Guidance for protocol content and reporting of dog-assisted interventions in randomised controlled trials:...

Dog-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.

Using 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.

The 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.

These 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.