Study Protocol on Defining Core Outcomes and Data Elements in Chronic Subdural Haematoma

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Abstract

BACKGROUND

Core Outcome Sets (COSs) are necessary to standardize reporting in research studies. This is urgently required in the field of chronic subdural hematoma (CSDH), one of the most common disease entities managed in neurosurgery and the topic of several recent trials. To complement the development of a COS, a standardized definition and baseline Data Elements (DEs) to be collected in CSDH patients, would further improve study quality and comparability in this heterogeneous population.

OBJECTIVE

To, first, define a standardized COS for reporting in all future CSDH studies; and, second, to identify a unified CSDH Definition and set of DEs for reporting in future CSDH studies.

METHODS

The overall study design includes a Delphi survey process among 150 respondents from 2 main stakeholder groups: healthcare professionals or researchers (HCPRs) and Patients or carers. HCPR, patients and carers will all be invited to complete the survey on the COS, only the HCPR survey will include questions on definition and DE.

EXPECTED OUTCOMES

It is expected that the COS, definition, and DE will be developed through this Delphi survey and that these can be applied in future CSDH studies. This is necessary to help align future research studies on CSDH and to understand the effects of different treatments on patient function and recovery.

DISCUSSION

This Delphi survey should result in consensus on a COS and a standardized CSDH Definition and DEs to be used in future CSDH studies.

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Most cited references 23

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Developing core outcome sets for clinical trials: issues to consider

Paula Williamson, Douglas G. Altman, Jane Blazeby … (2012)

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

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Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Jamie Kirkham, Katherine Davis, Douglas G. Altman … (2017)

Background The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). Methods and findings An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1–9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. Conclusions The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

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Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

Jamie Kirkham, Sarah Gorst, Douglas G. Altman … (2019)

Background Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol. Methods The COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants. Results The COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes. Conclusions Journal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out. Electronic supplementary material The online version of this article (10.1186/s13063-019-3230-x) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Dana C Holl:

ORCID: https://orcid.org/0000-0001-7514-8825

Aswin Chari

Christian Iorio-Morin:

ORCID: https://orcid.org/0000-0003-2995-7255

Ruben Dammers:

ORCID: https://orcid.org/0000-0001-7033-0644

Niels A van der Gaag:

ORCID: https://orcid.org/0000-0001-8086-9870

Angelos G Kolias:

ORCID: https://orcid.org/0000-0003-3992-0587

Peter J Hutchinson:

ORCID: https://orcid.org/0000-0002-2796-1835

Ellie Edlmann:

ORCID: https://orcid.org/0000-0002-7253-9115

Journal

Journal ID (nlm-ta): Neurosurgery

Journal ID (iso-abbrev): Neurosurgery

Journal ID (publisher-id): neurosurgery

Title: Neurosurgery

Publisher: Oxford University Press

ISSN (Print): 0148-396X

ISSN (Electronic): 1524-4040

Publication date Collection: October 2021

Publication date (Electronic): 28 July 2021

Publication date PMC-release: 28 July 2021

Volume: 89

Issue: 4

Pages: 720-725

Affiliations

Department of Neurosurgery, Erasmus Medical Centre, Erasmus MC Stroke Centre , Rotterdam, the Netherlands

Developmental Neurosciences, Great Ormond Street Institute of Child Health, University College London , London, UK

Department of Neurosurgery, Great Ormond Street Hospital , London, UK

Division of Neurosurgery, Université de Sherbrooke , Sherbrooke, Canada

Department of Neurosurgery, Erasmus Medical Centre, Erasmus MC Stroke Centre , Rotterdam, the Netherlands

University Neurosurgical Centre Holland (UNCH), Leiden University Medical Centre, Haaglanden Medical Centre, Haga Teaching Hospital , the Netherlands

Division of Neurosurgery, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust , Cambridge, UK

NIHR Global Health Research Group on Neurotrauma, University of Cambridge , Cambridge, UK

Division of Neurosurgery, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust , Cambridge, UK

NIHR Global Health Research Group on Neurotrauma, University of Cambridge , Cambridge, UK

Department of Neurosurgery, South West Neurosurgical Centre, University Hospitals Plymouth NHS Trust , Plymouth, UK

Faculty of Health, Peninsula Medical School, University of Plymouth , Plymouth, UK

Author notes

Correspondence: Dana C. Holl, MSc, Department of Neurosurgery, Erasmus Medical Centre, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. Email: d.holl@ 123456erasmusmc.nl

Author information

Dana C Holl https://orcid.org/0000-0001-7514-8825

Christian Iorio-Morin https://orcid.org/0000-0003-2995-7255

Ruben Dammers https://orcid.org/0000-0001-7033-0644

Niels A van der Gaag https://orcid.org/0000-0001-8086-9870

Angelos G Kolias https://orcid.org/0000-0003-3992-0587

Peter J Hutchinson https://orcid.org/0000-0002-2796-1835

Ellie Edlmann https://orcid.org/0000-0002-7253-9115

Article

Publisher ID: nyab268

DOI: 10.1093/neuros/nyab268

PMC ID: 8440066

PubMed ID: 34318894

SO-VID: 8c1cb0af-a9b3-4e08-8cb9-7735e72dd430

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@ 123456oup.com

History

Date received : 20 April 2021

Date accepted : 09 May 2021

Page count

Pages: 6

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Study Protocol on Defining Core Outcomes and Data Elements in Chronic Subdural Haematoma

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Abstract

BACKGROUND

OBJECTIVE

METHODS

EXPECTED OUTCOMES

DISCUSSION

Related collections

Trace Elements and Electrolytes

Most cited references 23

Developing core outcome sets for clinical trials: issues to consider

Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

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