Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents

2020 ◽  
Vol 35 (2) ◽  
pp. 187-190
Author(s):  
Masahiro Tohkin ◽  
Yoshiro Saito ◽  
Satomi Yagi ◽  
Kunihito Asano ◽  
Keiko Maekawa ◽  
...  
2012 ◽  
Vol 18 (3) ◽  
pp. 50
Author(s):  
Maria G. Tanzi
Keyword(s):  

2018 ◽  
Vol 02 (03) ◽  
pp. 169-183
Author(s):  
Sharath Kumar G G ◽  
Chinmay Nagesh

AbstractAppropriate patient selection and expedient recanalization are the mainstay of modern management of acute ischemic stroke (AIS). Only a minority of patients (7–15%) of patients are eligible for endovascular therapy. Patient selection may be time based or perfusion based. Central to both paradigms is the selection of a patient with a small core, a significant penumbra that can be differentiated from areas of oligemia. A brief review of patient selection methods is presented. Endovascular thrombectomy techniques using stentrievers or aspiration catheters have now become the treatment of choice for AIS with large vessel occlusion. A range of devices, each with its own advantages and disadvantages, are available in the market for the neurointerventionist to choose. Techniques vary between devices and between operators, but standardization and protocolization are important within each center. Complications must be anticipated to be avoided. Once reperfusion is achieved, outcomes must be safeguarded with competent postprocedure management to prevent secondary brain injury. These aspects are reviewed in this article.


Neurosurgery ◽  
2019 ◽  
Vol 86 (1) ◽  
pp. 14-18
Author(s):  
Christopher E Louie ◽  
Erin D’Agostino ◽  
Alexander Woods ◽  
Timothy Ryken

Abstract There is inadequate neurosurgical literature discussing appropriate clinical study design. Here, we explore considerations for 2 fundamental study designs of epidemiology: experimental and observational cohort studies, through examples of theoretical yet realistic neurosurgical research questions. By examining 2 common neurosurgical procedures—namely, subdural drains for evacuation of chronic subdural hematoma, and the utility of navigation for placing external ventricular drains—we characterize the framework of cohort study models for clinical research applications.


2018 ◽  
Vol 32 (6) ◽  
pp. 2789-2801 ◽  
Author(s):  
Aalok K. Kacha ◽  
Sarah L. Nizamuddin ◽  
Junaid Nizamuddin ◽  
Harish Ramakrishna ◽  
Sajid S. Shahul

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Wafi Bibars ◽  
Amelia K Boehme ◽  
Sheryl Martin-Schild ◽  
James C Grotta ◽  
...  

Background and Objective: Recent RCTs have failed to show benefit of intra-arterial therapy (IAT). We sought to determine whether these trials have affected the views and practice of IAT amongst stroke-treating physicians. Methods: An international web-based survey was sent to 753 stroke-treating physicians across the globe. Results: 322 physicians responded (43% rate); 25% were interventionalists; 80% practice in 24/7 IAT capable centers (fig 1). IAT volume per year prior to the RCTs (fig 2) has now decreased according to nearly half of the respondents. Physicians are now more selective (59%) while a third made no changes in pursuing IAT and 6% “do not pursue IAT anymore” (fig 3). Although 76% still perceive IAT is effective under certain criteria, two thirds said they feel “less obligated” to offer IAT. When asked about the RCTs, respondents felt the devices were outdated (36%), patient selection methods were “not optimal” (32%), recanalization rates could have been better (25%) or the trials should have been better designed (20%). Interestingly, centers currently enrolling in IAT trials intervene on large proportions of patients outside of studies (fig 4). The single most important factor in patient selection is shown in fig 5. Over half prefer a CT modality for patient selection; while 16% chose MRI and 11% use clinical criteria only when deciding to pursue IAT. Finally, three quarters of the contributors said that patients should be taken to IAT only in the context of clinical trials to test its efficacy, 21% said IAT should be continued “outside of trials” and only 3% pronounced it not useful (fig 6). Conclusion: While the results of recent RCTs have changed the views of stroke treating physicians, IAT continues to be practiced worldwide. The majority of our respondents is more selective and awaits results of new trials with the stent retrievers and better selection methods. Despite endorsing the practice of IAT only within trials, over half are still treating cases outside studies.


1997 ◽  
Vol 31 (3) ◽  
pp. 655-663 ◽  
Author(s):  
Rafe M. J. Donahue ◽  
Stephen J. Ruberg

2018 ◽  
pp. 41-51
Author(s):  
Richard B. North ◽  
Jane Shipley
Keyword(s):  

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