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BACKGROUND: Latin American and Caribbean Health Sciences Literature (LILACS) is the main reference database in the region; however, the way in which this resource is used in Cochrane systematic reviews has not been studied. OBJECTIVES: To assess the search methods of Cochrane reviews that used LILACS as a source of information and explore the Cochrane community's perceptions about this resource. METHODS: We identified all Cochrane reviews of interventions published during 2019, which included LILACS as a source of information, and analysed their search methods and also ran a survey through the Cochrane Community. RESULTS: We found 133 Cochrane reviews that reported the full search strategies, identifying heterogeneity in search details. The respondents to our survey highlighted many areas for improvement in the use of LILACS, including the usability of the search platform for this purpose. DISCUSSION: The use and reporting of LILACS in Cochrane reviews demonstrate inconsistencies, as evidenced by the analysis of search reports from systematic reviews and surveys conducted among members of the Cochrane community. CONCLUSION: With better guidance on how LILACS database is structured, information specialists working on Cochrane reviews should be able to make more effective use of this unique resource.

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Exposure to heavy metals may cause the overproduction of reactive oxygen species, generating oxidative stress and consequently, various harms to human health. The soil surrounding the Ventanas Industrial Complex, in Puchuncaví and Quintero municipal districts on the central Chilean coast, contains heavy metal concentrations (As, Cu, Pb, Zn, among others) that far exceed the maximum permissible levels established by Italian soil standards (used as a reference). This study aimed to investigate the potential association between heavy metal exposure in humans and the levels of oxidative stress biomarkers in inhabitants of these locations. We took blood samples from 140 adults living in sites with high concentrations of heavy metals in the soil and compared them with blood samples from 140 adults living in areas with normal heavy metal concentrations. We assessed lipid peroxidation, damage to genetic material, and Total Antioxidant Capacity in these blood samples. Our results indicate an association between oxidative damage and heavy metal exposure, where the inhabitants living in exposed areas have a higher level of DNA damage compared with those living in control areas. Given that DNA damage is one of the main factors in carcinogenesis, these results are of interest, both for public health and for public policies aimed at limiting human exposure to environmental pollution.

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OBJECTIVE: To assess the effectiveness of non-pharmacological interventions for the treatment of autism spectrum disorder (ASD) in children. DESIGN: Overview of systematic reviews (SRs). PARTICIPANTS: Children aged 12 years and under with ASD. SEARCH METHODS: In October 2021, we searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and Epistemonikos placing no restrictions on language or date of publication. INTERVENTIONS: 17 non-pharmacological interventions compared with placebo, no-treatment (including waiting list) or other interventions (ie, usual care, as defined by the authors of each study). DATA COLLECTION AND ANALYSIS: We rated the methodological quality of the included SRs using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2). We reported the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) certainty of the evidence (CoE) according to the analysis conducted by the authors of the included SRs. MAIN OUTCOME MEASURES: A multidisciplinary group of experts agreed on analysing nine critical outcomes evolving core and non-core ASD symptoms. PUBLIC AND PATIENT INVOLVEMENT STATEMENT: Organisations of parents of children with ASD participated in external revision of the final version of the report. RESULTS: We identified 52 reports that were within our scope, of which 48 were excluded for various reasons. After excluding less reliable SRs, we included four SRs. Non-pharmacological interventions (ie, Early Intensive Behavioural Intervention, Applied Behaviour Analysis, Picture Exchange Communication System and Naturalistic Developmental Behavioural Interventions) may have favourable effects on some core outcomes including language, social and functioning, play or daily living skills in children with ASD (with either no GRADE assessment, very low or low CoE). In addition, we identified a lack of report for other key outcomes in the included SRs (ie, restricted, repetitive behaviour; play and sensory processing). CONCLUSIONS: Synthesised evidence regarding the efficacy of non-pharmacological interventions for children with ASD is scarce. High-quality SRs addressing the variety of both non-pharmacological interventions and relevant outcomes are needed. PROSPERO REGISTRATION NUMBER: CRD42020206535.

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OBJECTIVES: To assess the effectiveness and safety of risperidone and aripiprazole in children with autism spectrum disorder (ASD). DESIGN AND SETTING: Overview of systematic reviews (SRs). SEARCH METHODS: In October 2021, we searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycInfo and Epistemonikos placing no restrictions on language or date of publication. PARTICIPANTS: Children aged 12 years or less with ASD. INTERVENTIONS: Risperidone and aripiprazole with no dosage restrictions. DATA COLLECTION AND ANALYSIS: We rated the methodological quality of the included SRs using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2). We reported the Grading of Recommendations, Assessment, Development and Evaluation certainty of the evidence according to the analysis conducted by the authors of the included SRs. MAIN OUTCOMES MEASURED: A multidisciplinary group of experts agreed on analysing nine critical outcomes evolving core and non-core ASD symptoms. PATIENT AND PUBLIC INVOLVEMENT: Organisations of parents of children with ASD were involved during part of the process, participating in external revision of the final version of the report for the Chilean Ministry of Health with no additional comments (ID 757-22-L120 DIPRECE, Ministry of Health, Chile). The organisations involved were: Fundación Unión Autismo y Neurodiversidad, Federación Nacional de Autismo, Vocería Autismo del Sur, and Vocería Autismo del Norte. RESULTS: We identified 22 SRs within the scope of this overview, of which 16 were of critically low confidence according to AMSTAR 2 and were excluded from the analysis. Both aripiprazole and risperidone were effective for reducing autism symptoms severity, repetitive behaviours, inappropriate language, social withdrawal and behavioural problems compared with placebo. The certainty of the evidence for most outcomes was moderate. Risperidone and aripiprazole are associated with metabolic and neurological adverse events. Follow-up was short termed. CONCLUSIONS: We found that aripiprazole and risperidone probably reduce symptom severity at short-term follow-up but may also cause adverse events. High-quality and updated SRs and larger randomised controlled trials with longer term follow-up are needed on this topic. OVERVIEW PROTOCOL: PROSPERO CRD42020206535.

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BACKGROUND: Both perfectionism and social anxiety have been described in patients with eating disorders (ED) and medical students. Academic stress also can increase the risk of developing ED. AIM: To analyze the dimensions of perfectionism, social anxiety, and academic stress associated with the risk of developing ED in female medical students. MATERIAL AND METHODS: The Multidimensional Perfectionism Scale, the Liebowitz Social Anxiety Scale, the SISCO academic stress inventory and the Eating Attitudes Test-26, were applied to 163 female medical students from all levels of the career. The groups with and without risk of ED were compared according to these variables. Results: Twenty-four percent of respondents were at risk of ED. There were significant differences between scores of perfectionism, social anxiety, and academic stress between respondents with and without risk for ED. In general, there was a significant correlation among the variables. In a multivariate analysis, the predictors of ED risk were the perception of academic stress (Odds ratio (OR) 1.09; 95% confidence intervals (CI) 1.03-1.16) and personal standards in the context of perfectionism (OR 1.16; 95% CI 1.06-1.27). CONCLUSIONS: A substantial proportion of female medical students were at risk for ED. The risk of ED was determined mainly by academic stress and personal standards in the context of perfectionism. In this sample, social anxiety did not play a relevant role.

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INTRODUCTION: Clinical research broadly aims to influence decision-making in order to promote appropriate healthcare. Funding agencies should prioritise research projects according to needed research topics, methodological and cost-effectiveness considerations, and expected social value. In Chile, there is no local diagnosis regarding recent clinical research that might inform prioritisation for future research funding. This research aims to comprehensively identify and classify Chilean health research studies, elaborating evidence gap maps for the most burdensome local conditions. METHODS AND ANALYSIS: We will search in electronic databases (MEDLINE, Embase, PsycINFO, CINAHL, LILACS and WoS) and perform hand searches to retrieve, identify and classify health research studies conducted in Chile or by authors whose affiliations are based in Chile, from 2000 onwards. We will elaborate evidence matrices for the 20 conditions with the highest burden in Chile (according to the Global Burden of Disease 2019) selected from those defined under the General Regime of the Health Guarantees Act. To elaborate the evidence gap maps, we will consider prioritised interventions and core outcome sets. To identify knowledge gaps and estimate redundant research, we will contrast these gap maps with the available international evidence of high or moderate certainty of evidence, for each specific clinical question. For this purpose, we will search systematic reviews using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: No ethical approval is required to conduct this project. We will submit our results in both peer-reviewed journals and scientific conferences. We will aim to disseminate our findings through different academic platforms, social media, local press, among others. The final results will be communicated to local funding agencies and government stakeholders. DISCUSSION: We aim to provide an accurate and up-to-date picture of the research gaps-to be filled by new future findings-and the identification of redundant research, which will constitute relevant information for local decision-makers.

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Overlap of primary studies among systematic reviews (SRs) is one of the main methodological challenges when conducting overviews. If not assessed properly, overlapped primary studies may mislead findings, since they may have a major influence either in qualitative analyses or in statistical weight. Moreover, overlapping SRs may represent the existence of duplicated efforts. Matrices of evidence and the calculation of the overall corrected covered area (CCA) are appropriate methods to address this issue, but they seem to be not comprehensive enough. In this article we present Graphical Representation of Overlap for OVErviews (GROOVE), an easy-to-use tool for overview authors. Starting from a matrix of evidence, GROOVE provides the number of included primary studies and SRs included in the matrix; the absolute number of overlapped and non-overlapped primary studies; and an overall CCA assessment. The tool also provides a detailed CCA assessment for each possible pair of SRs (or "nodes"), with a graphical and easy-to-read representation of these results. Additionally, it includes an advanced optional usage, incorporating structural missingness in the matrix. In this article, we show the details about how to use GROOVE, what results it achieves and how the tool obtains these results. GROOVE is intended to improve the overlap assessment by making it easier, faster, and more friendly for both authors and readers. The tool is freely available at http://doi.org/10.17605/OSF.IO/U2MS4 and https://es.cochrane.org/es/groovetool.

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Gene expression can be modified in people who are chronically exposed to high concentrations of heavy metals. The soil surrounding the Ventanas Industrial Complex, located on the coastal zone of Puchuncaví and Quintero townships (Chile), contain heavy metal concentrations (As, Cu, Pb, Zn, among others) that far exceed international standards. The aim of this study was to determine the potential association of the heavy metals in soils, especially arsenic, with the status of methylation of four tumor suppressor genes in permanent residents in those townships. To study the methylation status in genes p53, p16, APC, and RASSF1A, we took blood samples from adults living in areas near the industrial complex for at least 5 years and compared it to blood samples from adults living in areas with normal heavy metal concentrations of soils. Results indicated that inhabitants of an area with high levels of heavy metals in soil have a significantly higher proportion of methylation in the promoter region of the p53 tumor suppressor gene compared with control areas (p-value: 0.0035). This is the first study to consider associations between heavy metal exposure in humans and aberrant DNA methylation in Chile. Our results suggest more research to support consistent decision-making on processes of environmental remediation or prevention of exposure.

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BACKGROUND: Both perfectionism and social anxiety have been described in patients with eating disorders (ED) and medical students. Academic stress also can increase the risk of developing ED. AIM: To analyze the dimensions of perfectionism, social anxiety, and academic stress associated with the risk of developing ED in female medical students. MATERIAL AND METHODS: The Multidimensional Perfectionism Scale, the Liebowitz Social Anxiety Scale, the SISCO academic stress inventory and the Eating Attitudes Test-26, were applied to 163 female medical students from all levels of the career. The groups with and without risk of ED were compared according to these variables. RESULTS: Twenty-four percent of respondents were at risk of ED. There were significant differences between scores of perfectionism, social anxiety, and academic stress between respondents with and without risk for ED. In general, there was a significant correlation among the variables. In a multivariate analysis, the predictors of ED risk were the perception of academic stress (Odds ratio (OR) 1.09; 95% confidence intervals (CI) 1.03-1.16) and personal standards in the context of perfectionism (OR 1.16; 95% CI 1.06-1.27). CONCLUSIONS: A substantial proportion of female medical students were at risk for ED. The risk of ED was determined mainly by academic stress and personal standards in the context of perfectionism. In this sample, social anxiety did not play a relevant role.

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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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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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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 reviews 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.

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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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. PROSPERO REGISTRATION NUMBER: CRD42020182495. PROTOCOL PREPRINT DOI: 10.31219/osf.io/vp9nj.

OBJETIVO: Esta revisión sistemática viva tiene como objetivo proporcionar un resumen oportuno, riguroso y continuamente actualizado de la evidencia disponible sobre el rol de los inhibidores de la enzima convertidora de angiotensina (iECA) y los bloqueadores del receptor de angiotensina II (ARA-II) en el tratamiento de pacientes con COVID-19. FUENTES DE DATOS: Realizamos búsquedas en PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), literatura gris y en el repositorio centralizado L·OVE (Living OVerview of Evidence) que recupera artículos de múltiples fuentes como PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Embase, entre otros repositorios de preprints y protocolos. En respuesta a la emergencia de COVID-19, L·OVE (Living OVerview of Evidence) se adaptó para ampliar el rango de información que cubre y se personalizó para agrupar toda la evidencia en torno a COVID-19 en un solo lugar, en una base de búsqueda diaria. La búsqueda cubrió el período hasta el 31 de julio de 2020. CRITERIOS DE ELEGIBILIDAD PARA LA SELECCIÓN DE ESTUDIOS Y MÉTODOS: Adaptamos un protocolo común ya publicado para múltiples revisiones sistemáticas vivas paralelas a las especificidades de esta pregunta. Se incluyeron ensayos aleatorizados que evaluaban el efecto de la suspensión o la indicación de inhibidores de la enzima convertidora de angiotensina o bloqueadores de los receptores de angiotensina II, como monoterapia o en combinación, versus placebo o ningún tratamiento, en pacientes con COVID-19. Se buscaron ensayos aleatorizados que evaluaran el efecto de los inhibidores de la enzima convertidora de angiotensina/bloqueadores del receptor de angiotensina II versus placebo o ningún tratamiento en pacientes con COVID-19. Dos revisores examinaron de forma independiente la elegibilidad de cada estudio, extrajeron los datos y evaluaron el riesgo de sesgo. Los resultados se agruparon mediante un metanálisis y se aplicó GRADE para evaluar la certeza de la evidencia para cada resultado. Cada vez que cambien las conclusiones o hayan actualizaciones sustanciales, volveremos a enviar un reporte. RESULTADOS: Analizamos 772 artículos, pero ninguno cumplió con los criterios de inclusión. Identificamos 55 estudios en curso, incluidos 41 ensayos aleatorizados que evaluaban inhibidores de la enzima convertidora de angiotensina/bloqueadores del receptor de angiotensina II para pacientes con COVID-19. CONCLUSIONES: No encontramos ningún ensayo clínico aleatorizado que cumpliera con nuestros criterios de inclusión y, por lo tanto, no hay pruebas que respalden el papel de los inhibidores de la enzima convertidora de angiotensina y los bloqueadores de los receptores de angiotensina II en el tratamiento de pacientes con COVID-19. Identificamos un número considerable de estudios en curso que podría proporcionar evidencia valiosa para informar a los investigadores y a los responsables de la toma de decisiones en un futuro próximo.

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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.

INTRODUCCIÓN: El manejo del dolor postoperatorio contribuye a reducir la morbilidad postoperatoria y los reingresos no programados. Pocos ensayos clínicos aleatorizados han evaluado la eficacia de la administración intraoperatoria de metadona en comparación con otros opioides como morfina, para el tratamiento del dolor postoperatorio, como para proporcionar evidencia de su uso regular o incluirse en guías clínicas. MÉTODOS: Realizamos un ensayo clínico aleatorizado comparando el uso de metadona intraoperatoria para evaluar su impacto sobre el dolor postoperatorio. Ochenta y seis pacientes sometidos a colecistectomía laparoscópica electiva fueron asignados para recibir metadona (0,08 mg/kg) o morfina (0,08 mg/kg). RESULTADOS: El grupo de pacientes que recibió metadona requirió menos morfina de rescate en la unidad de cuidados post-anestésicos para el manejo del dolor posoperatorio, en comparación con el grupo morfina (p = 0,0078). Los pacientes del grupo metadona reportaron menos dolor a los 5 y 15 minutos, y a las 12 y 24 horas postoperatorias, además de presentar menos episodios de náuseas. El tiempo de despertar entre ambos grupos fue equivalente. CONCLUSIÓN: El uso intraoperatorio de metadona es superior a morfina en el manejo del dolor postoperatorio, apoyando su uso como parte de la estrategia de manejo multimodal del dolor para colecistectomía laparoscópica bajo anestesia total endovenosa con remifentanilo.

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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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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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This article is part of a collaborative methodological series of narrative reviews on biostatistics and clinical epidemiology. This review aims to present basic concepts about the minimal clinically important difference and its use in the field of clinical research and evidence synthesis. The minimal clinically important difference is defined as the smallest difference in score in any domain or outcome of interest that patients can perceive as beneficial. It is a useful concept in several aspects since it links the magnitude of change with treatment decisions in clinical practice and emphasizes the primacy of the patients perception, affected by endless variables such as time, place, and current state of health, all of which can cause significant variability in results.

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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