Clinical Perspective on Core Outcome Sets in Chronic Kidney Disease Trials: A Web-Based Survey Study

Introduction: Clinical trials are crucial for medical advancements, with Core Outcome Sets (COS) proving to be an important tool for reducing variability and standardizing outcome measurements. Given the high prevalence and severe complications of Chronic Kidney Disease (CKD), utilizing COS in CKD research can lead to more effective preventative and therapeutic measures. This study aims to understand the adoption of COS within the CKD research community, identify potential barriers and improvements, and provide insights for future strategies to maximize the quality and comparability of CKD trial outcomes.

Methods: The participants comprised of clinical trial professionals who have been involved in CKD 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 Core Outcome Sets (COS) in CKD 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 project, our data will offer insights into how clinical trialists use and comprehend the COS. The knowledge obtained from this research may act as the groundwork for future initiatives and interventions aimed at enhancing the utilization of COS among clinical trialists. These outcomes may promote standardization in clinical COS reporting, ultimately improving patient outcomes with CKD.