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13. Use of hormone replacement therapy (HRT)

A number of studies have shown a marked reduction in risk of coronary heart disease among postmenopausal women using estrogen (1, 2). Reduction of risk is reported to be even greater among women using combined estrogen/progesterone therapy when compared to non-users or estrogen-only users (2).

13.1 Questions

13.1.1 WHO MONICA Project

In the MONICA Manual (3) there is one question about the use of estrogen for the menopausal symptoms and two questions about the menopausal status of woman.

1. "Are you still having monthly periods?"
1 = yes, as usual
2 = yes, but irregularly
3 = no
8 = not relevant
9 = insufficient data
|__|
2. "How old were you when your periods stopped completely?
88 = not relevant
99 = insufficient data
|__||__|
3. "Are you taking (in the last month) sex hormones (estrogens) for menopausal symptoms?"
1 = yes
2 = no
8 = not relevant
9 = insufficient data
|__|

The MONICA Manual (3) has additional instructions for the above questions.

Question 1.

Code 1 if she has her monthly periods (as her usual pattern)
Code 2 if she has had periods within the last 6 months but not as regularly as they used to be (excluding pregnancy)
Code 3 if she has had no periods for a period of six months or more
Code 8 for men and known pregnant women
Code 9 if insufficient information is available to use the other codes.

Question 2.

Code the age in years when she had six months free of periods.
Code 88 if Question 1 was coded 1, 2 or 8
Code 99 if insufficient information is available to use the other codes.

Question 3.

Code 1 if yes
Code 2 if no
Code 8 if Question 1 was coded 1 or 8
Code 9 if insufficient information is available to use the other codes.

13.1.2 Risk factor monitoring  in the Netherlands

In the Monitoring Project on Cardiovascular Disease Risk Factors no information about the use of hormone replacement therapy was collected. In the MORGEN-project following question was asked: (4)

1. Did you ever use estrogens for menopause related complaints?
1. Yes
2. No
3. Not relevant
|__|

13.1.3 Risk factor monitoring in Germany

The German Federal Health Survey 1998 collected through a physician interview information on the use of pharmacological agents. These were grouped into 34 categories depending on their indication (5). The question asked whether, during the past 12 months, medications of a particular drug category were used :

daily, or several times per week, or 1-2 times per week, or less than once a week, or 1-3 times per month, or seldom, or never.

One of the drug categories was for "medication for controlling problems during menopause", another was "other hormone preparations (estrogens)".

13.1.4 UK National Health Survey

The questions for women about their menopausal status and use of HRT, asked in the self-administered form, are as follows (2). 

1. Are you still having periods (menstruating)?
Yes (Go to Question 4)
No (Go to Question 2)
 |__|
2. Did your periods stop as a result of an operation?
Yes (Go to Question 3)
No (Go to Question 4)
|__|
3. Have you had any ovaries removed?
Yes
No
|__|
4. Have you ever been on Hormone Replacement Therapy (HRT)?
Yes
No (Stop filling in the questionnaire)
|__|
5. At what age did you start Hormone Replacement Therapy? |__||__|
6. Are you still on Hormone Replacement Therapy?
Yes (Stop filling in the questionnaire)
No
|__|
7. At what age did you stop Hormone Replacement Therapy? |__||__|

13.1.5 National Health and Nutrition Examination Survey (NHANES III), US

During the examination at Mobile Examination Center (MEC),  the following questions were put to female respondents age 17 and over (6):

1. Are you pregnant now?
1. Yes 
2. No (Go to Question 3)
9. Don't know (Go to Question 3)
|__|
2. Which month of pregnancy are you in?
___ month
|__|__|
3. Have you had a period in the past 12 months?
1. Yes
2. No  (Go to Question 5)
9. Don't know (Go to Question 5)
|__|
4. About how long ago was your last period?
1. Having it now (Go to Question 9)
2. Less than 2 months age (Go to Question 9)
3. 2-3 months (Go to Question 7)
4. 4-6 months (Go to Question 7)
5. 7-9 months (Go to Question 7)
6. 10-12 months (Go to Question 7)
|__|
5. About how old were you when you had your last period?
Age (Go to Question 7)
Don't know (Go to Question 6)
|__||__|
6. Where you younger than 20, 20 to 29, 30 to 39, 40 to 44, 45 to 49, 50 to 54, or 55 or older?
1. Younger than 20
2. 20-29
3. 30-39
4. 40-44
5. 45-49
6. 50-54
7. 55+
9. Don't know
|__|
7. Have you ever had a hysterectomy?
1. Yes
2. No (Go to Question 9)
9. Don't know (Go to Question 9)
|__|
8. How old were you when you had your (hysterectomy/uterus/womb removed)?
Age
|__||__|
9. Have you had one or both of your ovaries removed (either when you had your uterus removed or at another time)?
1. Yes
2. No
9. Don't know (Go to Question about birth control pills)
|__|
10. Were both ovaries removed or only one?
1. Both
2. One
9. Don't know
|__|
11. How old were you when you had your (ovary/ovaries) removed?
Age
Don't know
|__||__|
12. Have your periods presently stopped due to radiation or chemotherapy?
1. Yes
2. No
9. Don't know
|__|
13. Have you ever taken estrogen or female hormone pills by mouth other than oral contraceptive pills?
1. Yes
2. No (Go to Question 17)
9. Don't know (Go to Question 17)
|__|
14. How old were you when you first took the estrogen or female hormone pills?
Age
Don't know
|__||__|
15. How long ago did you stop taking the estrogen or female hormone pills or are you still taking them?
Still taking now
Less than 1 month ago
___ months ago
___ years ago
|__||__|
16. Not counting any time when you stopped taking them for how many years altogether have you taken estrogen or female hormone pills?
Less than 1 year
___ years
|__||__|
17. Have you ever taken or used estrogen or female hormones in the for of vaginal cream, suppository, or injection?
1. Yes
2. No (Go to Question 21)
9. Don't know (Go to Question 21)
|__|
18. How old were you when you first used female hormones in the form of a vaginal cream, suppository, or injection?
Age
|__||__|
19. How long ago did you stop using the vaginal cream, suppository, or injection or are you still using them?
Still using
Less than 1 month ago
___ months ago
___ years ago
|__||__|
20. Not counting any time when you stopped using the vaginal cream, suppository, or injection, for how many years altogether have you used them?
Less than 1 year
___ years
Don't know
|__||__|
21. Have you ever used female hormones in the form of patches that are placed on the skin?
1. Yes 
2. No
9. Don't know
|__|
22. How old were you when you first used the hormone patches?
Age
Don't know
|__||__|
23. How long ago did you stop using the hormone patches or are you still using them?
Still using
Less than 1 month ago
___ months ago
___ years ago
Don't know
|__||__|
24. Not counting any time when you stopped using the female hormone patches, for how many years altogether have you used them?
Less than 1 year
___ years
|__||__|

Following detailed instructions were given for the above questions:

Question 1. Question is only asked of SP's less than 50 years of age.

Question 2. We want the current month of pregnancy. For example, a women in her fifth month of pregnancy (4-12 months pregnancy) has completed her fourth month, but five is the correct response to the question. The number of months since the beginning of her last normal menstrual period. A normal period is one which lasts approximately the same amount of time with the same amount of flow as usual. If the SP is unsure, use probes to help her differentiate the last normal period from periodic spotting or bleeding during the pregnancy. If the SP still is unsure, try to probe for which trimester she is in and indicate to the nearest month based on her response to the probe.

Question 3. Probe to clarify whether or not the SP has had any bleeding or spotting in the last 12 months. We consider that women who report irregular bleeding or "spotting" have not completed menopause and should be coded "yes" in response to this question.

Question 4. Probe to obtain the number of days ago the SP's last period ended. Have the SP use the calendar to help count the days. It may be necessary to have the SP locate the first day of her last period on the calendar, then count through the last day for the SP. Enter "1" if the SP is currently having her period.

If the SP indicates that she is currently having her period, or if it ended less than two months ago, you will proceed to Question 9. However, if her period ended longer than two months ago, have the SP indicate the number of months and mark the corresponding response option. You will then skip to Question 7.

Questions 5 and 6. These questions are asked only of women whose periods have stopped entirely. Some SP's may remember this by a date or year. If this occurs, help the SP convert this to an age. If the SP cannot remember her exact age, obtain a "best estimate".

If the response to Question 5 is Don't know, ask Question 6 in an attempt to probe the response into an age range. Otherwise, skip to Question 7.

Question 7. If the SP is currently pregnant, you will not ask Question 7. The surgical removal of the uterus or womb is called a hysterectomy. A tubal ligation would not be counted as a "yes" response to this question.

Question 8. Obtain as exact an age as possible. If the SP remembers the operation in terms of a year rather than her age, help her to convert the year to her age at the time she underwent her hysterectomy.

Question 9. An operation to remove her ovaries is called an oophorectomy. If the ovaries were removed at the same time as a hysterectomy (removal or the uterus) was performed, it would be called a total hysterectomy. It is possible to have both ovaries removed, only one ovary removed, or only part of an ovary removed. If only part of the ovary was removed, enter "no", and record this information in the comments. You will then skip to Question about contraceptive pills. The removal of one or both ovaries should be considered a "yes" answer.

Question 11. Question asks for the SP's age at time of that surgery. If both ovaries were removed, record the age of the SP at the time of the most recent surgery.

Question 12. This question is only asked of SP's who have not had a period in the last 2 months and have not had a hysterectomy.

Question 13. This refers to the use of hormone pills (e.g. estrogen, premarin) prescribed by a doctor and taken orally to regulate the menstrual cycle.

Question 14. Be sure the SP indicates the age when hormone pills were first taken, regardless of the reason for initiating hormone treatment.

Question 15. Obtain information on how recently the SP last took pills or whether she is currently taking them. Probe for as accurate information as possible.

Questions 17-20. SP's who answer "no" or "Don't know" to Question 17 are skipped out of this series to Question 21. If a number of years have elapsed since the SP stopped using the vaginal cream, suppositories or injections, be sure to obtain the best estimate of the number of years since they were used. In Question 20, give the SP sufficient time to add up various periods of time during which the vaginal cream, suppositories or injections were used.

Questions 21-24. If the SP has never used patches or does not know, you will skip this set of questions.

13.1.6 Risk factor monitoring in Norway

In the National Cardiovascular Screening, following questions were asked for women:

1. How old were you when you got your first periods? |__||__| year old
2. Do you still have regular periods? 
Regular meaning that periods have not been missing more than 3 months at the time during the past year.
1. Yes
2. No
|__|
3. For those who answered yes: About how many days ago did your last periods before this healthexamination start?
1. Less than 8
2. 8-14
3. 15-21
4. More than 21 days ago
|__|
4. If you at the time don't have regular periods, give the reason
1. Periods stopped naturally at least 6 months ago (menopause)
2. Periods stopped because of operation, radiotherapy or chemotherapy
3. Uncertain why periods stopped (probably menopause)
4. Pregnant for less than 6 months 
5. Pregnant for 6 months or more
6. Have just given birth or is breast feeding and has not jet got periods back
7. Have irregular periods with very short or long pauses
8. No periods at all or irregular periods due to use of hormone replacement therapy
9. Has never had periods
|__|
5. If you haven't in long time had periods, how old were you when they stopped? |__||__| years old
6. How many children (live births) have you given birth? |__||__|
7. How long have you breast fed your children in total?
(For example. 3 children: 1+6+10=17 months)
|__||__| months
8. Do you use not or have you used earlier
1. Contraceptive pills (also minipills) or contraceptive injections
2. Regular intrauterine device (IUD)
3. Hormone-releasing IUD
4. Estrogen/progesteron (tablets, plaster, injection)
5. Estrogen (cream or vaginal suppositories)
Now  Earlier, not now  Never
|__|              |__|              |__|
|__|              |__|              |__|
|__|              |__|              |__|
|__|              |__|              |__|
|__|              |__|              |__|
9. If you now use contraceptive pills, hormone-releasing IUD or hormones for menopause: 
Which brand(s) you use?
|______________________|
10. About how long have you used this brand?
All together |__||__| years
Less than a year: |__||__| months

13.2 Quality assurance

WHO MONICA Project

The detailed information about the availability and quality of data on use of estrogen is given in the quality assessment of data on menopausal status and hormones in the WHO MONICA Project (7). In MONICA, some centres asked about the ever use of hormones for menopausal symptoms. This can cause results to be misleading for present use of estrogen.

No information on the quality assurance procedures and result are available for Risk factor monitoring in the Netherlands, Risk factor monitoring in Germany, UK  National Health Surveys, and NHANES III.

13.3 Indicators used for reporting the results

WHO MONICA Project

In the WHO MONICA Project the proportion of women using estrogen for menopausal symptoms is reported (8).

Risk factor monitoring in the Netherlands

No information available

Risk factor monitoring in Germany

The German Federal Health Survey 1998 reported prevalence of medication use by drug categories and ranked them by prevalence for men and women and for the old and new states (5). One such drug category defined medication for problems during menopause.

UK  National Health Surveys

In the National Health Survey in the UK the proportion of current, past and ever users of hormone replacement therapy were reported by 10-year age groups. Also the proportion of women in the above user groups who reported having surgical menopause were reported. Age distribution for the age when women started using hormone replacement therapy and mean duration of the use were reported. (9)

NHANES III

No information available.

13.4 Discussion and conclusions

The different studies did not ask the question on use of hormone replacement therapy in a uniform way. MONICA asks about the use of estrogen, National Health Survey in UK did not specify the type of hormone replacement therapy, and NHANES III combined estrogen and other female hormone use.

If the question is phrased to emphasize menopausal problems as indication for HRT, postmenopausal subjects on HRT may be missed. The questions in the UK Health Survey have addressed this problem, but there may be a simpler way to achieve the same goal. 

Most surveys did not distinguish between different forms of the hormone use, e.g. in form of pills, or patch, or injection, or vaginal cream, etc.


References

  1. Barrett-Connor E, Grady D. Hormone replacement therapy, heart disease, and other considerations. Annu Rev Public Health 1998;19:55-72.
  2. Calaf i Alsina J. Benefits of hormone replacement therapy--overview and update. Int J Fertil Womens Med 1997;42(Suppl 2):329-46.
  3. WHO MONICA Project. MONICA Manual. Part III: Population Survey. Section 1: Population survey data component. (1997). Available from: URL:http://www.ktl.fi/publications/monica/manual/part3/iii-1.htm, URN:NBN:fi-fe19981151
  4. Verschuren W. The protocol of the Monitoring Project on Cardiovascular Disease Risk Factors and the MORGEN-project. Personal communication. 2001
  5. Knopf H, Melchert HU. Subjective Angaben zur täglichen Anwendung ausgewählter Arzneimittelgruppen - Erste Ergebnisse des Bundes-Gesundheitssurveys 1998. Gesundheitswesen 1999;61 Spec No:S151-7.
  6. U.S. Department of Health and Human Services. National Health and Nutrition Examination Survey III. Interviewer's Manual. 1993. Available from: URL:http://www.cdc.gov/nchs/about/major/nhanes/nhanes3/cdrom/NCHS/MANUALS/FIELDINT.PDF 
  7. Lundberg V, Tolonen H, Kuulasmaa K, for the WHO MONICA Project. Quality assessment of data on menopausal status and hormones in the WHO MONICA Project. (1999). Available from: URL:http://www.ktl.fi/publications/monica/womenqa/womenqa.htm, URN:NBN:fi-fe19991131
  8. Tolonen H, Kuulasmaa K, Ruokokoski E, for the WHO MONICA Project. MONICA Population Survey Data Book. (2000). Available from: URL:http://www.ktl.fi/publications/monica/surveydb/title.htm, URN:NBN:fi-fe20001206
  9. The Stationary Office. Health Survey of England, Cardiovascular disease. Volume 1: Findings; Volume 2: Methodology & Documentation. 1999. Available from: URL:http://www.official-documents.co.uk/document/doh/survey98/hse98.htm

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