ENABLE II项目随机对照试验：改善农村晚期癌症患者的姑息治疗——基线研究结果、方法学挑战及解决方案
The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.
作者信息
Bakitas Marie, Lyons Kathleen Doyle, Hegel Mark T, Balan Stefan, Barnett Kathleen N, Brokaw Frances C, Byock Ira R, Hull Jay G, Li Zhongze, McKinstry Elizabeth, Seville Janette L, Ahles Tim A
机构信息
Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire 03756, USA.
出版信息
Palliat Support Care. 2009 Mar;7(1):75-86. doi: 10.1017/S1478951509000108.
OBJECTIVE
There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues.
METHODS
Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death.
RESULTS
Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described.
SIGNIFICANCE OF RESULTS
It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.
目的
评估姑息治疗模式的随机对照试验（RCT）数量不足。尽管干预措施各不相同，但都面临着各种方法学挑战，包括足够的招募、数据缺失以及对照组的污染。我们描述了ENABLE II干预措施、方法和样本基线特征，以提高干预措施和方法的透明度，并描述我们对选定方法学问题的解决方案。
方法
从我们位于美国农村的综合癌症中心及附属诊所招募的参与者中，一半被随机分配到一种由护士主导的、基于电话的教育、护理协调姑息治疗干预模式。在第一个月，每周为一半的参与者提供干预服务，之后每月提供一次，直至死亡，包括对护理人员进行丧亲后续随访电话。另一半参与者被分配接受常规护理。每3个月评估一次症状、生活质量、情绪和功能状态，直至死亡。
结果
279名参与者的基线数据与标准样本相似。描述了应对招募、数据缺失和 “常规护理” 对照组污染等方法学挑战的解决方案。
结果的意义
克服开展严格的姑息治疗随机对照试验的许多方法学挑战是可行的。
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