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
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. ,   on behalf of the AO SPINE RECODE-DCM Steering Committee and AO Spine RECODE DCM Community
Published: August 2024

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.