Karl Y. Bilimoria

Does Surgical Quality Improve in the American College of Surgeons National Surgical Quality Improvement Program: An Evaluation of All Participating Hospitals

Background/Objective:The National Surgical Quality Improvement Program (NSQIP) has demonstrated quality improvement in the VA and pilot study of 14 academic institutions. The objective was to show that American College of Surgeons (ACS)-NSQIP helps all enrolled hospitals. Methods:ACS-NSQIP data was used to evaluate improvement in hospitals longitudinally over 3 years (2005–2007). Improvement was defined as reduction in risk-adjusted “Observed/Expected” (O/E) ratios between periods with risk adjustment held constant. Multivariable logistic regression-based adjustment was performed and included indicators for procedure groups. Additionally, morbidity counts were modeled using a negative binomial model, to estimate the number of avoided complications. Results:Multiple perspectives reflected improvement over time. In the analysis of 118 hospitals (2006–2007), 66% of hospitals improved risk-adjusted mortality (mean O/E improvement: 0.174; P < 0.05) and 82% improved risk adjusted complication rates (mean improvement: 0.114; P < 0.05). Correlations between starting O/E and improvement (0.834 for mortality, 0.652 for morbidity), as well as relative risk, revealed that initially worse-performing hospitals had more likelihood of improvement. Nonetheless, well-performing hospitals also improved. Modeling morbidity counts, 183 hospitals (2007), avoided ∼9598 potential complications: ∼52/hospital. Due to sampling this may represent only 1 of 5 to 1of 10 of the true total. Improvement reflected aggregate performance across all types of hospitals (academic/community, urban/rural). Changes in patient risk over time had important contributions to the effect. Conclusions:ACS-NSQIP indicates that surgical outcomes improve across all participating hospitals in the private sector. Improvement is reflected for both poor- and well-performing facilities. NSQIP hospitals appear to be avoiding substantial numbers of complications- improving care, and reducing costs. Changes in risk over time merit further study.

Extent of Surgery Affects Survival for Papillary Thyroid Cancer

Background:The extent of surgery for papillary thyroid cancers (PTC) remains controversial. Consensus guidelines have recommended total thyroidectomy for PTC ≥1 cm; however, no study has supported this recommendation based on a survival advantage. The objective of this study was to examine whether the extent of surgery affects outcomes for PTC and to determine whether a size threshold could be identified above which total thyroidectomy is associated with improved outcomes. Methods:From the National Cancer Data Base (1985–1998), 52,173 patients underwent surgery for PTC. Survival was estimated by the Kaplan-Meier method and compared using log-rank tests. Cox Proportional Hazards modeling stratified by tumor size was used to assess the impact of surgical extent on outcomes and to identify a tumor size threshold above which total thyroidectomy is associated with an improvement in recurrence and long-term survival rates. Results:Of the 52,173 patients, 43,227 (82.9%) underwent total thyroidectomy, and 8946 (17.1%) underwent lobectomy. For PTC <1 cm extent of surgery did not impact recurrence or survival (P = 0.24, P = 0.83). For tumors ≥1 cm, lobectomy resulted in higher risk of recurrence and death (P = 0.04, P = 0.009). To minimize the influence of larger tumors, 1 to 2 cm lesions were examined separately: lobectomy again resulted in a higher risk of recurrence and death (P = 0.04, P = 0.04). Conclusions:The results of this study demonstrate that total thyroidectomy results in lower recurrence rates and improved survival for PTC ≥1.0 cm compared with lobectomy. This is the first study to demonstrate that total thyroidectomy for PTC ≥1.0 cm improves outcomes.

Development and Evaluation of the Universal ACS NSQIP Surgical Risk Calculator: A Decision Aid and Informed Consent Tool for Patients and Surgeons

BACKGROUND Accurately estimating surgical risks is critical for shared decision making and informed consent. The Centers for Medicare and Medicaid Services may soon put forth a measure requiring surgeons to provide patients with patient-specific, empirically derived estimates of postoperative complications. Our objectives were to develop a universal surgical risk estimation tool, to compare performance of the universal vs previous procedure-specific surgical risk calculators, and to allow surgeons to empirically adjust the estimates of risk. STUDY DESIGN Using standardized clinical data from 393 ACS NSQIP hospitals, a web-based tool was developed to allow surgeons to easily enter 21 preoperative factors (demographics, comorbidities, procedure). Regression models were developed to predict 8 outcomes based on the preoperative risk factors. The universal model was compared with procedure-specific models. To incorporate surgeon input, a subjective surgeon adjustment score, allowing risk estimates to vary within the estimates confidence interval, was introduced and tested with 80 surgeons using 10 case scenarios. RESULTS Based on 1,414,006 patients encompassing 1,557 unique CPT codes, a universal surgical risk calculator model was developed that had excellent performance for mortality (c-statistic = 0.944; Brier score = 0.011 [where scores approaching 0 are better]), morbidity (c-statistic = 0.816, Brier score = 0.069), and 6 additional complications (c-statistics > 0.8). Predictions were similarly robust for the universal calculator vs procedure-specific calculators (eg, colorectal). Surgeons demonstrated considerable agreement on the case scenario scoring (80% to 100% agreement), suggesting reliable score assignment between surgeons. CONCLUSIONS The ACS NSQIP surgical risk calculator is a decision-support tool based on reliable multi-institutional clinical data, which can be used to estimate the risks of most operations. The ACS NSQIP surgical risk calculator will allow clinicians and patients to make decisions using empirically derived, patient-specific postoperative risks.

National Failure to Operate on Early Stage Pancreatic Cancer

Background:Despite studies demonstrating improved outcomes, pessimism persists regarding the effectiveness of surgery for pancreatic cancer. Our objective was to evaluate utilization of surgery in early stage disease and identify factors predicting failure to undergo surgery. Methods:Using the National Cancer Data Base (1995–2004), 9559 patients were identified with potentially resectable tumors (pretreatment clinical Stage I: T1N0M0 and T2N0M0). Multivariate models were employed to identify factors predicting failure to undergo surgery and assess the impact of pancreatectomy on survival. Results:Of clinical Stage I patients 71.4% (6823/9559) did not undergo surgery; 6.4% (616/9559) were excluded due to comorbidities; 4.2% (403/9559) refused surgery; 9.1% (869/9559) were excluded due to age; and 38.2% (3,644/9559) with potentially resectable cancers were classified as “not offered surgery.” Of the 28.6% (2736/9559) of patients who underwent surgery, 96.0% (2630/2736) underwent pancreatectomy, and 4.0% (458/2736) had unresectable tumors. Patients were less likely to undergo surgery if they were older than 65 years, were black, were on Medicare or Medicaid, had pancreatic head lesions, earned lower annual incomes, or had less education (P < 0.0001). Patients were less likely to receive surgery at low-volume and community centers. Patients underwent surgery more frequently at National Cancer Institute/National Comprehensive Cancer Network-designated cancer centers (P < 0.0001). Patients who were not offered surgery had significantly better survival than those with Stage III or IV disease but worse survival than patients who underwent pancreatectomy for Stage I disease (P < 0.0001). Conclusions:This is the first study to characterize the striking underuse of pancreatectomy in the United States. Of early stage pancreatic cancer patients without any identifiable contraindications, 38.2% failed to undergo surgery.

Validation of the 6th edition AJCC pancreatic cancer staging system: Report from the National Cancer Database

With the development of stage‐specific treatments for pancreatic cancer, controversies exist concerning optimal clinical and pathologic staging. The most recent edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 6th Edition included some notable modifications. In anticipation of the 7th editions publication, the authors evaluated the predictive ability of the current pancreatic adenocarcinoma staging system.

Small bowel cancer in the United States: changes in epidemiology, treatment, and survival over the last 20 years.

Background:Previous studies have shown an increasing incidence of small bowel tumors in the United States. Our objective was to assess this increase by examining changes in histology-specific incidence, treatment, and survival. Methods:Patients with small bowel malignancies were identified from the National Cancer Data Base (NCDB, 1985–2005) and the Surveillance Epidemiology and End Results (SEER, 1973–2004) database. Age-adjusted incidence rates were calculated using SEER. Treatment and survival trends over time were examined using the National Cancer Data Base. Regression models were developed to assess survival over time. Results:Sixty-seven thousand eight hundred forty-three patients were identified with small bowel malignancies: 37.4% carcinoid, 36.9% adenocarcinomas, 8.4% stromal tumors, and 17.3% lymphomas. From 1973 to 2004, the incidence of carcinoid tumors increased more than 4-fold (2.1 to 9.3 per million), whereas changes in adenocarcinomas, stromal tumors, and lymphomas were less pronounced. From 1985 to 2005, utilization of surgery increased significantly for carcinoid tumors from 78.8% to 87.4% (P < 0.0001). Adjuvant chemotherapy utilization for adenocarcinoma increased from 8.1% in 1985 to 23.8% in 2005 (P < 0.0001). Treatment over time was generally unchanged for lymphoma and stromal tumors. Five-year survival after resection remained unchanged over time for all histologic subtypes even after adjusting for changes in patient demographics, tumor characteristics, and treatment approaches. Conclusions:The overall incidence of small intestine malignancies has increased considerably, primarily because of carcinoid tumors which are now the most common small bowel cancer. With current treatments, survival has remained relatively unchanged over the last 20 years. Novel therapeutic options need to be investigated.

Underlying Reasons Associated With Hospital Readmission Following Surgery in the United States

IMPORTANCE Financial penalties for readmission have been expanded beyond medical conditions to include surgical procedures. Hospitals are working to reduce readmissions; however, little is known about the reasons for surgical readmission. OBJECTIVE To characterize the reasons, timing, and factors associated with unplanned postoperative readmissions. DESIGN, SETTING, AND PARTICIPANTS Patients undergoing surgery at one of 346 continuously enrolled US hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) between January 1, 2012, and December 31, 2012, had clinically abstracted information examined. Readmission rates and reasons (ascertained by clinical data abstractors at each hospital) were assessed for all surgical procedures and for 6 representative operations: bariatric procedures, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass. MAIN OUTCOMES AND MEASURES Unplanned 30-day readmission and reason for readmission. RESULTS The unplanned readmission rate for the 498,875 operations was 5.7%. For the individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass. The most common reason for unplanned readmission was surgical site infection (SSI) overall (19.5%) and also after colectomy or proctectomy (25.8%), ventral hernia repair (26.5%), hysterectomy (28.8%), arthroplasty (18.8%), and lower extremity vascular bypass (36.4%). Obstruction or ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%), after colectomy or proctectomy (18.1%), ventral hernia repair (16.7%), and hysterectomy (13.4%). Only 2.3% of patients were readmitted for the same complication they had experienced during their index hospitalization. Only 3.3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization. There was no time pattern for readmission, and early (≤7 days postdischarge) and late (>7 days postdischarge) readmissions were associated with the same 3 most common reasons: SSI, ileus or obstruction, and bleeding. Patient comorbidities, index surgical admission complications, non-home discharge (hazard ratio [HR], 1.40 [95% CI, 1.35-1.46]), teaching hospital status (HR, 1.14 [95% CI 1.07-1.21]), and higher surgical volume (HR, 1.15 [95% CI, 1.07-1.25]) were associated with a higher risk of hospital readmission. CONCLUSIONS AND RELEVANCE Readmissions after surgery were associated with new postdischarge complications related to the procedure and not exacerbation of prior index hospitalization complications, suggesting that readmissions after surgery are a measure of postdischarge complications. These data should be considered when developing quality indicators and any policies penalizing hospitals for surgical readmission.

Comparison of Sentinel Lymph Node Biopsy Alone and Completion Axillary Lymph Node Dissection for Node-Positive Breast Cancer

PURPOSE For women with breast cancer, the role of completion axillary lymph node dissection (ALND) after identification of nodal metastases by sentinel lymph node biopsy (SLNB) has been questioned. Our objectives were to assess national nodal evaluation practice patterns and to examine differences in recurrence and survival for SLNB alone versus SLNB with completion ALND. PATIENTS AND METHODS From the National Cancer Data Base (1998 to 2005), women with clinically node-negative breast cancer who underwent SLNB and who had nodal metastases were identified. Practice patterns and outcomes were examined for patients who underwent SLNB alone versus SLNB with completion ALND (median follow-up, 63 months). RESULTS Of 97,314 patients, 20.8% underwent SLNB alone, and 79.2% underwent SLNB with completion ALND. In 2004 to 2005, patients were significantly more likely to undergo SLNB alone if they were older, had smaller tumors, or were treated at non-National Cancer Institute-designated cancer centers. In patients with macroscopic nodal metastases (n = 20,075 during 1998 to 2000), there was a nonsignificant trend toward better outcomes for completion ALND (v SLNB alone) after analysis was adjusted for differences between the two groups: axillary recurrence (hazard ratio [HR], 0.58; 95% CI, 0.32 to 1.06) and overall survival (HR, 0.89; 95% CI, 0.76 to 1.04). In patients with microscopic nodal metastases (n = 2,203 during 1998 to 2000), there were no significant differences in axillary recurrence or survival for patients who underwent SLNB alone versus completion ALND. CONCLUSION Compared with SLNB alone, completion ALND does not appear to improve outcomes for breast cancer patients with microscopic nodal metastases; however, there was a nonsignificant trend toward better outcomes with completion ALND for those with macroscopic disease.

Development of an American College of Surgeons National Surgery Quality Improvement Program: Morbidity and Mortality Risk Calculator for Colorectal Surgery

BACKGROUND Surgical decision-making and informed patient consent both benefit from having accurate information about risk. But currently available risk estimating systems have one or more limitations associated with lack of specificity to operation type, size of sample (reliability), range of outcomes predicted, and appreciation of hospital effects. STUDY DESIGN Data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) patients who underwent colorectal surgery in 2006 to 2007 were used to generate logistic prediction models for 30-day morbidity, serious morbidity, and mortality. Results for these three models were then used to construct a universal multivariable model to predict risk for all three outcomes. Model performance was externally validated against 2005 data. RESULTS For 2006 to 2007, 28,863 patients were identified who underwent major colorectal operations at 182 hospitals. A single 15-variable predictor model exhibited discrimination (c-statistic) close to that observed for the separate models on all three outcomes. Similar discrimination was found when the 2006 to 2007 universal model was applied to 3,037 operations conducted in 2005 at 37 hospitals. CONCLUSIONS The ACS NSQIP colorectal risk calculator allows surgeons to preoperatively provide patients with detailed information about their personal risks of overall morbidity, serious morbidity, and mortality. Because ACS NSQIP can also categorize hospitals as performing better or worse than expected (or as expected), surgeons have the opportunity to adjust risk probabilities for patients at their institutions accordingly.

Prognostic score predicting survival after resection of pancreatic neuroendocrine tumors: analysis of 3851 patients.

Background:Pancreatic neuroendocrine tumors (PNET) have a poorly defined natural history, and a staging system is not available. The objective of this study was to identify factors predicting survival after pancreatectomy for PNETs and to establish a postresection prognostic score. Patients and Methods:From the National Cancer Data Base (1985–2004), patients were identified who underwent PNET resection. Multivariable Cox proportional hazards modeling was used to assess the impact of patient, tumor, treatment, and hospital factors on survival. A prognostic score based on the predictive factors from the Cox model was developed. Results:Three thousand eight hundred fifty-one patients underwent resection for PNETs. Five-year overall survival was 59.3%, and the 10-year survival was 37.7%. On multivariable analysis, age, grade, distant metastases, tumor functionality, and type of resection were independent predictors of survival after resection of PNETs (P < 0.0001). Gender, race, socioeconomic status, tumor size, nodal status, margins, adjuvant chemotherapy, and hospital volume were not associated with survival. Age, grade, and distant metastases were the most significant predictors of survival and were incorporated into a PNET postresection prognostic score. The prognostic score correlated with outcomes and offered excellent survival discrimination by each of the 3 score subgroups: 76.7%, 50.9%, and 35.7% (P < 0.0001). The concordance index was 0.63 (95% CI 0.59–0.67), indicating reasonable agreement between actual outcomes and that predicted by the prognostic score. Conclusions:The prognostic score can be used to predict outcomes, guide adjuvant treatment, and stratify patients for clinical trials.