Table 3.

Design and analysis characteristics of re-randomization trials

	Re-randomization trials (n = 5)
Explicitly stated that randomizations for the same patient were independent
No	5 (100)
Yes	0 (0)
Explicitly stated that patients were only re-randomized when the follow-up period from their previous enrollment was complete
No	5 (100)
Yes	0 (0)
Placed limit on maximum number of times each patient could be enrolled in the trial?
No	0 (0)
Yesa	1 (20)
Not reported	4 (80)
Based sample size calculation on a parallel group design
No	0 (0)
Yes	3 (60)
No sample size calculation reported	2 (40)
Analyzed data on a per-episode or per-patient basis
Per-episode	5 (100)
Per-patient	0 (100)
Both	0 (100)
Did analysis account for correlation between treatment episodes from the same patient?
No (independence analysis)	5 (100)
Yes (e.g., GEE or mixed-effects models)	0 (0)
Did analysis adjust for any factors associated with re-randomization, such as episode number?
No	5 (100)
Yes	0 (0)
Reported the number of treatment episodes for each patientb
No	2 (40)
Yes	3 (60)

^aOne trial used a limit of four treatment episodes.

^bIn two trials, all patients were enrolled for one or two treatment episodes. In the third trial, most patients were enrolled for one or two treatment episodes, and a small proportion of patients were enrolled for three or more episodes.