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

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....

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Published in:PLoS medicine 2024-08, Vol.21 (8)
Main Authors: Davies, Benjamin M, Yang, Xiaoyu, Khan, Danyal Z, Mowforth, Oliver D, Touzet, Alvaro Y, Nouri, Aria, Harrop, James S, Aarabi, Bizhan, Rahimi-Movaghar, Vafa, Kurpad, Shekar N, Guest, James D, Tetreault, Lindsay, Kwon, Brian K, Boerger, Timothy F, Rodrigues-Pinto, Ricardo, Furlan, Julio C, Chen, Robert, Zipser, Carl M, Curt, Armin, Milligan, James, Kalsi-Rayn, Sukhivinder, Sarewitz, Ellen, Sadler, Iwan, Blizzard, Tammy, Treanor, Caroline, Anderson, David, Fallah, Nader, Hazenbiller, Olesja, Salzman, Carla, Zimmerman, Zachary, Wandycz, Anne M, Widdop, Shirley, Reeves, Margaret, Raine, Rye, Ryan, Sukvinder K, Malone, Ailish, Gharooni, Ali, Wilson, Jefferson R, Martin, Allan R, Fehlings, Michael G, McNair, Angus G. K, Kotter, Mark R. N
Format: Article
Language:English
Subjects:
Degeneration (Pathology)
Information management
Measurement
Medical research
Medicine, Experimental
Methods
Spinal cord injuries
Spinal diseases
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Summary: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. A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). 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.
ISSN:1549-1277
DOI:10.1371/journal.pmed.1004447