Parches transdérmicos anticonceptivos: evaluación de tecnología sanitaria / Contraceptive transdermal patches: health technology assessment

INTRODUCCIÓN: La anticoncepción es un derecho, y es obligación del Estado garantizar el acceso a métodos anticonceptivos efectivos, seguros y de calidad. Se realizó una evaluación de tecnología sanitaria sobre los parches anticonceptivos transdérmicos. MÉTODOS: Un equipo multidisciplinario e independiente designado por el Comité Provincial de Biotecnologías de Neuquén buscó información epidemiológica, regulatoria y evidencias científicas sobre eficacia, seguridad y adherencia. Se analizó y sistematizó siguiendo metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) y CASPe (Critical Appraisal Skills Programme Español). RESULTADOS: El único parche autorizado en Argentina para su comercialización libera 33,9 µg/día de etinilestradiol y 203 µg/día de norelgestromina. Su prospecto en Argentina, EE.UU. y Europa lo asocia al doble de riesgo de enfermedad tromboembólica venosa si se compara con las píldoras anticonceptivas que provee el Estado. Esto coincide con resultados de estudios de cohortes de alta calidad. Los parches proveen similar eficacia anticonceptiva a corto plazo, pero con altas tasas de abandono en el seguimiento. La Organización Mundial de la Salud no los ha incluido en su listado de medicamentos esenciales. Los parches son más costosos que otros métodos disponibles. DISCUSIÓN: Sobre la base de los principios de beneficencia, no maleficencia, de precaución y de proporcionalidad, no se recomienda la incorporación de parches.(AU)

INTRODUCTION: Contraception is a right, being an obligation of the State to guarantee access to effective, safe and quality contraceptive methods. A health technology assessment was carried out on transdermal contraceptive patches. METHODS: A multidisciplinary and independent team appointed by the Provincial Biotechnology Committee of Neuquén searched for epidemiological and regulatory information and scientific evidence on efficacy, safety and adherence. It was analyzed and systematized following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) and CASPe (Critical Appraisal Skills Programme Español) methodology. RESULTS: The only patch authorized for commercialization in Argentina releases 33.9 µg/day of ethinylestradiol and 203 µg/day of norelgestromin. Its package insert in Argentina, the US and Europe highlights that the risk of venous thromboembolic disease is twice as high compared to the contraceptive pills provided by the State. This is consistent with results from high-quality cohort studies. Patches provide similar short-term contraceptive efficacy, but with high dropout rates at follow-up. The World Health Organization has not included them in its list of essential medicines. Patches are more expensive than other available methods. DISCUSSION: Based on the principles of beneficence, non-maleficence, precaution and proportionality, the incorporation of patches is not recommended.(AU)

Are Premature Birth and Low Birth Weight Associated with Delay on the Eruption of Deciduous Teeth? A Systematic Review and Meta-analysis

ABSTRACT Objective: To investigate whether children with premature birth (PB) and/or with low birth weight (LBW) have different tooth eruption patterns than those born at term or with normal weight. Material and Methods: Searches were performed in the PubMed, Cochrane Library, Sc1opus, Web of Science, LILACS, and BBO databases as well as the grey literature. Three independent reviewers were involved in study selection, data extraction, and bias assessment. The risk of bias was assessed using the Modified Newcastle-Ottawa Scale. Meta-analysis was conducted to compute the mean difference (MD) in mean chronological or adjusted age at the eruption of the first deciduous tooth between preterm children and those born at full term. The GRADE approach was used. Results: Among a total of 316 articles identified, 21 were eligible for inclusion and three were included in the meta-analysis. PB was associated with the delay in the first tooth deciduous eruption when chronological age was considered (MD: 1.36; 95%CI: 1.02-1.69) but not when considering adjusted age (MD: -0.30; 95%CI: -0.67-0.07). The evidence was graded as having very low quality. Conclusion: Based on a low certainty of evidence the PB is associated with the delayed eruption of the first deciduous tooth when considering chronological age but not when adjusted age is considered.

Effect of interactive media on the development of children and adolescents: systematic review with meta-analysis

Abstract Aim: to investigate through a systematic review of randomized controlled trials (RCTs) the effects of interactive media on the cognitive, language, and motor development of children and adolescents. Methods: Searches were performed with the Medline, AMED, Embase, PEDro, Cochrane, Psychinfo, and ERIC databases in May 2017 with updated in July 2020. For the search strategy, we used descriptors related to "randomized controlled trial", "interactive media" and "children and adolescents up to 18 years old". RCTs that investigated the effectiveness of interactive media in cognitive, motor, and language development of children and adolescents up to 18 years of age with typical development were included. When appropriate, meta-analyses were conducted using a random-effects model. Pooled data were presented using standardized mean difference and 95% confidence interval. We assessed the quality of evidence using the GRADE methodology and the methodological quality using the PEDro scale. Results: of the trials found, 14 references were eligible for this study. The GRADE methodology was used in 13 RCTs. Estimates showed a low level of evidence of a small effect of media use on cognitive development compared to that in the control group and another intervention. No effect on motor and language development. Conclusion: The results of this systematic review do not support claims about the advantages or disadvantages of interactive media in child development. High-quality evidence was found that interactive media is not superior to other interventions for cognitive and language development outcomes and quality of moderate evidence for motor and language development.

Incorporating equity issues into the development of Colombian clinical practice guidelines: suggestions for the GRADE approach / Incorporando equidad al desarrollo de guías de práctica clínica colombianas: sugerencias para la aproximación Grade

Objective To propose how to incorporate equity issues, using the GRADE approach, into the development and implementation of Colombian Clinical Practice Guidelines. Methodology This proposal was developed in four phases: 1. Included a literature review and the development of a preliminary proposal about how to include equity issues; 2. Involved an informal discussion to reach a consensus on improving the first proposal; 3. Was a survey of the researchers' acceptance levels of the proposal, and; 4. A final informal consensus was formed to adjust the proposal. Results A proposal on how to incorporate equity issues into the GRADE approach was developed. It places particular emphasis on the recognition of disadvantaged populations in the development and implementation of the suggested guideline. PROGRESS-Plus is recommended for use in exploring the various categories of disadvantaged people. The proposal suggests that evidence be rated differentially by giving higher ratings to studies that consider equity issues than those that do not. The proposal also suggests the inclusion of indicators to monitor the impacts of the implementation of CPGs on disadvantaged people. Conclusions A consideration of equity in the development and implementation of clinical practice guidelines and quality assessments of the evidence would achieve more in the participation of potential actors in the process and reflect on the effectiveness of the proposed interventions across all social groups.(AU)

Objetivo Proponer como incorporar temas de equidad en el desarrollo e implementación de guías de práctica clínica colombianas utilizando el acercamiento GRADE. Metodología Esta propuesta fue desarrollada en 4 fases: una revisión de la literatura y desarrollo de una propuesta preliminar sobre como incluir temas de equidad, discusión informal para alcanzar un consenso que mejore la primera propuesta; una encuesta sobre los niveles de aceptación de la propuesta y un consenso informal final para ajustar la propuesta. Resultados Se desarrolló una propuesta sobre como incorporar temas de equidad con el acercamiento GRADE. Este hace énfasis especial en el reconocimiento de poblaciones en desventaja al desarrollar e implementar guías. Se recomienda el uso del PROGRESS-Plus para explorar las categorías de las poblaciones en desventaja. La propuesta sugiere una calificación diferencial de la evidencia dando clasificaciones superiores a los estudios que toman en consideración temas de equidad. Esta propuesta también sugiere la inclusión de indicadores que monitoreen el impacto de la implementación de GPC en personas en desventaja. Conclusiones Tener en cuenta la equidad en el desarrollo e implementación de las guías de práctica clínica y la evaluación de calidad de la evidencia puede lograr más en la participación de los actores potenciales del proceso y reflejarse en la efectividad de las intervenciones propuestas en todos los grupos sociales.(AU)