Beclomethasone dipropionate in microscopic colitis: Results of an exploratory open-label multicentre study (COLCO).

Background: Budesonide has been proven to be an effective treatment for microscopic colitis (MC). However, the two current commercially available preparations are released in the ileum. Beclomethasone dipropionate (Clipper®) is a synthetic corticosteroid with topical colonic release. Objective: This study aimed to explore whether an open-label treatment with beclomethasone dipropionate is an effective treatment for MC. Methods: Prospectively collected data of 30 patients from six centres were retrospectively analysed. All patients had a confirmed diagnosis of idiopathic MC (lymphocytic and collagenous colitis) and were symptomatic (i.e. ≥ 21 loose stools over a seven-day period). Treatment consisted of 10 mg beclomethasone daily for four weeks, followed by 5 mg daily for another four weeks. The primary end point was the proportion of patients in remission (i.e. a mean of < 3 stools/day and a mean of <1 watery stool per day) after an eight-week treatment period. Secondary end points were the proportion of patients responding to therapy at weeks 4 and 8, remission at weeks 4 and 12 and relapse at week 12. Reported adverse events were collected. Results: Overall, at week 8, remission was achieved in 70%, and 77% of patients were responding to treatment. After four weeks of treatment, 80% were responding, and 67% were in remission. Four weeks after stopping treatment, 60% were still in remission. Conclusion: This open-label study suggests that an eight-week course of beclomethasone could be a promising and relatively safe treatment for MC. A randomised controlled study is warranted.

Six-day postoperative impact of a standardized nurse observation and escalation protocol: a preintervention and postintervention study.

PURPOSE: The purpose of the study is to determine the impact of a standardized nurse observation and escalation protocol on observation frequency, the measurement of vital signs, and the incidence of in-hospital mortality and resurgery. METHODS: This is a preintervention and postintervention study by analysis of patient records for a 6-day postoperative period of all adult patients hospitalized in 4 hospital wards after surgery during a preintervention (November 2010 to March 2011; n = 2359) and postintervention (November 2011 to March 2012; n = 1888) period implementing a standardized nurse observation and escalation protocol including the Modified Early Warning Score. RESULTS: The mean patient observation frequency per nursing shift increased from 0.9076 (95% confidence interval [CI], 0.8921-0.9231) preintervention to 0.9940 (95% CI, 0.9708-1.0172; P < .001) postintervention and was lower in case of 6-day postoperative mortality (0.6686 [95% CI, 0.4984-0.8388] vs other patients 0.9475 [95% CI, 0.9340-0.9610]; P = .003) or resurgery (0.8402 [95% CI, 0.7894-0.8909] vs other patients 0.9564 [95% CI, 0.9378-0.9657]; P = .003). The mean number of vital signs measured per observation episode increased from a mean of 1.81 (95% CI, 1.79-1.83) preintervention to 2.45 (95% CI, 2.39-2.51; P < .001) postintervention. The relative risk reduction was 73.7% (95% CI, 22.8-91.0; P = .015) for 6-day postoperative in-hospital mortality and 30.9% (95% CI, 9.5-47.2; P = .007) for 6-day postoperative resurgery.

Use of interval-specific likelihood ratios improves clinical interpretation of serum FLC results for the diagnosis of malignant plasma cell disorders.

BACKGROUND: We examined whether the use of test result interval-specific likelihood ratios (LR) could improve the clinical interpretation of serum FLC kappa/lambda ratio for the diagnosis of malignant plasma cell disorders. METHODS: We calculated LRs for different FLC kappa/lambda intervals using sera from patients diagnosed with intact multiple myeloma (MM), light chain MM (LCMM), non-secretory MM (NSMM) and light chain amyloidosis (AL-A). Consecutive patients with a clinical suspicion of a monoclonal B-cell disorder that were diagnosed with MGUS or no B-cell monoclonal disorder served as the disease control group. RESULTS: Using LRs for different test result intervals, a distinction can be made between FLC kappa/lambda ratios that are within the normal diagnostic range, ratios that are inconclusive (1.66-5.0, LR+/-1), ratios that indicate the possible presence of a malignant plasma cell disorder (0.05-0.25 and >5.0-10, LR+/-10) and ratios that were suggestive of a malignant plasma cell disorder (<0.05 or >10; LR+/-50). A FLC kappa/lambda ratio within the normal diagnostic range virtually excluded LCMM and AL-A, but not intact MM or NSMM. CONCLUSIONS: Interpreting serum FLC kappa/lambda ratios using LRs for different result intervals improves the clinical interpretation for the diagnosis of malignant plasma cell disorders excluding plasmacytoma.