This study will (a) seek consensus regarding the minimum items required in a children’s trial protocol, (b) develop a plan of research to develop guidelines for researchers on how to implement checklist items, and (c) plan a knowledge translation strategy to disseminate the SPIRIT-C guidelines and to ensure endorsement. By standardizing how researchers conduct trials in children, the SPIRIT-C guidelines may improve the safety, use and impact of clinical research.
The evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalized (available on request). SPIRIT-C Statement and Explanation and Elaboration document will be published in Q2 2021.
Details from the systematic review can be found here: Clyburne-Sherin AVP, Thurairajah P, Kapadia M.Z, Sampson M, Chan WWY, Offringa M (2015). Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews – BMC Trials, 16: 417.
Updated February 2021