Prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads: an observational study protocol

M. Wiens, J. Trawin, Yashodani Pillay, Vuong Nguyen, C. Komugisha, N. Kenya-Mugisha, Angella Namala, L. Bebell, J. Ansermino, N. Kissoon, Beth Payne, M. Vidler, Astrid Christoffersen-Deb, Pascal M. Lavoie, J. Ngonzi
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Abstract

In low-income country settings, the first six weeks after birth remain a critical period of vulnerability for both mother and newborn. Despite recommendations for routine follow-up after delivery and facility discharge, few mothers and newborns receive guideline recommended care during this period. Prediction modelling of post-delivery outcomes has the potential to improve outcomes for both mother and newborn by identifying high-risk dyads, improving risk communication, and informing a patient-centered approach to postnatal care interventions. This study aims to derive post-discharge risk prediction algorithms that identify mother-newborn dyads who are at risk of re-admission or death in the first six weeks after delivery at a health facility.This prospective observational study will enroll 7,000 mother-newborn dyads from two regional referral hospitals in southwestern and eastern Uganda. Women and adolescent girls aged 12 and above delivering singletons and twins at the study hospitals will be eligible to participate. Candidate predictor variables will be collected prospectively by research nurses. Outcomes will be captured six weeks following delivery through a follow-up phone call, or an in-person visit if not reachable by phone. Two separate sets of prediction models will be built, one set of models for newborn outcomes and one set for maternal outcomes. Derivation of models will be based on optimization of the area under the receiver operator curve (AUROC) and specificity using an elastic net regression modelling approach. Internal validation will be conducted using 10-fold cross-validation. Our focus will be on the development of parsimonious models (5–10 predictor variables) with high sensitivity (>80%). AUROC, sensitivity, and specificity will be reported for each model, along with positive and negative predictive values.The current recommendations for routine postnatal care are largely absent of benefit to most mothers and newborns due to poor adherence. Data-driven improvements to postnatal care can facilitate a more patient-centered approach to such care. Increasing digitization of facility care across low-income settings can further facilitate the integration of prediction algorithms as decision support tools for routine care, leading to improved quality and efficiency. Such strategies are urgently required to improve newborn and maternal postnatal outcomes. https://clinicaltrials.gov/, identifier (NCT05730387).
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母婴二人组出院后再入院和死亡率的预后算法:观察研究方案
在低收入国家的环境中,产后六周仍然是母亲和新生儿易受伤害的关键时期。尽管建议在分娩和出院后进行常规随访,但很少有母亲和新生儿在此期间接受指南推荐的护理。产后结果预测模型可通过识别高危人群、改善风险沟通以及为以患者为中心的产后护理干预提供信息,从而改善产妇和新生儿的预后。这项前瞻性观察研究将从乌干达西南部和东部的两家地区转诊医院招募 7000 名产妇和新生儿。在研究医院分娩单胎和双胞胎的 12 岁及以上妇女和少女均有资格参与。候选预测变量将由研究护士进行前瞻性收集。结果将在分娩后六周通过电话随访收集,如果电话联系不上,则进行面访。将建立两套独立的预测模型,一套用于预测新生儿的结果,另一套用于预测产妇的结果。模型的推导将基于使用弹性网回归建模方法对接收者运算曲线下面积(AUROC)和特异性的优化。内部验证将采用 10 倍交叉验证。我们将重点开发灵敏度高(>80%)的简约模型(5-10 个预测变量)。我们将报告每个模型的 AUROC、灵敏度和特异性,以及阳性和阴性预测值。以数据为导向的产后护理改进措施可以促进以患者为中心的产后护理。在低收入环境中,设施护理的数字化程度不断提高,可进一步促进预测算法的整合,使其成为常规护理的决策支持工具,从而提高护理质量和效率。https://clinicaltrials.gov/, identifier (NCT05730387)。
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