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Abstract
Objective To measure agreement between the client’s
and the clinician’s responses to questions regarding
client history as answered on a questionnaire based
on the UK Medical Eligibility Criteria for Contraceptive
Use (UKMEC) for combined hormonal contraception
(CHC).
Methods Clients aged 18 years and over, attending a
central London community contraceptive clinic
requesting a repeat supply of CHC, completed a history
questionnaire and an evaluation form. Clinicians then
completed their copy of the same questionnaire during
the consultation. Percentage agreement and the Kappa
statistic were used to assess the level of client–clinician
agreement.
Results Data from 328 client–clinician pairs were
analysed. Agreement was above 93% for all identified
risk factors. There was complete agreement for
thrombosis, diabetes, stroke, cancer and liver problems.
Least agreement was noted in the recording of migraine
and abnormal bleeding. For all risk factors except
51
©FSRH J Fam Plann Reprod Health Care 2008: 34(1)
Introduction
The combined hormonal oral contraceptive pill (COC) is
the most commonly used method of contraception in the
UK, used currently by 24% of all women aged 16–49
years.
1
Women requesting repeat prescriptions of the COC
constitute the major part of contraceptive workload in
primary care, both in community contraceptive clinics and
in general practice.
2
Ways of improving the management of
COC users’ care are needed to ensure safe, efficient and
accessible service provision.
The World Health Organization Medical Eligibility
Criteria for Contraceptive Use (WHOMEC) provides clear
evidence-based recommendations on the selection of the
most appropriate method of contraception. Services can
use these criteria to develop guidelines for delivery of
contraceptives locally.
3
Family Health International have
used them to develop checklists to initiate COCs in
Feasibility of a self-completed history questionnaire in
women requesting repeat combined hormonal
contraception
Jagruti S Doshi, Rebecca S French, Hannah E R Evans, Christopher L Wilkinson
ARTICLE
Margaret Pyke Centre, London, UK
Jagruti S Doshi, MRCOG, MFFP, Subspecialty Trainee, Sexual and
Reproductive Healthcare
Centre for Sexual Health and HIV Research, Department of
Primary Care and Population Sciences, Margaret Pyke
Centre, London, UK
Rebecca S French,
MSc, Senior Research Fellow
Centre for Sexual Health and HIV Research, Department of
Primary Care and Population Sciences, Mortimer Market
Centre, London, UK
Hannah E R Evans,
BSc, Statistician
Margaret Pyke Centre and Mortimer Market Centre,
London, UK
Christopher L Wilkinson,
MBBS, FFFP, Consultant
Correspondence to: Dr Jagruti Doshi, Margaret Pyke
Centre, 73 Charlotte Street, London W1T 4PL, UK.
E-mail: jsdoshi@doctors.org.uk
smoking, the proportion of clients reporting a risk factor
was more than the proportion of clinicians reporting a
risk factor. No clinically important information relevant to
a particular client’s use of CHC was missed and none of
them would have been wrongly prescribed the CHC
based just on their self-completed questionnaires. Most
women (97%) were happy with this method of history
taking.
Conclusions A self-completed history questionnaire is
acceptable to women and can potentially replace
traditional routine medical history taking for continuing
CHC. Women completed the questionnaire with a high
degree of reliability. There was complete client–clinician
agreement on UKMEC Category 4 criteria. Overall,
clients reported more risk factors than clinicians, which
increases the safety of the questionnaire.
Keywords client history, hormonal contraception,
questionnaire survey, risk factors
J Fam Plann Reprod Health Care 2008; 34(1): 51–54
(Accepted 8 July 2007)
community-based programmes to increase the quality of
services and care and to increase women’s access to
contraceptives.
4
The UK Medical Eligibility Criteria for Contraceptive
Use (UKMEC) were developed from the WHO document
in 2005.
5
These criteria are classified into four categories,
ranging from UKMEC 1 – a condition for which there is no
restriction for the use of the contraceptive method (e.g.
parity) to UKMEC 4 – a condition which represents an
unacceptable health risk if the contraceptive method is used
(e.g. thrombosis). History taking and appropriate
examination allow clinicians to assess medical eligibility
for COC use. The medical and family history should alert
the clinician to conditions or risk factors that might be a
strong or absolute contraindication to COC use. A woman
with multiple risk factors may need to avoid COC use,
although individual risk factors would not necessarily
contraindicate use. Blood pressure and body mass index
(BMI) should be documented for all women before a first
prescription of COC
6
and at follow-up.
In this article we describe the use of a history
questionnaire for established users of combined hormonal
contraception (CHC), which includes COCs and the
contraceptive patch. The aim of this study was to determine
Key message points
● A self-completed history questionnaire is a reliable and
acceptable method of recording client history prior to
continuing combined hormonal contraception.
● Except for smoking, clients reported more risk factors
than the clinicians.
● Questions on a clinical outcome or disease that generate
discrete responses yield a greater agreement between
the client and the clinician than do questions on
behaviour.
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whether a self-completed history questionnaire was a safe
and acceptable way of obtaining relevant information from
clients before continuing their CHC.
Methods and analysis
This study was carried out at a central London community
contraceptive clinic. During the study period of 1–31
October 2006, all women who were existing service users
established on CHC and requesting repeat supplies were
approached to participate in the study. To evaluate the
accuracy of a self-completed history, a one-page
questionnaire was designed for the women to complete
prior to seeing the clinician (Figure 1). This questionnaire
was informed by the UKMEC.
5
A short evaluation of the
self-completed history method was included in their
questionnaire. A questionnaire with the same history
checklist was also designed for the clinicians. The
clinician’s questionnaire formed part of the client’s case
notes. This included documentation of the client’s blood
pressure and BMI. Any specific comments or
documentation of any other service provided at that visit
was done on the back of the clinician’s copy of the
questionnaire.
Clients aged 18 years and over requesting repeat
supplies of their CHC, and who were proficient in English
and able to complete the questionnaire without the help of
an interpreter, were given an information sheet describing
the study by the reception staff. Following their verbal
consent to participate, clients were asked to complete the
questionnaire and return it to the receptionist. The client
was then seen by the clinician, who took their history,
completed their copy of the questionnaire and performed
the consultation as usual. The clinician was unaware of the
responses the client had made. The clinician’s
questionnaire was photocopied and linked with the client’s
copy for comparison. The client’s clinic number was on
both questionnaires so that their notes could be examined if
there were any inconsistencies between the client and
clinician questionnaires.
Questionnaire data were entered into and analysed
using SPSS (v.12) (SPSS Inc., Chicago, IL, USA).
Univariate descriptive statistics were created to describe
the proportions of the client and clinician responses to each
of the risk factors. Agreement between the client and the
clinician was measured using percentage agreement and
the Kappa statistic. The Kappa statistic allows us to
measure agreement above and beyond that expected by
chance alone. A Kappa value of one is where there is
complete agreement and a value of zero is where there is no
more agreement than would be expected by chance alone.
7
A negative Kappa statistic can result if agreement occurs
less often than predicted by chance alone. Agreement was
defined as either a yes–yes or a no–no client–clinician
response to each question. In order to assess safety, we
wished to obtain 100% agreement for UKMEC 3/4 criteria
and over 90% agreement for UKMEC 1/2 criteria.
Ethical approval
The study proposal was reviewed and approved by the
Camden and Islington Community Local Research Ethics
Committee. This research study was also registered with
the North Central London Research Consortium
(NoCLoR).
Results
During the study period, 370 clients met the inclusion
criteria and were given the information sheet describing the
study. One client declined to participate. Forty-two
questionnaires were excluded from the analysis for the
following reasons: five women left the clinic before being
seen, four client-completed questionnaires were lost, nine
women attended the clinic for other reasons therefore the
clinician did not complete a questionnaire and in 23 cases
the clinicians used routine notes to document the
consultation instead of completing the questionnaire. The
results are therefore based on the analyses of 328 pairs of
client–clinician questionnaires.
Table 1 shows the frequency of risk factors identified
by clients and clinicians and their level of agreement. Ten
percent of clients were aged 35 years or more. The risk
factor most commonly reported was smoking. UKMEC 4
criteria were less reported, as would be expected of
established CHC users. There was complete agreement in
risk factors of thrombosis, diabetes, stroke, cancer and liver
problems. Agreement was above 93% for all the identified
risk factors. Migraine and abnormal bleeding were the risk
factors where the proportion of client–clinician agreement
was the least. For all risk factors except smoking, the
proportion of clients reporting a risk factor was more than
the proportion of clinicians reporting a risk factor.
Where the client reported a risk factor but the clinician
did not, it was unlikely to affect the repeat prescription of
the CHC as these clients would be seen by the clinicians to
discuss their history further. However, where the client did
52
©FSRH J Fam Plann Reprod Health Care 2008: 34(1)
Doshi et al.
Question Yes No
1. Have you read and understood the information ■■ ■■
sheet given?
2. Are you aged 35 years or over? ■■ ■■
3. Do you smoke? ■■ ■■
4. Do you have any abnormal vaginal bleeding, for ■■ ■■
instance after sex or at a time when you should
not bleed?
5. Have you had or do you currently have any of the
following medical conditions:
Migraine ■■ ■■
High blood pressure ■■ ■■
Thrombosis (blood clots in legs or in lungs) ■■ ■■
Diabetes ■■ ■■
Stroke ■■ ■■
Heart disease ■■ ■■
Cancer ■■ ■■
6. Do you currently have or have you had since
your last visit any of the following conditions:
Liver problems or jaundice ■■ ■■
Breast problems ■■ ■■
Abnormal smear (Pap) test ■■ ■■
Any other serious illness ■■ ■■
7. Have you had a pregnancy since your last ■■ ■■
visit here?
8. Have your mother, father, brother or sister had ■■ ■■
stroke, heart attack or thrombosis when they
were under the age of 46?
9. Do you have more than one relative (any type)
who has had stroke, heart attack or thrombosis
when he/she was under the age of 46?
■■ ■■
10. Are you taking St John’s wort or any other
regular medications? ■■ ■■
11. Have you ever been advised not to use the ■■ ■■
combined pill/patch?
12. Would you like to discuss other methods of
■■ ■■
contraception such as long-acting methods that
you do not have to remember to take each day?
13. Do you want to see a doctor or nurse for any
■■ ■■
other reason apart from more pills/patches?
Evaluation Form
1. Were the questions easy to understand and ■■ ■■
answer?
2. If not, which question was difficult?
3. Would you be happy with this method of
■■ ■■
recording your history?
4. Comments:
Figure 1 Questionnaire for clients requesting repeat supplies of
combined hormonal oral contraceptive pill/patch
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not identify a risk factor but the clinician did, a risk factor
could be missed if the self-history method were to be
adopted. In these cases, we looked into any comments
made by the client or the clinician and at the client’s case
notes to establish the cause for disagreement. In all such
cases no clinical contraindication to CHC for that particular
client was missed. The disagreement was noted to be more
in subjective or open-ended questions. For example,
clinicians identified women who smoked occasionally as
‘smokers’ while the clients had not identified themselves as
a smoker. Similarly, in cases of abnormal bleeding the
client did not identify occasional breakthrough bleeding
with late or missed pills as abnormal. Removal of a benign
spinal tumour was marked as a serious illness by the
clinician but not by the client. Referral for termination of
pregnancy at her last visit was reported as a pregnancy by
the clinician but not by the client. One client taking
Roaccutane
®
did not report this as taking medication.
Nine clients were not prescribed their CHC. This was
for reasons such as wanting other contraceptive methods or
having side effects associated with the use of CHC.
Table 2 shows the results of the clients’ evaluation of
this method of history taking.
Discussion
Our study sample included clients already established on
CHC. This is an important population to study, as new
health problems can develop over time and can affect the
safety of ongoing contraceptive use. In our study, critical
medical history questions that would affect the prescription
of the CHC such as stroke, thrombosis, diabetes, cancer
and liver problems obtained 100% agreement. All risk
factors had more than 93% client–clinician agreement.
Women could understand the questions and found this
method of recording history acceptable. Overall, clients
were more likely to report a risk factor than the clinician,
which increases the safety of the questionnaire. In all cases
of disagreement it was confirmed from the client’s case
notes that no clinically important information relevant to
that particular client’s use of the COC was missed. None of
these 328 patients would have been wrongly prescribed the
COC based just on their self-completed questionnaires.
Subjective questions like smoking, migraine and
abnormal bleeding generated more disagreement. Whilst
this may not prohibit CHC use for most women (in this
study it did not affect any of the respondents getting the
CHC), it will be relevant to some women, particularly if
they have other risk factors.
5,8
Six clients who smoked only
occasionally did not identify themselves as smokers.
Similarly, three clients did not report a history of simple
migraine. This may have been because of the way the
questions were worded. This illustrates that questions need
to be carefully worded to identify all women with any of
the risk factors. For example, a better wording for the
question on smoking may be: ‘Have you smoked at all in
the last year?’ A better way of asking a question on
migraine may be to actually describe a migraine headache.
A study done in the USA on self-completed
questionnaires amongst women aged 15–45 years attending
family planning clinics for a variety of reasons has reported
similar areas of disagreement. In the USA study, questions
that in general generate discrete responses (e.g. presence or
absence of gall bladder disease) yielded the highest
agreement. Conversely, questions regarding more
subjective queries such as menstruation patterns or
smoking habits generated greater disagreement.
9
We did not collect any sociodemographic data such as
the level of education, income and parity as our aim was to
53
©FSRH J Fam Plann Reprod Health Care 2008: 34(1)
Self-completed history questionnaire for repeat CHC
Table 1 Risk factors identified by combined oral contraceptive users and clinicians
Risk factor Valid Clients Clinicians Client Client Agreement
b
Kappa
pairs
a
reporting reporting marked marked [n (%)]
risk factor risk factor yes, no,
[n (%)] [n (%)] clinician clinician
marked no marked yes
[n (%)] [n (%)]
Age ≥35 years 328 33 (10.0) 34 (10.4) 0 1 (0.3) 327 (99.7) 0.98
Smoking 325 72 (22.1) 77 (23.7) 1 (0.3) 6 (1.8) 318 (97.8) 0.939
Abnormal bleeding 324 35 (10.8) 32 (9.9) 8 (2.5) 5 (1.5) 311 (95.9) 0.784
Migraine 326 39 (11.9) 23 (7.0) 19 (5.8) 3 (0.9) 304 (93.3) 0.611
High blood pressure 319 3 (0.9) 3 (0.9) 2 (0.6) 2 (0.6) 315 (98.7) 0.327
Thrombosis 321 0 0 0 0 321 (100.0) NA
e
Diabetes 322 1 (0.3) 1 (0.3) 0 0 322 (100.0) 1
Stroke 322 0 0 0 0 322 (100.0) NA
e
Heart disease 322 1 (0.3) 0 1 (0.3) 0 321 (99.7) NA
e
Cancer 322 0 0 0 0 322 (100.0) NA
e
Liver problems 324 0 0 0 0 324 (100.0) NA
e
Breast problems 323 2 (0.6) 1 (0.3) 1 (0.3) 0 322 (99.7) 0.665
Serious illness 322 0 1 (0.3) 0 1 (0.3) 321 (99.7) NA
e
Pregnancy 323 0 1 (0.3) 0 1 (0.3) 322 (99.7) NA
e
Immediate family history
c
326 10 (3.0) 6 (1.8) 4 (1.2) 0 322 (98.7) 0.744
More than one relative
d
326 9 (2.7) 4 (1.2) 6 (1.8) 1 (0.3) 319 (97.8) 0.452
Medication 323 9 (2.8) 6 (1.9) 5 (1.5) 2 (0.6) 316 (97.8) 0.523
Ever advised not to use COC 325 9 (2.8) 5 (1.5) 6 (1.8) 2 (0.6) 317 (97.5) 0.417
a
Number of cases where the question was answered by both (i.e. the client and the clinician).
b
Agreement on these questions was based on the number of yes–yes/no–no client–clinician responses.
c
Have your mother, father, brother or sister had a stroke, heart attack or thrombosis under the age of 46?
d
Do you have more than one relative (any type) who has had a stroke, heart attack or thrombosis under the age of 46?
e
Kappa cannot be calculated if the table is not balanced, for example, either the client or the clinician never uses one of the categories (either
yes or no).
NB. Although the number of clinicians and clients reporting a risk factor may be similar they may not be matched pairs and hence the Kappa.
COC, combined oral contraceptive; NA, not available.
Table 2 Clients’ evaluation of method
Client response Valid (n) Yes (%)
Read and understood information sheet 319 99.7
Questions easy to understand 322 98.4
Happy with method 319 96.9
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assess use of this questionnaire in routine practice, amongst
all clients attending the service, rather than to investigate
the effects sociodemographic data have on the levels of
agreement. The USA study, however, found no statistical
difference in agreement between the responses in
subgroups of age, income, education and prior
contraceptive use.
9
Another important consideration is to ensure there is
standardisation of what is being measured. For example,
clinicians may differ in their criteria for a diagnosis of
hypertension.
10
Surprisingly, despite clear local guidelines,
both the cases in our study where the clinician reported
high blood pressure as a risk factor had neither a history of
hypertension nor elevated blood pressure readings
documented in the client case notes.
As the questionnaires were linked to and part of the
case notes, the person responsible for data collection and
analysis (JSD) was not blinded to which clinician saw each
client. This is a limitation of our study as, for example,
assumptions could be made on the accuracy of risk factor
identification depending on the level of a clinician’s
experience.
Benefits of a self-completed questionnaire include
increased client participation during the history taking
process, more complete client records, standardisation in
the recording of client information, minimal interview bias
and the clinician identification of additional medical
problems that may not be noted during a consultation.
11
It
can make it easy to audit the service guidelines and enable
a long-term research study on changes in health in long-
term CHC users. For women established on CHC with no
risk factors, a self-taken history can speed up consultations.
There is also scope to develop roles for health care
assistants. They could record the client’s blood pressure
and BMI, check the self-completed history questionnaire,
and if there is no indication to refer to a doctor or a nurse,
then they could issue the CHC to clients under patient
group direction. Our study showed that it is feasible to
record history this way and that it is acceptable to clients.
Conclusions
A self-completed history questionnaire could be a valuable
tool to potentially improve the care given to established
CHC users in contraceptive clinics. Our study has shown
that clients can complete a history questionnaire with a
high degree of reliability. Discrete questions that ask about
a clinical outcome, a disease or whether an event has
occurred (e.g. thrombosis) rather than a behaviour (e.g.
smoking) or a symptom (e.g. menstrual bleeding patterns)
yield a greater agreement between the client and the
clinician. In further research, subjective history questions
should be worded in such a way as to obtain an
unambiguous yes/no answer. Further work needs to assess
the impact the questionnaire has on service delivery, such
as the effect on consultation times. Use of this tool could be
explored in other settings such as general practice and
pharmacies, as well as for clients requesting CHC for the
first time or for clients established on CHC in other
services.
Statements on funding and competing interests
Funding None identified.
Competing interests None identified.
References
1 Office for National Statistics. Contraception and Sexual Health,
2005/06 (Omnibus Survey Report No. 30). http://
www.statistics.gov.uk/downloads/theme_health/contraception
2005-06.pdf [Accessed 1 March 2007].
2 Kishen M, Belfield T. Contraception in crisis. J Fam Plann
Reprod Health Care 2006; 32: 211–212.
3 World Health Organization (WHO). Medical Eligibility Criteria
for Contraceptive Use (3rd edn). Geneva, Switzerland: WHO,
2004.
4 Family Health International. Provider Checklists for
Reproductive Health Services: Reference Guide.
http://www.fhi.org/en/RH/Pubs/servdelivery/checklists/index.
htm [Accessed 4 February 2007].
5 Faculty of Family Planning and Reproductive Health Care. UK
Medical Eligibility Criteria for Contraceptive Use (UKMEC
2005/2006). http://www.ffprhc.org.uk/admin/uploads/298_
UKMEC_200506.pdf [Accessed 15 September 2006].
6 Faculty of Family Planning and Reproductive Health Care
Clinical Guidance. First Prescription of Combined Oral
Contraception (published July 2006, updated January 2007).
http://www.fsrh.org/admin/uploads/FirstPrescCombOralCont
Jan06.pdf [Accessed 1 March 2007].
7 McGinn T, Wyer PC, Newman TB, Keitz S, Leipzig R, For GG;
Evidence-Based Medicine Teaching Tips Working Group.Tips
for learners of evidence-based medicine: 3. Measures of
observer variability (kappa statistic). CMAJ 2004; 171:
1369–1373.
8 MacGregor EA. Hormonal contraception and migraine. J Fam
Plann Reprod Health Care 2001; 27: 49–52.
9 Shotorbani S, Miller L, Blough D, Gardner J. Agreement
between women’s and providers’ assessment of hormonal
contraceptive risk factors. Contraception 2006; 73: 501–506.
10 Colidtz GA, Martin P, Stampfer MJ, Willett WC, Sampson L,
Rosner B, et al. Validation of questionnaire information on risk
factors and disease outcomes in a prospective cohort study of
women. Am J Epidemiol 1986; 123: 894–900.
11 Boissonnault WG, Badke MB. Collecting health history
information: the accuracy of a patient self-administered
questionnaire in an orthopedic outpatient setting. Phys Ther
2005; 85: 531–543.
54
©FSRH J Fam Plann Reprod Health Care 2008: 34(1)
Doshi et al./Book review
Stolen Tomorrows: Understanding and
Treating Women’s Childhood Sexual Abuse. S
Levenkron, A Levenkron. New York, NY: W W
Norton, 2007. ISBN: 0-393-06086-1. Price:
£16.99. Pages: 288 pages (hardcover)
It’s always worth celebrating an addition to the
coverage of therapy for abuse survivors. When
this addition is written well, sensitively and by an
experienced expert in the field, that’s even more
cause for celebration.
Steven Levenkron, already known for his
work on self-harm and eating disorders – his
celebrity patients included Karen Carpenter –
now focuses his attention on the issue of abuse.
Stolen Tomorrows, written with his wife Abby,
also a therapist, fulfils all of the above criteria,
and consists of a series of 19 extended case
histories with comment, with supporting sections
on the causes, progression and treatment of
female childhood abuse. It’s an insightful work,
and therapists both new to and working in the
field will find it useful, particularly if they wish
to have a window into what happens in the
counselling room. Non-therapists who work with
abuse survivors will also benefit from that
window, as well as gaining a good overview of
what can be done in a therapeutic context were
they to refer on.
So where’s my flinch, for flinch there is. I
have no doubts about this book’s appropriateness
to the professional reader. But then I turn to the
back cover – and I read the advertising blurb on
several bookstore websites and the reviews
quoted on the author’s own site – and that’s
where I have my reservations. For the book
claims to be appropriate for the abuse survivor,
and that it will help such ‘victims’ seek help for
‘their secret shame’.
That may have been the book’s aim, but it’s
not what it has achieved. The case histories are
moving, but accompanied by objective and
entirely therapy-aimed commentaries that might
well frighten any but the most informed, educated
and therapeutically advanced client. At the end of
the 276 pages, the four and a half pages aimed at
such clients seem like – and perhaps are – an
afterthought, and though compassionate, by no
means comprehensive or sufficient. None of this
would matter had the book been advertised as
being for a therapy market. But to major on its
use to survivors of abuse seems to me to be
inaccurate and unfortunate.
Final verdict? If you are a therapist,
absolutely buy it for your own library and
recommend it to colleagues. But on no account
give it to your clients until the work you are doing
with them is complete and they can take a long
view.
Reviewed by Susan Quilliam, BA, Cert Ed, MNLP
Freelance Writer, Broadcaster and Agony Aunt,
Cambridge, UK
BOOK REVIEW
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combined hormonal contraception
questionnaire in women requesting repeat
Feasibility of a self-completed history
L Wilkinson
Jagruti S Doshi, Rebecca S French, Hannah E R Evans and Christopher
doi: 10.1783/147118908783332203
2008 34: 51-54 J Fam Plann Reprod Health Care
http://jfprhc.bmj.com/content/34/1/51
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