There are an estimated 14,000 randomized trials published in chronic
kidney disease. The most frequently reported outcomes are biochemical endpoints,
rather than clinical and patient-reported outcomes including cardiovascular
disease, mortality, and quality of life. While many trials have focused on
optimizing kidney health, the heterogeneity and uncertain relevance of outcomes
reported across trials may limit their policy and practice impact. The
international Standardized Outcomes in Nephrology (SONG) Initiative was formed
to identify core outcomes that are critically important to patients and health
professionals, to be reported consistently across trials. We convened a SONG
Implementation Workshop to discuss the implementation of core outcomes.
Eighty-two patients/caregivers and health professionals participated in plenary
and breakout discussions. In this report, we summarize the findings of the
workshop in two main themes: socializing the concept of core outcomes, and
demonstrating feasibility and usability. We outline implementation strategies
and pathways to be established through partnership with stakeholders, which may
bolster acceptance and reporting of core outcomes in trials, and encourage their
use by end-users such as guideline producers and policymakers to help improve
patient-important outcomes.
IntroductionEnd-stage kidney disease (ESKD) is a major public health problem affecting more than 2 million people worldwide. It is one of the most severe chronic non-communicable diseases. Haemodialysis (HD) is the most common therapeutic option but is also associated with a risk of cardiovascular events, hospitalisation and suboptimal quality of life. Over the past decades, haemodiafiltration (HDF) has become available. Although high-dose HDF has shown some promising survival advantage compared to conventional HD, the evidence remains controversial. A Cochrane systematic review found, in low-quality trials, with various convective forms of dialysis, a reduction in cardiovascular, but not all-cause mortality and the effects on non-fatal cardiovascular events and hospitalisation were uncertain. In contrast, an individual patient data analysis suggested that high-dose HDF reduced both all-cause and cardiovascular mortality compared to HD. In view of these discrepant results, a definitive trial is required to determine whether high-dose HDF is preferable to high-flux HD. The comparison of high-dose HDF with high-flux HD (CONVINCE) study will assess the benefits and harms of high-dose HDF versus a conventional high-flux HD in adults with ESKD.Methods and analysisThis international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.Ethics and disseminationThe CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.Trial registration numberNetherlands National Trial Register (NTR 7138).
Haemodiafiltration (HDF) provides a greater removal of larger solutes and protein-bound compounds than conventional high-flux haemodialysis (HD). There are indications that the patients receiving the highest convection volumes of HDF result in an improved survival compared with HD. However, the comparative efficacy of HDF vs HD remains unproven. Here we provide a comparative account of the methodology and aims of ‘the comparison of high-dose HDF with high-flux HD’ (CONVINCE) study in the context of the totality of evidence and how this study will contribute to reaching a higher level of certainty regarding the comparative efficacy of HDF vs HD in people with end-stage kidney disease (ESKD).
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