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Using Machine Learning Imputed Outcomes to Assess Drug-Dependent Risk of Self-Harm in Patients with Bipolar Disorder: A Comparative Effectiveness Study
JMIR Mental Health ( IF 5.2 ) Pub Date : 2021-04-21 , DOI: 10.2196/24522
Anastasiya Nestsiarovich , Praveen Kumar , Nicolas Raymond Lauve , Nathaniel G Hurwitz , Aurélien J Mazurie , Daniel C Cannon , Yiliang Zhu , Stuart James Nelson , Annette S Crisanti , Berit Kerner , Mauricio Tohen , Douglas J Perkins , Christophe Gerard Lambert

Background: Incomplete suicidality coding in administrative claims data is a known obstacle for observational studies. With most of the negative outcomes missing from the data, it is challenging to assess the evidence on treatment strategies for the prevention of self-harm in bipolar disorder (BD), including pharmacotherapy and psychotherapy. There are conflicting data from studies on the drug-dependent risk of self-harm, and there is major uncertainty regarding the preventive effect of monotherapy and drug combinations. Objective: The aim of this study was to compare all commonly used BD pharmacotherapies, as well as psychotherapy for the risk of self-harm, in a large population of commercially insured individuals, using self-harm imputation to overcome the known limitations of this outcome being underrecorded within US electronic health care records. Methods: The IBM MarketScan administrative claims database was used to compare self-harm risk in patients with BD following 65 drug regimens and drug-free periods. Probable but uncoded self-harm events were imputed via machine learning, with different probability thresholds examined in a sensitivity analysis. Comparators included lithium, mood-stabilizing anticonvulsants (MSAs), second-generation antipsychotics (SGAs), first-generation antipsychotics (FGAs), and five classes of antidepressants. Cox regression models with time-varying covariates were built for individual treatment regimens and for any pharmacotherapy with or without psychosocial interventions (“psychotherapy”). Results: Among 529,359 patients, 1.66% (n=8813 events) had imputed and/or coded self-harm following the exposure of interest. A higher self-harm risk was observed during adolescence. After multiple testing adjustment (P≤.012), the following six regimens had higher risk of self-harm than lithium: tri/tetracyclic antidepressants + SGA, FGA + MSA, FGA, serotonin-norepinephrine reuptake inhibitor (SNRI) + SGA, lithium + MSA, and lithium + SGA (hazard ratios [HRs] 1.44-2.29), and the following nine had lower risk: lamotrigine, valproate, risperidone, aripiprazole, SNRI, selective serotonin reuptake inhibitor (SSRI), “no drug,” bupropion, and bupropion + SSRI (HRs 0.28-0.74). Psychotherapy alone (without medication) had a lower self-harm risk than no treatment (HR 0.56, 95% CI 0.52-0.60; P=8.76×10-58). The sensitivity analysis showed that the direction of drug-outcome associations did not change as a function of the self-harm probability threshold. Conclusions: Our data support evidence on the effectiveness of antidepressants, MSAs, and psychotherapy for self-harm prevention in BD. Trial Registration: ClinicalTrials.gov NCT02893371; https://clinicaltrials.gov/ct2/show/NCT02893371

中文翻译:

使用机器学习估算的结果评估双相情感障碍患者的药物依赖性自我伤害风险:一项比较有效性研究

背景:行政索赔数据中不完整的自杀式编码是观察研究的已知障碍。由于大多数阴性结果均未从数据中剔除,因此难以评估有关预防双相情感障碍(BD)自我伤害的治疗策略的证据,包括药物治疗和心理治疗。关于药物依赖性自我伤害风险的研究数据相互矛盾,并且关于单一疗法和药物组合的预防作用存在重大不确定性。客观的:这项研究的目的是比较大量商业保险个体中所有常用的BD药物疗法以及心理疗法对自我伤害的风险,并使用自我伤害插补来克服已知结果不足的局限性在美国电子医疗记录中。方法:IBM MarketScan行政声明数据库用于比较65种药物治疗和无药物治疗后BD患者的自我伤害风险。可能的但未编码的自残事件是通过机器学习估算出来的,在敏感性分析中检查了不同的概率阈值。比较者包括锂,稳定情绪的抗惊厥药(MSA),第二代抗精神病药(SGA),第一代抗精神病药(FGA)和五种抗抑郁药。针对个体治疗方案以及任何有或没有社会心理干预措施(“心理治疗”)的药物治疗,均建立了具有随时间变化的协变量的Cox回归模型。结果:在529,359名患者中,有1.66%(n = 8813个事件)在受到关注后遭受了自我和/或编码的自我伤害。在青春期观察到较高的自我伤害风险。后多重检验调整(P ≤.012),以下六个方案有自我伤害比锂的更高的风险:三/四环抗抑郁药+ SGA,FGA + MSA,FGA,血清素-去甲肾上腺素再摄取抑制剂(SNRI)+ SGA,锂+ MSA和锂+ SGA(危险比[HRs] 1.44-2.29),以下9种风险较低:拉莫三嗪,丙戊酸,利培酮,阿立哌唑,SNRI,选择性5-羟色胺再摄取抑制剂,“无药物”,安非他酮和安非他酮+ SSRI(HRs 0.28-0.74)。单独进行心理治疗(不使用药物)比没有治疗具有更低的自我伤害风险(HR 0.56,95%CI 0.52-0.60;P = 8.76×10-58)。敏感性分析表明,药物-结果关联的方向没有根据自残概率阈值而变化。结论:我们的数据支持了抗抑郁药,MSA和心理疗法对BD自我伤害预防的有效性的证据。试用注册: ClinicalTrials.gov NCT02893371;https://clinicaltrials.gov/ct2/show/NCT02893371
更新日期:2021-04-21
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