The CEDAR trial was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration, a UK Clinical Research Collaboration Registered Clinical Trials Unit in receipt of National Institute for Health Research (NIHR) Clinical Trials Unit support funding.
The study sponsor was the University of Bristol, and we would particularly like to acknowledge the support of Birgit Whitman. We would like to thank the independent members of our oversight committees:
Trial Steering Committee: Jonathan Mant, Cambridge University, UK (chairperson); Kay Wang, Oxford University, UK; Alan Smyth, Nottingham University, UK; and Victoria Wilson, patient and public involvement member.
Data Monitoring Committee: Toby Prevost, Imperial College London, UK (chairperson); Christian Mallen, Keele University, UK; and Alecia Nickless, Oxford University, UK.
We would like to acknowledge the essential contributions made to the CEDAR trial by the administrators at Bristol (Annie Sadoo, Kate Rowley, Penny Seume) Cardiff (Catherine Aymar) and Southampton (Oyinkan Alli-Balogen).
Study data were collected and managed using REDCap (Research Electronic Data Capture) tools (University of Colorado, Denver, CO, USA) hosted at the University of Bristol. REDCap is a secure, web-based application designed to support data capture for research studies, providing (1) an intuitive interface for validated data entry, (2) audit trails for tracking data manipulation and export procedures, (3) automated export procedures for seamless data downloads to common statistical packages and (4) procedures for importing data from external sources.
Funding history
The CEDAR trial was funded by the NIHR Health Technology Assessment programme. The project start date was 1 January 2015 and the planned study end date was 31 March 2018.
The project closed early, on 31 December 2017, as required by the funders. Issues were encountered with a lengthy delay to the IMP supply. Although the IMP supplier was identified through a competitive procurement process, the supplier failed to deliver the active drops and placebo in line with expected and revised timeframes. There were particular problems with the production of the matched placebo and the ability of the supplier to source materials to replicate the active drops. This contributed to the early closure of this important trial.
Contributions of authors
Alastair D Hay (University of Bristol) was the chief investigator chaired study management group, and contributed to the primary care expertise, study design, protocol development, trial monitoring, writing and approval of final report.
Harriet Downing (University of Bristol) was the trial manager and study management group member, and contributed to the protocol development and trial monitoring.
Nick A Francis (Cardiff University) was the principal investigator for Cardiff Centre and study management group member, and contributed to the primary care expertise, protocol development, trial monitoring, writing and approval of final report.
Grace J Young (University of Bristol) was the study statistician, and contributed to the statistical analysis, reporting to the data monitoring committee, writing and approval of final report.
Clare Clement (University of Bristol) was the qualitative researcher, and contributed to the qualitative interviews and analysis, writing and approval of final report.
Sue D Harris (University of Bristol) was the study nurse and study management group member, and contributed to the primary care expertise and approval of final report.
Aideen Ahern (University of Bristol) was the health economics researcher, and contributed to the health economics analysis and writing and approval of final report.
Behnaz Schofield (Cardiff University) was a study management group member, and contributed to the primary care expertise, protocol development, trial monitoring and approval of final report.
Tammy E Thomas (Southampton University) was a study management group member, and contributed to the primary care expertise, protocol development, trial monitoring and approval of final report.
Jeremy Horwood (University of Bristol) was the senior qualitative researcher, and contributed to the protocol development, study management group member, qualitative analysis, writing and approval of final report.
Peter S Blair (University of Bristol) was the senior statistician, and contributed to the protocol development, study management group, statistical analysis, writing and approval of final report.
William Hollingworth (University of Bristol) was the senior health economist, and contributed to the protocol development, study management group, health economic analysis, writing and approval of final report.
Victoria Wilson (University of Bristol) was the trial manager and study management group member, and contributed to the trial monitoring, writing and approval of final report.
Chris Metcalfe (University of Bristol) was the senior trials methodologist, and contributed to the study management group, writing and approval of final report.
Peter Stoddart (Bristol Royal Hospital for Children) was a study management group member, and contributed to the secondary care expertise, protocol development and approval of final report.
Desmond Nunez (University of British Columbia) was a study management group member, and contributed to the primary care expertise, protocol development, writing and approval of final report.
Mark D Lyttle (Bristol Royal Hospital for Children) was a study management group member, and contributed to the secondary care expertise, protocol development, approval of final report.
Paul Little (Southampton University) was a study management group member, and contributed to the primary care expertise, protocol development and approval of final report.
Michael V Moore (Southampton University) was the principal investigator for the Southampton Centre and was a study management group member, and contributed to the primary care expertise, protocol development, trial monitoring, writing and approval of final report.
Publication
Venekamp RP, Prasad V, Hay AD. Are topical antibiotics an alternative to oral antibiotics for children with acute otitis media and ear discharge? BMJ 2016;352:i308.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
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 and Social Care. 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 and Social Care.
