10/26/2013. Mary-Ann Fitzcharles is a consultant, speaker, or member of an advisory board for the following companies: Lilly, Purdue, Pfizer, Valeant

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1 Mary-Ann Fitzcharles, MBChB Associate Professor of Medicine Division of Rheumatology and Alan and Louise Edwards Pain Management Center McGill University, Montreal Canada Mary-Ann Fitzcharles is a consultant, speaker, or member of an advisory board for the following companies: Lilly, Purdue, Pfizer, Valeant Clinical Focus Course Meeting the challenges of measuring outcomes in Rheumatology clinical practice American College of Rheumatology Meeting October, 2013 And has provided testimony for plaintiff and defendant Arnold, L. M., Williams, D. A., Hudson, J. I., Martin, S. A., Clauw, D. J., Crofford, L. J.,... Mease, P. J. (2012). Development of responder definitions for fibromyalgia clinical trials. Arthritis Rheum, 64(3), Sotocinal SG, Sorge RE, Zaloum A,.. Mogil JS. (2011) The Rat Grimace Scale: a partially automated method for quantifying pain in the laboratory rat via facial expressions. Mol Pain. 29;7: Nüesch E, Häuser W, Bernardy K, Barth J, Jüni P. Comparative efficacy of pharmacological and non-pharmacological interventions in fibromyalgia syndrome: network meta-analysis. (2013) Ann Rheum Dis.72(6): Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Shir Y. (2013) Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag May-Jun;18(3): Evidence-based medicine governed by measures Measures provide Security in patient care Drive rational treatments Ideal measure is a biomarker Evidence-based medicine Clinical decisions are informed by results of trials The trial world is increasingly different from clinical practice The clinical world using fibromyalgia as an example fibromyalgia affects 2% of the population governed by time constraints clinical decisions are made immediately Patient assessment addresses clinical condition, treatments, and function A composite of subjective symptoms Waxing and waning course Patients are not homogenous in symptoms 1

2 Pain the defining feature Fatigue Sleep Disturbance Mood Cognition Other somatic symptoms Pain 30% reduction Function 10% improved + Other core symptoms 30% improved 1. Sleep FM30 short- 1 or 2 2. Fatigue 3. Depression FM30 long- any 2 of Anxiety 5. Cognition Arnold LM et al (2012). Arthritis Rheum, 64(3), The symptom severity scale for FM 12 Reasoning that is approximate rather than exact 19 An overall gestalt of the patient appearance + body language The health care professionals art of medicine innate clinical ability + experience A balance of disease and drug effects Wolfe F et al (2010) Arthritis Care Res. 62(5): m fitzcharles Average primary care MD visit lasts 20 mins!!! How are you doing? I feel much better patient global impression change (much worse..same much better) Function and goal attainment Back to work Back into the swing of life Sotocinal SG et al. (2011) Mol Pain. 29;7:

3 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, Grade C]. 42. Patient goals and their levels of achievement should be recorded as a useful strategy to follow outcome [Level 5, Consensus]. statistically significant vs. clinically meaningful 43. Tender point examination should not be used as an outcome measure [Level 3, Grade C]. Fitzcharles MA et al (2013) Pain Res Manag. 18(3): studies with 14,982 patients pharmacological & non-pharmacological treatments TCAs, SSRI, SNRIs, pregabalin, aerobic exercise, balneotherapy, CBT, multicomponent therapy Drugs: with large sample size statistical significance for SNRIs & pregabalin? clinically meaningful Non-drug: exercise, CBT, multicomponent better than placebo 36 yr old female police officer, still working 35 hrs/wk (desk job) At 30 yrs - regional pain (right scapula) At 35 yrs - diffuse pain Complaining of mostly pain, with sleep, mood & energy fairly good Nüesch E et al (2013) Ann Rheum Dis.72(6): Measure Baseline Follow-up (12 months) FM Impact Quest. (/100) Global VAS (/10) Pain VAS (/10) ACR 2010 (/31) McGill Pain Quest. (/78) 32 3 Body Map (/50) Pain Catastrophizing Scale (/52) 33 8 Pain Disability Index (/70) The measures make sense PGIC fits in with measures Exercise is wonderful 4.5hr/week Medications progressively reduced Duloxetine 60mg/day, discontinued gabapentin I have control over FM Which measure is driving her feeling of well being? 3

4 44 yr old female postal worker, still full time work Spontaneous onset diffuse pain aged 37yrs On 5 different drugs for FM Main complaint is pain, but also depression, anxiety, sleep disturbance and very inactive Measure Baseline Follow-up (40 months) FM Impact Quest. (/100) Global VAS (/10) Pain VAS (/10) ACR 2010 (/31) McGill Pain Quest. (/78) Body Map (/50) Pain Catastrophizing Scale (/52) Pain Disability Index (/70) Measures are all over the place But patient reports no change Passive and external locus of control 37 yr old female, after 3 day sailing trip, neck pain During manipulation by chiropractor had acute electric whole body pain that persists. No structural changes Which measure is driving her feeling of status quo? Measures are more or less the same PGIC..MUCH BETTER!!!! Which measure is driving her feeling of well being? Is it because she got much worse and now is back to baseline? 4

5 The patient with pain, fatigue and cognitive problems how committed is the patient to report accurately The questionnaires Time frames Questionnaire fatigue Bias intrusion where & who administers the questionnaire But symptoms of FM fluctuate over time Learned experience Social environment Innate personal qualities Locus of control..internal or external Personality.coping vs. passive Mood depression/anxiety Catastrophizing Measurement of subjective symptoms remains a challenge Composite measures Will remain the standard in research setting Efforts to refine meaningful measures are applauded The clinical world Will keep it simple will likely use fuzzy logic until there is an identified biomarker 5