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Research Strategies for Assessing Adverse Events Associated with Vaccines A Workshop Summary (1994) / Chapter Skim
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LARGE-LINKED DATABASES
Pages 10-13

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 10...
... Alternatively, working forward from the vaccine exposure, it is possible to identify children who have or have not been vaccinated and determine the rates at which particular outcomes occur. The Datalink presently involves more than 500,000 children from birth through 6 years of age (with an annual birth cohort of about 70,000)
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From page 11...
... Thus, case ascertainment is accomplished directly from diagnoses upon hospital discharge, treatment records at clinics and urgent care centers, and death certificates and autopsy reports and indirectly from records of laboratory cultures and tests, specialist referrals, diagnostic procedures, and drug prescriptions; all of these data exist in the computerized data systems of the HMOs. Even the use of a system that includes records of all treatments for putatively vaccine-related adverse reactions does not guarantee that all relevant information will be obtained, because diagnoses are not always made, medical attention is not always sought, and the disposition to resolve medical problems and to be vaccinated may be related.
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From page 12...
... A PHS representative indicated that LLDBs have indeed been used to look at one particular efficacy issue. Recently, results from a clinical research study led a manufacturer to question the potency of a lot of a particular vaccine.
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From page 13...
... Given an interest in a particular outcome, it is necessary to delineate the appropriate combination of possible discharge diagnoses, laboratory data, radiology procedures, pharmaceutical information, and so forth that will be both sensitive and specific in helping to detect cases of the outcome in question. Evaluation of LLDBs A formal system for evaluating LLDBs on a regular basis was suggested.
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Key Terms

  • urgent care
  • antibody levels
  • particular outcome
  • identify children
  • hospital discharge

  • vaccine exposure
  • study statisticians
  • care facilities
  • relevant information
  • national passive

  • reporting efficiency
  • research study
  • participants urged
  • diagnostic procedures
  • currently undiscovered

  • larger investment
  • particular outcomes
  • datalink presently
  • medical reports
  • recent vaccine

  • associations regardless
  • outcomes occur
  • obtain health
  • association based
  • medical attention

  • time allotted
  • annual birth
  • detectable statistically
  • collection plans
  • carefully reviewed


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