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Benefit evaluation in multiple sclerosis relapse treatment from the patients' perspective - Development and
Helen Beckmann1, Matthias Augustin1, Christoph Heesen2
1German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, Hamburg, Germany.
Background:
Little is known on how to measure patient-relevant benefit of relapse treatment in relapsing-remitting multiple sclerosis (MS). The objective of this study was to develop and validate a new method for monitoring recovery from MS relapses and patient-relevant treatment benefits.
Methods:
A 27-item questionnaire was developed using a multi-step approach comprising open item collection, multidisciplinary expert panel and cognitive debriefing. It was evaluated regarding psychometric properties and feasibility in a longitudinal validation study with 100 patients with MS undergoing relapse treatment. Construct validity was tested by correlations with patient and physician global impressions of change as well as disease-specific and generic health-related quality of life (HRQoL) measures.
Results:
Results of the feasibility survey indicated high patient acceptance. Reliability was high (Cronbach's α = 0.90). While the Expanded Disability Status Scale (EDSS) was not sensitive to change, Patient Benefit Index for Multiple Sclerosis (PBI-MS) showed a high correlation cross-sectionally with patient global impression of change (PaGIC) (r = 0.60, p < 0.001). Significant moderate to high correlations were found with change in generic HRQoL (r = 0.55-0.61, p < 0.001) and lower correlations with change in disease-specific HRQoL (r = -0.36, p < 0.01).
Conclusion:
The PBI-MS is a reliable and valid instrument for ascertaining patient-relevant benefits of acute relapse treatment; it appears suited for use in routine care and in clinical or health care studies.