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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 Publisher Pubmed



Davies BM1, 2 ; Yang X1 ; Khan DZ3, 4 ; Mowforth OD1, 2 ; Touzet AY5 ; Nouri A1, 6 ; Harrop JS7 ; Aarabi B8 ; Rahimimovaghar V9 ; Kurpad SN10 ; Guest JD11 ; Tetreault L12 ; Kwon BK13 ; Boerger TF10 Show All Authors
Authors
  1. Davies BM1, 2
  2. Yang X1
  3. Khan DZ3, 4
  4. Mowforth OD1, 2
  5. Touzet AY5
  6. Nouri A1, 6
  7. Harrop JS7
  8. Aarabi B8
  9. Rahimimovaghar V9
  10. Kurpad SN10
  11. Guest JD11
  12. Tetreault L12
  13. Kwon BK13
  14. Boerger TF10
  15. Rodriguespinto R14, 15
  16. Furlan JC16
  17. Chen R17
  18. Zipser CM18
  19. Curt A18
  20. Milligan J19
  21. Kalsirayn S20
  22. Sarewitz E2
  23. Sadler I2
  24. Blizzard T2
  25. Treanor C2
  26. Anderson D21
  27. Fallah N22
  28. Hazenbiller O23
  29. Salzman C2
  30. Zimmerman Z2
  31. Wandycz AM2
  32. Widdop S2
  33. Reeves M2
  34. Raine R2
  35. Ryan SK16
  36. Malone A24
  37. Gharooni A1
  38. Wilson JR25
  39. Martin AR26
  40. Fehlings MG25
  41. Mcnair AGK27
  42. Kotter MRN1, 2

Source: PLoS Medicine Published:2024


Abstract

Background 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. Methods and findings 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). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. Conclusions 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. © 2024 Davies et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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