okay but where in the question is it asking whether it's intention to treat or per protocol or as treated???
are we to assume its ITT if they don't mention anything or the part of the question that says "primary analysis" the giveway to ITT??
I got this one wrong, but based on the ITT perspective others mentioned, maybe the "in their primary analysis" part of the question is a tip off. They'd start with including them in the original groups and then do additional analysis to try and tease out the impact? IDK
https://slideplayer.com/slide/5957557/
The first slide
By default you should use intention to treat analysis b/c it's the most conservative.
said simply, in biomedical research, the default is to use an intention-to-treat analysis instead of an as-treated analysis.
I find this counterintuitive but such is life.
I didn't think much on this question for me the key was the word random- HTN pts were randomly given A or B medication. Don't know which so if people in the study leave or dont take medicine. I dont care. I am including all random data regardless!
Can someone please explain this to me? I don't understand why starting the other drug would not count as exclusion criteria?
submitted by โosgoodschlatter10(41)
The question stem mentions 3 subsets of patients: a) Some patients were inconsistent with taking medication or "not adherent" to medication regimen b) Some patients discontinued the drug they were randomized to completely c) A subset of these patients in point 'b', who stopped the medication were then prescribe the medication from the comparison group.
The ultimate question however is regarding whether patients under point 'a'(as above) should be included or excluded.
Ideally this depends upon your study protocol. In essence you may have an 'Intention to treat protocol' or an 'Adherent protocol'. As part of an adherent protocol you only include patients or study subjects (as referred to in basic science research) you only include those patients that strictly followed the protocol and exclude everyone else. This is mostly how basic science protocols are designed.
With clinical research however being completely per protocol is difficult and that's where the intention-to-treat protocol apples. This is to accommodate the subjective nature of human subjects in clinical research. Following up with human subjects is but obvious harder than manually handling mice or pigs in the lab. So in such cases as long as the study team has followed protocol in contacting the patient and playing their role all patient data can be included even if there are some minor protocol deviations due to logistical issues. All these deviations need to be reported to the IRB ofcourse and specified in the manuscript in the most appropriate manner.