TY - JOUR
T1 - Reporting of environmental outcomes in randomised clinical trials
T2 - a protocol for a scoping review
AU - Petersen, Johanne Juul
AU - Hemberg, Linn
AU - Thabane, Lehana
AU - Hopewell, Sally
AU - Chan, An-Wen
AU - Hróbjartsson, Asbjørn
AU - Mathiesen, Ole
AU - Kandasamy, Sujane
AU - Siegfried, Nandi
AU - Williamson, Paula R
AU - Fox, Lisa
AU - Kamp, Caroline Barkholt
AU - Hoffmann, Jean-Marc
AU - Brorson, Stig
AU - Jakobsen, Janus C
AU - Bentzer, Peter
N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
PY - 2025/9/23
Y1 - 2025/9/23
N2 - 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.
AB - 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.
KW - Scoping Review as Topic
KW - Humans
KW - Randomized Controlled Trials as Topic/standards
KW - Research Design
KW - Environment
KW - Outcome Assessment, Health Care
KW - PUBLIC HEALTH
KW - Climate Change
KW - STATISTICS & RESEARCH METHODS
UR - http://www.scopus.com/inward/record.url?scp=105017101715&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2025-101709
DO - 10.1136/bmjopen-2025-101709
M3 - Review
C2 - 40987741
SN - 2044-6055
VL - 15
SP - e101709
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e101709
ER -