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随机试验中沟通干预措施治疗效果的异质性。

Heterogeneity of Treatment Effect in a Randomized Trial of a Communication Intervention.

机构信息

Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA.

Department of Medicine (A.L.J., L.D., R.A.E., J.R.C.), Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence (A.L.J., L.D., R.A.E., J.R.C.), University of Washington, Seattle, Washington, USA.

出版信息

J Pain Symptom Manage. 2022 Sep;64(3):298-303. doi: 10.1016/j.jpainsymman.2022.05.006. Epub 2022 May 23.

DOI:10.1016/j.jpainsymman.2022.05.006
PMID:35618247
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9378632/
Abstract

CONTEXT

Interventions to promote serious illness conversations have shown promise in promoting high-quality care. However, in randomized trials, some participants may benefit more from the intervention than others.

OBJECTIVES

To examine heterogeneity of treatment effect and identify subgroups of patients with serious illness who might benefit most from interventions to enhance communication about goals of care.

METHODS

We used data from a multi-center cluster-randomized trial evaluating a communication intervention to increase goals-of-care discussions in the outpatient setting. Patients (n = 249 intervention, n = 288 usual care) had serious illness with an expected median survival of two years. Using model-based recursive partitioning, we tested heterogeneity of the intervention's effect on the occurrence of patient-reported goals-of-care discussions, electronic health record documentation of goals-of-care discussions, patients' ratings of quality of communication, and patients' symptoms of psychological distress at three and six months.

RESULTS

We found two significant interactions. For patients' overall rating of clinician communication (n = 251), the intervention effect was positive for patients with higher household income, but not those with lower income (P < 0.001). For patients' symptoms of depression at six months (n = 288), the intervention was associated with fewer symptoms of depression among those whose self-assessed health was poor, but not among those with fair to excellent health (P < 0.001).

CONCLUSIONS

Identifying heterogeneity of treatment effect can be a valuable exercise following completion of a randomized trial. Interactions between the intervention and patient income and self-assessed health suggest these factors could be used to design more effective interventions to enhance communication about goals of care.

摘要

背景

促进严重疾病对话的干预措施已显示出在促进高质量护理方面的潜力。然而,在随机试验中,一些参与者可能比其他人从干预中获益更多。

目的

检查治疗效果的异质性,并确定可能从增强有关护理目标的沟通干预中获益最多的严重疾病患者亚组。

方法

我们使用了一项多中心集群随机试验的数据,该试验评估了一种在门诊环境中增加目标护理讨论的沟通干预措施。患者(n=249 例干预组,n=288 例常规护理组)患有严重疾病,预计中位生存期为两年。使用基于模型的递归分区,我们测试了干预对患者报告的目标护理讨论、电子健康记录中目标护理讨论的记录、患者对沟通质量的评分以及患者在三个月和六个月时心理困扰症状的发生的影响的异质性。

结果

我们发现了两个显著的交互作用。对于患者对临床医生沟通的总体评分(n=251),对于家庭收入较高的患者,干预效果为正,但对于家庭收入较低的患者则不然(P <0.001)。对于患者在六个月时的抑郁症状(n=288),对于自我评估健康状况较差的患者,干预与抑郁症状减少有关,但对于健康状况良好至优秀的患者则无关(P <0.001)。

结论

在完成随机试验后,识别治疗效果的异质性可能是一项有价值的工作。干预与患者收入和自我评估健康之间的相互作用表明,这些因素可用于设计更有效的干预措施,以增强有关护理目标的沟通。

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