Osteoarthritis Patients With Pain Scores More Than 8/10 Should Be Analyzed Separately Or Excluded From Clinical Trial Protocols, As 72% Screen Positive For Fibromyalgia And/Or Depression On A Multidimensional Health Assessment Questionnaire

Purpose: To analyze a hypothesis that patients with osteoarthritis (OA) who have pain visual numeric scale (VNS) scores greater than 8 on a 0-10 scale are more likely to screen positive for fibromyalgia (FM) and/or depression according on a multidimensional health assessment questionnaire (MDHAQ) than patients with lower VNS pain scores. Patients with FM and/or depression generally have poorer responses to therapies for OA and all types of arthritides. Inclusion criteria for most OA clinical trial protocols require a VNS pain score of 4/10 and allow scores up to 10/10. While scores higher than 8/10 appear to provide a statistically greater possibility for improvement, patients with these scores may dilute any treatment effect due to poorer responses than seen in patients with lower scores. Two MDHAQ indices, FAST3F (fibromyalgia assessment screening tool-fatigue) and MDS2 (MDHAQ depression screen) agree, respectively, >90% with revised 2011 FM criteria (and does not include a pain VNS) and >80% with PHQ-9 and HADS-D depression scales, within a single 2-page MDHAQ.