Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 3.5/5
Usefulness Score: 3.5/5
This was a large multicenter double-blind RCT to compare ketafol in a 1:1 ratio to propofol failed to find a 10% absolute reduction in adverse respiratory events but did find significantly more transient hypotension in the propofol group. We felt that while both medications appear to be safe, JC attendees questioned desaturation (SpO2 ≤93%) as one of the composite outcomes as majority only required oxygen and airway repositioning. The study was not powered to detect differences in the more serious respiratory events (laryngospasm, aspiration or airway obstruction).
By: Dr. Talia Burwash-Brennan
Epi lesson
Modified Intention-to-treat (M-ITT) Analyses
Intention-to-treat (ITT) analyses are widely recommended as the preferred approach to the analysis of most clinical trials. The basic intention-to-treat principle is that participants in trials should be analysed in the groups to which they were randomized, regardless of whether they received or adhered to the allocated intervention, crossed over to other treatments, or were withdrawn from the study. Post-randomization exclusions may be acceptable when patients are inappropriately randomized into a clinical trial or when pre-randomization information on patients’ eligibility status is not available at the time of randomization. Such an approach is known as “modified intention-to-treat” analysis and must be pre-specified in the protocol. M-ITT is most likely to be seen in RCTs of critical situations, e.g. cardiac arrest.
Intention-to-treat (ITT) analyses are widely recommended as the preferred approach to the analysis of most clinical trials. The basic intention-to-treat principle is that participants in trials should be analysed in the groups to which they were randomized, regardless of whether they received or adhered to the allocated intervention, crossed over to other treatments, or were withdrawn from the study. Post-randomization exclusions may be acceptable when patients are inappropriately randomized into a clinical trial or when pre-randomization information on patients’ eligibility status is not available at the time of randomization. Such an approach is known as “modified intention-to-treat” analysis and must be pre-specified in the protocol. M-ITT is most likely to be seen in RCTs of critical situations, e.g. cardiac arrest.
Dr. Venkatesh Thiruganasambandamoorthy
