Impact of enhanced pain knowledge on core outcomes in fibromyalgia patients with high self-reported pain education needs: a target trial emulation using the DANFIB registry

Abstract

Objective: Relationships between patient education and long-term clinical outcomes are complex. This study used real-world data to evaluate the impact of improved pain knowledge on clinical outcomes in fibromyalgia patients.

Methods: Prospectively collected registry-based observational data were analysed to emulate a randomised clinical trial. Study participants were diagnosed with fibromyalgia, had a high need to learn about pain (Numeric Rating Scale >7), had attended a 2-day therapeutic educational programme and re-rated their learning needs after the programme. A good educational outcome was defined as a re-rating score <5, while a poor outcome was ≥5. The primary endpoint at 9 months was the overall impact of fibromyalgia, measured by the Fibromyalgia Impact Questionnaire Revised (FIQR) impact subscale.

Results: The eligible cohort comprised 450 participants. The intention-to-treat from population included 121 participants (26.9%) with a good educational outcome and 329 participants (73.1%) with a poor educational outcome (comparator group). Missing outcome data were handled implicitly by the repeated measures linear mixed models, assuming data are missing at random.At the 9-month endpoint, the fully adjusted FIQR impact subscale score was lower in the good educational outcome group (8.0 (95% CI 7.3 to 8.7)) compared with the poor educational outcome group (9.6 (95% CI 9.0 to 10.2)), indicating a better clinical outcome for those with a good educational outcome. The model-estimated between-group difference was -1.6 (95% CI -2.5 to -0.7; p=0.0006) FIQR impact subscale units.

Conclusions: This study suggests that achieving pain educational learning objectives leads to better clinical outcomes in fibromyalgia patients, supporting the integration of pain education into patient programmes.

Keywords: Fibromyalgia; Health-Related Quality Of Life; Outcome and Process Assessment, Health Care; Pain; Rehabilitation.

Figure 1. Flow chart of study participants. DANFIB, Danish Fibromyalgia registry; NRS, Numeric Rating Scale.

Figure 2. Bar charts of the primary outcome at baseline and the 9 months follow-up in the ITT population. (A) Estimates with inverse probability weighting. (B) Non-weighted estimates. FIQ, Fibromyalgia Impact Questionnaire; ITT, intention to treat.