Evidence Table 12Quality assessment of urticaria trials in children

Internal validityExternal validity
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 contaminationLoss to follow-up: differential/highIntention-to-treat (ITT) analysisPost-randomization exclusionsFundingQuality RatingNumber screened/eligible/enrolledRun-in/WashoutClass naïve patients onlyControl group standard of careRelevance
La Rosa 2001
YesMethod not reportedYes for age, sex, height- data not reported, other characteristics not reportedYesStates “double-blind” but not specifiedStates “double-blind” but not specifiedYesAttrition reported (5/62)NoNo, 57/62 analyzed; no mention cross-oversNoUCB Laboratories, Pianezza, Torino, ItalyFairNR/NR/62NR/4-d washout, or 14-d washout if patients had been treated with ketotifen or corticosteroidsNRNRUnclear
Simons 2001, Simons 1999
Europe and Canada
ETAC study
YesYesYes for age; others NRYesStates “double-blind” but not specified; AE reviewed by blinded observerStates “double-blind” but not specifiedYesAttrition reported, others notNo; 12% over 18 months, no differentialNo; attrition 99/817NRUCB, SA (Belgium)FairNone; NoneNRNRYoung children (12–24 months)

From: Evidence Tables

Cover of Drug Class Review: Newer Antihistamines
Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].
Carson S, Lee N, Thakurta S.
Portland (OR): Oregon Health & Science University; 2010 May.
Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.