Core Outcome Measures in Effectiveness Trials


Research agenda

Guidance for trialists




Kirkham, J. J., S. Gorst, D. G. Altman, J. M. Blazeby, M. Clarke, S. Tunis and P. R. Williamson (2019). "Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement." Trials 20(1): 116.

Qiu R, Li M, Han S, He T, Huang Y, CHen J, Shang H. Interpretation of the COMET Handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine Chinese Journal of Evidence-based Medicine 2017, 17: 12. Chinese version / English version

Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, Clarke M, Gargon E, Gorst S, Harman N, et al: The COMET Handbook: version 1.0. Trials 2017, 18:280.

Gargon E, Williamson PR, Young B: Improving core outcome set development: qualitative interviews with developers provided pointers to inform guidance. J Clin Epidemiol 2017, 86:140-152.

Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, Williamson PR: Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLoS Med 2017, 14:e1002447.

Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, Moher D, Schmitt J, Tugwell P, et al: Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med 2016, 13:e1002148.

Saldanha, I. J., T. Li, et al. (2015). "Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS." Journal of Clinical Epidemiology.

Schmitt, J., C. Apfelbacher, et al. (2014). "The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: A Methodological Framework to Develop Core Sets of Outcome Measurements in Dermatology." Journal of Investigative Dermatology.

Prinsen, C. A., S. Vohra, et al. (2014). "How to select outcome measurement instruments for outcomes included in a  "Core Outcome Set" - a practical guideline." Trials 17(1): 449.

Macefield, R. C., M. Jacobs, et al. (2014). "Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs)." Trials 15: 49.

Paula R Williamson, Douglas G Altman, Jane M Blazeby, Mike Clarke, Declan Devane, Elizabeth Gargon and Peter Tugwell (2012). "Developing core outcome sets for clinical trials: issues to consider" Trials 2012, 13:132.

Sinha, I. P., D. G. Altman, et al. (2012). "Standard 5: Selection, Measurement, and Reporting of Outcomes in Clinical Trials in Children." Pediatrics 129(Supplement 3): S146-S152.

Sinha, I. P., 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.



Other COMET publications

Gargon, E., P. R. Williamson, et al. (2014). "The COMET Initiative database: progress and activities from 2011 to 2013." Trials 15(1): 279.

Gargon, E., B. Gurung, et al. (2014). "Choosing important health outcomes for comparative effectiveness research: a systematic review." PLoS ONE 9(6): e99111.

P. R. Williamson, M. Clarke. (2012). " The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: its role in improving Cochrane Reviews" The Cochrane Library Editorial April 2012.

P. R. Williamson, et al. (2012). "Driving up the quality and relevance of research through the use of agreed core outcomes" J Health Serv Res Policy January 2012 vol. 17 no. 1 1-2.

Sinha, I. P., P. R. Williamson, et al. (2009). "Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. " PLoS One 4(7): e6276.

Sinha, I., L. Jones, et al. (2008). "A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children." PLoS Med 5(4): e96.



Other relevant publications

Bautista-Molano, W., V. Navarro-Compán, et al. (2014). "How well are the ASAS/OMERACT core outcome sets for ankylosing spondylitis implemented in randomized clinical trials? A systematic literature review." Clinical Rheumatology 33(9): 1313-1322.

Idzerda, L., T. Rader, et al. (2014). "Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets." J Rheumatol.

Boers, M., J. R. Kirwan, et al. (2014). "Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0." Journal of Clinical Epidemiology.

Kirkham, J. J., M. Boers, et al. (2013). "Outcome measures in rheumatoid arthritis randomised trials over the last 50 years." Trials 14(1): 324.

Ethan Basch et al. (2012). "Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research. The PCORI Perspective." JAMA. 2012;307(15):1636-1640.

Williamson et al. "The COMET (Core Outcome Measures in Effectiveness Trials) Initiative." Trials 2011 12(Suppl 1):A70.

Whistance RN, Blencowe NS, Blazeby JM. "The need for standardised outcome reporting in colorectal surgery." Gut.2011.

INVOLVE report - This report from INVOLVE refers to public involvement and impact on the choice of outcome measures in clinical trials (p10 and section 4.2)

Clarke M. "Standardising Outcomes in Paediatric Clinical Trials." PLoS Medicine / Public Library of Science. 2008; 5(4):e102.

Clarke M. "Standardising outcomes for clinical trials and systematic reviews." Trials 2007:39.

Tugwell, P., M. Boers, et al. (2007). "OMERACT: an international initiative to improve outcome measurement in rheumatology." Trials 8: 38.


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