Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline “Unipolar Depression” has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression. This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by ‘multiple imputation using chained equations’ based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered. We found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [−€259;€10,290) and effects (+ 0.008 QALY; 95%-CI: [− 0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained). We found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual. NCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

中文翻译：

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一项针对抑郁症患者的基于指南的阶梯式协作医疗与常规治疗相比的成本效益-一项集群随机试验。

抑郁症与患者的主要负担有关。其治疗需要复杂和协作的方法。事实证明，基于德国国家临床实践指南“单极抑郁症”的分步护理模型是有效的。在这项研究中，我们评估了基于指南的阶梯式护理模型相对于抑郁症常规治疗的成本效益。这项前瞻性整群随机对照试验包括737名抑郁症成年患者。初级保健实践被随机分为干预组（IG）或对照组（CG）。干预措施包括四级阶梯式护理模型。CG照常接受治疗。从社会角度进行了成本效用分析，时间跨度为12个月。我们使用基于EQ-5D-3L的质量调整生命年（QALY）作为效果量度。通过患者问卷评估资源利用率。缺失值通过基于预测均值匹配的“使用链式方程式多次插补”来插补。我们计算了调整后的小组在成本和效果方面的差异，以及增加的成本效益比。为了描述统计和决策不确定性，在具有自举标准误差（1000个重复）的净收益回归的基础上构建了成本效益可接受性曲线。考虑了基于抑郁严重程度的完整样本和亚组。我们发现IG和CG之间在成本和效果上没有明显的静态差异。与IG相比，IG的增量总社会成本（+€5016; 95％-CI：[-€259;€10,290）和影响（+ 0.008 QALY; 95％-CI：[-0.030; 0.046]）更高CG。与CG相比，IG的门诊医生服务和精神病医生服务费用要高得多。在重度抑郁症组中，与重症肌无力相比，中耳炎的总成本和生产力损失明显更高。与CG相比，IG的成本效益比增加不利（完整样本：627.000欧元/ QALY获得;轻度抑郁：占主导;中度重度抑郁：645.154欧元/ QALY获得;重度抑郁：2082,714欧元/ QALY获得），且干预措施成本效益的可能性很低，但中度抑郁的人群除外（ICER：优势； 70,000欧元/ QALY的支付意愿门槛）。我们发现，与常规治疗相比，没有证据表明该干预措施具有成本效益。NCT，NCT01731717。