Departments of Psychiatry and of Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
The Feinstein Institutes for Medical Research, Institute of Behavioral Science, Manhasset, NY, USA.
Schizophr Bull. 2022 Sep 1;48(5):1021-1031. doi: 10.1093/schbul/sbac053.
To examine long-term effects of early intervention services (EIS) for first-episode psychosis, we compared Heinrichs-Carpenter Quality of Life (QLS) and Positive and Negative Syndrome Scale (PANSS) scores and inpatient hospitalization days over 5 years with data from the site-randomized RAISE-ETP trial that compared the EIS NAVIGATE (17 sites; 223 participants) and community care (CC) (17 sites; 181 participants). Inclusion criteria were: age 15-40 years; DSM-IV diagnoses of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified; first psychotic episode; antipsychotic medication taken for ≤6 months. NAVIGATE-randomized participants could receive NAVIGATE from their study entry date until NAVIGATE ended when the last-enrolled NAVIGATE participant completed 2 years of treatment. Assessments occurred every 6 months. 61% of participants had assessments conducted ≥2 years; 31% at 5 years. Median follow-up length was CC 30 months and NAVIGATE 38 months. Primary analyses assumed data were not-missing-at-random (NMAR); sensitivity analyses assumed data were missing-at-random (MAR). MAR analyses found no significant treatment-by-time interactions for QLS or PANSS. NMAR analyses revealed that NAVIGATE was associated with a 13.14 (95%CI:6.92,19.37) unit QLS and 7.73 (95%CI:2.98,12.47) unit PANSS better improvement and 2.53 (95%CI:0.59,4.47) fewer inpatient days than CC (all comparisons significant). QLS and PANSS effect sizes were 0.856 and 0.70. NAVIGATE opportunity length (mean 33.8 (SD = 5.1) months) was not associated (P = .72) with QLS outcome; duration of untreated psychosis did not moderate (P = .32) differential QLS outcome. While conclusions are limited by the low rate of five-year follow-up, the data support long-term benefit of NAVIGATE compared to community care.
为了研究首发精神病的早期干预服务（EIS）的长期效果，我们将 Heinrichs-Carpenter 生活质量量表（QLS）和阳性与阴性症状量表（PANSS）评分，以及 5 年内住院天数，与 RAISE-ETP 试验的现场随机 NAVIGATE（17 个地点；223 名参与者）和社区护理（CC）（17 个地点；181 名参与者）的数据进行了比较。纳入标准为：年龄 15-40 岁；DSM-IV 诊断为精神分裂症、分裂情感障碍、分裂样障碍、短暂精神病性障碍或未特定的精神病性障碍；首发精神病；抗精神病药物治疗时间≤6 个月。NAVIGATE 随机分组的参与者可从研究入组日期开始接受 NAVIGATE，直到最后一名入组的 NAVIGATE 参与者完成 2 年治疗时 NAVIGATE 结束。评估每 6 个月进行一次。61%的参与者进行了≥2 年的评估；31%在 5 年内进行了评估。中位随访时间 CC 为 30 个月，NAVIGATE 为 38 个月。主要分析假设数据不是随机缺失（NMAR）；敏感性分析假设数据是随机缺失（MAR）。MAR 分析发现，QLS 和 PANSS 均未显示治疗与时间之间存在显著的交互作用。NMAR 分析显示，与 CC 相比，NAVIGATE 与 QLS 改善 13.14（95%CI：6.92，19.37）单位，PANSS 改善 7.73（95%CI：2.98，12.47）单位，住院天数减少 2.53（95%CI：0.59，4.47）（所有比较均有统计学意义）。QLS 和 PANSS 的效应量分别为 0.856 和 0.70。NAVIGATE 的机会长度（平均 33.8（SD=5.1）个月）与 QLS 结局无关（P=0.72）；未治疗精神病的持续时间并未调节（P=0.32）QLS 结局的差异。尽管由于五年随访率较低，结论受到限制，但数据支持 NAVIGATE 与社区护理相比具有长期益处。
