STrengthening the reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement
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Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change, susceptibility, and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and the body components or processes. The need for improved reporting of scientific research led to influential statements of recommendations such as STrengthening Reporting of Observational studies in Epidemiology (STROBE) statement. The STROBE initiative established in 2004 aimed to provide guidance on how to report observational research. Its guidelines provide a user-friendly checklist of 22 items to be reported in epidemiological studies, with items specific to the three main study designs: cohort studies, case–control studies and cross-sectional studies. The present STrengthening the Reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME) initiative builds on the STROBE Statement implementing 9 existing items of STROBE and providing 17 additional items to the 22 items of STROBE checklist. The additions relate to the use of biomarkers in epidemiological studies, concerning collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical considerations. The STROBE-ME recommendations are intended to complement the STROBE recommendations.
KeywordsEpidemiology Molecular epidemiology Biomarkers Validation Reporting recommendations
This paper is part of an activity sponsored by the ECNIS network (EC grant FOOD-CT-2005-513943) (www.ecnis.org). We acknowledge the contribution of Dan Segerbäck, Jim Vaught, Soterios Kyrtopoulos, Franz Oesch, Jelle Vlaanderen, and Jouni Jaakkola to the discussion of an earlier version of the paper. We also would like to thank all the reviewers for their valuable contribution and constructive feedback.
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