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Core Outcome Measures in Effectiveness Trials comet-initiative Twitter: @ COMETinitiative

Core Outcome Measures in Effectiveness Trials www.comet-initiative.org Twitter: @ COMETinitiative Email: info@comet-initiative.org. Core outcome set.

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Core Outcome Measures in Effectiveness Trials comet-initiative Twitter: @ COMETinitiative

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  1. Core Outcome Measures in Effectiveness Trials • www.comet-initiative.org • Twitter: @COMETinitiative • Email: info@comet-initiative.org

  2. Core outcome set • An agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care. • COMET definition

  3. Advantages of core outcome sets • Increases consistency across trials • Maximise potential for trial to contribute to systematic reviews of these key outcomes • Much more likely to measure appropriate outcomes • Major reduction in selective reporting

  4. ILAR/WHO Core Outcome Set for RA (7 outcomes) • Tender joints • Swollen Joints • Pain • Physician Global Assessment • Patient Global Assessment • Physical Disability • Acute Phase Reactants Boers M, Tugwell P, Felson DT, et al. World health organization and international league of associations for rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol 1994;21 (suppl 41):86-9.

  5. Improvements over time (Kirkham et al, BMJ 2017) Studies reporting full RA COS (%) 100 80 60 drug studies 40 20 0 1985 1990 1995 2000 2005 2010 2015 WHO/ILAR RA COS BMJ 2017;357:j2262

  6. COMET Initiative • To raise awareness of current problems with outcomes in clinical trials • To encourage COS development and uptake • To promote patient and public involvement in COS development • To provide resources to facilitate this • To avoid unnecessary duplication of effort • To encourage evidence-based COS development

  7. www.comet-initiative.org

  8. Systematic review of COS • >300 published COS for trials • >180 ongoing COS studies

  9. Promotion and collaboration • Trialists – SPIRIT guidelines • Trial funders - NIHR, ARUK, AMRC, HRB Ireland, Horizon 2020 • Industry – EFPIA • Regulators – EMA, FDA • Systematic reviewers – Cochrane • Guideline developers – NICE, CMTP, GIN • Journal editors – CROWN • Patients and the public – PoPPIE

  10. Promotion and collaboration • Trial funders – NIHR HTA guidance: ‘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 at www.comet-initiative.org to identify whether Core Outcomes have been established.'

  11. COMET People and Patient Participation Involvement and Engagement (PoPPIE) Working Group To lead and oversee the public participation, involvement and engagement work of the COMET Initiative, as set out in the COMET Public Involvement Strategy

  12. Acknowledgements • COMET Management Group: Doug Altman, Jane Blazeby, Mike Clarke, Paula Williamson, Sean Tunis • COMET project coordinator: Elizabeth Gargon • International collaborators and ambassadors

  13. Reading list • Clarke, M. (2007). "Standardising outcomes for clinical trials and systematic reviews." Trials 8: 39. • Williamson, P., D. Altman, et al. (2012). "Driving up the quality and relevance of research through the use of agreed core outcomes." J Health Serv Res Policy 17(1): 1-2. • Gargon, E., B. Gurung, et al. (2014). "Choosing important health outcomes for comparative effectiveness research: a systematic review." PLoS ONE 9(6): e99111. • Gorst, S. L., E. Gargon, et al. (2016). "Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey." PLoS ONE 11(1): e0146444. • Gorst, S. L., E. Gargon, et al. (2016). "Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps." PLoS ONE 11(12): e0168403. • Sinha, I., R. L. Smyth, et al. (2011). "Using the delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies." PLoS Med 8(1): e1000393. • Kirkham, J. J., M. Boers, et al. (2013). "Outcome measures in rheumatoid arthritis randomised trials over the last 50 years." Trials 14(1): 324. • Young, B. and H. Bagley (2016). "Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates." Research Involvement and Engagement 2(1): 1-13. • Prinsen, C. A., S. Vohra, et al. (2016). "How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline." Trials 17(1): 449. • Kirkham, J. J., S. Gorst, et al. (2016). "Core Outcome Set-STAndards for Reporting: The COS-STAR Statement." PLoS Med 13(10): e1002148. • Williamson, P. R., D. Altman, et al. (2017). “The COMET Handbook: version 1.0“. Trials 18(Suppl 3): 280.

  14. www.comet-initiative.org • info@comet-initiative.org • Twitter: @COMETinitiative

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