International surveillance study in acute spinal cord injury confirms viability of multinational clinical trials

BMC Medicine, 2022 · DOI: https://doi.org/10.1186/s12916-022-02395-0 · Published: May 4, 2022

Spinal Cord Injury Neurology Public Health

Simple Explanation

This study looked at data from over 4600 patients with spinal cord injuries over 20 years. The goal was to see if the types of injuries and how well people recovered changed over time. Researchers found the average age of people getting these injuries increased. However, the amount of recovery patients experienced remained the same. An online tool was created that researchers, doctors, and policymakers can use to learn from the study results and help plan future clinical trials.

Study Duration

20 years

Participants

4601 patients with acute SCI

Evidence Level

Observational cohort study

Key Findings

1
The ratio of male to female patients with spinal cord injury remained stable at 3:1 over 20 years.
2
The age at injury significantly shifted from a unimodal to a bimodal distribution, indicating an increase in older individuals sustaining spinal cord injuries.
3
The rate and pattern of neurological and functional recovery remained unchanged throughout the surveillance period, despite the increasing age at injury.

Research Summary

The study aimed to outline the epidemiological landscape of acute spinal cord injury over the last 20 years and provide a benchmark for neurological and functional outcomes. The mean age at injury has been steadily increasing, consistent with an aging general population. However, the rate nor the pattern of neurological and functional recovery has changed since 2001. The study provides a benchmark for expected changes in standardized outcomes after traumatic spinal cord injury, informing the development of future clinical trials.

Practical Implications

Clinical Practice

The study provides real-time clinical practice insights, allowing physicians to provide a reference context to newly injured patients based on similar demographics and injury characteristics.

Clinical Trials

The surveillance data refines patient selection and stratification for future clinical trials targeting neural repair and neural plasticity.

Historical Control Data

Observational data from EMSCI can be implemented as historical control data in clinical trials, potentially replacing a concurrent control and increasing the number of participants exposed to treatment.

Study Limitations

1
The EMSCI database lacks information on mortality.
2
The standard of care after spinal cord injury was not standardized across EMSCI centers.
3
Neither the EMSCI nor the Sygen trial included non-traumatic spinal cord injury, with the exception of ischemic injuries.

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