Advanced Nursing Inquiry and Evidence Based Practice

6/15/2021 MAIN_MSN5300_FN2 R_2021-GRAD2: Eligibility Criteria

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Eligibility Criteria refer to both inclusion and exclusion criteria set the stage for the population that the study will examine, as they include characteristics that must be shared by all study subjects as well as exclude characteristics that may confound study results  affect who participates in the study, the way the study is conducted, and, consequently, the results includes both inclusion and exclusion criteria; may be comprised of age, sex, medical history, current health status, severity of the disease being studies, and concomitant medications eligibility criteria help to keep study volunteers as safe as possible make the study more meaningful by selecting subjects most representative of the study population set the stage for study approval by regulatory agencies 

Inclusion Criteria

characteristics that a person must possess in order to participate in a study typically includes personal characteristics such as age and gender as well as disease characteristics such as the specific symptoms a person is experiencing specific criteria help to select participants who are similar in characteristics or who have a similar disease course in order to monitor their reaction to a specific treatment in a measureable way meeting all of the inclusion criteria is 1 step in the qualification process for enrollment; however, subjects must also successfully not meet any of the exclusion criteria as well

Exclusion Criteria

if any of the exclusion criteria apply to a subject, he or she would not be considered for the study target specific characteristics such as too severe disease, complications of disease, other medical conditions, and previous or concomitant treatment identifies specific characteristics that may 1. put the participant at risk; 2. limit potential efficacy of a study treatment; 3. adversely affect the person’s condition in a way that makes participation dangerous; 4. make the individual less likely to successfully complete the study, or 5. potentially confound study results weighing pros and cons of more restrictive vs less stringent eligibility criteria plays a role in the rate of subject enrollment: ie., less stringent enrollment requirements may be easier to enroll but may result in a more heterogeneous patient population and leave the study open to confounding factors versus more restrictive enrollment requirements may benefit a trial by making endpoints easier to reach but may make enrollment more difficult. 

Ref: Yadav S.K., Singh S., Gupta R. (2019). Sampling Methods. In: Biomedical Statistics. Springer, Singapore. 

Last modified: Sunday, June 13, 2021, 5:04 PM

6/15/2021 MAIN_MSN5300_FN2 R_2021-GRAD2: Eligibility Criteria

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