Inclusion, delivery, assessment, and outcomes in longitudinal research on sleep disturbance and agitation in TBI-rehabilitation: lessons learned and future considerations

ABSTRACT

Purpose

This article presents some issues for consideration before scaling from a pilot study to a larger investigation in longitudinal observational studies of traumatic brain injury (TBI) rehabilitation.

Materials and methods

We present a case to discuss protocol improvements in longitudinal TBI-rehabilitation studies. The case was a pilot study conducted at two university hospitals in Denmark investigating 1-year outcomes related to sleep disturbance and agitation during neurointensive care. We included patients with moderate and severe TBI determined by the Glasgow Coma Scale, sleep disturbance was assessed using actigraphy, and agitation was assessed using the Agitated Behavior Scale.

Results

Patients (n = 29) were more severely ill and had poorer six-month outcomes in Eastern vs. Western Denmark. Recovery was similar at one-year follow-up. Protocol improvements were needed in relation to inclusion criteria, intervention delivery, patient assessment, and follow-up outcomes.

Conclusion

In TBI-rehabilitation studies, we suggest adding the severity of disease score to the initial GCS score and a delirium detection score to the ABS score. Actigraphy should not be used during deep sedation. Established procedures should be in place along all stages of the study protocol, including preparation and periodic assessment of study nurses to optimize data quality.

KEYWORDS:

• Agitation
• outcomes research
• rehabilitation
• sleep disturbance
• traumatic brain injury

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author statement

Substantial contributions to the conception, acquisition, analysis, and interpretation of data were made by all authors. The paper was drafted by IE and revised for critically important intellectual content by all authors. All authors approved the version to be published and are accountable for all aspects of the work.