STrengthening the Reporting of OBservational studies in Epidemiology: Molecular Epidemiology STROBE-ME. An extension of the STROBE statement

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

doi:10.1136/jech-2011-200318

STrengthening the Reporting of OBservational studies in Epidemiology: Molecular Epidemiology STROBE-ME. An extension of the STROBE statement

¹Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, UK
²Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, UK
³Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
⁴International Agency for Research on Cancer, Centre International de Recherche sur le Cancer (IARC) Lyon, France
⁵Department of Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK
⁶Stanford Prevention Research Centre, Stanford University School of Medicine, Stanford, USA
⁷Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
⁸Laboratory for Cell Genetics, Vrije Universiteit Brussel, Brussels, Belgium
⁹HuGeF Human Genetics Foundation, Turin, Italy
¹⁰Department of Genetics, Biology and Biochemistry, University of Turin, Turin, Italy
¹¹Institute of Cancer Research, Sutton, UK
¹²National Institute of Environmental Health, Budapest, Hungary
¹³Division of Occupational and Environmental Medicine, Lund University, Lund, Sweden
¹⁴Institute for Risk Assessment Sciences (IRAS), Division Environmental Epidemiology, Utrecht University, Utrecht, The Netherlands
¹⁵Institut Municipal d'Investigacio Medica (IMIM), Universitat Autonoma de Barcelona, Barcelona, Spain

Correspondence to Dr Valentina Gallo, MD, LSHTM-MSc, Research Associate, School of Public Health, Imperial College London, St Mary's Campus, Norfolk place, W2 1PG London, UK

Contributors A multidisciplinary group of epidemiologists, biostatisticians and laboratory scientists has developed the current recommendations. The group met twice in London (UK), once in Turin (Italy), and once in Łódź (Poland) and sought external opinions from the partners of Environmental Cancer Risk, Nutrition, and Individual Susceptibility (ECNIS) European Network of Excellence—which was the initiator of the STROBE-ME initiative.

Accepted 20 September 2011
Published Online First 24 October 2011

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.

Footnotes

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.
Funding This paper is part of an activity sponsored by the ECNIS network (EC grant FOOD-CT-2005-513943) (http://www.ecnis.org).
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.