The Natural History of Asymptomatic Gallstones: A Longitudinal Study and Prediction Model.

BACKGROUND & AIMS: Despite the high prevalence of asymptomatic gallstones (AGs), there are limited data on their natural history. We aimed to determine the rate of symptom development in a contemporary population, determine factors associated with progression to symptomatic gallstones (SGs), and develop a clinical prediction model. METHODS: We used a retrospective cohort design. The time to first SG was shown using Kaplan-Meier curves. Multivariable competing risk (death) regression analysis was used to identify variables associated with SGs. A prediction model for the development of SGs after 10 years was generated and calibration curves were plotted. Participants were patients with AGs based on ultrasound or computed tomography from the general medical population. RESULTS: From 1996 to 2016, 22,257 patients (51% female) with AGs were identified; 14.5% developed SG with a median follow-up period of 4.6 years. The cumulative incidence was 10.1% (±0.22%) at 5 years, 21.5% (±0.39%) at 10 years, and 32.6% (±0.83%) at 15 years. In a multivariable model, the strongest predictors of developing SGs were female gender (hazard ratio [HR], 1.50; 95% CI, 1.39-1.61), younger age (HR per 5 years, 1.15; 95% CI, 1.14-1.16), multiple stones (HR, 2.42; 95% CI, 2.25-2.61), gallbladder polyps (HR, 2.55; 95% CI, 2.14-3.05), large stones (HR, 2.03; 95% CI, 1.80-2.29), and chronic hemolytic anemia (HR, 1.90; 95% CI, 1.33-2.72). The model showed good discrimination (C-statistic, 0.70) and calibration. CONCLUSIONS: In general medical patients with AGs, symptoms developed at approximately 2% per year. A predictive model with good calibration could be used to inform patients of their risk of SGs.

Application of optical character recognition with natural language processing for large-scale quality metric data extraction in colonoscopy reports.

BACKGROUND AND AIMS: Colonoscopy is commonly performed for colorectal cancer screening in the United States. Reports are often generated in a non-standardized format and are not always integrated into electronic health records. Thus, this information is not readily available for streamlining quality management, participating in endoscopy registries, or reporting of patient- and center-specific risk factors predictive of outcomes. We aim to demonstrate the use of a new hybrid approach using natural language processing of charts that have been elucidated with optical character recognition processing (OCR/NLP hybrid) to obtain relevant clinical information from scanned colonoscopy and pathology reports, a technology co-developed by Cleveland Clinic and eHealth Technologies (West Henrietta, NY, USA). METHODS: This was a retrospective study conducted at Cleveland Clinic, Cleveland, Ohio, and the University of Minnesota, Minneapolis, Minnesota. A randomly sampled list of outpatient screening colonoscopy procedures and pathology reports was selected. Desired variables were then collected. Two researchers first manually reviewed the reports for the desired variables. Then, the OCR/NLP algorithm was used to obtain the same variables from 3 electronic health records in use at our institution: Epic (Verona, Wisc, USA), ProVation (Minneapolis, Minn, USA) used for endoscopy reporting, and Sunquest PowerPath (Tucson, Ariz, USA) used for pathology reporting. RESULTS: Compared with manual data extraction, the accuracy of the hybrid OCR/NLP approach to detect polyps was 95.8%, adenomas 98.5%, sessile serrated polyps 99.3%, advanced adenomas 98%, inadequate bowel preparation 98.4%, and failed cecal intubation 99%. Comparison of the dataset collected via NLP alone with that collected using the hybrid OCR/NLP approach showed that the accuracy for almost all variables was >99%. CONCLUSIONS: Our study is the first to validate the use of a unique hybrid OCR/NLP technology to extract desired variables from scanned procedure and pathology reports contained in image format with an accuracy >95%.

Comparative Effectiveness of Commercial Bowel Preparations in Ambulatory Patients Presenting for Screening or Surveillance Colonoscopy.

BACKGROUND: Inadequate bowel preparation (IBP) is associated with reduced adenoma detection. However, limited research has examined the impact of different commercial bowel preparations (CBPs) on IBP and adenoma detection. We aim to determine whether type of CBP used is associated with IBP or adenoma detection. METHODS: We retrospectively evaluated outpatient, screening or surveillance colonoscopies performed in the Cleveland Clinic health system between January 2011 and June 2017. IBP was defined by the Aronchick scale. Multilevel mixed-effects logistic regression was performed to assess the association between CBP type and IBP and adenoma detection. Fixed effects were defined as demographics, comorbidities, medication use, and colonoscopy factors. Random effect of individual endoscopist was considered. RESULTS: Of 153,639 colonoscopies, 75,874 records met inclusion criteria. Median age was 54; 50% were female; 17.7% had IBP, and adenoma detection rate was 32.6%. In adjusted analyses, compared to GoLYTELY, only NuLYTELY [OR 0.66 (95% CI 0.60, 0.72)] and SuPREP [OR 0.53 (95% CI 0.40, 0.69)] were associated with reduced IBP. Adenoma detection did not vary based on the type of bowel preparation used. CONCLUSIONS: Among patients referred for screening or surveillance colonoscopy, choice of CBP was not associated with adenoma detection. Decisions about CBP should be based on other factors, such as tolerability, cost, or safety.

Patient-Initiated Colonoscopy Scheduling Effectively Increases Colorectal Cancer Screening Adherence.

BACKGROUND AND AIM: We identified patients without medical record evidence of up-to-date colorectal cancer (CRC) screening and sent an invitation letter to self-schedule a colonoscopy without requiring prior primary care or gastroenterologist consultation. The aim of the study was to evaluate the response rate to the letter and factors associated with colonoscopy completion. METHODS: A computer algorithm invited patients not up to date with CRC screening, with an INR < 1.5, and living within 300 miles of the Cleveland Clinic main campus through a letter. Patients scheduled a colonoscopy through a dedicated phone line without any prior physician consultation. Clinical, demographic, and socioeconomic variables were extracted from the EMR through natural language algorithms. We analyzed the percentage of patients who completed a colonoscopy within 6 months of sending the letter and factors associated with colonoscopy completion. RESULTS: A total of 145,717 letters were sent. 1451 patients were deceased and excluded from analysis. 3.8% (5442) of letter recipients completed a colonoscopy. The strongest factors associated with colonoscopy completion on multivariate analysis included family history of polyps (OR 3.1, 95% CI 2.3, 4.2) or CRC (OR 2.1, 95% CI 1.7, 2.5). Other factors included younger age, male gender, married status, closer distance to endoscopy center, number of visits in the year prior, statin use, and diabetes. There were no immediate procedural complications. CONCLUSIONS: Patient-initiated colonoscopy in response to letter invitation for CRC screening is effective and safe with safeguards established a priori. Consultation with a gastroenterologist or primary care physician is not necessary prior to colonoscopy. To our knowledge, this is the first study to evaluate patient-initiated colonoscopy for CRC cancer screening.

Common bile duct dilation after bariatric surgery.

BACKGROUND: Biliary dilation suggests obstruction and prompts further work up. Our experience with endoscopic ultrasound and endoscopic retrograde cholangiopancreatography in the symptomatic post-bariatric surgery population revealed many patients with radiographically dilated bile ducts, but endoscopically normal studies. It is unclear if this finding is phenomenological or an effect of surgery. Additionally, it is unknown whether the type of bariatric surgery alters biliary pathophysiology. Thus, we studied whether a change occurs in biliary diameter following Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). METHODS: A single-center retrospective study assessing biliary diameter before and after RYGB or SG based on radiographic imaging. All adult patients undergoing RYGB or SG from January 2010 to December 2013 who had imaging studies before and > 3 months after surgery were included. Those with known obstructive etiologies and those without post-operative imaging were excluded. Common bile duct (CBD) diameter was re-read by a radiologist at the same location in the CBD for pre- and post-operative imaging. Baseline clinical factors and cholecystectomy status were collected. RESULTS: 269 patients met inclusion criteria (193 RYGB;76 SG). Between the groups, there were no significant differences in pre-operative characteristics. Average time from surgery to repeat imaging was 24.1 months. After adjusting for pre-operative factors, subjects who underwent an RYGB had an increase in CBD diameter of 1.4 mm (95% CI 0.096, 0.18), which was greater than the change following SG 0.5 mm(95% CI - 0.007, 0.11). The magnitude of this change did not depend on prior cholecystectomy in the RYGB cohort. Within the SG group, for patients without a prior cholecystectomy, there was a significant increase in post-operative CBD diameter of 0.8 mm(95% CI 0.02, 0.14). CONCLUSION: Bariatric surgery results in CBD dilation, with changes more pronounced after RYGB. Biliary dilation occurs irrespective of cholecystectomy status. Further work is necessary to determine the cause and clinical implications of this phenomenon.

Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial.

OBJECTIVES: Regulatory changes requiring the use of capnographic monitoring for endoscopic procedures using moderate sedation have placed financial challenges on ambulatory and hospital endoscopy centers across the United States due to the increased cost of training endoscopy personnel and purchasing both capnography-monitoring devices and specialized sampling ports. To date, there has been no published data supporting the use of capnographic monitoring in adult patients undergoing routine endoscopic procedures with moderate sedation. The aim of this randomized, parallel group assignment trial was to determine whether intervention based on capnographic monitoring improves detection of hypoxemia in patients undergoing routine esophagogastroduodenoscopy (EGD) or colonoscopy with moderate sedation. METHODS: Healthy patients (ASA Physical Classification (ASAPS) I and II)) scheduled for routine outpatient EGD or colonoscopy under moderate sedation utilizing opioid and benzodiazepine combinations were randomly assigned to a blinded capnography alarm or open capnography alarm group. In both study arms, standard cardiopulmonary monitoring devices were utilized with additional capnographic monitoring. The primary end point was the incidence of hypoxemia defined as a fall in oxygen saturation (SaO2) to <90% for ≥10 s. Secondary outcomes included severe hypoxemia, apnea, disordered respirations, hypotension, bradycardia, and early procedure termination for any cause. RESULTS: A total of 452 patients were randomized; 218 in the EGD and 234 in the colonoscopy groups; 75 subjects in the EGD group (35.9%) and 114 patients (49.4%) in the colonoscopy group were male, and average body mass index was 27.9 and 29.1 (kg/m(2)), respectively. The blinded and open alarm groups in each study arm were similar in regards to use of opioids and/or benzodiazepines and ASAPS classification. There was no significant difference in rates of hypoxemia between the blinded and open capnography arms for EGD (54.1% vs. 49.5; P=0.5) or colonoscopy (53.8 vs. 52.1%; P=0.79). CONCLUSIONS: Capnographic monitoring in routine EGD or colonoscopy for ASAPS I and II patients does not reduce the incidence of hypoxemia (ClinicalTrials.gov number, NCT01994785).

Pre-operative opioid analgesia reduces clinical success of laparoscopic gastric electrical stimulation placement in patients with gastroparesis.

INTRODUCTION: Gastroparesis is a common chronic and costly disorder for which medical therapy is often unsuccessful. Gastric electrical stimulation (GES) has been used to treat refractory cases, however, response is variable and difficult to predict. This study aims to assess whether pre-operative opioid analgesics (OA) use affects clinical success of GES. METHODS: Records of 128 patients who underwent laparoscopic GES placement from March 2001 to September 2012 were analyzed retrospectively. Data collected included demographics, surgical outcomes, and clinical parameters. Pre- and post-operative opioid analgesic dosing (No = 0 morphine equivalents (ME)/day, Low = 0-40 ME/day, Mid = 41-80 ME/day, High >80 ME/day), as well as clinical symptom assessment was collected for up to 3 years post-operatively. Clinical success was defined as (1) OA reduction of >50 %, (2) maintenance of weight, or (3) symptom improvement. Descriptive statistics were computed for all factors. A p < 0.05 was considered statistically significant. RESULTS: Fifty-three patients were on OA pre-operatively compared to 69 patients who were not. Patients not on OA pre-operatively were less likely than those on OA pre-op group to be on OA post-operatively (p = 0.005); however, there were no differences in weight or symptom improvement. Sub-group analysis of the 53 patients on OA demonstrated significant improvement in clinical symptoms in the low-morphine cohort compared to the mid-morphine cohort (p = 0.02), and OA dosing post-operatively in the low-morphine cohort diminished significantly compared to mid- and high-morphine cohort (p = 0.032). There was no significant difference in weight. CONCLUSION: OA dosing pre-operatively significantly affects clinical success of GES placement. Criteria for offering GES implantation may need to take OA dosing into consideration.

Adenoma detection at colonoscopy by polypectomy in withdrawal only versus both insertion and withdrawal: a randomized controlled trial.

UNLABELLED: Colonic configuration during insertion phase (IP) and withdrawal phase (WP) is different and some polyps seen during IP are difficult to find during WP and vice versa. To determine if polypectomy performed during both IP and WP of colonoscopy (study arm) increases adenoma detection rate (ADR) compared to WP only (control arm). In this prospective randomized controlled trial, adults undergoing out-patient colonoscopy were enrolled. The primary outcome was mean number of adenomas detected per patient. Secondary outcomes were ADR, defined as the proportion of colonoscopies with at least one adenoma, polyp detection rates (PDR), number of patients classified as high-risk group (presence of ≥3 adenomas of any size, any adenoma ≥1 cm in size, or adenoma with villous component, or high grade dysplasia), procedural times, patients discomfort, and ease of procedure. Among 772 patients enrolled, 610 were included (329 in study arm and 281 in control arm). In both arms, mean number of adenomas detected per patient were similar, 0.78 ± 1.4 vs. 0.74 ± 1.5, P = 0.75. Also, ADR (39.2 vs. 38.1 %, P = 0.77) and PDR (57.1 and 54.1 %, P = 0.45) were similar. Mean insertion time was significantly higher in study arm (10.2 ± 5.8 vs. 9.3 ± 5.6 min, p = 0.046). Proportion of patients identified as high-risk group were significantly higher in study arm (18.8 vs. 11.7 %, P = 0.016). CONCLUSIONS: Polypectomy performed during both IP and WP compared to the WP only, did not improve ADR or mean number of adenomas detected per patient. TRIAL REGISTRATION: Clinicaltrials.gov, #NCT01025960.

Hospital readmissions in patients with inflammatory bowel disease.

OBJECTIVES: We aimed to identify the frequency and costs of, and the disease predictors and inpatient process issues that may predispose to, 30-day readmission for an inflammatory bowel disease (IBD) patient. METHODS: IBD patients admitted to an inpatient gastroenterology service were followed for a time-to-readmission analysis assessing factors associated with readmission within 30 days. RESULTS: Index admissions were more costly among those readmitted than among those not readmitted. Patients admitted with evidence of increased inflammation, infection, or obstruction or for dehydration or pain control had a higher risk of readmission. Patients treated with opioid analgesia during index admission were no less likely to be readmitted, and there was a 2.2-fold increase in readmissions when patients were discharged with no opioid analgesia. Scheduling variability and outpatient follow-up compliance were associated with readmission. CONCLUSIONS: Predicting readmission is complex. A predictive model developed to be used at discharge yielded an area under the curve of 0.757.

Dialysis costs for a health system participating in value-based care.

OBJECTIVES: Unplanned "crash" dialysis starts are associated with worse outcomes and higher costs, a challenging problem for health systems participating in value-based care (VBC). We examined expenditures and utilization associated with these events in a large health system. STUDY DESIGN: Retrospective, single-center study at Cleveland Clinic, a large, integrated health system participating in VBC contracts, including a Medicare accountable care organization. METHODS: We analyzed beneficiaries who transitioned to dialysis between 2017 and 2020. Crash starts involved initiating inpatient hemodialysis (HD) with a central venous catheter (CVC). Optimal starts were initiated with either home dialysis or outpatient HD without a CVC. Suboptimal starts were initiated with outpatient HD with a CVC or inpatient HD without a CVC. RESULTS: A total of 495 patients initiated chronic dialysis: 260 crash starts, 130 optimal starts, and 105 suboptimal starts. Median predialysis 12-month cost was $67,059 for crash starts, $17,891 for optimal starts, and $7633 for suboptimal starts (P < .001). Median postdialysis 12-month cost was $71,992 for crash starts, $55,427 for optimal starts, and $72,032 for suboptimal starts (P = .001). Predialysis inpatient admission per 1000 beneficiaries was 1236 per 1000 for crash starts vs 273 per 1000 for optimal starts and 170 per 1000 for suboptimal starts (P < .001). Postdialysis inpatient admission for crash starts was 853 per 1000 vs 291 per 1000 for optimal starts and 184 per 1000 for suboptimal starts (P < .001). CONCLUSIONS: In a major health system, crash starts demonstrated the highest cost and hospital utilization, a pattern that persisted after dialysis initiation. Developing strategies to promote optimal starts will improve VBC contract performance.

Frequency of Use and Outcomes of Colonoscopy in Individuals Older Than 75 Years.

Importance: The benefits from colorectal cancer (CRC) screening may take 10 to 15 years to accrue. Therefore, screening is recommended for older adults who are in good health. Objective: To determine the number of screening colonoscopies done in patients older than 75 years with a life expectancy of fewer than 10 years, diagnostic yield, and associated adverse events within 10 days and 30 days of the procedure. Design: This cross-sectional study with a nested cohort between January 2009 and January 2022 in an integrated health system assessed asymptomatic patients older than 75 years who underwent screening colonoscopy in the outpatient setting. Reports with incomplete data, any indication other than screening, patients who had a colonoscopy within the previous 5 years, and patients with a personal history of inflammatory bowel disease or CRC were excluded. Exposures: Life expectancy based on a prediction model from previous literature. Main Outcomes and Measures: The primary outcome was the percentage of screened patients who had limited (<10 years) life expectancy. Other outcomes included colonoscopy findings and adverse events that developed within 10 days and 30 days of the procedure. Results: A total of 7067 patients older than 75 years were included. The median (IQR) age was 78 (77-79) years, 3967 (56%) were women, and 5431 (77%) were White with an average of 2 comorbidities (taken from a select group of comorbidities). The proportion of colonoscopies performed on patients with a life expectancy of fewer than 10 years aged 76 to 80 years was 30% in both sexes and increased with age-82% of men and 61% of women aged 81 to 85 years (71% total), and 100% of patients beyond the age of 85 years. Adverse events requiring hospitalizations were common at 10 days (13.58 per 1000) and increased with age, particularly among patients older than 85 years. The detection of advanced neoplasia varied from 5.4% among patients aged 76 to 80 years to 6.2% in those aged 81 to 85 years and 9.5% among patients older than 85 years (P = .02). Of the total population, 15 patients (0.2%) had invasive adenocarcinoma; among patients with a life expectancy of fewer than 10 years, 1 of 9 was treated, whereas 4 of 6 patients with a life expectancy of greater than or equal to 10 years were treated. Conclusions and Relevance: In this cross-sectional study with a nested cohort, most screening colonoscopies performed in patients older than 75 years were in patients with limited life expectancy and associated with increased risk of complications. Colorectal cancer was exceedingly rare.

Differential epidural block predicts the success of visceral block in patients with chronic visceral abdominal pain.

BACKGROUND AND AIMS: Differential thoracic epidural regional block, also known as a differential neural block (DNB), involves the placement of an epidural catheter placed in the thoracic epidural space to achieve appropriate anesthesia in a dermatomal distribution. This is a retrospective case series evaluating how well a DNB may predict success of subsequent visceral blockade in patients with chronic abdominal pain of visceral origin. METHODS: Of 402 patients who had a DNB performed for unexplained abdominal pain from January 2000 to January 2009, 81 patients were found to have results consistent with visceral pain and thus underwent subsequent visceral blockade. Basic demographic data, years of chronic pain, history of psychosocial issues, initial visual analog scale (VAS) pain score, pain location, and medication usage were documented in our electronic medical record database. Parameters regarding DNB and visceral blocks also were documented. Descriptive statistics were computed for all variables. The positive predictive value (PPV) for DNB for whom visceral block was successful (at least a 50% reduction in VAS) was calculated. Additionally, subjects with successful visceral blocks were compared to those with unsuccessful visceral blocks. PARTICIPANTS: All patients with chronic abdominal pain with normal gastrointestinal studies who underwent DNB. SETTING: Tertiary Outpatient Pain Management Clinic. DESIGN: Retrospective Cohort Study. RESULTS: Mean age of patients was 46 (± 15) years, 73% were female, and median duration of pain was 5 years. 67% of subjects were taking opioid analgesics. PPV of DNB was 70.4%. Only factor found to be statistically significant with visceral block success was baseline VAS with higher scores associated with DNB predictive success (6.8 ± 1.7 vs. 5.5, 1.8; P = 0.004). Use of membrane stabilizing medications was significantly more common in subjects for whom visceral block was not successful (46% vs. 25%; P = 0.058). Area underneath curve (AUC) for VAS was found to be 0.70 (95% CI: 0.57, 0.82), which signifies fair discrimination. CONCLUSION: Differential neural block is fairly predictive of subsequent visceral block success in patients with chronic abdominal pain of visceral origin. An initial VAS ≥ 5 provides a sensitivity of 93%, which implies that VAS < 5 may predict unsuccessful visceral block. Contrarily, a value of ≥ 8 would provide a specificity of 92% and may be used to predict success of subsequent visceral block.