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Open Access Correspondence

Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration

Douglas G Altman1*, Lisa M McShane2, Willi Sauerbrei3 and Sheila E Taube4

Author Affiliations

1 Centre for Statistics in Medicine, University of Oxford, Oxford, OX2 6UD, UK

2 US National Cancer Institute, Bethesda, MD 20892, USA

3 Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, 79104 Freiburg, Germany

4 ST-Consulting, Bethesda, MD 20817, USA

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BMC Medicine 2012, 10:51  doi:10.1186/1741-7015-10-51

Published: 29 May 2012

Abstract

Background

The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published tumor marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

Methods

REMARK recommends including a transparent and full description of research goals and hypotheses, subject selection, specimen and assay considerations, marker measurement methods, statistical design and analysis, and study results. Each checklist item is explained and accompanied by published examples of good reporting, and relevant empirical evidence of the quality of reporting. We give prominence to discussion of the 'REMARK profile', a suggested tabular format for summarizing key study details.

Summary

The paper provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing tumor marker studies and prognostic studies in medicine in general.

To encourage dissemination of the Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration, this article has also been published in PLoS Medicine.