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

Abstract

Aim: There is a paucity of data from randomized controlled treatment trials in childhood arterial ischaemic stroke. Our objectives were to identify and plan a trial through use of a Delphi consensus process. Method: The Delphi panel consisted of Australian, New Zealand, and European paediatric neurologists with interests in childhood stroke. Four rounds were conducted using a REDCap (Research Electronic Data Capture) Web-based application: the first consisted of open-ended questions; the second evaluated agreement for the most important trial; the third and fourth reached consensus on design. Results: Forty-seven out of 66 neurologists answered the first round. Eight areas of research for important and feasible trials were identified. In the second round, 43 paediatric neurologists ranked the three highest rated trials: (1) aspirin versus aspirin plus steroids in focal arteriopathy (n=31); (2) heparin versus aspirin (n=6); and (3) heparin versus aspirin versus modern anticoagulation (n=6). The third and fourth surveys reached consensus among 43 out of 44 respondents on design of the highest ranked trial, and allowed agreement on inclusion/exclusion criteria, clinical/neuroimaging data, and treatment protocols. Conclusion: The Delphi consensus process is an efficient method of identifying and planning paediatric stroke trials. An international, multicentre trial is now in preparation.