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.
- 2.Atkinson AJ, Colburn WA, DeGruttola VG, DeMets DL, Downing GJ, Hoth DF, Oates JA, Peck CC, Schooley RT, Spilker BA, Woodcock J, Zeger SL, Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89–95.CrossRefGoogle Scholar
- 5.Castaldi PJ, Dahabreh IJ, Ioannidis JP. An empirical assessment of validation practices for molecular classifiers. Brief Bioinform. 2011;12(3):189–202. Epub 2011 Feb 7.Google Scholar
- 6.Casteleyn L, Dumez B, Jamers A, Van Damme K. Ethics and data protection in human biomarker studies. Lodz: ECNIS Publications; 2010.Google Scholar
- 8.Da Costa B, Cevallos M, Altman D, Rutjes AW, Egger M. Uses and misuses of the STROBE statement: bibliographic study. BMJ 2010 Open doi: 10.1136/bmjopen-2010-000048.
- 18.Ioannidis JP, Tarone R, McLaughlin JK. The false-positive to false-negative ratio in epidemiologic studies. Epidemiology. 2011 Apr 12 (in press).Google Scholar
- 24.Little J, Higgins JP, Ioannidis JP, Moher D, Gagnon F, von Elm E, Khoury MJ, Cohen B, Davey-Smith G, Grimshaw J, Scheet P, Gwinn M, Williamson RE, Zou GY, Hutchings K, Johnson CY, Tait V, Wiens M, Golding J, van Duijn C, McLaughlin J, Paterson A, Wells G, Fortier I, Freedman M, Zecevic M, King R, Infante-Rivard C, Stewart AF, Birkett N. Strengthening the reporting of genetic association studies (STREGA)-an extension of the strengthening the reporting of observational studies in epidemiology (STROBE) statement. J Clin Epidemiol. 2009;62:597–608.e4.PubMedCrossRefGoogle Scholar
- 32.Porta M (ed.) A dictionary of epidemiology. 5th ed. New York: Oxford University Press, 2008. p. 21, 69, pp. 129–130, 152, 157–158.Google Scholar
- 36.Ruchirawa M, Mahidol C, Tangjarukij C, Pui-ock S, Jensen O, Kampeerawipakorn O, Tuntaviroon J, Aramphongphan A, Autrup H. Exposure to genotoxins present in ambient air in Bangkok, Thailand––particle associated polycyclic aromatic hydrocarbons and biomarkers. Sci Total Environ. 2002;287:121–32.PubMedCrossRefGoogle Scholar
- 49.Vineis P, Gallo V. Epidemiological concepts of validation of biomarkers for the identification/quantification of environmental carcinogenic exposures. 2007. Poland, ECNIS.Google Scholar
- 52.Wild C, Vineis P, Garte S, editors. Molecular epidemiology of chronic diseases. Amsterdam: Wiley; 2008.Google Scholar