Trabajo final diplomado de profundización en farmacovigilancia

Este trabajo está enfocado en las conceptualizaciones de la Farmacovigilancia donde se desarrollará una retroalimentación de cada uno de los temas y las fases de las diferentes unidades del diplomado de profundización en Farmacovigilancia. En ese orden de ideas se mostrarán diferentes reflexiones que fundamentan la importancia de la Farmacovigilancia y la función primaria del Regente de Farmacia como supervisor profesional en todos los procesos de la actividad farmacéutica. Así, la seguridad del paciente toma relevancia de principio a fin convirtiéndose en el objeto principal de la Farmacovigilancia.This work is focused on the conceptualizations of the pharmacovigilance, where a feedback of each one of the subjects and the phases of the different units of the diplomat of deepening in pharmacovigilance will be developed. In that order of ideas, different reflections will be shown that support the importance of pharmacovigilance and the primary role of the Pharmacy Regent as a professional supervisor in all the processes of pharmaceutical activity. Thus, patient safety takes relevant from start to finish, becoming in the main objective of pharmacovigilance

Over 40 years (1981-2023) assessing stigma with the Community Attitudes to Mental Illness (CAMI) scale: a systematic review of its psychometric properties

BACKGROUND: The Community Attitudes to Mental Illness (CAMI) scale measures social stigma towards people with mental illness. Although it has been used worldwide, the psychometric properties of the CAMI have not been systematically reviewed. The main aim of this study was to systematically review the psychometric properties of the different versions of the CAMI more than 40 years after of its publication. METHODS: A systematic search was conducted in MEDLINE, PsycINFO, Web of Science, and EMBASE from 1981 (year of publication) to 2023 (present). A double review was performed for eligibility, data extraction, and quality assessment. RESULTS: A total of 15 studies enrolling 10,841 participants were included. The most frequently reported factor structure comprises 3 or 4 factors. Overall, the internal consistency seems adequate for the global scale (α ≥ 0.80), except for CAMI-10 (α = 0.69). Internal consistency of the subscales are not supported, with authoritarianism being the weakest factor (α = 0.27 to 0.68). The stability over time of the total scale has been assessed in the CAMI-40, CAMI-BR, and CAMI-10 (r ≥ 0.39). Few studies have assessed the temporal stability of the CAMI subscales. Most of the correlations with potentially related measures are significant and in the expected direction. CONCLUSIONS: The 3 and 4 factor structure are the most widely reported in the different versions of the CAMI. Even though reliability and construct validity are acceptable, further item refinement by international consensus seems warranted more than 40 years after the original publication. SYSTEMATIC REVIEW REGISTRATION: PROSPERO identification number: CRD42018098956

Real-world Implementation of a Smartphone-Based Psychoeducation Program for Bipolar Disorder: Observational Ecological Study

Background: SIMPLe is an internet-delivered self-management mobile app for bipolar disorder (BD) designed to combine technology with evidence-based interventions and facilitate access to psychoeducational content. The SIMPLe app was launched to the real world to make it available worldwide within the context of BD treatment. Objective: The main aims of this study are as follows: to describe app use, engagement, and retention rates based on server data; to identify patterns of user retention over the first 6-month follow-up of use; and to explore potential factors contributing to discontinuation of app use. Methods: This was an observational ecological study in which we pooled available data from a real-world implementation of the SIMPLe app. Participation was open on the project website, and the data-collection sources were a web-based questionnaire on clinical data and treatment history administered at inclusion and at 6 months, subjective data gathered through continuous app use, and the use patterns captured by the app server. Characteristics and engagement of regular users, occasional users, and no users were compared using 2-tailed t tests or analysis of variance or their nonparametric equivalent. Survival analysis and risk functions were applied to regular users' data to examine and compare use and user retention. In addition, a user evaluation analysis was performed based on satisfaction, perceived usefulness, and reasons to discontinue app use. Results: We included 503 participants with data collected between 2016 and 2018, of whom 77.5% (n=390) used the app. Among the app users, 44.4% (173/390) completed the follow-up assessment, and data from these participants were used in our analyses. Engagement declined gradually over the first 6 months of use. The probability of retention of the regular users after 1 month of app use was 67.4% (263/390; 95% CI 62.7%-72.4%). Age (P=.002), time passed since illness onset (P<.001), and years since diagnosis of BD (P=.048) correlate with retention duration. In addition, participants who had been diagnosed with BD for longer used the app on more days (mean 97.73, SD 69.15 days; P=.002) than those who had had a more recent onset (mean 66.49, SD 66.18 days; P=.002) or those who had been diagnosed more recently (mean 73.45, SD 66 days; P=.01). Conclusions: The user retention rate of the app decreased rapidly after each month until reaching only one-third of the users at 6 months. There exists a strong association between age and app engagement of individuals with BD. Other variables such as years lived with BD, diagnosis of an anxiety disorder, and taking antipsychotics seem relevant as well. Understanding these associations can help in the definition of the most suitable user profiles for predicting trends of engagement, optimization of app prescription, and management

Machine learning to understand the immune-inflammatory pathways in fibromyalgia

Fibromyalgia (FM) is a chronic syndrome characterized by widespread musculoskeletal pain, and physical and emotional symptoms. Although its pathophysiology is largely unknown, immune-inflammatory pathways may be involved. We examined serum interleukin (IL)-6, high sensitivity C-reactive protein (hs-CRP), CXCL-8, and IL-10 in 67 female FM patients and 35 healthy women while adjusting for age, body mass index (BMI), and comorbid disorders. We scored the Fibromyalgia Severity Score, Widespread Pain Index (WPI), Symptom Severity Scale (SSS), Hospital Anxiety (HADS-A), and Depression Scale and the Perceived Stress Scale (PSS-10). Clinical rating scales were significantly higher in FM patients than in controls. After adjusting for covariates, IL-6, IL-10, and CXCL-8 were lower in FM than in HC, whereas hs-CRP did not show any difference. Binary regression analyses showed that the diagnosis FM was associated with lowered IL-10, quality of sleep, aerobic activities, and increased HADS-A and comorbidities. Neural networks showed that WPI was best predicted by quality of sleep, PSS-10, HADS-A, and the cytokines, while SSS was best predicted by PSS-10, HADS-A, and IL-10. Lowered levels of cytokines are associated with FM independently from confounders. Lowered IL-6 and IL-10 signaling may play a role in the pathophysiology of F

Guía de práctica clínica para la prevención, detección temprana, diagnóstico, tratamiento y seguimiento de las dislipidemias en la población mayor de 18 años

La Guía de práctica clínica para la prevención, detección temprana, diagnóstico, tratamiento y seguimiento de las dislipidemias en la población mayor de 18 años está dirigida a los adultos en riesgo para el desarrollo de dislipidemia o con diagnóstico establecido de dislipidemia, como también, para todo el personal de salud encargado de su atención en los diferentes niveles de complejidad del sistema de salud colombiano. Permitirá brindar parámetros de práctica clínica, basados en la mejor evidencia disponible para la atención en salud y el uso racional de recursos en esta patología. Se introducen cambios en el proceso de atención, que buscan disminuir la variabilidad injustificada en el abordaje de este grupo de pacientes generando procesos eficientes, sencillos y ajustados a la población colombiana; la guía es el resultado de un arduo proceso en el que se contó con la participación de expertos temáticos y expertos metodológicos, así como representantes de los pacientes y de las sociedades científicas y las universidades involucradas, y del Ministerio de Salud y Protección Social. En la siguiente sección se presentarán de forma resumida las recomendaciones y los puntos de buena práctica clínica para cada una de las preguntas formuladas, información que se amplía posteriormente en el capítulo respectivo.Guía de práctica clínica1-6

Peripheral immune aberrations in fibromyalgia : a systematic review, meta-analysis and meta-regression

This study was awarded both with the Grant PSSJD & FSJD 2016 and with the I Premio del Instituto esMindfulness 2016The objective was to identify immune alterations in patients with fibromyalgia syndrome (FMS) compared to healthy controls (HC) using meta-analysis and meta-regression. Six electronic databases were searched for suitable original articles investigating immune biomarkers in FMS in comparison to HC. We extracted outcomes and variables of interest, such as mean and SD of peripheral blood immune biomarkers, age or sex. A random-effects model with restricted maximum-likelihood estimator was used to compute effect sizes (standardized mean difference and 95% CI, Hedges' g) and meta-analysis, group meta-analysis and meta-regressions were conducted. Forty-three papers were included in this systematic review, of which 29 were suitable for meta-analysis. Interleukin (IL)-6 (g = 0.36 (0.09-0.63); I2 = 85.94; p = 0.01), IL-4 (g = 0.50 (0.03-0.98); I2 = 81.87; p = 0.04), and IL-17A (g = 0.53 (0.00-1.06); I2 = 87.15; p = 0.05), were significantly higher in FMS compared to HC while also combinations of cytokines into relevant phenotypes were significantly upregulated including M1 macrophage (g = 0.23 (0.03-0.43); I2 = 77.62; p = 0.02), and immune-regulatory (g = 0.40 (0.09-0.72); I2 = 84.81; p = 0.01) phenotypes. Heterogeneity levels were very high and subgroup and meta-regression analyses showed that many covariates explained part of the heterogeneity including medication washout, sex, time of blood sampling and exclusion of patients with major depressive disorder. In conclusion, FMS is accompanied by a disbalance between upregulated pro-inflammatory (M1 and Th-17) and immune-regulatory cytokines although effect sizes are small-to-moderate. Based on our results we provide specific methodological suggestions for future research, which should assess Th-1, Th-17, chemokines, and Th-2 phenotypes while controlling for possible confounding variables specified in this study

Patients with fibromyalgia reporting severe pain but low impact of the syndrome : clinical and pain-related cognitive features

Background: Fibromyalgia (FM) is a prevalent and highly disabling chronic pain syndrome. However, differences among patients regarding how pain impacts on daily life are remarkable. The main aim of this study was to identify clinical and pain-related cognitive variables characterizing patients reporting high adaptability despite experiencing severe chronic pain. Methods: 283 Spanish patients with FM with high levels of pain were classified on two groups: (1) those reporting low impact of the syndrome, and (2) those with moderate-to-high impact. Perceived stress, anxiety, and depressive symptoms along with pain catastrophizing, psychological inflexibility, and perceived control over pain were evaluated. Differences in sociodemographics, years with FM, past/current major depressive disorder comorbidity, and health-related economic costs (i.e. medications, use of medical services, lost productivity due to sick leave) were also assessed. Stepwise logistic regression analyses predicting group membership from clinical variables and pain-related cognitive processes as predictors were performed. Results: Lower stress, anxiety and depressive symptoms along with reduced pain catastrophism, psychological inflexibility and perceived control over pain were found in the low-impact group. Significant predictors of group membership (low-impact vs. moderate-to-high impact) in regression analyses were "cognitive fusion" (psychological inflexibility), "helplessness" (pain catastrophizing) and depressive symptomatology, together with pain intensity and other FM symptoms. Conclusions: The present study provides further evidence on resilience resources in chronic pain by identifying some variables (i.e. reduced depressive symptomatology, pain catastrophizing and psychological inflexibility) differentially characterizing a profile of FM patients who are especially able to adapt to high levels of pain

Real-world implementation of a smartphone-based psychoeducation program for bipolar disorder: observational ecological study

Background: SIMPLe is an internet-delivered self-management mobile app for bipolar disorder (BD) designed to combine technology with evidence-based interventions and facilitate access to psychoeducational content. The SIMPLe app was launched to the real world to make it available worldwide within the context of BD treatment. Objective: The main aims of this study are as follows: to describe app use, engagement, and retention rates based on server data; to identify patterns of user retention over the first 6-month follow-up of use; and to explore potential factors contributing to discontinuation of app use. Methods: This was an observational ecological study in which we pooled available data from a real-world implementation of the SIMPLe app. Participation was open on the project website, and the data-collection sources were a web-based questionnaire on clinical data and treatment history administered at inclusion and at 6 months, subjective data gathered through continuous app use, and the use patterns captured by the app server. Characteristics and engagement of regular users, occasional users, and no users were compared using 2-tailed t tests or analysis of variance or their nonparametric equivalent. Survival analysis and risk functions were applied to regular users' data to examine and compare use and user retention. In addition, a user evaluation analysis was performed based on satisfaction, perceived usefulness, and reasons to discontinue app use. Results: We included 503 participants with data collected between 2016 and 2018, of whom 77.5% (n=390) used the app. Among the app users, 44.4% (173/390) completed the follow-up assessment, and data from these participants were used in our analyses. Engagement declined gradually over the first 6 months of use. The probability of retention of the regular users after 1 month of app use was 67.4% (263/390; 95% CI 62.7%-72.4%). Age (P=.002), time passed since illness onset (P<.001), and years since diagnosis of BD (P=.048) correlate with retention duration. In addition, participants who had been diagnosed with BD for longer used the app on more days (mean 97.73, SD 69.15 days; P=.002) than those who had had a more recent onset (mean 66.49, SD 66.18 days; P=.002) or those who had been diagnosed more recently (mean 73.45, SD 66 days; P=.01). Conclusions: The user retention rate of the app decreased rapidly after each month until reaching only one-third of the users at 6 months. There exists a strong association between age and app engagement of individuals with BD. Other variables such as years lived with BD, diagnosis of an anxiety disorder, and taking antipsychotics seem relevant as well. Understanding these associations can help in the definition of the most suitable user profiles for predicting trends of engagement, optimization of app prescription, and management

Cost-Utility of Mindfulness-Based Stress Reduction for Fibromyalgia versus a Multicomponent Intervention and Usual Care : A 12-Month Randomized Controlled Trial (EUDAIMON Study)

Fibromyalgia (FM) is a prevalent, chronic, disabling, pain syndrome that implies high healthcare costs. Economic evaluations of potentially effective treatments for FM are needed. The aim of this study was to analyze the cost-utility of Mindfulness-Based Stress Reduction (MBSR) as an add-on to treatment-as-usual (TAU) for patients with FM compared to an adjuvant multicomponent intervention (FibroQoL) and to TAU. We performed an economic evaluation alongside a 12 month, randomized, controlled trial; data from 204 (68 per study arm) of the 225 patients (90.1%) were included in the cost-utility analyses, which were conducted both under the government and the public healthcare system perspectives. The main outcome measures were the EuroQol (EQ-5D-5L) for assessing Quality-Adjusted Life Years (QALYs) and improvements in health-related quality of life, and the Client Service Receipt Inventory (CSRI) for estimating direct and indirect costs. Incremental cost-effectiveness ratios (ICERs) were also calculated. Two sensitivity analyses (intention-to-treat, ITT, and per protocol, PPA) were conducted. The results indicated that MBSR achieved a significant reduction in costs compared to the other study arms (p &lt; 0.05 in the completers sample), especially in terms of indirect costs and primary healthcare services. It also produced a significant incremental effect compared to TAU in the ITT sample (Delta QALYs = 0.053, p &lt; 0.05, where QALYs represents quality-adjusted life years). Overall, our findings support the efficiency of MBSR over FibroQoL and TAU specifically within a Spanish public healthcare context

Improving depressive symptoms through personalised exercise and activation (IDEA): study protocol for a randomised controlled trial

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild-moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021