The Neuro-QoL project: implications for multiple sclerosis research

Background: Neuro-QoL is an NIH (National Institute for Neurological Disease and Stroke) funded project. This 5-year study is designed to construct a clinically relevant and useful health-related quality of life (HRQL) measurement system for major neurological conditions using item response theory and computer adaptive testing. Phase 1 includes 1) Defining criteria for acceptance by neurology researchers 2) Selecting 5 adult and 2 pediatric conditions for field testing 3) Selecting domains and sub-domains to generate generic item banks and disease targeted scales, 4) Creating item pools for generic and targeted scales and 5) Translation into Spanish. Phase 2 involves field testing the Neuro-QoL instrument and create/test item bank-derived generic short forms and disease targeted scales. Objective: Describe the rationale for including multiple sclerosis (MS) in the first phase of this project as a key neurological condition for which item banks are developed and tested. Methods: Phase 1 methods included a comprehensive methodology involving qualitative and quantitative approaches. Identification of neurological conditions was accomplished using literature review, interviews with 44 experts, and a consensus panel of 13 neurology experts. Generic domains and disease-specific scales were selected using literature reviews, expert interviews and focus groups. Results: Selection of conditions: literature review identified MS as a major neurological condition; 33 of 44 experts identified MS as having an important impact on HRQL; using criteria established by the consensus group, MS was identified as meeting criteria by 12 of 13 experts. The generic domains selected for the Neuro-QoL measurement platform include Physical, Mental and Social. Each Domain has multiple domains. MS targeted scales include Weakness/Fatigue, Sexual Function, Sleep Disturbance, Personality/Behavioral Change, and Bowel/Bladder Function. Conclusions: Neuro-QOL will enable the MS clinical and research communities to precisely assess the impact of treatment on HRQL (both generic and MS-specific) as well as compare the relative impact and burden of this disease with other major neurological conditions, using a standard metric.