The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial.

BACKGROUND & AIMS: The use of computer-aided detection (CADe) has increased the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance in randomized controlled trials (RCTs) but has not shown benefit in real-world implementation studies. We performed a single-center pragmatic RCT to evaluate the impact of real-time CADe on ADRs in colonoscopy performed by community gastroenterologists. METHODS: We enrolled 1100 patients undergoing colonoscopy for CRC screening, surveillance, positive fecal-immunohistochemical tests, and diagnostic indications at one community-based center from September 2022 to March 2023. Patients were randomly assigned (1:1) to traditional colonoscopy or real-time CADe. Blinded pathologists analyzed histopathologic findings. The primary outcome was ADR (the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy (APC), sessile-serrated lesion detection rate, and non-neoplastic resection rate. RESULTS: The median age was 55.5 years (interquartile range, 50-62 years), 61% were female, 72.7% were of Hispanic ethnicity, and 9.1% had inadequate bowel preparation. The ADR for the CADe group was significantly higher than the traditional colonoscopy group (42.5% vs 34.4%; P = .005). The mean APC was significantly higher in the CADe group compared with the traditional colonoscopy group (0.89 ± 1.46 vs 0.60 ± 1.12; P < .001). The improvement in adenoma detection was driven by increased detection of <5 mm adenomas. CADe had a higher sessile-serrated lesion detection rate than traditional colonoscopy (4.7% vs 2.0%; P = .01). The improvement in ADR with CADe was significantly higher in the first half of the study (47.2% vs 33.7%; P = .002) compared with the second half (38.7% vs 34.9%; P = .33). CONCLUSIONS: In a single-center pragmatic RCT, real-time CADe modestly improved ADR and APC in average-detector community endoscopists. (ClinicalTrials.gov number, NCT05963724).

An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model.

BACKGROUND & AIMS: The use of computer-aided detection (CAD) increases the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance. This study aimed to evaluate the requirements for CAD to be cost-effective and the impact of CAD on adenoma detection by endoscopists with different ADRs. METHODS: We developed a semi-Markov microsimulation model to compare the effectiveness of traditional colonoscopy (mean ADR, 26%) to colonoscopy with CAD (mean ADR, 37%). CAD was modeled as having a $75 per-procedure cost. Extensive 1-way sensitivity and threshold analysis were performed to vary cost and ADR of CAD. Multiple scenarios evaluated the potential effect of CAD on endoscopists' ADRs. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay threshold of $100,000/quality-adjusted life year. RESULTS: When modeling CAD improved ADR for all endoscopists, the CAD cohort had 79 and 34 fewer lifetime CRC cases and deaths, respectively, per 10,000 persons. This scenario was dominant with a cost savings of $143 and incremental effectiveness of 0.01 quality-adjusted life years. Threshold analysis demonstrated that CAD would be cost-effective up to an additional cost of $579 per colonoscopy, or if it increases ADR from 26% to at least 30%. CAD reduced CRC incidence and mortality when limited to improving ADRs for low-ADR endoscopists (ADR <25%), with 67 fewer CRC cases and 28 CRC deaths per 10,000 persons compared with traditional colonoscopy. CONCLUSIONS: As CAD is implemented clinically, it needs to improve mean ADR from 26% to at least 30% or cost less than $579 per colonoscopy to be cost-effective when compared with traditional colonoscopy. Further studies are needed to understand the impact of CAD when used in community practice.

Cost-effectiveness of second-line axicabtagene ciloleucel in relapsed refractory diffuse large B-cell lymphoma.

The ZUMA-7 (Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma) study showed that axicabtagene ciloleucel (axi-cel) improved event-free survival (EFS) compared with standard of care (SOC) salvage chemoimmunotherapy followed by autologous stem cell transplant in primary refractory/early relapsed diffuse large B-cell lymphoma (DLBCL); this led to its recent US Food and Drug Administration approval in this setting. We modeled a hypothetical cohort of US adults (mean age, 65 years) with primary refractory/early relapsed DLBCL by developing a Markov model (lifetime horizon) to model the cost-effectiveness of second-line axi-cel compared with SOC using a range of plausible long-term outcomes. EFS and OS were estimated from ZUMA-7. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $150 000 per quality-adjusted life-year (QALY). Assuming a 5-year EFS of 35% with second-line axi-cel and 10% with SOC, axi-cel was cost-effective at a WTP of $150 000 per QALY ($93 547 per QALY). axi-cel was no longer cost-effective if its 5-year EFS was ≤26.4% or if it cost more than $972 061 at a WTP of $150 000. Second-line axi-cel was the cost-effective strategy in 73% of the 10 000 Monte Carlo iterations at a WTP of $150 000. If the absolute benefit in EFS is maintained over time, second-line axi-cel for aggressive relapsed/refractory DLBCL is cost-effective compared with SOC at a WTP of $150 000 per QALY. However, its cost-effectiveness is highly dependent on long-term outcomes. Routine use of second-line chimeric antigen receptor T-cell therapy would add significantly to health care expenditures in the United States (more than $1 billion each year), even when used in a high-risk subpopulation. Further reductions in the cost of chimeric antigen receptor T-cell therapy are needed to be affordable in many regions of the world.

Safety of endoscopic retrograde cholangiopancreatography (ERCP) in pregnancy: A systematic review and meta-analysis.

BACKGROUND/AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure rarely associated with severe postprocedure complications. Hormonal changes during pregnancy promote cholelithiasis, but there are limited clinical data available on the outcomes of ERCP in pregnant women. ERCP techniques without irradiation were recently introduced as potential alternative. We performed a systematic review and meta-analysis to assess the safety of ERCP in pregnancy and to compare outcomes of radiation versus nonradiation ERCP. MATERIALS AND METHODS: A systematic search of PubMed, Medline/Ovid, Web of Science, and Google Scholar through April 18th, 2018 using PRISMA and MOOSE guidelines identified 27 studies reporting the outcomes of ERCP in pregnancy. Random effects pooled event rate and 95% confidence intervals (CIs) were estimated. Heterogeneity was measured by I2, and meta-regression analysis was conducted. Adverse outcomes were divided into fetal, maternal pregnancy-related, and maternal nonpregnancy-related. RESULTS: In all, 27 studies reporting on 1,307 pregnant patients who underwent ERCP were identified. Median age was 27.1 years. All results were statistically significant (P < 0.01). The pooled event rate for overall adverse outcomes was 15.9% (95% CI = 0.132-0.191) in all studies combined, 17.6% (95% CI = 0.109-0.272) in nonradiation ERCP (NR-ERCP) subgroup and 21.6% (95% CI = 0.154-0.294) in radiation ERCP subgroup. There was no significant difference in the pooled event rate for fetal adverse outcomes in NR-ERCP 6.2% (95% CI = 0.027-0.137) versus 5.2% (95% CI = 0.026-0.101) in radiation ERCP group. There was no significant difference in maternal pregnancy-related adverse outcome event rate between NR-ERCP (8.4%) (95% CI = 0.038-0.173) and radiation ERCP (7.1%) (95% CI = 0.039-0.125). Maternal nonpregnancy-related adverse outcome event rate in NR-ERCP was 7.6% (95% CI = 0.038-0.145), which was half the event rate in radiation ERCP group of 14.9% (95% CI = 0.102-0.211). CONCLUSIONS: ERCP done by experienced endoscopists is a safe procedure during pregnancy. Radiation-free techniques appear to reduce the rates of nonpregnancy-related complications, but not of fetal and pregnancy-related complications.

Antitumor necrosis factor α is more effective than conventional medical therapy for the prevention of postoperative recurrence of Crohn's disease: a meta-analysis.

BACKGROUND: There have seen several studies evaluating the efficacy of anti-tumor necrosis factor α (anti-TNFα) compared with conventional therapy (i.e. immunomodulators, mesalamine, or placebo) at preventing postoperative Crohn's disease (CD) recurrence. The results of these studies have been variable and the magnitude by which anti-TNFα therapy alters the natural history of CD in the postoperative setting has not yet been fully defined. METHODS: A comprehensive search of PubMed/MEDLINE, Scopus, CINAHL, and Cochrane databases was performed (May 2014). All studies on adult patients with CD that compared anti-TNFα therapy versus conventional therapy or placebo to prevent CD recurrence were included. Meta-analysis was performed using the Mantel-Haenszel (fixed effects) model with odds ratio (OR) to assess for clinical remission. RESULTS: In the pooled analysis, there was a higher frequency of achieving clinical remission beyond 1 year from time of surgery among patients receiving anti-TNFα therapy compared with conventional therapy [OR 6.41; 95% confidence interval (CI) 2.88-14.27]. There was also a significantly higher rate of achieving both endoscopic (OR 26.44; 95% CI 10.48-66.68) and histologic remission (OR 9.80; 95% CI 2.54-37.81) in the anti-TNFα therapy group compared with the conventional therapy group. CONCLUSION: Anti-TNFα therapy is more effective at preventing clinical, endoscopic, and histologic recurrence of CD beyond 1 year from time of surgery compared with conventional therapy.