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Protocol for development of SPIRIT and CONSORT extensions for reporting climate and environmental outcomes in randomised trials (SPIRIT-ICE and CONSORT-ICE)

Petersen, Johanne Juul ; Hemberg, Linn LU orcid ; Thabane, Lehana ; Hopewell, Sally ; Chan, An Wen ; Hróbjartsson, Asbjørn ; Mathiesen, Ole ; Kandasamy, Sujane ; Siegfried, Nandi and Williamson, Paula R. , et al. (2025) In BMJ Open 15(9).
Abstract

Introduction The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes. Methods and analysis This is a protocol for SPIRIT and CONSORT extensions on... (More)

Introduction The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes. Methods and analysis This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes. Ethics and dissemination The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Climate Change, PUBLIC HEALTH, STATISTICS & RESEARCH METHODS
in
BMJ Open
volume
15
issue
9
article number
e106708
publisher
BMJ Publishing Group
external identifiers
  • scopus:105016768780
  • pmid:40976669
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-106708
language
English
LU publication?
yes
id
94ffd316-aa14-4788-8459-d1439d4bc794
date added to LUP
2025-11-26 15:25:57
date last changed
2025-11-27 03:36:09
@article{94ffd316-aa14-4788-8459-d1439d4bc794,
  abstract     = {{<p>Introduction The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes. Methods and analysis This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes. Ethics and dissemination The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.</p>}},
  author       = {{Petersen, Johanne Juul and Hemberg, Linn and Thabane, Lehana and Hopewell, Sally and Chan, An Wen and Hróbjartsson, Asbjørn and Mathiesen, Ole and Kandasamy, Sujane and Siegfried, Nandi and Williamson, Paula R. and Fox, Lisa and Kamp, Caroline Barkholt and Hoffmann, Jean Marc and Brorson, Stig and Boutron, Isabelle and McGain, Forbes and McAlister, Scott and Mutengu, Lilian and Slutzman, Jonathan and Sherman, Jodi D. and Bentzer, Peter and Jakobsen, Janus C.}},
  issn         = {{2044-6055}},
  keywords     = {{Climate Change; PUBLIC HEALTH; STATISTICS & RESEARCH METHODS}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Protocol for development of SPIRIT and CONSORT extensions for reporting climate and environmental outcomes in randomised trials (SPIRIT-ICE and CONSORT-ICE)}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-106708}},
  doi          = {{10.1136/bmjopen-2025-106708}},
  volume       = {{15}},
  year         = {{2025}},
}