. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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).
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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).
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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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