The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.
The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.
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DOI：
10.1017/s1478951509000108
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发表时间：
2009-03
影响因子：
2.2
通讯作者：
Ahles TA
中科院分区：
文献类型：
--
作者：
Bakitas M;Lyons KD;Hegel MT;Balan S;Barnett KN;Brokaw FC;Byock IR;Hull JG;Li Z;McKinstry E;Seville JL;Ahles TA
有一个随机对照试验（RCT）的评价姑息治疗模式的缺乏。虽然干预措施各不相同，但都面临着各种方法上的挑战，包括：招募充足、数据缺失和对照组污染。我们描述ENABLE II干预，方法和样本基线特征，以增加干预和方法透明度，并描述我们对选定方法问题的解决方案。从我们的农村，美国综合癌症中心和附属诊所招募的参与者中有一半被随机分配到一个基于电话的，护士主导的教育，护理协调姑息治疗干预模型。在第一个月每周向一半的参与者提供干预服务，然后每月一次，直到死亡，包括对照顾者的丧亲后续电话。另一半的参与者被分配到照顾像往常一样。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。279名参与者的基线数据与正常样本相似。招募，缺失的数据，和“常规护理”对照组污染的方法学挑战的解决方案进行了说明。这是可行的，以克服许多方法上的挑战，进行严格的姑息治疗随机对照试验。
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. Half of the participants recruited from our rural, US 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 a bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, QOL, mood, and functional status were assessed every 3 months until death. 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. It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.