Contributions
Abstract: P392
Type: Poster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Background: MS PATHS is a collaborative network of 10 healthcare institutions in the United States and Europe, with a goal of enrolling over 10,000 MS patients. With high participation rates (>90%), it is likely the MS PATHS cohort is representative of MS patients seeking care at these institutions. At each clinic visit, patients completed a computer adaptive version of the Quality of Life in Neurologic Disorders (Neuro-QoL) instrument. MS PATHS represents the first attempt to capture QoL on all MS patients during routine care across 10 institutions in 3 countries.
Objectives: To establish the validity of Neuro-QoL captured during routine care in a large, cross-sectional sample of MS patients.
Methods: During routine clinic visits, patients used an iPad-based device, the Multiple Sclerosis Performance Test (MSPT), to complete an MS history, including disease progression using the patient determined disease steps (PDDS), 12 scales of Neuro-QoL, and electronic adaptations of the Multiple Sclerosis Functional Composite (MSFC). Concurrent validity of Neuro-QoL was assessed using Spearman's correlations (r) between Neuro-QoL scales and the PDDS and functional composite. Known groups validity was assessed using ANOVA to compare Neuro-QoL t-scores in patients grouped by living situation and employment.
Results: The patient sample comprised 1353 patients. The mean (SD) age was 48.9 years (12.0), mean (SD) disease duration 12.2 years (9.4), 72% were female and 85% were white. Correlations between Neuro-QoL and PDDS were statistically significant for all scales (p< 0.001) except emotional behavioral dyscontrol. Each Neuro-QoL scale showed lower QoL with increasing disease progression. Correlations between Neuro-QoL and the functional composite were statistically significant for all scales (p< 0.001), with the strongest associations found for lower extremity function (r =-0.65), upper extremity function (r =-0.55), and satisfaction with social roles (r =-0.47). Neuro-QoL depression, anxiety, fatigue and sleep disturbance scales were significantly worse in patients living with assistance or in nursing homes (all p< 0.05) and in patients who were unemployed or disabled (all p< 0.0001).
Conclusions: Lower Neuro-QoL scores were associated with disease progression, functional performance and patient demographic groups reflecting increased disability. This supports the validity of Neuro-QoL administration during routine clinical care in a real world MS patient sample.
Disclosure: Project funded by Biogen, Inc.
Author disclosures:
Aaron Boster has received consulting fees and/or honoraria from Teva, Biogen, Novartis, Genzyme, Mallinckrodt and Medtronic.
Robert Naismith has received consulting fees and/or honoraria from Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis and Teva.
Lauren Krupp has received consultant fees from EMD Serono, Projects in Knowledge, Novartis, Pfizer (for serving on a DSMB), Biogen, PK Law and Teva Neurosciences; Royalty payments from Abbvie Inc. and Grifols World Wide Services; and research grant support from Novartis, Teva Neurosciences, Biogen, NIH, National Multiple Sclerosis Society, Department of Defense and the Lourie Foundation.
Deborah Miller has received consulting fees from Hoffmann-Roche and Biogen.
James R. Williams, Carl de Moor, Glenn A. Phillips, Himanshu Pandya and Richard Rudick are employees of, and stockholders in, Biogen.
Abstract: P392
Type: Poster
Abstract Category: Clinical aspects of MS - 8 Clinical assessment tools
Background: MS PATHS is a collaborative network of 10 healthcare institutions in the United States and Europe, with a goal of enrolling over 10,000 MS patients. With high participation rates (>90%), it is likely the MS PATHS cohort is representative of MS patients seeking care at these institutions. At each clinic visit, patients completed a computer adaptive version of the Quality of Life in Neurologic Disorders (Neuro-QoL) instrument. MS PATHS represents the first attempt to capture QoL on all MS patients during routine care across 10 institutions in 3 countries.
Objectives: To establish the validity of Neuro-QoL captured during routine care in a large, cross-sectional sample of MS patients.
Methods: During routine clinic visits, patients used an iPad-based device, the Multiple Sclerosis Performance Test (MSPT), to complete an MS history, including disease progression using the patient determined disease steps (PDDS), 12 scales of Neuro-QoL, and electronic adaptations of the Multiple Sclerosis Functional Composite (MSFC). Concurrent validity of Neuro-QoL was assessed using Spearman's correlations (r) between Neuro-QoL scales and the PDDS and functional composite. Known groups validity was assessed using ANOVA to compare Neuro-QoL t-scores in patients grouped by living situation and employment.
Results: The patient sample comprised 1353 patients. The mean (SD) age was 48.9 years (12.0), mean (SD) disease duration 12.2 years (9.4), 72% were female and 85% were white. Correlations between Neuro-QoL and PDDS were statistically significant for all scales (p< 0.001) except emotional behavioral dyscontrol. Each Neuro-QoL scale showed lower QoL with increasing disease progression. Correlations between Neuro-QoL and the functional composite were statistically significant for all scales (p< 0.001), with the strongest associations found for lower extremity function (r =-0.65), upper extremity function (r =-0.55), and satisfaction with social roles (r =-0.47). Neuro-QoL depression, anxiety, fatigue and sleep disturbance scales were significantly worse in patients living with assistance or in nursing homes (all p< 0.05) and in patients who were unemployed or disabled (all p< 0.0001).
Conclusions: Lower Neuro-QoL scores were associated with disease progression, functional performance and patient demographic groups reflecting increased disability. This supports the validity of Neuro-QoL administration during routine clinical care in a real world MS patient sample.
Disclosure: Project funded by Biogen, Inc.
Author disclosures:
Aaron Boster has received consulting fees and/or honoraria from Teva, Biogen, Novartis, Genzyme, Mallinckrodt and Medtronic.
Robert Naismith has received consulting fees and/or honoraria from Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis and Teva.
Lauren Krupp has received consultant fees from EMD Serono, Projects in Knowledge, Novartis, Pfizer (for serving on a DSMB), Biogen, PK Law and Teva Neurosciences; Royalty payments from Abbvie Inc. and Grifols World Wide Services; and research grant support from Novartis, Teva Neurosciences, Biogen, NIH, National Multiple Sclerosis Society, Department of Defense and the Lourie Foundation.
Deborah Miller has received consulting fees from Hoffmann-Roche and Biogen.
James R. Williams, Carl de Moor, Glenn A. Phillips, Himanshu Pandya and Richard Rudick are employees of, and stockholders in, Biogen.