Clinical Utility of a Blood-based Protein Assay on Diagnostic Colonoscopy Referrals for Elevated-risk Colorectal Cancer Patients in Primary Care

Abstract

Background: Colonoscopies are effective in finding early stage colorectal cancer (CRC), which when found in a timely manner, dramatically improve survival rates. A significant number of at-risk patients are still not screened. We investigated the utility of a blood-based protein assay to assess for CRC in patients with elevated risk on the quality of preventive care delivered by board-certified primary care physicians (PCPs) in the United States. Methods: We report on the results of a 3-part, longitudinal, randomized controlled trial. Part 1 assessed physicians’ ability to identify simulated patients at risk for CRC and found PCPs missed colonoscopy referrals for high-risk patients ~40% of the time. Part 2 randomized PCPs into control and intervention arms and demonstrated that a novel blood-based protein assay increased referral rates for a diagnostic colonoscopy when caring for simulated patients. Part 3, reported herein, compares real-world colonoscopy rates of actual patients cared for by control versus intervention physicians. Part 3 was executed to confirm whether the use of the assay demonstrated the same utility in their real world, high-risk patients as found in part 2 using simulated patients. Results: In the simulations, physicians with access to the assay were significantly more likely to order diagnostic colonoscopies. Similarly, in real-world practice, patients were also more likely to be referred for a diagnostic colonoscopy (odds ratio, 4.57; 95% confidence interval, 1.19-17.57). Conclusions: An increase in CRC risk, as indicated by the assay in simulated and real-life patients, was associated with a higher likelihood of appropriate patients being referred to diagnostic colonoscopy.

Clinical Utility of a Biomarker to Detect Contrast-Induced Acute Kidney Injury during Percutaneous Cardiovascular Procedures

“…We conducted a prospective, randomized in silico study using Clinical Performance and Value (CPV®) vignettes to determine if introducing L-FABP as a biomarker increased the identification of patients at risk for CI-AKI and led to greater prevention and better treatment. CPV vignettes are well-known, validated simulated patient cases used to determine if diagnostic tests meet the criteria of clinical utility for payor coverage and reimbursement [18, 19]. The CPVs involve a physician evaluating and providing care for a simulated patient by having the physician respond to open-ended queries divided into 5 domains of care: (1) taking a history, (2) performing a physical examination, (3) ordering diagnostic workup, (4) making a diagnosis, and (5) determining the treatment and follow-up care [20, 21].…”

Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug–Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results

“…The newer approach uses validated patient simulations in randomized clinical trials, which are lower cost and less time-intensive than large, multicenter, patient-based trials. CPVs, which are extensively validated simulated patients, [10,11,17,18] have important advantages over real-world patients: (1) they specify the use case and eliminate patient heterogeneity;…”

“…Payers and regulators, who ultimately decide on coverage and reimbursement, likewise want new diagnostic and therapeutic products to be introduced [ 15 ] but need high quality data showing that the test changes clinical practice and improves patient health without introducing more costs [ 16 ]. To overcome these temporal and financial barriers, a newer, validated approach to large multicenter randomized controlled trials is increasingly being used to secure coverage and reimbursement [ 17 ]. The newer approach uses validated patient simulations in randomized clinical trials, which are lower cost and less time-intensive than large, multicenter, patient-based trials.…”

“…The newer approach uses validated patient simulations in randomized clinical trials, which are lower cost and less time-intensive than large, multicenter, patient-based trials. CPVs, which are extensively validated simulated patients, [ 10 , 11 , 17 , 18 ] have important advantages over real-world patients: (1) they specify the use case and eliminate patient heterogeneity; (2) they focus on whether the test changes physician behavior; and (3) they can generate high-quality data in short periods of time. Despite CPVs’ ability to track actual clinical practice in multiple settings among a legion of clinical conditions, for some, the question remains as to how well these changes in CPVs translate into specific changes in clinical practice and better outcomes.…”

“…There have been other examples of real-world patient studies confirming simulated CPV studies [ 17 ]. Therein, we examined the clinical utility of a blood-based protein assay to quantify the potential for colorectal cancer in patients with elevated risk, and ascertained whether physicians with this information were more likely to screen their patients for cancer.…”