Academic Medical Center Amsterdam, The Netherlands.
BMC Pregnancy Childbirth. 2010 Aug 10;10:42. doi: 10.1186/1471-2393-10-42.
Many perinatal interventions are performed to improve long-term neonatal outcome. To evaluate the long-term effect of a perinatal intervention follow-up of the child after discharge from the hospital is necessary because serious sequelae from perinatal complications frequently manifest themselves only after several years. However, long-term follow-up is time-consuming, is not in the awareness of obstetricians, is expensive and falls outside the funding-period of most obstetric studies. Consequently, short-term outcomes are often reported instead of the primary long-term end-point. With this project, we will assess the current state of affairs concerning follow-up after obstetric RCTs and we will develop multivariable prediction models for different long-term health outcomes. Furthermore, we would like to encourage other researchers participating in follow-up studies after large obstetric trials (> 350 women) to inform us about their studies so that we can include their follow-up study in our systematic review. We would invite these researchers also to join our effort and to collaborate with us on the external validation of our prediction models.
METHODS/DESIGN: A systematic review of neonatal follow-up after obstetric studies will be performed. All reviews of the Cochrane Pregnancy and Childbirth group will be assessed for reviews on interventions that aimed to improve neonatal outcome. Reviews on interventions primary looking at other aspects than neonatal outcome such as labour progress will also be included when these interventions can change the outcome of the neonate on the short or long-term. Our review will be limited to RCTs with more than 350 women. Information that will be extracted from these RCTs will address whether, how and for how long follow-up has been performed. However, in many cases long-term follow-up of the infants will not be feasible. An alternative solution to limited follow-up could be to develop prediction models to estimate long-term health outcomes of the newborn based on specific perinatal outcomes and other covariates. For the development of multivariable prediction models for several health outcomes, we will use data available from a Dutch cohort study of preterm (< 32 weeks) and/or small for gestational age infants (< 1500 g). These infants were born in The Netherlands in 1983 and followed until they reached the age of 19.
The systematic review will provide insight in the extent and methods used for follow-up assessments after obstetric RCTs in the past. The prediction models can be used by future studies to extrapolate short-term outcomes to a long-term horizon or to indicate for which neonates long-term follow-up is required, as their outcomes (either absence or presence of sequelae) cannot be adequately predicted from short-term outcomes and clinical background characteristics.
许多围产期干预措施旨在改善新生儿的长期预后。为了评估围产期干预措施的长期效果，有必要对出院后的儿童进行随访，因为围产期并发症的严重后遗症通常要在几年后才会显现。然而，长期随访既耗时，又不在产科医生的意识范围内，而且费用高昂，超出了大多数产科研究的资金周期。因此，通常报告短期结果而不是主要的长期终点。通过本项目，我们将评估产科随机对照试验后随访的现状，并为不同的长期健康结果开发多变量预测模型。此外，我们还希望鼓励其他参与大型产科试验（>350 名妇女）后随访研究的研究人员告知我们他们的研究情况，以便我们可以将他们的随访研究纳入我们的系统评价。我们还将邀请这些研究人员加入我们的工作，并就我们的预测模型的外部验证与我们合作。
方法/设计：将对产科研究后的新生儿随访进行系统评价。将评估 Cochrane 妊娠和分娩组的所有综述，以确定旨在改善新生儿结局的干预措施的综述。如果干预措施主要着眼于新生儿结局以外的方面，如分娩进展，并且这些干预措施可能会在短期或长期内改变新生儿的结局，也将包括这些综述。我们的综述将仅限于超过 350 名妇女的 RCT。从这些 RCT 中提取的信息将涉及是否、如何以及进行了多长时间的随访。然而，在许多情况下，对婴儿进行长期随访是不可行的。解决有限随访的一种替代方法可能是开发预测模型，根据特定的围产期结局和其他协变量来估计新生儿的长期健康结局。为了开发几种健康结局的多变量预测模型，我们将使用荷兰一个早产儿（<32 周）和/或小于胎龄儿（<1500 克）队列研究中的可用数据。这些婴儿于 1983 年在荷兰出生，并随访至 19 岁。
系统评价将提供过去产科 RCT 后随访评估的范围和方法的深入了解。预测模型可被未来的研究用于将短期结果推断到长期，或者表明哪些新生儿需要进行长期随访，因为无法从短期结果和临床背景特征中充分预测他们的结局（有无后遗症）。
