Published on 2 Nov 2025

Evidence-Based Clinical Pathway for Biotoxin-Related Illnesses

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The Australian Department of Health, Disability and Ageing engaged Allen + Clarke to develop an evidence-based clinical pathway for biotoxin-related illnesses following a House of Representatives inquiry in 2018. We evaluated available evidence, identified knowledge gaps, and collaborated with medical specialists and consumer representatives to create a practical decision-making framework. This groundbreaking pathway now supports Australian GPs in diagnosing and managing patients with complex symptoms related to indoor mould exposure, filling a critical gap in clinical guidance.

Key Takeaways:

  • Developed Australia's first evidence-based clinical pathway for biotoxin-related illnesses through comprehensive evaluation of primary research, secondary studies and grey literature

  • Created a practical framework that balances scientific rigour with clinical flexibility, respecting both medical evidence and patient experiences

  • Delivered a decision-making tool tailored specifically to the Australian healthcare context that supports improved outcomes for previously underserved patients
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This project demonstrates Allen + Clarke's ability to navigate complex health challenges, bringing together diverse stakeholders to create practical, evidence-based solutions that improve healthcare delivery and patient outcomes.

The Challenge

The Australian Department of Health, Disability and Ageing develops and delivers policies and programs that support better health outcomes for all Australians. Following a 2018 House of Representatives inquiry into biotoxin-related illnesses, the Department identified a significant gap in clinical guidance for healthcare professionals treating patients with symptoms potentially related to mould exposure.

While conditions like Chronic Inflammatory Response Syndrome (CIRS) had been described both in Australia and internationally, they weren't widely recognised within the Australian medical profession. Patients reporting debilitating symptoms following mould exposure often struggled to receive appropriate care, as there were no established clinical guidelines for diagnosis and treatment.

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Our Approach

Allen + Clarke's expertise in evidence evaluation and health policy development positioned us perfectly to address this challenge. We understood the need to balance rigorous scientific evidence with practical, patient-centred approaches while navigating a complex and sometimes contentious area of healthcare.

Working in close partnership with the Department, we implemented a structured, collaborative approach:

  • Comprehensive evidence evaluation - we developed a robust methodology to assess primary studies, secondary research and grey literature, identifying the current evidence base and critical knowledge gaps.

  • Stakeholder consultation - we collaborated with the Biotoxin-related Illness Advisory Committee (BIAC), comprising specialists from various medical fields and consumer representatives, ensuring diverse perspectives informed the pathway's development.

  • Clinical pathway development - we translated complex evidence into a practical decision-making framework that respects clinical judgment while providing clear guidance for assessment and management.

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The Evidence

Our evidence evaluation revealed important insights about the relationship between indoor dampness, mould exposure and health effects. Rather than focusing on contested diagnoses, we concentrated on established associations between exposure and symptoms, creating a pathway that could be applied regardless of diagnostic labels.

The resulting Biotoxins (indoor damp and mould) Clinical Pathway provides a structured approach for GPs assessing patients with either new onset or unresolved debilitating symptoms with a history of mould exposure. Importantly, the pathway doesn't prescribe specific treatments but offers a framework for decision-making, allowing clinicians to tailor their approach to individual patient needs.

The Biotoxins Clinical Pathway represents an important step forward in addressing complex, difficult-to-diagnose conditions. By bridging the gap between rigorous evidence and practical clinical application, we've helped create a tool that supports better outcomes for a previously underserved patient group while maintaining the integrity of clinical practice.

This project has delivered significant benefits for both healthcare providers and patients:

  • Improved clinical confidence - Australian GPs now have evidence-based guidance for assessing and managing patients with complex, previously unexplained symptoms related to mould exposure.

  • Enhanced patient care - patients with biotoxin-related symptoms now have a clearer pathway to appropriate assessment and management, reducing diagnostic delays and improving outcomes.

  • System-wide clarity - the pathway establishes a consistent approach to these complex conditions across the Australian healthcare system, addressing a key recommendation from the House of Representatives inquiry.

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