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

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    Published version (799.7Kb)
    Volume
    2
    Pagination
    71 - ?
    DOI
    10.1186/s40814-016-0112-9
    Journal
    Pilot Feasibility Stud
    ISSN
    2055-5784
    Metadata
    Show full item record
    Abstract
    BACKGROUND: Despite 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. METHODS: A 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). RESULTS: The 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. CONCLUSIONS: Almost 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.
    Authors
    Altowati, MA; Jones, AP; Hickey, H; Williamson, PR; Barakat, FM; Plaatjies, NC; Hardwick, B; Russell, RK; Jaki, T; Ahmed, SF
    URI
    http://qmro.qmul.ac.uk/xmlui/handle/123456789/18182
    Collections
    • Centre for Immunobiology [1029]
    Language
    eng
    Licence information
    This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
    Copyright statements
    © The Author(s), 2016.
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