What is a Pragmatic Trial?

Pragmatic trials often test treatments in real-world clinical settings and day-to-day care. The pragmatic design decreases cost, burden, and patient exclusion. Using a pragmatic design allows all patients to participate in a trial, including patients who would otherwise be excluded from traditional clinical trials(e.g., due to illness).

Pragmatic trials test safe, simplified procedures within routine care. Care providers and patients are aware of the allocated therapy (open label), and questions can be answered by the patients care team. Pragmatic trials can run without the need for complex traditional consent processes, additional patient visits, or extensive data collection. Pragmatic trials may use existing data sources, such as ICES, to answer important trial questions.

Why use a pragmatic approach in nephrology?

Maintenance hemodialysis provides a life-saving treatment for approximately 3 million patients with end-stage kidney disease worldwide (25,000 in Canada) however, the quality of life for these patients can be poor, and often their life expectancy can be short – approximately 3 years after diagnosis, on average. Often, patients on hemodialysis die due to cardiovascular causes, rather than kidney failure.

Nephrology conducts the fewest clinical trials of any medical discipline, despite there being no shortage of promising treatments that warrant testing. Trials that are conducted often fail to provide conclusive evidence because they use small and unrepresentative participant sample sizes, missing data, and poor adherence to allocated interventions. As a result, hemodialysis care is largely based on expert opinion rather than robust trial-based scientific evidence. As health care costs and our need for more efficient and informed health care grow, we must search for innovative ways to conduct clinical trials.

What makes Dial-Mag Trial pragmatic?

Large-scale randomized controlled trials generate tangible evidence to improve patient outcomes and health care provision. Our team, with support from CIHR, provincial health authorities, Canadian dialysate suppliers, and others, has focused on advancing trial-based scientific evidence in a large-scale, cost-effective manner by embedding the trial into routine care, thus reducing the burden on patients and health care providers. Randomizing entire dialysis units allows all patients to participate in the trial, resulting in more impactful results. With the use of routinely collected administrative data we can follow and analyze patient outcomes without the need for onsite research staff.