Španiel Filip, Hrdlička Jan, Novák Tomáš, Kožený Jiří, Höschl Cyril, Mohr Pavel, Motlová Lucie Bankovská
Prague Psychiatric Center, 3rd Faculty of Medicine, Charles University, Center of Neuro psychiatric Studies, Prague, Czech Republic.
J Psychiatr Pract. 2012 Jul;18(4):269-80. doi: 10.1097/01.pra.0000416017.45591.c1.
To evaluate the effectiveness of the Information Technology-Aided Program of Re lapse Prevention in Schizophrenia (ITAREPS).
Relapse-prone outpatients with schizophrenia or schizoaffective disorder were randomized to the active (n=75) or control group (n=71). In the active arm, according to the protocol, investigators were prompted to increase the antipsychotic dose upon occurrence of a pharmacological inter vention requiring event (PIRE) detected by ITAREPS.
Intention-to-treat (ITT) analysis found no between-group difference in the hospitalization-free survival rate at 12 months. However, the trial suffered from high non-adherence of investigators in the active group, with no antipsychotic dose increase in 61% of PIREs. Furthermore, Cox regression analysis showed a 11-fold increased risk of hospitalization in the absence of pharmacological intervention following a PIRE (hazard ratio [HR]=10.8; 95% confidence interval [CI] 1.4-80.0; p=0.002). Therefore, a post-hoc as-treated analysis was performed, which demonstrated a nine-fold reduction in the risk of hospitalization in ITAREPS Algorithm-Adherers (IAAs, n=25) compared with the ITAREPS Non-interventional group (INIs, n=70; Kaplan-Meier survival analysis, HR=0.11, 95% CI 0.05-0.28, p=0.009; number needed to treat [NNT]=4, 95% CI 3-10). A significant difference in favor of the IAA group was seen in the number of inpatient days (p<0.05) and costs (p<0.05).
Future ITAREPS trials should target the underlying mechanisms that cause low investigator adherence to the program.
Clinical Trials NCT00712660.
评估精神分裂症信息技术辅助复发预防项目（ITAREPS）的有效性。
将易复发的精神分裂症或分裂情感性障碍门诊患者随机分为干预组（n = 75）和对照组（n = 71）。在干预组中，根据方案，当ITAREPS检测到需要进行药物干预的事件（PIRE）时，研究人员会被提示增加抗精神病药物剂量。
意向性分析（ITT）发现，12个月时两组间无住院生存率差异。然而，该试验存在干预组研究人员高不依从性的问题，61%的PIRE事件中未增加抗精神病药物剂量。此外，Cox回归分析显示，PIRE事件后未进行药物干预时，住院风险增加11倍（风险比[HR]=10.8；95%置信区间[CI] 1.4 - 80.0；p = 0.002）。因此，进行了事后实际治疗分析，结果显示，与ITAREPS非干预组（INIs，n = 70）相比，ITAREPS算法依从者（IAAs，n = 25）的住院风险降低了9倍（Kaplan - Meier生存分析，HR = 0.11，95% CI 0.05 - 0.28，p = 0.009；治疗所需人数[NNT]=4，95% CI 3 - 10）。在住院天数（p<0.05）和费用（p<0.05）方面，IAA组有显著优势。
未来的ITAREPS试验应针对导致研究人员对该项目依从性低的潜在机制。
临床试验NCT00712660。
