Establishing the internal and external validity of experimental studies

Marion K. Slack, Jo Laine R. Draugalis

Research output: Contribution to journalArticlepeer-review

92 Scopus citations


The information needed to determine the internal and external validity of an experimental study is discussed. Internal validity is the degree to which a study establishes the cause-and-effect relationship between the treatment and the observed outcome. Establishing the internal validity of a study is based on a logical process. For a research report, the logical framework is provided by the report's structure. The methods section describes what procedures were followed to minimize threats to internal validity, the results section reports the relevant data, and the discussion section assesses the influence of bias. Eight threats to internal validity have been defined: history, maturation, testing, instrumentation, regression, selection, experimental mortality, and an interaction of threats. A cognitive map may be used to guide investigators when addressing validity in a research report. The map is based on the premise that information in the report evolves from one section to the next to provide a complete logical description of each internal-validity problem. The map addresses experimental mortality, randomization, blinding, placebo effects, and adherence to the study protocol. Threats to internal validity may be a source of extraneous variance when the findings are not significant. External validity is addressed by delineating inclusion and exclusion criteria, describing subjects in terms of relevant variables, and assessing generalizability. By using a cognitive map, investigators reporting an experimental study can systematically address internal and external validity so that the effects of the treatment are accurately portrayed and generalization of the findings is appropriate.

Original languageEnglish (US)
Pages (from-to)2173-2184
Number of pages12
JournalAmerican Journal of Health-System Pharmacy
Issue number22
StatePublished - Nov 15 2001
Externally publishedYes


  • Clinical studies
  • Control, quality
  • Methodology
  • Researach

ASJC Scopus subject areas

  • Pharmacology
  • Health Policy


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