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BackgroundDegenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM have among the lowest quality of life scores (Short Form Health Survey–36 item [SF-36]) of chronic disease, although the drivers of the imapact of DCM are not entirely understood. DCM research faces a number of challenges, including the heterogeneous reporting of study data. The AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) project is an international consensus process that aims to improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains that represent key aspects of the disease. To facilitate this, we sought to qualitatively explore the context and impact of patient-reported outcomes in DCM on study participants. ObjectiveThe goal of the research was to qualitatively explore the patient-reported outcomes in DCM to improve understanding of patient perspective and assist the organization of outcomes into domains for the consensus process. MethodsFocus group sessions were hosted in collaboration with Myelopathy.org, a charity and support group for people with DCM. A 40-minute session was audiorecorded and transcribed verbatim. Two authors familiarized themselves with the data and then performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun and Clarke’s 6-phase approach. The themes were subsequently reviewed with an independent stakeholder with DCM, assisting in the process of capturing the true context and importance of themes. ResultsFive people with DCM (3 men and 2 women) participated in the focus group session. The median age was 53 years, and the median score on the modified Japanese Orthopaedic Association scale was 11 (interquartile range 9.5-11.5), indicating the participants had moderate to severe DCM. A total of 54 codes were reviewed and grouped into 10 potential themes that captured the impact of the disability on people with DCM: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness and isolation, and social stigma. ConclusionsThis qualitative analysis of the perspectives of people with DCM has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. Continued inclusion of online communities and use of targeted digital software will be important in establishing a consensus-based COS for patients with DCM that is inclusive of all relevant stakeholders including people with DCM.

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.