In conjunction with the ongoing BAG-RECALL study, as well as the prior B-Unaware study, we will conduct pre-specified meta-analyses of approximately 38,000 patients prospectively studied at 4 institutions.
The interviewers were unaware of study hypotheses and case-control status of study participants as they used/applied the structured questionnaires.
[ 37] To ensure that participants remain unaware of study group, it is necessary to carefully describe the study to patients.
Clinical outcomes data for each patient were collected by a member of the research team who was unaware of study group allocation and then verified by the senior investigator who was also unaware of the study group allocation.
Carotid ultrasound evaluation was performed by two trained investigators who were unaware of study protocol.
All cognitive evaluations were made by trained physicians who were unaware of study protocol.
Moreover osteopaths were unaware of study design and outcomes.
The staff were unaware of study group status.
These were verified, in accordance with predefined criteria, by a member of the research team unaware of study group allocation.
One author (GHG) made these decisions by using blinded copies of articles while unaware of study outcomes.
All end points were classified by an independent end point classification committee whose members were unaware of study group assignments.
