A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical...

Area of Science:

• Neurology
• Spinal Cord Injury Research
• Clinical Trial Methodology

Background:

• Degenerative cervical myelopathy (DCM) affects 1 in 50 adults, presenting a significant challenge in spinal cord injury research.
• Lack of standardized guidance leads to inconsistent outcome selection in DCM studies, hindering comparability and data interpretation.
• A consensus-driven minimum data set is crucial for addressing these limitations in DCM research.

Purpose of the Study:

• To develop a standardized minimum data set for Degenerative Cervical Myelopathy (DCM) research.
• To establish a Core Outcome Set (COS), Core Data Elements (CDE), and Core Measurement Set (CMS) for DCM clinical trials.
• To improve the quality, comparability, and reporting of data in DCM studies.

Main Methods:

• A multi-phase modified Delphi process involving international stakeholders was employed.
• The process included defining outcomes, data elements, and measurement tools through consensus meetings and systematic literature reviews.
• The final minimum data set was integrated into template clinical research forms (CRFs) for trial implementation.

Main Results:

• A comprehensive minimum data set for DCM research was successfully developed.
• The final Core Outcome Set (COS) includes 28 outcomes across 6 domains, and the Core Data Elements (CDE) comprise 32 outcomes across 4 domains.
• Four key outcome instruments (mJOA, NDI, SF-36v2, SAVES2) were identified for the Core Measurement Set (CMS), with specific recommendations for post-surgical outcome assessment.

Conclusions:

• The AO Spine RECODE-DCM initiative has produced a vital minimum data set for current DCM clinical trials.
• The developed COS and CDE are expected to have lasting relevance in DCM research.
• Future updates to the CMS may be necessary to accommodate evolving measurement tools and research focusing on non-surgical patient cohorts.