Say someone runs an RCT and publishes results on the initial primary/secondary outcomes. Later, they publish another study on other outcomes not mentioned in the first publication. Is calling the second study an RCT accurate?
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was there a (published or registered) protocol with an analysis plan that included these outcomes? what did the protocol say about missing data?
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There was a registered protocol that did not initially include these outcomes until 90%+ of the sample was recruited. There was a published protocol but it was only published 6 years after the study started recruiting
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it almost sounds like you're talking about an ICU study; except the primary outcome wasn't also underpowered
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That 50% cases were missing [certain] data raises questions, including “where’s my red flag?”.
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Is this about masks?
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