Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients' and health professionals' appraisals: a qualitative study protocol

Victoria Mailen Arfuch, Rosa Caballol Angelats, Carina Aguilar Martín, Noèlia Carrasco-Querol, Maria Cinta Sancho Sol, Gemma González Serra, Immaculada Fusté Anguera, Alessandra Queiroga Gonçalves, Anna Berenguera, Victoria Mailen Arfuch, Rosa Caballol Angelats, Carina Aguilar Martín, Noèlia Carrasco-Querol, Maria Cinta Sancho Sol, Gemma González Serra, Immaculada Fusté Anguera, Alessandra Queiroga Gonçalves, Anna Berenguera

Abstract

Introduction: Fibromyalgia syndrome (FMS) is a complex condition still scarcely understood and with ambiguity when prescribing treatment. Both patients and healthcare providers can supply valuable information for the development of new treatment strategies. The qualitative narrative analysis of participant's accounts is potentially helpful to reveal new insights about their opinions, needs, and experiences and, consequently, to model healthcare interventions accurately. International treatment guidelines suggest a promising future for multicomponent intervention (MI) approaches for FMS. This study aims to assess the benefits of a MI for patients with FMS in the context of primary care (PC) in Terres de L'Ebre, Catalonia (Spain). Furthermore, it is intended to detect the overall perception of effectiveness and to understand patients' lived experience and its impact on the quality of life.

Method and analysis: Qualitative research from a socioconstructivism paradigm perspective and a Hermeneutic Phenomenological method. For data collection, four focus group discussions (FGDs) of 8-12 people (2 FGDs of patients and 2 of professionals) and 10-12 key informant interviews with the participants in the MI group will be carried out. All the information will be recorded and verbatim transcribed to perform an interpretive thematic analysis.

Ethics and dissemination: This study protocol has been approved by the Clinical Research Ethics Committee from the IDIAPJGol Institute, on 25 April 2018 (code P18/068), according to the Declaration of Helsinki/Tokyo. All participants will receive oral/written information about the study, and they will be required to sign an informed consent sheet. Data anonymity will be guaranteed. Dissemination will be carried out through publications in scientific journals, presentations in academic meetings, workshops and through the local and national media.

Trial registration number: ClinicalTrials.gov: NCT04049006; Pre-results.

Keywords: primary care; public health; qualitative research; rheumatology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow diagram of the qualitative study. FGD, focus group discussions; KII, key informant interview; MI, multicomponent intervention; PhCs, phone calls.

References

    1. Wuytack F, Miller P. The lived experience of fibromyalgia in female patients, a phenomenological study. Chiropr Man Therap 2011;19:22. 10.1186/2045-709X-19-22
    1. Mas AJ, Carmona L, Valverde M, et al. . Prevalence and impact of fibromyalgia on function and quality of life in individuals from the general population: results from a nationwide study in Spain. Clin Exp Rheumatol 2008;26:519–26.
    1. Lichtenstein A, Tiosano S, Amital H. The complexities of fibromyalgia and its comorbidities. Curr Opin Rheumatol 2018;30:94–100. 10.1097/BOR.0000000000000464
    1. Wolfe F, Smythe HA, Yunus MB, et al. . The American College of rheumatology 1990 criteria for the classification of fibromyalgia. Report of the multicenter criteria Committee. Arthritis Rheum 1990;33:160–72. 10.1002/art.1780330203
    1. Wolfe F, Clauw DJ, Fitzcharles M-A, et al. . Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR preliminary diagnostic criteria for fibromyalgia. J Rheumatol 2011;38:1113–22. 10.3899/jrheum.100594
    1. Wolfe F, Clauw DJ, Fitzcharles M-A, et al. . 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum 2016;46:319–29. 10.1016/j.semarthrit.2016.08.012
    1. Seoane-Mato D, Sánchez-Piedra C, Silva-Fernández L, et al. . Prevalence of rheumatic diseases in adult population in Spain (EPISER 2016 study): aims and methodology. Reumatol Clin 2019;15:90–6. 10.1016/j.reuma.2017.06.009
    1. Cabo-Meseguer A, Cerdá-Olmedo G, Trillo-Mata JL. Fibromyalgia: prevalence, epidemiologic profiles and economic costs. Med Clin 2017;149:441–8. 10.1016/j.medcli.2017.06.008
    1. Villanueva VL, Valía JC, Cerdá G, et al. . Fibromialgia: diagnóstico Y tratamiento. El estado de la cuestión. Rev Soc Esp Dolor 2004;11.
    1. Marques AP, Santo AdeSdoE, Berssaneti AA, et al. . Prevalence of fibromyalgia: literature review update. Rev Bras Reumatol Engl Ed 2017;57:356–63. 10.1016/j.rbre.2017.01.005
    1. Wolfe F, Walitt B, Perrot S, et al. . Fibromyalgia diagnosis and biased assessment: sex, prevalence and bias. PLoS One 2018;13:e0203755. 10.1371/journal.pone.0203755
    1. Häuser W, Sarzi-Puttini P, Fitzcharles M-A. Fibromyalgia syndrome: under-, over- and misdiagnosis. Clin Exp Rheumatol 2019;37 Suppl 116:S90–7.
    1. Samulowitz A, Gremyr I, Eriksson E, et al. . "Brave Men" and "Emotional Women": A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain. Pain Res Manag 2018;2018:1–14. 10.1155/2018/6358624
    1. Fleming KC, Volcheck MM. Central sensitization syndrome and the initial evaluation of a patient with fibromyalgia: a review. Rambam Maimonides Med J 2015;6:e0020–12. 10.5041/RMMJ.10204
    1. Fitzcharles MA, Ste-Marie PA, Pereira JX. Md for Canadian fibromyalgia guidelines Committee. fibromyalgia: evolving concepts over the past 2 decades. CMAJ 2013;185:E645–51.
    1. Gran JT, Tore Gran J. The epidemiology of chronic generalized musculoskeletal pain. Best Pract Res Clin Rheumatol 2003;17:547–61. 10.1016/S1521-6942(03)00042-1
    1. Abeles AM, Pillinger MH, Solitar BM, et al. . Narrative review: the pathophysiology of fibromyalgia. Ann Intern Med 2007;146:726–34. 10.7326/0003-4819-146-10-200705150-00006
    1. Malatji BG, Meyer H, Mason S, et al. . A diagnostic biomarker profile for fibromyalgia syndrome based on an NMR metabolomics study of selected patients and controls. BMC Neurol 2017;17:88. 10.1186/s12883-017-0863-9
    1. D'Agnelli S, Arendt-Nielsen L, Gerra MC, et al. . Fibromyalgia: genetics and epigenetics insights may provide the basis for the development of diagnostic biomarkers. Mol Pain 2019;15:1744806918819944. 10.1177/1744806918819944
    1. Helfenstein M, Goldenfum MA, Siena CAF. Fibromyalgia: clinical and occupational aspects. Rev Assoc Med Bras 2012;58:358–65.
    1. Burke KG. Year in Review-2019. J Nurses Prof Dev 2019;35:303–4. 10.1097/NND.0000000000000590
    1. Bush AJ, Webber SC, Richards RS. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev 2013;12:CD0108.
    1. Bernardy K, Klose P, Bush AJ, et al. . Cognitive behavioral therapies for fibromyalgia. Cochrane Database Syst Rev 2013;3:CD00979.
    1. Luciano JV, Guallar JA, Aguado J, et al. . Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study). Pain 2014;155:693–702. 10.1016/j.pain.2013.12.029
    1. Aman MM, Jason Yong R, Kaye AD, et al. . Evidence-Based non-pharmacological therapies for fibromyalgia. Curr Pain Headache Rep 2018;22:33. 10.1007/s11916-018-0688-2
    1. Prabhakar A, Kaiser JM, Novitch MB, et al. . The role of complementary and alternative medicine treatments in fibromyalgia: a comprehensive review. Curr Rheumatol Rep 2019;21:14. 10.1007/s11926-019-0814-0
    1. Baranowsky J, Klose P, Musial F, et al. . Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int 2009;1:30.
    1. McMahon L, Murray C, Simpson J. The potential benefits of applying a narrative analytic approach for understanding the experience of fibromyalgia: a review. Disabil Rehabil 2012;34:1121–30. 10.3109/09638288.2011.628742
    1. Hyland ME, Hinton C, Hill C, et al. . Explaining unexplained pain to fibromyalgia patients: finding a narrative that is acceptable to patients and provides a rationale for evidence based interventions. Br J Pain 2016;10:156–61. 10.1177/2049463716642601
    1. Bourgault P, Lacasse A, Marchand S, et al. . Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial. PLoS One 2015;10:e0126324. 10.1371/journal.pone.0126324
    1. Kashikar-Zuck S, Tran ST, Barnett K, et al. . A qualitative examination of a new combined cognitive-behavioral and neuromuscular training intervention for juvenile fibromyalgia. Clin J Pain 2016;32:70–81. 10.1097/AJP.0000000000000221
    1. Miranda NACG, Berardinelli LMM, Sabóia VM, et al. . Interdisciplinary care praxis in groups of people living with fibromyalgia. Rev Bras Enferm 2016;69:1115–23. 10.1590/0034-7167-2016-0279
    1. Sim J, Madden S. Illness experience in fibromyalgia syndrome: a metasynthesis of qualitative studies. Soc Sci Med 2008;67:57–67. 10.1016/j.socscimed.2008.03.003
    1. Oliveira JPR, Berardinelli LMM, Cavaliere MLA, et al. . The routines of women with fibromyalgia and an interdisciplinary challenge to promote self-care. Rev Gauch Enferm 2019;40:e20180411.
    1. Giusti EM, Castelnuovo G, Molinari E. Differences in multidisciplinary and interdisciplinary treatment programs for fibromyalgia: a mapping review. Pain Res Manag 2017;2017:1–19. 10.1155/2017/7261468
    1. Ollevier A, Vanneuville I, Carron P. A 12-week multicomponent therapy in fibromyalgia improves health but not in concomitant moderate depression, an exploratory pilot study. Disabil Rehabil 2019;0:1–8.
    1. Martín J, Torre F, Padierna A, et al. . Six-and 12-month follow-up of an interdisciplinary fibromyalgia treatment programme: results of a randomised trial. Clin Exp Rheumatol 2012;30:103–11.
    1. Saral I, Sindel D, Esmaeilzadeh S, et al. . The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial. Rheumatol Int 2016;36:1379–89. 10.1007/s00296-016-3473-8
    1. Stein KF, Miclescu A. Effectiveness of multidisciplinary rehabilitation treatment for patients with chronic pain in a primary health care unit. Scand J Pain 2013;4:190–7. 10.1016/j.sjpain.2013.06.003
    1. Jacobs H, Bockaert M, Bonte J, et al. . The impact of a group-based multidisciplinary rehabilitation program on the quality of life in patients with fibromyalgia: results from the QUALIFIBRO study. J Clin Rheumatol 2019. 10.1097/RHU.0000000000001120. [Epub ahead of print: 19 Jun 2019].
    1. Martín J, Torre F, Padierna A, et al. . Six-and 12-month follow-up of an interdisciplinary fibromyalgia treatment programme: results of a randomised trial. Clin Exp Rheumatol 2012;30:S103–11.
    1. Thieme K, Mathys M, Turk DC. Evidenced-Based guidelines on the treatment of fibromyalgia patients: are they consistent and if not, why not? have effective psychological treatments been overlooked? J Pain 2017;18:747–56. 10.1016/j.jpain.2016.12.006
    1. Arnold B, Häuser W, Arnold M, et al. . Multicomponent therapy of fibromyalgia syndrome. Der Schmerz 2012;26:287–90.
    1. Nüesch E, Häuser W, Bernardy K, et al. . Comparative efficacy of pharmacological and non-pharmacological interventions in fibromyalgia syndrome: network meta-analysis. Ann Rheum Dis 2013;72:955–62. 10.1136/annrheumdis-2011-201249
    1. Papadopoulou D, Fassoulaki A, Tsoulas C, et al. . A meta-analysis to determine the effect of pharmacological and non-pharmacological treatments on fibromyalgia symptoms comprising OMERACT-10 response criteria. Clin Rheumatol 2016;35:573–86. 10.1007/s10067-015-3144-2
    1. de SD. Guia per a L avaluació de la fibromi lgia I de la síndrome de fatiga crònica. Generalitat de Catalunya, 2017.
    1. Generaliat de Catalunya, Agència de Qualitat i Avaluació Sanit ries de Catalunya . Evaluació Y abordaje de la fibromialgia Y síndrome de fatiga crónica, 2017. Available: [Accessed 12 Feb 2020].
    1. Generalitat de Catalunya Pla operatiu d’atenció a les persones afectades per les síndromes de senzibilització central: fibromi lgia, síndrome de fatiga crònica i síndrome de sensibilitat química múltiple, 2016. Available: [Accessed 12 Feb 2020].
    1. Caballol Angelats R, Gonçalves AQ, Aguilar Martín C, et al. . Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: a mixed methods study protocol. Medicine 2019;98:e17289. 10.1097/MD.0000000000017289
    1. Caballol Angelats R, Gonçalves AQ, Aguilar Martín C, et al. . Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: a mixed methods study protocol. Med 2019;98.
    1. NHS Health Research Authority Protocol guidance and template for use in qualitative research. Available: [Accessed 14 Feb 2020].
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349–57. 10.1093/intqhc/mzm042
    1. O'Brien BC, Harris IB, Beckman TJ, et al. . Standards for reporting qualitative research: a synthesis of recommendations. Acad Med 2014;89:1245–51. 10.1097/ACM.0000000000000388
    1. Brownson R, Colditz G, Proctor E. Dissemination and implementation research in health. New York, USA: Oxford University Press, 2012.
    1. Proctor EK, Landsverk J, Aarons G, et al. . Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health 2009;36:24–34. 10.1007/s10488-008-0197-4
    1. Wilson HJ. The myth of objectivity: is medicine moving towards a social constructivist medical paradigm? Fam Pract 2000;17:203–9. 10.1093/fampra/17.2.203
    1. Tindall L. Book review from Smith JA, flower P, Larkin M (2009), interpretative phenomenological analysis: theory, method and research. Qual Res Psychol 2009;6:346–7.
    1. Laverty SM, Phenomenology H. Hermeneutic phenomenology and phenomenology: a comparison of historical and methodological considerations. Int J Qual Methods 2003;2:21–35. 10.1177/160940690300200303
    1. Villegas M. Hermenéutica Y constructivismo en psicoterapia. 3 Revista de Psicoterapia, 1992: 5–16.
    1. Szilas RF. Multiperspective qualitative research methodology for researching work stress. World J Res Rev 2017;5:62–6.
    1. Kendall M, Murray SA, Carduff E, et al. . Use of multiperspective qualitative interviews to understand patients’ and carers’ beliefs, experiences, and needs. BMJ 2010;340:196.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. 10.1191/1478088706qp063oa
    1. Ossó AB, Vigués MP, Fernández RC, et al. . To listen, to observe and to understand: bringing back narrative into the health sciences: contributions of qualitative research. 232 Institut Universitari d'Investigació en Atenció Prim ria Jordi Gol (IDIAP Jordi Gol), 2017.
    1. Medical Research Council Implementation science. Available: [Accessed 20 Feb 2020].
    1. GACD global alliance for chronic diseases. Available: [Accessed 20 Feb 2020].
    1. NIH National cancer Institute. qualitative Methodsational cancer, implementation science, 2018. Available: [Accessed 20 Feb 2020].
    1. Briones-Vozmediano E. The social construction of fibromyalgia as a health problem from the perspective of policies, professionals, and patients. Glob Health Action 2017;10:1275191. 10.1080/16549716.2017.1275191
    1. Arnold LM, Crofford LJ, Mease PJ, et al. . Patient perspectives on the impact of fibromyalgia. Patient Educ Couns 2008;73:114–20. 10.1016/j.pec.2008.06.005

Source: PubMed

3
Sottoscrivi