Interspecies extrapolation in environmental exposure standard setting: A Bayesian synthesis approach.

Currently the extrapolation of evidence from studies of non-human species to the setting of environmental exposure standards for humans includes the imposition of a variety of uncertainty factors reflecting unknown aspects of the procedure, including the relevance of evidence from one species to impacts in another. This paper develops and explores more flexible modelling of aspects of this extrapolation, using models proposed by DuMouchel [DuMouchel, W.H., Harris, J.E., 1983. Bayes methods for combining the results of cancer studies in humans and other species (with comment). J. Am. Statist. Assoc. 78, 293-308.] The approaches are based on Bayesian meta-analysis methods involving explicit modelling of relevance in the prior distributions, estimated using Markov chain Monte Carlo (MCMC) methods. The methods are applied to evidence relating chlorinated by-products exposure to adverse reproductive health effects. The relative merits of various approaches are discussed, and developments and next steps are outlined.

[1]  A. Renwick.  Data-derived safety factors for the evaluation of food additives and environmental contaminants. , 1993, Food additives and contaminants.

[2]  Jukka Juutilainen,et al.  Do extremely low frequency magnetic fields enhance the effects of environmental carcinogens? A meta-analysis of experimental studies , 2006, International journal of radiation biology.

[3]  D A Savitz,et al.  Drinking water and pregnancy outcome in central North Carolina: source, amount, and trihalomethane levels. , 1995, Environmental health perspectives.

[4]  W. King,et al.  Trihalomethanes in public water supplies and adverse birth outcomes. , 1999 .

[5]  Douglas G. Altman,et al.  Systematic Reviews in Health Care: Meta-Analysis in Context: Second Edition , 2008 .

[6]  L S Freedman,et al.  Meta-analysis of animal experiments on dietary fat intake and mammary tumours. , 1994, Statistics in medicine.

[7]  V A Benignus.  Quantitative cross-species extrapolation in noncancer risk assessment. , 2001, Regulatory toxicology and pharmacology : RTP.

[8]  K Claxton,et al.  Bayesian approaches to the value of information: implications for the regulation of new pharmaceuticals. , 1999, Health economics.

[9]  B. Ritz,et al.  Estimated effects of disinfection by-products on birth weight in a population served by a single water utility. , 2006, American journal of epidemiology.

[10]  Katherine Campbell,et al.  Setting Environmental Standards: The Statistical Approach to Handling Uncertainty and Variation , 1997 .

[11]  Manuel J Rodriguez,et al.  Trihalomethanes in Drinking Water of Greater Québec Region (Canada): Occurrence, Variations and Modelling , 2003, Environmental monitoring and assessment.

[12]  M L Dourson,et al.  Using human data to protect the public's health. , 2001, Regulatory toxicology and pharmacology : RTP.

[13]  Jeffrey E. Harris,et al.  Bayes Methods for Combining the Results of Cancer Studies in Humans and other Species , 1983 .

[14]  A. O'Hagan,et al.  Statistical Methods for Eliciting Probability Distributions , 2005 .

[15]  Michael Dourson,et al.  Replacing the Default Values of 10 With Data Derived Values: A Comparison of Two Different Data-Derived Uncertainty Factors for Boron , 1999 .

[16]  M J Nieuwenhuijsen,et al.  Use of routinely collected data on trihalomethane in drinking water for epidemiological purposes , 2001, Occupational and environmental medicine.

[17]  Nicky Best,et al.  Relation of Trihalomethane Concentrations in Public Water Supplies to Stillbirth and Birth Weight in Three Water Regions in England , 2004, Environmental health perspectives.

[18]  M L Dourson,et al.  Evolution of science-based uncertainty factors in noncancer risk assessment. , 1996, Regulatory toxicology and pharmacology : RTP.

[19]  Alex J. Sutton,et al.  A Bayesian approach to Markov modelling in cost‐effectiveness analyses: application to taxane use in advanced breast cancer , 2003 .

[20]  Nicola J Cooper,et al.  Evidence‐based sample size calculations based upon updated meta‐analysis , 2007, Statistics in medicine.

[21]  David R. Jones,et al.  How vague is vague? A simulation study of the impact of the use of vague prior distributions in MCMC using WinBUGS , 2005, Statistics in medicine.

[22]  Jeremy E. Oakley,et al.  Uncertain Judgements: Eliciting Experts' Probabilities , 2006 .

[23]  Jens Timmer,et al.  Optimal weighted bayesian design applied to dose-response-curve analysis , 1997 .

[24]  Colin B. Begg,et al.  Random Effects Models for Combining Results from Controlled and Uncontrolled Studies in a Meta-Analysis , 1994 .

[25]  E. Chelimsky,et al.  Cross-design Synthesis: A New Form of Meta-analysis for Combining Results from Randomized Clinical Trials and Medical-practice Databases , 1993, International Journal of Technology Assessment in Health Care.

[26]  Alex J. Sutton,et al.  Methods for Meta-Analysis in Medical Research , 2000 .

[27]  A G Renwick,et al.  Human variability and noncancer risk assessment--an analysis of the default uncertainty factor. , 1998, Regulatory toxicology and pharmacology : RTP.

[28]  D Krewski,et al.  Procedures for calculating benchmark doses for health risk assessment. , 1998, Regulatory toxicology and pharmacology : RTP.

[29]  Michael E Ginevan,et al.  Updated weight of evidence for an association between adverse reproductive and developmental effects and exposure to disinfection by-products. , 2006, Regulatory toxicology and pharmacology : RTP.

[30]  K. G. Brown,et al.  Utilizing data from multiple studies (meta-analysis) to determine effective dose-duration levels. Example: rats and mice exposed to hydrogen sulfide. , 2003, Regulatory toxicology and pharmacology : RTP.

[31]  Lorann Stallones,et al.  Exposure to Trihalomethanes and Adverse Pregnancy Outcomes , 1998, Epidemiology.

[32]  Walter W. Piegorsch,et al.  Combining environmental information. II: Environmental epidemiology and toxicology , 1996 .

[33]  Alex J. Sutton,et al.  A Systematic Review of Systematic Reviews and Meta-Analyses of Animal Experiments with Guidelines for Reporting , 2006 .

[34]  M. Nieuwenhuijsen,et al.  Chlorination disinfection byproducts in water and their association with adverse reproductive outcomes: a review , 2000, Occupational and environmental medicine.

[35]  Daniel Wartenberg,et al.  Guidelines for Application of Metaanalysis in Environmental Epidemiology , 1995 .

[36]  D. Spiegelhalter,et al.  Disease Mapping With WinBUGS and MLwiN, Bayesian Approaches to Clinical Trials and Health Care Evaluation , 2004 .

[37]  P. Chapman,et al.  A critical evaluation of safety (uncertainty) factors for ecological risk assessment , 1998 .

[38]  B. D. Beck,et al.  Uncertainty/Safety Factors in Health Risk Assessment: Opportunities for Improvement , 2001 .

[39]  David M. Eddy,et al.  Meta-analysis by the confidence profile method , 1992 .

[40]  D. Rubin,et al.  Inference from Iterative Simulation Using Multiple Sequences , 1992 .

[41]  Douglas W Dockery,et al.  The effect of disinfection by-products and mutagenic activity on birth weight and gestational duration. , 2004, Environmental health perspectives.

[42]  Alex J. Sutton,et al.  Bayesian methods for the cross‐design synthesis of epidemiological and toxicological evidence , 2005 .

[43]  David R. Jones,et al.  Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. , 2000, Statistics in medicine.

[44]  B. Mallick,et al.  Combining information from several experiments with nonparametric priors , 1997 .

[45]  S. Olshansky,et al.  An interspecies prediction of the risk of radiation-induced mortality. , 1998, Radiation research.

[46]  Daniel Goodman,et al.  Extrapolation in Risk Assessment: Improving the Quantification of Uncertainty, and Improving Information to Reduce the Uncertainty , 2002 .

[47]  Irene Kwan,et al.  Does animal experimentation inform human healthcare? Observations from a systematic review of international animal experiments on fluid resuscitation , 2002, BMJ : British Medical Journal.

[48]  L. Mignini,et al.  Methodological quality of systematic reviews of animal studies: a survey of reviews of basic research , 2006, BMC medical research methodology.

[49]  Michael S Victoroff,et al.  Evidence-based toxicology: a comprehensive framework for causation , 2005, Human & experimental toxicology.

[50]  C. Lynch,et al.  The Association of Waterborne Chloroform with Intrauterine Growth Retardation , 1992, Epidemiology.

[51]  Andrew Thomas,et al.  WinBUGS - A Bayesian modelling framework: Concepts, structure, and extensibility , 2000, Stat. Comput..

[52]  J Schwartz,et al.  Effect of trihalomethane exposure on fetal development , 2003, Occupational and environmental medicine.

[53]  Richard Reiss,et al.  Use of benchmark dose and meta-analysis to determine the most sensitive endpoint for risk assessment for dimethoate. , 2005, Regulatory toxicology and pharmacology : RTP.

[54]  David Turner,et al.  Comprehensive decision analytical modelling in economic evaluation: a Bayesian approach. , 2004, Health economics.

[55]  Mark J Nieuwenhuijsen,et al.  Description of trihalomethane levels in three UK water suppliers† , 2003, Journal of Exposure Analysis and Environmental Epidemiology.

[56]  W DuMouchel,et al.  A Bayesian methodology for scaling radiation studies from animals to man. , 1989, Health physics.

[57]  Wout Slob,et al.  Probabilistic risk characterization: an example with di(2-ethylhexyl) phthalate. , 2005, Regulatory toxicology and pharmacology : RTP.

[58]  D R Saunders,et al.  Addressing human variability in risk assessment--the robustness of the intraspecies uncertainty factor. , 1999, Regulatory toxicology and pharmacology : RTP.

[59]  G L Kimmel,et al.  Harmonization of cancer and noncancer risk assessment: proceedings of a consensus-building workshop. , 2001, Toxicological sciences : an official journal of the Society of Toxicology.

[60]  Sandra J. S. Baird,et al.  Noncancer Risk Assessment: A Probabilistic Alternative to Current Practice , 1996 .

[61]  J. Paxton,et al.  Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, 1994: THE ALLOMETRIC APPROACH FOR INTERSPECIES SCALING OF PHARMACOKINETICS AND TOXICITY OF ANTI‐CANCER DRUGS , 1995 .

[62]  W. Slob,et al.  A Probabilistic Approach for Deriving Acceptable Human Intake Limits and Human Health Risks from Toxicological Studies: General Framework , 1998 .

[63]  N Keiding,et al.  Benchmark Dose Calculation from Epidemiological Data , 2001, Biometrics.