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4 Evidence Identification
Pages 40-62

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From page 40...
... Scoping Human Human Human Develop Problem Protocols for Animal Identify Animal Evaluate Animal Integrate Formulation Systematic Evidence Studies Evidence Reviews Mechanistic Mechanistic Mechanistic Systematic Reviews Broad Literature Search Dose Response Assessment Hazard and Derivation Identification of Toxicity Values FIGURE 4-1 The IRIS process; the evidence-identification step is highlighted. The committee views public input and peer review as integral parts of the IRIS process, although they are not specifically noted in the figure.
From page 41...
... Systematic review does not identify the presence of reporting biases themselves. However, a comprehensive search will include the types of studies particularly prone to reporting biases, such as industry-supported studies in the health sciences.
From page 42...
... Although the IOM standards for conducting systematic reviews focus on assessing the comparative effectiveness of medical or surgical interventions and the evidence supporting the standards is based on clinical research, the committee considers the approach useful for a number of aspects of IRIS assessments because the underlying principles are inherent to the scientific process (see Hoffman and Hartung 2006; Woodruff and Sutton 2011; Silbergeld and Scherer 2013)
From page 43...
... However, the materials do not describe information specialists trained in systematic reviews. (Continued)
From page 44...
... , evidence review requires who is trained in peer review like any other evidence part. Given the specialized identification for skills required, a person systematic reviews with similar skills would be to strengthen the expected to serve as peer search process.
From page 45...
... and that the contractor searches regularly undergo peer review or outside assessment. 3.1.5 Search citation See 3.1.4 -- The literature search EPA mentions citation indexes, The preamble The preamble Document specific indexes (p.
From page 46...
... Draft IRIS Preamble Draft IRIS Handbook Assessment Assessment for Further and Rationale (EPA 2013a, Appendix B) (EPA 2013a, Appendix F)
From page 47...
... Not mentioned. Consider searching databases, clinical trial "regulatory resources and other other gray literature registries, and other sources websites" for additional databases beyond of unpublished information resources.
From page 48...
... as missing critical information, it is preferable to ask the investigators directly for the information. 3.2.3 Invite all study EPA posts the results of the EPA endorses requesting public Section 3.1 of the Section 3.1 of the Create a structured sponsors and researchers to literature search on the IRIS Web scrutiny of the list of identified Preamble to the Preamble to the process for inviting submit unpublished data, site and requests information from studies from the initial literature benzo[a]
From page 49...
... to search for studies and non-English-language reported in Rationale: There is databases are not included in the languages other limited evidence that discussion of search strategies. than English for negative, null, or IRIS assessments undesirable findings might and revisit question be published in languages periodically.
From page 50...
... (EPA 2013d,e) Development 3.3 Screen and select studies 3.3.1 Include or exclude Exposure route is a key design EPA specifically mentions that Protocol not Protocol not Provide inclusion studies based on the consideration for selecting pertinent "casting a wide net" is a goal of provided so unable provided so unable and exclusion protocol's pre-specified experimental animal studies or the search process and that results to judge whether to judge whether criteria in IRIS criteria (p.
From page 51...
... Figure F-1 suggests that titles and Not mentioned. A preliminary Clearly document strategies to select studies: abstracts are screened first, and manual screen of screening and 1)
From page 52...
... Draft IRIS Preamble Draft IRIS Handbook Assessment Assessment for Further and Rationale (EPA 2013a, Appendix B) (EPA 2013a, Appendix F)
From page 53...
... database and the documentation of the by-line search strategy. Appendix C: Table Appendix D: Table date of the search search processes ensures C-1 provides search D-1 provides search for each database transparency of the strategies for more strings for four and any Web methods used in the review, than four databases subject-specific searches.
From page 54...
... Draft IRIS Preamble Draft IRIS Handbook Assessment Assessment for Further and Rationale (EPA 2013a, Appendix B) (EPA 2013a, Appendix F)
From page 55...
... . Rationale: Standardized structured form may be useful for evidence tables and were used; data forms are broadly recording the key features needed exposure-response evidence tables applied quality-assurance to evaluate a study.
From page 56...
... Because identifying evidence for IRIS involves all five elements reflected in the IOM standards, a concise preamble would not be expected to serve as a stand-alone roadmap for evidence-identification methods in IRIS assessments. The draft handbook (EPA 2013a, Appendix F)
From page 57...
... The committee commends EPA's collaboration with the National Toxicology Program of the National Institute of Environmental Health Sciences in this regard and encourages incorporation of insights gained into the IRIS process. Use a Database to Capture Study Information and Relevant Quantitative Data The NRC formaldehyde report recommended that EPA use a database, such as HERO, to serve as a repository for documents supporting its toxicity assessments.
From page 58...
... For example, a targeted research effort could address the question of whether it is useful and necessary to search the gray literature -- research literature that has not been formally published in journal articles, such as conference abstracts, book chapters, and theses -- and the non-English-language literature in systematic reviews for IRIS assessments. Given how quickly methods for systematic reviews are evolving, including databases and indexing terms, methodologic research related to systematic reviews for IRIS assessments should be kept current to ensure that standards are up to date and relevant.
From page 59...
... Recommendation: The current process can be enhanced with more explicit documentation of methods. Protocols for IRIS assessments should include a section on evidence identification that is written in collaboration with information specialists trained in systematic reviews and that includes a search strategy for each systematic-review question being addressed in the assessment.
From page 60...
... Explicit recognition of and mechanisms for dealing with multiple publications that include overlapping data from the same study are important components of data management that are not yet evident in the draft handbook. Recommendation: EPA should engage information specialists trained in systematic reviews in the process of evidence identification, for example, by having an information specialist peer review the proposed evidence-identification strategy in the protocol for the systematic review.
From page 61...
... 2013. Progress in using systematic reviews of animal studies to improve translational research.
From page 62...
... 2006. Methodological quality of systematic reviews of animal studies: A survey of reviews of basic research.


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