Inclusion and exclusion criteria: Difference between revisions
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==See also== |
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Revision as of 14:23, 10 April 2015
- For Wikipedia's inclusion criteria, see: What Wikipedia is not.
Definition
In a clinical trial, the investigators must specify Inclusion and exclusion criteria for participation in the study.
Inclusion criteria are characteristics that the prospective subjects must have if they are to be included in the study, while exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the study. Inclusion and exclusion criteria may include factors such as age, sex, race, ethnicity, type and stage of disease, the subject’s previous treatment history, and the presence or absence (as in the case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional conditions.
Exclusion criteria
Poorly Justified Reasons for Exclusion:[1]
Any criteria unless the condition or intervention is specific to the criterion, or the criterion has a direct bearing on condition/intervention/results.
Strongly Justified Reasons for Exclusion:[2]
Unable to provide informed consent
Placebo or intervention would be harmful
Lack of equipoise (intervention harmful)
Effect of intervention difficult to interpret
Potentially Justified Reasons for Exclusion[3]
Individual may not adhere
Individual may not complete follow up
Example of Inclusion and exclusion criteria
Coronary Heart Disease[4]
Include criteria:
Minimum outcomes: coronary deaths & non-fatal myocardial infarction
Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension)
Cohort, nested case-control, cardiovascular trial follow-up study (or systematic review or meta-analysis of these study types) that measures a novel risk factor and estimates its predictive value after adjusting for Framingham variables
Exclude criteria:
No data
Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes)
Does not include minimum outcomes
Does not measure Framingham variables appropriately
Wrong study design/article format
See also
References
- ^ Van Spall, Harriette (21 Mar 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". The Journal of American Medical Association. 297 (11): 1233–40. doi:10.1001/jama.297.11.1233. PMID 17374817.
- ^ Van Spall, Harriette (21 Mar 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". The Journal of American Medical Association. 297 (11): 1233–40. doi:10.1001/jama.297.11.1233. PMID 17374817.
- ^ Van Spall, Harriette (21 Mar 2007). "Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review". The Journal of American Medical Association. 297 (11): 1233–40. doi:10.1001/jama.297.11.1233. PMID 17374817.
- ^ Helfand M, Buckley D, Fleming C; et al. (2009). Screening for Intermediate Risk Factors for Coronary Heart Disease. Rockville (MD): Agency for Healthcare Research and Quality (US).
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External links
- ICH Website: Guidelines for Clinical Trial Management
- FDA Website
- Careers in Clinical Research
- Clinical Research Services
- Clinical Trial Management Companies Listings
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