Patient and Public Involvement (PPI)

The PLEASANT trial research team is committed to the principles of patient and public involvement (PPI). Children with asthma and their parents were involved in the design of the trial and will be involved throughout the conduct of the study.

PPI in the design of the trial

During the design of the trial, a PPI consultation event was held in January 2011 with a group of children with asthma and their parents. This event was used to investigate whether the hypothesis underlying the trial was supported by children with asthma and their parents, to give an opportunity for the children and parents to discuss the wording of the intervention and to give their views on to whom the letter should be addressed (i.e. should it be addressed to the child or to their parent/guardian). This initial PPI consultation event was written up as a University of Sheffield report.

PPI throughout the trial

PPI during the conduct of the study will have two components: (1) two further PPI consultation events will be held in September 2012 and December 2014/January 2015, involving up to 6 children and their parents/guardians; (2) two parents of children with asthma will be invited to become members of the Trial Steering Committee, which will meet twice in the first year and once in the final year of the study.

PPI consultation events

The September 2012 PPI consultation event was used to:
• Remind attendees of the purpose of the study and give feedback on outcome of the HTA application
• Discuss the children’s adherence with their medication over the school holidays and subsequently since they have been back at school
• To present the intervention that was discussed at the January 2011 consultation event and to show how it has changed as a result of the consultation and peer review, and to invite further discussion on how the wording of the intervention could be improved.
• To invite any further comment on the design and endpoints to be used in the study, and in particular to invite comments on what, from their perspective, is a scheduled and unscheduled contact
• To discuss plans for PPI for the study, and to invite interested parents onto the Trial Steering Committee
• To discuss the ethics application and the research team’s rationale for how the ethics of the study are being addressed in the REC application.
• To invite comment on the lay summary of the REC and the PPI section
• Invite opinions on the study logo and the website.

The second PPI consultation event was written up as a University of Sheffield report.

The December 2014/January 2015 PPI consultation event will be used to consider the findings of the trial from the perspective of children with asthma and their parents. It will also provide an opportunity to discuss how the findings should best be disseminated to children and to parents.

For attending the consultation events, each child will be provided with a £20 gift voucher and their parents will be able to claim for their expenses such as travel.

PPI members of the Trial Steering Committee

Two parents of children with asthma will be recruited onto the Trial Steering Committee. The study's PPI lead will meet with the parent members of the Trial Steering Committee before or after each meeting to discuss the agenda items and any issues of concern, and will act as a mentor for them.

PPI outputs

A report of each PPI consultation event will be produced and these will be uploaded onto the study website. A paper reflecting on the PPI in the design and conduct of this study will be submitted to a peer-reviewed journal at the end of the trial.