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Review Article| Volume 135, ISSUE 2, P249-256, February 2023

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The research status and progress of core outcome set in oral health

  • Yansong Song
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
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  • Ling Ren
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
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  • Jiaxin Liu
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
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  • Xin Zeng
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
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  • Qianming Chen
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China

    Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Hangzhou, China
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  • Hongxia Dan
    Correspondence
    Corresponding author: Hongxia Dan
    Affiliations
    State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Research Unit of Oral Carcinogenesis and Management, Chinese Academy of Medical Sciences, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
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Published:November 10, 2022DOI:https://doi.org/10.1016/j.oooo.2022.11.002
      The core outcome set (COS) refers to the minimum set of outcomes that should be reported by all clinical trials in a particular health field. The use of COS in clinical studies can reduce the heterogeneity caused by using different outcomes across different clinical studies, facilitate the systematic review of different clinical studies on the same topic, reduce selective reporting bias, and increase the utility of clinical studies. The importance of COS in oral health has recently been recognized. This review summarizes the history, necessity, and key methodological points of COS development, with emphasis on the research status and existing problems in COS development, in the field of oral health.
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      REFERENCES

        • Kassebaum NJ
        • Smith AGC
        • Bernabé E
        • et al.
        Global, regional, and national prevalence, incidence, and disability-adjusted life years for oral conditions for 195 countries, 1990-2015: a systematic analysis for the global burden of diseases, injuries, and risk factors.
        J Dent Res. 2017; 96: 380-387
        • Vos T
        • Lim SS
        • Abbafati C
        • et al.
        Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the global burden of disease study 2019.
        Lancet. 2020; 396: 1204-1222
        • Institute for Health Metrics and Evaluation (IHME)
        GBD Compare Data Visualization.
        IHME, University of Washington, Seattle, WA2022
        • Peres MA
        • Macpherson L
        • Weyant RJ
        • et al.
        Oral diseases: a global public health challenge.
        Lancet. 2019; 394: 249-260
        • Clarke M
        • Williamson PR.
        Core outcome sets and systematic reviews.
        Syst Rev. 2016; 5: 11
        • Glasziou P
        • Altman DG
        • Bossuyt P
        • et al.
        Reducing waste from incomplete or unusable reports of biomedical research.
        Lancet. 2014; 383: 267-276
        • Ioannidis JPA
        • Greenland S
        • Hlatky MA
        • et al.
        Research: Increasing value, reducing waste 2: increasing value and reducing waste in research design, conduct, and analysis.
        Lancet. 2014; 383: 166-175
        • Chalmers I
        • Glasziou P.
        Avoidable waste in the production and reporting of research evidence.
        Lancet. 2009; 374: 86-89
        • Hutton JL
        • Williamson PR.
        Bias in meta-analysis due to outcome variable selection within studies.
        J R Stat Soc Ser C Appl Stat. 2000; 49: 359-370
        • Dwan K
        • Gamble C
        • Williamson PR
        • et al.
        Systematic review of the empirical evidence of study publication bias and outcome reporting bias—an updated review.
        PLoS One. 2013; 8: e66844
        • Clarke M.
        Standardising outcomes for clinical trials and systematic reviews.
        Trials. 2007; 8: 39
        • Gargon E.
        The COMET (Core Outcome Measures in Effectiveness Trials) initiative.
        Maturitas. 2016; 91: 91-92
        • Wuytack F
        • Smith V
        • Clarke M
        • Williamson P
        • Gargon E.
        Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews.
        Syst Rev. 2015; 4: 73
        • Kirkham JJ
        • Gargon E
        • Clarke M
        • Williamson PR.
        Can a core outcome set improve the quality of systematic reviews?—a survey of the Co-ordinating Editors of Cochrane Review Groups.
        Trials. 2013; 14: 21
        • Rosenbaum SE
        • Glenton C
        • Oxman AD.
        Summary-of-findings tables in Cochrane reviews improved understanding and rapid retrieval of key information.
        J Clin Epidemiol. 2010; 63: 620-626
        • Page MJ
        • McKenzie JE
        • Kirkham J
        • et al.
        Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.
        Cochrane Database Syst Rev. 2014; 2014MR000035
        • Miller AB
        • Hoogstraten B
        • Staquet M
        • Winkler A.
        Reporting results of cancer treatment.
        Cancer. 1981; 47: 207-214
        • Tugwell P
        • Boers M
        • Brooks P
        • et al.
        OMERACT: an international initiative to improve outcome measurement in rheumatology.
        Trials. 2007; 8: 38
        • Tugwell P
        • Boers M.
        OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction.
        J Rheumatol. 1993; 20: 528-530
        • Kirkham JJ
        • Boers M
        • Tugwell P
        • Clarke M
        • Williamson PR.
        Outcome measures in rheumatoid arthritis randomised trials over the last 50 years.
        Trials. 2013; 14: 324
        • Dworkin RH
        • Turk DC
        • Farrar JT
        • et al.
        Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
        Pain. 2005; 113: 9-19
        • Schmitt J
        • Williams H
        Harmonising Outcome Measures for Eczema (HOME). Report from the First International Consensus Meeting (HOME 1), 24 July 2010, Munich, Germany.
        Br J Dermatol. 2010; 163: 1166-1168
        • Gottrup F
        • Apelqvist J
        • Price P.
        Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management.
        J Wound Care. 2010; 19: 237-268
        • 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; 8e1000393
        • Gargon E
        • Gorst SL
        • Matvienko-Sikar K
        • Williamson PR.
        Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research.
        PLoS One. 2021; 16e244878
        • Gargon E
        • Gurung B
        • Medley N
        • et al.
        Choosing important health outcomes for comparative effectiveness research: a systematic review.
        PLoS One. 2014; 9: e99111
        • Gorst SL
        • Gargon E
        • Clarke M
        • et al.
        Choosing important health outcomes for comparative effectiveness research: an updated review and user survey.
        PLoS One. 2016; 11e146444
        • Kirkham JJ
        • Gorst S
        • Altman DG
        • et al.
        Core Outcome Set–STAndards for Reporting: the COS-STAR Statement.
        PLoS Med. 2016; 13e1002148
        • Kirkham JJ
        • Gorst S
        • Altman DG
        • et al.
        COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).
        Trials. 2015; 16: 373
        • Gorst SL
        • Gargon E
        • Clarke M
        • Smith V
        • Williamson PR.
        Choosing important health outcomes for comparative effectiveness research: an updated review and identification of gaps.
        PLoS One. 2016; 11e168403
        • Kirkham JJ
        • Davis K
        • Altman DG
        • et al.
        Core Outcome Set-STAndards for Development: the COS-STAD recommendations.
        PLoS Med. 2017; 14e1002447
        • Williamson PR
        • Altman DG
        • Bagley H
        • et al.
        The COMET Handbook: version 1.0.
        Trials. 2017; 18: 280
        • Prinsen CAC
        • Vohra S
        • Rose MR
        • et al.
        Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.
        Trials. 2014; 15: 247
        • Prinsen CAC
        • Vohra S
        • Rose MR
        • et al.
        How to select outcome measurement instruments for outcomes included in a “Core Outcome Set”—a practical guideline.
        Trials. 2016; 17: 449
        • Kirkham JJ
        • Gorst S
        • Altman DG
        • et al.
        Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement.
        Trials. 2019; 20: 116
        • Gargon E
        • Gorst SL
        • Williamson PR.
        Choosing important health outcomes for comparative effectiveness research: 5th annual update to a systematic review of core outcome sets for research.
        PLoS One. 2019; 14e225980
        • Schwendicke F
        • Lamont T
        • Innes N.
        Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol.
        Trials. 2015; 16: 397
        • Qin D
        • Wang Y
        • Levey C
        • et al.
        Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL).
        Trials. 2021; 22: 507
        • Clarke M
        • Williamson P.
        Core outcome sets and trial registries.
        Trials. 2015; 16: 216
        • Young B
        • Bagley H.
        Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates.
        Res Involv Engagem. 2016; 2: 25
        • Gargon E
        • Gorst SL
        • Harman NL
        • et al.
        Choosing important health outcomes for comparative effectiveness research: 4th annual update to a systematic review of core outcome sets for research.
        PLoS One. 2018; 13e209869
        • Gargon E
        • Williamson PR
        • Altman DG
        • et al.
        The COMET Initiative database: progress and activities update (2015).
        Trials. 2017; 18: 54
        • Davis K
        • Gorst SL
        • Harman N
        • et al.
        Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle income countries.
        PLoS One. 2018; 13e190695
        • Bernabe E
        • Marcenes W
        • Hernandez CR
        • et al.
        Global, regional, and national levels and trends in burden of oral conditions from 1990 to 2017: a systematic analysis for the global burden of disease 2017 study.
        J Dent Res. 2020; 99: 362-373
        • Biggane AM
        • Brading L
        • Ravaud P
        • Young B
        • Williamson PR.
        Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.
        Trials. 2018; 19: 113
        • Keeley T
        • Williamson P
        • Callery P
        • et al.
        The use of qualitative methods to inform Delphi surveys in core outcome set development.
        Trials. 2016; 17: 230
        • Biggane AM
        • Williamson PR
        • Ravaud P
        • Young B.
        Participating in core outcome set development via Delphi surveys: qualitative interviews provide pointers to inform guidance.
        BMJ OPEN. 2019; 9: e32338
        • Farag AM
        • Albuquerque R
        • Ariyawardana A
        • et al.
        World Workshop in Oral Medicine VII: reporting of IMMPACT-recommended outcome domains in randomized controlled trials of burning mouth syndrome: a systematic review.
        Oral Dis. 2019; 25: 122-140
        • Matvienko-Sikar K
        • Avery K
        • Blazeby JM
        • et al.
        Use of core outcome sets was low in clinical trials published in major medical journals.
        J Clin Epidemiol. 2021; 142: 19-28
        • Saldanha IJ
        • Dodd S
        • Gorst SL
        • Williamson PR.
        More than half of systematic reviews have relevant core outcome sets.
        J Clin Epidemiol. 2021; 136: 168-179
        • Hughes KL
        • Clarke M
        • Williamson PR.
        A systematic review finds core outcome set uptake varies widely across different areas of health.
        J Clin Epidemiol. 2021; 129: 114-123
        • Akinremi A
        • Turnbull AE
        • Chessare CM
        • et al.
        Delphi panelists for a core outcome set project suggested both new and existing dissemination strategies that were feasibly implemented by a research infrastructure project.
        J Clin Epidemiol. 2019; 114: 104-107
        • Hughes KL
        • Kirkham JJ
        • Clarke M
        • Williamson PR.
        Assessing the impact of a research funder's recommendation to consider core outcome sets.
        PLoS One. 2019; 14e222418
        • Kirkham JJ
        • Bracken M
        • Hind L
        • et al.
        Industry funding was associated with increased use of core outcome sets.
        J Clin Epidemiol. 2019; 115: 90-97
        • Kirkham JJ
        • Clarke M
        • Williamson PR.
        A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.
        BMJ. 2017; 357: j2262