| Internal validity | External validity | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Author Year Country | Randomization adequate? | Allocation concealment adequate? | Groups similar at baseline? | Eligibility criteria specified? | Outcome assessors masked? | Care provider masked? | Patient masked? | Reporting of attrition, crossovers, adherence, and contamination | Loss to follow-up: differential/high | Intention-to-treat (ITT) analysis | Post-randomization exclusions | Funding | Quality Rating | Number screened/eligible/enrolled | Run-in/Washout | Class naïve patients only | Control group standard of care | Relevance |
| La Rosa 2001 Italy | Yes | Method not reported | Yes for age, sex, height- data not reported, other characteristics not reported | Yes | States “double-blind” but not specified | States “double-blind” but not specified | Yes | Attrition reported (5/62) | No | No, 57/62 analyzed; no mention cross-overs | No | UCB Laboratories, Pianezza, Torino, Italy | Fair | NR/NR/62 | NR/4-d washout, or 14-d washout if patients had been treated with ketotifen or corticosteroids | NR | NR | Unclear |
| Simons 2001, Simons 1999 Europe and Canada ETAC study | Yes | Yes | Yes for age; others NR | Yes | States “double-blind” but not specified; AE reviewed by blinded observer | States “double-blind” but not specified | Yes | Attrition reported, others not | No; 12% over 18 months, no differential | No; attrition 99/817 | NR | UCB, SA (Belgium) | Fair | None; None | NR | NR | Young children (12–24 months) | |
From: Evidence Tables
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.