PLEASANT TRIAL: 2nd Consultation event with children with asthma and their parents
Steven Julious, Michelle Horspool, Jonathan Boote & Henry Smithson
supported by Helen Wakefield
September 2012
Ó 2012 School of Health and Related Research (ScHARR), University of Sheffield
ISBN 1 900752 14 X
Published by the School of Health and Related Research (ScHARR), University of Sheffield
ScHARR Report Series No: 28
Principal Investigator
Steven A. Julious, Medical Statistics Group, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA
Patient and Public Involvement Team
Michelle Horspool, Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA
Jonathan Boote, NIHR Research Design Service for Yorkshire and the Humber, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA
Heather Elphick, Paediatric Respiratory Medicine, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH
Henry Smithson, Academic Unit of Primary Medical Care, Samuel Fox House Northern General Hospital, Herries Road, Sheffield, S5 7AU
Supported by
Helen Wakefield, Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA
Parents and children present:
Children;
Ayman Salman
Saleha Khanunm
Mia Mills
Morgan Mills
Parents;
Ms Bibi
Mrs Khanunm
Mrs Mills
Table of Contents
1. Introduction to the event and background to the study
2. The intervention letter: wording, timing and translation
3. The PLEASANT study logo and website
4. The lay summary of the Research Ethics Committee application
5. Membership of the Trial Steering Committee
6. Thanks, payment and expenses
7. Summary of the consultation
3
1. Introduction to the event and background to the study
Steven welcomed all parents and children to the meeting and delivered a short presentation setting out why the PLEASANT trial is being carried out. Steven explained that there is a spike in seasonal exacerbations in childhood asthma at the beginning of the school year. He went on to explain that the PLEASANT study is being carried out to see if an intervention from a GP to a parent of a child with asthma could reduce the incidence of children having to go to their GP or to hospital due to their asthma once the new school year has started.
The purpose of the study was seen to be important by all the parents and children attending the consultation event.
2. The intervention: wording, timing and translation
Much discussion took place regarding the intervention that is going to be sent out from GP practices to parents of children with asthma. The general feeling among the group was that the intervention did not adequately reflect the seriousness of asthma as a health condition. It was felt therefore that there was a danger that the intervention could be ignored by parents, or that the information it contained could be forgotten about. Therefore, the group agreed on new wording that will appear in bold. This would then stress that the content is important and that it has the potential to impact directly on the health of the parent’s child with asthma.
The group discussed whether or not the intervention should be sent more than once. Although this was seen as a good idea in principle, as it would reinforce the message, the research team explained that it would not be possible because of the study design. The research team would not be able to tell if it was the first or the reminder intervention that had the main effect.
One parent enquired about whether the intervention will be translated for parents for whom English is not their first language. It was explained that translation services are available and that the research team will be able to translate into different languages.
The timing of the intervention was also discussed. One parent stated that it shouldn’t be sent out at the end of July because, at that point, the start of the new school year seems so far off. After discussion, it was agreed that 5-9th August 2013 would be the most appropriate time period in which to send out the intervention.
3. The PLEASANT study logo and website
The group considered three possible logos for the study. It was agreed that the logo should feature a girl and a boy, with the name of the study featured inside a drawing of an inhaler if at all possible or put the inhaler between the boy and girl. The research team agreed to see if such a logo could be produced, and if it could, then this logo will go onto the study website and onto all study documentation.
The group was then shown the study website, and the list of all the researchers who are involved in the study. It was agreed that there should be a link to a folder which would include information about the involvement of children with asthma and their parents in the study. All the parents and children present agreed for their names to appear on this new webpage. The research team agreed to contact the parents and children once this new webpage has been uploaded onto the internet.
4. The lay summary of the Research Ethics Committee application
Michelle and Steven explained that before any study involving NHS patients or staff can start, there has to be approval from a Research Ethics Committee. The group was asked to comment on the lay summary of the application that the research team will shortly be making to the Research Ethics Committee. Michelle and Steven explained that a lay summary is a short section of the Research Ethics Committee application form that summarises the whole of the study in non-technical language, which has to be understood by a general audience. The group thought that the summary was understandable and gave a clear summary account of the aims and methods of the study. No major changes were suggested by the group to the wording of the summary, although it was agreed that certain words be removed in order to improve its clarity.
5. Membership of the Trial Steering Committee
Michelle and Steven explained that the study will be overseen by a Trial Steering Committee, which makes sure that the study runs at it should. It was stressed that, as well as GPs, asthma experts and statisticians, it is also important that two parents of children with asthma are also members of this Committee. Michelle explained that the intention is to only have a small number of these meetings throughout the conduct of the study, and that there will probably be no more than four meetings of the Trial Steering Committee in total. Those parents present at the meeting were invited to attend the first meeting of the Trial Steering Committee, which will be held on 21st September at the University of Sheffield between 11am-1pm. One parent present, Ms Bibi, agreed to attend the meeting, and she will be sent all the relevant papers as hard copy to her home address. A further parent present expressed interest in being a member of the Trial Steering Committee but was unable to make the time of the first meeting. One parent not present at the meeting is to be approached to see if he would be willing to join the Committee.
6. Thanks, payment and expenses
The parents and children were thanked for their contributions at the meeting. All children present were given £20 in gift vouchers, and parents were given a form in order to claim their travel expenses. The children present will also be sent a certificate of attendance through the post.
Finally, Steven invited all attendees to a final consultation event which will be held in January 2015, to discuss the findings of the study. This will be held in January 2015.
7. Summary of the Consultation
· The logo for the PLEASANT study was finalised after discussion with the children. We now have a boy and a girl with an inhaler in the middle
· Input was provided on the intervention to be sent out. An opening sentence was added to highlight the letters importance
· Three parents agreed to join the trial steering committee
3