All the following are true in a randomized control trial (RCT) except –
Correct Answer: The drop-outs from the trial should be excluded from the analysis
Description: Ans. is 'd' i.e., The dropouts from the trial should be excluded from the analysis There is confusion about option c and d. But after reading following text you will not have any confusion. Option 'c' o As I have explained in previous explanation sample size depends upon underlying expected event rate in the control group. o The underlying expected event rate is established usually from previous studies, including observational coho study. So, the expected event rate will depends on the hypothesis made by previous study e.g., Coho study. o As the expected event rate is one of the component to calculate sample size, previously made hypothesis will determine the sample size (see above explanation). Option `d' Many subjects under study do not come for follow up, i.e., they dropout. This may cause misleading aifacts. o To avoid this intention to treat trial (intention to treat analysis) approch is utilized. "Intention to treat" is a strategy for the analysis of randomized control trials that compares patients in the groups to which they were originally randomly assigned. o Everyone who begins the treatment is considered to be a pa of the trial, whether they finish or not (dropouts not excluded). So, intentention to treat analysis avoids the effects of : - i) Crossover --> Because patients are compared in the groups to which they were originally randomly assigned. ii)Dropouts --> Everyone considered to be a pa of study whether they finish treatment or not. About remaining two options o Basline characteristics of study and control groups should be similar. Randomization is the statistical procedure in on RCT by which an attempt is made to make the study and control group comparable. o Double blinding minimizes both investigator bias and subject bias.
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