GRADE summary of findings table for the important outcomes
| Quality assessment | Patients (n) | Effect | Quality | ||||||||
| Studies (n) | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Simultaneous | Delayed | Relative risk (RR (95% CI)) | Absolute | |
| Need for repeat misoprostol | |||||||||||
| 1 | RCTs | Serious*† | No serious inconsistency | No serious indirectness | Very serious‡ | None | 2/40 (5%) | 1/40 (2.5%) | 2.00 (0.19 to 21.18) | 25 more per 1000 (from 20 fewer to 505 more) | Very low |
| Time to onset of bleeding (after misoprostol; hours) | |||||||||||
| 1 | RCTs | Serious* | No serious inconsistency | No serious indirectness | No serious imprecision§ | None | Median (range) 3.7 (0–74; n=554) | Median (range) 2 (−23–24; n=546) | NE¶ | NE¶ | Moderate |
| Time to onset of bleeding (after misoprostol; hours) | |||||||||||
| 1 | RCTs | Very serious*† | No serious inconsistency | No serious indirectness | Serious** | None | 40 | 40 | NE | MD 0.74 higher (0.07 to 1.41 higher) | Very low |
| Time to onset of cramping (after misoprostol; hours) | |||||||||||
| 1 | RCTs | Serious* | No serious inconsistency | No serious indirectness | No serious imprecision§ | None | Median (range) 2.5 (0–143; n=554) | Median (range) 1.7 (-24–115; n=546) | NE¶ | NE¶ | Moderate |
| Incomplete abortion with the need for surgical intervention | |||||||||||
| 3 | RCTs | Serious†† | No serious inconsistency | No serious indirectness | Very serious‡ | None | 29/694 (4.2%) | 22/686 (3.2%) | 1.30 (0.76 to 2.25) | 10 more per 1000 (from 8 fewer to 40 more) | Very low |
*Unblinded study.
†Unclear adequacy of allocation concealment.
‡The CI crosses 0.8 and 1.25.
§No minimal important difference available for this outcome as it is only reported as medians and ranges. N>400.
¶Cannot be calculated as the study only reports medians and ranges (not means and SDs) which were statistically significantly different (p<0.001; Mann-Whitney U-test).
**Minimal important difference boundaries −0.62 and 0.62 (+/-1.24 * 0.5); clinically important effect=1.24*0.5=0.62 or above or −0.62 or below; the CI crossed one minimal important difference threshold.
††Unclear randomisation sequence generation and/or allocation concealment adequacy in two of the three studies. All the studies were unblinded.
MD, mean difference; NE, not estimable; RCT, randomised controlled trial; RR, relative risk.