Understanding trial representation; development of an interactive dynamic CONSORT flow diagram

Supervisors:

• Professor Laura Gray lg48@leicester.ac.uk
• Professor Alex Sutton
• Dr Ash Routen

Project Description:

Background

Randomised controlled trials (RCTs) are the gold standard for generating evidence to inform clinical practice. However, persistent concerns remain regarding the completeness and quality of trial reporting. The CONSORT statement, most recently updated in 2025, aims to address this through a structured checklist and a participant flow diagram. Despite widespread endorsement, evidence indicates that flow diagrams are often incomplete and inconsistently reported, limiting the assessment of trial validity and generalisability.

At the same time, improving diversity and inclusion in clinical research is a critical policy priority. The NIHR Research Inclusion Strategy (2022–2027) and recent HRA/MHRA guidance (2024) emphasise the systematic collection and monitoring of equality characteristics, including protected characteristics defined in the Equality Act 2010, alongside socio-economic and geographic factors. However, equality monitoring data are not routinely integrated into trial reporting or real-time trial management. Current CONSORT flow diagrams present aggregate counts only and do not enable examination of recruitment or retention across diverse subgroups or intersections of identity.

Advances in digital technologies and data visualisation provide an opportunity to modernise CONSORT flow diagrams into interactive tools that support both reporting and trial conduct. Embedding equality monitoring data into such tools could enable better identification of recruitment gaps, support timely interventions, and improve the representativeness of trial populations.

Aim

To develop and pilot an enhanced, interactive CONSORT flow diagram that integrates equality monitoring data to improve transparency, inclusivity, and decision-making in RCTs.

Objectives

• Systematically identify, review, and critically appraise existing automated and digital tools for generating CONSORT flow diagrams, evaluating their functionality, usability, and alignment with CONSORT guidance, and assessing their capacity to support comprehensive, transparent, and inclusive reporting.
• Explore and define the functional requirements for interactive CONSORT flow diagram tools through stakeholder surveys and interviews, capturing perspectives on usability, reporting needs, and integration within trial workflows.
• Design and develop a prototype interactive CONSORT diagram incorporating participant characteristics 
  and intersectionality.
• Pilot the tool within ongoing NIHR-supported trials to assess feasibility and usability.

Methods

A mixed-methods approach will be undertaken across four phases. First, a systematic review will identify and critically appraise existing automated and digital tools for generating CONSORT flow diagrams, assessing their functionality, usability, and alignment with CONSORT 2025 guidance. Second, stakeholder surveys and qualitative interviews with trialists, methodologists, data managers, and patient and public contributors will explore current practices and define functional requirements, including usability, reporting needs, and integration within trial workflows. Third, findings will inform a co-design process to develop an interactive, dashboard-style CONSORT flow diagram incorporating participant characteristics and enabling exploration of recruitment and retention patterns, including intersectional subgroups. Fourth, the prototype will be piloted within ongoing NIHR supported trials, including those supported by NIHR ARC East Midlands, to assess feasibility, usability, and acceptability in real-world settings.

Expected Outcomes and Impact

This project will deliver a novel, user-centred tool to enhance both trial reporting and conduct. It will generate evidence on the current landscape and limitations of automated CONSORT tools, alongside stakeholder-informed requirements for next-generation solutions. By enabling dynamic visualisation of participant flow and integration of equality monitoring data, the research has potential to improve transparency, support real-time recruitment monitoring, and enhance inclusivity in RCTs. The findings will inform future development of digital reporting tools and contribute to evolving CONSORT guidance and wider national priorities on improving diversity and representation in health research.

Training and Environment

The studentship will provide interdisciplinary training in trial methodology, qualitative 
research, and digital health. Supported by NIHR infrastructure, the project benefits from strong collaborations and access to real-world trial settings to ensure feasibility and impact.

References

Hopewell S, Chan A, Collins G S, Hróbjartsson A, Moher D, Schulz K F et al. CONSORT 2025 statement: updated guideline for reporting randomised trials BMJ 2025; 389 :e081123 doi:10.1136/bmj-2024-081123

Hopewell S, Hirst A, Collins GS, Mallett S, Yu LM, Altman DG. Reporting of participant flow diagrams in published reports of randomized trials. Trials. 2011 Dec 5;12:253. doi: 10.1186/1745-6215-12-253. PMID: 22141446; PMCID: PMC3260171.

Please refer to the application advice below.