Lynch syndrome (LS) is the most common form of hereditary colorectal cancer (CRC). Identification of patients with LS is important due to the high risk of colorectal and endometrial cancer, the increased risk of other types of cancers including a second colorectal cancer, available screening and risk-reduction options, and the potential for prevention of cancer in affected family members. The benefits of LS screening for patients with a new diagnosis of CRC within the Veteran population have not been studied.
The overarching goal of this HSR&D Pilot project is to evaluate the rates of LS screening and the budget impact of the Veterans Integrated Service Network (VISN) 22 Lynch Syndrome Screening Program (LSSP). The specific aims of the project are as follows:
Aim 1 - Assess the frequency of LS screening before and after implementation of the VISN 22 LSSP.
Aim 2 - Identify patient, provider, and facility-level factors associated with LS screening within VISN 22 after implementation of the LSSP.
Aim 3 - Determine the costs of the LSSP and the potential incremental budget impact of implementing the LSSP in VISN 22.
All newly diagnosed cases of CRC within 4 hospitals in VISN 22 (Greater Los Angeles, Loma Linda, Long Beach, and San Diego) were pulled from the Regional Data Warehouse for creation of a LS registry. The eligibility for the LSSP was defined as follows: (1) reflexive screening by the pathologist for patients with a new diagnosis of CRC that are 60 years; (2) patients with a new diagnosis of CRC > 60 years that have a high risk personal or family history of cancer concerning for LS can be screened through a consult to the VISN 22 Clinical Genetics Service. Baseline data was retrospectively collected for 35 months (October 1, 2011-August 31, 2014) prior to implementation of the VISN22 LSSP. Prospective data collection was performed for 18 months after implementation of the LSSP (September 1, 2014 - February 29, 2016). The analysis for Aim 1 compares the frequency of LS screening before and after the implementation of the VISN 22 LSSP. The analysis for Aim 2 utilizes logistic regression to identify characteristics associated with LS screening. The analysis for Aim 3 determines the costs of LS screening using multiple sources (e.g. provider time logs and costs of laboratory tests) to determine the budget impact of the cost of implementing the LSSP in VISN 22.
Aim 1 Results: Implementation of the LSSP resulted in increased rates of LS screening; screening rates were high for the high risk groups of individuals who were age 60 years (96.8%), those with personal history concerning for LS (86%), and those with family history concerning for LS (93.3%). In the 35 months prior to the introduction of the LSSP, there were 570 new diagnoses of CRC; 64 patients (11.2%) were screened on a case-by-case basis for LS according to provider discretion. During the first 18 months under the LSSP, there were 267 new diagnoses of CRC; 115 patients (43.1%) were screened. Prior to implementation of the LSSP the screen positive rate was 38%; after implementation of the LSSP the screen positive rate was 10%. The screen positive rate was lower than expected given the high risk patients that were being screened by the LSSP.
Aim 2 Results: Using multivariate analysis several patient factors were associated with increased odds of screening including young age, female gender, Asian race, and patients referred to clinical genetics for consultation. There was also variation in LS screening rates by hospital.
Aim 3 Results: A budget impact analysis was performed to estimate the cost for 12 months of the LSSP. Preliminary analysis of the cost data shows that the cost for the 74 cases that underwent LS screening (including additional workup if needed) was $113,843.47. The cost for the 127 CRC cases that were not eligible for LS screening (e.g. age > 60 years and no personal/family history concerning for LS) was low (approximately $2,185.67 for the case manager to maintain the registry which identifies all patients within VISN 22 with a new diagnosis of CRC). The non-recurring costs for the development of the LS registry as well as outreach to each of the 4 hospital sites regarding the LSSP are not included in the above calculations.
Based on the above results and lessons learned from the implementation of the LSSP further work is needed to evaluate the lower than expected screen positive rate in the Veteran population and the value of a targeted screening program based on an age threshold (e.g. reflexive screening for 60 years) versus universal screening program. Further work is also needed to better understand the variability by hospitals in VISN 22 before attempting to expand the LSSP to hospitals in other VISNs. Incorporation of LS screening into a broader effort on implementation of precision medicine within CRC may also be warranted.
There is currently no systematic approach to screening for LS within VHA; this work is an important step to understand the implications of such screening in the Veteran population. The cost of the LSSP as well as the lower than expected rate of diagnosis of LS in the Veteran population will contribute to future strategic planning and policy making regarding implementation of LS screening within VHA.
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