Effect of adverse events on non-adherence and study non-completion in malaria chemoprevention during pregnancy trial: A nested case control study.
Effect of adverse events on non-adherence and study non-completion in malaria chemoprevention during pregnancy trial: A nested case control study.
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DOI：
10.1371/journal.pone.0262797
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Chirwa T
中科院分区：
文献类型：
--
作者：
Patson N;Mukaka M;Peterson I;Divala T;Kazembe L;Mathanga D;Laufer MK;Chirwa T
在药物试验中，不良事件（AE）负担可能导致治疗不依从或停药。不依从和停药导致选择偏倚，影响药物安全性解释。巢式病例对照（NCC）研究可以有效地量化AE的影响，尽管采样方法的选择具有挑战性。我们研究了在条件logistic或加权考克斯模型下，采用发病密度抽样的NCC研究在评估AE对妊娠试验期间治疗不依从性和参与预防性抗疟药物的影响方面是否比采用路径抽样的NCC研究更有效。使用来自一项药物预防妊娠期疟疾试验的数据，该试验将600名妇女随机分配至妊娠期接受氯喹或磺胺嘧啶-乙胺嘧啶，我们进行了一项NCC研究，评估前瞻性收集的AE（作为关注的暴露）对治疗不依从性和研究未完成的作用。在条件Logistic和加权考克斯模型下，我们比较了NCC研究中的发病密度估计值和NCC研究中的路径抽样估计值。在599名具有关注结局的女性中，474名（79%）在分娩前至少发生了一起AE。对于条件logistic模型，发生率密度采样下AE发生对治疗不依从性影响的风险比为0.70（95% CI：0.42，1.17; p = 0.175），路径采样下为0.68（95% CI：0.41，1.13; p = 0.137）。对于研究未完成，发病率密度采样下的风险比为1.02（95% CI：0.56，1.83; p = 0.955），路径采样下的风险比为0.85（95% CI：0.45，1.60; p = 0.619）。无论采用加权考克斯模型还是条件Logistic模型，我们在发病率密度抽样和路径抽样下获得了相似的风险比和标准误。无论是条件logistic还是加权考克斯分析方法，采用发病密度抽样的NCC和采用路径抽样的NCC在效率上几乎相似，尽管路径抽样使用了更独特的控制来实现相似的估计。ClinicalTrials.gov：NCT01443130。
In drug trials, adverse events (AEs) burden can induce treatment non-adherence or discontinuation. The non-adherence and discontinuation induce selection bias, affecting drug safety interpretation. Nested case-control (NCC) study can efficiently quantify the impact of the AEs, although choice of sampling approach is challenging. We investigated whether NCC study with incidence density sampling is more efficient than NCC with path sampling under conditional logistic or weighted Cox models in assessing the effect of AEs on treatment non-adherence and participation in preventive antimalarial drug during pregnancy trial. Using data from a trial of medication to prevent malaria in pregnancy that randomized 600 women to receive chloroquine or sulfadoxine-pyrimethamine during pregnancy, we conducted a NCC study assessing the role of prospectively collected AEs, as exposure of interest, on treatment non-adherence and study non-completion. We compared estimates from NCC study with incidence density against those from NCC with path sampling under conditional logistic and weighted Cox models. Out of 599 women with the outcomes of interest, 474 (79%) experienced at least one AE before delivery. For conditional logistic model, the hazard ratio for the effect of AE occurrence on treatment non-adherence was 0.70 (95% CI: 0.42, 1.17; p = 0.175) under incidence density sampling and 0.68 (95% CI: 0.41, 1.13; p = 0.137) for path sampling. For study non-completion, the hazard ratio was 1.02 (95% CI: 0.56, 1.83; p = 0.955) under incidence density sampling and 0.85 (95% CI: 0.45, 1.60; p = 0.619) under path sampling. We obtained similar hazard ratios and standard errors under incidence density sampling and path sampling whether weighted Cox or conditional logistic models were used. NCC with incidence density sampling and NCC with path sampling are practically similar in efficiency whether conditional logistic or weighted Cox analytical methods although path sampling uses more unique controls to achieve the similar estimates. ClinicalTrials.gov: NCT01443130.
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影响因子：
2
作者：
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DOI：
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发表时间：
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影响因子：
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