Nineteen volunteers (mean age, 39 ± 13 years; 8 men/11 women) were studied in a randomized (exposure sequence), single-blind (operator), crossover design.
Within the available timescale, it was found impossible to blind each operator to the other operator's markings.
Moreover, it seemed impossible to blind the operator or the patient in such a design.
It was not possible to blind the operator who made the measurements given the nature of the study because it would have been easy to recognise and understand the sequence of the digital models.
12 Three experienced endoscopists, blind to operator and patient, independently reviewed and scored a random sample of 188 recordings of study procedures.
This resulted in 10 H&E-stained sections, 5 of each hemisphere, for each mouse, which were subsequently masked and coded, blinding the operator to the clinical phenotype of the source mouse.
The study groups were numbered to blind the operators.
At each reading time point, the slides were relabeled and randomized by a person who was not involved in slide reading to blind the operators to slide identity.
The slides were relabeled by an independent investigator between the morning and afternoon sessions to blind the operators to the identity of the slides.
Nevertheless, we attempted to minimize the potential bias by blinding the operator of the algometer to the threshold values, while another observer recorded the values displayed on the LCD screen.
