Contributions
Abstract: 116
Type: Oral
Background: Evidence is insufficient to support the effectiveness of inpatient multidisciplinary rehabilitation (MDR) for improving health-related quality of life (HRQoL) in patients with multiple sclerosis (MS). We investigated whether inpatient MDR improved HRQoL in a large randomised controlled trial.
Methods: In this pragmatic two-center trial with 6-month follow-up, we recruited a heterogeneous MS patient sample (aged 18-65 years; expanded disability status scale score ≤7·5). Patients were randomly assigned (1:1) to immediate inpatient MDR comprising 4 weeks (20 days) of continuous hospitalization or a 6-month waiting list. The primary and secondary outcomes were MS-specific HRQoL and generic HRQoL, respectively. Primary outcomes were measured by the Functional Assessment of Multiple Sclerosis (FAMS) and Multiple Sclerosis Impact Scale version 2 (MSIS-29), and secondary outcomes by the EQ-5D-5L and the 15D. All outcomes were self-reported. To correct for multiple statistical tests, a significance level of 0·01 was used for secondary outcomes.
Findings: Between March 2012 and June 2014, 427 patients were included, 204 referred to a 6-month waiting list and 208 admitted immediately. In the main analysis, 195 and 179 patients were included in the control and intervention groups, respectively. The intervention group gained from the MDR and experienced significantly improved HRQoL measured by MSIS-29 Psychological dimension (p=0·0258) and 15D (p=0·0061) at 6-month follow-up compared with the control group. At discharge, the scores on FAMS, MSIS-29 Physical, MSIS-29 Psychological, and EQ-VAS were significantly better than at baseline (all p< 0·0001). A post-hoc analysis of change scores revealed that HRQoL was unchanged or improved at 6 months in a significantly greater proportion of the intervention group than in the control group for FAMS (p=0·0487) and MSIS-29 Psychological (p=0·0121). The control group deteriorated during the study period and scored significantly worse on FAMS at 6-month follow-up (p=0·0004). A true intention-to-treat (sensitivity) analysis, generally supported the findings of the main analysis.
Interpretation: The results show positive effects of inpatient MDR on HRQoL in MS patients over a longer period (6-months follow-up). This pragmatic trial reflects the complexity and diversity of actual clinical practice and has relevance to clinical practitioners and management. Further studies are needed to confirm these findings.
Disclosure: There was no funding source for this study. Finn Boesen, Michael Nørgaard, Thor Petersen, Brita Løvendahl and Jan Sørensen declare that they have no competing interests. Peter Vestergaard Rasmussen has received honoraria for serving on advisory boards from Biogen Idec, TEVA, Novartis, Genzyme, and for speaking from Allergan, outside this work.
Abstract: 116
Type: Oral
Background: Evidence is insufficient to support the effectiveness of inpatient multidisciplinary rehabilitation (MDR) for improving health-related quality of life (HRQoL) in patients with multiple sclerosis (MS). We investigated whether inpatient MDR improved HRQoL in a large randomised controlled trial.
Methods: In this pragmatic two-center trial with 6-month follow-up, we recruited a heterogeneous MS patient sample (aged 18-65 years; expanded disability status scale score ≤7·5). Patients were randomly assigned (1:1) to immediate inpatient MDR comprising 4 weeks (20 days) of continuous hospitalization or a 6-month waiting list. The primary and secondary outcomes were MS-specific HRQoL and generic HRQoL, respectively. Primary outcomes were measured by the Functional Assessment of Multiple Sclerosis (FAMS) and Multiple Sclerosis Impact Scale version 2 (MSIS-29), and secondary outcomes by the EQ-5D-5L and the 15D. All outcomes were self-reported. To correct for multiple statistical tests, a significance level of 0·01 was used for secondary outcomes.
Findings: Between March 2012 and June 2014, 427 patients were included, 204 referred to a 6-month waiting list and 208 admitted immediately. In the main analysis, 195 and 179 patients were included in the control and intervention groups, respectively. The intervention group gained from the MDR and experienced significantly improved HRQoL measured by MSIS-29 Psychological dimension (p=0·0258) and 15D (p=0·0061) at 6-month follow-up compared with the control group. At discharge, the scores on FAMS, MSIS-29 Physical, MSIS-29 Psychological, and EQ-VAS were significantly better than at baseline (all p< 0·0001). A post-hoc analysis of change scores revealed that HRQoL was unchanged or improved at 6 months in a significantly greater proportion of the intervention group than in the control group for FAMS (p=0·0487) and MSIS-29 Psychological (p=0·0121). The control group deteriorated during the study period and scored significantly worse on FAMS at 6-month follow-up (p=0·0004). A true intention-to-treat (sensitivity) analysis, generally supported the findings of the main analysis.
Interpretation: The results show positive effects of inpatient MDR on HRQoL in MS patients over a longer period (6-months follow-up). This pragmatic trial reflects the complexity and diversity of actual clinical practice and has relevance to clinical practitioners and management. Further studies are needed to confirm these findings.
Disclosure: There was no funding source for this study. Finn Boesen, Michael Nørgaard, Thor Petersen, Brita Løvendahl and Jan Sørensen declare that they have no competing interests. Peter Vestergaard Rasmussen has received honoraria for serving on advisory boards from Biogen Idec, TEVA, Novartis, Genzyme, and for speaking from Allergan, outside this work.