Establishing the internal and external validity of experimental studies.
ABSTRACT 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.
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ABSTRACT: Decision makers want to know which healthcare services matter the most, but there are no well-established, practical methods for providing evidence-based answers to such questions. Led by the National Commission on Prevention Priorities, the authors update the methods for determining the relative health impact and economic value of clinical preventive services. Using new studies, new preventive service recommendations, and improved methods, the authors present a new ranking of clinical preventive services in the companion article. The original ranking and methods were published in this journal in 2001. The current methods report focuses on evidence collection for a priority setting exercise, guidance for which is effectively lacking in the literature. The authors describe their own standards for searching, tracking, and abstracting literature for priority setting. The authors also summarize their methods for making valid comparisons across different services. This report should be useful to those who want to understand additional detail about how the ranking was developed or who want to adapt the methods for their own purposes.American Journal of Preventive Medicine 08/2006; 31(1):90-6. · 3.95 Impact Factor