83_FR_45804 83 FR 45629 - Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children

83 FR 45629 - Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 175 (September 10, 2018)

Page Range45629-45630
FR Document2018-19536

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.

Federal Register, Volume 83 Issue 175 (Monday, September 10, 2018) 
[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45629-45630]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19536]


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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.

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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

Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45629 Registered speakers/organizations will Commissioner Monahan announcing the opening of a docket to be allowed five (5) minutes, and will • Memorial Report—Vice Chair obtain public comment on a Systematic need to provide written copies of their Fountain Review of the evidence on the presentations. Requests to comment, • Fundraising Report—Commissioner diagnosis, prognosis, and management together with presentations for the Sedgwick of pediatric mild traumatic brain injury meeting, must be received by 5:00 p.m. • International Report— (mTBI), and an evidence-based EDT, on Friday, September 28, 2018. Commissioner Seefried Guideline that offers clinical Please contact Mr. Dayton at the email Other Business: recommendations for healthcare address above to obtain meeting • Chairman’s Report providers (82 FR 45588). CDC also materials. provided an opportunity for public Upcoming Meeting Dates FOR FURTHER INFORMATION CONTACT: comments during the National Center Daniel S. Dayton, Designated Federal • January 22, 2019, via phone for Injury Prevention and Control’s Officer, World War 1 Centennial • April 21–22, 2019, Washington, DC Board of Scientific Counselors meeting Commission, 701 Pennsylvania Avenue • July 2019, Kansas City, MO on September 7, 2016 (81 FR 49657). NW, 123, Washington, DC 20004–2608, Motion to Adjourn The Systematic Review and Guideline 202–380–0725 (Note: this is not a toll- Dated: September 4, 2018. were developed through a rigorous free number). Daniel S. Dayton, process guided by the American Designated Federal Official, World War I Academy of Neurology methodology SUPPLEMENTARY INFORMATION: Centennial Commission. and 2010 National Academy of Sciences Background [FR Doc. 2018–19491 Filed 9–7–18; 8:45 am] methodology for the development of The World War One Centennial evidence-based guidelines. An extensive BILLING CODE 6820–95–P Commission was established by Public review of the scientific literature, Law 112–272 (as amended), as a spanning 25 years of research, formed commission to ensure a suitable the basis of the Guideline. DEPARTMENT OF HEALTH AND The goal of the CDC Guideline is to observance of the centennial of World HUMAN SERVICES War I, to provide for the designation of help healthcare providers take action to memorials to the service of members of improve the health of their pediatric Centers for Disease Control and the United States Armed Forces in patients with mTBI. The Guideline Prevention World War I, and for other purposes. consists of 19 clinical recommendation Under this authority, the Committee [Docket No. CDC–2017–0089] sets that cover diagnosis, prognosis, and will plan, develop, and execute management and treatment. These programs, projects, and activities to Systematic Review and Final CDC recommendations are applicable to commemorate the centennial of World Guideline on the Diagnosis and healthcare providers working in War I, encourage private organizations Management of Mild Traumatic Brain inpatient, emergency, primary, and and State and local governments to Injury Among Children outpatient care settings. CDC received organize and participate in activities AGENCY: Centers for Disease Control and comments on the draft Systematic commemorating the centennial of World Prevention (CDC), Department of Health Review and Guideline from two external War I, facilitate and coordinate activities and Human Services (HHS). peer reviewers: throughout the United States relating to b Both provided references for ACTION: Notice; availability of final the centennial of World War I, serve as literature that was published following guidance. the close of the literature review period a clearinghouse for the collection and dissemination of information about SUMMARY: The Centers for Disease for the Guideline and Systematic events and plans for the centennial of Control and Prevention (CDC), located Review. Both reviewers requested World War I, and develop within the Department of Health and details about definitions of terms such recommendations for Congress and the Human Services (HHS), announces the as mTBI and concussion and how they President for commemorating the availability of the Systematic Review are similar or different. centennial of World War I. Notice of this and Final CDC Guideline on the b Other comments focused on how meeting is being provided according to Diagnosis and Management of Mild an existing consensus statement on the requirements of the Federal Traumatic Brain Injury Among sports-related concussion aligns with Advisory Committee Act, 5 U.S.C. App. Children. CDC recommendations; lack of 10(a)(2). information available on children who DATES: CDC published the final never seek medical attention to Agenda Systematic Review and Final CDC highlight this current information gap; Guideline on the Diagnosis and and specificity of the recommendations Tuesday October 2, 2018 Management of Mild Traumatic Brain for clinicians in the acute care and Old Business: Injury Among Children on September 4, outpatient settings. • Acceptance of minutes of last 2018 in JAMA Pediatrics. CDC also received 10 public meeting FOR FURTHER INFORMATION CONTACT: • Public Comment Period comments from professional Arlene I. Greenspan, National Center for organizations, academia, and the public: New Business: • Executive Director’s Report— Injury Prevention and Control, Centers b Five were from medical and Executive Director Dayton for Disease Control and Prevention, clinical professional organizations. daltland on DSKBBV9HB2PROD with NOTICES • 2019 Signature Event Proposals— 4770 Buford Highway NE, Mailstop These groups shared their perspective Executive Director Dan Dayton F–63, Atlanta, Georgia 30341. on diagnosis and treatment of mTBI and • Financial Committee Report— Telephone: (770) 488–4694; email: how specialty groups are affected Commissioner Dunning duipinquiries@cdc.gov. differently. • Education Committee Report— SUPPLEMENTARY INFORMATION: On b Two were from community Commissioner O’Connell September 29, 2017, CDC published a members and parents sharing their • ACE Committee Report— notice in the Federal Register support of the work. 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45630 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices b One was from a commenter who to strengthen and improve the quality of for Children and Families administers did not provide an affiliation. The the Systematic Review and Guideline. the Tribal MIECHV Program while commenter shared concerns regarding The final Systematic Review and HRSA administers the State/Territory how the level of evidence was graded. Guideline on the Diagnosis and MIECHV Program. Tribal MIECHV b One was from a healthcare Management of Mild Traumatic Brain discretionary grants support cooperative provider who shared citations for Injury Among Children can be found at agreements to conduct community consideration. https://jamanetwork.com/journals/ needs assessments; plan for and b One was from an advocacy group jamapediatrics/fullarticle/2698456? implement high-quality, culturally- that provided a comment outside the guestAccessKey=80a9ecdc-ea57-447d- relevant, evidence-based home visiting scope of the docket. a1b3-b4a87cadd40d (Guideline) and programs in at-risk tribal communities; A summary of the revisions made to https://jamanetwork.com/journals/ establish, measure, and report on the final Systematic Review and jamapediatrics/fullarticle/2698455? progress toward meeting performance Guideline based on external peer guestAccessKey=24b78e3d-571f-49fb- measures in six legislatively-mandated reviewer comments are posted in the 9daf-499d2b3e2cc1 (Systematic benchmark areas; and conduct rigorous Supporting Documents section of the Review). evaluation activities to build the docket (document titled ‘‘Ped mTBI Dated: September 5, 2018. knowledge base on home visiting among Guideline Response to Peer Reviewer Lauren Hoffmann, Native populations. Comments’’). Acting Executive Secretary, Centers for The proposed data collection form is CDC also revised the document based Disease Control and Prevention. as follows: In order to continuously on public comments. For example, a few [FR Doc. 2018–19536 Filed 9–7–18; 8:45 am] monitor, provide grant oversight, quality commenters expressed concern BILLING CODE 4163–18–P improvement guidance, and technical regarding recommendations not being assistance to Tribal MIECHV grantees, applicable in the emergency care ACF is seeking to collect services setting. As the clinical DEPARTMENT OF HEALTH AND utilization data on a quarterly basis. The recommendations in the guideline were HUMAN SERVICES Tribal MIECHV Quarterly Data created for both the acute care and Performance Reporting Form, is made primary care setting, CDC added Administration for Children and up of five categories of data—program language to emphasize that the Families capacity, place-based services, family recommendations were drafted to be engagement, staff recruitment and relevant for both settings. As another Proposed Information Collection retention and staff vacancies. This form example, multiple comments were Activity; Comment Request will be used by Tribal MIECHV grantees received regarding the content in the Title: Tribal Maternal, Infant, and that receive grants under the Tribal systematic review on the use of CT Early Childhood Home Visiting Program MIECHV Program to collect data in imaging. Commenters explained that Quarterly Performance Reporting Form. order to determine the caseload capacity current evidence that provides the basis OMB No.: New Collection. grantees are achieving, where services for CT imaging focus on ruling out Description: The Administration for are being delivered, the retention and clinically-important traumatic brain Children and Families (ACF), Office of attrition of enrolled families, and the injury among pediatric patients Child Care, in collaboration with the retention and attrition of program staff presenting with a TBI. In response, CDC Health Resources and Services on a quarterly basis. revised the conclusion to specify that Administration (HRSA), Maternal and Respondents: Tribal Maternal, Infant, the recommendations are for children Child Health Bureau, administers the and Early Childhood Home Visiting presenting with mTBI versus TBI of all Maternal, Infant, and Early Childhood Program Managers. The information severity levels in the acute care setting. Home Visiting (MIECHV) Program, as collection does not include direct All public and peer reviewer comments authorized by Title V, Section 511 of the interaction with individuals or families were carefully reviewed and considered Social Security Act. The Administration that receive the services. ANNUAL BURDEN ESTIMATES Average Number of Number of burden per Total Type of respondent Form name responses per respondents response burden hours respondent (in hours) Tribal MIECHV Grantees .................. Tribal MIECHV Quarterly Reporting 25 4 24 2,400 Form. Total ........................................... ........................................................... ........................ ........................ ........................ 2,400 Estimated Total Annual Burden information can be obtained and The Department specifically requests Hours: 2,400. comments may be forwarded by writing comments on: (a) Whether the proposed In compliance with the requirements to the Administration for Children and collection of information is necessary daltland on DSKBBV9HB2PROD with NOTICES of the Paperwork Reduction Act of 1995 Families, Office of Planning, Research for the proper performance of the (Pub. L. 104–13, 44 U.S.C. Chap 35), the and Evaluation, 330 C Street SW, functions of the agency, including Administration for Children and Washington DC 20201. Attn: ACF whether the information shall have Families is soliciting public comment Reports Clearance Officer. Email practical utility; (b) the accuracy of the on the specific aspects of the address: infocollection@acf.hhs.gov. All agency’s estimate of the burden of the information collection described above. requests should be identified by the title proposed collection of information; (c) Copies of the proposed collection of of the information collection. the quality, utility, and clarity of the VerDate Sep<11>2014 17:54 Sep 07, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1


Document Created: 2018-09-08 00:42:08
Document Modified: 2018-09-08 00:42:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; availability of final guidance.
DatesCDC 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.
ContactArlene 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]
FR Citation83 FR 45629 
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