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试验和观察性研究中报告的腹膜透析相关性腹膜炎结局:一项系统评价。

Peritoneal dialysis-associated peritonitis outcomes reported in trials and observational studies: A systematic review.

作者信息

Sahlawi Muthana Al, Wilson Gregory, Stallard Belinda, Manera Karine E, Tong Allison, Pisoni Ronald L, Fuller Douglas S, Cho Yeoungjee, Johnson David W, Piraino Beth, Schreiber Martin J, Boudville Neil C, Teitelbaum Isaac, Perl Jeffrey

机构信息

Division of Nephrology, St. Michael's Hospital and the Keenan Research Center in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.

Department of Internal Medicine, College of Medicine, King Faisal University, Al-Hasa, Saudi Arabia.

出版信息

Perit Dial Int. 2020 Mar;40(2):132-140. doi: 10.1177/0896860819893810. Epub 2020 Jan 17.

DOI:10.1177/0896860819893810
PMID:32063197
Abstract

BACKGROUND

Peritoneal dialysis (PD)-associated peritonitis carries significant morbidity, mortality, and is a leading cause of PD technique failure. This study aimed to assess the scope and variability of PD-associated peritonitis reported in randomized trials and observational studies.

METHODS

Cochrane Controlled Register of Trials, MEDLINE, and Embase were searched from 2007 to June 2018 for randomized trials and observational studies in adult and pediatric patients on PD that reported PD-associated peritonitis as a primary outcome or as a part of composite primary outcome. We assessed the peritonitis definitions used, characteristics of peritonitis, and outcome reporting and analysis.

RESULTS

Seventy-seven studies were included, three were randomized trials. Thirty-eight (49%) of the included studies were registry-based observational studies. Twenty-nine percent ( = 22) of the studies did not specify how PD-associated peritonitis was defined. Among those providing a definition of peritonitis, three components were reported: effluent cell count ( = 42, 54%), clinical features consistent with peritonitis (e.g. abdominal pain and/or cloudy dialysis effluent) ( = 35, 45%), and positive effluent culture ( = 19, 25%). Of those components, 1 was required to make the diagnosis in 6 studies (8%), 2 out of 2 were required in 22 studies (29%), 2 out of 3 in 11 studies (14%), and 3 out of 3 in 4 studies (5%). Peritonitis characteristics and outcomes reported across studies included culture-negative peritonitis ( = 47, 61%), refractory peritonitis ( = 42, 55%), repeat peritonitis ( = 9, 12%), relapsing peritonitis ( = 5, 7%), concomitant exit site ( = 16, 21%), and tunnel infections ( = 8, 10%). Peritonitis-related hospitalization was reported in 38% of the studies ( = 29), and peritonitis-related mortality was variably defined and reported in 55% of the studies ( = 42). Peritonitis rate was most frequently reported as episodes per patient year ( = 40, 52%).

CONCLUSION

Large variability exists in the definitions, methods of reporting, and analysis of PD-associated peritonitis across trials and observational studies. Standardizing definitions for reporting of peritonitis and associated outcomes will better enable assessment of the comparative effect of interventions on peritonitis. This will facilitate continuous quality improvement measures through reliable benchmarking of this patient-important outcome across centers and countries.

摘要

背景

腹膜透析(PD)相关腹膜炎具有较高的发病率和死亡率,是导致PD技术失败的主要原因。本研究旨在评估随机试验和观察性研究中报道的PD相关腹膜炎的范围和变异性。

方法

检索Cochrane对照试验注册库、MEDLINE和Embase,检索时间为2007年至2018年6月,以查找关于成人和儿童PD患者的随机试验和观察性研究,这些研究将PD相关腹膜炎作为主要结局或作为复合主要结局的一部分进行报道。我们评估了所使用的腹膜炎定义、腹膜炎特征以及结局报告和分析。

结果

纳入77项研究,其中3项为随机试验。纳入的研究中有38项(49%)是基于注册库的观察性研究。29%(n = 22)的研究未明确说明如何定义PD相关腹膜炎。在给出腹膜炎定义的研究中,报告了三个组成部分:腹水细胞计数(n = 42,54%)、与腹膜炎一致的临床特征(如腹痛和/或浑浊的透析液)(n = 35,45%)以及腹水培养阳性(n = 19,25%)。在这些组成部分中,6项研究(8%)诊断需要1个组成部分,22项研究(29%)需要2个组成部分,11项研究(14%)需要3个组成部分中的2个,4项研究(5%)需要3个组成部分全部具备。各研究报告的腹膜炎特征和结局包括培养阴性腹膜炎(n = 47,61%)、难治性腹膜炎(n = 42,55%)、复发性腹膜炎(n = 9,12%)复发型腹膜炎(n = 5,7%)、合并出口处感染(n = 16,21%)和隧道感染(n = 8,10%)。38%的研究(n = 29)报告了与腹膜炎相关的住院情况,55%的研究(n = 42)对与腹膜炎相关的死亡率进行了不同的定义和报告。腹膜炎发生率最常报告为每患者年的发作次数(n = 40,52%)。

结论

在不同的试验和观察性研究中,PD相关腹膜炎的定义、报告方法和分析存在很大差异。标准化腹膜炎及相关结局的报告定义将更有助于评估干预措施对腹膜炎的比较效果。这将通过在不同中心和国家对这一重要患者结局进行可靠的基准比较,促进持续质量改进措施。

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