A modified Glasgow Blatchford Score improves risk stratification in upper gastrointestinal bleed: a prospective comparison of scoring systems.

BACKGROUND: Several risk scoring systems exist for upper gastrointestinal bleed (UGIB). We hypothesised that a modified Glasgow Blatchford Score (mGBS) that eliminates the subjective components of the GBS might perform as well as current scoring systems. AIM: To compare the performance of the mGBS to the most widely reported scoring systems for prediction of clinical outcomes in patients presenting with UGIB. METHODS: Prospective cohort study from 9/2010 to 9/2011. Accuracy of the mGBS was compared with the full GBS, full Rockall Score (RS) and clinical RS using area under the receiver operating characterstics-curve (AUC). PRIMARY OUTCOME was need for clinical intervention: blood transfusion, endoscopic, radiological or surgical intervention. Secondary outcome was repeat bleeding or mortality. RESULTS: One hundred and ninety-nine patients were included. Median age was 56 with 40% women. Thirty-two per cent patients required blood transfusion, 24% endoscopic interventions, 0.5% radiological intervention, 0 surgical interventions, 5% had repeat bleeding and 0.5% mortality. PRIMARY OUTCOME: the mGBS (AUC 0.85) performed as well as the GBS (AUC = 0.86, P = 0.81), and outperformed the full RS (AUC 0.75, P = 0.005) and clinical RS (AUC 0.66, P < 0.0001). Secondary outcome: the mGBS (AUC 0.83) performed as well as the GBS (AUC 0.81, P = 0.38) and full RS (AUC 0.69, and outperformed the clinical RS (AUC 0.59, P = 0.0007). CONCLUSIONS: The modified Glasgow Blatchford Score performed as well as the full Glasgow Blatchford Score while outperforming both Rockall Scores for prediction of clinical outcomes in American patients with upper gastrointestinal bleed. By eliminating the subjective components of the Glasgow Blatchford Score, the modified Glasgow Blatchford Score may be easier to use and therefore more easily implemented into routine clinical practice.

Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.

BACKGROUND: Pancreatic enzyme supplementation is standard treatment for malabsorption caused by chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications to continue to market these agents because published data demonstrated variation in formulation, bioavailability and shelf-life while providing limited data about efficacy and safety. AIM: To review systematically the design and results of randomized, parallel-design trials of pancreatic enzyme supplements in chronic pancreatitis patients with steatorrhea. METHODS: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Two authors performed duplicate data extraction on study design, improvement in coefficient of fat absorption (CFA), diarrhoea and adverse events using pre-specified forms. Agreement between investigators for data extraction was greater than 95%. RESULTS: Of 619 articles found through literature searching, 20 potentially relevant articles were identified and four manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared with placebo, but fat malabsorption remained abnormal. Important differences in patient population, study endpoint, study design, pancreatic enzyme dosage and measurement of CFA were present across trials, which precluded comparison of different agents. CONCLUSIONS: Enzyme supplementation improves CFA compared to placebo, but may not abolish steatorrhoea.

The early prediction of mortality in acute pancreatitis: a large population-based study.

BACKGROUND: Identification of patients at risk for mortality early in the course of acute pancreatitis (AP) is an important step in improving outcome. METHODS: Using Classification and Regression Tree (CART) analysis, a clinical scoring system was developed for prediction of in-hospital mortality in AP. The scoring system was derived on data collected from 17,992 cases of AP from 212 hospitals in 2000-2001. The new scoring system was validated on data collected from 18,256 AP cases from 177 hospitals in 2004-2005. The accuracy of the scoring system for prediction of mortality was measured by the area under the receiver operating characteristic curve (AUC). The performance of the new scoring system was further validated by comparing its predictive accuracy with that of Acute Physiology and Chronic Health Examination (APACHE) II. RESULTS: CART analysis identified five variables for prediction of in-hospital mortality. One point is assigned for the presence of each of the following during the first 24 h: blood urea nitrogen (BUN) >25 mg/dl; impaired mental status; systemic inflammatory response syndrome (SIRS); age >60 years; or the presence of a pleural effusion (BISAP). Mortality ranged from >20% in the highest risk group to <1% in the lowest risk group. In the validation cohort, the BISAP AUC was 0.82 (95% CI 0.79 to 0.84) versus APACHE II AUC of 0.83 (95% CI 0.80 to 0.85). CONCLUSIONS: A new mortality-based prognostic scoring system for use in AP has been derived and validated. The BISAP is a simple and accurate method for the early identification of patients at increased risk for in-hospital mortality.

Adjusting for drop-out in clinical trials with repeated measures: design and analysis issues.

Recently, Wu and Follmann developed summary measures to adjust for informative drop-out in longitudinal studies where drop-out depends on the underlying true value of the response. In this paper we evaluate these procedures in the common situation where drop-out depends on the observed responses. We also discuss various design and analysis strategies which minimize the bias obtained with this type of drop-out. Of particular interest is the use of multiple measurements of the response at each visit to reduce bias. These strategies are evaluated with a simulation study. The results are highlighted with applications to both a hypertensive and a respiratory disease clinical trial, where multiple measurements of the primary response were made for all participants at each visit.