This blog post summarises the key insights from the latest Virtual Education Session (VES) presented by Virginia Hickey, principal at the board table and a corporate governance specialist, board advisor, strategy facilitator, lawyer, and company director with extensive commercial, government, and nonfor-profit experience. She is committed to working with organisations with the goal of raising standards of governance to clarify strategic direction and has served on around 20 boards over a 20-year period, a testament to her immense experience. The session unpacked some of the incredible work being done by OMERACT – a global not-for-profit organisation that’s reshaping how outcomes are measured in rheumatology clinical trials.
For more free resources, access our in-depth and targeted information brochures here, or click here for more information on Raynaud’s phenomenon.
What is OMERACT and Why Does it Matter?
OMERACT (Outcome Measures in Rheumatology) was founded in 1992 by a small group of rheumatologists who saw the need for better, more consistent outcome reporting in clinical trials. Their goal? To improve the quality of research – and ultimately treatment options – for patients living with rheumatological conditions, including scleroderma.
What makes OMERACT unique is its strong focus on patient involvement. People with lived experience, known as Patient Research Partners (PRPs), are embedded in every stage of the research process. Virginia herself is one of these PRPs, representing Australian voices on the global stage.
The Focus: Vascular Disease in Scleroderma
Virginia’s working group has spent the last four years looking specifically at the vascular complications of scleroderma – primarily Raynaud’s phenomenon and digital ulcers. These are not rare occurrences; around 95% of people with scleroderma experience Raynaud’s, and up to 50% develop digital ulcers.
Raynaud’s causes blood vessels in the fingers and toes to spasm, often in response to cold or stress, leading to pain, colour changes, and discomfort. Digital ulcers, on the other hand, are painful open sores on the fingers that can severely affect daily life.
People with these vascular complications have to constantly adapt – wearing gloves, avoiding cold areas like supermarkets – which often goes unrecognised and increases the emotional burden and social awkwardness that deserves to be addressed in management.
The Problem: A Lack of Reliable Clinical Tools
Despite the prevalence of these conditions, Virginia highlighted a major issue: limited clinical evidence for the treatments currently in use. That’s because there’s a gap in how we measure outcomes like pain, healing, and life impact. Without reliable tools, it’s hard to prove what treatments work – and that means slower progress in finding better options.
The Solution: Defining Core Outcome Sets
The group is tackling this by identifying and validating what are known as “core outcome sets”. These are the minimum outcomes that should be measured and reported in all clinical trials related to a particular condition.
For Raynaud’s and digital ulcers, the core domains identified include:
- Pain intensity
- Frequency, duration, and severity of attacks
- Overall life impact
- Number and healing of ulcers
- Physical function and quality of life
These domains were selected with input from patients, clinicians, and researchers alike – including Australian patients who responded to surveys sent out via Scleroderma Australia.
This patient-centered measurement development is crucial for the wellbeing of patients, as historically, patient and clinician priorities have differed when measuring Raynaud’s symptoms. For example, patients prioritised “coldness” more than clinicians did.
The Next Step: Finding the Right Instruments
Once the core outcomes are agreed on, the group is now working on choosing or developing instruments to measure them – often in the form of questionnaires or clinical assessments. These tools must be valid, practical, and meaningful to patients and researchers alike.
Some existing tools (like pain scales) are being adapted for use in scleroderma, while others may need to be developed from scratch. Once validated, these tools will help researchers assess treatments more accurately and consistently across global trials.
Virginia also raised the need for language in research tools to reflect lived experience accurately. For example, she questioned the term “attack” used in clinical language, as for her, symptoms are constant and worsen with environmental triggers. With the correct terminology, better understanding can be given to Raynaud’s.
Why This Work Matters
Raynaud’s and digital ulcers are neglected areas – both clinically and in research. And, as Virginia pointed out, regulatory agencies like the FDA in the U.S. are paying close attention to this work. They want to see clinical outcomes that genuinely reflect how a person feels, functions, or survives. Having robust, patient-informed outcome measures can fast-track the approval of better therapies.
Virginia summed it up by saying: “This technical work might seem dry, but it’s laying the foundation for real, meaningful improvements in how we live with scleroderma.”
This virtual session gave a rare behind-the-scenes look at how people with lived experience are driving research forward. It’s a reminder that patient voices aren’t just being heard – they’re helping to shape the future of scleroderma treatment.
For people living with Scleroderma, staying updated and informed can make a world of difference. Connecting with others can also be hugely beneficial. Find out more about support in your area here.
If you’d like to gain firsthand knowledge, our National Education Sessions and Virtual Education Sessions are available to you at no charge. Our Virtual Education Sessions are held every month through Google Meet. You can sign up for these free Virtual Education Sessions here.
These sessions provide an opportunity to engage with medical professionals and seasoned legal experts who will address common inquiries about Scleroderma and related topics.