Assessment of the methodological and ethical quality of clinical trials published in family medicine journals
Castaño-García A (1), Guillén-Grima F (2), León-Sanz P (3).
(1) Centro de Salud de Corella, Servicio Navarro de Salud, Corella, Navarra.
(2) Servicio de Medicina Preventiva, Clínica Universitaria de Navarra, Pamplona, Navarra; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Navarra.
(3) Facultad de Medicina, Departamento de Humanidades Biomédicas, Universidad de Navarra, Pamplona, Navarra, España.
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Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7).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 κ 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).
CITATION Gac Med Mex. 2018;154(1):92-104. doi: 10.24875/GMM.17002699