Abstract
Purpose
Colorectal cancer (CRC) screening is effective in finding early stage CRC and dramatically improves survival rates. Despite this, the number of eligible patients who do not obtain CRC screening is unacceptably high.
Methods
We conducted a longitudinal, randomized controlled trial investigating the utility of a blood-based protein assay on the quality of care delivered by practicing PCPs in the United States. We used standardized simulated patients (CPVs), presenting with symptoms suggestive of a higher likelihood of CRC, to measure how frequently these PCPs ordered diagnostic colonoscopy. 190 PCPs cared for three patients at baseline and three patients post-intervention. The PCPs were randomized into one of two study arms: control and intervention. The intervention arm consisted of educational materials about the blood-based protein assay and positive test results. Each simulated patient in the intervention arm had a positive test result that was given to the doctor. The controls were given neither intervention materials nor blood-based protein assay results. Physician responses in both groups were scored against evidence-based criteria. Data were collected at baseline and post-intervention.
Results
At baseline, we found that 71% of physicians ordered diagnostic colonoscopy. In round 2, 23% of physicians in the intervention arm adopted the new blood-based protein assay. Ordering physicians were 3.88 (95% CI 1.67–9.03) times more likely to order a diagnostic colonoscopy. In percentage terms, those who ordered the assay were more likely to order colonoscopy (92%) than either intervention physicians who did not order the assay (77%) or control physicians (66%) (p < 0.001). A marginal effects estimation showed that use of the assay would increase ordering colonoscopy to nearly 95%.
Conclusion
Over one-third of adults in the United States do not follow the recommended screening guidelines for CRC. The introduction of a blood-based protein assay significantly increased the likelihood that physicians would order diagnostic colonoscopies in elevated-risk patients compared to those without access to the assay results. The overall change in clinical utility observed here has the potential to significantly improve clinical care.
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Dr. JP was responsible for planning the study, interpreting data, and drafting the manuscript. Dr. ES was responsible for planning the study, and drafting the manuscript. Dr. SF was responsible for planning the study and drafting the manuscript. Mr. DP was responsible for interpreting data and drafting the manuscript. Ms. MT was responsible for conducting the study, collecting the data, and drafting the manuscript. All authors have approved the final draft submitted. Dr. JP is the author who is accepting full responsibility for the conduct of the study. He has had access to the data and has control of the decision to publish.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Funding
This study was funded by Applied Proteomics, Inc., San Diego, CA.
Conflict of interest
Dr. Peabody is the owner of CPV Technologies, Inc., which owns the intellectual property used in this study.
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Peabody, J., Paculdo, D., Swagel, E. et al. Clinical utility of a blood-based protein assay to increase screening of elevated-risk patients for colorectal cancer in the primary care setting. J Cancer Res Clin Oncol 143, 2301–2307 (2017). https://doi.org/10.1007/s00432-017-2469-4
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DOI: https://doi.org/10.1007/s00432-017-2469-4