Skip to main content

Advertisement

Log in

STrengthening the reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement

  • GUIDELINES
  • Published:
European Journal of Epidemiology Aims and scope Submit manuscript

An Erratum to this article was published on 01 February 2012

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  1. Altman DG, Royston P. What do we mean by validating a prognostic model? Stat Med. 2000;19(4):453–73.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  Google Scholar 

  3. Blair A, Saracci R, Vineis P, Cocco P, Forastiere F, Grandjean P, Kogevinas M, Kriebel D, McMichael A, Pearce N, Porta M, Samet J, Sandler DP, Costantini AS, Vainio H. Epidemiology, public health and the rhetoric of false positives. Environ Health Perspect. 2009;117:1809–13.

    PubMed  Google Scholar 

  4. Bonassi S, Au WW. Biomarkers in molecular epidemiology studies for health risk prediction. Mutat Res. 2002;511:73–86.

    Article  PubMed  CAS  Google 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 

  7. Caporaso NE. Why have we failed to find the low penetrance genetic constituents of common cancers? Cancer Epidemiol Biomarkers Prev. 2002;11:1544–9.

    PubMed  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.

  9. Decordier I, VandeLoock K, Kirsch-Volders M. Phenotyping for DNA repair capacity. Mutat Res. 2010;705(2):107–29.

    Article  PubMed  CAS  Google Scholar 

  10. Dusinska M, Vallova B, Ursinyova M, Hladikova V, Smolkova B, Wsolova L, Raslova K, Collins AR. DNA damage and antioxidants; fluctuations through the year in a central European population group. Food Chem Toxicol. 2002;40:1119–23.

    Article  PubMed  CAS  Google Scholar 

  11. Fung AE, Palanki R, Bakri SJ, Depperschmidt E, Gibson A. Applying the CONSORT and STROBE statements to evaluate the reporting quality of neovascular age-related macular degeneration studies. Ophthalmology. 2009;116:286–96.

    Article  PubMed  Google Scholar 

  12. Gallo V, Khan A, Gonzales C, Phillips DH, Schoket B, Győrffy E, Anna L, Kovács K, Moller P, Loft S, Kyrtopoulos S, Matullo G, Vineis P. Validation of biomarkers for the study of environmental carcinogens: a review. Biomarkers. 2008;13:505–34.

    Article  PubMed  CAS  Google Scholar 

  13. Giovannelli L, Saieva C, Masala G, Testa G, Salvini S, Pitozzi V, Riboli E, Dolara P, Palli D. Nutritional and lifestyle determinants of DNA oxidative damage: a study in a Mediterranean population. Carcinogenesis. 2002;23:1483–9.

    Article  PubMed  CAS  Google Scholar 

  14. Haines DA, Arbuckle TE, Lye E, Legrand M, Fisher M, Langlois R, Fraser W. Reporting results of human biomonitoring of environmental chemicals to study participants: a comparison of approaches followed in two Canadian studies. J Epidemiol Community Health. 2011;65:191–8.

    Article  PubMed  Google Scholar 

  15. Hunter DJ. The future of molecular epidemiology. Int J Epidemiol. 1999;28:S1012–4.

    PubMed  CAS  Google Scholar 

  16. Ioannidis JPA. Genetic and molecular epidemiology. J Epidemiol Community Health. 2007;61:757–8.

    Article  PubMed  Google Scholar 

  17. Ioannidis JP, Tzoulaki I. What makes a good predictor? the evidence applied to coronary artery calcium score. JAMA. 2010;303(16):1646–7.

    Article  PubMed  CAS  Google Scholar 

  18. Ioannidis JP, Tarone R, McLaughlin JK. The false-positive to false-negative ratio in epidemiologic studies. Epidemiology. 2011 Apr 12 (in press).

  19. Ioannidis JPA, Panagiotou O. Comparison of effect sizes of biomarkers reported in highly-cited articles versus subsequent meta-analyses. JAMA. 2011;305:2200–10.

    Article  PubMed  CAS  Google Scholar 

  20. Kristensen P. Bias from nondifferential but dependent misclassification of exposure and outcome. Epidemiology. 1992;3:210–5.

    Article  PubMed  CAS  Google Scholar 

  21. Kyzas PA, Loizou KT, Ioannidis JP. Selective reporting biases in cancer prognostic factor studies. J Natl Cancer Inst. 2005;97(14):1043–55.

    Article  PubMed  Google Scholar 

  22. Kyzas PA, Denaxa-Kyza D, Ioannidis JP. Almost all articles on cancer prognostic markers report statistically significant results. Eur J Cancer. 2007;43:2559–79.

    Article  PubMed  Google Scholar 

  23. Leek JT, Scharpf RB, Bravo HC, Simcha D, Langmead B, Johnson WE, Geman D, Baggerly K, Irizarry RA. Tackling the widespread and critical impact of batch effects in high-throughput data. Nat Rev Genet. 2010;11(10):733–9.

    Article  PubMed  CAS  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.

    Article  PubMed  Google Scholar 

  25. Lumbreras B, Parker LA, Porta M, Pollan M, Ioannidis JP, Hernandez-Aguado I. Overinterpretation of clinical applicability in molecular diagnostic research. Clin Chem. 2009;55:786–94.

    Article  PubMed  CAS  Google Scholar 

  26. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumour marker prognostic studies (REMARK). J Natl Cancer Inst. 2005;97:1180–4.

    Article  PubMed  CAS  Google Scholar 

  27. Milikan R. The changing face of epidemiology in the genomics era. Epidemiology. 2002;13:472–80.

    Article  Google Scholar 

  28. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7(2):e1000217.

    Article  PubMed  Google Scholar 

  29. Moller P, Wallin H, Holst E, Knudsen LE. Sunlight-induced DNA damage in human mononuclear cells. FASEB J. 2002;16:45–53.

    Article  PubMed  CAS  Google Scholar 

  30. Phillips DH, Castegnaro M. Standardization and validation of DNA adduct postlabelling methods: report of interlaboratory trials and production of recommended protocols. Mutagenesis. 1999;14:301–15.

    Article  PubMed  CAS  Google Scholar 

  31. Porta M, Pumarega J, Ferrer-Armengou O, López T, Alguacil J, Malats N, et al. Timing of blood extraction in epidemiologic and proteomic studies. Results and proposals from the PANKRAS II Study. Eur J Epidemiol. 2007;22:577–88.

    Article  PubMed  Google 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.

  33. Porta M, Pumarega J, López T, Jariod M, Marco E, Grimalt JO. Influence of tumour stage, symptoms and time of blood draw on serum concentrations of organochlorine compounds in exocrine pancreatic cancer. Cancer Causes Control. 2009;20:1893–906.

    Article  PubMed  Google Scholar 

  34. Ransohoff DF. Rules of evidence for cancer molecular-marker discovery and validation. Nat Rev Cancer. 2004;4:309–14.

    Article  PubMed  CAS  Google Scholar 

  35. Riley RD, Sauerbrei W, Altman DG. Prognostic markers in cancer: the evolution of evidence from single studies to meta-analysis, and beyond. Br J Cancer. 2009;100(8):1219–29.

    Article  PubMed  CAS  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.

    Article  PubMed  Google Scholar 

  37. Rundle AG, Vineis P, Ahsan H. Design options for molecular epidemiology research within cohort studies. Cancer Epidemiol Biomarkers Prev. 2005;14:1899–907.

    Article  PubMed  Google Scholar 

  38. Schulz KF, Altman DG, Moher D. CONSORT group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.

    Article  PubMed  Google Scholar 

  39. Sigounas DE, Tatsioni A, Christodoulou DK, Tsianos EV, Ioannidis JP. New prognostic markers for outcome of acute pancreatitis: overview of reporting in 184 Studies. Pancreas. 2011;40(4):522–32.

    Article  PubMed  Google Scholar 

  40. Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network’s survey of guideline authors. PLoS Med. 2008;5(6):e139.

    Article  PubMed  Google Scholar 

  41. Simera I, Moher D, Hoey J, Schulz KF, Altman DG. A catalogue of reporting guidelines for health research. Eur J Clin Invest. 2010;40(1):35–53.

    Article  PubMed  CAS  Google Scholar 

  42. Sorensen M, Autrup H, Hertel O, Wallin H, Knudsen LE, Loft S. Personal exposure to PM2.5 and biomarkers of DNA damage. Cancer Epidemiol Biomarkers Prev. 2003;12:191–6.

    PubMed  CAS  Google Scholar 

  43. Vahakangas K. Ethical aspects of molecular epidemiology of cancer. Carcinogenesis. 2004;25:465–71.

    Article  PubMed  Google Scholar 

  44. Vainio H. Genetic biomarkers and occupational epidemiology–recollections, reflections and reconsiderations. Scand J Work Environ Health. 2004;30:1–3.

    Article  PubMed  Google Scholar 

  45. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M. STROBE initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007;4(10):e297. Review.

    Article  PubMed  Google Scholar 

  46. Vineis P. Individual susceptibility to carcinogens. Oncogene. 2004;23:6477–83.

    Article  PubMed  CAS  Google Scholar 

  47. Vineis P, Matullo G, Berwick M. Molecular epidemiology. In: Ahrens W, Pigeot I, editors. Handbook of epidemiology. Berlin & Heidelberg: Springer; 2005. p. 1111–38.

    Chapter  Google Scholar 

  48. Vineis P, Perera F. Molecular epidemiology and biomarkers in etiologic cancer research: the new in light of the old. Cancer Epidemiol Biomarkers Prev. 2007;16:1954–65.

    Article  PubMed  CAS  Google Scholar 

  49. Vineis P, Gallo V. Epidemiological concepts of validation of biomarkers for the identification/quantification of environmental carcinogenic exposures. 2007. Poland, ECNIS.

  50. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007;4:e296.

    Article  Google Scholar 

  51. Whiting PF, Weswood ME, Rutjes AW, Reitsma JB, Bossuyt PN, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003;3:25.

    Article  PubMed  Google Scholar 

  52. Wild C, Vineis P, Garte S, editors. Molecular epidemiology of chronic diseases. Amsterdam: Wiley; 2008.

    Google Scholar 

Download references

Acknowledgments

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.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Valentina Gallo.

Additional information

This article is being simultaneously published in 2011 in PLoS Medicine, Journal of Clinical Epidemiology, Preventive Medicine, Mutagenesis, Journal of Epidemiology and Community Health, European Journal of Epidemiology and European Journal of Clinical Investigation. Reproduced by permission of the authors.

An erratum to this article can be found at http://dx.doi.org/10.1007/s10654-012-9662-1.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gallo, V., Egger, M., McCormack, V. et al. STrengthening the reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement. Eur J Epidemiol 26, 797–810 (2011). https://doi.org/10.1007/s10654-011-9622-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10654-011-9622-1

Keywords

Navigation