Adding Patient-Reported Outcomes to the American College of Surgeons National Surgical Quality Improvement Program: Results of the First 33,842 Patients from 65 Hospitals.

OBJECTIVES: To investigate the initial set of patient-reported outcomes (PROs) in the ACS NSQIP and their associations with 30-day surgical outcomes. BACKGROUND: PROs provide important information that can be used to improve routine care and facilitate quality improvement. The ACS conducted a demonstration project to capture PROs into the NSQIP to complement clinical data. METHODS: From 2/2020-3/2023, 65 hospitals collected PROMIS measures assessing global health, pain interference, fatigue, and physical function from patients accrued into the NSQIP. Using multivariable mixed regression, we compared the scores of patients with and without 30-day complications and further analyzed scores exceeding one standard deviation (1-SD) worse than national benchmarks. RESULTS: Overall, 33842 patients completed the PROMIS measures a median 58 days (IQR 47-72) postoperatively. Among patients without complications (n=31210), 33.9% had PRO scores 1-SD worse than national benchmarks. Patients with complications were 1.7-times more likely to report worse PROs (95% CI 1.6-1.8). Patients with complications had lower scores for global physical health (adjusted mean difference [AMD] 2.6, 95% CI 2.2-3.0), lower for global mental health (AMD 1.8, 95% CI 1.4-2.2), higher for pain interference (AMD 2.4, 95% CI 2.0-2.8), higher fatigue (AMD 2.7, 95% CI 2.3-3.1), and lower physical function (AMD 3.2, 95% CI 2.8-3.5). CONCLUSIONS: Postoperative complications negatively affect multiple key dimensions of patients' health-related quality of life. PROs were well below national benchmarks for many patients, even among those without complications. Identifying solutions to improve PROs after surgery thus remains a tremendous quality opportunity.

Quality and Outcome Assessment for Surgery.

ABSTRACT: This forum summarizes the proceedings of the joint European Surgical Association (ESA)/American Surgical Association (ASA) symposium on Quality and Outcome Assessment for Surgery that took place in Bordeaux, France, as part of the celebrations of the 30th anniversary of the ESA. Three presentations focused on a) the main messages from the Outcome4Medicine Consensus Conference, which took place in Zurich, Switzerland, in June 2022, b) the patient perspective, and c) benchmarking were hold by ESA members and discussed by ASA members in a symposium attended by members of both associations.

Incidence and Relative Burden of Surgical Site Infections in Children Undergoing Nonemergent Surgery: Implications for Performance Benchmarking and Prioritization of Prevention Efforts.

OBJECTIVE: To establish surgical site infection (SSI) performance benchmarks in pediatric surgery and to develop a prioritization framework for SSI prevention based on procedure-level SSI burden. BACKGROUND: Contemporary epidemiology of SSI rates and event burden in elective pediatric surgery remain poorly characterized. METHODS: Multicenter analysis using sampled SSI data from 90 hospitals participating in NSQIP-Pediatric and procedural volume data from the Pediatric Health Information System (PHIS) database. Procedure-level incisional and organ space SSI (OSI) rates for 17 elective procedure groups were calculated from NSQIP-Pediatric data and estimates of procedure-level SSI burden were extrapolated using procedural volume data. The relative contribution of each procedure to the cumulative sum of SSI events from all procedures was used as a prioritization framework. RESULTS: A total of 11,689 nonemergent procedures were included. The highest incisional SSI rates were associated with gastrostomy closure (4.1%), small bowel procedures (4.0%), and gastrostomy (3.7%), while the highest OSI rates were associated with esophageal atresia/tracheoesophageal fistula repair (8.1%), colorectal procedures (1.8%), and small bowel procedures (1.5%). 66.1% of the cumulative incisional SSI burden from all procedures were attributable to 3 procedure groups (gastrostomy: 27.5%, small bowel: 22.9%, colorectal: 15.7%), and 72.8% of all OSI events were similarly attributable to 3 procedure groups (small bowel: 28.5%, colorectal: 26.0%, esophageal atresia/tracheoesophageal fistula repair: 18.4%). CONCLUSIONS: A small number of procedures account for a disproportionate burden of SSIs in pediatric surgery. The results of this analysis can be used as a prioritization framework for refocusing SSI prevention efforts where they are needed most.

Association Between Biliary Pathogens, Surgical Site Infection, and Pancreatic Fistula: Results of a Randomized Trial of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy.

OBJECTIVE: To establish the association between bactibilia and postoperative complications when stratified by perioperative antibiotic prophylaxis. BACKGROUND: Patients undergoing pancreatoduodenectomy experience high rates of surgical site infection (SSI) and clinically relevant postoperative pancreatic fistula (CR-POPF). Contaminated bile is known to be associated with SSI, but the role of antibiotic prophylaxis in mitigation of infectious risks is ill-defined. METHODS: Intraoperative bile cultures (IOBCs) were collected as an adjunct to a randomized phase 3 clinical trial comparing piperacillin-tazobactam with cefoxitin as perioperative prophylaxis in patients undergoing pancreatoduodenectomy. After compilation of IOBC data, associations between culture results, SSI, and CR-POPF were assessed using logistic regression stratified by the presence of a preoperative biliary stent. RESULTS: Of 778 participants in the clinical trial, IOBC were available for 247 participants. Overall, 68 (27.5%) grew no organisms, 37 (15.0%) grew 1 organism, and 142 (57.5%) were polymicrobial. Organisms resistant to cefoxitin but not piperacillin-tazobactam were present in 95 patients (45.2%). The presence of cefoxitin-resistant organisms, 92.6% of which contained either Enterobacter spp. or Enterococcus spp., was associated with the development of SSI in participants treated with cefoxitin [53.5% vs 25.0%; odds ratio (OR)=3.44, 95% CI: 1.50-7.91; P =0.004] but not those treated with piperacillin-tazobactam (13.5% vs 27.0%; OR=0.42, 95% CI: 0.14-1.29; P =0.128). Similarly, cefoxitin-resistant organisms were associated with CR-POPF in participants treated with cefoxitin (24.1% vs 5.8%; OR=3.45, 95% CI: 1.22-9.74; P =0.017) but not those treated with piperacillin-tazobactam (5.4% vs 4.8%; OR=0.92, 95% CI: 0.30-2.80; P =0.888). CONCLUSIONS: Previously observed reductions in SSI and CR-POPF in patients that received piperacillin-tazobactam antibiotic prophylaxis are potentially mediated by biliary pathogens that are cefoxitin resistant, specifically Enterobacter spp. and Enterococcus spp.

Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.

Importance: Despite improvements in perioperative mortality, the incidence of postoperative surgical site infection (SSI) remains high after pancreatoduodenectomy. The effect of broad-spectrum antimicrobial surgical prophylaxis in reducing SSI is poorly understood. Objective: To define the effect of broad-spectrum perioperative antimicrobial prophylaxis on postoperative SSI incidence compared with standard care antibiotics. Design, Setting, and Participants: Pragmatic, open-label, multicenter, randomized phase 3 clinical trial at 26 hospitals across the US and Canada. Participants were enrolled between November 2017 and August 2021, with follow-up through December 2021. Adults undergoing open pancreatoduodenectomy for any indication were eligible. Individuals were excluded if they had allergies to study medications, active infections, chronic steroid use, significant kidney dysfunction, or were pregnant or breastfeeding. Participants were block randomized in a 1:1 ratio and stratified by the presence of a preoperative biliary stent. Participants, investigators, and statisticians analyzing trial data were unblinded to treatment assignment. Intervention: The intervention group received piperacillin-tazobactam (3.375 or 4 g intravenously) as perioperative antimicrobial prophylaxis, while the control group received cefoxitin (2 g intravenously; standard care). Main Outcomes and Measures: The primary outcome was development of postoperative SSI within 30 days. Secondary end points included 30-day mortality, development of clinically relevant postoperative pancreatic fistula, and sepsis. All data were collected as part of the American College of Surgeons National Surgical Quality Improvement Program. Results: The trial was terminated at an interim analysis on the basis of a predefined stopping rule. Of 778 participants (378 in the piperacillin-tazobactam group [median age, 66.8 y; 233 {61.6%} men] and 400 in the cefoxitin group [median age, 68.0 y; 223 {55.8%} men]), the percentage with SSI at 30 days was lower in the perioperative piperacillin-tazobactam vs cefoxitin group (19.8% vs 32.8%; absolute difference, -13.0% [95% CI, -19.1% to -6.9%]; P < .001). Participants treated with piperacillin-tazobactam, vs cefoxitin, had lower rates of postoperative sepsis (4.2% vs 7.5%; difference, -3.3% [95% CI, -6.6% to 0.0%]; P = .02) and clinically relevant postoperative pancreatic fistula (12.7% vs 19.0%; difference, -6.3% [95% CI, -11.4% to -1.2%]; P = .03). Mortality rates at 30 days were 1.3% (5/378) among participants treated with piperacillin-tazobactam and 2.5% (10/400) among those receiving cefoxitin (difference, -1.2% [95% CI, -3.1% to 0.7%]; P = .32). Conclusions and Relevance: In participants undergoing open pancreatoduodenectomy, use of piperacillin-tazobactam as perioperative prophylaxis reduced postoperative SSI, pancreatic fistula, and multiple downstream sequelae of SSI. The findings support the use of piperacillin-tazobactam as standard care for open pancreatoduodenectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03269994.

Health-related quality of life outcomes after neoadjuvant chemoradiotherapy for rectal cancer in NRG Oncology/NSABP R-04.

BACKGROUND: There has been limited evaluation of health-related quality of life (HRQOL) in rectal cancer patients receiving neoadjuvant chemoradiotherapy. HRQOL outcomes in the National Surgical Adjuvant Breast and Bowel Project R-04 trial are examined in this article. METHODS: Between 2004 and 2010, R-04 patients were invited to enroll in the HRQOL substudy, with questionnaires administered before randomization, after completion of chemoradiotherapy, and 1-year after surgery. HRQOL measures included: Functional Assessment of Cancer Therapy for colorectal cancer (FACT-C); Short Form-36v.2 Vitality scale; a treatment-specific symptom scale; and the FACT neurotoxicity scale. A 5-year postsurgery assessment was added to the protocol in 2012. Mixed-effects models examined neoadjuvant therapy treatment effects in the 1-year sample and models that explored associations of host factors and treatment impact on 5-year HRQOL. RESULTS: A total of 1373 patients completed baseline HRQOL and at least one additional assessment. The average age was 58 years (range, 23-85 years), male (68%), and 59% Stage II. There were no statistically significant differences in HRQOL outcomes by treatment arm, but HRQOL worsened from baseline to postneoadjuvant chemoradiotherapy, with statistically significant effect sizes changes ranging from 0.6 (Vitality) to 0.9 (FACT-C Trial Outcome Index). Neurotoxicity was greater in the oxaliplatin-treated groups. Obese/overweight patients had statistically significantly worse FACT-C Trial Outcome Index scores than did underweight/normal weight groups. At 5 years, younger patients and those with normal baseline weight had statistically significantly better physical function scores and older patients had better mental health outcomes. CONCLUSIONS: HRQOL did not differ across the four R-04 treatment arms; however, host factors explained significant variation in posttreatment HRQOL. CLINICALTRIALS: gov: NCT00058474 (https://ClinicalTrials.gov/ct2/show/NCT00058474). LAY SUMMARY: This article reports on the health-related quality of life (HRQOL) outcomes of patients treated with four different chemotherapy regimens combined with radiation in rectal cancer patients before definitive surgical treatment. There were no significant differences in HRQOL by treatment regimen, but all patients experienced decreased vitality (energy) and physical functioning. By 1 year after treatment, most patients had returned to pretreatment vitality and physical functioning, with the exception of increased neurotoxicity. In a subsample of patients assessed at 5 years after surgery, physical function was better in those who at pretreatment were younger, normal weight, and had better performance status. Mental function was better in those who at pretreatment were older and had better performance status.

Accelerating Surgical Site Infection Abstraction With a Semi-automated Machine-learning Approach.

OBJECTIVE: To demonstrate that a semi-automated approach to health data abstraction provides significant efficiencies and high accuracy. BACKGROUND: Surgical outcome abstraction remains laborious and a barrier to the sustainment of quality improvement registries like ACS-NSQIP. A supervised machine learning algorithm developed for detecting SSi using structured and unstructured electronic health record data was tested to perform semi-automated SSI abstraction. METHODS: A Lasso-penalized logistic regression model with 2011-3 data was trained (baseline performance measured with 10-fold cross-validation). A cutoff probability score from the training data was established, dividing the subsequent evaluation dataset into "negative" and "possible" SSI groups, with manual data abstraction only performed on the "possible" group. We evaluated performance on data from 2014, 2015, and both years. RESULTS: Overall, 6188 patients were in the 2011-3 training dataset and 5132 patients in the 2014-5 evaluation dataset. With use of the semi-automated approach, applying the cut-off score decreased the amount of manual abstraction by >90%, resulting in < 1% false negatives in the "negative" group and a sensitivity of 82%. A blinded review of 10% of the "possible" group, considering only the features selected by the algorithm, resulted in high agreement with the gold standard based on full chart abstraction, pointing towards additional efficiency in the abstraction process by making it possible for abstractors to review limited, salient portions of the chart. CONCLUSION: Semi-automated machine learning-aided SSI abstraction greatly accelerates the abstraction process and achieves very good performance. This could be translated to other post-operative outcomes and reduce cost barriers for wider ACS-NSQIP adoption.

Are Kids More Than Just Little Adults? A Comparison of Surgical Outcomes.

INTRODUCTION: While complication rates have been well described using the National Surgical Quality Improvement Program (NSQIP) and National Surgical Quality Improvement Program-Pediatric registries, there have been no direct comparisons of outcomes between adults and children. Our objective was to describe differences in postoperative outcomes between children and adults undergoing common surgical procedures. METHODS: Using data from 2013 to 2017, we identified patients undergoing laparoscopic appendectomy, laparoscopic cholecystectomy, thyroidectomy, and colectomy. Propensity score matching on gender, race, American Society of Anesthesiologists class, surgical indication, and procedure type was performed. Outcomes included surgical site infection (SSI), readmission rates, mortality/serious morbidity, and hospital length of stay and were analyzed using χ2 and student's t-test with statistical significance defined as P < 0.05. RESULTS: We matched 79,866 patients from 812 hospitals. Compared to adults, children had higher rates of SSI following appendectomy (4.12% versus 1.40%, P < 0.01) and cholecystectomy (0.96% versus 0.66%, P = 0.04), readmission following appendectomy (4.26% versus 2.47%, P < 0.01), and longer length of stay in all procedures. In adults, 30-day mortality/serious morbidity was higher for all procedures. CONCLUSIONS: Compared to adults, children demonstrate unique surgical complication and outcome profiles. Quality improvement efforts such as SSI prevention bundles and enhanced recovery protocols used in adults should be expanded to children.

Registry-based randomized clinical trials in surgery: Working with ACS-NSQIP and the AHPBA to conduct pragmatic trials.

Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high-quality data to guide clinical care. Registry-based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low-cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS-NSQIP-based registry trial.

Hyperamylasemia grade versus drain fluid amylase: which better predicts pancreatectomy outcomes?

BACKGROUND: The clinical importance of postoperative hyperamylasemia (POHA) grade is unknown. Our objectives were to evaluate the association of POHA grade with clinically relevant postoperative pancreatic fistula (CR-POPF) and compare its prognostic utility against postoperative day 1 drain fluid amylase (DFA-1). METHODS: Patients who underwent pancreatectomy from January 2019 through March 2020 were identified in the ACS NSQIP pancreatectomy-targeted dataset. POHA grade was assigned using post-operative serum amylase and clinical sequelae. The primary outcome was CR-POPF within 30 days. The association of POHA grade with CR-POPF was assessed using multivariable logistic regression, and c-statistics were used to compare POHA grade versus DFA-1. RESULTS: POHA occurred in 520 patients at 98 hospitals, including 261 (50.2%) with grade A, 234 (45.0%) with grade B, and 25 (4.8%) with grade C POHA. CR-POPFs were increased among patients with grade B (66.2%, OR 9.28 [5.84-14.73]) and C (68.0%, OR 10.50 [3.77-29.26]) versus grade A POHA (19.2%). POHA-inclusive models better predicted CR-POPF than those with DFA-1 alone (p < 0.002) and models with both predictors outperformed POHA alone (p = 0.039). CONCLUSION: POHA grade represents a measure of post-pancreatectomy outcomes that predicts CR-POPF and outperforms DFA-1 but must be aligned with new international definitions.

Successful Implementation of Enhanced Recovery in Elective Colorectal Surgery is Variable and Dependent on the Local Environment.

OBJECTIVE: To evaluate local hospital success with enhanced recovery implementation as measured by colorectal surgery process measure (PM) compliance and characterize local environment factors associated with success within a contemporary quality improvement collaborative. SUMMARY BACKGROUND DATA: Enhanced recovery programs (ERP) have proven an effective perioperative quality improvement strategy, but local variation in implementation can hinder patient outcome improvement. METHODS: Individual hospitals participating in a national colorectal ERP quality improvement program were evaluated with quantitative (patient-level process and outcome) and qualitative (survey and structured interviews with hospital teams) data between 2017 and 2020. Hospitals with implementation success were identified: high performers (80% of elective colorectal surgery patients compliant with >6/9 PMs) and high improvers (top quartile of PM adherence improvement over time). Hospital and implementation characteristics were compared with chi-square tests. Trends in average annual outcome change were estimated with logistic and linear regression. RESULTS: Of 207 total hospitals, 62 were characterized as High Performance and 52 as High Improvement. High Performance hospitals were larger, with more annual colorectal surgeries (128 vs 101, P = 0.039). Qualitative assessment revealed fewer barriers of staff buy-in and competing priorities, and more experience with standardized perioperative care in High Performance hospitals. High Improvement hospitals had lower baseline PM adherence (54.1% vs 69.6%, P < 0.001) and less experience with standardized perioperative care (30.8% vs 58.1%, P < 0.001) but were noted to have a positive trend in annual patient outcomes: annual morbidity (Δ-1.14% vs -0.20%, P = 0.035), readmission (Δ-1.85% vs 0.002%, P = 0.037), and prolonged length of stay (Δ-3.94 vs -1.19, P = 0.037) compared to Low Improvement hospitals. CONCLUSIONS: When evaluating a collection of hospitals implementing ERP, only half of hospitals reached consistent High Performance or high improvement. Characteristics of the local environment need further study to understand the barriers to effective implementation in a pragmatic setting.

Association of Surgical Resident Wellness With Medical Errors and Patient Outcomes.

OBJECTIVES: The aims of this study were to: (1) measure the prevalence of self-reported medical error among general surgery trainees, (2) assess the association between general surgery resident wellness (ie, burnout and poor psychiatric well-being) and self-reported medical error, and (3) examine the association between program-level wellness and objectively measured patient outcomes. SUMMARY OF BACKGROUND DATA: Poor wellness is prevalent among surgical trainees but the impact on medical error and objective patient outcomes (eg, morbidity or mortality) is unclear as existing studies are limited to physician and patient self-report of events and errors, small cohorts, or examine few outcomes. METHODS: A cross-sectional survey was administered immediately following the January 2017 American Board of Surgery In-training Examination to clinically active general surgery residents to assess resident wellness and self-reported error. Postoperative patient outcomes were ascertained using a validated national clinical data registry. Associations were examined using multivariable logistic regression models. RESULTS: Over a 6-month period, 22.5% of residents reported committing a near miss medical error, and 6.9% reported committing a harmful medical error. Residents were more likely to report a harmful medical error if they reported frequent burnout symptoms [odds ratio 2.71 (95% confidence interval 2.16-3.41)] or poor psychiatric well-being [odds ratio 2.36 (95% confidence interval 1.92-2.90)]. However, there were no significant associations between program-level resident wellness and any of the independently, objectively measured postoperative American College of Surgeons National Surgical Quality improvement Program outcomes examined. CONCLUSIONS: Although surgical residents with poor wellness were more likely to self-report a harmful medical error, there was not a higher rate of objectively reported outcomes for surgical patients treated at hospitals with higher rates of burnout or poor psychiatric well-being.

The Association Between Risk Aversion of Surgeons and Their Clinical Decision-Making.

BACKGROUND: The extent to which a surgeon's risk aversion influences their clinical decisions remains unknown. We assessed whether a surgeon's attitude toward risk ("risk aversion") influences their surgical decisions and whether the relationship can be explained by differences in surgeons' perception of treatment risks and benefits. MATERIALS AND METHODS: We presented a series of detailed clinical vignettes to a national sample of surgeons (n = 1,769; 13.4% adjusted response rate) and asked them to complete an instrument that measured how risk averse they are within their clinical practice (scale 6-36; higher number indicates greater risk aversion). For each vignette, participants rated their likelihood of recommending an operation and judged the likelihood of complications or full recovery. We examined whether differences in perceived likelihood of complications versus recovery could explain why risk-averse surgeons may be less likely to recommend an operation. RESULTS: Surgeons varied in their self-reported risk aversion score (median = 25, interquartile range[22,28]). Scores did not differ by level of surgeon experience or gender. Risk-averse surgeons were significantly less likely to recommend an operation for patients with exactly the same condition (65.5% for surgeons in highest quartile of risk aversion versus 62.3% for lowest quartile; P = 0.02). However, after controlling for surgeons' perception of the likelihood of complications versus recovery, there was no longer a significant association between surgeons' risk aversion and the decision to recommend an operation (64.7% versus 64.8%; P = 0.96). CONCLUSIONS: Surgeons vary widely in their self-reported risk aversion. Risk-averse surgeons were significantly less likely to recommend an operation, a finding that was explained by a higher perceived probability of post-operative complications than their colleagues.

A NSQIP-based randomized clinical trial evaluating choice of prophylactic antibiotics for pancreaticoduodenectomy.

Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents. This article describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin-tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first US randomized surgical trial to utilize a clinical registry for data collection, this study serves as proof of concept for registry-based clinical trials.

Association of Patient-reported Experiences and Surgical Outcomes Among Group Practices: Retrospective Cohort Study.

OBJECTIVE: The aim of the study was to determine the association of patient-reported experiences (PREs) and risk-adjusted surgical outcomes among group practices. BACKGROUND: The Centers for Medicare and Medicaid Services required large group practices to submit PREs data for successful participation in the Physician Quality Reporting System (PQRS) using the Consumer Assessment of Healthcare Providers and Systems for PQRS survey. Whether these PREs data correlate with perioperative outcomes remains ill defined. METHODS: Operations between January 1, 2014 and December 31, 2016 in the American College of Surgeons' National Surgical Quality Improvement Program registry were merged with 2015 Consumer Assessment of Healthcare Providers and Systems for PQRS survey data. Hierarchical logistic models were constructed to estimate associations between 7 subscales and 1 composite score of PREs and 30-day morbidity, unplanned readmission, and unplanned reoperation, separately, while adjusting for patient- and procedure mix. RESULTS: Among 328 group practices identified, patients reported their experiences with clinician communication the highest (mean ±â€Šstandard deviation, 82.66 ±â€Š3.10), and with attention to medication cost the lowest (25.96 ±â€Š5.14). The mean composite score was 61.08 (±6.66). On multivariable analyses, better PREs scores regarding medication cost, between-visit communication, and the composite score of experience were each associated with 4% decreased odds of morbidity [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.92-0.99], readmission (OR 0.96, 95% CI 0.93-0.99), and reoperation (OR 0.96, 95% CI 0.93-0.99), respectively. In sensitivity analyses, better between-visit communication remained significantly associated with fewer readmissions. CONCLUSIONS: In these data, patients' report of better between-visit communication was associated with fewer readmissions. More sensitive, surgery-specific PRE assessments may reveal additional unique insights for improving the quality of surgical care.

Post Hepatectomy Liver Failure Risk Calculator for Preoperative and Early Postoperative Period Following Major Hepatectomy.

BACKGROUND: Post hepatectomy liver failure (PHLF) is associated with significant perioperative morbidity and mortality. A tool to identify patients at risk for PHLF may allow for earlier intervention to mitigate its severity and help clinicians when counseling patients. Our objective was to develop a PHLF risk calculator. STUDY DESIGN: Patients who underwent hepatectomy for any indication from 2014 to 2017 were identified from ACS NSQIP. A multivariable logistic regression model was developed that included preoperative and intraoperative variables. Model fit was assessed for discrimination using the C-statistic, and calibration using Hosmer and Lemeshow (HL) Chi square. Validation of the calculator was performed utilizing tenfold cross validation. RESULTS: Among 15,636 hepatectomy patients analyzed, the overall incidence of clinically significant PHLF was 2.8%. Preoperative patient factors associated with increased PHLF were male gender, preoperative ascites within 30 days of surgery, higher ASA class, preoperative total bilirubin greater than 1.2 mg/dl, and AST greater than 40 units/l. Disease related factors associated with PHLF included histology, and use of neoadjuvant therapy. Intraoperative factors associated with PHLF were extent of resection, open surgical approach, abnormal liver texture, and biliary reconstruction. The calculator's C-statistic was 0.83 and the HL Chi square was 10.9 (p = 0.21) demonstrating excellent discrimination and calibration. On tenfold cross validation, the mean test group C-statistic was 0.82 and the HL p value was 0.26. CONCLUSION: We present a multi-institutional preoperative and early postoperative PHLF risk calculator, which demonstrated excellent discrimination and calibration. This tool can be used to help identify high-risk patients to facilitate earlier interventions.

Assessing the Quality of Rectal Cancer Pathology Reports in National Surgical Adjuvant Breast and Bowel Project Protocol R-04/NRG Oncology.

BACKGROUND: Accurate and comprehensive surgical pathology reports are integral to the quality of cancer care. Despite guidelines from the College of American Pathologists, variations in reporting quality continue to exist. OBJECTIVE: The aim of this study was to evaluate the quality of rectal cancer pathology reports and to identify areas of deficiency and potential sources of reporting variations. DESIGN: This is a retrospective analysis of prospectively obtained pathology reports. SETTING: This study is based at the hospitals participating in the National Surgical Adjuvant Breast and Bowel Project Protocol R-04 study. PATIENTS: Patients with rectal cancer undergoing surgical resection between July 2004 and August 2010 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the adherence to the College of American Pathologists guidelines and the impact of synoptic reporting, academic status, rural/urban setting, and hospital bed size on reporting quality. RESULTS: We identified 1004 surgical pathology reports for rectal cancer surgery from 383 hospitals and 755 pathologists. The overall adherence rate to the College of American Pathologists guidelines was 73.3%. Notable reporting deficiencies were found in several key pathology characteristics, including tumor histologic grade (reporting rate 77.8%), radial margin (84.6%), distance from the closest margin (47.9%), treatment effect (47.1%), and lymphovascular (73.1%)/perineural invasions (35.4%). Synoptic reporting use and urban hospital settings were associated with better adherence rates, whereas academic status and hospital bed size had no impact. Reporting variations existed not only between institutions, but also within individual hospitals and pathologists. There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001). LIMITATIONS: Data were obtained from a restricted setting (ie, hospitals participating in a randomized clinical trial). CONCLUSIONS: Wide variations in the quality of pathology reporting are observed for rectal cancer. The National Accreditation Program for Rectal Cancer mandates that programs meet strict quality standards for surgical pathology reporting. Further improvement is needed in this key aspect of oncology care for patients with rectal cancer. See Video Abstract at http://links.lww.com/DCR/B238.ClinicalTrials.gov registration: NCT00058 EVALUACIÓN DE LA CALIDAD DE LOS INFORMES DE PATOLOGÍA QUIRÚRGICA EN CASOS DE CÁNCER DE RECTO DEL NSABP R-04/ ONCOLOGÍA DEL NRG: Un informe de patología quirúrgica preciso y completo es fundamental en la calidad de atención de pacientes con cáncer. A pesar de las normas establecidas por el Colegio Americano de Patología, la variabilidad en la calidad de los informes es evidente.Evaluar la calidad de los informes de patología en casos de cáncer de recto para así identificar las áreas con deficiencias y las posibles fuentes variables en los mencionados informes.Análisis retrospectivo de informes de patología quirúrgica obtenidos prospectivamente.Hospitales que participan del Protocolo del Estudio Nacional R-04 como Adyuvantes Quirúrgicos de Mama e Intestino.Todos aquellos pacientes con cáncer de recto sometidos a resección quirúrgica entre Julio 2004 y Agosto 2010.Cumplimiento de las normas del Colegio Americano de Patología, del impacto de los informes sinópticos, del estado académico, del entorno rural / urbano y el número de camas hospitalarias en en la calidad de los informes.Identificamos 1,004 informes de patología quirúrgica en casos de cirugía en cáncer de recto en 383 hospitales y 755 patólogos. La tasa general de adherencia a las directivas del Colegio Americano de Patología fue del 73.3%. Se encontraron deficiencias notables en los informes en varias características patológicas clave incluidos, el grado histológico del tumor (tasa de informe 77.8%), margenes radiales (84.6%), distancia del margen más cercano (47.9%), efecto del tratamiento (47.1%) invasión linfovascular (73.1 %) / invasion perineural (35.4%). El uso de informes sinópticos y los entornos hospitalarios urbanos se asociaron con mejores tasas de adherencia, mientras que el estado académico y el número de camas hospitalarias no tuvieron ningún impacto. Hubo variaciones en los informes no solo entre instituciones, sino también dentro de hospitales y patólogos individuales. Hubo una tendencia a una mejor adherencia a lo largo del tiempo (2005 = 65.7% v 2010 = 82.3%, p < 0.001), que coincidió con la mayor adopción de informes sinópticos por parte de los patólogos (2005 v 2010, 9.4% v 25.3%, p < 0.001)Datos obtenidos de un entorno restringido (es decir, hospitales que participan en un ensayo clínico aleatorizado).Se observaron grandes variaciones en la calidad de los informes de patología quirúrgica en casos de cáncer de recto. El Programa Nacional de Acreditación para Cáncer de Recto exige que los programas cumplan con estrictos estándares de calidad para los informes de patología quirúrgica. Se necesita una mejoría adicional en este aspecto clave de la atención oncológica para pacientes con cáncer de recto. Video Resumen en http://links.lww.com/DCR/B238.Registro de Clinical Trials.gov: NCT00058.

Hospital variation in use of prophylactic drains following hepatectomy.

BACKGROUND: Prophylactic drainage following hepatectomy is frequently performed despite evidence that drainage is unnecessary. It is unknown to what extent drain use is influenced by hospital practice patterns. The objectives of this study were to identify factors associated with the use of prophylactic drains following hepatectomy and assess hospital variation in drain use. METHODS: Retrospective cohort study of patients following hepatectomy without concomitant bowel resection or biliary reconstruction from the ACS NSQIP Hepatectomy Targeted Dataset. Factors associated with the use of prophylactic drains were identified using multivariable logistic regression and hospital-level variation in drain use was assessed. RESULTS: Analysis included 10,530 patients at 130 hospitals. Overall, 42.3% of patients had a prophylactic drain placed following hepatectomy. Patients were more likely to receive prophylactic drains if they were ≥65 years old (adjusted odds ratio [aOR]: 1.34, 95%CI: 1.16-1.56), underwent major hepatectomy (aOR: 1.42, 95%CI 1.15-1.74), or had an open resection (aOR 1.94, 95%CI 1.49-2.53). There was notable hospital variability in drain use (range: 0%-100% of patients), and 77.5% of measured variation was at the hospital level. CONCLUSION: Prophylactic drains are commonly placed in both major and minor hepatectomy. Hospital-specific patterns appear to be a major driver and represent a target for improvement.

Association of preoperative biliary drainage technique with postoperative outcomes among patients with resectable hepatobiliary malignancy.

BACKGROUND: Endoscopic biliary stenting (EBS) and percutaneous transhepatic biliary drainage (PTBD) are two techniques used for preoperative biliary drainage prior to hepatobiliary resection. The objectives of this study were to determine predictors of the drainage technique selection and to evaluate the association between drainage technique and postoperative outcomes. METHODS: Using ACS NSQIP data (2014-2017), patients who underwent preoperative biliary drainage prior to hepatobiliary resection for malignancy were identified. Separate multivariable-adjusted, propensity score (PS) adjusted, and PS matched logistic regression models were constructed to evaluate the association between drainage technique and postoperative outcomes. RESULTS: Of 527 patients identified, 431 (81.8%) received EBS and 96 (18.2%) received PTBD. Patients who underwent PTBD had more preoperative co-morbidities, including higher ASA class, recent weight loss, and hypoalbuminemia (all p < 0.05). After multivariable adjustment, PTBD was significantly associated with 30-day DSM (OR 1.92, 95% CI 1.24-2.97, p = 0.004), overall SSI (OR 1.74, 95% CI 1.10-2.76, p = 0.019), and superficial SSI (OR 2.08, 95% CI 1.20-3.60, p = 0.010). These findings remained significant for both PS-adjusted and PS-matched models. CONCLUSION: Patients undergoing hepatobiliary resection selected for PTBD had significantly more preoperative co-morbidities and nutritional deficits. Compared to EBS, PTBD was associated with significantly higher odds of postoperative morbidity and mortality.

Beyond death and graft survival-Variation in outcomes after kidney transplantation. Results from the NSQIP Transplant beta phase.

The National Surgical Quality Program (NSQIP) Transplant was designed by transplant surgeons from the ground up to track posttransplant outcomes beyond basic recipient and graft survival. After an initial pilot phase, the program has expanded to 29 participating sites and enrolled more than 4300 recipient-donor pairs into the database, including 2876 complete kidney transplant cases. In this analysis, surgical site infection (SSI), urinary tract infection (UTI), and reoperation/intervention were evaluated for kidney transplant recipients. We observed impressive variation in the crude incidence between sites for SSI (0%-17%), UTI (0%-14%), and reoperation/intervention (0%-25%). After adjustment for donor and recipient factors, 2 sites were outliers with respect to their incidence of UTI. For the first time, the field of transplantation has data that demonstrate variation in kidney recipient surgical outcomes between sites. More importantly, NSQIP Transplant provides a powerful platform to improve care beyond basic patient and graft survival.