A new study, beginning in 2023 is set to explore new possibilities in stroke treatments for individuals with a disability.
During clinical research, investigations will aim to control as many variables as possible, which in turn makes it easier to examine the effectiveness of new treatments.
What this does mean, is that strict requirements can lead to only a narrow population of patients being eligible to be enrolled in a trial.
This is something Eva Mistry of the University of Cincinnati highlights that as stroke researchers make strides in the field, traditional approaches has led to a large portion of patients who had a disability pre-stroke being denied trial entry.
She says: “We typically measure improvement related to a stroke treatment based on if the patient’s function got better or back to normal or not.
“You can imagine if your patient starts with a functional disability, they can’t get to excellent function because they have a certain baseline limitation, and we end up excluding these patients.”
Mistry notes that minority patients, older patients and female patients are affected by this current practice due to these groups being statistically more likely to be living with a disability in the US.
Currently guidelines from charities like the American Heart Association and the American Stroke Association recommend that effective treatments should only be given to patients with no history of a pre-stroke disability.
On this, Mistry says: “The clinicians kind of take that as gospel and they hedge and say that we can’t offer this treatment.
“It’s not necessarily because it doesn’t work, but it’s just because we never studied this patient population before.”
Mistry is the principal investigator of this new study, which has received a $9.6 million funding from the Patient Centred Outcomes Research Institute (PCORI).
The main goal of this research is to produce data that describes stroke outcomes among patients with a pre-stroke disability. Almost 30 per cent of patients who have an ischaemic stroke have pre-existing disability.
Mistry says: “We can then offer tools and data to future researchers and scientists such that they don’t reflexively exclude patients based on their baseline disability from any research, and thereby evidence-based clinical care.”
The research team will focus on the effectiveness of thrombectomy, which you can get Dr Sanjeev Nayak’s description of, here.
Over a four year period, approximately 1,100 patients at 12 sites across the US will be enrolled in this study, with researchers comparing outcomes between a subset who received thrombectomy and a subset who did not. Enrolment is projected to begin before the end of 2023.
Mistry says: “We’re going to collect a lot of usual outcomes that we measure for stroke, but also a lot of novel outcomes like granular measurement of their disability and function before and after stroke, the quality of life before and after stroke, their social support and the caregiving burden before and after stroke.”
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