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........................................................................................................................................................................................................... Disparities in knowledge and interest about benefits and risks of combined oral contraceptives Claudia Vogt and Marion Schaefer Institut fu ¨r klinische Pharmakologie und Toxikologie, Charite ´ Universita ¨tsmedizin, Berlin, Germany ABSTRACT Objectives This pilot study aimed at identifying counselling topics relevant to young women, at comparing their perceived and actual knowledge about combined oral contraceptives (COCs), and at determining the appropriate scope of counselling material about benefits and risks of COCs. Method Thirty women aged 18–24 completed an online questionnaire assessing information needs and knowledge about 25 medical conditions under consideration as potential counselling items (benefits, risks and myths) and preferences about counselling material. Results Respondents were unable to identify non-contraceptive benefits of COCs or potential severe health risks and had some misconceptions. They rated their knowledge of specific COC effects significantly lower than their corresponding interest in the effect. In contrast, the assessment of how well participants felt they were informed about benefits and risks was rated predominantly as ‘rather well’. Eleven items were identified as relevant to patients, the most relevant being cancer-related effects of COCs whereas there was less interest in thrombotic risk. Participants preferred detailed counselling materials and considered gynaecologists, patient information leaflets and the internet as their major sources of information. Conclusion While most women were confident of being knowledgeable about COCs, many were unaware of their knowledge gap. Healthcare professionals should proactively educate about items relevant to their patients. Counselling materials provided by the gynaecologist seem to be an appropriate communication channel. Additional efforts are needed to improve knowledge of the thrombotic and other risk associated with COCs. KEYWORDS Combined oral contraceptives; Knowledge; Benefits and risks; Contraception; Counselling; Evidence-based patient information ........................................................................................................................................................................................................... INTRODUCTION Informing patients adequately about benefits and risks of a medical treatment is essential for enabling them to give their informed consent for a treatment 1 . Sharing all relevant information with a patient is particularly necessary when other treatments are available and choice mainly depends on personal preferences 2 . One prominent example is the choice of a family planning (FP) method, where the selection ranges from less Correspondence: Claudia Vogt, Charite ´ Universita ¨tsmedizin Berlin, Institut fu ¨r klinische Pharmakologie und Toxikologie, Charite ´platz 1, 10117 Berlin, Germany. E-mail: [email protected] The European Journal of Contraception and Reproductive Health Care, June 2011;16:183–193 ª 2011 The European Society of Contraception and Reproductive Health DOI: 10.3109/13625187.2011.561938 Eur J Contracept Reprod Health Care Downloaded from informahealthcare.com by Laurentian University on 09/16/13 For personal use only.
Transcript
Page 1: Disparities in knowledge and interest about benefits and risks of combined oral contraceptives

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Disparities in knowledge and interest

about benefits and risks of combined

oral contraceptivesClaudia Vogt and Marion Schaefer

Institut fur klinische Pharmakologie und Toxikologie, Charite Universitatsmedizin, Berlin, Germany

A B S T R A C T Objectives This pilot study aimed at identifying counselling topics relevant to young

women, at comparing their perceived and actual knowledge about combined oral

contraceptives (COCs), and at determining the appropriate scope of counselling material

about benefits and risks of COCs.

Method Thirty women aged 18–24 completed an online questionnaire assessing information

needs and knowledge about 25 medical conditions under consideration as potential counselling

items (benefits, risks and myths) and preferences about counselling material.

Results Respondents were unable to identify non-contraceptive benefits of COCs or

potential severe health risks and had some misconceptions. They rated their knowledge of

specific COC effects significantly lower than their corresponding interest in the effect. In

contrast, the assessment of how well participants felt they were informed about benefits and

risks was rated predominantly as ‘rather well’. Eleven items were identified as relevant to

patients, the most relevant being cancer-related effects of COCs whereas there was less

interest in thrombotic risk. Participants preferred detailed counselling materials and

considered gynaecologists, patient information leaflets and the internet as their major sources

of information.

Conclusion While most women were confident of being knowledgeable about COCs,

many were unaware of their knowledge gap. Healthcare professionals should proactively

educate about items relevant to their patients. Counselling materials provided by the

gynaecologist seem to be an appropriate communication channel. Additional efforts are

needed to improve knowledge of the thrombotic and other risk associated with COCs.

K E Y W O R D S Combined oral contraceptives; Knowledge; Benefits and risks; Contraception; Counselling;

Evidence-based patient information

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I N T R O D U C T I O N

Informing patients adequately about benefits and risks

of a medical treatment is essential for enabling them to

give their informed consent for a treatment1. Sharing

all relevant information with a patient is particularly

necessary when other treatments are available and

choice mainly depends on personal preferences2. One

prominent example is the choice of a family planning

(FP) method, where the selection ranges from less

Correspondence: Claudia Vogt, Charite Universitatsmedizin Berlin, Institut fur klinische Pharmakologie und Toxikologie, Chariteplatz 1, 10117

Berlin, Germany. E-mail: [email protected]

The European Journal of Contraception and Reproductive Health Care, June 2011;16:183–193

ª 2011 The European Society of Contraception and Reproductive Health

DOI: 10.3109/13625187.2011.561938

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reliable but side effect-free behavioural methods to

highly effective hormonal contraceptives or surgical

procedures associated with rare but potentially serious

risks.

Women’s attitudes to a particular contraceptive

method are mainly influenced by the perceived risk-

benefit-ratio3. Worries about side effects and health risks

are major hurdles for the acceptance and usage of

hormonal contraceptives. They are the most important

reason for discontinuation and the second most

important reason for rejecting hormonal methods4,5.

The impact that perceived risks have on attitudes is

more evident for combined oral contraceptives

(COCs) – the most prevalent FP method in Germany6 –

than for contraceptives in general3,7. Several studies have

shown that women have an inaccurate perception of

risks and lack knowledge about benefits8,9. Research on

contraceptive counselling provides no clear evidence of

whether any method of counselling is able to improve

adherence to and continuation of a contraceptive

regimen10. Correct knowledge about birth control

methods seems to be positively associated with appro-

priate use, although it represents only one of several

factors affecting contraceptive adherence11. Several

approaches to improve contraceptive knowledge have

proved successful, including educational leaflets about

the correct use of contraceptives and computerised

decision aid to chose an appropriate method12,13.

We are legally and ethically bound to inform

women about the benefits and risks of COCs. The

German Federal Supreme Court (Bundesgerichtshof,

BGH) decided in March 2005 that simply referring the

patient to the patient information leaflet is not

sufficient for informed consent prior to administration

of medication in general, and for COCs in particu-

lar14. Additional counselling materials could improve

and facilitate, but never substitute for, the patient

information from a physician, nurse or health

educator, and the patient information leaflet. Coun-

selling brochures published by different institutions are

available in Germany. These materials are focused on

questions about the use of the method and do not

cover the risk-benefit aspects in a very detailed

manner. At present, none of the available counselling

material about COCs meets the criteria of evidence-

based patient information (EBPI) recommendations15.

Looking at currently available evidence-based material

for healthcare professionals16,17, it is clear that the

scientific interpretations are very complex, that they

include inconsistent findings and vary in the quality of

the evidence they present. Current recommendations

for evidence-based patient information18 state that use

of reliable sources of evidence is mandatory.

In order for them to give informed consent, patients

should have received all relevant and available

scientific information. However, counselling material

meeting all these criteria can be overwhelming for

patients19. A German medical association (AZQ) has

published a manual20 for developing evidence-based

patient information material; it recommends providing

only information that is relevant for the target group.

This pilot study was the first step in a research

programme setting out to improve knowledge of risks

and benefits among COC users and potential users.

The aim of this study was to identify counselling

topics relevant to patients and to determine the

appropriate scope of counselling material about

benefits and risks of COCs. The study results

presented below will help to identify which typical

side effects and non-contraceptive benefits of COCs

are of greatest interest and relevance for patients. The

study also sought to identify whether women are

aware of the rarer but potentially severe side effects

associated with COC use. Common misconceptions

around COCs were investigated. The second objec-

tive of the study was to investigate the congruence

between perceived and actual knowledge about the

benefits and risks of COCs among young German

women. We assessed a non-representative, stratified

sample to generate hypotheses about group differ-

ences. Results will be used to support further research

in larger and more representative samples.

This research is focused on the risk-benefit counsel-

ling as this is the most critical aspect of patient

information. Ideally, any information material for

women should also explain efficacy and appropriate use.

M A T E R I A L S A N D M E T H O D S

A questionnaire gathered information on participants’

needs for counselling material and their actual knowl-

edge of benefits and risks associated with COCs. It

included a list of 25 potential counselling items (23

symptoms and disease processes, and two summary

items: see Tables 1 & 2). German law requires that

physicians inform patients, before prescribing a drug,

about all typical and severe adverse events or health

risks1,21. Benefits and typical and severe side effects,

Disparities in knowledge and interest Vogt and Schaefer

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mentioned in the questionnaire, were identified by

reviewing a Health Technology Assessment Report of

the DIMDI (German Institute for Medical Documenta-

tion and Information)17, the clinical guidelines of the

Faculty of Family Planning and Reproductive Health

Care16, the WHO Family planning handbook22, and the

patient information leaflets of the two most commonly

used COCs in Germany (Valette1 and Yasmin1).

Despite scientific evidence that COCs are not

teratogenic, do not adversely affect fertility after

discontinuation, and do not cause weight gain,

these events – which are feared by women – were

included, as were items allowing to check the importance

of counselling and actual knowledge. The potential

counselling items were written in lay terms. The

sequence of the item listing was altered randomly, so

that 30 different patterns were presented to the

participants.

The following areas were covered in the ques-

tionnaire:

Table 1 Women’s (N¼30) assessment of 25 potential counselling items. Interest and Knowledge rating on a 7-point

rating scale

Column: 1

Item

category

2

Item

3

Interest

rating

4

Mandatory

item

5

Cluster

6

Knowledge

rating

þ: mean &

CI 4 4;

0/þ: mean 44,

CI overlapping;

0/-: mean 54,

CI overlapping

Selected

by at least

15 women

1: positive interest

and mandatory;

2: positive interest

or mandatory;

3: neutral interest,

not mandatory

0/-: mean 54,

CI overlapping;

-: mean &

CI 54

Risk Risk of cervical cancer þ x 1 7Change in sexual desire þ x 1 7Depressed mood þ x 1 7Heart attack, stroke 0/þ x 2 7Vaginal discharge þ 2 7Headache, migraine þ 2 7Interference with liver function 0/þ 3 7Thrombosis 0/þ 3 7Itching 0/þ 3 7Breast pain 0/þ 3 7Skin rash, chloasma 0/þ 3 7Nausea 0/þ 3 7Breakthrough bleeding 0/þ 3 7Change in blood pressure 0/- 3 7

No effect Subfertility after discontinuation þ x 1 7Weight gain þ x 1 0/-

Damage to fetus 0/þ x 2 7

Conflicting

evidence

Total cancer risk þ x 1 7Breast cancer risk þ x 1 7

Benefit Benign breast disease þ x 1 7Pelvic inflammatory disease þ x 1 7Dysmenorrhoea, menorrhagia þ x 1 0/-

Acne þ x 1 0/-

Risk of ovarian cancer þ 2 7Risk of endometrial cancer þ 2 7

‘CI overlapping’: 95% confidence interval is overlapping the neutral rating of 4.

Disparities in knowledge and interest Vogt and Schaefer

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(1) General assessment of knowledge about

benefits and risk: two separate questions for

benefits and risks on a 4-point-rating-scale

(answer formats: not at all – rather poorly –

rather well – very well).

(2) List of potential counselling items (25 items,

see Tables 1 and 2, column 2):

(a) Assessment of interest:

(i) Rating of interest on a 7-point-

scale (1¼ no interest at all, 7¼ high

interest).

(ii) Identification of items for patient

information that participants felt

must be included in an information

document or transmission: respon-

dents could choose as many items from

the list as they wanted or ‘none of

these’.

(iii) Identification of missing topics:

participants could choose between

‘no’ and an open answer.

(b) Assessment of perceived knowledge:

Rating of perceived knowledge on a

7-point-scale (1¼ I don’t know

anything about it, 7¼ I am well

informed).

Table 2 Assessment of combined oral contraceptives (COCs) effects on listed conditions in absolute number of

respondents (N¼ 30)

Dark gray: first choice, light gray: second choice

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(c) Ability to identify risks and benefits of COCs:

Respondents were asked to indicate

whether they thought COCs decreased

(category ‘benefit’), did not affect (category

‘no relation’), or increased (category ‘side

effect’ or ‘severe health risk’) the risk of

each specific item. They could also choose

the answer ‘don’t know’.

(3) Attitudes and preferences related to infor-

mation materials (two questions)

(a) Preferred scope of information material

(answer formats: 1¼ ‘Is not necessary, the

patient information leaflet is enough’,

2¼ ‘only the most important information’,

3¼ ‘very detailed’, 4¼ ‘summary of most

important information, followed by de-

tailed information’, 5¼ ‘Wikipedia-style’ or

6¼ open answer).

(b) Assessment of impact of evidence-based

information material on attitude towards

COCs (yes/no/perhaps).

(4) Current source of information (one question,

answer formats: gynaecologist/other physician/

relatives/friends/patient information leaflet/in-

ternet/information material about contracep-

tives/other: open answer, multiple answers

possible).

Rating scales were for measurement of attitudes. Equal

interval scales assessed interest and perceived knowl-

edge. The online template of the questionnaire was

designed to ensure complete response on every

accepted question. Women could either respond to

all questions or discontinue the survey.

The intended sample size was 30 women aged

18–24. The selected age group has the highest

utilisation rates of COCs. To avoid confounding, all

non-native German speakers and women with

previous pregnancies, professional medical back-

ground, and previous participation in similar re-

search, were screened out.

The sample was recruited by random selection out of

a representative German panel (N¼ 97,987). To

explore differences by educational level or experience

with COCs the sample should be approximately equally

distributed between three educational levels and three

experience levels of COC usage (current/past/never

users). However, we recognise that eager volunteers

may differ importantly from non-participants.

The study was conducted with an online ques-

tionnaire. Online access was not considered to be

confounding, because 95% of this age group use the

internet regularly23.The expected completion time

was 10–15 minutes. Minimum completion time was

determined to be five minutes. Respondents falling

short of this minimum were excluded from analysis.

Participants did not receive any financial reward.

The data were transferred into the Statistical

Package for the Social Sciences (SPSS, 17.0). Beside

descriptive statistics about frequencies, mean values

and two-sided 95% confidence intervals for means

were used for all results on 7-point-rating scales. The

middle of the rating scale (the value 4) was considered

a neutral rating. All items with confidence intervals

not overlapping with the neutral rating were con-

sidered positive or negative, respectively. All items

that were selected by at least 50% of respondents were

considered to be mandatory for inclusion in counsel-

ling materials. These two criteria were used to group

the items into three clusters. Cluster 1 covers all items

where both parameters indicate a patient relevance,

while cluster 3 contains all items that seem to be of no

interest and cluster 2 all items with inconsistent

ratings.

The Ethics Committee of the Charite does not

evaluate surveys of this kind. Participants had been

informed in the invitation to the online-study about

its scope and aim. They implicitly consented to

participate by pressing on the start button.

R E S U L T S

During the spring of 2009, 3344 members from a

representative research panel were randomly selected

and invited by e-mail to participate in the study. Of

these, 323 responded positively. This response rate of

10% was considered normal for a non-rewarded study

participation. Of the 323 responders, 114 did not meet

the screening criteria, 176 were rejected in order to

obtain the quota distribution, and two discontinued

the screening.

The questionnaire was completed by 31 young

women. One participant who dealt with the ques-

tionnaire in 3 minutes and 39 seconds was excluded

from analysis. For the remaining 30, the mean time to

complete the online questionnaire was 10 minutes and

18 seconds (minimum: 501200, maximum: 3804800).

Disparities in knowledge and interest Vogt and Schaefer

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The discarded questionnaire showed a monotonic

answer pattern indicating that it had not been filled

out in a differentiated manner. Mean interest and

knowledge results, calculated to include the answers of

this respondent, did not change the results reported

below to one decimal place.

The remaining 30 participants, with a median age of

20, represent all educational levels (high [n¼ 10],

middle [n¼ 13], and low [n¼ 7]) and the three types

of COC experience without prior pregnancy (current

users [n¼ 10], past users [n¼ 13], and never users

[n¼ 7]).

Self-assessment of knowledge of COCs

Twenty-six of the 30 respondents stated that they felt

rather well (n¼ 20) or very well (n¼ 6) informed

about benefits of COCs. With respect to COC risks,

19 women rated their knowledge as rather good

(n¼ 15) or very good (n¼ 4). The two ratings were

highly correlated. Only one participant rated her

knowledge about risks as higher than her knowledge

about benefits, 12 respondents rated their knowledge

of benefits above their knowledge of risks, and the

others rated both on the same level. The self-ratings of

knowledge about either benefits or risks did not

correlate significantly with either educational level or

COC experience (Spearman correlation coefficient:

r¼ 0.023, p¼ 0.904 for benefits/educational level;

r¼70.288, p¼ 0.122 for benefits/COC experience,

r¼ 0.138, p¼ 0.467 for risks/educational level;

r¼70.267, p¼ 0.154 for risks/COC experience).

Potential counselling items: Assessment of

interest and knowledge

The mean rating of interest for all 25 potential

counselling items was 5.0 on a 7-point scale (median

ranking¼ 5). All but one item (change in blood

pressure) had mean ratings above 4, the neutral rating.

Fifteen items had confidence intervals not overlapping

the 4 rating and were considered to reflect a positive

interest rating (Table 1, column 3). The mean number

of selected mandatory items per respondent was 12.5

(median¼ 12). Thirteen items were considered to be

mandatory, having been selected by at least half of the

respondents (Table 1, column 4).

The mean rating of perceived knowledge of all 25

potential counselling items was 2.9 on a 7-point scale

(median ranking¼ 2). All mean ratings were below

the neutral rating of 4, but three items (weight gain,

acne and menstrual complaints) had confidence

intervals overlapping the neutral rating (Table 1,

column 6).

We clustered the items into three groups (Table 1,

column 5) based on the participants’ ratings. The first

cluster contains 11 items. These items had positive

interest ratings and each was a mandatory item, i.e.,

selected by 15 or more respondents. They indicated

patient relevance. This cluster contained three cancer

risk items (including the total cancer risk), four non-

contraceptive benefits (lesser occurrence or severity of

pelvic inflammatory disease, menstrual complaints,

benign breast diseases and acne), two side effects

(depressive mood, change in sexual desire), and two

misconceptions (negative fertility impact, weight gain).

Cluster 2 had mixed responses with regard to

interest rating and mandatory item selection. The

cluster comprised six items: cardiovascular disease

(heart attack, stroke), identified as a severe health risk;

two side effects; two non-contraceptive benefits (less

frequent occurrence of ovarian and endometrial

cancer); and one misconception (teratogenic effect).

The eight items in cluster 3 were identified as being

of neutral to low interest to women. This cluster

included the risk of thrombosis associated with COC

use. The seven other items in cluster 3 were non-

severe side effects usually described in patient

information leaflets.

The mean interest rating (5.3) for all items

considered mandatory was significantly higher than

that (4.7) for the non-mandatory items (p¼ 0.004). In

Figure 1 the mean interest and knowledge ratings by

educational level or by COC experience showed no

clear trends, except that – as reported above – interest

was greater than knowledge in all groups. Never users

tended to report higher interest levels than current or

past users and exhibited the least knowledge.

Only one respondent stated that a counselling topic

was missing in the questionnaire. She named the topic

‘hormonal changes’.

Potential counselling items: Ability to identify

risks and benefits of COCs

Columns 3 to 7 in Table 2 show the number of

respondents selecting each choice for each of the 25

conditions itemised. For 19 of the conditions ‘don’t

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know’ was the modal response or was tied for the

modal response. Figure 2 showed no statistically

significant differences in the number of ‘don’t know’

answers according to educational level and COC

experience. Nine individuals never chose this cate-

gory, five chose this option for all 25 items.

Only three respondents correctly identified throm-

bosis as a severe health risk, whereas eight seemed to

underestimate the seriousness of thrombosis, and five

denied any association between thrombosis and

COCs. For the main cardiovascular complications

(e.g., heart attack, stroke) the participants were only

slightly more knowledgeable (five identified these as

severe health risks, five as side effects, and four stated

there was no relationship).

No respondents thought COCs decreased cancer

risk. Ten of the 17 women who had not answered

‘don’t know’ (except for cervical cancer; n¼ 7) saw no

relationship with COCs, while seven respondents

believed there was an increased risk.

All items usually seen as side effects of COCs were

correctly assigned by the majority of women who did

not select the ‘don’t know’ answer. However, items

either representing a beneficial or no proven effect

were also considered to be adverse drug reactions by

most women in this subgroup.

Figure 1 Mean interest ratings (plain) and mean knowledge ratings (striped) by educational level (a) and combined oral

contraceptive (COC)-experience (b), N ¼ 30.

Figure 2 Mean number of ‘don’t know’ answers by educational level (a) and combined oral contraceptive (COC)-

experience (b), N¼ 30.

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Attitudes and preferences related to information

materials

Most respondents (n¼ 17) preferred counselling

material with a summary of the most important

information, followed by a full and detailed descrip-

tion of all relevant topics. Four participants voted for a

full description, four voted for internet-based in-

formation in a ‘Wikipedia’ style, where detailed

explanations could be consulted as needed, three

stated that additional counselling material beside

the patient information leaflet is not necessary,

and two voted for providing the most important facts

only.

A little over half of the respondents (n¼ 16) stated

that materials providing scientific information in an

understandable manner might ‘perhaps’ change their

attitude towards COCs and six more indicated that it

would change it. The distribution of respondents by

COC experience shows noticeable, but not statisti-

cally significant differences between the COC groups

in Figure 3.

Current source of information

Main sources of information about benefits and risks

were the gynaecologist (mentioned by 21 respon-

dents), the patient information leaflet (n¼ 15), and the

internet (n¼ 15). The other sources were less

frequent: friends (n¼ 7), other physicians and infor-

mation materials about contraceptives (n¼ 6 each),

and relatives (n¼ 3).

D I S C U S S I O N

This pilot study is, to our knowledge, the first in

Germany to explore the information needs of a target

population of potential, current and past COC users

by means of the ‘evidence-based patient information’

approach.

The major limitations of the study were the small

sample size and self-selection of the participants. The

sample was selected in order to target the group with

the highest usage rate of COCs. While the narrow

sample could be said to be unrepresentative, strict

inclusion criteria were chosen to reduce confounding.

Whether a qualitative approach (e.g., a focus group)

might have been more suitable than a quantitative

approach to study patient perceptions and preferences

is debatable. Another important consideration is that,

while some benefits of COCs are immediate (e.g.,

menstrual regulation), others, such as the reduction in

ovarian cancer risk, are dependent on age and duration

of COC use. It could, therefore, be argued that interest

in the risks and benefits associated with COCs may

differ according to age. Our data show, however, that

fear about cancer or other potential risks in the future is

common in young women, even if their risk is low

compared with that among older women. A final

limitation is that some of the medical items (thrombosis,

liver function) may not be well understood by

respondents, and may therefore have been considered

less relevant to them. However, to overcome such

issues, we presented the questionnaire items in lay terms.

The sample allowed comparisons of ratings by

educational level and COC experience. There were

no statistically significant differences in the results for

the various educational levels and the three COC-use

groups. This finding could be interpreted as indicating

equally poor detailed knowledge about the benefits

and risks of COC use among all respondents,

irrespective of their educational level. In contrast,

interest in the counselling items is high in all groups.

Our data show no clear difference in interest and

knowledge between current and never-users. This

could indicate that patient information and education

are inadequate at present, otherwise current users

would demonstrate noticeably better knowledge at a

detailed level than never-users. It may also mean that

our sample was too small for an analysis of three

groups. Past users were slightly less interested than

other women.

Figure 3 Number of respondents indicating that they

would change their attitude to combined oral

contraceptives if understandable scientific information

would be provided to them (N¼ 30).

Disparities in knowledge and interest Vogt and Schaefer

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Relevance of counselling items to patients

Presented with a list of 25 conditions potentially

related to COC use, at least 15 participants gave 11

items (including three cancer risk items) a positive

interest rating and these should be considered

mandatory inclusions in a patient information sheet

or brochure. The risk of thrombosis – definitely

something that women should be informed about

before initiating oral contraception – was identified as

non-interesting and non-mandatory. In addition only

few patients identified thrombosis as a severe health

risk, many underestimated the seriousness of this

event, and some even denied any association between

thrombosis and COCs. From a safety point of view,

low awareness about the thrombotic effects of COC is

a concern. A prompt and correct diagnosis and

treatment could be delayed if patients underestimate

the seriousness of their symptoms or do not report use

of COCs because they do not know about this rare

but serious risk. Additional counselling efforts to

improve communication of the risk of thrombosis

with COCs are required.

The seven other items with low ratings are non-

severe side effects usually mentioned in patient

information leaflets. These side effects seem to be less

relevant to patients and could be described in brief in

counselling materials.

Further research with larger representative samples

is needed before conclusions about the patient

relevance of the items in cluster 2 can be drawn.

The scope of researched counselling items seems to

be sufficient from a patient perspective in this study

because only one additional topic of interest was

identified, and this was by only one respondent.

More research must be carried out to confirm the

scope.

Perceived knowledge and ability to identify risks

and benefits of COCs

The respondents felt well informed about the benefits

of COCs but less knowledgeable about the risks. In

contrast, the actual knowledge per item was rather

poor as shown by the high percentage of ‘don’t know’

answers in the section of the questionnaire where

participants were asked to assign each itemised

condition to a degree of severity or relation to COCs.

Unawareness of the knowledge gap may result in

women failing to ask proactive questions with regard

to risks because they might already consider them-

selves to be adequately informed. Therefore, health-

care professionals should be proactive in explaining

benefits and risks to their patients. It is unlikely

that women will search for this information by

themselves.

Participants could not identify severe health risks

associated with COCs. The congenital malformations

item received the highest rating (n¼ 7) as severe

health risk, although many studies have shown no

association with COC intake24. The answer patterns

for the COC effect on some types of cancer was

homogeneous, despite scientific evidence demonstrat-

ing a decreased risk of endometrial and ovarian cancer,

an increased risk for cervical cancer in long-term users

and controversy about the breast and total cancer risk.

The women studied also seemed to be unaware of

other non-contraceptive benefits of COCs. Despite

the fact that acne and menstrual complaints received

the best knowledge rating and the fewest ‘don’t know’

answers, most women thought these symptoms are

more frequent during COC use; these ratings were

even worse than those observed in a US study9. The

distribution of answers for pelvic inflammatory and

benign breast disease also indicated little knowledge,

with even fewer patients identifying any benefits and

even more patients selecting ‘don’t know’ as their

response.

The impact of COCs on fertility was not clear to the

study population, with half of the patients choosing the

‘don’t know’ option and ten patients identifying a

negative effect. These results seem to be less favourable

than results of previous German studies25. But, due to

different response formats (no ‘don’t know’ option),

the results are not entirely comparable.

The belief that COCs cause weight gain, despite a

lack of evidence, was also an observation made by the

authors of a study carried out in the US9.

Scope and potential impact of communication

With regard to the preferences for information

material, a strong preference for detailed presentations

with summary information was reported. The main

external sources for information were the gynaecol-

ogist, followed by printed material and the internet. It

appears, therefore, that providing additional printed

counselling material at the time of the first prescription

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would be the best approach to communicate informa-

tion to the target group.

Although this study was focused on the counselling

about benefits and risks, a comprehensive information

material for women should also cover efficacy and

appropriate use.

Conclusion

Our data show that there is a clear need for more

contraceptive counselling. Women are interested in

many aspects of potential COC effects, particularly the

cancer-related effects but less so the cardiovascular

effects. Counselling about the thrombotic impact of

COCs needs to be improved, as knowledge about this

complication is lacking. Patient-oriented counselling

should also explain whether and how COCs influence

fertility, pelvic inflammatory disease, mood, menstrual

complaints, breast diseases, libido, weight, and acne.

Other typically mentioned side effects seem to be less

important for patients.

Young women appear to be unaware of both the

non-contraceptive benefits and the severe health risks

of COCs. They have misconceptions about potential

side effects of COCs, such as weight change and

teratogenicity. The women in our study were

unaware of their knowledge gap; they generally felt

well informed about the risks of COCs. Healthcare

professionals should proactively inform about all

patient-relevant benefits and risks. They should

anticipate that patients will probably not look for this

information themselves.

Detailed evidence-based patient information for

contraceptive counselling in the gynaecologist’s office

seems to be an appropriate channel for providing

women with information about COCs. Providing

additional scientific information, pitched at the correct

level for COC users, has the potential to change

attitudes towards COCs.

Further research with a larger, broader sample is

warranted to refine the results of this pilot study.

Declaration of interest: Funding for this study was

provided by Bayer Schering Pharma AG. Claudia

Vogt is a doctoral student at Charite University

Medicine Berlin and part-time employee of Bayer

Schering Pharma (Berlin, Germany). Editing assistance

was provided by Claire Byrne of inScience com-

munications, and funded by Bayer Schering Pharma

AG.

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