Reporting and analysis of process-of-care time measures in clinical trials for hyperacute stroke interventions: a scoping review protocol.

Abstract

The objective of this scoping review is to investigate the reporting and comparison of process-of-care time measures in hyperacute stroke trials and systematic reviews of trials (subsequently referred to as "studies"). Stroke is a leading cause of death and disability worldwide. A crucial factor in determining the effectiveness of stroke care in improving patient outcomes is time; therefore, time measures are frequently reported in studies of hyperacute stroke interventions. However, there is inconsistency in how these measures are reported and compared. Furthermore, there is a lack of clarity in how compatible the reporting methods are with the statistical analysis methods. This scoping review will include studies that report and/or compare time measures between key events of interest in the delivery of hyperacute stroke care. Studies of thrombolytic therapy and/or thrombectomy, as well as controlled trials of mobile stroke unit interventions, will be included. The scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the JBI methodology for scoping reviews. The search will be executed in MEDLINE (PubMed), Embase (Ovid), and clinical trial registries ANZCTR, ISRCTN, and ClinicalTrials.gov. Title and abstract screening will be followed by full-text screening and subsequent data extraction from eligible studies. The results from this scoping review will be presented in tables and narratively summarized. Open Science Framework https://osf.io/y98wz.