Driving up the quality and relevance of research-based knowledge through the identification and use of core outcomes: the COMET Initiative

People doing clinical trials and other types of health research often struggle when trying to choose the outcomes to measure which would be of most use to the patients, practitioners and policy makers who will use their research to help them make decisions. These difficulties for trialists are passed on to those producing and reading systematic reviews of trials, many of whom have experienced the frustration of finding that the original researchers either did not measure certain outcomes or measured them in such different ways that it is difficult or impossible to compare, contrast or combine the studies.

Much could be gained if there was an agreed minimum set of core outcomes for each medical condition, which were measured and reported in all clinical trials in that area. Last year, the COMET Initiative was launched to bring together an international network of individuals and organisations interested in the development, application and promotion of such core outcome sets.

COMET aims to collate relevant resources in a publically available, searchable database; to provide guidance on methods for developing core outcome sets; and to develop reporting standards for such studies. Through personal contacts we already know of work on core outcome sets in over 70 areas but there is likely to be much more than this. This proposal is for a two year project to consolidate and develop the COMET Initiative, that has started and that is supported by many stakeholders. The project will include three workstreams: core activity, research, and strategic development.

Core activity will include periodic searching of the literature to identify all relevant work and keep the database up to date, provision of advice to researchers, delivery of training workshops, collation of information about methodological research, organisation of international meetings, and development of the website as a resource for those interested in outcome measurement. We will also examine the level and nature of any patient involvement in this work, since examples exist where patients have identified an outcome important to them as a group that might not have been considered if the core outcome set was developed by practitioners on their own.

An initial review of the studies identified to date shows that the methods used to develop core outcome sets vary and there is limited empirical evidence regarding whether different methods result in similar or different conclusions. Our research will involve undertaking a survey of researchers to understand their experience of core outcome set development and their choice of approach. From the survey, we will identify key methodological research questions and subsequently undertake feasibility work alongside ongoing core outcome set development in particular clinical areas.
This workstream will provide a starting point for methodological research in this area, with the goal of improving methodological standards for COS development.

Our strategic development will involve working towards three main goals: (i) to increase the number of core outcome sets developed using evidence-based methods, (ii) to increase their impact on the quality of research-based knowledge, by raising awareness and increasing implementation, and (iii) to establish methods for standards of core outcome set development.

A 'core outcome set' (COS) is a set of outcomes which should be measured and reported, as a minimum, in all clinical trials for a specific condition. COS could have implications across all areas of research in health and health care, reduce heterogeneity between trials, lead to research that is more likely to have measured relevant outcomes, and be of potential value in clinical audit. COS would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information. COS will increase the efficiency of the research process.

The COMET (Core Outcome Measures in Effectiveness Trials, http://www.comet-initiative.org.uk) Initiative brings together researchers interested in the development and application of COS. The objectives of this 2-year project are to consolidate and develop the ongoing COMET Initiative, which is supported by many stakeholders. There are three workstreams (section 3.3): core activity, research, and strategic development.

We will systematically search for and classify studies that have determined which outcomes to measure in clinical trials, and include them in a publically available internet-based resource. Our research objectives are (i) to undertake a survey of COS developers to understand their choice of approach, to describe their experience of COS development and implementation, and to identify priority areas for methodological research, and (ii) to undertake feasibility work for methodological projects alongside COS development.

The results of our work will provide a useful, central resource for clinical trialists, systematic reviewers, trial funders, regulators and guideline developers, so they may identify existing core outcome sets in specific clinical areas. Our feasibility studies will benefit other academics working in the fields of consensus methodology research. The project has implications across all areas of research in health and healthcare.

People doing clinical trials and other types of health research often struggle when trying to choose the outcomes to measure which would be of most use to the patients, practitioners and policy makers who will use their research to help them make decisions. These difficulties for trialists are passed on to those producing and reading systematic reviews of trials, many of whom have experienced the frustration of finding that the original researchers either did not measure certain outcomes or measured them in such different ways that it is difficult or impossible to compare, contrast or combine the studies.

A 'core outcome set' (COS) is a set of outcomes which should be measured and reported, as a minimum, in all clinical trials for a specific condition. COS could have implications across all areas of research in health and health care, reduce heterogeneity between trials, lead to research that is more likely to have measured relevant outcomes, and be of potential value in clinical audit. COS would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information. COS will increase the efficiency of the research process, by reducing the inefficiencies of trials of similar topics measuring outcomes in different ways.

The results of our work will provide a valuable, central resource for clinical trialists, systematic reviewers, trial funders, health service users, clinical teams, medical sociologists, journal editors, policy makers, trials registries regulators and guideline developers, by identifying the consensus about outcomes that are important in particular clinical areas.

The work will benefit other researchers in the field wishing to develop new core outcome sets, by developing a unique resource which should serve to minimise duplication, and by providing a starting point for methodological research in this area, with the goal of improving methodological standards for COS development.

Outcomes need to be relevant to health service users and other people making decisions about health care, if the research findings of pragmatic trials are to influence health-care decision-making. Patients and the public will be able to access information on outcomes recommended for clinical research.