Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy: a signal detection study protocol.
Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy: a signal detection study protocol.
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DOI：
10.1136/bmjopen-2023-073162
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发表时间：
2023-10-09
期刊：
影响因子：
2.9
通讯作者：
MuM PreDiCT Grp
中科院分区：
文献类型：
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作者：
Subramanian, Anuradhaa;Lee, Siang Ing;Sudasinghe, Sudasing Pathirannehelage Buddhika Hemali;Wambua, Steven;Phillips, Katherine;Singh, Megha;Azcoaga-Lorenzo, Amaya;Cockburn, Neil;Wang, Jingya;Fagbamigbe, Adeniyi;Usman, Muhammad;Damase-Michel, Christine;Yau, Christopher;Kent, Lisa;McCowan, Colin;OReilly, Dermot;Santorelli, Gillian;Hope, Holly;Kennedy, Jonathan;Mhereeg, Mohamed;Abel, Kathryn Mary;Eastwood, Kelly-Ann;Black, Mairead;Loane, Maria;Moss, Ngawai;Brophy, Sinead;Brocklehurst, Peter;Dolk, Helen;Nelson-Piercy, Catherine;Nirantharakumar, Krishnarajah;MuM PreDiCT Grp
考虑到孕妇中多种用药的高发率，以及对其复杂治疗方案的风险-收益-安全概况的认识差距，需要更多的研究来优化处方。在本研究中，我们旨在检测妊娠期间暴露于单独和成对组合药物的不良和保护作用信号。使用来自英国的一系列真实数据来源，我们的目标是进行一项药物警戒研究，以评估孕前（怀孕前3个月）和妊娠头三个月期间处方药物的安全性。在临床实践研究数据链（CPRD）怀孕登记、威尔士安全匿名信息链接（SAIL）、苏格兰发病率记录（SMR）数据集和北爱尔兰生育系统（NIMATS）中有怀孕记录的15至49岁的妇女将被包括在内。将进行一系列病例对照研究，以估计不均衡的措施，检测一系列妊娠结果与个人和联合用药暴露之间的关联信号。将邀请多学科专家小组参加信号检测研讨会。通过采用结构化框架，团队的每个成员将使用调查问卷对信号进行透明评估，评估信号的时间性、选择、时间和测量相关的偏差以及潜在疾病或药物的混淆。通过小组讨论，专家团队将对每个药物暴露-结果信号达成共识，从而排除虚假信号，留下提示因果关系的信号供进一步评估。获得了独立科学咨询委员会、SAIL信息治理审查小组、圣安德鲁斯大学教学和研究伦理委员会以及北爱尔兰研究伦理委员会办公室（ORECNI）的伦理批准，可以分别访问和使用CPRD、SAIL、SMR和NIMATS数据。
Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk–benefit safety profile of their often-complex treatment plan, more research is needed to optimise prescribing. In this study, we aim to detect adverse and protective effect signals of exposure to individual and pairwise combinations of medications during pregnancy. Using a range of real-world data sources from the UK, we aim to conduct a pharmacovigilance study to assess the safety of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy. Women aged between 15 and 49 years with a record of pregnancy within the Clinical Practice Research Datalink (CPRD) Pregnancy Register, the Welsh Secure Anonymised Information Linkage (SAIL), the Scottish Morbidity Record (SMR) data sets and the Northern Ireland Maternity System (NIMATS) will be included. A series of case control studies will be conducted to estimate measures of disproportionality, detecting signals of association between a range of pregnancy outcomes and exposure to individual and combinations of medications. A multidisciplinary expert team will be invited to a signal detection workshop. By employing a structured framework, signals will be transparently assessed by each member of the team using a questionnaire appraising the signals on aspects of temporality, selection, time and measurement-related biases and confounding by underlying disease or comedications. Through group discussion, the expert team will reach consensus on each of the medication exposure–outcome signal, thereby excluding spurious signals, leaving signals suggestive of causal associations for further evaluation. Ethical approval has been obtained from the Independent Scientific Advisory Committee, SAIL Information Governance Review Panel, University of St. Andrews Teaching and Research Ethics Committee and Office for Research Ethics Committees Northern Ireland (ORECNI) for access and use of CPRD, SAIL, SMR and NIMATS data, respectively.
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作者：
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通讯作者：
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