Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial.

OBJECTIVE: To perform an economic evaluation on a multicomponent intervention programme for patients with fibromyalgia syndrome compared with usual clinical practice in primary care. DESIGN: A cost-utility analysis was conducted alongside a pragmatic randomised controlled trial (ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT04049006) from a societal perspective, a human capital approach, and a 1-year time horizon. PATIENTS: Patients diagnosed with fibromyalgia  syndrome from the public health system in south Catalonia, Spain. METHODS: Crude and adjusted incremental cost- utility ratios were estimated to compare the treatment strategies based on cost estimations (direct medical costs and productivity losses) and quality-adjusted life years. One-way and 2-way deterministic sensitivity analyses were performed. RESULTS: The final analysed sample comprised 297 individuals, 161 in the intervention group and 136 in the control group. A crude incremental cost-utility ratio of € 1,780.75 and an adjusted ratio of € 851.67 were obtained, indicating that the programme  significantly improved patients' quality of life with a cost-increasing outcome that fell below the cost-effectiveness threshold. The sensitivity analysis  confirmed these findings when  varying large cost components, and showed dominance when increasing session attendance. CONCLUSION: The proposed multicomponent intervention programme was cost-effective compared with usual care for fibromyalgia, which supports its addition to standard practice in the regional  primary care service.

Usefulness of a Multicomponent Group Intervention Program for Fibromyalgia Patients in Primary Care: A Qualitative Study of Health Professionals.

OBJECTIVE: To explore the perceptions and experiences of health professionals who participated in a multicomponent program for fibromyalgia (FM) patients based on health education, physical exercise and cognitive-behavioral therapy. METHODS: In this qualitative, descriptive study that was based on a pragmatic and utilitarian approach, we conducted two focus groups (FGs) with 12 professionals (nurses and general practitioners) from the primary healthcare system of Spain who had been trained as FM experts. A thematic content analysis was carried out. RESULTS: The findings were organized into four key domains, each with explanatory emerging themes. Overall, the professionals positively valued the program for the knowledge gain it offered, its integrated approach, the group effect and other benefits to patients. Work overload and peers' lack of acknowledgement of the program's value were identified as barriers. A reduction in the amount of content in each session, the creation of quality-of-care indicators and the promotion of the new professional role (FM expert) were proposed. CONCLUSIONS: The FM experts supported the program and recognized its usefulness. To implement the program within the primary healthcare system, the program needs to be adjusted to accommodate professionals' and patients' reality, and institutional health policies must be improved by providing training on FM to the healthcare community.

Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary Care: A Qualitative Interview Study.

Fibromyalgia syndrome (FMS) disrupts patients' biopsychosocial spheres. A multicomponent intervention (MCI) program, which combined health education, cognitive behavioral therapy, and physical activity, was conducted in South Catalonia's primary care centers with the aim of improving symptom self-management and quality of life. A qualitative interview study was carried out to understand patients' lived experiences during the intervention program. Sampled purposively, 10 patients were interviewed via phone calls and face-to-face. The encounters were audio-recorded, verbatim transcribed, and analyzed through thematic analysis. As a result, four themes emerged: legitimizing fibromyalgia through the MCI, the MCI as a socializing experience, learning how to live with FMS through the MCI, and room for improving the MCI. Participants agreed on the program being an insightful experience that promoted illness knowledge and acceptance and that improved their coping skills and symptom self-management. The inclusion of additional psychological guidance, expressive psychological group therapy, and providing relatives with information were proposed for enhancing the program. Our findings have contributed to gaining insight into the subjective impact of the MCI and identifying new therapeutic targets to tailor the program to patients' needs, which will hopefully increase its effectiveness and improve their quality of life.

Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: a focus group study.

PURPOSE: To assess fibromyalgia patients' experiences and appraisals about a multidisciplinary intervention programme, in Catalonia's primary care, regarding its format and contents, benefits, and health impact in the short and long term. METHOD: Qualitative interpretative research design through hermeneutic phenomenology perspective. Two focus groups discussions were conducted in February and July 2020. The purposive heterogeneous sample included 19 fibromyalgia patients who attended a multicomponent programme. In addition, thematic analysis on the verbatims was performed. RESULTS: Findings were organized into five main domains with an explanatory theme each. Overall, the informants valued the programme as a positive experience due to its holistic approach, health benefits, suffering relief, group effect, and fibromyalgia legitimacy promotion. Detected improvable aspects focused on extending the timeframe, including family members as beneficiaries, deepening the thematic contents, and getting regular access to this healthcare service. Furthermore, the intervention was considered feasible to be incorporated into usual clinical care. CONCLUSION: the programme fulfilled users' expectations about results and procedure and showed promise as a treatment strategy to reinforce the usual practice. Our findings suggest a broad perspective on fibromyalgia patients' suffering, which urges us to adjust the intervention programme to their real health needs.

Cost-utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial.

INTRODUCTION: Fibromyalgia syndrome (FMS) imposes a high cost on society. The significant economic burden from the use of healthcare and, especially, social resources is a spur to revising the usual clinical care (UCC) and to improving treatment strategies. FMS has a deleterious effect on the quality of life (QOL) and productivity, which considerably increase the indirect costs to society. This study reports an economic evaluation comparing the cost and health benefits in a multicomponent intervention programme and UCC of patients with FMS who attend primary healthcare centres of the Gerència Territorial Terres de L'Ebre region of Catalonia, Spain. This article is linked to the pre-results of a randomised control trial study on the implementation of this intervention programme (ClinicalTrials.gov: NCT04049006). METHOD AND ANALYSIS: A cost-utility analysis will be conducted from a societal perspective. Quality-adjusted life years will be calculated from the results of the SF-36 questionnaire, a QOL measurement instrument. Direct and indirect healthcare costs will be obtained from official prices and reports published by the Spanish Public Health Administration and the National Statistics Institute. The incremental cost-utility ratio will be estimated to compare the two healthcare practices. Deterministic sensitivity analysis will also be used to compare different cost scenarios, modifying the items with the highest weight in the cost composition. ETHICS AND DISSEMINATION: The Clinical Research Ethics Committee of the IDIAPJGol Institute approved this study on 25 April 2018 (code P18/068) in accordance with the Helsinki/Tokyo Declaration. Information will be provided orally and in writing to participants, and their informed consent will be required. Participant anonymity will be guaranteed. The dissemination strategy includes publications in scientific journals and presentations in local and national media and at academic conferences. Trial registration number: NCT04049006; Pre-results.

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.

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.

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.

INTRODUCTION: Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS). METHODS AND ANALYSIS: A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. ANALYSIS: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out. ETHICS AND DISSEMINATION: This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals. TRIAL REGISTRATION: Clinical-Trials.gov: NCT04049006.