Objective:

The Danish OPUS trial showed significant efficacy of early intervention services for first-episode schizophrenia spectrum disorders compared with standard treatment, leading to implementation of the OPUS intervention in clinical practice. The authors sought to determine whether the effectiveness of OPUS treatment in real-world clinical practice is comparable to the efficacy seen in the trial.

Methods:

The study compared patients who received OPUS treatment as part of the original randomized trial to those who received standard treatment in the trial (the control group) and those who received OPUS treatment after it was implemented in Denmark. The authors investigated whether the three groups differed on register-based outcomes, such as use of secondary health care, functional outcomes, and death. Analyses were adjusted for relevant confounders.

Results:

Compared with trial study participants, patients who received OPUS treatment after implementation (N=3,328) had a tendency toward lower mortality (hazard ratio=0.60, 95% CI=0.33, 1.09), fewer and shorter psychiatric admissions, and possibly fewer filled prescriptions of antipsychotics and other psycholeptics after 4 or 5 years. While at first less likely to be working or studying, patients who received postimplementation OPUS treatment eventually had higher odds of working than did those in the OPUS trial (after 5 years, odds ratio=1.49, 95% CI=1.07, 2.09). The odds of being in a couple relationship were also higher among patients in the postimplementation group than those in the trial. Other outcomes showed less clear associations with treatment group. Generally, the control group in the trial fared worse than both of the OPUS treatment groups.

Conclusions:

Not only did OPUS treatment maintain its efficacy after it was implemented as a standard treatment, it paralleled or surpassed many of the effects observed when the OPUS intervention was delivered in a randomized trial. The study results provide further evidence in support of implementation and funding of early intervention services worldwide.

中文翻译：

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丹麦 OPUS 首发精神病早期干预服务：一项 4 期前瞻性队列研究，比较随机试验和真实世界数据

客观的：

丹麦 OPUS 试验表明，与标准治疗相比，早期干预服务对首发精神分裂症谱系障碍具有显着疗效，从而在临床实践中实施了 OPUS 干预。作者试图确定实际临床实践中 OPUS 治疗的有效性是否与试验中观察到的疗效相当。

方法：

该研究将在原始随机试验中接受 OPUS 治疗的患者与在试验中接受标准治疗的患者（对照组）和在丹麦实施 OPUS 治疗的患者进行了比较。作者调查了三组是否在基于注册的结果方面存在差异，例如二级医疗保健的使用、功能结果和死亡。对相关混杂因素的分析进行了调整。

结果：

与试验研究参与者相比，实施后接受 OPUS 治疗的患者 (N = 3,328) 有降低死亡率的趋势（风险比 = 0.60，95% CI = 0.33，1.09）、精神病入院次数越来越少、处方可能越来越少4 或 5 年后抗精神病药和其他精神病药。虽然起初不太可能工作或学习，但接受实施后 OPUS 治疗的患者最终比 OPUS 试验中的患者有更高的工作几率（5 年后，优势比 = 1.49，95% CI = 1.07, 2.09）。实施后组患者发生夫妻关系的几率也高于试验组。其他结果显示与治疗组的关联不太明确。一般来说，试验中的对照组比两个 OPUS 治疗组的表现都差。

结论：

OPUS 治疗不仅在作为标准治疗实施后仍保持其疗效，而且在随机试验中实施 OPUS 干预时观察到的许多效果与观察到的效果相似或超过。研究结果为支持全球早期干预服务的实施和资助提供了进一步的证据。