TY - JOUR

T1 - Inclusion, delivery, assessment, and outcomes in longitudinal research on sleep disturbance and agitation in TBI-rehabilitation

T2 - lessons learned and future considerations

AU - Egerod, Ingrid

AU - Poulsen, Ingrid

AU - Langhorn, Leanne

AU - Aadal, Lena

N1 - Publisher Copyright: © 2021 Taylor & Francis Group, LLC.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Agitation

KW - outcomes research

KW - rehabilitation

KW - sleep disturbance

KW - traumatic brain injury

U2 - 10.1080/02699052.2021.1978546

DO - 10.1080/02699052.2021.1978546

M3 - Journal article

C2 - 34550819

AN - SCOPUS:85115311413

VL - 35

SP - 1616

EP - 1623

JO - Brain Injury

JF - Brain Injury

SN - 0269-9052

IS - 12-13

ER -