Summary of Findings Table, PICO 3: “In Patients With a CDI Episode, Should Bezlotoxumab be Used as a Co-Intervention Along With Standard-of-Care Antibiotics Rather Than Standard-of-Care Antibiotics Alone?”
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With SOC Antibiotics . | Risk Difference With Bezlotoxumab + SOC Antibiotics (95% CI) . |
| CDI recurrence after ICC a (follow-up: 12 weeks) | 1246 (1 RCT) [18] | ⊕⊕⊕◯ Moderateb,c | .62 (.51 to .75) | 326 per 1000 | 125 fewer per 1000 (174 fewer to 77 fewer) |
| CDI-associated hospital readmission (follow-up: 30 days) | 1050 (1 RCT) [19] | ⊕◯◯◯ Very lowc,d,e | .46 (.29 to .71) | 112 per 1000 | 61 fewer per 1000 (93 fewer to 28 fewer) |
| Drug-related adverse events (follow-up: 4 weeks) | 1567 (1 RCT) [18] | ⊕⊕◯◯ Low b,c,f | 1.27 (.88 to 1.85) | 59 per 1000 | 16 more per 1000 (9 fewer to 41 more) |
| All-cause mortality (follow-up: 12 weeks) | 1567 (1 RCT) [19] | ⊕⊕◯◯ Low b,c,f | .94 (.66 to 1.34) | 76 per 1000 | 4 fewer per 1000 (30 fewer to 22 more) |
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With SOC Antibiotics . | Risk Difference With Bezlotoxumab + SOC Antibiotics (95% CI) . |
| CDI recurrence after ICC a (follow-up: 12 weeks) | 1246 (1 RCT) [18] | ⊕⊕⊕◯ Moderateb,c | .62 (.51 to .75) | 326 per 1000 | 125 fewer per 1000 (174 fewer to 77 fewer) |
| CDI-associated hospital readmission (follow-up: 30 days) | 1050 (1 RCT) [19] | ⊕◯◯◯ Very lowc,d,e | .46 (.29 to .71) | 112 per 1000 | 61 fewer per 1000 (93 fewer to 28 fewer) |
| Drug-related adverse events (follow-up: 4 weeks) | 1567 (1 RCT) [18] | ⊕⊕◯◯ Low b,c,f | 1.27 (.88 to 1.85) | 59 per 1000 | 16 more per 1000 (9 fewer to 41 more) |
| All-cause mortality (follow-up: 12 weeks) | 1567 (1 RCT) [19] | ⊕⊕◯◯ Low b,c,f | .94 (.66 to 1.34) | 76 per 1000 | 4 fewer per 1000 (30 fewer to 22 more) |
Abbreviations: CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; ICC, initial clinical cure; PICO, Patient/Population, Intervention/Indicator, Comparator/Control, Outcome; RCT, randomized controlled trial; RR, risk ratio; SOC, standard of care.
aRecurrent CDI after ICC was defined as a new episode of C. difficile infection after initial clinical cure of the baseline episode.
bDespite many subgroup analyses without prior stratification of the randomization reported in the study, it was not considered at high risk of bias for this outcome since the complete modified intention-to-treat population was included in our analysis.
cRated down for indirectness due to concerns on the generalizability of the evidence to current practice: SOC antibiotics received in Wilcox et al (2017) [18] study were as follows: 46.7% of patients received metronidazole, 47.7% received vancomycin, and only 3.6% received fidaxomicin; SOC antibiotics in current practice now include fidaxomicin and vancomycin, but not metronidazole.
dRated down for risk of bias due to subgroup analysis addressing patients who were inpatients at the time of the randomization (post hoc analysis for prespecified risk factors without stratified randomization).
eFew events reported do not meet the optimal information size and suggest fragility of the estimate.
fThe 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.
Summary of Findings Table, PICO 3: “In Patients With a CDI Episode, Should Bezlotoxumab be Used as a Co-Intervention Along With Standard-of-Care Antibiotics Rather Than Standard-of-Care Antibiotics Alone?”
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With SOC Antibiotics . | Risk Difference With Bezlotoxumab + SOC Antibiotics (95% CI) . |
| CDI recurrence after ICC a (follow-up: 12 weeks) | 1246 (1 RCT) [18] | ⊕⊕⊕◯ Moderateb,c | .62 (.51 to .75) | 326 per 1000 | 125 fewer per 1000 (174 fewer to 77 fewer) |
| CDI-associated hospital readmission (follow-up: 30 days) | 1050 (1 RCT) [19] | ⊕◯◯◯ Very lowc,d,e | .46 (.29 to .71) | 112 per 1000 | 61 fewer per 1000 (93 fewer to 28 fewer) |
| Drug-related adverse events (follow-up: 4 weeks) | 1567 (1 RCT) [18] | ⊕⊕◯◯ Low b,c,f | 1.27 (.88 to 1.85) | 59 per 1000 | 16 more per 1000 (9 fewer to 41 more) |
| All-cause mortality (follow-up: 12 weeks) | 1567 (1 RCT) [19] | ⊕⊕◯◯ Low b,c,f | .94 (.66 to 1.34) | 76 per 1000 | 4 fewer per 1000 (30 fewer to 22 more) |
| . | . | . | . | Anticipated Absolute Effects . | |
|---|---|---|---|---|---|
| Outcomes (Follow-up) . | No. of Participants (Studies) . | Certainty of the Evidence (GRADE) . | Relative Effect, RR (95% CI) . | Risk With SOC Antibiotics . | Risk Difference With Bezlotoxumab + SOC Antibiotics (95% CI) . |
| CDI recurrence after ICC a (follow-up: 12 weeks) | 1246 (1 RCT) [18] | ⊕⊕⊕◯ Moderateb,c | .62 (.51 to .75) | 326 per 1000 | 125 fewer per 1000 (174 fewer to 77 fewer) |
| CDI-associated hospital readmission (follow-up: 30 days) | 1050 (1 RCT) [19] | ⊕◯◯◯ Very lowc,d,e | .46 (.29 to .71) | 112 per 1000 | 61 fewer per 1000 (93 fewer to 28 fewer) |
| Drug-related adverse events (follow-up: 4 weeks) | 1567 (1 RCT) [18] | ⊕⊕◯◯ Low b,c,f | 1.27 (.88 to 1.85) | 59 per 1000 | 16 more per 1000 (9 fewer to 41 more) |
| All-cause mortality (follow-up: 12 weeks) | 1567 (1 RCT) [19] | ⊕⊕◯◯ Low b,c,f | .94 (.66 to 1.34) | 76 per 1000 | 4 fewer per 1000 (30 fewer to 22 more) |
Abbreviations: CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; ICC, initial clinical cure; PICO, Patient/Population, Intervention/Indicator, Comparator/Control, Outcome; RCT, randomized controlled trial; RR, risk ratio; SOC, standard of care.
aRecurrent CDI after ICC was defined as a new episode of C. difficile infection after initial clinical cure of the baseline episode.
bDespite many subgroup analyses without prior stratification of the randomization reported in the study, it was not considered at high risk of bias for this outcome since the complete modified intention-to-treat population was included in our analysis.
cRated down for indirectness due to concerns on the generalizability of the evidence to current practice: SOC antibiotics received in Wilcox et al (2017) [18] study were as follows: 46.7% of patients received metronidazole, 47.7% received vancomycin, and only 3.6% received fidaxomicin; SOC antibiotics in current practice now include fidaxomicin and vancomycin, but not metronidazole.
dRated down for risk of bias due to subgroup analysis addressing patients who were inpatients at the time of the randomization (post hoc analysis for prespecified risk factors without stratified randomization).
eFew events reported do not meet the optimal information size and suggest fragility of the estimate.
fThe 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.
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