Figure 4.

Flowchart to assess added value of an outcome adjudication committee in trials with prospective randomized open blinded end point (PROBE) design. Flowchart for differential misclassification (A) and nondifferential misclassification (B). *The likelihood of unblinding during outcome assessment is low. †The likelihood of unblinding during outcome assessment is high. ‡The likelihood of unblinding is lower for a central assessor than for on-site assessors. §The acceptable rate of correctly indicated treatment allocations by the assessor depend on the number of treatment arms. For example, in a trial with 2 treatment arms, the assessor should not be able to indicate the correct treatment allocation in significantly more than 50% of the cases.²⁷ ∥The nondifferential misclassification rate can be reduced by standardized outcome assessment. #The impact of nondifferential misclassification also depends on the size of the treatment effect.