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

Altowati, M. A. et al. (2016) Assessing the feasibility of injectable growth-promoting therapy in Crohn's disease. Pilot and Feasibility Studies, 2, 71. (doi: 10.1186/s40814-016-0112-9) (PMID:27965886) (PMCID:PMC5153677)

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.

• Item Type: Articles
• Additional Information: This study was supported by funding from Crohn’s in Childhood Research Association (CICRA). MA is funded by the Higher Education Ministry of Libyan Government for a postgraduate studentship. RR is supported by a NHS Research Scotland career fellowship award and has received support from a Medical Research Council (MRC) patient research cohort initiative grant (G0800675) for PICTS. The work of the IBD team at the Royal Hospital for Sick Children is supported by the Catherine McEwan Foundation and the Yorkhill IBD fund.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Russell, Dr Richard and Ahmed, Professor Syed Faisal
• Authors: Altowati, M. A., Jones, A. P., Hickey, H., Williamson, P. R., Barakat, F. M., Plaatjies, N. C., Hardwick, B., Russell, R. K., Jaki, T., Ahmed, S. F., and Sanderson, I. R.
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Pilot and Feasibility Studies
• Publisher: BioMed Central
• ISSN: 2055-5784
• ISSN (Online): 2055-5784
• Copyright Holders: Copyright © 2016 The Authors
• First Published: First published in Pilot and Feasibility Studies 2: 71
• Publisher Policy: Reproduced under a Creative Commons License