2012 Canadian Fibromyalgia Guidelines

Executive committee: Dr. Mary-Ann Fitzcharles, Peter A. Ste-Marie, Dr. Don L. Goldenberg, Dr. John X. Pereira, Dr. Susan Abbey, Dr. Manon Choinière, Dr. Gordon Ko, Dr. Dwight Moulin, Dr. Pantelis Panopalis, Johanne Proulx, Dr. Yoram Shir

Why develop Guidelines?

• Recent guidelines ±10 years old• Advances in understanding FM

– Neurophysiologic– Treatments

• New diagnostic criteria (ACR 2010)• Call for guidance & direction

– Requested by Canadian Pain Society

Objectives

• To provide Canadian healthcare professionals clinically applicable guidelines for use in daily practice

– Diagnosis– Management– Patient trajectory

Makeup of guideline group

• Executive committee:– 11 persons– Health care professionals, international expert, project coordinator,

patient representative

• National Fibromyalgia Guideline Advisory Panel (NFGAP)– 139 healthcare professionals invited– 35 agreed to participate and completed voting process

All healthcare professionals active in the care of FM and chronic pain patients.

Methods

• Step 1: Needs assessment• Step 2: Literature search• Step 3: Grading of evidence• Step 4: Writing• Step 5: Advisory Panel votes on recommendations• Step 6: External Revision• Step 7: Publication & Dissemination

Financial support & conflicts of interest

• Guideline development requested by CPS• Louise and Alan Edwards Foundation

– Research assistant: salary support• All participants stated conflicts of interest• Needs assessment

– Unrestricted educational grant by Valeant without any input to content

• No additional industry support

The literature search

• 18 key questions• McGill Librarians did formal lit search

– Embase, MEDLINE, PsychInfo, Pubmed, Cochrane, grey literature, hand search

• >5000 articles– Titles, abstracts reviewed, duplicates removed– 360 retained

How we did the job

• 18 questions & 360 articles • Each article

– read – graded (JADAD) – level of evidence (Oxford)

• Literature is summarized in three sections• Recommendations are formulated by the

Executive committee, assigned a level of evidence and a grade.

Methods: Assessing individual studies

Grading of individual articles was by JADAD method (out of 5):• Was the study described as randomized? • Was the study described as double blind?• Was there a description of withdrawals and dropouts? • The method of randomization was described in the paper, and that method was appropriate. • The method of blinding was described, and it was appropriate.

Points deducted if:• The method of randomization was described, but was inappropriate. • The method of blinding was described, but was inappropriate.

Assigning a level of evidence for each recommendation

Overview of the Oxford Centre for Evidence Based Medicine (level of evidence table)

Level 1 Level 2 Level 3 Level 4 Level 5Systematic review of RCTs

RCT (or observational studies with dramatic effect)

Non-RCT cohort/follow-up study

case-control studies, historically controlled studies

Opinion

Grading of recommendationsA consistent level 1 studies

B consistent level 2 or 3 studies or extrapolations from level 1 studies

C level 4 studies or extrapolations from level 2 or 3 studies

D level 5 evidence or troublingly inconsistent or inconclusive studies of any level

* Level may be graded down or up by experts

46 recommendations formulatedNFGAP voting process:• SurveyMonkey used• Advisors had access to full document • Voted in three sections:

– Recommendation– Grading of recommendation

• 80% required for acceptance

Guidelines address three broad concepts

• Diagnosis and evaluation 12• Management 23• Patient trajectory and follow-up 11

new clinical concepts regarding FM have been incorporated into these guidelines.

Where we currently stand

• 44 page document (12 000 words)• 336 references• Endorsed by Canadian Pain Society and

Canadian Rheumatology Association.• Publication & dissemination in progress

The diagnosis• Composite of symptoms (level 5)

– 2/3 pain– 1/3 other (Sleep disturbance, fatigue, cognitive dysfunction..)

• Diagnosis (level 5)– Clinical construct– Simple blood tests only

• Physical exam must be done (level 5)– Exclude other conditions– Tender points not required

Diagnosis (cont.)

• As early as possible (level 5)• Primary care is ideal setting (level 1)• Access to team member for support (level 3)• Specialist referral only if (level 5)

– Atypical symptoms– Difficulties in management

• eg. sleep specialist, psychologist

Diagnosis (cont.)

• Healthcare professionals– need education (level 5)– Empathetic, shared decision-making (level 3)

• Contributing factors such as genetics or triggering events must not hinder care(level 5)

• ACR 2010 criteria (level 3)– May validate clinical diagnosis

Management (overview)

• No ideal treatment• Patient tailored approach (level 5)

– Symptom-based management– Non-pharmacologic & pharmacologic strategies

• Aim to – symptoms– Maintain / improve function

Management(overview cont.)

• Self-management strategies are imperative (level 1)– Patient active participant!! (level 1)– Multimodal approach (level 1)– Realistic goals (level 5)– Pacing, but continue normal life (level 4)

Management(psychological interventions)

• Internal locus of control• Recognize psychological distress (level 3)• Patient education – better coping skills (level

5)• Improve self-efficacy (level 1)• Psych counselling helpful for some (level 5)• CBT (level 1)

Management (non-pharmacologic)

• Exercise (level 1)– Best available evidence – Any type

• aerobics, water based, stretching, etc.

• CAM – Insufficient evidence (level 1)– Encourage disclosure of use (level 5)

Management (pharmacologic)

• No perfect drug• Lowest dose, gradual increase (level 5)• Expect only a modest response• Consider combination drugs (level 5)• Be knowledgeable regarding drug mechanisms

(level 5)• Constant evaluation re risk vs. benefit (level 5)

Management(pharmacologic cont.)

• WHO step-up analgesic ladder (level 5)• NSAIDS – low dose, short use (level 5)• Tramadol – moderate/severe pain (level 2)• Strong opioids – discouraged (level 5)• Cannabinoid (pharma) – sleep (level 3)

Management(pharmacologic cont.)

• Antidepressants– Explain mechanism to patient (level 5)– TCAs, SSRIs & SNRIs can be used (level 1)– Choice – MD knowledge, Pt characteristics (level 5)

• Anticonvulsants– Explain mechanism to patient (level 5)– Low dose (level 1)

Patient trajectory

• Follow-up time interval depends on MD judgment (level 5)

• New symptoms– Evaluate using clinical judgment (level 5)

• FM symptoms persist, wax and wane (level 3)• No value to dwell on past lifetime events,

move forward (level 5)

Patient trajectory (continued)

• Poor outcome when (level 5)– Passive patient– External locus of control– Untreated prominent mood disorder

• Outcome tools– Patient Global Impression of Change (level 3)– Goal attainment (level 5)– Do not use tender points for outcome (level 3)

Patient trajectory (work & costs)

• Retention in workforce encouraged (level 3)• Rehab program if necessary (level 5)• Reduce costs by treating depression (level 3)

Key points…• Clinical construct

– Primary setting is recommended– Do not over medicalize patient

• Non-pharma strategies VIP– Patient ownership

• Symptom-based management– No ideal drug– Drugs show modest effects only

• Encourage retention in workforce

Thank you!!

Any questions?