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Observational Study
. 2022 Jul 1;5(7):e2220969.
doi: 10.1001/jamanetworkopen.2022.20969.

Comparative Effectiveness of Diversion of Cerebrospinal Fluid for Children With Severe Traumatic Brain Injury

Michael J Bell  1 , Bedda L Rosario  2 , Patrick M Kochanek  3 , P David Adelson  4 , Kevin P Morris  5 , Alicia K Au  3 , Michelle Schober  6 , Warwick Butt  7 , Richard J Edwards  8 , Jerry Zimmerman  9 , Jose Pineda  10 , Truc M Le  11 , Nathan Dean  1 , Michael J Whalen  12 , Anthony Figaji  13 , James Luther  2 , Sue R Beers  14 , Deepak K Gupta  15 , Jessica Carpenter  16 , Sandra Buttram  4 , Stephen R Wisniewski  2 ; Approaches and Decisions for Acute Pediatric TBI (ADAPT) Investigators
Collaborators, Affiliations
Observational Study

Comparative Effectiveness of Diversion of Cerebrospinal Fluid for Children With Severe Traumatic Brain Injury

Michael J Bell et al. JAMA Netw Open. .

Erratum in

  • Errors in Abstract and Main Text Results.
    [No authors listed] [No authors listed] JAMA Netw Open. 2022 Aug 1;5(8):e2232865. doi: 10.1001/jamanetworkopen.2022.32865. JAMA Netw Open. 2022. PMID: 36044225 Free PMC article. No abstract available.

Abstract

Importance: Diversion of cerebrospinal fluid (CSF) has been used for decades as a treatment for children with severe traumatic brain injury (TBI) and is recommended by evidenced-based guidelines. However, these recommendations are based on limited studies.

Objective: To determine whether CSF diversion is associated with improved Glasgow Outcome Score-Extended for Pediatrics (GOS-EP) and decreased intracranial pressure (ICP) in children with severe TBI.

Design, setting, and participants: This observational comparative effectiveness study was performed at 51 clinical centers that routinely care for children with severe TBI in 8 countries (US, United Kingdom, Spain, the Netherlands, Australia, New Zealand, South Africa, and India) from February 2014 to September 2017, with follow-up at 6 months after injury (final follow-up, October 22, 2021). Children with severe TBI were included if they had Glasgow Coma Scale (GCS) scores of 8 or lower, had intracranial pressure (ICP) monitor placed on-site, and were aged younger than 18 years. Children were excluded if they were pregnant or an ICP monitor was not placed at the study site. Consecutive children were screened and enrolled, data regarding treatments were collected, and at discharge, consent was obtained for outcomes testing. Propensity matching for pretreatment characteristics was performed to develop matched pairs for primary analysis. Data analyses were completed on April 18, 2022.

Exposures: Clinical care followed local standards, including the use of CSF diversion (or not), with patients stratified at the time of ICP monitor placement (CSF group vs no CSF group).

Main outcomes and measures: The primary outcome was GOS-EP at 6 months, while ICP was considered as a secondary outcome. CSF vs no CSF was treated as an intention-to-treat analysis, and a sensitivity analysis was performed for children who received delayed CSF diversion.

Results: A total of 1000 children with TBI were enrolled, including 314 who received CSF diversion (mean [SD] age, 7.18 [5.45] years; 208 [66.2%] boys) and 686 who did not (mean [SD] age, 7.79 [5.33] years; 437 [63.7%] boys). The propensity-matched analysis included 98 pairs. In propensity score-matched analyses, there was no difference between groups in GOS-EP (median [IQR] difference, 0 [-3 to 1]; P = .08), but there was a decrease in overall ICP in the CSF group (mean [SD] difference, 3.97 [0.12] mm Hg; P < .001).

Conclusions and relevance: In this comparative effectiveness study, CSF diversion was not associated with improved outcome at 6 months after TBI, but a decrease in ICP was observed. Given the higher quality of evidence generated by this study, current evidence-based guidelines related to CSF diversion should be reconsidered.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Rosario reported receiving grants from University of Pittsburgh during the conduct of the study. Dr Edwards reported receiving personal fees from Integra and BBraun, and serving on a scientific advisory board for Microbot Medical outside the submitted work. Dr Zimmerman reported receiving grants Immunexpress and personal fees from Elsevier outside the submitted work. Dr Whalen reported receiving personal fees from Springer Publishing outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participant Recruitment Flowchart
Participants were stratified based on decisions regarding cerebrospinal fluid (CSF) diversion and were enrolled prior to obtaining consent for outcomes. ICP indicates intracranial pressure.
Figure 2.
Figure 2.. Intracranial Pressure (ICP) Response Between Groups
Dots indicate individual data points; lines, trends. CSF indicates cerebrospinal fluid.
See this image and copyright information in PMC

Comment in

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