Understanding the meaning of care trials and why they are essential to good practice: An example from ISAT-2 on ruptured aneurysms

Abstract

Background

The research-care separation encourages clinicians to experiment without methods within the care context and trialists to design studies that may not properly inform practice. Care trials integrated into practice may solve these problems.

Methods

We first discuss clinical decision-making for SAH patients prior to the ISAT trial which compared surgery with coiling, and how the ISAT results changed practices. We then review the ISAT-2 care trial and its impact on practice in the presence of clinical uncertainty.

Results

Historically, ruptured aneurysms were treated with surgical clipping, with endovascular treatment limited to patients judged difficult to clip. ISAT was a turning point when it showed that many patients routinely treated with surgery would have better outcomes with coiling. With the proliferation of new endovascular devices, practices evolved and more patients could be treated endovascularly, but uncertainty regarding best management remained for numerous ruptured aneurysm patients that were not part of ISAT. Practicing under uncertainty, outside of a trial, is like performing research without methods within care. Without a scientific method of assessment, the notion of good surgical care is impossible to define, so ISAT-2 was designed. After 10 years, ISAT-2 remained inconclusive, but because the trial balanced risks for each patient, practicing within ISAT-2 provided the opportunity to realize that trial methods optimized care in real-time, long before conclusive results could be shown.

Conclusion

Care trials are integral to a good clinical practice, whether they provide final results or not. The research-care separation should be revised to encourage care research.