Key result
Blinding in trials of interventional procedures is feasible and worthwhile, utilizing various strategies to simulate active procedures and prevent bias associated with subjective outcomes.
Blinding in interventional and surgical trials is feasible and essential to prevent bias and patient drop-out in the control arm.
Blinding of patients, assessors, and caregivers is feasible in interventional trials; extends prior surgical RCT reviews with practical placebo strategies.
In this paper, we use evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible. We give examples of ingenious strategies that have been used to simulate the active procedure and to make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and what types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.
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Wartolowska et al. (2018) conducted a review in Interventional procedures. Blinding vs. Open-label trials was evaluated. Blinding in trials of interventional procedures is feasible and worthwhile, utilizing various strategies to simulate active procedures and prevent bias associated with subjective outcomes.
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