2014-02668. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 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 requests OMB approval for one year 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).

A review of the medical coding data for additional ICD-9 CM codes that are not part of the CDC TBI definition will also take place to determine whether the addition of any of these codes improves the sensitivity of the CDC TBI definition to detect TBI.

The Emergency Department medical records of 150 patients will be abstracted in order to review ICD-9 codes and TBI diagnoses. Each record will take 60 minutes to abstract. Also, 50 patient medical records from the Concussion Clinic, located within the hospital, will be abstracted in order to review the selection criteria to confirm eligibility, which includes age of the patient, and the valid encounter with physician or nurse related to an injury consistent with a TBI. Each record will take 60 minutes to abstract. The same Research Assistant will be abstracting the data within the Emergency Department and the Concussion Clinic.

There are no costs to respondents other than their time. The total estimated annual burden hours are 200.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)
Emergency Department Research Assistant	TBI Records Data Tool	1	150	1
Concussion Clinic Research Assistant	TBI Records Data Tool	1	50	1

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.