The Italian Fibromyalgia Registry: a new way of using routine real-world data concerning patient-reported disease status in healthcare research and clinical practice

OBJECTIVES: Fibromyalgia (FM), the most frequently encountered cause of widespread musculoskeletal pain, affects an estimated 2% of the general Italian population. However, it is not a homogeneous clinical entity, and a number of interacting factors can influence patient prognosis and the outcomes of standardised treatment programmes. Registries are a source of high-quality data for clinical research, but relating this information to individual patients is technically challenging. The aim of this article is to describe the structure and objectives of the first Italian Fibromyalgia Registry (IFR), a new web-based registry of patients with FM. METHODS: The IFR was developed to collect, store, and share information electronically entered by physicians throughout Italy who are members of the Italian Society of Rheumatology and have a particular interest in FM. It has a web-based architecture that uses two separate servers and an encryption algorithm to ensure the confidentiality and integrity of the exchanged data. The questionnaires included on the platform are the Revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status (ModFAS), and the Polysymptomatic Distress Scale (PDS). RESULTS: The registry includes data relating to 2,339 patients (93.2% female) who satisfied the 1990 or 2010/2011 American College of Rheumatology Classification Criteria for Fibromyalgia at the time of diagnosis. At the time of this analysis, the patients had a mean age of 51.9 years (SD 11.5) and a mean disease duration of 7.3 years (SD 6.9). The majority were married (71.3%), and generally well educated. The overall median FIQR, ModFAS and PDS scores and 25th-75th percentiles were respetively 61.16 (41.16-77.00), 8.91 (41.16-77.00), and 19.0 (13.00-24.00). The six highest scoring items indicating the greatest impact of the disease on the patients related to fatigue/energy (7.18), sleep quality (6.87), tenderness (6.69), pain (6.68), stiffness (6.66), and environmental sensitivity (6.35). A high proportion of the responding patients reported experiencing pain in the neck (80.46%), upper back (68.36%), and lower back (75.05%). CONCLUSIONS: The IFR is the most comprehensive FM registry in Italy, and provides healthcare professionals with a secure, reliable, and easy-to-use means of monitoring the patients' clinical progression, treatment history and treatment responses. This can help clinicians to plan patient management, facilitates research study patient recruitment, and provides the participating pain clinics with statistics based on real-world data. It also helps address the Italian Ministry of Health long-term goal of using precision medicine for chronic pain prevention and treatment. It is hoped that the IFR will enhance both scientific research and clinical practice.