[Disparity in the criteria for including patients with neonatal sepsis in scientific medical studies. Are we swimming in a sea without limits?]. / Disparidad en los criterios para incluir pacientes con sepsis neonatal en estudios médicos científicos. 'Nadamos en un mar sin límites?

OBJECTIVE: To characterize disparity in the criteria used for patient enrollment in clinical research on neonatal sepsis. MATERIAL AND METHODS: We used MEDLINE to identify clinical research in neonatal sepsis published in English from 1993 to 2005. We used the criteria of the International Consensus Conference Panel: International Pediatric Sepsis Consensus Conference: Definitions for Sepsis and Organ Dysfunction in Pediatrics (IPSCC) published in 2005 as an arbitrary standard in each of the articles. Articles were considered to define neonatal sepsis clearly if they mentioned the criteria and described the values used. Articles were considered not to define neonatal sepsis clearly if they used the phrase "septic patients were included" without describing the variables or values used for inclusion. RESULTS: We identified 150 articles, of which 26.6 % specified the criteria and values of the IPSCC. The remaining 110 articles did not mention the values or the variables used to define neonatal sepsis. CONCLUSION: There is a disparity in the criteria used to operatively define neonatal sepsis in clinical studies performed in distinct parts of the world.

Disparidad en los criterios para incluir pacientes con sepsis neonatal en estudios médicos científicos. ¿Nadamos en un mar sin límites? / Disparity in the criteria for including patients with neonatal sepsis in scientific medical studies. Are we swimming in a sea without limits?

Objetivo Observar la disparidad de los criterios utilizados para incluir pacientes considerados con sepsis neonatal en la literatura médica científica. Material y métodos Buscamos mediante la base de datos Medline, artículos que utilizaron poblaciones definidas como "sepsis neonatal", publicados en el idioma inglés de los años 1993 a 2005. Utilizamos como estándar arbitrario en cada uno de los artículos los criterios del Consenso Internacional de Sepsis Pediátrica (CISP) publicada en 2005. Consideramos como artículos que la definieron claramente, a los que mencionaron los criterios y describieron los valores utilizados. Se consideraron como artículos con definición poco clara de sepsis neonatal a los que utilizaron el párrafo "se incluyeron pacientes sépticos" sin describir variables ni valores utilizados para la inclusión. Resultados Fueron evaluados 150 artículos, el 26,6 % especificaban los criterios y valores del CISP. Los restantes 110 no mencionaron los valores y/o las variables que tomaban en cuenta. Conclusión Existe disparidad en los criterios utilizados para definir operativamente sepsis neonatal en los estudios clínicos realizados a nivel mundial

Objective To characterize disparity in the criteria used for patient enrollment in clinical research on neonatal sepsis. Material and methods We used MEDLINE to identify clinical research in neonatal sepsis published in English from 1993 to 2005. We used the criteria of the International Consensus Conference Panel: International Pediatric Sepsis Consensus Conference: Definitions for Sepsis and Organ Dysfunction in Pediatrics (IPSCC) published in 2005 as an arbitrary standard in each of the articles. Articles were considered to define neonatal sepsis clearly if they mentioned the criteria and described the values used. Articles were considered not to define neonatal sepsis clearly if they used the phrase "septic patients were included" without describing the variables or values used for inclusion. Results We identified 150 articles, of which 26.6 % specified the criteria and values of the IPSCC. The remaining 110 articles did not mention the values or the variables used to define neonatal sepsis. Conclusion There is a disparity in the criteria used to operatively define neonatal sepsis in clinical studies performed in distinct parts of the world