There is also a defined process to ‘break the blind’ of a single participant when required. Unblinding a trial is a necessary process to protect participants in the event of medical or safety reasons. The process of unblinding is planned and included in the study protocol. Unblinding is the disclosure to the participant and/or study team of which treatment the participant received during the trial. Participant, clinicians / data collectors and outcome adjudicators / data analysts are all unaware of the treatment the participant receives Double blind is the term researchers frequently use, and readers frequently accept, as a key marker of validity of a randomised controlled trial (RCT). The participant and the clinicians / data collectors are unaware of the treatment the participant receives Only the participant is unaware of the treatment they receive Table listing the different types of blinding TypeĪll parties are aware of the treatment the participant receives A trial in which no blinding is used and all parties are aware of the treatment groups is called open label or unblinded. Triple blinded studies also extend blinding to the data analysts. If both participants and study staff are blinded, it is called a double blind study. Types of blindingĪ clinical trial is called single blind when only one party is blinded, usually the participants.
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