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Book ; Online: Revisión bibliográfica sobre eficacia y seguridad de la luz ultravioleta y ozono para la desinfección de superficies

Garcia-Carpintero, Esther Elena / Cardaba Arranz, M. / Sanchez-Gomez, Luis Maria

2020

Abstract: Informes de Evaluación de Tecnologías Sanitarias AETS-ISCIII ... Objetivos El objetivo de esta revisión bibliográfica es analizar la información disponible sobre la eficacia y seguridad de los dispositivos de luz ultravioleta (UV) y ozono en la ... ...

Abstract	Informes de Evaluación de Tecnologías Sanitarias AETS-ISCIII Objetivos El objetivo de esta revisión bibliográfica es analizar la información disponible sobre la eficacia y seguridad de los dispositivos de luz ultravioleta (UV) y ozono en la desinfección de virus, especialmente en la desinfección del SARS-CoV-2. Metodología Se ha realizado una revisión sistemática de la información científica recogida en las principales bases de datos biomédicas, PubMed, EMBASE y Cochrane Library, así como en las bases de datos WoS y CRD. También se realizó una búsqueda en las bases de datos de las principales agencias de evaluación de tecnologías sanitarias. Resultados La búsqueda bibliográfica ha permitido incluir 15 estudios sobre la eficacia de la luz ultravioleta y ozono en la desinfección de virus. Ninguno de estos estudios analiza la eficacia de la desinfección en el SARS-CoV-2. Para analizar la eficacia de la radiación UV se han incluido 8 estudios primarios y un informe de evaluación de tecnologías sanitarias. Solo un estudio evaluaba la eficacia de la radiación en el ámbito hospitalario. Este estudio realizó un análisis de la eficacia de la radiación UV en la desinfección de habitaciones en un hospital pediátrico concluyendo que este tipo de dispositivo puede reducir la incidencia de infecciones en las vías respiratorias altas en niños. Dos de los estudios incluidos analizaron la eficacia de la radiación UV para la desinfección y reutilización de mascarillas. Los resultados de estos estudios indicaban que la radiación UV disminuía la carga vírica de las mascarillas, pero esta reducción podría no ser suficiente para lograr la desinfección. Por otro lado, la reducción de patógenos depende del tipo de patógeno y del diseño y material de las mascarillas. Por último, se han incluido cinco estudios que estudian a escala de laboratorio la eficacia de la radiación UV en la desinfección de distintos patógenos, entre los que se incluyen SARS-CoV y MERS-CoV. En todos estos estudios se concluye que la UV sería eficaz en la reducción de patógenos, aunque sería más efectiva para la desinfección de bacterias que para virus. de Evaluación de Tecnologías Sanitarias AETS-ISCIII Sí
Keywords	Luz ultravioleta ; Ozono ; desinfección ; SARS- Cov_2 ; COVID-19 ; covid19
Language	Spanish
Publisher	Instituto de Salud Carlos III
Publishing country	es
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Study designs for clinical trials applied to personalised medicine: a scoping review.

Superchi, Cecilia / Brion Bouvier, Florie / Gerardi, Chiara / Carmona, Montserrat / San Miguel, Lorena / Sánchez-Gómez, Luis María / Imaz-Iglesia, Iñaki / Garcia, Paula / Demotes, Jacques / Banzi, Rita / Porcher, Raphaël

BMJ open

2022 Volume 12, Issue 5, Page(s) e052926

Abstract: Objective: Personalised medicine (PM) allows treating patients based on their individual demographic, genomic or biological characteristics for tailoring the 'right treatment for the right person at the right time'. Robust methodology is required for PM ...

Abstract	Objective: Personalised medicine (PM) allows treating patients based on their individual demographic, genomic or biological characteristics for tailoring the 'right treatment for the right person at the right time'. Robust methodology is required for PM clinical trials, to correctly identify groups of participants and treatments. As an initial step for the development of new recommendations on trial designs for PM, we aimed to present an overview of the study designs that have been used in this field. Design: Scoping review. Methods: We searched (April 2020) PubMed, Embase and the Cochrane Library for all reports in English, French, German, Italian and Spanish, describing study designs for clinical trials applied to PM. Study selection and data extraction were performed in duplicate resolving disagreements by consensus or by involving a third expert reviewer. We extracted information on the characteristics of trial designs and examples of current applications of these approaches. The extracted information was used to generate a new classification of trial designs for PM. Results: We identified 21 trial designs, 10 subtypes and 30 variations of trial designs applied to PM, which we classified into four core categories (namely, Master protocol, Randomise-all, Biomarker strategy and Enrichment). We found 131 clinical trials using these designs, of which the great majority were master protocols (86/131, 65.6%). Most of the trials were phase II studies (75/131, 57.2%) in the field of oncology (113/131, 86.3%). We identified 34 main features of trial designs regarding different aspects (eg, framework, control group, randomisation). The four core categories and 34 features were merged into a double-entry table to create a new classification of trial designs for PM. Conclusions: A variety of trial designs exists and is applied to PM. A new classification of trial designs is proposed to help readers to navigate the complex field of PM clinical trials.
MeSH term(s)	Biomarkers ; Humans ; Medical Oncology ; Precision Medicine/methods ; Records ; Research Design
Chemical Substances	Biomarkers
Language	English
Publishing date	2022-05-06
Publishing country	England
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-052926
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Efficacy and safety of robotic spine surgery: systematic review and meta-analysis.

Luengo-Matos, Setefilla / Sánchez-Gómez, Luis María / Hijas-Gómez, Ana Isabel / García-Carpintero, Esther Elena / Ballesteros-Massó, Rafael / Polo-deSantos, Mar

Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology

2022 Volume 23, Issue 1, Page(s) 49

Abstract: Background: Robotic surgery (RS) may offer benefits compared with freehand/conventional surgery (FS) in the treatment of patients with spinal disease. The aim of this study was to evaluate the efficacy and safety of RS versus FS in spinal fusion.: ... ...

Abstract	Background: Robotic surgery (RS) may offer benefits compared with freehand/conventional surgery (FS) in the treatment of patients with spinal disease. The aim of this study was to evaluate the efficacy and safety of RS versus FS in spinal fusion. Methods: A systematic review and meta-analysis was performed. Data analysis and risk of bias assessment were analysed using REVMAN V5.3. Results: We found 11 randomised clinical trials involving 817 patients (FS: 408, RS: 409). The main diagnosis was degenerative spine disease. SpineAssist, Renaissance (Mazor Robotics), Tianji Robot and TiRobot robots (TINAVI Medical Technologies) were used. Pedicle screw placement within the safety zone (grades A + B according to the Gertzbein and Robbins scale) ranged from 93% to 100% in FS versus 85-100% in RS (relative risk 1.01, 95% CI 1.00-1.03, p = 0.14). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 6.45 min (95% CI -13.59 to 26.49, p = 0.53). Mean hospital stay was MD of -0.36 days (95% CI -1.03 to 0.31, p = 0.30) with no differences between groups. Contradictory results were found regarding fluoroscopy time, although there seems to be a lower radiation dose in RS versus FS (p < 0.05). Regarding safety, the studies included surgical revision frequency. Conclusions: No conclusive results were found suggesting that there are benefits in using RS over FS for spinal fusion. Further research with adequate patient selection, robot type and quality-of-life variables is needed. Level of evidence: level 1.
MeSH term(s)	Humans ; Lumbar Vertebrae/surgery ; Pedicle Screws ; Retrospective Studies ; Robotic Surgical Procedures/adverse effects ; Robotic Surgical Procedures/methods ; Robotics ; Spinal Diseases/surgery ; Spinal Fusion/methods ; Spine/surgery
Language	English
Publishing date	2022-10-15
Publishing country	Italy
Document type	Meta-Analysis ; Systematic Review
ZDB-ID	2043336-0
ISSN	1590-9999 ; 1590-9921
ISSN (online)	1590-9999
ISSN	1590-9921
DOI	10.1186/s10195-022-00669-0
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Book ; Online: Tipología de estudios clínicos

Sanchez-Gomez, Luis Maria / Garcia-Carpintero, Esther Elena / Plaza-Ramos, Jose A. / Molina, Pampa / Álvarez-del Arco, Débora / Grupo de Análisis Científico de Coronavirus del ISCIII (GACC-ISCIII)

2020

Abstract: Este informe está realizado con la evidencia científica disponible en la fecha de su elaboración y podrá ser actualizado si surgen nuevas evidencias ... Los estudios clínicos son investigaciones en las que se incluyen personas para analizar la seguridad y ... ...

Abstract	Este informe está realizado con la evidencia científica disponible en la fecha de su elaboración y podrá ser actualizado si surgen nuevas evidencias Los estudios clínicos son investigaciones en las que se incluyen personas para analizar la seguridad y la eficacia de productos, técnicas, medicamentos u otras novedades médicas o sanitarias que permitan la mejora de la salud de la población. La pandemia de COVID-19 está generando un aumento no sólo en la producción científica, sino en la búsqueda de soluciones frente a la infección por SARS-CoV-2, por lo que son muchos los estudios clínicos que hay planeados o en marcha. Conviene saber que no todos los estudios clínicos son iguales. Antes de llegar a las investigaciones con humanos en ensayo clínico hay que pasar por fases previas que garanticen la seguridad de lo que va a analizarse en el ensayo con personas. Por ello, de manera previa se hacen ensayos in vitro (en laboratorio, sobre células, tejidos u órganos) e in vivo sobre animales no humanos. Si se demuestra seguridad y la técnica o el medicamento que se prueba muestra eficacia, llega el turno de probarla en personas. Los ensayos clínicos tienen varias fases. En las fases I, II y III se va probando progresivamente la seguridad y la eficacia en humanos, antes de que la técnica, producto o medicamento llegue al mercado y a los pacientes. La fase IV estudia los efectos a largo plazo una vez ya se está utilizando, tras su aprobación. Una manera de dividir los estudios clínicos es calificándolos de experimentales u observacionales. En los primeros se controla y modifica el factor de estudio, es decir, se seleccionan los pacientes y se elige qué intervención se va a hacer. En los segundos no hay control ni influencia sobre el objeto de estudio y la investigación se limita a observar, medir y analizar. Los ensayos experimentales incluyen los ensayos clínicos aleatorizados, que se consideran los más completos y que pueden aportar una mejor evidencia para evaluar la eficacia de una intervención; y los ensayos comunitarios. Los ensayos observacionales incluyen diferentes tipos: estudios de cohortes, casos controles, transversales, ecológicos y estudios de caso o series de caso. Cada tipo de estudio clínico tiene sus características y no todos persiguen los mismos objetivos ni permiten las mismas posibilidades y resultados. La fiabilidad del estudio depende de diferentes factores, como su metodología, la cantidad de pacientes que incluya o la duración, entre muchos otros. Todos deben seguir unas normas éticas, incluir determinados protocolos de actuación y ser publicados en registros, que regulan su aprobación y desarrollo. En España existe el Registro Español de ensayos clínicos (REec), que está gestionado por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Con motivo de la COVID-19, la AEMPS ha establecido medidas excepcionales aplicables a los ensayos clínicos para gestionar las necesidades derivadas de la pandemia. Otros ejemplos de registros destacados son el de la Organización Mundial de la Salud (OMS), el de la Unión Europea o el de Estados Unidos. En el registro de Estados Unidos he han identificado 1.982 estudios sobre COVID-19, de los cuales 1.131 son estudios clínicos controlados -la mayoría en fase 2-, y 833 son estudios observacionales. No
Keywords	Coronavirus ; COVID-19 ; SARS- Cov_2 ; Investigación en salud ; Estudios clínicos ; covid19
Language	Spanish
Publishing date	2020-06-16
Publishing country	es
Document type	Book ; Online
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Article ; Online: Hormone therapy for preventing cardiovascular disease in post-menopausal women.

Main, Caroline / Knight, Beatrice / Moxham, Tiffany / Gabriel Sanchez, Rafael / Sanchez Gomez, Luis Maria / Roqué i Figuls, Marta / Bonfill Cosp, Xavier

The Cochrane database of systematic reviews

2013 , Issue 4, Page(s) CD002229

Abstract: Background: Evidence from systematic reviews of observational studies suggest that hormone replacement therapy (HT) may have beneficial effects in reducing the incidence of cardiovascular disease (CVD) events in post-menopausal women. This is an updated ...

Abstract	Background: Evidence from systematic reviews of observational studies suggest that hormone replacement therapy (HT) may have beneficial effects in reducing the incidence of cardiovascular disease (CVD) events in post-menopausal women. This is an updated version of a Cochrane review first published in 2005 (Gabriel-Sanchez 2005). Objectives: To assess the effects of HT for the prevention of CVD in post-menopausal women, and whether there are differential effects between use of single therapy alone compared to combination HT and use in primary or secondary prevention. Search methods: We searched the following databases to April 2010: Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE and LILACS. Selection criteria: Randomised controlled trials (RCTs) of women comparing orally administered HT with placebo with a minimum of six-months follow-up. Data collection and analysis: Two authors independently assessed study quality and extracted data. Risk Ratios (RR) with 95% confidence intervals were calculated for each outcome. Results were combined using fixed-effect meta-analyses, and where possible, further stratified analyses conducted to assess the effect of time on treatment. Additionally, univariate meta-regression analyses were undertaken to assess whether length of trial follow-up, single or combination treatment, or whether treatment for primary or secondary prevention were potential predictors for a number of CVD outcomes in the trials. Main results: Four new trials were identified through the update; one trial included in the previous review was excluded. Therefore the review included 13 trials with a total of 38,171 post-menopausal women. Overall, single and combination HT in both primary and secondary prevention conferred no protective effects for all cause mortality, CVD death, non-fatal MI, or angina. There were no significant differences in the number of coronary artery by-pass procedures or angioplasties performed between the trial arms. However there was an increased risk of stroke for both primary and secondary prevention when combination and single HT was combined, RR 1.26 (95% CI 1.11 to 1.43), in venous thromboembolic events, RR 1.89 (95% CI 1.58 to 2.26) and in pulmonary embolism RR 1.84 (95% CI 1.42 to 2.37) relative to placebo. The associated numbers needed-to-harm (NNH) were 164, 109 and 243 for stroke, venous thromboembolism and pulmonary embolism respectively. Authors' conclusions: Treatment with HT in post-menopausal women for either primary or secondary prevention of CVD events is not effective, and causes an increase in the risk of stroke, and venous thromboembolic events. HT should therefore only be considered for women seeking relief from menopausal symptoms. Short-term HT treatment should be at the lowest effective dose, and used with caution in women with predisposing risk factors for CVD events.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Cardiovascular Diseases/prevention & control ; Estrogen Replacement Therapy/adverse effects ; Estrogen Replacement Therapy/methods ; Female ; Hormone Replacement Therapy/adverse effects ; Hormone Replacement Therapy/methods ; Humans ; Middle Aged ; Postmenopause ; Stroke/chemically induced ; Venous Thromboembolism/chemically induced
Language	English
Publishing date	2013-04-30
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD002229.pub3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

Serrano-Aguilar, Pedro / Gutierrez-Ibarluzea, Iñaki / Díaz, Pilar / Imaz-Iglesia, Iñaki / González-Enríquez, Jesús / Castro, José Luis / Espallargues, Mireia / García-Armesto, Sandra / Arriola-Bolado, Paloma / Rivero-Santana, Amado / Perestelo-Pérez, Lilisbeth / González-Pacheco, Himar / Álvarez-Pérez, Yolanda / Faraldo-Vallés, María José / Puñal-Riobóo, Janet / Ramallo-Fariña, Yolanda / Sánchez-Gómez, Luis María / Asua-Batarrita, José / Reviriego-Rodrigo, Eva /

Moreno-Rodríguez, Anai / Juárez-Rojo, Celia / Vicente-Saiz, Marisa / Orejas-Pérez, Eugenia / Knabe-Guerra, Jutta / Prieto-Yerro, Isabel / González Del Yerro-Valdés, Cristina

International journal of technology assessment in health care

2021 Volume 37, Issue 1, Page(s) e63

Abstract: The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making ... ...

Abstract	The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.
MeSH term(s)	Costs and Cost Analysis ; Decision Making ; Humans ; Reproducibility of Results ; Spain ; Technology Assessment, Biomedical
Language	English
Publishing date	2021-05-04
Publishing country	England
Document type	Journal Article
ZDB-ID	632573-7
ISSN	1471-6348 ; 0266-4623
ISSN (online)	1471-6348
ISSN	0266-4623
DOI	10.1017/S0266462321000295
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Article ; Online: The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Serrano-Aguilar, Pedro / Asua-Batarrita, José / Molina-López, María Teresa / Espallargues, Mireia / Pons-Rafols, Joan / García-Armesto, Sandra / Arriola-Bolado, Paloma / López-García, Marisa / Faraldo-Vallés, María José / Sánchez-Gómez, Luis María / Juárez-Rojo, Celia / Prieto-Yerro, Isabel / Casado-Durández, Paloma / Sarria-Santamera, Antonio

International journal of technology assessment in health care

2019 Volume 35, Issue 3, Page(s) 176–180

Abstract: Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health ... ...

Abstract	Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.
MeSH term(s)	Cost-Benefit Analysis ; Guidelines as Topic ; Humans ; International Cooperation ; Organizational Objectives ; Spain ; State Medicine/organization & administration ; State Medicine/standards ; Technology Assessment, Biomedical/organization & administration ; Technology Assessment, Biomedical/standards
Language	English
Publishing date	2019-04-22
Publishing country	England
Document type	Journal Article
ZDB-ID	632573-7
ISSN	1471-6348 ; 0266-4623
ISSN (online)	1471-6348
ISSN	0266-4623
DOI	10.1017/S0266462319000205
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Article ; Online: Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol.

García-Olmos, Luis / Rodríguez-Salvanés, Francisco / Batlle-Pérez, Maurice / Aguilar-Torres, Río / Porro-Fernández, Carlos / García-Cabello, Alfredo / Carmona, Montserrat / Ruiz-Alonso, Sergio / Garrido-Elustondo, Sofía / Alberquilla, Ángel / Sánchez-Gómez, Luis María / Sánchez de Madariaga, Ricardo / Monge-Navarrete, Elena / Benito-Ortiz, Luis / Baños-Pérez, Nicolás / Simón-Puerta, Amaya / López Rodríguez, Ana Belén / Martínez-Álvarez, Miguel Ángel / Velilla-Celma, María Ángeles /

Bernal-Gómez, María Isabel

BMJ open

2017 Volume 7, Issue 6, Page(s) e014840

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Aged ; Aged, 80 and over ; Chronic Disease ; Disability Evaluation ; Female ; Heart Failure/diagnosis ; Hospitalization/statistics & numerical data ; Humans ; Male ; Middle Aged ; Predictive Value of Tests ; Prospective Studies ; Risk Assessment/methods ; Risk Factors ; Spain
Language	English
Publishing date	2017-06-08
Publishing country	England
Document type	Journal Article ; Validation Studies ; Research Support, Non-U.S. Gov't
ZDB-ID	2747269-3
ISSN	2044-6055 ; 2044-6055 ; 2053-3624
ISSN (online)	2044-6055
ISSN	2044-6055 ; 2053-3624
DOI	10.1136/bmjopen-2016-014840
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Article ; Online: Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters.

Rodríguez-Salvanés, Francisco / Novella, Blanca / Fernández Luque, María Jesús / Sánchez-Gómez, Luis María / Ruiz-Díaz, Lourdes / Sánchez-Alcalde, Rosa / Sierra-García, Belén / Mayayo, Soledad / Ruiz-López, Marta / Loeches, Pilar / López-Gónzález, Javier / González-Gamarra, Amelia

BMC family practice

2011 Volume 12, Page(s) 21

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Cardiovascular Diseases/prevention & control ; Cluster Analysis ; Cross-Sectional Studies ; Double-Blind Method ; Education, Medical, Continuing ; Female ; Follow-Up Studies ; Humans ; Information Dissemination/methods ; Male ; Medical Records ; Middle Aged ; Practice Guidelines as Topic ; Primary Health Care/methods ; Research Design ; Risk Factors ; Spain
Language	English
Publishing date	2011-04-19
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1471-2296
ISSN (online)	1471-2296
DOI	10.1186/1471-2296-12-21
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Article ; Online: A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.

Sánchez-Gómez, Luis María / Fernández-Luque, María Jesús / Ruiz-Díaz, Lourdes / Sánchez-Alcalde, Rosa / Sierra-García, Belén / Mayayo-Vicente, Soledad / Ruiz-López, Marta / Loeches-Belinchón, Pilar / López-Gónzález, Javier / González-Gamarra, Amelia / Gallego-Arenas, Angela / Cubillo-Serna, Ana / Gil-Juberias, Gema / Pérez-Cayuela, Pilar / Cañedo-Arguelles, Celina Arana / García-Pascual, Julia Natividad / Ruiz-Chércoles, Esther / Suarez-Fernández, Carmen / Garcia-Polo, Iluminada /

Abad-Perez, Daniel / Ballesteros-Arribas, Juan M / Izquierdo-Martínez, Maravillas / Salvador-Alcaide, Elena / Arribas-Vela, Ana B / Alonso-Pérez, Juan M / Veja-Piris, Lorena / Rodríguez-Salvanés, Francisco / Novella-Arribas, Blanca

BMC public health

2012 Volume 12, Page(s) 1024

Abstract: 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 ...

Abstract	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 β 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.
MeSH term(s)	Breakfast ; Cardiovascular Diseases/prevention & control ; Child ; Cluster Analysis ; Female ; Follow-Up Studies ; Health Education/methods ; Health Knowledge, Attitudes, Practice ; Health Promotion/methods ; Humans ; Male ; Music ; Obesity/prevention & control ; Program Evaluation ; Single-Blind Method
Language	English
Publishing date	2012-11-23
Publishing country	England
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial
ISSN	1471-2458
ISSN (online)	1471-2458
DOI	10.1186/1471-2458-12-1024
Database	MEDical Literature Analysis and Retrieval System OnLINE

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