Introduction

2012 Canadian Guidelines for the Diagnosis and Management of Fibromyalgia Syndrome

Mary-Ann Fitzcharles1,2, Peter A. Ste-Marie2,3, Don L. Goldenberg4, John X. Pereira5, Susan Abbey6, Manon Choinière7, Gordon Ko8, Dwight Moulin9, Pantelis Panopalis1, Johanne Proulx10, Yoram Shir2

Fibromyalgia (FM) was recognized as a true syndrome with the publication of the American College of Rheumatology (ACR) classification criteria in 1990, which were updated in 2010 [1, 2]. Taking into account neurophysiologic evidence of pain dysregulation as well as newer treatment options, these guidelines provide direction for optimal patient care and align with best clinical practice. Clinical challenge persists as symptoms are subjective, assessment is dependent entirely on patient report, no objective or laboratory test exists to confirm the diagnosis, and there is an absence of a gold standard of treatment.

With the pivot symptom of pain, the syndrome of FM includes fatigue, nonrestorative sleep, cognitive dysfunction, mood disorder, as well as variable somatic symptoms [3]. Canadian prevalence rates are in the order of 2% – 3%, with females affected between 6 to 9 times more commonly than males [4]. Although seen most commonly in middle-aged women, FM can also affect children, teenagers, and the elderly.

Patients with FM commonly experience symptoms for a number of years prior to diagnosis. Repeated investigations, referral to various specialists, and frequent healthcare visits all contribute to considerable cost associated with this condition. Direct healthcare costs attributed to patient care are over $4000 Canadian per year, an amount 30% higher than non-FM patients in a Quebec healthcare database [5]. Although a reduction in healthcare utilization occurred immediately following a diagnosis of FM, this was not sustained in subsequent years [6].

While there is currently no cure for FM, ideal management will address pain as well as the composite of symptoms that comprise this syndrome. Treatment must incorporate non-pharmacologic strategies and may also include drug therapy, in a patient-tailored approach. Healthcare professionals must understand the interplay of neurophysiologic and psychological mechanisms operative in FM and appreciate that a spectrum of symptoms exists.

These guidelines are presented as recommendations pertinent to patient care in Canada, graded according to the level of supporting evidence, and accompanied by a brief explanation to clarify their context and facilitate clinical care. They should be viewed as an aid in the care of patients with FM, taking into account the unique needs of an individual patient, and should not be interpreted as the rule by which each patient should be managed.

Need for a Guideline

As previous guidelines for the management of FM were based on literature searches up to December 2006, updating is required [7-9]. There is a need for guidance which goes beyond management, and also incorporates diagnosis and the patient trajectory. We have set out to consolidate information published mostly in the last two decades to develop evidence based recommendations which will have good clinical utility in the day to day management of FM patients.

Leadership

The Canadian Fibromyalgia Guidelines Committee (CFGC) is a multidisciplinary team representing healthcare professionals from relevant fields managing FM patients, a patient representative, an external international expert, and a research coordinator. All CFGC members are listed as authors, had access to all data, participated in the data compilation, analysis, and writing of this report.

Objectives

To develop evidence-based guidelines for the evaluation, diagnosis and management of persons with FM in Canada taking into account new advances in the understanding of the pathogenesis of FM and new diagnostic criteria, and to identify and assess the evidence supporting these recommendations. Application of these guidelines should facilitate patient care with the goal to reduce symptoms and maintain function.

Target Audience

The target of this guideline is all Canadian healthcare professionals including primary care providers, medical specialists, and members of multidisciplinary teams who treat patients with FM. To a lesser degree, it is also relevant to patients with FM, who will also benefit from an understanding of this condition.

The Area the Guideline Does Not Cover

This guideline is limited to the adult population who suffer from FM. It does not address other conditions associated with a chronic pain syndrome such as peripheral neuropathy, regional pain syndrome, complex regional pain syndrome, etc.

Limitations

It is recognized that each patient is unique and treatments should be individualized, with recommendations serving as a starting template. There is currently a paucity of evidence to support many aspects of these guidelines, with reliance therefore placed on clinical experience and consensus in some areas. As access to care is not equal across all geographic regions of Canada, differences in care will be evident. Although no cost analysis of the implementation of these guidelines has been made, development of simple clinically useful tools will be required. The full document is extensive and lengthy and should therefore serve as a reference frame, rather than as a tool for day to day clinical practice.

Involvement and Affiliations of Other People or Organizations Including User-representative Organizations and Pharmaceutical Companies in the Development of the Guideline

All members of the CFGC are listed as authors. A patient representative made a significant contribution to these guidelines. No representatives of pharmaceutical companies were involved in the guideline development. These guidelines have been formally endorsed by the Canadian Rheumatology Association (CRA) and have been submitted to the executive committee of the Canadian Pain Society (CPS) with comments contributing to the final version.

Development

Needs assessment

A needs assessment developed a series of questions following input from 139 Canadian healthcare professionals. Participants included family physicians, anaesthesiologists, neurologists, psychiatrists, psychologists, physiatrists, rheumatologists, nurses, chiropractors, physiotherapists, and a single naturopathic doctor. Input was sought regarding current knowledge, knowledge gaps, uncertainties, and challenges in the clinical care of patients with FM.

Scope of literature search, strategy employed, and document revision

A comprehensive literature search, directed by each question, was conducted at the McGill University Health Sciences library. Databases searched were EMBASE, MEDLINE, PSYCHINFO, PUBMED, and Cochrane Library within a 20 year timeframe from 1990 to July 2010. The details of individual search strategies were recorded (Appendix A). A manual search from the references cited by original studies, reviews, and evidence-based guidelines was also used. Two authors (MAF & PSM) extracted data independently onto a specially designed pro forma and cross checked the data. Evidence was graded according to the strength of literature to support each statement according to the classification system of the Oxford Centre for Evidence Based Medicine (Appendix B) and the document was prepared in accordance with the principles outlined [10].

Sixty recommendations were initially drafted, assigned a level of evidence, and graded by the CFGC. Recommendations were then submitted via Internet to the 35 members who form the National Fibromyalgia Guidelines Advisory Panel (NFGAP). Recommendations were accepted if they obtained 80% approval after a first pass. Eleven recommendations that did not obtain approval at the initial vote were modified according to suggestions, submitted to a second vote, and achieved approval at the second vote. The entire document was reviewed by Dr. Don Goldenberg, our external expert and first author of the American Pain Society fibromyalgia guidelines, who was then asked to become a member of the CFGC after his formal review of the manuscript. Further external review was conducted by the executive committee of the CPS using the AGREE II Score Sheet guideline appraisal tool, with resulting shortening of the guideline document and combination but not elimination of recommendations to reduce the number from 60 to 46 (Appendix C).

Updating

These guidelines will be in the governance of both endorsing bodies, CRA and CPS, who will oversee the updating process in 2015.

Implementation

All members of the CFGC will participate in the dissemination process in order to have maximum visibility across all relevant disciplines throughout Canada. These guidelines have been presented at the 2012 annual meetings of the CRA and CPS, and updates will be presented by members of the CFGC at various regional meetings. Clinical review papers will be submitted by members of the CFGC to various peer-reviewed journals addressing some of the strategies outlined in these guidelines. Cards and pamphlets that are easily applicable and provide advice for certain areas of FM management will be produced and disseminated to healthcare professionals who have contact with FM patients.

Funding and conflict of interest

These guidelines were developed at the request of the CPS. The needs assessment was supported by an unrestricted educational grant from Valeant. The process of guideline development was facilitated by funding from the Louise and Alan Edwards Foundation. None of the funding sources had a role in the collection, analysis or interpretation of the data or in the decision to publish this report. Conflicts of interest for all members of the steering committee have been declared.

1 Division of Rheumatology, McGill University, Montreal, Quebec, Canada
2Alan Edwards Pain Management Unit, McGill University Health Center, Montreal, Quebec, Canada
3Faculty of Law, Université de Montréal, Montreal, Quebec, Canada
4Division of Rheumatology, Tufts University School of Medicine, Boston, Massachusetts, USA
5Department of Family Medicine, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada
6Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
7Centre de la recherche du Centre hospitalier de l’Université de Montréal; Department of Anesthesiology, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada
8Division of Physiatry, University of Toronto, Toronto, Ontario, Canada
9Departments of Clinical Neurological Sciences and Oncology, University of Western Ontario, London, Ontario, Canada
10Patient representative