Population Characteristics in Randomized Trials for HDF

In this study, Krister Cromm, Senior Director of Person-Centered Outcomes Research, and Ngoc Pham, Manager of Person-Centered Outcomes Research, set out to answer a very practical and important question in dialysis care: Do patients included in randomized controlled trials (RCT) for hemodiafiltration (HDF) actually reflect the patients we treat in everyday clinical practice?

We already know from the CONVINCE randomized trial that HDF reduces all-cause mortality compared with conventional guideline-based hemodialysis and that it also improves patient reported outcomes, including health-related quality of life. However, a key challenge remained: RCTs are often criticized for enrolling selected patient populations. This matters because treatment recommendations should only change if trial results are relevant to real-world patients.

Using a rigorous and multi-step methodological approach, researchers found substantial overlap between patients enrolled in RCTs for HDF and those treated with HDF in real-world registries. Some differences were expected; for example, trials included fewer patients with diabetes and a higher proportion of fistula access. But importantly, these differences were not large enough to suggest that trial populations were fundamentally unrepresentative.

Watch the Research in Brief below and explore the full findings published in the Clinical Journal of the American Society of Nephrology: Characteristics of Populations Included in Randomized Controlled Trials of Hemodiafiltration and Registry Real-Life Populations: A Systematic Review.