OS Participants

Women's Health Initiative Observational Study (NHLBI)

SS_A_Attachment_3-OS_Participant_Questionnaire_Instructions

OS Participants

OMB: 0925-0414

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0414 can be found here:

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Supporting Statement A
Attachment 3
OS Participant Questionnaire
Instructions

OBSERVATIONAL STUDY
PARTICIPANT QUESTIONNAIRE INSTRUCTIONS

Medical History Update
Activities of Daily Life
Health Follow-Up by Proxy
Medication and Supplement Inventory
Breast Cancer Prevention and Treatment Medications

WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

Page 1

FORM:

153 – MEDICATION AND SUPPLEMENT INVENTORY

Version:

1 – November, 2008

Description:

Self-administered or interviewer-administered; 9-page booklet; key-entered at the Clinical
Coordinating Center (CCC).

When used:

Collected one time as part of the annual contacts for Clinical Trial (CT) and Observational Study (OS)
participants enrolled in the WHI Extension Study. Completed at a non-routine contact when a
participant death is reported.

Purpose:

To collect updated information on the prescription and over-the-counter medications and nutritional
supplements currently being used by participants.

GENERAL INSTRUCTIONS
1.

The form is printed in both English (Form 153) and Spanish (Form 153S) versions.

The Form 153 for WHI Extension Study participants will be labeled and mailed from the CCC directly to the
participant.
•

The CCC mails the form to the participant and asks her to mail it back in a return envelope by a specified date.
Following the CCC mailing, if the participant does not return the Form 153 within 3 months of the first
mailing, it will be sent again. If the form is not returned within 2 months of the second mailing, the form will
be sent a third time. If the form is still not returned, CCC staff will contact the participants by telephone to
collect the information from willing participants. The CCC will data enter the forms, and will use the Medispan
database to code medications during the data entry process.

In the event that this form is collected by FC staff, the form should be sent to the CCC for data entry.

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WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

Page 2

Item Instructions
Cover page
1.

Date Received

Fill in date received at the CCC.

Reviewed By

Fill in standard 3-digit WHI employee ID of staff member reviewing the form for
data entry.

Contact Type

Mark appropriate box (phone, mail, other).

Prescription Medications
1.

Currently Taking
Prescription Medications

No/Yes. Participants indicating “No” skip to Q 4 in Section B.

2a.

Prescription Medication
Name

For each prescription medication listed, participant records the name of the
medication.

2b.

Prescription Medication
Strength

For each prescription medication listed, participant records the strength of the
medication.

2c.

Prescription Medication
Type

For each prescription medication listed, participant records the medication type,
e.g., capsule, tablet, cream, liquid, suppository, inhaler, injection.

2d.

Prescription Medication
Duration

For each prescription listed, participant indicates length of time taking medication.
Response choices are: 1. Less than a month; 2. 1-12 months; 3. More than 1 year.
Those indicating response 3 provide the actual number of years.

Repeat 2a-d for each prescription medication, up to 10 medications.
3.

Other Prescription
Medications

Participant records name of any other prescription medications they are taking, if
there was not enough room to list them in item 2 above.

Barriers to Prescription
Medications

Participant checks all barriers that apply.

Non-Prescription Medications
Participant indicates the following information for each of these non-prescription medications: aspirin, antiinflammatories, antacid or heartburn medicines, and natural female hormones. Participants can list up to 2 types of antiflammatories, antacids, and natural hormones.
5.

Taken the NonPrescription Medication
in Past Two Weeks

Yes/No. Participants indicating “No” skip to the next non-prescription medication.

Name of the NonPrescription Medication

For each medication they are taking, participant provides the name of the product.

Strength of the NonPrescription Medication

For each medication they are taking, participant provides the strength of the
product.

Non-Prescription
Medication – Frequency

Prescription Medication
Duration

For each medication they are taking, participant indicates how often they take it.
The options are: 1. Once a day or more; 2. 4-6 days a week; 3. 2-3 days a week; 4.
Once a week; 5. 1-3 days a month.
For each medication they are taking, participant indicates how long they have been
taking it. Response choices are: 1. Less than a month; 2. 1-12 months; 3. More
than 1 year. Those indicating response 3 also indicate the actual number of years.

I153V1.DOC 12/01/08

WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

Over-the-Counter Insulin

Page 3

Participants are asked if they are taking over-the-counter insulin Yes/No. Those
who indicate yes, are asked to provide the name of the product, the strength, how
often it is taken (1. Once a day or more; 2. Less than once a day) and how long it
has been taken (1. Less than a month; 2. 1-12 months; 3. More than 1 year. How
many years?)

Dietary Supplements
7
M/V.

7
Cal/
VitD.

7
Cal.

Daily Multi-Vitamin
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Daily Multi-Vitamin
Supplement – Product
Name

Participant provides the name of the product.

Daily Multi-Vitamin
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Daily Multi-Vitamin
Supplement – Duration

Participant indicates how long they have been taking it. Response choices are: 1.
Less than a month; 2. 1-12 months; 3. More than 1 year. Those indicating response
3 also indicate the actual number of years.

Calcium/Vitamin D
Supplementation Mixture
– Taken in Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Calcium/Vitamin D
Supplementation Mixture
– Product Name

Participant provides the name of the product.

Calcium/Vitamin D
Supplementation Mixture
– Strength

Participant provides strength of calcium and strength of vitamin D.

Calcium/Vitamin D
Supplementation Mixture
– Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Calcium/Vitamin D
Supplementation Mixture
– Duration

Calcium Single
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Calcium Single
Supplement – Product
Name

Participant provides the name of the product.

Calcium Single
Supplment - Strength

Participant provides strength of calcium.

Calcium Single
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Calcium Single
Supplement – Duration

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WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

7
VitD.

Page 4

Vitamin D Single
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Vitamin D Single
Supplement – Product
Name

Participant provides the name of the product.

Vitamin D Single
Supplment - Strength

Participant indicates strength of the vitamin D.

Vitamin D Single
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Vitamin D Single
Supplement – Duration

Date

Month/Day/Year the form was completed.

I153V1.DOC 12/01/08

WHI Extension Study - Form 154 - Breast Cancer Prevention and Treatment Medications (Ver. 1)

Page 1

FORM:

154 – BREAST CANCER PREVENTION AND TREATMENT MEDICATIONS

Version:

1 – November, 2008

Description:

Self-administered or interviewer-administered; 3-page booklet; key-entered at the Clinical
Coordinating Center (CCC).

When used:

Collected one time as part of the annual contacts for Clinical Trial (CT) and Observational Study (OS)
participants enrolled in the WHI Extension Study who have indicated a previous breast biopsy or
diagnosis of breast cancer on WHI Form 33/33D.

Purpose:

To collect updated information on specific types of medications (SERMS and aromatase inhibitors)
currently being prescribed for the prevention and treatment of breast cancer.

GENERAL INSTRUCTIONS
1.

The form is printed in both English (Form 154) and Spanish (Form 154S) versions.

The Form 154 for WHI Extension Study participants will be labeled and mailed from the CCC directly to the
participant. Form is only mailed to participants with a previous breast biopsy or diagnosis of breast cancer.
•

In the event that this form is collected by FC staff, the form should be sent to the CCC for data entry.

I154V1.DOC 12/01/08

WHI Extension Study - Form 154 - Breast Cancer Prevention and Treatment Medications (Ver. 1)

Page 2

Item Instructions
1.

Tamoxifen (Nolvadex) –
Ever Taken

No/Yes/DK. Participants indicating “No” or “DK” skip to Q2.

1.1.

Tamoxifen – Duration