Table 3.
Summary of Findings (SoF) for the comparison antipsychotics versus placebo –dichotomous outcomes
| Antipsychotics versus no antipsychotics – dichotomous outcomes | ||||||
|---|---|---|---|---|---|---|
| Population: children and adolescents with ASD Setting: outpatients and inpatients Intervention: Antipsychotics Comparator: no Antipsychotics | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with no Antipsychotics | Risk with Antipsychotics | |||||
| Serious adverse events | 16 per 1.000 | 17 per 1.000 (8 to 39) | RR 1.07 (0.48 a 2.43) | 1057 (13 RCTs) | ⨁⨁◯◯ LOW a,b | Antipsychotics may increase the risk of severe adverse events slightly |
| Adverse events | 657 per 1.000 | 781 per 1.000 (703 to 867) | RR 1.19 (1.07 a 1.32) | 924 (10 RCTs) | ⨁⨁⨁◯ MODERATE c | Antipsychotics probably increase the risk of adverse events |
| Dropout due to any cause | 244 per 1.000 | 149 per 1.000 (117 to 190) | RR 0.61 (0.48 a 0.78) | 1124 (15 RCTs) | ⨁⨁⨁◯ MODERATE d | Antipsychotics probably reduce the risk of dropout due to any cause |
| Drop-out due to adverse events | 39 per 1.000 | 39 per 1.000 (22 to 70) | RR 0.99 (0.55 to 1.79) | 1010 (12 RCTs) | ⨁⨁◯◯ LOW b,e | Antipsychotics may have little or no effect on the risk of dropouts due to adverse events |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; SMD: Standardised mean difference; RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
Explanations
a. Downgraded by one level because most studies showed an unclear risk for selection bias, three studies were at high risk for attrition bias, one study was at high risk for selection bias and one study was at high risk for reporting bias
b. Downgraded by one level because the 95%CI for SMD goes from considerable beneficial effects to considerable undesirable effects
c. Downgraded by one level because most studies showed an unclear risk of bias for selection bias and two studies were at high risk for attrition bias
d. Downgraded by one level because most studies showed an unclear risk for selection bias, four studies were at high risk for attrition bias, one study was at high risk for selection bias and one study was at high risk for reporting bias
e. Downgraded by one level because most studies showed an unclear risk for selection bias, four studies were at high risk for attrition bias, one was at high risk for selection bias and one was at high risk for reporting bias