opioid prescribing in surgery. METHODS: A multispecialty multidisciplinary initiative was designed to change the culture of postoperative opioid prescribing, including: consensus-built opioid guidelines for 42 procedures from 11 specialties, provider-focused posters displayed in all surgical units, patient opioid/pain brochures setting expectations, and educational seminars to residents, advanced practice providers, residents and nurses. Pre- (April 2016-March 2017) versu post-initiative (April 2017-May 2018) analyses of opioid prescribing at discharge [median oral morphine equivalent (OME)] were performed at the specialty, prescriber, patient, and procedure levels. Refill prescriptions within 3 months were also studied. RESULTS: A total of 23,298 patients were included (11,983 pre-; 11,315 post-initiative). Post-initiative, the median OME significantly decreased for 10 specialties (all P values < 0.001), the percentage of patients discharged without opioids increased from 35.7% to 52.5% (P < 0.001), and there was no change in opioids refills (0.07% vs 0.08%, P = 0.9). Similar significant decreases in OME were observed when the analyses were performed at the provider and individual procedure levels. Patient-level analyses showed that the preinitiative race/sex disparities in opioid-prescribing disappeared post-initiative. CONCLUSION: We describe a comprehensive multi-specialty intervention that successfully reduced prescribed opioids without increase in refills and decreased sex/race prescription disparities.

Spine surgeon specialty differences in single-level percutaneous kyphoplasty.

BACKGROUND: Percutaneous kyphoplasty (PKP) is a procedure performed by a spine surgeon who undergoes either orthopedic or neurosurgical training. The relationship between short-term adverse outcomes and spine specialty is presently unknown. To compare short-term adverse outcomes of single-level PKP when performed by neurosurgeons and orthopedic surgeons in order to develop more concretely preventive strategies for patients under consideration for single-level PKP. METHODS: We evaluated patients who underwent single-level PKP from 2012 to 2014 through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). We used univariate analysis and multivariate logistic regression to assess the association between spine surgeon specialty and short-term adverse events, including postoperative complication and unplanned readmission, and to identify different independent risk predictors between two specialties. RESULTS: Of 2248 patients who underwent single-level PKP procedure, 1229 patients (54.7%) had their operations completed by a neurosurgeon. There were no significant differences in the development of the majority of postoperative complications and the occurrence of unplanned readmission between the neurosurgical cohort (NC) and the orthopedic cohort (OC). A difference in the postoperative blood transfusion rate (0.7% NS vs. 1.7% OC, P = 0.039) was noted and may due to the differences in comorbidities between patients. Multivariate regression analysis revealed different independent predictors of postoperative adverse events for the two spine specialties. CONCLUSIONS: By comparing a large range of demographic feature, preoperative comorbidities, and intraoperative factors, we find that short-term adverse events in single-level PKP patients does not affect by spine surgeon specialty, except that the OC had higher postoperative blood transfusion rate. In addition, the different perioperative predictors of postoperative complications and unplanned readmissions were identified between the two specialties. These findings can lead to better evidence-based patient counseling and provide valuable information for medical evaluation and potentially devise methods to reduce patients' risk.

Derivation, Validation and Application of a Pragmatic Risk Prediction Index for Benchmarking of Surgical Outcomes.

BACKGROUND: Despite the existence of multiple validated risk assessment and quality benchmarking tools in surgery, their utility outside of high-income countries is limited. We sought to derive, validate and apply a scoring system that is both (1) feasible, and (2) reliably predicts mortality in a middle-income country (MIC) context. METHODS: A 5-step methodology was used: (1) development of a de novo surgical outcomes database modeled around the American College of Surgeons' National Surgical Quality Improvement Program (ACS-NSQIP) in South Africa (SA dataset), (2) use of the resultant data to identify all predictors of in-hospital death with more than 90% capture indicating feasibility of collection, (3) use these predictors to derive and validate an integer-based score that reliably predicts in-hospital death in the 2012 ACS-NSQIP, (4) apply the score in the original SA dataset and demonstrate its performance, (5) identify threshold cutoffs of the score to prompt action and drive quality improvement. RESULTS: Following step one-three above, the 13 point Codman's score was derived and validated on 211,737 and 109,079 patients, respectively, and includes: age 65 (1), partially or completely dependent functional status (1), preoperative transfusions ≥4 units (1), emergency operation (2), sepsis or septic shock (2) American Society of Anesthesia score ≥3 (3) and operative procedure (1-3). Application of the score to 373 patients in the SA dataset showed good discrimination and calibration to predict an in-hospital death. A Codman Score of 8 is an optimal cutoff point for defining expected and unexpected deaths. CONCLUSION: We have designed a novel risk prediction score specific for a MIC context. The Codman Score can prove useful for both (1) preoperative decision-making and (2) benchmarking the quality of surgical care in MIC's.

LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis.

BACKGROUND: The LINX® magnetic sphincter augmentation system (MSA) is a surgical technique with short-term evidence demonstrating efficacy in the treatment of medically refractory or chronic gastroesophageal reflux disease (GERD). Currently, the Nissen fundoplication is the gold-standard surgical treatment for GERD. We are the first to systematically review the literature and perform a meta-analysis comparing MSA to the Nissen fundoplication. METHODS: A comprehensive search of electronic databases (e.g., MEDLINE, EMBASE, SCOPUS, Web of Science and the Cochrane Library) using search terms "Gastroesophageal reflux or heartburn" and "LINX or endoluminal or magnetic" and "fundoplication or Nissen" was completed. All randomized controlled trials, non-randomized comparison study and case series with greater than 5 patients were included. Five hundred and forty-seven titles were identified through primary search, and 197 titles or abstracts were screened after removing duplicates. Meta-analysis was performed on postoperative quality of life outcomes, procedural efficacy and patient procedural satisfaction. RESULTS: Three primary studies identified a total of 688 patients, of whom 273 and 415 underwent Nissen fundoplication and MSA, respectively. MSA was statistically superior to LNF in preserving patient's ability to belch (95.2 vs 65.9%, p < 0.00001) and ability to emesis (93.5 vs 49.5%, p < 0.0001). There was no statistically significant difference between MSA and LNF in gas/bloating (26.7 vs 53.4%, p = 0.06), postoperative dysphagia (33.9 vs 47.1%, p = 0.43) and proton pump inhibitor (PPI) elimination (81.4 vs 81.5%, p = 0.68). CONCLUSION: Magnetic sphincter augmentation appears to be an effective treatment for GERD with short-term outcomes comparable to the more technically challenging and time-consuming Nissen fundoplication. Long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation.

An Online Tool for Global Benchmarking of Risk-Adjusted Surgical Outcomes.

BACKGROUND: Increasing evidence demonstrates significant variation in adverse outcomes following surgery between countries. In order to better quantify these variations, we hypothesize that freely available online risk calculators can be used as a tool to generate global benchmarking of risk-adjusted surgical outcomes. METHODS: This is a prospective cohort study conducted at an academic teaching hospital in South Africa (GSH). Consecutive adult patients undergoing major general or vascular surgery who met the ACS-NSQIP inclusion criteria for a 3-month period were included. Data variables required by the ACS risk calculator were prospectively collected, and patients were followed for 30 days post-surgery for the occurrence of endpoints. Calculating observed-to-expected ratios for ten outcome measures of interest generated risk-adjusted outcomes benchmarked against the ACS-NSQIP consortium. RESULTS: A total of 373 major general and vascular surgery procedures met the inclusion criteria. The GSH operative cohort varied significantly compared to the 2012 ACS-NSQIP database. The risk-adjusted O/E ratios were significant for any complication O/E 1.91 (95 % CI 1.57-2.31), surgical site infections O/E 4.76 (95 % CI 3.71-6.01), renal failure O/E 3.29 (95 % CI 1.50-6.24), death O/E 3.43 (95 % CI 2.19-5.11), and total length of stay (LOS) O/E 3.43 (95 % CI 2.19-5.11). CONCLUSION: Freely available online risk calculators can be utilized as tools for global benchmarking of risk-adjusted surgical outcomes.

Impact of Expanded Insurance Coverage on Racial Disparities in Vascular Disease: Insights From Massachusetts.

OBJECTIVE: To evaluate the impact of health insurance expansion on racial disparities in severity of peripheral arterial disease. BACKGROUND: Lack of insurance and non-white race are associated with increased severity, increased amputation rates, and decreased revascularization rates in patients with peripheral artery disease (PAD). Little is known about how expanded insurance coverage affects disparities in presentation with and management of PAD. The 2006 Massachusetts health reform expanded coverage to 98% of residents and provided the framework for the Affordable Care Act. METHODS: We conducted a retrospective cohort study of nonelderly, white and non-white patients admitted with PAD in Massachusetts (MA) and 4 control states. Risk-adjusted difference-in-differences models were used to evaluate changes in probability of presenting with severe disease. Multivariable linear regression models were used to evaluate disparities in disease severity before and after the 2006 health insurance expansion. RESULTS: Before the 2006 MA insurance expansion, non-white patients in both MA and control states had a 12 to 13 percentage-point higher probability of presenting with severe disease (P < 0.001) than white patients. After the expansion, measured disparities in disease severity by patient race were no longer statistically significant in Massachusetts (+3.0 percentage-point difference, P = 0.385) whereas disparities persisted in control states (+10.0 percentage-point difference, P < 0.001). Overall, non-white patients in MA had an 11.2 percentage-point decreased probability of severe PAD (P = 0.042) relative to concurrent trends in control states. CONCLUSIONS: The 2006 Massachusetts insurance expansion was associated with a decreased probability of patients presenting with severe PAD and resolution of measured racial disparities in severe PAD in MA.

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.

Continuous Positive Airway Pressure Mitigates Opioid-induced Worsening of Sleep-disordered Breathing Early after Bariatric Surgery.

BACKGROUND: Bariatric surgery patients are vulnerable to sleep-disordered breathing (SDB) early after recovery from surgery and anesthesia. The authors hypothesized that continuous positive airway pressure (CPAP) improves postoperative oxygenation and SDB and mitigates opioid-induced respiratory depression. METHODS: In a randomized crossover trial, patients after bariatric surgery received 30% oxygen in the postanesthesia care unit (PACU) under two conditions: atmospheric pressure and CPAP (8 to 10 cm H2O). During 1 h of each treatment, breathing across cortical arousal states was analyzed using polysomnography and spirometry. Arousal state and respiratory events were scored in accordance with American Academy of Sleep Medicine guidelines. Data on opioid boluses in the PACU were collected. The primary and secondary outcomes were the apnea hypopnea index (AHI) and apnea after self-administration of opioids in the PACU. Linear mixed model analysis was used to compare physiologic measures of breathing. RESULTS: Sixty-four percent of the 33 patients with complete postoperative polysomnography data demonstrated SDB (AHI greater than 5/h) early after recovery from anesthesia. CPAP treatment decreased AHI (8 ± 2/h vs. 25 ± 5/h, P < 0.001), decreased oxygen desaturations (5 ± 10/h vs. 16 ± 20/h, P < 0.001), and increased the mean oxygen saturation by 3% (P = 0.003). CPAP significantly decreased the respiratory-depressant effects observed during wakefulness-sleep transitions without affecting hemodynamics. The interaction effects between CPAP treatment and opioid dose for the dependent variables AHI (P < 0.001), inspiratory flow (P = 0.002), and minute ventilation (P = 0.015) were significant. CONCLUSIONS: This pharmacophysiologic interaction trial shows that supervised CPAP treatment early after surgery improves SDB and ameliorates the respiratory-depressant effects of opioids without undue hemodynamic effects.

Influence of Health Insurance Expansion on Disparities in the Treatment of Acute Cholecystitis.

OBJECTIVE: To evaluate the impact of the 2006 Massachusetts (MA) health reform on disparities in the management of acute cholecystitis (AC). BACKGROUND: Immediate cholecystectomy has been shown to be the optimal treatment for AC, yet variation in care persists depending upon insurance status and patient race. How increased insurance coverage impacts these disparities in surgical care is not known. METHODS: A cohort study of patients admitted with AC in MA and 3 control states from 2001 through 2009 was performed using the Hospital Cost and Utilization Project State Inpatient Databases. We examined all nonelderly white, black, or Latino patients by insurance type and patient race, evaluating changes in the probability of undergoing immediate cholecystectomy and disparities in receiving immediate cholecystectomy before and after Massachusetts health reform. RESULTS: Data from 141,344 patients hospitalized for AC were analyzed. Before the 2006 reform, government-subsidized/self-pay (GS/SP) patients had a 6.6 to 9.9 percentage-point lower (P < 0.001) probability of immediate cholecystectomy in both MA control states. The MA insurance expansion was independently associated with a 2.5 percentage-point increased probability of immediate cholecystectomy for all GS/SP patients in MA (P = 0.049) and a 5.0 percentage-point increased probability (P = 0.011) for nonwhite, GS/SP patients compared to control states. Racial disparities in the probability of immediate cholecystectomy seen before health care reform were no longer statistically significant after reform in MA while persisting in control states. CONCLUSIONS: The MA health reform was associated with increased probability of undergoing immediate cholecystectomy for AC and reduced disparities in undergoing cholecystectomy by insurance status and patient race.

Does routine upper gastrointestinal swallow study after metabolic and bariatric surgery lead to earlier diagnosis of leak?

BACKGROUND: It is unclear whether routine upper gastrointestinal swallow study (SS) in the immediate postoperative period is associated with earlier diagnosis of gastrointestinal leak after bariatric surgery. OBJECTIVE: To investigate the relationship between routine SS and time to diagnosis of postoperative gastrointestinal leak. SETTING: MBSAQIP-accredited hospitals in the United States and Canada. METHODS: We conducted an observational cohort study of adults who underwent laparoscopic primary Roux-en-Y gastric bypass (RYGB) (n = 82,510) and sleeve gastrectomy (SG) (n = 283,520) using the MBSAQIP 2015-2019 database. Propensity scores were used to match patient cohorts who underwent routine versus no routine SS. Primary outcome was time to diagnosis of leak. Median days to diagnosis of leak were compared. The Nelson-Aalen estimator was used to determine the cumulative hazards of leak. RESULTS: In our study, 36,280 (23%) RYGB and 135,335 (33%) SG patients received routine SS. Routine SS was not associated with earlier diagnosis of leak (RYGB routine SS median 7 [IQR 3-12] days v. no routine SS 6 [2-11] days, P = .9; SG routine SS 15 [9-22] days v. no routine SS 14 [8-21] days, P = .06) or lower risk of developing leak (RYGB HR 1.0, 95%-CI .8-1.2; SG HR 1.1, 95%-CI 1.0-1.4). More routine SS patients had a length of stay 2 days or greater (RYGB 78.3% v. 61.1%; SG 48.6% v. 40.3%). CONCLUSIONS: Routine SS was not associated with earlier diagnosis of leaks compared to the absence of routine SS. Surgeons should consider abandoning the practice of routine SS for the purpose of obtaining earlier diagnosis of postoperative leaks.

First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program.

BACKGROUND: Health-related quality-of-life (HRQoL) is one of the most important outcomes to metabolic and bariatric surgery (MBS) patients but was not measured by the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP). A patient-reported outcome measures (PROMs) program pilot started in 2016 with MBSAQIP implementation in 2019. OBJECTIVES: To measure how MBS impacts patient HRQoL 1 and 2 years after primary laparoscopic Roux-en-Y gastric bypass (bypass) or laparoscopic sleeve gastrectomy (sleeve). SETTING: The 82 centers in the United States participating in the MBSAQIP PROMs program. METHODS: Preoperative HRQoL scores and satisfaction were compared with postoperative scores 1 and 2 years after surgery with univariate comparisons and adjusted regression models. RESULTS: There were 13,901 PROMs responses from 11,146 patients. Patient satisfaction with their MBS decision was 97%. On average, patients had significant improvement in Obesity-related Problem (OP) scores (65.8 preoperatively, 23.0 at 1 yr, and 26.3 at 2 yr; P <.05), Obesity and Weight-Loss Quality-of-Life (OWLQOL) scores (36.7 preoperatively, 77.2 at 1 yr, and 74.6 at 2 yr; P < .05), their physical health (39.2 preoperatively versus 51.7 at 1 yr and 50.0 at 2 yr), and mental health (45.6 preoperatively versus 53.3 at 1 yr and 51.4 at 2 yr). Compared with bypass patients, sleeve patients had significantly lower odds of having low OP scores postoperatively (odds ratio [95% CI) ] .67 [.53, .83]) and lower odds of high OWLQOL (.61 [.48, .77]) at 1 year. CONCLUSION: All patients regardless of procedure on average report significant improvement in their scores for OP, OWLQOL, and physical and mental health after MBS. At 1 and 2 years, bypass patients reported greater improvement in their obesity-related PROMs than sleeve patients.

Current recommendations for procedure selection in class I and II obesity developed by an expert modified Delphi consensus.

Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2. Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future.

Black-versus-White racial disparities in 30-day outcomes at Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited centers: a needed quality indicator.

BACKGROUND: Creating a metric in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) to assess Black-versus-White disparities is critical if we are to ensure equitable care for all. OBJECTIVE: To investigate Black-versus-White disparities while replicating MBSAQIP methodology with regard to covariates and modeling so that the results can serve as the foundation to create a benchmarked site-level Disparities Metric for MBSAQIP. SETTING: United States and Canada. METHODS: Across the 2015-2019 MBSAQIP cohorts, 543,976 adults underwent primary or revision sleeve gastrectomy or Roux-en-Y gastric bypass and were reported as either White or Black. Using a set of covariates derived from published MBSAQIP performance models, we performed multivariable logistic modeling with 10-fold cross-validation for the 11 outcomes evaluated in MBSAQIP Semiannual Reports, plus venous thromboembolism (VTE) and death. We analyzed primary and revision cases separately. RESULTS: After risk adjustment, Black patients experienced higher odds of all-occurrence morbidity (odds ratio [OR], 1.22; 95% confidence interval [CI], 1.19-1.25; P < .001), serious events (OR, 1.08; 95% CI, 1.04-1.13; P < .001), all-cause intervention (OR, 1.31; 95% CI, 1.24-1.37; P < .001), related intervention (OR, 1.29; 95% CI, 1.22-1.37; P < .001), all-cause readmission (OR, 1.37; 95% CI, 1.33-1.41; P < .001), related readmission (OR, 1.41; 95% CI, 1.36-1.46; P < .001), venous thromboembolism (OR, 1.49; 95% CI, 1.34-1.65; P < .001), and death (OR, 1.59; 95% CI, 1.34-1.89; P < .001) after primary procedures. Black patients experienced lower odds of morbidity (OR, .94; 95% CI, .91-.98; P = .004) and surgical-site infection (OR, .72; 95% CI, .66-.78; P < .001). CONCLUSIONS: Black patients experienced a higher risk for serious complications and required more readmissions, reoperations, and postoperative interventions. This study supports the creation of a site-level Disparities Metric for the MBSAQIP and provides the framework to do so.

Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program.

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP) assesses safety after metabolic and bariatric surgery and the impact on weight and obesity-related diseases. However, changes in quality of life are likely what matters most to patients, and these are not currently assessed. The best way to measure health-related quality of life (HRQoL) is to use validated patient-reported outcomes measures (PROMs), which capture patients' perspectives of their quality of life both before and after surgery. OBJECTIVES: Identify the outcomes most important to bariatric surgery patients and identify the most appropriate validated PROMs to implement in a national program for the MBSAQIP. SETTING: Five hospitals from a single healthcare system in New England. METHODS: A series of 18 focus groups and/or interviews conducted with patients, patients' family members, and bariatric health providers determined the outcomes most important to bariatric patients and which validated PROMs would accurately measure those outcomes. Immersion crystallization was used to analyze focus group data and identify appropriate PROMs. RESULTS: Focus group participants ranked health as the most important outcome for metabolic and bariatric surgery. Self-confidence, mobility, and everyday activities were the next highest ranked HRQoL domains. The Patient-Reported Outcomes Measurement Information System 10-Item Global Health Survey was selected as the general health measure. The Obesity-Related Problems scale and the Obesity and Weight-Loss Quality of Life Instrument were the disease-specific measures selected for inclusion in the MBSAQIP PROMs program. CONCLUSION: The addition of PROMs to the MBSAQIP provides a unique opportunity to monitor HRQoL at the national level, which can foster improved shared decision-making before surgery.

Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery.

BACKGROUND: Development of patient-reported outcomes (PROs) to include traditionally clinic-reported data has the potential to decrease the data-collection burden for patients and clinicians and increase follow-up rates. However, replacing clinic report by patient report requires that the data reasonably agree. OBJECTIVE: To assess agreement between PROs and clinical registry data at 1 year after bariatric surgery. SETTING: Not-for-profit organization, bariatric surgery data registry, PROs platform. METHODS: Patient- and clinic-reported 1-year postoperative weight and co-morbidities were compared for matched PROs and registry records. The co-morbidities evaluated were diabetes, sleep apnea, hypertension, gastroesophageal reflux disease, and hyperlipidemia. Weight difference in pounds and nominal groupings (binary, 4-level) for co-morbidities were assessed for agreement between data sources using descriptive statistics, Bland-Altman plots, multiple regression, and kappa coefficients. Sensitivity analyses and follow-up by response method were examined. RESULTS: Among 1130 patients with both 1-year PROs and registry weights, 95% of patient-reported weights were within 13 lb of the registry-recorded weight, and patients underreported their weight by ∼2 lb, on average. Percent agreement and kappa coefficients were highest for diabetes (n = 999; binary: 94%, κ = .72; 4-level: 86%, κ = .71) and lowest for gastroesophageal reflux disease (n = 1032; binary: 75%, κ = .40; 4-level: 57%, κ = .35). Of patients eligible for both PROs and registry 1-year follow-up, 21% had PROs only. CONCLUSIONS: One-year patient- and clinic-reported weights and disease status for patients with diabetes and hypertension showed high agreement. The degree of bias from patient report was low. Patient report is a viable alternative to clinic report for certain objective measurements and may increase follow-up.

Morbidity and effectiveness of laparoscopic sleeve gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity.

LSG, LAGB, and LRYGB are all safe and effective modern surgical options for the treatment of morbid obesity. Recent quality improvement successes in bariatric surgical care delivery have resulted in low mortality and morbidity after these procedures. All seem to result in sustained weight loss and improvement in weight-related comorbidities, although appropriate long-term outcomes data for all procedure types are needed. The LRYGB seems to be associated with the most risk but offers the most benefit, whereas the LAGB seems to have the lowest risk and to be least effective. The LSG seems to be positioned between the LRYGB and LAGB in associated morbidity and effectiveness in short-term and medium-term studies. Because the LSG has only recently been performed, there are currently no data about its long-term effectiveness. A better understanding of the unique risk/benefit profile associated with each procedure type will better inform patient selection and has the potential to further optimize outcomes.