Open access Protocol 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 ‍ ‍,1,2 Rosa Caballol Angelats,3,4 Carina Aguilar Martín,1,5 Noèlia Carrasco-­Querol,1 Maria Cinta Sancho Sol,1,4 Gemma González Serra,1,4 Immaculada Fusté Anguera,3,4 Alessandra Queiroga Gonçalves,1,6 Anna Berenguera ‍ ‍2,7 To cite: Arfuch VM, Caballol ABSTRACT Angelats R, Aguilar Martín C, Introduction Fibromyalgia syndrome (FMS) is a complex Strengths and limitations of this study et al. Assessing the benefits condition still scarcely understood and with ambiguity when on quality of life of a ►► This study will provide information on barriers and prescribing treatment. Both patients and healthcare providers multicomponent intervention facilitators about the multicomponent intervention can supply valuable information for the development of new for fibromyalgia syndrome (MI) programme for fibromyalgia syndrome to de- in primary care: patients’ treatment strategies. The qualitative narrative analysis of sign more flexible treatment strategies adapted to and health professionals’ participant’s accounts is potentially helpful to reveal new patients’ health needs. appraisals: a qualitative insights about their opinions, needs, and experiences and, ►► The results of this study will help to improve the study protocol. BMJ Open consequently, to model healthcare interventions accurately. contents of a MI considering patients’ and profes- 2020;10:e039873. doi:10.1136/ International treatment guidelines suggest a promising future bmjopen-2020-039873 sionals’ opinions and the available resources in pri- for multicomponent intervention (MI) approaches for FMS. mary care. ►► Prepublication history for This study aims to assess the benefits of a MI for patients with ►► In-­depth patient interviews will contribute to a richer this paper is available online. FMS in the context of primary care (PC) in Terres de L’Ebre, understanding of their health needs, lived experi- To view these files, please visit Catalonia (Spain). Furthermore, it is intended to detect the ences and the subjective benefits of the MI to pro- the journal online (http://​dx.​doi.​ overall perception of effectiveness and to understand patients’ vide accurate and higher quality health services. org/​10.​1136/​bmjopen-​2020-​ lived experience and its impact on the quality of life. ►► A pre-­ implementation phase through qualitative 039873). Method and analysis Qualitative research from a methodology has not been conducted before the MI socioconstructivism paradigm perspective and a Hermeneutic Received 28 April 2020 started. Phenomenological method. For data collection, four focus Revised 07 October 2020 ►► The results of this study will not be generalisable to group discussions (FGDs) of 8–12 people (2 FGDs of patients Accepted 23 October 2020 other contexts due to the limitations of the method. 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. compromising personal and occupational Ethics and dissemination This study protocol has been aspects, plans and relationships.1 Conse- approved by the Clinical Research Ethics Committee from the quently, global health status and quality of life IDIAPJGol Institute, on 25 April 2018 (code P18/068), according (QOL) could be distorted.2 to the Declaration of Helsinki/Tokyo. All participants will receive Fibromyalgia syndrome (FMS) is a complex oral/written information about the study, and they will be required to sign an informed consent sheet. Data anonymity condition associated with several symptoms will be guaranteed. Dissemination will be carried out through and comorbidities, such as rheumatological © Author(s) (or their publications in scientific journals, presentations in academic and psychiatric disorders.3 FMS diagnosis employer(s)) 2020. Re-­use meetings, workshops and through the local and national media. is based on clinical criteria where the most permitted under CC BY-­NC. No commercial re-­use. See rights Trial registration number ​ClinicalTrials.​gov: NCT04049006; frequent manifestations are: generalised and permissions. Published by Pre-­results. musculoskeletal pain, fatigue, sleep distur- BMJ. bance, gastrointestinal disorders, psycholog- For numbered affiliations see INTRODUCTION ical distress which can trigger anxiety and end of article. Fibromyalgia is a long-­term condition, poten- depression, loss of functioning, low tolerance Correspondence to tially disabling characterised especially by an to physical effort, migraines and dizziness.4–6 Dr Anna Berenguera; atypical perception of pain. This syndrome The worldwide prevalence of FMS in the ​aberenguera@​idiapjgol.​org disrupts patients’ biopsychosocial universe general population is estimated between Arfuch VM, et al. BMJ Open 2020;10:e039873. doi:10.1136/bmjopen-2020-039873 1 Open access 0.2% and 6.6% and, 2.45% on average in Spain.7 8 It is pain at a 6-­month follow-­up. Although these results were usually diagnosed in middle-­aged people,2 9 and it is more maintained at 12 months, they were not compared with frequent in women with a prevalence ranged between a control group, nor were they studied in the context of 2.4% and 6.8% and with a female/male ratio of 21:1.10 primary care (PC).41 Although this difference in prevalence between women Multicomponent intervention (MI) programmes have and men cannot be fully explained yet, studies suggest been recommended in international treatment guide- that these rates are overestimated for women and underes- lines.42–45 Nevertheless, this intervention strategy for timated for men due to diagnostic criteria bias.11 12 More- FMS is in its infancy in the usual clinical care46 into the over, another study identifies the existence of gender bias Spanish public health sector. In Catalonia, and since in healthcare towards patients with chronic pain, which 2016, 18 accredited units specialised in Central Sensitivity helps to demystify the FMS as a predominantly female Syndromes located in PC centres and hospitals47 provide condition due to intrinsic factors.13 multidisciplinary healthcare to patients with FMS.48 Although FMS is classified as a central sensitivity This study aims to search out, through qualitative syndrome,14 15 its pathogenesis, aetiology and evolution research methodology and from patients with FMS and are still medically unexplained. Some experts suggest healthcare providers’ points of view, the overall percep- an interaction between neurophysiological, genetic, tion of effectiveness about a MI and its benefits on epigenetics and psychosocial factors.16–19 This knowledge patients’ QOL. Moreover, the specific objectives of the gap complexes and delays the diagnosis process, discred- study are: iting the authenticity of the fibromyalgia, and generating ►► To assess the subjective benefits on patients’ func- ambivalence about the provision of healthcare.20 21 tional impact, mood and pain management. Diverse treatment strategies have been tested focusing ►► To assess professionals’ experience about the MI on severity symptom management, QOL improvement and their appraisal regarding the benefits of the and the prevention of chronicity. Physical exercise, programme for patients’ health. psychological approaches such as cognitive–behavioural ►► To detect improvable aspects of the MI, based on the therapy (CBT), health education and complementary opinions and experiences of participants (users and medicine have demonstrated some clinical improve- professionals), in order to standardise the programme ment in symptom control.22–27 Nevertheless, the evidence so that it can be replicated in other health settings. remains uncertain, and there is scope for further research ►► To explore the subjective benefits and the impact of to determine the best treatment option. In this context, the MI on patients’ daily life and to understand the users’ and professionals’ opinions become a strategic structure of their lived experiences. resource for the design of treatments tailored to health This MI programme is provided within the 11 PC needs. A qualitative analytic approach to understanding centres of the Gerència Territorial Terres de L’Ebre of the their point of views and necessities is a valuable method Catalan Institute of Health. It consists of a 3-­ month which reveals novel insights about how people make sense group programme combining: health education, phys- of this condition and how they experience treatments.28 ical activity and CBT. The purpose of this proposal is to There are few published qualitative studies about the promote patients’ QOL by increasing control over their effectiveness of interventions in patients suffering from health in order to improve it. FMS. According to the evidence, qualitative methodology It is expected that the results will support and extend the is a useful approach to assess in-­depth participants’ treat- results of the randomized clinical trial (RCT) from which ment experience and detect patients' global impression this project arises (​ClinicalTrials.​gov: NCT04049006).49 of change regarding pain management, functionality and The contents of each MI session and other details of the QOL.29–34 However, authors acknowledged that it would design are fully described in the published protocol of be important to include the clinicians’ appraisals as well.30 the RCT study.50 Multidisciplinary interventions that combine phar- macological and non-­pharmacological treatments have shown to be effective in some clinical trial studies after 3–12 months of follow-­up.30 35–39 A recent study, based on METHOD a comprehensive 8-­ week group-­ based multidisciplinary Design rehabilitation programme that included CBT and grad- This protocol has been drafted based on the literature uated activity training, showed significant improvements review and following the protocol guidance for qual- in health-­related QoL at the end of the intervention, at itative research of the Health Research Authority.51 6 months and one year of follow-­ up.40 Regarding the Furthermore, this study will be reported following Spanish population, a study of similar characteristics was the Consolidated Criteria for Reporting Qualitative conducted in the Basque Country in 2012, about a 6-­week Research52 and the Standards for Reporting Qualitative interdisciplinary treatment in the hospital context. This Research: A Synthesis of Recommendations.53 Finally, programme that combined psychological, medical, educa- the evaluation of the intervention will be founded on the tional and physiotherapeutic components demonstrated constructs and guidelines suggested by experts of imple- significant improvements in QOL, physical function and mentation research.54 55 2 Arfuch VM, et al. BMJ Open 2020;10:e039873. doi:10.1136/bmjopen-2020-039873 Open access For the design of this study, interpretive qualitative communicate (orally and written) effectively in Catalan research will be carried out based on the theoretical or Spanish, have a phone number, have participated in a framework of the socioconstructivism paradigm56 and a minimum of 75% of the intervention programme (equal Hermeneutic Phenomenological method.57 This perspec- to or more than 9 out of 12 sessions), accept participation tive aims to answer what are the meanings that give sense in the qualitative study, sign the informed consent. On to our individual and collective existence, and how they the other hand, the exclusion criteria involve: having an come to be constituted.58 In this way, the narrative occurs actively psychotic episode, having an intellectual impair- and evolves in the process of social interaction, where ment, having severe depression and personality disorder, the discourse does not pre-­exist but is constructed in the registering auto/hyperaggressive behaviour, detecting intersubjective setting. Therefore, socially constructed use of psychoactive substances, having not attended to a narrative realities give significance and structure to our minimum of 75% of the MI group sessions (less than 9 existence, and the interpretation of this experience chal- out of 12 sessions), not sign the informed consent. lenges the way of being in a particular context.59 This study The criteria for professional recruitment include sign design is also accurate since it incorporates the preunder- the informed consent sheet, have participated in some standing of the researcher as part of the experience and stage of the MI in the last 6 months, not having declared so it is not necessary bracketing particular beliefs about conflicts of interest. the phenomena in order to explore it. Group and individual interviews with patients and The multiperspective research approach collects data professionals will be carried out in a PC centre from Terres from informants with different positioning regarding de L'Ebre area. Sound insulation criteria will be consid- the study phenomenon, expanding not only the narra- ered to guarantee the confidentiality of the information. tive themes of the accounts but also enriching the under- standing of the structure and dynamics of interaction Patient and public involvement between them.60 61 Patients or the public will not be involved in the design or conducting, or reporting, or dissemination plans of our Intervention strategy research. The MI consists of a 12-­week group programme of 2 hours weekly combining: 7 health education instructions deliv- ered by a general practitioner and a nurse, 11 pieces of Sampling and recruitment training on physical activity delivered by a physiotherapist, Theoretical sampling will be used to achieve maximum and 7 interventions of CBT delivered by a psychologist. discursive variability. First, two lists of possible candidates Regarding the contents of the programme, the health among patients will be drafted based on time criteria education component includes an introduction to (up to <6 months of follow-­ up after the intervention multicomponent therapy, neurophysiology and phar- and, between ≥6 and 12 months of follow-­up) in order macology of pain, techniques of postural hygiene, nutri- to assess the perception of the benefits in the short and tion, insomnia management, memory and sexuality. The medium-­long term. Second, those patients who accom- physical activity component focuses on breathing and plish with a minimum attendance of 75% to the interven- relaxation, stretching, strength/joint and coordination tion group will be included in the recruitment sample. exercises, and the 6 min walking test. Finally, the psycho- Then, criteria based on gender, age, working status and logical component works on CBT strategies, pain and geographical area will be applied to draft a list of possible attention management, mood and emotional manage- candidates. Finally, patients will be contacted by phone, ment, strategies for coping with difficulty, and the plan- and only those who accept participating in the qualitative ning of goals and pleasant activities. study will be included in the final data collection sample. This MI programme aims to: the patients’ acquisition of Regarding PC professionals, general practitioners and knowledge, skills and attitudes for the daily management nurses of different genders, age groups, geographical of the FMS; the improvement of their physical condition; areas of work will be included. the relief of their emotional distress, and to provide skills Additionally, and in order to understand the reasons to overcome psychological difficulties. for MI dropout and the possible lack of adherence, 4–6 phone calls will be done to patients who have been Participants and setting recruited to participate in the study and have signed This study will include patients who have had a minimum the informed consent but who, finally, did not start the of participation in the MI group and PC professionals programme or wanted to leave it early. Members of the involved in some stage of the programme. All participants research group will carry out these phone calls according will be recruited from any of the 11 PC centres belonging to the data protection low. to the Gerència Territorial Terres de l’Ebre (Catalan Health Informants will be invited to participate in the study Institute). through telephone contact. They will be informed about The inclusion criteria for patients are: have a clinical diag- the characteristics and objectives of the study, the audio– nosis of FMS (International Classification of Diseases-10 video recording of the interviews, and they will be guaran- codes: M79.0, M79.7), being over 18 years, be able to teed with the anonymity of the data management. Arfuch VM, et al. BMJ Open 2020;10:e039873. doi:10.1136/bmjopen-2020-039873 3 Open access Figure 1 Flow diagram of the qualitative study. FGD, focus group discussions; KII, key informant interview; MI, multicomponent intervention; PhCs, phone calls. People who have participated in both study groups lived experience in the intervention programme and because of an ethical requirement (first control and then exploring their subjective impact. The interviews are intervention group) will be recruited for some of the expected to last no more than 65 min. individual interviews. Although this subsample cannot The question protocols for the FGDs and the KIIs be included in the quantitative study for methodological will include open-­ended questions aimed to cover the reasons, they could provide valuable information for the research objectives: patients’ experiences during the MI qualitative analysis since they will have experienced both and the subjective benefits, its impact on QOL and daily treatment interventions. life, patients’ and professionals’ overall perception of effectiveness, and barriers and facilitators on the inter- Data collection vention implementation. Data collection includes four focus group discussions (FGDs) of 8–12 people (2 FGDs of patients and 2 of Data analysis professionals) and 10–12 key informant interviews (KIIs) A thematic analysis will be carried out to identify, inter- with patients that have participated in the MI group. pret and report patterns (themes) within data. First, FGDs and KIIs will be carried out through different literal transcripts of the audio recordings will be included samples. When necessary, additional discussion groups in a text corpus according to a published guide, which and personal interviews will be conducted to achieve enlists the steps for thematic analysis.62 Secondly, succes- discourse saturation. Data collection is expected to be sive readings of the text corpus will be completed as well complete by January 2021. Figure 1 describes the design as the formulation of pre-­analytical intuitions. Thirdly, and methodology of data collection. the coding process will be delivered, organising the data The FGDs and KIIs will be audio and video recorded, into the most basic meaningful elements (codes). Consec- prior informed consent, and will be literally and system- utively, the emergent themes from the interpretative anal- atically transcribed. Identifying data of the informants in ysis will be registered and clustered where appropriate the transcripts will be anonymised. under superordinate themes or salient phrases. In this An experienced moderator will conduct the FGDs way, all the relevant coded data extracts will be organised using a semistructured guide. A comoderator and an within the identified themes to catch the essential attri- observer will also participate as part of the research team. butes of the participants’ accounts. These themes will be The FGDs are expected to last no more than 95 min. The reviewed and named checking the existence of coherent guide will cover the following topics: the overall opinion patterns. Finally, a report will be drafted writing up the about the MI effectiveness, an evaluation of the elements results of the analysis and the interpretation of it. of the framework (time, space, professionals and benefi- Furthermore, a triangulation process of this first ciaries), improvable aspects, and the benefits of the inter- thematic analysis will be fulfilled between two or more vention on patients’ QOL. members of the research team.63 Discrepancies in the KIIs will be delivered by an experienced qualitative data analysis triangulation process will be resolved researcher and will be based on open-­ended structured primarily through consensus. In case this is not achieved, questions. The objective is to assess the patients’ personal the majority criteria will be implemented, if applicable. 4 Arfuch VM, et al. BMJ Open 2020;10:e039873. doi:10.1136/bmjopen-2020-039873 Open access If none of these strategies worked, the external expert topics related to FMS. Patients’ experiences could guide opinion would be appealed to solve the struggle. Never- researchers on the path to resolve the FMS dilemma. theless, an attempt will be made to reach agreements Understanding the experience of illness and how this between researchers that include all points of view, syndrome impacts at different levels such as work, social, fulfilling the criterion of internal coherence. The mean- physical, psychological and sexual functionality could ings extract from the triangulation will be interpreted, help to determine how to approach it from the health- and an explanatory framework will be created with the care services to improve patients’ QOL and overcome its contributions of each type of informant (users and profes- legitimacy debate. sionals participating in the FGDs and the KIIs). Attending the limitations of the qualitative method- ology, the results of this study will not be generalisable to other contexts. Moreover, due to the nature of self-­ DISCUSSION reported data, the results could be affected by memory, FMS has become a challenge for health providers due group effect, overestimation or underestimation, selec- to its heterogeneity, unclear aetiopathogenesis and the tion, or attribution biases. In addition to the intrinsic particularities of the patients’ profile.20 Faced with this limitations of the method, this qualitative study also pres- scenario, it is vital to incorporate a holistic perspective of ents shortcomings. Firstly, any pre-­implementation phase all those involved in the development and implementa- was conducted. Secondly, inclusion criteria in the FGDs tion of treatment strategies, including people suffering and KIIs will be limited only to those people who agree from this condition. to participate in the qualitative study so that they could From a methodological perspective and according to have a greater interest and a more positive perception of the Medical Research Council, the qualitative approach the MI. Another limitation is that, initially, no external provides relevant information for the validation and expert in qualitative methodology will be included in the modelling of new intervention programmes in order to triangulation analysis process to avoid investigator bias. effectively implement them in the real world and to iden- It will only be considered in case of major discrepancies tify and understand the main barriers.64 65 Moreover, the between the researchers. Finally, there will be no FGDs communication with stakeholder groups informs if the according to sex due to the lack of a necessary sample of intervention addresses the priority issues for the people male patients. involved and uses appropriate, feasible and acceptable Regarding the healthcare context, PC services could methods.66 address this issue, providing support to their patients, Accordingly, the qualitative assessment is expected to preventing health decline, and motivating these people reveal key details of the MI implementation, from patients’ to feel empowered in coping with FMS. Effective manage- and professionals’ points of view involved. This infor- ment actions in PC could reduce the costs of specialised mation will allow adjusting the setting elements (time- professional care, overprovision and overmedication, line, number of participants in the group), therapeutic avoiding system overload, and providing more holistic components and thematic contents that cover patients’ care to the needs of patients with FMS. health needs. Additionally, the results of this study will Equally important, new health policies and specialised likely improve the adherence to the MI, the adequacy of training programmes that increase knowledge and sensi- health centres and the impact on family members. Conse- tisation of health providers are needed to resolve fibro- quently, healthcare services for FMS, provided on the myalgia’s lack of recognition and stigma based on social recently established units specialised in Central Sensitivity construction in the Spanish context.67 A comprehensive Syndromes in the area, will increase their effectiveness assessment of the FMS symptomatology and its impact on and efficiency. As well, this programme will be hopefully the QoL of patients should be part of the usual clinical replicated and considering as an intervention model in care.68 other healthcare systems. A triangulation technique will be implemented to achieve complex analysis. The multiperspective qualita- tive approach can also help to study relationships and ETHICS AND DISSEMINATION dynamics between patients and professionals and to The Clinical Research Ethics Committee from the Fundació explore similarities and differences in their perceptions. Institut Universitariper a la recerca a l’Atenció Primària de Salut Furthermore, in-­depth patient interviews will contribute Jordi Gol i Gurina (IDIAPJGol), has approved this study to a richer understanding of their real health needs, lived protocol on 25/04/2018 (code P18/068), according to experiences and the subjective benefits of the MI. This the Declaration of Helsinki/Tokyo. All participants will information is crucial for providing accurate and high-­ receive oral/written information about the study, and quality health services and collaborates with FMS accep- they will be required to sign an informed consent sheet. tance and self-­management. Data anonymity will be guaranteed. Dissemination will Even though the qualitative approach is considered be carried out through publications in scientific jour- a weak method to achieve reliable evidence, it can also nals, presentations in academic meetings, workshops and be successful in seeking little studied and controversial through the local and national media. Arfuch VM, et al. BMJ Open 2020;10:e039873. doi:10.1136/bmjopen-2020-039873 5 Open access Author affiliations 5 Wolfe F, Clauw DJ, Fitzcharles M-­A, et al. Fibromyalgia criteria 1 Unitat de Suport a la Recerca Terres de l’Ebre, IDIAP Jordi Gol, Barcelona, and severity scales for clinical and epidemiological studies: Catalunya, Spain a modification of the ACR preliminary diagnostic criteria for 2 fibromyalgia. J Rheumatol 2011;38:1113–22. Department of Pediatrics, Obstetrics and Gynecology, and Preventive Medicine, 6 Wolfe F, Clauw DJ, Fitzcharles M-­A, et al. 2016 revisions to the Universitat Autonoma de Barcelona, Barcelona, Catalunya, Spain 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum 3 Equip d’Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Catalunya, 2016;46:319–29. Spain 7 Seoane-­Mato D, Sánchez-­Piedra C, Silva-­Fernández L, et al. 4 Prevalence of rheumatic diseases in adult population in Spain Unitat d’Expertesa en Sindromes de Sensibilització Central Terres de l’Ebre, Institut Català de la Salut, Tortosa, Catalunya, Spain (EPISER 2016 study): aims and methodology. Reumatol Clin 5 Unitat d’Avaluació, Direcció d’Atenció Primària Terres de l’Ebre, Institut Català de la 2019;15:90–6. 8 Cabo-­Meseguer A, Cerdá-Olmedo G, Trillo-­Mata JL. Fibromyalgia: Salut, Tortosa, Catalunya, Spain prevalence, epidemiologic profiles and economic costs. Med Clin 6 Unitat Docent de Medicina de Família i Comunitària Tortosa-­Terres de L‘Ebre, 2017;149:441–8. Institut Català de la Salut, Tortosa, Catalunya, Spain 9 Villanueva VL, Valía JC, Cerdá G, et al. Fibromialgia: diagnóstico Y 7 Central Research Unit, IDIAP Jordi Gol, Barcelona, Catalunya, Spain tratamiento. El estado de la cuestión. Rev Soc Esp Dolor 2004;11. 10 Marques AP, Santo AdeSdoE, Berssaneti AA, et al. Prevalence of fibromyalgia: literature review update. Rev Bras Reumatol Engl Ed Twitter Anna Berenguera @ABerenguera 2017;57:356–63. Acknowledgements All authors thank the contributions of the ICS, especially 11 Wolfe F, Walitt B, Perrot S, et al. Fibromyalgia diagnosis and biased to the Gerència Territorial ICS Terres de l’Ebre, la Direcció d’Atenció Primària de assessment: sex, prevalence and bias. PLoS One 2018;13:e0203755. Terres de l’Ebre, and the Unitat de Sistemes d’ informació de la Gerència Territorial 12 Häuser W, Sarzi-­Puttini P, Fitzcharles M-­A. Fibromyalgia syndrome: Terres de l’Ebre. Likewise, the participation and support of all healthcare and non-­ under-, over- and misdiagnosis. Clin Exp Rheumatol 2019;37 Suppl 116:S90–7. healthcare professionals, who collaborate in the implementation of this study and 13 Samulowitz A, Gremyr I, Eriksson E, et al. "Brave Men" and data collection, are appreciated. "Emotional Women": A Theory-­Guided Literature Review on Gender Contributors VMA, AB, CAM, RCA and AQG participated in the design of the study. Bias in Health Care and Gendered Norms towards Patients with VMA wrote the draft versions with the review of all authors. All authors are involved Chronic Pain. Pain Res Manag 2018;2018:1–14. in the development of the general project and the RCT study from which this 14 Fleming KC, Volcheck MM. Central sensitization syndrome and the initial evaluation of a patient with fibromyalgia: a review. Rambam qualitative study is related. Maimonides Med J 2015;6:e0020–12. Funding This project received a research grant from the Instituto de Salud 15 Fitzcharles MA, Ste-­Marie PA, Pereira JX. Md for Canadian Carlos III (ISCIII) awarded in 2018 with reference PI1800943. This grant belongs fibromyalgia guidelines Committee. fibromyalgia: evolving concepts to the Health Strategy Action 2017–2020 within the National Research Program; over the past 2 decades. CMAJ 2013;185:E645–51. the Technical, Scientific and Innovation Research National Plan 2017-2020; 16 Gran JT, Tore Gran J. The epidemiology of chronic generalized musculoskeletal pain. Best Pract Res Clin Rheumatol and it is also co-­funded by the European Union ERDF funds (European Regional 2003;17:547–61. Development Fund). Furthermore, a Predoctoral grant for training in health research 17 Abeles AM, Pillinger MH, Solitar BM, et al. Narrative review: the was obtained in 2019 from the ISCIII (reference FI19/00254). Finally, this project pathophysiology of fibromyalgia. Ann Intern Med 2007;146:726–34. was funded with a scholarship from Dr Ferran Foundation in 2017. 18 Malatji BG, Meyer H, Mason S, et al. A diagnostic biomarker profile Disclaimer The funders financed the project but will not participate in any for fibromyalgia syndrome based on an NMR metabolomics study of selected patients and controls. BMC Neurol 2017;17:88. phase of the investigation. The funders will not have any authority over any of the 19 D'Agnelli S, Arendt-­Nielsen L, Gerra MC, et al. Fibromyalgia: genetics activities of the project. and epigenetics insights may provide the basis for the development Competing interests None declared. of diagnostic biomarkers. Mol Pain 2019;15:1744806918819944. 20 Helfenstein M, Goldenfum MA, Siena CAF. Fibromyalgia: clinical and Patient and public involvement Patients and/or the public were not involved in occupational aspects. Rev Assoc Med Bras 2012;58:358–65. the design, or conduct, or reporting, or dissemination plans of this research. 21 Burke KG. Year in Review-2019. J Nurses Prof Dev 2019;35:303–4. 22 Bush AJ, Webber SC, Richards RS. Resistance exercise training for Patient consent for publication Not required. fibromyalgia. Cochrane Database Syst Rev 2013;12:CD0108. Provenance and peer review Not commissioned; externally peer reviewed. 23 Bernardy K, Klose P, Bush AJ, et al. Cognitive behavioral therapies for fibromyalgia. Cochrane Database Syst Rev 2013;3:CD00979. Open access This is an open access article distributed in accordance with the 24 Luciano JV, Guallar JA, Aguado J, et al. Effectiveness of group Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which acceptance and commitment therapy for fibromyalgia: a permits others to distribute, remix, adapt, build upon this work non-­commercially, 6-­month randomized controlled trial (EFFIGACT study). Pain and license their derivative works on different terms, provided the original work is 2014;155:693–702. properly cited, appropriate credit is given, any changes made indicated, and the use 25 Aman MM, Jason Yong R, Kaye AD, et al. Evidence-­Based non-­ is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. pharmacological therapies for fibromyalgia. Curr Pain Headache Rep 2018;22:33. ORCID iDs 26 Prabhakar A, Kaiser JM, Novitch MB, et al. The role of Victoria Mailen Arfuch http://​orcid.​org/​0000-​0001-​5935-​6907 complementary and alternative medicine treatments in Anna Berenguera http://​orcid.​org/​0000-​0002-​0889-​2002 fibromyalgia: a comprehensive review. Curr Rheumatol Rep 2019;21:14. 27 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. 28 McMahon L, Murray C, Simpson J. 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