Shen Jenny I, Cho Yeoungjee, Manera Karine E, Brown Fiona, Dong Jie, Al Sahlawi Muthana, Acevedo Rafael G, Htay Htay, Ito Yasuhiko, Kanjanabuch Talerngsak, Nessim Sharon J, Ngaruiya Grace, Piraino Beth, Szeto Cheuk-Chun, Teitelbaum Isaac, Amir Noa, Craig Jonathan C, Baumgart Amanda, Gonzalez Andrea M, Scholes-Robertson Nicole, Viecelli Andrea K, Wilkie Martin, Tong Allison, Perl Jeffrey
Division of Nephrology and Hypertension, The Lundquist Research Institute at Harbor-UCLA Medical Center, Torrance, California, USA.
Faculty of Medicine, Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
Kidney Int Rep. 2022 May 26;7(8):1737-1744. doi: 10.1016/j.ekir.2022.05.020. eCollection 2022 Aug.
Peritoneal dialysis (PD)-related peritonitis is one of the leading causes of discontinuation of PD and is considered a critically important outcome for patients on PD. However, there is no universally accepted method of measuring this outcome in clinical trials.
We convened an online consensus workshop to establish a core outcome measure for PD-related peritonitis in clinical trials.
A total of 53 participants, including 18 patients and caregivers, from 12 countries engaged in breakout discussions in this workshop. Transcripts were analyzed thematically. We identified the following 3 themes: (i) feasibility and applicability across diverse settings, which reflected the difficulty with implementing laboratory-based measures in resource-limited environments; (ii) ensuring validity, which included minimizing false positives and considering the specificity of symptoms; and (iii) being meaningful and tangible to patients, which meant that the measure should be easy to interpret, reflect the impact that symptoms have on patients, and promote transparency by standardizing the reporting of peritonitis among dialysis units.
A core outcome measure for PD-related peritonitis should include both symptom-based and laboratory-based criteria. Thus, the International Society for Peritoneal Dialysis (ISPD) definition of peritonitis is acceptable. However, there should be consideration of reporting suspected peritonitis in cases where laboratory confirmation is not possible. The measure should include all infections from the time of catheter insertion and capture both the rate of infection and the number of patients who remain peritonitis free. A core outcome measure with these features would increase the impact of clinical trials on the care and decision-making of patients receiving PD.
腹膜透析（PD）相关腹膜炎是导致终止PD治疗的主要原因之一，被视为PD患者的一项至关重要的结局。然而，在临床试验中，尚无普遍接受的测量这一结局的方法。
我们召开了一次在线共识研讨会，以确立临床试验中PD相关腹膜炎的核心结局指标。
来自12个国家的总共53名参与者，包括18名患者及护理人员，参与了本次研讨会的分组讨论。对会议记录进行了主题分析。我们确定了以下3个主题：（i）在不同环境中的可行性和适用性，这反映了在资源有限的环境中实施基于实验室的测量方法存在困难；（ii）确保有效性，包括尽量减少假阳性结果并考虑症状的特异性；（iii）对患者有意义且切实可行，这意味着该指标应易于解释，反映症状对患者的影响，并通过规范透析单位之间腹膜炎的报告来提高透明度。
PD相关腹膜炎的核心结局指标应包括基于症状和基于实验室的标准。因此，国际腹膜透析学会（ISPD）对腹膜炎的定义是可接受的。然而，在无法进行实验室确诊的情况下，应考虑报告疑似腹膜炎病例。该指标应涵盖自导管插入时起的所有感染情况，并记录感染率和无腹膜炎患者的数量。具有这些特征的核心结局指标将增强临床试验对接受PD治疗患者的护理和决策的影响。
