Propofol or Ketofol for Procedural Sedation and Analgesia in Emergency Medicine - The POKER Study: A Randomized Double-Blind Clinical Trial
Usefulness Score: 3.5/5
Ann Emerg Med. 2016 Nov;68(5):574-582.
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regardless of whether they received or adhered to the allocated intervention, crossed over to other treatments, or were withdrawn from the study.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.