A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening.

BACKGROUND: Colorectal cancer is the third most diagnosed cancer in adults in the United States. Early detection could prevent more than 90% of colorectal cancer-related deaths, yet more than one third of the screening-eligible population is not up to date with screening despite multiple available tests. A blood-based test has the potential to improve screening adherence, detect colorectal cancer earlier, and reduce colorectal cancer-related mortality. METHODS: We assessed the performance characteristics of a cell-free DNA (cfDNA) blood-based test in a population eligible for colorectal cancer screening. The coprimary outcomes were sensitivity for colorectal cancer and specificity for advanced neoplasia (colorectal cancer or advanced precancerous lesions) relative to screening colonoscopy. The secondary outcome was sensitivity to detect advanced precancerous lesions. RESULTS: The clinical validation cohort included 10,258 persons, 7861 of whom met eligibility criteria and were evaluable. A total of 83.1% of the participants with colorectal cancer detected by colonoscopy had a positive cfDNA test and 16.9% had a negative test, which indicates a sensitivity of the cfDNA test for detection of colorectal cancer of 83.1% (95% confidence interval [CI], 72.2 to 90.3). Sensitivity for stage I, II, or III colorectal cancer was 87.5% (95% CI, 75.3 to 94.1), and sensitivity for advanced precancerous lesions was 13.2% (95% CI, 11.3 to 15.3). A total of 89.6% of the participants without any advanced colorectal neoplasia (colorectal cancer or advanced precancerous lesions) identified on colonoscopy had a negative cfDNA blood-based test, whereas 10.4% had a positive cfDNA blood-based test, which indicates a specificity for any advanced neoplasia of 89.6% (95% CI, 88.8 to 90.3). Specificity for negative colonoscopy (no colorectal cancer, advanced precancerous lesions, or nonadvanced precancerous lesions) was 89.9% (95% CI, 89.0 to 90.7). CONCLUSIONS: In an average-risk screening population, this cfDNA blood-based test had 83% sensitivity for colorectal cancer, 90% specificity for advanced neoplasia, and 13% sensitivity for advanced precancerous lesions. (Funded by Guardant Health; ECLIPSE ClinicalTrials.gov number, NCT04136002.).

Mailed fecal immunochemical test outreach for colorectal cancer screening: Summary of a Centers for Disease Control and Prevention-sponsored Summit.

Uptake of colorectal cancer screening remains suboptimal. Mailed fecal immunochemical testing (FIT) offers promise for increasing screening rates, but optimal strategies for implementation have not been well synthesized. In June 2019, the Centers for Disease Control and Prevention convened a meeting of subject matter experts and stakeholders to answer key questions regarding mailed FIT implementation in the United States. Points of agreement included: 1) primers, such as texts, telephone calls, and printed mailings before mailed FIT, appear to contribute to effectiveness; 2) invitation letters should be brief and easy to read, and the signatory should be tailored based on setting; 3) instructions for FIT completion should be simple and address challenges that may lead to failed laboratory processing, such as notation of collection date; 4) reminders delivered to initial noncompleters should be used to increase the FIT return rate; 5) data infrastructure should identify eligible patients and track each step in the outreach process, from primer delivery through abnormal FIT follow-up; 6) protocols and procedures such as navigation should be in place to promote colonoscopy after abnormal FIT; 7) a high-quality, 1-sample FIT should be used; 8) sustainability requires a program champion and organizational support for the work, including sufficient funding and external policies (such as quality reporting requirements) to drive commitment to program investment; and 9) the cost effectiveness of mailed FIT has been established. Participants concluded that mailed FIT is an effective and efficient strategy with great potential for increasing colorectal cancer screening in diverse health care settings if more widely implemented.

Association between racial residential segregation and screening uptake for colorectal and cervical cancer among Black and White patients in five US health care systems.

BACKGROUND: Despite increased recognition that structural racism contributes to poorer health outcomes for racial and ethnic minorities, there are knowledge gaps about how current patterns of racial residential segregation are associated with cancer screening uptake. The authors examined associations between Black residential segregation and screening for colorectal cancer (CRC) and cervical cancer among non-Hispanic Black and non-Hispanic White adults. METHODS: This was a retrospective study of CRC and cervical cancer screening-eligible adults from five health care systems within the Population-Based Research to Optimize the Screening Process (PROSPR II) Consortium (cohort entry, 2010-2012). Residential segregation was measured using site-specific quartiles of the Black local isolation score (LIS). The outcome was receipt of CRC or cervical cancer screening within 3 years of cohort entry (2010-2015). Logistic regression was used to calculate associations between the LIS and screening completion, adjusting for patient-level covariates. RESULTS: Among CRC (n = 642,661) and cervical cancer (n = 163,340) screening-eligible patients, 456,526 (71.0%) and 106,124 (65.0%), respectively, received screening. Across PROSPR sites, living in neighborhoods with higher LIS tended to be associated with lower odds of CRC screening (Kaiser Permanente Northern California: adjusted odds ratio [aOR] LIS trend in Black patients, 0.95 [p < .001]; aOR LIS trend in White patients, 0.98 [p < .001]; Kaiser Permanente Southern California: aOR LIS trend in Black patients, 0.98 [p = .026]; aOR LIS trend in White patients, 1.01 [p = .023]; Kaiser Permanente Washington: aOR LIS trend in White patients, 0.97 [p = .002]. However, for cervical cancer screening, associations with the LIS varied by site and race (Kaiser Permanente Washington: aOR LIS trend in White patients, 0.95 [p < .001]; Mass General Brigham: aOR LIS trend in Black patients, 1.12 [p < .001]; aOR LIS trend in White patients, 1.03 [p < .001]). CONCLUSIONS: Across five diverse health care systems, the direction of the association between Black residential segregation and screening varied by PROSPR site, race, and screening type. Additional research, including studies that examine multiple dimensions of segregation and structural racism using intersectional approaches, are needed to further disentangle these relationships.

AGA Clinical Practice Update on Risk Stratification for Colorectal Cancer Screening and Post-Polypectomy Surveillance: Expert Review.

DESCRIPTION: Since the early 2000s, there has been a rapid decline in colorectal cancer (CRC) mortality, due in large part to screening and removal of precancerous polyps. Despite these improvements, CRC remains the second leading cause of cancer deaths in the United States, with approximately 53,000 deaths projected in 2023. The aim of this American Gastroenterological Association (AGA) Clinical Practice Update Expert Review was to describe how individuals should be risk-stratified for CRC screening and post-polypectomy surveillance and to highlight opportunities for future research to fill gaps in the existing literature. METHODS: This Expert Review was commissioned and approved by the American Gastroenterological Association (AGA) Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. These Best Practice Advice statements were drawn from a review of the published literature and from expert opinion. Because systematic reviews were not performed, these Best Practice Advice statements do not carry formal ratings regarding the quality of evidence or strength of the presented considerations. Best Practice Advice Statements BEST PRACTICE ADVICE 1: All individuals with a first-degree relative (defined as a parent, sibling, or child) who was diagnosed with CRC, particularly before the age of 50 years, should be considered at increased risk for CRC. BEST PRACTICE ADVICE 2: All individuals without a personal history of CRC, inflammatory bowel disease, hereditary CRC syndromes, other CRC predisposing conditions, or a family history of CRC should be considered at average risk for CRC. BEST PRACTICE ADVICE 3: Individuals at average risk for CRC should initiate screening at age 45 years and individuals at increased risk for CRC due to having a first-degree relative with CRC should initiate screening 10 years before the age at diagnosis of the youngest affected relative or age 40 years, whichever is earlier. BEST PRACTICE ADVICE 4: Risk stratification for initiation of CRC screening should be based on an individual's age, a known or suspected predisposing hereditary CRC syndrome, and/or a family history of CRC. BEST PRACTICE ADVICE 5: The decision to continue CRC screening in individuals older than 75 years should be individualized, based on an assessment of risks, benefits, screening history, and comorbidities. BEST PRACTICE ADVICE 6: Screening options for individuals at average risk for CRC should include colonoscopy, fecal immunochemical test, flexible sigmoidoscopy plus fecal immunochemical test, multitarget stool DNA fecal immunochemical test, and computed tomography colonography, based on availability and individual preference. BEST PRACTICE ADVICE 7: Colonoscopy should be the screening strategy used for individuals at increased CRC risk. BEST PRACTICE ADVICE 8: The decision to continue post-polypectomy surveillance for individuals older than 75 years should be individualized, based on an assessment of risks, benefits, and comorbidities. BEST PRACTICE ADVICE 9: Risk-stratification tools for CRC screening and post-polypectomy surveillance that emerge from research should be examined for real-world effectiveness and cost-effectiveness in diverse populations (eg, by race, ethnicity, sex, and other sociodemographic factors associated with disparities in CRC outcomes) before widespread implementation.

Health System-Provided Rideshare Is Safe and Addresses Barriers to Colonoscopy Completion.

In 2019, nearly 14 million colonoscopies were performed in the United States.1 In these settings, the accepted practice is that a responsible person drives and chaperones patients home after receiving procedural sedation, including colonoscopy.2 Lack of access to transportation and/or a chaperone is a persistent barrier to care in safety-net health systems and federally qualified health centers as a result of lower incomes, underinsurance, and higher social needs.3 Given racial, ethnic, and socioeconomic disparities in many digestive diseases that require colonoscopy for diagnosis and management, innovative solutions are needed to overcome logistical barriers to colonoscopy completion, especially in these settings.

Tools to Measure the Impact of Structural Racism and Discrimination on Gastrointestinal and Hepatology Disease Outcomes: A Scoping Review.

BACKGROUND & AIMS: Structural racism and discrimination (SRD) are important upstream determinants of health perpetuated by discriminatory laws and policies. Therefore, measuring SRD and its impact on health is critical to developing interventions that address resultant health disparities. We aimed to identify gastrointestinal (GI) or liver studies that report measures of SRD or interventions to achieve health equity in these domains by addressing upstream determinants of health. METHODS: We conducted a scoping review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses scoping reviews guidelines. Studies that used an SRD measure or examined an upstream intervention in GI or liver disease were included. Studies that described health disparities in GI or liver conditions without mentioning SRD were excluded. Study characteristics, findings, and limitations were extracted. RESULTS: Forty-six articles (19 studies using SRD measures and 27 studies of upstream interventions) were identified. Measures of residential racial segregation were reported most frequently. SRD was associated with poorer health outcomes for racial and ethnic minority populations. Although upstream intervention studies focused primarily on policies related to colon cancer screening and organ graft allocation, racial and ethnic disparities often persisted post-intervention. CONCLUSIONS: To achieve health equity in GI and liver conditions, there is an urgent need for research that goes beyond describing health disparities to incorporating measures of SRD and implementing interventions that address this understudied determinant of health.

Diversity, Equity, and Inclusion in Gastroenterology and Hepatology: A Survey of Where We Stand.

BACKGROUND & AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. METHODS: We developed and administered a 33-item electronic cross-sectional survey to members of 5 national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. RESULTS: Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.

Diversity, equity, and inclusion in gastroenterology and hepatology: A survey of where we stand.

BACKGROUND AND AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. APPROACH AND RESULTS: We developed and administered a 33-item electronic cross-sectional survey to members of five national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.

Performance of OC-Auto Micro 80 Fecal Immunochemical Test in an Integrated Academic-Community Health System.

GOALS: We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system. BACKGROUND: The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration-cleared FIT products have not been evaluated in clinical settings. STUDY: We performed a retrospective cohort study of patients (50 to 75 y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non-safety-net clinical settings. RESULTS: We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women (P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively. CONCLUSIONS: In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.

Primary care provider perspectives on the role of community pharmacy in colorectal cancer screening: a qualitative study.

BACKGROUND: The United States Preventive Services Task Force (USPSTF) lists 32 grade A or B recommended preventive services for non-pregnant United States (US) adults, including colorectal cancer screening (CRC). Little guidance is given on how to implement these services with consistency and fidelity in primary care. Given limited patient visit time and competing demands, primary care providers (PCPs) tend to prioritize a small subset of these recommendations. Completion rates of some of these services, including CRC screening, are suboptimal. Expanding delivery of preventive services to other healthcare providers, where possible, can improve access and uptake, particularly in medically underserved areas or populations. Fecal immunochemical testing (FIT) (at-home, stool-based testing) for CRC screening can be distributed and resulted without PCP involvement. Pharmacists have long delivered preventive services (e.g., influenza vaccination) and may be a good option for expanding CRC screening delivery using FIT, but it is not clear how PCPs would perceive this expansion. METHODS: We used semi-structured interviews with PCPs in North Carolina and Washington state to assess perceptions and recommendations for a potential pharmacy-based FIT distribution program (PharmFIT™). Transcripts were coded and analyzed using a hybrid inductive-deductive content analysis guided by the Consolidated Framework for Implementation Research (CFIR) to elucidate potential multi-level facilitators of and barriers to implementation of PharmFIT™. RESULTS: We completed 30 interviews with PCPs in North Carolina (N = 12) and Washington state (N = 18). PCPs in both states were largely accepting of PharmFIT™, with several important considerations. First, PCPs felt that pharmacists should receive appropriate training for identifying patients eligible and due for FIT screening. Second, a clear understanding of responsibility for tracking tests, communication, and, particularly, follow-up of positive test results should be established and followed. Finally, clear electronic workflows should be established for relay of test result information between the pharmacy and the primary care clinic. CONCLUSION: If the conditions are met regarding pharmacist training, follow-up for positive FITs, and transfer of documentation, PCPs are likely to support PharmFIT™ as a way for their patients to obtain and complete CRC screening using FIT.

Diversity, equity, and inclusion in gastroenterology and hepatology: a survey of where we stand.

BACKGROUND & AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. METHODS: We developed and administered a 33-item electronic cross-sectional survey to members of 5 national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. RESULTS: Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.

Analysis of Speaker Introduction Formality by Gender at the American College of Gastroenterology 2020 Annual Scientific Meeting.

BACKGROUND: Gender-based differences in the use of professional titles during speaker introductions have been described in other medical specialties. AIMS: Our primary aim was to assess gender-based differences in the formality of speaker introductions at the American College of Gastroenterology 2020 Virtual Annual Scientific Meeting. Our secondary aim was to assess gender-based differences in the formality of speaker self-introductions. METHODS: Reviewed presentations from the American College of Gastroenterology Annual Meeting for gender-based differences in professional title use during speaker introductions and self-introductions. RESULTS: Speakers included 29 women (37.2%) and 49 men (62.8%). We found no significant gender differences in the use of professional titles by introducers (t(67) = - 0.775, p = 0.441) or in self-introductions (36.4% of women vs. 41.9% of men, t(63) = 0.422, p = 0.674). CONCLUSION: The lack of gender differences in professional title use may represent a novel advantage of virtual meeting formats or suggest increased attention to gender bias in introductions.

What Multilevel Interventions Do We Need to Increase the Colorectal Cancer Screening Rate to 80%?

Screening reduces colorectal cancer mortality; however, this remains the second leading cause of cancer deaths in the United States and adherence to colorectal cancer screening falls far short of the National Colorectal Cancer Roundtable goal of 80%. Numerous studies have examined the effectiveness of interventions to increase colorectal cancer screening uptake. Outreach is the active dissemination of screening outside of the primary care setting, such as mailing fecal blood tests to individuals' homes. Navigation uses trained personnel to assist individuals through the screening process. Patient education may take the form of brochures, videos, or websites. Provider education can include feedback about screening rates of patient panels. Reminders to healthcare providers can be provided by dashboards of patients due for screening. Financial incentives provide monetary compensation to individuals when they complete screening tests, either as fixed payments or via a lottery. Individual preference for specific screening strategies has also been examined in several trials, with a choice of screening strategies yielding higher adherence than recommendation of a single strategy.

Standardized Workflows Improve Colonoscopy Follow-Up After Abnormal Fecal Immunochemical Tests in a Safety-Net System.

BACKGROUND: How clinical teams function varies across sites and may affect follow-up of abnormal fecal immunochemical test (FIT) results. AIMS: This study aimed to identify the characteristics of clinical practices associated with higher diagnostic colonoscopy completion after an abnormal FIT result in a multi-site integrated safety-net system. METHODS: We distributed survey questionnaires about tracking and follow-up of abnormal FIT results to primary care team members across 11 safety-net clinics from January 2017 to April 2017. Surveys were distributed at all-staff clinic meetings and electronic surveys sent to those not in attendance. Participants received up to three reminders to complete the survey. RESULTS: Of the 501 primary care team members identified, 343 (68.5%) completed the survey. In the four highest-performing clinics, nurse managers identified at least two team members who were responsible for communicating abnormal FIT results to patients. Additionally, team members used a clinic-based registry to track patients with abnormal FIT results until colonoscopy completion. Compared to higher-performing clinics, lower-performing clinics more frequently cited competing health issues (56% vs. 40%, p = 0.03) and lack of patient priority (59% vs. 37%, p < 0.01) as barriers and were also more likely to discuss abnormal results at a clinic visit (83% vs. 61%, p < 0.01). CONCLUSIONS: Our findings suggest organized and dedicated efforts to communicate abnormal FIT results and track patients until colonoscopy completion through registries is associated with improved follow-up. Increased utilization of electronic health record platforms to coordinate communication and navigation may improve diagnostic colonoscopy rates in patients with abnormal FIT results.

Impact of COVID-19 on colorectal cancer disparities and the way forward.

In response to the coronavirus disease 2019 (COVID-19) pandemic, the U.S. Surgeon General advised all hospitals and ambulatory care centers to delay nonurgent medical procedures and surgeries. This recommendation, echoed by a multigastroenterology society guideline, led to the suspension of colonoscopies for colorectal cancer (CRC) screening and surveillance. Although this temporary suspension was necessary to contain COVID-19 infections, we as gastroenterologists, patient advocates, and CRC researchers have witnessed the downstream impact of COVID-19 and this recommendation on CRC screening, research, and advocacy. These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest. COVID-19-related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations. In this perspective, we present the unique challenges COVID-19 poses to health equity in CRC prevention and provide potential solutions as we navigate these uncharted waters.

Disseminated adenovirus infection after autologous stem cell transplant.

Adenovirus is an infrequent but challenging viral complication of transplantation that is rarely reported after autologous stem cell transplant. We present a case of disseminated adenovirus infection in a woman who received an autologous stem cell transplant for treatment of multiple sclerosis. After presenting with post-transplant episodic diarrhea and viremia, endoscopic biopsies and immunohistochemical staining confirmed the diagnosis of disseminated adenovirus infection. Her symptoms and viremia resolved after treatment with cidofovir. This case demonstrates that a high index of suspicion, a systematic clinical approach, and immunohistochemical tissue staining are necessary to diagnose disseminated adenovirus infection in an unexpected host.

Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples.

BACKGROUND & AIMS: The fecal immunochemical test (FIT) is an alternative to colonoscopy and can increase overall screening for colorectal cancer (CRC). However, little is known about the frequency of and reasons for mishandled FIT samples. METHODS: We performed a prospective study, nested within a randomized controlled trial of patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old). The patients were randomly assigned to usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both. We examined frequency of and reasons for mishandled FIT samples, including absence of collection date; time from collection to laboratory receipt of more than 14 days; or mishandling of stool, buffer, or cap. The outcomes were the frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples. RESULTS: FIT samples were returned from 1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call. In total, 19.8% of samples were mishandled; most of these (93.7%) had not labeled the date of stool collection but were still processed. Of the received samples, 1.2% of were not processed because the time from patient collection to laboratory receipt was more than 14 days. Outreach was associated with a lower proportion of mishandled samples (16.5% vs 25.0% for usual care; P < .0001). The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001). There was no significant difference in proportions of positive results between properly processed samples (7.5%) and improperly processed samples (6.2%) (P = .14). CONCLUSION: In a prospective study of patients who were not up to date with colorectal cancer screening, we found that almost 20% of FIT samples were mishandled, with most patients missing the stool collection date. Patient outreach was associated with a lower proportion of mishandled samples, but there was no difference in proportions of positive results between properly and improperly handled samples. Our findings indicate that routine processing of undated FIT samples is associated with similar rates of positive results. There are limited data on test characteristics for FIT samples beyond the 14 days of stool acquisition. The inclusion of low literacy level instructions with reminder calls was associated with improved patient handling of the FIT sample. ClincialTrials.gov no: NCT02613260.

Population health interventions to improve colorectal cancer screening by fecal immunochemical tests: A systematic review.

Despite clear evidence that colorectal cancer (CRC) screening reduces mortality, screening, including fecal immunochemical tests (FIT), is underutilized. We conducted a systematic review to determine the evidence of efficacy of interventions to improve FIT completion that could be scaled and utilized in population health management. We systematically searched publication databases for studies evaluating provider- or system-level interventions to improve CRC screening by FIT between 1 January 1996 and 13 December 2017 without language restrictions. Twenty articles describing 25 studies were included, 23 were randomized controlled trials with 1 quasi-experimental and 1 observational study. Ten studies discussed mailed FIT outreach, 4 pre-FIT patient reminders, 3 tailored patient messages, 2 post-FIT reminders, 2 paired FIT with influenza vaccinations, 2 provider alerts and 1 study each described the use of high-quality small media and patient financial incentives. Mailed FIT outreach was consistently effective with median improvement in CRC screening of 21.5% (interquartile range (IQR) 13.6%-29.0%). FIT paired with vaccinations led to a median 15.9% (IQR 15.6%-16.3%) improvement, while pre-FIT and post-FIT reminders demonstrated modest efficacy with median 4.1% (IQR 3.6%-6.7%) and 3.1% (IQR 2.9%-3.3%) improvement in CRC screening, respectively. More than half the studies were at high or unclear risk of bias; heterogeneous study designs and characteristics precluded meta-analysis. FIT-based CRC screening programs utilizing multilevel interventions (e.g. mailed FIT outreach, FIT paired with other preventative services, and provider alerts) have the potential to significantly increase screening participation. However, such programs must also follow-up patients with abnormal FIT results.