My colleague, Duncan Barron, recently attended the COMET IV meeting in Rome and has written a guest post about the conference, the reasons for developing Core Outcome Sets (COS) and some of the presentations.
COMET IV meeting Rome 19-21st Nov 2014
Guest post by Duncan Barron, PPI Lead, Research Design Service South East
“Clinical trials are only as credible as their outcomes” (Tugwell, 1993).
The COMET (Core Outcome Measures in Effectiveness Trials) 4th meeting in Rome was held recently on the 19th-21st November in Rome and I was lucky enough to attend.
The COMET Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as a ‘core outcome set.’ These sets should represent the minimum that should be measured and reported in all clinical trials, audits of practice or other forms of research for a specific condition.
There were speakers attending from all over Europe (with good representation from the UK) including patient representatives, some of whom presented on their experiences of being involved in developing outcome measures relevant to patients and their conditions.
The Core Outcome Sets (COS) are an “agreed standardised set of outcomes measures and reported as a minimum”. The aim of the COS is to increase consistency of reporting across trials and improve the quality of research.
The outcomes need to be appropriate, including being so to patients and the public. COMET provides guidance on what should be measured when developing a COS. This includes considering thing such as which domains to measure (eg. QoL; adverse effects) and considering the different ways of measuring outcomes.
A summary of some of the sessions
Roberto D’Amico spoke about his research in relapse remitting MS. He found that different reporting of data in trials meant it was impossible to analyse in a Systematic Review and therefore a waste of patient data. Therefore, there is a need for Core Outcome Scales.
Silvio Gavattini spoke on surrogate and composite end-points, highlighting that end-points of relevance to the patients (e.g. better QoL; decreasing mortality) are important. He gave an example of cholesterol as a surrogate for lowering MI, but that cholesterol is not a good surrogate for all drugs. In cancer, research decreasing the size of volume of tumour is usually viewed as good, but this is not always equivalent to a therapeutic end point. Survival is often the patients’ focus. Reducing tumour size can happen, but there can be considerable side effects which are not positive for the patient. Composite end points are a combination of individual end points in to one single measure (this can benefit in reducing the number of patients needed in a trial). However, the new measure can be influenced by the contribution of just one of the components which may be less meaningful overall. Therefore, each component should be equally meaningful.
Paula Williamson, from the Uni of Liverpool, spoke about the remit of COMET to encourage evidence based COS development and uptake. She highlighted a Systematic Review (Gargon et al (2014) of 198 COS (from 250 papers) that has been used to populate the COMET COS database – see here for more details. The systematic review revealed PPI in COS development in only 16% of the published COS. However, ongoing current PPI in COS is 90%. The Delphi technique is a regularly used component of COS (85% in ongoing COS work).
Trial funders including the NIHR Health Technology Assessment programme endorse COMET and recommend consulting the COMET database. “Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise. Please see The COMET Initiative website to identify whether Core Outcomes have been established.”
See here for more details.
Christian Apfelbacher (Uni of Regensburg) spoke about the methods used to develop COS in the field of atopic eczema in the HOME study.
1) Define the scope of the condition eg. setting (eg. trials); geo scope; stakeholders
2) Define the domains: what to measure
– used a Delphi to decide on domains
– 4 diff domains decided (eg. QoL; L/T flares).
3) Define core set of outcome measurement instruments
– beginning with a systematic review of existing tools (which are good enough instruments)
4) Dissemination and implementation:
– roadmap completed for one domain (“clinical signs”)
See here for more details.
Finn Gottrup, Prof of Surgery, Uni of Southern Denmark spoke about the development of Wound COS. Pervious COS had focused mainly on healing. His team undertook a Delphi study to identify a consensus on core outcomes for wound research. The work is still underway, but is linked with the European Wound Management (EWMA) group.
Holgar Schunemann (McMaster Uni, Canada) gave an interesting talk on Summary of Findings (SOF) Tables in published journals (as part of the The Grading of Recommendations Assessment, Development and Evaluation (short GRADE) Working Group). SOF tables help improves understanding of findings for journal readers. He is working on Interactive SOF tables (electronic) where the reader can manipulate way info is presented and Diagnostic SOF tables where the reader can test the accuracy of outcomes.
Peter Tugwell (Uni of Ottawa) & David Tovey (Cochrane Collaboration) spoke about core outcomes in pain research. Different Cochrane working groups all have an interest in chronic pain. These groups are beginning to develop alliances in developing outcomes across groups. The focus should be on the patient perspective for example pain interference with function versus Pain intensity.
Rosemary Humphreys spoke about a patient perspective in COS in the HOME (Eczema) study at the Uni of Notts. She highlighted the following:
– Patients can help define outcomes and new ones researchers haven’t considered
– Clinicians know about the condition but
– Patients know about the impact on their lives incl family, relationships.
– Involve patients early help design the COS
– Challenges to patients: language; jargon – produce a glossary for the condition of interest
Iain Bruce (Royal Manchester Children’s Hospital) MOMENT (cleft palate) study highlighted some lessons learned in involving patients and carers:
– Benefit from patients with direct experience of condition
– Involved the CEO of CLAPA, a patient support group in the cleft palate field
– Ensure patient voice is heard (lived experience)
– Ensure outcomes of most importance to patients are considered
– PPI is not an add on. It’s a fundamental theme!
– Challenges: engaging patients and use of language; practical meeting dates/ costs; scientific studies can be daunting
– Researchers need to explain why patients’ opinions are important.
– Use the same PES for clinicians + patients for Delphi survey
– Use SMOG calculator for PES and readability
– GRADE system 1-9 (Guyatt et al)
– Traffic light system for children
– All views are given equal value
– Advice to researchers developing COS: use lay language and variety of diff views; sell the benefits, tell them why it’s important for them to be involved; engage early at the design stage