Patients with excellent outcomes can still have substantial deficits that affect their daily lives, researcher say.
After a stroke, a substantial portion patients with excellent outcomes—at least according to their modified Rankin Scale score—may still have deficits in cognitive function, trouble reintegrating into regular life, and symptoms of depression, according to a new study. The authors suggest that a more holistic approach to assessing stroke outcomes is in order.
“There are certainly multiple dimension to how people function and how people think.” Joseph Broderick, MD (University of Cincinnati, Cincinnati, OH), who was not involved in the research, told Neurovascular Exchange. “There are different tools that are more focused on those different domains, but the key issue for Rankin is: is it looking at the whole person over a range and is it detecting a change? Those are the things you want to have in an outcome measure for a trial.”
For their study published early online April 24, 2017, in Stroke, Richard H. Swartz, MD, PhD (Sunnybrook Health Sciences Centre, Toronto, Canada), and colleagues conducted telephone interviews with patients 2 to 3 years after they had experienced a stroke. They sought to assess outcome on multiple levels of functioning, based on the WHO International Classification of Functioning. These comprised body function (Montreal Cognitive Assessment and Patient Health Questionnaire-2); activity (modified Rankin Scale); and participation (Reintegration to Normal Living Index).
Of the 270 patients eligible for the study, 43 were lost to follow-up, 65 declined to participate, and 20 had passed away. This left 142 patients who were interviewed at an average age of 67.6 years. At baseline, there were no significant differences in age, education, mRS score, depressive symptoms, or cognition between those who enrolled and those who either declined or were lost to follow-up.
Ninety-six participants (68%) had an mRS < 2. Yet years after their stroke, 54% of those evaluated showed signs of cognitive impairment, 52% had restrictions in reintegration, and 32% had symptoms of depression. Notably, there were no differences in values on the two body function scores between those who had activity limitations and those who had none.
“It is not surprising that stroke survivors have a high frequency of cognitive impairment, symptoms of depression, or difficulty fully reintegrating to their normal activities,” Swartz told Neurovascular Exchange in an email. “The surprise here is that this study looked at survivors with the best outcomes [mRS < 2] and found that mood and cognitive symptoms were just as common in this group as [in] survivors with more severe functional impairments.”
Rankin Remains Excellent Measure
The findings call into question whether mRS alone is an adequate assessment of poststroke outcomes, but Swartz does not endorse throwing the baby out with the bathwater.
“The mRS will and should continue to be the core outcome measure for acute trials,” he said, adding, “[It] is an excellent general assessment of global functioning and reflects patient-oriented outcomes spanning the range from ‘normal’ to mild impairment to full dependence to death, but it is a simple scale covering this range from normal to death in 7 points. There are many other symptoms (eg, mood, thinking, memory, fatigue/sleep) that impact people’s quality of life, ability to work, and degree of independence that aren’t captured and don’t seem to correlate well with the global measure.”
He did acknowledge that there are limitations to the study. These include attrition, survivor bias, and the fact that follow-up was limited to telephone interviews.
Swartz would like to see future poststroke trials include multiple domains of functioning in combination with the mRS, either by using direct assessments of key individual outcomes, such as those used in this trial, or broader outcome scales, such as the AMC Linear Disability Scale or the Boston University Activity Measure for Post-Acute Care. It would also be beneficial, he added, to evaluate how burden of care affects quality of life for stroke patients’ caregivers.
“In short,” he said, “our study highlights the need for a more holistic approach to outcome assessment that could inform treatment interventions and optimize recovery.”
For his part, Broderick pointed out that the study fails to address whether the deficits uncovered in the patients were present before the stroke occurred. “Stroke is a disease of older people. A lot of people who are older have cognitive impairment,” he said. “The key issue is, is stroke changing the state in a way that the Rankin can’t measure?” This study does not answer that question.
In addition, Broderick noted that the Rankin was used a little bit differently in this study than it is typically. “They looked at activities, but they seem to be focusing on motor activity rather than social activities or job activities,” he explained.
Agreeing in principle that there is room to go beyond the Rankin Scale, Broderick also pointed out that many trials already include these measures. The key, he said, is to select measures judiciously so as not to overwhelm patients.
There is no point in including a measure unless it helps inform care or identifies factors that are meaningful to patients, Broderick stressed, offering the example of the FLAME trial, which is examining the role of fluoxetine in stroke recovery. Since fluoxetine is an antidepressant, this trial must tease out whether the drug’s effects are due solely to relief of depressive symptoms or where it has other independent impacts.
Source:
Kapoor A, Lanctôt, KL, Bayley M, et al. “Good outcome” isn’t good enough: Cognitive impairment, depressive symptoms, and social restrictions in physically recovered stroke patients. Stroke. 2017;Epub ahead of print.
Disclosures:
Swartz and Broderick report no relevant conflicts of interest.
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