Enhancing the transparency and communication of the results of randomised trials to research participants and the public
- Project No: NDORMS 2023/6
- Intake: 2023
Research Project Outline
Randomised controlled trials provide the best evidence about the benefits and harms of health care interventions and are a crucially important part of the practice of evidence-based healthcare. Patient and public involvement (PPI) plays a key role in the development of successful trials. It is an essential part of the research process, improving the relevance and overall quality of research and ensuring it focuses on the issues of importance to patients. This includes, for example, working with research funders to prioritise research; development of patient-relevant research questions, study designs, and outcomes; offering the patient perspective as members of a project steering group; developing research materials to improve readability; and assisting with trial recruitment.
A key aspect of PPI activities is dissemination of the trial results to maximise awareness, ensure adoption of trial results in clinical practice, and ensure patients are informed about their care options. Information about a trial’s findings should be available to those who took part in the study, interested groups or communities and the general public in a format that is clear, transparent and easy to understand. The CONSORT Statement is an evidence-based minimum set of recommendations for reporting randomised trials. It offers a standard way for researchers to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. Similar guidelines have been developed for reporting the main results of a randomised trial in a journal or conference abstract. However, no such guidelines exist for reporting the design and results of randomised trials for patients and the public, for example alongside the scientific abstract, the main trial results or the trial protocol.
The aim of this project is to develop evidence-based consensus guidelines for reporting the main results of a randomised trial for patients and the public. It will used established methods for development of reporting guidelines developed by the EQUATOR Network, following similar mixed methods methodology currently being used to update SPIRIT 2013 and CONSORT 2010. This project will also explore different ways of presenting the results of randomised trials to patient and the public.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869: https://www.bmj.com/content/340/bmj.c869
Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF; CONSORT Group. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008 Jan 22;5(1):e20. doi: 10.1371/journal.pmed.0050020: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050020
Details of Research Group
The DPhil will be jointly supervised by Prof Sally Hopewell, Prof Gary Collins and Dr Jennifer de Beyer, based at the Oxford Clinical Trials Research Unit (OCTRU) and Centre for Statistics in Medicine (CSM), based at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford. The UK EQUATOR Centre (De Beyer, Collins) is housed within the Centre for Statistics in Medicine, and is the founding and administrative hub for the EQUATOR Network.
The Botnar Research Centre plays host to the University of Oxford's Institute of Musculoskeletal Sciences, which enables and encourages research and education into the causes of musculoskeletal disease and their treatment.
The Centre for Statistics in Medicine, UK EQUATOR Centre and Oxford Clinical Trials Research Unit are located in the Botnar Research Centre. CSM has more than 20 years’ experience in medical statistics and clinical trials. OCTRU, part of the CSM, is a fully registered UKCRC Clinical Trials Unit, involved in the design, conduct, analysis and reporting in both early and later phase clinical trials in surgery, musculoskeletal sciences, respiratory medicine, gastroenterology and oncology.
Training will be provided in relevant related research methodology, including evidence synthesis, handling and analysis of datasets, and statistical techniques. Attendance at formal training courses will be encouraged, and will include the one-week “Randomised Controlled Trials Course” run by CSM and courses in statistics and publication ethics as relevant. In addition, courses from the Medical Sciences Division Skills Training Team, Oxford University Computer Sciences, and other Departments on key skills for the completion of a successful DPhil thesis will be available. All students are required to attend a 2-day Statistical and Experimental Design course at NDORMS and run by the IT department (information will be provided once accepted to the programme). Additional on the job training opportunities will arise, and the supervisors will encourage the student to pursue such opportunities.
A core curriculum of lectures organized departmentally will be taken in the first term to provide a solid foundation in a broad range of subjects including epidemiology, health economics, and data analysis. Students will attend weekly seminars within the department and those relevant in the wider University. Students will be expected to present data regularly to the department, the research group and to attend external conferences to present their research globally, with limited financial support from the Department.
Please contact: Prof Sally Hopewell (firstname.lastname@example.org).
How to Apply
The Department accepts applications throughout the year but it is recommended that, in the first instance, you contact the relevant supervisor(s) or the Graduate Studies Office (email@example.com) who will be able to advise you of the essential requirements.
Interested applicants should have, or expect to obtain, a first or upper second-class BSc degree or equivalent in a relevant subject and will also need to provide evidence of English language competence (where applicable).
The application guide and form is found online and the DPhil or MSc by research will commence in October 2023.
Applications should be made to one of the following programmes using the specified course code:
D.Phil in Clinical Epidemiology and Medical Statistics (course code: RD_NNRA1)
D.Phil in Musculoskeletal Sciences (course code: RD_ML2)
MSc by research in Musculoskeletal Sciences (course code: RM_ML2)
For further information, please visit http://www.ox.ac.uk/admissions/graduate/applying-to-oxford