A minimum data set—Core outcome set, core data elements, and core measurement set—For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study

PLOS Medicine, 2024 · DOI: https://doi.org/10.1371/journal.pmed.1004447 · Published: August 22, 2024

Spinal Cord Injury Neurology Research Methodology & Design

Simple Explanation

This study addresses the lack of standardized guidance in clinical research for degenerative cervical myelopathy (DCM). Clinical research studies have selected outcomes at their discretion, which limits comparability between studies. The study defines a minimum data set for DCM research using a multi-stakeholder consensus. This data set includes a core outcome set (COS), core data elements (CDEs), and a core measurement set (CMS). The aim is to improve the quality and comparability of clinical trials in DCM by standardizing the outcomes measured and the sampling characteristics reported. These are available at https://myelopathy.org/minimum-dataset/.

Study Duration

Not specified

Participants

International DCM stakeholder group

Evidence Level

Not specified

Key Findings

1
The final COS includes 28 outcomes and 6 domains: Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events.
2
The final CDE includes 32 outcomes and 4 domains: Individual, Disease, Investigation, and Intervention.
3
The CMS identifies 4 outcome instruments: mJOA, NDI, SF-36v2, and SAVES2, recommending baseline and 6-month postoperative measurements for surgical trials.

Research Summary

This study developed a minimum data set for degenerative cervical myelopathy (DCM) clinical trials, including a core outcome set (COS), core data elements (CDE), and core measurement set (CMS). The COS comprises 28 outcomes across 6 domains, the CDE consists of 32 outcomes within 4 domains, and the CMS recommends using mJOA, NDI, SF-36v2, and SAVES2, with assessments at baseline and 6 months post-surgery. This minimum data set aims to standardize research, improve data comparability, and address key research priorities in DCM, while acknowledging the need for future updates as new measurement tools and research themes emerge.

Practical Implications

Standardized Research

Provides a standardized framework for clinical trials in DCM, enhancing the comparability and quality of research outcomes.

Improved Data

Facilitates aggregate data analysis and meta-analyses, leading to more robust conclusions about DCM treatments and interventions.

Patient-Centered Care

Ensures that research addresses patient priorities and incorporates patient-reported outcomes, leading to more patient-centered care strategies.

Study Limitations

1
The initial CMS focuses on existing instruments, potentially overlooking new tools and those in languages other than English.
2
The selection of one instrument per domain may have overlooked core outcomes.
3
The data set may need to evolve as new instruments arise and as specific research themes increase.

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