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1.
Int J Gynecol Cancer ; 2023 Nov 16.
Article in English | MEDLINE | ID: mdl-37973363

ABSTRACT

OBJECTIVE: This systematic review and meta-analysis aimed to assess the rate of sentinel lymph node (SLN) metastases in patients with a pre-operative diagnosis of atypical hyperplasia/endometrial intra-epithelial neoplasia and endometrial cancer in hysterectomy specimens. METHODS: A systematic literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and the protocol was registered in PROSPERO (CRD42023416769). MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from inception until April 2023. The inclusion criteria were patients with a pre-operative diagnosis of atypical hyperplasia/endometrial intra-epithelial neoplasia undergoing hysterectomy who did or did not undergo SLN assessment. RESULTS: Four studies met the inclusion criteria. All studies were non-randomized studies with a total of 10 217 patients, 1044 in the SLN group and 9173 in the non-nodal assessment group. The unilateral and bilateral detection rate was 89% (I2=27.6%, 2 studies, 342 participants, 304 events) and 79% (I2=89.2%, 2 studies, 342 participants, 271 events), respectively. The rate of involved SLNs was 1.6% (I2=0%, 3 studies, 424 participants, 7 involved SLN) and 3.5% (I2=0%, 3 studies, 197 participants, 7 involved SLN) in patients with a pre-operative diagnosis of atypical hyperplasia/endometrial intra-epithelial neoplasia as the denominator and in those with endometrial cancer in the hysterectomy specimen, respectively. The cancer rate in the hysterectomy specimen was 45% (I2=72.8%, 3 studies, 503 participants, 224 events) and the most frequent endometrial cancer International Federation of Gynecology and Obstetrics 2009 stage was IA in 199 (89.2%) patients. The complication rate was similar between the groups. CONCLUSION: The rate of SLN metastases in patients with pre-operative atypical hyperplasia/endometrial intra-epithelial neoplasia is less than 2%, suggesting that routine SLN evaluation may not be necessary in this population.

2.
J Clin Med ; 12(13)2023 Jun 29.
Article in English | MEDLINE | ID: mdl-37445406

ABSTRACT

Multiple drugs currently used in clinical practice have been approved by regulatory agencies based on studies that utilize composite endpoints. Composite endpoints are appealing because they reduce sample size requirements, follow-up periods, and costs. However, interpreting composite endpoints can be challenging, and their misuse is not uncommon. Incorrect interpretation of composite outcomes can lead to misleading conclusions that impact patient care. To correctly interpret composite outcomes, several important questions should be considered. Are the individual components of the composite outcome equally important to patients? Did the more and less important endpoints occur with similar frequency? Do the component endpoints exhibit similar relative risk reductions? If these questions receive affirmative answers, the use and interpretation of the composite endpoint would be appropriate. However, if any component of the composite endpoint fails to satisfy the aforementioned criteria, interpretation can become difficult, necessitating additional steps. Regulatory agencies acknowledge these challenges and have specific considerations when approving drugs based on studies employing composite endpoints. In conclusion, composite endpoints are valuable tools for evaluating the efficacy and net clinical benefit of interventions; however, cautious interpretation is advised.

3.
BMC Pediatr ; 22(1): 696, 2022 12 03.
Article in English | MEDLINE | ID: mdl-36463122

ABSTRACT

INTRODUCTION: There are a trend towards increasing use of High-Flow Nasal Cannula (HFNC), outside of paediatric intensive care unit. Give this trend is necessary to update the actual evidence and to assess available published literature to determinate the efficacy of HFNC over Continuous Positive Air Pressure (CPAP) as treatment for children with severe bronchiolitis. METHODS: We searched MEDLINE, EMBASE, LILACS, and COCHRANE Central, and gray literature in clinical trials databases ( www. CLINICALTRIALS: gov ), from inception to June 2022. The inclusion criteria for the literature were randomized clinical trials (RCTs) that included children < 2 years old, with acute moderate or severe bronchiolitis. All study selection and data extractions are performed independently by two reviewers. RESULTS: The initial searches including 106 records. Only five randomized controlled trial that met the inclusion criteria were included in meta-analysis. The risk of invasive mechanical ventilation was not significantly different in CPAP group and HFNC group [OR: 1.18, 95% CI (0.74, 1.89), I² = 0%] (very low quality). The risk of treatment failure was less significantly in CPAP group than HFNC group [OR: 0.51, 95% CI (0.36, 0.75), I² = 0%] (very low quality). CONCLUSION: In conclusion, there was no significant difference between HFNC and CPAP in terms of risk of invasive mechanical ventilation. CPAP reduces de risk of therapeutic failure with a highest risk of non severe adverse events. More trials are needed to confirm theses results.


Subject(s)
Bronchiolitis , Cannula , Child , Humans , Child, Preschool , Oxygen , Bronchiolitis/therapy , Continuous Positive Airway Pressure , Respiration, Artificial , Randomized Controlled Trials as Topic
4.
Ther Adv Drug Saf ; 13: 20420986221127501, 2022.
Article in English | MEDLINE | ID: mdl-36211626

ABSTRACT

Self-medication (SM) is a global and growing phenomenon. It represents a public health problem due to antibiotic resistance, risk of adverse drug reactions, drug-drug interactions, disease masking, and increased morbidity. There is not a consensus on the definition of SM. The definitions found in different studies make it difficult to address this problem from a theoretical perspective and therefore find an adequate solution to this public health problem. The aim of this article is to search the medical literature to characterize the current understanding of SM in the medical community. We conducted a scoping review of definitions of SM by searching on PubMed - Medline, Embase, and LILACS using the following combination of keywords: 'self-prescription' or 'self prescription', 'self-medication' or 'self medication', or 'automedication' and 'definition' or 'explanation'. The search was limited to articles containing the definition of SM, with no limit on language or year. Duplicate studies and those that did not mention the definition of SM were excluded from the final review. A total of 65 studies were included in the final selection. We found a vast heterogeneity in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, nonadherence to a prescription, reuse of stored drugs, and sharing and lending medicines were also considered forms of SM by other authors, however. This study highlights the need to reach a consensus regarding the definition of SM to adequately propose strategies to address this global health problem. This study shows the diverse concepts that need to be included in a future definition of SM. Plain Language Summary: Definition of self-medication: a review with systematic methodology Self-medication (SM) is a global and growing phenomenon that represents a public health problem due to antibiotic resistance, risk of dangerous side effects, interactions between drugs, and disease masking. Currently, there is not a consensus on the definition of SM, which makes it difficult to address this problem and therefore find an adequate solution. Making a standard definition would allow the development of programs focused on addressing drug-related problems associated with self-medication behavior. The purpose of this article is to search the medical literature to define the current understanding of SM in the medical community. We included a total of 65 studies and found a great variance in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, not following a prescription, reuse of stored drugs, and sharing and lending medicines were also considered forms of SM by other authors, however. Furthermore, this study highlights that SM is a wider concept that goes beyond aiming to promote and restore health, as aesthetic and recreational purposes are also reasons for SM that can put individuals at risk and compromise the correct and safe use of medications.

5.
J Asthma ; 59(10): 2008-2015, 2022 10.
Article in English | MEDLINE | ID: mdl-34516322

ABSTRACT

BACKGROUND: An important proportion of asthma patients remain uncontrolled despite the use of inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, like azithromycin, have been recommended for this subgroup of patients. The purpose of this study was to assess the cost-effectiveness of azithromycin as an add-on therapy to ICS + LABA for patients with severe asthma. METHODS: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. The total costs and QALYS of two interventions, including standard therapy (ICS + LABA), and add-on therapy with azithromycin, were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. RESULTS: The model suggests a potential gain of 0.037 QALYs per patient per year on azithromycin, with a difference of US $718 in favor of azithromycin, showing dominance with respect to SOC. A position of dominance negates the need to calculate an incremental cost-effectiveness ratio. In the deterministic sensitivity analyses, our base-case results were robust to variations in all assumptions and parameters. CONCLUSION: Add-on therapy with azithromycin was found to be cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA.


Subject(s)
Asthma , Adrenal Cortex Hormones/therapeutic use , Asthma/drug therapy , Azithromycin/therapeutic use , Humans , Markov Chains , Quality-Adjusted Life Years
6.
J Pharm Policy Pract ; 14(1): 2, 2021 Jan 04.
Article in English | MEDLINE | ID: mdl-33397498

ABSTRACT

INTRODUCTION: Acute bronchiolitis is the leading cause of hospitalization in the pediatric population. The inappropriate prescription of antibiotics in acute bronchiolitis is associated with bacterial resistance, higher costs, and risk of adverse effects in this population. The objective of this work is to develop a predictive model of inappropriate use of antibiotics in children with acute bronchiolitis in Colombia. METHODS: A retrospective cohort study was conducted in patients under 2 years of age with a diagnosis of acute bronchiolitis from two hospitals in Rionegro, Colombia. To identify factors independently associated with inappropriate use of antibiotics, we used logistic regression and estimated odds ratios (ORs). To assess discrimination, area under the curve (AUC) was estimated with a 95% confidence interval and plotted using AUC-ROC plots. To correct sampling bias of variance parameters and to evaluate the internal validity of the model, repeated curved validation "tenfold cross-validation" was used, comparing the area under the ROC curve obtained in the repetitions with that observed in the model RESULTS: A total of 415 patients were included. 142 patients (34.13%) had a prescription of some antibiotic during their hospital stay. In 92 patients (64.78%, 95% CI 56.3 to 72.6%) the prescription of antibiotics was classified as inappropriate. Age older than 1 year, chest retractions, temperature between 37.5 °C and 38.5 °C and leukocyte count between 10,000 and 15,000 million/mm3 were the predictive variables of inappropriate use of medications in this population. CONCLUSION: The presence of fever between 37.5 °C and 38.5 °C, leukocytosis between 10,000 and 15,000 million/mm3, and age older than 1 year and presence of chest retractions, should alert the physician regarding the high risk of inappropriate prescription of antibiotics. Patients with acute bronchiolitis with a score on our scale greater than 2 should be carefully evaluated regarding the need for the use of antibiotics, if prescribed.

7.
Rev. colomb. cancerol ; 23(2): 45-55, abr.-jun. 2019. tab
Article in Spanish | LILACS | ID: biblio-1042751

ABSTRACT

Resumen Antecedentes: La radioterapia de intensidad modulada (IMRT) es una técnica avanzada que se usa ampliamente a nivel mundial; sin embargo, su uso adecuado en nuestro país requiere ser revisado. Objetivo: Actualizar un protocolo clínico (PC) basado en evidencia que contiene las indicaciones clínicas para la utilización de la técnica IMRT en el tratamiento de las patologías oncológicas tratadas más frecuentemente en el servicio de oncología radioterápica del Instituto Nacional de Cancerología (INC) - Colombia. Métodos: La elaboración de este documento fue realizada por un equipo multidisciplinario empleando un manual nacional para el desarrollo de PC. Se realizó una búsqueda sistemática de la literatura, seguido por la selección de los artículos relevantes y su evaluación utilizando las herramientas apropiadas. La evidencia fue resumida, contextualizada y empleada para generar las recomendaciones mediante un consenso formal tipo RAND/UCLA. Resultados: Se generaron indicaciones para el uso de la IMRT en pacientes con alguno de los siguientes tipos de cáncer: próstata y pene, cabeza y cuello, piel, sistema nervioso central, mama, sarcomas de tejidos blandos, pulmón, gastrointestinal, ginecológico y urgencias oncológicas. Conclusiones: En el periodo 2014 a 2017 ha surgido escasa evidencia sobre el impacto de la IMRT en desenlaces relacionados con la supervivencia y la calidad de vida y por tanto el uso de la IMRT sigue siendo en pacientes seleccionados.


Abstract Background: Intensity-Modulated Radiation Therapy (IMRT) is an advanced technique which has been put into service in several clinical settings around the world; however, its proper use in Colombia requires to be revisited. Aim: To update an evidence-based clinical care protocol (CCP) that contains clinical recommendations for using IMRT in order to treat the most common oncological malignancies seen in the Radiotherapy Unit of the Instituto Nacional de Cancerología - Colombia. Methods: The elaboration of this CCP was undertaken by a multidisciplinary team who abided by a domestic CCP-development handbook. Briefly, a systematic search of literature was conducted; afterwards, relevant papers were selected and evaluated using appropriate appraisal tools; finally, evidence was summarized, contextualized, and used for generating the recommendations through a formal consensus approach (RAND/UCLA). Results: We established a handful of recommendations for using the IMRT technique in patients with any of the following types of cancer: prostate & penis, head & neck, skin, central nervous system, breast, soft tissue sarcoma, lung, gastrointestinal, and gynecologic, as well as oncologic emergencies. Conclusions: During the period 2014 - 2017, few evidence has emerged about the impact of IMRT on outcomes related to survival and quality of life; therefore, IMRT use still remains in selected patients.


Subject(s)
Humans , Clinical Protocols , Radiotherapy, Intensity-Modulated , Radiation Oncology , Consensus , Neoplasms
8.
Rev Assoc Med Bras (1992) ; 56(3): 293-8, 2010.
Article in English | MEDLINE | ID: mdl-20676535

ABSTRACT

OBJECTIVE: To estimate prevalence and distribution of cardiovascular risk factors and Metabolic Syndrome (MS) in young individuals admitted to the National University of Colombia in Bogotá. METHODS: An analytic cross-sectional study was conducted in a sample of 249 individuals of both genders aged 15 to 20 years. A questionnaire was personally administered to collect demographic, socioeconomic, smoking, perinatal, and women's health data. Anthropometric measurements, blood pressure, and a fasting blood sample were taken. Prevalence of MS was determined and compared using criteria from several qualified institutions. RESULTS: We found a high prevalence of smoking (18.9%), arterial prehypertension (14.1%) and overweight (11.2%), 9.2% of study participants had prediabetes, and the most frequent dyslipidemia was low HDL cholesterol (13.3%). Alcoholic beverage consumption was declared by 60.6% of study terol and plasma triglyceride levels. Gestational age at birth was inversely associated with presence of low HDL cholesterol levels and high blood pressure. Prevalence of the MS varied markedly according to the definition employed: 9.2% using REGODCI (Research Group on Diabetes and Chronic Illnesses) criteria, 2% using IDF (International Diabetes Federation) criteria, and 2.4% using AHA (American Heart Association) criteria. CONCLUSION: The encountered prevalence of modifiable cardiovascular risk factors justifies promotion of therapeutic lifestyle changes among this age group in Colombia. Further harmonization of MS criteria in young individuals is needed.


Subject(s)
Cardiovascular Diseases/etiology , Metabolic Syndrome/epidemiology , Adolescent , Birth Weight , Cardiovascular Diseases/diagnosis , Colombia/epidemiology , Epidemiologic Methods , Female , Gestational Age , Humans , Male , Metabolic Syndrome/diagnosis , Metabolic Syndrome/etiology , Reference Values , Risk Factors , Students/statistics & numerical data , Universities , Young Adult
9.
Rev. Assoc. Med. Bras. (1992) ; 56(3): 293-298, 2010.
Article in English | LILACS | ID: lil-553294

ABSTRACT

OBJECTIVE: To estimate prevalence and distribution of cardiovascular risk factors and Metabolic Syndrome (MS) in young individuals admitted to the National University of Colombia in Bogotá. METHODS: An analytic cross-sectional study was conducted in a sample of 249 individuals of both genders aged 15 to 20 years. A questionnaire was personally administered to collect demographic, socioeconomic, smoking, perinatal, and women's health data. Anthropometric measurements, blood pressure, and a fasting blood sample were taken. Prevalence of MS was determined and compared using criteria from several qualified institutions. RESULTS: We found a high prevalence of smoking (18.9 percent), arterial prehypertension (14.1 percent) and overweight (11.2 percent), 9.2 percent of study participants had prediabetes, and the most frequent dyslipidemia was low HDL cholesterol (13.3 percent). Alcoholic beverage consumption was declared by 60.6 percent of study terol and plasma triglyceride levels. Gestational age at birth was inversely associated with presence of low HDL cholesterol levels and high blood pressure. Prevalence of the MS varied markedly according to the definition employed: 9.2 percent using REGODCI (Research Group on Diabetes and Chronic Illnesses) criteria, 2 percent using IDF (International Diabetes Federation) criteria, and 2.4 percent using AHA (American Heart Association) criteria. CONCLUSION: The encountered prevalence of modifiable cardiovascular risk factors justifies promotion of therapeutic lifestyle changes among this age group in Colombia. Further harmonization of MS criteria in young individuals is needed.


OBJETIVO: Estimar a prevalência e distribuição de fatores de risco cardiovasculares e da síndrome X metabólica (SM) em indivíduos jovens admitidos na Universidade Nacional da Colômbia, em Bogotá. MÉTODOS: Foi realizado um estudo analítico transversal em uma amostra de 249 indivíduos de ambos os sexos, com idades entre 15 e 20 anos. Um questionário foi administrado pessoalmente para recolher dados demográficos e socioeconômicos, presença ou ausência de tabagismo, características perinatais e sobre saúde da mulher. Medidas antropométricas e de pressão arterial foram realizadas, e uma amostra de sangue em jejum foi coletada. A prevalência da SM foi determinada e comparada utilizando-se os critérios de diferentes instituções especializadas. RESULTADOS: Encontramos uma alta prevalência de tabagismo (18,9 por cento), pré-hipertensão arterial (14,1 por cento) e sobrepeso (11,2 por cento); 9,2 por cento dos participantes tinham pré-diabetes, e a mais frequente dislipidemia foi baixo HDL-colesterol (13,3 por cento). Um total de 66,6 por cento dos participantes declarou consumir bebidas alcoólicas. O índice de massa corporal foi positivamente associado a aumento na pressão arterial, colesterol LDL e triglicérides plasmáticos. A idade gestacional ao nascimento foi inversamente associada a baixo HDL colesterol e à pressão arterial elevada. A prevalência de SM variou acentuadamente, de acordo com a definição empregada: 9,2 por cento segundo REGODCI (Grupo de Pesquisa em Diabetes e Doenças Crônicas), 2 por cento segundo IDF (International Diabetes Federation), e 2,4 por cento segundo AHA (American Heart Association). CONClUSÃO: A prevalência encontrada de fatores de risco cardiovasculares justifica o incentivo a mudanças de estilo de vida neste grupo etário na Colômbia. Uma maior padronização dos critérios definidores de SM em indivíduos jovens é necessária.


Subject(s)
Adolescent , Female , Humans , Male , Young Adult , Cardiovascular Diseases/etiology , Metabolic Syndrome/epidemiology , Birth Weight , Cardiovascular Diseases/diagnosis , Colombia/epidemiology , Epidemiologic Methods , Gestational Age , Metabolic Syndrome/diagnosis , Metabolic Syndrome/etiology , Reference Values , Risk Factors , Students/statistics & numerical data , Universities
10.
Rev. Fac. Med. (Bogotá) ; 54(4): 269-282, oct.-dic. 2006. ilus
Article in Spanish | LILACS | ID: lil-440756

ABSTRACT

La necesidad de alcanzar un tratamiento óptimo para el tabaquismo, la obesidad y sus comorbilidades, conocidos factores de riesgo cardiovascular, ha fomentado la búsqueda de objetivos terapéuticos novedosos. Es el caso del sistema endocanabinoide, involucrado en diversos fenómenos fisiológicos entre los que se encuentran el refuerzo de ciertos comportamientos y la regulación del apetito. La sobreactivación de este sistema altera la homeostasis corporal predisponiendo a dependencias o a un aumento en la ingesta alimentaria, lo que puede traducirse en tabaquismo u obesidad. La intervención farmacológica sobre el sistema endocanabinoide puede contribuir al manejo de estos factores de riesgo cardiovascular, teniendo en cuenta que a tales beneficios se suman otros independientes de la suspensión del tabaquismo o la reducción de peso, como el aumento del colesterol de alta densidad, la disminución de triglicéridos y la mejoría del control glucémico en pacientes con diabetes. Ensayos clínicos controlados aleatorizados adelantados en poblaciones con diferentes características, han evaluado la utilidad de la regulación farmacológica del sistema endocanabinoide; confirmando su eficacia en personas con factores de riesgo cardiovascular establecidos...


Subject(s)
Humans , Obesity/metabolism , Receptors, Cannabinoid/metabolism , Tobacco Use Disorder , Risk Factors
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