RESUMO
BACKGROUND AND AIMS: A systematic review and a meta-analysis of the literature was conducted to assess efficacy and safety of proactive therapeutic drug monitoring (TDM) versus conventional management during maintenance treatment with anti-tumour necrosis factor (anti-TNFα) in patients with inflammatory bowel disease (IBD). METHODS: A search was conducted up to January 2022 (MEDLINE, EMBASE, and the Cochrane Library). The primary outcome was the ability to maintain clinical remission at 12 months. The certainty of evidence was determined using the GRADE approach. RESULTS: Nine studies were identified: one systematic review, six randomised clinical trials, and two cohort studies. No superior efficacy of proactive TDM [relative risk 1.16; 95% confidence interval (CI): 0.98-1.37, n=528; I2=55%] was shown. Proactive TDM could improve the durability of anti-TNFα treatment [odds ratio (OR) 0.12; 95%CI: 0.05-0.27; n=390; I2=45%), prevent acute infusion reactions (OR 0.21; 95%CI: 0.05-0.82; n=390; I2=0%), decrease adverse events (OR 0.38; 95%CI: 0.15-0.98; n=390; I2=14%), and reduce the probability of surgery, at lower economical expenditure. CONCLUSIONS: The analysed evidence did not confirm the superiority of proactive TDM of anti-TNFα treatment over conventional management in patients with IBD, so proactive TDM should not currently be recommended.
Assuntos
Doenças Inflamatórias Intestinais , Inibidores do Fator de Necrose Tumoral , Humanos , Inibidores do Fator de Necrose Tumoral/efeitos adversos , Monitoramento de Medicamentos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Fator de Necrose Tumoral alfa/uso terapêutico , Indução de Remissão , Infliximab/uso terapêuticoRESUMO
Hypertension is one of the main cardiovascular risk factors. In the elderly, the most common form is isolated systolic hypertension, a consequence of the increase in arterial stiffness. None of the antihypertensives currently used affects arterial stiffness, whereas nitrates seem to have an effect. The aim of this work was to assess their effect on elderly patients with uncontrolled isolated systolic hypertension, defined as systolic blood pressure over 140 mmHg and diastolic blood pressure under 90 mmHg. The present study is a phase III, randomized, multicenter, double-blind, placebo-controlled clinical trial, conducted at the University Hospital La Princesa in Madrid. Patients of both sexes, aged 65 years or older, with poorly controlled isolated systolic hypertension, were treated with 40-60 mg of sustained-release isosorbide mononitrate or matching placebo for 12 weeks. The main objective was to assess the effect on clinical pulse pressure (PP); in addition, its effect on vascular function was evaluated. Analysis was performed by intention to treat. The study was registered at the European Union Clinical Trials Register (EUDRACT 2012-002988-10) and was funded by the Spanish Ministry of Health. A total of 58 patients with an average age of 77 years were enrolled, 32 were treated with nitrate, and 26 with placebo. No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function. There were no differences in adverse events. The results of this study have not confirmed the benefit of nitrate treatment in isolated systolic hypertension or the improvement of vascular function.
Assuntos
Hipertensão , Dinitrato de Isossorbida , Idoso , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Preparações de Ação Retardada/farmacologia , Preparações de Ação Retardada/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Dinitrato de Isossorbida/análogos & derivados , Dinitrato de Isossorbida/farmacologia , Dinitrato de Isossorbida/uso terapêutico , MasculinoRESUMO
[This corrects the article DOI: 10.1371/journal.pone.0173947.].
RESUMO
BACKGROUND: Chronic heart failure (CHF) reduces quality of life and causes hospitalisation and death. Identifying predictive factors of such events may help change the natural history of this condition. AIM: To develop and validate a stratification system for classifying patients with CHF, according to their degree of disability and need for hospitalisation due to any unscheduled cause, over a period of 1 year. METHODS AND ANALYSIS: Prospective, concurrent, cohort-type study in two towns in the Madrid autonomous region having a combined population of 1 32 851. The study will include patients aged over 18 years who meet the following diagnostic criteria: symptoms and typical signs of CHF (Framingham criteria) and left ventricular ejection fraction (EF)<50% or structural cardiac lesion and/or diastolic dysfunction in the presence of preserved EF (EF>50%).Outcome variables will be(a) Disability, as measured by the WHO Disability Assessment Schedule V.2.0 Questionnaire, and (b) unscheduled hospitalisations. The estimated sample size is 557 patients, 371 for predictive model development (development cohort) and 186 for validation purposes (validation cohort). Predictive models of disability or hospitalisation will be constructed using logistic regression techniques. The resulting model(s) will be validated by estimating the probability of outcomes of interest for each individual included in the validation cohort. ETHICS AND DISSEMINATION: The study protocol has been approved by the Clinical Research Ethics Committee of La Princesa University Teaching Hospital (PI-705). All results will be published in a peer-reviewed journal and shared with the medical community at conferences and scientific meetings.
Assuntos
Avaliação da Deficiência , Insuficiência Cardíaca/diagnóstico , Hospitalização/estatística & dados numéricos , Medição de Risco/métodos , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Risco , EspanhaRESUMO
INTRODUCTION: The increase and persistence of inflammation in community-acquired pneumonia (CAP) patients can lead to higher mortality. Biomarkers capable of measuring this inadequate inflammatory response are likely candidates to be related with a bad outcome. We investigated the association between concentrations of several inflammatory markers and mortality of CAP patients. MATERIAL AND METHODS: This was a prospective study of hospitalised CAP patients in a Spanish university hospital. Blood tests upon admittance and in the early-stage evolution (72-120 hours) were carried out, where C-reactive protein, procalcitonin, proadrenomedullin, copeptin, white blood cell, Lymphocyte Count Percentage (LCP), Neutrophil Count Percentage (NCP) and Neutrophil/Lymphocyte Ratio (NLR) were measured. The outcome variable was mortality at 30 and 90 days. Statistical analysis included logistic regression, ROC analysis and area-under-curve test. RESULTS: 154 hospitalised CAP patients were included. Patients who died during follow-up had higher levels of procalcitonin, copeptin, proadrenomedullin, lower levels of LCP, and higher of NCP and NLR. Remarkably, multivariate analysis showed a relationship between NCP and mortality, regardless of age, severity of CAP and comorbidities. AUC analysis showed that NLR and NCP at admittance and during early-stage evolution achieved a good diagnostic power. ROC test for NCP and NLR were similar to those of the novel serum biomarkers analysed. CONCLUSIONS: NLR and NCP, are promising candidate predictors of mortality for hospitalised CAP patients, and both are cheaper, easier to perform, and at least as reliable as the new serum biomarkers. Future implementation of new biomarkers would require comparison not only with classic inflammatory parameters like White Blood Cell count but also with NLR and NCP.
Assuntos
Biomarcadores/sangue , Infecções Comunitárias Adquiridas/mortalidade , Inflamação/sangue , Linfócitos , Neutrófilos , Admissão do Paciente , Pneumonia/mortalidade , Idoso , Idoso de 80 Anos ou mais , Infecções Comunitárias Adquiridas/sangue , Feminino , Humanos , Masculino , Pneumonia/sangue , Estudos ProspectivosRESUMO
Decrease blood loss associated with the analytical laboratory is a determinant of safety and quality in the preanalytical phase, in order to achieve an optimal level of care, where nurses have leading role to be responsible for the care of the critically ill patient.
Assuntos
Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/normas , Cuidados Críticos , Erros de Diagnóstico , Testes Hematológicos/instrumentação , Testes Hematológicos/normas , Humanos , Estudos Longitudinais , Estudos ProspectivosRESUMO
OBJECTIVES: To estimate the prevalence of undiagnosed human immunodeficiency virus (HIV) infection detected by routine testing of patients seeking care in an emergency department and to describe the characteristics associated with new HIV-infection diagnosis. MATERIAL AND METHODS: Walk-in patients between the ages of 15 and 75 years who required a blood test were included. Routine fourth-generation enzyme-linked immunoassays were performed to detect HIV infection in all samples extracted. Patients with positive results were referred to the infectious diseases department for monitoring and treatment. RESULTS: Blood samples for 1722 patients were analyzed. Twenty-one patients (1.2%) refused to allow their samples to be tested; 19 more samples (1.1%) could not be tested. The prevalence of undiagnosed HIV infection among the remaining 1682 remaining patients was 0.6% (95% CI, 0.23%-0.96%). The prevalence tended to be nonsignificantly higher among patients born outside Spain (0.97% [95% CI, 0.3%-2.20%]) and in 36-50-year-olds (1.46% [95% CI, 0.4%-2.5%]). Characteristics associated with undiagnosed HIV infection were male sex (odds ratio [OR], 5.78 [95% CI, 1.0-31.4]), presenting with a chief complaint that suggested infection (OR, 8.14 [95% CI, 1.6-41.4]), and a history of hepatitis (OR, 5.53 [95% CI, 1.1-27.7]). CONCLUSION: The prevalence of undiagnosed HIV infection in our emergency department was high at 0.6%. The rate of patient acceptance of routine HIV testing was high. Strategies that target improving the detection of undiagnosed HIV infection are advisable.
OBJETIVO: Estimar la prevalencia de la infección por el virus de la inmunodeficiencia humana (VIH) no diagnosticada entre la población que acude al servicio de urgencias hospitalario (SUH) mediante la realización rutinaria del test para VIH, y describir los factores asociados al diagnóstico. METODO: Estudio descriptivo transversal que incluyó a los pacientes entre 15 y 75 años valorados en la zona de pacientes ambulantes del SUH y a los que se les realizó una analítica sanguínea por su motivo de consulta, en la que se obtuvo una muestra para realizar la prueba del VIH de manera rutinaria mediante test de enzimoinmunoanálisis (EIA) de 4ª generación. Los pacientes con resultado positivo fueron remitidos al servicio de infecciosas para seguimiento y tratamiento. RESULTADOS: Se obtuvieron muestras de sangre de 1.722 pacientes. De estos, 21 (1,2%) rechazaron la realización de la serología y 19 (1,1%) no fueron finalmente analizados. La prevalencia de infección VIH no diagnosticada entre los 1.682 pacientes analizados fue del 0,6% [IC 95%: 0,23-0,96%]. Fue, sin significación estadística, mayor en los pacientes nacidos en otros países 0,97% [IC 95%: 0,3-2,20] y en los pacientes de 36 a 50 años 1,46% [IC 95%: 0,4-2,5]. Los factores que se asociaron con infección no conocida por VIH fueron ser hombre [OR: 5,78 (IC 95%: 1,0-31,4)], tener un motivo de consulta sugerente de infección [OR: 8,14 (IC 95%: 1,6-41,4)] y tener antecedentes de hepatitis [OR: 5,53 (IC 95%: 1,1-27,7)]. CONCLUSIONES: Hubo una alta prevalencia (0,6%) de infección por VIH no diagnosticada entre los pacientes atendidos en urgencias, los cuales mostraron una alta aceptación para realizar una serología VIH de manera rutinaria y universal. Estos resultados aconsejan mejorar las estrategias de detección de infección oculta por VIH.
Assuntos
Serviço Hospitalar de Emergência , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Programas de Rastreamento/métodos , Adolescente , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prevalência , Espanha/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Late prognosis of Community-Acquired Pneumonia (CAP) patients is related to cardiovascular events. Persistence of inflammation-related markers, defined by high circulatory levels of interleukin 6 and 10 (IL-6/IL-10), is associated with a higher post-event mortality rate for CAP patients. However, association between these markers and other components of the immune response, and the risk of cardiovascular events, has not been adequately explored. The main objectives of this study are: 1) to quantify the incidence of cardiovascular disease, in the year post-dating their hospital admittance due to CAP and, 2) to describe the distribution patterns of a wide spectrum of inflammatory markers upon admittance to and release from hospital, and to determine their relationship with the incidence of cardiovascular disease. METHODS/DESIGN: A cohort prospective study. All patients diagnosed and hospitalized with CAP will be candidates for inclusion. The study will take place in the Universitary Hospital La Princesa, Spain, during two years. Two samples of blood will be taken from each patient: the first upon admittance and the second one prior to release, in order to analyse various immune agents. The main determinants are: pro-adrenomedullin, copeptin, IL-1, IL-6, TNF-α, IL-17, IFN-γ, IL-10 and TGF-ß, E-Selectin, ICAM-1, VCAM-1 and subpopulations of peripheral T lymphocytes (T regulator, Th1 and Th17), together with other clinical and analytical variables. Follow up will start at admittance and finish a year after discharge, registering incidence of death and cardiovascular events. The main objective is to establish the predictive power of different inflammatory markers in the prognosis of CAP, in the short and long term, and their relationship with cardiovascular disease. DISCUSSION: The level of some inflammatory markers (IL-6/IL-10) has been proposed as a means to differentiate the degree of severity of CAP, but their association with cardiovascular risk is not well established. In this study we aim to define new inflammatory markers associated with cardiovascular disease that could be helpful for the prognosis of CAP patients, by describing the distribution of a wide spectrum of inflammatory mediators and analyzing their association with the incidence of cardiovascular disease and mortality one year after release from hospital.
Assuntos
Biomarcadores/sangue , Doenças Cardiovasculares/epidemiologia , Pneumonia Bacteriana/epidemiologia , Adulto , Idoso , Doenças Cardiovasculares/imunologia , Estudos de Coortes , Infecções Comunitárias Adquiridas/epidemiologia , Infecções Comunitárias Adquiridas/imunologia , Feminino , Hospitalização , Humanos , Incidência , Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Pneumonia Bacteriana/imunologia , Prognóstico , Estudos ProspectivosRESUMO
OBJECTIVE: To update the system for nutritional screening. The high prevalence of nutritional unstability that causes the Clinical Undernutrition (CU), especially within the hospitals and assisted residencies, makes it necessary to use screening tools for the constant control of undernutrition to combat it during its development. CU is not so much due to a nutritional deficiency but to the illness and its treatments. However, the screening systems currently used are aimed at detecting an already established undernutrition rather than at detecting any nutritional risk that may be present. The metabolic changes of the nutritional status that have a trophopathic effect, can be easily and automatically detected in plasma, which allows to make the necessary changes in treatments that might be too aggressive, as well as to apply nutritional support according to each case. The manual screening systems can detect those somatic changes typical of undernutrition only after many days or weeks, which might be too late. Plasma albumin is a very reliable parameter for nutritional control. A lowered amount of it, due to whatever reason, is a clear sign of a possible deficit as well as of a nutritional risk suffered by the cell way before the somatic signs of undernutrition will become apparent. A fast detection of nutritional risk, anticipating undernutrition, offers prognostic abilities, which makes screening tools based on analytic parameters the most useful, ergonomic, reliable and efficient system for nutritional screening and prognosis in the clinical practice. CONCLUSION: It is necessary to update some concepts, to leave behind old myths and to choose modern screening systems that have proven to be efficient. This is the only way achieving the dream of controlling CU among ill and vulnerable patients.
Objetivo: Actualizar el cribado nutricional. La alta prevalencia del desequilibrio nutricional que genera la Desnutrición Clínica (DC), especialmente en hospitales y residencias asistidas, obliga al uso de herramientas de cribado y a controlar su evolución para combatirla sobre la marcha. La DC deriva menos de la carencia nutricional que de los efectos de la enfermedad y sus tratamientos, pero los actuales sistemas de cribado buscan más la desnutrición ya establecida que el riesgo nutricional existente. Las alteraciones metabólicas del equilibrio nutricional que constituyen la trofopatía se pueden captar en el plasma sin demoras, automáticamente, permitiendo rectificar actitudes terapéuticas demasiado agresivas o complementarlas con el adecuado soporte nutricional. Con los sistemas manuales de cribado, solo pasados días o semanas se evidenciarán, tardíamente, los cambios somáticos expresivos de esa desnutrición. La concentración de la albúmina plasmática es un parámetro muy valioso en el control nutricional. Su disminución, cualquiera que sea la causa, expresa un posible déficit pero también el riesgo nutricional a que se ve sometida la célula, antes de que la desnutrición se manifieste somáticamente. La precocidad de la detección del riesgo nutricional, anticipándose a la desnutrición y su gran capacidad pronóstica hacen de las herramientas basadas en parámetros analíticos, el procedimiento más útil, ergonómico, seguro y eficiente para el cribado y pronóstico nutricional en el entorno clínico. Conclusión: es hora de actualizar conceptos, deshacer mitos y optar por sistemas modernos de cribado eficientes, única manera de alcanzar el sueño de controlar la DC en nuestras poblaciones enfermas y frágiles.
Assuntos
Desnutrição/diagnóstico , Avaliação Nutricional , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Deficiências Nutricionais/diagnóstico , Feminino , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Adulto JovemRESUMO
PURPOSE: The aim of this study was to analyze the relationship between bone density obtained by cone-beam computed tomography (CBCT) and morphometric parameters of bone analyzed by microcomputed tomography (µ-CT). MATERIAL AND METHODS: An overall of 32 subjects ≤8 mm of bone height were included in the study. One site per patient was randomly selected to obtain bone core. Totally, 27 biopsies were available for µ-CT analysis. In addition, CBCT was taken after positioning a previously fabricated acrylic resin template with a 2-mm-diameter metal rod at the randomly selected implant site to study radiographic bone density (RBD). The relationship between µ-CT and CBCT quantitative variable and RBD was analyzed using Spearman correlation. RESULTS: Positive correlations between BV/TV (r = 0.769, P < 0.001), BS/TV (r = 0.563, P = 0.002), Tb.Th (r = 0.491, P = 0.009), Tb.N (r = 0.518, P = 0.005) and vBMD (r = 0.699, P < 0.001) with RBD were identified. On the contrary, BS/BV (r = -0.509, P = 0.006), Tb.Sp (r = -0.539, P = 0.003) and Tb.Pf (r = -0.636, P < 0.001) were negatively correlated with RBD. Moreover, SMI (r = -0.380, P = 0.050) and DA (-0.245, P = 0.217) were negatively correlated but not statistically significant. CONCLUSION: This study demonstrated the correlation between radiographic bone density (RBD) and bone density assessed by µ-CT. Therefore, our data supported the use of CBCT as pre-operative tool for implant treatment planning because it is shown to be reliable to assess atrophic posterior maxilla density and microarchitecture.
Assuntos
Densidade Óssea , Tomografia Computadorizada de Feixe Cônico , Maxila/diagnóstico por imagem , Microtomografia por Raio-X , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Atrofia , Biópsia , Implantação Dentária Endóssea , Feminino , Humanos , Masculino , Maxila/patologia , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
BACKGROUND: Isolated systolic hypertension is a highly prevalent disease among the elderly. The little available evidence on the efficacy of nitrates for treating the disease is based on small experimental studies. METHODS/DESIGN: We performed a multicenter, randomized, double-blind, phase III, placebo-controlled trial in 154 patients aged over 65 years with refractory isolated systolic hypertension. Patients were randomized to placebo or 40 mg/day of extended-release isosorbide mononitrate added to standard therapy and titrated to 60 mg/day at week 6 if blood pressure exceeded 140/90 mmHg.The primary objective was to assess the effect on clinical pulse pressure of extended-release isosorbide mononitrate added to standard therapy in patients aged over 65 years with refractory isolated systolic hypertension after 3 months of treatment.The secondary objectives were as follows: to quantify the effect of adding the study drug on central blood pressure and vascular compliance using the augmentation index and pulse wave velocity; to evaluate the safety profile by recording adverse effects (frequency, type, severity) and the percentage of patients who had to withdraw from the trial because of adverse events; to quantify the percentage of patients who reach a clinical systolic blood pressure <140 mmHg or <130 mmHg measured by ambulatory blood pressure monitoring; and to quantify the change in pulse pressure measured by ambulatory blood pressure monitoring. DISCUSSION: Few clinical trials have been carried out to test the effect of oral nitrates on isolated systolic hypertension, even though these agents seem to be effective. Treatment with extended-release isosorbide mononitrate could improve control of systolic blood pressure without severe side effects, thus helping to reduce the morbidity and mortality of the disease. TRIAL REGISTRATION: EUDRACT Number: 2012-002988-10.
Assuntos
Anti-Hipertensivos/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/tratamento farmacológico , Dinitrato de Isossorbida/análogos & derivados , Projetos de Pesquisa , Rigidez Vascular/efeitos dos fármacos , Vasodilatadores/administração & dosagem , Administração Oral , Idoso , Monitorização Ambulatorial da Pressão Arterial , Protocolos Clínicos , Preparações de Ação Retardada , Método Duplo-Cego , Elasticidade , Humanos , Hipertensão/diagnóstico , Hipertensão/fisiopatologia , Dinitrato de Isossorbida/administração & dosagem , Análise de Onda de Pulso , Espanha , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7-8 years. METHODS/DESIGN: This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7-8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a ß of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. DISCUSSION: The intervention providing the best results could be recommended as part of health education for young schoolchildren. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01418872.
Assuntos
Doenças Cardiovasculares/prevenção & controle , Educação em Saúde/métodos , Conhecimentos, Atitudes e Prática em Saúde , Promoção da Saúde/métodos , Obesidade/prevenção & controle , Desjejum , Criança , Análise por Conglomerados , Feminino , Seguimentos , Humanos , Masculino , Música , Avaliação de Programas e Projetos de Saúde , Método Simples-CegoRESUMO
BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.
Assuntos
Qualidade de Vida , Deficiência de Vitamina B 12/tratamento farmacológico , Vitamina B 12/uso terapêutico , Complexo Vitamínico B/uso terapêutico , Administração Oral , Idoso , Pesquisa Comparativa da Efetividade , Vias de Administração de Medicamentos , Feminino , Humanos , Injeções Intramusculares , Masculino , Cooperação do Paciente , Satisfação do Paciente , Atenção Primária à Saúde , Qualidade de Vida/psicologia , Projetos de Pesquisa , Tamanho da Amostra , Fatores Socioeconômicos , Resultado do Tratamento , Vitamina B 12/administração & dosagem , Vitamina B 12/sangue , Deficiência de Vitamina B 12/epidemiologia , Complexo Vitamínico B/administração & dosagemRESUMO
UNLABELLED: This work describes the methodology used to assess a strategy for implementing clinical practice guidelines (CPG) for cardiovascular risk control in a health area of Madrid. BACKGROUND: The results on clinical practice of introducing CPGs have been little studied in Spain. The strategy used to implement a CPG is known to influence its final use. Strategies based on the involvement of opinion leaders and that are easily executed appear to be among the most successful. AIM: The main aim of the present work was to compare the effectiveness of two strategies for implementing a CPG designed to reduce cardiovascular risk in the primary healthcare setting, measured in terms of improvements in the recording of calculated cardiovascular risk or specific risk factors in patients' medical records, the control of cardiovascular risk factors, and the incidence of cardiovascular events. METHODS: This study involved a controlled, blinded community intervention in which the 21 health centres of the Number 2 Health Area of Madrid were randomly assigned by clusters to be involved in either a proposed CPG implementation strategy to reduce cardiovascular risk, or the normal dissemination strategy. The study subjects were patients ≥ 45 years of age whose health cards showed them to belong to the studied health area. The main variable examined was the proportion of patients whose medical histories included the calculation of their cardiovascular risk or that explicitly mentioned the presence of variables necessary for its calculation. The sample size was calculated for a comparison of proportions with alpha = 0.05 and beta = 0.20, and assuming that the intervention would lead to a 15% increase in the measured variables. Corrections were made for the design effect, assigning a sample size to each cluster proportional to the size of the population served by the corresponding health centre, and assuming losses of 20%. This demanded a final sample size of 620 patients. Data were analysed using summary measures for each cluster, both in making estimates and for hypothesis testing. Analysis of the variables was made on an intention-to-treat basis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01270022.
Assuntos
Doenças Cardiovasculares/prevenção & controle , Disseminação de Informação/métodos , Guias de Prática Clínica como Assunto , Atenção Primária à Saúde/métodos , Análise por Conglomerados , Estudos Transversais , Método Duplo-Cego , Educação Médica Continuada , Feminino , Seguimentos , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Projetos de Pesquisa , Fatores de Risco , EspanhaRESUMO
INTRODUCTION AND OBJECTIVES: The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up. METHODS: The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome. RESULTS: Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A(1c) <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003). CONCLUSIONS: Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up.
Assuntos
Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Assistência Integral à Saúde , Cuidados Críticos , Prevenção Secundária , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: In recent years there has been controversy around the treatment demands of people who, without meeting diagnostic criteria for a mental disorder, have certain symptoms and are referred to mental health professionals. AIMS: To determine the prevalence of individuals assessed by mental health service, referred from primary care, who do not meet the diagnosis criteria of mental disorders according to ICD-10. To analyze the medical treatment given to these individuals, measured by the indication for discharge or follow-up and by the pharmacological intervention decided in the first interview, as well as the associated variables. DESIGN: descriptive study. SCOPE: urban area. POPULATION: all patients referred to the Salamanca mental health service during a year, without any exclusion (n = 1,187). VARIABLES: sociodemographics; clinical and health service utilization gathered through clinical interview, GHQ-28, SCL-90-R and an expectations scale. RESULTS: Of the 1,004 patients who attended interview, 24.4% (CI 95%: 21.6-27.0) did not present any diagnosable mental disorder (Z codes); they constitute the body of this study. 50.8% of these were referred from primary care with a psychotropic drug treatment already prescribed. Any drug intervention (addition, suspension or modification) was performed in 37.2% of the cases by the mental health service. Regardless of the treatment indicated, 52% were discharged after the first interview. CONCLUSIONS: The prevalence of patients who failed to reach diagnostic criteria for a mental disorder in this health service is similar to other studies, in spite of the filter provided by primary care. Many individuals without a diagnosable mental disorder received treatment both in primary care and in the mental health service.
Assuntos
Assistência Ambulatorial , Transtornos Mentais , Adulto , Feminino , Humanos , Entrevista Psicológica , Masculino , Transtornos Mentais/diagnóstico , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/epidemiologia , Transtornos Mentais/fisiopatologia , Serviços de Saúde Mental/estatística & dados numéricos , Pessoa de Meia-Idade , Prevalência , Atenção Primária à Saúde/estatística & dados numéricos , Espanha/epidemiologiaRESUMO
BACKGROUND: In Spain, more than 85% of coronary heart disease deaths occur in adults older than 65 years. However, coronary heart disease incidence and mortality in the Spanish elderly have been poorly described. The aim of this study is to estimate the ten-year incidence and mortality rates of myocardial infarction in a population-based large cohort of Spanish elders. METHODS: A population-based cohort of 3729 people older than 64 years old, free of previous myocardial infarction, was established in 1995 in three geographical areas of Spain. Any case of fatal and non-fatal myocardial infarction was investigated until December 2004 using the "cold pursuit method", previously used and validated by the the WHO-MONICA project. RESULTS: Men showed a significantly (p < 0.001) higher cumulative incidence of myocardial infarction (7.2%; 95%CI: 5.94-8.54) than women (3.8%; 95%CI: 3.06-4.74). Although cumulative incidence increased with age (p < 0.05), gender-differences tended to narrow. Adjusted incidence rates were higher in men (957 per 100 000 person-years) than in women (546 per 100 000 person-years) (p < 0.001) and increased with age (p < 0.001). The increase was progressive in women but not in men. Adjusted mortality rates were also higher in men than in women (p < 0.001), being three times higher in the age group of > or = 85 years old than in the age group of 65-74 years old (p < 0.001). CONCLUSION: Incidence of fatal and non-fatal myocardial infarction is high in the Spanish elderly population. Men show higher rates than women, but gender differences diminish with age.
Assuntos
Idoso Fragilizado/estatística & dados numéricos , Infarto do Miocárdio/epidemiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Evolução Fatal , Feminino , Humanos , Incidência , Masculino , Infarto do Miocárdio/mortalidade , Vigilância da População , Vigilância de Evento Sentinela , Distribuição por Sexo , Fatores Sexuais , Espanha/epidemiologia , Fatores de TempoRESUMO
The development of a questionnaire or a measuring instrument is a laborious and complex process and requires verification of its usefulness before implementation. We present a methodological work on the psychometric characteristics of assessment instruments and analysis of their main features, reliability and validity.
RESUMO
INTRODUCTION AND OBJECTIVES: To determine the incidence of and mortality due to myocardial infarction and coronary heart disease in the elderly population of Madrid, Spain. METHODS: The study involved a population-based cohort of 1297 individuals aged over 64 years without cardiovascular disease who were recruited in 1995. All cases of fatal and non-fatal myocardial infarction recorded up until December 2004 were investigated and classified using WHO-MONICA (World Health Organization-Multinational MONItoring of trends and determinants in CArdiovascular disease) criteria. RESULTS: Men had a significantly higher cumulative incidence of ischemic events (P< .001) and sudden death (P< .001), and a non-significantly higher risk of myocardial infarction (6.30%; 95% confidence interval [CI], 4.33%-8.76%) than women (4.90%; 95% CI, 3.54%-6.70%; P=.181). While the risk of myocardial infarction increased with age (P< .05), gender differences tended to narrow. The incidence was higher in men (889/100 000 person-years) than women (610/100,000 person-years; P< .001) and increased with age (P< .01). This increase was progressive in women but not in men. The mortality rate was also higher in men (472/100,000 person-years; 95% CI, 248-697) than women (328/100,000 person-years; 95% CI, 188-469; P< .001), and was six times higher in the 385-year-old age group than in those aged 65-74 years (P< .001). CONCLUSIONS: The incidence of fatal and non-fatal myocardial infarction was very high in the elderly population of Madrid. Both incidence and mortality rates increased dramatically with age after 64 years. Rates were higher in men than women at all ages, though gender differences decreased with age.
Assuntos
Idoso/estatística & dados numéricos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Fatores Etários , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Espanha/epidemiologiaRESUMO
UNLABELLED: The Internet contains a large amount of useful information on many subjects, but also information of doubtful quality. To help identify Web sites on vaccine safety that fulfil good practice, the Global Advisory Committee on Vaccine Safety of the World Health Organization (WHO) has published criteria to which sites should adhere and a listing of Web sites that fulfil them. There are no studies describing the common attributes of these sites. OBJECTIVE: To examine the attributes, design characteristics and resources of Web sites belonging to the Vaccine Safety Net (VSN) of the WHO. MATERIAL AND METHODS: A cross-sectional, descriptive observational study using an evaluation questionnaire was carried out applied to the VSN web sites listed in March-April 2007. RESULTS: Twenty-six Web sites accredited by the VSN by April 2007 were analysed. With respect to design and quality, all sites contained information about the site manager. Postal and Email addresses were available for 84.6% of the sites. About privacy and personal data processing, 73.1% of sites specified the data protection procedure used and stated that data were not sold or passed third parties. The most-used language was English (76.9%). 96.3% of sites had links to other pro-vaccination sites and 19.2% provided the addresses of vaccination centres. 63.6% of webs were aimed at general public and health care workers but there was no clear separation of documents or different entry routes. With respect to information on vaccine safety, 84.6% of sites had information on adverse effects. In the general information section, 92.3% of sites had a new developments section. Some sites had multiple sources of financing and in 57% of sites, the financing was public. CONCLUSIONS: The most-important plus factors found were the transparency of financing, the lack of links to the pharmaceutical industry, the transparency of site management and responsibility and the proven scientific quality and constant updating of contents.