We gratefully acknowledge the hard work, support and advice from the following: Hilary Pinnock (Reader, University of Edinburgh) for her advice; Gerry McCann and Zaynah Gurreebun (CPRD) for their contribution to site recruitment and Tjeer Van Staa (CPRD) for his advice on CPRD; Cara Mooney and David White (University of Sheffield) for support with study set-up, site recruitment, site set-up and site close-down; and Dan Beever and Helen Wakefield for administrative and clerical support.
We would like to especially thank the GP Adjudication Panel: Dr Mark Boon (Conisbrough Group Practice), Dr Karen Forshaw (Bentley Surgery) and Dr Julie Hackney (The Avenue Surgery) for their advice, steer and valued contributions.
We offer special thanks to the members of our oversight committee (TSC): Dr Steve Holmes (Independent Chairperson, GP), Professor Andrew Wilson (Independent Academic GP, University of Leicester), Dr Martyn Lewis (Independent Statistician, Keele University), Zaiada Bibi (Independent Parent Representative) and Camilla Mills (Independent Parent Representative).
The PLEASANT Research Team
Writing Group: Professor Steven A Julious, Dr Michelle J Horspool, Neil Shephard, Mike Bradburn, Dr Amanda Loban, Sarah Davis, Professor Cindy L Cooper, Dr Matthew Franklin (University of Sheffield), Robin May, Rachael Williams and Jennifer Campbell (CPRD).
TMG: Professor Steven A Julious, Dr Michelle J Horspool, Neil Shephard, Dr Amanda Loban, Cara Mooney, David White, Professor Paul Norman, Sarah Davis (University of Sheffield), Dr Jonathan Boote (University of Hertfordshire), Professor W Henry Smithson (University of Cork), Dr Heather Elphick (Sheffield Children’s Hospital), Mr Robin May, Rachael Williams and Jennifer Campbell (CPRD).
TSC: Dr Steve Holmes (Independent Chair, GP), Professor Andrew Wilson (Independent Academic GP, University of Leicester), Dr Martyn Lewis (Independent Statistician, Keele University), Camilla Mills (Independent Parent Representative), Professor Steven A Julious (Chief Investigator, University of Sheffield), Dr Michelle Horspool (Trial Manager, University of Sheffield), Mike Bradburn (Senior Statistician, University of Sheffield) and Dr Amanda Loban (Data Manager, University of Sheffield).
Co-applicants: Professor Steven A Julious, Dr Michelle J Horspool, Professor Paul Norman, Sarah Davis, Professor Cindy L Cooper (University of Sheffield), Dr Jonathan Boote (University of Hertfordshire), Professor W Henry Smithson (University of Cork) and Dr Heather Elphick (Sheffield Children’s Hospital).
GP Adjudication Panel: Dr Mark Boon (Conisbrough Group Practice), Dr Julie Hackney (Avenue Medical Centre) and Dr Karen Forshaw (Bentley Surgery).
Contributions of authors
Steven A Julious (Professor of Medical Statistics), Michelle J Horspool (Trial Manager), Sarah Davis (Health Economist), Mike Bradburn (Senior Statistician), Amanda Loban (Data Manager), Matthew Franklin (Health Economist), Wei Sun Kua (Health Economist), Robin May (CPRD), Jennifer Campbell (CPRD) and Rachael Williams (CPRD) together produced the first draft of the report.
The following conceived of or designed the work: Steven A Julious (Professor of Medical Statistics), Michelle J Horspool (Trial Manager), Sarah Davis (Health Economist), Paul Norman (Professor of Health Psychology), Cindy L Cooper (Sheffield CTRU Director), W Henry Smithson (Professor of Primary Care), Jonathan Boote (PPI Lead) and Heather Elphick (Consultant Respiratory Paediatrician).
The following were involved in the acquisition of data for the work: Jennifer Campbell (CPRD) and Rachael Williams (CPRD).
The following were involved in the interpretation of data for the work: Steven A Julious (Professor of Medical Statistics), Michelle J Horspool (Trial Manager), Neil Shephard (Medical Statistician), W Henry Smithson (Professor of Primary Care), Amanda Loban (Data Manager) and Saleema Rex (Data Analyst).
The following were involved in the analysis of data: Neil Shephard (Medical Statistician), Sarah Davis (Health Economist), Mike Bradburn (Senior Statistician), Matthew Franklin (Health Economist) and Oscar Bortolami (Medical Statistician).
The following drafted the monograph: Steven A Julious (Professor of Medical Statistics), Michelle J Horspool, (Trial Manager), Sarah Davis (Health Economist), Mike Bradburn (Senior Statistician), Amanda Loban (Data Manager), Matthew Franklin (Health Economist), Wei Sun Kua (Health Economist), Robin May (CPRD) and Jennifer Campbell (CPRD).
The following reviewed the work critically for important intellectual content: Steven A Julious (Professor of Medical Statistics), Michelle J Horspool, (Trial Manager), Sarah Davis (Health Economist), Mike Bradburn (Senior Statistician), Paul Norman (Professor of Health Psychology), Neil Shephard (Medical Statistician), Cindy L Cooper (CTRU Director), W Henry Smithson (Professor of Primary Care), Heather Elphick (Consultant Respiratory Paediatrician), Amanda Loban (Data Manager), Matthew Franklin (Health Economist) Robin May (CPRD) and Jennifer Campbell (CPRD).
All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Journal articles and reports
Boote J, Julious S, Horspool M, Elphick H, Smithson WH, Norman P. 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. Prim Health Care Res Dev 2016;17:536–48.
Hatfield I, Julious SA, Davis S, Horspool M, Norman P and Mooney C. An Assessment of the Resources Used by General Practices in the Intervention Arm of the PLEASANT Study in Sending out the Intervention. ScHARR Report Series No: 30. Sheffield: School of Health and Related Research (ScHARR), University of Sheffield; 2015.
Horspool MJ, Julious SA, Boote J, Bradburn MJ, Cooper CL, Davis S, et al. Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term (PLEASANT): study protocol for a cluster randomised control trial. BMC Trials 2013;14:297.
Horspool MJ, Julious SA, Mooney C, May R, Sully B, Smithson WH. Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT): recruiting primary care research sites – the PLEASANT experience. NPJ Prim Care Respir Med 2015;25:15066.
Conference presentations
Horspool MJ. Recruiting Primary Care Research Sites – The PLEASANT Experience. Invited presentation at Primary Care Respiratory Society UK, Hinkley, September 2014.
Horspool MJ, Julious SA. Recruiting Primary Care Research Sites – The PLEASANT Experience. Presented at International Primary Care Respiratory Group, Athens, May 2014.
Horspool MJ, Julious SA. Preventing and Lessening Exacerbations of Asthma in School age children Associated with a New Term: PLEASANT. Clinical Trials Methodology Conference, Edinburgh, November 2013.
Patient and public involvement reports
Julious SA, Lai J, Boote J, Elphick H, Smithson WH. A Report of a Patient and Public Involvement Consultation Event with Children with Asthma and their Parents to Review a Proposal for a Primary Care Intervention around the September School Return. ScHARR Report Series No: 25. Sheffield: School of Health and Related Research (ScHARR), University of Sheffield; 2011.
Julious SA, Horspool MJ, Boote J, Smithson WH. PLEASANT TRIAL: 2nd Consultation Event with Children with Asthma and their Parents. ScHARR Report Series No: 28. Sheffield: School of Health and Related Research (ScHARR), University of Sheffield: 2012.
Simpson RM, Julious SA, Mooney CD and Norman P. PLEASANT TRIAL: 3rd CONSULTATION Event with Children with Asthma and their Parents. ScHARR Report Series No: 32. Sheffield: School of Health and Related Research (ScHARR), University of Sheffield; 2015.
Data sharing statement
Access to patient-level data is provided by the CPRD for health research purposes and is dependent on approval of a study protocol by the Medicines and Healthcare products Regulatory Agency Independent Scientific Advisory Committee. More information on the Independent Scientific Advisory Committee and the protocol submission process can be found at www.cprd.com/isac (date accessed 30 May 2016).
Disclaimers
This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health.
