A patient-reported outcome measure questionnaire (GCA PRO)

An evidenced-based patient reported outcome measure for use in clinical trials and as a communication tool for use in clinical practice in patients with Giant Cell Arteritis.

Giant cell arteritis (GCA) is the commonest form of systemic vasculitis and is caused by inflammation of the blood vessels around the head and neck. GCA is a medical emergency due to the risk of blindness in 20% of cases. Glucocorticoids (GCs) alone have been the mainstay of treatment in GCA for many decades. While GCs are relatively inexpensive, adverse effects are common. Patients need to weigh up the necessity of treatment with GCs to prevent blindness versus their fears about adverse effects.

Adverse effects include diabetes, weight gain, hypertension, osteoporosis, anxiety, and depression.

There is an expanding interest in randomised controlled trials of novel agents in GCA, which are more targeted and have fewer adverse effects – however costs may be higher than for GCs. It is therefore essential to include the patient view in assessing outcomes.

The GCA PRO questionnaire measures the symptoms of GCA and its impact on health-related quality of life from the patient perspective. It is underpinned by in-depth qualitative research with 35 patients in the UK and Australia, followed by a large-scale validation survey in the NHS (n >400 patients) to determine the final scale structure and measurement properties.

The GCA PRO:

• is validated (known groups analysis, test-retest analysis, correlation with other measures) for use as an endpoint within clinical trials in giant cell arteritis.
• can help facilitate virtual appointments  within clinical practice and allow the collation of the impact of GCA on the patient at each clinic visit and compared over time.
• can help discriminate between active disease and remission (patient report).
• provides an effective communication tool for patient and clinician discussion, helping to focus on areas of most importance.
• consists of 30 questions in four domains (acute symptoms, activities of daily living, psychological impact and impact on participation). Total and individual domain scores can be calculated and are psychometrically appropriate to be used as a repeated measure.

The GCA PRO was developed through a collaboration involving Professor Jo Robson (UWE Bristol) Professor Jill Dawson (University of Oxford) and Dr Celia Almeida (UWE Bristol) with funding from United Hospitals Bristol and Weston Charity and the National Institute for Health Research, UK.

• Patient perceptions of health-related quality of life in giant cell arteritis: international development of a disease-specific patient-reported outcome measure, Robson JC et.al. Rheumatology (Oxford) 2021 2; 60 (10) 4671-4680.

• Validation of a patient-reported outcome measure for giant cell arteritis - PubMed (nih.gov)

The GCA PRO is available for licensing through our partner organisation, Clinical Outcomes, Oxford University Innovations.

For information about the GCA PRO please contact the Clinical Outcomes team at Oxford University Innovation in the first instance.