Challenges in Enrollment of Minority, Pediatric, and Geriatric Patients in Emergency and Acute Care Clinical Research

Study objective

Emergency department (ED) –based clinical research has the potential to include patient populations that are typically underrepresented in clinical research. The objective of this study is to assess how emergency clinical care and research processes, informed consent, and patient demographic factors (age, sex, and ethnicity/race) affect enrollment and consent in clinical research in the ED.

Methods

This was an analysis of prospectively collected data of all patients (aged 2 to 101 years) eligible for one of 7 clinical research studies from February 2005 to April 2007 in an academic ED. We measured rates of enrollment and consent in the clinical studies.

Results

One thousand two hundred two of the 4418 patients screened for participation in 7 clinical studies were clinically eligible for enrollment. Of the 868 patients who were able to provide a voluntary decision regarding consent, 639 (73.6%) agreed to participate; an overall enrollment rate of 53.2%. The mean age of patients enrolled was 51.8 years (range 3 to 98 years). Black patients (49.2% enrollment) and Latino patients (18.4% enrollment) were less likely to be enrolled in comparison with white patients (58.3% enrollment) (adjusted odds ratio [OR] of enrollment for blacks=0.64; 95% confidence interval [CI] 0.50 to 0.82; adjusted OR of enrollment for Latinos=0.16; 95% CI 0.08 to 0.33). Enrollment rates were lower among pediatric (40.0%) and geriatric patients (49.1%) in comparison with adult patients ages 18 to 64 years (55.5%) (adjusted OR of enrollment for pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of enrollment for geriatric patients=0.69, 95% CI 0.53 to 0.90). Unique issues contributing to underenrollment included challenges in consent among pediatric and elderly patients, language issues in Latino patients, reduced voluntary consent rates among black patients, and perhaps underuse of minimal risk waivers.

Conclusion

In a large academic ED, minority, pediatric, and geriatric patients were less likely to be enrolled in acute care clinical research studies than middle-aged whites. Enrollment and consent strategies designed to enhance research participation in these important patient populations may be necessary to address disparities in the development and application of evidence-based emergency and acute care.

Introduction

The 2006 Institute of Medicine report on emergency care in the United States emphasized the need to develop clinical research to enhance the evidence base and quality of acute and disaster care.¹ Emergency departments (EDs) treated 115 million patients in 2005 and serve an inclusive patient population, including pediatric, geriatric, medically underserved, and minority populations. Thus, ED-based clinical research has the potential to include patient populations that are typically underrepresented in clinical research.

There are several major challenges that affect the ability to conduct clinical research in emergency settings. These challenges are multifactorial and include unique aspects of emergency care (ie, complex clinical environment consisting of patients with acute, undifferentiated disease), challenges in the consent process (including brief intervals for subject identification and recruitment and lack of preexisting relationships with patients), and the broad diversity of emergency patient populations.

There are few studies describing enrollment and consent experiences with emergency care research. We used prospectively collected data from 7 diagnostic clinical trials in acute and trauma care in the ED at a large academic medical center to identify how the process of ED informed consent and patient characteristics, including age, race/ethnicity, and sex, affected consent and enrollment.