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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.

Study designNarrative review.ObjectiveThe current review aimed to describe the role of existing techniques and emerging methods of imaging and electrophysiology for the management of degenerative cervical myelopathy (DCM), a common and often progressive condition that causes spinal cord dysfunction and significant morbidity globally.MethodsA narrative review was conducted to summarize the existing literature and highlight future directions.ResultsAnatomical magnetic resonance imaging (MRI) is well established in the literature as the key imaging tool to identify spinal cord compression, disc herniation/bulging, and inbuckling of the ligamentum flavum, thus facilitating surgical planning, while radiographs and computed tomography (CT) provide complimentary information. Electrophysiology techniques are primarily used to rule out competing diagnoses. However, signal change and measures of cord compression on conventional MRI have limited utility to characterize the degree of tissue injury, which may be helpful for diagnosis, prognostication, and repeated assessments to identify deterioration. Early translational studies of quantitative imaging and electrophysiology techniques show potential of these methods to more accurately reflect changes in spinal cord microstructure and function.ConclusionCurrently, clinical management of DCM relies heavily on anatomical MRI, with additional contributions from radiographs, CT, and electrophysiology. Novel quantitative assessments of microstructure, perfusion, and function have the potential to transform clinical practice, but require robust validation, automation, and standardization prior to uptake.

Study designLiterature Review (Narrative).ObjectiveTo propose a new framework, to support the investigation and understanding of the pathobiology of DCM, AO Spine RECODE-DCM research priority number 5.MethodsDegenerative cervical myelopathy is a common and disabling spinal cord disorder. In this perspective, we review key knowledge gaps between the clinical phenotype and our biological models. We then propose a reappraisal of the key driving forces behind DCM and an individual's susceptibility, including the proposal of a new framework.ResultsPresent pathobiological and mechanistic knowledge does not adequately explain the disease phenotype; why only a subset of patients with visualized cord compression show clinical myelopathy, and the amount of cord compression only weakly correlates with disability. We propose that DCM is better represented as a function of several interacting mechanical forces, such as shear, tension and compression, alongside an individual's vulnerability to spinal cord injury, influenced by factors such as age, genetics, their cardiovascular, gastrointestinal and nervous system status, and time.ConclusionUnderstanding the disease pathobiology is a fundamental research priority. We believe a framework of mechanical stress, vulnerability, and time may better represent the disease as a whole. Whilst this remains theoretical, we hope that at the very least it will inspire new avenues of research that better encapsulate the full spectrum of disease.

BackgroundDegenerative cervical myelopathy (DCM) involves spinal cord compression, which causes neurological decline. Neurological impairment in DCM is variable and can involve complex upper limb dysfunction including loss of manual dexterity, hyperreflexia, focal weakness, and sensory impairment. The modified Japanese Orthopaedic Association (mJOA) score relies on the patients' subjective perceptions, whereas existing objective measures such as strength and sensory testing do not capture subtle changes in dexterity and function.Objective1) To characterize arm and hand function in DCM; and 2) To develop and validate Graded Redefined Assessment of Strength, Sensibility, and Prehension Version-Myelopathy (GRASSP-M), a clinical assessment that quantifies upper limb impairment.MethodsA total of 148 DCM patients (categorized into mild, moderate, and severe based on mJOA grade) and 21 healthy subjects were enrolled. A complete neurological exam, the mJOA, the QuickDASH, grip dynamometry, and the GRASSP-M were administered.ResultsStrength, sensation, and manual dexterity significantly declined with increasing DCM severity (P ≤ .05). Impairment in hand dexterity showed better discrimination between mild, moderate, and severe DCM categories than strength or sensation. The GRASSP-M was found to be both a reliable (intraclass correlation coefficient >0.75 for intra- and inter-rater reliability) and valid (with both concurrent and construct validity) tool.ConclusionThese results demonstrate that patients' subjective reporting of functional status, especially in the mild DCM category, may underrepresent the extent of functional impairment. The GRASSP-M is an objective tool designed to characterize patients' functional impairment related to the upper limb, which proves useful to diagnose and quantify mild dysfunction, monitor patients for deterioration, and help determine when patients should be treated surgically.

Background and purpose Methods Results Conclusion In 1916, Hans H. G. Queckenstedt (1876–1918) was the first to describe a test aimed at detecting spinal cerebrospinal fluid (CSF) space obstruction through lumbar CSF pressure measurements in paraplegic patients. For this test, bilateral jugular vein compression was applied during lumbar puncture and consecutive changes in lumbar CSF pressure were then observed. Findings were rated as normal, or indicative of incomplete or complete spinal block. This test, known as Queckenstedt's test, became widely adopted and further developed in the field.This systematic literature review provides an overview of the milestones in research using Queckenstedt's test.Clinical research involving Queckenstedt's test was widely disseminated across the globe. In 1922, the proof of concept for Queckenstedt's test was provided by James B. Ayer (1882–1963) through simultaneous cisternal and lumbar CSF pressure measurements. He found that the cisternal (in contrast to lumbar) pressure remained responsive in cases with spinal block. The test was further refined up until the 1960s, and was considered a routine diagnostic procedure for testing of spinal canal obstruction. Developments in non‐invasive spinal computed tomography and magnetic resonance imaging led to a significant decline in interest in Queckenstedt's test, and the test eventually disappeared from textbooks and clinical routine. However, at the beginning of the 21st century there was renewed interest in revealing the biomechanical properties of the CSF through advanced recording and computational techniques to complement spinal imaging.Spine and spinal cord physicians should be familiar with Queckenstedt's test, which not only represented a milestone in spinal diagnostics, but provided a physiological framework for the appreciation of spinal cord compression that is still valid today. [ABSTRACT FROM AUTHOR]

Study designThis is a focused review article.ObjectivesThis review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified.MethodsThe methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review.ResultsCOAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered.ConclusionsWith an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA.SponsorsCraig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.