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NBME 22 Answers

nbme22/Block 4/Question#20 (35.7 difficulty score)
During a study of symptomatic proximal deep ...
Open-label clinical trial🔍
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 +3 
submitted by aesalmon(80),
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jackie_chan  How are we supposed to know in the question the patients and providers are aware that they know what they are being given? +  
haydenelise  I went back and forth about it, but in the end figured that they were aware since one regimen involved subQ injection + oral med and the other was subQ injection alone with no oral placebo. +2  



 +2 
submitted by asharm10(17),

When you are comparing the therapeutic effects of two drugs it's a clinical trial and when both the patients and providers know which drug it's open label. Clinical trial could be done between tx/control or tx/tx. It can't be crossover as there is no wash out phase




 +1 
submitted by hello(259),
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yWh itns' shit a rhtcoo ?tdusy

drdoom  This is a cohort study! (Since it involves splitting people into "groups"; group = cohort.) But the stem asks what "best describes" the design. So, yes, it's a cohort study but a more precise ("more specific") description is Open-label. In other words, "Open-label clinical trial" is a type of cohort study, and, in this case, "Open-label" is a more precise description of what is described in the stem. +6  
drdoom  For a more technical explanation of "Cohort studies", see the definition from the National Library of Medicine: https://meshb.nlm.nih.gov/record/ui?ui=D015331 +1  
angelaq11  It is a cohort, just as @drdoom said, but it isn't an "Observational" one. +2  
pg32  It's actually not a cohort study, imo. In a cohort you find people with an exposure and see if they develop some outcome. In this experiment, people were RANDOMLY ASSIGNED to the different exposures. That doesn't happen in cohorts. +7  
pg32  It may be a cohort in that these people are in groups, but for the purposes of Step 1, I don't think we will deal with typical "Cohort" studies in which participants are randomly assigned. +2  
ashli777  you don't administer an intervention in a cohort study, you just observe what happens. it is an observational study. +  
drdoom  ^ i retract my earlier subcomment! thanks @ashli777 and @pg32 — you guys are right that cohorts do not intervene! in two senses: (1) there is no treatment intervention and (2) there is no “assignment” intervention (either randomly or by selection; that is, investigators do not DESIGN or DETERMINE how groups are formed, even if that means random determination by computer). +  



 +0 
submitted by niboonsh(299),
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I ma n.cfsuonoi why nlwdtuo shti be a ssroc roev y?tdsu

shokay  there is no washout period and the order of drugs given isn't switched +7