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Published on: February 8, 2019
Beyond the symptoms: Personalizing giant cell arteritis care through multidimensional patient reported outcome
Y El Miedany1, M El Gaafary2, M Toth3
1Professor Canterbury Christ Church University, England; H. Senior Clinical Lecturer, King's College London, England.
Insights
A new questionnaire, the Giant Cell Arteritis Patient-Reported Outcome Measures (GCA-PROMs), has been developed. This reliable and valid tool assesses GCA patients
Area of Science:
- Rheumatology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Giant Cell Arteritis (GCA) is the most prevalent systemic vasculitis in individuals over 50.
- Existing research indicates a deficiency in disease-specific patient-reported outcome measures (PROMs) for GCA.
Purpose of the Study:
- To evaluate the validity, reliability, and responsiveness of a newly developed, disease-specific PROM for GCA.
- To establish a robust tool for assessing patient experiences in Giant Cell Arteritis.
Main Methods:
- The GCA-PROMs questionnaire was designed referencing OMERACT frameworks and FDA guidelines.
- Item pool generation through cognitive interviews, followed by patient and expert interdisciplinary selection.
- Rasch analysis and internal consistency reliability analyses were performed.
Main Results:
- The GCA-PROMs questionnaire demonstrated high reliability (standardized alpha 0.878-0.983) with 54 GCA patients.
- Significant correlations were found between GCA-PROMs (functional disability, QoL) and established measures (HAQ, EQ-5D, p<0.01).
- Changes in functional disability and QoL significantly correlated with disease activity and treatment response (p<0.01).
Conclusions:
- The GCA-PROMs is a reliable and valid instrument for assessing Giant Cell Arteritis patients.
- This tool supports tailored patient management strategies considering individual risk factors, preferences, and comorbidities.
Background:
Giant Cell Arteritis (GCA) is the commonest form of systemic vasculitis in people over the age of 50. Published research highlighted the lack of a disease-specific patient reported outcomes (PROMs) for GCA.
Objectives:
To assess the validity, reliability and responsiveness to change of a devised disease specific patient self-reported outcome measures questionnaire for Giant Cell Arteritis (GCA).
Methods:
The GCA-PROMs was conceptualized based on frameworks outlined in the OMERACT developed core set of Outcome Measures for Large-Vessel Vasculitis and the guiding principles of the FDA guidance. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented.
Results:
A total of 54 GCA patients completed the questionnaire. The GCA-PROMs questionnaire was reliable as demonstrated by a high standardized alpha (0.878-0.983). Content construct assessment of the GCA-PROMs functional disability and QoL revealed significant correlation (p< 0.01) with both HAQ and EQ-5D. Changes in functional disability, QoL showed significant (p< 0.01) variation with diseases activity status in response to therapy.
Conclusions:
The developed GCA-PROMs questionnaire is a reliable and valid instrument for assessment of GCA patients. A stratified treatment regimen depending on the individual patient's risk factors as well as preferences and associated comorbidities is the best approach to tailored patient management.
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