Elsevier

Medicina Clínica

Volume 125, Supplement 1, December 2005, Pages 21-27
Medicina Clínica

Ensayos clínicos aleatorizados (CONSORT)Randomized clinical trials (CONSORT)

https://doi.org/10.1016/S0025-7753(05)72205-3Get rights and content

Se ha puesto de manifiesto repetidamente que la información facilitada en las publicaciones de ensayos clínicos es muchas veces insuficiente o inexacta y que ciertos problemas metodológicos se asocian a estimaciones exageradas del efecto de las intervenciones sanitarias. Para mejorar la calidad de la comunicación de los ensayos clínicos, un grupo de científicos y editores desarrolló el CONSORT statement (Consolidated Standards of Reporting Trials), una guía de 22 puntos (y un diagrama de flujo), que pueden utilizar autores, editores, revisores y lectores. Tras su publicación en 1996, diversas revistas y grupos editoriales adoptaron la guía CONSORT. En 1999 se elaboró una segunda versión revisada que se publicó en 2001.

En este artículo se presenta la traducción al castellano de los dos elementos que integran la guía CONSORT revisada, el diagrama de flujo y la lista-guía de 22 puntos, acompañada de un breve comentario sobre cada uno de ellos. Las publicaciones previas del CONSORT statement y otros recursos útiles, como ejemplos de lo que se consideran comunicaciones correctas, pueden obtenerse en la página web de CONSORT (http://www.consort-statement.org).

It has been repeatedly shown that the information supplied in publications of clinical trials is frequently insufficient or inaccurate and that some methodologic problems are associated with exaggerated estimates of the effect of healthcare interventions.

To improve the quality of reports of clinical trials, a group of scientists and editors developed the CONSORT statement (Consolidated Standards of Reporting Trials), a 22-item checklist (plus flow diagram), that can be used by authors, editors, reviewers, and readers. After publication in 1996, CONSORT was adopted by several journals and editorial groups. In 1999, a second version was drawn up, which was published in 2001.

This article presents the Spanish translation of the two elements integrating the revised CONSORT, the flow diagram and the 22-item checklist, and provides a short comment on each of them. Previous publications of the CONSORT statement and other useful resources such as examples of what are considered good communications may be obtained from the CONSORT web site (http://www.consort-statement.org).

Referencias bibliográficas (85)

  • L. Kjaergård et al.

    Quality of randomised clinical trials affects estimates of intervention efficacy [Abstract]

  • K. Adetugbo et al.

    How well are randomized controlled trials reported in the dermatology literature?

    Arch Dermatol

    (2000)
  • L.L. Kjaergård et al.

    Randomized clinical trials in HEPATOLOGY: predictors of quality

    Hepatology

    (1999)
  • R. DerSimonian et al.

    Reporting on methods in clinical trials

    N Engl J Med

    (1982)
  • D. Moher et al.

    Statistical power, sample size, and their reporting in randomized controlled trials

    JAMA

    (1994)
  • S. Hollis et al.

    What is meant by intention to treat analysis? Survey of published randomised controlled trials

    BMJ

    (1999)
  • K.F. Schulz et al.

    Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals

    JAMA

    (1994)
  • S.M. Gore et al.

    Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976

    Br Med J

    (1977)
  • S.J. Pocock et al.

    Statistical problems in the reporting of clinical trials. A survey of three medical journals

    N Engl J Med

    (1987)
  • D.G. Altman

    The scandal of poor medical research [editorial]

    BMJ

    (1994)
  • A proposal for structured reporting of randomized controlled trials

    JAMA

    (1994)
  • Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature

    Ann Intern Med

    (1994)
  • C. Begg et al.

    Improving the quality of reporting of randomized controlled trials. The CONSORT statement

    JAMA

    (1996)
  • M.K. Campbell et al.

    CONSORT statement: extension to cluster randomised trials

    BMJ

    (2004)
  • D. Moher et al.

    Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond

    CMAJ

    (2004)
  • D. Moher et al.

    Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. The CONSORT Group

    JAMA

    (2001)
  • M. Egger et al.

    Value of flow diagrams in reports of randomized controlled trials. The CONSORT Group

    JAMA

    (2001)
  • C.L. Meinert

    Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials

    JAMA

    (1998)
  • D. Moher et al.

    The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. The CONSORT Group

    Ann Intern Med

    (2001)
  • D. Moher et al.

    The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. The CONSORT Group

    JAMA

    (2001)
  • D.G. Altman et al.

    The revised CONSORT statement for reporting randomized trials: explanation and elaboration

    Ann Intern Med

    (2001)
  • K. Dickersin et al.

    Identifying relevant studies for systematic reviews

    BMJ

    (1994)
  • Recommendations guiding physicians in biomedical research involving human subjects

    JAMA

    (1997)
  • J. Lau et al.

    Cumulative meta-analysis of therapeutic trials for myocardial infarction

    N Engl J Med

    (1992)
  • C. Roberts

    The implications of variation in outcome between health professionals for the design and analysis of randomized controlled trials

    Stat Med

    (1999)
  • I. McDowell et al.

    Measuring Health: A Guide to Rating Scales and Questionnaires

    (1996)
  • M. Marshall et al.

    Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia

    Br J Psychiatry

    (2000)
  • C. Sanders et al.

    Reporting on quality of life in randomised controlled trials: bibliographic study

    BMJ

    (1998)
  • S.N. Goodman et al.

    The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results

    Ann Intern Med

    (1994)
  • N.L. Geller et al.

    Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners

    Biometrics

    (1987)
  • S.J. Pocock

    When to stop a clinical trial

    BMJ

    (1992)
  • D.A. Berry

    Interim analyses in clinical trials: classical vs. Bayesian approaches

    Stat Med

    (1985)
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