Jellen Patricia A, Brogan Frances L, Kuzma Anne Marie, Meldrum Catherine, Meli Yvonne M, Grabianowski Carla L
Center for Chest Disease, New York Presbyterian Hospital, New York, NY 10032, USA.
Proc Am Thorac Soc. 2008 May 1;5(4):412-5. doi: 10.1513/pats.200707-108ET.
The National Emphysema Treatment Trial (NETT) required the coordinated evaluation and treatment of thousands of patients with emphysema simultaneous with data collection to evaluate the safety and efficacy of surgery versus medical treatment for emphysema. These tasks were performed by a multidisciplinary team led by the clinic coordinator at each NETT center. The clinic coordinators functioned as members of the research team as well as communicators, managers, and members of the patient care team. The clinic coordinators' ability to balance these roles was instrumental to the successful completion of NETT, as evidenced by randomization of 1,218 subjects with only 10 subjects being lost to follow-up. Striving to achieve recruitment goals and working to retain study subjects was very labor intensive. The coordinator role was complicated by the study population's severity of illness combined with the complexity of the NETT protocol. Management of the study subjects' medical condition had to be balanced with the management of a multicenter, randomized clinical trial to ensure quality data collection and protocol adherence.
国家肺气肿治疗试验(NETT)要求对数千名肺气肿患者进行协调评估和治疗,同时收集数据以评估手术与药物治疗肺气肿的安全性和有效性。这些任务由每个NETT中心的临床协调员领导的多学科团队执行。临床协调员既是研究团队的成员,也是沟通者、管理者和患者护理团队的成员。临床协调员平衡这些角色的能力对NETT的成功完成至关重要,1218名受试者随机分组,仅10名受试者失访就证明了这一点。努力实现招募目标并留住研究对象非常耗费人力。研究人群的疾病严重程度以及NETT方案的复杂性使协调员的角色变得复杂。必须在管理研究对象的医疗状况与管理多中心随机临床试验之间取得平衡,以确保高质量的数据收集和方案依从性。