Exhibits 1. Overview of Proposed Improvements

Exhibits

Exhibit 1. Overview of Proposed Improvements

Type	Elements Affected	Number of Elements
Deletions from Current MDE Requirements	MDE Version, second-hand smoke, quality of life, hip circumference, measurement dates, priority areas, stage of change, length of lifestyle program/health coaching, type of lifestyle program/health coaching setting of lifestyle program/health coaching, and completion of lifestyle program/health coaching	20
Modifications to Data Elements/Questions or Response Options	Disease diagnosis history, heart related conditions, medication history, medication adherence, dietary and exercise behavior, blood pressure screening date, blood pressure measurements, follow-up alert status, and follow-up alert dates	25 Combined elements: 16 reduced to 6 Rephrased elements: 6 Renamed elements: 3
New Elements	Navigation status, aspirin/statin therapy, medication follow-up dates, alcohol consumption, and quality of life.	5

Number of Current MDEs	Delete	Combine	Add	Number of MDEs
84	-20	-10	+5	59

Exhibit 2: Deletions from Current MDE (20):

CDC proposes to remove twenty MDEs that were determined not to be useful for analysis. The rationale for no longer requiring each one of the twenty is provided in the last column.

MDE Field Number	Current Information Collection Phrasing	Rationale
Item 0a	0a. MDE Version Version of MDE Manual	We propose to eliminate this MDE because it is no longer useful as the version number rarely changes.
Item 9b	9b. About how many hours a day, on average, are you in the same room or vehicle with another person who is smoking? ___ Number of hours Less than one None Don’t want to answer No answer recorded	We propose to eliminate this MDE because grantees report their participants found it difficult to quantify responses to this question, therefore rendering it statistically unreliable.
Item 11d.	11d. Hip Circumference ___ Hip circumference in inches Unable to obtain Client refused No measurement recorded	We propose to delete hip measurement as it has no analytical utility. Newly published scientific findings suggest that change in waist circumference alone is a sufficient predictor of obesity. Change in circumference is MDE 11C.
Item 12d. Item 12e.	12d. Systolic Blood Pressure Measurement #2 Blood pressure (mmHg) 12e. Diastolic Blood Pressure Measurement #2 Blood pressure (mmHg)	We propose to remove these MDEs because Item 12b and 12c now allow up to four measurements (see Exhibit 3). Combining them in one place will facilitate questionnaire flow.
Item 14a Item 15a Item 17a	14a. Cholesterol Measurement Date MM/DD/CCYY Date 15a. Glucose/A1c Measurement Date MM//DD/CC/YY Date 17a. Risk Reduction Counseling Date MM/DD/CCYY Date	We propose to eliminate cholesterol, glucose, and risk-reduction measurement dates because they are redundant with the date of blood pressure screening, which occurs on the same day and is captured in MDE 12a.
Item 16c Item 16d	16c. If GLUCOSE ≤50 or GLUCOSE ≥250, what is the status of the workup? Workup complete Follow-up – workup by alternate provider Not an alert reading Client refused workup Workup not completed, client lost to follow-up 16d. If GLUCOSE ≤50 or GLUCOSE ≥250 Workup Exam Date MM/DD/CCYY Date	We propose to eliminate these questions because data for very high blood sugar levels are already collected by the provider during on-site blood sugar readings. Reflected in existing MDE 15B.
Item 17c Item 17d Item 17e Item 17f	17c. Participant Decided Nutrition is a Priority Area Yes No 7. Unknown 17d. Participant Decided Physical Activity is a Priority Area Yes No 7. Unknown 17e. Participant Decided Smoking Cessation is a Priority Area Yes No Unknown 17f. Participant Decided Medication Adherence for Hypertension (high blood pressure) is a Priority Area Yes No Unknown	We propose to eliminate these questions as grantees report that these questions are not phrased clearly enough to yield accurate responses and some participants have difficulty answering them; therefore, they do not yield statistically reliable program-specific information.
Item 18a	18a. Readiness to Change Assessment Date MM/DD/CCYY Date	We propose to eliminate the readiness to change date. Regression analyses conducted since current OMB approval (0920-0612, exp. 12/31/2018) reveal that readiness to change does not predict participation in Lifestyle Program and Health Coaching.
Item 18b	18b. Participant Stage-of-Change Pre-contemplation Contemplation Preparation Action Maintenance Refused No answer recorded	We propose to eliminate the Stage-of-change MDE. Regression analyses conducted since current OMB approval (0920-0612, exp. 12/31/2018) reveal that stage of change does not predict participation in Lifestyle Program and Health Coaching; it is therefore no longer useful.
Item 20d.	20d. Length of Lifestyle Program (LSP) /Health Coaching (HC) Session Received by the Participant ___ Length of session	We propose to eliminate collecting the length of each lifestyle program or health coaching session because all of the standardized lifestyle programs have a known length of session, so it is not a useful data element. Although the length of each health coaching session is variable, statistically, the skill of each coach is more important than the length of time.
Item 20e Item 20f	20e Type of Lifestyle Program/Health Coaching Session Face-to-face Phone Smart phone/tablet application Evidence that mailed materials were opened and reviewed Evidence that audiotape or DVD as opened and reviewed Evidence that non-interactive computer-based session was completed Evidence that interactive computer-based session was completed Other 9. No answer recorded 20f. Setting of Lifestyle Program (LSP) / Health Coaching (HC) Session Individual Group Combination No answer recorded	We propose to eliminate the type and setting of each session because it can be derive from the ID which CDC assigns to the lifestyle program/health coaching session, which makes this redundant information to collect through MDEs.
Item 20g	20g. Completion of Lifestyle Program (LSP)/ Health Coaching (HC) Yes – Lifestyle Program/Health Coaching is Complete Yes – Intensive Follow-Up No – Lifestyle Program/Health Coaching is still in progress No – Withdrawal/Discontinued No answer recorded	We propose to eliminate the completion of lifestyle program/ health coaching of each session because it can be derive from the ID which CDC assigns to the lifestyle program/health coaching session, which makes this redundant information to collect through MDEs.

Exhibit 3. Modifications to Element Questions or Response Options (25):

We propose to rename 3 elements (12a, 12b, and 12c) to increase data clarity; rephrase 6 elements (4d, 7c, 7d, 7e, 16a, and 16b) to increase analytical utility; and combine 16 elements into 6 (4a, 4b, 4c, 5a, 5b, 5c, 5d, 5e, 5f, 7a, 7b, 8a, 8b, 10a, 10b, and 10c) to streamline questionnaire flow and strengthen the analytical framework. The table below describes these elements in further detail:

MDE Field Number	Current Information Collection Phrasing	Proposed Changes	Rationale
Item 4a Item 4b Item 4c	4a. Do you have high cholesterol? Yes No Don’t know/Not sure Don’t want to answer No answer recorded 4b. Do you have hypertension (high blood pressure)? Yes No Don’t know/Not sure Don’t want to answer No answer recorded 4c. Do you have diabetes (Type 1 or Type 2)? Yes No Don’t know/Not sure Don’t want to answer No answer recorded	*4a. Which of the following conditions do you have? (1 for yes/2 for no): ___ Hypertension (high blood pressure) ___ High cholesterol ___ Diabetes (Type 1or Type 2) Don’t know/Not sure Don’t want to answer No answer recorded	Combining all three questions into just one question is based on input from grantees to enhance questionnaire flow.
Item 4d	4d. Have you been diagnosed by a healthcare provider as having any of these conditions: coronary heart disease/chest pain, heart attack, heart failure, stroke/transient ischemic attack (TIA), vascular disease, or congenital heart defects? Yes No Don’t know/Not sure Don’t want to answer No answer recorded	*4b. Have you had any of the following? (1 for yes/2 for no): ___ Stroke/TIA ___ Heart attack ___ Coronary heart disease ___ Heart failure ___ Vascular disease (peripheral arterial disease) ___ Congenital heart disease and defects Don’t know/Not sure Don’t want to answer No answer recorded	We propose to ask the participants to choose any of the following conditions because it will facilitate questionnaire flow and improve data quality.
Item 5a Item 5b Item 5c	5a. Do you take medication to lower your high cholesterol? Yes No No- could not obtain medication Not applicable Don’t know/Not sure Don’t want to answer No answer recorded 5b. Do you take medication to lower your blood pressure? Yes No No- could not obtain medication Not applicable Don’t know/Not sure Don’t want to answer No answer recorded 5c. Do you take medication to lower your blood sugar? Yes No No- could not obtain medication Not applicable Don’t know/Not sure Don’t want to answer No answer recorded	*5a. Was medication prescribed to lower (1 for yes; 2 for no): ___ Blood Pressure ___ Cholesterol (Statin) ___ Cholesterol (Other Prescribed Medications) ___ Blood Sugar Not Applicable Don’t know/Not sure Don’t want to answer 9. No answer recorded	We propose to combine all three questions regarding medication into a rephrased question based on input received from grantees to facilitate questionnaire flow.
Item 5d Item 5e Item 5f	5d. During the past 7 days, on how many days did you take prescribed medication to lower your cholesterol? Number of days 0. None 55. Not applicable 77. Don’t know/Not sure 88. Don’t want to answer 99. No answer recorded 5e. During the past 7 days, on how many days did you take prescribed medication (including diuretics/water pills) to lower your blood pressure? Number of days None 55. Not applicable 77. Don’t know/Not sure 88. Don’t want to answer 99. No answer recorded 5f. During the past 7 days, on how many days did you take prescribed to lower your blood sugar (for diabetes)? Number of days None 55. Not applicable 77. Don’t know/Not sure 88. Don’t want to answer 99. No answer recorded	*5c. During the past 7 days, how many days did you take prescribed medication for the following conditions: (0-7) High Blood Pressure (0-7) High Cholesterol (0-7) High Blood sugar Don’t want to answer Not applicable	We propose to combine the participant’s medication adherence into a single question to streamline questionnaire flow.
Item 7a Item 7b	7a. How much fruit do you eat in an average day? Number of cups 00. None Don’t want to answer No answer recorded 7b. How many vegetables do you eat in an average day? Number of cups 00. None Don’t want to answer No answer recorded	*7a. How many cups of fruits and vegetables do you eat in an average day? __ Number of cups 00. None 88. Don’t want to answer No answer recorded	We propose to combine these into one question. Scientific studies demonstrate there is no analytical significance to separating the two measurements.
Item 7c	7c. Do you eat two servings or more of fish weekly? Yes No Don’t want to answer No answer recorded	*7c. Do you eat fish at least two times a week? Yes No Don’t want to answer No answer recorded	We propose to rephrase this question as grantees report that participants often are unable to quantify two servings. Simplifying the question to capture the behavior will result in more accurate responses.
Item 7d	7d. Do you eat 3 ounces or more of whole grain daily? Yes No Don’t want to answer No answer recorded	*7d. Thinking about all the servings of grain products you eat in a typical day, how many are whole grains? Less than half About half More than half Don’t want to answer No answer recorded	We propose to rephrase this question as grantees report that participants often are unable to quantify three ounces of whole grain. Simplifying the question to capture the behavior will result in more accurate responses.
Item 7e	7e. Do you drink less than 36 ounces (450 calories) of beverages with added sugars weekly? Yes No Don’t want to answer No answer recorded	*7e. Do you drink less than 36 ounces (450 calories) of sugar sweetened beverages weekly? 1. Yes 2. No 8. Don’t want to answer 9. No answer recorded	We propose to rephrase this question to align with common language. Simplifying the question to capture the behavior will result in more accurate responses.
Item 8a Item 8b	8a. How much moderate physical activity do you get in a week? Number of minutes 000. None 888. Don’t want to answer 999. No answer recorded 8b. How much vigorous physical activity do you get in a week? Number of minutes 000.aNone 888. Don’t want to answer 999. No answer recorded	*8a. How many minutes of physical activity (exercise) do you get in a week? __ Number of minutes 000. None 888. Don’t want to answer 999. No answer recorded	We propose to combine this question because it is statistically relevant to measure the combined minutes of physical activity, regardless of moderate or vigorous.
Item 10a Item 10b Item 10c	10a. Thinking about your physical health, which includes physical illness and injury, on how many days during the past 30 days was your physical health not good? ___ Number of days Don’t know/Not sure Don’t want to answer No answer recorded 10b. Thinking about your mental health, which includes stress, depression, and problems with emotions, how many days during the past 30 days was your mental health not good? ___ Number of days Don’t know/Not sure Don’t want to answer No answer recorded 10c. During the past 30 days, on about how many days did poor physical or mental health keep you from doing your usual activities, such as self-care, work, or recreation? ___ Number of days Don’t know/Not sure Don’t want to answer No answer recorded	*10a. Over the past 2 weeks, how often have you been bothered by any of the following problems? (Check 0 ̶ not at all/1 ̶ several days/2 ̶ more than half/3 ̶ nearly every day) ___ Little interest of pleasure in doing things ___ Feeling down, depressed, or hopeless Don’t want to answer 9. No answer recorded	Previously we utilized the 30-day mental screener that was part of a Quality of Life screening tool. The National Institute of Health suggested to use the Patient Health Questionnaire (PHQ-2), which is a mental health survey, will now accurately reflect stress-related hypertension.
Item 12a.	12a. Blood Pressure Measurement Date (Office Visit Date) MM/DD/CCYY Date	* 12a Clinical Assessment Date (Office Visit Date) MM/DD/CCYY Date	We propose to rename Blood Pressure Measurement Date to Clinical Assessment Date because it is at the clinical assessment that the blood pressure is measured.
Item 12b.	12b. Systolic Blood Pressure Measurement #1 Blood pressure (mmHg)	*12b. Systolic Blood Pressure Measurement Blood pressure (mmHg)	We propose to rename Systolic Blood Pressure Measurement #1 to Systolic Blood Pressure Measurement. We will allow up to four entries under this MDE. The first entry will be mandatory; however, grantees have requested these optional fields so that they can enter up to three additional readings.
Item 12c.	12c. Diastolic Blood Pressure Measurement #1 Blood pressure (mmHg)	*12c. Diastolic Blood Pressure Measurement Blood pressure (mmHg)	We propose to rename Diastolic Blood Pressure Measurement #1 to Diastolic Blood Pressure Measurement. We will now allow up to four entries under this MDE. The first entry will be mandatory; however, grantees have requested these optional fields so that they can enter up to three additional readings.
Item 16a.	16a. If average SBP >180 or DBP >110, what is the status of the workup? Workup complete Follow-up – workup by alternate provider Not an alert reading Client refused workup ____ Workup not completed, client lost to follow-up	*16a. Is a medical follow-up for blood pressure reading necessary? Medically necessary Not medically needed Medically necessary follow-Up appointment declined	We propose to modify this question as the current question and the response option are not capturing sufficient detail to assist with program monitoring. Grantees have requested more flexibility in the use of this field which will be accomplished by this new wording.
Item 16b.	16b. If Average SBP >180 or DBP >110, Workup Date MM/DD/CCYY Date	*16b. What is the date of the medically necessary follow-up appointment? MM/DD/CCYY date	We propose to modify the language of the question to enhance program monitoring. This will assure that all participants with potentially uncontrolled hypertension can be referred to a medically necessary follow-up appointment. This change will synchronize this MDE with questionnaire flow.

Exhibit 4. Supplemental Elements/Questions (5)

We purpose to add five supplemental programmatic elements detailed in the table below.

MDE Field Name/Proposed Location	Proposed Supplemental MDEs	Rationale
Navigation Proposed Location: 2d.	*2d. Were the navigation services paid for by: NBCCEDP funds WISEWOMAN funds Indian Health Service/Tribal funds Other Not Applicable	We propose to capture navigation status within the intake categories to accurately account for all women served through federally-funded WISEWOMAN, which is relevant due to the changing healthcare landscape. CDC is required to report this number annually.
Aspirin Proposed Location: 5b	*5b. Are you taking aspirin daily to help prevent a heart attack or stroke: Yes No Don’t know/Not sure Don’t want to answer No answer recorded	We propose to supplement the medication questions because of its important use as a treatment for cardiovascular events.
Monitored Proposed Location: 5d	*5d. After being prescribed medication, on what date(s) did the participant have her blood pressure re-measured either by a healthcare provider, or with another community resource? MM/DD/CCYY Date	We propose to have multiple date options included as an MDE because grantees have requested these optional fields so that they can enter up to four follow-up dates for participants who have been prescribed blood pressure medications, and better monitor participants
AlcDay Proposed Location: 7f	*7f. In the past 7 days, how often do you have a drink containing alcohol? (0-7) days Don’t want to answer No answer Recorded	As a part of our nutrition evaluation we were not accurately accounting for significant source calories from alcohol consumption. This supplements our existing nutrition questions.
AlcFreq Proposed Location: 7g	*7g. How many alcoholic drinks, on average, do you consume during a day you drink? (0-7) days Don’t want to answer No answer Recorded	As a part of our nutrition evaluation we were not accurately accounting for significant source calories from for an alcohol consumption. This supplements our existing nutrition questions.