bluuebunny/crossref_metadata_2025_split huggingface dataset:
2822 Twelve-Month Durability of Microbiota-Based Drug RBX2660 for Preventing Clostridioides difficile Infection (CDI) Is Not Associated With Patient Demographics: Sub-Population Analysis of a Phase 2 Open-Label Study
Authors: Ray Arnab , Mische Sarah , Blount Ken , Bancke Lindy , Su Xin , Harvey Adam , Gerding Dale 
Published: October 2019

INTRODUCTION:
Recurrent Clostridioides difficile infection (rCDI) is an urgent public health threat that is associated with significant mortality and substantial medical cost. Microbiota therapy is gaining acceptance to prevent rCDI in multi-recurrent individuals. Two Phase 2 clinical studies have reported the efficacy of RBX2660, a standardized, stabilized microbiota-based drug, in preventing rCDI. To address the suggestion of demographic differences on treatment outcome, we investigated two key demographic stratifications (age and gender) of rCDI subjects enrolled in the Phase 2 open-label study and their associations with outcomes through 12 months post-RBX2660 treatment.

METHODS:
Data were drawn from a multi-center, open-label Phase 2 study (NCT02589847) in which subjects with multi-recurrent CDI received <2 doses of RBX2660 delivered via enema 7 days apart; this analysis includes data to 12 months after completion of dosing, with ongoing follow-up through 24 months. Efficacy was defined as absence of CDI recurrence through 56 days after the last dose; and durability is defined as a continued lack of reported CDI occurrence. Subjects were censored from subsequent time intervals if they experienced a new CDI occurrence. Fisher’s exact test was performed comparing the proportion of treatment subjects who were recurrence-free by subgroup: age, >65 years vs. <65 years; sex, male vs. female.

RESULTS:
This study included 149 RBX2660-treated participants in the USA and Canada. Eight-week efficacy for RBX2660 in preventing rCDI (76.5%; 114/149) was higher than CDI-free rates in the historical control group (51.8%, 57/110; P < 0.0001). Of the 114 RBX2660 subjects who achieved treatment success through 8-weeks, 109 subjects had 6-month follow-up data. Of those, three experienced a new CDI episode through 6 months. Between 6 and 12 months, two additional subjects experienced a CDI occurrence. The overall durability through 12 months is 91.7%, as four of the 109 subjects didn’t complete 12-month follow-up and were conservatively assessed as failures. Age and gender did not have a statistically significant impact on efficacy outcome (Table 1). The safety profile through 12 months is consistent with previous reports for RBX2660.

CONCLUSION:
RBX2660, a microbiota-based drug, was efficacious for preventing rCDI, with clinical durability to at least 12-months after treatment. Importantly, durability was not dependent on age or gender. Twenty-four month follow-up of efficacy and safety are ongoing.
2826 Trends of Sepsis Mortality in Colon Cancer Patients
Authors: Aijazi Muaz , Ahuja Ashish , Masood Jamil , Bhatti Waqas , Williams George W. 
Published: October 2019

INTRODUCTION:
Investigations have revealed that 1 in 6 severe sepsis patients have underlying neoplastic disease. Cancer patients have been shown to be nearly 10 times more likely to acquire sepsis than the noncancer US population. Moreover, this patient population was also shown to have a 30% higher risk of mortality compared with other severe sepsis patients (1, 2). We utilize a national database - Surveillance, Epidemiology, and End Results (SEER) - to analyze and elucidate trends in sepsis mortality over the years in patients diagnosed with colon cancer.

METHODS:
Incidence data was derived from the 9 original registries of the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer. 10% of US population was accounted for under the 9 original SEER registries. (3) Cancer incidences were collected from 1985 to December 31, 2014. Septicemia was chosen as the end point for our patient population. SEER data of death events occurring from 1/1/1985-12/31/2014 were used in change point analysis. We fitted the two-piece linear trend line with jump located at each year in 1990 to 2010. Root-mean-square error (RMSE) was obtained for each trend line. Year of jump was determined by choosing the trend line with smallest RMSE.

RESULTS:
In 1985 to 2014, a total of 185,582 deaths were recorded in patients diagnosed with primary colon malignancies. Septicemia was listed as the cause of death for 1,517 of these patients. When assessing temporal changes in sepsis mortality, a statistically significant change in trend was seen in the year 1999 across the colon cancer cohort (+0.39%, P < 0.001).

CONCLUSION:
There was a statistically significant increase in the ratio of sepsis deaths to total deaths in patients with colon cancer in 1999. It is difficult to declare at this point one single reason for this trend, however the authors believe it could in large part be attributed to earlier diagnosis of colon cancer, and thus an apparent prolonged duration of life. Interestingly, in 1998, Medicare began to cover colon cancer screening via fecal occult blood testing (FOBT) and sigmoidoscopy. In mid-2001, universal coverage was advanced to screening colonoscopy. 1) Martin GS et al. The Epidemiology of Sepsis in the United States from 1979 through 2000. The New England Journal of Medicine. 2003;348(16):1546-54. 2) Danai PA et al. The Epidemiology of Sepsis in Patients With Malignancy. Chest. 2006;129(6):1432-40.
2827 Fecal Microbiota Transplant for Recurrent Clostridium difficile Infection in Patients With Multiple Comorbidities: A Case Series From a Tertiary Care Community Hospital
Authors: Subramanian Charumathi Raghu , Talluri Swapna , Khan Safi U. , Georgetson Michael J. , Preetika Sinh 
Published: October 2019

INTRODUCTION:
Cure rates of Clostridium difficile infection (CDI) with Fecal Microbioata Transplant (FMT) have been promising. However, there is debate regarding success of FMT in patients with co-morbidities. In this case series, we describe a tertiary care center’s experience with FMT for recurrent CDI in patients with varied clinical background including those with co-morbidities and IBD.

METHODS:
CDI was defined as diarrhea (≥3 loose stools in 24 hours) and stool test positive for C. difficile toxins by PCR. Early FMT failure was defined as diarrhea and positive stool test within 8 weeks, and recurrence/late FMT failure was defined as that after 8 weeks. Adults >18 years of age with 3 or more recurrences of CDI were included in the study. There were no specific exclusion criteria. Electronic chart review was done to collect data on patients who underwent FMT from January 2015 to August 2017. Charts were analyzed in November 2018 with a median follow up of 25.4 months (IQR 10.4). The study was approved by Institutional Review Board (IRB). Descriptive analyses like frequencies and measures of central tendencies were used for continuous variables. Due to low sample size, further statistical analysis could not be performed.

RESULTS:
20 patients underwent FMT (Table 1). The primary success rate at our institution was 90% (Figure 1) and overall recurrence rate was 100%. 6 patients (43%) had FMT failure (early and late). 2 patients (10%), both of whom were immunosuppressed, had early FMT failure. 4 (20%) patients had late FMT failure or recurrence of CDI and had successful resolution either with repeat FMT or antibiotic treatment . None of the 20 patients reported side effects from FMT. All-cause mortality was noted in 2 (10%) patients unrelated to FMT. Charlson comorbidity index was not associated with failure of FMT.

CONCLUSION:
50% FMT failure patients were immunosuppressed compared to 21% in the primary success group. Immunosuppression was due to medications in all patients. 33% of FMT failure patients had IBD (vs 7% in the FMT cure group), all of them had sustained cure after repeat treatments. Mean age of FMT failure patients was lower than those in the primary cure group (59 vs 64), while the subgroup of patients with early failure were older (65.5). PPI use was higher in late failure patients (75% vs 64%), but overall there was no difference between patients with failure and cure. Our case series reiterates the safety and efficacy of FMT for recurrent CDI in patients with comorbidities.
2833 Too Open for Business? Audit of Our “Open Access” Colonoscopy Program
Authors: Piech Gregory , Bhuta Rajiv , Reichenbach Zachary , Toro Butros , Gotfried Jonathan 
Published: October 2019

INTRODUCTION:
Open access colonoscopy programs are designed to decrease barriers to colorectal cancer (CRC) screening and streamline processes for patients and providers. Appropriate pre-procedure selection and patient education around bowel preparation are essential to successfully complete screening. We performed an audit of the current open access program at our urban, tertiary care university hospital in an effort to determine utilization of our program and quality of procedures for participating patients.

METHODS:
We performed a prospective analysis of the first, consecutive 100 patients enrolled for open access colonoscopy from February – May 2019. Patients answered standard screening questions about medical history to determine eligibility for open access CRC screening. To account for all patients, the electronic health record was modified for schedulers to designate patients as 'open access' at the time of scheduling. Patients were followed over the subsequent three months to determine show rate, reasons for incomplete procedure, quality of screening examination and findings on colonoscopy.

RESULTS:
A total of 98/100 patients were included for analysis (excluded two patients inadvertently designated as screening colonoscopy). The average screening age was 56 (range 45 - 73) with the majority females (62%). The overall show rate for scheduled procedure was 74/98 (75.5%). Of the 24 patients who did not show for scheduled procedure, 12.5% required pre-procedure cardiology clearance, 12.5% did not have appropriate in-network insurance, 12.5% did not complete bowel preparation, 8.3% cancelled for personal reasons and 54.2% did not show and could not be reached for follow up. There was no statistically significant difference between no-show rate depending on the PCP's affiliation: health system [14] vs. outside referral [10]). For those completing colonoscopy, 14.9% (11/74) had poor prep, 10.8% (8/74) had fair/adequate prep and 74% (55/74) had good/excellent prep. The most commonly prescribed bowel regimens were 4L PEG (53%) and 2L PEG + Vit C (22%).

CONCLUSION:
Despite a majority of patients completing colonoscopy for CRC screening, a significant group of patients did not complete screening through our open access system. By performing an audit, several barriers were identified that can be modified in future quality improvement projects to maximize open access success and completion rates.
2842 Do Socioeconomic Factors Really Have an Impact on Early Detection of Hepatocellular Carcinoma and Colorectal Cancer?
Authors: Zafar Yousaf , Kaur Anahat , Khan Ghazal , Asif Samia , Saeed Lyla , Simon Stephen , Shrestha Anuj 
Published: October 2019

INTRODUCTION:
Improving surveillance in Hepatocellular Carcinoma (HCC) and Colorectal Cancer (CRC) is an important topic in the field of Gastroenterology and Oncology due to significant benefit associated with early detection and better outcomes. Multiple studies have been undertaken to assess association between socioeconomic status of the population and its impact on HCC/CRC screening and survival after diagnosis. Most of these studies used self-reporting surveys and faced limitations due to reporting bias. We aimed to assess the relevance of socioeconomic factors in diagnosis of HCC and CRC in Jackson County, Kansas City, Missouri by means of a census-based survey.

METHODS:
We retrospectively studied 190 HCC and 690 CRC cases at our institution using a census-based analysis, which consisted of geocoding home addresses of patients and then attaching block level census variables for household occupancy, education level and household income. Survival was assessed using time of last contact at our facility. Statistical analysis was performed using Cox proportional hazard model and ordinal logistic regression.

RESULTS:
We did not find a statistically significant association between socioeconomic factors and adherence to surveillance guidelines for HCC and CRC leading to improved overall survival. Variables that were analyzed included high school education or better (P = 0.5), four-person households with one or more workers (P = 0.08) and income less than 25 thousand dollars (P = 0.58). Study results were risk adjusted for age, race and gender. Separate ordinal logistic regression analysis was done to also adjust for stage at time of eventual cancer diagnosis, no statistically significant result was obtained.

CONCLUSION:
Our study showed no association between socioeconomic variables and participation in HCC or CRC surveillance. The study is limited by a relatively small sample size confined to local patients seen at our institution. Multicenter census-based surveys and meta-analyses need to be conducted to determine whether socioeconomic factors really have an appreciable impact on early screening and detection of HCC and CRC.
2846 Colorectal Cancer Screening in Individuals Ages 45-49 Years: Point Sensitivity of the Multi-Target Stool DNA Test
Authors: Domanico MIchael , Statz Sandra , Weiser Emily , Swartz Rebecca , Berger Barry M. , Limburg Paul 
Published: October 2019

INTRODUCTION:
Colorectal cancer (CRC) incidence and mortality rates in the ≥55 year old population is decreasing, while CRC incidence and mortality is increasing in those < 55 years old (SEER Cancer Stat Facts: Colorectal Cancer. NCI, Bethseda, MD). Recently, the American Cancer Society revised its CRC screening guidelines to recommend screening initiation at age 45 years for average-risk individuals (American Cancer Society, 2018). To date, most endorsed CRC screening tests have not been rigorously studied in younger age groups. In this study, we examined the point sensitivity of the multi-target stool DNA (mt-sDNA) test in patients ages 45-49 years. The mt-sDNA test is currently FDA-approved to qualitatively detect biomarkers associated with colorectal neoplasia in individuals 50 years and older and at average risk for CRC, and data do not suggest age-related changes in sensitivity of the mt-sDNA test (Imperiale et al, 2014, NEJM).

METHODS:
Clinical listings of Exact Sciences-sponsored studies were queried to identify archived stool samples previously collected from individuals ages 45-49 years, with confirmed diagnoses of CRC or advanced adenomas (AA; defined as ≥1 cm, or ≥25% villous morphology or high-grade dysplasia of any size). Historical information regarding CRC risk was limited. Stool samples were collected at least 7 days after the screening colonoscopy, prior to lesion excision and any pre-surgical prep or neoadjuvant treatment. Samples were analyzed per the mt-sDNA test label instructions. Mt-sDNA test sensitivity for advanced colorectal neoplasia (CRC + AA), CRC, and AA were the primary study study endpoints.

RESULTS:
Archived stool was available from 13 individuals with CRC and 6 with AA. Mt-sDNA test sensitivity for advanced neoplasia (CRC + AA), CRC, and AA were 89% (17/19 samples), 92% (12/13 samples), and 83% (5/6 samples), respectively.

CONCLUSION:
This small study using archived stool samples from individuals ages 45-49 years without complete risk status information found that mt-sDNA test sensitivity was similar to previously reported data for individuals ages 50 years and older (Imperiale et al, 2014, NEJM), providing initial demonstration of test sensitivity in this younger population. Larger studies are needed to confirm and more broadly evaluate mt-sDNA performance characteristics in an average risk screening population in this age group.
2847 Outside the Scope a Better FIT for Some Patients
Authors: Ghiya Ronak , Lin Harris , Calderon Joanattan 
Published: October 2019

INTRODUCTION:
Colorectal cancer is the 3rd most common cancer in American adults and is the 2nd most common cause of cancer death. Colorectal cancer screening (CRCS) is unique because it not only detects but also prevents cancer from ever developing, something no other cancer screening accomplishes. Despite this advantage, in 2015 the national average for CRCS compliance was only 63%, below the National Colorectal Cancer Roundtable (NCCR) goal of 80%. The reason for the low rate of CRCS is multifactorial including the fear of having a colonoscopy. At the Baylor Scott & White Primary Care Clinic in Round Rock, TX, CRCS compliance in 2019 was 54% for commercial insurance and 73% for Medicare patients. Our goal was to increase our CRCS compliance and provide better preventative care for our patients.

METHODS:
We reviewed the charts of 200 randomly selected patients who were considered non-compliant with CRCS between September 2017 to September 2018. Non-compliance was defined as a patient who was eligible for CRCS in this one-year time frame but failed to have CRCS. This helped identify causes for why CRCS was not performed. In our review, 0% of these patients were offered alternative methods of CRCS besides colonoscopy. This information led us to educate attending and resident physicians with oral presentations on the availability of alternative testing modalities for CRCS. In addition, one of these modalities, fecal immunochemical test (FIT) kits, were placed in patient rooms in our primary care clinic. Providers were asked to offer patients a colonoscopy for CRCS, and if a patient refused, to then offer FIT testing.

RESULTS:
Among noncompliant patients, no modalities aside from colonoscopy were mentioned by providers for CRCS to non-compliant patients. With the implementation of FIT kits, patients were more inclined to undergo CRCS. From January to March 2019, there was a 12% CRCS compliance rate. After our intervention in April 2019, CRCS compliance was 18% in April 2019, with the entire 6% increase in compliance coming from FIT test kits.

CONCLUSION:
Despite its benefit, CRCS remains below compliance goals set by NCCR. By having FIT kits placed in all the clinic rooms, it was more convenient for patients to have CRCS. There will be continued education on the benefits and modalities of CRCS to more health care providers. We plan to implement this project at other Baylor Scott & White Primary Care Clinics in the region.
2855 To Determine the Clinical Profile of Patients With Esophageal Cancers
Authors: Adnan Muhammad , Nasar Aida 
Published: October 2019

INTRODUCTION:
Cancer of the esophagus ranks twelfth among the major cancers in the number of new cases diagnosed and seventh in the number of cancer death. Its high mortality rate makes it a major concern. Numerous approaches have been described for resection of esophagus. Combined modality therapy including radiotherapy and chemotherapy has raised hope for improvement of survival with promising preliminary data.Finally, for palliation of dysphagia in those patients with advanced disease,various newer therapeutic options have been introduced like endoscopic stenting and laser ablation. Thus this study elaborates view of current literature pertaining to the disease and concludes by comparing the results of the present study with the former national and international scenario.

METHODS:
The one year cross sectional study was conducted at tertiary care hospital. All the patients either gender who were diagnosed as esophageal cancer were included in the study. These patients were allowed to undergo necessary investigations and treatment while the subjects excluded from study were patients who were lost to follow up and the non cooperative patients who not interested to participate in the study while the frequency / percentages (%) and means ± SD computed for study variables.

RESULTS:
During one year study period total fifty patients with esophageal carcinoma were explored and studied. the frequency for male and female population was 32 (64%) and 18 (36%) with mean ± sd for age of male and female individuals was 54.47 ± 5.87 and 51.75 ± 7.72 respectively. Gender male 32 (64%) and female 18 (36%), type of lesion exophytic 05 (10%), infiltrative 10 (20%), ulcerative 35 (70%), location upper third 05 (10%), middle third 30 (60%) and lower third 15 (30%). Histological type squamous cell carcinoma 36 (72%) and adenocarcinoma 14 (28%).

CONCLUSION:
Carcinoma esophagus is one of the most common gastrointestinal tract malignancies. It was the second most common gastrointestinal cancer in our hospital, second only to carcinoma stomach, constituting 6.2% of all malignancies. Squamous cell carcinomas accounts for the vast majority of cancers arising in high- incidence areas throughout the world.Seventy two percent of our patients had squamous cell cancer while twenty eight percent had adenocarcinoma. This reflects the difference in epidemiology and the fact that adenocarcinoma is not rising in incidence in less well- developed nations like ours compared to the West.
2856 The Epidemiology of Barrett’s Esophagus in Chronic Kidney Disease in the U.S.: A Population-Based Study
Authors: Alkhayyat Motasem , Saleh Mohannad Abou , Sanghi Vedha , Rouphael Carol , Mansoor Emad , Thota Prashanthi N. , Chak Amitabh 
Published: October 2019

INTRODUCTION:
Background and Aims: Patients with chronic kidney disease (CKD) frequently suffer from gastroesophageal reflux disease (GERD) and have increased risk of various cancers including esophageal cancer. There is limited data in the literature regarding the epidemiology of Barrett’s esophagus (BE) in patients with CKD and if there is any association between both conditions. Using a large database, we sought to describe the epidemiology of BE in CKD.

METHODS:
Methods: We queried a commercial database (Explorys Inc, Cleveland, OH, USA), an aggregate of electronic health record data from 26 major integrated US healthcare systems. We identified a cohort of patients with a Systematized Nomenclature of Medicine—Clinical Terms (SNOMED-CT) diagnosis of BE without a diagnosis of CKD from 2014-2019. This was used as the control group. Similarly, we identified a cohort of patients with SNOMED-CT diagnosis of new BE after at least one year of CKD diagnosis. We performed analyses to describe age-, gender-, and race-based distributions and evaluate underlying associations.

RESULTS:
Of the 36,893,970 individuals in the database (2014-2019), 1,298,830 had the diagnosis of CKD (3.5%) and 179,610 (0.49%) had the diagnosis of BE. Amongst CKD patients, 7,030 (0.54%) individuals had a new diagnosis of BE after at least one year of being diagnosed with CKD. When compared to individuals without a history of CKD, CKD patients were more likely to develop BE [OR: 1.29; 95% CI 1.26-1.33, P < 0.0001]. The prevalence rates of BE in patients with CKD is increasing in the past 5 years as illustrated in Figure 1. Individuals with CKD and BE were more likely to be males vs females, elderly (age >65) vs young adults (age< 65), and African American vs Caucasian. They were also more likely to be smokers, with history of metabolic syndrome, obesity, obstructive sleep apnea, and with diagnosis of GERD when compared to individuals without CKD (Table 1).

Limitations:
Endoscopic and histological data are not available. This database is at risk of confounding bias.

CONCLUSION:
Conclusions: In this large database, there is 30% higher prevalence of BE in CKD patients compared to those without CKD. This may be due to increased utilization of health care by CKD patients or an unknown confounding factor or a true association. Given the aforementioned limitations, this association needs to be confirmed in further studies.