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Review Advance Publication

Environ Health Perspect; DOI:10.1289/ehp.1307923

The Navigation Guide—Evidence-Based Medicine Meets Environmental Health: Integration of Animal and Human Evidence for PFOA Effects on Fetal Growth

Juleen Lam,1 Erica Koustas,2 Patrice Sutton,3 Paula I. Johnson,3 Dylan S. Atchley,3 Saunak Sen,4 Karen A. Robinson,5 Daniel A. Axelrad,6 and Tracey J. Woodruff3
Author Affiliations close
1Johns Hopkins University, Department of Health Policy & Management, Baltimore, Maryland, USA; 2Oak Ridge Institute for Science and Education (ORISE) Post-doctoral Fellow with the U.S. Environmental Protection Agency, Office of Policy, National Center for Environmental Economics, Washington, DC, USA; 3University of California San Francisco, Program on Reproductive Health and the Environment, Oakland, California, USA; 4University of California San Francisco, Department of Epidemiology and Biostatistics, San Francisco, California, USA; 5Johns Hopkins University, Departments of Medicine, Epidemiology and Health Policy and Management, Baltimore, Maryland, USA; 6U.S. Environmental Protection Agency, Office of Policy, National Center for Environmental Economics, Washington, DC, USA
About This Article open

This EHP Advance Publication article has been peer-reviewed, revised, and accepted for publication. EHP Advance Publication articles are completely citable using the DOI number assigned to the article. This document will be replaced with the copyedited and formatted version as soon as it is available. Through the DOI number used in the citation, you will be able to access this document at each stage of the publication process.

Citation: Lam J, Koustas E, Sutton P, Johnson PI, Atchley DS, Sen S, Robinson KA, Axelrad DA, Woodruff TJ. The Navigation Guide—Evidence-Based Medicine Meets Environmental Health: Integration of Animal and Human Evidence for PFOA Effects on Fetal Growth. Environ Health Perspect; http://dx.doi.org/10.1289/ehp.1307923.

Received: 22 November 2013
Accepted: 20 June 2014
Advance Publication: 25 June 2014

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Abstract

Background: The Navigation Guide is a novel systematic review method to synthesize scientific evidence and reach strength-of-evidence conclusions for environmental health decision-making.

Objective: Integrate scientific findings from human and non-human studies to determine the overall strength of evidence for the question: “Does developmental exposure to perfluorooctanoic acid (PFOA) affect fetal growth in humans?”

Methods: We developed and applied a priori criteria to systematically and transparently: (1) rate the quality of the scientific evidence as ‘high,’ ‘moderate’ or ‘low’; (2) rate the strength of the human and non-human evidence separately as: ‘sufficient,’ ‘limited,’ ‘moderate,’ or ‘evidence of lack of toxicity’; and (3) integrate the strength of the human and non-human evidence ratings into a strength of the evidence conclusion.

Results: We identified 18 epidemiology and 21 animal toxicology studies relevant to our study question. We rated both the human and non-human mammalian evidence as ‘moderate’ quality and ‘sufficient’ strength. Integration of these evidence ratings produced a final strength of evidence rating where review authors concluded that PFOA is ‘known to be toxic’ to human reproduction and development based on sufficient evidence of decreased fetal growth in both human and non-human mammalian species.

Conclusion: The authors of this review concluded that developmental exposure to PFOA adversely affects human health based on sufficient evidence of decreased fetal growth in both human and non-human mammalian species. The results of this case study demonstrated the application of a systematic and transparent methodology, via the Navigation Guide, for reaching strength of evidence conclusions in environmental health.


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