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Published in: Trials 1/2023

Open Access 01-12-2023 | Methodology

How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development

Authors: James Webbe, Benjamin Allin, Marian Knight, Neena Modi, Chris Gale

Published in: Trials | Issue 1/2023

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Abstract

Background

Core outcomes sets are increasingly used to define research outcomes that are most important for a condition. Different consensus methods are used in the development of core outcomes sets; the most common is the Delphi process. Delphi methodology is increasingly standardised for core outcomes set development, but uncertainties remain. We aimed to empirically test how the use of different summary statistics and consensus criteria impact Delphi process results.

Methods

Results from two unrelated child health Delphi processes were analysed. Outcomes were ranked by mean, median, or rate of exceedance, and then pairwise comparisons were undertaken to analyse whether the rankings were similar. The correlation coefficient for each comparison was calculated, and Bland-Altman plots produced. Youden’s index was used to assess how well the outcomes ranked highest by each summary statistic matched the final core outcomes sets.
Consensus criteria identified in a review of published Delphi processes were applied to the results of the two child-health Delphi processes. The size of the consensus sets produced by different criteria was compared, and Youden’s index was used to assess how well the outcomes that met different criteria matched the final core outcomes sets.

Results

Pairwise comparisons of different summary statistics produced similar correlation coefficients. Bland–Altman plots showed that comparisons involving ranked medians had wider variation in the ranking. No difference in Youden’s index for the summary statistics was found.
Different consensus criteria produced widely different sets of consensus outcomes (range: 5–44 included outcomes). They also showed differing abilities to identify core outcomes (Youden’s index range: 0.32–0.92). The choice of consensus criteria had a large impact on Delphi results.

Discussion

The use of different summary statistics is unlikely to affect how outcomes are ranked during a Delphi process: mean, median, and rates of exceedance produce similar results. Different consensus criteria have a large impact on resultant consensus outcomes and potentially on subsequent core outcomes sets: our results confirm the importance of adhering to pre-specified consensus criteria.
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Literature
1.
go back to reference Tugwell P, Boers M. Omeract conference on outcome measures in rheumatoid-arthritis clinical-trials - introduction. J Rheumatol. 1993;20(3):528–30.PubMed Tugwell P, Boers M. Omeract conference on outcome measures in rheumatoid-arthritis clinical-trials - introduction. J Rheumatol. 1993;20(3):528–30.PubMed
3.
go back to reference Zarin DA, Goodman SN, Kimmelman J. Harms from uninformative clinical trials. JAMA. 2019;322(9):813–4.PubMedCrossRef Zarin DA, Goodman SN, Kimmelman J. Harms from uninformative clinical trials. JAMA. 2019;322(9):813–4.PubMedCrossRef
4.
go back to reference 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(7):e6276.PubMedPubMedCentralCrossRef 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(7):e6276.PubMedPubMedCentralCrossRef
5.
go back to reference 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(4):569–78.CrossRef 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(4):569–78.CrossRef
6.
go back to reference Webbe JWH, Ali S, Sakonidou S On behalf of the COIN Project Steering Committee, et al. Inconsistent outcome reporting in large neonatal trials: a systematic review Archives of Disease in Childhood - Fetal and Neonatal Edition. 2020;105:69-75. Webbe JWH, Ali S, Sakonidou S On behalf of the COIN Project Steering Committee, et al. Inconsistent outcome reporting in large neonatal trials: a systematic review Archives of Disease in Childhood - Fetal and Neonatal Edition. 2020;105:69-75.
7.
go back to reference Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.PubMedPubMedCentralCrossRef Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132.PubMedPubMedCentralCrossRef
8.
go back to reference Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson PR. Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research. PLoS ONE. 2018;13(12):e0209869.PubMedPubMedCentralCrossRef Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson PR. Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research. PLoS ONE. 2018;13(12):e0209869.PubMedPubMedCentralCrossRef
9.
go back to reference Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PloS One. 2014;9(6). Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PloS One. 2014;9(6).
10.
go back to reference Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson PR. Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research. PloS one. 2018;13(12):e0209869.PubMedPubMedCentralCrossRef Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson PR. Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research. PloS one. 2018;13(12):e0209869.PubMedPubMedCentralCrossRef
11.
go back to reference Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.PubMedPubMedCentralCrossRef Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.PubMedPubMedCentralCrossRef
12.
go back to reference Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59–99.PubMedCrossRef Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59–99.PubMedCrossRef
14.
go back to reference Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.PubMedPubMedCentralCrossRef Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.PubMedPubMedCentralCrossRef
15.
go back to reference Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Manag Sci. 1963;9:158–467. Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Manag Sci. 1963;9:158–467.
16.
go back to reference Sinha IP, Smyth RL, Williamson PR. 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. 2011;8(1):e1000393.PubMedPubMedCentralCrossRef Sinha IP, Smyth RL, Williamson PR. 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. 2011;8(1):e1000393.PubMedPubMedCentralCrossRef
17.
go back to reference Humphrey-Murto S, de Wit M. The Delphi method-more research please. J Clin Epidemiol. 2019;106:136–9.PubMedCrossRef Humphrey-Murto S, de Wit M. The Delphi method-more research please. J Clin Epidemiol. 2019;106:136–9.PubMedCrossRef
18.
go back to reference Blazeby JM, Macefield R, Blencowe NS, Jacobs M, McNair AGK, Sprangers M, et al. Core information set for oesophageal cancer surgery. BJS. 2015;102(8):936–43.CrossRef Blazeby JM, Macefield R, Blencowe NS, Jacobs M, McNair AGK, Sprangers M, et al. Core information set for oesophageal cancer surgery. BJS. 2015;102(8):936–43.CrossRef
19.
go back to reference Coulman KD, Hopkins J, Brookes ST, Chalmers K, Main B, Owen-Smith A, et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLoS Med. 2016;13(11):e1002187.PubMedPubMedCentralCrossRef Coulman KD, Hopkins J, Brookes ST, Chalmers K, Main B, Owen-Smith A, et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLoS Med. 2016;13(11):e1002187.PubMedPubMedCentralCrossRef
20.
go back to reference Potter S, Holcombe C, Ward JA, Blazeby JM, Group tBS. Development of a core outcome set for research and audit studies in reconstructive breast surgery. BJS. 2015;102(11):1360–71.CrossRef Potter S, Holcombe C, Ward JA, Blazeby JM, Group tBS. Development of a core outcome set for research and audit studies in reconstructive breast surgery. BJS. 2015;102(11):1360–71.CrossRef
21.
go back to reference Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Pract Assess Res Evaluation. 2007;12(10). Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Pract Assess Res Evaluation. 2007;12(10).
22.
go back to reference Grant S, Booth M, Khodyakov D. Lack of preregistered analysis plans allows unacceptable data mining for and selective reporting of consensus in Delphi studies. J Clin Epidemiol. 2018;99:96–105.PubMedCrossRef Grant S, Booth M, Khodyakov D. Lack of preregistered analysis plans allows unacceptable data mining for and selective reporting of consensus in Delphi studies. J Clin Epidemiol. 2018;99:96–105.PubMedCrossRef
23.
go back to reference De Meyer D, Kottner J, Beele H, Schmitt J, Lange T, Van Hecke A, et al. Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection. J Clin Epidemiol. 2019;111:23–31.PubMedCrossRef De Meyer D, Kottner J, Beele H, Schmitt J, Lange T, Van Hecke A, et al. Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection. J Clin Epidemiol. 2019;111:23–31.PubMedCrossRef
24.
go back to reference Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 2017;14(11):e1002447.PubMedPubMedCentralCrossRef Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: the COS-STAD recommendations. PLoS Med. 2017;14(11):e1002447.PubMedPubMedCentralCrossRef
25.
go back to reference Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–9.PubMedCrossRef Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014;67(4):401–9.PubMedCrossRef
26.
go back to reference Wylde V, MacKichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.PubMedCrossRef Wylde V, MacKichan F, Bruce J, Gooberman-Hill R. Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set. Eur J Pain. 2015;19(5):611–20.PubMedCrossRef
27.
go back to reference Allin BSR, Hall NJ, Ross AR on behalf of the NETS1G collaboration, et al. Development of a gastroschisis core outcome set Archives of Disease in Childhood - Fetal and Neonatal Edition. 2019;104:F76-F82. Allin BSR, Hall NJ, Ross AR on behalf of the NETS1G collaboration, et al. Development of a gastroschisis core outcome set Archives of Disease in Childhood - Fetal and Neonatal Edition. 2019;104:F76-F82.
28.
go back to reference Webbe JWH, Duffy JMN, Afonso E, Al-Muzaffar I, Brunton G, Greenough A, et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2020;105(4):425.PubMedCrossRef Webbe JWH, Duffy JMN, Afonso E, Al-Muzaffar I, Brunton G, Greenough A, et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch Dis Child Fetal Neonatal Ed. 2020;105(4):425.PubMedCrossRef
29.
go back to reference Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatrics Open. 2017;1(1):e000048.PubMedPubMedCentralCrossRef Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatrics Open. 2017;1(1):e000048.PubMedPubMedCentralCrossRef
30.
go back to reference Pearson K. Note on regression and inheritance in the case of two parents. Proc R Soc Lond. 1895;58:240–2.CrossRef Pearson K. Note on regression and inheritance in the case of two parents. Proc R Soc Lond. 1895;58:240–2.CrossRef
31.
go back to reference Altman DG, Bland JM. Measurement in medicine - the analysis of method comparison studies. J Roy Stat Soc D-Sta. 1983;32(3):307–17. Altman DG, Bland JM. Measurement in medicine - the analysis of method comparison studies. J Roy Stat Soc D-Sta. 1983;32(3):307–17.
33.
go back to reference Hilden J, Glasziou P. Regret graphs, diagnostic uncertainty and Youden’s index. Stat Med. 1996;15(10):969–86.PubMedCrossRef Hilden J, Glasziou P. Regret graphs, diagnostic uncertainty and Youden’s index. Stat Med. 1996;15(10):969–86.PubMedCrossRef
34.
go back to reference Beattie E, Mackway-Jones K. A Delphi study to identify performance indicators for emergency medicine. Emergency medicine journal : EMJ. 2004;21(1):47–50.PubMedPubMedCentralCrossRef Beattie E, Mackway-Jones K. A Delphi study to identify performance indicators for emergency medicine. Emergency medicine journal : EMJ. 2004;21(1):47–50.PubMedPubMedCentralCrossRef
35.
go back to reference Bennett WL, Robinson KA, Saldanha IJ, Wilson LM, Nicholson WK. High priority research needs for gestational diabetes mellitus. J Womens Health (Larchmt). 2012;21(9):925–32.PubMedCrossRef Bennett WL, Robinson KA, Saldanha IJ, Wilson LM, Nicholson WK. High priority research needs for gestational diabetes mellitus. J Womens Health (Larchmt). 2012;21(9):925–32.PubMedCrossRef
36.
go back to reference De Lima L, Krakauer EL, Lorenz K, Praill D, Macdonald N, Doyle D. Ensuring palliative medicine availability: the development of the IAHPC list of essential medicines for palliative care. J Pain Symptom Manage. 2007;33(5):521–6.PubMedCrossRef De Lima L, Krakauer EL, Lorenz K, Praill D, Macdonald N, Doyle D. Ensuring palliative medicine availability: the development of the IAHPC list of essential medicines for palliative care. J Pain Symptom Manage. 2007;33(5):521–6.PubMedCrossRef
37.
go back to reference Playfor S, Jenkins I, Boyles C, Choonara I, Davies G, Haywood T, et al. Consensus guidelines on sedation and analgesia in critically ill children. Intensive Care Med. 2006;32(8):1125–36.PubMedCrossRef Playfor S, Jenkins I, Boyles C, Choonara I, Davies G, Haywood T, et al. Consensus guidelines on sedation and analgesia in critically ill children. Intensive Care Med. 2006;32(8):1125–36.PubMedCrossRef
38.
go back to reference Qureshi AI, Feldmann E, Gomez CR, Johnston SC, Kasner SE, Quick DC, et al. Consensus conference on intracranial atherosclerotic disease: rationale, methodology, and results. J Neuroimaging. 2009;19(Suppl 1):1S-10S.PubMedCrossRef Qureshi AI, Feldmann E, Gomez CR, Johnston SC, Kasner SE, Quick DC, et al. Consensus conference on intracranial atherosclerotic disease: rationale, methodology, and results. J Neuroimaging. 2009;19(Suppl 1):1S-10S.PubMedCrossRef
39.
go back to reference Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol. 2011;131(3):623–30.PubMedCrossRef Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol. 2011;131(3):623–30.PubMedCrossRef
40.
go back to reference Liu M, Gao Y, Yuan Y, Shi S, Yang K, Lu C, et al. Inconsistency and low transparency were found between core outcome set protocol and full text publication: a comparative study. J Clin Epidemiol. 2021;131:59–69.PubMedCrossRef Liu M, Gao Y, Yuan Y, Shi S, Yang K, Lu C, et al. Inconsistency and low transparency were found between core outcome set protocol and full text publication: a comparative study. J Clin Epidemiol. 2021;131:59–69.PubMedCrossRef
42.
go back to reference Murray WF, Jarman BO. Predicting future-trends in adult fitness using the Delphi approach. Res Q Exercise Sport. 1987;58(2):124–31.CrossRef Murray WF, Jarman BO. Predicting future-trends in adult fitness using the Delphi approach. Res Q Exercise Sport. 1987;58(2):124–31.CrossRef
43.
go back to reference Greatorex J, Dexter T. An accessible analytical approach for investigating what happens between the rounds of a Delphi study. J Adv Nurs. 2000;32(4):1016–24.PubMed Greatorex J, Dexter T. An accessible analytical approach for investigating what happens between the rounds of a Delphi study. J Adv Nurs. 2000;32(4):1016–24.PubMed
44.
go back to reference Beiderbeck D, Frevel N, von der Gracht HA, Schmidt SL, Schweitzer VM. Preparing, conducting, and analyzing Delphi surveys: cross-disciplinary practices, new directions, and advancements. MethodsX. 2021;8:101401.PubMedPubMedCentralCrossRef Beiderbeck D, Frevel N, von der Gracht HA, Schmidt SL, Schweitzer VM. Preparing, conducting, and analyzing Delphi surveys: cross-disciplinary practices, new directions, and advancements. MethodsX. 2021;8:101401.PubMedPubMedCentralCrossRef
45.
go back to reference Gargon EA. Developing the agenda for core outcome set development. Liverpool: University of Liverpool; 2016. Gargon EA. Developing the agenda for core outcome set development. Liverpool: University of Liverpool; 2016.
46.
go back to reference Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS ONE. 2015;10(6):e0129514.PubMedPubMedCentralCrossRef Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS ONE. 2015;10(6):e0129514.PubMedPubMedCentralCrossRef
47.
go back to reference Keeney S, Hasson F, McKenna HP. A critical review of the Delphi technique as a research methodology for nursing. Int J Nurs Stud. 2001;38(2):195–200.PubMedCrossRef Keeney S, Hasson F, McKenna HP. A critical review of the Delphi technique as a research methodology for nursing. Int J Nurs Stud. 2001;38(2):195–200.PubMedCrossRef
Metadata
Title
How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development
Authors
James Webbe
Benjamin Allin
Marian Knight
Neena Modi
Chris Gale
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07285-1

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