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Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) / Chapter Skim
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Appendix C: Human Study Designs
Pages 198-205

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From page 198...
... One common descriptive design that offers considerable information on selected outcomes, such as birth defects, is the case series design. As the name suggests, this design encompasses a series of cases with the same outcome.
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From page 199...
... These designs ensure the temporal ordering between an exposure and outcome and minimize confounding via the randomization process by maximizing the internal validity of findings; externalvalidity maybe limited. Such designs have limited applicability to environmental and occupational epidemiology, given that exposures typically cannot be randomly assigned.
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From page 200...
... Information must be collected on exposure, outcome, and effect modifiers or confounders. There are several methods available for ascertaining information on exposures and outcomes, such as self-reported data obtained in personal or telephone interviews, selfadministered questionnaires, diaries, observation, existing records, actual physical measurements, and collection of biological specimens (Armstrong et al.
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From page 201...
... For European countries with centralized health care systems, some prospectively collected exposure data can be linked to other registries, such as birth defect or live birth registries. The increasing frequency of pregnancy termination when prenatal diagnosis detects fetal anomalies could underestimate the accuracy of registry data.
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From page 202...
... The plan must be appropriate for the study design and hypothesis under study, type of data collected and scale of measurement, completeness of data (e.g., percentage of missing data) , distributions Of variables, appropriateness of assumptions that underlie statistical techniques for the data set, consideration of potential effect modification or confounding, and statistical significance testing for sample data.
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From page 203...
... To that end, a priori power estimates are extremely useful for determining the statistical power of the study and for assessing Type ~ and IT errors. Interpretation of findings requires evaluation of bias (systematic distortion)
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From page 204...
... Scientists must consider formalized strategies for weighing scientific evidence to assist in the interpretation of available information (Weed 1997~.
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From page 205...
... 205 C~ 1 Lo a: u an cn o o U)
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Key Terms

  • assessing causality
  • live birth
  • design phase
  • biological specimens
  • descriptive studies

  • exposure data
  • effect modification
  • registry data
  • birth defects
  • study participants

  • analytical studies
  • disease status
  • test hypotheses
  • fetal death
  • produce effects

  • external validity
  • exposure status
  • developmental outcomes
  • misclassification bias
  • pregnancy loss

  • adverse outcomes
  • random error
  • standardized methodology
  • death registries
  • estimated exposure

  • carefully weighing
  • minimizing bias
  • simulation techniques
  • voluntary nature
  • loss rate


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