American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Completed Clinical Trials and Research Projects

Illinois Surgical Quality Improvement Collaboration Conference

Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Project Period: 02/01/11-01/31/12
Total Award: $45,625
P.I.: Mark Eskandari, MD, FACS

This yearlong grant is funded by AHRQ’s small conference grant mechanism. The grant will support a conference for the Illinois Surgical Quality Improvement Collaboration (ISQIC). The conference, scheduled for November 5, 2011, will be a forum for dissemination and implementation of a state-wide quality improvement effort targeting venous thromboembolism (VTE). Throughout this conference emphasis will be placed on sharing evidence-based interventions and best-practices toward VTE prevention through a symposium to include national expertise, educational syllabi, and literature review. We also want to identify realistic QI interventions to be adopted and tracked at hospitals through breakout workshops that address a multidisciplinary team approach. It is hoped that the conference will lead to the measuring and review of risk-adjusted outcomes over time with follow-up of specific variables not captured by ACS NSQIP. Dr. Mark Eskandari of Northwestern Memorial Hospital is the PI for the grant.

Explore Risk Adjustment for Claims Data for Surgical Outcome Measures Developed by the American College of Surgeons (ACS)

Funding Source: Center for Medicare & Medicaid Services (CMS)
Project Period: 09/01/10-08/31/11
Total Award: $95,000
P.I.: Clifford Ko, MD, FACS

To provide the public with a broader spectrum of quality measures, CMS plans to expand the domains of the measures posted on Hospital Compare (HC) to include surgical outcomes, preferably outcomes based on clinical data. The American College of Surgeons (ACS) has developed five risk-adjusted Surgical Outcome Measures using clinical data collected by the ACS’ National Surgical Quality Improvement Program (NSQIP). The five measures are listed below.

  1. Risk Adjusted Lower Extremity Bypass Surgery Outcomes
  2. Risk Adjusted Colorectal Surgery Outcome Measure
  3. Risk Adjusted Case Mix Adjusted Elderly Surgery Outcomes Measure
  4. Risk Adjusted Surgical Site Infection Outcome Measure
  5. Risk Adjusted Urinary Tract Infection Outcome Measure

CMS is considering adopting these measures for public reporting on HC since they met CMS’s program need for outcome measures that are based on clinical data. The ACS will elucidate whether risk adjustment embedded in the ACS measure methodology can be preformed using a hybrid database (i.e., a mix of chart and claims data) or a database with claims data only. The findings will be important to inform CMS decision making on public reporting of the ACS surgical measures in HC.

Understanding and Reducing Variation in the Outcomes of Cancer Surgery

Funding Source: National Cancer Institute (NCI)
Project Period: 09/01/08-08/31/11
Total Award: $68,551
P.I. John Birkmeyer, MD, FACS

Wide variations in mortality rates across both hospitals and surgeons suggest that the safety of cancer surgery could be improved substantially, but quality improvement efforts are currently limited by a lack of understanding about mechanisms underlying variations in hospital performance. In this context, our project has two specific aims: (1) To determine the causes of excess operative deaths at hospitals with high cancer surgery mortality. Using data from the National Cancer Database, we will identify 20 hospitals with among the lowest cancer surgery mortality rates in the United States (approximately 1.5 percent) and 30 hospitals with the highest mortality rates (approximately 10 percent). Based on clinical chart review, we will first compare these two groups of hospitals with regard to cause-specific mortality rates. We will then examine whether differences in cause-specific mortality rates are attributable to differences in the incidence of complications or failure to rescue rates. (2) To identify resources and processes of care that account for differences in complication rates and mortality. With a better understanding of the clinical causes of excess deaths at high mortality hospitals, we will then examine specific structural variables and processes of care that underlie differences in outcomes between the two hospital groups.

We will use an empirically-derived composite quality measure to rank hospitals based on information from the NCDB. Best and Worst hospitals will be selected from the top and bottom of the list, respectively, until sample size requirements are satisfied. We will calculate the composite measure using two inputs: (1) the risk-adjusted mortality with cancer surgery and (2) the overall cancer surgery volume.

Collaboration for Improving and Promoting Standardized Cancer Staging Using the Collaborative Staging System

Funding Source: Centers for Disease Control & Prevention (CDC)
Project Period: 09/30/08-09/29/13
Total Award: $1,710,095
P.I. David P. Winchester, MD, FACS

The American Joint Committee on Cancer (AJCC), headquartered at and staffed by the ACS, provides the program management for the development and maintenance of the Collaborative Staging (CS) System: a Tumor, Node, and Metastasis coding system used by cancer registries to collect information on the extent of disease for cancer patients seen at their facility. The ACS received a five-year CDC cooperative agreement to provide staff and committee support to revise the current CS System and release a Version 2 compatible with the new AJCC 7th edition Cancer Staging Manual. The agreement is currently in its third year of funding. The second year progress report and application for funding request for year three was submitted; for year three we received $422,019, an increase of $100,000 over the previous year. Dr. David P. Winchester is the Principal Investigator for the project.

EMSC Targeted Issue Grants

Funding Source: Health Resources and Services Administration (HRSA)
Project Period: 09/01/10-08/31/13
Total Award: $896,426
P.I. J. Wayne Meredith, MD, FACS

Injury is the leading cause of death and disability in children above the age of one. HRSA’s EMS for Children program, through the performance measures associated with its state partnership grant program, encourages the designation of all emergency departments in each state according to their ability to care for childhood emergencies. This performance measure is also consistent with the recommendations framed in the Institute of Medicine’s work titled EMS for Children – Growing Pains. Several states have achieved some level of compliance with this performance measure. Criteria for emergency department recognition in pediatrics involve both equipment and personnel measures. In a similar process, many states have designated acute care facilities according to their capacities to care for injured patients, including pediatrics, as part of inclusive and integrated trauma systems. The impact of emergency department recognition in pediatric on injury outcomes in pediatric populations has not been measured. Likewise, the degree of overlap and integration between emergency department recognition in pediatrics and trauma center designation has not been confirmed or described. Through this grant we hope to fulfill two objectives. First, determine the impact of statewide emergency department pediatric recognition programs on the care of injured children. And second, determine the degree of integration of systems and resources in a state with both ED pediatric recognition and trauma center designations. The grant is sub-awarded through Wake Forest University, and J. Wayne Meredith, MD, FACS, will serve as PI for the grant.

Evaluate the Safety and Effectiveness of Gastric Banding and Bypass Surgery

Funding Source: Food & Drug Administration (FDA)
Project Period: 09/21/09-02/20/11
Total Award: $70,000
P.I.: Clifford Ko, MD, FACS

The FDA & the ACS believe there is an absolute need for continuing evaluation of safety and effectiveness of gastric banding and other bariatric surgeries in a larger study population for a longer period of time (e.g. 2-5 years post surgery).  With that belief, in September 2009 the ACS was engaged by the FDA to undertake a quality improvement study of laparoscopic adjustable gastric banding (LAGB) medical devices as compared to three other surgeries, LapRYGBP, OpenRYGDP, and SleeveGast. 

In the past the ACS Bariatric Database did not query ACS Bariatric Accredited Centers for the brand of LAGB used per hospital or per patient. Prospectively, centers are required to collect the LAGB device manufacturers through a data point in the ACS Bariatric Database. The data point allows the user to choose between the Ethicon/Realize Band™ and Inamed/Lap Band™. The sole purpose of this is to provide the FDA with the data that will allow them to evaluate possible quality improvement information.

The ACS will identify the types and numbers of bariatric surgeries. After collecting the LAGB data, the ACS will then compare the long term effectiveness of LAGB and other bariatric surgeries.  Following this, the ACS will analyze the patterns of bariatric procedure choice. The last step will be for the ACS to investigate the patterns of procedure choice over time and the identification of patient characteristics, hospital type and size, and geographic regions related to the patterns of procedure choice.

Plan for Extracting Intraoperative Anesthesia Data to the ACS NSQIP Database

Funding Source: National Libraries of Medicine
Project Period: 07/15/08-07/14/10
Total Award: $265,978
PI: Clifford Ko, MD, FACS

In this project, members from the ACS NSQIP and the Anesthesia Patient Safety Foundation (APSF) collaborated to expand the ACS NSQIP data repository to include anesthesia-related intraoperative data. The standardized data and methodologies allowed for the sharing of information among surgery and anesthesiology departments and greatly enhanced collaborative research efforts among multiple institutions and quality improvement efforts. The long-term goal of this project was to facilitate benchmarking among hospitals, reveal best practices, and develop evidence-based practice guidelines.

The incorporation of intraoperative variables from AIMS into the ACS NSQIP system directly supported and promoted the IAIMS Next Generation Agenda: namely creating tools and resources to build national research data repositories to support discovery, innovation and dissemination of research results to improve health outcomes. This objective required a plan to implement the collection of intraoperative variables from hundreds of academic medical centers and community hospitals. This plan addressed both technical and organization issues such as modification of the web platform and the software utilities presently used to collect ACS NSQIP data. However, standardization of the data definitions and the data model for the anesthesia record must precede such changes. This planning project defined, implemented, and tested the prototype model to demonstrate technical feasibility.

Inguinal Hernia Management: Watchful Waiting vs. Operation

Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Project Period: 9/30/99-9/29/06
Total Award: $6,337,476
P.I.: Robert J. Fitzgibbons, MD, FACS

Inguinal hernia is one of the most common worldwide afflictions of men. Because the presence of an inguinal hernia is usually considered an indication for its repair, little is known about the natural history of this abnormality in minimally symptomatic patients. Approximately 700,000 herniorrhaphies are performed in the U.S. each year, with large direct costs of surgical care and indirect costs to the economy resulting from time off from work, school, or usual activities. The indications for surgical repair of a minimally symptomatic hernia are vague, and it is not known whether patients with inguinal hernias can safely delay surgical treatment and if they will accept Watchful Waiting (WW) as the method of management for their hernia. The multi-center collaborative project between the American College of Surgeons, Northwestern University, and the VA Cooperative Studies Program, proposed to enroll 753 men with asymptomatic or minimally symptomatic inguinal hernias, either primary or recurrent. Patients will be recruited at five community and academic sites over a 2.5 year period with follow-up for a minimum of two years and an average of 3.25 years. 

WW was compared with tension-free open repair (TFH). Primary outcome measurements were: (1) Pain or discomfort limiting usual activities; (2) Changes in the Physical Component Summary score of the SF-36. Secondary outcome comparisons included cost, complications (including hernia accident and recurrence), satisfaction, and the incidence of any hernia-related operation. The role of age and comorbidity and their interactions in influencing the patient-centered outcome of hernia management were determined. This trial substantially increased knowledge of the natural history of inguinal hernia in men, provided useful information on medical, patient-centered, and cost outcomes of the various treatment options, and guided selection of the appropriate treatment of this common surgical disease.

National Surgical Quality Improvement Program

Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Project Period: 9/30/01-8/31/2006
Total Award: $5,245,741
P.I.: Shukri Khuri, MD, FACS

Safety-related adverse events after major surgical operations are a major contributor to the incidence of morbidity and mortality for patients. In the National Surgical Quality Improvement Program (NSQIP), a risk-adjusted adverse event reporting system for major surgical operations in the Department of Veterans Affairs, the rates of adverse events (30-day postoperative morbidity and mortality) have been compared annually since 1994. All the surgical programs have been ranked anonymously by the ratio of observed to expected (O/E) adverse events. The information derived is provided to each hospital annually, and each year's performance is compared to the last. Postoperative surgical morbidity and mortality have declined 43 percent and 28 percent, respectively, since the initiation of the program. 

The aim of this demonstration project was to achieve similar improvements in adverse event rates after major operations in a sample of nonfederal hospitals by applying the methodology of NSQIP. The hypothesis, that NSQIP methods can be successfully integrated into nonfederal hospitals and that feedback of comparative risk-adjusted adverse event data will produce improvement in the rates of postoperative adverse events in these hospitals, were tested in 10 selected institutions. The interventions that were tested were: (1) ongoing feedback of performance data in the form of comparative rates of adverse events (O/E ratios); (2) structured site visits to low and high outlier institutions focusing on the systems issues, latent process failures, and processes and structures that promote patient safety and reduce preventable adverse events; (3) identification of safe systems and human factors issues that contribute to the reduction of preventable adverse events found in institutions with consistently low adverse event rates and dissemination of this information to institutions that have consistently high rates of adverse events; and (4) analysis of cases of low-risk patients who experience an unexpected adverse event to detect latent errors in patient safety systems in surgery.

Educating Surgeons in Patient Safety

Funding Source: Agency for Healthcare Research and Quality (AHRQ)
Project Period: 9/30/01-5/31/06
Total Award: $677,550
P.I.: Ajit K. Sachdeva, MD, FACS, FRCS 

The office provides grant administration support and technical assistance to the Division of Education for this project. The American College of Surgeons (ACS) will demonstrate innovative approaches to educate surgeons in advances in patient safety, including those found in ongoing and new research studies originating from ACS. Strategies to avoid errors and improve quality of surgical care, including dissemination of best practices identified through studies conducted by the ACS, are essential educational components of the programs described in this proposal. In this project, the ACS has two specific aims:

  1. To modify existing educational programs to emphasize patient safety and quality of care, and
  2. To develop new programs that are innovative and consistent with proven methods of adult education.

Committee on Trauma ASBI

Funding Source: National Highway Traffic Safety Administration (NHTSA)
Project Period: 07/25/05-01/24/07
Total Award: $25,000
P.I.: Mary Margaret Knudson, MD, FACS

In 2003, alcohol-related fatalities accounted for 40 percent of all motor vehicle fatalities in the United States. NTHSA set three priorities for addressing impaired driving: 1) high visibility enforcement; 2) supporting prosecution, adjudication, and sentencing; and 3) promoting screening and brief intervention. The purpose of this cooperative agreement award between the ACS and NHTSA is to develop and adapt screening and brief intervention materials for use by trauma center personnel to identify and address alcohol use problems in trauma patients.

National Sample Project Phase, II

Funding Source: Centers for Disease Control and Prevention
Project Period: 9/30/05-9/29/06
Total Award: $75,000
P.I.: John Fildes, MD, FACS

The ACS National Trauma Data Bank (NTDB) is the largest compilation of trauma injury data ever assembled. It currently contains over 1.4 million records voluntarily provided by over 500 U.S. trauma centers. Because the NTDB does not capture data about every trauma patient at every trauma center, the data cannot be used to determine national estimates of rates for clinical measures of trauma care. The National Sample Project (NSP) addressed this through the development of a nationally representative sample of U.S. trauma patients at Level I and II facilities. The NSP provided detailed clinical indicators and other trauma care information that are not available in other data systems. 

The project included a survey of all NSP hospitals that helped to assess differences in case definitions and helped determine a standard case definition for reporting national estimates of trauma care. The internal database management system was developed to maintain the de-identified NTDB-NSP data files, and provide user-friendly methods for timely access to NSP data by interested clinical and injury researchers. 

National Trauma Registry Standardization Project

Funding Source: Health Resources and Services Administration
Project Period: 09/30/04-09/28/06
Total Award: $99,100
P.I.: John Fildes, MD, FACS 

Data collection is the foundation for building effective statewide trauma programs. Data is a principal driver in trauma systems strategic planning and in trauma care improvement. Trauma data quantifies the magnitude of the injury problem. Unfortunately, most states do not have a comprehensive trauma registry from which to measure the severity of the problem, costs, personnel needs, and the like. Additionally, it is essential to determine the quality of health care delivered and to evaluate patient outcomes. In FY2005, the HRSA Trauma-EMS Systems Program Grant Guidance placed special emphasis on the importance of data collection and effective statewide trauma registries. 

The ACS NTDB, under HRSA contract 03-0234P, convened a group of national experts and stakeholders to research and refine the elements and definitions of trauma care data fields. The result of their work was the creation of a minimum standard trauma care dataset for use on the national level, data definitions, and inclusion/exclusion criteria for trauma care. These results were presented to a larger, national group for consensus and ultimate adoption into trauma registries. 

Trauma Systems Consultation Planning and Evaluation Projects

Funding Source: Health Resources and Services Administration
Project Period: 09/29/05-03/28/07
Total Award: $90,225
P.I.: Robert C. Mackersie, MD, FACS 

Title XII of the Public Health Services Act requires the Federal program to assist the States with enhancing the quality of trauma care as well as promoting the number of States with statewide, effective trauma systems. HRSA partnered with the ACS Committee on Trauma in an effort to improve the quality of trauma care and to promote trauma system improvements through 1) provision of specialized expert technical assistance consultation and recommendations through a multidisciplinary process as established by the ACS; 2) orientation of additional experts by becoming trainees for the program to be able to offer consulting services to the States; 3) convening, attending, and participating in various national trauma centered meetings and events; and 4) provision of detailed data analysis of the extracted existing databases within the ACS Committee on Trauma.