Table 2 Consensus for 15 revised draft recommendations was reached after three rounds of a Delphi exercise

1.Targeted patients

Who are the targeted patients?

Patients completing ACR preliminary diagnostic criteria for FM 2010.

1

A

8.2 ± 1.1

85

H

2. Treatment targets

Can treat to target be adopted in FM, and what are targets to be identified?

There is no cure for FM, and T2T recommendations should be directed to reduction of symptoms, healthy lifestyle practices, and maintenance of optimal function, with patient outcome goals, clearly defined at the first visit.

1

B

8.2 ± 1.3

92

H

3. Diagnosis

How is FM (FM) diagnosed?

A combination of suggested symptoms together with normal investigations may help in FM diagnosis; for confirmation of diagnosis, use the ACR preliminary diagnostic criteria for FM 2010 which depends mainly on WPI and SSS, bearing in mind that the specific tender point examination according to the 1990 ACR diagnostic criteria is not required to confirm a clinical diagnosis of FM. The patients are diagnosed if the following 3 conditions are met: (i) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) Scale score ≥ 5 or WPI 3–6 and SS scale score ≥ 9, (ii) symptoms have been present at a similar level for at least 3 months, and (iii) the patient does not have a disorder that would otherwise explain the pain.

1

A

8.5 ± 0.8

92

H

Should tender points be considered in the diagnosis of FM?

Tender points may be useful for the diagnosis of FM when evaluated in combination with other functional disorders covered in the ACR 2010 criteria. The tender point count may be correlated with the intensity of somatic symptoms, particularly emotional stress.

2

A

8.2 ± 0.9

92

H

4. Investigations

What investigations should be done in a patient presenting with widespread pain?

There is no laboratory investigation that confirms a clinical diagnosis of FM. FM is not a diagnosis of exclusion [24]. Laboratory testing should be limited to a CBC, ESR, CRP, TSH, HCV Ab, vit. D and anti-tissue transglutaminase IgA Ab test, and creatine kinase to rule out conditions that can present similarly to FM like endocrine disease (hypothyroidism), rheumatic conditions (early inflammatory arthritis or polymyalgia rheumatica), celiac disease, or neurological disease (myopathy, or multiple sclerosis), depending upon the clinical evaluation. MSUS can be used to rule out inflammatory arthritic conditions wherever applicable. Appropriate additional testing might include psychological evaluation in selected patients.

2

B

8.3 ± 1.1

92

H

5. Patient evaluation

Can patient-reported outcomes be used as a tool for the diagnosis and evaluation of patients with FM?

Patients with FM have higher risks for somatic symptoms, depression, and panic syndrome than patients with rheumatoid arthritis. Furthermore, they have worse pain, sleep quality, and quality of life indices. Patients’ reported outcomes give the opportunity to collect all these data in a patient-friendly format.

1

A

8.3 ± 1.1

92

H

6. Treatment

What are the treatment strategies for FM?

Through a multidisciplinary team, the treatment strategy for patients with FM should include a graduated, multimodal, and patient-tailored approach with close monitoring and regular follow-up, particularly in the early stages of management.

1

A

8.3 ± 0.9

92

H

What are the recommended non-pharmacologic treatments?

Initial management should focus on non-pharmacological therapies, based on availability, cost, and patient’s preferences. The patient should be encouraged for graded incremental aerobic and strengthening exercise to maintain or improve function, then if needed, add cognitive behavioral therapies, multicomponent therapies (at least one educational or psychological therapy+ at least one exercise therapy), and defined physical therapies: acupuncture or hydrotherapy, meditative movement therapies (yoga, tai chi), and mindfulness-based stress reduction. Diet recommendations for FM patients should include cessation of tobacco, as well as the consumption of chemical-laden foods, aspartame, and monosodium glutamate (MSG); encourage gluten-free diet; slowly wean the patient off caffeine; and to be avoided before bed-time, also promote sound general nutrition, appropriate vitamin supplementation, bone health, and weight reduction, if needed. Partially recommend against direct long-time exposure to electromagnetic field devices.

2

A

8.5 ± 0.9

92

H

Which type of exercise is most effective: strength and/or aerobic training?

No big differences, although supervised aerobic exercise may improve more physical capacity and FM symptoms. Water exercises also may improve both the physical and emotional aspects of FM. The subjective muscle pain may be a barrier to optimal exercise activity, so patients should be encouraged to choose an activity either land-based or water, that is enjoyable, easy to follow, convenient, and within budget to improve adherence.

1

A

8.5 ± 0.7

85

H

What are the recommended pharmacologic treatments?

In case of a lack of effect of the above non-pharmacologic approaches, we recommend a symptom-based pharmacologic approach after reassessment of the patient. For patients with severe pain, these drugs should be considered (duloxetine or milnacipran, pregabalin); tramadol can be used for appropriate patients. We conditionally recommend against the use of NSAIDs which act mostly in the periphery, and their continuous use has plenty of side effects, so their use should be limited to the associated conditions like osteoarthritis. Sleep disturbance, (amitriptyline, cyclobenzaprine, pregabalin) should be considered. Pharmacologic treatments should be initiated in low doses with gradual titration to reduce medication intolerance with regular follow-up for the efficacy and side effect profile, especially some drug side effects may appear similar to the symptoms of FM. Multiple symptoms simultaneously may require a combination of medications, so attention must be paid to drug interactions. We strongly recommend against growth hormone, strong opioids, and corticosteroids.

*Macfarlane GJ, et al. Ann Rheum Dis 2017;76:318–328. doi:10.1136/annrheumdis-2016-209724

1

A

8.4 ± 0.9

85

H

Are combined pharmacological and non-pharmacological approaches to management more effective than single modality management?

Ideal management includes both non-pharmacologic and pharmacologic treatments in a multimodal approach. Both are effective in improving key symptoms of FM including pain, fatigue, depression, and quality of life.

1

A

8.6 ± 0.8

92

H

7. Treatment of FM as a comorbidity

How should FM be managed when it occurs as a comorbidity to inflammatory arthritis?

The same as primary FM, in combination with the proper management of the causing inflammatory disease, taking into consideration the drugs interaction side effects.

1

B

8.5 ± 0.7

85

H

8. Outcome

What factors may help predict outcome in FM?

FM symptoms do persist and fluctuate over time even with treatment; however, early treatment response to a specific medication could be a treatment effect indicator. Factors such as passivity, poor internal locus of control, cognitive dysfunction, prominent mood disorder, perfectionist, meticulous and obsessive personalities, and uncontrolled underlying disease (if any) may have a negative influence on the outcome.

2

A

8.5 ± 0.7

100

H

9. Monitoring

How should patients with FM be followed as regards function, global status, and quality of life?

Clinical follow-up depending on the case evaluation by the physician with recommended more frequent visits during the initial phase of management or until symptoms is stabilized. In case of the development of a new symptom, clinical evaluation to ensure that symptoms are not due to some other medical illness is required.

1

A

8.5 ± 0.7

100

H

10. Self-management

What is the role of self-management in the treatment of patients with FM?

Education and active participation with reassurance regarding “no harm” caused by physical activity should be the focal point of treatment, especially if a patient is passive; hence, encouraging self-efficacy and social support will facilitate the practice of health-promoting lifestyles; this is achieved by using a graded incremental activity to maintain or improve function.

1

B

8.7 ± 0.6

100

H