Clinical perspective on core outcome sets in stroke trials: A web-based survey study
Frias Perez, Luis ; Major, Joshua ; Bagaruka, Eddy ; Keefer, Kellen ; Compton, Wyatt ; Crotty, Patrick ; Ernst, Zachary ; Chaudhry, Asaad ; Cox, Katherine ; Hughes, Griffin ... show 1 more
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Abstract
Background: Clinical trials are fundamental for advancing medical knowledge, and Core Outcome Sets (COS) serve as a vital tool for reducing variability and in standardizing outcome measurements across various areas of research. Given the widespread prevalence and profound consequences of strokes as the second leading cause of death globally, integrating COS in stroke clinical trials holds promise for more beneficial and efficacious interventions. This study aims to explore the adoption of COS within the stroke research community, identifying limitations and avenues for improvement. The insights gained will guide future efforts to enhance the understanding and applicability of stroke clinical trials.
Methods: The participants comprised of clinical trial professionals who have been involved in stroke trials over the past five years. Investigators reached out to participants via email to distribute a comprehensive web-based survey. The survey, conducted via REDCap, will gather demographic information and assess participant familiarity with COS in stroke clinical trials. The selection of COS was informed by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database. The survey will be open for responses for a duration of eight weeks, with bi-weekly reminders sent via email to encourage participation. Participants will be required to provide informed consent before commencing the survey.
Results: Data is currently in the collection phase of this study. Analysis of survey responses will include: (i) descriptive statistics to summarize patient demographics and responses to close-ended questions, (ii) inferential statistics, such as chi-square tests and t-tests, to identify relationships between variables or differences among subgroups, and (iii) qualitative data, which will undergo thematic analysis to discern recurring themes and patterns.
Conclusion: Upon completion of this endeavor, our data will not only provide new insights into how clinical trialists use and understand COS, but also may serve as the foundation for future initiatives and interventions. These efforts will be aimed at encouraging stroke clinical trialists to integrate COS into their research practices. The resulting outcomes have the potential to promote standardization in the reporting of clinical COS, ultimately enhancing patient outcomes pertaining to stroke patients.