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Vol. 38. Issue 12.
Pages 574-579 (December 2002)
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Vol. 38. Issue 12.
Pages 574-579 (December 2002)
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Calidad de los ensayos clínicos publicados en España sobre el asma: comparación con los ensayos clínicos publicados en revistas anglosajonas
Quality of clinical trials published in Spain on asthma in comparison to trials in English language journals
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D. Quiñonesa, J. Llorcaa,
Corresponding author
llorcaj@unican.es

Correspondencia: Medicina Preventiva y Salud Pública. Facultad de Medicina. Avda. Cardenal Herrera Oria, s/n. 39011 Santander. España
, D. Prieto-Salcedaa, M. Delgado-Rodrígueza,b
a Medicina Preventiva y Salud Pública. Facultad de Medicina. Universidad de Cantabria. Santander. España
b Medicina Preventiva y Salud Pública. Universidad de Jaén. España
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Abstract
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Objetivos

Evaluar la calidad de los ensayos clínicos sobre asma publicados en revistas españolas y compararla con los publicados en revistas anglosajonas.

Método

Los ensayos clínicos se obtuvieron por búsqueda en Medline e Índice Médico Español, completando con búsqueda manual a partir de los artículos previamente seleccionados. La calidad se evaluó mediante la escala propuesta por Detsky et al (J Clin Epidemiol 1992;45:255-65).

Resultados

Los artículos publicados en revistas españolas tuvieron menor calidad media que los aparecidos en otras revistas europeas o norteamericanas. Los ensayos publicados en España detallaban con menos frecuencia algunos aspectos metodológicos, incluyendo la aprobación del estudio por un comité de ética, la descripción del método de aleatorización o del flujo de pacientes y el enmascaramiento. Dentro de los ensayos publicados en España, los que tenían autor extranjero tuvieron menor calidad media.

Conclusión

Los ensayos clínicos publicados en España sobre el tratamiento del asma son de menor calidad que los publicados en revistas anglosajonas. Los editores deberían considerar el uso de listas de marcas en el proceso de revisión por pares de los ensayos clínicos para aumentar los estándares de calidad de los trabajos publicados.

Palabras clave:
Asma
Ensayo clínico controlado
Método epidemiológico
Objectives

To evaluate the quality of clinical trials on asthma published in Spanish journals in comparison with those published in European or North American English-language journals.

Method

Clinical trials were identified by searching MEDLINE and the Spanish Medical Index (Índice Médico Español), and by manual searches for trials mentioned in the bibliographies of the previously identified trials. Quality was assessed by the method proposed by Detsky and colleagues in their 1992 article in Journal of Clinical Epidemiology.

Results

The articles published in Spanish journals had lower mean quality scores than those in European or North American English-language journals. Trials published in Spain were less likely to give certain details of methodology, including ethics committee approval, details of randomization or patient enrollment and blinding. Among trials published in Spain, those with non-Spanish authors had lower mean quality scores.

Conclusions

Clinical trials published in Spain on asthma treatments are of poorer quality than those published in English-language journals. Editors should consider using clinical trial quality checklists during the peer review process to raise the standards for published articles.

Keywords:
Asthma
Controlled clinical trial
Epidemiological methodology
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Copyright © 2002. Sociedad Española de Neumología y Cirugía Torácica
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