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. Author manuscript; available in PMC: 2019 Apr 26.
Published in final edited form as: Clin Trials. 2018 Apr 2;15(3):294–304. doi: 10.1177/1740774518761666

Table 4.

Details of the adherence-adjusted analyses performed.

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

a

The threshold chosen to define the binary non-adherence was based on a previous study.

b

All possible definitions of binary adherence explored (> 1 dose,> 2 doses and full exposure)

c

Carried out a safety outcome analysis.

d

Failed to adjust for clustering in the analysis.