Change Request and Justification

Well-Integrated Screening and Evaluation for Women Across the Nation

(WISEWOMAN) Reporting System

(OMB no. 0920-0612, exp. date 12/31/2016)

Change Request and Justification

July 19, 2016

Background

Cardiovascular disease (CVD), which includes heart disease, myocardial infarction, and stroke, is the leading cause of death for women in the United States. It is a primary contributor to mortality, morbidity, and decreased quality of life, especially among older women. Addressing risk factors such as high blood pressure, elevated blood cholesterol, obesity, sedentary lifestyle, diabetes, and smoking greatly reduces a woman’s risk of CVD-related illness and death. Women in lower income brackets, with lower levels of education, or without health insurance have an increased risk of CVD morbidity and mortality, as they have limited access to health services and have been shown to be more likely to smoke cigarettes, engage in limited physical activity, and have poor nutrition.

WISEWOMAN awardees are state, local, or tribal health departments that deliver CVD screening and assessment services, and lifestyle intervention programs, to reduce cardiovascular disease (CVD) risk factors. The target population for WISEWOMAN services is medically underserved, at-risk women between the ages of 40 and 64. Through the WISEWOMAN cooperative agreement program, awardees agree to submit 2 types of information to CDC.

• Each WISEWOMAN awardee submits an Annual Progress Report to CDC which provides a narrative summary of programmatic activities (Attachment 5).

• Each WISEWOMAN awardee transmits an electronic data file to CDC that contains de-identified, client-level information about the services provided to the target population. The data file is called the Screening and Assessment and Lifestyle Minimum Data Elements (MDE) (Attachment 3).

CDC uses the information for continuous program improvement.

Summary of Change Request

No changes to the Progress Report are proposed. CDC requests OMB approval to delete one variable from the Screening and Assessment MDE and Lifestyle Program MDE file. This variable, “Saltcon,” is based on the following question and response options:

7(f) Do you eat 1,500 mg of sodium or less daily?

• 1 - Yes

• 2 - No

• 8 - Don’t want to Answer

• 9 - No answer recorded

Deletion of the Saltcon variable will result in minimal labeling and page number changes for the remaining data elements in the MDE file.

Type of Change	MDE Field Name	Location
DELETE	Saltcon	7f
RENUMBER	SaltWatch	Was 7g; will be relabeled as 7f

Justification

This request is the result of a review of the WISEWOMAN MDE by program staff at CDC at the request of the awardees and their representative group the Program Directors/Program Manager’s Workgroup. We reviewed the request and concluded that significant variability in reporting the information requested is due to varied interpretation of this MDE by respondents across awardees resulting in significant data quality issues. These data quality issues limit CDC’s ability to do meaningful analyses on this MDE. Additionally, the current 2015-2020 Dietary Guidelines for Americans, published in December 2015 by the U.S. Department for Health and Human Services and the U.S. Department of Agriculture, recommends less than 2,300 mg per day for adults rendering this MDE obsolete.

Effect on Burden Estimate

The total number of MDEs will be reduced from 85 to 84. There is no change to the estimated burden of transmitting the MDE data file to CDC. The program scope, purpose, burden, protocol, methodology, and planned analyses remain unchanged from the previous approval. Attachment 3_revised shows the updated specifications for the Screening and Assessment and Lifestyle MDE data file to the previous version of the specifications resulting from deletion of the Saltcon variable (in track changes).

Implementation Schedule

Immediate. Due to data quality concerns, the Saltcon variable is not currently maintained or used for analysis. Its submission will be formally discontinued upon OMB approval of this Change Request.

Attachments

Attachment 3 (revised). Screening and Assessment and Lifestyle Program MDE. (Proposed changes shown in track-changes format in Table of Contents and Pages 36 and 37)