Examinando por Autor "Madrid, Eva"

Mostrando 1 - 15 de 15
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    Angiotensin-converting-enzyme inhibitors and angiotensin II re-ceptor blockers for COVID-19: A living systematic review of randomized clinical trials
    (Medwave, 2021) Meza, Nicolás; Pérez-Bracchiglione, Javier; Pérez, Ignacio; Carvajal, Cristhian; Ortiz-Muñoz, Luis; Olguín, Pablo; Rada, Gabriel; Madrid, Eva
    Objective: This living systematic review aims to provide a timely, rigorous, and continuously updated summary of the evidence available on the role of angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) in the treatment of patients with COVID-19. Data sources: We conducted searches in PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), grey literature and in a centralized repository in L·OVE (Living OVerview of Evidence), which retrieves articles from multiple sources such as PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Embase, among other pre-print and protocols repositories. In response to the COVID-19 emergency, L·OVE (Living OVerview of Evidence) was adapted to expand the range of evidence and customized to group all COVID-19 evidence in one place on a daily search basis. The search covered a period of time up to July 31, 2020. Eligibility criteria for selecting studies and methods: We adapted an already published standard protocol for multiple parallel living systematic reviews to this question's specificities. We included randomized trials evaluating the effect of either suspension or indication of angiotensin-converting-enzyme inhibitors or angiotensin II receptor blockers as monotherapy, or in combination versus placebo or no treatment in patients with COVID-19.We searched for randomized trials evaluating the effect of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers versus placebo or no treatment in patients with COVID-19. Two reviewers independently screened each study for eligibility, extracted data, and assessed the risk of bias. We pooled the results using meta-analysis and applied the GRADE system to assess the certainty of the evidence for each outcome. We will resubmit results every time the conclusions change or whenever there are substantial updates. Results: We screened 772 records, but none was considered for eligibility. We identified 55 ongoing studies, including 41 randomized trials evaluating angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers for patients with COVID-19. Conclusions: We did not find a randomized clinical trial meeting our inclusion criteria, and hence there is no evidence for supporting the role of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers in the treatment of patients with COVID-19. A substantial number of ongoing studies would provide valuable evidence to inform researchers and decision-makers in the near future.
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    Diferencia mínima clínicamente importante: conceptos básicos
    (Medwave, 2021) Julieta Aldana Salas Apaza, Julieta; Ariel Franco, Juan Victor; Meza, Nicolás; Madrid, Eva; Loézar, Cristobal; Garegnani, Luis
    Este artículo es parte de una serie metodológica colaborativa de revisiones narrativas sobre temáticas de bioestadística y epidemiología clínica. El objetivo de esta revisión es presentar conceptos básicos sobre la diferencia mínima clínicamente importante y su utilización en el ámbito de la investigación clínica y la síntesis de evidencia. La diferencia mínima clínicamente importante se define como la diferencia más pequeña en la puntuación en cualquier dominio o desenlace de interés que los pacientes son capaces de percibir como beneficiosa. Es un concepto útil en varios aspectos, ya que vincula la magnitud del cambio con las decisiones de tratamiento en la práctica clínica y enfatiza la primacía de la percepción del paciente, que es afectada por un sinfín de variables tales como el tiempo, el lugar y el estado actual de salud, que pueden ocasionar gran variabilidad en los resultados.
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    Efficacy of methadone for the management of postoperative pain in laparoscopic cholecystectomy: A randomized clinical trial
    (Medwave, 2021) Arriaza, Nicolás; Papuzinski, Cristian; Kirmayr, Matías; Matta, Marcelo; Aranda, Fenando; Stojanova, Jana; Madrid, Eva
    Background: Postoperative pain management contributes to reducing postoperative morbidity and unscheduled readmission. Compared to other opioids that manage postoperative pain like morphine, few randomized trials have tested the efficacy of intraoperatively administered methadone to provide evidence for its regular use or be included in clinical guidelines. Methods: We conducted a randomized clinical trial comparing the use of intraoperative methadone to assess its impact on postoperative pain. Eighty-six patients undergoing elective laparoscopic cholecystectomy were allocated to receive either methadone (0.08 mg/kg) or morphine (0.08 mg/kg). Results: Individuals who received methadone required less rescue morphine in the Post Anesthesia Care Unit for postoperative pain than those who received morphine (p =0.0078). The patients from the methadone group reported less pain at 5 and 15 minutes and 12 and 24 hours following Post Anesthesia Care Unit discharge, exhibiting fewer episodes of nausea. Time to eye-opening was equivalent between the two groups. Conclusion: Intraoperative use of methadone resulted in better management of postoperative pain, supporting its use as part of a multimodal pain management strategy for laparoscopic cholecystectomy under remifentanil-based anesthesia.
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    Follow-up care over 12months of patients with prostate cancer in Spain
    (Wolters Kluwer Health, 2021) Bonfill, Xavier; Martinez-Zapata, María José; Vernooij, Robin W.M.; Sánchez, María José; Morales-Suárez-Varela, María; Emparanza, José Ignacio; Ferrer, Montse; Pijoan, José Ignacio; Palou, Joan; Madrid, Eva; Abraira, Victor; Zamora, Javier
    The therapeutic approach is crucial to prostate cancer prognosis. We describe treatments and outcomes for a Spanish cohort of patients with prostate cancer during the first 12months after diagnosis and identify the factors that influenced the treatment they received. This multicenter prospective cohort study included patients with prostate cancer followed up for 12months after diagnosis. Treatment was stratified by factors such as hospital, age group (<70 and ≥70 years), and D’Amico cancer risk classification. The outcomes were Eastern Cooperative Oncology Group (ECOG) performance status, adverse events (AEs), and mortality. The patient characteristics associated with the different treatment modalities were analyzed using multivariate logistic regression. We included 470 men from 7 Spanish tertiary hospitals (mean (standard deviation) age 67.8 (7.6) years), 373 (79.4%) of which received treatment (alone or in combination) as follows: surgery (n=163; 34.7%); radiotherapy (RT) (n=149; 31.7%); and hormone therapy (HT) (n=142; 30.2%). The remaining patients (n=97) were allocated to no treatment, that is, watchful waiting (14.0%) or active surveillance (5.7%). HT was the most frequently administered treatment during follow-up and RT plus HT was the most common therapeutic combination. Surgery was more frequent in patients aged <70, with lower histologic tumor grades, Gleason scores <7, and lower prostate-specific antigen levels; while RT was more frequent in patients aged ≥70 with histologic tumor grade 4, and higher ECOG scores. HT was more frequent in patients aged ≥70, with histologic tumor grades 3 to 4, Gleason score ≥8, ECOG ≥1, and higher prostate-specific antigen levels. The number of fully active patients (ECOG score 0) decreased significantly during follow-up, from 75.3% at diagnosis to 65.1% at 12months (P<.001); 230 (48.9%) patients had at least 1 AE, and 12 (2.6%) patients died. Surgery or RT were the main curative options. A fifth of the patients received no treatment. Palliative HT was more frequently administered to older patients with higher tumor grades and higher Gleason scores. Close to half of the patients experienced an AE related to their treatment.
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    Graficando el cuerpo de la evidencia: lo esencial para comprender el enfoque de los mapas de brecha de evidencia
    (Medwave, 2021) Schuller-Martínez, Bastián; Meza, Nicolás; Pérez-Bracchiglione, Javier; Ariel Franco, Juan Victor; Loezar, Cristóbal; Madrid, Eva
    El gran aumento en la producción de evidencia científica ha llevado a la creación de métodos para facilitar su revisión y síntesis, surgiendo distintos diseños según el objetivo principal que se busque cumplir. Los mapas de brecha de evidencia constituyen un enfoque novedoso de revisión de literatura. Corresponden a colecciones temáticas de un amplio campo de evidencia, utilizando una estrategia de búsqueda sistemática que destaca por identificar brechas o lagunas en el cuerpo de la evidencia disponible y por involucrar tempranamente a la audiencia definida como blanco para el diseño de un producto gráfico amigable. Se han establecido como una herramienta a considerar para guiar la agenda y el financiamiento de futuras investigaciones, y como apoyo en la toma de decisiones y en la creación de políticas basadas en evidencia. Los formatos más utilizados para representar sus hallazgos son el gráfico de burbujas y la grilla intervención-desenlace. Este artículo corresponde al sexto de una serie de revisiones narrativas acerca de tópicos generales en bioestadística y epidemiología clínica, y tiene por objetivo describir las características generales de los mapas de brecha de evidencia, destacar sus principales objetivos y utilidades, explorar los formatos de mapeo más utilizados y comparar este enfoque con otras propuestas de síntesis.
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    Graphical representation of the body of the evidence: the essentials for understanding the evidence gap map approach
    (Medwave, 2021) Schuller-Martínez, Bastián; Meza, Nicolás; Pérez-Bracchiglione, Javier; Ariel Franco, Juan Victor; Loezar, Cristóbal; Madrid, Eva
    The significant increase in scientific evidence production has led to the creation of methods to facilitate evidence review and synthesis. This has turned, this has resulted in the emergence of different designs depending on the review’s objective. Evidence gap maps constitute a novel approach for literature review. They are thematic collections of a broad field of evidence, using a systematic search strategy that identifies gaps in knowledge and engages, early on, the target audience to design a friendly graphic product. Evidence maps are a tool to be considered in the roster of options available for research funders in that they are particularly useful for evidence-based decision-making and evidence-based policy development. The most commonly used formats to display the findings of evidence gap search designs are the bubble plot and the intervention-outcome framework. This article corresponds to the sixth of a series of narrative reviews on general topics of biostatistics and clinical epidemiology. The purpose of this review is to describe the principal features of evidence gap maps, highlighting their main objectives and utility, exploring the most commonly used mapping formats, and comparing this approach with other evidence synthesis designs.
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    Inclusión de salud basada en evidencia en carreras de la salud en Chile y el modelo integrado Metodología de la Investigación Científica-Medicina Basada en Evidencia en la Universidad de Valparaíso
    (Elsevier, 2019) Papuzinski, Cristian; Loézar, Cristóbal; Carvajal, Natalia; Vargas, Manuel; Borgeat, Marjorie; Madrid, Eva; Pérez-Bracchiglione, Javier; Arancibia, Marcelo
    Introducción: La salud basada en evidencia (SBE) integra el uso de la mejor evidencia, la experiencia clínica y los valores y preferencias del paciente para la toma de decisiones. Su incorporación en las carreras sanitarias de Chile es desconocida. Métodos: Se realizó un estudio de corte transversal para evaluar la incorporación de SBE en los programas de las carreras sanitarias en Chile hasta 2019. Se describe la integración del modelo Metodología de la Investigación Científica (MIC)-Medicina Basada en la Evidencia (MBE) en la Escuela de Medicina de la Universidad de Valparaíso. Resultados: Un total de 49 universidades imparten carreras sanitarias. Un 8,13% incorpora SBE como asignatura explícitamente. Todas incorporan asignaturas que potencialmente incluyen contenidos de SBE. Las carreras de Medicina y Enfermería son las que más incorporan SBE, pero solo una carrera de Medicina incluye SBE como asignatura por más de un semestre. El modelo integrado MIC/MBE (4 semestres), orientado en competencias y centrado en el alumno, involucra el diseno ̃ y ejecución de un protocolo de investigación, así como el análisis crítico de la mejor evidencia, integrado con los valores de los pacientes. Conclusión: La incorporación de SBE como asignatura es muy infrecuente en carreras sanitarias chilenas. Se enfatiza su inclusión transdisciplinaria como asignatura individual desde un modelo que integre la ensenanza ̃ de MIC, sobre todo en universidades estatales.
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    Limiting low-value practices to contribute to a sustainable, efficient and equitable health system
    (Medwave, 2021) Ariel Franco, Juan Víctor; Kopitowski, Karin; Madrid, Eva
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    Making wise choices about low-value health care in the COVID-19 pandemic
    (Wiley, 2021) Clarke, Mike; Born, Karen; Johansson, Minna; Jørgensen, Karsten Juhl; Levinson, Wendy; Madrid, Eva; Muscat Meng, Dina; Ariel Franco, Juan Victor
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    Maternal and perinatal outcomes related to COVID-19 and pregnancy: An overview of systematic reviews
    (Wiley, 2021) Vergara-Merino, Laura; Meza, Nicolás; Couve-Pérez, Constanza; Carrasco, Cynthia; Ortiz-Muñoz, Luis; Madrid, Eva; Bohorquez-Blanco, Sandra; Pérez-Bracchiglione, Javier
    Introduction: Evidence about coronavirus disease 2019 (COVID-19) and pregnancy has rapidly increased since December 2019, making it difficult to make rigorous evidence-based decisions. The objective of this overview of systematic reviews is to conduct a comprehensive analysis of the current evidence on prognosis of COVID-19 in pregnant women. Material and methods: We used the Living OVerview of Evidence (L·OVE) platform for COVID-19, which continually retrieves studies from 46 data sources (including PubMed/MEDLINE, Embase, other electronic databases, clinical trials registries, and preprint repositories, among other sources relevant to COVID-19), mapping them into PICO (population, intervention, control, and outcomes) questions. The search covered the period from the inception date of each database to 13 September 2020. We included systematic reviews assessing outcomes of pregnant women with COVID-19 and/or their newborns. Two authors independently screened the titles and abstracts, assessed full texts to select the studies that met the inclusion criteria, extracted data, and appraised the risk of bias of each included systematic review. We measured the overlap of primary studies included among the selected systematic reviews by building a matrix of evidence, calculating the corrected covered area, and assessing the level of overlap for every pair of systematic reviews. Results: Our search yielded 1132 references. 52 systematic reviews met inclusion criteria and were included in this overview. Only one review had a low risk of bias, three had an unclear risk of bias, and 48 had a high risk of bias. Most of the included reviews were highly overlapped among each other. In the included reviews, rates of maternal death varied from 0% to 11.1%, admission to intensive care from 2.1% to 28.5%, preterm deliveries before 37 weeks from 14.3% to 61.2%, and cesarean delivery from 48.3% to 100%. Regarding neonatal outcomes, neonatal death varied from 0% to 11.7% and the estimated infection status of the newborn varied between 0% and 11.5%. Conclusions: Only one of 52 systematic reviews had a low risk of bias. Results were heterogeneous and the overlap of primary studies was frequently very high between pairs of systematic reviews. High-quality evidence syntheses of comparative studies are needed to guide future clinical decisions.
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    Misleading clinical evidence and systematic reviews on ivermectin for COVID-19
    (Bmj, 2021) Garegnani, Luis Ignacio; Madrid, Eva; Meza, Nicolás
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    Patients’ participation in government-sponsored guidelines in Latin America: a cross-sectional study
    (Bmj, 2022) Garegnani, Luis Ignacio; Meza, Nicolás; Rosón-Rodriguez, Pablo; Escobar-Liquitay, Camila Micaela; Arancibia, Marcelo; Madrid, Eva; Franco, Juan Victor Ariel
    Background. It is recommended that patients actively participate in clinical practice guideline (CPG) development, which allows consideration of their values and preferences and improves adherence to recommendations. The development of CPGs throughout Latin America is variable and diverse, and the inclusion of patients’ participation is unknown. Objectives. To evaluate the methods of patients’ participation in government-sponsored CPGs in Latin America, the type of CPG development and the use of Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methods. Design Cross-sectional study. We included CPGs developed over the last 10 years through a comprehensive hand search in official national government websites and biomedical databases. Main outcome measure. The type of patients’ participation was coded according to five predefined categories. We also report the proportion of application of GRADE methods. Results. We included 408 CPGs from 10 countries: 74% (n=303) were de novo development, 13%(n=55) used an adaptation method and 10%(n=41) used both adaptation and de novo methods. Only 45% (n=185) applied the GRADE approach, ranging from 14% (n=12) of CPGs in Brazil to 89% (n=56) of CPGs in Colombia. Only 23% (n=95) of CPGs included at least one method of patients’ participation. Mexico was one of the largest CPG producers (100 CPGs), but none included methods of patients’ participation; in turn, in countries with lower production of government-sponsored CPGs, patients’ participation was found in almost 88%. Guidelines using the GRADE approach were more likely to use methods of patients’ participation. These methods were highly variable: 46% (n=44) incorporated patients in the panel, 81% (n=77) searched for evidence about patients’ values and preferences, 43% (n=39) used an external review of the draft recommendations by patients, 38% (n=36) used public comments, and 2% included other methods for stakeholders’ participation. Conclusion. Only one quarter of government-sponsored CPGs in the Latin American region incorporated a method for patients’ participation, which varied considerably across the selected countries. These findings highlight the need to improve CPG development methods to systematically incorporate patients’ values and preferences when drafting recommendations.
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    Registered trials address questions already answered with high-certainty evidence: A sample of current redundant research
    (Elsevier, 2021) Vergara-Merino, Laura; Verdejo, Catalina; Ariel Franco, Juan Victor; Escobar Liquitay, Camila; Urrútia, Gerard; Klabundea, Rachel; Pérez, Paulina; Sánchez, Luna; Madrid, Eva
    Objective. To identify clinical trials registered later than 2015, that study the effect of an intervention on a primary outcome whose “Certainty of Evidence” (CoE) has already been rated “high” in a Cochrane SR. Study Design and Setting. We searched the Cochrane Library for all SRs from 2015. We analyzed SRs of interventions and excluded withdrawn reviews or those with no Summary of Findings (SoF) table. We retrieved the GRADE CoE ratings of each SR's primary outcomes in the SoF tables and identified those rated “high.” We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials to identify records of clinical studies that tackled those outcomes and were registered after the date of publication of the respective 2015 SR. Results. We selected 602 SRs. Eighty-one contained a “high” CoE rating on at least one primary outcome, totaling 152 primary outcomes rated “high.” We found 39 clinical trials registered for primary outcomes with evidence already rated as “high” in a 2015 Cochrane SR. Conclusion. This study shows the existence of clinical trials registered to study primary outcomes whose CoE has already been rated “high” in a Cochrane SR.
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    Stem cell therapy for dilated cardiomyopathy (Review)
    (Cochrane, 2021) Díaz-Navarro, Rienzi; Urrútia, Gerard; Cleland, John Gf; Poloni, Daniel; Villagran, Francisco; Acosta-Dighero, Roberto; Bangdiwala, Shrikant I; Rada, Gabriel; Madrid, Eva
    Background. Stem cell therapy (SCT) has been proposed as an alternative treatment for dilated cardiomyopathy (DCM), nonetheless its effectiveness remains debatable. Objectives. To assess the effectiveness and safety of SCT in adults with non‐ischaemic DCM. Search methods. We searched CENTRAL in the Cochrane Library, MEDLINE, and Embase for relevant trials in November 2020. We also searched two clinical trials registers in May 2020. Selection criteria. Eligible studies were randomized controlled trials (RCT) comparing stem/progenitor cells with no cells in adults with non‐ischaemic DCM. We included co‐interventions such as the administration of stem cell mobilizing agents. Studies were classified and analysed into three categories according to the comparison intervention, which consisted of no intervention/placebo, cell mobilization with cytokines, or a different mode of SCT. The first two comparisons (no cells in the control group) served to assess the efficacy of SCT while the third (different mode of SCT) served to complement the review with information about safety and other information of potential utility for a better understanding of the effects of SCT. Data collection and analysis. Two review authors independently screened all references for eligibility, assessed trial quality, and extracted data. We undertook a quantitative evaluation of data using random‐effects meta‐analyses. We evaluated heterogeneity using the I² statistic. We could not explore potential effect modifiers through subgroup analyses as they were deemed uninformative due to the scarce number of trials available. We assessed the certainty of the evidence using the GRADE approach. We created summary of findings tables using GRADEpro GDT. We focused our summary of findings on all‐cause mortality, safety, health‐related quality of life (HRQoL), performance status, and major adverse cardiovascular events. Main results. We included 13 RCTs involving 762 participants (452 cell therapy and 310 controls). Only one study was at low risk of bias in all domains. There were many shortcomings in the publications that did not allow a precise assessment of the risk of bias in many domains. Due to the nature of the intervention, the main source of potential bias was lack of blinding of participants (performance bias). Frequently, the format of the continuous data available was not ideal for use in the meta‐analysis and forced us to seek strategies for transforming data in a usable format. We are uncertain whether SCT reduces all‐cause mortality in people with DCM compared to no intervention/placebo (mean follow‐up 12 months) (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.54 to 1.31; I² = 0%; studies = 7, participants = 361; very low‐certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection in people with DCM (data could not be pooled; studies = 7; participants = 361; very low‐certainty evidence). We are uncertain whether SCT improves HRQoL (standardized mean difference (SMD) 0.62, 95% CI 0.01 to 1.23; I² = 72%; studies = 5, participants = 272; very low‐certainty evidence) and functional capacity (6‐minute walk test) (mean difference (MD) 70.12 m, 95% CI –5.28 to 145.51; I² = 87%; studies = 5, participants = 230; very low‐certainty evidence). SCT may result in a slight functional class (New York Heart Association) improvement (data could not be pooled; studies = 6, participants = 398; low‐certainty evidence). None of the included studies reported major adverse cardiovascular events as defined in our protocol. SCT may not increase the risk of ventricular arrhythmia (data could not be pooled; studies = 8, participants = 504; low‐certainty evidence). When comparing SCT to cell mobilization with granulocyte‐colony stimulating factor (G‐CSF), we are uncertain whether SCT reduces all‐cause mortality (RR 0.46, 95% CI 0.16 to 1.31; I² = 39%; studies = 3, participants = 195; very low‐certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection (studies = 1, participants = 60; very low‐certainty evidence). SCT may not improve HRQoL (MD 4.61 points, 95% CI –5.62 to 14.83; studies = 1, participants = 22; low‐certainty evidence). SCT may improve functional capacity (6‐minute walk test) (MD 140.14 m, 95% CI 119.51 to 160.77; I² = 0%; studies = 2, participants = 155; low‐certainty evidence). None of the included studies reported MACE as defined in our protocol or ventricular arrhythmia. The most commonly reported outcomes across studies were based on physiological measures of cardiac function where there were some beneficial effects suggesting potential benefits of SCT in people with non‐ischaemic DCM. However, it is unclear if this intermediate effects translates into clinical benefits for these patients. With regard to specific aspects related to the modality of cell therapy and its delivery, uncertainties remain as subgroup analyses could not be performed as planned, making it necessary to wait for the publication of several studies that are currently in progress before any firm conclusion can be reached. Authors' conclusions. We are uncertain whether SCT in people with DCM reduces the risk of all‐cause mortality and procedural complications, improves HRQoL, and performance status (exercise capacity). SCT may improve functional class (NYHA), compared to usual care (no cells). Similarly, when compared to G‐CSF, we are also uncertain whether SCT in people with DCM reduces the risk of all‐cause mortality although some studies within this comparison observed a favourable effect that should be interpreted with caution. SCT may not improve HRQoL but may improve to some extent performance status (exercise capacity). Very low‐quality evidence reflects uncertainty regarding procedural complications. These suggested beneficial effects of SCT, although uncertain due to the very low certainty of the evidence, are accompanied by favourable effects on some physiological measures of cardiac function. Presently, the most effective mode of administration of SCT and the population that could benefit the most is unclear. Therefore, it seems reasonable that use of SCT in people with DCM is limited to clinical research settings. Results of ongoing studies are likely to modify these conclusions.
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    Taxanes for advanced non-small cell lung cancer (Protocol)
    (Cochrane, 2018) Madrid, Eva; Barros Monge, Manuel J; Urrútia, Gerard; Roqué I Figuls, Marta; Pérez Bracchiglione, Javier; Vargas Peirano, Manuel; Loézar Hernández, Cristóbal Nicolás; Bonfill Cosp, Xavier
    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of taxanes as part of a combined or single‐agent therapy versus other agents or best supportive care as first‐ or second‐line treatment for advanced non‐small cell lung cancer (NSCLC). A secondary objective is to assess different modes or schemes of administration of taxanes in patients with this disease.