[Impact on weight loss and body composition of a food education intervention associated with Liraglutide treatment to address obesity]. / Impacto en la pérdida de peso y la composición corporal de una intervención de educación alimentaria asociada al tratamiento con liraglutida para el abordaje de la obesidad.

Introduction: Introduction: clinical practice guidelines recommend considering pharmacological treatment of obesity only as a complement to lifestyle modification. Drugs alone are usually ineffective in the long term after discontinuation, so pharmacological weight loss strategies should always be accompanied by lifestyle modifications. Objective: to analyze the changes in weight, body mass index and body composition by means of electrical bioimpedance after a 32-week treatment with liraglutide in patients with obesity, associated or not with a food education program. Materials and methods: the study involved 68 patients who were randomly divided into 2 groups. One group received treatment with liraglutide 3.0 mg/day along with individual dietary education, and the other group was treated with liraglutide 3.0 mg/day and standard medical follow-up for 32 weeks. The data collected were weight (kg), height (m) (Seca® brand), body mass index (kg/m2) and body composition using multifrequency bioimpedance (SECA 112® brand). The variables were analyzed at the beginning and at the end of the treatment. Results: after 32 weeks of treatment, both study groups lost weight significantly. The group treated with liraglutide and individual dietary education had a reduction of 8.77 kg (9.08 %) (p < 0.001) and the group treated with liraglutide without education had a reduction of 3.55 kg (3.45 %) (p < 0.001). The BMI of the participants treated with liraglutide and education decreased by -4,04 kg/m2 (10.35 %) (p < 0.001) and in the group without education it decreased by -3.22 kg/m2 (8.30 %) (p = 0.003). In the educated group, fat mass decreased by -7.65 kg (15.89 %) (p < 0.001), although skeletal muscle mass also decreased by -1.62 kg (6.8 %) (p < 0.001). In those treated with liraglutide without education, a reduction in fat mass and skeletal muscle mass was also observed - fat mass by -4.72 kg (9.43 %) (p < 0.001) and skeletal muscle mass by -0.17 kg (0.70 %) (p < 0.001). Differences were also observed between groups, observing a greater reduction in weight, BMI, fat mass and skeletal muscle mass in the group with liraglutide and education compared to the group without education, although these differences were not statistically significant. Conclusions: dietary education associated with liraglutide treatment may contribute to increasing weight and fat mass losses. However, it was also associated with an unwanted loss of skeletal muscle mass, probably related to the greater intensity of weight loss, which will have to be reversed in future therapeutic approaches. Habit modification through multidisciplinary treatment, including nutritional education, combined strength and resistance exercise, and cognitive-behavioral therapy, could be an effective way to treat obesity and maintain weight, body composition, and adherence to a lifestyle.

Introducción: Introducción: las guías de práctica clínica recomiendan considerar el tratamiento farmacológico de la obesidad únicamente como complemento de la modificación del estilo de vida. Objetivo: analizar los cambios sobre el peso, el índice de masa corporal y la composición corporal mediante bioimpedancia eléctrica tras un tratamiento de 32 semanas con liraglutida en pacientes con obesidad, asociado o no a un programa de educación alimentaria. Materiales y métodos: participaron 68 pacientes que fueron divididos aleatoriamente en 2 grupos. Uno recibió tratamiento con liraglutida 3,0 mg/día junto con educación alimentaria individual y el otro fue tratado con liraglutida 3,0 mg/día y seguimiento médico estándar durante 32 semanas.Datos recogidos:l peso, talla, IMCl y composición corporal mediante bioimpedancia multifrecuencia. Se analizaron las variables al inicio y al final del tratamiento. Resultados: tras 32 semanas de tratamiento, los dos grupos de estudio redujeron el peso de manera significativa. El grupo tratado con liraglutida y educación alimentaria individual tuvo una reducción de 8,77 kg (9,08 %) (p < 0,001) y el grupo tratado con liraglutida sin educación tuvo una reducción de 3,55 kg (3,45 %) (p < 0,001). El IMC de los participantes tratados con liraglutida y educación disminuyó en -4,04 kg/m2 (10,35 %) (p < 0,001) y en el grupo sin educación se redujo en -3,22 kg/m2 (8,30 %) (p = 0,003). En el grupo con educación disminuyó la masa grasa en -7,65 kg (15,89 %) (p < 0,001), aunque también la masa muscular esquelética en -1,62 kg (6,8 %) (p < 0,001). En los tratados con liraglutida sin educación también se observó una reducción de la masa grasa y masa muscular esquelética: la masa grasa en -4,72 kg (9,43 %) (p < 0,001) y la masa muscular esquelética en -0,17 kg (0,70 %) (p < 0,001). También se observaron diferencias entre grupos, observándose mayor reducción del peso, del IMC, de lamasa grasa y de la masa muscular esquelética en el grupo con liraglutida y educación con respecto al grupo sin educación, aunque estas diferencias no llegaron a ser estadísticamente significativas. Conclusiones: la educación alimentaria asociada al tratamiento con liraglutida puede contribuir a incrementar la pérdida de peso y de la masa grasa. Sin embargo, llevó también asociada una pérdida no deseada de masa muscular esquelética, probablemente relacionada con la mayor intensidad de pérdida de peso, que habrá que revertir en futuras aproximaciones terapéuticas.

Nutrition and Chronobiology as Key Components of Multidisciplinary Therapeutic Interventions for Fibromyalgia and Associated Chronic Fatigue Syndrome: A Narrative and Critical Review.

Fibromyalgia (FM) is often accompanied by chronic fatigue syndrome (CFS). It is a poorly understood disorder that mainly affects women and leads to chronic pain, fatigue, and insomnia, among other symptoms, which decrease quality of life. Due to the inefficiency of current pharmacological treatments, increasing interest is being directed towards non-pharmacological multicomponent therapies. However, nutrition and chronobiology are often overlooked when developing multicomponent therapies. This narrative and critical review explore the relevance of nutritional and chronobiological strategies in the therapeutic management of FM and the often-associated CFS. Reviewed literature offers scientific evidence for the association of dietary habits, nutrient levels, body composition, gut microbiota imbalance, chronobiological alterations, and their interrelation with the development and severity of symptoms. This review highlights the key role of nutrition and chronobiology as relevant and indispensable components in a multidisciplinary approach to FM and CFS.

Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial.

INTRODUCTION AND OBJECTIVES: The management of atrial fibrillation is complex and requires improvement at strategic points, such as in the control of patients treated with vitamin K antagonists. The aim of this study was to evaluate the impact on health outcomes of a nonvalvular atrial fibrillation decision support tool based on visualization of the time in therapeutic range in primary care. METHODS: The present randomized clinical trial was conducted in 2018 with a 1-year follow-up in 325 primary care centers in Catalonia. In the intervention centers, the decision support tool was installed to control the time in therapeutic range of patients treated with vitamin K antagonists. The tool was not visualized in the control group. This clinical trial was registered with ClinicalTrials.gov (NCT03367325). RESULTS: In total, 44 556 patients were studied. The intervention protected against admission for stroke (adjusted odds ratio [OR], 0.70; 95% confidence interval [95%CI], 0.55-0.88). The number needed to treat was 3502 (95%CI, 3305-3725) while the number of admissions for stroke avoided was 12.63 (95%CI, 11.88-13.38). The intervention also protected against mortality (adjusted OR, 0.78; 95%CI, 0.67-0.90), with a number needed to treat of 13 687 (95%CI, 10 789-18 714) and number of deaths avoided of 3.23 (95%CI, 2.36-4.10). CONCLUSIONS: The decision support tool was associated with slight reductions in the numbers of admissions for ischemic stroke and mortality. Although the follow-up time was short and the effect of the intervention was small, the results are valuable and could improve implementation of the tool.

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.

Effectiveness and health benefits of a nutritional, chronobiological and physical exercise primary care intervention in fibromyalgia and chronic fatigue syndrome: SYNCHRONIZE + mixed-methods study protocol.

INTRODUCTION: Chronic pain, fatigue and insomnia are classic symptoms of fibromyalgia (FM) and chronic fatigue syndrome (CFS) and seriously affect quality of life. Nutrition and chronobiology are often overlooked in multicomponent approach despite their potential. This study aims to evaluate the effectiveness of a multidisciplinary group intervention based on nutrition, chronobiology, and physical exercise in the improvement of lifestyle and quality of life in FM and CFS. METHODS: Mixed-methods study based on a randomized clinical trial and qualitative analysis with a descriptive phenomenological approach. The study will be conducted in primary care in Catalonia. The control group will follow the usual clinical practice and the intervention group the usual practice plus the studied intervention (12 hours over 4 days). The intervention based on nutrition, chronobiology and physical exercise will be designed considering participants' opinions as collected in 4 focus groups. To evaluate effectiveness, EuroQol-5D, multidimensional fatigue inventory, VAS pain, Pittsburgh Sleep Quality Index, erMEDAS-17, biological rhythms interview of assessment in neuropsychiatry, REGICOR-Short, FIQR and Hospital Anxiety and Depression Scale questionnaires will be collected at baseline, and at 1, 3, 6, and 12 months post-intervention. Food intake, body composition, resistance and, strength will also be evaluated. The effect size will be calculated using Cohen d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. DISCUSSION: It expected that the intervention will improve the patients' quality of life, fatigue, pain and insomnia, as well as food and physical exercise habits, providing effectiveness evidence of a new therapy in addressing these syndromes in Primary Heath Care. Improvements in the quality of life will have a positive socioeconomic impact by reducing health expenditure on recurrent medical consultation, medication, complementary medical tests, etc and favor the maintenance of an active working life and productivity.

Gender, Mental Health and Socioeconomic Differences in Fibromyalgia: A Retrospective Cohort Study Using Real-World Data from Catalonia.

The main objective of our study was to assess the associated risk between fibromyalgia (FM) and the incidence of the diagnosis of anxiety and depression in the general population during the years 2010-2017 in Catalonia. METHOD: A retrospective cohort study was designed using the Information System for Research Development in Primary Care database. All patients with FM were included (n = 56,098) and matched to the control group in a 1:2 pairing ratio (n = 112,196). The demographic variables studied were sex, age and socio-economic status. RESULTS: Patients with FM have a lower survival rate if they are also diagnosed with anxiety and depression during the entire study period, with the rate being 26.6% lower in FM patients at an 8-year follow-up (0.58, 95%CI: 0.57-0.59 vs. 0.79, 95%CI: 0.78-0.79). There is a 58% reduction in the risk of developing anxiety and/or depression in the control group vs. the FM group (p-value < 0.05), and by 45% in male vs. female sex (p-value < 0.05). CONCLUSIONS: FM is a disease that is associated with anxiety and depression, and men are at lower risk of anxiety and depression after FM diagnosis.

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.

Early Detection of the Start of the Influenza Epidemic Using Surveillance Systems in Catalonia (PREVIGrip Study).

Sentinel physician networks are the method of influenza surveillance recommended by the World Health Organization. Weekly clinical diagnoses based on clinical history are a surveillance method that provides more immediate information. The objective of this study is to evaluate which influenza surveillance system is capable of the earliest detection of the start of the annual influenza epidemic. We carried out an ecological time-series study based on influenza data from the population of Catalonia from the 2010-2011 to the 2018-2019 seasons. Rates of clinical diagnoses and of confirmed cases in Catalonia were used to study the changes in trends in the different surveillance systems, the differences in area and time lag between the curves of the different surveillance systems using Joinpoint regression, Simpson's 1/3 method and cross-correlation, respectively. In general, changes in the trend of the curves were detected before the beginning of the epidemic in most seasons, using the rates for the complete seasons and the pre-epidemic rates. No time lag was observed between clinical diagnoses and the total confirmed cases. Therefore, clinical diagnoses in Primary Care could be a useful tool for early detection of the start of influenza epidemics in Catalonia.

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.

Concordance between the Clinical Diagnosis of Influenza in Primary Care and Epidemiological Surveillance Systems (PREVIGrip Study).

INTRODUCTION: Health authorities use different systems of influenza surveillance. Sentinel networks, which are recommended by the World Health Organization, provide information on weekly influenza incidence in a monitored population, based on laboratory-confirmed cases. In Catalonia there is a public website, DiagnostiCat, that publishes the number of weekly clinical diagnoses at the end of each week of disease registration, while the sentinel network publishes its reports later. The objective of this study was to determine whether there is concordance between the number of cases of clinical diagnoses and the number of confirmed cases of influenza, in order to evaluate the predictive potential of a clinical diagnosis-based system. METHODS: Population-based ecological time series study in Catalonia. The period runs from the 2010-2011 to the 2018-2019 season. The concordance between the clinical diagnostic cases and the confirmed cases was evaluated. The degree of agreement and the concordance were analysed using Bland-Altman graphs and intraclass correlation coefficients. RESULTS: There was greater concordance between the clinical diagnoses and the sum of the cases confirmed outside and within the sentinel network than between the diagnoses and the confirmed sentinel cases. The degree of agreement was higher when influenza rates were low. CONCLUSIONS: There is concordance between the clinical diagnosis and the confirmed cases of influenza. Registered clinical diagnostic cases could provide a good alternative to traditional surveillance, based on case confirmation. Cases of clinical diagnosis of influenza may have the potential to predict the onset of annual influenza epidemics.

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.

Gender and Socioeconomic Inequality in the Prescription of Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation in Primary Care in Catalonia (Fantas-TIC Study).

BACKGROUND: Evidence points to unequal access to direct oral anticoagulant (DOAC) therapy, to the detriment of the most socioeconomically disadvantaged patients in different geographic areas; however, few studies have focused on people with atrial fibrillation. This study aimed to assess gender-based and socioeconomic differences in the prescriptions of anticoagulants in people with non-valvular atrial fibrillation who attended Primary Care. METHOD: A cross-sectional study with real-world data from patients treated in Primary Care in Catalonia (Spain). Data were obtained from the SIDIAP database, covering 287 Primary Care centers in 2018. Results were presented as descriptive statistics and odds ratios estimated by multivariable logistic regression. RESULTS: A total of 60,978 patients on anticoagulants for non-valvular atrial fibrillation were identified: 41,430 (68%) were taking vitamin K antagonists and 19,548 (32%), DOACs. Women had higher odds of treatment with DOAC (adjusted odds ratio [ORadj] 1.12), while lower DOAC prescription rates affected patients from Primary Care centers located in high-deprivation urban centers (ORadj 0.58) and rural areas (ORadj 0.34). CONCLUSIONS: DOAC prescription patterns differ by population. Women are more likely to receive it than men, while people living in rural areas and deprived urban areas are less likely to receive this therapy. Following clinical management guidelines could help to minimize the inequality.

Anticoagulation Control with Acenocoumarol or Warfarin in Non-Valvular Atrial Fibrillation in Primary Care (Fantas-TIC Study).

Introduction: The use of vitamin K antagonists (VKAs) in non-valvular atrial fibrillation (NVAF) is complicated due to the narrow therapeutic margin they present and their unpredictable dose-response relationship. Most studies are based on warfarin, with the results being extrapolated to acenocoumarol. However, studies comparing the two treatments in terms of the degree of anticoagulation control are scarce, justifying the present study. Main factors associated with poor control of time in therapeutic range (TTR) of anticoagulated patients are also studied. Methods: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System for the Improvement of Research in PC (SIDIAP) database, covering 60,978 NVAF-anticoagulated patients from 287 PC centres in 2018. Descriptive statistics were derived, and odds ratios were estimated by multivariate logistic regression. Results: 41,430 patients were considered: 93% were being treated with acenocoumarol and 7% with warfarin. There was no difference in poor control of TTR between the two types of VKA treatment, acenocoumarol and warfarin (38.9 vs. 38.4; p = 0.610). Poor anticoagulation control was mainly associated with advanced alcoholism (OR = 1.38), liver failure (OR = 1.37) and intracranial haemorrhage (OR = 1.35) as well as female sex, age < 60 years, cardiovascular history, diabetes mellitus and other variables. Conclusions: There is no association between poor anticoagulation control and the type of VKA treatment administered. Factors associated with poor control of TTR must be considered in clinical practice to improve control and decision-making.

Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

Background: Oral anticoagulants (OAs) are the treatment to prevent stroke in atrial fibrillation (AF). Anticoagulant treatment choice in non-valvular atrial fibrillation (NVAF) must be individualized, taking current guidelines into account. Adequacy of anticoagulant therapy under the current criteria for NVAF in real-world primary care is presented. Methods: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System for the Improvement of Research in Primary Care (SIDIAP) database, covering 60,978 NVAF-anticoagulated patients from 287 PC centers in 2018. Results: In total, 41,430 (68%) were treated with vitamin K antagonists (VKAs) and 19,548 (32%) NVAF with direct-acting oral anticoagulants (DOACs). Inadequate prescription was estimated to be 36.0% and 67.6%, respectively. Most DOAC inadequacy (77.3%) was due to it being prescribed as a first-line anticoagulant when there was no history of thromboembolic events or intracranial hemorrhage (ICH). A total of 22.1% had missing estimated glomerular filtration rate (eGFR) values. Common causes of inadequate VKA prescription were poor control of time in therapeutic range (TTR) (98.8%) and ICH (2.2%). Conclusions: Poor adequacy to current criteria was observed, being inadequacy higher in DOACs than in VKAs. TTR and GFR should be routinely calculated in electronic health records (EHR) to facilitate decision-making and patient safety.

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.

Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.

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.