A survey of frameworks for best practices in weight-of-evidence analyses

References

• Adami HO, Berry SC, Breckenridge C, et al. (2011). Toxicology and epidemiology: improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference. Toxicol Sci, 122, 223–34
   PubMed Web of Science ®Google Scholar
• Becker RA, Janus ER, White RD, et al. (2010). Good Laboratory Practices: Becker et al. Respond. Environ Health Perspect, 118, A194–5
   Web of Science ®Google Scholar
• Bevan C, Strother D. (2012). Best practices for evaluating method validity, data quality and study reliability of toxicity studies for chemical hazard and risk assessment. Developed for ACC’s Center for Advancing Risk Assessment Science and Policy. Available from: http://arasp.americanchemistry.com/Data-Quality-Evaluation [last accessed 22 Mar 2013]
   Google Scholar
• Boekelheide K, Campion SN. (2010). Toxicity testing in the 21st century: using the new toxicity testing paradigm to create a taxonomy of adverse effects. Toxicol Sci, 114, 20–4
   PubMed Web of Science ®Google Scholar
• Boffetta P, Winn DM, Ioannidis JP, et al. (2012). Recommendations and proposed guidelines for assessing the cumulative evidence on joint effects of genes and environments on cancer occurrence in humans. Int J Epidemiol, 41, 686–704
   PubMed Web of Science ®Google Scholar
• Boobis AR, Cohen SM, Dellarco V, et al. (2006). IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit Rev Toxicol, 36, 781–92
   PubMed Web of Science ®Google Scholar
• Boobis AR, Daston GP, Preston RJ, Olin SS. (2009). Application of key events analysis to chemical carcinogens and noncarcinogens. Crit Rev Toxicol, 49, 690–707
   Google Scholar
• Boobis AR, Doe JE, Heinrich-Hirsch B, et al. (2008). IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol, 38, 87–96
   PubMed Web of Science ®Google Scholar
• Borgert CJ, Mihaich EM, Ortego LS, et al. (2011). Hypothesis-driven weight of evidence framework for evaluating data within the US EPA’s Endocrine Disruptor Screening Program. Regul Toxicol Pharmacol, 61, 185–91
   PubMed Web of Science ®Google Scholar
• Boyles AL. (2012). NTP Update: systematic Review Incorporating Data Mining with Graphical Tools for Researchers. National Toxicology Program (NTP), Office of Health Assessment and Translation, 30p., March 6
   Google Scholar
• Centers for Disease Control and Prevention (CDC). (2004). The Health Consequences of Smoking: a Report of the Surgeon General. US Public Health Service, Office of the Surgeon General. [Online] Available from: http://www.cdc.gov/tobacco/data_statistics/sgr/2004/complete_report/index.htm [last accessed 11 Feb 2013]
   Google Scholar
• Cole P. (1997). Causation in epidemiology, health policy, and law. Environ Law Rep, 27, 10279–85
   Google Scholar
• European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). (2009). Framework of the Integration of Human and Animal Data in Chemical Risk Assessment. ECETOC Technical Report No. 104. 130p., January
   Google Scholar
• European Chemicals Agency (ECHA). (2010). Practical Guide 2: how to Report Weight of Evidence. ECHA-10-B-05-EN. 26p
   Google Scholar
• European Commission, Directorate-General for Health & Consumers, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). (2012). Memondum on the Use of the Scientific Literature for Human Health Risk Assessment Purposes – Weighing of Evidence and Expression of Uncertainty. 46p., March 19
   Google Scholar
• European Food Safety Authority (EFSA). (2010). Application of systematic review methodology to food and feed safety assessments to support decision making. EFSA J, 8, 1637, 1--90
   Google Scholar
• Goodman JE, Dodge DG, Bailey LA. (2010). A framework for assessing causality and adverse effects in humans with a case study of sulfur dioxide. Regul Toxicol Pharmacol, 58, 308–22
   PubMed Web of Science ®Google Scholar
• Gray GM, Baskin SI, Charnley G, et al. (2001). The annapolis accords on the use of toxicology in risk assessment and decision-making. Annapolis, MD: The Annapolis Center for Science-Based Public Policy, 13p
   Google Scholar
• Guyatt GH, Oxman AD, Kunz R, et al. (2008a). What is quality of evidence and why is it important to clinicians? BMJ, 336, 995–8
   PubMed Web of Science ®Google Scholar
• Guyatt GH, Oxman AD, Vist GE, et al. (2008b). GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 336, 924–6
   PubMed Web of Science ®Google Scholar
• Guzelian PS, Victoroff MS, Halmes NC, et al. (2005). Evidence-based toxicology: a comprehensive framework for causation. Hum Exp Toxicol, 24, 161–201
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Green S, eds. (2011). Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). The Cochrane Collaboration. [Online] Available from: http://www.cochrane-handbook.org [last accessed 11 Feb 2013]
   Google Scholar
• Hill AB. (1965). The environment and disease: association or causation? Proc R Soc Med, 58, 295–300
   PubMed Web of Science ®Google Scholar
• Institute of Medicine (IOM). (2008). Improving the presumptive disability decision-making process for veterans. Washington, DC: National Academies Press
   Google Scholar
• Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). (1997). Validation and Regulatory Acceptance of Toxicological Test Methods. Research Triangle Park, NC: National Institute of Environmental Health Sciences. [Online] Available from: http://alttox.org/ttrc/us/validation-centers.html [last accessed 22 Mar 2013]
   Google Scholar
• International Agency for Research on Cancer (IARC). (2006). Preamble to the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Lyon, France: World Health Organisation; IARC. [Online] Available from: http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf [last accessed 11 Feb 2013]
   Google Scholar
• Ioannidis JP, Boffetta P, Little J, et al. (2008). Assessment of cumulative evidence on genetic associations: interim guidelines. Int J Epidemiol, 37, 120–32
   PubMed Web of Science ®Google Scholar
• Julien E, Boobis AR, Olin SS. (2009). The Key Events Dose-Response Framework: a cross-disciplinary mode-of-action based approach to examining dose-response and thresholds. Crit Rev Food Sci Nutr, 49, 682–9
   PubMed Web of Science ®Google Scholar
• Klimisch HJ, Andreae M, Tillmann U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol, 25, 1–5
   PubMed Web of Science ®Google Scholar
• Krimsky S. (2005). The weight of scientific evidence in policy and law. Am J Public Health, 95, S129–36
   PubMed Web of Science ®Google Scholar
• Kundi M. (2007). Causality and the interpretation of epidemiologic evidence. Cien Saude Colet, 12, 419–28
   PubMed Web of Science ®Google Scholar
• Lewis RW, Billington R, Debryune E, et al. (2002). Recognition of adverse and nonadverse effects in toxicity studies. Toxicol Pathol, 30, 66–74
   PubMed Web of Science ®Google Scholar
• Li AA, Levine TE, Burns CJ, Anger WK. (2012). Integration of epidemiology and animal neurotoxicity data for risk assessment. Neurotoxicology, 33, 823–32
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, et al. (2009). The PRISMA Statement for reporting systematic reviews and meta-analyses of studies that evaluate health care intverventions: explanation and elaboration. Ann Intern Med, 151, W65–94
   PubMed Web of Science ®Google Scholar
• Linkov I, Loney D, Cormier S, et al. (2009). Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches. Sci Total Environ, 407, 5199–205
   PubMed Web of Science ®Google Scholar
• Linkov I, Welle P, Loney D, et al. (2011). Use of multicriteria decision analysis to support weight of evidence evaluation. Risk Anal, 31, 1211–25
   PubMed Web of Science ®Google Scholar
• Meek ME, Bucher JR, Cohen SM, et al. (2003). A framework for human relevance analysis of information on carcinogenic modes of action. Crit Rev Toxicol, 33, 591–653
   PubMed Web of Science ®Google Scholar
• Myers JP, Vom Saal FS, Akingbemi BT, et al. (2009). Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A. Environ Health Perspect, 117, 309–15
   PubMed Web of Science ®Google Scholar
• National Research Council (NRC). (2007). Toxicity testing in the twenty-first century: a vision and a strategy. Washington, DC: National Academies Press
   Google Scholar
• National Research Council (NRC). (2009). Science and decisions: advancing risk assessment. [The Silver Book.] Committee on Improving Risk Analysis Approaches Used by the US EPA. Washington, DC: National Academies Press
   Google Scholar
• National Research Council (NRC). (2011). Review of the environmental protection agency’s draft IRIS assessment of formaldehyde. Washington, DC: National Academies Press
   Google Scholar
• National Toxicology Program (NTP). (2005). National toxicology program center for the evaluation of risks to human reproduction: guidelines for CERHR expert panel members, 23p., January 27
   Google Scholar
• National Toxicology Program (NTP). (2012). Summary Minutes of NTP Board of Scientific Counselors Meeting, held June 21–22, 2012, in Research Triangle Park, North Carolina. 36p
   Google Scholar
• Proctor DM, Otani JM, Finley BL, et al. (2002). Is hexavalent chromium carcinogenic via ingestion? A weight-of-evidence review. J Toxicol Environ Health A, 65, 701–46
   PubMed Web of Science ®Google Scholar
• Prueitt RL, Goodman JE, Bailey LA, Rhomberg LR. (2011). Hypothesis-based weight-of-evidence evaluation of the neurodevelopmental effects of chlorpyrifos. Crit Rev Toxicol, 41, 822–903
   PubMed Web of Science ®Google Scholar
• Rhomberg LR, Bailey LA, Goodman JE. (2010). Hypothesis-based weight of evidence: a tool for evaluating and communicating uncertainties and inconsistencies in the large body of evidence in proposing a carcinogenic mode of action – Naphthalene as an example. Crit Rev Toxicol, 40, 671–96
   PubMed Web of Science ®Google Scholar
• Rhomberg LR, Goodman JE, Bailey LA, Prueitt, RL. (2012). Workshop Discussion Draft: best Practices for Weight-of-Evidence Evaluations. October 22, 79p
   Google Scholar
• Schunemann H, Hills S, Guyatt G, et al. (2011). The GRADE approach and Bradford Hill’s criteria for causation. J Epidemiol Community Health, 65, 392–5
   PubMed Web of Science ®Google Scholar
• Seed J, Carney EW, Corley RA, et al. (2005). Overview: using mode of action and life stage information to evaluate the human relevance of animal toxicity data. Crit Rev Toxicol, 35, 664–72
   PubMed Web of Science ®Google Scholar
• Shea BJ, Grimshaw JM, Wells GA, et al. (2007). Development of AMSTAR: a measurement tool to assess the methodological quality of systematic review. BMC Med Res Methodol, 7, 10
   PubMed Web of Science ®Google Scholar
• Sonich-Mullin C, Fielder R, Wiltse J, et al. (2001). IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul Toxicol Pharmacol, 34, 146–52
   PubMed Web of Science ®Google Scholar
• Stroup DF, Berlin JA, Morton SC, et al. (2000). Meta-analysis of observational studies in epidemiology: a proposal for reporting. JAMA, 283, 2008–12
   PubMed Web of Science ®Google Scholar
• Suter GW II, Cormier SM. (2011). Why and how to combine evidence in environmental assessments: weighing evidence and building cases. Sci Total Environ, 409, 1406–17
   PubMed Web of Science ®Google Scholar
• Swaen G, van Amelsvoort L. (2009). A weight of evidence approach to causal inference. J Clin Epidemiol, 62, 270–7
   PubMed Web of Science ®Google Scholar
• Swaen GM. (2006). A framework for using epidemiological data for risk assessment. Hum Exp Toxicol, 25, 147–55
   PubMed Web of Science ®Google Scholar
• Thayer K. (2012). Systematic Review and New Tools for Information Management and Data Display. National Toxicology Program (NTP), Office of Health Assessment and Translation, 1p
   Google Scholar
• Tyl RW. (2009). Basic exploratory research versus guideline-compliant studies used for hazard evaluation and risk assessment: bisphenol A as a case study. Environ Health Perspect, 117, 1644–51
   PubMed Web of Science ®Google Scholar
• United Nations. (2011). Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (Fourth Revised Edition). ST/SG/AC.10/30/Rev.4, 568p
   Google Scholar
• US EPA. (1986a). Guidelines for mutagenicity risk assessment. Fed Reg, 51, 34006–12
   Google Scholar
• US EPA. (1986b). Guidelines for carcinogen risk assessment. Fed Reg, 51, 33992–4003
   Google Scholar
• US EPA. (1991). Guidelines for developmental toxicity risk assessment. Fed Reg, 56, 63798–826
   Google Scholar
• US EPA. (1994). Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. Environmental Criteria and Assessment Office. EPA-600/8-90/066F, October
   Google Scholar
• US EPA. (1998). Guidelines for neurotoxicity risk assessment. Fed Reg, 63, 26926–54
   Google Scholar
• US EPA. (2002). A Review of the Reference Dose and Reference Concentration Processes (Final). Risk Assessment Forum, Reference Dose/Reference Concentration (RfD/RfC) Technical Panel. EPA/630-P-02/002F, 192p., December
   Google Scholar
• US EPA. (2005a). Guidelines for Carcinogen Risk Assessment. Risk Assessment Forum. EPA/630/P-03/001F, March
   Google Scholar
• US EPA. (2006). A Framework for Assessing Health Risks of Environmental Exposures to Children. National Center for Environmental Assessment (NCEA). EPA/600/R-05/093F, 145p., September
   Google Scholar
• US EPA. (2007). Framework for Determining a Mutagenic Mode of Action for Carcinogenicity: using EPA’s 2005 Cancer Guidelines and Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens [External Peer Review Draft]. Risk Assessment Forum Technical Panel on Mutagenic Mode of Action. EPA 120/R-07/002-A, 50p., September
   Google Scholar
• US EPA. (2010). Framework for Incorporating Human Epidemiologic & Incident Data in Health Risk Assessment (Draft). Office of Pesticide Programs. 68p., January 7
   Google Scholar
• US EPA. (2011a). Integrated Science Assessment for Ozone and Related Photochemical Oxidants (Second External Review Draft). National Center for Environmental Assessment (NCEA): EPA/600/R-10/076B, 1222p., September
   Google Scholar
• US EPA (2011b). Evaluation Guidelines for Ecological Toxicity Data in the Open Literature. Available from: http://www.epa.gov/pesticides/science/efed/policy_guidance/team_authors/endangered_species_reregistration_workgroup/esa_evaluation_open_literature.htm [last accessed 11 Feb 2013].
   Google Scholar
• US EPA (2011c). Weight-of-Evidence: evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing. Office of Chemical Safety and Pollution Prevention. Washington DC. Available from: http://www.epa.gov/scipoly/oscpendo/index.htm [last accessed 11 Feb 2013]
   Google Scholar
• US EPA. (2012a). EPA’s Integrated Risk Information System Program: progress Report and Report to Congress. 29p., June. [Online] Available from: http://www.epa.gov/ncea/iris/pdfs/irisprogressreport2012.pdf [last accessed 11 Feb 2013]
   Google Scholar
• US EPA. (2012b). Preamble to IRIS Toxicological Reviews. National Center for Environmental Assessment (NCEA), EPA/635/R-11/013A, 13p., June
   Google Scholar
• US EPA. (2012c). Framework for Human Health Risk Assessment to Inform Decision Making (EPA External Review Draft). Risk Assessment Forum, EPA-601-D12-001, 85p., July 12
   Google Scholar
• US Food and Drug Administration (US FDA). (2009). Guidance for Industry: evidence-Based Review System for the Scientific Evaluation of Health Claims (Final). 29p., January. [Online] Available from: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm [last accessed 11 Feb 2013]
   Google Scholar
• Vlaanderen J, Vermeulen R, Heederik D, Kromhout H. (2008). Guidelines to evaluate human observational studies for quantitative risk assessment. Environ Health Perspect, 116, 1700–5
   PubMed Web of Science ®Google Scholar
• von Elm E, Altman DG, Egger M, et al. (2007). Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ, 335, 806–8
   PubMed Web of Science ®Google Scholar
• Vyskocil A, Truchon G, Leroux T, et al. (2011). A weight of evidence approach for the assessment of the ototoxic potential of industrial chemicals. Toxicol Ind Health, 28, 796–819
   PubMed Web of Science ®Google Scholar
• Walker VR. (1996). Risk characterization and the weight of evidence: adapting gatekeeping concepts from the courts. Risk Anal, 16, 793–9
   Web of Science ®Google Scholar
• Waters M, Stasiewicz S, Merrick BA, et al. (2008). CEBS – Chemical Effects in Biological Systems: a public data repository integrating study design and toxicity data with microarray and proteomics data. Nucleic Acids Res, 36, D892–900
   Web of Science ®Google Scholar
• Weed DL. (2005). Weight of evidence: a review of concepts and methods. Risk Anal, 25, 1545–57
   PubMed Web of Science ®Google Scholar
• Woodruff TJ, Sutton P. (2011). An evidence-based medicine methodology to bridge the gap between clinical and environmental health sciences. Health Aff (Millwood), 30, 931–7
   PubMed Web of Science ®Google Scholar
• World Health Organization/International Programme on Chemical Safety (WHO/IPCS). (2009). IPCS Risk Assessment Terminology. Part 1: IPCS/OECD Key Generic Terms used in Chemical Hazard/Risk Assessment Part 2: IPCS Glossary of Key Exposure Assessment Terminology]. Available from: http://www.inchem.org/documents/harmproj/harmproj/harmproj1.pdf [last accessed 11 Feb 2013]
   Google Scholar
• Youngstrom E, Kenworthy L, Lipkin PH, et al. (2011). A proposal to facilitate weight-of-evidence assessments: harmonization of Neurodevelopmental Environmental Epidemiology Studies (HONEES). Neurotoxicol Teratol, 33, 354–9
   PubMed Web of Science ®Google Scholar