[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45629-45630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19536]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2017-0089]


Systematic Review and Final CDC Guideline on the Diagnosis and 
Management of Mild Traumatic Brain Injury Among Children

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice; availability of final guidance.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), announces the 
availability of the Systematic Review and Final CDC Guideline on the 
Diagnosis and Management of Mild Traumatic Brain Injury Among Children.

DATES: CDC published the final Systematic Review and Final CDC 
Guideline on the Diagnosis and Management of Mild Traumatic Brain 
Injury Among Children on September 4, 2018 in JAMA Pediatrics.

FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center 
for Injury Prevention and Control, Centers for Disease Control and 
Prevention, 4770 Buford Highway NE, Mailstop F-63, Atlanta, Georgia 
30341. Telephone: (770) 488-4694; email: [email protected].

SUPPLEMENTARY INFORMATION: On September 29, 2017, CDC published a 
notice in the Federal Register announcing the opening of a docket to 
obtain public comment on a Systematic Review of the evidence on the 
diagnosis, prognosis, and management of pediatric mild traumatic brain 
injury (mTBI), and an evidence-based Guideline that offers clinical 
recommendations for healthcare providers (82 FR 45588). CDC also 
provided an opportunity for public comments during the National Center 
for Injury Prevention and Control's Board of Scientific Counselors 
meeting on September 7, 2016 (81 FR 49657).
    The Systematic Review and Guideline were developed through a 
rigorous process guided by the American Academy of Neurology 
methodology and 2010 National Academy of Sciences methodology for the 
development of evidence-based guidelines. An extensive review of the 
scientific literature, spanning 25 years of research, formed the basis 
of the Guideline.
    The goal of the CDC Guideline is to help healthcare providers take 
action to improve the health of their pediatric patients with mTBI. The 
Guideline consists of 19 clinical recommendation sets that cover 
diagnosis, prognosis, and management and treatment. These 
recommendations are applicable to healthcare providers working in 
inpatient, emergency, primary, and outpatient care settings. CDC 
received comments on the draft Systematic Review and Guideline from two 
external peer reviewers:
    [ballot] Both provided references for literature that was published 
following the close of the literature review period for the Guideline 
and Systematic Review. Both reviewers requested details about 
definitions of terms such as mTBI and concussion and how they are 
similar or different.
    [ballot] Other comments focused on how an existing consensus 
statement on sports-related concussion aligns with CDC recommendations; 
lack of information available on children who never seek medical 
attention to highlight this current information gap; and specificity of 
the recommendations for clinicians in the acute care and outpatient 
settings.
    CDC also received 10 public comments from professional 
organizations, academia, and the public:
    [ballot] Five were from medical and clinical professional 
organizations. These groups shared their perspective on diagnosis and 
treatment of mTBI and how specialty groups are affected differently.
    [ballot] Two were from community members and parents sharing their 
support of the work.

[[Page 45630]]

    [ballot] One was from a commenter who did not provide an 
affiliation. The commenter shared concerns regarding how the level of 
evidence was graded.
    [ballot] One was from a healthcare provider who shared citations 
for consideration.
    [ballot] One was from an advocacy group that provided a comment 
outside the scope of the docket.
    A summary of the revisions made to the final Systematic Review and 
Guideline based on external peer reviewer comments are posted in the 
Supporting Documents section of the docket (document titled ``Ped mTBI 
Guideline Response to Peer Reviewer Comments'').
    CDC also revised the document based on public comments. For 
example, a few commenters expressed concern regarding recommendations 
not being applicable in the emergency care setting. As the clinical 
recommendations in the guideline were created for both the acute care 
and primary care setting, CDC added language to emphasize that the 
recommendations were drafted to be relevant for both settings. As 
another example, multiple comments were received regarding the content 
in the systematic review on the use of CT imaging. Commenters explained 
that current evidence that provides the basis for CT imaging focus on 
ruling out clinically-important traumatic brain injury among pediatric 
patients presenting with a TBI. In response, CDC revised the conclusion 
to specify that the recommendations are for children presenting with 
mTBI versus TBI of all severity levels in the acute care setting. All 
public and peer reviewer comments were carefully reviewed and 
considered to strengthen and improve the quality of the Systematic 
Review and Guideline. The final Systematic Review and Guideline on the 
Diagnosis and Management of Mild Traumatic Brain Injury Among Children 
can be found at https://jamanetwork.com/journals/jamapediatrics/fullarticle/2698456?guestAccessKey=80a9ecdc-ea57-447d-a1b3-b4a87cadd40d 
(Guideline) and https://jamanetwork.com/journals/jamapediatrics/fullarticle/2698455?guestAccessKey=24b78e3d-571f-49fb-9daf-499d2b3e2cc1 
(Systematic Review).

    Dated: September 5, 2018.
Lauren Hoffmann,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-19536 Filed 9-7-18; 8:45 am]
 BILLING CODE 4163-18-P