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Table 4 Reported forms of departure from treatment protocol

From: Nonadherence to treatment protocol in published randomised controlled trials: a review

 

Number (%)

Reported some form of nonadherence to treatment protocol a

98

Participants who did not initiate allocated treatment

39

Participants with incomplete treatment (among those who initiated allocated treatment)

78

Participants who switched trial treatments

12

Participants who started open label treatment (not as per protocol)

7

Participants who started disallowed or non-trial treatment

4

Evidence of contamination between treatment groups

3

Other forms of nonadherence to treatment dose or schedule

23

Nonadherence on the part of treatment providers

12

Did not report any nonadherence to treatment protocol

2

Percentage of patients experiencing or displaying some form of nonadherence to treatment protocol

 

None reported

2

0 to 5%

23

5 to 10%

10

10 to 20%

22

20 to 30%

11

30 to 50%

12

>50%

9

>0% but unclearb

11

  1. aTrial publications may have reported the number of participants in more than one of the categories listed. bFor example, trial report states only that the treatment providers were not adherent to some degree, or it was not possible to distinguish withdrawal from treatment for legitimate reasons (for example, death or treatment changes permitted by protocol following adverse events) from withdrawal due to nonadherence.