Hewawasam Erandi, Gulyani Aarti, Davies Christopher E, Sullivan Elizabeth, Wark Sally, Clayton Philip A, McDonald Stephen P, Jesudason Shilpanjali
Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, South Australia, Australia
Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.
BMJ Open. 2020 May 25;10(5):e036329. doi: 10.1136/bmjopen-2019-036329.
Achieving parenthood is challenging in individuals receiving renal replacement therapy (RRT; dialysis or kidney transplantation) for end-stage kidney disease. Decision-making regarding parenthood in RRT recipients should be underpinned by robust data, yet there is limited data on parental factors that drive adverse health outcomes. Therefore, we aim to investigate the perinatal risks and outcomes in parents receiving RRT.
This is a multijurisdictional probabilistic data linkage study of perinatal, hospital, birth, death and renal registers from 1991 to 2013 from New South Wales, Western Australia, South Australia and the Australian Capital Territory. This study includes all babies born ≥20 weeks' gestation or 400 g birth weight captured through mandated data collection in the perinatal data sets. Through linkage with the Australian and New Zealand Dialysis and Transplant (ANZDATA) registry, babies exposed to RRT (and their parents) will be compared with babies who have not been exposed to RRT (and their parents) to determine obstetric and fetal outcomes, birth rates and fertility rates. One of the novel aspects of this study is the method that will be used to link fathers receiving RRT to the mothers and their babies within the perinatal data sets, using the birth register, enabling the identification of family units. The linked data set will be used to validate the parenthood events directly reported to ANZDATA.
Ethics approval was obtained from Human Research Ethics Committees (HREC) and Aboriginal HREC in each jurisdiction. Findings of this study will be disseminated at scientific conferences and in peer-reviewed journals in tabular and aggregated forms. De-identified data will be presented and individual patients will not be identified. We will aim to present findings to relevant stakeholders (eg, patients, clinicians and policymakers) to maximise translational impact of research findings.
对于接受终末期肾病肾脏替代治疗（RRT；透析或肾移植）的个体而言，实现为人父母的愿望具有挑战性。关于RRT接受者生育问题的决策应以可靠数据为依据，但关于导致不良健康结局的父母因素的数据有限。因此，我们旨在调查接受RRT的父母的围产期风险和结局。
这是一项多辖区概率性数据关联研究，涉及新南威尔士州、西澳大利亚州、南澳大利亚州和澳大利亚首都地区1991年至2013年的围产期、医院、出生、死亡和肾脏登记数据。本研究包括通过围产期数据集中的强制数据收集获取的所有妊娠≥20周或出生体重≥400克的婴儿。通过与澳大利亚和新西兰透析与移植（ANZDATA）登记处的数据关联，将接受RRT的婴儿（及其父母）与未接受RRT的婴儿（及其父母）进行比较，以确定产科和胎儿结局、出生率和生育率。本研究的一个新颖之处在于，将利用出生登记册，在围产期数据集中将接受RRT的父亲与母亲及其婴儿进行关联的方法，从而能够识别家庭单位。关联后的数据集将用于验证直接报告给ANZDATA的生育事件。
已获得各辖区人类研究伦理委员会（HREC）和原住民HREC的伦理批准。本研究结果将以表格和汇总形式在科学会议和同行评审期刊上发表。将展示去识别化的数据，不会识别个体患者。我们的目标是向相关利益攸关方（如患者、临床医生和政策制定者）介绍研究结果，以最大限度地提高研究结果的转化影响力。
