Sisk Jane E, Horowitz Carol R, Wang Jason J, McLaughlin Mary Ann, Hebert Paul L, Tuzzio Leah
Department of Health Policy, Mount Sinai School of Medicine, New York, NY 10029, USA.
Mt Sinai J Med. 2008 Jan-Feb;75(1):37-43. doi: 10.1002/msj.20014.
Heart failure, a leading cause of hospitalization among elderly people, disproportionately afflicts African-American and other non-White populations. Studies of health care interventions often do not include these groups in proportion to numbers in the patient population. Our objective was to assess whether a randomized controlled effectiveness trial enrolled patients by ethnicity/race, gender, and age in proportion to those eligible.
We conducted a randomized controlled trial comparing nurse management and usual care among ambulatory heart failure patients at the four hospitals in East and Central Harlem, New York. We incorporated culturally sensitive and age-appropriate strategies to enroll a demographically representative group into the trial. Recruitment proceeded in several steps: identifying patients with billing code and visit criteria, documenting systolic dysfunction, obtaining clinician permission and correct addresses, contacting patients, and enrolling eligible patients. We assessed differences by ethnicity/race and gender at successive steps in the recruitment process, and differences between enrollees and refusals regarding overall health, evaluation of medical care, and difficulty receiving care.
We enrolled 406 ambulatory patients by ethnicity/race and gender in proportion to the numbers eligible to be contacted (46% African-American/Black, 33% Hispanic, and 47% female). Among patients contacted, however, those 18 through 74 years were 2.0 to 3.3 times more likely than those > or = 75 years to enroll (p < 0.001).
The recruitment strategy successfully enrolled patients by ethnicity/race, gender, and age through 74 years, but not those > or = 75 years. Registries of patients who refuse to enroll in trials could provide guidance for clinical and public policy.
心力衰竭是老年人住院的主要原因，在非裔美国人和其他非白人人群中更为常见。医疗保健干预措施的研究通常没有按照患者群体中的比例纳入这些群体。我们的目标是评估一项随机对照有效性试验是否按照种族/民族、性别和年龄的比例纳入符合条件的患者。
我们在纽约市哈莱姆东区和中区的四家医院进行了一项随机对照试验，比较门诊心力衰竭患者的护士管理和常规护理。我们采用了具有文化敏感性和适合年龄的策略，以纳入一个具有人口统计学代表性的试验组。招募过程分几个步骤进行：根据计费代码和就诊标准识别患者、记录收缩功能障碍、获得临床医生许可和正确地址、联系患者以及纳入符合条件的患者。我们在招募过程的连续步骤中评估了种族/民族和性别的差异，以及入选者和拒绝者在总体健康、医疗护理评估和接受护理困难方面的差异。
我们按照符合联系条件的人数比例，按种族/民族和性别纳入了406名门诊患者（46%为非裔美国人/黑人，33%为西班牙裔，47%为女性）。然而，在被联系的患者中，18至74岁的患者入选的可能性是75岁及以上患者的2.0至3.3倍（p<0.001）。
招募策略成功地按照种族/民族、性别和年龄纳入了74岁及以下的患者，但未纳入75岁及以上的患者。拒绝参加试验的患者登记册可为临床和公共政策提供指导。
