Abstract
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 comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p < 0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p < 0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. 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.
Highlights
The introduction of the American College of Rheumatology (ACR) 2010 fibromyalgia criteria paved the way for a new era of patient centred approach and better understanding of the disease nature [1]
One hundred and forty-six patients (71 males, 75 females; mean age 41.6 ± 7.8 years, mean disease duration 2.3 ± 1.9 years) who meet the modified ACR 2010 criteria for fibromyalgia were included in this work to assess the validity and reliability of the Patient Reported Outcome Measures (PROMs)-FM questionnaire
Results of this work revealed that the content construct of the PROMsFM scales for functional disability and quality of life revealed correlation with both HAQ (r = 0.93) and EuroQoL-5D scores (r = 0.88)
Summary
The introduction of the American College of Rheumatology (ACR) 2010 fibromyalgia criteria paved the way for a new era of patient centred approach and better understanding of the disease nature [1]. In 2011, the diagnostic criteria were revised to include 19 specific pain locations and 6 self-administered symptoms questionnaires including sleep difficulty, fatigue, headache, depression, abdominal pain, and poor cognitive status [3]. This scale consists of the summation of the 2 components of the 2010 criteria, the Widespread Pain Index (WPI) and the Symptom Severity Score (SSS). It was developed in view of Arthritis the suggestion that “fibromyalgia is a syndrome that lie(s) at the extreme end of the spectrum of polysymptomatic distress.”. It was developed in view of Arthritis the suggestion that “fibromyalgia is a syndrome that lie(s) at the extreme end of the spectrum of polysymptomatic distress.” The Polysymptomatic Distress Scale made it possible to assess whether the patient meets the criteria, and where the patient is on the distress continuum [4, 5]
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