October 5, 2018 | Lindsay Morgan
With every procedure, surgeons have to make choices—which medications to prescribe, which surgical techniques to employ—that impact patient outcomes. Every surgeon wants to make the very best choices, but clear best practices do not always exist.
In the world of Inflammatory Bowel Disease (IBD), despite evidence from large, single-institution studies, there remains disagreement about key surgical practices. For example, the use of biologic agents may reduce inflammation and help to control the disease but may impair surgical wound healing. Ileal pouch surgery can be done in one-, two-, and three-stages, and there remains controversy about which is the best technique. Teasing out which of many factors is responsible for a suboptimal outcome can be challenging.
- Includes general and vascular surgery cases as well as subspecialties and targeted procedures
- Program uses clinical data, not administrative data
- Outcomes assessed at 30 days after index surgery (inpatient or outpatient). 30-day follow up is achieved through review of the chart, outside chart, and patient outreach (letters and phone calls).
- Highly standardized and validated clinical data definitions
- Training in data entry and hospital audits ensure data quality
- Advanced data analytics provide risk adjustment and smoothing (reliability adjustment for small sample sizes)
To fill this knowledge gap, a collaborative was formed in 2017 to leverage NSQIP data with the goal of developing and disseminating best practices specific to this disease. NSQIP—the National Surgical Quality Improvement Program of the American College of Surgeons—is the gold standard in surgical quality improvement. A nationally validated, risk-adjusted, outcomes-based program, NSQIP measures—and can help to improve—the quality of surgical care. In the program, participating hospitals collect data related to preoperative risk factors, intraoperative variables, and 30-day postoperative mortality and morbidity outcomes for patients undergoing major surgical procedures. Data is analyzed by NSQIP and reports shared with hospitals that identify problem areas. Hospitals create action plans to address those gaps and monitor their progress. There are currently more than 700 hospitals implementing NSQIP.
In the IBD collaborative, 13 high-volume IBD surgery centers convened to collect five IBD-specific variables in NSQIP, for which there remain disagreement on best practice, specifically:
- biologic usage
- immunomodulator medications usage
- ileostomy utilization
- ileal pouch anastomotic technique
- colonic dysplasia/neoplasia
In the fall of 2018, the group added a sixth indicator to the mix: asking whether an ileal pouch was performed at the time of the procedure.
|Samuel Eisenstein, MD|
Samuel Eisenstein, MD, assistant professor in the Department of Surgery and IBD specialist, leads the IBD Collaborative. He says: “When you look at surgical outcomes for IBD, there are a couple places where the game has really changed. In the early 1980s, we instituted ileal j-pouches for all ulcerative colitis, which was a game-changer. When we started administering biologic therapies for treating ulcerative colitis—that was a game-changer. But there’s been a lot of controversy over best practices. There are a number of different ways to do things and significant disagreement among various groups about what is the best way.”
The group modeled the intervention after the experience of the hepatobiliary collaborative, which initiated a targeted variable set in 2011. Today, this data set includes 92 institutions and 42 variables and has been successful at establishing best practices for hepatobiliary surgery.
IBD data collection began March 1, 2017 and in the first year, the five variables were found to be accurately collected. A forthcoming article describes the process of, and lessons learned from, implementation.
Says Eisenstein: “Implementation is really where we’ve been doing most of our learning right now. One of the great things was that we were actually able to get this group together to do this project in the first place. People often want to keep their data close to themselves and are reluctant to share. The fact that people are willing to come together, share and discuss for the purposes of research is a big achievement.”
NSQIP has been implemented at UC San Diego since 2006, under the leadership of Sonia Ramamoorthy, MD, Chief of the Division of Colon and Rectal Surgery and Vice Chair for Quality. “NSQIP has really helped us improve our practice by providing us with a user-friendly, risk adjusted system for assessing our patient outcomes. NSQIP allows us to compare ourselves to the rest of the national cohort or specifically to similar health systems such as our sister UC health sciences campuses" says Ramamoorthy. “The IBD Collaborative is a great opportunity to work with other high volume IBD centers with a common goal of improving the surgical care of this high-risk population. Dr. Eisenstein is to be congratulated for spear-heading this.”
The IBD Collaborative promises to do even more with the data generated by NSQIP, and, so far, things are off to a promising start.
“To learn lessons you have to know what lessons you want to learn and what questions to ask,” says Eisenstein. “Our goal in the IBD Collaborative is to provide the framework with which surgeons can ask questions and get answers. By getting together large-volume, multi-institutional data, we’re able to look at these things in a more heterogeneous way so that, down the line, we can develop best practices.”