Outcome

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

3.1 How should patients with FM be followed?

The optimal clinical follow up for FM patients will depend on good clinical judgement.  Healthcare visits will occur more frequently at treatment initiation, and then be less frequent when the treatment strategy has been stabilized.   The ideal outcome measurement for use in clinical practice is also unknown.  Although improvement in pain is paramount, change in other symptoms may hold equal importance and should be addressed. A recently proposed severity index for FM symptoms requires testing in clinical practice to determine sensitivity to change [294].

As treatment objective should be reduction of symptoms and improved function, symptom improvement alone requires reassessment of treatments, with side effects possibly contributing to poor function, or other factors such as poor patient motivation.  Realistic outcome goals should be emphasized.

New symptoms should be clinically evaluated with appropriate testing where required and healthcare professionals should be cautious about attributing any new symptom to FM.  Alternately, prudence should be exercised regarding additional investigations, which should be driven by sound clinical principals.  As FM patients generally undergo more tests and are more costly to the healthcare system than the average population, excessive testing should be avoided [5, 6, 295].

Recommendations:

36. Clinical follow up should be dependent on the judgement of the physician or healthcare team with likely more frequent visits during the initial phase of management or until symptoms are stabilized [Level 5, Consensus].

37. In the continued care of a patient with fibromyalgia, the development of a new symptom requires clinical evaluation to ensure that symptoms are not due to some other medical illness [Level 5, Consensus].

3.2 What factors may help predict outcome in FM?

There are currently no reliable predictors of outcome or response to treatment for patients with FM.  In a single study a response to treatment with duloxetine within the first 1-2 weeks predicted continued response at 3 months, suggesting that early treatment response to this specific medication could be a treatment effect indicator [296]. Contrary to popular belief, outcome is not universally poor in the majority of patients, although symptoms do persist and fluctuate over time, with record of persistence up to seven years [12, 13].

A favourable outcome has been reported when patients were followed in community studies, with some even reporting resolution of symptoms, especially for those with recent onset [12, 297-299]. Improved outcome is further supported by the findings that 65% of subjects improved over a 2-year period in a community based study in England [300]. Although early life adverse events are associated with FM, they did not predict response to treatment in a single trial [127].  Some authors have reported a poorer outcome in patients who developed FM following a traumatic event [130, 301]. FM affects health-related quality of life from multiple perspective including physical functioning, emotional and psychological health [302]. Factors that may affect outcome include personality traits such as neuroticism and catastrophizing, poor internal locus of control, uncontrolled depression, and extreme obesity [303, 304].

Confirmation of a diagnosis of FM has a positive effect on overall healthcare costs in studies conducted in Europe [6]. Additionally, a definitive diagnosis does not adversely affect outcome from the patient perspective, is likely reassuring and facilitates engaging in optimal healthcare management [95]. Reduction in excessive use of pharmacotherapy improved outcome in a single study [206].

Recommendations:

38. Patients should be informed that the outcome in many individuals is favourable even if symptoms of fibromyalgia tend to wax and wane over time [Level 3 [297-299], Grade B].

39. Patients who have experienced previous adverse lifetime events that have impacted on psychological wellbeing and have not been effectively addressed should be offered appropriate support to facilitate attaining health-related outcome goals [Level 5, Consensus].

40. Physicians should be alert that factors such as passivity, poor internal locus of control and prominent mood disorder may have a negative influence on outcome [Level 5, Consensus].

3.3 What measures of outcome may be used to follow patients with FM?

Any measurement tool for outcome must be reliable and valid, simple to use and reflect change over time. Physicians generally remain reticent regarding the usefulness of questionnaires to follow patients in clinical practice.

Patient narrative report of symptoms or a report of global impression of change (PGIC), measured as a 7-point Likert scale, ranging from 1=much worse, to 7=much better, are simple and practical assessments for clinical practice [305, 306]. Documenting patient goals and their levels of achievement is a strategy that has concrete meaning for a patient [109]. Questionnaires that have been used include measures of function such as the Fibromyalgia Impact Questionnaire (FIQ), Revised FIQ (FIQR), Health Assessment Questionnaire (HAQ), as well as others measuring pain, sleep, fatigue and depression [307-310].  Measurement of tender points or pain intensity of tender points is not a clinically relevant or reliable outcome measurement [58].

3.3.1 Examples of tools to assess function, global status and quality of life

Various questionnaires specific to FM have been used mostly in the research setting, but are less applicable to routine patient care.

  1. The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures quality of life in patients with FM  [308]. A change of 14% on the FIQ indicates a clinically meaningful difference in health status [311]. It is complex to score, has questions that may not be currently applicable today and does not address cognition.
  2. A modification of the FIQ, termed the revised FIQ (FIQR) can be completed in two minutes, is simpler to score than the FIQ and includes questions regarding cognition, environmental sensitivity, balance and tenderness [307]. It has shown good reliability and equivalency with the original FIQ as well as the generic functional questionnaire, the SF36.
  3. The FM Severity Scale, a measurement tool component of the revised diagnostic criteria, has not yet been tested in the trial or clinical setting. This simple tick sheet questionnaire is scored out of 31, with a value of 13 or more used to identify patients with FM [294].
  4. Quality of life measures in FM patients, such as SF36,consistently show important effects, but are not practical for use in routine clinical care [312].

3.3.2 Examples of tools to assess pain

Numerous measures can be used to assess pain in FM, with recognition that pain is a single component of this condition, and therefore should not be assessed in isolation.

  1. The numerical pain intensity scale (0=no pain, 10= worst possible pain) and the pain visual analogue scale (VAS) are validated and simple measurements. These measures do not address other aspects of pain such as the quality, interference of daily function or timing of pain [313, 314]. A change in pain score of 30 % reflects a clinically meaningful change [315].
  2. Body pain diagrams may identify the distribution of pain, although the pain of FM is fluid and moves location in time frames from hours to days to weeks.  Pain diagrams give a pictorial image of the location of pain, but do not address intensity, quality or variation over time [316].
  3. Tender point count: although previously used as an outcome measure, the tender point count correlates poorly with global patient status and should not be used. When objective dolorimetry was applied in a random way, the correlation with subjective report was more consistent [317].

Recommendations:
41. Outcome can be measured by narrative report of symptom status or patient global impression of change (PGIC), without need for more complex questionnaires [Level 3 [305, 306], Grade C].

42. Patient goals and their levels of achievement should be recorded as a useful strategy to follow outcome [Level 5, Consensus].

43. Tender point examination should not be used as an outcome measure [Level 3 [58], Grade C].

3.4 What recommendations can be given regarding work?

The work ability of persons with FM is often contentious, with subjective report of functional impairment difficult to reconcile with a mostly healthy looking person. In the United States up to 35% of patients with FM are receiving work disability benefits [318].

FM patients in the workforce have generally less severe symptoms and better quality of life than those unemployed, but without evidence that remaining in the workforce positively affects health status [319, 320]. This finding holds true when patients were followed longitudinally over a five year period [321]. Therefore, it might be surmised that symptom severity is a determining factor in ability to work, missed workdays and loss of productivity, indicating a substantial burden of illness [322]. Compared to persons with RA, those with FM reported more short-term disability days, but overall mean costs for absence from work were similar for the two conditions [323].

Pacing, especially when applied to the workforce, may improve retention in employment [143]. Specific reasonable adjustments in the working environment may be helpful [144]. Although the physical and psychological demands of a job influence employment and eventual return to work, the life situation, attitude of the patient and ability to influence work parameters are additional contributing factors [324]. Combined exercise and cognitive strategies improved return to work in one study, and physical fitness in another [325, 326]. Regularity in scheduling will encourage a steady routine and regular sleep pattern. In an internet survey, FM patients reported higher physical function to be associated with younger age, higher education, less fatigue, less medication use and more exercise activity [327]. Pain locus of control with positive expectations was a good predictor of return to work in a Spanish multidisciplinary treatment program [140].  Patients’ perceived physical limitation better predicted employment status than affective symptoms or pain [328]. Although return to work is perceived as an ideal health economic outcome, this may not be applicable for many women with FM who may be homemakers [326].

Recommendations:

44. Physicians should encourage patients to remain in the workforce, and if necessary may provide recommendations that could help maintain optimal productivity, as outcome is generally more favourable for those who are employed [Level 3 [321], Grade C].

45. Patients with fibromyalgia on a prolonged sick leave should be encouraged to participate in an appropriate rehabilitation program with focus on improving function, including return to work if possible [Level 5 [326], Grade D].

3.5 How can healthcare costs be contained when treating patients with FM?

FM is a condition associated with considerable direct and indirect healthcare costs.  Costs are reported to be equal to persons with low back pain and rheumatoid arthritis and greater than persons with ankylosing spondylitis [323, 329]. In the US, the cost for service utilization in an individual FM patient was over $2000 in 1997, with reports in the order of $4000 per year per patient for Canada and Europe [5, 295, 330, 331]. Healthcare costs were three times higher for FM patients compared to other randomly selected patients over a 12 month period [332].

Treatment strategies to reduce healthcare costs have seldom been examined. Social support or social support and education did not reduce costs when compared to a control group over a one year period [333]. Healthcare costs for FM are greatest for non-drug therapies, with a threefold increase over drug therapy [330]. Even in the primary care setting, FM patients incurred higher annual costs compared to a reference population of non-FM patients [334] This is particularly true for FM patients with other comorbidities [335]. Concomitant depression and FM resulted in greater healthcare use, with mean incremental employer payments over 9000$, an amount greater than for FM or depression alone [336].

Using prediction of cost analysis over four years in the United Kingdom, a diagnosis of FM reduced healthcare costs and resource utilization driven by less tests, imaging, medication use, specialist referrals and primary care visits [82].

Recommendations:
46. In persons with fibromyalgia, other co morbid conditions including depression should be recognized and addressed in order to reduce healthcare costs [Level 3 [335, 336], Grade C].

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