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  • Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS)

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Neurology
Protocol
Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS)
  1. Benjamin M Davies1,
  2. Alvaro Yanez Touzet2,
  3. Oliver D Mowforth3,
  4. Keng Siang Lee4,
  5. Danyal Khan5,
  6. Julio C Furlan6,
  7. Michael G Fehlings7,
  8. James S Harrop8,
  9. Carl Moritz Zipser9,
  10. Ricardo Rodrigues-Pinto10,11,
  11. James Milligan12,
  12. Ellen Sarewitz13,
  13. Armin Curt14,
  14. Vafa Rahimi-Movaghar15,
  15. Bizhan Aarabi16,
  16. Timothy F Boerger17,
  17. Lindsay Tetreault18,19,
  18. Robert Chen20,
  19. James D Guest21,
  20. Sukhvinder Kalsi-Ryan22,
  21. Iwan Sadler13,
  22. Shirley Widdop13,
  23. Angus G K McNair23,24,
  24. Brian K Kwon25,
  25. Mark R N Kotter26,27
  26. on behalf of the AO Spine RECODE-DCM Steering Committee
  1. 1Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
  2. 2School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
  3. 3Department of Academic Neurosurgery, University of Cambridge, Cambridge, UK
  4. 4Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK
  5. 5Academic Neurosurgery Unit, University College London, London, UK
  6. 6Department of Medicine, Division of Physical Medicine and Rehabilitation, University of Toronto, Toronto, Ontario, Canada
  7. 7Division of Neurosurgery and Spinal Program, Toronto Western Hospital, Toronto, Ontario, Canada
  8. 8Thomas Jefferson University, Jefferson Health System, St Louis, Missouri, USA
  9. 9Neurology, University Hospital Balgrist, Zurich, Switzerland
  10. 10Spinal Unit (UVM), Department of Orthopaedics, Centro Hospitalar Universitário do Porto EPE, Porto, Portugal
  11. 11Instituto de Ciências Biomédicas Abel Salazar, Porto, Portugal
  12. 12Family Medicine, McMaster University, Hamilton, Ontario, Canada
  13. 13Myelopathy.org, Cambridge, UK
  14. 14University Hospital Balgrist, Zürich, Switzerland
  15. 15Academic Department of Neurological Surgery, Sina Trauma and Surgery Research Center, Tehran, Iran
  16. 16Division of Neurosurgery, University of Maryland Baltimore, Baltimore, Maryland, USA
  17. 17Neurosurgery, Medical College of Wisconsin, Wauwatosa, Wisconsin, USA
  18. 18Department of Surgery, University of Toronto, Toronto, Ontario, Canada
  19. 19Department of Medicine, University College Cork, Cork, Ireland
  20. 20Neurology, Toronto Western Hospital, Toronto, Ontario, Canada
  21. 21Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA
  22. 22Toronto Rehabilitation Institute, Toronto, Ontario, Canada
  23. 23Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, Avon, UK
  24. 24GI Surgery, North Bristol NHS Trust, Bristol, UK
  25. 25Department of Orthopaedics, University of British Columbia, Blusson Spinal Cord Center, Vancouver, British Columbia, Canada
  26. 26Department of Clinical Neurosurgery, University of Cambridge, Cambridge, UK
  27. 27Department of Clinical Neurosciences, Ann McLaren Laboratory of Regenerative Medicine, Cambridge, UK
  1. Correspondence to Dr Benjamin M Davies; bd375{at}cam.ac.uk

Abstract

Introduction Progress in degenerative cervical myelopathy (DCM) is hindered by inconsistent measurement and reporting. This impedes data aggregation and outcome comparison across studies. This limitation can be reversed by developing a core measurement set (CMS) for DCM research. Previously, the AO Spine Research Objectives and Common Data Elements for DCM (AO Spine RECODE-DCM) defined ‘what’ should be measured in DCM: the next step of this initiative is to determine ‘how’ to measure these features. This protocol outlines the steps necessary for the development of a CMS for DCM research and audit.

Methods and analysis The CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials and the Consensus-based Standards for the selection of health Measurement Instruments. The process involves five phases. In phase 1, the steering committee agreed on the constructs to be measured by sourcing consensus definitions from patients, professionals and the literature. In phases 2 and 3, systematic reviews were conducted to identify tools for each construct and aggregate their evidence. Constructs with and without tools were identified, and scoping reviews were conducted for constructs without tools. Evidence on measurement properties, as well as on timing of assessments, are currently being aggregated. These will be presented in phase 4: a consensus meeting where a multi-disciplinary panel of experts will select the instruments that will form the CMS. Following selection, guidance on the implementation of the CMS will be developed and disseminated (phase 5). A preliminary CMS review scheduled at 4 years from release.

Ethics and dissemination Ethical approval was obtained from the University of Cambridge (HBREC2019.14). Dissemination strategies will include peer-reviewed scientific publications; conference presentations; podcasts; the identification of AO Spine RECODE-DCM ambassadors; and engagement with relevant journals, funders and the DCM community.

  • neurosurgery
  • neurological injury
  • neurological pain
  • neuromuscular disease
  • adult neurology
  • neurology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-060436

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    Footnotes

    • BMD and AYT are joint first authors.

    • Twitter @AYanezTouzet, @angusgkmcnair

    • BMD and AYT contributed equally.

    • Collaborators The members of the AO Spine RECODE-DCM Steering Committee are: Evangeline Howard, Iwan Sadler, Ellen Sarewitz, Delphine Houlton, Julia Carter, Margot Miller, Theresa Brislin, Timothy F Boerger, Carla Salzman, Jillian Polasik, Shirley Widdop, Armin Curt, Sukhvinder Kalsi-Ryan, Anoushka Sing, Julio C Furlan, Chen Robert, Katherine Palmieri, Geno J Merli, James Milligan, Michelle Starkey, Michael G Fehlings, Brian K Kwon, Shekar Kurpad, Bizhan Aarabi, Vafa Rahimi Movaghar, James Harrop, James Guest, Mark R N Kotter, Benjamin M Davies, Jefferson R Wilson and Ricardo Rodrigues-Pinto.

    • Contributors BD was responsible for conceiving the article. AGKM contributed to the study design. BD and AYT wrote the protocol and manuscript and contributed equally to this paper. BK, MGF, MK and IS facilitated international collaboration. BD, AYT, ODM, KSL, DK, JCF, MGF, JSH, CMZ, RR-P, JM, ES, AC, VR-M, BA, TFB, LT, RC, JDG, SK-R, IS, SW, AGKM, MK provided critical appraisal of the manuscript. All authors critically revised and approved the manuscript.

    • Funding This work was supported by AO Spine through the AO Spine Knowledge Forum Spinal Cord Injury, a focused group of international Spinal Cord Injury experts. AO Spine is a clinical division of the AO Foundation, which is an independent, medically guided not-for-profit organisation. Study support was provided directly through the AO Spine Research Department. An award/grant number is not applicable.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.