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Reporting of environmental outcomes in randomised clinical trials : a protocol for a scoping review

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: To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE). Methods and analysis:... (More)

Introduction: To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE). Methods and analysis: This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed. Ethics and dissemination: This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders. Open science: Registered with Open Science 28 of February 2025.

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organization
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
e101709
publisher
BMJ Publishing Group
external identifiers
  • pmid:40987741
  • scopus:105017101715
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-101709
language
English
LU publication?
yes
id
d14c5324-44d0-428c-96a7-bc93143d7d80
date added to LUP
2025-11-26 14:52:23
date last changed
2025-11-27 03:36:09
@article{d14c5324-44d0-428c-96a7-bc93143d7d80,
  abstract     = {{<p>Introduction: To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE). Methods and analysis: This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed. Ethics and dissemination: This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders. Open science: Registered with Open Science 28 of February 2025.</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 Jakobsen, Janus C. and Bentzer, Peter}},
  issn         = {{2044-6055}},
  keywords     = {{Climate Change; PUBLIC HEALTH; STATISTICS & RESEARCH METHODS}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Reporting of environmental outcomes in randomised clinical trials : a protocol for a scoping review}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-101709}},
  doi          = {{10.1136/bmjopen-2025-101709}},
  volume       = {{15}},
  year         = {{2025}},
}