The menopause, hormone replacement therapy and informed consent:Are women in an under-resourced country adequately aware?

N. R. MAHARAJ, R. GANGARAM & J. MOODLEY

Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of KwaZulu, Natal, Durban,

South Africa

SummaryRecent evidence on the long-term effects of HRT have resulted in increased emphasis being placed on individualisedcounselling, patient choice and informed consent when managing the menopause. We assessed whether women in an under-resourced country have adequate knowledge of the menopause/HRT to engage in patient – provider discussions and providefull informed consent for HRT. Specific ‘knowledge scores’ for the menopause and HRT were developed and utilised instructured questionnaires to determine the existing levels of knowledge in 150 women from different racial, educational andoccupational backgrounds. Some 92% were aware of the menopause and 54% were aware of HRT. Specific knowledge aboutthe menopause and HRT overall was low (39% and 38%, respectively). There was a significant association between highereducation levels, race and occupational status on the knowledge of the menopause but not of HRT. Television, radio andpamphlets were the preferred sources to gain further information. There is a need to create awareness and provide furthereducation to women in under-resourced countries about the menopause and HRT to empower them to make informedchoices about their health during this period.

Keywordsmenopause, hormone therapy, awareness, consent

Introduction

Hormone replacement therapy (HRT) has been widely

used for the treatment of menopausal symptoms since the

1950s (Barret-Connor 2003). However, accumulating

evidence from recent trials (Rossouw et al. 2002; Hulley

et al. 1998; Grady et al. 2002) on the risks and side-effects

of hormonal therapy (HRT) has resulted in a change in the

management of the menopause from ‘over the counter’

prescriptions to individualised counselling, patient choice

and informed consent when developing a suitable plan of

care. Women in both poor- and well-resourced countries

are therefore left with the daunting task of making

decisions on hormonal treatment for menopausal symp-

toms and long term prophylaxis. Informed consent for the

use of HRT however, can only be suitably obtained if

women are adequately informed, have availed them-

selves to information, and have an appropriate level of

knowledge and understanding of the menopause and its

treatment.

The experience of the menopause among women in

under-resourced countries is probably framed within a

different set of social and cultural parameters than those in

well-resourced countries, where most women are educated

and employed, and where awareness of menopausal issues

can easily be achieved through readily available resources,

such as the mass media. In South Africa, high rates of

illiteracy, diversity in occupational status and racial and

economic differences, among others, contribute to low

levels of awareness of the menopause and HRT, further

providing a barrier to successful individualised counselling

and the attainment of true informed consent.

In this study, the level of awareness of the menopause

and HRT among a heterogeneous group of women was

assessed and the impact of factors like education, race and

occupational status evaluated. The study also aimed to

identify the most appropriate means to provide further

education in the community, in order to fill this potential

void.

Method

A study population comprising 150 urban women (50%

African, 22% Indian, 8% coloured, and 20% white) from

various sites around Durban, South Africa, aged between

18 and 40 years were recruited and informed of the study,

following institutional ethical approval. Following in-

formed consent, the women were provided with structured

questionnaires (in English and isiZulu, the local indigenous

language), which were evaluated on completion. The

questionnaire assessed: (1) sociodemographic characteris-

tics; (2) knowledge of the existence and specific issues

relating to the menopause; and (3) knowledge of the

existence and specific issues on HRT. Statistical analyses

were made in the following categories: demographic data,

educational levels, racial variations and occupational

differences with regard to knowledge of the menopause

and HRT. Analyses regarding the sources of information

and preferences on the ways to educate the community

Correspondence: N. R. Maharaj, Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, Private Bag 7, Congella 4013,

South Africa. E-mail: maharajn13@ukzna.c.za

Journal of Obstetrics and Gynaecology, April 2007; 27(3): 300 – 304

ISSN 0144-3615 print/ISSN 1364-6893 online � 2007 Informa UK Ltd.

DOI: 10.1080/01443610701227943

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were also analysed. The most appropriate means of

providing future education about the menopause to the

women was also assessed. The questionnaire was validated

by the evaluation of the initial 10 randomly allocated

questionnaires in each racial group, which were completed

successfully. Women above 40 years were excluded in

order to minimise positive bias, resulting from those who

were perimenopausal, had an early menopause, or who

may have acquired specific information about the meno-

pause transition. Women who were past or present users of

HRT were also excluded. Teenagers were excluded due to

the poor association of the menopause with adolescent

reproductive health issues. Tertiary education was defined

as completion of at least 1 year of study at a tertiary

institution. Occupational categories of these women

included teachers, administrators, accountants and engi-

neers, who were classified as ‘other professionals’. Sales

personnel included saleswomen and sales representatives.

Unskilled workers included cleaners, caretakers and gen-

eral assistants. General workers included semi-skilled

personnel and manual labourers employed in factories.

Women in technical and administration fields were also

included.

Statistical analysis

The assessment of knowledge of the menopause and HRT

was determined by the application of a ‘knowledge score’ to

part of the questionnaire (Table I). This was calculated by

allocating a point to positive answers to questions relating

to the menopause and HRT. Questionnaires from those

respondents who were aware of the menopause and HRT

were subjected to further analysis. A secondary analysis of

differences in the knowledge of menopause and HRT in

educational, occupational and racial categories was also

performed. This was achieved with the application of the

Bonferroni correction factor for multiple comparisons.

ANOVA was used to calculate the mean score between

the two educational groups. Univariate categorical data

analysis in the form of w2 tests for association between the

education categories and the outcome on the ways to

educate the community on the menopause and HRT was

performed.

Results

Data from 139/150 questionnaires were found suitable for

further analysis, those remaining were incomplete. Table II

represents the demographic data obtained from all women.

The mean age was 31 years. The majority of the patients

had obtained secondary school education (45.3%) and

tertiary education (49.6%), in comparison with those

having only reached primary school level (4.3%) and those

having had no formal education (0.7%). The racial com-

position of the study cohort, i.e. 70 African, 30 Indian,

27 white and 11 coloured, was representative of the racial

composition of the area. There was also a significant

association (p5 0.001) between race and educational

levels, the majority of African women (71.4%) had received

only primary and secondary school education in contrast to

white women, the majority of whom (77.8%) had received

tertiary education.

The majority of women were aware of the entity of meno-

pause in both education groups (92% overall), however

there was a low mean score (38.8%) and a significant

difference (p5 0.001) in the knowledge scores between the

groups, where better educated women achieved significantly

higher scores (Table III).

In contrast to the high percentage that were aware of the

entity of the menopause (92%), only just over half (54%

overall) of the women were aware of HRT. There was a

significant difference in the number of women aware of

the existence of HRT between the two education groups

(p5 0.001), with a greater number of better educated

women being aware. However, the mean knowledge

score was low (38), and there was no significant difference

in the score between the two groups (p¼ 0.154)

(Table IV).

Table I. Determination of knowledge scores

Menopause HRT

Enquiry Point Enquiry Point

Awareness of entity called menopause 1 Awareness of HRT 1

Physiological ageing of ovary 1 Beneficial effects of HRT: 5

Development of health associated problems 1 Hot flushes

Specific health related problems: 13 Urogenital symptoms

Hot flushes Mood swings

Irritability Bone strengthening

Moodiness Maintaining memory

Poor concentration Side-effects of HRT: 5

Insomnia Breast tenderness

Dyspareunia Breast cancer

Dryness of vagina Thromboembolism

Loss of libido Menstruation

Pruritis Heart disease

Dysuria Routes of treatment: 4

Frequency Tablets

Backache Through skin

Depression Through tissue fat

Through vagina

Total 16 (100%) Total 15 (100%)

HRT and informed consent 301

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There was no significant difference in the awareness of

the existence of the menopause and HRT among the racial

groups, but a significant difference in the mean menopau-

sal and HRT awareness score was noted, with African

women having a significantly lower knowledge in compar-

ison to the other race groups, after application of the

Bonferroni correction factor was applied. Assessments

along occupational categories showed a significant differ-

ence in the menopause knowledge score (p¼ 0.000) be-

tween the category of ‘cleaning staff’ and other occupation

groups but the HRT knowledge score was not significantly

different (p¼ 0.179) (Table V).

The latter part of the study investigated preferences of

the women regarding the options that could be used to

disseminate knowledge. The majority of women (66.2%)

preferred television as a suitable source from which to gain

information, followed by radio (54.7%) and pamphlet

education (50.4%) respectively (Table VI).

The main sources of information on the menopause and

HRT was family (52.5%), friends (44.6%) and the media

(41.7%), respectively. Surprisingly, healthcare settings like

the hospital, local clinic and general practitioners were

poor sources of information at 9.4%, 11.5% and 14.4 %,

respectively.

Discussion

In South Africa, as in many other middle income countries,

life expectancy is increasing and many women are likely to

use hormonal therapy as part of the armamentarium for the

management of the menopause (Kinsela and Ferreira

1997). The data, implications and reactions from ‘The

Women’s Health Initiative Study’ and other fronts regard-

ing hormone therapy, is notably reaching women, even in

under-resourced countries, more rapidly than ever in the

past (Rossouw et al. 2002; Arulkumaran and Johnson

2004). Furthermore, there is evidence to support the

importance of patient – provider discussions in achieving

optimal care (Akong 2001). The utilisation of tailored

decision aids is also beneficial in assisting women to make

appropriate decisions about hormone therapy (McBride

et al. 2002). Adequate knowledge and understanding of

the menopause and HRT is therefore necessary to enable

women to engage in meaningful discussions and to ensure

judicious use of HRT. However, this study shows that

the level of knowledge that woman in all groups in the local

community has to make informed choices on HRT remains

poor (mean score 38.8%, 38%, respectively).

While women in affluent societies may be better infor-

med about the implications of the menopause, a lack of

awareness of these implications among their counterparts

in under-resourced countries may result in fewer women

Table II. Demographic profile of all participants

Number of participants 139

Education:

Primary and secondary only (%) 50.4

Tertiary (%) 49.6

Menopause awareness:

Number of participants in group 1 64

Number of participants in group 2 64

HRT awareness:

Number of participants in group 1 21

Number of participants in group 2 54

Mean age (years) 31

Median parity 1.56

Married (%) 54

Highest education attained (%)

No education 0.7

Primary school 4.3

Secondary school 45.3

Tertiary education 49.6

Habits:

Smoking (%) 7.2

Alcohol (%) 18

Table III. Awareness of the menopause according to education

category

Education

category

No. aware of

the menopause

Mean

score (%)* SD 95% CI

Group 1 64 (91.4%) 30.3 20.3 25.4 – 35.2

Group 2 64 (92.8%) 47.2 17.2 51.3 – 43.0

Total 128/139 (92%) 38.75

*p value between the mean scores 50.001. SD, standard

deviation; CI, confidence interval.

Table IV. Awareness of HRT according to education category

Education

category

No. aware

of HRT

Mean

score (%) SD 95% CI

Group 1 21 (30%) 35.2 13.5 41.0 – 29.5

Group 2 54 (78.3%) 40.8 15.8 45 – 36.7

Total 75/139 (54%) 38

* **

SD, standard deviation; CI, confidence interval. *p5 0.001.

**p¼ 0.154.

Table V. Menopause knowledge scores in occupational categories (Bonferroni)

Dependent variable Occupation (I)** Occupation (J)** Mean difference (I – J) SE p 95% CI

Menopause

knowledge

score

Cleaner Teacher 730.3* 4.563 0.000 744.45 to 716.14

Technologist 729.13* 6. 396 0.000 748.97 to 79.28

General 716.21* 4.629 0.014 730.57 to 71.85

Administrator 727.32* 5.203 0.000 743.46 to 71.18

Other professionals 724.75 8.374 0.079 34.16 to 717.08

Sales 734.33 6.645 0.000 738.28 to 72.03

*The mean difference is significant at the 0.05 level. **Bonferroni application. SE, standard error.

302 N. R. Maharaj et al.

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being able to commence HRT for menopausal symptoms

or prophylaxis against long-term complications. Similar

findings were demonstrated by Arulkumaran and Johnson

(2004) and Pan et al. (2002). Inappropriately, women

received little information from healthcare providers

(general practitioners 35.3%, hospitals 33.1%), thus

emphasising the need for increased emphasis to be placed

on menopausal issues within the local healthcare system.

Most women in this study received their education about

the menopause from family and friends (52.5% and 44.6%,

respectively), consistent with findings from a smaller study

(Mashiloane et al. 2001) in the same metropolitan area.

Women therefore, tend to seek information from within

their own social circles, which constitutes an information

network.

The findings from the study also show that a higher

education level impacts positively on knowledge of the

menopause, although overall knowledge of specific issues

relating to the menopause and HRT remains low

(low mean menopausal knowledge score and mean HRT

score in the group with tertiary education (47.2% and

40.8%) and the even lower score (30.3% and 35.2%) in the

group with only school education (Tables III and IV).

Akong (2001) also showed low awareness of menopausal

information and therapeutic options even among educated

women. Since health issues may not be widely emphasised

in tertiary educational institutions, women with better

education are likely to obtain information due to better

access and the ability to identify and interpret infor-

mation received randomly. Although educated women are

more aware of the existence of HRT, the complex nature of

HRT treatments and related controversies may have

precluded a satisfactory interpretation of this, therefore

accounting for the lack of a significant difference in

the HRT knowledge scores between the two groups

(Table IV).

Multiple comparisons on racial groups revealed that

African women had a significantly lower knowledge of the

menopause compared with women of other race groups

when the Bonferroni correction factor was applied

(Table V). This probably reflects the lower levels of edu-

cation within this group, shown by the significant associa-

tion between race and educational level. Lack of exposure

to tertiary education in these women is probably due to

multiple factors including social, political, cultural and

financial reasons restricting access to higher education. In a

population-based survey carried out in South London, it

was further shown that women from minority ethnic groups

were less likely than white women to use hormone replace-

ment therapy (Harris et al. 1999).

Cleaning staff, when compared with most other occu-

pational categories, had significantly lower levels of know-

ledge of the menopause. A lower educational background,

social status and poor understanding of the information

may contribute to this. There was no significant difference

between the groups regarding knowledge of HRT.

The assessment of urban women only may constitute

bias, however in the absence of data, it is estimated that in

rural areas, the percentage of knowledgeable women may

be lower due to lower levels of education, language barriers

and less pervasiveness of information there.

In conclusion, the data obtained reveal the need to edu-

cate and empower women about issues of the menopause,

at a time when individualised counselling and informed

consent is paramount in the administration of HRT.

Education strategies for healthcare workers, e.g. work-

shops, lectures and continuing medical education initia-

tives are necessary for healthcare personnel serving

the community, to enable them to counsel menopausal

women adequately. Academic departments and academic

societies also have a role to play in promoting consensus

opinions where controversy exists. Taking into considera-

tion the diverse educational backgrounds, socioeconomic,

occupational, racial and physical characteristics of the

study cohort, overall, television, followed by radio and

pamphlets was found to be the most popular means to fill

this void.

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Table VI. Optimal medium to promote awareness

Knowledge medium (%)

Pamphlets 50.4

Newspapers 34.5

Radio 54.7

Television 66.2

Internet 18.7

General practitioner 35.3

Specialists 13.7

Hospitals 33.1

Forums 20.1

Religious gatherings 20.1

Traditional healers 5.0

Community leaders 9.4

Workshops 35.3

Local store 7.9

Magazines 1.4

HRT and informed consent 303

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