A descriptive study of epidemiology, somatic symptoms, comorbidities and treatment patterns in people with fibromyalgia in England using the Clinical Practice Research Datalink (CPRD) Aurum database

Study type
Protocol
Date of Approval
Study reference ID
24_003861
Lay Summary

Fibromyalgia is a condition where people experience long-lasting pain all over their body. They often also report other problems like headaches, feeling down, and trouble sleeping. The severity of fibromyalgia can vary, affecting how people go about their daily lives. Fibromyalgia severity is often established by how many other symptoms (like headaches and sleep problems) people report.
We will find out how often people are diagnosed with fibromyalgia and how many other symptoms they report. We will investigate other health problems that people with fibromyalgia have. We will also explore what treatments people with fibromyalgia receive. It's important that we know this information so we can plan medical services.

Technical Summary

Our overall aim is to investigate the epidemiology of diagnosed fibromyalgia. We will estimate annual: 1) active prevalence (proportion of registered individuals with fibromyalgia recorded in specific year); 2) lifetime prevalence (proportion of registered individuals with new/existing fibromyalgia recorded in specific year); and 3) incidence (proportion of registered individuals with first-ever recorded fibromyalgia). We will describe characteristics (including consultations for somatic symptoms, comorbidities, treatment patterns) of people with a new fibromyalgia diagnosis. We will compare comorbidity burden in adults with fibromyalgia to matched comparators. This study will improve public health planning and resource allocation by providing insights into the healthcare needs of individuals with fibromyalgia.

We will use cross-sectional studies (2016-2022) to estimate annual prevalence and incidence. In individuals with incident fibromyalgia, we will describe comorbidities, estimate the proportion of people recorded with somatic symptoms at 12, 24 and 36 months after first fibromyalgia diagnosis, and records of potential treatments for fibromyalgia: 12 months before, and 1, 6, 12, 24 and 36 months after first fibromyalgia diagnosis.

In a matched cohort study (2016-2022) we will compare specific new and existing comorbidities in adults with and without fibromyalgia. We will match (age, sex, general practice, calendar date ) adults with fibromyalgia with up to five adults without. We will use logistic regression conditional on matched set to estimate odds ratios (95%CIs) comparing odds of existing comorbidity diagnoses on or before cohort entry (i.e., first fibromyalgia diagnosis date for those with fibromyalgia, and, for matched comparators, the cohort-entry date of their matched adult with fibromyalgia). We will use Cox regression stratified by matched set to estimate hazard ratios (95%CIs) comparing hazards of new comorbidity diagnoses in the 12 months after cohort entry. Regression analyses will be implicitly adjusted for age, sex, general practice and calendar time and explicitly adjusted for socioeconomic deprivation.

Health Outcomes to be Measured

Fibromyalgia prevalence; fibromyalgia incidence; demographic characteristics including age, sex, region, referral status and socioeconomic deprivation; clinical characteristics including somatic symptoms related to fibromyalgia, number of GP consultations; specific comorbidities (cardiometabolic disorders i.e., myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, vascular dementia, dyslipidaemia, diabetes mellitus, hypertension, and inflammatory arthritis [i.e., rheumatoid arthritis, systemic lupus erythematosus [although systemic lupus erythematosus does not always include inflammatory arthritis], juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis]); comorbidity burden using Charlson comorbidity index score; pharmacological treatment patterns; non-pharmacological treatment patterns

Collaborators

Moninder Kaur - Chief Investigator - UCB Pharma Ltd
Moninder Kaur - Corresponding Applicant - UCB Pharma Ltd
Bernard Lauwerys - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Chao Lu - Collaborator - UCB BioSciences, Inc.
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation