ABSTRACT
Introduction Underrepresentation of minority groups, particularly Black patients, has been a major issue for most clinical trials. A commonly cited reason is mistrust amongst Black patients due to historical abuse. In a Historically Black College and University (HBCU) at a major metropolitan area with predominant Black patient population, we examined the patient participation rate in a clinical trial compared to other study sites with primarily White patient population. Methods In April 2021, a large prospective, multi-center clinical trial designed to validate a multiomics blood test for early detection of CRC (PREEMPTCRC) was initiated at a HBCU. To optimize study recruitment, culturally-sensitive methods were employed, including racially congruent recruitment staff, and synchronized timing of consent/study procedures with pre-endoscopy COVID testing and clinic visits. Information for all eligible participants screened for the study were recorded and evaluated for a 7- month period (April 1 - October 31, 2021). The enrollment numbers (defined as those consented to the study and had blood samples drawn) for the HBCU and across all other study sites were compared. Demographic and socio-economic data for patients who enrolled and not enrolled at the HBCU were collected to identify potential factors that affect participation. Results During the study period, the number of patients enrolled at the HBCU site (N=229) was significantly higher than the average number enrolled across the other 168 sites (N=90, p<0.0001). In fact, the HBCU site ranked at the top 11th percentile for patient enrollment across all study sites. The main difference between the HBCU site and other study site was race: participants at HBCU were 88.2% Black and 5.2% White, while at the other sites, the participants were 12.0% Black and 71.5% White (p< 0.0001). Comparison of demographic characteristics and socio-demographic data of the enrolled and not-enrolled subjects at the HBCU were similar (Table 1) and did not identify factors that affect participation in clinical trials. Discussion The enrollment of Black patients at a HBCU site was comparable to other study sites in a large prospective, multi-center study of a multiomics blood test for average-risk CRC screening. The findings of our study highlight the importance of providing access to Black patients to clinical trials to ensure adequate representation in research studies. (Table Presented) Table 1. Baseline Patient Demographic and Sociodemographic Information
ABSTRACT
Background and Aims: The COVID-19 pandemic profoundly impacted clinical services globally, including colorectal cancer (CRC) testing such as fecal immunochemical test (FIT) screening and colonoscopy. We investigated the impact of the pandemic on FIT and colonoscopy utilization, and colorectal neoplasia detection in a large community-based population in the United States. Methods: We performed a retrospective cohort study of patients ages 18-89 years undergoing FIT screening or colonoscopy in 2019 and 2020 within Kaiser Permanente Northern California (KPNC), a large integrated healthcare organization. We calculated percentage changes in FIT kits mailed, FITs completed, positive FITs, colonoscopies performed overall and by indication, and colorectal neoplasia detection (advanced adenoma and CRC) in 2020 compared to 2019. Results: FIT kit mailings ceased in mid- March through April 2020 but rebounded thereafter leading to an 8.7% increase in total FIT kits mailed in 2020 compared to 2019. However, with the later mailing of FIT kits, there were 9.0% fewer FITs completed and 10.1% fewer positive tests in 2020 compared to 2019. Colonoscopy volumes nadired in April 2020, with a 79.4% reduction compared with April 2019, but recovered to near pre-pandemic monthly volumes in September through December 2020. However, overall, there was a 26.9% decline in colonoscopies performed in 2020 compared to 2019. Declines of 41.5%, 38,3%, 19.9%, and 20.0% were seen for screening, surveillance, diagnostic, and FIT positive colonoscopies, respectively, in 2020 compared to 2019. With the gradual recovery of colonoscopy volumes after the initial pandemic lockdown, by November and December 2020 the numbers of patients with advanced adenomas or CRC detected by colonoscopy were comparable to those same months in 2019. However, the total number of patients with advanced adenomas or CRC detected by colonoscopy declined by 26.9% and 8.7%, respectively, in 2020 compared to 2019. Conclusions: The COVID-19 pandemic led to fewer FIT screenings and colonoscopies performed in 2020 compared with 2019. However, after the lifting of regional lockdowns, FIT screenings exceeded, and colonoscopy volumes nearly reached numbers from those same months in 2019. Overall, the pandemic led to 27% and 9% reductions in advanced adenoma and CRC detection, respectively, in 2020 compared to 2019, validating concerns about the potential for stage progression for cancers that went undetected due to the pandemic. Strategies to identify high-risk patients for expedited colonoscopy procedure scheduling and resolve remaining colonoscopy procedure backlogs are needed to mitigate this risk.(Figure Presented)Figure 1. Number of FIT kits mailed, completed, and positive in 2019 and 2020(Figure Presented)Figure 2. Number of colonoscopies and advanced adenomas and colorectal cancers detected by colonoscopy in 2019 and 2020
ABSTRACT
Objectives Colorectal cancer (CRC)-related services decreased substantially as a result of the COVID-19 pandemic. Large numbers of procedures were suspended and many have not yet been completed. Resulting delays in cancer screening and diagnosis may negatively impact CRC outcomes. In this study, we predict this impact, and compare different recovery scenarios in the United States. Methods The MISCAN-Colon model was used to simulate the US population in 2020, and evaluate different impact and recovery scenarios. Scenarios were defined in terms of the duration and severity of the disruption (% of eligible adults affected), the length of delays, and the duration of the recovery. In the base-case analysis, we considered a 12-month disruption period, starting in March 2020. During this period, part of preventive and diagnostic procedures were cancelled and delayed. The severity of disruption by month was based on published literature (Embase and Ovid Medline, through December 21, 2020). The assumed delays in services followed a discrete-time distribution, which was a function of the severity of disruption. During recovery, colonoscopy capacity was increased to catch up missed procedures, over a period of 6, 12, or 24 months. In sensitivity analyses, we varied the disruption period (6-18 months) and severity of disruption (lower/higher). Primary outcomes were excess CRC cases and deaths, required excess colonoscopy capacity during recovery, and additional number-needed-to-scope during recovery to prevent one death. Results The COVID-19 pandemic reduced preventive colonoscopies by an estimated 30% in 2020, and overall colonoscopies by 25%. For a 24-month recovery period, the model predicted 8,010 (0.21%) excess CRC cases during 2020-2040, 7,370 (0.69%) excess CRC deaths (Figure 1), and required 103,900 (8.3%) excess colonoscopies per recovery month (Table 1). Shorter recovery periods decreased long-term excess CRC cases to 5,540 and 2,740, for 12 and 6 months, respectively and excess deaths to 5,150 and 4,820. However, this reduction in excess cases came at a cost of 254,600 and 579,600 excess colonoscopies per month. The prevention of the excess CRC deaths through the shorter recovery periods of 6 or 12 months required an additional 1,150 and 840 colonoscopies per excess death prevented compared to the 24-month recovery. In sensitivity analysis, the predicted overall impact varied between 1,930-12,630 deaths, and 83,600-887,700 colonoscopies (Table 1). Conclusions Delayed cancer-related services due the pandemic will likely cause thousands of CRC cases and deaths in the next 20 years. The impact could be limited if the backlog were cleared within 6 or 12 months vs. 24 months. However, additional endoscopy capacity needs should be balanced against competing medical interests. Keywords: COVID-19, Colorectal cancer, screening, diagnosis (Figure Presented) (Table Presented)
ABSTRACT
Background: The USPSTF recently recommended colorectal cancer (CRC) screening for adults aged 45 to 49 years in addition to those aged 50 to 75 years. This guideline update, which increases the number of screen-eligible individuals by∼19 million, is similar to the recommendation in 2018 by the American Cancer Society (ACS) and is based on the modeling studies that reflect rising CRC incidence rates in younger adults. Currently, only 67% of average-risk individuals over the age of 50 years are up-to-date on CRC screening, and adherence to screening is lower in younger individuals (e.g., 50-54 years). Despite the non-invasive nature of existing stool-based CRC tests, barriers remain to adoption, including a dislike for manipulating stool and a requirement for substantial navigational support. Blood tests may overcome these barriers through ease of sample collection and integration into routine blood work. Methods: Here we describe our prospective, multi-center registrational study for validating a blood-based multiomics test for average-risk CRC screening: PREEMPT CRC. Eligible participants include those aged 45-85 with no known history of CRC or colorectal adenomas who are undergoing CRC screening by colonoscopy. The target enrollment is 25,000 participants, and primary outcome measures are sensitivity for CRC and specificity for advanced colorectal neoplasia, which includes CRC and advanced adenomas. Secondary outcome measures include positive predictive value for CRC, negative predictive value for advanced colorectal neoplasia, and sensitivity for advanced adenomas. Novel recruitment methods have been implemented by combining traditional, site-based recruitment and virtual recruitment using an online web portal, coupled with mobile phlebotomy, to make participation broadly accessible, especially during the COVID19 pandemic. Participants have been enrolled from 40 states as of August 2021, and virtual recruitment has enabled widespread participation, potentially from any zip code in the continental US. To ensure adequate representation of the intended use population, community organizations, federally qualified health centers (FQHCs), and universities have been engaged to reach underserved and minority patient populations. The study was initiated in May 2020 and to our knowledge will be the largest prospective, multi-center registrational validation study of an averagerisk CRC screening test to date.
ABSTRACT
BACKGROUND AND AIM: Colorectal cancer (CRC) screening reduces CRC mortality by early detection and CRC incidence by polypectomy. Kaiser Permanente Northern California (KPNC) initiated organized CRC screening in 2006 using annual mailed fecal immunochemi-cal test (FIT) screening and opportunistic colonoscopy, with high screening rates. Public health guidance related to the COVID-19 pandemic led to elective colonoscopies and mailed FIT outreach being paused in March 2020. This study evaluated the impact of the pandemic on CRC screening at KPNC. METHODS: For January-December 2019 and January-October 2020, we evaluated: the KPNC screening-eligible population aged 50-75;those up to date with screening due to colonoscopy;eligible for a FIT;mailed a FIT kit;completed a FIT;completed a follow-up colonoscopy after a positive FIT;completed a colonoscopy unrelated to a positive FIT;and up to date with screening by end of follow-up (i.e., 2019 and end of October 2020, respectively). RESULTS: There were 913,873 and 941,763 eligible members in 2019 and 2020;151,252 (16.6%) and 150,407 (16.0%) were up to date with screening due to prior colonoscopy, leaving 762,621 and 791,356 eligible for FIT, respectively. Compared to 2019, when FIT kits were mailed to 627,260 of 762,621 (82.3%) FIT-eligible members, FIT kits were mailed to 521,239 of 791,356 (65.9%) eligible members by the end of October 2020, with mailings ongoing. Declines in FIT mailings occurred in March-May 2020 but rebounded quickly thereafter (Fig 1a). FIT kits were returned by 504,152 of 762,621 (66.1%) members in 2019, and 365,972 of 791,356 (46.2%) members through October 2020, with lower returns in March-June 2020 (Fig 1b). In 2019, 11,119 of 15,402 (72.2%) FIT-positive patients received a follow-up colonoscopy by year end, and through October 2020, 6,856 of 10,922 (62.8%) received a follow-up colonoscopy after a positive FIT (Fig 1c). Another 14,420 of 762,621 (1.9%) and 9,902 of 791,356 (1.3%) members completed a colonoscopy during 2019 and 2020, respectively (Fig 2). By the end of 2019, 665,541 of 913,873 (72.8%) were up to date with screening, and through October 2020, 522,215 of 941,763 (55.5%) were up to date with screening (Fig 2). CONCLUSION: The COVID-19 pandemic resulted in temporary delays in the mailing and return of FITs;and a reduction in colonoscopies performed, due, in part, to patient reluctance to respond to FIT outreach or complete follow-up colonoscopy during the pandemic. Also, fewer individuals were up to date with screening, although outreach continues through December 2020. The organized mailed FIT program allowed for the rapid resumption of outreach;however, follow-up is needed to assess the impact of screening delays on CRC outcomes and to identify ways to improve adherence with FIT screening, including colonoscopy follow-up after a positive FIT.(Figure presented) (Figure presented) (Figure presented) (Figure presented)