Peritoneal dialysis access outcomes reported in randomized controlled trials: A systematic review

2020 ◽  
pp. 089686082096689
Author(s):  
Mohamed Elbokl ◽  
Bogdan Momciu ◽  
Teruko Kishibe ◽  
Matthew J Oliver ◽  
Jeffrey Perl
Keyword(s):  
Peritoneal Dialysis ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Dialysis Access ◽  
Comparative Effect ◽  
Insertion Technique ◽  
Flow Restriction ◽  
Randomized Controlled ◽  
Central Registry ◽  
Definition Of

Background: Functional peritoneal dialysis (PD) access is critical to the success of PD therapy. The aim of this review is to describe the spectrum of definitions and methods employed in the measurement of unique outcomes across PD access trials particularly focusing on the outcomes of PD access flow restriction and operative-related outcomes. Methods: Using Cochrane CENTRAL registry, MEDLINE, and EMBASE, we searched for studies restricted to randomized controlled trials (RCTs) involving interventions related to PD access without restrictions on age, language, or publication year. Studies were screened and data abstracted by two independent reviewers. Definitions, outcome measures, and time points of measurements were captured and documented separately. Unique combinations of these variables resulted in reporting the different ways of measurements. Results: Of the 1768 screened studies, 47 RCTs were included among which 817 PD access outcomes were grouped into 7 broad categories. Interventions evaluated in the RCTs were catheter type/configuration ( n = 17), insertion technique ( n = 15), multiple interventions ( n = 3), and other (6 interventions, n = 12). PD access flow restriction (a subcategory of mechanical outcomes) and operative-related outcomes were reported in 91% and 58% of the included trials, respectively. Tip migration was the most frequently reported flow restriction outcome (59% of RCTs) followed by catheter dysfunction (23% of RCTs). Of the components utilized in definition of flow restriction, description of the impaired flow was reported in 37% of RCTs, need for intervention in 42% of RCTs, and presumed etiology of flow restriction in 60% of RCTs. Conclusion: Variability exists in the definitions, reporting methods, choice of outcomes, and analysis of the PD access outcomes across RCTs. Operative-related outcomes remain underreported across RCTs. Outcomes relating to PD access flow restriction were the most common complications reported in the included RCTs but were reported heterogeneously with variability in reporting of the three key components of its definition including description and severity of the flow restriction, the need for intervention and etiology of flow restriction. In the future, defining PD access flow restriction should include all of these components to better evaluate the comparative effect of various PD access interventions.

scholarly journals Impact of icodextrin on clinical outcomes in peritoneal dialysis: a systematic review of randomized controlled trials

2013 ◽  
Vol 28 (7) ◽  
pp. 1899-1907 ◽  
Author(s):  
Yeoungjee Cho ◽  
David W. Johnson ◽  
Sunil Badve ◽  
Jonathan C. Craig ◽  
Giovanni F.K. Strippoli ◽  
...  
Keyword(s):  
Systematic Review ◽  
Peritoneal Dialysis ◽  
Randomized Controlled Trials ◽  
Clinical Outcomes ◽  
Controlled Trials ◽  
Randomized Controlled

Randomized controlled trials

2020 ◽  
pp. 187-218
Author(s):  
Sube Banerjee ◽  
Rod S. Taylor ◽  
Jennifer Hellier
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Key Factors ◽  
Randomized Controlled ◽  
Study Population ◽  
Primary Hypothesis ◽  
Definition Of

This chapter on randomized controlled trials (RCTs) considers some of the key factors in the design, conduct, analysis, and interpretation of RCTs. The chapter provides an overview of what constitutes an RCT and why they are needed. The chapter also provides an overview of the major practical elements of the design and conduct of RCTs, including undertaking a background review of literature, the need for formulation of a clear primary hypothesis and objective, selection and definition of the study population, collecting outcomes at baseline and follow-up, and appropriate methods of statistical analysis and inference. The chapter concludes with a consideration of the need for clinical trial units, complex interventions, and alternative RCT designs.

scholarly journals Effects of ACEIs and ARBs on the Residual Renal Function in Peritoneal Dialysis Patients: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Lei Ding ◽  
Jingjuan Yang ◽  
Lizhu Li ◽  
Yi Yang
Keyword(s):  
Renal Function ◽  
Peritoneal Dialysis ◽  
Randomized Controlled Trials ◽  
Active Control ◽  
Meta Analysis ◽  
Residual Renal Function ◽  
Control Group ◽  
Controlled Trials ◽  
Active Control Group ◽  
Randomized Controlled

Background. In peritoneal dialysis (PD) patients, whether angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) could protect residual renal function is still controversial. To assess the effects of ACEIs and ARBs on the residual renal function and cardiovascular (CV) events in peritoneal dialysis patients, we performed a meta-analysis of randomized controlled trials. Materials and Methods. We searched PubMed, EMBASE, the Cochrane Library, the CNKI database, and the Wanfang database for relevant articles from database inception to November 30, 2019. Randomized controlled trials were included. The primary outcome was the decline in the residual renal function (RRF). Results. Thirteen trials with 625 participants were included in the meta-analysis. The average residual GFR declined by 1.79 ml/min per 1.73 m2 in the ACEI/ARB group versus 1.44 ml/min per 1.73 m2 in the placebo or active control group at 3 mo. The average residual GFR declined by 2.02 versus 2.06, 2.16 versus 2.72, and -0.04 versus 2.74 ml/min per 1.73 m2 in the placebo or active control group at 6 months (mo), 12 mo, and 24 mo, respectively. The decline in residual GFR showed a significant difference between the ACEI/ARB group and the placebo or active control group at 12 mo (MD=−0.64 ml/min per 1.73 m2; 95% CI: -0.97~-0.32; I2=44%; P<0.0001). No significant difference was observed in Kt/V, urinary protein excretion, weekly creatinine clearance, CV events, or serum potassium levels. Conclusions. In the present study, we found that the use of ACEIs and ARBs, especially long-term treatment, decreased the decline of RRF in patients on PD. ACEIs and ARBs do not cause an additional risk of side effects.

scholarly journals Randomized Controlled Trials for Comparison of Laparoscopic Versus Conventional Open Catheter Placement in Peritoneal Dialysis Patients: A Meta-Analysis

2020 ◽  
Author(s):  
Mei-Lan Sun ◽  
Yong Zhang(Former Corresponding Author) ◽  
Bo Wang ◽  
Tean Ma ◽  
Hong Jiang ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Catheter Placement ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Large Sample Size ◽  
Advantages And Disadvantages ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Aim: The application of laparoscopic catheterization technology in peritoneal dialysis (PD) patients has recently increased. However, the advantages and disadvantages of laparoscopic versus conventional open PD catheter placement are still controversial. The aim of this meta-analysis is to assess the complications of catheterization in PD patients and to provide a reference for choosing a PD-catheter placement technique in the clinic.Methods: We searched numerous databases, including Embase, PubMed, CNKI and the Cochrane Library, for published randomized controlled trials (RCTs).Results: Eight relevant studies (n=646) were included in the meta-analysis. The pooled results showed a lower incidence of catheter migration (OR: 0.42, 95% CI: 0.19 to 0.90, P: 0.03) and catheter removal (OR: 0.41, 95% CI: 0.21 to 0.79, P: 0.008) but a higher incidence of bleeding (OR: 3.25, 95% CI: 1.18 to 8.97, P: 0.02) with a laparoscopic approach than with a conventional approach. There was no significant difference in the incidence of omentum adhesion (OR: 0.32, 95% CI: 0.05 to 2.10, P: 0.24), hernia (OR: 0.38, 95% CI: 0.09 to 1.68, P: 0.20), leakage (OR: 0.69, 95% CI: 0.38 to 1.26, P: 0.23), intestinal obstruction (OR: 0.96, 95% CI: 0.48 to 1.91, P: 0.90) or perforation (OR: 0.95, 95% CI: 0.06 to 15.42, P: 0.97). The statistical analysis showed no significant difference in early (OR: 0.44, 95% CI: 0.15 to 1.33, P: 0.15) , late (OR: 0.89, 95% CI: 0.41 to 1.90, P: 0.76) or total (OR: 0.68, 95% CI: 0.42 to 1.12, P: 0.13) peritonitis infections between the 2 groups, and there are no no significant difference in early ( OR: 0.39, 95% CI: 0.06 to 2.36, P: 0.30), late ( OR: 1.35, 95% CI: 0.78 to 2.33, P: 0.16) or total ( OR: 1.20, 95% CI: 0.71 to 2.02, P: 0.17) tunnel or exit-site infections between the 2 groups.Conclusion: Laparoscopic catheterization and conventional open catheter placement in PD patients have unique advantages, but laparoscopic PD catheterization may be superior to conventional open catheter placement. However, this conclusion needs to be confirmed with further large-sample-size, multi-centre, high-quality RCTs.

Conditional copula models for correlated survival endpoints: Individual patient data meta-analysis of randomized controlled trials

2021 ◽  
pp. 096228022110463
Author(s):  
Takeshi Emura ◽  
Casimir Ledoux Sofeu ◽  
Virginie Rondeau
Keyword(s):  
Randomized Controlled Trials ◽  
Individual Patient Data ◽  
Controlled Trials ◽  
Kendall’S Tau ◽  
Kendall's Tau ◽  
Randomized Controlled ◽  
Conditional Copula ◽  
Survival Endpoints ◽  
Definition Of ◽  
Meta Analyses

Correlations among survival endpoints are important for exploring surrogate endpoints of the true endpoint. With a valid surrogate endpoint tightly correlated with the true endpoint, the efficacy of a new drug/treatment can be measurable on it. However, the existing methods for measuring correlation between two endpoints impose an invalid assumption: correlation structure is constant across different treatment arms. In this article, we reconsider the definition of Kendall's concordance measure (tau) in the context of individual patient data meta-analyses of randomized controlled trials. According to our new definition of Kendall's tau, its value depends on the treatment arms. We then suggest extending the existing copula (and frailty) models so that their Kendall's tau can vary across treatment arms. Our newly proposed model, a joint frailty-conditional copula model, is the implementation of the new definition of Kendall's tau in meta-analyses. In order to facilitate our approach, we develop an original R function condCox.reg(.) and make it available in the R package joint.Cox ( https://CRAN.R-project.org/package=joint.Cox ). We apply the proposed method to a gastric cancer dataset (3288 patients in 14 randomized trials from the GASTRIC group). This data analysis concludes that Kendall's tau has different values between the surgical treatment arm and the adjuvant chemotherapy arm ( p-value<0.001), whereas disease-free survival remains a valid surrogate at individual level for overall survival in these trials.

Operationalizing the Concept of “Immobility” for Better Targeting of Thromboprophylaxis in Medical Patients: How the Literature Falls Short.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 968-968
Author(s):  
Laura Desrosiers ◽  
Susan R. Kahn ◽  
Jessica Emed
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Medical Patients ◽  
Exclusion Criteria ◽  
Vte Prophylaxis ◽  
Randomized Controlled ◽  
Thrombosis Risk ◽  
Pharmacologic Thromboprophylaxis ◽  
Definition Of ◽  
Current Guidelines

Abstract Background: Venous thromboembolism (VTE) is one of the most common, serious and preventable complications in hospitalized medical patients. Based on data from randomized trials, current guidelines recommend that pharmacologic thromboprophylaxis be administered to such patients until they are ambulatory, as immobility is a significant VTE risk factor. Hence, assessment of the ambulatory status of hospitalized patients is a key element in (1) identifying risk of VTE; and (2) decision-making regarding when to initiate and when to discontinue VTE prophylaxis. Audits continue to show low rates of thromboprophylaxis in medical patients, which could be due in part to difficulties operationalizing the terms “ambulatory” and “immobile” in the clinical setting. Clearer definitions of these terms could improve practitioners’ adherence to thromboprophylaxis guidelines. Objectives: We conducted a systematic review of trials of thromboprophylaxis in hospitalized medical patients to characterize how ambulation and immobility were defined and operationalized, and for what purpose. Methods: Pubmed and CINHAL electronic databases were searched up to August 2007 for randomized controlled trials of VTE prophylaxis in medical patients, including patients with stroke. Articles retrieved were hand-searched to identify additional trials. Definitions of “immobility”, “mobility”, “bedridden”, “bedrest”, and “confined to bed/chair” were extracted, and how the concept of mobility/immobility was used was documented. Results: Seventeen randomized controlled trials were retrieved. All studies provided definitions of the concept of “ambulation”, “mobility” or “immobility”, however definitions varied widely across studies. Twelve studies defined the concept in terms of time (definition of “ambulatory” ranged widely from <20 hours/day spent in bed, to >28 days of full “mobilizing”), 2 studies defined the concept in terms of distance (e.g. ambulatory if able to walk 10 meters), 14 studies defined the concept in terms of degree of activity (e.g. “ambulatory” if not confined to bed/chair; or if able to walk autonomously) and 11 studies used definitions that combined time or distance with degree of activity. Overall, only 11/17 studies used definitions that were clearly operationalized and could be objectively replicated. In terms of how the concept of mobility was utilized, 16 studies used the concept in inclusion or exclusion criteria, of which 11 studies provided clearly operationalized definitions; 5 studies used the concept to guide treatment (e.g. “continue treatment until patient is ambulatory”), of which 4 provided clearly operationalized definitions; and 7 studies discussed mobility in the study’s results or conclusions (e.g. “prophylaxis is appropriate in all immobilized patients”), of which 5 provided clear and operationalized definitions. Conclusions: Although all trials of VTE prophylaxis in medical patients provided definitions of the concept of mobility/immobility, there was a marked lack of consistency of such definitions across trials, many definitions could not be readily operationalized by a practitioner in clinical practice and the purpose for using mobility as a concept differed greatly among trials. In order to help clinicians better assess thrombosis risk and thereby use thromboprophylaxis more consistently in hospitalized medical patients, further research is needed to define, standardize and operationalize the concept of mobility/immobility in such patients.

scholarly journals Definition of infection after fracture fixation: A systematic review of randomized controlled trials to evaluate current practice

Injury ◽  
2018 ◽  
Vol 49 (3) ◽  
pp. 497-504 ◽  
Author(s):  
WJ. Metsemakers ◽  
K. Kortram ◽  
M. Morgenstern ◽  
T.F. Moriarty ◽  
I. Meex ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Fracture Fixation ◽  
Current Practice ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Definition Of
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