Sex and Gender Differences in Stroke and Their Practical Implications in Acute Care / 대한뇌졸중학회지

There are several controversies regarding the role of sex and gender in the pathophysiology and management of acute stroke. Assessing the role of sex, i.e., biological/pathophysiological factors, and gender, i.e., sociocultural factors, in isolation is often not possible since they are closely intertwined with each other. To complicate matters even more, the functional baseline status of women and men at the time of their first stroke is substantially different, whereby women have, on average, a poorer reported/ascertained baseline function compared to men. These differences in baseline variables account for a large part of the differences in post-stroke outcomes between women and men. Adjusting for these baseline differences is difficult, and in many cases, residual confounding cannot be excluded. Despite these obstacles, a better understanding of how patient sex and gender differences influence acute stroke and stroke care pathways is crucial to avoid biases and allow us to provide the best possible care for all acute stroke patients. Disregarding patient sex and gender on one hand and ignoring potential confounding factors in sex- and gender-stratified analyses on the other hand, may cause researchers to come to erroneous conclusions and physicians to provide suboptimal care. This review outlines sex- and gender-related factors in key aspects of acute stroke, including acute stroke epidemiology, diagnosis, access to care, treatment outcomes, and post-acute care. We also attempt to outline knowledge gaps, which deserve to be studied in further detail, and practical implications for physicians treating acute stroke patients in their daily practice.

The Challenge of Designing Stroke Trials That Change Practice: MCID vs. Sample Size and Pragmatism / 대한뇌졸중학회지

Randomized controlled trials (RCT) are the basis for evidence-based acute stroke care. For an RCT to change practice, its results have to be statistically significant and clinically meaningful. While methods to assess statistical significance are standardized and widely agreed upon, there is no clear consensus on how to assess clinical significance. Researchers often refer to the minimal clinically important difference (MCID) when describing the smallest change in outcomes that is considered meaningful to patients and leads to a change in patient management. It is widely accepted that a treatment should only be adopted when its effect on outcome is equal to or larger than the MCID. There are however situations in which it is reasonable to decide against adopting a treatment, even when its beneficial effect matches or exceeds the MCID, for example when it is resource- intensive and associated with high costs. Furthermore, while the MCID represents an important concept in this regard, defining it for an individual trial is difficult as it is highly context specific. In the following, we use hypothetical stroke trial examples to review the challenges related to MCID, sample size and pragmatic considerations that researchers face in acute stroke trials, and propose a framework for designing meaningful stroke trials that have the potential to change clinical practice.