Comparison of patient-reported outcome measures in multiple sclerosis.

BACKGROUND: Patient-reported outcome measurements (PROMS) have been proposed sensitive outcome parameters in multiple sclerosis (MS). In this study, we assessed a German version of the Multiple Sclerosis Impact Scale (MSIS-29) and a revised version of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) in comparison with rater- and physician-based tools. METHODS: Consecutive MS patients (n = 117) of the MS outpatient unit were included. In addition to MSIS-29 and HAQUAMS, the following parameters were obtained: Expanded Disability Status Scale (EDSS) and modified Multiple Sclerosis Functional Composite (MSFC) [9-hole peg test (9HPT), 25-foot walk test and symbol digit modalities test]. We investigated validity, internal consistency and test-retest reliability as well as correlation between these measures. RESULTS: Internal consistency (Cronbach's α ≤ 0.96) and test-retest coefficients (ICC ≤ 0.87) of both scales were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlation with other rater-based measures depending on the functional subdomain. Both MSIS-29 and HAQUAMS correlated with EDSS (ρ = 0.55 vs 0.62), but stronger correlation was found between MSIS-29 and HAQUAMS total score (ρ = 0.90). Both scales distinguished between patient groups of varied disease severity and cognitive impairment. CONCLUSION: Patient-reported outcome measurements as MSIS-29 and HAQUAMS seem to be valid instruments to detect different impairment levels in comparison with traditional rater-based instruments like EDSS or MSFC.

Accuracy of diagnostic tests in multiple sclerosis--a systematic review.

New diagnostic criteria for multiple sclerosis (MS) have been recently proposed and further updates are upcoming. This systematic literature review summarizes diagnostic studies in suspected MS to clarify the value of diagnostic tests. We included studies of at least 40 patients followed up for 2 years. All studies are limited by the fact that no gold standard to validate diagnostic tests is available. A second relapse is used as a surrogate in relapsing-remitting MS, but long follow-up of at least 5 years is necessary to detect all cases. Many studies showed selection bias, partly because of the vague definition of a clinically isolated syndrome. Based on these limitations, sensitivity of magnetic resonance imaging (MRI) criteria was between 35% and 100%, and specificity was between 36% and 92%. Cerebrospinal fluid (CSF) oligoclonal banding showed sensitivities between 69% and 91% with specificities between 59% and 94%. Combination studies of MRI and CSF indicate enhanced sensitivity (56-100%) and specificity (53-96%). Studies on evoked potentials did not justify conclusions about their value. A combination of simplified MRI criteria with CSF might be the best approach for an early MS diagnosis. However, the value of a very early diagnosis stays questionable as patients' benefit of new diagnostic criteria has never been addressed.

Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet.

BACKGROUND: Parallel to the establishment of early treatments in multiple sclerosis (MS), new diagnostic criteria have made an earlier diagnosis possible. While there is ongoing discussion about possible benign courses and only partial effective treatments, there have been no attempts today to facilitate shared decision making on diagnostic testing between patients with suspected MS and their physicians. OBJECTIVE: This study describes the development and validation process of a leaflet to be presented to people with suspected MS to engage them in a diagnostic decision-making process. METHODS: After a qualitative study showing acceptability among five patients, the leaflet was presented to a retrospective cohort (n = 87 of which 70 replied)) of patients being diagnosed within the last 2 years as well to a prospective cohort of n = 51 patients with symptoms suggestive of MS. RESULTS: Approximately 70% of patients in the prospective as well as in the retrospective cohort wanted to be informed about a possible MS before testing, whereas 10% did not. The leaflet did not seem to elicit anxieties. The attitude to undergo diagnostic testing was not influenced by the leaflet, which can be explained by the nonexperimental design of the study. CONCLUSION: Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary.