I am designing a small RCT for pediatric depression. If participants need continued treatment after the intervention, and before 6-week follow-up measures are administered, ethically we will need to provide continued treatment and forgo follow-up data collection for that individual. Given our sample will be quite small (a total of 30 participants in the study), what would our options be in this scenario? Would imputation be a possibility if there are few such cases? Similarly, participants may drop out of our waitlist control group because they need immediate treatment. How have other researchers planned around these kind of ethical dilemmas in the grant proposal stage?
Hello, If any patient needs treatment, ethically, and morally the necessary treatment should be provided. The way to handle these type of situations in a trial have to be stated in the protocol before the start of the trial. The intention-to-treat analysis can be used in which you can compute the stats even after some participants opt out of the study for certain reasons. I have attached a link below to one such paper that explains it in detail. Hope this is helpful.
Intention-to-treat analysis in clinical trials: principles and practical importance - PubMed (nih.gov)
Check https://www.unicef-irc.org/publications/pdf/brief_7_randomized_controlled_trials_eng.pdf
Also check https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5765645/
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