I am analyzing a recently finished randomized controlled trial. One patient was randomized, completed her first visit and decided not to participate 1 day later. She also told me I was not allowed to perform follow-up or use the data she already shared for research.
This was before start of treatment....
So now I have 1 patient...with absolutely no information. She is not 'lost to follow-up'...but also included in a study which she does not wants to be included in. How do I go from here? It feels pointless to add this person in my analysis? As it is all missing data?
Hello Geertje,
It's certainly disappointing when participants withdraw from a study, but modern practice (and informed consent) dictate that we must honor their wish, and without consequence. While some might argue that prior data, given with (prior) consent, could be used, it's likely best to omit this case completely from your analysis.
Should it be the case that a disproportionate fraction of drop-out cases have come from one treatment condition/arm, this could be informative as to the acceptability of the treatment. If a sufficient number of drop-out cases occur, regardless of condition to which they were assigned, I think it would be acceptable to ask whether pre-treatment data were systematically related to study completion/non-completion status (as an aggregate analysis only, of course). This information might prove helpful to future researchers in the same area.
Good luck with your work.
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