PGSQ in children with cerebral palsy: a preliminary validation study

• Research type

  Research Study

• Full title

  Using the Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in children with cerebral palsy: a preliminary validation study.

• IRAS ID

  273604

• Contact name

  Mark Tighe

• Contact email

  mark.tighe@poole.nhs.uk

• Sponsor organisation

  Poole Hospitals NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT04293107, ClinicalTrials.gov Identifier

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Background
  Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach leaks up into the oesophagus (food pipe) causing highly unpleasant symptoms and sometimes needing hospital admission. Children with cerebral palsy suffer from a poorly contracting food-pipe (oesophageal dysmotility). As a result, GORD is more problematic in these children and more common; of the 8000 children with cerebral palsy aged 5-16 in the UK, around half suffer from reflux disease. This is treated with medicines or surgery. We don't have an accurate measure of their symptoms, though we do have a suitable questionnaire in well children (the PGSQ). NICE have recommended research to assess the effectiveness of medicines to treat GORD in these children (NG1 research recommendation). In the first phase, we will ask 6 parents/carers their opinions about the PGSQ using qualitative interviews, and alter the PGSQ if needed; then in the second phase, ask 20 parents/carers about their child's symptoms to understand the reliability of the PGSQ at two timepoints 2 weeks apart (test-retest). We won't do any invasive tests on the children but will ask parents about their opinions of their children taking part in pH-impedance monitoring, which is used to assess severity of GORD and may be useful in designing future studies.

  Public and Patient Involvement and Engagement:
  This proposal was inspired by a parent of a child with GORD. Other parents and a children’s group helped shape the study. Parents will also advise on study materials/processes, and support interpretation/dissemination.

  Dissemination:
  Via academic journals, newsletters/patient support groups/national charities/paediatric networks and conferences.

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  20/YH/0162

• Date of REC Opinion

  19 May 2020

• REC opinion

  Favourable Opinion