Abbreviations: CI, confidence interval; EOT, end of therapy; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; PICO, Patient/Population, Intervention/Indicator, Comparator/Control, Outcome; RCT, randomized controlled trial; RR, risk ratio; SOC, standard of care.

^aDespite many subgroup analyses without prior stratification of the randomization reported in the study, Cornely et al (2012) [15] and Louie et al (2011) [14] were not considered at high risk of bias since the complete modified intention-to-treat population was used in our analysis. The Guery et al (2018) [16] study was at high risk of bias for self-reported outcomes due to potentially inadequate blinding. Guery et al (2018) and Mikamo et al (2018) [17] were considered at unclear risk of bias for possible attrition bias (significant loss to follow-up for the primary endpoint with imputation of missing data with failure for sustained clinical response).

^bNot rated down for indirectness since patients with an initial CDI episode represented most patients included in the 4 reported (between 80% and 85%).

^cInitial clinical cure was defined as no diarrhea for 2 consecutive days after completion of SOC antibiotic therapy administered for ≤16 days.

^dOutcome determined as the primary endpoint in Cornely et al (2012) [15] and Louie et al (2011) [14] (while Mikamo et al (2018) [17] used global cure rate). Not rated down for imprecision, based on their prespecified margin of noninferiority of −10% (1-sided lower 97.5% CI).

^eThe 95% CI includes the potential for both appreciable benefit as well as appreciable harm (ie, includes the null value) and few events reported do not meet the optimal information size.