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01.10.2011 | GUIDELINES

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

verfasst von: Valentina Gallo, Matthias Egger, Valerie McCormack, Peter B. Farmer, John P. A. Ioannidis, Micheline Kirsch-Volders, Giuseppe Matullo, David H. Phillips, Bernadette Schoket, Ulf Stromberg, Roel Vermeulen, Christopher Wild, Miquel Porta, Paolo Vineis

Erschienen in: European Journal of Epidemiology | Ausgabe 10/2011

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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.

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

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.CrossRef

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

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

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.

Casteleyn L, Dumez B, Jamers A, Van Damme K. Ethics and data protection in human biomarker studies. Lodz: ECNIS Publications; 2010.

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

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.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

15.

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

16.

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

17.

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

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.PubMedCrossRef

20.

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

21.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

27.

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

28.

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

29.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

34.

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

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.PubMedCrossRef

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.PubMedCrossRef

37.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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

43.

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

44.

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

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.PubMedCrossRef

46.

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

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.CrossRef

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.PubMedCrossRef

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.CrossRef

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.PubMedCrossRef

52.

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

Titel: STrengthening the reporting of OBservational studies in Epidemiology—Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement
verfasst von: Valentina Gallo
Matthias Egger
Valerie McCormack
Peter B. Farmer
John P. A. Ioannidis
Micheline Kirsch-Volders
Giuseppe Matullo
David H. Phillips
Bernadette Schoket
Ulf Stromberg
Roel Vermeulen
Christopher Wild
Miquel Porta
Paolo Vineis
Publikationsdatum: 01.10.2011
Verlag: Springer Netherlands
Erschienen in: European Journal of Epidemiology / Ausgabe 10/2011
Print ISSN: 0393-2990
Elektronische ISSN: 1573-7284
DOI: https://doi.org/10.1007/s10654-011-9622-1

Springer Medizin

Abstract

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