Table 3.
Pooled results and certainty assessment of randomized clinical trials and observational studies involving children with VUR of any grade (third clinical question).
| Certainty Assessment | No. of Patients | Effect | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Studies | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Antibiotic Prophylaxis | No Prophylaxis | Relative (95% CI) |
Absolute (95% CI) |
|
| Risk of UTI recurrence (follow-up: mean 18 months; assessed as rates of recurrence) | |||||||||||
| 5 [20,22,40,41,42] | randomized trials | not serious a | not serious | not serious | not serious | none | 140/632 (22.2%) | 195/656 (29.7%) |
RR 0.75 (0.62 to 0.90) |
74 fewer per 1000 (113 fewer–30 fewer) |
⨁⨁⨁⨁ High |
| Risk of UTI recurrence (follow-up: mean 44 months; assessed as rates of recurrence) | |||||||||||
| 2 [43,44] | observational studies | not serious b | not serious | not serious | serious c | none | 80/449 (17.8%) | 53/368 (14.4%) |
RR 1.11 (0.96 to 1.30) |
16 more per 1000 (6 fewer–43 more) |
⨁◯◯◯ Very low |
| Risk of new renal scars (follow-up: mean 20 months; assessed as rates of new renal scars on DMSA scan) | |||||||||||
| 3 [22,41,42] | randomized trials | not serious | not serious | not serious | serious c | none | 23/325 (7.1%) | 21/335 (6.3%) |
RR 1.13 (0.64 to 2.00) |
8 more per 1000 (23 fewer–63 more) |
⨁⨁⨁◯ Moderate |
| Risk of new antimicrobial resistances (follow-up: mean 24 months; assessed as rates of infections resistant to empiric antibiotics) | |||||||||||
| 1 [41] | randomized trials | not serious | not serious | not serious | serious d | strong association | 26/38 (68.4%) | 17/69 (24.6%) |
RR 2.78 (1.74 to 4.42) |
439 more per 1000 (182 more–843 more) |
⨁⨁⨁⨁ High |
| Risk of drug-related adverse events (follow-up: mean 24 months; assessed as rates of drug-related adverse event) | |||||||||||
| 1 [41] | randomized trials | not serious | not serious | not serious | serious e | none | 153/302 (50.7%) | 165/305 (54.1%) |
RR 0.94 (0.80 to 1.09) |
32 fewer per 1000 (108 fewer–49 more) |
⨁⨁⨁◯ Moderate |
CI: confidence interval; RR: risk ratio. a: complete risk of bias analysis with results for single domains of the RoB2 tool is presented in Supplementary Tables and Figures. b: complete risk of bias analysis with results for Newcastle–Ottawa Scale tool is presented in Supplementary Tables and Figures. c: OIS criterion is not met and 95% CI overlaps no effect. d: OIS criterion is not met. e: 95% CI overlaps no effect.