Prioritising health research is an important mechanism for improving health, yet much of this research money is wasted, as highlighted by the University of Nottingham
The inefficient use of research funding can be solved by prioritising health research and ensuring that researchers answer questions that are important to healthcare users. They can do this by using efficient study designs, avoiding duplication of effort, measuring clinically relevant things and ensuring that results are reported transparently, in full and in a timely way (Chalmers and Glaziou 2009).
Although some progress has been made in this regard through initiatives such as the All Trials Campaign, so much more can be achieved by working together (Moher et al 2015).
For many years, the Centre of Evidence-Based Dermatology at the University of Nottingham has endeavoured to ensure that its work is based on an appraisal of the existing knowledge base on systematic reviews, and that prioritised research questions are addressed using large, high quality pragmatic, multi-centre clinical trials, followed by full publication and active disseminations strategies to a community of users.
In this way, we hope to improve research efficiency and to achieve maximum benefits for patients and healthcare providers. One important way of improving the quality of clinical trials and systematic reviews is to establish an internationally agreed core outcome set, which is the focus of this commentary.
Why prioritising health research is an important core outcome?
A core outcome set is a minimum set of outcomes that are agreed by all relevant stakeholders as being the most important aspects to be measured when evaluating treatment response in clinical trials (Clarke 2007).
They reflect aspects of the disease that may be affected by treatments, and commonly include domains such as symptoms, physical signs, quality of life and harms.
In the absence of an agreed core outcome set, many trials are conducted, but the results of the trials are difficult to compare because the same outcomes have not been used. Clinical decision-making is best informed by combining results of different trials in systematic reviews – but without a common language (as provided by a core outcome set), meta-analyses are often impossible and conclusions are limited.
What can the research community do?
Funders, academic institutions, journal editors and researchers have an ethical duty to ensure that the information provided by participants of clinical trials is used to best effect. Such an aspiration can only be achieved by working together internationally and agreeing on a consistent way of measuring important outcomes, in a way that is valid and reliable.
Only by working together, using a transparent and rigorous methodology, will the research community have fulfilled its obligation to patients and funders of medical research to ensure that research funding, time and effort are not wasted.
Experiences in the field of eczema
The Centre of Evidence Based Dermatology has been leading efforts to improve the quality of clinical trials in dermatology for many years. In 2008 Williams and Schmitt initiated the Harmonising Outcome Measure for Eczema (HOME) initiative. This group of clinicians, patients, researchers, regulatory bodies and representatives of the pharmaceutical industry are working together to achieve international consensus over a core outcome set for eczema.
Over the last 6 years, much progress has been made resulting in international agreement over what should be measured:
– Clinician assessed signs;
– Patient-assessed symptoms;
– Quality of Life;
– Long-term control.
The Group has also achieved consensus that eczema signs should be captured using the Eczema Area and Severity Index (EASI) instrument, and those symptoms should be captured using the Patient-Oriented Eczema Measure (POEM) scale. Decisions over the best quality of life scales and the best way of capturing long-term control of eczema will be discussed at the next consensus meeting in Brazil in 2017. An important outcome for the group has been the development and adoption of the HOME Roadmap, which provides a useful guide for other groups developing core outcome sets.
Core outcome sets in dermatology
The success of the HOME initiative has prompted other researchers around the world to establish core outcome sets for other skin conditions such as psoriasis, vitiligo and hidradenitis supprativa.
In order to support these groups and to provide methodological advice on how to develop internationally agreed high-quality core outcome sets, the Cochrane Skin Group Core Outcome Set Initiative (CSG COUSIN), led by Schmitt, has been established. CSG-COUSIN provides a virtual hub for dermatology core outcome set developers, with the remit of sharing best practice and expertise ( www.uniklinikum-dresden.de/COUSIN ).
How can you get involved?
Membership of both HOME and CSGCOUSIN is free and open to anyone with an interest in core outcome set development. For regular updates and details of forthcoming activities please check our websites or get in contact with the individual project coordinator ( HOME@nottingham.ac.uk or COUSIN@uniklinikum-dresden.de ). If you are interested in developing a core outcome set in a specific skin condition, then register your interest (COUSIN@uniklinikum-dresden.de).
If you are a funder of medical research, we appeal for you to consider funding applications seeking to establish core outcome sets because they represent the foundation on which all future research builds.
Regulatory bodies and pharmaceutical companies involved in the development and approval of new drugs can also play their part by speedily adopting agreed core outcome sets, so that the results of future research can be combined and placed in context throughout the world.
Professor Kim Thomas
Professor of Applied Dermatology Research
University of Nottingham
Tel: +44 (0)115 8468632
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