The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases. The Steroid PRO has also shown both face validity and content validity in evaluating the effects of glucocorticoids on patients with inflammatory conditions affecting the respiratory, gastrointestinal, and dermatological systems, including asthma, inflammatory bowel disease, and eczema.

The four domains of the Steroid PRO include social impact, impact on appearance, psychological impact and treatment concerns.

The Steroid PRO is the first validated generic patient reported outcome measure for GC impact across rheumatic diseases and is suitable to be used in clinical trials, or practice, as a validated outcome measure.

The PRO has been designed to be generic, i.e. wording talks about “your condition” rather than any specific condition and no disease specific symptoms have been included.

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The Steroid PRO development has been underpinned by patient involvement at every stage, including sixty in-depth qualitative and cognitive interviews with patients across the major rheumatic diseases, from the UK, Australia and the USA. The qualitative work developed and refined a long-list of candidate questionnaire items, including a linguistic translatability assessment. Please find the link to the underpinning qualitative work here: https://pubmed.ncbi.nlm.nih.gov/36840642/

A large-scale validation survey of more than 900 patients from the UK, USA, Australia and New Zealand was then performed to determine the final scale structure and validation of the Steroid PRO. The final Steroid PRO, which is 15 items with 4-sub-scales (social impact, impact on appearance, psychological impact, and treatment concerns) has been designed to be highly relevant to patients. Data from the Steroid PRO was shown to have adequate fit to the Rasch measurement model, confirming its construct validity, and statistical sufficiency of the sub-scales and the total score, therefore providing accurate estimates of HRQoL due to GC therapy. The tool can thus be used in clinical trials, or practice, as a validated outcome measure.

The Steroid PRO items were shown to target well across different levels of HRQoL and provide consistent measures in patients with different personal characteristics (age, gender, education, and occupation), cultures (UK, USA, Australia and New Zealand) and disease groups (inflammatory arthritis, connective tissue disease or vasculitis, and giant cell arteritis and/or polymyalgia rheumatica). For more information, please refer to the validation paper.

Validation of the Steroid PRO in other inflammatory lung diseases (asthma, chronic obstructive airways disease, interstitial lung disease and sarcoidosis), bowel (ulcerative colitis and Crohn’s disease) and skin diseases (eczema, pemphigus vulgaris, pemphigoid, pyoderma gangrenosum) is currently underway.

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The Steroid PRO responses options are presented across a 5 item Likert scale, with a numerical value attributed to the response:

• Never (0)
• Rarely (1)
• Sometimes (2)
• Often (3)
• Always (4)

Typically, each item or domain in the Steroid PRO is assigned a numerical value or score based on the response options provided. These scores may reflect the severity, frequency, or impact of symptoms, side effects, or other aspects of steroid therapy on the patient’s well-being.

The four subscales plus a total score can be used. Rasch conversion scales are also available.

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The Steroid PRO was originally validated for paper-and-pen completion, any transitions to digital format should be approached with care and reviewed by our team. You can contact us if you have any questions around digital migrations.

Pen and Paper

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You may also be interested in the following PROs developed by the same team:

• GCA-PRO. The GCA-PRO is a validated outcome measure for use in clinical trials, observation studies and clinical practice. It can also be used as a communication tool between patients and their clinicians, to highlight areas of greatest importance to patients, within face to face or online consultations.
• AAV-PRO. The AAV-PRO is a new 29-item, disease-specific PRO measure for ANCA-associated vasculitis and used to assess the health-related quality of life and disease burden experienced by patients.

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