Benefit evaluation in multiple sclerosis relapse treatment from the patients' perspective - Development and validation of a new questionnaire
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Benefit evaluation in multiple sclerosis relapse treatment from the patients' perspective - Development and validation of a new questionnaire. / Beckmann, Helen; Augustin, Matthias; Heesen, Christoph; Poettgen, Jana; Blome, Christine.
In: MULT SCLER RELAT DIS, Vol. 28, 02.2019, p. 256-261.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Benefit evaluation in multiple sclerosis relapse treatment from the patients' perspective - Development and validation of a new questionnaire
AU - Beckmann, Helen
AU - Augustin, Matthias
AU - Heesen, Christoph
AU - Poettgen, Jana
AU - Blome, Christine
N1 - Copyright © 2018 Elsevier B.V. All rights reserved.
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1016/j.msard.2018.12.021
DO - 10.1016/j.msard.2018.12.021
M3 - SCORING: Journal article
C2 - 30639826
VL - 28
SP - 256
EP - 261
JO - MULT SCLER RELAT DIS
JF - MULT SCLER RELAT DIS
SN - 2211-0348
ER -