Analyzing intent-to-treat and per-protocol effects on safety outcomes using a medical information database: an application to the risk assessment of antibiotic-induced liver injury
Analyzing intent-to-treat and per-protocol effects on safety outcomes using a medical information database: an application to the risk assessment of antibiotic-induced liver injury
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使用医疗信息数据库分析意向治疗和符合方案对安全结果的影响：抗生素引起的肝损伤风险评估的应用
DOI：
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发表时间：
2018
影响因子：
3.1
通讯作者：
Y. Matsuyama
中科院分区：
文献类型：
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作者：
Yoshinori Takeuchi;T. Shinozaki;H. Kumamaru;Tatsuo Hiramatsu;Y. Matsuyama
摘要目的：在一项与抗生素使用（大环内酯类、青霉素类抗生素和氟喹诺酮类）相关的30天肝损伤风险的安全性结局研究中，应用因果分析方法估计意向治疗和符合方案效应。研究设计和方法：对于每种抗生素，我们使用大学医院的电子病历数据库构建了一个与未治疗事件相匹配的治疗事件合并队列。使用基线患者特征、合并用药和病史作为替代混杂因素计算高维倾向评分。使用忽略后续治疗变化的治疗加权离散风险模型的逆概率估计意向治疗风险比（HR）。在首次治疗变更时终止每次发作的观察后，使用治疗的逆概率和删失加权模型计算符合方案HR。结果：对于大环内酯类药物，意向治疗HR（95%置信区间）为1.22（0.75-1.98），符合方案HR为1.22（0.67-2.22）。对于青霉素类抗生素，意向治疗HR为4.01（3.16-5.08），符合方案HR为7.25（5.58-9.41）。对于氟喹诺酮类药物，意向治疗HR为1.60（1.27-2.03），符合方案HR为1.69（1.23-2.30）。结论：研究者应明确定义目标被估量，并仔细估计和解释两种效应。
ABSTRACT Objective: To apply a causal analysis approach to estimate the intent-to-treat and per-protocol effects in a safety outcome study of the 30-day risk of liver injury associated with antibiotic use (macrolides, penicillin-based antibiotics, and fluoroquinolones). Research design and methods: For each antibiotic class, we constructed a pooled cohort of treated episodes matched with untreated episodes using an electronic medical record database from a university hospital. High-dimensional propensity scores were calculated using baseline patient characteristics, concomitant medications and medical history as surrogate confounders. Intent-to-treat hazard ratios (HRs) were estimated using inverse probability of treatment weighted discrete hazard models that ignored subsequent treatment changes. Per-protocol HRs were calculated using inverse probability of treatment and censoring weighted models after terminating each episode’s observation at the first treatment change. Results: For macrolides, the intent-to-treat HR (95% confidence interval) was 1.22 (0.75–1.98) and the per-protocol HR was 1.22 (0.67–2.22). For penicillin-based antibiotics, the intent-to-treat HR was 4.01 (3.16–5.08) and the per-protocol HR was 7.25 (5.58–9.41). For fluoroquinolones, the intent-to-treat HR was 1.60 (1.27–2.03) and the per-protocol HR was 1.69 (1.23–2.30). Conclusion: Researchers should clearly define the target estimands, and carefully estimate and interpret both effects.
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影响因子：
5
作者：
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通讯作者：
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影响因子：
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