Detalle Publicación

Valoración de la calidad metodológica y ética de los ensayos clínicos publicados en revistas de medicina de familia (2010-2013)

Autores: Castano-Garcia, A. (Autor de correspondencia); Guillén Grima, Francisco; León Sanz, Pilar
Título de la revista: GACETA MEDICA DE MEXICO
ISSN: 0016-3813
Volumen: 154
Número: 1
Páginas: 92 - 104
Fecha de publicación: 2018
Resumen:
Objective: To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Methods: Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. Results: CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI; 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average K was 0.96 (95% CI: 0.93-0.99). Conclusions: We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013).
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