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基于症状测量增加单一活动障碍指标预测急性期治疗结局:来自 STAR*D 和 CO-MED 试验的交互式计算器的开发和验证。

Prediction of Acute-Phase Treatment Outcomes by Adding a Single-Item Measure of Activity Impairment to Symptom Measurement: Development and Validation of an Interactive Calculator from the STAR*D and CO-MED Trials.

机构信息

Center for Depression Research and Clinical Care, UT Southwestern Medical Center, Dallas, Texas.

Departments of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, New York.

出版信息

Int J Neuropsychopharmacol. 2019 May 1;22(5):339-348. doi: 10.1093/ijnp/pyz011.

DOI:10.1093/ijnp/pyz011
PMID:30958879
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6499251/
Abstract

BACKGROUND

Day-to-day functioning is impaired in major depressive disorder. Yet there are no guidelines to systematically assess these functional changes. This report evaluates prognostic utility of changes in activity impairment to inform clinical decision-making at an individual level.

METHODS

Mixed model analyses tested changes in activity impairment (sixth item of Work and Activity Impairment scale, rated 0-10) at mid-point (week 6) and end of step 1 (weeks 12-14) in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial (n = 2697) after controlling for depression severity [Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR)]. Interactive calculators for end of step 1 remission (QIDS-SR ≤5) and no meaningful benefit (<30% QIDS-SR reduction from baseline) were developed for participants with complete data (n = 1476) and independently replicated in the Combining Medications to Enhance Depression Outcomes trial (n = 399).

RESULTS

Activity impairment improved independently with acute-phase treatment in STARD (F = 7.27; df = 2,2625; P < .001). Baseline to mid-point activity impairment change significantly predicted remission (P < .001, model area under the curve = 0.823) and no meaningful benefit (P < .001, area under the curve = 0.821) in the STARD trial. Adding activity impairment variables to depression severity measures correctly reclassified 28.4% and 15.8% remitters and nonremitters (net reclassification improvement analysis, P < .001), and 11.4% and 16.8% of those with no meaningful benefit and meaningful benefit (net reclassification improvement analysis, P < .001). The STAR*D trial model estimates accurately predicted remission (area under the curve = 0.80) and no meaningful benefit (area under the curve = 0.82) in the Combining Medications to Enhance Depression Outcomes trial and was used to develop an interactive calculator.

CONCLUSION

A single-item self-report measure of activity impairment changes independently with antidepressant treatment. Baseline to week 6 changes in activity impairment and depression severity can be combined to predict acute-phase remission and no meaningful benefit at an individual level.

摘要

背景

在重度抑郁症中,日常功能会受到损害。然而,目前还没有指南系统地评估这些功能变化。本报告评估了活动障碍变化对个体水平临床决策的预后价值。

方法

混合模型分析测试了 Sequenced Treatment Alternatives to Relieve Depression (STAR*D) 试验(n=2697)中在第 1 步中点(第 6 周)和结束时(第 12-14 周)活动障碍(工作和活动障碍量表第六项,评分 0-10)的变化,在控制抑郁严重程度[Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR)]后。为具有完整数据的参与者(n=1476)开发了用于第 1 步结束时缓解(QIDS-SR≤5)和无明显获益(从基线减少<30%QIDS-SR)的交互式计算器,并在合并药物以改善抑郁结局试验(n=399)中独立复制。

结果

STARD 中的急性期治疗可独立改善活动障碍(F=7.27;df=2,2625;P<.001)。基线至中点活动障碍变化显著预测缓解(P<.001,模型曲线下面积=0.823)和无明显获益(P<.001,曲线下面积=0.821)。在 STARD 试验中,将活动障碍变量添加到抑郁严重程度测量中,可以正确重新分类 28.4%和 15.8%的缓解者和非缓解者(净重新分类改善分析,P<.001),以及 11.4%和 16.8%的无明显获益和有明显获益者(净重新分类改善分析,P<.001)。STAR*D 试验模型估计值准确预测了合并药物以改善抑郁结局试验中的缓解(曲线下面积=0.80)和无明显获益(曲线下面积=0.82),并用于开发交互式计算器。

结论

一项活动障碍变化的单一项自我报告测量可独立于抗抑郁治疗而变化。在个体水平上,基线至第 6 周活动障碍和抑郁严重程度的变化可以结合起来预测急性期缓解和无明显获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/e9c099e8a267/pyz011f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/c2dc8f623f66/pyz011f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/afff66a3e773/pyz011f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/d034aafca125/pyz011f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/e9c099e8a267/pyz011f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/c2dc8f623f66/pyz011f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/afff66a3e773/pyz011f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/d034aafca125/pyz011f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72dc/6499251/e9c099e8a267/pyz011f0004.jpg

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