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



Altowati, Mabrouka A, Jones, Ashley P, Hickey, Helen ORCID: 0000-0003-0467-0362, Williamson, Paula R ORCID: 0000-0001-9802-6636, Barakat, Farah M, Plaatjies, Nicolene C, Hardwick, Ben, Russell, Richard K, Jaki, Thomas, Ahmed, S Faisal
et al (show 1 more authors) (2016) Assessing the feasibility of injectable growth-promoting therapy in Crohn's disease. Pilot and feasibility studies, 2. 71 - ?.

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Abstract

<h4>Background</h4>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.<h4>Methods</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>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.

Item Type: Article
Depositing User: Symplectic Admin
Date Deposited: 23 Jan 2019 14:40
Last Modified: 11 Oct 2021 20:12
DOI: 10.1186/s40814-016-0112-9
Open Access URL: https://pilotfeasibilitystudies.biomedcentral.com/...
URI: https://livrepository.liverpool.ac.uk/id/eprint/3031679