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.

Radiofrequency lesion formation prediction with contact force versus local impedance.

PURPOSE OF REVIEW: Safe and effective radiofrequency (RF) myocardial ablation requires real-time monitoring of lesion formation. Here, we review conventional and novel approaches proposed to guide titration of RF energy application. RECENT FINDINGS: Conventional monitoring modalities, such as ablation electrode temperature, generator impedance, and tissue electrophysiological properties have been of limited value in predicting efficacy and safety of ablation. Therefore, several input-driven indices have been proposed to improve the quality and durability of RF ablation lesion while maintaining safety. These metrics predominantly incorporate RF power output, duration of RF application, and firmness and stability of electrode-tissue contact. More recently, novel catheters have enabled measuring local impedance at the catheter-tissue interface, which has been found valuable for real-time monitoring of RF lesion formation. SUMMARY: It is likely that using the combination of multiple metrics would be required to improve the quality and safety of RF lesions, but further investigation is still required.

Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort.

BACKGROUND AND AIMS: Data are limited regarding colonoscopy risk during long-term, programmatic colorectal cancer screening and follow-up. We aimed to describe adverse events during follow-up in a colonoscopy screening program after the baseline examination and examine factors associated with increased risk. METHODS: Cooperative Studies Program no. 380 includes 3121 asymptomatic veterans aged 50 to 75 years who underwent screening colonoscopy between 1994 and 1997. Periprocedure adverse events requiring significant intervention were defined as major events (other events were minor) and were tracked during follow-up for at least 10 years. Multivariable odds ratios (ORs) were calculated for factors associated with risk of follow-up adverse events. RESULTS: Of 3727 follow-up examinations in 1983 participants, adverse events occurred in 105 examinations (2.8%) in 93 individuals, including 22 major and 87 minor events (examinations may have had >1 event). Incidence of major events (per 1000 examinations) remained relatively stable over time, with 6.1 events at examination 2, 4.8 at examination 3, and 7.2 at examination 4. Examinations with major events included 1 perforation, 3 GI bleeds requiring intervention, and 17 cardiopulmonary events. History of prior colonoscopic adverse events was associated with increased risk of events (major or minor) during follow-up (OR, 2.7; 95% confidence interval, 1.6-4.6). CONCLUSIONS: Long-term programmatic screening and surveillance was safe, as major events were rare during follow-up. However, serious cardiopulmonary events were the most common major events. These results highlight the need for detailed assessments of comorbid conditions during routine clinical practice, which could help inform individual decisions regarding the utility of ongoing colonoscopy follow-up.

Racial and Socioeconomic Disparities in Utilization of Telehealth in Patients with Liver Disease During COVID-19.

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic resulted in a rapid expansion of telehealth services in hepatology. However, known racial and socioeconomic disparities in internet access potentially translate into barriers for the use of telehealth, particularly video technology. The specific aim of this study was to determine if disparities in race or socioeconomic status exist among patients utilizing telehealth visits during COVID-19. METHODS: We performed a retrospective cohort study of all adult patients evaluated in hepatology clinics at Duke University Health System. Visit attempts from a pre-COVID baseline period (January 1, 2020 through February 29, 2020; n = 3328) were compared to COVID period (April 1, 2020 through May 30, 2020; n = 3771). RESULTS: On multinomial regression modeling, increasing age was associated with higher odds of a phone or incomplete visit (canceled, no-show, or rescheduled after May 30,2020), and non-Hispanic Black race was associated with nearly twice the odds of completing a phone visit instead of video visit, compared to non-Hispanic White patients. Compared to private insurance, Medicaid and Medicare were associated with increased odds of completing a telephone visit, and Medicaid was associated with increased odds of incomplete visits. Being single or previously married (separated, divorced, widowed) was associated with increased odds of completing a phone compared to video visit compared to being married. CONCLUSIONS: Though liver telehealth has expanded during the COVID-19 pandemic, disparities in overall use and suboptimal use (phone versus video) remain for vulnerable populations including those that are older, non-Hispanic Black, or have Medicare/Medicaid health insurance.

Ten or More Cumulative Lifetime Adenomas Are Associated with Increased Risk for Advanced Neoplasia and Colorectal Cancer.

BACKGROUND: Colorectal cancer (CRC) screening guidelines recommend frequent colonoscopies and consideration of genetic testing in individuals with ≥10 cumulative adenomas. However, it is unclear how these guidelines apply to routine practice. AIMS: We estimated the proportion of participants found to have ≥10 cumulative adenomas in a screening population and described their outcomes of advanced neoplasia (AN), CRC, and extra-colonic malignancy. METHODS: We performed a secondary analysis of VA CSP#380, which includes 3121 veterans aged 50-75 who were followed up to 10 years after screening colonoscopy. We calculated the cumulative risk of ≥10 cumulative adenomas by Kaplan-Meier method. We compared baseline risk factors in those with and without ≥10 cumulative adenomas as well as the risk for AN (adenoma ≥1 cm, villous adenoma or high-grade dysplasia, or CRC) and extra-colonic malignancy by multivariate logistic regression. RESULTS: The cumulative risk of ≥10 cumulative adenomas over 10.5 years was 6.51% (95% CI 4.38%-9.62%). Age 60-69 or 70-75 at baseline colonoscopy was the only factors associated with the finding of ≥10 cumulative adenomas. Compared to those with 0-9 cumulative adenomas, participants with ≥10 cumulative adenomas were more likely to have had AN (OR 17.03; 95% CI 9.41-30.84), including CRC (OR 7.00; 95% CI 2.84-17.28), but not extra-colonic malignancies. CONCLUSIONS: Approximately 6.5% of participants in this screening population were found to have ≥10 cumulative adenomas over 10.5 years, which was uncommon before age 60. These participants were found to have AN and CRC significantly more often compared to those with lower cumulative adenomas.

Feasibility study of a novel digital health platform for patients undergoing transcatheter aortic valve replacement.

INTRODUCTION: Despite abundant evidence indicating that digital health solutions improve outcomes in chronic medical conditions, there are few validated solutions for acute surgical episodes. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to open surgery that is becoming more prevalent. We assessed the feasibility of ManageMySurgery (MMS), a smartphone application that combines patient education and outcomes tracking for patients undergoing TAVR procedures. METHODS: MMS was offered to patients receiving TAVR at an academic health center. Pre- and postoperatively, patients completed app-based tasks and reported clinical results using validated NYHA and KCCQ-12 surveys. Additionally, users reported levels of satisfaction with the digital platform. RESULTS: Sixty-nine patients were invited to use MMS, of which 43 (62%) downloaded and used the platform. The median age of patients was 77 years and 66.7% were male. The platform was accessed at an average of 2.6 times per user, with 79.1% of patients logging in one to three times. On average, 5.2 frequently asked questions were viewed. Of the 37 patients who completed the feedback survey (86%), 73.0% said it was helpful in preparation for surgery and 86.5% would recommend MMS to others. DISCUSSION: It is possible to utilize a digital health platform to guide patients undergoing TAVR through their interventional journey. Additional research is warranted to assess whether digital patient navigation tools provide an added benefit over traditional perioperative care alone, in terms of long-term patient engagement and outcomes.

Baseline Colonoscopy Findings Associated With 10-Year Outcomes in a Screening Cohort Undergoing Colonoscopy Surveillance.

BACKGROUND & AIMS: Few studies have evaluated long-term outcomes of ongoing colonoscopic screening and surveillance in a screening population. We aimed to determine the 10-year risk for advanced neoplasia (defined as adenomas ≥10mm, adenomas with villous histology or high-grade dysplasia, or colorectal cancer [CRC]) and assessed whether baseline colonoscopy findings were associated with long-term outcomes. METHODS: We collected data from the Department of Veterans Affairs Cooperative Studies Program Study on 3121 asymptomatic veterans (50-75 years old) who underwent a screening colonoscopy from 1994 through 1997 at 13 medical centers and were then followed for 10 years or until death. We included 1915 subjects with at least 1 surveillance colonoscopy and estimated cumulative incidence of advanced neoplasia by Kaplan-Meier curves. We then fit a longitudinal joint model to estimate risk of advanced neoplasia at each subsequent examination after baseline, adjusting for multiple colonoscopies within individuals. RESULTS: Through 10 years of follow-up, there were 146 individuals among all baseline colonoscopy groups found to have at least 1 incident advanced neoplasia. The cumulative 10-year incidence of advanced neoplasia was highest among those with baseline CRC (43.7%; 95% CI 13.0%-74.4%), followed by those with baseline advanced adenoma (AA) (21.9%; 95% CI 15.7-28.1). The cumulative 10-year incidence of advanced neoplasia was 6.3% (95% CI 4.1%-8.5%) and 4.1% (95% CI 2.7%-5.4%) for baseline 1 to 2 small adenomas (<1cm, and without villous histology or high-grade dysplasia) and no neoplasia, respectively (log-rank P = .10). After adjusting for prior surveillance, the risk of advanced neoplasia at each subsequent examination was not significantly increased in veterans with 1 or 2 small adenomas at baseline (odds ratio 0.96; 95% CI 0.67-1.41) compared with veterans with no baseline neoplasia. CONCLUSIONS: Baseline screening colonoscopy findings associate with advanced neoplasia within 10 years. Individuals with only 1 or 2 small adenomas at baseline have a low risk of advanced neoplasia over 10 years. Alternative surveillance strategies, could be considered for these individuals.

Outcome of transvenous lead extraction of leads older than 20 years.

BACKGROUND: In patients undergoing transvenous lead extraction (TLE), lead dwell time has been recognized as a risk factor for extraction failure and procedure-related complications. OBJECTIVES: The aim of this study was to evaluate the safety and effectiveness of TLE in patients with pacemaker or ICD leads with a dwell time of ≥20 years. METHODS: This is a single-center retrospective study of all patients who underwent TLE of at least 1 pacemaker or ICD leads a dwell time of ≥20 years. RESULTS: During the study period, 124 patients were included in this analysis (50.8% female, mean age: 74.6 ± 10.7 years). Device-related infection was the most common (92.7%) indication for TLE. Extraction was attempted for a total 313 leads, of which 182 leads had dwell times ≥20 years (median: 276 months; interquartile range: 255-300 months). Complete procedural success was achieved in 112/124 patients (90.3%), and clinical success in 119/124 patients (96.0%). Complete removal was achieved for 294 leads (93.9%), partial removal in 10 leads, and failure in 9 leads. Clinical success (combined complete and partial success) rates were higher for leads with dwell times <20 years compared to older leads (99.2% vs. 95.6%, p = .017). Major procedural complications (including 1 death) occurred in 7/124 patients (5.6%). Minor complications were observed in 8 patients (6.5%). CONCLUSIONS: TLE of very old (≥20 years) leads can be performed with reasonable success and safety when conducted at centers with expertise in lead management.

Outcome of transvenous lead extraction in patients on minimally interrupted periprocedural direct oral anticoagulation therapy.

BACKGROUND: Direct oral anticoagulants (DOACs) have increasingly been used for several indications for systemic anticoagulation in patients with cardiac implantable electronic devices (CIEDs). The optimal management of anticoagulation therapy in patients undergoing transvenous lead extraction (TLE) procedures remains uncertain. OBJECTIVES: The aim of this study was to evaluate the feasibility and safety of TLE during minimally interrupted DOAC therapy. METHODS: This is a single-center retrospective study of all patients who underwent TLE of a pacemaker or implantable cardioverter-defibrillator lead while on DOAC therapy. In patients deemed to be at high thromboembolic risk, the last DOAC dose was administered the morning of the day before the procedure (regardless of the type of DOAC) and was restarted as soon as possible after the procedure, without bridging with parenteral anticoagulation. RESULTS: During the study period, a total of 84 patients underwent TLE while on minimally interrupted DOAC therapy (54% female, mean age: 74 ± 12 years). TLE was attempted for 161 leads, with a median lead dwell time of 61 months (interquartile range, 38-101). Complete procedural success was achieved for 156 leads (96.9%) and partial success for additional two leads (1.2%). One patient developed RV perforation and required pericardiocentesis and blood transfusion, but no surgical repair. Two patients developed pocket hematomas requiring invasive evacuation. No systemic or venous thromboembolic events were observed. There was no in-hospital mortality. CONCLUSIONS: In selected CIED patients at high risk for thromboembolism, TLE during minimally interrupted DOAC therapy may be considered when performed at experienced centers.

Utility of fluoroscopy alone for monitoring of intrathoracic bleeding complications during transvenous lead extraction.

BACKGROUND: Transvenous lead extraction (TLE) carries a significant risk of major complications, namely bleeding into the pericardial sac or thoracic cavity. While echocardiographic imaging has been recommended for intraprocedural monitoring for those complications, no studies had examined the potential benefits of fluoroscopy alone as an alternative to echocardiography. The aim of this study was to evaluate the utility of fluoroscopy for monitoring intrathoracic bleeding complications during TLE. METHODS: This is a single-center retrospective study of consecutive patients who underwent TLE of a pacemaker or ICD lead with fluoroscopy-only monitoring. At the beginning of each TLE procedure, baseline fluoroscopic images were obtained for both lung fields and the cardiac silhouette. Similar images were acquired again when hypotension develops during the procedure. RESULTS: Fluoroscopy alone (without echocardiographic imaging) was used in 783 consecutive patients (54% women; average age, 71.5 ± 12.9 years) who underwent TLE. There were 93 patients (11.9%) who experienced significant hypotension. Fluoroscopy showed no obvious cause for hypotension in 63 patients. Right ventricular inversion was implied by fluoroscopy in 27 patients. Fluoroscopy detected new pericardial effusion in two patients and new right pleural effusion in one patient, which prompted halting the extraction procedure and therapeutic intervention. Additionally, routine fluoroscopic images revealed the development of an unsuspected new small left pleural effusion in one patient and a pericardial effusion in another. In-hospital mortality rate was 0%. CONCLUSIONS: In selected patients undergoing TLE, fluoroscopy can provide valuable information for identifying or excluding cardiovascular causes during periods of intraprocedural hemodynamic instability.

Balloon Valvuloplasty for Congenital Aortic Stenosis: Experience at a Tertiary Center in a Developing Country.

BACKGROUND: Aortic valve stenosis accounts for 3-6% of congenital heart disease. Balloon aortic valvuloplasty (BAV) is the preferred therapeutic intervention in many centers. However, most of the reported data are from developed countries. MATERIALS AND METHODS: We performed a retrospective single-center study involving consecutive eligible neonates and infants with congenital aortic stenosis admitted for percutaneous BAV between January 2005 and January 2016 to our tertiary center. We evaluated the short- and mid-term outcomes associated with the use of BAV as a treatment for congenital aortic stenosis (CAS) at a tertiary center in a developing country. Similarly, we compared these outcomes to those reported in developed countries. RESULTS: During the study period, a total of thirty patients, newborns (n = 15) and infants/children (n = 15), underwent BAV. Left ventricular systolic dysfunction was present in 56% of the patients. Isolated AS was present in 19 patients (63%). Associated anomalies were present in 11 patients (37%): seven (21%) had coarctation of the aorta, two (6%) had restrictive ventricular septal defects, one had mild Ebstein anomaly, one had Shone's syndrome, and one had cleft mitral valve. BAV was not associated with perioperative or immediate postoperative mortality. Immediately following the valvuloplasty, a more than mild aortic regurgitation was noted only in two patients (7%). A none-to-mild aortic regurgitation was noted in the remaining 93%. One patient died three months after the procedure. At a mean follow-up of 7 years, twenty patients (69%) had more than mild aortic regurgitation, and four patients (13%) required surgical intervention. Kaplan-Meier freedom from aortic valve reintervention was 97% at 1 year and 87% at 10 years of follow-up. CONCLUSION: Based on outcomes encountered at a tertiary center in a developing country, BAV is an effective and safe modality associated with low complication rates comparable to those reported in developed countries.

Patient, Physician, and Procedure Characteristics Are Independently Predictive of Polyp Detection Rates in Clinical Practice.

BACKGROUND: Variability in colon polyp detection impacts patient outcomes. However, the relative influence of physician, patient, and procedure-specific factors on polyp detection is unclear. Therefore, determining how these factors contribute to adenoma and sessile serrated polyp (SSP) detection is important to contextualize measures of colonoscopy quality such as adenoma detection rate and patient outcomes. AIMS: To determine the relative contribution of physician, patient, and procedure-specific factors in total polyp, adenoma, and SSP detection rates. METHODS: We performed a retrospective study of patients undergoing screening colonoscopy and used a two-level generalized linear mixed regression model to identify factors associated with polyp detection. RESULTS: 7799 average risk screening colonoscopies were performed between July 2016 and October 2017. The patient factor most strongly associated with increased risk of adenoma and sessile serrated polyp detection was white race (OR 1.21, 95% CI 1.05-1.39 and OR 3.17, 95% CI 2.34-4.30, respectively). Adenomatous (OR 1.92, 95% CI 1.04-3.57) and sessile serrated polyps (OR 5.56, 95% CI 1.37-20.0) were more likely to be found during procedures performed with anesthesia care as compared to those with moderate sedation. Physician with a luminal gastrointestinal focus had increased odds of adenoma detection (OR 1.61, 95% CI 1.02-2.50). CONCLUSIONS: In a multi-level model accounting for clustering effects, we identified patient, provider and procedural factors independently influence adenoma and sessile serrated polyp detection. Our findings suggest that to compare polyp detection rates between endoscopists, even at the same institution, risk adjustment by characteristics of the patient population and practice is necessary.

High-Risk Adenomas at Screening Colonoscopy Remain Predictive of Future High-Risk Adenomas Despite an Intervening Negative Colonoscopy.

INTRODUCTION: Limited data inform the current postpolypectomy surveillance guidelines, which suggest a shortened interval to third colonoscopy after a negative second examination if high-risk adenomas (HRA) were present on the initial screening colonoscopy. Therefore, we examined the risk of HRA at third colonoscopy stratified by findings on 2 previous examinations in a prospective screening colonoscopy cohort of US veterans. METHODS: We identified participants who had 3 or more colonoscopies from CSP#380. We examined the risk of HRA on the third examination based on findings from the previous 2 examinations. Multivariate logistic regression was used to adjust for multiple covariates. RESULTS: HRA were found at the third examination in 114 (12.8%) of 891 participants. Those with HRA on both previous examinations had the greatest incidence of HRA at third examination (14/56, 25.0%). Compared with those with no adenomas on both previous examinations, participants with HRA on the first examination remained at significantly increased risk for HRA at the third examination at 3 years after a negative second examination (odds ratio [OR] 3.41, 95% confidence interval [CI] 1.28-9.08), 5 years (OR 3.14, 95% CI 1.49-6.61), and 7 years (OR 2.89, 95% CI 1.08-7.74). DISCUSSION: In a screening population, HRA on the first examination identified individuals who remained at increased risk for HRA at the third examination, even after a negative second examination. This finding supports current colorectal cancer surveillance guidelines, which suggest a shortened, 5-year time interval to third colonoscopy after a negative second examination if high-risk findings were present on the baseline examination.

A Roadmap for Value-Based Payment Models Among Patients With Cirrhosis.

Healthcare reimbursement is shifting from fee-for-service to fee-for-value. Cirrhosis, which costs the U.S. healthcare system as much as heart failure, is a prime target for value-based care. This article describes models in which physician groups or health systems are paid for improving quality and lowering costs for a given population of patients with cirrhosis. If done correctly, we believe that such frameworks, once adopted, could help reduce burnout by freeing physicians of the burden of checking boxes in the electronic medical record so that they can devote their energies to managing populations. Conclusion: Value-based payment models for cirrhosis have the potential to benefit patients, physicians, and healthcare insurers.

Terminal ileum intubation is not associated with colonoscopy quality measures.

BACKGROUND AND AIM: Intubation of the terminal ileum (TI) demonstrates a complete colonoscopy, but its clinical value during screening exams is unknown. We aimed to determine whether TI intubation during screening colonoscopy is associated with colonoscopy quality measures or identifies subclinical pathology. METHODS: We performed a retrospective cohort study examining average-risk screening colonoscopies performed at an academic health system between July 2016 and October 2017. Data were extracted from an internal colonoscopy quality registry and the electronic health record. Appropriate statistical tests were used for group comparisons, to correlate TI intubation rate (TIIR) with measures of colonoscopy quality and to examine factors associated with the likelihood of TI intubation. RESULTS: There were 7799 colonoscopies performed with adequate prep quality by 28 gastroenterologists. Most patients were female (56.4%) with a median age of 58. The median TIIR was 37.0%, with significant variability among physicians (2-93%). The detection rates for all polyps, adenomas, and sessile serrated polyps were 62.1%, 45.5%, and 7.2%, respectively, and none correlated with TIIR. Intubation of the TI was associated with significantly longer withdrawal times. In a random 10% sample of cases with TI intubation, no clinically significant pathology was found. CONCLUSIONS: There is wide variability in TIIR among endoscopists. Except to provide photodocumentation of exam extent when other images may be difficult to obtain, the lack of correlation between TI intubation and meaningful clinical outcomes together with the associated time costs suggest routine TI intubation during screening colonoscopy may not be warranted.

Advanced neoplasia in Veterans at screening colonoscopy using the National Cancer Institute Risk Assessment Tool.

BACKGROUND: Adapting screening strategy to colorectal cancer (CRC) risk may improve efficiency for all stakeholders however limited tools for such risk stratification exist. Colorectal cancers usually evolve from advanced neoplasms that are present for years. We applied the National Cancer Institute (NCI) CRC Risk Assessment Tool, which calculates future risk of CRC, to determine whether it could be used to predict current advanced neoplasia (AN) in a veteran cohort undergoing a baseline screening colonoscopy. METHODS: This was a prospective assessment of the relationship between future CRC risk predicted by the NCI tool, and the presence of AN at screening colonoscopy. Family, medical, dietary and physical activity histories were collected at the time of screening colonoscopy and used to calculate absolute CRC risk at 5, 10 and 20 years. Discriminatory accuracy was assessed. RESULTS: Of 3121 veterans undergoing screening colonoscopy, 94% had complete data available to calculate risk (N = 2934, median age 63 years, 100% men, and 15% minorities). Prevalence of AN at baseline screening colonoscopy was 11 % (N = 313). For tertiles of estimated absolute CRC risk at 5 years, AN prevalences were 6.54% (95% CI, 4.99, 8.09), 11.26% (95% CI, 9.28-13.24), and 14.21% (95% CI, 12.02-16.40). For tertiles of estimated risk at 10 years, the prevalences were 6.34% (95% CI, 4.81-7.87), 11.25% (95% CI, 9.27-13.23), and 14.42% (95% CI, 12.22-16.62). For tertiles of estimated absolute CRC risk at 20 years, current AN prevalences were 7.54% (95% CI, 5.75-9.33), 10.53% (95% CI, 8.45-12.61), and 12.44% (95% CI, 10.2-14.68). The area under the curve for predicting current AN was 0.60 (95% CI; 0.57-0.63, p < 0.0001) at 5 years, 0.60 (95% CI, 0.57-0.63, p < 0.0001) at 10 years and 0.58 (95% CI, 0.54-0.61, p < 0.0001) at 20 years. CONCLUSION: The NCI tool had modest discriminatory function for estimating the presence of current advanced neoplasia in veterans undergoing a first screening colonoscopy. These findings are comparable to other clinically utilized cancer risk prediction models and may be used to inform the benefit-risk assessment of screening, particularly for patients with competing comorbidities and lower risk, for whom a non-invasive screening approach is preferred.

Content Validity and Reliability of a Self-Report Measure of Medication Nonadherence in Hepatitis C Treatment.

BACKGROUND: Nonadherence to direct-acting agents (DAAs) for hepatitis C (HCV) decreases viral response. To measure nonadherence to DAAs, a reliable, valid, and easily implemented method is needed. AIMS: The goals of this study were to refine a previously validated (in patients with hypertension) self-report measure of extent of nonadherence and reasons for nonadherence in the context of DAAs and to obtain initial evidence of content validity and reliability. METHODS: Phase I involved two focus groups with patients with HCV (n = 12) and one focus group with prescribers of HCV medications (n = 6) to establish content validity of reasons for nonadherence. Subsequent cognitive interviews with patients (n = 11) were conducted to refine items. Phase II was a prospective cohort study involving weekly administration of the refined measure by telephone to patients (n = 75) who are prescribed DAAs to evaluate reliability and consistency with viral response. RESULTS: In the cohort study, internal consistency ranged from acceptable (α = .69) to very high (α = 1.00) across time points and was quite high on average (α = .91). Across the 75 participants, there were 895 measurement occasions; of those, nonadherence was reported on only 27 occasions (3%), all of which occurred in the first 12 weeks. These 27 occasions represented 19 (26%) different individuals. At 12 weeks, 1 (1%) of patients had a detectable HCV viral load; at 12-24 weeks posttreatment, 4 (5%) had a sustained viral response. Nonadherent patients reported an average of 1.41 reasons for nonadherence. CONCLUSIONS: This multi-method study established content validity of reasons for nonadherence and reliability of extent of nonadherence. High rates of adherence and viral response were consistent with previous studies using other nonadherence measurement methods.

Adoption of direct-acting antiviral medications for hepatitis C: a retrospective observational study.

BACKGROUND: Approximately 3.5 million Americans are infected with the hepatitis C virus (HCV). Although many patients with HCV are asymptomatic, HCV is the leading cause of infection-related death in the U.S. With advances in curative medication therapy for HCV, many of these deaths are preventable. Access to innovative therapies may be unevenly distributed. Our objective was to describe medication prescribers' adoption of innovative HCV pharmacotherapy across prescriber, geographical location, and time. METHODS: This is a retrospective, secondary data analysis among a national cohort of patients prescribed direct-acting antiviral HCV medications with curative intent. We assessed prescriptions by time, geographic location, and provider type. RESULTS: The peak of the adoption rate occurred within 45 days; nearly one-sixth of all prescribers had already prescribed one of the new drugs. Geographical regions (Midwest, South, and West all p ≥ 0.05) nor gender (p = 0.455) of a prescriber impacted adoption. Similarly, patient income did not influence the likelihood of a prescriber to adopt the new drugs earlier (p = 0.175). Gastroenterologists or hepatologists were more likely earlier adopters compared to primary care physicians (p = 0.01). CONCLUSIONS: Because of the relative advantage of newer therapies, we anticipated that there would be an initial surge as early adopters prescribed the new medications and use would dwindle over time as the initial HCV cohort was cured. The data demonstrate that our hypothesis is essentially supported. There is a reduction in prescriptions at approximately 5 months post-approval and treatment is typically required for 3 months. There has been a surge in clinicians' adoption of innovative HCV treatments. As patients are cured of their infection, we anticipate a decreased need for chronic management of HCV. TRIAL REGISTRATION: Not applicable.