Costs associated with adverse events from remission induction for children with Acute Lymphoblastic Leukemia (ALL).

BACKGROUND: ALL is the most frequent hematological tumor in children, so during remission induction chemotherapy protocol (RICP) adverse events (AEs) may appear. The public program in Mexico in charge of financial support to oncologic children without social security delivered a fix amount for ALL chemotherapy, but additional money needed to treat any other unexpected condition should be taken from the budget of the oncologic healthcare providers. So the purpose of our study was to estimate and evaluate the direct medical costs associated to EAs during RICP in children with ALL. METHODS: This study was retrospective, longitudinal, and observational based on medical records review of patients in RICP. The CTCAE was used to identify and classify AEs according to a SOC category. We focused on extracting resources data that were consumed both for inpatients and outpatients AEs. A micro-costing approach was adopted which involve quantification of each healthcare resource consumed by the hospital multiplying them by unit cost. The probability distributions of data were evaluated to identify the appropriated statistical tests to be used for comparisons between groups that were performed with Wilcoxon rank sum test. Generalized linear models (GLM) were adjusted to evaluate the effects of patient characteristics on total cost. RESULTS: Forty patients accumulated 204 inpatient and 81 outpatient AEs during RICP. Comparison of total costs between groups showed an incremental cost of $7,460.23 likewise attributable to AEs. The total cost of a pediatric patient undergoing RICP without adverse events was $3,078.36 and the total cost of a patient with AEs exceeds it threefold. CONCLUSIONS: The costs associated with AEs during RICP in Mexican children with ALL representing a high burden for the healthcare provider. Generalized linear models showed that variables such as sex, risk category and alive status are associated with the total costs of AEs. This is the first study aiming to analyze the effect of ALL-related AEs on health care costs in pediatric population, so our results may help not only to local decision making but also it may contribute to the research agenda in this field.

Validity and reliability of the Mexican resilience measurement scale in families of children with chronic conditions.

BACKGROUND: The resilience to face disease is a process of positive adaptation despite the loss of health. It involves developing vitality and skills to overcome the negative effects of adversity, risks, and vulnerability caused by disease. In Mexico, the Mexican Resilience Measurement Scale (RESI-M) has been validated with a general population and has a five-factor structure. However, this scale does not allow evaluation of resilience in specific subpopulations, such as caregivers. METHOD: This study investigated the psychometric properties of RESI-M in 446 family caregivers of children with chronic diseases. A confirmatory factor analysis (CFA) was performed, internal consistency values were calculated using Cronbach's alpha coefficient, and mean comparisons were determined using t-tests. RESULTS: The expected five-factor model showed an adequate fit with the data based on a maximum likelihood test. The internal consistency for each factor ranged from .76 to .93, and the global internal consistency was .95. No average difference in RESI-M and its factors was found between women and men. CONCLUSION: The RESI-M showed internal consistency and its model of five correlated factors was valid among family caregivers of children with chronic diseases.

Self-perception and knowledge of evidence based medicine by physicians.

BACKGROUND: The influence, legitimacy and application of Evidence Based Medicine (EBM) in the world is growing as a tool that integrates, the best available evidence to decision making in patient care. Our goal was to identify the relationship between self-perception about the relevance of Evidence Based Medicine (EBM) and the degree of basic knowledge of this discipline in a group of physicians. METHODS: A survey was carried out in a third level public hospital in Mexico City. Self-perception was measured by means of a structured scale, and the degree of knowledge through parameter or "rubrics" methodology. RESULTS: A total of 320 questionnaires were given to 55 medical students (17 %); 45 pre-graduate medical interns (14 %); 118 medical residents (37 %) and 102 appointed physicians of different specialties (32 %). Self-perception of EBM: The majority of those surveyed (n = 274, 86 %) declared that they were very or moderately familiar with EBM. The great majority (n = 270, 84 %) believe that EBM is very important in clinical practice and 197 physicians (61 %) said that they implement it always or usually. The global index of self-perception was 75 %. Knowledge of EBM: Definition of EBM; Seven of those surveyed (2 %) included 3 of the 4 characteristics of the definition, 82 (26 %) mentioned only two characteristics of the definition, 152 (48 %) mentioned only one characteristic and 79 (25 %) did not include any characteristic of EBM. Phases of the EBM process: The majority of those surveyed (n = 218, 68 %) did not include the steps that characterize the practice of EBM, of which 79 participants (25 %) mentioned elements not related to it. The global index of knowledge was 19 %. CONCLUSIONS: The majority of the surveyed physicians have a high self-perception of the relevance of EBM. In spite of this, the majority of them did not know the characteristics that define the EBM and phases of the process for its practice. A major discrepancy was found between self-perception and the level of basic knowledge of EBM among the surveyed physicians.

Systemic antibiotics for treating diabetic foot infections.

BACKGROUND: Foot infection is the most common cause of non-traumatic amputation in people with diabetes. Most diabetic foot infections (DFIs) require systemic antibiotic therapy and the initial choice is usually empirical. Although there are many antibiotics available, uncertainty exists about which is the best for treating DFIs. OBJECTIVES: To determine the effects and safety of systemic antibiotics in the treatment of DFIs compared with other systemic antibiotics, topical foot care or placebo. SEARCH METHODS: In April 2015 we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library); Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE, and EBSCO CINAHL. We also searched in the Database of Abstracts of Reviews of Effects (DARE; The Cochrane Library), the Health Technology Assessment database (HTA; The Cochrane Library), the National Health Service Economic Evaluation Database (NHS-EED; The Cochrane Library), unpublished literature in OpenSIGLE and ProQuest Dissertations and on-going trials registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating the effects of systemic antibiotics (oral or parenteral) in people with a DFI. Primary outcomes were clinical resolution of the infection, time to its resolution, complications and adverse effects. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed the risk of bias, and extracted data. Risk ratios (RR) were estimated for dichotomous data and, when sufficient numbers of comparable trials were available, trials were pooled in a meta-analysis. MAIN RESULTS: We included 20 trials with 3791 participants. Studies were heterogenous in study design, population, antibiotic regimens, and outcomes. We grouped the sixteen different antibiotic agents studied into six categories: 1) anti-pseudomonal penicillins (three trials); 2) broad-spectrum penicillins (one trial); 3) cephalosporins (two trials); 4) carbapenems (four trials); 5) fluoroquinolones (six trials); 6) other antibiotics (four trials).Only 9 of the 20 trials protected against detection bias with blinded outcome assessment. Only one-third of the trials provided enough information to enable a judgement about whether the randomisation sequence was adequately concealed. Eighteen out of 20 trials received funding from pharmaceutical industry-sponsors.The included studies reported the following findings for clinical resolution of infection: there is evidence from one large trial at low risk of bias that patients receiving ertapenem with or without vancomycin are more likely to have resolution of their foot infection than those receiving tigecycline (RR 0.92, 95% confidence interval (CI) 0.85 to 0.99; 955 participants). It is unclear if there is a difference in rates of clinical resolution of infection between: 1) two alternative anti-pseudomonal penicillins (one trial); 2) an anti-pseudomonal penicillin and a broad-spectrum penicillin (one trial) or a carbapenem (one trial); 3) a broad-spectrum penicillin and a second-generation cephalosporin (one trial); 4) cephalosporins and other beta-lactam antibiotics (two trials); 5) carbapenems and anti-pseudomonal penicillins or broad-spectrum penicillins (four trials); 6) fluoroquinolones and anti-pseudomonal penicillins (four trials) or broad-spectrum penicillins (two trials); 7) daptomycin and vancomycin (one trial); 8) linezolid and a combination of aminopenicillins and beta-lactamase inhibitors (one trial); and 9) clindamycin and cephalexin (one trial).Carbapenems combined with anti-pseudomonal agents produced fewer adverse effects than anti-pseudomonal penicillins (RR 0.27, 95% CI 0.09 to 0.84; 1 trial). An additional trial did not find significant differences in the rate of adverse events between a carbapenem alone and an anti-pseudomonal penicillin, but the rate of diarrhoea was lower for participants treated with a carbapenem (RR 0.58, 95% CI 0.36 to 0.93; 1 trial). Daptomycin produced fewer adverse effects than vancomycin or other semi-synthetic penicillins (RR 0.61, 95%CI 0.39 to 0.94; 1 trial). Linezolid produced more adverse effects than ampicillin-sulbactam (RR 2.66; 95% CI 1.49 to 4.73; 1 trial), as did tigecycline compared to ertapenem with or without vancomycin (RR 1.47, 95% CI 1.34 to 1.60; 1 trial). There was no evidence of a difference in safety for the other comparisons. AUTHORS' CONCLUSIONS: The evidence for the relative effects of different systemic antibiotics for the treatment of foot infections in diabetes is very heterogeneous and generally at unclear or high risk of bias. Consequently it is not clear if any one systemic antibiotic treatment is better than others in resolving infection or in terms of safety. One non-inferiority trial suggested that ertapenem with or without vancomycin is more effective in achieving clinical resolution of infection than tigecycline. Otherwise the relative effects of different antibiotics are unclear. The quality of the evidence is low due to limitations in the design of the included trials and important differences between them in terms of the diversity of antibiotics assessed, duration of treatments, and time points at which outcomes were assessed. Any further studies in this area should have a blinded assessment of outcomes, use standardised criteria to classify severity of infection, define clear outcome measures, and establish the duration of treatment.

The validity of recommendations from clinical guidelines: a survival analysis.

BACKGROUND: Clinical guidelines should be updated to maintain their validity. Our aim was to estimate the length of time before recommendations become outdated. METHODS: We used a retrospective cohort design and included recommendations from clinical guidelines developed in the Spanish National Health System clinical guideline program since 2008. We performed a descriptive analysis of references, recommendations and resources used, and a survival analysis of recommendations using the Kaplan-Meier method. RESULTS: We included 113 recommendations from 4 clinical guidelines with a median of 4 years since the most recent search (range 3.9-4.4 yr). We retrieved 39 136 references (range 3343-14 787) using an exhaustive literature search, 668 of which were related to the recommendations in our sample. We identified 69 (10.3%) key references, corresponding to 25 (22.1%) recommendations that required updating. Ninety-two percent (95% confidence interval 86.9-97.0) of the recommendations were valid 1 year after their development. This probability decreased at 2 (85.7%), 3 (81.3%) and 4 years (77.8%). INTERPRETATION: Recommendations quickly become outdated, with 1 out of 5 recommendations being out of date after 3 years. Waiting more than 3 years to review a guideline is potentially too long.

Antibiotic prophylaxis for preventing burn wound infection.

BACKGROUND: Infection of burn wounds is a serious problem because it can delay healing, increase scarring and invasive infection may result in the death of the patient. Antibiotic prophylaxis is one of several interventions that may prevent burn wound infection and protect the burned patient from invasive infections. OBJECTIVES: To assess the effects of antibiotic prophylaxis on rates of burn wound infection. SEARCH METHODS: In January 2013 we searched the Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE - In-Process & Other Non-Indexed Citations (2013); Ovid EMBASE; EBSCO CINAHL and reference lists of relevant articles. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: All randomised controlled trials (RCTs) that evaluated the efficacy and safety of antibiotic prophylaxis for the prevention of BWI. Quasi-randomised studies were excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed the risk of bias, and extracted relevant data. Risk ratio (RR) and mean difference (MD) were estimated for dichotomous data and continuous data, respectively. When sufficient numbers of comparable RCTs were available, trials were pooled in a meta-analysis to estimate the combined effect. MAIN RESULTS: This review includes 36 RCTs (2117 participants); twenty six (72%) evaluated topical antibiotics, seven evaluated systemic antibiotics (four of these administered the antibiotic perioperatively and three administered upon hospital admission or during routine treatment), two evaluated prophylaxis with non absorbable antibiotics, and one evaluated local antibiotics administered via the airway.The 11 trials (645 participants) that evaluated topical prophylaxis with silver sulfadiazine were pooled in a meta analysis. There was a statistically significant increase in burn wound infection associated with silver sulfadiazine compared with dressings/skin substitute (OR = 1.87; 95% CI: 1.09 to 3.19, I(2) = 0%). These trials were at high, or unclear, risk of bias. Silver sulfadiazine was also associated with significantly longer length of hospital stay compared with dressings/skin substitute (MD = 2.11 days; 95% CI: 1.93 to 2.28).Systemic antibiotic prophylaxis in non-surgical patients was evaluated in three trials (119 participants) and there was no evidence of an effect on rates of burn wound infection. Systemic antibiotics (trimethoprim-sulfamethoxazole) were associated with a significant reduction in pneumonia (only one trial, 40 participants) (RR = 0.18; 95% CI: 0.05 to 0.72) but not sepsis (two trials 59 participants) (RR = 0.43; 95% CI: 0.12 to 1.61).Perioperative systemic antibiotic prophylaxis had no effect on any of the outcomes of this review.Selective decontamination of the digestive tract with non-absorbable antibiotics had no significant effect on rates of all types of infection (2 trials, 140 participants). Moreover, there was a statistically significant increase in rates of MRSA associated with use of non-absorbable antibiotics plus cefotaxime compared with placebo (RR = 2.22; 95% CI: 1.21 to 4.07).There was no evidence of a difference in mortality or rates of sepsis with local airway antibiotic prophylaxis compared with placebo (only one trial, 30 participants). AUTHORS' CONCLUSIONS: The conclusions we are able to draw regarding the effects of prophylactic antibiotics in people with burns are limited by the volume and quality of the existing research (largely small numbers of small studies at unclear or high risk of bias for each comparison). The largest volume of evidence suggests that topical silver sulfadiazine is associated with a significant increase in rates of burn wound infection and increased length of hospital stay compared with dressings or skin substitutes; this evidence is at unclear or high risk of bias. Currently the effects of other forms of antibiotic prophylaxis on burn wound infection are unclear. One small study reported a reduction in incidence of pneumonia associated with a specific systematic antibiotic regimen.

Interventions to improve compliance with hand hygiene in patient care.

Healthcare-associated infections are a significant cause of morbidity and mortality. Hand hygiene is considered an effective method of prevention. This article summarizes the results of a Cochrane systematic review evaluating methods for improving hand hygiene compliance in patient care.

Las infecciones asociadas con la atención médica son una causa importante de morbilidad y mortalidad. La higiene de las manos se considera un método eficaz de prevención. Este documento resume los resultados de una revisión sistemática Cochrane que evalúa los métodos para mejorar el cumplimiento de la higiene de manos en la atención al paciente.

Models of comprehensive care for older persons with chronic diseases: a systematic review with a focus on effectiveness.

INTRODUCTION: Ageing entails a variety of physiological changes that increase the risk of chronic non-communicable diseases. The prevalence of these diseases leads to an increase in the use of health services. The care models implemented by health systems should provide comprehensive long-term healthcare. We conducted this systematic review to determine whether any model of care for older persons have proven to be effective. METHODS: A systematic review of literature was carried out to identify randomised clinical trials that have assessed how effective a care model for older patients with chronic diseases. A searches electronic databases such as MEDLINE, Turning Research Into Practice Database, Cochrane Library and Cochrane Central Register of controlled Trials was conducted from January 1966 to January 2021. Two independent reviewers assessed the eligibility of the studies. Interventions were identified and classified according to the taxonomies developed by the Cochrane Effective Practice and Organisation of Care and Cochrane Consumers and Communication groups. RESULTS: Of the 4952 bibliographic references that were screened, 577 were potentially eligible and the final sample included 25 studies that evaluated healthcare models in older people with chronic diseases. In the 25 care models, the most frequently implemented interventions were educational, and those based on the provision of healthcare. Only 22% of the outcomes of interventions were identified as being effective, whereas 21% were identified as being partially effective; thus, more than 50% of the outcomes were identified as being ineffective. CONCLUSIONS: It was not possible to determine a care model as effective. The interventions implemented in the models are variable. The most effective outcomes were focused on improving the patient-healthcare professional relationship in the early stages of the intervention. The interventions addressed in the studies were similar to public health interventions as their main objectives focused on promoting health. Most studies were of low methodological quality.

Development of SARS-CoV-2 vaccines.

Background: The coronavirus disease 2019 (COVID-19) pandemic has posed significant challenges globally. Continuous transmission of the virus is mostly due to insufficient infection control measures and a lack of vaccines. Therefore, this review aimed to identify and describe possible vaccines for the prevention of COVID-19. Methods: A systematic review of the scientific literature was performed through electronic searches of the main databases to identify published reports or studies on vaccines under development against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Websites from international organizations, institutes of health and research, Google, and references from identified studies were also reviewed. Studies examining the mechanisms of infection, immunopathology, and genomics were excluded. Results: A total of 141 vaccines in development against SARS-CoV-2 were identified. The technologies used include weakened and inactive viruses, viral vectors, nucleic acids, and proteins. So far, 13 vaccines (9.2%) are under clinical evaluation; only the AZD1222 vaccine is under clinical evaluation Phase II-III. Ad5-nCoV and mRNA-1273 vaccines showed to produce neutralizing antibodies and also to be safe. Conclusions: Despite efforts invested in developing SARS-CoV-2 vaccines, more research is still required. The vaccine developers, international health organizations, and the decision-makers of health policies must carry out conjunct cooperation to face the different challenges and guarantee the development of an effective vaccine.

Introducción: La pandemia de COVID-19 ha planteado grandes retos en todo el mundo. La transmisión continua del virus se debe, en gran parte, a las medidas deficientes para el control de infecciones y a la falta de vacunas. El objetivo de esta revisión fue identificar y describir las posibles vacunas para la prevención de la COVID-19. Métodos: Se realizó una revisión sistemática de la literatura científica mediante búsquedas en las principales bases de datos electrónicas, para identificar informes o estudios publicados sobre las vacunas en proceso de desarrollo contra el SARS-CoV-2. También se revisaron páginas web de organismos internacionales, institutos de salud e investigación, Google y las referencias de los estudios identificados. Se excluyeron los estudios que examinaron los mecanismos de infección, inmunopatológicos y de genómica. Resultados: En total se identificaron 141 vacunas en desarrollo contra el SARS-CoV-2. Las tecnologías utilizadas incluyen virus debilitados e inactivos, vectores virales, ácidos nucleicos y proteínas. Hasta el momento solo 13 vacunas (9.2%) se encuentran en proceso de evaluación clínica y solo la vacuna AZD1222 se encuentra en fase II-III. Las vacunas Ad5-nCoV y mRNA-1273 han mostrado producción de anticuerpos neutralizantes, además de ser seguras. Conclusiones: A pesar de los esfuerzos invertidos para el desarrollo de vacunas contra el SARS-CoV-2, aún se requiere más investigación. Es necesario que los desarrolladores de vacunas, los organismos internacionales de salud y los tomadores de decisiones de políticas sanitarias cooperen para afrontar los diferentes desafíos y garantizar el desarrollo de una vacuna eficaz.

[Aromatase inhibitors for short stature in male children and adolescents]. / Inhibidores de la aromatasa para estatura baja en niños y adolescentes de sexo masculino.

Los inhibidores de la aromatasa son fármacos disponibles por vía oral que inhiben la conversión de la testosterona en estradiol. Los estrógenos desempeñan un papel esencial en la maduración del cartílago de crecimiento y del cierre epifisario, evento que marca el final del proceso de crecimiento esquelético. Por este motivo, los inhibidores de la aromatasa se han probado como una intervención para mejorar la talla en niños y adolescentes de sexo masculino mediante el retraso en la maduración esquelética al disminuir la concentración de estradiol en la placa de crecimiento. Se resumen los resultados de una revisión sistemática Cochrane en la cual se evaluaron la eficacia y la seguridad de los inhibidores de la aromatasa para el tratamiento de la estatura baja en niños.

[Peritoneal drainage versus laparotomy for perforated necrotizing enterocolitis in preterm low birth weight infants.] / Drenaje peritoneal versus laparotomía como abordaje para enterocolitis necrosante perforada en recién nacidos pretérmino de bajo peso.

El desarrollo de enterocolitis necrosante, con la consecuente perforación intestinal, es frecuente en los recién nacidos pretérmino. El tratamiento estándar de la perforación intestinal es quirúrgico. Sin embargo, se sugiere que la inserción de un drenaje en el abdomen puede ser efectivo para tratar esta afección. Se resumen los resultados de una revisión sistemática Cochrane que compara la efectividad del drenaje peritoneal con la de la laparotomía en neonatos con enterocolitis necrosante perforada.Necrotizing enterocolitis is common in preterm newborns, with consequent intestinal perforation. The standard treatment for intestinal perforation is surgery. However, it is suggested that inserting a drain into the abdomen may be effective in treating this condition. This document summarizes the results of a Cochrane systematic review comparing the effectiveness of peritoneal drainage with laparotomy in neonates with perforated necrotizing enterocolitis.

miRNAs as biomarkers for diagnosis of type 2 diabetes: A systematic review.

BACKGROUND: This systematic review summarizes results of studies that evaluated the expression of microRNAs (miRs) in prediabetes or type 2 diabetes (T2D). METHODS: The information was obtained from PubMed, EMBL-EBI, Wanfang, Trip Database, Lilacs, CINAHL, Human microRNA Disease Database (HMDD) v3.0, and Google. A qualitative synthesis of the results was performed and miRs frequency was graphically represented. From 1893 identified studies, only 55 fulfilled the inclusion criteria. These 55 studies analyzed miRs in T2D, and of them, 13 also described data of prediabetes. RESULTS: In diabetics, 122 miRs were reported and 35 miRs for prediabetics. However, we identified that five miRs (-122-5p, 144-3p, 210, 375, and -126b) were reported more often in diabetics and four (144-3p, -192, 29a, and -30d) in prediabetics. CONCLUSIONS: Circulating miRs could be used as biomarkers of T2D. However, it is necessary to validate these microRNAs in prospective and multicenter studies with different population subgroups, considering age, gender, and risk factors.

Physical interventions to interrupt or reduce the spread of respiratory viruses.

Viral epidemics or pandemics of acute respiratory infections, like influenza or severe acute respiratory syndrome pose a global threat. Antiviral drugs and vaccination may be insufficient to prevent their spread. Therefore, a Cochrane systematic review evaluated effectiveness of physical interventions to interrupt or reduce the spread of respiratory viruses.

Las epidemias virales o pandemias de infecciones respiratorias agudas, como la gripe o el síndrome respiratorio agudo grave, representan una amenaza mundial. Los medicamentos antivirales y las vacunas pueden ser insuficientes para prevenir su propagación. Por lo anterior, una revisión sistemática Cochrane evaluó la eficacia de las intervenciones físicas para interrumpir o reducir la propagación de virus respiratorios.

Use of sildenafil for pulmonary hypertension in neonates.

Pulmonary arterial hypertension is a multifactorial nosological entity that increases neonatal mortality as a result of heart failure. Pulmonary vasodilators are the cornerstone of treatment, of which sildenafil is the most commonly used drug. Therefore, the results of a recently updated Cochrane systematic review are summarized, in which the efficacy and safety of sildenafil for the treatment of pulmonary hypertension in neonates was evaluated.

La hipertensión arterial pulmonar es una enfermedad multifactorial que incrementa la mortalidad en el neonato como consecuencia de falla cardiaca. Los vasodilatadores pulmonares son la piedra angular del tratamiento, de los cuales el ­sildenafil es el fármaco más empleado. A continuación, se resumen los resultados de una revisión sistemática Cochrane en la que se evaluaron la eficacia y la seguridad del sildenafil para el tratamiento de la hipertensión arterial pulmonar en neonatos.

Use of methylphenidate in attention-deficit hyperactivity disorder.

Hospital Infantil de México Federico Gómez is affiliated with the Cochrane Collaboration. As part of the activities of the Cochrane Center of the Hospital Infantil de México, the use of systematic reviews in health decision making is promoted. With this objective, summaries of Cochrane systematic reviews on relevant topics will be periodically published to support the clinical practice.

El Hospital Infantil de México Federico Gómez se encuentra afiliado a la Colaboración Cochrane. Como parte de las actividades del Centro Cochrane del Hospital Infantil de México Federico Gómez, se promueve el uso de las revisiones sistemáticas para la toma de decisiones en salud. Con ese objetivo, se realizará la publicación periódica de resúmenes de revisiones sistemáticas Cochrane sobre temas relevantes que apoyen la práctica clínica.

[Ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México: un análisis crítico]. / Clinical trials published in the Boletín Médico del Hospital Infantil de México: a critical analysis.

Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación. Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

Interventions to improve compliance with hand hygiene in patient care / Intervenciones para mejorar el cumplimiento de la higiene de manos en la atención al paciente

Abstract Healthcare-associated infections are a significant cause of morbidity and mortality. Hand hygiene is considered an effective method of prevention. This article summarizes the results of a Cochrane systematic review evaluating methods for improving hand hygiene compliance in patient care.

Resumen Las infecciones asociadas con la atención médica son una causa importante de morbilidad y mortalidad. La higiene de las manos se considera un método eficaz de prevención. Este documento resume los resultados de una revisión sistemática Cochrane que evalúa los métodos para mejorar el cumplimiento de la higiene de manos en la atención al paciente.

BADERI: an online database to coordinate handsearching activities of controlled clinical trials for their potential inclusion in systematic reviews.

BACKGROUND: Systematic reviews provide the best evidence on the effect of health care interventions. They rely on comprehensive access to the available scientific literature. Electronic search strategies alone may not suffice, requiring the implementation of a handsearching approach. We have developed a database to provide an Internet-based platform from which handsearching activities can be coordinated, including a procedure to streamline the submission of these references into CENTRAL, the Cochrane Collaboration Central Register of Controlled Trials. METHODS: We developed a database and a descriptive analysis. Through brainstorming and discussion among stakeholders involved in handsearching projects, we designed a database that met identified needs that had to be addressed in order to ensure the viability of handsearching activities. Three handsearching teams pilot tested the proposed database. Once the final version of the database was approved, we proceeded to train the staff involved in handsearching. RESULTS: The proposed database is called BADERI (Database of Iberoamerican Clinical Trials and Journals, by its initials in Spanish). BADERI was officially launched in October 2015, and it can be accessed at www.baderi.com/login.php free of cost. BADERI has an administration subsection, from which the roles of users are managed; a references subsection, where information associated to identified controlled clinical trials (CCTs) can be entered; a reports subsection, from which reports can be generated to track and analyse the results of handsearching activities; and a built-in free text search engine. BADERI allows all references to be exported in ProCite files that can be directly uploaded into CENTRAL. To date, 6284 references to CCTs have been uploaded to BADERI and sent to CENTRAL. The identified CCTs were published in a total of 420 journals related to 46 medical specialties. The year of publication ranged between 1957 and 2016. CONCLUSIONS: BADERI allows the efficient management of handsearching activities across different countries and institutions. References to all CCTs available in BADERI can be readily submitted to CENTRAL for their potential inclusion in systematic reviews.

[Archibald Cochrane: evidence, effectiveness and decision-making in health]. / Archibald Cochrane: evidencia, efectividad y toma de decisiones en salud.

Nowadays, Evidence-Based Medicine plays a fundamental role while making medical decisions, considering that through the methods of science, it attempts to justify the variety of alternatives that may be offered to patients. In order to understand the historical evolution of this way of practicing medicine, it is necessary to review the contribution of one of the main participants in this cultural movement: Archibald Leman Cochrane, who helped to define the theoretical framework that has allowed the integration of science into the practice of medicine. Since he insisted in the need of integrating scientific evidence into clinical experience, his role became a fundamental and decisive element in the development of a new discipline: Evidence-Based Medicine.

Development of SARS-CoV-2 vaccines / Desarrollo de vacunas contra el SARS-CoV-2

Abstract Background: The coronavirus disease 2019 (COVID-19) pandemic has posed significant challenges globally. Continuous transmission of the virus is mostly due to insufficient infection control measures and a lack of vaccines. Therefore, this review aimed to identify and describe possible vaccines for the prevention of COVID-19. Methods: A systematic review of the scientific literature was performed through electronic searches of the main databases to identify published reports or studies on vaccines under development against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Websites from international organizations, institutes of health and research, Google, and references from identified studies were also reviewed. Studies examining the mechanisms of infection, immunopathology, and genomics were excluded. Results: A total of 141 vaccines in development against SARS-CoV-2 were identified. The technologies used include weakened and inactive viruses, viral vectors, nucleic acids, and proteins. So far, 13 vaccines (9.2%) are under clinical evaluation; only the AZD1222 vaccine is under clinical evaluation Phase II-III. Ad5-nCoV and mRNA-1273 vaccines showed to produce neutralizing antibodies and also to be safe. Conclusions: Despite efforts invested in developing SARS-CoV-2 vaccines, more research is still required. The vaccine developers, international health organizations, and the decision-makers of health policies must carry out conjunct cooperation to face the different challenges and guarantee the development of an effective vaccine.

Resumen Introducción: La pandemia de COVID-19 ha planteado grandes retos en todo el mundo. La transmisión continua del virus se debe, en gran parte, a las medidas deficientes para el control de infecciones y a la falta de vacunas. El objetivo de esta revisión fue identificar y describir las posibles vacunas para la prevención de la COVID-19. Métodos: Se realizó una revisión sistemática de la literatura científica mediante búsquedas en las principales bases de datos electrónicas, para identificar informes o estudios publicados sobre las vacunas en proceso de desarrollo contra el SARS-CoV-2. También se revisaron páginas web de organismos internacionales, institutos de salud e investigación, Google y las referencias de los estudios identificados. Se excluyeron los estudios que examinaron los mecanismos de infección, inmunopatológicos y de genómica. Resultados: En total se identificaron 141 vacunas en desarrollo contra el SARS-CoV-2. Las tecnologías utilizadas incluyen virus debilitados e inactivos, vectores virales, ácidos nucleicos y proteínas. Hasta el momento solo 13 vacunas (9.2%) se encuentran en proceso de evaluación clínica y solo la vacuna AZD1222 se encuentra en fase II-III. Las vacunas Ad5-nCoV y mRNA-1273 han mostrado producción de anticuerpos neutralizantes, además de ser seguras. Conclusiones: A pesar de los esfuerzos invertidos para el desarrollo de vacunas contra el SARS-CoV-2, aún se requiere más investigación. Es necesario que los desarrolladores de vacunas, los organismos internacionales de salud y los tomadores de decisiones de políticas sanitarias cooperen para afrontar los diferentes desafíos y garantizar el desarrollo de una vacuna eficaz.