# CDC PRAMS Guidelines 

**for**

**Conducting Multi-State Analyses**

2008

**Overview of PRAMS**

The Pregnancy Risk Assessment Monitoring System (PRAMS) is an ongoing,
population-based surveillance system that collects information on
maternal characteristics, behaviors, and experiences that occur several
months prior to conception, during pregnancy, and immediately following
delivery. PRAMS survey data supplement birth certificate information and
provide participating project areas with information specific to their
jurisdiction which can be used to plan and evaluate maternal and child
health programs and make health policy decisions. As of June 2008, 39
vital records registry areas (37 states, New York City and the South
Dakota Tribal project) participate in the project.

## **Methods**

Each month, mothers who are state residents and have recently delivered
a live-born infant during the preceding 2-4 months are randomly selected
from a file of birth certificate records using stratified systematic
sampling. Mothers who gave birth outside their state of residence and
mothers who had a multiple birth greater than three gestations are
excluded from the sampling frame. From 1992 through 1995, supplemental
hospital-based sampling was conducted in four states. All states
oversample mothers who are at increased risk for adverse pregnancy
outcomes. Popular state stratification variables include infant birth
weight, maternal race/ethnicity, and geographic location. For a detailed
listing of the state data availability by year refer to the document
titled, \"Data availability by state and year" posted on the PRAMS Web
site in the same section as these mini-proposal guidelines.

Sampled mothers are mailed a letter that introduces them to the project,
followed by a self-administered 14-page standardized questionnaire
several days later. The PRAMS questionnaire consists of about 55 core
questions that are asked by all projects. In addition, each project
inserts 10-30 questions they develop themselves or modules of questions
developed by CDC standard questions. For a detailed description of core,
standard, and state questionnaire topics, refer to the Topics Reference
document located on the PRAMS Web site in the "Questionnaire" section or
request a copy of this document from the research proposal coordinator.
Depending upon the state, one to two additional questionnaire mailings
are sent. All states conduct telephone interview follow-up for
nonresponding mothers. The PRAMS questionnaire has been translated into
Spanish for states with sizable Spanish-speaking populations.

## **Data Sets**

States collect and submit data to CDC from three different sources: the
PRAMS questionnaire, the birth certificate, and survey operational data.
The data are weighted annually for each state to adjust for nonresponse,
noncoverage, and sampling fractions. The annual weighted data sets
contain data from all three sources. The questionnaire data contain
mothers= responses to the questionnaire. The birth certificate data
contain information on selected maternal characteristics (e.g. race,
ethnicity, age) and pregnancy outcomes (e.g. birth weight, gestational
age). The operations data are generated by the PRAMS operational
software and are used primarily for operational evaluations and analyses
of survey methods. In addition, a comment data set is maintained
separately from the weighted project area data sets. The comment data
set consists of mothers= comments to the questions or their comments
about answering questions related to their pregnancies (either directly
written on a mailed questionnaire or spoken during a telephone
interview). Analysts use the comment file to re-code maternal responses
or to obtain qualitative data from written or verbatim comments.

**Summary of Variables included in PRAMS dataset**

The following core variables are included in the analysis datasets
provided to mini-proposal authors.

1\) The variables id and state.

2\) All core birth certificate variables except for: the birth
certificate number; "day" portion of infant date of birth, mother date
of birth, and date of last menses; county of residence; and hospital of
birth.

3\) The following operations variables:

batch; babydead; modecont; particip; mode_prt; urb_rur; and hispanic. 4)
All core questionnaire variables except for the "day" portion of: infant
date of birth; mother date of birth; today's date; date of discharge;
date of admission; due date; and date of infant death.

5\) All variables computed from the birth certificate and questionnaire,
except for the variables stored in SAS date format.

6\) The following weighting and SUDAAN analysis variables: cell;
sud_nest; stratumc; nest_yr; samcnt; totcnt; wtone; wttwo; wtthree; and
wtanal. 7) Any other variables must be specifically requested in the
mini-proposal and authorized by each individual state.

## **Analysis software**

Due to the complex survey design used by PRAMS, CDC recommends that
analysts use SUDAAN (Survey Data Analysis, Research Triangle Institute,
NC) software or another software product that allows for complex
sampling designs, to compute variance estimates and perform significance
testing. Nevertheless, standard software products can be used to compute
point estimates because analysis weights can be incorporated into
statistical procedures. When conducting operational analyses that do no
involve weighted data, standard statistical software packages can be
used for these computations.

## **Approval to analyze PRAMS data**

To facilitate the planning and implementation of analyses, ensure
scientific quality and appropriate use of the data, and avoid
duplication of efforts, any researcher intending to analyze PRAMS data
from more than one state must prepare a brief research proposal.
Proposals should be sent to the CDC PRAMS research proposal coordinator.
Details concerning research proposal content and the review process
follow. Requests to analyze individual state data should be directed to
the respective state PRAMS Coordinator.

# 

# 

# 

# Research proposal process

**[Proposal content]{.underline}**

Research proposals vary between 4-8 pages in length. We recommend that
every research proposal contain the following information: a title;
background; methods; results; discussion; resources needed; project time
frame; and references. In brief, each proposal section should include
the following information:

*Title page* Include a working study title; a list of study researchers,
their institutional affiliations and contact information; and names of
journal(s) where the findings will be sent.

*Background* Summarize the literature, cite strengths and limitations of
earlier research, and state the purpose for the proposed study. Provide
a rationale for why PRAMS data are useful for the proposed project.

*Methods* Mention which states and years of PRAMS data you will need for
your analysis, the kinds (if possible, names) of variables you will need
and the statistical methods you will use to conduct your analysis.
Describe whether your analysis relies on any implicit assumptions.

*Results* Although the analysis has not been initiated, we recommend
that researchers provide some sample table shells or figures for CDC and
PRAMS state review.

*Discussion* While the results are not known, we suggest that
researchers discuss the strengths and limitations of their project and
how the findings from the proposed project will enhance the literature
and public health practice.

*Resource need*

Indicate whether technical assistance will be needed from CDC PRAMS or
PRAMS states. If assistance is needed, describe the extent of technical
assistance needed.

*Experience with SAS, SUDAAN, or other statistical package*

> Indicate the level of experience with SUDAAN software, or another
> software package that can be used to analyze complex survey data. CDC
> technical assistance for SUDAAN is limited.

*Time frame* List a starting date and anticipated milestones for the
project.

*References* Provide a listing of references cited in the research
proposal.

**[Authorship]{.underline}**

Because PRAMS is a collaborative effort among state health departments
and CDC=s Division of Reproductive Health, CDC and PRAMS states created
a PRAMS Working Group. The PRAMS Working Group is comprised of one
designated representative from each PRAMS state and the entire CDC PRAMS
Team. The PRAMS Working Group serves as a mechanism for acknowledging
state and CDC participation and identifies contact persons in PRAMS
states, if additional information is needed. CDC and PRAMS states have
agreed to support the following authorship guidelines:

For projects that use data from more than one PRAMS state, the PRAMS
Working Group should appear as an acknowledgment, with a listing of the
working group members. The following example illustrates how the
acknowledgment should appear:

*Acknowledgments*

The PRAMS Working Group

PRAMS Working Group: Alabama -- Albert Woolbright, PhD ; Alaska - Kathy
Perham-Hester, MS, MPH; Arkansas - Mary McGehee, PhD; Colorado - Alyson
Shupe, PhD; Delaware -- Charlon Kroelinger, PhD; Florida -- Jamie
Fairclough, MPH; Georgia - Carol Hoban, MS, MPH; Hawaii - Sharon
Sirling; Illinois - Theresa Sandidge, MA; Louisiana - Joan Wightkin;
Maine - Kim Haggan; Maryland - Diana Cheng, MD; Massachusetts - Hafsatou
Diop, MD, MPH; Michigan -- Violanda Grigorescu, MD, MSPH; Minnesota -
Jan Jernell; Mississippi -- Vernesia Wilson, MPH; Missouri - Venkata
Garikapaty, MSc, MS, PhD, MPH; Montana - JoAnn Dotson; Nebraska -
Jennifer Severe-Oforah; New Jersey - Lakota Kruse, MD; New Mexico -
Eirian Coronado; New York State - Anne Radigan-Garcia; New York City -
Candace Mulready-Ward, MPH; North Carolina - Paul Buescher, PhD; North
Dakota - Sandra Anseth; Ohio -- Lily Tatham; Oklahoma --Dick Lorenz;
Oregon - Kenneth Rosenberg, MD; Pennsylvania - Kenneth Huling; Rhode
Island - Sam Viner-Brown, PhD; South Carolina - Jim Ferguson, DrPH;
South Dakota -- Christine Rinki, MPH; Texas -- Eric Miller, PhD;
Tennessee - David Law, PhD; Utah -- Laurie Baksh; Vermont - Peggy
Brozicevic; Virginia -- Michelle White; Washington - Linda Lohdefinck;
West Virginia - Melissa Baker, MA; Wisconsin - Katherine Kvale, PhD;
Wyoming - Angi Crotsenberg; CDC PRAMS Team, Applied Sciences Branch,
Division of Reproductive Health

**Submission steps**

1.  Send research proposals electronically to Denise D'Angelo, MPH
    (DDAngelo@cdc.gov).

2.  Proposals will be circulated among the CDC PRAMS team to solicit
    input regarding the suitability of PRAMS data for the proposed
    analysis and the appropriateness of the analysis plan considering
    the PRAMS survey design.

3.  CDC PRAMS will respond to the primary researcher within three weeks.
    This response will include a summary of comments received from the
    CDC PRAMS team and notification of an approval to conduct the
    analysis. Approved proposals will be sent out by CDC for state
    review. Several states require additional state-specific paperwork
    that CDC will send to the researcher to fill out and return directly
    to the state.

4.  Upon receipt of state and CDC approval, all researchers who are
    listed on the proposal will complete a Data Sharing agreement and
    return the form to CDC via fax (770-488-6291) or scanned electronic
    copy. Approval to analyze PRAMS data applies only to the topic
    described in the research proposal. If a researcher desires to
    conduct additional analyses, a separate research proposal is
    required.

5.  CDC will create a SAS analysis data set on a CD-ROM or a diskette(s)
    for the primary researcher. A letter describing the contents of the
    CD-ROM or diskette will accompany the data. Sample SAS and SUDAAN
    programs are available upon request.

6.  Once the analysis described in the research proposal has been
    completed, researchers are to destroy their copy of the data
    (confirm in writing) or return the data to CDC.

**Publication or presentation**

Before giving an oral presentation using PRAMS data, researchers must
submit their slides and abstract to PRAMS states and the CDC PRAMS Team
two weeks prior to the presentation.

Before submitting a manuscript for publication, researchers not
affiliated with CDC are required to send a copy of the manuscript to CDC
PRAMS and PRAMS states two weeks prior to submitting the manuscript to a
peer-reviewed journal*.* CDC researchers are required to submit copies
of their work to the CDC PRAMS team and PRAMS States at the time the
manuscript is being submitted for CDC clearance.

**PRAMS DATA SHARING AGREEMENT**

I, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, as
principal investigator on this proposed analysis of Pregnancy Risk
Assessment Monitoring System (PRAMS) data, agree to the following
requirements for the use of PRAMS data and assure compliance with the
requirements.

1\. I will not use nor permit others to use these data except for
statistical analysis and reporting.

2\. I will not use nor permit others to use these data to conduct
analyses other than those described in the proposal, titled
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_,
which accompanies this statement.

3\. I will not release nor permit others to release the data set or any
part of it to any person others than those listed as collaborators in
the attached proposal.

4\. I will not attempt or permit others to use the data set to attempt
to learn the identity of any participant. If the identity of a
respondent should be inadvertently discovered, I will make no use of
this knowledge, nor will I permit others to use the knowledge. I will
inform the CDC‑PRAMS staff of the discovery, so they can prevent future
discoveries. I pledge that neither I nor other members of my team will
inform anyone else of this knowledge.

5\. All oral or written presentations of the results of the analyses
will include an acknowledgment of the PRAMS Working Group and the
Centers for Disease Control and Prevention.

6\. All oral or written presentations of the results of the analyses
will be submitted to the PRAMS participating states and the Centers for
Disease Control for review *prior* to submission for publication or
presentation at a meeting. The acronym "PRAMS" will be submitted as a
keywords for any publications.

7\. CDC PRAMS staff and staff from states whose data were used in the
analysis will be notified upon final publication of an article and
provided with citation information.

8\. When the proposed analyses are completed, all copies of these data
will be destroyed (confirmed in writing) or returned to CDC.

My signature indicates my agreement to comply with these requirements.

Name:

Title:

Organization:

Signature: Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_