Performance-based outcome measures
| OMERACT domain | Assessment tool | Brief tool description (taken into account when considering participant burden) |
| Core domains | ||
| Tenderness | Tender point count using a dolorimeter set to apply 4 kg/cm2 of pressure—18 tender points as described by American College of Rheumatology | Time to complete: 2 min Number of administrations: 2 (first visit, final visit) The Manual Tender Point Survey/Fibromyalgia Intensity Score (MTPS/FIS) method will be used where the participant rates pain severity on application of the dolorimeter at each tender point on a verbal NRS. NRS≥2 is required to count a tender point as positive. A tender point about the size of a penny, located in clusters in soft tissues around the neck, chest, shoulders, elbows, hips and knees. These 18 specific tender points were identified by the American College of Rheumatology in 1990,71 and are often painful in FM patients. For a tender spot to be considered positive, the participant will experience temporary pain when a small amount of pressure is applied to the specific area. Positive tender points are no longer required to make a diagnosis of FM, but clinicians may still choose to examine these areas in routine practice to strengthen the probability of diagnosis and/or monitor response to treatment. Reliability and reproducibility will be ensured with the use of a dolorimeter set to apply a prespecified pressure at each of the tender points. Pain with 4 kg/cm2 pressure or less (taken to be equivalent to application of digital pressure until the pulp of the thumb nail becomes white) is considered to be a positive tender point.72 |
| Peripheral domains | ||
| Dyscognition | Stroop Test (to assess inhibitory control and processing speed) | Time to complete: 1 min Number of administrations: 2 (first visit, final visit) This is a computer-based test. A series of colours are spelt out on the screen; blue, red, yellow, green. Each time the word appears, it is presented in a different colour; blue, red, yellow or green. The participant must select the correct colour of the word. This is a timed task for 60 s. If the answer is selected incorrectly, the next word will appear. The test is scored by number of correct answers in this time period. No marks are lost for incorrect answers. |
Total completion time: 3 min.
FM, fibromyalgia; NRS, Numerical Rating Scale.