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1.
SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. impr.) ; 41(1): 3-12, ene.-mar. 2015. tab, ilus
Artículo en Español | IBECS | ID: ibc-132661

RESUMEN

Objetivos. Determinar la prevalencia e incidencia de los factores de riesgo y eventos cardiovasculares en España, así como la calidad de su seguimiento en la práctica clínica. En este artículo se presentan los datos correspondientes a los primeros 830 pacientes incluidos en el IBERICAN. Metodología. IBERICAN es un estudio longitudinal, observacional y multicéntrico en el que se están incluyendo pacientes atendidos en las consultas de atención primaria en España. El estudio está abierto a sujetos entre 18 y 85 años, seleccionados de manera consecutiva en las consultas de atención primaria. El tratamiento de los pacientes se realizará de acuerdo a los criterios clínicos del médico investigador sin ninguna intervención por parte del estudio. Se han considerado como criterios de adecuado control de hipertensión arterial los de las guías europeas de 2013, para el control del colesterol LDL los de las guías europeas de prevención cardiovascular de 2012, y para la diabetes una HbA1c < 7%. Resultados. La edad media fue de 57,9 ± 14,1 años. El 54,1% tenían dislipidemia; el 47,5% hipertensión arterial; el 17,7% diabetes; y el 10,8% ya presentaban historia de cardiopatía isquémica. Respecto a la prescripción de fármacos, el 55% de los hipertensos tomaba ≥ 2 fármacos antihipertensivos pero solo el 59,9% lograron los objetivos. Entre los hiperlipidémicos, el 65,7% tomaban estatinas pero solo el 35,6% estaban controlados. Entre los diabéticos, únicamente el 51,4% conseguían los niveles de HbA1c recomendados. Conclusiones. Los sujetos atendidos en atención primaria muestran una elevada prevalencia de factores de riesgo y un pobre control de los mismos (AU)


Aims. To determine the prevalence and incidence of cardiovascular risk factors and cardiovascular events in Spain, as well as the quality of the follow-up in clinical practice. In this study the baseline data of the first interim analysis of IBERICAN are shown (n = 830). Methods. IBERICAN is a multicenter, longitudinal and observational population-based study of patients daily attended in primary care setting according to clinical practice in Spain. Subjects between 18 and 85 years daily attended in primary care setting are being included consecutively. Treatment of patients will be performed according only to clinical criteria of investigators. Blood pressure control was defined according to 2013 European guidelines of hypertension; LDL-cholesterol control was defined according to 2012 European guidelines of cardiovascular prevention; diabetes control was defined as HbA1c < 7%. Results. Mean age was 57.9 ± 14.1 years. 54.1% of patients had dyslipidemia, 47.5% hypertension, 17.7% diabetes, and 10.8% history of ischemic heart disease. Regarding drugs, despite 55% of hypertensive patients were taking ≥ 2 antihypertensive agents, only 59.9% achieved blood pressure targets; 65.7% of patients with dyslipidemia were taking statins, but only 35.6% attained LDL-cholesterol goals. Only 51.4% of diabetics achieved HbA1c goals. Conclusions. Subjects attended in primary care showed a high prevalence of cardiovascular risk factors with a poor control (AU)


Asunto(s)
Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Atención Primaria de Salud/métodos , Atención Primaria de Salud/tendencias , Atención Primaria de Salud , Factores de Riesgo , Hipertensión/epidemiología , Hipertensión/prevención & control , Atención Primaria de Salud/organización & administración , Atención Primaria de Salud/normas , Estudios Longitudinales/normas , Estudios Longitudinales
3.
J Gerontol B Psychol Sci Soc Sci ; 69(4): 567-74, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23733858

RESUMEN

OBJECTIVES: Identify characteristics distinguishing people who do and do not continue to participate in a longitudinal study and determine whether the longitudinal changes for people who continue are representative of the changes that would have occurred had longitudinal data been available from all of the initial participants. METHOD: Moderately large samples of returning (N = 2,082) and nonreturning (N = 1,698) participants across a wide age range (i.e., 18-97 years of age) performed a battery of cognitive tests and completed personality and mood questionnaires. Differences between the groups were examined with multiple regression analyses with age, returner status, and their interaction as predictors. RESULTS: Compared with participants who did not return, returning participants at the initial occasion had higher levels of each cognitive ability and of certain personality characteristics (e.g., agreeableness and openness), but many of the differences were only apparent among adults older than 50 years of age. Importantly, there was no evidence that the longitudinal change for nonreturning participants would have been different from that among the participants who did return. DISCUSSION: The phenomenon of selective attrition is more complex than often assumed, and it may not necessarily limit the generalizability of longitudinal comparisons.


Asunto(s)
Cognición/fisiología , Interpretación Estadística de Datos , Estudios Longitudinales/normas , Personalidad/fisiología , Proyectos de Investigación/normas , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Humanos , Estudios Longitudinales/estadística & datos numéricos , Persona de Mediana Edad , Pacientes Desistentes del Tratamiento/psicología , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Proyectos de Investigación/estadística & datos numéricos , Adulto Joven
4.
Rev Saude Publica ; 47 Suppl 2: 105-12, 2013 Jun.
Artículo en Portugués | MEDLINE | ID: mdl-24346727

RESUMEN

The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.


Asunto(s)
Servicios de Salud para Ancianos/normas , Garantía de la Calidad de Atención de Salud , Control de Calidad , Adulto , Brasil , Enfermedades Cardiovasculares/prevención & control , Enfermedad Crónica , Diabetes Mellitus/prevención & control , Monitoreo Epidemiológico , Humanos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Proyectos Piloto
5.
Rev Saude Publica ; 47 Suppl 2: 79-86, 2013 Jun.
Artículo en Portugués | MEDLINE | ID: mdl-24346724

RESUMEN

OBJECTIVE: The article describes the strategies adopted by the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) for participation and retention of subjects. This is key to ensure internal validity of longitudinal studies, and to identify, investigate, and ascertain outcomes of interest. METHODS: The follow-up strategies include annual telephone contacts with new assessments and interviews every three to four years this approach aims to identify transient outcomes (reversible or not), permanent outcomes as well as complications related to the progression of major diseases--cardiovascular diseases and diabetes--to be studied. RESULTS: Telephone interviews are designed to monitor subjects' health status and to identify potential health-related events such as hospital admissions, medical visits or pre-selected medical procedures. Subjects are also encouraged to report to the ELSA-Brasil team any new health-related events. When a potential event is identified, a thorough investigation is carried out to collect relevant information about that event from medical records. All data are blinded and reviewed and analyzed by a medical expert committee. Incident outcome ascertainment follows well-established international criteria to ensure data comparability and avoid misclassification. In addition to these strategies, the occurrence of health-related events is also investigated through linkage of secondary databases, such as national mortality and hospital admission databases. CONCLUSIONS: Accurate identification of outcomes will allow to estimating their incidence in the study cohort and to investigate the effect of the exposures studied in the ELSA-Brasil at baseline and at its subsequent waves.


Asunto(s)
Enfermedades Cardiovasculares/complicaciones , Complicaciones de la Diabetes , Estudios Longitudinales/métodos , Estudios Multicéntricos como Asunto , Cooperación del Paciente/estadística & datos numéricos , Adulto , Brasil , Enfermedad Crónica , Humanos , Entrevistas como Asunto , Estudios Longitudinales/normas
6.
Rev. esp. cir. ortop. traumatol. (Ed. impr.) ; 57(6): 391-397, nov.-dic. 2013. ilus
Artículo en Español | IBECS | ID: ibc-116865

RESUMEN

Objetivo. Recordar una enfermedad poco tratada en la literatura científica. Material y métodos. Estudio observacional, longitudinal y ambispectivo de una serie de 51 lipomas intramusculares en 50 pacientes. Se ha calculado la distribución de frecuencias de las variables cualitativas y la mediana y el rango intercuartil (RIC) de las cuantitativas. La relación entre el tamaño de los lipomas (recodificada en 2 valores) y las variables de estudio se ha analizado con el test exacto de Fisher. Resultados. El 62% de los pacientes de la serie fueron varones y la mediana de edad, 61 años, con sobrepeso en el 55% del total. Se describe su localización, sus características de presentación clínica y de imagen, su tratamiento y resultados. Discusión. Los lipomas intramusculares tienen un aspecto característico, aunque a veces la RM no los distingue de liposarcomas bien diferenciados. El tamaño como criterio único de derivación de un paciente con una lesión de partes blandas a un centro de referencia es discutible. Conclusiones. Los pacientes con lipomas intramusculares, aunque estos puedan ser típicos en su presentación, sobre todo cuando sean grandes y muestren signos que los puedan confundir con liposarcomas bien diferenciados de bajo grado, se deberían tratar en centros con experiencia (AU)


Objective: To review a poorly studied pathology in the scientific literature. Material and methods: An observational, longitudinal and ambispective study of a series of 51 intramuscular lipomas in 50 patients. The frequency distribution of qualitative variables, and the median and the interquartile range (IQR) for continuous variables were calculated. The relationship between the size of the lipomas (recoded into two values) and the study variables were analyzed using the Fisher exact test. Results: Men made up 62% of the series, and the median age was 61 years, with 55% of the total being overweight. About half of the patients were diagnosed in the upper limb. More than threequarters (78%) were strictly intramuscular lipomas. Location, clinical and image presentation, treatment and results are described. Discussion: Intramuscular lipomas have their own particular characteristics. Nevertheless, MRI is sometimes unable to distinguish them from well differentiated liposarcomas. Using size as the only criterion for referring a patient with a soft tissue injury to a reference center is still debatable. Conclusions: Patients with intramuscular lipomas, although they may be typical in their presentation, especially when they are large and show findings that can be confused with a well-differentiated low grade liposarcoma, should be treated in experienced centers (AU)


Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Lipoma/complicaciones , Lipoma/diagnóstico , Neoplasias de los Tejidos Blandos/complicaciones , Neoplasias de los Tejidos Blandos , Neoplasias de los Músculos/complicaciones , Neoplasias de los Músculos , Lipoma/fisiopatología , Lipoma , Estudios Longitudinales/normas , Estudios Longitudinales , Tiempo de Internación/economía , Imagen por Resonancia Magnética/métodos
7.
BJOG ; 120 Suppl 2: 33-7, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23841486

RESUMEN

Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21(st) Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this process. After initial training and standardisation, the USQU monitors the performance of all ultrasonographers involved in the project by continuously assessing the quality of the images and the consistency of the measurements produced. Ultrasonographers are identified when they exceed preset maximum allowable differences. Corrective action is then taken in the form of retraining or simply advice regarding changes in practice. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.


Asunto(s)
Pesos y Medidas Corporales/normas , Desarrollo Fetal , Gráficos de Crecimiento , Estudios Multicéntricos como Asunto/normas , Proyectos de Investigación/normas , Ultrasonografía Prenatal/normas , Pesos y Medidas Corporales/métodos , Competencia Clínica , Protocolos Clínicos , Femenino , Humanos , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/métodos , Variaciones Dependientes del Observador , Embarazo , Control de Calidad , Ultrasonografía Prenatal/métodos
8.
BJOG ; 120 Suppl 2: 42-7, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23841804

RESUMEN

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detail, the selection of anthropometric personnel, equipment, and measurement and calibration protocols used to construct the new standards. Implementing these protocols at each study site ensures that the anthropometric data are of the highest quality to construct the international standards.


Asunto(s)
Pesos y Medidas Corporales/métodos , Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales/instrumentación , Pesos y Medidas Corporales/normas , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Embarazo , Proyectos de Investigación/normas
9.
BJOG ; 120 Suppl 2: 48-55, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23841854

RESUMEN

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards.


Asunto(s)
Pesos y Medidas Corporales/normas , Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/normas , Proyectos de Investigación/normas , Pesos y Medidas Corporales/métodos , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Humanos , Lactante , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/métodos , Variaciones Dependientes del Observador , Control de Calidad
10.
BJOG ; 120 Suppl 2: 27-32, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23841904

RESUMEN

A unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21(st) Project. These standardised methods should minimise the systematic errors associated with pooling data from different study sites. They represent a model for carrying out similar research studies in the future.


Asunto(s)
Pesos y Medidas Corporales/métodos , Desarrollo Fetal , Gráficos de Crecimiento , Estudios Multicéntricos como Asunto/métodos , Ultrasonografía Prenatal/métodos , Líquido Amniótico/diagnóstico por imagen , Pesos y Medidas Corporales/instrumentación , Pesos y Medidas Corporales/normas , Protocolos Clínicos , Femenino , Edad Gestacional , Humanos , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Placenta/diagnóstico por imagen , Embarazo , Proyectos de Investigación/normas , Ultrasonografía Prenatal/instrumentación , Ultrasonografía Prenatal/normas
11.
Rev. saúde pública ; 47(supl.2): 79-86, jun. 2013. tab, graf
Artículo en Portugués | LILACS | ID: lil-688077

RESUMEN

OBJETIVO: O artigo descreve as estratégias do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) para a manutenção da adesão dos participantes ao longo do tempo e seu seguimento adequado. Isto é fundamental para garantir a validade interna de estudos longitudinais e identificar, investigar e classificar os desfechos incidentes de interesse. MÉTODOS: A metodologia de seguimento da coorte combina contatos telefônicos anuais com re-exames e entrevistas a cada três ou quatro anos. O objetivo é identificar desfechos incidentes de natureza transitória, reversíveis ou não; desfechos finais, de natureza irreversível; bem como complicações relacionadas à evolução das doenças cardiovasculares e diabetes, principais doenças estudadas. RESULTADOS: As entrevistas telefônicas visam monitorar a saúde dos participantes e identificar possíveis eventos ocorridos, como internações hospitalares, exames ou procedimentos especializados definidos previamente. O participante também é incentivado a comunicar a ocorrência de algum evento de saúde ao Centro de Pesquisa. A partir da identificação de um potencial evento, é iniciado um processo de investigação, que inclui acesso a prontuários médicos para verificação de datas e informações detalhadas sobre aquele evento. Os documentos obtidos são analisados sem identificação do paciente, profissional ou serviço de saúde e classificados por um comitê de especialistas médicos. A classificação de desfechos incidentes adotada baseia-se em critérios internacionais consagrados, garantindo comparabilidade e reduzindo o erro de classificação deles. Além dessas estratégias, a ocorrência de desfechos ...


OBJECTIVE: The article describes the strategies adopted by the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) for participation and retention of subjects. This is key to ensure internal validity of longitudinal studies, and to identify, investigate, and ascertain outcomes of interest. METHODS: The follow-up strategies include annual telephone contacts with new assessments and interviews every three to four years this approach aims to identify transient outcomes (reversible or not), permanent outcomes as well as complications related to the progression of major diseases - cardiovascular diseases and diabetes - to be studied. RESULTS: Telephone interviews are designed to monitor subjects' health status and to identify potential health-related events such as hospital admissions, medical visits or pre-selected medical procedures. Subjects are also encouraged to report to the ELSA-Brasil team any new health-related events. When a potential event is identified, a thorough investigation is carried out to collect relevant information about that event from medical records. All data are blinded and reviewed and analyzed by a medical expert committee. Incident outcome ascertainment follows well-established international criteria to ensure data comparability and avoid misclassification. In addition to these strategies, the occurrence of health-related events is also investigated through linkage of secondary databases, such as national mortality and hospital admission databases. CONCLUSIONS: Accurate identification of outcomes will allow to estimating their incidence in the study cohort and to investigate the effect of the exposures studied in the ELSA-Brasil at baseline and at its subsequent waves. .


Asunto(s)
Adulto , Humanos , Enfermedades Cardiovasculares/complicaciones , Complicaciones de la Diabetes , Estudios Longitudinales/métodos , Estudios Multicéntricos como Asunto , Cooperación del Paciente/estadística & datos numéricos , Brasil , Enfermedad Crónica , Entrevistas como Asunto , Estudios Longitudinales/normas
12.
Rev. saúde pública ; 47(supl.2): 105-112, jun. 2013. tab
Artículo en Portugués | LILACS | ID: lil-688079

RESUMEN

O Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) é um estudo de coorte composto de 15.105 adultos acompanhados para avaliar o desenvolvimento de doenças crônicas, especialmente diabetes e doença cardiovascular. Seu porte, natureza multicêntrica e diversidade de medidas exigiram mecanismos ágeis e efetivos de garantia e controle de qualidade. Entre as atividades de garantia de qualidade (aquelas desenvolvidas antes de iniciar a coleta de dados), destacam-se: seleção criteriosa dos instrumentos de pesquisa, treinamento e certificação centralizados, pré-testes e estudos pilotos, e elaboração de manuais de operações para os procedimentos. As atividades de controle de qualidade (realizadas durante a coleta e processamento dos dados) foram efetuadas mais intensivamente no início, quando as rotinas ainda não estavam estabelecidas. Entre elas, ressaltam-se: observação periódica dos aferidores, estudos de teste reteste, monitoramento dos dados, rede de supervisores e visitas cruzadas. Dados que estimam a confiabilidade das informações obtidas atestam que as metas de qualidade foram alcançadas.


The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.


Asunto(s)
Adulto , Humanos , Servicios de Salud para Ancianos/normas , Garantía de la Calidad de Atención de Salud , Control de Calidad , Brasil , Enfermedades Cardiovasculares/prevención & control , Enfermedad Crónica , Diabetes Mellitus/prevención & control , Monitoreo Epidemiológico , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Proyectos Piloto
13.
BJOG ; 120 Suppl 2: 9-26, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23678873

RESUMEN

INTERGROWTH-21(st) is a multicentre, multiethnic, population-based project, being conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from early pregnancy to infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. The new international standards will describe: (1) fetal growth assessed by clinical and ultrasound measures; (2) postnatal growth of term and preterm infants up to 2 years of age; and (3) the relationship between birthweight, length and head circumference, gestational age and perinatal outcomes. As the project has selected healthy cohorts with no obvious risk factors for intrauterine growth restriction, these standards will describe how all fetuses and newborns should grow, as opposed to traditional charts that describe how some have grown at a given place and time. These growth patterns will be related to morbidity and mortality to identify levels of perinatal risk. Additional aims include phenotypic characterisation of the preterm and impaired fetal growth syndromes and development of a prediction model, based on multiple ultrasound measurements, to estimate gestational age for use in pregnant women without access to early/frequent antenatal care.


Asunto(s)
Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales/métodos , Pesos y Medidas Corporales/normas , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Retardo del Crecimiento Fetal/diagnóstico , Retardo del Crecimiento Fetal/etiología , Edad Gestacional , Humanos , Lactante , Recién Nacido de Bajo Peso/crecimiento & desarrollo , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Embarazo , Nacimiento Prematuro/etiología , Fenómenos Fisiologicos de la Nutrición Prenatal , Estudios Prospectivos , Ultrasonografía Prenatal
14.
BJOG ; 120 Suppl 2: 38-41, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23678951

RESUMEN

Correct estimation of gestational age is essential for any study of ultrasound biometry and for everyday clinical practice. However, inconsistency in pregnancy dating may occur through differences in measurement methods or errors during measurement. In the INTERGROWTH-21(st) Project, pregnancies are dated by the last menstrual period, provided that it is certain and associated with a regular menstrual cycle, and the gestational age by dates concurs with a first-trimester ultrasound crown-rump length (CRL) estimation. Hence, there was a need to standardise CRL measurement methodology across the study sites in this international, multicentre project to avoid systematic differences in dating. To achieve uniformity we undertook the following steps: the ultrasound technique was standardised by disseminating an illustrated, operating manual describing CRL plane landmarks and calliper application, and posters describing the correct acquisition technique were disseminated for quick reference. To ensure that all ultrasonographers understood the methodology, they forwarded a log-book to the INTERGROWTH-21(st) Ultrasound Coordinating Unit, containing the answers to a written test on the manual material and five images of a correctly acquired CRL. Interpretation of CRL was also standardised by ensuring that the same CRL regression formula was used across all study sites. These methods should minimise potential systematic errors in dating associated with pooling data from different health institutions, and represent a model for standardising CRL measurement in future studies.


Asunto(s)
Largo Cráneo-Cadera , Desarrollo Fetal , Gráficos de Crecimiento , Estudios Multicéntricos como Asunto/normas , Proyectos de Investigación/normas , Ultrasonografía Prenatal/normas , Competencia Clínica , Protocolos Clínicos , Femenino , Edad Gestacional , Humanos , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/métodos , Embarazo , Ultrasonografía Prenatal/instrumentación , Ultrasonografía Prenatal/métodos
15.
BJOG ; 120 Suppl 2: 64-70, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23679040

RESUMEN

The INTERGROWTH-21(st) Project data management was structured incorporating both a centralised and decentralised system for the eight study centres, which all used the same database and standardised data collection instruments, manuals and processes. Each centre was responsible for the entry and validation of their country-specific data, which were entered onto a centralised system maintained by the Data Coordinating Unit in Oxford. A comprehensive data management system was designed to handle the very large volumes of data. It contained internal validations to prevent incorrect and inconsistent values being captured, and allowed online data entry by local Data Management Units, as well as real-time management of recruitment and data collection by the Data Coordinating Unit in Oxford. To maintain data integrity, only the Data Coordinating Unit in Oxford had access to all the eight centres' data, which were continually monitored. All queries identified were raised with the relevant local data manager for verification and correction, if necessary. The system automatically logged an audit trail of all updates to the database with the date and name of the person who made the changes. These rigorous processes ensured that the data collected in the INTERGROWTH-21(st) Project were of exceptionally high quality.


Asunto(s)
Desarrollo Infantil , Recolección de Datos/métodos , Bases de Datos Factuales , Desarrollo Fetal , Gráficos de Crecimiento , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Recolección de Datos/normas , Bases de Datos Factuales/normas , Humanos , Lactante , Recién Nacido/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Control de Calidad , Proyectos de Investigación/normas
16.
BJOG ; 120 Suppl 2: 117-22, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23679921

RESUMEN

There are approximately 10,000 births per year in the county of Oxfordshire in the UK, which is one of the two European sites for the International Fetal and Newborn Growth Consortium for the 21(st) Century (INTERGROWTH-21(st) ) Project. The samples for both components of the project--the Fetal Growth Longitudinal Study (FGLS) and Newborn Cross-Sectional Study (NCSS)--were drawn from the John Radcliffe Hospital, a major university hospital with a large regional role that covers more than 75% of deliveries in the county. Special activities to encourage participation in this population included the formation of a research coalition to streamline recruitment in the Maternity Unit and the distribution of study information leaflets to women using the hospital's antenatal care service. This was a demanding project and several challenges were overcome to reach recruitment targets and to maintain high standards of data quality. Amongst the major challenges for FGLS at this study site was the level of ineligibility because of maternal age, smoking and body mass index (BMI) ≥ 30. The major challenge for the NCSS field teams was to ensure that all anthropometric data were collected before the early discharge of uncomplicated deliveries, often within 6 hours of birth. It is evident from our experience in implementing this project that, when large-scale clinical studies are meticulously planned and avoid major disruption to routine clinical care, they are well received by hospital staff and can contribute to the improvement of the overall standard of clinical care.


Asunto(s)
Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Humanos , Lactante , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Selección de Paciente , Embarazo , Control de Calidad , Ultrasonografía Prenatal , Reino Unido
17.
BJOG ; 120 Suppl 2: 111-6, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23679957

RESUMEN

The Middle Eastern site in the INTERGROWTH-21(st) Project was Muscat, the capital city of Oman, with approximately 10,500 births per year. The sample for the Newborn Cross-Sectional Study (NCSS) was drawn from two hospitals covering 96% of the region's births. The Fetal Growth Longitudinal Study (FGLS) sample was recruited from four primary health facilities serving Khoula Hospital, using the eligibility criteria in the INTERGROWTH-21(st) protocol. Special activities to encourage participation in this population included local advocacy campaigns to encourage early antenatal booking and ultrasound dating in the population. The major challenges at the site were the recruitment of sufficient numbers of women at an early gestational age, and the timely measurement of all newborns within 12 hours of birth. Many individuals and institutions collaborated effectively over a period of several years on these studies, which required careful planning and close monitoring for their successful implementation.


Asunto(s)
Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Humanos , Lactante , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Omán , Selección de Paciente , Embarazo , Control de Calidad , Ultrasonografía Prenatal
18.
BJOG ; 120 Suppl 2: 87-93, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23679993

RESUMEN

The East Asian site in the INTERGROWTH-21(st) Project was Shunyi County, Beijing, China, which is an affluent suburb of north Beijing delivering approximately 7000 women annually. The Newborn Cross-Sectional Study (NCSS) sample was drawn from two hospitals, covering >85% of births in the county. The Fetal Growth Longitudinal Study sample (FGLS) was recruited from the antenatal clinic of Shunyi Maternal & Child Health Hospital, the larger of the two institutions. Special activities to promote the study in this population included: (1) the distribution of health education materials about the importance of antenatal care and (2) the organisation of seminars by the study team to brief key stakeholders at the two hospitals about the goals of the research. One of the major challenges at this site in the early stages of the study was a reluctance to have an early ultrasound dating scan (<14(+0) weeks of gestation). This challenge was overcome after a thorough evaluation of the literature regarding the benefits of an early ultrasound scan for dating purposes, as a result of which there was a formal change in hospital policy.


Asunto(s)
Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales , China , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Humanos , Lactante , Recien Nacido Prematuro/crecimiento & desarrollo , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Selección de Paciente , Embarazo , Control de Calidad , Ultrasonografía Prenatal
19.
BJOG ; 120 Suppl 2: 81-6, v, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23680026

RESUMEN

The Latin American site in the INTERGROWTH-21(st) Project was Pelotas, Brazil, with approximately 4000 births per year. The sample for the Newborn Cross-Sectional Study (NCSS) was drawn from four hospitals, covering 99% of births in the city. The Fetal Growth Longitudinal Study (FGLS) sample was recruited from one of the largest private ultrasound clinics in the city and 30 smaller, private, antenatal clinics serving middle to high socio-economic status women. Among this site's major challenges was the recruitment of women for FGLS from numerous different clinics. Several public relations activities were conducted to improve collaborative efforts between the research team and obstetricians, paediatricians and community leaders in Pelotas.


Asunto(s)
Desarrollo Infantil , Desarrollo Fetal , Gráficos de Crecimiento , Recién Nacido/crecimiento & desarrollo , Estudios Multicéntricos como Asunto/métodos , Proyectos de Investigación , Pesos y Medidas Corporales , Brasil , Protocolos Clínicos , Estudios Transversales/métodos , Estudios Transversales/normas , Femenino , Humanos , Lactante , Estudios Longitudinales/métodos , Estudios Longitudinales/normas , Estudios Multicéntricos como Asunto/normas , Selección de Paciente , Embarazo , Control de Calidad , Ultrasonografía Prenatal
20.
Aten. prim. (Barc., Ed. impr.) ; 45(4): 184-192, abr. 2013. tab, graf
Artículo en Español | IBECS | ID: ibc-111843

RESUMEN

Objetivos: a) Valorar la aplicabilidad de una consulta de alta resolución (CAR) para el diagnóstico de pacientes ambulatorios con insuficiencia cardíaca (IC) de inicio; b) caracterizar a los pacientes con IC y fracción de eyección preservada (ICFE-P) comparados con los de fracción de eyección reducida (ICFE-R), y c) determinar el nivel de péptido natriurético tipo B (PNB) para identificar la IC en esta población. Diseño: Estudio longitudinal observacional descriptivo. Emplazamiento: Atención primaria especializada. Participantes y mediciones: Ciento cuarenta y tres pacientes con síntomas iniciales de IC fueron incluidos en una CAR-IC con evaluación clínica, electrocardiograma, radiografía de tórax, PNB y ecocardiograma. Resultados: Se diagnosticó IC en 65,7% de los pacientes: 67% ICFE-P y 33% ICFE-R. La mayoría de pacientes con ICFE-P eran mujeres (71,4 versus 38,7%; p=0,002), con más edemas maleolares (61,9% versus 35,5%; p=0,016) e índice de masa corporal (29,8±5,1 versus 27,2±5,0; p=0,021). Ambos presentaron signos ecocardiográficos de disfunción diastólica e hipertensión pulmonar, con PNB (153,3±123,1 versus 400,8±579,8; p=0,025) y troponina I (0,024±0,019 versus 0,071±0,12; p=0,037) más elevados en ICFE-R. Resultaron predictores de ICFE-P el sexo femenino y los edemas maleolares, mientras que la onda Q, los valores elevados de PNB y la frecuencia cardíaca lo fueron de ICFE-R. El punto de corte de PNB=60,12 pg/ml identificó IC con sensibilidad del 83% y especificidad del 84% (ABC=0,898; IC 95% [0,848-0,948]; p<0,001). Conclusiones: La CAR-IC permitió el diagnóstico rápido y la caracterización de la IC de inicio, con mayor prevalencia de ICFE-P, en pacientes ambulatorios. El valor de PNB 60,12 pg/ml ofreció una sensibilidad y especificidad elevadas para identificar la IC en esta población(AU)


Objectives: a) To assess the usefulness of a one-stop clinic for the diagnosis of outpatients with new onset heart failure; b) to characterize these patients comparing preserved (HF-PEF) versus reduced ejection fraction (HF-REF), and c) to determine brain natriuretic peptide (BNP) cut-off limit to identify HF in outpatients. Design: Observational descriptive study. Setting: Primary care. Participants and measurements: A total of 143 outpatients with new onset HF were assessed in a one-stop clinic. A cardiologist evaluation, electrocardiogram, chest X-ray, BNP, and echocardiography (diastolic and systolic study) were performed. Results: Almost two-thirds (65.7%) were diagnosed with HF: 67% with HF-PEF and 33% HF-REF. Women (71.4% versus 38.7%, P=.002), presence of swelling ankles (61.9% versus 35.5%, P=.016) and higher body mass index (29.8±5.1 versus 27.2±5.0 P=.021) were more frequent in the first group of patients. Echocardiographic signs of diastolic dysfunction and pulmonary hypertension were found in both groups, with higher values of BNP (153.3±123.1 versus 400.8±579.8 P=.025) and troponin I (0.024±0.019 versus 0.071±0.12, P=.037) in HF-REF patients. Female gender and swelling ankles were predictors of HF-PEF in the multivariate analysis, while Q waves and higher values of BNP and heart rate were predictors of HF-REF. A cut-off value of 60.12 pg/ml for BNP provided 83% sensitivity, 84% specificity (AUC=0.898; 95% CI; 0.848-0.948; P <.001). Conclusions: The one-stop HF clinic has diagnosed and characterized outpatients with new onset HF and high prevalence of HF-PEF. The cut-off value of 60.12 pg/ml for BNP provides high sensitivity and specificity to identify HF in this population(AU)


Asunto(s)
Humanos , Masculino , Femenino , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/diagnóstico , Volumen Sistólico/fisiología , Péptidos Natriuréticos/uso terapéutico , Algoritmos , Atención Primaria de Salud , Insuficiencia Cardíaca , Ecocardiografía/métodos , Ecocardiografía , Atención Primaria de Salud/métodos , Sensibilidad y Especificidad , Estudios Longitudinales/normas , Estudios Longitudinales , Comorbilidad , Oportunidad Relativa , Intervalos de Confianza
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