Are OMERACT recommendations followed in clinical trials on fibromyalgia? A systematic review of patient-reported outcomes and their measures

Abstract

Purpose Patient-Reported Outcomes (PROs) and its measures (PROMs) are key to outcome assessment in Fibromyalgia (FM) trials. The aim of this review was to investigate which domains and instruments were assessed in recent FM trials and to compare them to recommendations by the Outcome Measures in Rheumatology (OMERACT) initiative. In addition, we investigated the overlap with a generic health assessment approach, i.e. eight domains suggested by the Patient-Reported Outcome Measurement Information System® (PROMIS®). Methods In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic literature search in scientific databases including PubMed, PsycInfo, and Embase was conducted to identify studies that assessed at least two dimensions of health-related quality of life (HRQoL) from 2015 to June 2022. Non-randomized and randomized controlled trials were included in the analysis. We extracted PROs and PROMs used in each study. Results From 1845 identified records, 107 records out of 105 studies met the inclusion criteria. Studies investigated 50 PROs using 126 different PROMs. Most frequently assessed domains were pain, depression, fatigue, and anxiety (> 95% of the studies). The disease-specific FIQ was the most frequently applied PROM (82%). Overall, only 9% of the studies covered all domains deemed mandatory by OMERACT. Very few studies covered all eight generic health domains suggested by PROMIS. Conclusion The majority of trials covered most OMERACT domains or generic PROMIS health domains. There was, however, great variability in the instruments used to assess the domains, which points at a limited degree of standardization in the field.

A systematic literature review on the clinical efficacy of low dose naltrexone and its effect on putative pathophysiological mechanisms among patients diagnosed with fibromyalgia

“…Many different scoring systems are currently in use including average pain daily score (ADPS), weekly average worst daily pain score (W-DPS), Brief Pain Inventory and Fibromyalgia Impact Questionnaire (FIQ) [ 27 ]. However, to date there is no consensus on patient reported outcome measures (PROMs) used in fibromyalgia research [ 28 ]. This makes comparison between different therapeutic agents challenging [ [29] , [30] , [31] ].…”

Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Revised Fibromyalgia Impact Questionnaire (FIQR) for Use in Arabic-Speaking Patients in Saudi Arabia

“…11 A systematic review published in 2023 found that 81.9% of 107 FM trials applied both versions of the FIQ as outcomes measures. 12 The revised version is strongly associated with the original FIQ and has excellent psychometric properties (Cronbach α = 0.95) and good convergent and discriminant validity, 13 and it distinguishes FM patients from patients with rheumatoid arthritis, systemic lupus erythematosus, and major depressive disorders. 13 The FIQR encompasses 3 domains: physical functioning, overall impact, and symptoms.…”