Example

See figure 2.421

 

Explanation

Some protocol deviations may be reported in the flow diagram (item 22a), for example, participants who did not receive the intended intervention. If participants were excluded after randomisation (contrary to the intention-to-treat principle) because they were found not to meet eligibility criteria, they should be included in the flow diagram. Use of the term “protocol deviation” in published articles is not sufficient to justify exclusion of participants after randomisation. The nature of the protocol deviation and the exact reason for excluding participants after randomisation should always be reported. Similarly, if participants did not complete the treatment intervention as allocated (ie, discontinued treatment), this should be reported by trial group, with reasons.

 

While attrition as a result of loss to follow-up is often unavoidable, it is important to report the number of participants who do not complete follow-up as planned; this should be reported by trial group along with reasons. For the primary outcome, loss to follow-up can be reported in the flow diagram.