Improving the primary care physicians’ decision making for fibromyalgia in clinical practice: development and validation of the Fibromyalgia Detection (FibroDetect®) screening tool

Health and Quality of Life Outcomes

Benoit Arnould³  Michael Spaeth⁷  Eric Serra⁵  Selwyn Richards²  Joëlle Margaux^1,10  Jules Desmeules⁴  Giorgio Cruccu¹  Hélène Gilet³  Ernest Choy⁶  Carla Dias-Barbosa³  Cayetano Alegre⁸  Isabelle Guillemin³  Serge Perrot⁹  Ralf Baron^1,11 

[1] Department of Neurology and Psychiatry, La Sapienza University, Rome, Italy;Poole Hospital NHS Trust, Rheumatology, Poole, UK;Mapi HEOR & Strategic Market Access, 27, Rue de la Villette, Lyon, 69003, France;Clinical Pharmacology and Toxicology & Multidisciplinary Pain Center, Geneva University Hospital, Geneva, Switzerland;Pain Unit, Amiens University Hospital, Amiens, France;Department of Rheumatology, Cardiff University, Cardiff, UK;Center for Clinical Rheumatology, Gräfelfing, Germany;Rheumatology, Hospital Universitari Valle d¿Hebron, Barcelona, Spain;Internal Medicine Department and Pain Center, Paris Descartes University, INSERM U987, Paris, France;Rheumatology and Physical Medicine Department, Erasme Hospital, Brussels, Belgium;Division of Neurological Pain Research and Therapy, Christian-Albrechts University, Kiel, Germany

关键词: FibroDetect;    Decision making;    Early diagnosis;    Screening tool;    Primary health care;    Fibromyalgia;   

Others  :  1164512
DOI  :  10.1186/s12955-014-0128-x

 received in 2013-11-19, accepted in 2014-08-07,  发布年份 2014

【 摘 要 】

Background

Fibromyalgia diagnosis is a challenging and long process, especially among primary care physicians (PCPs), because of symptom heterogeneity, co-morbidities and clinical overlap with other disorders. The purpose was to develop and validate a screening tool in French (FR), German (DE) and English (UK) to help PCPs identify patients with fibromyalgia.

Methods

The FibroDetect questionnaire was simultaneously developed in FR, DE and UK based on information obtained from a literature review, focus groups conducted with clinicians, and face-to-face interviews with fibromyalgia patients (FR, DE and UK, n?=?23). The resulting tool was comprehension-tested in patients with diagnosed or suspected fibromyalgia (n?=?3 and n?=?2 in each country, respectively). Acceptability and applicability were assessed and the tool modified accordingly, then assessed in clinical practice. A scoring method was created using an iterative process based on statistical and clinical considerations with American College of Rheumatology?+?(ACR+) patients and ACR¿ patients (n?=?276), and validated with fibromyalgia and non-fibromyalgia patients (n?=?312).

Results

The FibroDetect included 14 questions assessing patients¿ pain and fatigue, personal history and attitudes, symptoms and impact on lives. Six questions were retained in the final scoring, demonstrating satisfactory discriminative power between ACR?+?and ACR- patients with area under the Receiver Operating Characteristic curve of 0.74. The predictive accuracy of the tool increased to 0.86 for fibromyalgia and non-fibromyalgia patient detection, with a sensitivity of 90% and a specificity of 67% for a cut-off of 6 on the score.

Conclusions

The FibroDetect is a self-administered tool that can be used as a screening classification surrogate to the ACR criteria in primary care settings to help PCPs detect potential fibromyalgia patients among a population complaining of chronic widespread pain.

【 授权许可】

   
2014 Baron et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1][http://www.rheumatology.org/public/factsheets/fibromya_new.asp] webcite ACR website. In .
• [2]Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P: The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990, 33:160-172.
• [3]Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M: Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum 2009, 39:448-453.
• [4]Wolfe F: The epidemiology of fibromyalgia. J Musculoskelet Pain 1993, 1:137-148.
• [5]Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F: Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998, 41:778-799.
• [6]Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB: The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken) 2010, 62:600-610.
• [7]Bennett R: The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 2005, 23:S154-S162.
• [8]Mease P, Arnold LM, Bennett R, Boonen A, Buskila D, Carville S, Chappell A, Choy E, Clauw D, Dadabhoy D, Gendreau M, Goldenberg D, Littlejohn G, Martin S, Perera P, Russell IJ, Simon L, Spaeth M, Williams D, Crofford L: Fibromyalgia syndrome. J Rheumatol 2007, 34:1415-1425.
• [9]Rehm SE, Koroschetz J, Gockel U, Brosz M, Freynhagen R, Tolle TR, Baron R: A cross-sectional survey of 3035 patients with fibromyalgia: subgroups of patients with typical comorbidities and sensory symptom profiles. Rheumatology (Oxford) 2010, 49:1146-1152.
• [10]Wilson HD, Starz TW, Robinson JP, Turk DC: Heterogeneity within the fibromyalgia population: theoretical implications of variable tender point severity ratings. J Rheumatol 2009, 36:2795-2801.
• [11]Katz RS, Wolfe F, Michaud K: Fibromyalgia diagnosis: a comparison of clinical, survey, and American College of Rheumatology criteria. Arthritis Rheum 2006, 54:169-176.
• [12]Perrot S, Dickenson AH, Bennett RM: Fibromyalgia: harmonizing science with clinical practice considerations. Pain Pract 2008, 8:177-189.
• [13]Hauser W, Wolfe F: Diagnosis and diagnostic tests for fibromyalgia (syndrome). Reumatismo 2012, 64:194-205.
• [14]Choy E, Perrot S, Leon T, Kaplan J, Petersel D, Ginovker A, Kramer E: A patient survey of the impact of fibromyalgia and the journey to diagnosis. BMC Health Serv Res 2010, 10:102. BioMed Central Full Text
• [15]Annemans L, Le LK, Taieb C: Societal and patient burden of fibromyalgia syndrome. Pharmacoeconomics 2009, 27:547-559.
• [16]Hughes G, Martinez C, Myon E, Taieb C, Wessely S: The impact of a diagnosis of fibromyalgia on health care resource use by primary care patients in the UK: an observational study based on clinical practice. Arthritis Rheum 2006, 54:177-183.
• [17]Beck AT, Beamesderfer A: Assessment of depression: the depression inventory. Mod Probl Pharmacopsychiatry 1974, 7:151-169.
• [18]Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L: An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord 2007, 8:27. BioMed Central Full Text
• [19]Hays RD, Stewart AL: Sleep Measures. In Measuring Functioning and Well-Being; the Medical Outcomes Study Approach. Duke edition. Edited by Stewart AL, Ware JEJ. Duke University Press, Durham, North Carolina, USA; 1992:235-259.
• [20]Robinson ME, Riley JL III, Myers CD, Sadler IJ, Kvaal SA, Geisser ME, Keefe FJ: The Coping Strategies Questionnaire: a large sample, item level factor analysis. Clin J Pain 1997, 13:43-49.
• [21]Zachrisson O, Regland B, Jahreskog M, Kron M, Gottfries CG: A rating scale for fibromyalgia and chronic fatigue syndrome (the FibroFatigue scale). J Psychosom Res 2002, 52:501-509.
• [22]Serra E, Spaeth M, Carbonell J, Arnould B, Benmedjahed K, Barnes N, Le Lay K, Taieb C: Development of the Fibromyalgia burden assessment: measuring the multifaceted burden of fibromyalgia. Clin Exp Rheumatol 2010, 28:S87-S93.
• [23]White KP, Harth M, Speechley M, Ostbye T: Testing an instrument to screen for fibromyalgia syndrome in general population studies: the London Fibromyalgia Epidemiology Study Screening Questionnaire. J Rheumatol 1999, 26:880-884.
• [24]Pincus T: A multidimensional health assessment questionnaire (MDHAQ) for all patients with rheumatic diseases to complete at all visits in standard clinical care. Bull NYU Hosp Jt Dis 2007, 65:150-160.
• [25]Arnold LM, Stanford SB, Welge JA, Crofford LJ: Development and testing of the fibromyalgia diagnostic screen for primary care. J Womens Health (Larchmt) 2012, 21:231-239.
• [26]Perrot S, Bouhassira D, Fermanian J: Development and validation of the Fibromyalgia Rapid Screening Tool (FiRST). Pain 2010, 150:250-256.
• [27]Arnould B: Patient-reported outcomes and clinical practice. From measurement instruments to decision tools: much more than a simple change in format. PRO Newsl 2006, 36:21-24.
• [28]Smith JA: Semi-structured interviewing and qualitative analysis. In Rethinking Methods in Psychology. Edited by Smith JA, Harré R, van Langenhove L. Sage Publications, London, United Kingdom; 1995:9-26.
• [29]Bagneux V, Barnes N, Arnould B: Development of the standardized face and content validity test to evaluate patient questionnaires for clinical practice. PRO Newsl 2007, 38:12-14.
• [30]Bastien P, Esposito Vinzi V, Tenenhaus M: PLS generalised linear regression. Comput Stat Data Anal 2005, 48:17-46.
• [31]Perez-Enciso M, Tenenhaus M: Prediction of clinical outcome with microarray data: a partial least squares discriminant analysis (PLS-DA) approach. Hum Genet 2003, 112:581-592.
• [32]Eriksson L, Johansson E, Kettaneh-Wold N, Wold S: Multi- and Megavariate Data Analysis. Umetrics, Umea, Sweden; 2001.
• [33]Agresti A: Categorical Data Analysis. Wiley, Hobocken, NJ; 2002.
• [34]Patrick DL, Burke LB, Powers JH, Scott JA, Rock EP, Dawisha S, O¿Neill R, Kennedy DL: Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 2007, 10(Suppl 2):S125-S137.
• [35][http:/ / www.fda.gov/ downloads/ Drugs/ GuidanceComplianceRegulatoryInforma tion/ Guidances/ UCM193282.pdf] webcite U.S. Department of Health and Human Services; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health: Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labeling claims. In .
• [36]Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, Martin SA: Patient perspectives on the impact of fibromyalgia. Patient Educ Couns 2008, 73:114-120.
• [37]Hoffman DL, Dukes EM: The health status burden of people with fibromyalgia: a review of studies that assessed health status with the SF-36 or the SF-12. Int J Clin Pract 2008, 62:115-126.
• [38]Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, Abetz L, Martin SA: Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises. Arthritis Rheum 2008, 59:952-960.
• [39]Raymond MC, Brown JB: Experience of fibromyalgia. Qualitative study. Can Fam Physician 2000, 46:1100-1106.
• [40]Thompson D, Lettich L, Takeshita J: Fibromyalgia: an overview. Curr Psychiatry Rep 2003, 5:211-217.
• [41]Verbunt JA, Pernot DH, Smeets RJ: Disability and quality of life in patients with fibromyalgia. Health Qual Life Outcomes 2008, 6:8. BioMed Central Full Text
• [42]Edwards A, Elwyn G: Shared decision-making in health care: achieving evidence-based patient choice. In Shared Decision-Making in Health Care: Achieving Evidence-Based Patient Choice. 2nd edition. Edited by Edwards A, Elwyn G. Oxford University Press, Oxford, United Kingdom; 2009:1-10.