Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer deaths in both men and women. According to estimates, there will be over 100,000 new cases of colon cancer, and over 40,000 cases of rectal cancer diagnosed in the US this year.
One of most common treatments for CRC is a low anterior resection (LAR), a sphincter-sparing surgery in which the tumor and surrounding tissue are removed followed by the creation of a colorectal or coloanal anastomosis. Over 25,000 such procedures were performed in U.S. hospitals in 2014. Unfortunately, LAR surgery has a high risk of complications including anastomotic leaks, surgical site infections and bleeding.
These complications can be devastating to patient health and very costly to the healthcare system. To more accurately quantify the extent of the economic burden of LAR complications from both the hospital and payer perspective, we conducted a population-based retrospective cohort study in patients who underwent LAR for CRC, in collaboration with our colleagues Laura J. Goldstein, Director, Global & U.S. Health Economics & Market Access, Johnson & Johnson, Medical Devices; Deborah Nagle, Chief, Division of Colon and Rectal Surgery, Stony Brook Medicine; and David Wei, Director, Epidemiology and Real World Data Sciences – Medical Devices at Johnson & Johnson.
RWD is critical when conducting a study of this type. Such data provide us with rich insights into the everyday experience of large patient populations in ways that are not possible with traditional clinical trials. We leveraged two de-identified healthcare administrative data sources for our analysis: hospital billing data from the Premier Healthcare Database and health insurance claims data from the Optum Clinformatics Extended Data Mart. The Premier data contains information from over 700 U.S. hospitals and over 80 million visits representing nearly 25 percent of annual U.S. inpatient discharges. The Optum patient-level data includes claims from private insurance and Medicare Advantage beneficiaries from all 50 states and includes 12-14 million annual covered lives.
Our goal for the study was to quantify the LAR complications cost from the hospital side (supplies, supportive care of patients, extended length of stay, readmissions), as well as from the payer (insurance reimbursements) and patient (increased out of pocket expenses and co-pays) side. While one initial thought is that hospitals benefit from the increased billing resulting from the additional services required by the complications, the fact is that there are still additional unreimbursed costs that are borne by the hospital.
Once we selected the two data bases, the next step was conducting the analysis. We looked for a software platform that could offer greater speed and efficiency in our research. We used BHE’s Instant Health Data (IHD) platform for data management and statistical analysis. Many times the heavy lift is the data analysis and it can typically take several months depending upon the study. IHD made it easy to efficiently create the data file and create variables on the fly.
The results of the analysis showed that incidence of infection occurred in 6.6 percent of LARs, anastomotic leak in 10.4 percent, and bleeding in 11.1 percent in the inpatient data base (Premier). In the claims data base (Optum) the results were 5.8 percent infection, 11.2 percent anastomotic leak, and 10.3 percent bleeding. Our findings showed that complications increased average hospital costs by 54 percent for anastomotic leak, 100 percent for infection, and 34 percent for bleeding. From the payer perspective, the cost of anastomotic leak increased costs by 57 percent, for infection by 81 percent, and for bleeding by 24 percent.
*Incidence proportion during surgical admission
We concluded that in-hospital infection, anastomotic leak, and bleeding caused substantial economic burden for both hospitals and payers in patients undergoing LAR for CRC.
We felt it was critical to conduct a study like this since up-to-date information on the incidence and economic burden of complications is necessary to accurately evaluate the ROI of new technologies, applications and practice approaches that will help mitigate them. Research like this is important for demonstrating the potential value for surgical innovations and identifying areas where things can be improved.
By emphasizing the importance of surgical site infection reduction, our study also provides valuable information toward achieving the goals of Triple Aim – improving the patient experience of care - including quality and satisfaction, improving the health of populations, and reducing the per capita cost of health care.
Our study is part of a broader evidence generation strategy where we continually contribute to the body of knowledge in an effort to come up with a dossier of information to help people understand the importance of reducing LAR complications.
Peer-reviewed evidence published in a respected journal like Hospital Practice that is relevant to their profession, is important because hospital and payer stakeholders are much more receptive to accepting and acting on that type of information. We have shown hospitals the evidence and directly collaborated with them to create dashboards that they can use with their own data to track the economic burden of them.
Understanding the cost of LAR complications helps both hospitals and payers focus on reducing their incidence. This kind of reduction saves cost for the healthcare system and hospitals while improving the outcomes for patients and their families.
The final benefit of the study stems back to raising the awareness that LAR complication are still fairly common. Using RWD and advanced analytics to discover insights like these help to make hospitals and payers more aware as they increase their efforts to find ways to minimize their incidence. Obviously the best, most direct benefit to CRC patients is preventing complications from happening in the first place. Hopefully our research will help make that happen. There are ongoing efforts for quality improvement in the surgical community, and we hope our research will lead to even more impactful studies on the topic.
 Estimated number of new cases in 2018, worldwide, both sexes, all ages, World Health Organization web site.
 Colorectal Cancer, Facts & Figures, 2020-2022, American Cancer Society