Exclusion criteria

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Exclusion Criteria

Exclusion criteria (/ɪkˈskluːʒən kɹaɪˈtɪəɹiə/) are conditions or factors that prevent a potential participant from taking part in a clinical trial or research study. These criteria are established to ensure the safety of the participant and the integrity of the data collected.

Etymology

The term "exclusion criteria" is derived from the Latin words "excludere" meaning "to shut out" and "criterium" meaning "a standard for judging".

Related Terms

  • Inclusion criteria: The characteristics that must be met for an individual to be included in a research study.
  • Screening: The process of evaluating potential participants to determine if they are eligible for a study based on the inclusion and exclusion criteria.
  • Clinical trial: A type of research study that tests how well new medical approaches work in people.
  • Research study: An organized effort to gather information about a specific topic, such as a disease or treatment method.

Usage

Exclusion criteria are used in all types of research studies, including clinical trials, observational studies, and epidemiological studies. They are typically listed in the study protocol and may include factors such as age, gender, type and stage of a disease, previous treatment history, and other medical conditions. For example, many clinical trials for cancer treatments exclude patients who have had previous chemotherapy treatments to ensure that the results of the trial are due to the new treatment being tested and not influenced by the previous treatments.

Importance

Exclusion criteria are important for several reasons. They help to ensure that the study results are valid and reliable by eliminating potential sources of bias. They also protect the safety of the participants by excluding individuals who may be at higher risk of experiencing adverse effects from the treatment or intervention being studied.

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