Evidence map›Paper›PMID 42135700›Full record

ArticleBMC medical research methodology2026

Guidance for protocol content and reporting of dog-assisted interventions in randomised controlled trials: explanation and elaboration of the SPIRIT 2025 and CONSORT 2025 extensions.

Emily Shoesmith, Elena Ratschen, Evgenia Riga, Daniel S Mills, Selina Gibsone, Dean McMillan, Qi Wu, Chris Clarke, Kirsty Sprange, Kerstin Meints and 5 more

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In one paragraph

Article in BMC medical research methodology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Emily ShoesmithDepartment of Health Sciences, University of York, York, UK.
Elena RatschenDepartment of Health Sciences, University of York, York, UK.
Evgenia RigaDepartment of Health Sciences, University of York, York, UK.
Daniel S MillsDepartment of Life Sciences, University of Lincoln, Lincoln, UK.
Selina GibsoneDogs for Good, The Frances Hay Centre, Banbury, UK.
Dean McMillanDepartment of Health Sciences, University of York, York, UK.
Qi WuDepartment of Health Sciences, University of York, York, UK.
Chris ClarkeTees, Esk and Wear Valleys, Foss Park Hospital, NHS Foundation Trust, York, UK.
Kirsty SprangeNottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
Kerstin MeintsSchool of Psychology, Sports Science and Wellbeing, University of Lincoln, Lincoln, UK.
Nancy R GeeCenter for Human-Animal Interaction, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.
Leanne O NieforthCenter for the Human-Animal Bond, College of Veterinary Medicine, Purdue University, Lafayette, USA.
Nicolas DollionUniversité de Reims Champagne-Ardenne, Laboratoire C2S, UR6291, Reims, France.
Aubrey FineDepartment of Education, California State Polytechnic University, Pomona, CA, USA.
Sophie S HallNottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK. Sophie.hall@nottingham.ac.uk.

Funding

National Institute for Health and Care Research NIHR 205656
6 · The paper itself

Abstract

backgroundDog-assisted interventions (DAIs) to improve human health and wellbeing are increasingly implemented in health, care and educational settings. However, the quality and consistency of reporting of trial design and findings remains poor. Current trial reporting guidelines do not adequately address the unique methodological, ethical, and welfare considerations involved in DAI randomised controlled trials (RCTs). To improve the design and transparent reporting of these trials, we developed SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 and CONSORT (Consolidated Standards of Reporting Trials) 2025 extensions for DAI trials. The current paper presents the explanation and elaboration (E&E) for these extensions.

methodsUsing the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, a four-phase consensus approach was conducted: (1) a systematic review; (2) three-round Delphi survey; (3) expert consensus workshops, and (4) checklist finalisation. This E&E paper complements the DAI extensions checklist (reported elsewhere) by providing item-by-item rationales, guidance, and illustrative examples from DAI trials to demonstrate good reporting.

resultsThe four-phase consensus approach resulted in 69 extensions for DAI RCT reporting (35 applied to SPIRIT; 34 applied to CONSORT). This paper explains the purpose of each extension item and highlights best practice for reporting, based on examples from published DAI protocols and trial reports.

conclusionThese DAI extensions provide guidance for the design and reporting of high-quality and transparent DAI RCTs. This E&E paper supports the application of these extensions by offering detailed explanations and examples. Adoption by researchers, journal editors, funders, and ethics committees may enhance the credibility and impact of DAI research.

Indexed as

Guidelines as TopicRandomized Controlled Trials as TopicResearch DesignResearch ReportAnimalsChecklistConsensusDelphi TechniqueDogsHumansCONSORTDog-Assisted interventionsReporting guidelinesSPIRIT

Identifiers

PMID42135700
PMCPMC13173976

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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.