Tuesday, January 29, 2013

To Recruit or Not to Recruit for a Clinical Trial by Sal Cruz–Flores

Ms. J. M. arrived at the emergency room about 11 A.M. in the morning with stroke symptoms in the left side of her body. According to routine procedure with these patients our services were called via the “code stroke” system, to expedite her evaluation. She was a 65 year–old woman who the last time she was seen normal was about 7 A.M. the same morning. This fact is important as the only approved specific therapy for ischemic stroke is intravenous thrombolysis, which has to be administered within three hours from symptom onset or from the last time the patient was seen normal. To get to this point the patient has to be promptly evaluated to establish the time of onset, the severity of the stroke, exclude any contraindications for the use of thrombolysis and have a CT scan performed. All these steps were completed expeditiously but she was not a candidate for the approved treatment as she was clearly beyond the window of opportunity.

On evaluation Ms. J. M. seemed to be suffering a severe stroke affecting a large volume of the right hemisphere of her brain which causes very disabling impairment among survivors. The mortality of this condition is about 30% but might be higher if they develop brain swelling which occurs in many of these patients. The common scenario in most hospitals is that these patients do not receive thrombolysis and are admitted to the hospital for supportive care to avoid complications and start physical and rehabilitation services.

The options and the scenario change in a hospital like the one I practice in as there are more specific options than routine care otherwise offers. One option is the use of invasive interventions aimed at “de–clotting” the occluded intracranial vessel with devices inserted endovascularly through the femoral artery and navigated up to the occluded vessel within the skull. The rationale to use such devices is promulgated on the idea that opening the vessel increases the chance of having a good outcome by limiting the size of the stroke. The use of these devices was approved by the FDA as they are effective in opening the blood vessels however, the devices have not been shown to improve the outcome of stroke. The use of these devices has increased in the last few years and the increase use seems to parallel the appearance of a DRG code that permits the payment for the treatment. Suffice to say the payment for hospitals is considerable per procedure and therefore, they stand to gain financially from these procedures. Despite the uncertainty surrounding the use of these devices many of us feel that the use is justified considering the bad outcome many of these patients have when left untreated.

A second option available in our institution is the voluntary participation in clinical trials aimed at proving whether an intervention improves the outcome of the stroke. These interventions in some trials include the use of intravenous medications and in other trials, the use of the same intra–arterial devices that can be used outside a trial because they have been approved for another purpose (that of opening vessels). Most of these trials require the initiation of treatment usually within 6–8 hours depending on the specific study. Since Ms. J. M. presented within four hours from the last time she was seen normal, it was clear that she was not eligible to received intravenous thrombolysis but was eligible to be treated with an endovascular intervention or to participate in one of the clinical trials.

With these issues in mind my colleagues and I, but particularly myself, started struggling with what was the best decision for Ms. J. M. Why is it that we were struggling? For one, my colleagues were interventionalists and tended to favor the use of the endovascular devices. On the other hand, I was the physician in charge of her care, but I was also the principal investigator in these clinical trials testing treatments for stroke. It was obvious I also had a conflict of interests as I could potentially stand to gain from participation and recruitment of individuals into the trials and those conflict areas included professional prestige and perhaps some financial benefit. So what was best for this patient?

It is clear the patient had a devastating disease that was beyond the window of opportunity for the approved therapy and she could, on the one hand, have been treated with an intervention that might have potentially helped her, although this was yet uncertain, and in addition the hospital and my colleagues stood to benefit professionally and financially from performing the procedure. On the other hand, she could have been signed up for a clinical trial from which she might not have any personal benefit but might help answer a question about the efficacy of a treatment for a stroke victim, however, I stood to gain professional or financial benefit from her participation in the clinical trial.

We firmly believe that in the presence of clinical equipoise, if available, participation in clinical trials should be offered to patients and families, but then again whose equipoise anyway? In our special circumstance how could we approach somebody to participate in a clinical trial testing the efficacy of a device in improving the outcome of stroke and then turn around and say that we could treat him or her with the same device outside the clinical trial?

While disclosing potential conflicts of interests might be useful for these patients and their families, that still may not be helpful to them as they struggle with how much to trust the person presenting the information. Then there is the added issue of how the information is presented, which is known to influence the decision makers.

As I struggled with this decision, the decision, thankfully, was made for me. We could not find a person who could give consent on behalf of the patient and therefore, we could not offer her participation in the trial. This brings up an additional issue; how is it that we could invoke emergency treatment and justify the treatment with the device anyway? In the end, we did not treat her with the device as the intracranial vessel that was initially blocked was now open in the diagnostic angiography.

Copyright © 2011 The Johns Hopkins University Press. Narrative Inquiry in Bioethics, volume 1, issue 2. Used with permission.

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