Summary of Findings Table, PICO 2: “In Patients With a Recurrent CDI Episode, Should Fidaxomicin be Used Rather Than Vancomycin?”
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With Vancomycin . | Risk Difference With Fidaxomicin (95% CI) . |
| Sustained response of CDI (follow-up: 30 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,b | 1.27 (1.05 to 1.54) | 558 per 1000 | 151 more per 1000 (from 34 more to 269 more) |
| Sustained response of CDI (follow-up: 90 days after EOT) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,c | 1.56 (.99 to 2.44) | 410 per 1000 | 229 more per 1000 (9 more to 449 more) |
| CDI initial clinical cured (follow-up: 2 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,e | 1.03 (.94 to1.14) | 853 per 1000 | 26 more per 1000 (58 fewer to 110 more) |
| Serious adverse events (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,f | .68 (.35 to 1.29) | 410 per 1000 | 132 fewer per 1000 (from 345 fewer to 80 more |
| All-cause mortality (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕⊕◯◯ Lowf | .81 (.20 to 3.38) | 103 per 1000 | 19 fewer per 1000 (from 150 fewer to 112 more) |
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With Vancomycin . | Risk Difference With Fidaxomicin (95% CI) . |
| Sustained response of CDI (follow-up: 30 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,b | 1.27 (1.05 to 1.54) | 558 per 1000 | 151 more per 1000 (from 34 more to 269 more) |
| Sustained response of CDI (follow-up: 90 days after EOT) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,c | 1.56 (.99 to 2.44) | 410 per 1000 | 229 more per 1000 (9 more to 449 more) |
| CDI initial clinical cured (follow-up: 2 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,e | 1.03 (.94 to1.14) | 853 per 1000 | 26 more per 1000 (58 fewer to 110 more) |
| Serious adverse events (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,f | .68 (.35 to 1.29) | 410 per 1000 | 132 fewer per 1000 (from 345 fewer to 80 more |
| All-cause mortality (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕⊕◯◯ Lowf | .81 (.20 to 3.38) | 103 per 1000 | 19 fewer per 1000 (from 150 fewer to 112 more) |
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.
aRated down for risk of bias for self-reported outcomes due to potentially inadequate blinding in Guery et al (2018) [16]. Despite subgroup analyses performed with prior stratification of the randomization in both Cornely et al (2012) [15] and Louie et al (2011) [14] studies, unclear risk of bias regarding the random sequence generation in 2 very small sample size subgroups (some concerns were expressed by the authors regarding nonsignificant variability of patients (baseline characteristics in the pooled per protocol analysis, but the pooled full dataset is not presented).
bSmall sample size not meeting the optimal information size, which suggests fragility of the estimate.
cFew events reported and small sample size not meeting the optimal information size, which suggests fragility of the estimate.
dInitial clinical cure was defined as no diarrhea for 2 consecutive days after completion of SOC antibiotic therapy administered for ≤16 days.
eThe 95% CI includes the potential for both appreciable benefit as well as appreciable harm (ie, includes the null value) and small sample size, which does not meet the optimal information size.
fThe 95% CI includes the potential for both appreciable benefit as well as appreciable harm (ie, includes the null value), very few events reported, and small sample size, which do not meet the optimal information size.
Summary of Findings Table, PICO 2: “In Patients With a Recurrent CDI Episode, Should Fidaxomicin be Used Rather Than Vancomycin?”
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With Vancomycin . | Risk Difference With Fidaxomicin (95% CI) . |
| Sustained response of CDI (follow-up: 30 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,b | 1.27 (1.05 to 1.54) | 558 per 1000 | 151 more per 1000 (from 34 more to 269 more) |
| Sustained response of CDI (follow-up: 90 days after EOT) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,c | 1.56 (.99 to 2.44) | 410 per 1000 | 229 more per 1000 (9 more to 449 more) |
| CDI initial clinical cured (follow-up: 2 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,e | 1.03 (.94 to1.14) | 853 per 1000 | 26 more per 1000 (58 fewer to 110 more) |
| Serious adverse events (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,f | .68 (.35 to 1.29) | 410 per 1000 | 132 fewer per 1000 (from 345 fewer to 80 more |
| All-cause mortality (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕⊕◯◯ Lowf | .81 (.20 to 3.38) | 103 per 1000 | 19 fewer per 1000 (from 150 fewer to 112 more) |
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With Vancomycin . | Risk Difference With Fidaxomicin (95% CI) . |
| Sustained response of CDI (follow-up: 30 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,b | 1.27 (1.05 to 1.54) | 558 per 1000 | 151 more per 1000 (from 34 more to 269 more) |
| Sustained response of CDI (follow-up: 90 days after EOT) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,c | 1.56 (.99 to 2.44) | 410 per 1000 | 229 more per 1000 (9 more to 449 more) |
| CDI initial clinical cured (follow-up: 2 days after EOT) | 253 (3 RCTs) [14,–,16] | ⊕⊕◯◯ Lowa,e | 1.03 (.94 to1.14) | 853 per 1000 | 26 more per 1000 (58 fewer to 110 more) |
| Serious adverse events (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕◯◯◯ Very lowa,f | .68 (.35 to 1.29) | 410 per 1000 | 132 fewer per 1000 (from 345 fewer to 80 more |
| All-cause mortality (follow-up: 90 days) | 75 (1 RCT) [16] | ⊕⊕◯◯ Lowf | .81 (.20 to 3.38) | 103 per 1000 | 19 fewer per 1000 (from 150 fewer to 112 more) |
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.
aRated down for risk of bias for self-reported outcomes due to potentially inadequate blinding in Guery et al (2018) [16]. Despite subgroup analyses performed with prior stratification of the randomization in both Cornely et al (2012) [15] and Louie et al (2011) [14] studies, unclear risk of bias regarding the random sequence generation in 2 very small sample size subgroups (some concerns were expressed by the authors regarding nonsignificant variability of patients (baseline characteristics in the pooled per protocol analysis, but the pooled full dataset is not presented).
bSmall sample size not meeting the optimal information size, which suggests fragility of the estimate.
cFew events reported and small sample size not meeting the optimal information size, which suggests fragility of the estimate.
dInitial clinical cure was defined as no diarrhea for 2 consecutive days after completion of SOC antibiotic therapy administered for ≤16 days.
eThe 95% CI includes the potential for both appreciable benefit as well as appreciable harm (ie, includes the null value) and small sample size, which does not meet the optimal information size.
fThe 95% CI includes the potential for both appreciable benefit as well as appreciable harm (ie, includes the null value), very few events reported, and small sample size, which do not meet the optimal information size.
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