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

Johanne Juul Petersen¹, Linn Hemberg^{2

3}, Lehana Thabane^{4

5

6}, Sally Hopewell⁷, An-Wen Chan⁸, Asbjørn Hróbjartsson^{9

10}, Ole Mathiesen^{11

12}, Sujane Kandasamy^{13

14}, Nandi Siegfried¹⁵, Paula R Williamson¹⁶, Lisa Fox¹⁷, Caroline Barkholt Kamp¹⁸, Jean-Marc Hoffmann¹⁹, Stig Brorson²⁰, Isabelle Boutron^{21

22}, Forbes McGain^{23

24

25}, Scott McAlister^{26

27}, Lilian Mutengu²⁸, Jonathan Slutzman²⁹, Jodi D Sherman^{30

31}, Peter Bentzer^#^{2

32}, Janus C Jakobsen^#^{18

33}

Affiliations

¹ Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark johanne.juul.petersen@ctu.dk.
² Department of Clinical Sciences, Lund University, Lund, Sweden.
³ Lund University, Lund, Sweden.
⁴ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
⁵ Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
⁶ Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.
⁷ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁸ Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
⁹ Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
¹⁰ Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), University of Southern Denmark, Odense, Denmark.
¹¹ Department of Anaesthesia, Zealand University Hospital, Køge, Denmark.
¹² Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹³ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹⁴ Department of Child & Youth Studies, Brock University, St. Catharines, Ontario, Canada.
¹⁵ Mental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Cape Town, South Africa.
¹⁶ MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.
¹⁷ Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
¹⁸ Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.
¹⁹ Clinical Trials Center, University Hospital Zurich, Zürich, Switzerland.
²⁰ Centre for Evidence-Based Orthopedics, Zealand University Hospital, Koge, Denmark.
²¹ Centre for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Paris-Sorbonne University, Paris, France.
²² Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu de Paris, Paris, France.
²³ Department of Critical Care, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
²⁴ Departments of Anaesthesia and Intensive Care Medicine, Western Health, Footscray, Victoria, Australia.
²⁵ The University of Sydney School of Public Health, Sydney, New South Wales, Australia.
²⁶ Centre for Health Policy, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
²⁷ Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
²⁸ African Academy of Sciences, Nairobi, Kenya.
²⁹ Center for the Environment and Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
³⁰ Department of Anesthesiology, Yale School of Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
³¹ Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut, USA.
³² Department of Anaesthesia and Intensive Care, Hospital in Helsingborg, Helsingborg, Sweden.
³³ Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

^# Contributed equally.

PMID: 40976669
PMCID: PMC12458820
DOI: 10.1136/bmjopen-2025-106708

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

Johanne Juul Petersen et al. BMJ Open. 2025.

. 2025 Sep 21;15(9):e106708.

doi: 10.1136/bmjopen-2025-106708.

Authors

Affiliations

¹ Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark johanne.juul.petersen@ctu.dk.
² Department of Clinical Sciences, Lund University, Lund, Sweden.
³ Lund University, Lund, Sweden.
⁴ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
⁵ Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
⁶ Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.
⁷ Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁸ Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
⁹ Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
¹⁰ Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), University of Southern Denmark, Odense, Denmark.
¹¹ Department of Anaesthesia, Zealand University Hospital, Køge, Denmark.
¹² Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹³ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
¹⁴ Department of Child & Youth Studies, Brock University, St. Catharines, Ontario, Canada.
¹⁵ Mental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Cape Town, South Africa.
¹⁶ MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, UK.
¹⁷ Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
¹⁸ Rigshospitalet Copenhagen Trial Unit, Copenhagen, Denmark.
¹⁹ Clinical Trials Center, University Hospital Zurich, Zürich, Switzerland.
²⁰ Centre for Evidence-Based Orthopedics, Zealand University Hospital, Koge, Denmark.
²¹ Centre for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Paris-Sorbonne University, Paris, France.
²² Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu de Paris, Paris, France.
²³ Department of Critical Care, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
²⁴ Departments of Anaesthesia and Intensive Care Medicine, Western Health, Footscray, Victoria, Australia.
²⁵ The University of Sydney School of Public Health, Sydney, New South Wales, Australia.
²⁶ Centre for Health Policy, The University of Melbourne Faculty of Medicine Dentistry and Health Sciences, Melbourne, Victoria, Australia.
²⁷ Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
²⁸ African Academy of Sciences, Nairobi, Kenya.
²⁹ Center for the Environment and Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
³⁰ Department of Anesthesiology, Yale School of Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
³¹ Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut, USA.
³² Department of Anaesthesia and Intensive Care, Hospital in Helsingborg, Helsingborg, Sweden.
³³ Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

^# Contributed equally.

PMID: 40976669
PMCID: PMC12458820
DOI: 10.1136/bmjopen-2025-106708

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 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.

Keywords: Climate Change; PUBLIC HEALTH; STATISTICS & RESEARCH METHODS.

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Conflict of interest statement

Competing interests: NS is an employee of the South African Medical Research Council (SAMRC), and this work was conducted as part of salaried work for the SAMRC. LF and PRW have received institutional grants from the National Institute for Health and Care Research (NIHR), the NIHR-Medical Research Council Trials Methodology Research Partnership, Innovate UK, NIHR UK Research and Innovation, and the Wellcome Trust. LT is part of the Editoral Board of BMJ Open. All other authors declare no competing interests.

References

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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)

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

MeSH terms

LinkOut - more resources

Full Text Sources

Medical