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

Ian P Sinha, Rosalind L Smyth, Paula R Williamson, Ian P Sinha, Rosalind L Smyth, Paula R Williamson

Abstract

Ian Sinha and colleagues advise that when using the Delphi process to develop core outcome sets for clinical trials, patients and clinicians be involved, researchers and facilitators avoid imposing their views on participants, and attrition of participants be minimized.

Conflict of interest statement

RLS is a member of the PLoS Board of Directors.

References

    1. Sinha IP, Williamson PR, Smyth RL. Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. PLoS ONE. 2009;4:e6276. doi: .
    1. Gandhi GY, Murad MH, Fujiyoshi A, Mullan RJ, Flynn DN, et al. Patient-important outcomes in registered diabetes trials. JAMA. 2008;299:2543–2549.
    1. Guyatt GH, Meade MO. Outcome measures: methodologic principles. Sepsis. 1997;1:21–25.
    1. Clarke M. Standardising outcomes in paediatric clinical trials. PLoS Med. 2008;5:e102. doi: .
    1. Williamson PR, Gamble C, Altman DG, Hutton JL. Outcome selection bias in meta-analysis. Stat Methods Med Res. 2005;14:515–524.
    1. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE. 2008;3:e3081. doi: .
    1. Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials. 2007;8:39.
    1. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.
    1. Tugwell P, Boers M, Brooks P, Simon L, Strand V, et al. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials. 2007;8:38.
    1. Sinha I, Jones L, Smyth RL, Williamson PR. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med. 2008;5:e96. doi: .
    1. Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Management Science. 1963;9:458–467.
    1. Murphy MK, Black NA, Lamping DL, McKee CM, Sanderson CF, et al. Consensus development methods, and their use in clinical guideline development. Health Technol Assess. 1998;2:i–iv, 1–88.
    1. Goodman CM. The Delphi technique: a critique. J Adv Nurs. 1987;12:729–734.
    1. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000;32:1008–1015.
    1. Hsu CC, Sandford BA. The Delphi technique: making sense of consensus. Practical Assessment, Research & Evaluation. 2007;12:1–8.
    1. Serrano-Aguilar P, Trujillo-Martín MM, Ramos-Goñi JM, Mahtani-Chugani V, Perestelo-Pérez L, et al. Patient involvement in health research: a contribution to a systematic review on the effectiveness of treatments for degenerative ataxias. Soc Sci Med. 2009;69:920–925.
    1. Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum. 2008;59:952–960.
    1. Kirwan JR, Newman S, Tugwell PS, Wells GA. Patient perspective on outcomes in rheumatology—A position paper for OMERACT 9. J Rheumatol. 2009;36:2067–2070.
    1. Stewart R, Caird J, Oliver K, Oliver S. Patients' and clinicians' research priorities. Health Expect. 2011 In press.
    1. Devane D, Begley CM, Clarke M, Horey D, OBoyle C. Evaluating maternity care: A core set of outcome measures. Birth. 2007;34:164–172.
    1. Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000;31:1429–1438.
    1. Ruperto N, Ravelli A, Murray KJ, Lovell DJ, Andersson-Gare B, et al. Preliminary core sets of measures for disease activity and damage assessment in juvenile systemic lupus erythematosus and juvenile dermatomyositis. Rheumatology (Oxford) 2003;42:1452–1459.
    1. Lux AL, Osborne JP. A proposal for case definitions and outcome measures in studies of infantile spasms and West syndrome: Consensus statement of the west Delphi group. Epilepsia. 2004;45:1416–1428.
    1. Sackman H. Delphi critique. Lexington (Massachusetts): DC Health; 1975.
    1. Bardecki MJ. Participants' response to the Delphi method: an attitudinal perspective. Technological Forecasting and social change. 1984;25:281–292.

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