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准备肾脏护理研究:在晚期慢性肾脏病中准备肾脏透析与反应性管理。

The Prepare for Kidney Care Study: prepare for renal dialysis versus responsive management in advanced chronic kidney disease.

机构信息

Health Sciences, University of Southampton, Southampton, UK.

The Royal Free Hospital, Renal Center for Nephrology Royal Free Hospital NHS Trust, London, UK.

出版信息

Nephrol Dial Transplant. 2021 May 27;36(6):975-982. doi: 10.1093/ndt/gfaa209.

Abstract

Shared decision making in advanced chronic kidney disease (CKD) requires unbiased information on survival and person-centred outcomes known to matter to patients: quality of life, symptom burden and support from family and healthcare professionals. To date, when deciding between dialysis and conservative care, patients have had to rely on evidence from small observational studies. Clinicians recognize that like is not being compared with like in these studies, and interpret the results differently. Furthermore, support differs considerably between renal units. What patients choose therefore depends on which renal unit they attend. To address this, a programme of work has been underway in the UK. After reports on survival and symptoms from a small number of renal units, a national, mixed-methods study-the Conservative Kidney Management Assessment of Practice Patterns Study-mapped out conservative care practices and attitudes in the UK. This led to the Prepare for Kidney Care study, a randomized controlled trial comparing preparation for dialysis versus preparation for conservative care. Although powered to detect a positivist 0.345 difference in quality-adjusted life years between the two treatments, this trial also takes a realist approach with a range of person-centred secondary outcomes and embedded qualitative research. To understand generalizability, it is nested in an observational cohort study, which is nested in a CKD registry. Challenges to recruitment and retention have been rapidly identified and addressed using an established embedded mixed methods approach-the QuinteT recruitment intervention. This review considers the background to and progress with recruitment to the trial.

摘要

在晚期慢性肾脏病 (CKD) 中进行共同决策需要有关生存和以患者为中心的结果的无偏见信息,这些结果对患者很重要:生活质量、症状负担以及来自家庭和医疗保健专业人员的支持。迄今为止,在决定透析和保守治疗之间时,患者不得不依赖于来自小型观察性研究的证据。临床医生认识到,在这些研究中,相似的情况并未进行比较,并且对结果的解释也不同。此外,各肾脏单位之间的支持差异很大。因此,患者的选择取决于他们就诊的肾脏单位。为了解决这个问题,英国已经开展了一项工作计划。在少数肾脏单位报告了生存和症状数据之后,进行了一项全国性的、混合方法的研究——保守肾脏管理评估实践模式研究——绘制了英国保守治疗实践和态度的地图。这导致了 Prepare for Kidney Care 研究,该研究比较了透析准备和保守治疗准备。虽然该试验旨在检测两种治疗方法之间在调整质量的生命年方面存在阳性 0.345 差异,但它也采用了一种现实主义方法,具有一系列以患者为中心的次要结果和嵌入式定性研究。为了理解普遍性,它嵌套在一个观察性队列研究中,该研究嵌套在 CKD 登记处中。使用一种既定的嵌入式混合方法——QuinteT 招募干预措施,迅速确定并解决了招募和保留方面的挑战。本综述考虑了试验的背景和进展情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cad7/8160947/f2afd2a56a05/gfaa209f1.jpg

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