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Observational and descriptive studies (ODS) represent between 70 % and 80 % of the designs utilized in biomedical publications of the different scientific journals. Despite this, there are no tools to guide writers and to assist reviewers in reporting results with this type of research design. The aim of this study was to report the characteristics of a validated checklist for reporting the results using ODS as research designs in an English version. Two-stage study with qualitative methodology. In a first stage, a proposal was designed, by collecting items and domains from an extensive review of the literature. In the second, an instrument was developed by applying reduction items and domains through a panel of 45 experts comprised of clinical academics, reviewers and editors of biomedical journals, and experts in research methodology. These worked determining the validity of facade and content of the instrument. The items and domains incorporated into the final instrument were those in which over 80 % of agreement was achieved between the participants (36 of 45). In this way an instrument was created composed of 19 items, grouped into four domains. Characteristics of the design, construction and validation of a checklist that could help authors, reviewers and journal editors to write and review articles using ODS as research designs to report results was reported.

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, various groups have proposed tools for its assessment. Our team has designed and validated scales to assess MQ of therapy, diagnosis, and prognosis studies. However, as with other instruments, it is necessary to specify in detail how it is applied, in order to standardize the measurements made with this instrument. The aim of this article is to provide a guideline for the standardized application of the MInCir MQ scale for therapy or therapeutic procedure studies. A detailed description of the 3 domains and 6 items comprising the scale, specifying for each of them how to assess the characteristics and score articles on therapy or therapeutic procedures is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of the MInCir MQ scale for therapy or therapeutic procedures.

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, several groups have been proposed tools for its evaluation, between them our group has designed and validated scales to assess MQ in therapy, diagnosis and prognosis studies. However, as with other instruments, it is necessary to specify in detail how the measurement is performed. The aim of this article is to provide a guideline for the standardized application of MInCir MQ scale for prognosis studies. A detailed description of the 11 items and 4 domains of the scale, indicating for each of them how to assess and rate the characteristics in primary prognosis articles is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of MInCir MQ scale for prognosis studies. La evaluación de la calidad metodológica (CM) en la investigación biomédica es un área de desarrollo dinámico en los últimos años a nivel global. Entendida como un constructo multidimensional y complejo, diversos grupos han propuesto herramientas para su valoración, entre ellos nuestro equipo de trabajo ha diseñado y validado escalas para valorar CM de estudios de terapia, diagnóstico y pronóstico. Sin embargo, como ocurre con otros instrumentos, es necesario especificar detalladamente la forma en que se aplica, de forma tal de poder estandarizar las mediciones. El objetivo de este artículo es explicar la aplicación de la escala MInCir de CM para estudios de pronóstico. Se presenta una descripción pormenorizada de los 11 ítems y 4 dominios que componen la escala, precisando para cada uno de ellos las características a evaluar y puntuar en los artículos primarios de pronóstico. El presente artículo aporta una guía de aplicación que permite otorgar una adecuada confiabilidad intra e inter observador en las mediciones con la escala MInCir Pronóstico.

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, several groups have been proposed tools for its evaluation, between them our group has designed and validated scales to assess MQ in therapy, diagnosis and prognosis studies. However, as with other instruments, it is necessary to specify in detail how the measurement is performed. The aim of this article is to provide a guideline for the standardized application of MInCir MQ scale for prognosis studies. A detailed description of the 11 items and 4 domains of the scale, indicating for each of them how to assess and rate the characteristics in primary prognosis articles is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of MInCir MQ scale for prognosis studies.

The assessment of methodological quality (MQ) in biomedical research is an area of dynamic development over recent years globally. Understood as a complex and multidimensional construct, various groups have proposed tools for its assessment. Our team has designed and validated scales to assess MQ of therapy, diagnosis, and prognosis studies. However, as with other instruments, it is necessary to specify in detail how it is applied, in order to standardize the measurements made with this instrument. The aim of this article is to provide a guideline for the standardized application of the MInCir MQ scale for therapy or therapeutic procedure studies. A detailed description of the 3 domains and 6 items comprising the scale, specifying for each of them how to assess the characteristics and score articles on therapy or therapeutic procedures is presented. This article provides an application guideline that may help to improve interobserver and intraobserver reliability of the MInCir MQ scale for therapy or therapeutic procedures. La evaluación de la calidad metodológica (CM) en la investigación biomédica es un área de desarrollo dinámico en los últimos años a nivel global. Entendida ésta, como un constructo multidimensional y complejo; diversos grupos han propuesto herramientas para su valoración. Nuestro equipo de trabajo ha diseñado y validado escalas para valorar CM de estudios de terapia, diagnóstico y pronóstico. Sin embargo, como ocurre con otros instrumentos, es necesario especificar detalladamente la forma en que se aplica, de forma tal de poder estandarizar las mediciones efectuadas con dicho instrumento. El objetivo de este artículo es detallar la aplicación de la escala MInCir de CM de estudios de terapia o procedimientos terapéuticos. De este modo, se presenta una descripción pormenorizada de los 3 dominios y 6 ítems que componen la escala, precisando para cada uno de ellos las características a evaluar y puntuar en los artículos primarios de terapia o procedimientos terapéuticos. Este artículo aporta una guía de aplicación que permite otorgar una adecuada confiabilidad intra e inter observador a las mediciones que se realicen aplicando la escala MInCir de terapia o procedimientos terapéuticos.

Los estudios observacionales descriptivos (EOD) constituyen al menos el 70% de los artículos publicados en las distintas revistas científicas del ámbito de la cirugía; y, a pesar de ello, no existen instrumentos para guiar a los escritores en el reporte de resultados, como tampoco para colaborar con los revisores con este tipo de artículos. El objetivo de este estudio es diseñar y construir un sistema de verificación para el reporte de resultados con EOD. Estudio bietápico con metodología cualitativa. En una primera etapa, se diseñó una propuesta, mediante la recopilación de ítems y dominios a partir de una extensa revisión de la literatura relacionada. En la segunda, se construyó una lista de verificación, aplicando reducción de ítems y dominios a través de un panel de 45 expertos en metodología de investigación, académicos clínicos, revisores y editores de revistas biomédicas; aplicando de este modo validez de fachada y de contenido. Los ítems y dominios incorporados a la lista fueron aquellos en los que se logró más de un 80% de acuerdo entre los participantes (36 de 45). Se generó de este modo un instrumento compuesto por 19 ítems, agrupados en 4 dominios. Se diseñó y construyó una lista de verificación que ayudará al reporte de resultados con EOD. Descriptive observational studies (DOE) constitute at least 70% of the published articles in various scientific journals in the field of surgery, and despite this, there are no instruments to guide writers and to assist reviewers in the result report with DOE. The aim of this study is to design and build a checklist for reporting results with EOD. Two-stage study with qualitative methodology. In a first stage, a proposal was designed, by collecting items and domains from an extensive review of the literature. In the second one, an instrument was developed by applying reduction items and domains through a panel of 45 experts in research methodology, clinical academics, reviewers and editors of biomedical journals, thereby applying facade and content validity. The items and domains incorporated into the final instrument were those which achieved over 80% agreement between the participants (36 of 45). In this way an instrument composed of 19 items and grouped into four domains was created. A checklist that will help to report the results using DOE was designed and built.

In certain situations, which occur with particular frequency in the field of surgery and its related disciplines (where what predominates are observational-type studies), the management of randomized controlled clinical trials (RCT) is very difficult and as such, conducting a systematic review (SR) based on RCT and realice a meta-analysis is even more difficult. Therefore, we have generated a methodology for implementing a SR with different types of designs (including observational studies) as an alternative in order to clarify the uncertainty in the field of therapy when there are few RCT and the evidence relies so heavily on descriptive and observational studies. The aim of this study, was to set out a methodology that leads to a SR with various types of designs. Methodologycally, this is based on consideration of the different primary studies through the application of a methodological quality score made up of 3 items (type of study design, size of the population studied and methodology used in the study). Once assigned a point score, a calculation of weighted averages with their respective confidence intervals of 95% is applied to each variable to be studied, which finally enables to apply a meta-analysis and compare groups. A methodological proposal leading to a SR with various types of designs. En ciertas situaciones, en especial frecuentes en el ámbito de la cirugía y sus disciplinas afines (donde lo que predomina son estudios de tipo observacional), la conducción de ensayos clínicos con asignación aleatoria (EC) es muy difícil; por ende, realizar revisiones sistemáticas (RS) con base en EC y posteriormente meta-analizar la información lo es aún más. Por esta razón hemos generado una metodología para realizar RS con diferentes tipos de diseños (incluyendo estudios observacionales), como una alternativa para aclarar la incertidumbre en el ámbito de la terapia cuando existen pocos EC y la evidencia se apoya fundamentalmente en estudios descriptivos y observacionales. El objetivo de este estudio fue exponer una metodología para conducir RS con diversos tipos de diseños. La metodología, se basa en la ponderación de los diferentes estudios primarios a través de la aplicación de un escore de calidad metodológica compuesto por 3 ítems (tipo de diseño del estudio, tamaño de la población estudiada y metodología empleada en el estudio). Una vez asignado un puntaje se aplica un cálculo de promedios ponderados con sus respectivos intervalos de confianza del 95% a cada variable que se desee estudiar, lo que permite finalmente realizar un meta-análisis y comparar grupos. Se presenta una propuesta metodológica para conducir RS con diversos tipos de diseños.