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.

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.

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.

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.

A comparative evaluation of outcomes of endoscopic versus percutaneous drainage for symptomatic pancreatic pseudocysts.

BACKGROUND: Endoscopic drainage (ED) and percutaneous drainage (PD) have largely replaced surgical drainage as the initial approach for symptomatic pseudocysts. However, there are few studies comparing ED and PD. OBJECTIVE: To compare the outcomes of ED and PD for symptomatic pseudocysts. DESIGN: Retrospective cohort study. SETTING: Academic center. PATIENTS: Adult patients with symptomatic pseudocysts within ≤ 1 cm of the gastric or duodenal wall who underwent ED or PD between 1993 and 2011. Patients with walled-off pancreatic necrosis were excluded. INTERVENTION: ED or PD. MAIN OUTCOME MEASUREMENTS: Rates of technical success, procedural adverse events, clinical success, reinterventions, and failure. Other outcomes included the length of hospital stay and number of follow-up abdominal imaging studies. RESULTS: There were 81 patients, 41 who underwent ED and 40 who underwent PD, with no differences in age, sex, and comorbidity between the 2 groups. There were no differences in the rates of technical success (90.2% vs 97.5%; P = .36), adverse events (14.6% vs 15%; P = .96), and clinical success (70.7% vs 72.5%; P = .86) between ED and PD, respectively. Patients who underwent PD had higher rates of reintervention (42.5% vs 9.8%; P = .001), longer length of hospital stay (14.8 ± 14.4 vs 6.5 ± 6.7 days; P = .001), and median number [quartiles] of follow-up abdominal imaging studies (6 [3.25, 10] vs 4 [2.5, 6]; P = .02) compared with patients who underwent ED. LIMITATIONS: Single center, retrospective study. CONCLUSION: ED and PD have similar clinical success rates for symptomatic pseudocysts. However, PD is associated with significantly higher rates of reintervention, longer length of hospital stay, and increased number of follow-up abdominal imaging studies.

5-Fr vs. 3-Fr pancreatic stents for the prevention of post-ERCP pancreatitis in high-risk patients: a systematic review and network meta-analysis.

BACKGROUND AND STUDY AIMS: Placement of a pancreatic stent is recommended for the prevention of pancreatitis after endoscopic retrograde cholangiopancreatitis (ERCP) among high-risk patients. However, it is not known whether there is a particular feature of the pancreatic stent that is associated with a lower incidence of post-ERCP pancreatitis (PEP). This systematic review and network meta-analysis (NMA) aimed to examine whether a particular feature of pancreatic stents is associated with lower incidence of PEP. PATIENTS AND METHODS: The MEDLINE, Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs) that evaluated the efficacy of pancreatic stents in the prevention of PEP from September 1993 to June 2013. Trials that reported the incidence of PEP in high-risk patients randomized to one vs. another type of pancreatic stent or vs. no stent at all were included in the analysis. RESULTS: Among the 1377 citations identified from the database searches, 6 RCTs involving 561 patients were included. Three RCTs evaluated 5-Fr straight, flanged pancreatic stents, two RCTs evaluated 5-Fr single-pigtail, unflanged stents, and three RCTs evaluated 3-Fr single-pigtail, unflanged stents. The probability of being ranked the best was 50.3 % (SD = 0.5, Markov chain error = 0.003) for 5-Fr single-pigtail, unflanged pancreatic stents, 46.5 % for 5-Fr straight, flanged stents, and 3.1 % for 3-Fr single-pigtail, unflanged stents. CONCLUSION: The 5-Fr pancreatic stent is superior to the 3-Fr pancreatic stent for the prevention of PEP in high-risk patients. The 5-Fr single-pigtail, unflanged pancreatic stent and 5-Fr straight, flanged pancreatic stent performed similarly and both performed better than the 3-Fr pancreatic stent in preventing PEP, suggesting that stent diameter is more important for the prevention of PEP than type of stent or the presence of flanges.

Pre-existing Thyroid Autoimmunity and Risk of Papillary Thyroid Cancer: A Nested Case-Control Study of US Active-Duty Personnel.

PURPOSE: Thyroid autoimmunity has been associated with differentiated thyroid cancer although multiple potential biases might have influenced the results of previous studies. METHODS: We conducted a case-control study nested within the cohort of US active-duty personnel 1996-2014 to assess the association between thyroid autoimmunity, defined by serology, and thyroid cancer diagnosis. The primary exposure was thyroid peroxidase (TPO) antibody status 7-10 years before the thyroid cancer index date. We also assessed whether diagnosis of thyroid autoimmunity mediated any associations identified and if thyroid cancer features differed by autoimmunity status. RESULTS: Among 451 incident cases of papillary thyroid cancer and matched controls (median age 36 years, 61.4% men), TPO antibody positivity (v negative) 7-10 years prediagnosis was associated with thyroid cancer (odds ratio [OR] 1.90 [95% CI, 1.33 to 2.70]). Exploratory analyses suggested an increasing risk of thyroid cancer with higher TPO antibody titer (TPO antibody 550-1,399 IU/mL: OR 2.95 [95% CI, 1.37 to 6.36]; and ≥ 1,400 IU/mL: OR 3.91 [95% CI, 1.66 to 9.24]). Positive TPO antibody status remained associated with thyroid cancer after those with diagnosed autoimmunity were excluded, and the association was not mediated by diagnosis of thyroid autoimmunity. Among the cases with diagnosed autoimmunity, 58% thyroid cancers were ≤ 10 mm diameter. CONCLUSION: Longstanding prior thyroid autoimmunity up to 10 years before thyroid cancer diagnosis was associated with papillary thyroid cancer risk. The results could not be fully explained by diagnosis of thyroid autoimmunity although when autoimmunity had been identified, thyroid cancers were diagnosed at a very early stage.

Timing of myelosuppression during thiopurine therapy for inflammatory bowel disease: implications for monitoring recommendations.

BACKGROUND & AIMS: Thiopurines (azathioprine and 6-mercaptopurine) can induce life-threatening myelosuppression. This study determined the frequency, timing, and outcomes of mild and severe myelosuppression after initiation of thiopurine therapy. METHODS: This retrospective cohort study included patients with inflammatory bowel disease who were new users of thiopurines; those tested for thiopurine methyltransferase levels before therapy were excluded. Patients were followed from their first thiopurine prescription until the earliest of severe leukopenia (white blood cell count, <1.0 x 10(9)/L), severe thrombocytopenia (platelet level, <20 x 10(9)/L), the end of therapy, the first gap in therapy, disenrollment, or December 31, 2006. RESULTS: Among 1997 new users, the incidence of severe leukopenia per 100 person-months was 0.16 (95% confidence interval [CI], 0.03-0.29; n = 6) in weeks 0 to 8, 0.00 in weeks 9 to 24, and 0.01 (95% CI, 0-0.03; n = 3) after week 26 of therapy. The incidence of severe neutropenia and severe thrombocytopenia per 100 person-months during the first 8 weeks of therapy was 0.51 (95% CI, 0.31-0.80; n = 19) and 0.08 (95% CI, 0.02-0.23; n = 3), respectively. During the first 8 weeks, the median duration from a normal white blood cell count to severe leukopenia was 13 days (range, 8-26 d) and to severe neutropenia was 14 days (range, 7-23 d). CONCLUSIONS: The high incidence of severe myelosuppression justifies frequent monitoring during the first 8 weeks of therapy. Subsequently, the rate of severe myelosuppression and the proportion of patients who progress from mild to severe myelosuppression decrease, justifying less-frequent monitoring.

Angiotensin II receptor blockers and gastrointestinal adverse events of resembling sprue-like enteropathy: a systematic review.

BACKGROUND: Olmesartan, an angiotensin II receptor blocker (ARB), is associated with gastrointestinal symptoms resembling sprue-like enteropathy. Some have proposed that enteropathy may be a class effect rather than olmesartan-specific. We performed a systematic review to identify literature of sprue-like enteropathy for all ARBs. METHODS: Case reports, case series and comparative studies of ARBs were searched on PubMed and Embase databases through 21 November 2018 and then assessed. RESULTS: A total of 82 case reports and case series as well as 5 comparative studies, including 248 cases, were selected and analysed. The ARBs listed in the case reports were olmesartan (233 users; 94.0%), telmisartan (5 users; 2.0%), irbesartan (4 users; 1.6%), valsartan (3 users; 1.2%), losartan (2 users; 0.8%) and eprosartan (1 user; 0.4%). The periods between ARB initiation and onset of symptoms ranged from 2 weeks to 13 years. Histologic results were reported in 218 cases, in which 201 cases (92.2%) were villous atrophy and 131 cases (60.1%) were intraepithelial lymphocytosis. Human leucocyte antigen (HLA) testing was performed in 147 patients, among whom 105 (71.4%) had HLA-DQ2 or HLA-DQ8 haplotypes. Celiac-associated antibodies were tested in 169 patients, among whom 167 (98.8%) showed negative results. Gluten exclusion from the diet failed to relieve symptoms of enteropathy in 127 (97.7%) of 130 patients with information. Complete remission of symptoms after discontinuation of ARB was reported in 233 (97.4%) of the 239 patients with information. Seven cases (2.8%) reported recurrence of symptoms after restarting olmesartan; rechallenge was not reported for the non-olmesartan ARBs. The retrospective studies conducted worldwide had inconsistent study designs (e.g. differences in periods of study and case definition) and findings. CONCLUSIONS: Although enteropathy is rare, clinicians should remain vigilant of this potential adverse event even years after medication initiation.

Same-Day vs Different-Day Elective Upper and Lower Endoscopic Procedures by Setting.

Importance: Performing elective upper and lower endoscopic procedures on the same day is a patient-centered and less costly approach than a 2-stage approach performed on different days, when clinically appropriate. Whether this practice pattern varies based on practice setting has not been studied. Objectives: To estimate the rate of different-day upper and lower endoscopic procedures in 3 types of outpatient settings and investigate the factors associated with the performance of these procedures on different days. Design, Setting, and Participants: A retrospective analysis was conducted of Medicare claims between January 1, 2011, and June 30, 2018, for Medicare beneficiaries who underwent a pair of upper and lower endoscopic procedures performed within 90 days of each other at hospital outpatient departments (HOPDs), freestanding ambulatory surgery centers (ASCs), and physician offices. Main Outcomes and Measures: Undergoing an upper and a lower endoscopic procedure on different days, adjusted for patient characteristics (age, sex, race/ethnicity, residence location and region, comorbidity, and procedure indication) and physician characteristics (sex, years in practice, procedure volume, and primary specialty). Adjusted odds ratios (aORs) and 95% CIs were calculated. Results: A total of 4 028 587 procedure pairs were identified, of which 52.5% were performed in HOPDs, 43.3% in ASCs, and 4.2% in physician offices. The rate of different-day procedures was 13.6% in HOPDs, 22.2% in ASCs, and 47.7% in physician offices. For the 7564 physicians who practiced at both HOPDs and ASCs, their different-day procedure rate changed from 14.1% at HOPDs to 19.4% at ASCs. For the 993 physicians who practiced at both HOPDs and physician offices, their different-day procedure rate changed from 15.8% at HOPDs to 37.4% at physician offices. Patients were more likely to undergo different-day procedures at physician offices and ASCs compared with HOPDs, even after adjusting for patient and physician characteristics (physician office vs HOPD: aOR, 2.02; 95% CI, 1.85-2.20; ASC vs HOPD: aOR, 1.27; 95% CI, 1.23-1.32). Older age (85-94 years vs 65-74 years: aOR, 1.10; 95% CI, 1.08-1.11; 95 years or older vs 65-74 years: aOR, 1.14; 95% CI, 1.03-1.26), black and Hispanic race/ethnicity (black: aOR, 1.15; 95% CI, 1.12-1.17; Hispanic: aOR, 1.12; 95% CI, 1.10-1.14), and residing in the Northeast region (adjusted OR, 1.32; 95% CI, 1.28-1.36) were risk factors for undergoing different-day procedures. Micropolitan location (aOR, 0.94; 95% CI, 0.92-0.96) and rural location (aOR, 0.91; 95% CI, 0.89-0.93), more comorbidities (≥5: aOR, 0.75; 95% CI, 0.74-0.76), physician's fewer years in practice (aOR, 0.84; 95% CI, 0.81-0.87), physician's higher procedure volume (aOR, 0.65; 95% CI, 0.62-0.68), and physician's specialty of general surgery (aOR, 0.86; 95% CI, 0.80-0.91) were protective factors. Conclusions and Relevance: Physician offices and ASCs had much higher different-day procedure rates compared with HOPDs. This disparity may represent an opportunity for quality improvement and financial savings for common endoscopic procedures.

A randomized trial provided new evidence on the accuracy and efficiency of traditional vs. electronically annotated abstraction approaches in systematic reviews.

OBJECTIVES: Data Abstraction Assistant (DAA) is a software for linking items abstracted into a data collection form for a systematic review to their locations in a study report. We conducted a randomized cross-over trial that compared DAA-facilitated single-data abstraction plus verification ("DAA verification"), single data abstraction plus verification ("regular verification"), and independent dual data abstraction plus adjudication ("independent abstraction"). STUDY DESIGN AND SETTING: This study is an online randomized cross-over trial with 26 pairs of data abstractors. Each pair abstracted data from six articles, two per approach. Outcomes were the proportion of errors and time taken. RESULTS: Overall proportion of errors was 17% for DAA verification, 16% for regular verification, and 15% for independent abstraction. DAA verification was associated with higher odds of errors when compared with regular verification (adjusted odds ratio [OR] = 1.08; 95% confidence interval [CI]: 0.99-1.17) or independent abstraction (adjusted OR = 1.12; 95% CI: 1.03-1.22). For each article, DAA verification took 20 minutes (95% CI: 1-40) longer than regular verification, but 46 minutes (95% CI: 26 to 66) shorter than independent abstraction. CONCLUSION: Independent abstraction may only be necessary for complex data items. DAA provides an audit trail that is crucial for reproducible research.

Mortality by medication use among patients with inflammatory bowel disease, 1996-2003.

BACKGROUND & AIMS: Most previous population-based studies of mortality in inflammatory bowel disease (IBD) did not account for medication use. We evaluated mortality by IBD medication use among members of the Kaiser Permanente Northern California IBD Registry. METHODS: The retrospective, population-based cohort study included 9032 persons who received at least one inpatient or 2 outpatient diagnoses of IBD during 1996-2002. Age and sex standardized mortality ratios measured the associations between IBD and all-cause and cause-specific mortality. Age, sex, and smoking adjusted odds ratios measured the association of mortality by IBD medication use. RESULTS: Compared with health plan members without IBD, mortality was increased in patients with Crohn's disease (CD) (1.4; 95% confidence interval, 1.2-1.6) but not ulcerative colitis (UC) (1.0; 95% CI, 0.9-1.2). CD was associated with increased mortality from infectious and parasitic diseases (4.1; 95% CI, 1.7-8.5), septicemia (6.8; 95% CI, 2.2-15.8), small intestinal cancer (48.1; 95% CI, 5.8-17.4), respiratory diseases (1.9; 95% CI, 1.3-2.7), digestive diseases other than IBD (2.4; 95% CI, 1.0-4.8), and liver diseases (2.6; 95% CI, 1.0-5.3). UC was associated with increased mortality from digestive diseases other than IBD (3.9; 95% CI, 2.4-6.0). The relationship with CD mortality was 0.7 for aminosalicylates (95% CI, 0.5-1.1), 1.3 (95% CI, 0.9-1.9) for immunomodulators, and 1.0 (95% CI, 0.7-1.4) for corticosteroids. Among patients with UC, these odds ratios were 0.8 (95% CI, 0.5-1.1) for aminosalicylates, 0.5 (95% CI, 0.3-0.9) for immunomodulators, and 0.8 (95% CI, 0.6-1.1) for corticosteroids. CONCLUSIONS: Mortality is increased in CD. Infections, respiratory diseases, and digestive diseases are important specific causes of death. IBD medication use has varying associations with mortality.

Variation in Emergency Department vs Internal Medicine Excess Charges in the United States.

Importance: Uninsured and insured but out-of-network emergency department (ED) patients are often billed hospital chargemaster prices, which exceed amounts typically paid by insurers. Objective: To examine the variation in excess charges for services provided by emergency medicine and internal medicine physicians. Design, Setting, and Participants: Retrospective analysis was conducted of professional fee payment claims made by the Centers for Medicare & Medicaid Services for all services provided to Medicare Part B fee-for-service beneficiaries in calendar year 2013. Data analysis was conducted from January 1 to July 31, 2016. Main Outcomes and Measures: Markup ratios for ED and internal medicine professional services, defined as the charges submitted by the hospital divided by the Medicare allowable amount. Results: Our analysis included 12 337 emergency medicine physicians from 2707 hospitals and 57 607 internal medicine physicians from 3669 hospitals in all 50 states. Services provided by emergency medicine physicians had an overall markup ratio of 4.4 (340% excess charges), which was greater than the markup ratio of 2.1 (110% excess charges) for all services performed by internal medicine physicians. Markup ratios for all ED services ranged by hospital from 1.0 to 12.6 (median, 4.2; interquartile range [IQR], 3.3-5.8); markup ratios for all internal medicine services ranged by hospital from 1.0 to 14.1 (median, 2.0; IQR, 1.7-2.5). The median markup ratio by hospital for ED evaluation and management procedure codes varied between 4.0 and 5.0. Among the most common ED services, laceration repair had the highest median markup ratio (7.0); emergency medicine physician review of a head computed tomographic scan had the greatest interhospital variation (range, 1.6-27.7). Across hospitals, markups in the ED were often substantially higher than those in the internal medicine department for the same services. Higher ED markup ratios were associated with hospital for-profit ownership (median, 5.7; IQR, 4.0-7.1), a greater percentage of uninsured patients seen (median, 5.0; IQR, 3.5-6.7 for ≥20% uninsured), and location (median, 5.3; IQR, 3.8-6.8 for the southeastern United States). Conclusions and Relevance: Across hospitals, there is wide variation in excess charges on ED services, which are often priced higher than internal medicine services. Our results inform policy efforts to protect uninsured and out-of-network patients from highly variable pricing.

Surgeon-Level Variation in Postoperative Complications.

BACKGROUND: Variation in surgical outcomes is often attributed to patient comorbidities and the severity of underlying disease, but little is known about the extent of variation in outcomes by surgeon and the surgeon factors that are associated with quality. METHODS: Using the Maryland Health Services Cost Review Commission database, we evaluated risk-adjusted postoperative events by surgeon. Operations studied were elective laparoscopic and open colectomy procedures for colon cancer performed over a 2-year period (July 2012-September 2014). Postoperative events were defined using the Agency for Healthcare Research and Quality Patient Safety Indicators. Surgeons performing fewer than ten procedures during the study period were excluded. Logistic regression and post-estimation were used to calculate an observed-to-expected (O/E) ratio of postoperative complications for each surgeon, adjusting for patient and surgeon characteristics. RESULTS: A total of 2525 patients underwent an elective colectomy during the study period by 276 surgeons at 44 hospitals. Postoperative complications varied more by surgeon (range 0 to 30.0 %) than by hospital (range 0 to 18.2 %). Surgeon-level use of laparoscopic surgery to perform colectomy ranged from 0 to 100 %. After risk adjustment with patient factors, surgeon experience, surgeon medical school, surgeon gender, and annual surgeon colectomy volume were not associated with postoperative complications. Surgeon use of laparoscopy was the strongest predictor of lower complications (vs fourth quartile of surgeons, first quartile OR = 0.47 (0.26-0.85); second quartile OR = 0.41 (0.22-0.73); and third quartile OR = 0.84 (0.52-1.36). CONCLUSIONS: Quality metrics in health care have been measured at the hospital level, but a greater quality improvement potential exists at the surgeon level. Awareness of this variation could better inform patients undergoing elective surgery and their referring physicians.

Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial.

BACKGROUND: Data abstraction, a critical systematic review step, is time-consuming and prone to errors. Current standards for approaches to data abstraction rest on a weak evidence base. We developed the Data Abstraction Assistant (DAA), a novel software application designed to facilitate the abstraction process by allowing users to (1) view study article PDFs juxtaposed to electronic data abstraction forms linked to a data abstraction system, (2) highlight (or "pin") the location of the text in the PDF, and (3) copy relevant text from the PDF into the form. We describe the design of a randomized controlled trial (RCT) that compares the relative effectiveness of (A) DAA-facilitated single abstraction plus verification by a second person, (B) traditional (non-DAA-facilitated) single abstraction plus verification by a second person, and (C) traditional independent dual abstraction plus adjudication to ascertain the accuracy and efficiency of abstraction. METHODS: This is an online, randomized, three-arm, crossover trial. We will enroll 24 pairs of abstractors (i.e., sample size is 48 participants), each pair comprising one less and one more experienced abstractor. Pairs will be randomized to abstract data from six articles, two under each of the three approaches. Abstractors will complete pre-tested data abstraction forms using the Systematic Review Data Repository (SRDR), an online data abstraction system. The primary outcomes are (1) proportion of data items abstracted that constitute an error (compared with an answer key) and (2) total time taken to complete abstraction (by two abstractors in the pair, including verification and/or adjudication). DISCUSSION: The DAA trial uses a practical design to test a novel software application as a tool to help improve the accuracy and efficiency of the data abstraction process during systematic reviews. Findings from the DAA trial will provide much-needed evidence to strengthen current recommendations for data abstraction approaches. TRIAL REGISTRATION: The trial is registered at National Information Center on Health Services Research and Health Care Technology (NICHSR) under Registration # HSRP20152269: https://wwwcf.nlm.nih.gov/hsr_project/view_hsrproj_record.cfm?NLMUNIQUE_ID=20152269&SEARCH_FOR=Tianjing%20Li . All items from the World Health Organization Trial Registration Data Set are covered at various locations in this protocol. Protocol version and date: This is version 2.0 of the protocol, dated September 6, 2016. As needed, we will communicate any protocol amendments to the Institutional Review Boards (IRBs) of Johns Hopkins Bloomberg School of Public Health (JHBSPH) and Brown University. We also will make appropriate as-needed modifications to the NICHSR website in a timely fashion.

A population-based evaluation of severity and mortality among transferred patients with acute pancreatitis.

OBJECTIVES: This study aimed to compare severity of acute pancreatitis (AP) and mortality rates between transferred and nontransferred patients and to determine the factors that influence the decision to transfer. METHODS: A retrospective analysis coding a statewide administrative database in Maryland was conducted. Severity was defined by presence of organ failure (OF), need for intensive care unit (ICU), mechanical ventilation (MV), or hemodialysis. RESULTS: There were 71,035 discharges for AP, with 1657 (2.3%) patient transfers. Transferred patients had more multisystem OF (5.6% vs 1.2%), need for ICU (22.8% vs 4.3%), MV (13.1% vs 1.4%), hemodialysis (4.2% vs 2.7%), and higher mortality (6.1% vs 1.1%) compared with nontransferred patients (P < 0.0001). After adjusting for disease severity, mortality was similar between the transferred patients and the nontransferred patients (OR, 1.37; 95% confidence interval, 0.96-1.97). Younger (OR, 0.99), African American (OR, 0.55), and uninsured (OR, 0.46) patients were less likely to be transferred, whereas patients with multisystem OF (OR, 3.5), need for ICU (OR, 2.3), or MV (OR, 2.1) were more likely to be transferred (P < 0.0001). CONCLUSIONS: Transferred patients with AP have more severe disease and higher overall mortality. Mortality is similar after adjusting for disease severity. Disease severity, insurance status, race, and age all influence the decision to transfer patients with AP.

Comparative effectiveness of strategies to prevent weight gain among women with and at risk for breast cancer: a systematic review.

BACKGROUND: Obesity affects cancer risk and treatment outcomes. Preventing weight gain may prevent some cancers, improve cancer outcomes, reduce cancer recurrence and increase cancer-related survival. We performed a systematic review to identify strategies to prevent weight gain in individuals with or at risk for breast cancer. FINDINGS: We included 2 studies from 27,879 citations. In premenopausal women at risk for breast cancer, a low fat diet prevented weight gain at 12 months. Among women with breast cancer, effective strategies to prevent weight gain included low-fat dietary counseling with self-management techniques. One trial reported on cancer outcomes, mortality and adverse events. Low-fat dietary counseling wilth self-management techniques lowers the risk breast cancer relapse by 24% compared with less intensive counseling with maintenance of nutritional status goal. There was no difference in overall mortality and no adverse events were observed. CONCLUSION: Limited evidence suggests that women with or at risk for breast cancer may successfully employ dietary and exercise strategies to prevent weight gain for at least one year. Low fat dietary counseling may improve cancer outcomes in women with breast cancer. Future studies should confirm these findings and evaluate the impact of weight gain prevention on cancer incidence, recurrence and survival.

A population-based study of severity in patients with acute on chronic pancreatitis.

OBJECTIVES: The objectives of this study were to evaluate the severity of patients with acute pancreatitis (AP) on chronic pancreatitis (CP) and compare this to patients with AP without CP. METHODS: The Maryland Health Services database was queried for all adult inpatient discharges with a primary diagnosis of AP from 1994 to 2010. Acute pancreatitis on CP and AP without CP were defined by the presence of the associated diagnosis code for CP. Severity was defined as organ failure, intensive care unit stay, or mortality. RESULTS: Acute pancreatitis on CP accounted for 13.7% of all AP discharges (9747/70,944). The proportion of AP-on-CP discharges doubled during the study period (8.8% to 17.6%; P < 0.0001). When compared with patients with AP without CP, AP-on-CP patients were younger, were more likely to be male and black, had higher rates of alcohol and drug abuse, and had less severe disease with lower rates of mortality, organ failure, need for mechanical ventilation, and intensive care unit stay. Among AP-on-CP patients, significant predictors of severity included advanced age, weight loss, and 2 or more comorbidities. CONCLUSIONS: Patients with AP on CP have less severe disease than do those with AP without CP. Weight loss, advanced age, and comorbidity increase the risk of severity in patients with AP on CP.