Evidence map›Paper›PMID 28535776›Full record

Trial reportTrials2017

The role of anti-IgE (omalizumab/Xolair) in the management of severe recalcitrant paediatric atopic eczema (ADAPT): statistical analysis plan.

Tao Chen, Susan Chan, Gideon Lack, Suzie Cro, Victoria R Cornelius

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026
    Review
  3. Omalizumab in Refractory Adult-Onset Facial Atopic Dermatitis: A Case Report.Clinical, cosmetic and investigational dermatology · 2026
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Tao ChenDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.
Susan ChanGuy's and St. Thomas' NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH, UK.
Gideon LackKing's College London, King's Health Partners, Asthma-UK Centre in Allergic Mechanisms of Asthma, Allergy and Respiratory Science, Guy's Hospital, London, SE1 9RT, UK.
Suzie CroImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Victoria R CorneliusImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK. v.cornelius@imperial.ac.uk.
Imperial College London · GBGuy's and St Thomas' NHS Foundation Trust · GBKing's College London · GBLiverpool School of Tropical Medicine · GB

Funding

Medical Research Council G1000758Medical Research Council MC_PC_14136
6 · The paper itself

Abstract

backgroundThe Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) is a trial to determine the clinical efficacy and safety of omalizumab for children with severe atopic eczema. This article describes the detailed statistical analysis plan for the ADAPT as an update to the published protocol and is submitted prior to knowing all outcomes. METHOD AND

designThe ADAPT is a randomised, double-blind, placebo-controlled trial with a primary objective to determine whether anti-IgE reduces eczema severity as assessed by the validated eczema score (objective SCORAD) after 24 weeks of treatment in children with severe eczema. This articles outline the overall analysis principles including considerations on sample definition in each analysis, missing data, and adjusted covariates. Comparability and representativeness of the randomised groups, primary and sensitivity analyses of the primary and secondary outcomes as well as subgroup analysis are described.

resultsThis prespecified statistical analysis plan has been developed to comply with international guidelines which will increase the transparency of the data analysis for the ADAPT.

trial registrationISRCTN, identifier: ISRCTN15090567 . Registered on 3 December 2014; EU Clinical Trials Register, EudraCT Number: 2010-020841-29 . Registered on 14 May 2010. The first participant was enrolled on 15 January 2015.

Indexed as

AdolescentAge FactorsAnti-Allergic AgentsChildChild, PreschoolClinical ProtocolsData Interpretation, StatisticalDermatitis, AtopicDouble-Blind MethodHumansImmunoglobulin EModels, StatisticalOmalizumabResearch DesignSeverity of Illness IndexTime FactorsAnti-Allergic AgentsImmunoglobulin EOmalizumabAnti-IgEAtopic dermatitisEczemaOmalizumabPaediatricRandomised controlled trialStatistical analysis planXolair

Identifiers

PMID28535776
PMCPMC5442690
OpenAlexW2619352082

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.