UPDATE: In May 2019, the Final Research Plan for Colorectal Cancer: Screening was made available to the public on the USPSTF website. Why is this a big deal? The results could lead to a guideline update, for example, moving the age of screening for average-risk adults to below the age of age 50.
Fight CRC is committed to ensuring the voice of colorectal cancer (CRC) community is heard. We provided comments during the open comment period, and have had extensive discussions with our medical advisory board members and other experts about this effort (see italics below). After reviewing the Research Plan, the following were identified as continued areas of consideration:
- Include FIT and high-sensitivity gFOBT under stool-based tests
- In the decision analysis, consider the use of updated incidence and mortality data to more accurately take into account the rise of colon and rectal cancers in those under age 54.
- Compare the various screening strategies’ impact on CRC incidence as well as on mortality alone. Alternatively, using quality-adjusted life year (QALY) gained rather than life year (LY) gained alone would partially take into account the morbidity associated with the need for treatment for the primarily early detection tests, compared to those tests which are prevention and early detection tests, such as colonoscopy.
- Include adherence of each test in the model rather than assuming 100% adherence.
- Consider adding a follow up to the blood test SEPT9, capsule colonoscopy, and the urine test in addition to the other tests referenced in the following contextual question: “What is the adherence to follow-up diagnostic colonoscopy for abnormal screening test results (i.e., stool-based testing, flexible sigmoidoscopy, or computed tomography colonography)?”
- Review the cost-effectiveness analysis done by Ladabaum et al.(1) in the considerations or whether to recommend a starting age of 45 and consider modeling the most cost-effective strategy from that study (annual FIT from age 45-49 followed by colonoscopy from 50-75) in your new modeling analyses.
We are passionate about sharing this news with the CRC community as consumers and advocates alike benefit from understanding the complicated workings of guideline decision-making. The comment period is over because the plan has been finalized, but as a patient advocacy organization, we continue to urge the USPSTF to update their Research Plan. We look forward to following as the USPSTF moves ahead with this important research.
In early January 2019, the U.S. Preventive Services Task Force (USPSTF) released their Draft Research Plan for Colorectal Cancer: Screening, March 2021. The goal of the proposed research is to help guide the USPSTF’s review of screening research and approaches in preparation to update screening recommendations. The draft was open for public comment period, which expired on January 30, 2019.
Dear USPSTF Review Committee,
Fight Colorectal Cancer (Fight CRC), with key members of our Medical Advisory Board, appreciates the opportunity to submit the following comments to USPSTF regarding the Draft Research Plan for Colorectal Cancer: Screening, March 2021. Fight Colorectal Cancer (Fight CRC) is the leading national colorectal cancer advocacy non-profit organization. We offer support for patients and caregivers, and we serve as a resource for advocates, policymakers, and medical professionals. Additionally, we lead efforts to increase and improve research for colorectal cancer, for all stages, and throughout the cancer continuum.
As advocates in the colorectal cancer community, Fight CRC has seen the increase in early-age onset cases and has been passionate about both building awareness of this trend among the public, while engaging in research efforts to understand more and mitigating the increased incidence in young adults.
Through our work with the American Cancer Society (ACS), Memorial Sloan Kettering in the United States, and Erasmus University in the Netherlands, Fight CRC participated in the development of the manuscript “Colorectal Cancer Screening Initiation before the age of 50 years: A Microsimulation Analysis” which was accepted into Cancer in July 2018. Fight CRC and the task force group recognized the need to develop a modeling study that reassessed the age at which colorectal cancer screening should begin and end for the average-risk population, discovering that a more appropriate age to begin screening is 45 years of age. Fight CRC is working with diligence to further the research in this area.
Fight CRC believes in fully disclosing all potential conflicts of interest. As an organization, we have received sponsorships and/or educational grants from companies who have an interest in novel screening methods for colorectal cancer including Exact Sciences; Quest Diagnostics; Epigenomics; Clinical Genomics; and Medtronics. Neither these companies nor any of our corporate supporters have influenced our comments on this issue.
After review of the recommendations by our Medical Advisory Board and our staff, we would like to highlight the following responses regarding the USPSTF Draft Research Plan:
- Consider the feasibility of adding major known colorectal cancer risk factors (such as BMI and smoking status) as well as age, race, and sex to the commissioned modeling studies.
- Compare the screening strategies by incidence, use incidence endpoints in addition to mortality.
- Use current incidence and mortality data in the modeling studies, and consider real-world data and data from diverse settings.
Include not only compliance with the first step in screening such as FIT or FIT/DNA or mSeptin 9 but also the compliance with the colonoscopy for those that are positive.
- Assess each screening test on its own merits rather than grouping together.
- Consider a broader array of harms for each screening test, including over surveillance and test volume.
- Account for patient screening test preferences and individual barriers to screening methods.
- Consider comparing screening strategies rather than screening tests.
- Include the recent modeling done for the ACS in the literature review.
Thank you for the opportunity to provide comments to this proposed research plan.
Fight CRC reviewed the USPSTF thoroughly with its medical advisory board members, governing board leadership, and senior staff. These comments are based on ongoing input from stakeholders and review amongst diverse perspectives. The comments are reflective of Fight CRC in its entirety, not a single individual.
Reference 1. Cost-effectiveness and National Effects of Initiating Colorectal Cancer Screening for Average-risk Persons at Age 45 Years Instead of 50 Years Uri Ladabaum, M.D., M.S., Ajitha Mannalithara, Ph.D., Reinier G. S. Meester, Ph.D., Samir Gupta, M.D., M.S.C.S., Robert E. Schoen, M.D., M.P.H. PII: S0016-5085(19)33578-4 DOI: https://doi.org/10.1053/j.gastro.2019.03.023 Reference: YGAST 62536 To appear in: Gastroenterology