Inpatient Multidisciplinary Rehabilitation: Long-Term Effectiveness on Health-Related Quality of Life in MS Patients. - the Danish MS Hospitals Rehabilitation Study
MS can severely affect individuals on many levels, leading to continuing decline in quality of life. Research suggests that inpatient multidisciplinary rehabilitation can improve quality of life in MS patients. However, evidence of the effectiveness on a long-term basis is limited. Previous studies generally suffered from lack of statistical power, including our own study, as mentioned in our first reporting on health-related quality of life at 6-month follow-up.
Firstly, to investigate the long-term effectiveness of four weeks of inpatient multidisciplinary rehabilitation on the health-related quality of life in MS patients, and secondly, to increase statistical power in a post-hoc reanalysis of previously reported 6 months data.
The study was a pragmatic semi cross-over randomized controlled clinical trial with MS patients, aged 18-65, and Expanded Disability Status Scale score ≤7.5. Patients were initially randomized (1:1) to wait-list control group (A) or treatment group (B) with 6-month follow-up (A1 and B1) and for group B, 12-month follow-up (B2). Group A patients crossed-over and were admitted shortly after reassessment at 6-month follow-up and hence followed for an additionally 6 months (A2). Outcome, were self-reported health-related quality of life. It was measured by: Functional Assessment in Multiple Sclerosis (FAMS), Multiple Sclerosis Impact Scale-29 (MSIS-29), EQ-5D-5L and 15D.
To increase statistical power in our reanalysis of 6 months data we: 1) combined group A2 and B1 into a single treatment group, and 2) used a combined multiple outcome model by multivariate linear mixed effects model, taking advantage of the high correlation among the outcome measures. This made it possible to simultaneously analyze all six health-related quality of life measures, thereby reducing the six outcome measures into one single combined outcome.
We included 427 MS patients distributed between group A (213 patients) and B (214 patients) and admitted 402 patients. At 12-month follow-up better scores were seen in three of the six health-related quality of life measures, two of which were significant: EQ-VAS = 4.1 (95%-CI: 0.9-7.2, p=0.016), 15D = 0.017 (95%-CI: 0.006-0.028, p=0.004). In the combined multiple outcome model analysis the treatment effect at 6-month follow-up was found to be significant with an estimated Cohen´s effect size of 0.18 (95%-CI: 0.07-0.30, p=0.001).
Our results indicate that receiving inpatient multidisciplinary rehabilitation may set the ground for long lasting improvements in health-related quality of life in MS patients, supporting the findings from the few previous long-term studies. The result from the combined multiple outcome model analysis strengthens the results from the 6-month follow-up previously reported. Combined multiple outcome model analysis increases power and it could be an alternative to multiple testing in future reporting.