Fitness for Entering a Simple Exercise Program and Mortality: A Study Corollary to the Exercise Introduction to Enhance Performance in Dialysis (Excite) Trial

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Abstract

Background/Aims: In this corollary analysis of the EXCITE study, we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible (n=216) or because eligible but refusing to participate (n=116). Methods: Baseline characteristics and mortality data were recorded. Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses. Results: The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients (21.0 vs. 10.9 deaths/100 persons-year; P<0.001). The crude excess risk of death in non-eligible patients (HR 1.96; 95% CI 1.36 to 2.77; P<0.001) was reduced after adjustment for risk factors which differed in the two cohorts including age, blood pressure, phosphate, CRP, smoking, diabetes, triglycerides, cardiovascular comorbidities and history of neoplasia (HR 1.60; 95% CI 1.10 to 2.35; P=0.017) and almost nullified after including in the same model also information on deambulation impairment (HR 1.16; 95% CI 0.75 to 1.80; P=0.513). Conclusions: Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial. Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population.

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Determinants of Cardiovascular Risk in Haemodialysis Patients: Post hoc Analyses of the AURORA Study

Andreas Schneider, Alan Jardine, Markus P. Schneider … (2013)

Background: Haemodialysis patients are at high risk for cardiovascular (CV) events. The aim of the current study was to characterise the role of traditional and uraemia-specific CV risk factors in this patient population. Methods: A post hoc analysis of the AURORA trial which enrolled 2,776 haemodialysis patients from 280 centres and had a mean follow-up period of 3.2 years. Determinants of CV endpoints (time to major cardiovascular event (MACE), cardiac event, CV death) were identified by univariate Cox regression analysis. Subsequently, independent determinants were identified by multivariate regression analysis. Results: For the primary endpoint MACE (myocardial infarction, stroke and cardiac death), multivariate analysis revealed that independent determinants were: age (hazard ratio (HR) 1.03 per year), serum phosphate level (HR 1.50 per mmol/l), albumin level (HR 0.94 per g/l), years on haemodialysis (HR 1.03 per year), diabetes mellitus (HR 1.38), preexisting coronary heart disease (HR 1.54) and C-reactive protein (CRP) level (HR 1.14 per mg/l). However, conventional risk factors such as smoking, dyslipidaemia, systolic and diastolic blood pressure and pulse pressure had no significant effect. Conclusions : Although we identify CRP, low albumin, and high phosphorus as risk factors for MACE, lowering CRP did not influence MACE outcomes in our trial. Caution is therefore warranted in implying risk factors being causal in end-stage renal disease.

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The quality of reporting in clinical research: the CONSORT and STROBE initiatives.

Carmine Zoccali, Samar Abd ElHafeez, Claudia Torino … (2013)

Inaccurate reporting of data hampers the generalizability and the correct interpretation of results of scientific medical papers. The Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiatives, both included in the Enhancing the Quality and Transparency of Health Research (EQUATOR) international network, have elaborated appropriate guidelines in order to improve the transparence, clearness and completeness of scientific literature. The CONSORT statement consists of a 25 items checklist and a flow-chart diagram which provide guidance to Authors on how to report randomized clinical trials. The STROBE is a checklist of 22 items which should be addressed when observational studies (case-control, cohort and cross-sectional) are made up. Many editorial committees and prestigious international journals have now embraced these guidelines to improve the quality and methodology of their scientific reports.