title: PPI in the PLEASANT trial: involving children with asthma and their parents in designing an intervention for a randomised controlled trial based within primary care.
abstract: Aims We describe how patient and public involvement (PPI) was integrated into the design of an intervention for a randomised controlled trial (RCT) based within primary care. The RCT, known as the PLEASANT trial, aimed to reduce unscheduled medical contacts in children with asthma associated with start of the new school year in September with a simple postal intervention, highlighting the importance of maintaining asthma medication for helping to prevent increased asthma exacerbations.
  
  
  
  PPI is a key feature of UK health research policy, and is often a requirement of funding from the National Institute for Health Research. There are few detailed accounts of PPI in the design and conduct of clinical trials in the PPI literature for researchers to learn from.
  
  
  
  We held PPI consultation events to determine whether the proposed intervention for the trial was acceptable to children with asthma and their parents, and to ascertain whether enhancements should be made. Two PPI consultation events were held with children with asthma and their parents, prior to the research commencing. Detailed field notes were taken by the research team at each consultation event. Findings At the first consultation event, parents and children endorsed the trial's rationale, made suggestions to the wording of the trial intervention letter, and made recommendations about to whom the letter should be sent out. At the second consultation event, parents discussed the timing of the intervention, commented on the lay summary of the Research Ethics Application, and were invited to join the trial's steering committee, while the children selected a logo for the study. PPI has resulted in enhancements to the PLEASANT study's intervention. A further PPI consultation event is scheduled for the end of the trial, in order for children with asthma and their parents to contribute to the trial's dissemination strategy.
authors: 1Reader in Patient Experience and Public Involvement,Centre for Research in Primary and Community Care,University of Hertfordshire,Hertfordshire,UK.
authors: Jonathan
authors: J
authors: Boote
authors: 2Professor of Medical Statistics,Medical Statistics Group,School of Health and Related Research,University of Sheffield,Sheffield,UK.
authors: Steven
authors: S
authors: Julious
authors: 3Research Fellow,Clinical Trials Research Unit,School of Health and Related Research,University of Sheffield,Sheffield,UK.
authors: Michelle
authors: M
authors: Horspool
authors: 4Consultant in Paediatric Respiratory Medicine,Sheffield Children's NHS Foundation Trust,Sheffield,UK.
authors: Heather
authors: H
authors: Elphick
authors: 5Professor of General Practice,Department of General Practice,University College Cork,Cork,Ireland.
authors: W Henry
authors: WH
authors: Smithson
authors: 6Professor of Health Psychology,Department of Psychology,University of Sheffield,Sheffield,UK.
authors: Paul
authors: P
authors: Norman
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010290:Parents; D010358:Patient Participation; D011320:Primary Health Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D017010:Reminder Systems; D012107:Research Design; D006113:United Kingdom
keywords: asthma; clinical trial design; patient and public involvement; primary care