OMERACT 9 FM Module domain construct voting to determine which domains were essential to assess in all FM clinical trials (core set), or in some FM trials or electively as a research item. Endorsement by at least 70% of attendees is desirable for inclusion of a domain as a core set measure.
| Domain | Core Set % | Some Trials — Research % |
|---|---|---|
| Pain | 98 | 2 |
| Fatigue | 84 | 16 |
| Multidimensional function | 76 | 24 |
| Patient global | 73 | 27 |
| Tenderness | 61 (72)† | 39 |
| Sleep disturbance | 58 (77)† | 42 |
| Cognitive dysfunction | 39 | 61 |
| Depression | 35 | 65 |
| Stiffness | 25 | 75 |
| Adverse events | 23 | 77 |
| Anxiety | 18 | 82 |
| CFS Biomarkers | 4 | 96 |
| Functional imaging | 4 | 96 |
↵† In the initial voting on core domains, more than 50% endorsed tenderness (n voting = 102) and sleep disturbance (n voting = 107) as inner core set domains. The OMERACT process provides the opportunity for consensus building in an iterative manner throughout the course of the meeting. A final vote (n voting = 121) on sleep and tenderness, after further presentation and discussion, resulted in both domains reaching the OMERACT requirement for inner core set inclusion.