Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)—a list of key outcomes—and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further “how” these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research.
The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS
Study Protocol: Davies BM, Yanez Touzet A, Mowforth OD, Lee KS, Khan D, Furlan JC, et al. Development of a core
measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine
RECODE-DCM CMS). BMJ Open. 2022; 12(6):e060436. Epub 20220609. https://doi.org/10.1136/
bmjopen-2021-060436 PMID: 35680260
This study defines a COS, CDE, and CMS for DCM research.
ContributorsBenjamin M. Davies, Xiaoyu Yang, Danyal Z. Khan, Oliver D. Mowforth, Alvaro Y. Touzet, Aria Nouri, James S. Harrop, Bizhan Aarabi, Vafa Rahimi-Movaghar, Shekar N. Kurpad, James D. Guest, Lindsay Tetreault, Brian
K. Kwon, Timothy F. Boerger, Ricardo Rodrigues-Pinto, Julio C. Furlan, Robert Chen, Carl M. Zipser, Armin Curt, James Milligan, Sukhivinder Kalsi-Rayn, Ellen Sarewitz, Iwan Sadler, Tammy Blizzard, Caroline Treanor, David Anderson, Nader Fallah, Olesja Hazenbiller, Carla Salzman, Zachary Zimmerman, Anne M. Wandycz, Shirley Widdop, Margaret Reeves, Rye Raine, Sukvinder K. Ryan, Ailish Malone, Ali Gharooni, Jefferson R. Wilson, Allan R. Martin, Michael G. Fehlings, Angus G. K. McNair, Mark R.N. Kotter
Disease Category: Neurology
Disease Name: Cervical degenerative myelopathy (CDM)
Age Range: 18
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Patient/ support group representatives
- COS for clinical trials or clinical research
- Consensus conference
- Delphi process
- Systematic review
Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes
and data elements and formation into domains. Phase 3 prioritised the outcomes and core
data elements using a two-stage Delphi process. Phase 4 determined the final DCM minimal
data set using a consensus meeting. Using the COS, Phase 5 created definitions of the measurement construct for each outcome. Phase 6 undertook a systematic review of the literature, to
define the psychometric properties of currently used measurement tools. Phase 7 used a
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modified Delphi process to inform the short-listing of candidate measurement tools. The final
measurement set was formed using a consensus meeting (Phase 8). This included recommendations on the timing of assessments, which was supported by an expert review of recovery trajectories after surgery based on predefined and existing data sets. To support implementation,
the CMS and CDE were then integrated into template clinical research forms (CRFs) for use in
future clinical trials (Phase 9).