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Otol Neurotol ; 41(2): 153-166, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31743297


OBJECTIVE: To evaluate the efficacy of cognitive and/or behavioral therapies in improving health-related quality of life (HRQOL), depression, and anxiety associated with tinnitus. DATA SOURCES: EMBASE, MEDLINE, PubMed, PsycINFO, and the Cochrane Registry were used to identify English studies from database inception until February 2018. STUDY SELECTION: Randomized controlled trials (RCTs) comparing cognitive and/or behavioral therapies to one another or to waitlist controls for the treatment of tinnitus were included. DATA EXTRACTION: Quality and risk were assessed using GRADE and Cochrane's Risk of Bias tool respectively. DATA SYNTHESIS: Pairwise meta-analysis (12 RCTs: 1,144 patients) compared psychological interventions to waitlist controls. Outcomes were measured using standardized mean differences (SMDs) and 95% confidence intervals (CI). I and subgroup analyses were used to assess heterogeneity. Network meta-analysis (NMA) (19 RCTS: 1,543 patients) compared psychological therapies head-to-head. Treatment effects were presented by network diagrams, interval plots, and ranking diagrams indicating SMDs with 95% CI. Direct and indirect results were further assessed by inconsistency plots. CONCLUSIONS: Results are consistent with previously published guidelines indicating that CBT is an effective therapy for tinnitus. While guided self-administered forms of CBT had larger effect sizes (SMD: 3.44; 95% CI: -0.022, 7.09; I: 99%) on tinnitus HRQOL, only face-to-face CBT was shown to make statistically significant improvements (SMD: 0.75; 95% CI: 0.53, 0.97; I: 0%). Guided self-administered CBT had the highest likelihood of being ranked first in improving tinnitus HRQOL (75%), depression (83%), and anxiety (87%), though statistically insignificant. This NMA is the first of its kind in this therapeutic area and provides new insights on the effects of different forms of cognitive and/or behavioral therapies for tinnitus.

Terapia Cognitivo-Conductual , Acúfeno , Ansiedad , Cognición , Humanos , Metaanálisis en Red , Acúfeno/terapia
BMJ ; 366: l5221, 2019 09 18.
Artículo en Inglés | MEDLINE | ID: mdl-31533922


OBJECTIVE: To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN: Cross sectional analysis. SETTING: European regulatory documents, clinical trial registry records, protocols, journal publications, and supplementary appendices. ELIGIBILITY CRITERIA: Pivotal randomised controlled trials of new cancer drugs approved by the EMA between 2014 and 2016. MAIN OUTCOME MEASURES: Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents). RESULTS: Between 2014 and 2016, the EMA approved 32 new cancer drugs on the basis of 54 pivotal studies. Of these, 41 (76%) were randomised controlled trials and 13 (24%) were either non-randomised studies or single arm studies. 39/41 randomised controlled trials had available publications and were included in our study. Only 10 randomised controlled trials (26%) measured overall survival as either a primary or coprimary endpoint, with the remaining trials evaluating surrogate measures such as progression free survival and response rates. Overall, 19 randomised controlled trials (49%) were judged to be at high risk of bias for their primary outcome. Concerns about missing outcome data (n=10) and measurement of the outcome (n=7) were the most common domains leading to high risk of bias judgments. Fewer randomised controlled trials that evaluated overall survival as the primary endpoint were at high risk of bias than those that evaluated surrogate efficacy endpoints (2/10 (20%) v 16/29 (55%), respectively). When information available in regulatory documents and the scientific literature was considered separately, overall risk of bias judgments differed for eight randomised controlled trials (21%), which reflects reporting inadequacies in both sources of information. Regulators identified additional deficits beyond the domains captured in risk of bias assessments for 10 drugs (31%). These deficits included magnitude of clinical benefit, inappropriate comparators, and non-preferred study endpoints, which were not disclosed as limitations in scientific publications. CONCLUSIONS: Most pivotal studies forming the basis of EMA approval of new cancer drugs between 2014 and 2016 were randomised controlled trials. However, almost half of these were judged to be at high risk of bias based on their design, conduct, or analysis, some of which might be unavoidable because of the complexity of cancer trials. Regulatory documents and the scientific literature had gaps in their reporting. Journal publications did not acknowledge the key limitations of the available evidence identified in regulatory documents.

Antineoplásicos/uso terapéutico , Aprobación de Drogas/métodos , Neoplasias/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Sesgo , Estudios Transversales , Control de Medicamentos y Narcóticos , Humanos , Proyectos de Investigación , Informe de Investigación
Reprod Health ; 10: 4, 2013 Jan 29.
Artículo en Inglés | MEDLINE | ID: mdl-23360713


BACKGROUND: Antenatal corticosteroids administered to women at risk of preterm birth is an intervention which has been proved to reduce the risk of respiratory distress syndrome, intraventricular hemorrhage, and neonatal mortality. There is a significant gap in the literature regarding the prevalence of the use of antenatal corticosteroids in Latin American countries and the attitudes and opinions of providers regarding this practice. The aim of this study was to assess the knowledge, attitudes and practices of health care providers regarding the use of antenatal corticosteroids in women at risk of preterm birth in Latin America. METHODS: This was a multicenter, prospective, descriptive study conducted in maternity hospitals in Ecuador, El Salvador, Mexico and Uruguay. Physicians and midwives who provide prenatal care or intrapartum care for women delivering in the selected hospitals were approached using a self-administered questionnaire. Descriptive statistics was used. RESULTS: The percentage of use of ACT in threatened preterm labour (TPL) reported by providers varies from 70% in Mexico to 97% in Ecuador. However, 60% to 20% of the providers mentioned that they would not use this medication in women at risk and would limit its use when there was a threatened preterm labour. In only one country recommended regimens of antenatal corticosteroids are followed by around 90% of providers whereas in the other three countries recommended regimens are followed by only 21%, 61%, 69% of providers. Around 40% of providers mentioned that they would administer a new dose of corticosteroids again, regardless the patient already receiving an entire regimen. Between 11% and 35% of providers, according to the countries, mentioned that they do not have adequate information on the correct use of this medication. CONCLUSIONS: This study shows that the use of this intervention could be improved by increasing the knowledge of Latin American providers on its indications, benefits, and regimens.

Competencia Clínica , Glucocorticoides/administración & dosificación , Nacimiento Prematuro/tratamiento farmacológico , Atención Prenatal/métodos , Adulto , Actitud del Personal de Salud , Esquema de Medicación , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Glucocorticoides/efectos adversos , Glucocorticoides/provisión & distribución , Glucocorticoides/uso terapéutico , Humanos , Recién Nacido , Recien Nacido Prematuro , América Latina , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricos , Embarazo , Complicaciones del Embarazo/tratamiento farmacológico , Estudios Prospectivos , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control
Int J Gynaecol Obstet ; 108(1): 52-7, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-19892349


OBJECTIVE: To determine the prevalence of the use of prenatal corticosteroids in women who delivered prematurely in 3 Latin American counties and to evaluate the maternal characteristics associated with use. METHODS: A multicenter, prospective, descriptive study was conducted in 4 hospitals in Ecuador, 5 in Uruguay, and 3 in El Salvador between 2004 and 2008. Women who had delivered between 24 and 34 weeks of pregnancy responded to a questionnaire assessing sociodemographic characteristics, obstetric history, prenatal care, women's attitudes to health services and knowledge of preterm risk factors, prenatal corticosteroid administration, and characteristics of the delivery and neonate. The association between the prenatal corticosteroid use and the study variables was evaluated through a logistic regression analysis based on a hierarchical model. RESULTS: A total of 1062 women who had a preterm birth were included in the study. Prenatal corticosteroid use was 34.8% (95% CI, 29.9%-39.9%) in Ecuador, 54.6% (95% CI, 49.6%-59.6%) in El Salvador, and 71.0% (95% CI, 65.3%-76.2%) in Uruguay. Hospital admission-to-delivery time was associated with the use of prenatal corticosteroids in all 3 countries. CONCLUSION: The study revealed a varied pattern of use of prenatal corticosteroids across the 3 countries, and a diversity of influencing factors.

Glucocorticoides/uso terapéutico , Conocimientos, Actitudes y Práctica en Salud , Nacimiento Prematuro , Atención Prenatal/normas , Adolescente , Adulto , Ecuador , El Salvador , Femenino , Humanos , Modelos Logísticos , Embarazo , Resultado del Embarazo , Atención Prenatal/métodos , Estudios Prospectivos , Factores de Riesgo , Factores Socioeconómicos , Encuestas y Cuestionarios , Factores de Tiempo , Uruguay , Adulto Joven