<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0120-2448</journal-id>
<journal-title><![CDATA[Acta Medica Colombiana]]></journal-title>
<abbrev-journal-title><![CDATA[Acta Med Colomb]]></abbrev-journal-title>
<issn>0120-2448</issn>
<publisher>
<publisher-name><![CDATA[Asociacion Colombiana de Medicina Interna]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0120-24482024000300004</article-id>
<article-id pub-id-type="doi">10.36104/amc.2024.3248</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[The top of the evidence pyramid]]></article-title>
<article-title xml:lang="es"><![CDATA[La cúspide de la pirámide de la evidencia]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[SENIOR-SÁNCHEZ]]></surname>
<given-names><![CDATA[JUAN MANUEL]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Antioquia  ]]></institution>
<addr-line><![CDATA[Medellín ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2024</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2024</year>
</pub-date>
<volume>49</volume>
<numero>3</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0120-24482024000300004&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0120-24482024000300004&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0120-24482024000300004&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract Randomized clinical trials are the most rigorous way to establish a cause-effect relationship between an intervention's efficacy and the outcomes with the least level of uncertainty. Its key features are that the study subjects are randomly assigned to the intervention, the researcher and the subjects are blinded to the treatment they are receiving, and all groups receive the same care except for the experimental intervention. The intention-to-treat analysis involves analyzing the samples in the same group to which they were randomly assigned. The main goal of this analysis is to find out how much the predetermined outcomes of the intervention groups differed from one another. To evaluate the effectiveness of the interventions, observational studies must manage confounding variables that bias the association by being related to both the exposure and the intervention. They typically only show correlation, not causality, although investigators and clinicians tend to mistakenly interpret them as showing the latter. The idea of synthesizing the body of evidence mathematically using meta-analysis is very logical and attractive for the highest possible classification. However, despite being well developed and implemented, the results of meta-analyses are subject to the design of each original study, the inherent clinical heterogeneity and methodological aspects. The objective of the statistical analysis of an RCT is to estimate the magnitude of the difference caused by the interventions on the outcomes. First, a point estimate is determined, which corresponds to the observed difference. Then, the degree of uncertainty of the data must be determined, usually using 95% confidence intervals (95% CI). The type of estimate used depends on the nature of the outcome of interest; there are basically three types: binary, time-to-event and quantitative outcome. (Acta Med Colomb 2024; 49. DOI:https://doi.org/10.36104/amc.2024.3248).]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Un ensayo clínico con asignación aleatoria es la forma más rigurosa para establecer relación causa-efecto, con la menor incertidumbre posible, entre la eficacia de una intervención y un desenlace definido. Sus características más importantes son: la asignación aleatoria a la intervención, el investigador y el sujeto de estudio quienes desconocen cual tratamiento está recibiendo, es decir, están enmascarados; los grupos son tratados en igual forma, excepto por la intervención experimental, los sujetos de estudio son analizados en el mismo grupo al cual fueron asignados en forma aleatoria (análisis por intención a tratar) y el análisis está enfocado sobre la estimación del tamaño de la diferencia en desenlaces predefinidos entre los grupos intervenidos. Para evaluar la efectividad de las intervenciones, los estudios observacionales deben manejar las variables de confusión que sesgan la asociación al estar relacionadas tanto con la exposición como con la intervención. Estos estudios suelen demostrar correlación, mas no causalidad, aunque los investigadores y los clínicos tienden a interpretarlo erróneamente de esta última forma. La idea de sintetizar el cuerpo de la evidencia en forma matemática a través de metaanálisis es bastante lógica y atractiva, para clasificarla en el más alto nivel. Sin embargo, a pesar de ser bien desarrollados y conducidos, sus resultados están sujetos al diseño de cada estudio original, la heterogeneidad clínica inherente y aspectos metodológicos. El objetivo del análisis estadístico de un ensayo clínico de asignación aleatoria (ECA) es estimar la magnitud de la diferencia de las intervenciones sobre los desenlaces. Primero, se determina un estimativo puntual que corresponde a la diferencia observada. Luego, se determina el grado de incertidumbre de los datos, usualmente con el uso de los intervalos de confianza del 95% (IC 95%). El tipo de estimativo utilizado depende de la naturaleza del desenlace de interés, básicamente son tres: binario, tiempo al evento y desenlace cuantitativo. (Acta Med Colomb 2024; 49. DOI:https://doi.org/10.36104/amc.2024.3248).]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[clinical trial]]></kwd>
<kwd lng="en"><![CDATA[survival]]></kwd>
<kwd lng="en"><![CDATA[randomization]]></kwd>
<kwd lng="en"><![CDATA[replicability]]></kwd>
<kwd lng="en"><![CDATA[non inferiority]]></kwd>
<kwd lng="en"><![CDATA[hipothesis]]></kwd>
<kwd lng="en"><![CDATA[Hazard]]></kwd>
<kwd lng="en"><![CDATA[Kaplan Meier]]></kwd>
<kwd lng="en"><![CDATA[risk]]></kwd>
<kwd lng="en"><![CDATA[odds]]></kwd>
<kwd lng="es"><![CDATA[ensayo clínico]]></kwd>
<kwd lng="es"><![CDATA[supervivencia]]></kwd>
<kwd lng="es"><![CDATA[aleatorización]]></kwd>
<kwd lng="es"><![CDATA[replicabilidad]]></kwd>
<kwd lng="es"><![CDATA[no inferioridad]]></kwd>
<kwd lng="es"><![CDATA[hipótesis]]></kwd>
<kwd lng="es"><![CDATA[Hazard]]></kwd>
<kwd lng="es"><![CDATA[Kaplan Meier]]></kwd>
<kwd lng="es"><![CDATA[riesgo]]></kwd>
<kwd lng="es"><![CDATA[odds]]></kwd>
</kwd-group>
</article-meta>
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