Developing Core Outcome (Measurement) Sets for Critical Care Research Using the Modified Delphi Method

Abstract

Topic Importance

High-quality core outcome sets (COSs) and core outcome measurement sets (COMSs) can help to optimize research by allowing the results of clinical trials to be compared and combined in systematic reviews. The number of registered COSs and COMSs for critical care research is increasing, and most are developed using the Delphi method. However, the quality of these tools varies substantially.

Review Findings

At least 39 COSs and 10 associated COMSs have been designed for clinical research in critical care and at least 21 ongoing development projects. The Delphi method is the most common method used to foster agreement on the content of a COS or COMS. It is flexible and permits the development process to be tailored to the medical condition and population of interest. However, designing an effective Delphi study requires time and careful deliberation. Clearly defining scope, piloting survey materials, and crafting a consensus process that uses the strengths of each stakeholder group and minimizes loss to follow-up are encouraged. Reporting on COS and COMS development should be sufficiently detailed for readers to understand and critique both the process and the resulting research tool. Established checklists and guidelines are available to assist with both protocol development and peer review of manuscripts reporting on newly generated COSs and COMSs.

Summary

Thorough preliminary work, planning, and reporting increase the likelihood that COSs or COMSs related to critical care will reflect the opinions of knowledgeable stakeholders and will improve the usefulness of clinical trial data.