Mary Jo Grap1, Cindy L Munro. 1. Virginia Commonwealth University, School of Nursing, Richmond, Virginia, USA.
Abstract
PURPOSE: This article serves to describe subject recruitment issues in a funded study in a the medical respiratory intensive care unit. BACKGROUND: Subject recruitment can be difficult in the critical care environment. Inadequate recruitment can reduce the ability to detect treatment differences. Though causes of recruitment difficulty have been documented in medical trials, little is known concerning recruitment in critical care nursing studies. METHODS/ RESULTS: All patients admitted to a medical respiratory intensive care unit (ICU) were reviewed daily for study eligibility. Demographics and reasons for ineligibility and failure to consent were documented. Five hundred ninety-three patients were reviewed; 42 (7.1%) were enrolled; 457 (77.1%) were not eligible and not enrolled and 94 (15.8%) were eligible but not enrolled. Of those reviewed, 52% were male; 57% were black, and 41% were white. Of those eligible, but not enrolled, 40% were because of family unavailability for consent and 27% because of family unwillingness to consent. There were no significant differences in patient age or gender between those who consented and those who did not. However, those who did not consent consisted of a greater proportion of blacks than the population screened. Families' stated reasons for not consenting were primarily related to the family's stress level. CONCLUSIONS: Conducting clinical studies in the critical care environment, enrolling subjects, and obtaining consent may be complicated by the critical nature of the patient's illness, and researchers must be aware of these issues for study success.
PURPOSE: This article serves to describe subject recruitment issues in a funded study in a the medical respiratory intensive care unit. BACKGROUND: Subject recruitment can be difficult in the critical care environment. Inadequate recruitment can reduce the ability to detect treatment differences. Though causes of recruitment difficulty have been documented in medical trials, little is known concerning recruitment in critical care nursing studies. METHODS/ RESULTS: All patients admitted to a medical respiratory intensive care unit (ICU) were reviewed daily for study eligibility. Demographics and reasons for ineligibility and failure to consent were documented. Five hundred ninety-three patients were reviewed; 42 (7.1%) were enrolled; 457 (77.1%) were not eligible and not enrolled and 94 (15.8%) were eligible but not enrolled. Of those reviewed, 52% were male; 57% were black, and 41% were white. Of those eligible, but not enrolled, 40% were because of family unavailability for consent and 27% because of family unwillingness to consent. There were no significant differences in patient age or gender between those who consented and those who did not. However, those who did not consent consisted of a greater proportion of blacks than the population screened. Families' stated reasons for not consenting were primarily related to the family's stress level. CONCLUSIONS: Conducting clinical studies in the critical care environment, enrolling subjects, and obtaining consent may be complicated by the critical nature of the patient's illness, and researchers must be aware of these issues for study success.
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