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Summary
Pages 1-12

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From page 1...
... For instance, the handbook describes the inclusion of sophisticated, state-of-the-art methods that use systematic evidence maps to summarize literature characteristics for scoping and systematic review methods for hazard identification. Moreover, the IRIS program is clearly helping to advance the science of systematic review, as applied to hazard identification.
From page 2...
... Systematic review protocol: Describe systematic review procedures for PECO criteria, litera ture identification, study evaluation, and data extraction/display. Literature search and screening: Identify health effect studies and other informative studies relevant to evaluating potential health effects.
From page 3...
... For instance, definitions for key terms such as "scoping" and "sensitivity" are currently scattered across different chapters of the handbook. In other cases, the handbook assigns unconventional definitions to terms used for designating various IRIS-specific processes and products in the area of evidence synthesis.
From page 4...
... Recommendation 2.4: When systematic review methods are being used for parts of the IRIS assessment process, this should be stated and the relevant methodologi cal literature should be referenced. The handbook does not adequately describe the overall process or flow for developing IRIS assessments and the iterative nature of some of the steps in the process.
From page 5...
... The committee divided its critiques of the overall planning process for IRIS assessments into three general phases: problem formulation, protocol development, and organization of the hazard review. Problem Formulation The problem formulation process described in the handbook presents an important evolution in the understanding of how to use systematic evidence maps (also called "literature inventories" in the handbook)
From page 6...
... This approach contrasts with conventional systematic reviews, in which even within a relatively broad health effect category (e.g., cardiovascular disease) , a detailed PECO statement with specific outcomes is prespecified to be fully transparent and to minimize potential for bias via selective inclusion of literature in a review.
From page 7...
... At a minimum, all endpoints that may be used for toxicity values, including so-called "precursor" endpoints that might be viewed as "mechanistic," should require separate PECO statements; however, ap plication of systematic review methods to other mechanistic endpoints, such as mu tagenicity, may depend on the needs of the assessment. The key mechanistic and TK questions should be identified to the extent possible in the IRIS assessment plan and IRIS assessment protocol documents.
From page 8...
... The use of reporting quality as a distinct quality assessment item for study evaluation is not standard for systematic reviews, and procedures for evaluating reporting quality are very different for human epidemiological and animal toxicological studies. Recommendation 4.3: The handbook should address the apparent difference in as sessing reporting quality between the human epidemiological studies and animal toxicological studies by either (1)
From page 9...
... The handbook's considerations of mechanistic and TK data, and PK or physiologically based pharmacokinetic (PBPK) models outlined in evidence synthesis appear to mix in some elements of evidence integration, particularly through the concepts of "coherence" of study findings across different endpoints and "biological plausibility" of the findings.
From page 10...
... would help define the steps that should occur at each level and, more specifically, what data are to be syn thesized and where to expect the judgment narratives to be provided. Mechanistic data appear to be used to strengthen conclusions of the individual data streams or when there is a lack of evidence in a single stream, and yet some aspects of the handbook treat mechanistic data as their own unit of analysis for evidence synthesis.
From page 11...
... the study se lection process as applied to each endpoint, health outcome, study, and evidence stream in order to provide transparency as to study evaluation for toxicity value der ivation, and to support selection of overall toxicity values. It is especially important to capture study attributes for which EPA has designated an option as "preferred" versus "less preferred." Chapter 13 of the handbook provides important information relating to issues and considerations for developing points of departure (PODs)
From page 12...
... CONCLUDING REMARKS Overall, the committee concluded that the handbook reflects the significant improvements that EPA has made in its IRIS assessment process. The methods for developing IRIS assessments can serve as a model for other EPA programs that are implementing systematic review methods.


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