Sole Mary Lou, Middleton Aurea, Deaton Lara, Bennett Melody, Talbert Steven, Penoyer Daleen
Mary Lou Sole is dean and professor and holds the Orlando Health Endowed Chair in Nursing at the University of Central Florida College of Nursing, Orlando, Florida. Aurea Middleton and Lara Deaton are clinical research coordinators and Melody Bennett is the study project coordinator, Orlando Health, Orlando, Florida. Steven Talbert is a clinical assistant professor with the University of Central Florida, Orlando, Florida. Daleen Penoyer is director, Center for Nursing Research and Advanced Practice Nursing, Orlando Health.
Am J Crit Care. 2017 Sep;26(5):395-400. doi: 10.4037/ajcc2017511.
Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.
To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.
Two years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity.
Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients ( = .02).
Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.
重症监护研究面临的入组挑战很常见。促成因素包括入组窗口期短、危重病的危机性质、研究人员短缺、无法获得法定代理人、家庭动态以及语言障碍。
描述一项正在进行的重症监护护理试验的入组统计数据、招募障碍以及提高入组率的策略。
分析了一家医院对接受机械通气的成年危重症患者进行口腔护理干预试验的两年招募和入组数据。招募记录包括筛查、符合条件、入组和拒绝的患者数量以及患者的性别、种族和族裔。
目标入组率（每月15.5名患者）基于经验和历史数据。为促进入组实施的策略包括每周7天每天为研究人员提供至少18小时的时间、定期查房、与直接护理人员沟通以及西班牙语同意程序。在两年内，共筛查了6963名患者；1551名（22%）符合条件。向366名患者（符合条件患者的24%）寻求了同意。入组平均每月13.3名患者（预计目标的86%）。阻碍入组的主要因素是无法获得法定代理人提供同意（88%）。白人（11%）、黑人（13%）和西班牙裔（16%）患者的拒绝率没有显著差异。然而，被归类为亚洲人或属于多个种族的患者拒绝的频率（35%）明显高于白人或黑人患者（P = .02）。
在短时间的入组窗口期内无法获得法定代理人是入组的主要挑战。各种因素影响了同意决定。临床研究设计需要更保守的估计。
