A Core set of patient-reported outcome measures to measure quality of life in obesity treatment research.

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.

Weight Nadir and Long-Term Weight Outcomes After Laparoscopic Sleeve Gastrectomy in a Diverse Cohort of Adolescents and Young Adults.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) is currently the most common bariatric procedure performed in adolescents and young adults in the United States (USA), but there are limited data available on long-term postoperative weight outcomes in these patients. This single-institution US study follows longitudinal weight data in a diverse group of patients undergoing LSG at age 25 years or younger. METHODS: We retrospectively reviewed records of all patients 25 years or younger who underwent LSG at our institution between 2013 and 2020. All weight data documented in the medical record through January 2023 was included. We calculated weight change postoperatively as percent total weight loss (%TWL) relative to preoperative weight. RESULTS: One hundred forty-one patients underwent LSG, at a mean age of 23.1 years. Within this cohort, 56.1% identified as non-Hispanic Black or Hispanic, and 39.7% had private health insurance. The mean %TWL at weight nadir was 28.5% at a mean of 1.35 years postoperatively. The mean long-term %TWL (in patients with ≥ 4 years of follow-up) was 11.8% at a mean of 5.6 years postoperatively, with 43 of the 84 patients with long-term weight data (51%) within 10% of their preoperative weight at most recent follow-up. CONCLUSION: Adolescents and young adults undergoing LSG at our institution had weight nadir comparable to published results during the first 1 to 2 years postoperatively, but the majority developed significant weight recurrence over the ensuing years. Our findings highlight the need for adjuvant weight loss strategies to improve the durability of weight outcomes after LSG in this population.

Metabolic Bariatric Surgery Across the IFSO Chapters: Key Insights on the Baseline Patient Demographics, Procedure Types, and Mortality from the Eighth IFSO Global Registry Report.

INTRODUCTION: The International Federation for Surgery for Obesity and Metabolic Disorders (IFSO) Global Registry aims to provide descriptive data about the caseload and penetrance of surgery for metabolic disease and obesity in member countries. The data presented in this report represent the key findings of the eighth report of the IFSO Global Registry. METHODS: All existing Metabolic and Bariatric Surgery (MBS) registries known to IFSO were invited to contribute to the eighth report. Aggregated data was provided by each MBS registry to the team at the Australia and New Zealand Bariatric Surgery Registry (ANZBSR) and was securely stored on a Redcap™ database housed at Monash University, Melbourne, Australia. Data was checked for completeness and analyzed by the IFSO Global Registry Committee. Prior to the finalization of the report, all graphs were circulated to contributors and to the global registry committee of IFSO to ensure data accuracy. RESULTS: Data was received from 24 national and 2 regional registries, providing information on 502,150 procedures. The most performed primary MBS procedure was sleeve gastrectomy, whereas the most performed revisional MBS procedure was Roux-en-Y gastric bypass. Asian countries reported people with lower BMI undergoing MBS along with higher rates of diabetes. Mortality was a rare event. CONCLUSION: Registries enable meaningful comparisons between countries on the demographics, characteristics, operation types and approaches, and trends in MBS procedures. Reported outcomes can be seen as flags of potential issues or relationships that could be studied in more detail in specific research studies.

Collateral Benefit of Systematic Improvement in Bariatric Surgery Outcomes Following a Single Quality Improvement Project for Bleeding.

The study's aim was not only to use quality improvement system techniques to improve patient care specifically for bleeding but also to track other adverse outcomes. Key drivers were identified and mapped to interventions, namely venous thromboembolism prophylaxis, root cause analysis, indications conference, and operative technique standardization. Bleeding was reduced by 88%, and overall postoperative complications also fell by 63%. A targeted quality improvement project not only was effective in improving outcomes for the specific aim of bleeding but also resulted in improvement for other patient outcomes.

Role of the exercise professional in metabolic and bariatric surgery.

BACKGROUND: Physical activity (PA) is important for the long-term health and weight management of patients who undergo metabolic and bariatric surgery (MBS). However, the roles of exercise professionals in MBS settings have not been systematically determined. OBJECTIVES: To investigate: (1) who are the professionals implementing PA programming in MBS clinical settings; and (2) what patient-centric tasks do they perform? SETTING: Clinical and academic exercise settings worldwide. METHODS: This multimethod study included a scoping review of PA programs in MBS described in the research literature. Data about job tasks were extracted and provided to 10 experts to sort into categories. Cluster analysis was utilized to find the hierarchical structure of tasks. A Delphi process was used to agree on a final model. RESULTS: The majority of PA professionals were exercise physiologists in the USA and physiotherapists or other types of exercise professionals elsewhere. Forty-three tasks were identified, the most reported being supervision of exercise, fitness testing, and exercise prescription. Seven higher-order categories were determined: (1) Exercise-related health assessment, (2) Body composition and physical fitness assessment, (3) Lifestyle physical activity and sedentary behavior assessment, (4) Education, instruction, and prescription, (5) Exercise monitoring, (6) Behavioral counseling and psychosocial support, and (7) Dietary support. The following statements were rated an average of 9.0, classifying them as "imperative": 1) "Pre- and postoperative PA/exercise guidelines for MBS patients are needed", 2) "MBS programs need to include PA/exercise as part of multidisciplinary care". CONCLUSIONS: The expert group reached a consensus on 7 major classifications of job tasks for the exercise professional. It is important for governing medical associations across the world to formally recognize experienced exercise professionals as playing pivotal roles in continuing, multidisciplinary care for MBS patients. These findings also provide evidence-based information in the effort to solidify these positions within the greater context of healthcare.

Laparoscopic Adjustable Gastric Band Colonization May Indicate Re-classification of Surgical Wounds.

BACKGROUND: Surgical wounds are classified as either clean, clean-contaminated, contaminated, or dirty wounds. Historically laparoscopic adjustable gastric band (LAGB) removals have been classified as clean wounds since there is thought to be no existing infection and no transection of the gastrointestinal tract. Surgical site infection (SSI) remains a publicly reported source of morbidity after laparoscopic bariatric surgery and is considered a CMS hospital-acquired condition. We present a retrospective chart review to reveal the rate of bacterial colonization of gastric bands. METHODS: This retrospective chart review included 15 patients who underwent removal of LAGB. The entire LAGB and port were removed and then sent for aerobic and anaerobic cultures. Patients were followed up to 1 month, and the incidence of surgical site infection development was recorded. RESULTS: Of the fifteen LAGBs cultured, eight cases (53%) returned positive for bacterial growth. Five of the cultures (33%) were positive for coagulase-negative Staphylococcus. One culture was positive for micrococcus species (6.7%), one culture was positive for Bacteroides fragilis (6.7%) and another was positive for Propionibacterium (6.7%). None of the 15 patients followed in the study developed an SSI by the end of 1 month. CONCLUSIONS: Given the consideration of LAGB removals as clean wounds, the incidence of LAGB colonization is high. Classification of the surgical wounds in LAGB removals should be changed from clean to contaminated. Further studies need to be pursued to determine the correlation between colonized LAGBs and the rate of SSIs. KEY POINTS: • Gastric band removals are a common bariatric procedure. • Surgical site infection remains an outcome of interest to patient, surgeon and payor. • Fifty-three percent of recovered bands were positive for bacterial growth.

MBSAQIP database: are the data reliable?

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database collects data from all accredited centers in the US. A prior study showed data quality issues limiting use of up to 20% of the 2015 database. OBJECTIVES: To evaluate the completeness and data quality (internal validity, accuracy, and consistency) of the MBSAQIP database between 2015 and 2019. SETTING: United States. METHODS: All subsets of data from the MBSAQIP Participant User Data File (PUDF) were compiled into one main file. Completeness, internal validity, accuracy, and consistency were evaluated. Completeness was determined via missing values. Internal validity was assessed using the percentage of patients with a body mass index (BMI) < 30 kg/m2 who underwent primary bariatric surgery. Accuracy was evaluated using reported versus calculated BMI. Consistency was assessed using the percentage of patients with a gain of >5 or a loss of >20 units of BMI change in 30 days. Effects across years were assessed using a chi-squared test. RESULTS: Missing data for age, BMI, and ASA was consistently low (<2.5%) with no significant difference across years. Only .02% of patients who underwent a primary bariatric procedure had a reported BMI <30 kg/m2. The mean difference between reported versus calculated BMI was -.02 units. A maximum of .33% of patients gained >5 units of BMI, and a maximum of .85% of patients lost > 20 units of BMI in early follow-up. CONCLUSIONS: While the MBSAQIP is a database with acceptable data quality and minimal changes from 2015-2019, ongoing efforts are needed to improve data.

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.

Lessons learned from the metabolic and bariatric surgery accreditation and quality improvement program site surveys: common deficiencies and corrective actions.

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) is a joint program between the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS). On-site surveys of the applicant programs to determine adherence to the MBSAQIP standards are a hallmark of the accreditation process. OBJECTIVES: A retrospective review of 619 site surveys completed over 2 years was performed to include analysis of reviewer decisions, tabulation and cross-reference of identified deficiencies to the MBSAQIP standards and determine final disposition of corrective actions and overall accreditation rates. SETTING: Accredited Hospitals (Community and Academic) within MBSAQIP. METHODS: This is a retrospective review of site surveys by expert panel. RESULTS: ≥1 MBSAQIP Standards deficiencies were present at 149 of the 619 program site surveys (24.07%). The 3 leading Standards in Deficiency were in order: Commitment to Quality Care, Continuous Quality Improvement Process, and Data Collection. Within a year following initial site survey of the149 programs with Standards deficiencies, 59 programs demonstrated compliance, 83 programs were placed on probation (with a specific time-frame to demonstrate compliance) and 7 programs were denied accreditation. Ultimately, 98.9% of programs were able to gain or maintain MBSAQIP accreditation. CONCLUSIONS: The MBSAQIP accreditation through on-site surveys can identify and improve program adherence to MBSAQIP standards.

Gastroesophageal junction adenocarcinoma 1-year after sleeve gastrectomy.

Gastroesophageal malignancy after sleeve gastrectomy is rare. A 70-year-old male with a BMI of 46 underwent laparoscopic sleeve gastrectomy with normal endoscopy. By 10 months postop, the patient had reduced BMI to 30.5. Eleven months postop, he presented with emesis and endoscopy showed severe stenosis at the gastroesophageal junction with EUS showing a circumferential mass. Patient had adenocarcinoma of the distal esophagus HER 3+ and MMR proficient, clinical T2N1. He underwent esophageal stent placement followed by FOLFOX switched to carboplatin-Taxol with radiation therapy complicated by a localized perforation requiring antibiotics. After PET scan of esophageal mass indicated response, he underwent an open distal esophagectomy, total gastrectomy with Roux-en-Y esophagojejunostomy, and placement of feeding tube. Pathology revealed poorly differentiated invasive adenocarcinoma with negative margins. In the USA, this represents only the second adenocarcinoma following a sleeve gastrectomy and the first in a non-immune compromised patient.

Role of the exercise professional in metabolic and bariatric surgery.

Background: Physical activity (PA) is important for the long-term health and weight management of patients who undergo metabolic and bariatric surgery (MBS). However, the roles of exercise professionals in MBS settings have not been systematically determined. Objectives: To investigate: (1) who are the professionals implementing PA programming in MBS clinical settings; and (2) what patient-centric tasks do they perform? Setting: Clinical and academic exercise settings worldwide. Methods: This multimethod study included a scoping review of PA programs in MBS described in the research literature. Data about job tasks were extracted and provided to 10 experts to sort into categories. Cluster analysis was utilized to find the hierarchical structure of tasks. A Delphi process was used to agree on a final model. Results: The majority of PA professionals were exercise physiologists in the USA and physiotherapists or other types of exercise professionals elsewhere. Forty-three tasks were identified, the most reported being: supervision of exercise, fitness testing, and exercise prescription. Seven higher-order categories were determined: (1) Exercise-related health assessment, (2) Body composition and physical fitness assessment, (3) Lifestyle physical activity and sedentary behavior assessment, (4) Education, instruction, and prescription, (5) Exercise monitoring, (6) Behavioral counseling and psychosocial support, and (7) Dietary support. The following statements were rated an average of 9.0, classifying them as "imperative": 1) "Pre- and post-operative PA/exercise guidelines for MBS patients are needed", 2) "MBS programs need to include PA/exercise as part of multidisciplinary care". Conclusions: The expert group reached a consensus on 7 major classifications of job tasks for the exercise professional. It is important for governing medical associations across the world to formally recognize experienced exercise professionals as playing pivotal roles in continuing, multidisciplinary care for MBS patients. These findings also provide evidence-based information in the effort to solidify these positions within the greater context of healthcare.

Current use of the National Surgical Quality Improvement Program surgical risk calculator in academic surgery: a mixed-methods study.

Background: This study aims to quantitatively assess use of the NSQIP surgical risk calculator (NSRC) in contemporary surgical practice and to identify barriers to use and potential interventions that might increase use. Materials and methods: We performed a cross-sectional study of surgeons at seven institutions. The primary outcomes were self-reported application of the calculator in general clinical practice and specific clinical scenarios as well as reported barriers to use. Results: In our sample of 99 surgeons (49.7% response rate), 73.7% reported use of the NSRC in the past month. Approximately half (51.9%) of respondents reported infrequent NSRC use (<20% of preoperative discussions), while 14.3% used it in ≥40% of preoperative assessments. Reported use was higher in nonelective cases (30.2% vs 11.1%) and in patients who were ≥65 years old (37.1% vs 13.0%), functionally dependent (41.2% vs 6.6%), or with surrogate consent (39.9% vs 20.4%). NSRC use was not associated with training status or years in practice. Respondents identified a lack of influence on the decision to pursue surgery as well as concerns regarding the calculator's accuracy as barriers to use. Surgeons suggested improving integration to workflow and better education as strategies to increase NSRC use. Conclusions: Many surgeons reported use of the NSRC, but few used it frequently. Surgeons reported more frequent use in nonelective cases and frail patients, suggesting the calculator is of greater utility for high-risk patients. Surgeons raised concerns about perceived accuracy and suggested additional education as well as integration of the calculator into the electronic health record.

Improving Post-procedure Outcomes With Clinical Care Pathway for Enteral Access.

Our health system introduced an enteral access clinical pathway (EACP) hoping to increase nutritionist consults and decrease presentation to the Emergency Department, readmission to the hospital, and overall hospital length of stay. We followed patients with short-term access (STA), longterm access (LTA), and short-long-term conversions (SLT) seen in the six months prior to the EACP launch (baseline group) and the six months after (performance group). The baseline cohort consisted of 2,553 patients and the performance cohort of 2,419 patients. Those in the performance group were more likely to receive a nutrition consult (52.4% vs 48.0%, P < .01), less likely to re-present to the ED (31.9% vs 42.6%, P < .001), and less likely to be readmitted to the hospital (31.0% vs 41.6%, P < .001. These findings suggest that the EACP may increase the likelihood of both expert-driven nutritional support and effective discharge planning for hospitalized patients.

Generation of functional thymic organoids from human pluripotent stem cells.

The thymus is critical for the establishment of a functional and self-tolerant adaptive immune system but involutes with age, resulting in reduced naive T cell output. Generation of a functional human thymus from human pluripotent stem cells (hPSCs) is an attractive regenerative strategy. Direct differentiation of thymic epithelial progenitors (TEPs) from hPSCs has been demonstrated in vitro, but functional thymic epithelial cells (TECs) only form months after transplantation of TEPs in vivo. We show the generation of TECs in vitro in isogenic stem cell-derived thymic organoids (sTOs) consisting of TEPs, hematopoietic progenitor cells, and mesenchymal cells, differentiated from the same hPSC line. sTOs support T cell development, express key markers of negative selection, including the autoimmune regulator (AIRE) protein, and facilitate regulatory T cell development. sTOs provide the basis for functional patient-specific thymic organoid models, allowing for the study of human thymus function, T cell development, and transplant immunity.

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 role of preoperative toxicology screening in patients undergoing bariatric surgery.

BACKGROUND: Some programs and insurers may require patients to undergo toxicology screening despite lack of evidence that this practice affects postoperative outcomes. OBJECTIVES: To understand the prevalence of screening positive on toxicology testing in the bariatric surgical population and to examine the association between testing positive and important surgical outcomes. METHODS: We performed a retrospective review of patients who underwent laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass from an academic health system from 2017-2020. We described the rate of preoperative toxicology positivity as determined by serum and urine testing. We examined the association between toxicology positivity and outcomes of preoperative length, 30-day complications (bleeding, venous thromboembolism, leak, wound infection, pneumonia, urinary tract infection, and myocardial infarction), readmissions, and 1-year weight loss using chi-square and t-test analysis. RESULTS: Of 1057 patients, there were 134 patients (12.7%) who had positive toxicology testing. Of these, 37 (28%) were positive for opiates and 21 (16%) were positive for cotinine. Mean preoperative length was 381.8 days (standard deviation [SD], 222.5) for patients with positive testing versus 287.8 days (SD, 151.5; P = 1.00) for negative testing. Toxicology positivity was not associated with readmissions (5.2% versus 4.3%, X2 = 0.22; P = .64). The loss to follow-up at 1 year was 32.5%. There was no association with 1-year mean change in body mass index (mean of loss 12.23kg/m2 [SD, 5.61]) versus mean of loss 12.74 (SD, 6.44; P = .20)]. CONCLUSIONS: Our study is the first to describe preoperative toxicology positivity rates. We found no association between toxicology positivity and preoperative length, readmissions, or weight loss. Given its lack of impact on outcomes, toxicology testing prior to bariatric surgery may be an unnecessary burden on patients and healthcare, with regard to cost and wait times.