1) AO Spine RECODE-DCM
Degenerative Cervical Myelopathy (DCM) has been recognised as a condition for nearly 100 years and, although our understanding of the condition is improving, many critical questions about its treatment remain. People with DCM can play a critical role in providing knowledge and experience to healthcare professionals. Myelopathy.org’s community of people with DCM has very actively participated in delivery of this knowledge, to shape future research agenda.
AO Spine RECODE-DCM (REsearch objectives and COmmon Data Elements for Degenerative Cervical Myelopathy) is a consensus process to improve research efficiency in DCM, through a multi-stakeholder collaboration led by the AO Spine Spinal Cord Injury Knowledge Forum, Cambridge University, and the NIHR James Lind Alliance.
The group recognised that existing DCM research had many shortcomings: studies were duplicated (they repeated the same research question); studies were difficult to generalise (they measured different outcomes, at different time points, using different tools, and failed to account for key baseline determinants); and/or, they studied aspects of the disease that were immaterial to people with lived experience of DCM (the research focus was not aligned with the needs of those living with DCM or caring for someone living with DCM).
AO Spine RECODE-DCM was established to address these shortcomings and accelerate research that changes practise by:
- Establishing the top unanswered research questions, ranked according to priority.
- Establishing a standardised set of baseline characteristics and outcomes that should be measured in DCM research.
- Establishing the index term and its definition.
You can find more information about AO Spine RECODE-DCM.
The AO Spine RECODE-DCM Top 10 Research Priorities
At a consensus meeting in New York in November 2019, the questions below were identified as the Top 10 Priorities for research into Degenerative Cervical Myelopathy (DCM). Now, we hope to inspire researchers around the world to step up to the challenge of addressing these questions.
To stimulate discussion and raise awareness of the priorities, AO Spine launched a podcast series, with one episode per priority, bringing in expert guests including people with lived experience of DCM, surgeons and scientists. Links are included below.
1. Raising Awareness: What strategies can increase awareness and understanding of DCM amongst healthcare professionals and the public? Can these strategies help improve the timely diagnosis and management of DCM?
2. Natural History: What is the natural history of DCM? What is the relationship between DCM and asymptomatic spinal cord compression or canal stenosis? What factors influence the natural history of the disease?
3. Diagnostic Criteria: What are the diagnostic criteria of DCM? What is the role of imaging and when should imaging be used in the assessment of DCM?
4. Assessment and Monitoring: What assessment tools can be used to evaluate functional impairment, disability and quality of life in people with DCM? What instruments, tools or methods can be used or developed to monitor people with DCM for disease progression or improvement either before or after surgical treatment?
6. Rehabilitation: What is the role of rehabilitation following surgery for DCM? Can structured postoperative rehabilitation improve outcomes following surgery for DCM? What are the most effective strategies?
7. Novel Therapies: Can novel therapies, including stem-cell, gene, pharmacological and neuroprotective therapies, improve the health and wellbeing of people living with DCM and slow down disease progression?
8. Socio-Economic Impact: What is the socio-economic impact of DCM? (The financial impact of living with DCM to the individual, their supporters and society as a whole).
9. Imaging Techniques: What is the role of dynamic or novel imaging techniques and neurophysiology in the assessment of DCM?
10. Individualising/Timing of Surgery: Are there clinical and imaging factors that can help a surgeon select who should undergo surgical decompression in the setting of DCM? At what stage of the disease is surgery the preferred management strategy?
The Minimum Data Set
In combination with the Top 10 priorities, the ‘minimum dataset’ will accelerate research that improves the outcomes that matter most to patients. Once again determined via a multi-stakeholder consensus process, in October 2020, the AO Spine RECODE-DCM group agreed upon the core outcomes and data elements that should be measured in all future research to ensure that the studies are robust and comparable.
These results will be published soon. For more information, visit the study.
The Index Term
DCM goes by lots of different names – CSM, OPLL, cervical stenosis, compressive myelopathy, to name a few – and this confusion generates inefficiencies in research and discovery. In October 2020, the AO Spine RECODE-DCM group agreed that the name ‘Degenerative Cervical Myelopathy’ should be given to the disease going forward. This agreement will streamline literature searches and medical databases, reduce research wastage, and expedite the development of diagnostic criteria for the disease.
This is the world’s first regenerative medicine trial for myelopathy. The trial is led by Dr Mark Kotter with Dr Benjamin Davies from the University of Cambridge. The trial will evaluate whether Ibudilast, a phosphodiesterase 3 / 4 inhibitor, can improve recovery after surgical decompression. Ibudilast is currently licensed to treat post-stroke dizziness and asthma in Japan. It has shown preliminary effectiveness in other neurological conditions such as multiple sclerosis. The drug has been well tolerated in the studies.
RECEDE Myelopathy is a phase 3, double blind, randomised controlled trial. It is currently supported by the National Institute for Health Research, United Kingdom, with support from Medicinova.
The trial will soon commence at Cambridge University Hospitals. For further information, please contact the Cambridge Clinical Trials Unit.
On the 1st July 2021, funding commenced on a study led by Dr Mark Kotter and Dr Benjamin Davies to determine the optimal surgical management for certain cases of Degenerative Cervical Myelopathy (DCM).
Surgery on the spine may be performed either from the front (anterior) or from the back (posterior). In the UK, there are two main posterior options: laminectomy alone; and laminectomy and fusion. The choice of surgical procedure, rather than being evidence-based, is currently left to the discretion of the treating surgeon. This leads to variation in practice, with implications for both the patients and the healthcare providers.
The POLYFIX-DCM trial will establish the optimal surgical management, following patients’ functional outcome over 2 years following surgery, as well as other critical measures such as pain, quality of life, and cost-effectiveness.
For further details, please visit their website.
4) DCM COINS
Knowledgeable patients, equipped with the necessary skills and confidence in managing their own health, are more likely to have better clinical outcomes.
Living with a chronic condition usually involves a process of frequent selection between multiple intervention and management options. Too often people with ongoing illnesses find themselves unprepared to take part in decisions regarding treatment, surgical procedures, or adjustments to functional, social and quality of life changes based on their own considered preferences. Many patients do not see a role for themselves in the management of their own health.
In May 2021, Myelopathy.org was awarded an Evelyn Trust Health and Wellbeing Grant to develop the first Core Information Set (CIS) for DCM. CISs represent baseline information intended to facilitate a dialogue between patients and professionals in order for patients to make better value-based decisions about their healthcare when multiple options are available.
During the first step of this work, we conducted a review of the existing educational content sources. Scientific publications, videos, health websites and patient leaflets were included. Our analysis showed that an overwhelming majority (80%) of resources are geared towards professionals, leaving patients with limited resources to improve their knowledge.
Next, we wanted to understand the perspectives and information needs of people with DCM. We conducted and analysed qualitative, semi-structured interviews from twenty people with DCM recruited from the Myelopathy.org Facebook Support Group. Preliminary results indicated critical, wide-ranging knowledge deficiencies on the topics of the condition and its trajectory, pre-and post-operative guidance, finances, employment, and mental health management.
Taken together, our findings to date clearly highlight a patient knowledge gap in the DCM community. Our efforts now turn to addressing the quantity and quality of information made available to people with DCM throughout their patient journey. The next stage of this work will see us building the first diagnosis-stage CISs for DCM.
More to follow on this stage in due course!