Table A2:
GRADE Evidence Profile for Comparison of Fecal Microbiota Therapy to Antibiotics
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| 2 RCTs | No serious limitations | No serious limitations | No serious limitations | No serious limitations | Undetected Likely (−1) | Large magnitude of effect (+1) | ⊕⊕⊕⊕ High ⊕⊕⊕ Moderate |
| 40 observational case series | Serious limitations (−1) | Serious limitations (−1) | Serious limitations (−1) | Serious limitations (−1) | Very likely (−2) | Dose-response gradient (+1) | ⊕⊕ Low ⊕ Very Low |
| Very serious limitations (−2) | Very serious limitations (−2) | Very serious limitations (−2) | Very serious limitations (−2) | All plausible confounding increases confidence in estimate (+1) Other considerations (+1) |
|||
| Resolution | |||||||
| 2 RCTs | No serious limitations | No serious limitations | Serious limitations (−1)b | No serious limitations | Undetected | – | ⊕⊕⊕ Moderate |
| 40 observational case series | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | – | ⊕⊕ Low |
| Quality of life | |||||||
| 0 studies | – | – | – | – | – | – | – |
| Mortality | |||||||
| 2 RCTs | No serious limitations | No serious limitations | No serious limitations | Very serious limitations (−2)c | Undetected | ⊕⊕ Low | |
| 40 observational case series | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | – | ⊕⊕ Low |
| Adverse events | |||||||
| 2 RCTs | Serious limitations (−1)d | No serious limitations | No serious limitations | Serious limitations (−1)c | Undetected | – | ⊕⊕ Low |
| 40 observational case series | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | – | ⊕⊕ Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.
a
Observational uncontrolled, mostly retrospective case series.
b
Most fecal microbiota therapy in Ontario is via enema. Studies published to date mostly use colonoscopy and nasoduodenal or nasogastric tube.
c
Optimal information size not met. Wide confidence intervals.
d
Lack of long-term follow-up in RCTs (up to 10 weeks).