Table 4.
GRADE evidence profile for PICO 4.
| Certainty assessment | No of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Cilostazol + standard care treatment | No cilostazol + standard care treatment | Relative (95% CI) | Absolute (95% CI) | ||
| a) Shimizu et al. 109 | ||||||||||||
| Good outcome (mRS 0–2 at 90 days) all patients (approx 68% were lacunar stroke) | ||||||||||||
| 1 | Randomised trial | Serious a | Not serious | Serious | Serious b | None | 221/251 (88.1%) | 217/256 (84.8%) | OR 1.32 (0.79, 2.21) |
33 more per 1000 (from 33 fewer to 77 more) |
⨁○○○ Very low |
CRITICAL |
| Progressive symptoms (⩾4-point increase on NIHSS) in the subgroup (n = 343) with lacunar ischaemic stroke | ||||||||||||
| 1 | Randomised trial | Serious a | Not serious | Serious | Serious b | None | 7/154 (4.5%) | 9/173 (5.2%) | OR 0.87 (0.32, 2.39) |
6 fewer per 1000 (from 35 fewer to 64 more) |
⨁○○○ Very low |
CRITICAL |
| b) Nishi et al.
112
Good outcome (mRS 0–2 at 90 days) all patients (29 lacunar stroke, 23 BAD) | ||||||||||||
| 1 | randomised trial | Serious a | Not serious | Serious | Serious b | None | 22/28 (78%) | 17/25 (68%) | OR 1.73 (0.50, 5.92) |
106 more per 1000 (from 165 fewer to 246 more) | ⨁○○○ very low |
CRITICAL |
| Progressive symptoms (⩾2 point increase on NIHSS) all patients (29 lacunar stroke, 23 BAD) | ||||||||||||
| 1 | randomised trial | serious a | not serious | serious | serious b | none | 0/28 (0.0%) | 4/26 (15.4%) | OR 0.09 (0.00, 1.72) |
138 fewer per 1000 (from – to 84 more) |
⨁○○○ very lowow |
CRITICAL |
BAD: branch atheromatous disease; CI: confidence interval; OR: odds ratio. Unfortunately data were not available for either outcome for just the lacunar stroke subgroup.
Explanations.
a
Open-label trial.
b
Confidence interval crosses the clinical decision threshold and optimal information size not met.