Project grant application (non recommendations, 2017 template)
Project proposal
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Project title
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The implementation of the EULAR recommendations for the management of patients with fibromyalgia. |
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Project leaders
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Sella Aarrestad Provan MD PhD |
Convenor and methodologist
- Objectives
To assess the availability of structured management options for patients with fibromyalgia (FM) in Europe.
- Background
The first American Congress of Rheumatology (ACR) criteria for the classification of FM were published in 1990 and paved the way for increased recognition of the diagnosis. In order to fulfil the classification criteria for primary FM, the patient had to have tenderness upon pressure exerted at 11 out of 18 designated areas, in addition to widespread pain for at least 3 months, without other identifiable explanation [1]. The 2011 Fibromyalgia Survey Diagnostic Criteria (FSDC) did not include the tender point examination but based the diagnosis on patient self-reported number of areas afflicted by pain and severity of the key manifestations such as sleep disturbances and depression. A survey questionnaire for diagnosing FM according to the FSDC in epidemiological studies has been developed [2]. The prevalence of fibromyalgia in Scotland according to the FSDC was estimated to be 5.4% (95% CI: 4.7-6.1) in 2012-13[3], while the prevalence of fibromyalgia according to the 1990 criteria was estimated to be 1.3 % in Sweden [4] .
The impact of FM on the individual can be measured by the FIQ, a FM specific multi-dimensional questionnaire that captures health status, function and disease severity. The score range is 0-100, and a score <39 is categorised as less severe impact of FM, while a score ≥ 59 is considered a severe impact [5]. Outcome Measures in Rheumatology (OMERACT) have recommended that patients with FM who participate in studies be characterised across 12 domains; Pain, fatigue, sleep disturbance, depression, anxiety, stiffness, dys-cognition, patient global impression of health, multidimensional functioning, tenderness, cerebrospinal fluid biomarkers and pain-related neuroimaging (when available) [6].
The EULAR revised recommendations for the management of fibromyalgia lists 10 interventions which have variable levels of evidence for the treatment of FM [7]. Aerobic exercises have the highest strength of recommendation [7]. In addition two overarching principles concerning the need for prompt diagnosis, and a multidisciplinary approach to management are stated. Norwegian recommendations for health service priorities advice that patients with FM should be cared for at the primary level of health care, i.e. by their general practitioner (GP). A diagnosis of FM does not elicit any formal right to be referred to the specialist health-care level in Norway. If patients are to be referred to it should be for diagnostic purposes, for example if there are hereditary conditions or co-morbidities that suggest an increased risk of inflammatory joint disease. The diagnostic delay in FM is an average of 2 years and patients typically consult several different physicians in the years prior to diagnosis. There are no Norwegian national guidelines for the treatment of FM, but according to one study 37% of women and 30% of men contacted the primary health service due to musculoskeletal disorders during one year, the majority consulted a physician, but physiotherapists and chiropractors were also consulted [8]. To the best of our knowledge no studies have surveyed whether the health care services that are available for patients with FM in European countries is in accordance with the EULAR management recommendations.
- 3. Envisioned benefit/impact
Patients with FM are known to be frequent consumers of physician and complementary and alternative medicine services [9]. An assessment of the availability, use and cost of the health services suggested by the EULAR management recommendations can be helpful in the planning and management of health care services. The knowledge gained by our study can also be of benefit for FM patient advocacy groups.
- Detailed project description
The patients will be identified by surveying a cohort of the general population in at least 5 European countries. Validated translations of the FDC will be used to diagnose fibromyalgia.
A postal survey of 200 patients in each country who fulfil the diagnostic criteria in will subsequently be performed exploring primary and secondary endpoints by a combination of generic and study specific questionnaires.
Primary endpoints:
–Patient satisfaction with the management of fibromyalgia.
Secondary endpoints:
-Date at which symptoms started, and date at which the diagnosis was given.
-Profession of health personnel who gave the diagnosis.
-Disease severity according to the FIQ,
-Patient perception of adequate information regarding the disease and patient perception of shared decision making.
-Availability and cost to the patient of the management options suggested in EULAR guidelines:
Non-pharmacological management:
- Aerobic and strengthening exercises
- Cognitive behavioural therapies
- Multicomponent therapies
- Defined physical therapies
- Meditative movement
Pharmacological management:
- Amitryptiline
- Duloxetin/milnacipran
- Tramadol
- Pregabalin
- Cyklobenzaprine
- Project organisation, task force members
Note: The active involvement of at least two patients and at least one health professional is mandatory
Project leader: Sella Aarrestad Provan MD PhD Department for Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Project participants/Advisory panel:
Egil Andreas Fors Professor General Practice Research Unit, Norwegian University of Science and Technology, Trondheim, Norway
Loreto Carmona and Estebaliz Loza. Instituto de Salud Musculoesquelética, Madrid, Spain
Winfred Haüser Germany
Patient representatives:
The project will be a pilot of the EULAR task force on the implementation of the EULAR recommendations.
- Milestones of the project
| Action | Milestone | |
| Jan-March 2019 | Finalize recruitment of all centres. | 5 or more national centres in European countries |
| April-June 2019 | Ensure that validated translations of the FSDC are available in all participating countries.
· Translate and validate FSDC in any country where this is not available · Develop, translate and validate on questionnaire assessing endpoints. |
· Translated and validated FSDC available in 5 or more European countries
· Translated and validated questionnaires assessing use of health-care services available 5 or more European countries |
| July-Dec. 2019 | Data-collections | Data-collections completed at 5 or more national centres |
| Jan-June 2020 | Analyses of data and presentation of findings | Presentation at EULAR 2020. Submission of paper for publication |
- Relevance for EULAR
The project will give information on the implementation of the EULAR recommendations for the management of FM in 5 or more European countries.
8.Budget
We hereby apply for 55 000 euros
The cost of the project will be:
- Funding of a 5 month position for an academic fellow who will organize the data-collection together with the project leader: 25 000 euros
- Payment to each participating centre to cover cost of translation and validation of FSDC and questionnaire, and data-collection: 6000 euros
- Signature of convenor
