Ss B Sdy 0920-1092_1_25_19

SS B SDY 0920-1092_1_25_19.docx

Sudden Death in the Young Registry

OMB: 0920-1092

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Information Collection Request Reinstatement

Supporting Statement Part B







Sudden Death in the Young Registry

Reinstatement of OMB Number 0920-1092



Project Officer: Carri Cottengim

Health Scientist, Sudden Unexpected Infant Death Initiative

Division of Reproductive Health

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control & Prevention

770-488-4290 phone

wsh2@cdc.gov

(770) 488-6283 fax


January 25, 2019
















List of Attachments



  1. Applicable Laws

    1. Public Health Service Act, Section 301(a) and Section 317K, 42 USC 241(a), 42 USC 247b-12

    2. Sudden Unexpected Death Data Enhancement and Awareness Act, Public Law Number 113-236 (enacted into law on December 18, 2014)

  2. 60 Day Federal Register Notice

  1. Data Use Agreements

    1. Agreement between CDC and MPHI

    2. Agreement between CDC and state/jurisdiction awardees

  2. Data Security Policy documents

    1. MPHI Security Policy

    2. NCFRP Child Death Review – Case Reporting System Security Information

  3. Institutional Request for Determination of Research Status

  4. SDY awardees and expected number of cases

  5. Data Collection Tools

    1. SDY Module Section I

    2. Advanced Review Discussion Topics

    3. SDY Module Section N





Supporting Statement B

Collection of Information Employing Statistical Methods


1. Respondent Universe and Sampling Methods

Surveillance of a census (all) sudden deaths in the young (0-19 years old) within 14 awardee jurisdictions is being sought; thus no sampling methods will be employed. The anticipated number of SDY cases each year (739) was derived using CDC Wonder1 data (2012-16) to calculate the approximate estimated incidence of SDY (Attachment 6). CDC Wonder is an online database for the analysis of public health data. An estimated 739 SDY cases will have data entry completed on the SDY Module. Using data from CDC’s first SDY Case Registry funding cycle (2015-2018) we also estimated the number of SDY cases that will meet eligibility criteria for advanced review and be required to undergo review at an advanced review meeting. Per our assessment, approximately 50% of all SDY cases, or 370 cases will continue on to the advanced review process each year.


2. Procedures for the Collection of Information

Through their existing child death review (CDR) programs, awardees will compile data for 739 SDY cases on a defined set of SDY questions and enter them into the existing SDY module that is part of a larger National Fatality Review-Case Reporting System (NFR-CRS) run through the Michigan Public Health Institute’s (MPHI) National Center for Fatality Review and Prevention (NCFRP) program. The enhanced SDY modules I and N (Attachments 7a and 7c), which contain approximately 70 variables, will be completed for each case, yet not every variable will apply to every case.. Data will be abstracted from primary data sources, including medical examiner/coroner reports, death investigation reports, medical records, and child protective services records. For 370 of these cases, awardee jurisdictions will also convene an advanced review team with relevant clinical expertise, including state health personnel, pediatric cardiologists, pediatric neurologists or epileptologists, and forensic pathologists. This advanced review team will comprehensively review information from multiple data sources, discuss the information and use the information to classify cases according to a standardized algorithm that differentiates causes (Attachments 7b). Additional information from these advanced case reviews will be added to the SDY module as applicable. Password-controlled access for awardees is administered by the NCFRP per NCFRP’s data security policies and user agreements (Attachments 3a-b and 4a-b).


3. Methods to Maximize Response Rates and Deal with Non-response

Efforts are made to maximize the response rate as achieving population-level representativeness and data completeness is the primary purpose of this funding. CDC provides guidance to awardees on strategies to minimize missing or unknown responses to SDY variables. These methods include building partnerships with agencies that collect the primary data and providing feedback to these agencies so they might improve the quality of the data. As outlined in the funding announcement for the cooperative agreement, CDC and the Data Coordinating Center at the Michigan Public Health Institute (MPHI) will provide awardees with a quarterly Data Quality Summary report that will include the frequency of missing and unknown responses that are considered essential to the case definition and classification protocol. This allows CDC and the awardee to track the outcome of data improvement strategies and to track awardees’ progress over time. The goal is for the Registry to capture complete information from data abstracted from primary sources that will allow states and jurisdictions to calculate accurate and reliable SDY incidence.




4. Tests of Procedures or Methods to be Undertaken

This data collection is a reinstatement of a previously approved information collection (OMB #0920-1092, Expiration 12/31/2018). All of the variables in the SDY module have been used for the last 3 years. While CDC is not proposing any changes to any of the data collection tools, the SDY module, or the advanced review process, CDC has, with experience, been able to: 1) obtain better estimates of the actual numbers of respondents anticipated; 2) obtain more accurate estimates of the amount of time needed to completed the SDY modules; 3) better determine the number of cases that will need to continue to advance review and the types of medical experts that are needed.


5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

There are no statistical aspects related to the SDY Registry.



A number of individuals were consulted on the following: availability of data; frequency of collection; the clarity of instruction and record keeping; disclosure; reporting format; and the data elements to be recorded, disclosed, or reported. Experts CDC consulted formed the SDY Steering Committee, as listed in the table below.

Sudden Death in the Young (SDY) Experts Consulted

Biorepository

Years consulted

Name

Occupation

Role

Contact information

2014 - current

Mark Russell

Cardiologist

Director of Biorepository, University of Michigan

mruss@med.umich.edu

734-764-5176

2018 - current

Lindsay Wilkerson

Laboratory Technician

Biorepository Lead, University of Michigan

wilkerli@med.umich.edu

734-615-2429

2015-2016

Lauren Bienemann

Laboratory Technician

Biorepository Lead, University of Michigan

n/a

2016-2018

Alissa Novack

Laboratory Technician

Biorepository Lead, University of Michigan

n/a

Data Coordinating Center at Michigan Public Health Institute

2015 - current

Meghan Faulkner

SDY Data Coordinating Center Director

Data Manager for SDY Case Registry, Technical Assistance

mfaulkne@mphi.org

517-324-6014

2014 - current


Heather MacLeod

SDY Data Coordinating Center Senior Project Manager

Primary contact for SDY; expertise in genetic counseling, Technical Assistance

hmacleodgc@gmail.com

630-432-9918

2014-2107

Teri Covington

Directions of the National Center for Fatality Review and Prevention

Expert in fatality review protocols and procedures

n/a

National Institutes of Health

2014 - current

Kristin Burns

Medical Officer, National Heart, Lung, and Blood Institute (NHLBI)

Overall lead for SDY Case Registry Study.

Primary contact for questions related to cardiac conditions

kristin.burns@nih.gov

301-594-6859

2014 - current

Jonathan Kaltman

Branch Chief, NHLBI

Overall project guidance

kaltmanj@nhlbi.nih.gov

301-435-0528


2014 - current

Vicky Whittemore

Program Director,

National Institute of Neurologic Disorders and Stroke

Sudden Unexpected Death in Epilepsy (SUDEP) and epilepsy

vicky.whittemore@nih.gov

301-496-1917


2014-2016

Ellen Rosenberg

Clinical Trial Specialist, NHLBI

Consent Expert

n/a


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