In many settings of experimental studies, people have the assumption that the new/novel intervention is promising and that only positive things can happen when in reality the intervention is capable of having deleterious effects. While risks and benefits and even this idea of therapeutic misconception can be communicated to a participant or patient and their family, it does not mean that their belief will change.
For consent to participation in this study, I imagine that one would have to explain to patients’ families and to patients that they may be randomized to a group where they either have higher or lower oxygenation goals. Most people likely understand that oxygen is needed to survive and too little oxygen can kill people.
How was this scenario presented to patients and families such that they were agreeable to participating in the study and were not biased in what group they wanted to be in or worried about possible outcomes? Additionally, does this have any relation to the four participants who were excluded after randomization due to withdrawn consent or not meeting eligibility criteria?
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