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.

Screening and routine diagnosis of mental disorders among migrants in primary care: A cross-sectional study.

Background: Migrants in host countries are at risk for the development of mental health conditions. The two aims of the study were to describe routine diagnoses of mental disorders among migrant patients at primary healthcare level and the associated risk factors, and to test the utility of an innovative migrant mental health assessment by evaluating whether the health professionals followed the recommendations proposed by the clinical decision support system (CDSS) tool. Methods: A cross-sectional study was carried out in eight primary care centres (PCCs) in four non-randomly selected health regions of Catalonia, Spain from March to December 2018. Routine health data and mental health diagnoses based on the International Classification of Diseases (10th edition), including mental, behavioural and neuro developmental disorders (F01-F99), symptoms and signs involving emotional state (R45), and sleep disorders (G47), were extracted from the electronic health records. The proportion of mental health conditions was estimated and logistic regression models were used to assess any possible association with mental health disorders. The utility of the mental health assessment was assessed with the proportion of questionnaires performed by health professionals for migrants fulfilling the mental health screening criterion (country of origin with an active conflict in 2017) and the diagnoses given to the screened patients. Results: Of 14,130 migrants that visited any of the PCCs during the study period, 7,358 (52.1 %) were women with a median age of 38.0 years-old. There were 520/14,130 (3.7 %) migrant patients diagnosed with a mental disorder, being more frequent among women (342/7,358; 4.7 %, p-value < 0.001), migrants from Latin-America (177/3,483; 5.1 %, p < 0.001) and those who recently arrived in Spain (170/3,672; 4.6 %, p < 0.001). A lower proportion of mental disorders were reported in migrants coming from conflicted countries in 2017 (116/3,669, 3.2 %, p = 0.053).Out of the 547 mental health diagnoses reported in 520 patients, 69/14,130 (0.5 %) were mood disorders, 346/14,130 (2.5 %) anxiety disorders and 127/14,130 (0.9 %) sleeping disorders. Mood disorders were more common in migrants from Eastern Europe (25/2,971; 0.8 %, p < 0.001) and anxiety disorders in migrants from Latin-America (126/3,483; 3.6 %, p < 0.001), while both type of disorders were more often reported in women (p < 0.001).In the adjusted model, women (aOR: 1.5, [95 % CI 1.2-1.8, p < 0.001]), migrants with more than one visit to the health center during the study period (aOR: 4.4, [95 %CI 2.8-6.8, p < 0.001]) and who presented an infectious disease (aOR: 2.1, [95 %CI 1.5-3.1, p < 0.001]) had higher odds of having a mental disorder.Lastly, out of the 1,840 migrants coming from a conflicted country in 2017 who were attended in centres where the CDSS tool was implemented, 29 (1.6 %) had a mental health assessment performed and the tool correctly identified one individual. Conclusions: Mental health is a condition that may be overlooked in migrants at primary healthcare. Interventions at this level of care must be reinforced and adapted to the needs and circumstances of migrants to ensure equity in health services.

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.

Innovative Health and Social Integrated Care Model Effectiveness to Improve Quality Care for Chronic Patients: A Single Group Assignment Clinical Trial.

Background: Patients with chronic disease have become one of the major challenges for health and social protection systems in developed countries. Integrated care models (ICM) have demonstrably improved the quality of care of chronic patients. However, new models of integration need further evaluation of its effectiveness and outcomes. Methods: The ICM studied promoted coordination between the health and social sectors during a 6-month period, through an ad hoc developed application (app) that enabled a constant flow of communication between professionals from both sectors. Patients' quality of life, treatment adherence, chronic patient experience and caregiver overload were assessed by questionnaires at baseline, at the end of the intervention and 6 months post-intervention. Results: The implementation of the new health and social ICM permitted new case detection and medical and social services offered to chronic patients. Furthermore, the quality of life and treatment adherence of patients and caregiver overload were significantly improved. These positive effects lasted at least 6 months after the intervention. Conclusions: Integrated care may facilitate access to care services, increase perceived patient quality of life and treatment adherence. Enhanced access to medical and social services from complex chronic patients may have important implications for caregivers and the care systems who are struggling to adapt to an expanding demand.

Physical Activity and Exercise Experience in Spanish and US Men with Fibromyalgia: A Qualitative Cross-Cultural Study.

Physical exercise is an indispensable element in the multidisciplinary treatment of fibromyalgia syndrome (FMS). The present study examined if men diagnosed with FMS engaged in any type of physical activity or exercise, the perceived effects from exercise, and who specifically recommended exercise. A qualitative cross-cultural study was performed in fibromyalgia clinical units in Spain and the United States. A total of 17 participants, 10 men from Spain and 7 men from the US, were included. In Spain, a focus group was completed in two parts, one month apart in 2018. In the US, five individual interviews and one joint interview with two men were completed in 2018. Three central themes appeared in the qualitative data: (1) Understanding what constitutes physical activity or exercise, (2) Facilitating or discouraging the performance of physical exercise, and (3) Effects of physical activity or exercise on psychological and social symptoms. The actual practice of exercise by patients with FMS is often perceived as leading to pain and fatigue, rather than a treatment facilitator. Physical activity and exercise can provide benefits, including relaxation, socialization, and increased muscle tone. However, minor opioids limit physical activity as they cause addiction, drowsiness, and decrease physical activity in Spanish men. Recommendations in a clinical setting should incorporate exercise as well as physical activity via daily life activities.

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.

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.

Integrated Care Model Salut+Social Assessment by Professionals, Informal Caregivers and Chronic or Social Dependent Patients: A Qualitative Study.

We explored the views of the professionals (from primary care and social services) and users (caregivers and patients) who participated in the clinical trial of the Salut+Social integrated care model to identify the implementation barriers and facilitators, to assess the impact on health and wellbeing and to obtain an assessment of the program. A qualitative descriptive study with a pragmatic, utilitarian approach was performed. Participants were recruited by purposive and convenience sampling. A focus group (FG) and in-depth interviews were conducted with professionals and users, respectively. Thematic content analysis was employed. A total of 11 professionals and 8 users participated in the FG and interviews, respectively. Seven themes were identified: (1) contextualizing the previous scenario; (2) achievements of the program from the professionals' perspective; (3) facilitators and barriers of the integrated care model; (4) proposals for improving the integrated care model; (5) users' assessment of the care received within the program framework; (6) users' perception of the impact on health and wellbeing; (7) users' demands for better care. Professionals reported improved coordination between services and highlighted the need for a protocol for emergencies and to strengthen community orientation. Users proposed more frequent home visits. This study shows the acceptability of the new model by professionals and the users' satisfaction with the care received.

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.

Usefulness and practicality of a multidisease screening programme targeting migrant patients in primary care in Spain: a qualitative study of general practitioners.

OBJECTIVES: Some migrant groups are disproportionately affected by key infectious diseases in European countries. These pose a challenge for healthcare systems providing care to these groups. We aimed to explore the views of general practitioners (GPs) on the acceptability, adaptability and feasibility of a multidisease screening programme based on an innovative clinical decision-support system for migrants (the ISMiHealth tool), by examining the current gaps in healthcare provision and areas of good practice and the usefulness and limitations of training in the health needs of migrants. METHODS: We undertook a qualitative descriptive study and carried out a series of focus groups (FGs) taking a pragmatic utilitarian approach. Participants were GPs from the four primary healthcare (PHC) centres in Catalonia, Spain, that piloted an intervention of the ISMiHealth tool. GPs were recruited using purposive and convenience sampling. FG discussions were transcribed and analysed using thematic content analysis. RESULTS: A total of 29 GPs participated in four FGs. Key themes identified were: (1) GPs found the ISMiHealth tool to be very useful for helping to identify specific health problems in migrants, although there are several additional barriers to screening as part of PHC, (2) the importance of considering cultural perspectives when caring for migrants, and of the impact of migration on mental health, (3) the important role of PHC in healthcare provision for migrants and (4) key proposals to improve screening of migrant populations. GPs also highlighted the urgent need, to shift to a more holistic and adequately resourced approach to healthcare in PHC. CONCLUSIONS: GPs supported a multidisease screening programme for migrant populations using the ISMiHealth tool, which aided clinical decision-making. However, intercultural participatory approaches will need to be adopted to address linguistic and cultural barriers to healthcare access that exist in migrant communities.

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.

Multimorbidity worsened anxiety and depression symptoms during the COVID-19 pandemic in Brazil.

Multimorbidity is a global health issue impacting the quality of life of all ages. Multimorbidity with a mental disorder is little studied and is likely to have been affected by the COVID-19 pandemic. We used a survey of 14,007 respondents living in Brazil to investigate whether people who already had at least one chronic medical condition had more depression and anxiety symptoms during social distancing in 2020. Generalized linear models and structural equation modelling were used to estimate the effects. A 19 % and 15 % increase in depressive symptoms were found in females and males, respectively, for each unit of increase in the observed value of reported chronic disease. Older subjects presented fewer symptoms of depression and anxiety. There was a 16 % increase in anxiety symptoms in females for each unit increase in the reported chronic disease variable and a 14 % increase in males. Younger subjects were more affected by anxiety symptoms in a dose-response fashion. High income was significantly related to fewer depressive and anxiety symptoms in both males and females. Physical activity was significantly associated with fewer anxiety and depression symptoms. Structural equation modelling confirmed these results and provided further insight into the hypothesised paths.

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.

Improving the detection of infectious diseases in at-risk migrants with an innovative integrated multi-infection screening digital decision support tool (IS-MiHealth) in primary care: a pilot cluster-randomized-controlled trial.

BACKGROUND: There are major shortfalls in the identification and screening of at-risk migrant groups. This study aims to evaluate the effectiveness of a new digital tool (IS-MiHealth) integrated into the electronic patient record system of primary care centres in detecting prevalent migrant infections. IS-MiHealth provides targeted recommendations to health professionals for screening multiple infections, including human immunodeficiency virus (HIV), hepatitis B and C, active tuberculosis (TB), Chagas disease, strongyloidiasis and schistosomiasis, based on patient characteristics (including variables of country of origin, age and sex). METHODS: A pragmatic pilot cluster-randomized-controlled trial was deployed from March to December 2018. Eight primary care centres in Catalonia, Spain, were randomly allocated 1:1 to use of the digital tool for screening, or to routine care. The primary outcome was the monthly diagnostic yield of all aggregated infections. Intervention and control sites were compared before and after implementation with respect to their monthly diagnostic yield using regression models. This study is registered on international standard randomised controlled trial number (ISRCTN) (ISRCTN14795012). RESULTS: A total of 15 780 migrants registered across the eight centres had at least one visit during the intervention period (March-December 2018), of which 14 598 (92.51%) fulfilled the criteria to be screened for at least one infection. There were 210 (2.57%) individuals from the intervention group with new diagnoses compared with 113 (1.49%) from the control group [odds ratio: 2.08, 95% confidence interval (CI) 1.63-2.64, P < 0.001]. The intervention centres raised their overall monthly diagnosis rate to 5.80 (95% CI 1.23-10.38, P = 0.013) extra diagnoses compared with the control centres. This monthly increase in diagnosis in intervention centres was also observed if we consider all cases together of HIV, hepatitis B and C, and active TB cases [2.72 (95% CI 0.43-5.00); P = 0.02] and was observed as well for the parasitic infections' group (Chagas disease, strongyloidiasis and schistosomiasis) 2.58 (95% CI 1.60-3.57; P < 0.001). CONCLUSIONS: The IS-MiHealth increased screening rate and diagnostic yield for key infections in migrants in a population-based primary care setting. Further testing and development of this new tool is warranted in larger trials and in other countries.

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.

Fibromyalgia Pain and Fatigue Symptoms in Spanish and U.S. Men.

BACKGROUND AND AIMS: Fibromyalgia Syndrome (FMS) is a chronic centralized pain disorder characterized by widespread pain and fatigue. Of those affected by FMS, the majority are women, and minimal research exists involving men. The purpose of this paper is to describe the pain and fatigue experiences of men with FMS from two Western countries, Spain and the United States, in order to support more accurate and earlier recognition and diagnosis in men. DESIGN AND METHODS: We used individual and focus group interviews with qualitative and quantitative assessments. SETTINGS AND PARTICIPANTS/SUBJECTS: Ten men in Spain and seven men in the United States provided information about their symptoms, psychosocial and health-seeking behaviors, and gender experiences with FMS. RESULTS: Men articulated types, trends, and triggers of pain and fatigue that enrich an understanding of their symptoms. For example, men report more localized pain than generalized pain. Employment status and activities, among other contextual factors, impacted men's pain and fatigue experiences. CONCLUSIONS: Men experience distinct facets of pain and fatigue compared with women, with notable similarities and differences across the Spanish and U.S. SAMPLES: Cross-cultural comparisons highlight contextual factors that may inspire future inquiries about determinants of men's experiences with FMS. CLINICAL IMPLICATIONS: The present study could be useful for anyone treating men suffering from FMS, especially care providers in nursing, medical, and psychology fields. These initial findings may prompt a closer examination of recommendations for assessment and diagnostic criteria used internationally for patients with FMS with better recognition of men's experience.

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.

Impact of Implementing a Dyslipidemia Management Guideline on Cholesterol Control for Secondary Prevention of Ischemic Heart Disease in Primary Care.

Cardiovascular diseases (CVD) are the main cause of death worldwide. The control of CVD risk factors, such as dyslipidemia, reduces their mortality rate. Nonetheless, fewer than 50% of patients with ischemic heart disease (IHD) have good cholesterol control. Our objective is to assess whether the level of participation of general practitioners (GPs) in activities to implement a dyslipidemia management guideline, and the characteristics of the patient and physician are associated with cholesterol control in IHD patients. We undertook a quasi-experimental, uncontrolled, before-and-after study of 1151 patients. The intervention was carried out during 2010 and 2011, and consisted of a face-to-face training and online course phase (Phase 1), and another of face-to-face feedback (Phase 2). The main outcome variable was the low-density lipoprotein cholesterol (LDL-C) control, whereby values of <100 mg/dL (2.6 mmol/L) were set as a good level of control, according to the recommendations of the guidelines in force in 2009. After Phase 1, 6.7% more patients demonstrated good cholesterol control. With respect to patient characteristics, being female and being older were found to be risk factors of poor control. Being diabetic and having suffered a stroke were protective factors. Of the GPs' characteristics, being tutor in a teaching center for GP residents and having completed the online course were found to be protective factors. We concluded that cholesterol control in IHD patients was influenced by the type of training activity undertook by physicians during the implementation of the GPC, and patient and physician characteristics. We highlight that if we apply the recent targets of the European guideline, which establish a lower level of LDL-C control, the percentage of good control could be worse than the observed in this study.

Gender-based approach on the social impact and mental health in Spain during COVID-19 lockdown: a cross-sectional study.

OBJECTIVE: Lockdown has impacts on people's living conditions and mental health. The study aims to assess the relations between social impact and mental health among adults living in Spain during COVID-19 lockdown measures, taking a gender-based approach into account. DESIGN, SETTING AND PARTICIPANTS: We conducted a cross-sectional study among adults living in Spain during the lockdown of COVID-19 with an online survey from 8 April to 28 May 2020. The main variable was mental health measured by Generalized Anxiety Disorder Scale for anxiety and the Patient Health Questionnaire for depression. Sex-stratified multivariate ordinal logistic regression models were constructed to assess the association between social impact variables, anxiety and depression. RESULTS: A total of 7053 people completed this survey. A total of 31.2% of women and 17.7% of men reported anxiety. Depression levels were reported in 28.5% of women and 16.7% of men. A higher proportion of anxiety and depression levels was found in the younger population (18-35 years), especially in women. Poorer mental health was mainly related to fear of COVID-19 infection, with higher anxiety levels especially in women (adjusted ordinal OR (aOR): 4.23, 95% CI 3.68 to 4.87) and worsened economy with higher levels of depression in women (aOR: 1.51, 95% CI 1.24 to 1.84), and perceived inadequate housing to cope with lockdown was especially associated with anxiety in men (aOR: 2.53, 95% CI 1.93 to 3.44). CONCLUSION: The social impact of the lockdown is related to gender, age and socioeconomic conditions. Women and young people had worse mental health outcomes during lockdown. It is urgent to establish strategies for public health emergencies that include mental health and its determinants, taking a gender-based approach into account, in order to reduce health inequities.