Evidence map›Paper›PMID 40987741›Full record

ArticleBMJ open2025

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

Johanne Juul Petersen, Linn Hemberg, Lehana Thabane, Sally Hopewell, An-Wen Chan, Asbjørn Hróbjartsson, Ole Mathiesen, Sujane Kandasamy, Nandi Siegfried, Paula R Williamson and 6 more

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Johanne Juul PetersenRigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark johanne.juul.petersen@ctu.dk.ORCID http://orcid.org/0000-0001-9837-1958
Linn HembergAnaesthesia and Intensive Care, Lund University Department of Clinical Sciences Lund, Lund, Skåne County, Sweden.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, New Zealand, Canada.ORCID http://orcid.org/0000-0003-0355-9734
Sally HopewellNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6881-6984
An-Wen ChanDepartment of Medicine, University of Toronto, Toronto, Ontario, Canada.
Asbjørn HróbjartssonOpen Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark.
Ole MathiesenAnaesthesiology, Zealand University Hospital Koge, Køge, Denmark.
Sujane KandasamyMcMaster University Department of Health Research Methods Evidence and Impact, Hamilton, New zealand, Canada.ORCID http://orcid.org/0000-0003-4326-2783
Nandi SiegfriedMental Health, Alcohol, Substance Use and Tobacco Research Unit, South African Medical Research Council, Cape Town, WC, South Africa.
Paula R WilliamsonMRC-NIHR Trials Methodology Research Partnership, University of Liverpool Department of Health Data Science, Liverpool, England, UK.ORCID http://orcid.org/0000-0001-9802-6636
Lisa FoxClinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
Caroline Barkholt KampRigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark.
Jean-Marc HoffmannClinical Trials Center, University Hospital Zurich, Zürich, ZH, Switzerland.
Stig BrorsonDepartment of Orthopaedic Surgery, Zealand University Hospital Koge, Koge, Denmark.ORCID http://orcid.org/0000-0001-5337-758X
Janus C Jakobsen *Rigshospitalet Copenhagen Trial Unit, Copenhagen, Capital Region of Denmark, Denmark.
Peter Bentzer *Lund University Department of Clinical Sciences Lund, Lund, Skåne County, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo 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.

Indexed as

EnvironmentOutcome Assessment, Health CareRandomized Controlled Trials as TopicResearch DesignHumansScoping Reviews as TopicClimate ChangePUBLIC HEALTHSTATISTICS & RESEARCH METHODS

Identifiers

PMID40987741
PMCPMC12458732

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.