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Protocol - Hormonal Therapy

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Description:

Female participants are asked whether they have ever used prescription female hormones (number of months taken, types, dosage) and then asked whether they are currently using it. They are asked whether they are using any over-the-counter preparations for hormone replacement or post-menopause symptoms.

Specific Instructions:

Note: the prepopulated/embedded dates of the original study protocol were removed for clarity of Toolkit users.

Protocol:

1. Have you used prescription female hormones? (Not including contraceptives.)

[ ] Yes

a) How many months did you use hormones?

[ ] 1 - 4 months

[ ] 5 - 9 months

[ ] 10 - 14 months

[ ] 15 - 19 months

[ ] 20 - 25 months

[ ] 26 - 30 months

[ ] 31 - 35 months

36+[ ]months

b) Are you currently using them (within the last month)?

[ ] Yes

[ ] No

If no, skip to part d

c) Mark the type(s) of hormones you are CURRENTLY using:

[ ] Combined:

[ ] Prempro,

[ ] Premphase,

[ ] Combipatch,

[ ] FemHRT

[ ] Estrogen

[ ] Oral Premarin or Conjugated estrogen

[ ] Patch Estrogen

[ ] Vaginal Estrogen

[ ] Estrace

[ ] Estrogen gels, creams, or sprays on skin

[ ] Estratest

[ ] Other Estrogen Specify:____________

[ ] Progesterone/Progestin:

[ ] Provera/Cycrin/MPA

[ ] Vaginal

[ ] Micronized (e.g., Prometrium)

[ ] Other progesterone (specify type):___________

d) If you used oral conjugated estrogen (e.g., Premarin), what dose did you usually take?

.30[ ]mg/day or less

.45[ ]mg/day

.625[ ]mg/day

.9[ ]mg/day

1.25[ ]mg/day or higher

[ ] Unsure

[ ] Did not take oral conjugated estrogen

[ ] No (skip to 2)

2. Are you currently using any of these over-the-counter (OTC) preparations for hormone replacement?

[ ] Soy estrogen products

[ ] Black cohosh (e.g., Remifemin)

[ ] Natural progesterone cream/wild yam

[ ] Other OTC

Protocol Name from Source:

Nurses’ Health Study II (NHS II)

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

Pencil and paper

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self-administered questionnaire

Life Stage:

Adult

Participants:

Women aged 25-42 in 1989.

Selection Rationale

Among several vetted national surveys of hormonal therapy, this protocol is the most comprehensive, while not being too burdensome within the context of a general survey.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Female Endocrine Therapy 3007460 CDE Browser
Human Phenotype Ontology Premature ovarian insufficiency HP:0008209 HPO
Derived Variables

None

Process and Review

The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.

Guidance from ERP 5 includes the following:

• Updated protocol

• New Data Dictionary

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive (link)

Source

Harvard Medical School. (2015). Nurses’ Health Study II, 2015. Boston, MA. Question numbers 7-8.

General References

Townsend, M. K., Curhan, G. C., Resnick, N. M., & Grodstein, F. (2009). Postmenopausal hormone therapy and incident urinary incontinence in middle-aged women. American Journal of Obstetrics and Gynecology, 200(1), 86.e1-5.

Protocol ID:

100702

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX100702_Hormonal_Therapy_Over_The_Counter_OTC
PX100702020000 Are you currently using any of these more
over-the-counter (OTC) preparations for hormone replacement? show less
N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones
PX100702010100 Have you used prescription female hormones? more
(Not including contraceptives.) show less
N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Currently_Using
PX100702010300 Are you currently using them (within the more
last month)? show less
N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Currently_Using_Type
PX100702010401 Mark the type(s) of hormones you are more
CURRENTLY using: show less
N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Currently_Using_Type_Other
PX100702010402 Mark the type(s) of hormones you are more
CURRENTLY using: show less
N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Length_Use
PX100702010200 How many months did you use hormones? N/A
PX100702_Hormonal_Therapy_Prescription_Female_Hormones_Oral_Conjugated_Dose
PX100702010500 If you used oral conjugated estrogen (e.g., more
Premarin), what dose did you usually take? show less
N/A
Reproductive Health
Measure Name:

Hormonal Therapy

Release Date:

April 11, 2017

Definition

A question to determine whether a female has ever taken hormonal therapy for treatment or prevention of cancer or for another reason. As hormonal therapy is known to affect risk of cardiovascular disease and cancer, it is an important environmental risk factor for women.

Purpose

To assess use of hormonal therapy.

Keywords

Reproductive health, estrogen, Nurses’ Health Study, NHS