Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, Durham, NC, USA; Division of Emergency Medicine, Duke University School of Medicine, Durham, NC, USA.
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, Durham, NC, USA.
Am J Emerg Med. 2021 Dec;50:640-645. doi: 10.1016/j.ajem.2021.09.026. Epub 2021 Sep 16.
To identify multivariable subgroups of patients with differential responses to a nurse-delivered care transition intervention after an emergency department (ED) visit in a randomized controlled trial (RCT) using an emerging data-driven method.
Secondary analysis of RCT.
512 individuals enrolled in an RCT of a nurse-delivered care transition intervention after an ED visit. All 512 participants were included in a pre-specified subgroup analysis, and 451 of these had sufficient complete case data to be included in a model-based recursive (MoB) partitioning analysis.
The primary outcome was having at least one ED visit in 30 days after the index ED visit. Two analytical methods explored heterogeneity of treatment effects: data driven model-based recursive partitioning (MoB) using 37 candidate baseline variables, and a contextual point of comparison with prespecified subgroups defined by ED super-user status (≥ 3 ED visits in previous 6 months or not), sex (male/female), and age, individually examined via treatment arm by subgroup interaction terms in logistic regression models. Internal validation of the MoB analysis via bootstrap resampling with an optimism corrected c-statistic was conducted to provide a bias-corrected estimate.
MoB detected treatment effect heterogeneity in a single subgroup, marital status. Unmarried patients randomized to the intervention had a repeat ED use rate of 22% compared to 34% in the usual care group; married patients randomized to the intervention had a 27% ED return rate compared to 12% in the usual care group. Internal validation demonstrated an optimism corrected c-statistic of 0.54. No treatment-by-covariate subgroup interactions were identified among the 3 prespecified subgroups.
Although exploratory, the results of the MoB analysis suggest that patient factors related to social relationships such as marital status may be important contributors to differential response to a care transition intervention after an ED visit. These were characteristics that the investigators had not anticipated or planned to examine in the individual prespecified subgroup analysis. Data-driven methods can yield unexpected findings and contribute to a more complete understanding of differential treatment effects in subgroup analysis, which can inform further work on development of effective care transition interventions in the ED setting.
使用新兴的数据驱动方法，从一项随机对照试验（RCT）中识别出对急诊科（ED）就诊后护士提供的护理过渡干预有不同反应的患者的多变量亚组。
RCT 的二次分析。
512 名参加 ED 就诊后护士提供的护理过渡干预 RCT 的个体。所有 512 名参与者均纳入预先指定的亚组分析，其中 451 名参与者有足够的完整病例数据纳入基于模型的递归（MoB）分区分析。
主要结局是在索引 ED 就诊后 30 天内至少有一次 ED 就诊。两种分析方法探索了治疗效果的异质性：使用 37 个候选基线变量的基于数据的基于模型的递归分区（MoB），以及通过按亚组交互项在逻辑回归模型中逐个检查 ED 超级用户状态（过去 6 个月内就诊 3 次或以上/没有）、性别（男/女）和年龄定义的预设亚组的上下文比较点的方法，来探索治疗效果的异质性。通过 bootstrap 重采样进行 MoB 分析的内部验证，并使用校正后的 c 统计量提供偏倚校正估计。
MoB 在单个亚组婚姻状况中检测到治疗效果的异质性。随机分配到干预组的未婚患者再次 ED 使用率为 22%，而常规护理组为 34%；随机分配到干预组的已婚患者再次 ED 就诊率为 27%，而常规护理组为 12%。内部验证显示校正后的 c 统计量为 0.54。在 3 个预设亚组中未发现治疗与协变量亚组的交互作用。
尽管这是一项探索性研究，但 MoB 分析的结果表明，与社会关系相关的患者因素（如婚姻状况）可能是 ED 就诊后护理过渡干预反应不同的重要因素。这些是研究人员在个体预设亚组分析中没有预料到或计划研究的特征。数据驱动的方法可以产生意想不到的发现，并有助于更全面地了解亚组分析中的差异治疗效果，这可以为 ED 环境中有效护理过渡干预的进一步研究提供信息。
