In clinical research, information is recorded to monitor and evaluate care. However, unless there is consistency across research, information can be difficult to interpret or use. Research may also fail to measure critical aspects of the disease, which can limit its impact.
This is the case in Degenerative Cervical Myelopathy (DCM), where information is inconsistent . According to people living with the disease, research has often not captured the full effects of DCM [2, 3, 4]. A solution is to agree a “minimum dataset” — a list of information that should be recorded as a minimum in all research, including how it should be reported.
If all future studies, as a minimum, capture a core aspect of the disease in a consistent manner, this brings many benefits. For example,
The minimum dataset was a key component of the AO Spine RECODE-DCM project [1, 9]. A combination of systematic reviews [5, 6, 7], qualitative interviews [2, 3, 4], Delphi process , and two final virtual consensus meetings using a robust, global, stakeholder-centric process with a broad representation of healthcare professionals and individuals living with DCM, led to the following recommendations:
These are also available for investigators as template clinical research forms here.
In combination with the Top 10 priorities, the minimum dataset will accelerate research that improves the outcomes that matter most to patients. See Dr Benjamin Davies’ presentation to the International Spinal Cord Society 2021, to see further context.
More Information About the Minimum Dataset
Discover Why and How the Minimum Dataset Was Established
“Outcomes” are the effects of a disease we are trying to change; they are typically measured at multiple time points. However, studies also record other information, which is important to interpret those outcomes. We refer to these as other “data elements”. Consistency across both categories is essential to ensure that research can be interpreted efficiently.
The AO Spine RECODE-DCM group scoped numerous outcomes and data elements, and each was categorised according to importance: core, important but not core, or definitely not core. Through this process, the group developed a list of “core outcomes” and “core data elements”.
The group also scoped and decided on the optimal measurement tools to measure the core outcomes. They evaluated the measurement properties of these tools: their quality, their popularity, their feasibility to use (i.e. not too onerous on the patient) and how relevant they were to the core outcomes.
The newly established minimum dataset, in combination with the top ten priorities, and a definition for the index term, can accelerate research findings and improve outcomes that matter most to all stakeholders.
Dr Mark Kotter Reminds Us Why It Is Imperative to Listen to the Perspectives of the People Living with DCM when Deciding which Outcomes of the Condition Are the Most Important to Measure
Measuring What Matters: Spine Surgeon Dr Alex Vaccaro Urges Scientists to Now Adopt this Core Outcome Set in Their Research
None of this would have been possible without the support of AO Spine. We wholeheartedly thank them for kickstarting this important initiative.