In the majority of studies, no Data and Safety Monitoring Board (DSMB) is either needed or instituted. We report an investigator initiated study where we should have done this earlier than we did and discuss the lessons we learned. The EOLUS study was a single center, randomized controlled trial of the initiation of chronic home mechanical ventilation (HMV) at home. Typical indications for HMV ...

The physicochemical properties of aluminum salts are key determinants of their resultant adjuvanticity in vivo when administered as part of a vaccine. While there are links between particle size and the efficacy of the immune response, the limited literature directly characterizing the PSD of aluminum adjuvants has stymied the elucidation of such a relationship for these materials. Hence, this ...

INTRODUCTION Acute lung injury (ALI) is a devastating condition that places a heavy burden on public health resources. Although the need for effective ALI prevention strategies is increasingly recognised, no effective preventative strategies exist. The Lung Injury Prevention Study with Aspirin (LIPS-A) aims to test whether aspirin (ASA) could prevent and/or mitigate the development of ALI. ME...

Multi-input multi-output (MIMO) dynamic matrix control (DMC) technique is applied to control steam temperatures in a large-scale ultrasupercritical once-through boiler–turbine system. Specifically, four output variables (i.e., outlet temperatures of platen superheater, finish superheater, primary reheater, and finish reheater) are controlled using four input variables (i.e., two spray valves, b...

PLAIN ENGLISH SUMMARY Health technology appraisal involves reviewing the findings from clinical trials and economic data to produce guidance on how health technology should be used. This task is carried out by appraisal committees in NICE. One of the several ways in which patients can feed their views into these committees is via a written patient statement. We asked nine committee members abou...

ublic reporting of mortality following percutaneous coronary intervention is now mandated in 3 US states (New York, Massachusetts, and Washington) and has been associated with improvement in outcomes. However, there is evidence of growing risk aversion among percutaneous coronary intervention operators in public reporting states, manifest as avoidance of treating those critically ill patients w...

BACKGROUND Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention. AIMS To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT. METH...

We thank Drs Jenkins and Beasley for their comments in the recent editorial regarding tiotropium (SPIRIVA). Preceding the Singh et al analysis cited by the authors, Boehringer Ingelheim (BI) had analysed both the tiotropium HandiHaler and Respimat pooled datasets using patient-level data on-treatment as well as including vital status. The results showed a nominally statistically significant red...

Ethical reasons are presented for requiring 1) that a proposal for a clinical trial should be accompanied by a thorough review of all previous trials that have examined the same and closely related questions, and 2) that a trial should be approved by a research ethics committee only if the investigator undertakes to register it in an appropriate register of clinical trials as soon as one exists.

Background: Cellulite is a common disease whose exact mechanism is unknown. This study was aimed to assess the safety and efficacy of an anti-cellulite preparation compared with placebo in a randomized double-blind, right-left comparison clinical trial.Methods: Twelve healthy women aged 22 to 58 years with mild to moderate cellulite on their thighs and buttocks participated in this trial. The a...