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OBJECTIVE: To evaluate the effectiveness of the incorporation of the clinical assistant in improving the control of type 2 diabetes mellitus and hypertension in a primary care center. DESIGN: Quasi-experimental study (pre-post), with a control group, with a 1-year follow-up. SETTING: Primary care center. PARTICIPANTS: Patients between the ages of 18 and 85 with a diagnosis of diabetes type 2 and/or hypertension were selected. INTERVENTION: Incorporation of the figure of the clinical assistant, previously trained. The latter contacted the patient to explain their role and obtain informed consent, assessed compliance with the protocols, and when they were incomplete and/or detected warning signs, referred the patient directly to medicine and/or nursing. RESULTS: Three thousand and sixty-four patients participated, 30.74% assigned to the intervention group. Fifty percent were women. The mean age was 68.5 years (SD 11.07). 93.59% of diabetic patients in the intervention group had at least one determination of glycosylated hemoglobin compared to 86.83% in the control group (p=0.003). Fundus and diabetic foot screening was significantly higher in the intervention group (94.31% and 85.41% vs. 83.49% and 72.38%). 88.43% of the patients in the intervention group had registered blood pressure figures compared to 62.06% of the patients in the control group (p<0.05). There were not statistically significant differences in the control of blood pressure between the patients with recorded measures (p=0.478). CONCLUSIONS: Clinical assistants can facilitate the implementation and compliance with chronic diseases protocols, and in the long run improve the degree of control of these patients and the quality of care.
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Diabetes Mellitus Tipo 2 , Hipertensão , Atenção Primária à Saúde , Humanos , Feminino , Masculino , Idoso , Diabetes Mellitus Tipo 2/complicações , Pessoa de Meia-Idade , Adulto , Idoso de 80 Anos ou mais , Estudos Controlados Antes e Depois , AdolescenteRESUMO
BACKGROUND: Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19. METHODS: Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo. RESULTS: For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo. CONCLUSIONS: Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration. ClinicalTrials.gov: NCT04575597.
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COVID-19 , Adulto , Humanos , SARS-CoV-2 , Tratamento Farmacológico da COVID-19 , Medidas de Resultados Relatados pelo Paciente , Resultado do TratamentoRESUMO
AIM: To explore the implications for dentists and family doctors of the association between periodontal and systemic diseases and the role of dentists and family doctors in managing non-communicable diseases (NCDs) and promoting healthy lifestyles. MATERIALS AND METHODS: The consensus reports of the previous Focused Workshops on the associations between periodontitis and diabetes (2017) and periodontitis and cardiovascular diseases (2019) formed the technical reviews to underpin discussions on both topics. For the association with respiratory diseases, a systematic review was specifically commissioned for the Workshop discussions. Working groups prepared proposals independently, and then the proposals were discussed and approved at plenary meetings. RESULTS: Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea and COVID-19 complications. Dentists and family doctors should collaborate in managing NCDs, implementing strategies for early detection of periodontitis in primary care centres and of cardiovascular diseases or diabetes in dental settings. Family doctors should be informed about periodontal diseases and their consequences, and oral health professionals (OHPs) should be informed about the relevance of NCDs and the associated risk factors. CONCLUSIONS: Closer collaboration between OHPs and family doctors is important in the early detection and management of NCDs and in promoting healthy lifestyles. Pathways for early case detection of periodontitis in family medicine practices and of NCDs in dental practices should be developed and evaluated.
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COVID-19 , Doenças Cardiovasculares , Diabetes Mellitus , Doenças Periodontais , Periodontite , Doenças Respiratórias , Humanos , Consenso , Doenças Cardiovasculares/complicações , COVID-19/complicações , Doenças Periodontais/complicações , Doenças Periodontais/terapia , Periodontite/complicações , Doenças Respiratórias/complicações , Europa (Continente)RESUMO
BACKGROUND: Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. METHODS: The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. RESULTS: The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. CONCLUSION: The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).
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Doenças Cardiovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Humanos , Anti-Hipertensivos/efeitos adversos , LDL-Colesterol , Combinação de Medicamentos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/tratamento farmacológico , Colesterol , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversosRESUMO
BACKGROUND: There is a scarcity of information about patients with mild or moderate symptoms during the coronavirus disease 2019 (COVID-19). This is especially true for those who attended and were followed up at primary care settings. OBJECTIVES: We aim to measure the seroprevalence of antibodies against SARS-CoV-2 infection in a community sample of possible cases and among probable cases followed in primary care. METHODS: We selected a random sample of 600 individuals stratified by age groups from a total population of 19 899 individuals from a community area in Barcelona. We also invited all the patients that had been followed by General Practitioners (GPs). For both populations, we used COVID-19 rapid lateral flow immunoassays, which qualitatively assess the presence of patient-generated Immunoglobulins G (IgG) and Immunoglobulin M (IgM). RESULTS: Three hundred and eleven asymptomatic individuals from the randomly selected sample participated in the study. The mean age was 43.7 years [standard deviation (SD) = 21.79] and 55% were women. Seventeen individuals were seropositive for IgM and/or IgG, resulting in an overall prevalence of 5.47% (95% confidence interval = 3.44-8.58). Six hundred and thirty-four symptomatic patients were followed up by GPs. The mean age was 46.97 years (SD = 20.05) and 57.73% were women. Of these, 244 patients (38.49%) were seropositive. Results of the multivariate logistic regression analysis showed that the odds ratio for a positive test was significantly increased in patients who had fever, ageusia and contact with a patient diagnosed with COVID-19. CONCLUSIONS: The seroprevalence of antibodies against SARS-CoV-2 among possible cases was lower than expected. Approximately, 40% of the symptomatic patients followed up by GPs during the peak months of the pandemic were positive.
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Teste Sorológico para COVID-19 , COVID-19/diagnóstico , COVID-19/epidemiologia , Atenção Primária à Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos Transversais , Feminino , Seguimentos , Humanos , Lactente , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Estudos Soroepidemiológicos , Índice de Gravidade de Doença , Espanha/epidemiologia , Adulto JovemRESUMO
This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Description: Dietary guideline recommendations require consideration of the certainty in the evidence, the magnitude of potential benefits and harms, and explicit consideration of people's values and preferences. A set of recommendations on red meat and processed meat consumption was developed on the basis of 5 de novo systematic reviews that considered all of these issues. Methods: The recommendations were developed by using the Nutritional Recommendations (NutriRECS) guideline development process, which includes rigorous systematic review methodology, and GRADE methods to rate the certainty of evidence for each outcome and to move from evidence to recommendations. A panel of 14 members, including 3 community members, from 7 countries voted on the final recommendations. Strict criteria limited the conflicts of interest among panel members. Considerations of environmental impact or animal welfare did not bear on the recommendations. Four systematic reviews addressed the health effects associated with red meat and processed meat consumption, and 1 systematic review addressed people's health-related values and preferences regarding meat consumption. Recommendations: The panel suggests that adults continue current unprocessed red meat consumption (weak recommendation, low-certainty evidence). Similarly, the panel suggests adults continue current processed meat consumption (weak recommendation, low-certainty evidence). Primary Funding Source: None. (PROSPERO 2017: CRD42017074074; PROSPERO 2018: CRD42018088854).
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Dieta/normas , Produtos da Carne , Política Nutricional , Carne Vermelha , Doenças Cardiovasculares/epidemiologia , Humanos , Neoplasias/epidemiologiaRESUMO
Current clinical guidelines emphasize the unmet need for technological innovations to guide physician decision-making and to transit from conventional care to personalized cardiovascular medicine. Biomarker-guided cardiovascular therapy represents an interesting approach to inform tailored treatment selection and monitor ongoing efficacy. However, results from previous publications cast some doubts about the clinical applicability of biomarkers to direct individualized treatment. In recent years, the non-coding human transcriptome has emerged as a new opportunity for the development of novel therapeutic strategies and biomarker discovery. Non-coding RNA (ncRNA) signatures may provide an accurate molecular fingerprint of patient phenotypes and capture levels of information that could complement traditional markers and established clinical variables. Importantly, ncRNAs have been identified in body fluids and their concentrations change with physiology and pathology, thus representing promising non-invasive biomarkers. Previous publications highlight the translational applicability of circulating ncRNAs for diagnosis and prognostic stratification within cardiology. Numerous independent studies have also evaluated the potential of the circulating non-coding transcriptome to predict and monitor response to cardiovascular treatment. However, this field has not been reviewed in detail. Here, we discuss the state-of-the-art research into circulating ncRNAs, specifically microRNAs and long non-coding RNAs, to support clinical decision-making in cardiovascular therapy. Furthermore, we summarize current methodological and conceptual limitations and propose future steps for their incorporation into personalized cardiology. Despite the lack of robust population-based studies and technical barriers, circulating ncRNAs emerge as a promising tool for biomarker-guided therapy.
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Biomarcadores/sangue , Doenças Cardiovasculares , MicroRNA Circulante/sangue , Medicina de Precisão/métodos , RNA não Traduzido/sangue , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/terapia , HumanosRESUMO
BACKGROUND: The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event. METHODS: ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059. FINDINGS: Between July 5, 2007, and Nov 15, 2016, 12â546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36-3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group). INTERPRETATION: The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies. FUNDING: Bayer.
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Aspirina/administração & dosagem , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Idoso , Aspirina/efeitos adversos , Método Duplo-Cego , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Análise de Intenção de Tratamento , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Inibidores da Agregação Plaquetária/efeitos adversos , Modelos de Riscos Proporcionais , Fatores de Risco , Acidente Vascular Cerebral/epidemiologiaRESUMO
BACKGROUND: Patients who have experienced a cardiovascular clinical event such as a myocardial infarction or stroke qualify for intensive risk factor evaluation and management. The aim of this study is to explore lifestyle changes as well as the achievement of targets for risk factors in patients with established cardiovascular disease. METHODS: Cross-sectional study conducted in primary care practices. The study was carried out in six European countries (Croatia, France, Portugal, Slovenia, Spain and Turkey). Patients with established cardiovascular disease (coronary heart disease and stroke) attended in primary care were selected and assessed from January to June 2016. Patients were recruited and assessed at the practice by research assistants between 6 months and 3 years after the event. Statistical comparisons were done with the unpaired two-sided Student's t-test for continuous variables and Chi-square test for categorical variables. RESULTS: Nine hundred and seventy-three patients (32.4% females) were assessed. About 14% of them were smokers, 32% were physically inactive, and 30% had nutritionally poor eating behaviours. LDL cholesterol target value below 70 mg/dl was achieved in about 23% of patients, and in general, women were less cardio-protected by drugs than men. CONCLUSIONS: Many patients with established cardiovascular disease who attended in general practice still fail to achieve the lifestyle, risk factor, and therapeutic targets set by European guidelines. These results are relevant to general practitioners because these patients have a high risk of subsequent cardiovascular events, including MI, stroke, and death.
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Doenças Cardiovasculares/psicologia , Comportamento de Redução do Risco , Idoso , Doenças Cardiovasculares/prevenção & controle , Croácia , Estudos Transversais , Dieta Saudável/estatística & dados numéricos , Exercício Físico , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Portugal , Eslovênia , Abandono do Hábito de Fumar/estatística & dados numéricos , Espanha , Inquéritos e Questionários , TurquiaRESUMO
AIMS: This 12-week, open-label, primary care study (NCT02195817) evaluated the efficacy and safety of nalmefene, taken as needed, to reduce alcohol consumption in adults with a diagnosis of alcohol dependence and drinking at least at high drinking risk levels (DRL, > 60 g/day for men, > 40 g/day for women). METHODS: Following the Screening Visit, patients recorded their daily alcohol consumption for 2 weeks. Patients were then categorised by their self-reported drinking levels; those who maintained at least a high DRL in the 2-week period were included in Cohort-A, and those who reduced their alcohol consumption below high DRL were included in Cohort-B. Cohort-A received simple psychosocial interventions and were supplied with nalmefene 18 mg to be taken on days when they perceived a risk of drinking alcohol. Patients in Cohort-B received a simple psychosocial intervention and were treated per normal practice. RESULTS: Of the 378 enrolled patients, 330 were included in Cohort-A and 48 in Cohort-B. For patients in Cohort-A, the mean change from screening to Week-12 in the number of heavy drinking days/month was -13.1 days/month (95% CI -14.4 to -11.9, p < 0.0001). Overall, 55% of patients reduced their DRL by ≥2 risk levels and 44% of patients reduced to a low DRL. The most common adverse events were nausea (18.3%) and dizziness (17.7%). Patients in Cohort-B maintained their lower level alcohol consumption at the 12-week follow-up. CONCLUSIONS: Patients with alcohol dependence treated in primary care with nalmefene, taken as needed, in conjunction with simple psychosocial support, significantly reduced their alcohol consumption. Treatment was well tolerated.
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Alcoolismo/tratamento farmacológico , Naltrexona/análogos & derivados , Adulto , Alcoolismo/terapia , Terapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Naltrexona/efeitos adversos , Naltrexona/uso terapêutico , Fármacos Neuroprotetores/uso terapêutico , Atenção Primária à Saúde , Psicoterapia , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Hazardous and harmful alcohol use and high blood pressure are central risk factors related to premature non-communicable disease (NCD) mortality worldwide. A reduction in the prevalence of both risk factors has been suggested as a route to reach the global NCD targets. This study aims to highlight that screening and interventions for hypertension and hazardous and harmful alcohol use in primary healthcare can contribute substantially to achieving the NCD targets. METHODS: A consensus conference based on systematic reviews, meta-analyses, clinical guidelines, experimental studies, and statistical modelling which had been presented and discussed in five preparatory meetings, was undertaken. Specifically, we modelled changes in blood pressure distributions and potential lives saved for the five largest European countries if screening and appropriate intervention rates in primary healthcare settings were increased. Recommendations to handle alcohol-induced hypertension in primary healthcare settings were derived at the conference, and their degree of evidence was graded. RESULTS: Screening and appropriate interventions for hazardous alcohol use and use disorders could lower blood pressure levels, but there is a lack in implementing these measures in European primary healthcare. Recommendations included (1) an increase in screening for hypertension (evidence grade: high), (2) an increase in screening and brief advice on hazardous and harmful drinking for people with newly detected hypertension by physicians, nurses, and other healthcare professionals (evidence grade: high), (3) the conduct of clinical management of less severe alcohol use disorders for incident people with hypertension in primary healthcare (evidence grade: moderate), and (4) screening for alcohol use in hypertension that is not well controlled (evidence grade: moderate). The first three measures were estimated to result in a decreased hypertension prevalence and hundreds of saved lives annually in the examined countries. CONCLUSIONS: The implementation of the outlined recommendations could contribute to reducing the burden associated with hypertension and hazardous and harmful alcohol use and thus to achievement of the NCD targets. Implementation should be conducted in controlled settings with evaluation, including, but not limited to, economic evaluation.
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Consumo de Bebidas Alcoólicas/efeitos adversos , Determinação da Pressão Arterial/métodos , Hipertensão/induzido quimicamente , União Europeia , Guias como Assunto , Humanos , Fatores de RiscoRESUMO
OBJECTIVES: The objective of this study is to evaluate the effects of a soy drink with a high concentration of isoflavones (ViveSoy®) on climacteric symptoms. METHODS: An open-label, controlled, crossover clinical trial was conducted in 147 peri- and postmenopausal women. Eligible women were recruited from 13 Spanish health centers and randomly assigned to one of the two sequence groups (control or ViveSoy®, 500 mL per day, 15 g of protein and 50 mg of isoflavones). Each intervention phase lasted for 12 weeks with a 6-week washout period. Changes on the Menopause Rating Scale and quality of life questionnaires, as well as lipid profile, cardiovascular risk and carbohydrate and bone metabolism were assessed. Statistical analysis was performed using a mixed-effects model. RESULTS: A sample of 147 female volunteers was recruited of which 90 were evaluable. In both sequence groups, adherence to the intervention was high. Regular consumption of ViveSoy® reduced climacteric symptoms by 20.4% (p = 0.001) and symptoms in the urogenital domain by 21.3% (p < 0.05). It also improved health-related quality life by 18.1%, as per the MRS questionnaire (p <0.05). CONCLUSION: Regular consumption of ViveSoy® improves both the somatic and urogenital domain symptoms of menopause, as well as health-related quality of life in peri- and postmenopausal women.
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Isoflavonas/farmacologia , Menopausa/efeitos dos fármacos , Leite de Soja/farmacologia , Estudos Cross-Over , Feminino , Humanos , Pessoa de Meia-Idade , Proteínas de Soja/farmacologia , Resultado do TratamentoRESUMO
BACKGROUND: This study aimed to validate the IberScore cardiovascular risk model in a population attended in the primary care setting. METHODS: A cohort of patients with no history of cardiovascular disease visited in a primary care center during the years 2008 and/or 2009 and followed up until 2018 was selected. Cardiovascular risk was calculated with the IberScore formula for all the subjects of the cohort and the model was calibrated, graphically represented by risk deciles the proportion of expected events and proportion of observed events at 10-year follow-up, stratified by sex. The area under the ROC curve was calculated to assess the discrimination of the model. RESULTS: A total of 10,085 patients visited during the years 2008 and/or 2009 were included in the study. Men showed a mean 10-year risk of suffering a fatal or non-fatal cardiovascular events according to IberScore of 17.07% (SD 20.13), with a mean estimated vascular age of more than 4 years higher than the biological age; while women had a mean 10-year risk of 7.91% (SD 9.03), with an estimated vascular age of more than 2 years above the biological age. The area under the ROC curve showed a discrimination index of the model of 0.86 (95% CI 0.84-0.88) in men and 0.82 (95% CI 0.79-0.85) in women. CONCLUSION: IberScore model discriminates well in the population attended in primary care but the model overestimates the risk.
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Doenças Cardiovasculares , Fatores de Risco de Doenças Cardíacas , Atenção Primária à Saúde , Humanos , Masculino , Feminino , Doenças Cardiovasculares/epidemiologia , Pessoa de Meia-Idade , Idoso , Medição de Risco/métodos , Estudos de Coortes , Seguimentos , Fatores Sexuais , Adulto , Curva ROC , Fatores EtáriosRESUMO
BACKGROUND: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. OBJECTIVE: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season. METHODS: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination. RESULTS: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent. CONCLUSIONS: Across all age and risk groups for serious disease, no serious adverse events related to GSK's IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK's IIV4 across all recommended age groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: not applicable.
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BACKGROUND: Periodontitis is a chronic inflammatory non-communicable disease (NCD) characterised by the destruction of the tooth-supporting apparatus (periodontium), including alveolar bone, the presence of periodontal pockets, and bleeding on probing. OBJECTIVES: To outline, for family doctors, the implications of the association between periodontal and systemic diseases; to explore the role of family doctors in managing periodontitis as an ubiquitous non-communicable disease (NCD). METHODS: The consensus reports of previous focused collaborative workshops between WONCA Europe and the European Federation of Periodontology (using previously undertaken systematic reviews), and a specifically commissioned systematic review formed the technical papers to underpin discussions. Working groups prepared proposals independently, and the proposals were subsequently discussed and approved at plenary meetings. RESULTS: Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnoea, and COVID-19 complications. Treatment of periodontitis has been associated with improvements in systemic health outcomes. The article also presents evidence gaps. Oral health care professionals (OHPs) and family doctors should collaborate in managing these conditions, including implementing strategies for early case detection of periodontitis in primary medical care centres and of systemic NCDs in oral/dental care settings. There is a need to raise awareness of periodontal diseases, their consequences, and the associated risk factors amongst family doctors. CONCLUSION: Closer collaboration between OHPs and family doctors is important in the early case detection and management of NCDs like cardiovascular diseases, diabetes mellitus, and respiratory diseases. Strategies for early case detection/prevention of NCDs, including periodontitis, should be developed for family doctors, other health professionals (OHPs), and healthcare funders. Evidence-based information on the reported associations between periodontitis and other NCDs should be made available to family doctors, OHPs, healthcare funders, patients, and the general population.
Periodontitis is independently associated with cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, obstructive sleep apnoea, and COVID-19.Periodontal treatment for optimal outcomes improves diabetes outcomes and surrogate measures of cardiovascular risk.Closer collaboration between oral health care professionals and family doctors is important in the early case detection and management of non-communicable diseases.Information on the reported associations should be made available to family doctors, oral health professionals, healthcare funders, patients, and the general population.
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COVID-19 , Doenças Cardiovasculares , Humanos , Europa (Continente) , COVID-19/complicações , COVID-19/epidemiologia , Diabetes Mellitus/terapia , Diabetes Mellitus/epidemiologia , Doenças Periodontais/terapia , Periodontite/terapia , Periodontite/epidemiologia , ConsensoRESUMO
BACKGROUND: The successful implementation of cardiovascular disease (CVD) prevention guidelines relies heavily on primary care physicians (PCPs) providing risk factor evaluation, intervention and patient education. The aim of this study was to ascertain the degree of awareness and implementation of the Spanish adaptation of the European guidelines on CVD prevention in clinical practice (CEIPC guidelines) among PCPs. METHODS: A cross-sectional survey of PCPs was conducted in Spain between January and June 2011. A random sample of 1,390 PCPs was obtained and stratified by region. Data were collected by means of a self-administered questionnaire. RESULTS: More than half (58%) the physicians were aware of and knew the recommendations, and 62% of those claimed to use them in clinical practice, with general physicians (without any specialist accreditation) being less likely to so than family doctors. Most PCPs (60%) did not assess cardiovascular risk, with the limited time available in the surgery being cited as the greatest barrier by 81%. The main reason to be sceptical about recommendations, reported by 71% of physicians, was that there are too many guidelines. Almost half the doctors cited the lack of training and skills as the greatest barrier to the implementation of lifestyle and behavioural change recommendations. CONCLUSIONS: Most PCPs were aware of the Spanish adaptation of the European guidelines on CVD prevention (CEIPC guidelines) and knew their content. However, only one third of PCPs used the guidelines in clinical practice and less than half CVD risk assessment tools.
Assuntos
Doenças Cardiovasculares/prevenção & controle , Medicina de Família e Comunidade/estatística & dados numéricos , Fidelidade a Diretrizes/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde/normas , Adulto , Atitude do Pessoal de Saúde , Competência Clínica , Estudos Transversais , Medicina de Família e Comunidade/educação , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Medição de Risco , Espanha , Inquéritos e Questionários , Fatores de TempoRESUMO
INTRODUCTION: The function to estimate lifetime cardiovascular risk -IBERLIFERISK- in Spanish working population, obtained a satisfactory discrimination; however, there was a slight overestimation of the risk in men and an underestimation of the risk in women. OBJECTIVE: To recalibrate the current lifetime risk equation after extending the follow-up by 3 years. METHODS: Retrospective cohort study. 762.058 workers who underwent an occupational health examination between 2004 and 2007 were included. All episodes of temporary sickness and cardiovascular mortality up to December 2017 were evaluated. Regression models were combined to take into account the presence of competing risks in estimating cardiovascular risk in the derivation cohort. Calibration was performed by graphically representing the proportion of expected and observed events at 10 years of follow-up in the validation cohort, stratifying by risk deciles and calculating the Spiegelhalter Z statistic. Discrimination was evaluated graphically using the Receiver Operating Curve (ROC) and calculating Harrell's C index. RESULTS: The mean age was 35.48 years (SD 10.56). 71.14% were men. Harrell's C index was 0.78 (95% CI 0.76-0.79) in men and 0.73 (95% CI 0.69-0.77) in women. In general, there was a slight degree of underestimation in women and overestimation in men in the last decile of risk, although the Spiegelhalter Z statistic was not statistically significant in both sexes (p>0.05). CONCLUSIONS: The updated model continues to discriminate satisfactorily, although the model's calibration has not substantially improved with the new update.