I am designing a pragmatic clinical trial which involves a controlled drug group and an acupuncture group. According to the literature, the standard course of treatment with this medication is one week. However, previous studies have shown that acupuncture for this condition generally requires a two-week course of treatment. Can I use a one-week course of medication and a two-week course of acupuncture as a control? (The primary assessment endpoint was set uniformly at week two.)
I am not an expert in this, but my understanding of a 'pragmatic' trial is that you are comparing existing usual practices, so if the protocol you have is for a 2 week course for usual treatment with this method ( are there studies that justify that, or is that just an arbitrary figure that has been plucked out of usual practice ? ) then that would be what you would compare. Possibly look further into the justifications for these time periods, what research or studies support or justify these time periods recommended, or is it simply usual practice but unjustified ? If it is simply usual practices then that is what you should compare. Find someone who has published pragmatic trials and contact them for their views on this and also someone well versed in research methods.
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