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Review
. 2022 Jul 1;24(7):1048-1055.
doi: 10.1093/neuonc/noac062.

Opportunities and challenges for the development of "core outcome sets" in neuro-oncology

Christopher P Millward  1   2 , Terri S Armstrong  3 , Heather Barrington  4 , Andrew R Brodbelt  1   2 , Helen Bulbeck  5 , Anthony Byrne  6   7 , Linda Dirven  8   9 , Carrol Gamble  4 , Paul L Grundy  10 , Abdurrahman I Islim  1   2 , Mohsen Javadpour  11 , Sumirat M Keshwara  1   2 , Sandhya T Krishna  12 , Conor L Mallucci  12 , Anthony G Marson  13 , Michael W McDermott  14 , Torstein R Meling  15 , Kathy Oliver  16 , Barry Pizer  17 , Puneet Plaha  18 , Matthias Preusser  19 , Thomas Santarius  20 , Nisaharan Srikandarajah  1   2 , Martin J B Taphoorn  8   9 , Colin Watts  21 , Michael Weller  22 , Paula R Williamson  4 , Gelareh Zadeh  23 , Amir H Zamanipoor Najafabadi  24 , Michael D Jenkinson  1   2
Affiliations
Review

Opportunities and challenges for the development of "core outcome sets" in neuro-oncology

Christopher P Millward et al. Neuro Oncol. .

Abstract

Core Outcome Sets (COS) define minimum outcomes to be measured and reported in clinical effectiveness trials for a particular health condition/health area. Despite recognition as critical to clinical research design for other health areas, none have been developed for neuro-oncology. COS development projects should carefully consider: scope (how the COS should be used), stakeholders involved in development (including patients as both research partners and participants), and consensus methodologies used (typically a Delphi survey and consensus meeting), as well as dissemination plans. Developing COS for neuro-oncology is potentially challenging due to extensive tumor subclassification (including molecular stratification), different symptoms related to anatomical tumor location, and variation in treatment options. Development of a COS specific to tumor subtype, in a specific location, for a particular intervention may be too narrow and would be unlikely to be used. Equally, a COS that is applicable across a wider area of neuro-oncology may be too broad and therefore lack specificity. This review describes why and how a COS may be developed, and discusses challenges for their development, specific to neuro-oncology. The COS under development are briefly described, including: adult glioma, incidental/untreated meningioma, meningioma requiring intervention, and adverse events from surgical intervention for pediatric brain tumors.

Keywords: clinical trial; core outcome set; effectiveness; glioma; meningioma.

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References

    1. Pocock SJ. Clinical trials. a practical approach. New York, NY, USA: John Wiley & Sons; 1983.
    1. Williamson PR, Altman DG, Bagley H, et al. . The COMET handbook: version 1.0. Trials 2017;18(Suppl 3):280. - PMC - PubMed
    1. Tugwell P, Boers M. OMERACT conference on outcome measures in rheumatoid arthritis clinical trials: introduction. J Rheumatol. 1993;20(3):528–530. - PubMed
    1. Webbe J, Sinha I, Gale C. Core Outcome Sets. Arch Dis Childhood Educ Pract Ed. 2018;103(3):163–166. - PubMed
    1. Williamson PR, Altman DG, Blazeby JM, et al. . Developing core outcome sets for clinical trials: issues to consider. Trials 2012;13:132. - PMC - PubMed

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