Table 4

Patient-reported outcome measures

OMERACT domainAssessment toolBrief tool description (taken into account when considering participant burden)
Core domains
PainBrief 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
FatigueFatigue 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 disturbanceJenkins 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 GlobalPatient 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 functionRevised 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
AnxietyHADS-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’
DepressionHADS-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’
StiffnessTime to complete: N/A (subsection of FIQR)
Number of administrations: 3 (first visit, final visit, follow-up telephone call)
DyscognitionTime 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.