The second meeting of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative (COMET-2) was held on 11-12 July 2011 in Bristol and was attended by more than 150 researchers and trialists, systematic reviewers, health service users, healthcare practitioners, journal editors, research funders, policy makers and regulators. Attendees came from around the world to discuss the development and application of core outcome sets (COS) in different areas of health care.
A keynote speech from Professor Doug Altman (University of Oxford) opened the meeting on why we need a more scientific approach to outcomes in trials, and Professor Paula Williamson (NWHTMR, University of Liverpool) updated everyone on the substantial progress in the COMET initiative since COMET-1 in Liverpool in 2010. Monday afternoon was led by Professor John Kirwan (University of Bristol), who focused on optimising patient involvement in COS development, and introduced an interactive session. In 12 small groups, participants conducted a “SWOT” analysis considering the strengths and weaknesses of involving patients in developing a COS, as well as the opportunities and threats (or challenges) it could pose. Groups unanimously agreed that patient input was critical in the development of core outcome sets. The second day included a panel discussion with representation from the Health Technology Assessment programme, the National Institute for Health and Clinical Excellence (NICE), national audit committees and PLoS Medicine (pictured). The panel answered questions and stimulated debate on how to get the funding needed to develop a COS, getting work published, and the relevance to guideline developers and policy makers. Professor Maarten Boers of the OMERACT group (VU University Medical Center, Maastricht) then presented ideas for a conceptual framework of core areas of measurement for clinical trials of health interventions. The meeting closed with an insightful and inspiring presentation from Sir Iain Chalmers (James Lind Initiative), highlighting how researchers need to meet the challenges faced by patients and practitioners, and how COS will help achieve this.
The interactive meeting included 20 posters on display and short presentations on specific projects. The new COMET website was also available, giving participants an early view of the searchable database available and an opportunity to provide feedback. This feedback and the general discussions over the two days showed how the database will provide a vital resource to aid researchers. COMET-2 promoted much discussion and debate about the methodology, standards and science of outcomes standardisation for effectiveness trials in health care. The strong agreement that this will improve the quality of health research was balanced by the recognition of certain challenges and issues which will need to be tackled head on. Where will the money come from to fund COS development? How do we find the balance between wanting to include important outcomes that are difficult to measure, and including those outcomes which can be precisely measured but may be less important?
An important question raised was how people doing and using research can discriminate between a well developed and a not-so-well developed COS, when no validated standard exists. Two key themes kept cropping up throughout the meeting that will help to deal with these issues: there needs to be an international approach to COS development, and this needs to be truly collaborative, with all relevant stakeholder groups involved from the outset. An inclusive process is needed. Funders, peer reviewers, journal editors and regulatory authorities have a responsibility to make sure that issues are addressed in research, and the involvement of patients is critical to making sure that appropriate outcomes are measured in effectiveness trials.
COMET-2 was a success: “a good forum to facilitate change” said one of the participants and the enthusiasm for COMET-3 was obvious. There is clearly much to do in this field of research and the COMET Initiative is committed to driving it forward, to facilitate and promote research in this area and develop much needed standards for methods of COS development.
More details about the meeting and the COMET Initiative can be found at www.comet-initiative.org.
The blog was written by Elizabeth Gargon, the COMET Initiative’s project coordinator on behalf of the initiative’s management group.