Beune, I M

Ganzevoort, W

Gordijn, S J

English

Beune, I. M.

Ganzevoort, W.

Gordijn, S. J.

NARCIS 

Core outcome sets are valuable, but methodological evidence can improve robustness

Crossref

Dissertations of the University of Groningen

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 05-06-2022Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

Proceedings - University of Groningen

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 04-06-2022Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 31-10-2023Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

ARTS repository - University of Groningen

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 13-02-2023Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 10-09-2023Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

University of Groningen

   University of GroningenCore outcome sets are valuable, but methodological evidence can improve robustnessBeune, I M; Ganzevoort, W; Gordijn, S JPublished in:BJOG : An International Journal of Obstetrics and GynaecologyDOI:10.1111/1471-0528.16419IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2020Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Beune, I. M., Ganzevoort, W., & Gordijn, S. J. (2020). Core outcome sets are valuable, but methodologicalevidence can improve robustness. BJOG : An International Journal of Obstetrics and Gynaecology,127(12), 1527. https://doi.org/10.1111/1471-0528.16419CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Download date: 26-12-2020Core outcome sets are valuable, but methodological evidence canimprove robustnessIM Beune,a W Ganzevoort,b SJ Gordijnaa Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen,Groningen, The Netherlands b Department of Obstetrics and Gynaecology, Amsterdam University Medical Centres,University of Amsterdam, Amsterdam, The NetherlandsLinked article: This is a mini commentary on JMN Duffy et al., pp. 1516–1526 in this issue. To view this article visithttps://doi.org/10.1111/1471-0528.16319Published Online 26 September 2020.A core outcome set (COS) is theagreed minimum set of outcomes tobe measured in studies regarding aspecific topic. A COS is considered toencompass the most relevant outcomesand does not restrict researchers. Oneshould realise that outcomes notincluded in the COS may actually beimportant for specific research ques-tions and different study designs.The COMET handbook (Core Out-come Measures in Effectiveness Trials)(Williamson et al. Trials 2017;18[Suppl3]:280), used in the current study(Duffy et al. BJOG 2020; 127:1516–26),describes consensus methodology forCOS development. In a nutshell, it isadvised to start with a systematicreview to identify all possible out-comes; then use the Delphi strategy toconverge opinions to consensus; andfinally, the prioritised list of outcomesis discussed in a face-to-face consen-sus meeting in which the final COS isconducted. The team of Duffy et al.(BJOG 2020; 127:1516–26) havedeveloped an important COS usingthis methodology, meeting all qualityrecommendations for COSs as formu-lated in COS-STAD, and we com-mend them for it (Kirkham et al.PLoS Med 2017;14[11]:e1002447).We would like to raise the pointthat some elements of the COMETmethodology for COS developmentare by agreement rather than provenmethodology and we suggest thatalternatives may be considered.1. It remains unknown whether a sys-tematic review is preferable over ascoping review. A scoping review isadvised to clarify key concepts inthe literature (Munn et al. BMCMed Res Methodol 2018;18:143);chances are low that an outcomethat requires a systematic review toidentify it, is fundamental for allresearch in the field.2. COMET states that a response rateof 80% for each stakeholder groupis typical, but there is no frame ofreference to establish what attri-tion rate is acceptable to avoidlosing the strength of the panel.Did the drop-out of 37% of thetotal group in the Delphi roundsin this study have a significanteffect on the final COS?3. The crucial contribution of layexperts is recognised by COMETbut there is no advice as to the num-ber or percentage of lay experts in apanel. In previous COS procedures,the contribution of lay experts var-ied from 4 to 50% (Williamsonet al. Trials 2017;18[Suppl 3]:280).4. A consensus meeting facilitatesacceleration of the consensusbuilding procedure because thepanel members are in direct con-tact and clarifications are readilyavailable. However:• In contrast to the online Delphi proce-dure, a ‘strong voice’ may affect votingbehaviour, particularly when patientsor lay experts are impressed withknowledgeable professional experts.• In this study, 47 outcomes were pre-sented to participants in the consensusmeeting; ultimately 22 outcomes (in-cluding four newly introduced out-comes) were selected. It is unknownwhether an electronic meeting (inter-national and COVID-19 proof) mayreduce such selection bias.• A consensus-meeting at the end of aDelphi procedure may have a majorimpact, as it is not known whetherthe original panel agrees with thefinal COS. A consensus meeting heldat the beginning or between Delphirounds may have a different impact.Delphi and COMET methodologiesare valid and valuable tools for con-sensus building, particularly because aCOS is never (only) a gold standard.As there is also no gold standard ofthe methodology, it remains pivotalto appreciate the strengths and vul-nerabilities of the methodology bydoing studies that strengthen theCOMET and Delphi methodologies.Disclosure of interestsAll authors have no conflict of inter-ests to declare. Completed disclosureof interest forms are available to viewonline as supporting information.&A core outcome set for pre-eclampsia1527© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltdon behalf of Royal College of Obstetricians and GynaecologistsThis is an open access article under the terms of the Creative Commons Attribution License, which permits use,distribution and reproduction in any medium, provided the original work is properly cited.

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Core outcome sets are valuable, but methodological evidence can improve robustness

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