title: Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.
abstract: BACKGROUND
  The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor.
  
  
  OBJECTIVE
  To assess the methodological quality of RCTs published in Spanish-language dermatology journals.
  
  
  METHODS
  By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study.
  
  
  RESULTS
  The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies.
  
  
  CONCLUSIONS
  In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results.
authors.affiliation: Grupo de Investigación Dermatológica (GRID), Universidad de Antioquia, Medellín, Colombia. Electronic address: sanclementegloria@gmail.com.
authors.forename: G
authors.initials: G
authors.lastname: Sanclemente
authors.affiliation: Centro Cochrane Iberoamericano, Institut d'Investigació Biomèdica Sant Pau (IIB Sant Pau), Barcelona, España.
authors.forename: H
authors.initials: H
authors.lastname: Pardo
authors.affiliation: Grupo de Investigación Dermatológica (GRID), Universidad de Antioquia, Medellín, Colombia.
authors.forename: S
authors.initials: S
authors.lastname: Sánchez
authors.affiliation: Centro Cochrane Iberoamericano, Institut d'Investigació Biomèdica Sant Pau (IIB Sant Pau), CIBER Epidemiología y Salud Pública (CIBERESP), Universitat Autònoma de Barcelona, Barcelona, España.
authors.forename: X
authors.initials: X
authors.lastname: Bonfill
mesh_terms: D003880:Dermatology; D006801:Humans; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D013030:Spain
keywords: Bias; Dermatology journals; Ensayo clínico aleatorizado; Español; Methodology; Metodología; Randomized clinical trial; Revistas dermatológicas; Sesgos; Spanish