Evidence map›Paper›PMID 27965886›Full record

ArticlePilot and feasibility studies2016

Assessing the feasibility of injectable growth-promoting therapy in Crohn's disease.

Mabrouka A Altowati, Ashley P Jones, Helen Hickey, Paula R Williamson, Farah M Barakat, Nicolene C Plaatjies, Ben Hardwick, Richard K Russell, Thomas Jaki, S Faisal Ahmed and 1 more

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In one paragraph

Article in Pilot and feasibility studies, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Mabrouka A AltowatiDevelopmental Endocrinology Research Group, University of Glasgow, Scotland, UK ; Department of Paediatric Gastroenterology, Royal Hospital for Sick Children, Glasgow, UK.
Ashley P JonesMedicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
Helen HickeyMedicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
Paula R WilliamsonMedicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
Farah M BarakatCentre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.
Nicolene C PlaatjiesCentre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.
Ben HardwickMedicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
Richard K RussellDepartment of Paediatric Gastroenterology, Royal Hospital for Sick Children, Glasgow, UK.
Thomas JakiMedical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.
S Faisal AhmedDevelopmental Endocrinology Research Group, University of Glasgow, Scotland, UK.
Ian R SandersonCentre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.ORCID 0000-0002-9814-0161

Funding

Medical Research Council G0800675Medical Research Council MR/N003403/1
6 · The paper itself

Abstract

backgroundDespite optimal therapy, many children with Crohn's disease (CD) experience growth retardation. The objectives of the study are to assess the feasibility of a randomised control trial (RCT) of injectable forms of growth-promoting therapy and to survey the attitudes of children with CD and their parents to it.

methodsA feasibility study was carried out to determine study arms, sample size and numbers of eligible patients. A face-to-face questionnaire surveyed willingness to consent to future participation in the RCT. Eligibility to the survey was any child under 18 (with their parent/guardian) with CD whose height standard deviation score (HtSDS) was ≤+1. Of 118 questionnaires, 94 (80%) were returned (48 by children and 46 by parents).

resultsThe median age of the patients in the survey was 14.3 years (range 7.0 to 17.7), and 35 (73%) were male. Their median HtSDS was -1.2 (-3.01, 0.23), and it was lower than the median mid-parental HtSDS of -0.6 (-3.1, 1.4). We analysed the willingness of the children whose HtSDS <-1 to take part in the proposed RCT, being those most likely to require treatment. Overall, 18 (47%) children and 17 (46%) parents were willing. This increased to 61% of children who were slightly concerned about their height and 100% (4/4) of those very concerned. A common reason for not taking part in the RCT was fear of injections (44%); 111 children are required for randomisation into three study arms from nine centres.

conclusionsAlmost half of children and parents surveyed would take part in an RCT of growth-promoting therapy. Allaying fears about injections may result in higher recruitment rates.

Indexed as

Crohn’s diseaseGrowth hormoneGrowth retardationInflammatory bowel diseaseInsulin-like growth factor-1Puberty

Identifiers

PMID27965886
PMCPMC5153677

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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.