BDSTEPS_SupSta B_052016

Birth Defects Study To Evaluate Pregnancy exposureS

(BD-STEPS)

OMB 0920-0010

Supporting Statement B

Revision

Project Officer:

Jennita Reefhuis, PhD

Epidemiologist

Centers for Disease Control and Prevention

Phone: (404) 498-3917

Fax: (404) 498-3040

Email: [email protected]

June 13, 2016

Birth Defects Study to Evaluate Pregnancy exposureS

B. Collection of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods

Cases for BD-STEPS in Atlanta are selected from the MACDP surveillance system, and cases for all other Centers are selected from established state surveillance systems. The collection of information for cases of selected birth defects does not employ statistical methods because all infants with one of the 17 birth defects are included in Birth Defects surveillance systems, not just samples. Individual birth defects are rare occurrences so it is necessary to ascertain all cases in order to have enough cases of specific defects to study. Two Centers will collect information for all stillbirths without major defects in the respective state. However, the controls in the BD-STEPS are selected by a sampling process.

For BD-STEPS, each of the CBDRP will select randomly from the population (from either vital records or hospital birth logs) approximately 75 eligible controls each year for inclusion in the study. Whether hospital records or birth certificates are used as the source for control-infants, the records are reviewed to ensure that, given the available information, the selected control- infant does not have a birth defect. Records are also reviewed to abstract information for the purpose of follow up and contact.

B.2. Procedures for the Collection of Information

State-specific birth defects surveillance data are used to identify case subjects for the BD-STEPS. The selection of BD-STEPS controls is described in Section B.1. Once the children are identified for the study, a clinical geneticist reviews the information abstracted from the medical record to determine if they meet the case definition and are eligible for the study. Once eligibility has been established, the names and contact information for the families are sent to the Centers for the initial contact. The first contact, sent by mail to the mothers, is an introductory letter (Attachment U1/U2), along with a “Human Subjects” fact sheet (Attachment V1/V2), and a “Question and Answer” sheet (Attachment T1/T2). .

Approximately 10 days after the introductory packet has been sent, the centralized interview contractor makes follow up phone or email contact with the family (see Attachment X1/W2) for email and voicemail contact scripts). If email contact is made, arrangements are made for a follow up phone call. During this phone call, the interviewer obtains oral consent for the interview and either conducts the interview then or schedules the interview at a time convenient for the family. The interview is conducted with a CATI (see Attachment G1/G2 for a hard copy of the questionnaire). The script used in the telephone interview (including oral consent) is in Attachment N1/N2. The script varies slightly depending on the status of the child: control, living case, and died or stillborn case.

A thank you letter is sent after all interviews. For the states that allow CBDRP access of newborn bloodspots and require maternal consent, a request for sharing of residual newborn bloodspots is included in the interview thank you letter (Attachment Y1/Y2 ) along with a $10 gift card, and a written consent form pertaining to bloodspots (Attachment O1/O2). For parents of multiples (e.g. twins or triplets), consent for sharing data (including newborn bloodspots) of the siblings that were part of the multiple birth will be requested (Attachment P1/P2).

In addition, participants are asked in the questionnaire if they report working in one of eight occupational categories of interest. If yes, participants are sent a standardized introductory invitation that includes information about the online questionnaire and a link to the questionnaire (Attachment H1-H8).

Medical Records will be requested (Attachments Q1/Q2 and Z1/W2) for review for participants reporting certain medical conditions (see Section B.4).

Finally, two Centers will ask mothers of stillbirths with or without birth defects and controls to participate in a supplemental CATI. Mothers will be sent a standardized invitation that includes information about the supplemental interview (Attachment AA). Approximately 10 days after the introductory packet has been sent, the Center conducting interviews will make follow up phone or email contact with the family. If email contact is made, arrangements are made for a follow up phone call. During this phone call, the interviewer obtains oral consent for the interview and either conducts the interview then or schedules the interview at a time convenient for the family. The interview is conducted with the supplemental stillbirth CATI (Attachment I1/I2). The script used in the telephone interview (including oral consent) is in Attachment R1/R2. The script varies slightly depending on the status of the child: control or stillborn case.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

The response rate during the first year of the NBDPS was approximately 60% for cases and controls. With the addition of the $20 money order in the introductory packet, interview participation rates increased initially to over 70% in 2000. Given the changing communication landscape with increasingly difficult initial contact of potential new participants, in May of 2010, NBDPS recruitment tracking and tracing procedure was revised and approved by CDC IRB to include the use of e-mail (see Attachment X1/X2 for email and voicemail scripts). Interview participation rates ranged from approximately 60-70% from 2005-2009.

The token of appreciation amount for both the online questionnaire and the bloodspot consent request is ten dollars. This amount is less than the $20 gift card offered for the BD-STEPS CATI questionnaire. The direct interviewer contact required for the CATI was determined to be more time-consuming than the newly proposed data collections. Based on this difference and the experience of the research group with previous studies, the BD-STEPS coordinating council voted to implement $10 tokens of appreciation for both study segments.

For the two participating Centers, a $10 gift card will be sent to mothers asked to participate in the supplemental stillbirth CATI questionnaire along with a letter including information about the questionnaire (Attachment AA).

B.4. Tests of Procedures or Methods to be Undertaken

As mentioned before, a large portion of the BD-STEPS interview will be maintained from the NBDPS to make pooling of the CBDRP’s NBDPS and BD-STEPS data possible. Innovative questions were added for BD-STEPs and are detailed in section A.3.

The online occupational questionnaire (Attachment H1-H8) represents a new method for data collection for the study.

In addition, at the end of the interview, requests are planned for participants reporting certain procedures/conditions for mailing an additional consent for medical/dental records. Medical records contain specific information that might be hard for women to recall, and medical record review allows validation of exposures reported by the mother in the CATI. Initial topics for which medical records are planned include fertility treatments and dental treatments (See Attachments Q1/Q2 and Z1/Z2 for medical records request letter and medical records request form).

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

The statistical aspects of the design of the BD-STEPS are the responsibility of the Principal investigator:

Jennita Reefhuis, PhD

Epidemiologist & Principal Investigator, BD-STEPS

Division of Birth Defects & Developmental Disabilities

National Center on Birth Defects and Developmental Disabilities

Centers for Disease Control & Prevention

1600 Clifton Road, NE

Mailstop E-86

Atlanta, GA 30333

404-498-3917

Additional consultation on the development of the BD-STEPS was obtained from the Principal Investigators of the CBDRP (Attachment L). RTI International is currently contracted by CDC to manage all BD-STEPS interviewing activities; the RTI International primary contact is the following:

Nedra Whitehead, PhD, MS, CGC

Environmental Health Sciences RTI International

2951 Flowers Road, Suite 119

Atlanta, Georgia 30341

770-986-5051

Analysis of BD-STEPS data is the primary responsibility of Dr. Reefhuis, with assistance from the Principal Investigators of the CBDRP.