Lord Libby, Rogers Jenny, Gamble Greg D, Harding Jane E
The University of Auckland Liggins Institute, Auckland, New Zealand.
The University of Auckland Liggins Institute, Auckland, New Zealand
Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):643-651. doi: 10.1136/archdischild-2023-326455.
To describe strategies used to maximise follow-up after a neonatal randomised trial, how these differed for families of different ethnicity, socioeconomic status and urban versus rural residence and investigate relationships between the difficulty of follow-up and rate of neurosensory impairment.
hPOD was a multicentre randomised trial assessing oral dextrose gel prophylaxis for neonatal hypoglycaemia. Follow-up at 2 years was conducted from 2017 to 2021. We analysed all recorded contacts between the research team and participants' families. Neurosensory impairment was defined as blindness, deafness, cerebral palsy, developmental delay or executive function impairment.
Of 1321 eligible participants, 1197 were assessed (91%) and 236/1194 (19.8%) had neurosensory impairment. Participants received a median of five contacts from the research team (range 1-23). Those from more deprived areas and specific ethnicities received more contacts, particularly home tracking visits and home assessments. Impairment was more common among participants receiving more contacts (relative risk 1.81, 95% CI 1.34 to 2.44 for ≥7 contacts vs <7 contacts), and among those assessed after the intended age (76/318, 23.9% if >25 months vs 160/876, 18.3% if ≤25 months).
Varied contact strategies and long timeframes are required to achieve a high follow-up rate. Without these, the sociodemographics of children assessed would not have been representative of the entire cohort, and the rate of neurosensory impairment would have been underestimated. To maximise follow-up after randomised trials, substantial effort and resources are needed to ensure that data are useful for clinical decision-making.
描述在新生儿随机试验后用于最大化随访的策略，这些策略在不同种族、社会经济地位以及城市与农村居住情况的家庭中有何差异，并调查随访难度与神经感觉障碍发生率之间的关系。
hPOD是一项多中心随机试验，评估口服葡萄糖凝胶预防新生儿低血糖的效果。2017年至2021年进行了2年的随访。我们分析了研究团队与参与者家庭之间所有记录的联系。神经感觉障碍定义为失明、失聪、脑瘫、发育迟缓或执行功能障碍。
在1321名符合条件的参与者中，1197名接受了评估（91%），236/1194（19.8%）有神经感觉障碍。参与者从研究团队收到的联系中位数为5次（范围1 - 23次）。来自更贫困地区和特定种族的参与者收到的联系更多，特别是家庭追踪访问和家庭评估。在接受更多联系的参与者中，障碍更为常见（≥7次联系与<7次联系相比，相对风险1.81，95%置信区间1.34至2.44），以及在预期年龄之后接受评估的参与者中（如果>25个月，76/318，23.9%；如果≤25个月，160/876，18.3%）。
需要采用多样化的联系策略和较长的时间框架来实现高随访率。没有这些，接受评估儿童的社会人口统计学特征就不会代表整个队列，神经感觉障碍的发生率也会被低估。为了在随机试验后最大化随访，需要大量的努力和资源来确保数据对临床决策有用。
