Systematic Reviews and Evidence-Based Toxicology

ToxStrategies consulting scientists assist clients in conducting assessments that involve systematic reviews and evidence-based toxicology. In recent years, numerous medical and scientific organizations, universities, and government agencies (including the U.S. Food and Drug Administration and U.S. Environmental Protection Agency) have accepted and adopted several evidence-based methods in toxicology. Evidence-based medicine (EBM) and evidence-based toxicology (EBT) share a common foundation that uses scientific logic and rigorous, systematic evaluation of data to reach decisions on topics such as hazard identification and classification and causation of health effects, as well as disease management and prevention. Although practices in EBM are fairly well established, methods in EBT are still evolving, and there is not yet a general scientific consensus on which approach is best. Systematic reviews serve as the cornerstone of these evidence-based fields, requiring a predetermined, transparent, and objective approach to provide an unbiased and comprehensive assessment.

Systematic reviews and EBT are invaluable for state-of-the-science risk assessments. In conducting these analyses, ToxStrategies consulting scientists have managed the underlying complexities inherent in these cross-discipline endeavors by integrating components such as dynamically evolving research protocols, multiple scientific (and risk) techniques for quantitative analysis, collaboration with experts from diverse fields of expertise, and competing stakeholder, sponsor, user, and public interests. Examples of ToxStrategies’ consulting services using these evidence-based strategies include the following:

Systematic Review Protocol Development

  • PECO and PICO questions
  • Analytic framework
  • Conflict of interest (financial and non-financial)
  • Expert review team selection and management
  • Research strategy design
  • Software selection
  • Protocol refinement documentation
  • Timeline determination and management
  • Protocol publication

Systematic Review Implementation

  • Topic-specific search strategies
  • Inclusion and exclusion criteria
  • Data extraction processes and collection templates
  • Study and information screening and selection
  • Evidence table generation
  • Procedures and management of evidence analyst review
  • Information specialist and librarian guidance

Assessment of Individual Studies

  • Qualitative and quantitative study ranking for quality and relevance (e.g., assessment of generalizability or external validity)
  • Risk-of-bias (RoB) assessment (e.g., assessment of internal validity)
    • Implementation and customization of existing risk-of-bias tools (e.g., Office of Health Assessment and Translation or Cochrane Collaboration Assessment Tools)
    • Confounder identification and assessment
    • Selection bias (random sequence generation, allocation concealment)
    • Performance bias (blinding of participants and personal assessments)
    • Detection bias (blinding of outcome assessments)
    • Attrition bias (incomplete reporting of outcomes)
    • Reporting bias (selective reporting)
    • Other bias and other sources of bias

Body-of-Evidence Integration (Weight-of-Evidence Assessment)

  • Qualitative and quantitative body of literature syntheses
  • Confidence ratings
  • Meta-analyses
  • Dose-response assessment
  • Evaluation of lines of evidence and evidence streams
  • Assessment via adverse outcome pathways (AOPs)
  • Causation analyses (Hill criteria: strength, consistency, temporality, specific, biological gradient, plausibility, and experimental evidence)
  • Communication with stakeholders and users
  • Formulation of evidence-based conclusions or recommendations
  • Reporting and publication

For more information about ToxStrategies’ consulting services, please contact us.