[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53764-53765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13AGH]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Examining Traumatic Brain Injury in Youth--NEW--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Traumatic brain injury (TBI) is one of the highest priorities in 
public health because of its magnitude, economic and human impact, and 
preventability. The Centers for Disease Control and Prevention (CDC) 
estimates that approximately 1.7 million TBIs are sustained in the 
United States annually, either alone or in conjunction with another 
injury or condition. These figures may be an underestimation as they do 
not include people who are treated in physicians' offices or outpatient 
facilities, those who did not seek medical care, military personnel, or 
Americans living abroad. Moreover, the number of sports and recreation-
related TBIs treated in U.S. emergency departments is increasing and 
has increased steadily since the early 2000s. Children, ages 0 to 4 
years and adolescents, ages 15-19, are at the greatest risk of 
sustaining a TBI. A TBI is caused by a bump, blow or jolt to the head 
or a penetrating head injury that disrupts the normal function of the 
brain. The severity of a TBI may range from ``mild'' (a brief change in 
mental status or consciousness) to ``severe'' (an extended period of 
unconsciousness or amnesia after the injury).
    In 1996, Congress passed Public Law 104-166, the Traumatic Brain 
Injury Act, which charged CDC with implementing projects to reduce the 
incidence of traumatic brain injury. The CDC definition of TBI uses 
selected codes of the International Classification of Diseases, 9th 
Clinical Modification (ICD-9 CM) to identify cases of TBI from hospital 
and non-hospital databases containing billing records for services 
rendered to patients. It is thought, however, that the ICD-9 CM codes 
currently used in CDC's surveillance system to capture cases of TBI are 
not sufficiently sensitive to capture diagnosed TBI. CDC, therefore, 
would like to collect de-identified medical information of a 
representative sample of pediatric patients, from two clinical 
settings, who received a confirmed diagnosis of mild to severe TBI and 
link these patients to their administrative medical claims forms. 
Collectively, the data will allow CDC to estimate the sensitivity of 
currently utilized ICD-9 CM codes to capture cases of diagnosed TBI, as 
well as ICD-9 CM codes not currently being utilized that may improve 
the sensitivity to capture cases of TBI. We propose to conduct a 
retrospective cross-sectional study of a random sample of patients with 
a suspected TBI within two clinical settings (Emergency Departments and 
Concussion Clinics).
    Information for this study is being collected to better understand 
the coding practices related to TBI among children within multiple 
clinical settings. The data will benefit public health by providing a 
more accurate case definition of TBI for the Central Nervous System 
(CNS) Injury Surveillance. Results from this study will be shared with 
CDC stakeholders, such as state and local health departments, 
clinicians and TBI-related medical researchers through CDC reports and 
peer-reviewed publications.
    CDC requests OMB approval for three years to abstract data from 
medical and billing records dated April 1st to September 30, 2013. Data 
will be collected electronically, analyzed with findings compiled in a 
final report. The following information is needed from the medical 
record: Age at injury, encrypted or randomly generated identification 
number (that can be linked to billing system), head injury assessment 
value (indicator variable, Yes/No), Traumatic injury mechanism, Glasgow 
Coma Scale (GCS) score, ICD-9 CM codes and External cause of injury (E) 
codes if available, Head injury assessment value (indicator), Confirmed 
Diagnosis of TBI (Yes/No), based on the TBI case definition and if yes, 
Injury Type. The necessary data fields from the hospital billing system 
are: Encrypted or randomly generated identification number (that can be 
linked to medical chart), diagnosis codes (all available

[[Page 53765]]

fields for ICD-9-CM, E and V-codes), procedural codes (all available 
fields for ICD-9 CM, CPT-4) From the abstracted medical chart data 
contained in the TBI Data Abstraction Tool, a frequency of all observed 
ICD-9 CM codes will be created. Calculations of frequencies and code 
sensitivity of the ICD-9 CM codes will be calculated to develop 
recommendations for specific ICD-9 CM in the CDC IDC-9 Code definition.
    The TBI Data Abstraction tool will be used to create the final 
analytic dataset for the `Examining Traumatic Brain Injury in Youth' 
project. Data will be abstracted into the dataset in two separate 
phases during the study. During the first phase, a trained Research 
Assistant (RA) will review each sampled medical chart to determine 
whether the patient experienced a TBI during the specified visit 
according to the CDC TBI definition. The RA will first review the 
selection criteria to confirm eligibility into the study. 
Approximately, 150 medical records from Emergency Department Patients, 
obtained from emergency medical records (EMR) will be abstracted to 
determine if they fit the TBI case definition: (1) Any period of 
observed or self-reported confusion, memory dysfunction, or loss of 
consciousness, (2) observed signs of neurological/neuropsychological 
dysfunction or (3) an injury to the head that resulted in amnesia, 
skull fracture, or intracranial lesion. It is estimated that this data 
abstraction will take 105 minutes per record, totaling 263 annual 
burden hours. Also, 50 Concussion Service Patient records will be 
obtained from a hospital concussion clinic. These records will be 
abstracted to determine if they fit the TBI case definition as well. It 
is estimated that this abstraction will take 105 minutes per record, 
totaling 88 annual burden hours. The total annualized burden hours per 
year are 351. The RA will be blinded to all ICD-9 CM codes while 
reviewing medical charts and entering data into the TBI Data extraction 
tool.
    There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                      Number of responses      Avg. burden per        Total burden (in
        Type of respondents                 Form name         Number of respondents      per respondent       response (in hrs.)           hrs.)
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Emergency Department Patient.......  Allscripts ED           150...................  1....................  105/60...............  263
                                      electronic medical
                                      record (EMR) system.
Concussion Services Patient........  Microsoft Access        50....................  1....................  105/60...............  88
                                      Patient List.
                                                            --------------------------------------------------------------------------------------------
    Total..........................  ......................  ......................  .....................  .....................  351
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Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-21190 Filed 8-29-13; 8:45 am]
BILLING CODE 4163-18-P