Paediatric SBS and PS: Utility Study

  • Research type

    Research Study

  • Full title

    Paediatric Short Bowel Syndrome and Parenteral Support: a carer and patient utility study

  • IRAS ID

    223892

  • Contact name

    Rachel Ballinger

  • Contact email

    rachel.ballinger@iconplc.com

  • Sponsor organisation

    Shire

  • Duration of Study in the UK

    0 years, 3 months, 31 days

  • Research summary

    This research is a survey to assess impacts associated with short bowel syndrome (SBS) and parenteral support (PS) on paediatric patients and their carers. SBS patients have either been born with the condition or had part of their intestine removed because it stopped working due to injury or illness. SBS results in poor absorption of nutrients, often requiring artificial nutrition intravenously ("parenteral support", PS). PS administration can take several hours (including overnight), and range from one to seven days a week. As such, paediatric SBS patients need support in the management of their condition, treatment, and daily life from their parents, guardians, or wider family.

    The survey has been designed to assess the quality of life of paediatric patients with SBS and the impact of caring for SBS patients who receive PS. Carers must be aged 16 years or older and care for a paediatric SBS patient (aged 1 to 17 years old) who either currently receives, or have previously received, PS for one to seven days or nights per week. The survey was adapted from a survey used in a related study with carers of adult SBS patients receiving PS. The surveys were informed by literature review, unpublished interviews with carers of adult patients, input from scientific advisors to the study, and review by a relevant patient advocate group.

    We are seeking to recruit up to 75 carers. The survey will be completed online and take ≤30 minutes to complete, it can be completed in more than one sitting. The survey comprises three sections: about the carer, the child they care for, and type and impact of care provided. It includes study-specific questions and standardised measures including: items from the Valuation of Informal Care Questionnaire and Understanding Society Survey, EQ-5D-5L, and Work Productivity and Activity Impairment Questionnaire.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    17/NE/0098

  • Date of REC Opinion

    5 Apr 2017

  • REC opinion

    Favourable Opinion