Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process

Area of Science:

• Neurology
• Pediatric Stroke Research
• Clinical Trial Design

Background:

• Paucity of data from randomized controlled treatment trials in childhood arterial ischemic stroke.
• Need for structured consensus to guide future research in pediatric stroke.

Purpose of the Study:

• To identify and plan a randomized controlled trial for childhood arterial ischemic stroke using a Delphi consensus process.
• To establish consensus on trial design, inclusion/exclusion criteria, and treatment protocols.

Main Methods:

• Delphi consensus process involving Australian, New Zealand, and European pediatric neurologists.
• Four rounds of surveys conducted via REDCap (Research Electronic Data Capture) web application.
• Panel ranked potential trial areas, focusing on aspirin vs. aspirin plus steroids for focal arteriopathy.

Main Results:

• Eight important and feasible trial research areas were identified.
• Aspirin vs. aspirin plus steroids in focal arteriopathy emerged as the highest-ranked trial (31/43 neurologists).
• Consensus reached on trial design, inclusion/exclusion criteria, data collection, and treatment protocols among 43/44 respondents.

Conclusions:

• The Delphi consensus process is an efficient method for identifying and planning pediatric stroke trials.
• An international, multicenter trial for childhood arterial ischemic stroke is now in preparation.