Reporting Quality of Endoscopic Colorectal Cancer Screening Randomized Controlled Trials: Adherence to Recommendations and Interventions.

Background and Aims: In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) steering group published recommendations to standardize reporting quality in randomized controlled trials (RCTs). We aim to assess adherence to SPIRIT reporting guidelines in RCTs on endoscopic colorectal cancer (CRC) screening and participants' adherence to trial protocols. Methods: We searched databases for RCTs evaluating flexible sigmoidoscopy or colonoscopy for CRC screening published in English language through September 2023. Each eligible study was evaluated using the 8 core SPIRIT statement areas, totaling 51 points. Each item received 1 point if it met the criteria and 0 points if it did not. Adherence to SPIRIT items was calculated, and participant adherence to RCT protocols was assessed as the proportion of participants screened compared to those invited. Results: Five RCTs, including 4 on flexible sigmoidoscopy and 1 on colonoscopy, were analyzed. Adherence to SPIRIT guidance ranged from 82.4% to 92.2%. The most missed recommendation was item 2b (trial registrations), scored 0 across all studies. Additionally, item 32 (informed consent materials) scored 20%, and items 17a & b (blinding) scored 40% each. In total, 587,572 participants were randomized across the 5 RCTs. Of these, 37% (200,610) underwent CRC screening, with 69.8% (139,983/200,610) adhering to the protocol. The Nordic-European Initiative on Colorectal Cancer (NordICC) trial, employing a unique invitation method, had a lower adherence rate of 42%. Excluding this trial would raise the adherence rate to 74.3% (128,050/172,390). Conclusion: The published CRC screening trials have acceptable adherence to the SPIRIT reporting guidelines. However, reporting appended consent form materials and disclosing all WHO trial registration data can be improved.

Psychosocial predictors of return to alcohol use after liver transplant: A multicenter cohort study.

BACKGROUND: Alcohol use after liver transplant (LT) is associated with higher rates of graft loss and increased mortality; however, there are limited data evaluating predictors of return to alcohol use using biochemical markers like phosphatidylethanol (PEth). METHODS: This multicenter retrospective cohort study evaluated psychosocial predictors of return to alcohol use using PEth testing in patients transplanted for alcohol-associated liver disease (ALD). The study included 223 patients at three centers who had received a LT for ALD and had at least one PEth measurement post-LT. RESULTS: The rate of return to alcohol use was 6.9 cases per 100 person-years (26 patients total) over a median 555 days of follow-up after transplant. Younger age (HR 0.96; 95% CI 0.92-0.99, p = 0.02), mental health comorbidities (HR 2.83; 95% CI 1.25-6.39, p = 0.01), and non-Hispanic White race (HR 3.79; 95% CI 1.42-10.15, p = 0.01) were associated with return to alcohol use post-LT. There was no difference between post-LT return to alcohol use rates or short-term survival among patients with less than 6 months of sobriety prior to listing compared with those with more than 6 months. Patients with sustained alcohol use post-LT had increased odds of history of illicit substance use (OR 5.20; 95% CI 1.01-26.83, p = 0.04) but no significant difference in time from the last drink to listing (OR 1.03; 95% CI 0.18-5.80, p = 0.97). CONCLUSIONS: These findings emphasize the importance of mental health comorbidities rather than period of sobriety in predicting post-LT return to alcohol use. Furthermore, the higher risk of return to alcohol use in non-Hispanic White patients suggests a potential disparity with referral and selection of higher risk White patients.

Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection (CS-EMR) for Nonampullary Duodenal Polyps: Systematic Review and Meta-Analysis.

INTRODUCTION: There is an increasing interest in cold snare endoscopic mucosal resection (CS-EMR), and studies have shown its safety and efficacy for colonic polyps. This meta-analysis aims to assess the safety and efficacy of CS-EMR for the removal of duodenal adenomas. METHODS: We conducted a comprehensive literature search of several databases, from inception through February 2023, for studies that addressed outcomes of CS-EMR for nonampullary duodenal adenomas. We used the random-effects model for the statistical analysis. The weighted pooled rates were used to summarize the technical success, polyp recurrence, bleeding, and perforation events. Cochran Q test and I2 statistics adjudicated heterogeneity. RESULTS: Six studies were included in the analysis. In all, 178 duodenal polyps were resected using CS-EMR. The pooled rates were 95.8% (95% CI 89.1-98.5%, I2=21.5%) for technical success and 21.2% (95% CI 8.5-43.6%, I2=78%) for polyp recurrence. With regards to CS-EMR safety, the pooled rates were 4.2% (95% CI 1.6-10.5%, I2=12%) for immediate bleeding, 3.4% (95% CI 1.5-7.6%, I2=0%) for delayed bleeding, 2.8% (95% CI 1.1-6.7%, I2=0%) for perforation, and 2% (95% CL 0.5-7.5%, I2=0%) for post-polypectomy syndrome. Rates were not significantly different for large adenomas. Three studies reported data on CS-EMR and conventional EMR. Compared with conventional EMR, CS-EMR had lower odds of delayed bleeding, OR 0.11 (CI 0.02-0.62, P value 0.012, I2=0%). CONCLUSION: Our findings suggest that CS-EMR is a safe and effective strategy for the resection of nonampullary duodenal adenomas, with an acceptable recurrence rate. Data from larger randomized controlled studies are needed to validate our findings.

Epidemiology and genetics of early onset colorectal cancer-African overview with a focus on Ethiopia.

Colorectal cancer (CRC) is a common cause of cancer-related death worldwide, with high rates of late diagnosis and increased mortality in sub-Saharan Africa. Furthermore, there is an alarming uptrend in the incidence of early onset colorectal cancer (EOCRC) across the globe, thus necessitating the need for early screening in general and special populations. There is, however, limited data available on the incidence and genetic characteristics of EOCRC from resource-poor countries, particularly Africa. Moreover, there is lack of clarity if recommendations and mechanisms proposed based on data from resource-rich countries applies to other regions of the world. In this review, we appraise the literature on EOCRC, its overall incidence, and genetic components as it pertains to sub-Saharan Africa. In addition, we highlight epidemiologic and epigenetic findings of our EOCRC cohort in Ethiopia.

Analysis of Reported Adverse Events Associated with Over-the-Scope Endoscopic Suturing System: an FDA MAUDE Database Study.

PURPOSE: The over-the-scope endoscopic suturing system (ESS) (OverStitch™) is one of the most widely utilized endoscopic suturing systems in current clinical practice; however, data on the adverse events associated with this device is scarce. Our study aims to evaluate the adverse events and complications associated with the over-the-scope ESS using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIALS AND METHODS: We analyzed the post-marketing surveillance data from the FDA MAUDE database for the over-the-scope ESS from January 2008 through June 2022. RESULTS: Eighty-three reports were filed from January 2008 to June 2022. Adverse events were classified as device-related complications and patient-related adverse events. Seventy-seven device-related issues and 87 patient adverse events were identified. The most common device-related issue was difficulty to remove after deployment (n=12, 15.58%) followed by mechanical problem (n=10, 12.99%), mechanical jam (n=9, 11.69%), or entrapment of device (n=9, 11.69%). Of the 87 patient-related adverse events, the most common was perforation (n=19; 21.84%), followed by device embedded in tissue or plaque (n=10; 11.49%), and abdominal pain (n=8; 9.20%). Of the 19 patients who experienced perforation, two required open surgical repair and one required laparoscopic surgical repair. CONCLUSION: The overall adverse events from the over-the-scope ESS remain acceptable as evidenced by the number of reported cases since 2008. However, it is important to note that adverse event rates might increase as the use of the device increases; therefore, it is essential for endoscopists to be aware of the potential common and rare adverse events associated with the use of the over-the-scope ESS device.

A study of the interactions between carboplatin and blood plasma proteins using size exclusion chromatography coupled to inductively coupled plasma mass spectrometry.

To study the carboplatin-protein interaction, a sensitive method using size exclusion chromatography coupled to inductively coupled plasma mass spectrometry (SEC-ICP-MS) was developed. The complexes formed between plasma proteins and carboplatin were monitored and identified with this method. Composite blood plasma samples from patients who were undergoing chemotherapy were analyzed, and carboplatin was found to bind plasma proteins. In addition, blank plasma samples were spiked with carboplatin and were analyzed as a time course study, and the results confirmed that carboplatin formed complexes with plasma proteins, primarily albumin and gamma-globulin. To further substantiate the study, these two proteins were incubated with carboplatin. The binding between carboplatin and these proteins was then characterized qualitatively and quantitatively. In addition to a one-to-one binding of Pt to protein, protein aggregation was observed. The kinetics of the binding process of carboplatin to albumin and gamma-globulin was also studied. The initial reaction rate constant of carboplatin binding to albumin was determined to be 0.74 M(-1) min(-1), while that for gamma-globulin was 1.01 M(-1) min(-1), which are both lower than the rate constant of the cisplatin-albumin reaction previously reported.

Arsenic speciation analysis of human urine using ion exchange chromatography coupled to inductively coupled plasma mass spectrometry.

A sensitive and robust method for the determination of seven inorganic and organic arsenic species was developed using ion exchange chromatography combined with inductively coupled plasma mass spectrometry (IC-ICP-MS). Both anion and cation exchange columns were used in a complementary fashion. Arsenite (As(III)), arsenate (As(V)), monomethylarsonic acid (MMA(V)) and dimethylarsinic acid (DMA(V)) were selectively separated by an anion exchange column using sodium hydroxide (NaOH) gradient elution, while monomethylarsonous acid (MMA(III)), dimethylarsinous acid (DMA(III)) and arsenobetaine (AsB) were separated by a cation exchange column using 70 mM nitric acid as the mobile phase. Baseline separation, high repeatability and low detection limits (0.10-0.75 ng mL(-1)) were achieved. The spiked urine samples were analyzed with this method to evaluate the matrix effect on the method. The results suggest 1-10 dilutions should be made to urine samples before sample injection for the anion exchange analysis to minimize the matrix effect. To validate the method, a new standard reference material (NIST SRM-2670a) was also analyzed. The arsenic species in NIST SRM-2670a were determined by this method, and the sum of their concentrations agreed well with the total arsenic content certified for NIST SRM-2670a. Moreover, this method was applied to measure arsenic species in urine samples from one subject living in New Jersey who drank well water contaminated with arsenic. By this method, two key arsenic metabolites, MMA(III) and DMA(III), were found to be present in these urine samples, which has previously been rarely reported.

Characterization of the dust/smoke aerosol that settled east of the World Trade Center (WTC) in lower Manhattan after the collapse of the WTC 11 September 2001.

The explosion and collapse of the World Trade Center (WTC) was a catastrophic event that produced an aerosol plume impacting many workers, residents, and commuters during the first few days after 11 September 2001. Three bulk samples of the total settled dust and smoke were collected at weather-protected locations east of the WTC on 16 and 17 September 2001; these samples are representative of the generated material that settled immediately after the explosion and fire and the concurrent collapse of the two structures. We analyzed each sample, not differentiated by particle size, for inorganic and organic composition. In the inorganic analyses, we identified metals, radionuclides, ionic species, asbestos, and inorganic species. In the organic analyses, we identified polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls, polychlorinated dibenzodioxins, polychlorinated dibenzofurans, pesticides, phthalate esters, brominated diphenyl ethers, and other hydrocarbons. Each sample had a basic pH. Asbestos levels ranged from 0.8% to 3.0% of the mass, the PAHs were > 0.1% of the mass, and lead ranged from 101 to 625 microg/g. The content and distribution of material was indicative of a complex mixture of building debris and combustion products in the resulting plume. These three samples were composed primarily of construction materials, soot, paint (leaded and unleaded), and glass fibers (mineral wool and fiberglass). Levels of hydrocarbons indicated unburned or partially burned jet fuel, plastic, cellulose, and other materials that were ignited by the fire. In morphologic analyses we found that a majority of the mass was fibrous and composed of many types of fibers (e.g., mineral wool, fiberglass, asbestos, wood, paper, and cotton). The particles were separated into size classifications by gravimetric and aerodynamic methods. Material < 2.5 microm in aerodynamic diameter was 0.88-1.98% of the total mass. The largest mass concentrations were > 53 microm in diameter. The results obtained from these samples can be used to understand the contact and types of exposures to this unprecedented complex mixture experienced by the surviving residents, commuters, and rescue workers directly affected by the plume from 11 to 12 September and the evaluations of any acute or long-term health effects from resuspendable dust and smoke to the residents, commuters, and local workers, as well as from the materials released after 11 September until the fires were extinguished. Further, these results support the need to have the interior of residences, buildings, and their respective HVAC systems professionally cleaned to reduce long-term residential risks before rehabitation.