OBJECTIVES: Multiple sclerosis (MS) is a chronic neurodegenerative disease affecting the central nervous system. There are a variety of symptoms and activity limitations associated with MS including mobility problems, muscle spasticity, fatigue and mental health problems. In order to gain an accurate insight into the impact of MS on patients it is important for accurate patient-reported outcome (PRO) instruments to be applied. The purpose of this review was to evaluate the available MS-specific PRO measures.
METHODS: The online literature databases PubMed, Psychinfo and Web of Science were used for the search. The search identified all studies that used a PRO measure in the study design and was restricted to publications from the last fifteen years. Only measures used in at least three clinical trial studies were included. The measures identified were evaluated in terms of; source of items, item reduction methods, unidimensionality, practicality, responsiveness, reliability, internal consistency and face, content and construct validity.
RESULTS: The search yielded 2317 articles, of which 1066 were duplicates and removed. The review of the remaining articles identified six measures that met the review criteria: MSIS-29, LMSQoL, MSQoL-54, HAQUAMS, MSQLI and PRIMUS. In addition, the MUSIQoL was reviewed because of recent development activity. Most of the measures exhibited some weaknesses. Only the PRIMUS performed well on all the review criteria. It was the only measure to apply a clear theoretical framework and meet the strict measurement requirements of the Rasch model.
CONCLUSIONS: The PRIMUS is recommended for use in clinical trials. The review suggests that many clinical trials are using PROs that have not benefitted from the use of Item Response Theory and modern psychometric approaches.
