What are Pragmatic Trials?
Pragmatic trials often test treatments in real-world clinical settings and day-to-day care. The pragmatic design can decreases cost, burden, and patient exclusion. Using a pragmatic design typically 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 administrative data sources to answer important trial questions.
Why Conduct Pragmatic Trials in Dialysis Clinics?
Maintenance hemodialysis provides a life-saving treatment for over 2 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.
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. Pragmatic Trials can be efficiently “embedded” into dialysis clinics, leveraging existing care, sessions, and personnel. Embedding a trial into dialysis clinics ensures all patients, including those usually excluded from trials, are able to participate.
Pragmatic Features of the Dial-Bicarb Trial
