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Supporting Statement A for Request for Clearance:

COLLABORATING CENTER FOR QUESTIONNAIRE DESIGN AND EVALUATION RESEARCH

Pediatric Growth Charts Focus Groups

OMB No. 0920-0222

Expiration Date: 01/31/2026

Contact Information:

Amanda Titus

Behavioral Scientist, Collaborating Center for Questionnaire Design and Evaluation Research

Division of Research and Methodology

National Center for Health Statistics/CDC

3311 Toledo Road, Room 5451

Hyattsville, MD 20782

301-458-4579

[email protected]

August 28, 2024

Table of Contents

1. Justification

A.1. Circumstance Making the Collection of Information Necessary 2

A.2. Purpose and Use of Information Collection 2

A.9. Explanation of Any Payment of Gift to Respondents………………………….…….… 3

A.10. Protection of the Privacy and Confidentiality of Information Provided

by Respondents……………………………………………. 3

A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions 4

A.12. Estimates of Annualized Burden Hours and Costs 4

LIST OF ATTACHMENTS

Attachment 1: Focus Group Protocol

Attachment 2: Informed Consent

Attachment 3: Respondent Data Collection Sheet

Attachment 4: CCQDER Data Retention Policy

Attachment 5: NCHS Non-Disclosure Affidavit

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The NCHS Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) conducts qualitative and mixed method research. CCQDER data collection is authorized under a generic OMB clearance (OMB No. 0920-0222, Exp. Date 01/31/2026) and 42 U.S.C. 242k (Section 306 of the Public Health Service Act).

2. Purpose and Use of Information Collection

The purpose of the current project is to conduct a series of focus groups exploring how pediatricians are using and interacting with the NCHS’ recently released extended-body mass index (BMI) growth charts¹.

Obesity and severe obesity in the United States are defined via thresholds from CDC’s sex-specific BMI for-age growth charts. The current growth charts, which were revised in 2000, include data from National Health Examination Survey (NHES) II and III and incorporate National Health and Nutrition Examination Survey (NHANES) I, II, and III. They display a series of named percentile curves, with the largest being the 95th percentile. However, tracking of patients’ weights above the 95th percentile (which is the obesity cut point) is statistically unreliable. This is particularly important as the cut point for severe obesity (120% of the 95th percentile) lies in this uncalibrated and unreliable area of these charts. To enable clinical and research applications, NCHS’ Division of Health and Nutrition Examination Statistics (DHANES) and its partners across CDC developed and released a series of extended BMI growth charts in late 2022. These extended-BMI growth charts include NHANES data from 1988 through 2016 and provide health care providers and researchers with a new tool that they can use to identify obesity and better track a patient’s history.

To facilitate external communication with healthcare practitioners and other stakeholders, NCHS’ CCQDER plans to conduct a series of up to five focus groups with clinical and research pediatricians exploring the perceived advantages and challenges surrounding the extended-BMI growth charts. The methodological aim of this study is consistent with the design of most NCHS/CCQDER focus group studies, that is, to understand how members of the public think and communicate about areas of interest—in this case, the expanded growth charts, childhood obesity, and patient communication strategies. The procedure conforms to the focus group techniques that have been described in CCQDER’s generic clearance package (OMB No. 0920-0222, exp. 01/31/2026). Within that framework, the following procedures are particular to this study:

Recruitment. We propose to recruit up to 40 pediatricians, health care providers, and/or pediatric obesity researchers to participate in up to 5 focus groups. We would aim to have a maximum of 8 participants per focus group. CCQDER and DHANES will work jointly to recruit the focus group participants, and no recruitment ad or screening survey will be used.

Interview methods. Focus groups will be limited to 90 minutes. The outline of the protocol to be used in these focus groups is included as Attachment 1. The focus groups will be conducted by CCQDER staff or contractors and will take place either in-person in a private location or virtually, via video conference through Zoom. The Zoom platform has been approved by CDC and NCHS Information Security Offices. If interviews cannot be conducted virtually, NCHS staff propose holding them in person in the Questionnaire Design Research Laboratory (QDRL) or off-site location. The informed consent documents specific to this project are included as Attachment 2.

9. Explanation of Any Payment or Gift to Respondents

For this project participants will be given the standard remuneration of $150 previously approved by OMB for focus group participants. For virtual interviews, participants will be emailed the activation code and link for an $150 electronic gift card for remuneration. For in person interviews, participants will be given $150 in cash at the end of the focus group.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

Data will be kept private to the extent allowed by law.

The CCQDER continues to collect, on a confidential basis, data needed in order to conduct CCQDER studies. Confidentiality provided to respondents is assured by adherence to Section 308(d) of the Public Health Service Act (42 U.S.C. 242m) which states:

“No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section...306 (NCHS legislation),...may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and (1) in the case of information obtained in the course of health statistical or epidemiological activities under section...306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form...”

In addition, legislation covering confidentiality is provided according to the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 3561-3583), which states:

“Whoever, being an officer, employee, or agent of an agency acquiring information for exclusively statistical purposes, having taken and subscribed the oath of office, or having sworn to observe the limitations imposed by this section, comes into possession of such information by reason of his or her being an officer, employee, or agent and, knowing that the disclosure of the specific information is prohibited under the provisions of this subchapter, willfully discloses the information in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.”

Confidentiality of responses and safeguarding of data at NCHS

The CCQDER has a routine set of administrative, technical, and physical measures to safeguard confidentiality. Specific protocol for storage of confidential data, QDRL Lab, Q-video, Q-Notes, and Q-Bank access is described in CCQDER’s generic clearance package (OMB No. 0920-0222, exp. 01/31/2026).

Records Retention Schedule for Focus Groups

Storage and retention of CCQDER data is guided by the CCQDER Data Storage and Access Storage and retention of CCQDER data is guided by the CCQDER Data Storage and Access Policy which governs retention of interviews, their viewing audience, the data kept, and the length of time before retention of interviews is reassessed. The Data Storage and Access Policy has been approved by the NCHS ERB and is included in CCQDER’s generic OMB package. In accordance with this policy, data from the current project will be re-evaluated by the CCQDER Director to determine relevance, ongoing usefulness and qualitative value for likely use in question evaluation research after an initial retention period of 5 years (see data retention policy). No respondent information for this study will be kept in the CCQDER database.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

NCHS and CDC Institutional Review Board (IRB) approved this data collection on August 5, 2024.

12. Estimates of Annualized Burden hours and costs

In January 2023, OMB approved 71,925 total number of respondents and 21,450 total burden hours. This GenIC NCHS is requesting 40 respondents and 60.1 burden hours.

Table 1: Burden table for Growth Chart Focus Groups:

Form Name	Number of Participants	Number of Responses/Participants	Average hours per response	Response Burden (in hours)
Focus Group	40	1	85/60	56.8
Respondent Data Collection Sheets	40	1	5/60	3.33
Total	40			60.1

1 https://www.cdc.gov/growthcharts/extended-bmi.htm