Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 2/5
Bateman DN, et al.
Lancet. 2014 Feb 22;383(9918):697-704
This 2×2 factorial, intention to treat, randomized controlled trial of paracetamol overdose showed a modified 12 h NAC protocol vs 20.25h protocol and ondansetron pre-treatment vs placebo causes less nausea and vomiting . It is an interesting precursor to further studies that will be necessary to ascertain the efficacy and safety of modified 12 h NAC treatment to protect patients from liver toxicity; i.e. not yet ready for prime time.
By: Dr. Noam Katz
(presented Feb 2014)
Epi lesson: Design of Clinical Trials
“Design” refers to the type of trial, such as parallel group or factorial, and the conceptual framework, such as superiority or non-inferiority. Trials with participants individually randomised to one of two “parallel” groups are well known but only about half of published trials have such a design. The main alternative designs are multi-arm parallel, crossover, cluster, and factorial designs. Also, most trials are set to identify the superiority of a new intervention, if it exists, but others are designed to assess non-inferiority or equivalence. These details should be described in the abstract.
By: Dr. Ian Stiell