Patient reported outcomes (PROs) in multiple sclerosis: a systematic review

Background: Multiple Sclerosis (MS) affects many different aspects of the patient’s life. Neurologists often rely on the EDSS score, derived from an objective neurological examination, MRI imaging and cognitive tests to assess their patients’ clinical condition. However, PwMS’ perspectives on their health condition can vary considerably from their neurologists’, studies have demonstrated. The realization that patient’s self-report is in fact crucial to assess certain symptoms such as fatigue, depression, pain, bladder/bowel dysfunction and sexual dysfunction has prompted the use of patient reported outcomes (PROs), questionnaires completed by the patients themselves. They are becoming therefore more widespread and are increasingly incorporated into the decision-making process by clinicians. The large number of MS-specific PROs is posing a challenge to choose the right one. This study is therefore aimed to review some of the most common PROs in order to facilitate the task. Materials and methods: We have compared 48 different MS-specific and well recognized PRO’s: 36 of whom assess specific domains, and 12 that assess clustered domain. The comparison was based on several psychometric properties: reported in studies that have been found on “PubMed” and “Google Scholar”: reliability was assessed by test-retest reliability; validity was assessed both by internal consistency (Cronbach alpha) and interclass correlations with other well-validated measures, as well as minimally important change (MIC) and responsiveness. Additionally, interpretability and burden of administration, other two properties have also been collected with the above-mentioned properties in a summarizing table. The psychometric properties were also described according to standardized benchmarks. Results: The psychometric properties are presented in this systematic review. Please see the tables in the results § of the study. Conclusion: The psychometric properties and other properties that we collected can assist clinicians to select a suitable PRO for their patient in for both specific symptoms, and cluster of symptoms that mostly evaluate quality of life. Internal consistency and reliability measures were greatly available online, whereas data regarding responsiveness and clinically meaningful change was sparse, thus the latter two were not included in the results. We therefore highlight PROs that have been confirmed by authors for their validity and reliability. PROs that have met all 3 criteria, including at least ‘acceptable’ internal consistency, ‘moderate’ test-retest reliability and ‘moderate’ construct validity have been designated sufficiently valid and reliable by us: for the assessment of upper limbs function, both Neuro QOL SF and MSWS12; for the assessment of upper extremity functions -AMSQ, BBS and Neuro QOL SF; for the assessment of depression – CES-D; for the assessment of fatigue - FSIQ-RMS, FSS, MFIS; for the assessment of bladder function - I-QOL; for the assessment of sexual function – MSISQ-19; for the assessment of spasticity – MSSS-88. for the assessment of quality of life - MSQOL-54, MSIS-29, LMS QoL and FAMS. In the results, PROs that had only been designated as either valid or reliable are also described, this can be due to lack of investigation done by researchers or due to lack of access to the PROs/ articles reviewing them. However, this does not necessarily mean that they are not valid or reliable. We would like to iterate that more research to obtain data on responsiveness and clinically meaningful change could be helpful in evaluating PROs by better interpreting a PRO score change.