Background The modified 2010 ACR criteria for fibromyalgia shifted the role of somatic symptoms assessment from the physician to the patient and allowed subjects to rate specific self-reported symptoms. Yet, fibromyalgia patients need further assessment in particular for associated co-morbidities and impact of the disease on the patient's life.
Objectives To assess the validity, reliability and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and co-morbidities assessment in fibromyalgia patients.
Methods The PROMs was conceptualized based on frameworks used by the WHO Quality of Life tool and the PRO measurement information system (PROMIS). Initially, cognitive interviews were conducted with 51 fibromyalgia patients (diagnosed according to modified ACR criteria 2010), with a range of severity to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of physicians, nurses, and health educators, in addition to clinometric and psychometric methods. The latter included Rasch and internal consistency reliability analyses. The questionnaire included the modified ACR criteria main items (symptoms severity score and widespread pain index); in addition to assessment of functional disability, quality of life, review of the systems, falls and cardiovascular risks, as well as self-helplessness. In addition, every patient completed SF-36 and Euro QoL 5D questionnaires.
Results A total of 146 fibromyalgia patients and 101 subjects suffering from widespread pain completed the questionnaire. The modified ACR criteria were satisfied by 91.2% of fibromyalgia patients with and by 10.8% of subjects who had widespread pain (sensitivity and specificity are 91.2% and 89.2%, respectively). The PROMs questionnaire was reliable as demonstrated by a high-standardized alpha (0.893-0.967). Content construct assessment of the PROMs-functional disability and QoL revealed significant correlation (p<0.01) with both SF-36 and Euro QoL. Changes in functional disability, quality of life as well as self-helplessness scores showed significant (p<0.01) variation with diseases activity status and response to therapy. Mean time to complete the questionnaire was 8.04 ± 0.92 min.There was higher prevalence of autonomic symptoms in fibromyalgia patients (cold hands, p=0.039; flatulence, p=0.022; tiredness, p=0.001); CVS risk (44.8%, p=0.01), sexual dysfunction (64.4%, p=0.01) and falling (61.6%, p=0.01).
Conclusions The diagnosis of fibromyalgia can be self-reported of the typical symptom complex. The developed PROMs questionnaire is a reliable and valid instrument for assessment of patients suffering from fibromyalgia. Being short, rapid and comprehensive, this adds more to its applicability. The data support the value of completion of the simple 2 pages patient questionnaire, which provides a quantitative written documented record by the patient, at each visit to the clinic. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management.
Disclosure of Interest : None declared