Background:

International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding.

Methods:

In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations.

Results:

Forty-three sites were randomized to the experimental (n = 21) or control (n = 22) groups. In our primary analysis, we compared patients before (experimental group: n = 402 patients; control group: n = 424 patients) and after (experimental group: n = 361 patients; control group: n = 389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p = 0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%.

Interpretation:

This national knowledge translation–based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).

Background

Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).

Methods

In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.

Results

A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03).

Conclusions

Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)

BACKGROUND:

The Rosemont criteria (RC) were recently proposed by expert consensus to standardize endoscopic ultrasound (EUS) features and thresholds for diagnosing chronic pancreatitis (CP); however, they are cumbersome and are not validated.

OBJECTIVE:

To determine interobserver agreement between RC and conventional criteria (CC), and to assess intertest agreement in the diagnosis of CP.

METHODS:

Thirty-six consecutive patients who underwent EUS for abdominal pain or pancreatitis were retrospectively reviewed. Anonymized images were independently chosen as best representations of the pancreatic body and reviewed by three experts who recorded the presence of CC and RC features. Agreement (proportion and kappa statistic) between CC and RC was calculated. Interobserver agreement within the CC and RC was assessed. Secondary comparisons with endoscopic retrograde cholangiopancreatography were made where available.

RESULTS:

Using CC, 60 readings (83.3%) were negative for CP, while 12 readings (16.7%) were positive. Using RC, 59 readings (81.9%) were negative for CP, while 13 (18.1%) were positive. The weighted kappa for interobserver agreement for CC (four categories: normal/low probability, indeterminate, high probability or calcific) was 0.50, with 80.0% overall agreement, versus 0.27 and 68.1% for the four RC categories (normal, indeterminate, suggestive of and consistent with). Agreement on a positive diagnosis with CC was 86.1% (P=0.38 [McNemar’s exact test]), with a kappa of 0.47; for RC, agreement was lower at 80.6% (P=0.016 [McNemar’s exact test]), with a kappa of 0.38. For patients who underwent endoscopic retrograde cholangiopancreatography (n=12), false-negative and false-positive rates between CC and RC did not appear to be different.

CONCLUSIONS:

The RC do not appear to achieve the goals of improving accuracy and interobserver agreement for diagnosing CP.

Background

Endoscopic ultrasonography (EUS) is useful in determining mediastinal lymph node (LN) metastases in patients undergoing staging for lung cancer. However, fine needle aspiration (FNA) of LNs is often performed only if suspicious features are present. The utility of individual LN features in predicting malignant cytology remains unclear.

Objective

To evaluate the utility of EUS LN features for predicting malignant cytology.

Design

Prospective observational study.

Setting

Two tertiary care centers in USA.

Interventions

425 patients with primary lung cancer underwent EUS. All mediastinal LNs were described according to size, shape, echogenicity, and edge characteristics. FNA was performed on LNs with any features suggestive of malignancy. EUS-FNA cytology was classified as benign or abnormal (suspicious/malignant). The utility of LN features in predicting malignant cytology were determined and further analyzed by logistic regression and a predictive model was established.

Results

EUS detected 836 LNs in 425 patients, and FNA was obtained in 698. On multivariable analysis, only round shape, short axis >8.3 mm, and sharp margins were predictive of malignant cytology. According to the predictive model, the calculated probability of having malignancy is less than 4% (95% CI 0.022-0.064) when none of the LN features are present, and 63% (95% CI, 0.517-0.722) when all features were seen.

Limitations

No surgical histology as gold standard.

Conclusions

Among patients with lung cancer, EUS features of round shape, sharp margins and short axis > 8.3 mm are significant predictors of malignancy. The probability of malignancy is low when none of the features are present.

AIM: To evaluate the reliability of an instrument that measures disability arising from episodic abdominal pain in patients with suspected sphincter of Oddi dysfunction (SOD).

METHODS: Although several treatments have been utilized to reduce pain and associated disability, measurement tools have not been developed to reliably track outcomes. Two pilot studies were conducted to assess test-retest reliability of a newly developed instrument, the recurrent abdominal pain intensity and disability (RAPID) instrument. The RAPID score is a 90-d summation of days where productivity for various daily activities is reduced as a result of abdominal pain episodes, and is modeled after the migraine disability assessment instrument used to measure headache-related disability. RAPID was administered by telephone on 2 consecutive occasions in 2 consenting populations with suspected SOD: a pre-sphincterotomy population (Pilot I, n = 55) and a post-sphincterotomy population (Pilot II, n = 70).

RESULTS: The average RAPID scores for Pilots I and II were: 82 d (median: 81.5 d, SD: 64 d) and 48 d (median: 0 d, SD: 91 d), respectively. The concordance between the 2 assessments for both populations was very good: 0.81 for the pre-sphincterotomy population and 0.95 for the post-sphincterotomy population.

CONCLUSION: The described pilot studies suggest that RAPID is a reliable instrument for measuring disability resulting from abdominal pain in suspected SOD patients.

Meta-analytic methods for diagnostic test performance, Bayesian methods in particular, have not been well developed. The most commonly used method for meta-analysis of diagnostic test performance is the Summary Receiver Operator Characteristic (SROC) curve approach of Moses, Shapiro and Littenberg. In this paper, we provide a brief summary of the SROC method, then present a case study of a Bayesian adaptation of their SROC curve method that retains the simplicity of the original model while additionally incorporating uncertainty in the parameters, and can also easily be extended to incorporate the effect of covariates. We further derive a simple transformation which facilitates prior elicitation from clinicians. The method is applied to two datasets: an assessment of computed tomography for detecting metastases in non-small-cell lung cancer, and a novel dataset to assess the diagnostic performance of endoscopic ultrasound (EUS) in the detection of biliary obstructions relative to the current gold standard of endoscopic retrograde cholangiopancreatography (ERCP).

Squamous cell carcinoma of the pancreas has been sparsely described since the 1940s, and generally has a poor prognosis. Herein, we present a case of primary squamous cell carcinoma of the pancreas with liver metastasis, both confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). To the best of our knowledge, this is the first case report in literature utilizing EUS-FNA for a cell-type specific diagnosis of primary pancreatic squamous cell carcinoma with a liver metastasis.

BACKGROUND:

With the increase in the use of endoscopic retrograde cholangiopancreatography (ERCP) (necessitating real-time interpretation), it is unknown whether post-ERCP radiologist reporting is still necessary or helpful.

OBJECTIVES:

To determine the rate of discrepancy of results, and the rate of clinically relevant misses and additions, by the radiology report in a blinded setting.

METHODS:

A retrospective analysis of the procedure and blinded postprocedure radiology reports of 100 consecutive ERCP cases was performed. A list of clinically relevant pathology and subgroups was made a priori. Discrepancies are described as proportions, with 95% CIs. The radiology yield regarding pathology that was clearly demonstrated at ERCP (bile leaks and stones removed) was calculated. Clinical follow-up was used to clarify additional abnormalities reported by radiology.

RESULTS:

Clinically relevant discrepancies in report pairs occurred in 29.0% of cases (95% CI 20% to 39%), or 40.0% if discrepancies regarding bile duct dilation are considered (95% CI 30% to 50%). In 15 of 30 cases (50.0% [95% CI 31% to 69%]) in which bile duct stones were removed, the radiologist did not report a stone. The radiologist did not report five of eight bile leaks (62.5% [95% CI 24% to 91%]). In seven cases (7.0% [95% CI 2.9% to 13.9%]), an additional abnormality was noted by radiology, including a biliary stricture, bile duct and pancreatic duct stones, as well as sclerosing cholangitis. However, during a mean follow-up period of 5.6 months, it appeared that these radiology interpretations were likely incorrect. Discrepancy rates did not vary among the ERCP attendings or by radiology volume.

CONCLUSIONS:

Discrepancies between endoscopists’ and radiologists’ ERCP reports are common. Blinded radiology interpretation frequently misses important pathology, and falsely positive additional diagnoses may be made.

Background

Computerized tomographic (CT) colonography is a potential alternative to colonoscopy for colorectal cancer screening. Its main advantage, a better safety profile, may be offset by its limitations: lower sensitivity, need for colonoscopy in cases where results are positive, and expense.

Methods

We performed an economic evaluation, using decision analysis, to compare CT colonography with colonoscopy for colorectal cancer screening in patients over 50 years of age. Three-year outcomes included number of colonoscopies, perforations and adenomas removed; deaths from perforation and from colorectal cancer from missed adenomas; and direct health care costs. The expected prevalence of adenomas, test performance characteristics of CT colonography and colonoscopy, and probability of colonoscopy complications and cancer from missed adenomas were derived from the literature. Costs were determined in detail locally.

Results

Using the base-case assumptions, a strategy of CT colonography for colorectal cancer screening would cost $2.27 million extra per 100 000 patients screened; 3.78 perforation-related deaths would be avoided, but 4.11 extra deaths would occur from missed adenomas. Because screening with CT colonography would cost more and result in more deaths overall compared with colonoscopy, the latter remained the dominant strategy. Our results were sensitive to CT colonography's test performance characteristics, the malignant risk of missed adenomas, the risk of perforation and related death, the procedural costs and differences in screening adherence.

Interpretation

At present, CT colonography cannot be recommended as a primary means of population-based colorectal cancer screening in Canada.