Patient-reported outcome measures (PROMs) may help clinicians predict how disability will progress in their patients with multiple sclerosis (MS), according to results of a study published in Multiple Sclerosis and Related Disorders.
“Standardized, structured, and quantifiable patient reported outcome feedback may be a simple, costefficient, and remotely accessible method to suggest (relapse-independent) disability progression,” lead author Ahmed Abdelhak, MD, and coauthors wrote. “Our results provide evidence supporting that a more ‘patient-focused’ approach might have potential to contribute to classification, prediction of disability, and be subsequently considered as a valuable addition to the treatment decision algorithm.”
The ability to detect and predict disability progression in people with progressive multiple sclerosis (PwPMS) is an unmet and understudied need, they noted. To help fill that knowledge gap, Dr. Abdelhak and team investigated whether assessment of PROMs could track disease progression in PwPMS.
In the observational, prospective, multicentered EmBioProMS study, including 227 PwPMS at eith study sites, they assessed three PROMs—the Beck depression inventory-II (BDI-II), the multiple sclerosis impact scale29 (MSIS-29), and the fatigue scale for motor and cognition (FSMC)—in patients with primary and or secondary progressive MS.
As a validation of concept, they analyzed the diagnostic and prognostic value of another PROM—the short-form health survey (SF-36)—submitted by 137 participants with primary progressive MS in the placebo arm of the multinational ORATORIO randomized controlled trial.
The researchers compared what patients themselves felt with evidenced-based screening tests and clinical exam results. They evaluated the PROMs longitudinally and compared the measures of participants without disability progression to the measures of those with progression: at baseline; from retrospective evidence of disability progression, and during follow-up; and from prospective evidence of confirmed disability progression.
PROMs Helped Monitor Disability Progression
The study team found that:
- 136 EmBioProMS participants with evidence of disability progression during the 2 years prior to inclusion, and those with confirmed disability progression during follow-up (88 events) had worse BDI-II, MSIS-29, and FSMC scores compared to results of PwPMS without progression.
- In EmBioProMS participants with primary progressive MS, baseline MSIS29 physical above 70th, 80th, and 90th percentiles predicted future-confirmed disability progression independently of relapse activity (HRs, 3.7, P=0.002; 6.9, P<0.001; and 6.7, P=0.001, respectively).
- In patients in the placebo arm of ORATORIO who experienced progression over the preceding trial period, the physical component scale (PCS) score of SF-36 worsened at week 120 compared with baseline (P=0.018).
- Worse baseline PCS was linked with higher HRs of disability accumulation during the following 120 weeks (HRs, 2.01 [30th percentile], P=0.007; 2.11 [20th percentile], P=0.012; and 2.8 [10th percentile], P=0.005, respectively).
More Research Needed
These findings did not surprise Mamta Verma, MD, who was not involved in the study. “We see in practice that a patient’s own MS history and timeline can help predict their future course,” she said. “I ask my patients with MS, ‘How have you been faring over the previous 10 years with your MS? Knowing this helps us predict how you will fare in the next 10 years.’ “Even so, as the authors mention, the retrospective study design was a limitation,” Dr. Verma continues. “MS is quite unpredictable and varies a lot from person to person and from day to day in the same person. Some patients with a very bad MRI will not do well, while others will do extremely well. We see so much varied clinical response, despite all we predict.” Dr. Verma recommends further longitudinal multicenter research that begins monitoring patients in various demographics at the time of diagnosis, and that not only records how much disability they have based on cognition, weakness, and depression, but also based on MRI burden, age at diagnosis, and treatments received. “That may help indicate which patients are more likely to have future disability,” she adds.
