Table 4.
Study | Reason | Type | Differences in inference |
---|---|---|---|
Per protocol | |||
Acolet et al.[37] | Exploratory | Binary | PP* not shown, stated similar to ITT* |
Auger et al. [38] | Unclear | Binary | ITT not done |
Beer et al. [39] | Unclear | Binary | Evidence of effect with PP, but not with ITT |
Bickman et al.[40] | Unclear | Binary | No change |
Boorsma et al.[24]c | Unclear | Binary | Evidence of effect with PP, but not with ITT |
Cooke et al. [41] | Unclear | Binarya | ITT not done |
Cutrer et al. [42] | Unclear | Binary | ITT not done |
Dangour et al. [25]c | Exploratory | Binary | No change |
Estrada et al.[43] | Unclear | Binary | No change |
Luoto et al.[26]c | Unclear | Binary | No change |
Neuzil et al.[23]c,d | Safety | Binary | No change |
Smith et al. [44] | Additional analyses | Binary | No change |
Tagbor et al. [28]d | Unclear | Binaryb,d | Evidence of effect with PP, but not with ITT |
Taveras et al. [45] | Unclear | Binary | No change |
Zurovac et al.[46] | Unclear | Binary | No change |
As-treated | |||
Stiell et al. [47] | Additional analyses | Binary | No change |
Zamorano et al. [27]c | Efficacy | Binary | ITT not done |
LaBella et al. [48] | Unclear | Continuous | Evidence of effect with ITT, but not with AT |
Levine et al. [49] | Unclear | Continuous | AT not shown |
PP: Per protocol analysis, ITT: Intention to treat analysis
The threshold chosen to define the binary non-adherence was based on a previous study.
All possible definitions of binary adherence explored (> 1 dose,> 2 doses and full exposure)
Carried out a safety outcome analysis.
Failed to adjust for clustering in the analysis.