Patient-reported outcome measures
| OMERACT domain | Assessment tool | Brief tool description (taken into account when considering participant burden) |
| Core domains | ||
| Pain | Brief Pain Inventory Short Form (BPI-SF) | Time to complete: 3 min Number of administrations: 2 (first visit, final visit) Description: 12×11-point NRS |
| Widespread Pain Index (WPI) and Symptom Severity Score (SSS) | Time to complete: 4 min Number of administrations: 2 (first visit, final visit) Description: required to tick pain sites (0–19); three questions on symptom severity, 0=no problem, 3=severe; three questions on other symptoms, 0=no problem, 1=problem | |
| Fatigue | Fatigue Severity Scale (FSS) | Time to complete: 1.5 min Number of administrations: 2 (first visit, final visit) Description: 9×7-point Likert scale; 1=strongly disagree, 7=strongly agree |
| Sleep disturbance | Jenkins Sleep Questionnaire (JSQ) | Time to complete: 1 min Number of administrations: 2 (first visit, final visit) Description: 4×6-point questions; 0=not at all, 5=22–28 days |
| Patient Global | Patient Global Impression of Change (PGIC) | Time to complete: 1 min Number of administrations: 2 (final visit, follow-up telephone call) Description: 2 questions; first: change post-treatment, 0=no change, 7=considerable improvement. Second: 11-point NRS, 0=much better, 10=much worse. |
| Multidimensional function | Revised Fibromyalgia Impact Questionnaire (FIQR)* | Time to complete: 3.5 min Number of administrations: 3 (first visit, final visit, follow-up telephone call) Description: 21×11—point numerical rating scale (NRS); 0=no difficulty, 10=very difficult; total maximal score=100 |
| Peripheral domains | ||
| Anxiety | HADS-A Subsection of Hospital Anxiety and Depression Scale assessment | Time to complete: 1 min Number of administrations: 2 (first visit, final visit) Description: 7×4-point questions, ‘not at all’ → ‘most of the time’ |
| Depression | HADS-D Subsection of Hospital Anxiety and Depression Scale assessment | Time to complete: 1 min Number of administrations: 2 (first visit, final visit) Description: 7×4-point questions, ‘not at all’ → ‘most of the time’ |
| Stiffness | – | Time to complete: N/A (subsection of FIQR) Number of administrations: 3 (first visit, final visit, follow-up telephone call) |
| Dyscognition | – | Time to complete: N/A (subsection of FIQR) Number of administrations: 3 (first visit, final visit, follow-up telephone call) |
Total completion time: 16 min.
*The rationale for inclusion of FM questionnaires is fourfold; (1) a proportion of participants included in the study will have widespread pain symptoms secondary to FM, (2) multifaceted subjective scores, encompassing all aspects of chronic pain in a comprehensive manner, (3) FM is the best proxy for widespread chronic pain symptoms, (4) the FIQR can be utilised for any chronic condition—when it is known as Symptom Impact Questionnaire or SIQR.
FM, fibromyalgia; N/A, not applicable; NRS, Numerical Rating Scale.