Burden of Crohn's Disease in the United States Medicaid Population, 2010-2019.

BACKGROUND & AIMS: Twenty-five percent of the United States population is enrolled in Medicaid. Rates of Crohn's disease (CD) have not been estimated in the Medicaid population since the Affordable Care Act expansion in 2014. We aimed to estimate the incidence and prevalence of CD by age, sex, and race. METHODS: We identified all 2010-2019 Medicaid CD encounters using codes from the International Classification of Diseases, Clinical Modification versions 9 and 10. Individuals with ≥2 CD encounters were included. Sensitivity analyses were performed on other definitions (eg, ≥1 CD encounter). Incidence required ≥1 year of Medicaid eligibility prior to first CD encounter date (2013-2019). We calculated CD prevalence and incidence using the entire Medicaid population as the denominator. Rates were stratified by calendar year, age, sex, and race. Poisson regression models examined CD-associated demographic characteristics. We compared demographics and treatments of the entire Medicaid population with the multiple CD case definitions using percent and median. RESULTS: A total of 197,553 beneficiaries had ≥2 CD encounters. The CD point prevalence per 100,000 persons rose from 56 (2010) to 88 (2011) to 165 (2019). CD incidence per 100,000 person-years was 18 (2013) and 13 (2019). Higher incidence and prevalence rates correlated with female, white, or multiracial beneficiaries. Prevalence rates rose in later years. Incidence decreased over time. CONCLUSIONS: From 2010 to 2019, Medicaid population CD prevalence increased while incidence decreased from 2013 to 2019. Overall Medicaid CD incidence and prevalence ranges align with prior large administrative database studies.

Underutilization of Needle Biopsy Before Breast Surgery: A Measure of Low-Value Care.

BACKGROUND: Breast core needle biopsy (CNB) can obviate the need for breast surgery in patients with an unknown breast lesion; however, variation in compliance with this guideline may represent a disparity in health care and a surrogate measure of unnecessary surgery. We evaluated variation in breast CNB rates prior to initial breast cancer surgery. METHODS: We performed a retrospective analysis using Medicare claims from 2015 to 2017 to evaluate the proportion of patients who received a CNB within 6 months prior to initial breast cancer surgery. Outlier practice pattern was defined as a preoperative CNB rate ≤ 70%. Logistic regression was used to evaluate surgeon characteristics associated with outlier practice pattern. RESULTS: We identified 108,935 female patients who underwent initial breast cancer surgery performed by 3229 surgeons from July 2015 to June 2017. The mean CNB rate was 86.7%. A total of 7.7% of surgeons had a CNB performed prior to initial breast surgery ≤ 70% of the time, and 2.0% had a CNB performed ≤ 50% of the time. Outlier breast surgeons were associated with practicing in a micropolitan area (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.29-2.73), in the South (OR 1.84, 95% CI 1.20-2.84) or West region (OR 1.78, 95% CI 1.11-2.86), > 20 years in practice (OR 1.52, 95% CI 1.09-2.11), and low breast cancer surgery volume (< 30 cases in the study period; OR 4.03, 95% CI 2.75-5.90). CONCLUSIONS: Marked variation exists in whether a breast core biopsy is performed prior to initial breast surgery, which may represent unnecessary surgery on individual patients. Providing surgeon-specific feedback on guideline compliance may reduce unwarranted variation.

A micro-costing analysis of outpatient flexible cystoscopy: implications for adoption of single-use flexible cystoscopes.

PURPOSE: To evaluate the total cost of outpatient flexible cystoscopy associated with reusable device purchase, maintenance, and reprocessing, and to assess potential cost benefits of single-use flexible cystoscopes. METHODS: Cost data regarding the purchasing, maintaining, and reprocessing of reusable flexible cystoscopes were collected using a micro-costing approach at a high-volume outpatient urology clinic. We estimated the costs to facilities with a range of annual procedure volumes (1000-3000) performed with a fleet of cystoscopes ranging from 10 to 25. We also compared the total cost per double-J ureteral stent removal procedure performed using single-use flexible cystoscopes versus reusable devices. RESULTS: The cost associated with reusable flexible cystoscopes ranged from $105 to $224 per procedure depending on the annual procedure volume and cystoscopes available. As a practice became more efficient by increasing the ratio of procedures performed to cystoscopes in the fleet, the proportion of the total cost due to cystoscope reprocessing increased from 22 to 46%. For ureteral stent removal procedures, the total cost per procedure using reusable cystoscopes (range $165-$1469) was higher than that using single-use devices ($244-$420), unless the annual procedure volume was sufficiently high relative to the number of reusable cystoscopes in the fleet (≥ 350 for a practice with ten reusable cystoscopes, ≥ 700 for one with 20 devices). CONCLUSION: The cost of reprocessing reusable cystoscopes represents a large fraction of the total cost per procedure, especially for high-volume facilities. It may be economical to adopt single-use cystoscopes specifically for stent removal procedures, especially for lower-volume facilities.

Levels of Vitamin D Are Low After Crohn's Disease Is Established But Not Before.

BACKGROUND & AIMS: Low serum levels of vitamin D have been associated with Crohn's disease (CD). However, it is unclear whether low vitamin D levels cause CD or CD reduces serum vitamin D. METHODS: United States military personnel with CD (n = 240) and randomly selected individuals without CD (controls, n = 240) were matched by age, sex, race, military branch, and geography. We measured 25-hydroxyvitamin D in sera 8-3 years (pre-2) and 3 years to 3 months before diagnosis (pre-1) and 3 months before through 21 months after diagnosis (pre-0). We genotyped VDR and GC vitamin D related polymorphisms. We used conditional logistic regression, including adjustments for smoking, season, enlistment status, and deployment, to estimate relative odds of CD according to vitamin D levels and interactions between genetic factors and levels of vitamin D. RESULTS: Levels of vitamin D before diagnosis were not associated with CD in pre-2 (P trend = .65) or pre-1 samples (P trend = .84). However, we found an inverse correlation between CD and highest tertile of vitamin D level in post-diagnosis samples (P trend = .01; odds ratio, 0.51; 95% CI, 0.30-0.86). Interactions were not detected between vitamin D levels and VDR or GC polymorphisms. We observed an association between VDR Taq1 polymorphism and CD (independent of vitamin D) (P = .02). CONCLUSIONS: In serum samples from military personnel with CD and matched controls, we found no evidence for an association between CD and vitamin D levels up to 8 years before diagnosis. However, we observed an inverse-association between post-diagnosis vitamin D levels and CD. These findings suggest that low vitamin D does not contribute to development of CD-instead, CD leads to low vitamin D.

Endoscope infection transmission state-of-the-art: beyond duodenoscopes to a culture of infection prevention.

PURPOSE OF REVIEW: The elevator mechanism of the duodenoscope was the focus of endoscopically transmitted infections prior to the COVID-19 pandemic. Since that time, the 'suspicious suspects' in the endoscopy unit have grown in number in the eyes of both patients and endoscopists. RECENT FINDINGS: This review summarizes the existing guidelines related to infection control in the endoscopy unit and emerging technologies to address gaps, identifies recommendations proposed during the COVID-19 pandemic, and reminds the reader that infection prevention has not changed since the emergence of COVID-19, only the importance of infection prevention has increased in visibility. SUMMARY: Infection prevention has been and will always be necessary in the gastrointestinal endoscopy unit. Although outbreaks of antibiotic-resistant organisms and infectious diseases like COVID-19 raise the profile of infection control, there have been no major changes to infection control practice recommendations because of the global pandemic. The history of lapses in infection control, persistent contamination of reprocessed endoscopes, and failure of many endoscopy units to identify certain endoscopic procedures as aerosol-generating procedures prior to the pandemic emphasize the need for better knowledge and implementation of infection control practices within endoscopy units.

Rates of infection after colonoscopy and osophagogastroduodenoscopy in ambulatory surgery centres in the USA.

OBJECTIVE: Over 15 million colonoscopies and 7 million osophagogastroduodenoscopies (OGDs) are performed annually in the USA. We aimed to estimate the rates of infections after colonoscopy and OGD performed in ambulatory surgery centres (ASCs). DESIGN: We identified colonoscopy and OGD procedures performed at ASCs in 2014 all-payer claims data from six states in the USA. Screening mammography, prostate cancer screening, bronchoscopy and cystoscopy procedures were comparators. We tracked infection-related emergency department visits and unplanned in-patient admissions within 7 and 30 days after the procedures, examined infection sites and organisms and analysed predictors of infections. We investigated case-mix adjusted variation in infection rates by ASC. RESULTS: The rates of postendoscopic infection per 1000 procedures within 7 days were 1.1 for screening colonoscopy, 1.6 for non-screening colonoscopy and 3.0 for OGD; all higher than screening mammography (0.6) but lower than bronchoscopy (15.6) and cystoscopy (4.4) (p<0.0001). Predictors of postendoscopic infection included recent history of hospitalisation or endoscopic procedure; concurrence with another endoscopic procedure; low procedure volume or non-freestanding ASC; younger or older age; black or Native American race and male sex. Rates of 7-day postendoscopic infections varied widely by ASC, ranging from 0 to 115 per 1000 procedures for screening colonoscopy, 0 to 132 for non-screening colonoscopy and 0 to 62 for OGD. CONCLUSION: We found that postendoscopic infections are more common than previously thought and vary widely by facility. Although screening colonoscopy is not without risk, the risk is lower than diagnostic endoscopic procedures.

Is there evidence of a July effect among patients undergoing hysterectomy surgery?

BACKGROUND: It is hypothesized that the quality of health care decreases during trainee turnovers at the beginning of the academic year. The influx of new gynecology and surgery residents into hospitals in this setting may be associated with poorer surgical outcomes, known as the July effect. OBJECTIVE: We sought to systematically study hysterectomy outcomes in the state of Maryland during the 3-month period July through September as compared to all other months of the academic year, in order to assess for the presence of a July effect in hysterectomy surgery. STUDY DESIGN: This is a retrospective study of the Maryland Health Services Cost Review Commission Database from July 2012 through September 2015 focused on women undergoing hysterectomies for benign or malignant disease, either by obstetricians and gynecologists or gynecologic oncologists, during July through September vs October through June. Multivariable logistic regressions accounted for clustering by hospitals and adjusted for several cofactors. The primary outcome includes at least 1 of 11 major perioperative in-hospital complications; the secondary outcomes were extended postoperative length of stay (defined as >2 days) and 30-day inpatient readmission rates. RESULTS: We identified 6311 hysterectomies (78.2% benign) performed by 424 surgeons at 20 academic hospitals. Patients were primarily white (42.8%), 45-64 years old (54.4%), and had private insurance (66.3%). The unadjusted rate of in-hospital complications was 16.8%, extended length of stay was 30.3%, and 30-day readmissions was 6.6%. After adjustment, patients undergoing hysterectomies during July through September did not have more adverse outcomes relative to those undergoing surgery at other times of the year: complications (adjusted odds ratio, 0.87; 95% confidence interval, 0.75-1.01), length of stay >2 days (adjusted odds ratio, 1.03; 95% confidence interval, 0.90-1.19), and 30-day readmissions (adjusted odds ratio, 0.99; 95% confidence interval, 0.80-1.23). Sensitivity analyses assessing individual complications, hysterectomy outcomes at nonacademic hospitals, and benign vs malignant indications for hysterectomies yielded similar findings. CONCLUSION: Women in Maryland undergoing hysterectomy surgery at academic hospitals during July through September of the academic year did not experience worse outcomes relative to women having surgery in other months. Additional studies are necessary to further assess the possibility of a July effect in hysterectomy on a national basis. Institutions should continue to provide effective surgical training environments for new interns and residents transitioning to more senior roles, while maintaining optimal patient safety.

Smoking and Inflammatory Bowel Disease: A Comparison of China, India, and the USA.

BACKGROUND: Cigarette smoking is thought to increase the risk of Crohn's disease (CD) and exacerbate the disease course, with opposite roles in ulcerative colitis (UC). However, these findings are from Western populations, and the association between smoking and inflammatory bowel disease (IBD) has not been well studied in Asia. AIMS: We aimed to compare the prevalence of smoking at diagnosis between IBD cases and controls recruited in China, India, and the USA, and to investigate the impact of smoking on disease outcomes. METHODS: We recruited IBD cases and controls between 2014 and 2018. All participants completed a questionnaire about demographic characteristics, environmental risk factors and IBD history. RESULTS: We recruited 337 participants from China, 194 from India, and 645 from the USA. In China, CD cases were less likely than controls to be current smokers (adjusted odds ratio [95% CI] 0.4 [0.2-0.9]). There was no association between current or former smoking and CD in the USA. In China and the USA, UC cases were more likely to be former smokers than controls (China 14.6 [3.3-64.8]; USA 1.8 [1.0-3.3]). In India, both CD and UC had similar current smoking status to controls at diagnosis. Current smoking at diagnosis was significantly associated with greater use of immunosuppressants (4.4 [1.1-18.1]) in CD cases in China. CONCLUSIONS: We found heterogeneity in the associations of smoking and IBD risk and outcomes between China, India, and the USA. Further study with more adequate sample size and more uniform definition of smoking status is warranted.

Effectiveness of Guideline-Recommended Cholecystectomy to Prevent Recurrent Pancreatitis.

OBJECTIVES: Cholecystectomy during or within 4 weeks of hospitalization for acute biliary pancreatitis is recommended by guidelines. We examined adherence to the guidelines for incident mild-to-moderate acute biliary pancreatitis and the effectiveness of cholecystectomy to prevent recurrent episodes of pancreatitis. METHODS: Individuals in the 2010-2013 MarketScan Commercial Claims & Encounters database with a hospitalization associated with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes of 577.0 for acute pancreatitis and 574.x for gallstone disease were eligible. Guideline adherence was considered cholecystectomy within 30 days of the first/index hospitalization for biliary pancreatitis. Individuals with and without guideline-adherent cholecystectomy were compared for subsequent hospitalization for acute or chronic pancreatitis using a Cox proportional hazards model adjusted for age, sex, comorbidities, and length of index hospital stay. RESULTS: Of the 17,010 patients who met the inclusion criteria, 78% were adherent with the guidelines, including 10,918 who underwent cholecystectomy during the index hospitalization and 2,387 who underwent cholecystectomy within 30 days. Among 3,705 patients non-adherent with the guidelines, 1,213 had a cholecystectomy 1-6 months after the index hospitalization. Guideline-adherent cholecystectomy resulted in fewer subsequent hospitalizations for acute and chronic pancreatitis as compared with non-adherence to the guidelines (acute pancreatitis: 3% vs. 13%, P<0.001; chronic pancreatitis: 1% vs. 4%, P<0.001). CONCLUSIONS: Nearly four out of five patients underwent cholecystectomy for acute biliary pancreatitis in a timeframe, consistent with guidelines. Adherence resulted in a decrease in subsequent hospitalizations for both acute and chronic pancreatitis. However, the majority of non-adherent patients did not undergo a subsequent cholecystectomy. There may be factors that predict the need for immediate vs. delayed cholecystectomy.

Patient, surgeon, and hospital disparities associated with benign hysterectomy approach and perioperative complications.

BACKGROUND: Hysterectomy is among the most common major surgical procedures performed in women. Approximately 450,000 hysterectomy procedures are performed each year in the United States for benign indications. However, little is known regarding contemporary US hysterectomy trends for women with benign disease with respect to operative technique and perioperative complications, and the association between these 2 factors with patient, surgeon, and hospital characteristics. OBJECTIVE: We sought to describe contemporary hysterectomy trends and explore associations between patient, surgeon, and hospital characteristics with surgical approach and perioperative complications. STUDY DESIGN: Hysterectomies performed for benign indications by general gynecologists from July 2012 through September 2014 were analyzed in the all-payer Maryland Health Services Cost Review Commission database. We excluded hysterectomies performed by gynecologic oncologists, reproductive endocrinologists, and female pelvic medicine and reconstructive surgeons. We included both open hysterectomies and those performed by minimally invasive surgery, which included vaginal hysterectomies. Perioperative complications were defined using the Agency for Healthcare Research and Quality patient safety indicators. Surgeon hysterectomy volume during the 2-year study period was analyzed (0-5 cases annually = very low, 6-10 = low, 11-20 = medium, and ≥21 = high). We utilized logistic regression and negative binomial regression to identify patient, surgeon, and hospital characteristics associated with minimally invasive surgery utilization and perioperative complications, respectively. RESULTS: A total of 5660 hospitalizations were identified during the study period. Most patients (61.5%) had an open hysterectomy; 38.5% underwent a minimally invasive surgery procedure (25.1% robotic, 46.6% laparoscopic, 28.3% vaginal). Most surgeons (68.2%) were very low- or low-volume surgeons. Factors associated with a lower likelihood of undergoing minimally invasive surgery included older patient age (reference 45-64 years; 20-44 years: adjusted odds ratio, 1.16; 95% confidence interval, 1.05-1.28), black race (reference white; adjusted odds ratio, 0.70; 95% confidence interval, 0.63-0.78), Hispanic ethnicity (adjusted odds ratio, 0.62; 95% confidence interval, 0.48-0.80), smaller hospital (reference large; small: adjusted odds ratio, 0.26; 95% confidence interval, 0.15-0.45; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.79-0.96), medium hospital hysterectomy volume (reference ≥200 hysterectomies; 100-200: adjusted odds ratio, 0.78; 95% confidence interval, 0.71-0.87), and medium vs high surgeon volume (reference high; medium: adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97). Complications occurred in 25.8% of open and 8.2% of minimally invasive hysterectomies (P < .0001). Minimally invasive hysterectomy (adjusted odds ratio, 0.22; 95% confidence interval, 0.17-0.27) and large hysterectomy volume hospitals (reference ≥200 hysterectomies; 1-100: adjusted odds ratio, 2.26; 95% confidence interval, 1.60-3.20; 101-200: adjusted odds ratio, 1.63; 95% confidence interval, 1.23-2.16) were associated with fewer complications, while patient payer, including Medicare (reference private; adjusted odds ratio, 1.86; 95% confidence interval, 1.33-2.61), Medicaid (adjusted odds ratio, 1.63; 95% confidence interval, 1.30-2.04), and self-pay status (adjusted odds ratio, 2.41; 95% confidence interval, 1.40-4.12), and very-low and low surgeon hysterectomy volume (reference ≥21 cases; 1-5 cases: adjusted odds ratio, 1.73; 95% confidence interval, 1.22-2.47; 6-10 cases: adjusted odds ratio, 1.60; 95% confidence interval, 1.11-2.23) were associated with perioperative complications. CONCLUSION: Use of minimally invasive hysterectomy for benign indications remains variable, with most patients undergoing open, more morbid procedures. Older and black patients and smaller hospitals are associated with open hysterectomy. Patient race and payer status, hysterectomy approach, and surgeon volume were associated with perioperative complications. Hysterectomies performed for benign indications by high-volume surgeons or by minimally invasive techniques may represent an opportunity to reduce preventable harm.

Emergency department utilization and predictors of mortality for inpatient inguinal hernia repairs.

BACKGROUND: Although inguinal hernias are common surgical diagnoses, minimally symptomatic patients are often not scheduled for repairs and are asked to seek medical attention if they develop symptoms. We investigated factors associated with emergency department (ED) utilization for inguinal hernia repairs and determined whether ED utilization affected mortality for this otherwise electively treated condition. METHODS: We performed a retrospective analysis of the 2009-2013 Nationwide Inpatient Sample to identify patients who presented through the ED and were then admitted for unilateral inguinal hernia repairs. Multivariable logistic regressions that adjusted for several patient and hospital characteristics determined predictors of both ED admission and postoperative mortality. RESULTS: There were 116,357 inpatient hospitalizations. The majority (57%) resulted from ED admissions, of which most (85%) had a diagnosis of obstruction or gangrene. Notable predictors of ED admission from the multivariable analysis included obstruction (odds ratio, 9.77 [95% confidence interval: 9.05-10.55]), gangrene (18.24 [13.00-25.59]), Black race (1.47 [1.29-1.69]), Hispanic ethnicity (1.35 [1.18-1.54]), self-pay (2.29 [1.97-2.66]) and Medicaid insurance (1.76 [1.50-2.06]). While overall mortality decreased from 2.03% in 2009 to 1.36% in 2013, admission through the ED was independently associated with higher mortality compared with elective repair (1.67 [1.21-2.29]), even after adjusting for the diagnosis of obstruction and gangrene. Other predictors of mortality included patient age and comorbidities. CONCLUSIONS: In our study, Black, Hispanic, and self-pay patients were more likely to present through the ED. After adjusting for obstruction or gangrene, simply presenting through the ED was independently associated with a 67% higher postoperative mortality rate compared with that of an elective operation. Our findings suggest both a difference in ED utilization and subsequent difference in mortality by patient race and ethnicity and insurance for this common surgical condition.

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). PURPOSE: To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. DATA SOURCES: PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. STUDY SELECTION: Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. DATA EXTRACTION: Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. DATA SYNTHESIS: None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. LIMITATIONS: Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. CONCLUSION: No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Effectiveness of Prevention Strategies for Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: N-acetylcysteine, sodium bicarbonate, statins, and ascorbic acid have been studied for reducing contrast-induced nephropathy (CIN). PURPOSE: To evaluate the comparative effectiveness of interventions to reduce CIN in adults receiving contrast media. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and Scopus databases through June 2015. Risk of bias and overall strength of evidence (SOE) of studies were assessed. STUDY SELECTION: Randomized, controlled trials of N-acetylcysteine, sodium bicarbonate, statins, or ascorbic acid that used intravenous (IV) or intra-arterial contrast media and defined CIN with enough data for meta-analysis. DATA EXTRACTION: Two reviewers independently extracted data and assessed study quality. DATA SYNTHESIS: Low-dose N-acetylcysteine plus IV saline compared with IV saline (risk ratio [RR], 0.75 [95% CI, 0.63 to 0.89]; low SOE), N-acetylcysteine plus IV saline compared with IV saline in patients receiving low-osmolar contrast media (RR, 0.69 [CI, 0.58 to 0.84]; moderate SOE), and statins plus N-acetylcysteine plus IV saline versus N-acetylcysteine plus IV saline (RR, 0.52 [CI, 0.29 to 0.93]; low SOE) had clinically important and statistically significant benefits. The following 3 comparisons suggested a clinically important difference that was not statistically significant: sodium bicarbonate versus IV saline in patients receiving low-osmolar contrast media (RR, 0.65 [CI, 0.33 to 1.25]; low SOE), statins plus IV saline versus IV saline (RR, 0.68 [CI, 0.39 to 1.20]; low SOE), and ascorbic acid versus IV saline (RR, 0.72 [CI, 0.48 to 1.01]; low SOE). Strength of evidence was generally insufficient for comparisons of the need for renal replacement, cardiac events, and mortality. LIMITATION: Too few studies were done in patients receiving IV contrast media. CONCLUSION: The greatest reduction in CIN was seen with N-acetylcysteine plus IV saline in patients receiving LOCM and with statins plus N-acetylcysteine plus IV saline. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis.

BACKGROUND: Clinicians and patients need updated evidence on the comparative effectiveness and safety of diabetes medications to make informed treatment choices. PURPOSE: To evaluate the comparative effectiveness and safety of monotherapy (thiazolidinediones, metformin, sulfonylureas, dipeptidyl peptidase-4 [DPP-4] inhibitors, sodium-glucose cotransporter 2 [SGLT-2] inhibitors, and glucagon-like peptide-1 [GLP-1] receptor agonists) and selected metformin-based combinations in adults with type 2 diabetes. DATA SOURCES: English-language studies from MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials, indexed from inception through March 2015 (MEDLINE search updated through December 2015). STUDY SELECTION: Paired reviewers independently identified 179 trials and 25 observational studies of head-to-head monotherapy or metformin-based combinations. DATA EXTRACTION: Two reviewers independently assessed study quality and serially extracted data and graded the strength of evidence. DATA SYNTHESIS: Cardiovascular mortality was lower for metformin versus sulfonylureas; the evidence on all-cause mortality, cardiovascular morbidity, and microvascular complications was insufficient or of low strength. Reductions in hemoglobin A1c values were similar across monotherapies and metformin-based combinations, except that DPP-4 inhibitors had smaller effects. Body weight was reduced or maintained with metformin, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT-2 inhibitors and increased with sulfonylureas, thiazolidinediones, and insulin (between-group differences up to 5 kg). Hypoglycemia was more frequent with sulfonylureas. Gastrointestinal adverse events were highest with metformin and GLP-1 receptor agonists. Genital mycotic infections were increased with SGLT-2 inhibitors. LIMITATION: Most studies were short, with limited ability to assess rare safety and long-term clinical outcomes. CONCLUSION: The evidence supports metformin as first-line therapy for type 2 diabetes, given its relative safety and beneficial effects on hemoglobin A1c, weight, and cardiovascular mortality (compared with sulfonylureas). On the basis of less evidence, results for add-on therapies to metformin were similar to those for monotherapies. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Hospital admission volume does not impact the in-hospital mortality of acute pancreatitis.

BACKGROUND: Multiple factors influence mortality in Acute Pancreatitis (AP). METHODS: To evaluate the association of demographic, clinical, and hospital factors with the in-hospital mortality of AP using a population-based administrative database. The Maryland HSCRC database was queried for adult (≥18 years) admissions with primary diagnosis of AP between 1/94-12/10. Organ failure (OF), interventions, hospital characteristics and referral status were evaluated. RESULTS: There were 72,601 AP admissions across 48 hospitals in Maryland with 885 (1.2%) deaths. A total of 1657 (2.3%) were transfer patients, of whom 101 (6.1%) died. Multisystem OF was present in 1078 (1.5%), of whom 306 (28.4%) died. On univariable analysis, age, male gender, transfer status, comorbidity, OF, all interventions, and all hospital characteristics were significantly associated with mortality; however, only age, transfer status, OF, interventions, and large hospital size were significant in the adjusted analysis. Patients with commercial health insurance had significantly less mortality than those with other forms of insurance (OR 0.65, 95% CI: 0.52, 0.82, p = 0.0002). CONCLUSION: OF is the strongest predictor of mortality in AP after adjusting for demographic, clinical, and hospital characteristics. Admission to HV or teaching hospital has no survival benefit in AP after adjusting for OF and transfer status.

Effect of Direct-to-Consumer Advertising on Asthma Medication Sales and Healthcare Use.

RATIONALE: The United States is one of only two countries that permit direct-to-consumer advertising (DTCA) of prescription drugs, and many questions remain regarding its effects. OBJECTIVES: To quantify the association between asthma-related DTCA, pharmacy sales, and healthcare use. METHODS: This was an ecological study from 2005 through 2009 using linked data from Nielsen (DTCA television ratings), the IMS Health National Prescription Audit (pharmacy sales), and the MarketScan Commercial Claims data (healthcare use) for 75 designated market areas in the United States. We used multilevel Poisson regression to model the relationship between DTCA and rates of prescriptions and use within and across designated market areas. Main outcome measures include (1) volume of total, new, and refilled prescriptions for advertised products based on pharmacy sales; (2) prescription claims for asthma medications; and asthma-related (3) emergency department use, (4) hospitalizations, and (5) outpatient encounters among the commercially insured. MEASUREMENTS AND MAIN RESULTS: Four Food and Drug Administration-approved asthma medicines were advertised during the period examined: (1) fluticasone/salmeterol (Advair), (2) mometasone furoate (Asmanex), (3) montelukast (Singulair), and (4) budesonide/formoterol (Symbicort). After adjustment, each additional televised advertisement was associated with 2% (incident rate ratio, 1.02; 95% confidence interval, 1.01-1.03) higher pharmacy sales rate from 2005 through 2009, although this effect varied across the three consistently advertised therapies examined. Among the commercially insured, DTCA was positively and significantly associated with emergency room visits related to asthma (incident rate ratio, 1.02; 95% confidence interval, 1.01-1.04), but there was no relationship with hospitalizations or outpatient encounters. CONCLUSIONS: Among this population, DTCA was associated with higher prescription sales and asthma-related emergency department use.

Clinical Presentation and Five-Year Therapeutic Management of Very Early-Onset Inflammatory Bowel Disease in a Large North American Cohort.

OBJECTIVE: To evaluate the presentation, therapeutic management, and long-term outcome of children with very early-onset (VEO) (≤ 5 years of age) inflammatory bowel disease (IBD). STUDY DESIGN: Data were obtained from an inception cohort of 1928 children with IBD enrolled in a prospective observational registry at multiple centers in North America. RESULTS: One hundred twelve children were ≤ 5 years of age with no child enrolled at <1 year of age. Of those, 42.9% had Crohn's disease (CD), 46.4% ulcerative colitis (UC), and 10.7% had IBD-unclassified. Among the children with CD, children 1-5 years of age had more isolated colonic disease (39.6%) compared with 6- to 10-year-olds (25.3%, P = .04), and 11- to 16-year-olds (22.3%, P < .01). The change from a presenting colon-only phenotype to ileocolonic began at 6-10 years. Children 1-5 years of age with CD had milder disease activity (45.8%) at diagnosis compared with the oldest group (28%, P = .01). Five years postdiagnosis, there was no difference in disease activity among the 3 groups. However, compared with the oldest group, a greater proportion of 1- to 5-year-olds with CD were receiving corticosteroids (P < .01) and methotrexate (P < .01), and a greater proportion of 1- to 5-year-olds with UC were receiving mesalamine (P < .0001) and thiopurine immunomodulators (P < .0002). CONCLUSIONS: Children with VEO-CD are more likely to have mild disease at diagnosis and present with a colonic phenotype with change to an ileocolonic phenotype noted at 6-10 years of age. Five years after diagnosis, children with VEO-CD and VEO-UC are more likely to have been administered corticosteroids and immunomodulators despite similar disease activity in all age groups. This may suggest development of a more aggressive disease phenotype over time.

Human bile contains microRNA-laden extracellular vesicles that can be used for cholangiocarcinoma diagnosis.

UNLABELLED: Cholangiocarcinoma (CCA) presents significant diagnostic challenges, resulting in late patient diagnosis and poor survival rates. Primary sclerosing cholangitis (PSC) patients pose a particularly difficult clinical dilemma because they harbor chronic biliary strictures that are difficult to distinguish from CCA. MicroRNAs (miRs) have recently emerged as a valuable class of diagnostic markers; however, thus far, neither extracellular vesicles (EVs) nor miRs within EVs have been investigated in human bile. We aimed to comprehensively characterize human biliary EVs, including their miR content. We have established the presence of extracellular vesicles in human bile. In addition, we have demonstrated that human biliary EVs contain abundant miR species, which are stable and therefore amenable to the development of disease marker panels. Furthermore, we have characterized the protein content, size, numbers, and size distribution of human biliary EVs. Utilizing multivariate organization of combinatorial alterations (MOCA), we defined a novel biliary vesicle miR-based panel for CCA diagnosis that demonstrated a sensitivity of 67% and specificity of 96%. Importantly, our control group contained 13 PSC patients, 16 with biliary obstruction of varying etiologies (including benign biliary stricture, papillary stenosis, choledocholithiasis, extrinsic compression from pancreatic cysts, and cholangitis), and 3 with bile leak syndromes. Clinically, these types of patients present with a biliary obstructive clinical picture that could be confused with CCA. CONCLUSION: These findings establish the importance of using extracellular vesicles, rather than whole bile, for developing miR-based disease markers in bile. Finally, we report on the development of a novel bile-based CCA diagnostic panel that is stable, reproducible, and has potential clinical utility.

Systemic inflammatory response syndrome between 24 and 48 h after ERCP predicts prolonged length of stay in patients with post-ERCP pancreatitis: a retrospective study.

BACKGROUND: Early systemic inflammatory response syndrome (SIRS) has been associated with severe non-iatrogenic acute pancreatitis. The aims of this study were to determine whether early SIRS could be used to predict severe post-ERCP pancreatitis (PEP) and to determine the effect of prophylactic-pancreatic stenting (PS) on SIRS and severe PEP. METHODS: Between 1/2000 and 6/2012, all patients admitted for PEP after an outpatient ERCP and who had ≥1 abdominal CT scan during hospitalization were retrospectively evaluated. The presence of SIRS was assessed between 0 and 24 h and 24 and 48 h after the time of ERCP completion. SIRS was evaluated as a predictor of severe PEP using area under receiver operating characteristic (AUROC) curve analysis. RESULTS: There were 113 patients with PEP of whom 22 (19.5%) had severe PEP. SIRS was present in 44 (38.9%) and 33 (29.2%) patients between 0 and 24 h and 24 and 48 h, respectively. SIRS between 24 and 48 h had a higher predictive accuracy for severe PEP compared to SIRS between 0 and 24 h (AUROC = 0.7 vs. 0.5, p = 0.002). The prevalence of SIRS between 24 and 48 h was significantly less among the 19 patients who underwent PS (11% vs. 37%, p = 0.03). There was no difference between the prophylactic stenting and no stenting groups with regards to acute fluid collection(s), pancreatic necrosis, organ failure or mortality during hospitalization. CONCLUSIONS: SIRS between 24 and 48 h after ERCP is an accurate, easy to obtain, and inexpensive predictor of severe PEP. PS is associated with a decreased prevalence of SIRS between 24 and 48 h after ERCP.