Clifford Y. Ko

Surgical Site Infection Prevention: The Importance of Operative Duration and Blood Transfusion—Results of the First American College of Surgeons–National Surgical Quality Improvement Program Best Practices Initiative

BACKGROUND Surgical site infections (SSI) continue to be a significant problem in surgery. The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) Best Practices Initiative compared process and structural characteristics among 117 private sector hospitals in an effort to define best practices aimed at preventing SSI. STUDY DESIGN Using standard NSQIP methodologies, we identified 20 low outlier and 13 high outlier hospitals for SSI using data from the ACS-NSQIP in 2006. Each hospital was administered a process of care survey, and site visits were conducted to five hospitals. Comparisons between the low and high outlier hospitals were made with regard to patient characteristics, operative variables, structural variables, and processes of care. RESULT Hospitals that were high outliers for SSI had higher trainee-to-bed ratios (0.61 versus 0.25, p < 0.0001), and the operations took significantly longer (128.3+/-104.3 minutes versus 102.7+/-83.9 minutes, p < 0.001). Patients operated on at low outlier hospitals were less likely to present to the operating room anemic (4.9% versus 9.7%, p=0.007) or to receive a transfusion (5.1% versus 8.0%, p=0.03). In general, perioperative policies and practices were very similar between the low and high outlier hospitals, although low outlier hospitals were readily identified by site visitors. Overall, low outlier hospitals were smaller, efficient in the delivery of care, and experienced little operative staff turnover. CONCLUSIONS Our findings suggest that evidence-based SSI prevention practices do not easily distinguish well from poorly performing hospitals. But structural and process of care characteristics of hospitals were found to have a significant association with good results.

Directing Surgical Quality Improvement Initiatives: Comparison of Perioperative Mortality and Long-Term Survival for Cancer Surgery

PURPOSE Quality-improvement initiatives are being developed to decrease volume-based variability in surgical outcomes. Resources for national and hospital quality-improvement initiatives are limited. It is unclear whether quality initiatives in surgical oncology should focus on factors affecting perioperative mortality or long-term survival. Our objective was to determine whether differences in hospital surgical volume have a larger effect on perioperative mortality or long-term survival using two methods. PATIENTS AND METHODS From the National Cancer Data Base, 243,103 patients who underwent surgery for nonmetastatic colon, esophageal, gastric, liver, lung, pancreatic, or rectal cancer were identified. Multivariable modeling was used to evaluate 60-day mortality and 5-year conditional survival (excluding perioperative deaths) across hospital volume strata. The number of potentially avoidable perioperative and long-term deaths were calculated if outcomes at low-volume hospitals were improved to those of the highest-volume hospitals. RESULTS Risk-adjusted perioperative mortality and long-term conditional survival worsened as hospital surgical volume decreased for all cancer sites, except for liver resections where there was no difference in survival. When comparing low- with high-volume hospitals, the hazard ratios for perioperative mortality were substantially larger than for long-term survival. However, the number of potentially avoidable deaths each year in the United States, if outcomes at low-volume hospitals were improved to the level of highest-volume centers, was significantly larger for long-term survival. CONCLUSION Although the magnitude of the hazard ratios implies that quality-improvement efforts should focus on perioperative mortality, a larger number of deaths could be avoided by focusing quality initiatives on factors associated with long-term survival.

Comparison of Hospital Performance in Nonemergency Versus Emergency Colorectal Operations at 142 Hospitals

BACKGROUND Quality improvement efforts have demonstrated considerable hospital-to-hospital variation in surgical outcomes. However, information about the quality of emergency surgical care is lacking. The objective of this study was to assess whether hospitals have comparable outcomes for emergency and nonemergency operations. STUDY DESIGN Patients undergoing colorectal resections were identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 2005 to 2007 dataset. Logistic regression models for 30-day morbidity and mortality after emergency and nonemergency colorectal resections were constructed. Hospital risk-adjusted outcomes as measured by observed to expected (O/E) ratios, outlier status, and rank-order differences were compared. RESULTS Of 25,710 nonemergency colorectal resections performed at 142 ACS NSQIP hospitals, 6,138 (23.9%) patients experienced at least 1 complication, and 492 (1.9%) patients died. There were 5,083 emergency colorectal resections; 2,442 (48%) patients experienced at least 1 complication, and 780 (15.3%) patients died. Outcomes for nonemergency versus emergency operations were weakly correlated for morbidity and mortality (Pearson correlation coefficient: 0.28 versus 0.13). Median differences in hospital rankings based on O/E ratios between nonemergency and emergency performance were 30.5 ranks (interquartile range [IQR] 13 to 59) for morbidity and 34 ranks (interquartile ratio 17 to 61) for mortality. CONCLUSIONS Hospitals with favorable outcomes after nonemergency colorectal resections do not necessarily have similar outcomes for emergency operations. Hospitals should specifically examine their performance on emergency surgical procedures to identify quality improvement opportunities and focus quality improvement efforts appropriately.

National Assessment of Melanoma Care Using Formally Developed Quality Indicators

PURPOSE There is considerable variation in the quality of cancer care delivered in the United States. Assessing care by using quality indicators could help decrease this variability. The objectives of this study were to formally develop valid quality indicators for melanoma and to assess hospital-level adherence with these measures in the United States. METHODS Quality indicators were identified from available literature, consensus guidelines, and melanoma experts. Thirteen experts ranked potential measures for validity on the basis of the RAND/University of California, Los Angeles Appropriateness Methodology. Adherence with individual valid indicators and a composite measure of all indicators were assessed at 1,249 Commission on Cancer hospitals by using the National Cancer Data Base (NCDB; 2004 through 2005). RESULTS Of 55 proposed quality indicators, 26 measures (47%) were rated as valid. These indicators assessed structure (n = 1), process (n = 24), and outcome (n = 1). Of the 26 measures, 10 are readily assessable by using cancer registry data. Adherence with valid indicators ranged from 11.8% to 96.5% at the patient level and 3.7% to 83.0% at the hospital level. (Adherence required that >OR= 90% of patients at a hospital receive concordant care.) Most hospitals were adherent with 50% or fewer of the individual indicators (median composite score, five; interquartile range, four to seven). Adherence was higher for diagnosis and staging measures and was lower for treatment indicators. CONCLUSION There is considerable variation in the quality of melanoma care in the United States. By using these formally developed quality indicators, hospitals can assess their adherence with current melanoma care guidelines through feedback mechanisms from the NCDB and can better direct quality improvement efforts.

Effect of Hospital Type and Volume on Lymph Node Evaluation for Gastric and Pancreatic Cancer

HYPOTHESIS For gastric and pancreatic cancer, regional lymph node evaluation is important to accurately stage disease in a patient and may be associated with improved survival. We hypothesized that National Comprehensive Cancer Network (NCCN), National Cancer Institute (NCI)-designated institutions, and high-volume hospitals examine more lymph nodes for gastric and pancreatic malignant neoplasms than do low-volume centers and community hospitals. DESIGN Volume-outcome study. SETTING Academic research. PATIENTS Using the National Cancer Data Base (January 1, 2003, to December 31, 2004), patients were identified who underwent resection for gastric (n = 3088) and pancreatic (n = 1130 [pancreaticoduodenectomy only]) cancer. MAIN OUTCOME MEASURES Multivariable logistic regression analysis was used to assess the effect of hospital type and volume on nodal evaluation (>or=15 nodes). RESULTS Only 23.2% of patients with gastric cancer and 16.4% of patients with pancreatic cancer in the United States underwent evaluation of at least 15 lymph nodes. Patients undergoing surgery had more lymph nodes examined at NCCN-NCI hospitals than at community hospitals (median, 12 vs 6 for gastric cancer and 9 vs 6 for pancreatic cancer; P < .001). Patients at highest-volume hospitals had more lymph nodes examined than patients at low-volume hospitals (median, 10 vs 6 for gastric cancer and 8 vs 6 for pancreatic cancer; P < .001). On multivariable analysis, patients undergoing surgery at NCCN-NCI and high-volume hospitals were more likely to have at least 15 lymph nodes evaluated compared with patients undergoing surgery at community hospitals and low-volume centers (P < .001 and P =.02, respectively). CONCLUSIONS Nodal examination is important for staging, adjuvant therapy decision making, and clinical trial stratification. Moreover, differences in nodal evaluation may contribute to improved long-term outcomes at NCCN-NCI centers and high-volume hospitals for patients with gastric and pancreatic cancer.

Reliability of Superficial Surgical Site Infections as a Hospital Quality Measure

BACKGROUND Although rates of superficial surgical site infection (SSI) are increasingly used as measures of hospital quality, the statistical reliability of using SSI rates in this context is uncertain. We used the American College of Surgeons National Surgical Quality Improvement Program data to determine the reliability of SSI rates as a measure of hospital performance and to evaluate the effect of hospital caseload on reliability. STUDY DESIGN We examined all patients who underwent colon resection in hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program in 2007 (n = 18,455 patients, n = 181 hospitals). We first calculated the number of cases and the risk-adjusted rate of SSI at each hospital. We then used hierarchical modeling to estimate the reliability of this quality measure for each hospital. Finally, we quantified the proportion of hospital-level variation in SSI rates due to patient characteristics and measurement noise. RESULTS The average number of colon resections per hospital was 102 (SD 65). The risk-adjusted rate of superficial SSI was 10.5%, but varied from 0 to 30% across hospitals. Approximately 35% of the variation in SSI rates was explained by noise, 7% could be attributed to patient characteristics, and the remaining 58% represented true differences in SSI rates. Just more than half of the hospitals (54%) had a reliability >0.70, which is considered a minimum acceptable level. To achieve this level of reliability, 94 cases were required. CONCLUSIONS SSI rates are a reliable measure of hospital quality when an adequate number of cases have been reported. For hospitals with inadequate caseloads, the National Surgical Quality Improvement Program sampling strategy could be altered to provide enough cases to ensure reliability.

Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies

IMPORTANCE Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes. OBJECTIVE To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being. DESIGN, SETTING, AND PARTICIPANTS Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included. INTERVENTIONS In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver. MAIN OUTCOMES AND MEASURES Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE). RESULTS A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases. CONCLUSIONS AND RELEVANCE To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education. TRIAL REGISTRATION clinicaltrials.org Identifier: NCT02050789.

Improving Safety and Quality of Care With Enhanced Teamwork Through Operating Room Briefings

OBJECTIVES To describe the current state of the science for operating room (OR) briefings and debriefings, including an overview of key definitions, a review of the evidence of effectiveness, and a summary of our experiences as part of a comprehensive unit-based safety program. OVERVIEW Use of preoperative briefings has been shown to improve team communication, decrease disruptions to surgical workflow, improve compliance with antibiotic and deep vein thrombosis prophylaxis, and improve overall perceptions about the safety climate in the OR. Studies have demonstrated that an effective briefing can be performed in less than 2 minutes and reduce delays by more than 80%. Effective implementation involves changing workflows and expectations of interaction among OR team members, including participation from leaders at all levels. Briefings and debriefings are a strategy for revealing defects and facilitating adaptive change in the OR. CONCLUSIONS AND RELEVANCE Briefings and debriefings are a good method for improving teamwork and communication in the OR. Effective implementation may be associated with improved patient outcomes. Commitment by the participating providers is essential for effective briefings, which include discussion of relevant information pertaining to the procedure.

American College of Surgeons NSQIP: quality in-training initiative pilot study.

BACKGROUND Clinical outcomes data are playing an increasingly important role in medical decision-making, reimbursement, and provider evaluation, but there are no documented programs that provide outcomes data to surgical residents as part of a structured curriculum. Our objectives were to develop a national collaborative of training programs to unify the efforts between quality and education personnel and demonstrate the feasibility of generating customized reports of patient outcomes for use in surgical education. STUDY DESIGN The pool of potential hospitals was evaluated by comparing ACS NSQIP participants with the roster of clinical sites for general surgery residency programs maintained by FREIDA Online. A program and user guide was developed to generate custom reports based on institutional data, and a voluntary pilot was conducted, consisting of initial development, implementation, and feedback stages. Programs that successfully completed installation and report generation were queried for feedback on time and resources used. RESULTS Of 245 general surgery residency programs, 47% had a NSQIP-affiliated sponsor institution, and an additional 31% had at least 1 NSQIP-affiliated participant institution. Sixty general surgery residency programs have expressed interest in collaboration. Seventeen pilot sites completed training and installation, and were able to independently generate custom reports. The response rate for the post-report survey was 50%. Participants reported that training and installation typically required one 2-hour phone call, and that total time devoted to the project was less than 8 hours. CONCLUSIONS Collaboration between educators and quality improvement personnel from a diverse group of organizations to integrate outcomes data into surgical education is feasible. Obtaining resident and team reports from ACS NSQIP can be done with minimal effort. Future efforts will be aimed at developing a national data-centered curriculum for general surgery programs.

Effect of post-discharge venous thromboembolism on hospital quality comparisons following hip and knee arthroplasty

BACKGROUND Symptomatic pre-discharge venous thromboembolism (VTE) rates after total or partial hip or knee arthroplasty have been proposed as patient safety indicators. However, assessing only pre-discharge VTE rates may be suboptimal for quality measurement as the duration of stay is relatively short and the VTE risk extends beyond the inpatient setting. METHODS Patients who underwent total or partial hip or knee arthroplasty were identified in the 2008 through 2010 American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database. Outcomes of interest were the deep venous thrombosis (DVT), pulmonary embolism (PE), and overall VTE rates within thirty days after surgery and the rates during the pre-discharge and post-discharge portions of this time period. Risk-adjusted hospital rankings based on only pre-discharge (inpatient) events were compared with those based on both pre-discharge and post-discharge events within thirty days of surgery. RESULTS A total of 23,924 patients underwent total or partial hip arthroplasty (8499) or knee arthroplasty (15,425) at ninety-five hospitals. For hip arthroplasty, the VTE rate was 0.9%, with 57.9% of the events occurring after discharge. For knee arthroplasty, the VTE rate was 1.9%, with 38.3% of the events occurring after discharge. The median time of VTE occurrence was eleven days postoperatively for hip arthroplasty and three days for knee arthroplasty. The median duration of stay was three days for both hip and knee arthroplasty. When hospitals were ranked according to VTE rates, hospital outlier status designations changed when post-discharge events were included (κ = 0.386; 44% false-positive rate for low outliers). The median change in hospital quality ranking was 7 (interquartile range, 2 to 17), with a rank correlation of r = 0.82. CONCLUSIONS Nearly twice as many VTE complications were captured if both pre-discharge and post-discharge events were considered, and inclusion of post-discharge events changed hospital quality rankings. These data suggest that inclusion of post-discharge events should be considered when comparing the quality of hospitals on the basis of postoperative VTE rates. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.