Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)

James W. Mitchell; Adam Noble; Gus Baker; Rachel Batchelor; Francesco Brigo; Jakob Christensen; Jacqueline French; Antonio Gil-Nagel; Alla Guekht; Nathalie Jette; Reetta Kälviäinen; John Paul Leach; Melissa Maguire; Terence O’Brien; Felix Rosenow; Philippe Ryvlin; Phil Tittensor; Manjari Tripathi; Eugen Trinka; Samuel Wiebe; Paula R. Williamson; Tony Marson

doi:10.1186/s13063-022-06729-4

Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)

James W. Mitchell, Adam Noble, Gus Baker, Rachel Batchelor, Francesco Brigo, Jakob Christensen, Jacqueline French, Antonio Gil-Nagel, Alla Guekht, Nathalie Jette, Reetta Kälviäinen, John Paul Leach, Melissa Maguire, Terence O’Brien, Felix Rosenow, Philippe Ryvlin, Phil Tittensor, Manjari Tripathi, Eugen Trinka, Samuel WiebePaula R. Williamson, Tony Marson

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Background: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all clinical trials. In epilepsy, the choice of outcomes varies widely among existing studies, particularly in clinical trials. This diminishes opportunities for informed decision-making, contributes to research waste and is a barrier to integrating findings in systematic reviews and meta-analyses. Furthermore, the outcomes currently being measured may not reflect what is important to people with epilepsy. Therefore, we aim to develop a COS specific to clinical effectiveness research for adults with epilepsy using Delphi consensus methodology. Methods: The EPSET Study will comprise of three phases and follow the core methodological principles as outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 will include two focused literature reviews to identify candidate outcomes from the qualitative literature and current outcome measurement practice in phase III and phase IV clinical trials. Phase 2 aims to achieve international consensus to define which outcomes should be measured as a minimum in future trials, using a Delphi process including an online consensus meeting involving key stakeholders. Phase 3 will involve dissemination of the ratified COS to facilitate uptake in future trials and the planning of further research to identify the most appropriate measurement instruments to use to capture the COS in research practice. Discussion: Harmonising outcome measurement across future clinical trials should ensure that the outcomes measured are relevant to patients and health services, and allow for more meaningful results to be obtained. Core Outcome Set registration: COMET Initiative as study 118.

Original language	English
Article number	943
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06729-4
State	Published - Dec 2022

Keywords

Clinical trials
Consensus
Core outcome set
Delphi study
Epilepsy
Treatment outcome

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10.1186/s13063-022-06729-4

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Mitchell, J. W., Noble, A., Baker, G., Batchelor, R., Brigo, F., Christensen, J., French, J., Gil-Nagel, A., Guekht, A., Jette, N., Kälviäinen, R., Leach, J. P., Maguire, M., O’Brien, T., Rosenow, F., Ryvlin, P., Tittensor, P., Tripathi, M., Trinka, E., ... Marson, T. (2022). Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET). Trials, 23(1), [943]. https://doi.org/10.1186/s13063-022-06729-4

@article{c86a65a089be4c14920a725f8fe78a27,

title = "Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)",

abstract = "Background: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all clinical trials. In epilepsy, the choice of outcomes varies widely among existing studies, particularly in clinical trials. This diminishes opportunities for informed decision-making, contributes to research waste and is a barrier to integrating findings in systematic reviews and meta-analyses. Furthermore, the outcomes currently being measured may not reflect what is important to people with epilepsy. Therefore, we aim to develop a COS specific to clinical effectiveness research for adults with epilepsy using Delphi consensus methodology. Methods: The EPSET Study will comprise of three phases and follow the core methodological principles as outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 will include two focused literature reviews to identify candidate outcomes from the qualitative literature and current outcome measurement practice in phase III and phase IV clinical trials. Phase 2 aims to achieve international consensus to define which outcomes should be measured as a minimum in future trials, using a Delphi process including an online consensus meeting involving key stakeholders. Phase 3 will involve dissemination of the ratified COS to facilitate uptake in future trials and the planning of further research to identify the most appropriate measurement instruments to use to capture the COS in research practice. Discussion: Harmonising outcome measurement across future clinical trials should ensure that the outcomes measured are relevant to patients and health services, and allow for more meaningful results to be obtained. Core Outcome Set registration: COMET Initiative as study 118.",

keywords = "Clinical trials, Consensus, Core outcome set, Delphi study, Epilepsy, Treatment outcome",

author = "Mitchell, {James W.} and Adam Noble and Gus Baker and Rachel Batchelor and Francesco Brigo and Jakob Christensen and Jacqueline French and Antonio Gil-Nagel and Alla Guekht and Nathalie Jette and Reetta K{\"a}lvi{\"a}inen and Leach, {John Paul} and Melissa Maguire and Terence O{\textquoteright}Brien and Felix Rosenow and Philippe Ryvlin and Phil Tittensor and Manjari Tripathi and Eugen Trinka and Samuel Wiebe and Williamson, {Paula R.} and Tony Marson",

note = "Funding Information: The EPSET Project is funded and supported by an Association of British Neurologists and Guarantors of Brain Research Training Fellowship (awarded to JWM). There are no other funding sources. The views expressed are those of the authors and not necessarily those of the Association of British Neurologists or Guarantors of Brain Charity. Funding Information: TOB has nothing to disclose related to the submitted work. Outside of the submitted work, TOB has received research grant funding and/or consultancies from companies undertaking clinical trials of new epilepsy therapies: Eisai, UCB, LivaNova, ES Therapeutics, Supernus, BioGen. Funding Information: We would like to thank the members of the Epilepsy Action Research Volunteer Network (UK), who kindly provided comments and feedback on the design of this study. Please note that this protocol follows the recommendations of the Core Outcome Set-STAndardised Protocol Items, the COS-STAP checklist [21]. Funding Information: AGN has nothing to disclose related to the submitted work. Outside the submitted work, AGN has served in advisory boards and received honoraria as a speaker from Arvelle/Angelini, Bial, Biocodex, Esteve, GW Pharma, PTC Therapeutics, Stoke, UCB Pharma, and Zogenix. AGN has also received research grants from Biocodex, GW Pharma, PTC Therapeutics and Zogenix. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s13063-022-06729-4",

language = "English",

volume = "23",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

Mitchell, JW, Noble, A, Baker, G, Batchelor, R, Brigo, F, Christensen, J, French, J, Gil-Nagel, A, Guekht, A, Jette, N, Kälviäinen, R, Leach, JP, Maguire, M, O’Brien, T, Rosenow, F, Ryvlin, P, Tittensor, P, Tripathi, M, Trinka, E, Wiebe, S, Williamson, PR & Marson, T 2022, 'Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)', Trials, vol. 23, no. 1, 943. https://doi.org/10.1186/s13063-022-06729-4

TY - JOUR

T1 - Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy

T2 - the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)

AU - Mitchell, James W.

AU - Noble, Adam

AU - Baker, Gus

AU - Batchelor, Rachel

AU - Brigo, Francesco

AU - Christensen, Jakob

AU - French, Jacqueline

AU - Gil-Nagel, Antonio

AU - Guekht, Alla

AU - Jette, Nathalie

AU - Kälviäinen, Reetta

AU - Leach, John Paul

AU - Maguire, Melissa

AU - O’Brien, Terence

AU - Rosenow, Felix

AU - Ryvlin, Philippe

AU - Tittensor, Phil

AU - Tripathi, Manjari

AU - Trinka, Eugen

AU - Wiebe, Samuel

AU - Williamson, Paula R.

AU - Marson, Tony

N1 - Funding Information: The EPSET Project is funded and supported by an Association of British Neurologists and Guarantors of Brain Research Training Fellowship (awarded to JWM). There are no other funding sources. The views expressed are those of the authors and not necessarily those of the Association of British Neurologists or Guarantors of Brain Charity. Funding Information: TOB has nothing to disclose related to the submitted work. Outside of the submitted work, TOB has received research grant funding and/or consultancies from companies undertaking clinical trials of new epilepsy therapies: Eisai, UCB, LivaNova, ES Therapeutics, Supernus, BioGen. Funding Information: We would like to thank the members of the Epilepsy Action Research Volunteer Network (UK), who kindly provided comments and feedback on the design of this study. Please note that this protocol follows the recommendations of the Core Outcome Set-STAndardised Protocol Items, the COS-STAP checklist [21]. Funding Information: AGN has nothing to disclose related to the submitted work. Outside the submitted work, AGN has served in advisory boards and received honoraria as a speaker from Arvelle/Angelini, Bial, Biocodex, Esteve, GW Pharma, PTC Therapeutics, Stoke, UCB Pharma, and Zogenix. AGN has also received research grants from Biocodex, GW Pharma, PTC Therapeutics and Zogenix. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - Background: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all clinical trials. In epilepsy, the choice of outcomes varies widely among existing studies, particularly in clinical trials. This diminishes opportunities for informed decision-making, contributes to research waste and is a barrier to integrating findings in systematic reviews and meta-analyses. Furthermore, the outcomes currently being measured may not reflect what is important to people with epilepsy. Therefore, we aim to develop a COS specific to clinical effectiveness research for adults with epilepsy using Delphi consensus methodology. Methods: The EPSET Study will comprise of three phases and follow the core methodological principles as outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 will include two focused literature reviews to identify candidate outcomes from the qualitative literature and current outcome measurement practice in phase III and phase IV clinical trials. Phase 2 aims to achieve international consensus to define which outcomes should be measured as a minimum in future trials, using a Delphi process including an online consensus meeting involving key stakeholders. Phase 3 will involve dissemination of the ratified COS to facilitate uptake in future trials and the planning of further research to identify the most appropriate measurement instruments to use to capture the COS in research practice. Discussion: Harmonising outcome measurement across future clinical trials should ensure that the outcomes measured are relevant to patients and health services, and allow for more meaningful results to be obtained. Core Outcome Set registration: COMET Initiative as study 118.

AB - Background: A Core Outcome Set (COS) is a standardised list of outcomes that should be reported as a minimum in all clinical trials. In epilepsy, the choice of outcomes varies widely among existing studies, particularly in clinical trials. This diminishes opportunities for informed decision-making, contributes to research waste and is a barrier to integrating findings in systematic reviews and meta-analyses. Furthermore, the outcomes currently being measured may not reflect what is important to people with epilepsy. Therefore, we aim to develop a COS specific to clinical effectiveness research for adults with epilepsy using Delphi consensus methodology. Methods: The EPSET Study will comprise of three phases and follow the core methodological principles as outlined by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Phase 1 will include two focused literature reviews to identify candidate outcomes from the qualitative literature and current outcome measurement practice in phase III and phase IV clinical trials. Phase 2 aims to achieve international consensus to define which outcomes should be measured as a minimum in future trials, using a Delphi process including an online consensus meeting involving key stakeholders. Phase 3 will involve dissemination of the ratified COS to facilitate uptake in future trials and the planning of further research to identify the most appropriate measurement instruments to use to capture the COS in research practice. Discussion: Harmonising outcome measurement across future clinical trials should ensure that the outcomes measured are relevant to patients and health services, and allow for more meaningful results to be obtained. Core Outcome Set registration: COMET Initiative as study 118.

KW - Clinical trials

KW - Consensus

KW - Core outcome set

KW - Delphi study

KW - Epilepsy

KW - Treatment outcome

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U2 - 10.1186/s13063-022-06729-4

DO - 10.1186/s13063-022-06729-4

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AN - SCOPUS:85142139330

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 943

ER -

Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)

Abstract

Keywords

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