Change Request Memo

Change Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Pregnancy Risk Assessment Monitoring System (PRAMS)

(OMB Control No. 0920-1273, Expiration Date: 03/31/2026)

JUSTIFICATION MEMORANDUM FOR NON-SUBSTANTIVE CHANGE REQUEST

Summary

CDC requests OMB approval to amend response options and remove survey question on the Pregnancy Risk Assessment Monitoring System (PRAMS) core and standard questionnaires to 1) comply with Executive Order 14168, 2) add a new response option for vaccination questions, and 3) update name of social media platform.

Attachments

• Appendix A: RSV questions Cognitive and Field-Testing Report

• Attachments 8e and 8f: PRAMS Livebirth Phase 9 Core Mail Questionnaire, English and Spanish, track changes

• Attachments 8g and 8h: PRAMS Livebirth Phase 9 Core Phone Mail Questionnaire, English and Spanish, track changes

• Attachments 8i and 8j: PRAMS Livebirth Phase 9 Core Web Questionnaire, English and Spanish, track changes

• Attachments 10e and 10f: PRAMS Livebirth Phase 9 Standard Mail Questionnaire, English and Spanish, track changes

• Attachments 10g and 10h: PRAMS Livebirth Phase 9 Standard Phone Questionnaire, English and Spanish, track changes

• Attachments 10i and 10j: PRAMS Livebirth Phase 9 Standard Web Questionnaire, English and Spanish, track changes

• Supporting Statement A, clean and track changes

Background and Justification

The Pregnancy Risk Assessment Monitoring System (PRAMS) provides data that is not available from other sources. PRAMS is approved to collect information on maternal behaviors and experiences before, during and shortly after pregnancy on a variety of topics. PRAMS is a key data source used by CDC, states, jurisdictions, and researchers to monitor prevalence of maternal behaviors and experiences, investigate emerging issues in the field of reproductive health and to assess impacts of programs and policies aimed at reducing health problems among mothers and babies.

1. PRAMS is requesting to revise response options for questions core 15, standard BB6, and standard LL1, and remove standard question PP1, to comply with executive order 14168.

2. PRAMS is requesting to revise core questions 12 and 13 by adding response options to capture Respiratory Syncytial Virus (RSV) vaccination. This will expand on immunization-related data collected in the PRAMS Phase 9 core questionnaire which currently includes response options for Flu, Tdap, and COVID-19 vaccinations. The Advisory Committee on Immunization Practices (ACIP) recommends RSV vaccination during pregnancy for individuals 32-36 weeks pregnant between September through January. Limited data are available on the experiences and behaviors surrounding RSV vaccination during pregnancy, and PRAMS is in a unique position to collect these data from recently pregnant women in 50 U.S. jurisdictions. The data can help monitor RSV vaccination and inform public health messaging and strategies for RSV vaccination.

3. PRAMS is requesting to revise core question 18 and standard question O9 to update the name of the social media platform, to X (formerly Twitter).

Cognitive and Field Testing for RSV vaccination questions

Cognitive and field testing of the revisions to core questions 12 and 13 were conducted through a contractor from September through December 2024. Testing was conducted in two phases—cognitive testing followed by field testing. Cognitive testing assessed respondents’ ability to understand standardized terminology and whether the survey questions capture the scientific intent to ensure validity and appropriateness of proposed supplement. Cognitive testing methodology utilizes respondent narratives, collected using verbal probing techniques. Field testing of survey instruments was conducted to improve the questionnaire layout and survey questions by identifying issues that may affect implementation of module or quality of the data collected.

Cognitive and field-testing participants were recruited from a safety-net breastfeeding clinic and pediatric clinic. Women who delivered a live born infant and who were <12 months postpartum were eligible to participate. Nine women were recruited for cognitive testing (5 English speakers and 4-Spanish speakers). Fifteen women were recruited for field testing (8 English speakers and 7 Spanish speakers). Burden hours, methodology and questions for field testing of new and revised questions are included in the current PRAMS OMB PRA approval.

Both clinics had large, diverse client and patient populations. Testing was conducted using all four questionnaire versions: English mail and phone, and Spanish mail and phone. Phone surveys were read to participants, while mail surveys were printed and given to participants to be filled out on their own, answering at their pace. Testing emphasis included obtaining data to inform whether to refer to the virus with the acronym “RSV” or to spell out the name, “Respiratory Syncytial Virus”, understand the level of awareness about RSV, and whether women answered core questions 12 and 13 correctly, based on their level of awareness of RSV.

For more details on the cognitive testing and field-testing methodology, please see the full report titled Appendix A - RSV questions Cognitive and Field-Testing Report

Findings from Cognitive and Field Testing

Versions 1 (use of virus acronym) and 2 (full spelling of virus name) of the survey questions were used in initial testing. Interim findings suggested that while most respondents (English and Spanish speakers) are not aware of RSV (virus and vaccine), including text that explains what the vaccine does (similar to the Tdap response option) provides cues to respondents that RSV pertains to a respiratory condition. Version 3 (explanation of what the vaccine does) of the survey questions was developed based on feedback during testing. Most respondents requested or affirmed (versions 2 and 3) that having the meaning or definition/explanation was helpful to them in understanding and answering the question more accurately. Spanish speaking respondents did not recognize the formal translation of the virus in Spanish, VRS, but were more familiar with the English acronym, RSV. Both English and Spanish acronyms are used in all versions of the testing instruments. Please see the full report titled Appendix A - RSV questions Cognitive and Field-Testing Report.

Effect of Proposed Changes on Currently Approved Instruments

Form	Current Question/Item	Requested Change
Attachments 8e-8j	Core 12	Add response option d, “RSV shot (given during pregnancy to protect the baby from respiratory syncytial virus)”
Attachments 8e-8j	Core 13	Add response option d, “RSV shot”
Attachments 8e-8j	Core 18	Update social media platform name to “X/Twitter”
Attachments 8e-8j	Core 53	Remove “or gender” from option g
Attachments 10e-10j	Standard BB6	Remove “or gender” from option g
Attachments 10e-10j	Standard LL1	Revise question to remove reference to gender
Attachments 10e-10j	Standard PP1	Remove question from standard questionnaire
Attachments 10e-10j	Standard O9	Update social media platform name to “X/Twitter”
SSA	N/A: Current change request does not affect questions/ instruments	Removed language referring to diversity

Effect on Burden Estimate

No change to the burden estimate is requested.