Yvelynne Kelly, MD
Nephrology
PGY-9
October 10, 2018
Last Fall I was privileged to become a recipient of a
prestigious Brigham and Women’s Hospital Centers of Expertise Quality and
Safety Research Award for my proposed randomized controlled trial comparing
tunneled dialysis catheter to non-tunneled dialysis catheter use for renal
replacement therapy in the intensive care unit. I have long had a passion for critical
care nephrology and had seen first hand the difficulties that can arise with
temporary dialysis catheter use for emergent renal replacement therapy. My
mentor, Dr. Mallika Mendu, and I decided that the time was well overdue for a
high quality randomized trial to give an evidence-based answer as to whether
the complication rate with randomization to non-tunneled dialysis catheter use
is greater than that associated with tunneled dialysis catheter insertion.
This was my first foray into designing and initiating a
randomized controlled trial. What a journey it has been…and, in a sense, we
have not yet really begun. We met with interventional nephrologists and
critical care nephrologists to bring about a trial design that would be
feasible and sufficiently powered to answer our research question. We
registered the trial with www.clinicaltrials.gov. I
updated my Good Clinical Practice certification. We applied for a $100,000
grant, got amazing feedback, and then, at the last hurdle, the organization
decided that they were not interested in a study that focuses on acute kidney
injury, as opposed to chronic kidney disease. Still we continue to battle
through the grant minefield… In a sense, however, the greatest obstacle has
been getting IRB approval. This finally came through in September 2018 after
six months of preparing and submitting three different iterations. Like grant
writing itself, gaining ethical approval follows a learning curve of honing and
refining critical thinking and writing. In the case of IRB approval, however,
it serves as a timely reminder of the need to be truly patient-focused, both as
clinicians and researchers. One of my stumbling blocks, in particular, was
producing a patient consent form that was, in retrospect, far too detailed and
medically orientated. I was more interested in telling them every single little
thing that could happen, in complete detail, rather than providing a broad
overview and simplifying/clarifying language in a manner that would have been
beneficial to all involved.
Here’s the take-home point for now, until the trial starts
in earnest and all opportunities for learning begin to multiple exponentially: we
need to focus on our patients; their wants, needs, fears and frailties. That
way, we can shrink the paperwork and apply ourselves more fully to the true
task in hand – providing safe, efficacious and quality care for those whom we
serve.
