Implementation strategies in the Exploration and Preparation phases of a colorectal cancer screening intervention in community health centers.

BACKGROUND: Adoption of colorectal cancer (CRC) screening has lagged in community health center (CHC) populations in the USA. To address this implementation gap, we developed a multilevel intervention to improve screening in CHCs in our region. We used the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to guide this effort. Here, we describe the use of implementation strategies outlined in the Expert Recommendations for Implementing Change (ERIC) compilation in both the Exploration and Preparation phases of this project. During these two EPIS phases, we aimed to answer three primary questions: (1) What factors in the inner and outer contexts may support or hinder colorectal cancer screening in North Carolina CHCs?; (2) What evidence-based practices (EBPs) best fit the needs of North Carolina CHCs?; and (3) How can we best integrate the selected EBPs into North Carolina CHC systems? METHODS: During the Exploration phase, we conducted local needs assessments, built a coalition, and conducted local consensus discussions. In the Preparation phase, we formed workgroups corresponding to the intervention's core functional components. Workgroups used cyclical small tests of change and process mapping to identify implementation barriers and facilitators and to adapt intervention components to fit inner and outer contexts. RESULTS: Exploration activities yielded a coalition of stakeholders, including two rural CHCs, who identified barriers and facilitators and reached consensus on two EBPs: mailed FIT and navigation to colonoscopy. Stakeholders further agreed that the delivery of those two EBPs should be centralized to an outreach center. During Preparation, workgroups developed and refined protocols for the following centrally-delivered intervention components: a registry to identify and track eligible patients, a centralized system for mailing at-home stool tests, and a process to navigate patients to colonoscopy after an abnormal stool test. CONCLUSIONS: This description may be useful both to implementation scientists, who can draw lessons from applied implementation studies such as this to refine their implementation strategy typologies and frameworks, as well as to implementation practitioners seeking exemplars for operationalizing strategies in early phases of implementation in healthcare.

Exploring the Acceptability of Text Messages to Inform and Support Shared Decision-making for Colorectal Cancer Screening: Online Panel Survey.

BACKGROUND: While online portals may be helpful to engage patients in shared decision-making at the time of cancer screening, because of known disparities in patient portal use, sole reliance on portals to support cancer screening decision-making could exacerbate well-known disparities in this health care area. Innovative approaches are needed to engage patients in health care decision-making and to support equitable shared decision-making. OBJECTIVE: We assessed the acceptability of text messages to engage sociodemographically diverse individuals in colorectal cancer (CRC) screening decisions and support shared decision-making in practice. METHODS: We developed a brief text message program offering educational information consisting of components of shared decision-making regarding CRC screening (eg, for whom screening is recommended, screening test options, and pros/cons of options). The program and postprogram survey were offered to members of an online panel. The outcome of interest was program acceptability measured by observed program engagement, participant-reported acceptability, and willingness to use similar programs (behavioral intent). We evaluated acceptability among historically marginalized categories of people defined by income, literacy, and race. RESULTS: Of the 289 participants, 115 reported having a low income, 146 were Black/African American, and 102 had less than extreme confidence in their health literacy. With one exception, we found equal or greater acceptability, regardless of measure, within each of the marginalized categories of people compared to their counterparts. The exception was that participants reporting an income below US $50,000 were less likely to engage with sufficient content of the program to learn that there was a choice among different CRC screening tests (difference -10.4%, 95% CI -20.1 to -0.8). Of note, Black/African American participants reported being more likely to sign up to receive text messages from their doctor's office compared to white participants (difference 18.7%, 95% CI 7.0-30.3). CONCLUSIONS: Study findings demonstrate general acceptance of text messages to inform and support CRC screening shared decision-making.

Reach and effectiveness of a centralized navigation program for patients with positive fecal immunochemical tests requiring follow-up colonoscopy.

Completion rates for follow-up colonoscopies after an abnormal fecal immunochemical test (FIT) are suboptimal in federally qualified health center (FQHC) settings. We implemented a screening intervention that included mailed FIT outreach to North Carolina FQHC patients from June 2020 to September 2021 and centralized patient navigation to support patients with abnormal FITs in completing follow-up colonoscopy. We evaluated the reach and effectiveness of navigation using electronic medical record data and navigator call logs detailing interactions with patients. Reach assessments included the proportion of patients successfully contacted by phone and who agreed to participate in navigation, intensity of navigation provided (including types of barriers to colonoscopy identified and total navigation time), and differences in these measures by socio-demographic characteristics. Effectiveness outcomes included colonoscopy completion, timeliness of follow-up colonoscopy (i.e., within 9 months), and bowel prep adequacy. Among 514 patients who completed a mailed FIT, 38 patients had an abnormal result and were eligible for navigation. Of these, 26 (68%) accepted navigation, 7 (18%) declined, and 5 (13%) could not be contacted. Among navigated patients, 81% had informational needs, 38% had emotional barriers, 35% had financial barriers, 12% had transportation barriers, and 42% had multiple barriers to colonoscopy. Median navigation time was 48.5 min (range: 24-277 min). Colonoscopy completion differed across groups - 92% of those accepting navigation completed colonoscopy within 9 months, versus 43% for those declining navigation. We found that centralized navigation was widely accepted in FQHC patients with abnormal FIT, and was an effective strategy, resulting in high colonoscopy completion rates.

AGA Clinical Practice Update on Telemedicine in Gastroenterology: Commentary.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding best practices for use of telemedicine in gastroenterology and hepatology. METHODS: This CPU was commissioned and approved by the 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. This expert commentary incorporates important, as well as recently published, studies in this field, and it reflects the experiences of the authors who are active gastroenterologists and hepatologists with extensive experience using telemedicine in clinical practice.

Clock-Drawing Test as a Screening Tool for Cognitive Impairment Associated With Fecal Immunochemical Test Collection Errors.

PURPOSE: The purposes of this study were to determine if (1) certain demographic characteristics (potential predictors) of participants, and (2) clock-drawing test results (as a screening test for cognitive impairment) were associated with fecal immunochemical test (FIT) sample collection errors. METHODS: Patients scheduled for an upcoming colonoscopy were asked to collect stool samples using 5 different FITs. Patients completed a questionnaire that included the clock-drawing test. Errors included mistakes or omissions in recording the stool collection date and errors in stool collection. Each clock drawing was scored by 2 reviewers using 2 established methods. RESULTS: Of the 1,448 participants with a clock drawing, 63% were female with a mean age of 63 years. In this population there were 83% White, 6% Black, and 24% Hispanic persons. Cognitive impairment was found in 292 patients by the Mendes-Santos method. Kappa coefficient for the 2 clock-drawing scores was 0.79 (P <.001). The multivariable generalized linear mixed model for FIT collection errors indicated being female (adjusted odds ratio [AOR], 1.64; 95% CI, 1.09-2.48), having an 8th grade or less education (AOR, 3.40; 95% CI, 1.87-6.18), and having an abnormal Mendes-Santos method clock score (AOR, 1.65; 95% CI, 1.08-2.54) were associated with significantly more errors. CONCLUSION: Among the participants who do not have dementia, FIT collection errors were made not only by those who had abnormal clock drawing, but also, by those with normal clock drawings. Subjects being female, having 8th grade education or less, and having an abnormal clock drawing scored by Mendes-Santos's method were associated with FIT collection errors.

Predictors of Incident Serrated Polyps: Results from a Large Multicenter Clinical Trial.

BACKGROUND: Serrated polyps (SP) are important colorectal cancer precursors, yet their epidemiology is incompletely understood. We measured risk factors for incident sessile-serrated lesions (SSL) and microvesicular (MVHP) and goblet-cell rich (GCHP) hyperplastic polyp subtypes. METHODS: We conducted a cohort study of patients undergoing colonoscopic surveillance nested within a chemoprevention trial. Outcomes of interest were ≥1 SPs, including SSLs, MVHPs, and GCHPs specifically. Multivariable generalized estimating equation models were used to estimate adjusted risk ratios (RR) and 95% confidence intervals (CI) for different polyp types. RESULTS: Among 2,102 participants, a total of 1,615 SPs (including 212 SSLs) were found among 758 participants during follow-up. Prior history of SPs was strongly associated with subsequent occurrence of SPs. There was no apparent association between age, sex, or education and risk of SPs. Black participants were at lower risk of SSLs and MVHPs, but higher risk of GCHPs compared with white participants [RR, 0.40; 95% CI, 0.16-0.99); RR, 0.63 (95% CI, 0.42-0.96); and RR, 1.83 (95% CI, 1.23-2.72) respectively]. Alcohol and smoking exposure were also associated with SPs, including hyperplastic polyp subtypes in particular. CONCLUSIONS: In this prospective study, the risk of SP subtypes differed by race, alcohol, and smoking status, and prior history of SPs. Risk factor associations for SPs differ from risk factors for conventional adenomas, supporting the concept of etiologic heterogeneity of colorectal cancer. IMPACT: These findings allow for better risk stratification of patients undergoing colorectal cancer screening and could inform screening test selection.

Risk Factors for Colorectal Polyps and Cancer.

Colorectal cancer (CRC) is a common malignancy in the U.S. and worldwide. Most CRC cases arise from precancerous adenomatous and serrated polyps. Established risk factors for conventional adenomas and CRC include age, male sex, family history, obesity and physical inactivity, and red meat intake. White race and tobacco and alcohol use are important risk factors for serrated polyps, which have a distinct risk factor profile compared to conventional adenomas. A history of abdominopelvic radiation, acromegaly, hereditary hemochromatosis, or prior ureterosigmoidostomy also increases CRC risk. Understanding these risk factors allows for targeted screening of high-risk groups to reduce CRC incidence.

Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2021.

BACKGROUND & AIMS: Gastrointestinal diseases account for considerable health care use and expenditures. We estimated the annual burden, costs, and research funding associated with gastrointestinal, liver, and pancreatic diseases in the United States. METHODS: We generated estimates using data from the National Ambulatory Medical Care Survey; National Hospital Ambulatory Medical Care Survey; Nationwide Emergency Department Sample; National Inpatient Sample; Kids' Inpatient Database; Nationwide Readmissions Database; Surveillance, Epidemiology, and End Results program; National Vital Statistics System; Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research; MarketScan Commercial Claims and Encounters data; MarketScan Medicare Supplemental data; United Network for Organ Sharing registry; Medical Expenditure Panel Survey; and National Institutes of Health (NIH). RESULTS: Gastrointestinal health care expenditures totaled $119.6 billion in 2018. Annually, there were more than 36.8 million ambulatory visits for gastrointestinal symptoms and 43.4 million ambulatory visits with a primary gastrointestinal diagnosis. Hospitalizations for a principal gastrointestinal diagnosis accounted for more than 3.8 million admissions, with 403,699 readmissions. A total of 22.2 million gastrointestinal endoscopies were performed, and 284,844 new gastrointestinal cancers were diagnosed. Gastrointestinal diseases and cancers caused 255,407 deaths. The NIH supported $3.1 billion (7.5% of the NIH budget) for gastrointestinal research in 2020. CONCLUSIONS: Gastrointestinal diseases are responsible for millions of health care encounters and hundreds of thousands of deaths that annually costs billions of dollars in the United States. To reduce the high burden of gastrointestinal diseases, focused clinical and public health efforts, supported by additional research funding, are warranted.

Characteristics and Survival of Patients With Inflammatory Bowel Disease and Postcolonoscopy Colorectal Cancers.

BACKGROUND & AIMS: Postcolonoscopy colorectal cancers (PCCRCs) account for up to 50% of colorectal cancers (CRCs) in patients with inflammatory bowel disease (IBD). We investigated characteristics of IBD patients with PCCRC and their survival. METHODS: We identified IBD patients (ulcerative colitis [UC] and Crohn's disease) diagnosed with CRC from 1995 to 2015. We defined PCCRC as diagnosed between 6 and 36 months, and detected CRC (dCRC) as diagnosed within 6 months after colonoscopy. We computed prevalence ratios comparing PCCRC vs dCRC and followed up patients from the diagnosis of PCCRC/dCRC until death, emigration, or study end. Mortality was compared using Cox proportional hazards regression models adjusted for sex, age, year of CRC diagnosis, and stage. The main analyses focused on patients with UC. RESULTS: Among 23,738 UC patients undergoing colonoscopy, we identified 352 patients with CRC, of whom 103 (29%) had PCCRC. Compared with dCRC, PCCRC was associated with a higher prevalence of metastatic cancer (33% vs 20%; prevalence ratio, 1.64; 95% CI, 1.13-2.38), cancers showing mismatch repair deficiency (79% vs 56%; prevalence ratio, 1.40; 95% CI, 1.13-1.72), and proximally located cancers (54% vs 40%; prevalence ratio, 1.34; 95% CI, 1.06-1.69). The 1- and 5-year adjusted hazard ratios of death for PCCRC vs dCRC among UC patients were 1.29 (95% CI, 0.77-2.18) and 1.24 (95% CI, 0.86-1.79), respectively. CONCLUSIONS: The characteristics of UC-related PCCRC suggest tumor biology as an important factor in the progression to cancer. However, the prognosis of PCCRC appears similar to that of dCRC.

Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial.

BACKGROUND & AIMS: Serrated polyps are important colorectal cancer precursors and are most commonly located in the proximal colon, where post-polypectomy bleeding rates are higher. There is limited clinical trial evidence to guide best practices for resection of large serrated polyps (LSPs). METHODS: In a multicenter trial, patients with large (≥20 mm) non-pedunculated polyps undergoing endoscopic mucosal resection (EMR) were randomized to clipping of the resection base or no clipping. This analysis is stratified by histologic subtype of study polyp(s), categorized as serrated [sessile serrated lesions (SSLs) or hyperplastic polyps (HPs)] or adenomatous, comparing clip vs control groups. The primary outcome was severe post-procedure bleeding within 30 days of colonoscopy. RESULTS: A total of 179 participants with 199 LSPs (191 SSLs and 8 HPs) and 730 participants with 771 adenomatous polyps were included in the study. Overall, 5 patients with LSPs (2.8%) experienced post-procedure bleeding compared with 42 (5.8%) of those with adenomas. There was no difference in post-procedure bleeding rates between patients in the clip vs control group among those with LSPs (2.3% vs 3.3%, respectively, difference 1.0%; P = NS). However, among those with adenomatous polyps, clipping was associated with a lower risk of post-procedure bleeding (3.9% vs 7.6%, difference 3.7%; P = .03) and overall serious adverse events (5.5% vs 10.6%, difference 5.1%; P = .01). CONCLUSION: The post-procedure bleeding risk for LSPs removed via EMR is low, and there is no discernable benefit of prophylactic clipping of the resection base in this group. This study indicates that the benefit of endoscopic clipping following EMR may be specific for >2 cm adenomatous polyps located in the proximal colon. CLINICALTRIALS: gov, Number: NCT01936948.

AGA Clinical Practice Update on Strategies to Improve Quality of Screening and Surveillance Colonoscopy: Expert Review.

The purpose of this American Gastroenterological Association Institute Clinical Practice Update was to review the available evidence and provide best practice advice regarding strategies to improve the quality of screening and surveillance colonoscopy. This review is framed around 15 best practice advice statements regarding colonoscopy quality that were agreed upon by the authors, based on a review of the available evidence and published guidelines. This is not a formal systematic review and thus no formal rating of the quality of evidence or strength of recommendation has been carried out.

Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.

BACKGROUND: There are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings. METHODS: A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard. RESULTS: We have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed. CONCLUSIONS: Our focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.

AGA Clinical Practice Update on Chemoprevention for Colorectal Neoplasia: Expert Review.

DESCRIPTION: The purpose of this expert review is to describe the role of medications for the chemoprevention of colorectal neoplasia. Neoplasia is defined as precancerous lesions (e.g., adenoma and sessile serrated lesion) or cancer. The scope of this review excludes dietary factors and high-risk individuals with hereditary syndromes or inflammatory bowel disease. METHODS: The best practice advice statements are based on a review of the literature to provide practical advice. A formal systematic review and rating of the quality of evidence or strength of recommendation were not performed. BEST PRACTICE ADVICE 1: In individuals at average risk for CRC who are (1) younger than 70 years with a life expectancy of at least 10 years, (2) have a 10-year cardiovascular disease risk of at least 10%, and (3) not at high risk for bleeding, clinicians should use low-dose aspirin to reduce CRC incidence and mortality. BEST PRACTICE ADVICE 2: In individuals with a history of CRC, clinicians should consider using aspirin to prevent recurrent colorectal neoplasia. BEST PRACTICE ADVICE 3: In individuals at average risk for CRC, clinicians should not use non-aspirin NSAIDs to prevent colorectal neoplasia because of a substantial risk of cardiovascular and gastrointestinal adverse events. BEST PRACTICE ADVICE 4: In individuals with type 2 diabetes, clinicians may consider using metformin to prevent colorectal neoplasia. BEST PRACTICE ADVICE 5: In individuals with CRC and type 2 diabetes, clinicians may consider using metformin to reduce mortality. BEST PRACTICE ADVICE 6: Clinicians should not use calcium or vitamin D (alone or together) to prevent colorectal neoplasia. BEST PRACTICE ADVICE 7: Clinicians should not use folic acid to prevent colorectal neoplasia. BEST PRACTICE ADVICE 8: In individuals at average risk for CRC, clinicians should not use statins to prevent colorectal neoplasia. BEST PRACTICE ADVICE 9: In individuals with a history of CRC, clinicians should not use statins to reduce mortality.

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps.

BACKGROUND AND STUDY AIM : Delayed bleeding is a common adverse event following endoscopic mucosal resection (EMR) of large colorectal polyps. Prophylactic clip closure of the mucosal defect after EMR of nonpedunculated polyps larger than 20 mm reduces the incidence of severe delayed bleeding, especially in proximal polyps. This study aimed to evaluate factors associated with complete prophylactic clip closure of the mucosal defect after EMR of large polyps. METHODS : This is a post hoc analysis of the CLIP study (NCT01936948). All patients randomized to the clip group were included. Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when no remaining mucosal defect was visible and clips were less than 1 cm apart. Factors associated with complete closure were evaluated in multivariable analysis. RESULTS : In total, 458 patients (age 65, 58 % men) with 494 large polyps were included. Complete clip closure of the resection defect was achieved for 338 polyps (68.4 %); closure was not complete for 156 (31.6 %). Factors associated with complete closure in adjusted analysis were smaller polyp size (odds ratio 1.06 for every millimeter decrease [95 % confidence interval 1.02-1.08]), good access (OR 3.58 [1.94-9.59]), complete submucosal lifting (OR 2.28 [1.36-3.90]), en bloc resection (OR 5.75 [1.48-22.39]), and serrated histology (OR 2.74 [1.35-5.56]). CONCLUSIONS : Complete clip closure was not achieved for almost one in three resected large nonpedunculated polyps. While stable access and en bloc resection facilitate clip closure, most factors associated with clip closure are not modifiable. This highlights the need for alternative closure options and measures to prevent bleeding.

Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial.

BACKGROUND & AIMS: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.

Valuing innovative endoscopic techniques: prophylactic clip closure after endoscopic resection of large colon polyps.

BACKGROUND AND AIMS: Clip closure of the mucosal defect after resecting large (≥20 mm) nonpedunculated colorectal polyps reduces postprocedure bleeding and is cost saving for payers. Clip costs are not reimbursed by payers, posing a major barrier to adoption of this technique in the community. We aimed to determine appropriate clip costs to support broader use of this procedure in practice. METHODS: We performed budget impact analysis using our recent decision analytic model, comparing prophylactic clip closure with no clip closure on national cost and outcomes data, to determine the maximum feasible clip price while maintaining cost savings in practice. Sensitivity analyses were performed on important clinical factors. RESULTS: In the original model, the baseline postprocedure bleeding risk was 6.8%, increasing cost of care by $614.11 averaged among all patients undergoing large polyp resection without clip closure. Prophylactic clip closure of only large right-sided polyps reduced postprocedure bleeding risk by 70.7% but resulted in cost saving only if the price of clips was $100 or less. Comparatively, prophylactic clip closure of large left-sided polyps had no clinical benefit and was not cost saving. Clip closure strategies focused only on extra-large polyps (≥40 mm), or patients taking antithrombotics regardless of polyp characteristics, were only minimally cost saving. Cost savings and maximum tolerated clip prices depended on medical comorbidity, which directly influences the costs of care to manage postprocedure bleeding. CONCLUSIONS: Prophylactic clip closure after endoscopic resection of large colon polyps, particularly those in the right colon segment, is cost saving but requires clip costs less than $100. Translating these findings into practice requires gastroenterology practices to obtain reimbursement from payers for improved clinical outcomes and to align commercial clip prices with this clinical indication.