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L'étude complète (en anglais) publiée dans The journal of the european society of Contraception

L'étude complète (en anglais) publiée dans The journal of the european society of Contraception

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 Correspondence: Steven Weyers, MD, PhD, Ghent University Hospital, De Pintelaan 185, B-9000 Gent, Belgium. Tel:
 32 93325446.Fax:
 32 93324854. E-mail: steven.weyers@ugent.be
INTRODUCTION
In Western countries, there is a wide choice of con-traceptive options. Yet, abortion rates remain unac-ceptably high and are even rising. In Belgium, whereabortion is legally permitted, the reported abortionrate of about one in 100 women per year is amongthe lowest in the world
1 – 3
 , and the lifetime risk of having an induced abortion is about one in six
2
 . Half 
The European Journal of Contraception and Reproductive Health Care, December 2011; 16: 418–429 
 Does structured counselling influencecombined hormonal contraceptivechoice?
Mireille Merckx
*
 
, Gilbert G. Donders
,
, Pascale Grandjean
§
, Tine Van de Sande
#
and Steven Weyers
^
 
*
 
Universitair Medisch Centrum St Pieter, VUB/ULB, Brussels,
Heilig Hart Ziekenhuis, Tienen,
Universitair ZiekenhuisLeuven, Leuven,
§
Centre Hospitalier Régional de Mons, Mons,
#
 Medical Department MSD Belgium, and
^
 Universitair Ziekenhuis Gent, Ghent, Belgium
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 ABSTRACT
Objective
To assess the effect of structured counselling on womens contraceptive decisionsand to evaluate gynaecologists’ perceptions of comprehensive contraceptive counselling.
Methods
Belgian women (18 – 40 years old) who were considering using a combinedhormonal contraceptive (CHC) were counselled by their gynaecologists about availableCHCs (combined oral contraceptive [COC], transdermal patch, vaginal ring), using a com-prehensive leaflet. Patients and gynaecologists completed questionnaires that gathered infor-mation on the womans pre- and post-counselling contraceptive choice, her perceptions, andthe reasons behind her post-counselling decision.
Results
The gynaecologists (
 
121) enrolled 1801 eligible women. Nearly all women(94%) were able to choose a method after counselling (53%, 5%, and 27% chose the COC,the patch, and the ring, respectively). Counselling made many women (39%) select a differ-ent method: patch use increased from 3% to 5% (
 p
 
0.0001); ring use tripled (from 9% to27%,
 p
 
0.0001). Women who were undecided before counselling most often opted for themethod their gynaecologist recommended, irrespective of counselling.
Conclusion
Counselling allows most women to select a contraceptive method; a sizeableproportion of them decide on a method different from the one they initially had in mind.Gynaecologists’ preferences influenced the contraceptive choices of women who were ini-tially undecided regarding the method to use.
KEYWORDS
Combined hormonal contraception; Combined oral contraceptives; Transdermal patch; Vaginal contraceptive ring; Counselling
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
© 2011 The European Society of Contraception and Reproductive HealthDOI: 10.3109/13625187.2011.625882
   E  u  r   J   C  o  n   t  r  a  c  e  p   t   R  e  p  r  o   d   H  e  a   l   t   h   C  a  r  e   D  o  w  n   l  o  a   d  e   d   f  r  o  m   i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m   b  y   M  e  r  c   k   &   C  o .   (   A  c   t   i  v  e   )  o  n   1   2   /   0   5   /   1   1   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .
 
 Influence of counselling on contraceptive choice Merckx et al.
The European Journal of Contraception and Reproductive Health Care 
419
of the women seeking an abortion in Belgium werenot using reliable contraception, 15% relied only oncondoms, and 26% were taking a combined oral con-traceptive (COC). These figures are consistent withthose from the United States (US), where up to 20%of all unwanted pregnancies are due to the incorrector inconsistent use of oral contraceptives
4
 . Trussellrecently showed that in the US the unintended preg-nancy rate during the first year of ‘typical use’ is 9%for all types of combined hormonal contraceptives(CHCs)
5
 . While irregular use was thought to be mostcommon among adolescents and young women,recent research indicates that non-use and poor com-pliance are common in
all 
age groups
6
 . Lack of com-pliance is related to deficient knowledge
7
and poor motivation. Another, possibly underestimated, reasonis womens dissatisfaction with their chosen contra-ceptive method.During the last decade, two alternatives to COCshave expanded womens options: the CHCs concernedare the transdermal patch and the vaginal ring. Thepatch is replaced once per week; the ring once per month. A recent survey by Lete
et al 
 . showed a sub-stantial improvement in compliance in users of thesenew non-daily methods: 68% and 78% of patch- andring users, respectively, reported consistent use com-pared with only 29% of COC users
8
 .However, widening the range of CHC options withmethods not requiring a daily intervention may notsuffice to increase compliance. Glasier 
et al 
 . showedthat neither the wide availability of contraceptivemethods nor the free provision of emergency contra-ception changed womens behaviour or reduced theneed for abortion
9
 . While effective counselling is cru-cial to maximise contraceptive compliance
10,11
 , thewide range of products available today makes counsel-ling more difficult for the clinician
12,13
 . Easy-to-usecounselling tools such as information leaflets can assisthealthcare professionals and women during counsel-ling sessions
6
 .The Contraceptive Health Research Of InformedChoice Experience (CHOICE) study was initiated in11 countries to encourage healthcare professionals(HCPs) to study and improve counselling of womencontemplating the use of a CHC. It assesses the influ-ence a standardised counselling guide may have onwomens contraceptive decisions and evaluates how themethod finally chosen by women differs from that theyoriginally thought they would employ. In Belgium, theCHOICE study included an additional questionnairethat was offered to HCPs to assess whether they pre-ferred structured contraceptive counselling and/or theuse of the specially designed leaflet over their usualcontraceptive counselling approach.
MATERIALS AND METHODS
The cross-sectional, multinational CHOICE studyinvolved 11 countries with very different contracep-tive service provision and practices: eight Europeancountries (Austria, Belgium, the Czech Republic, TheNetherlands, Poland, Slovakia, Sweden, and Switzer-land), Israel, the St. Petersburg and Moscow regionsof the Russian Federation, and Ukraine. The targetfor Belgium was to include 1850 women between 18and 40 years old. In Belgium, only gynaecologistswere asked to participate. Gynaecologists (
 
121)were expected each to recruit ten or more womenwhom they would see during hospital consultationsor in their individual practices. Gynaecologists kept alog of 
all 
women consulting for contraception duringthe study period regardless of whether they wereenrolled in the CHOICE study or not. Women whoconsidered starting a CHC method or switching fromone CHC method to another were invited to partici-pate. Women who
a priori 
excluded one or more of the three methods (COC, patch or ring, possiblybecause they were not satisfied with their currentmethod and wanted to switch to another CHC) werenot eligible to participate. A counselling leaflet pre-sented information about the different types of CHCs,including their mode of action, mode of administra-tion, benefits and side effects. The counselling leaflet,which was derived from a leaflet used in the TEAM-06-study by Lete
et al 
 .
14
 , was prepared in cooperationwith the European Society of Contraception andReproductive Health (ESC) and was offered to theclinician for use during counselling. If, during theconsultation (i.e., when the woman was being invitedto participate in the CHOICE study) the gynaecolo-gist believed that another (non-CHC) method wasmore appropriate, the counselling leaflet was not usedbut the study questionnaires were still completed. Thestudy was approved by the central ethical committeeof Ghent University Hospital and subsequently by allother required local ethics committees. All participatingwomen gave written informed consent prior to enrole-ment. A local Belgian steering committee (made up of 
   E  u  r   J   C  o  n   t  r  a  c  e  p   t   R  e  p  r  o   d   H  e  a   l   t   h   C  a  r  e   D  o  w  n   l  o  a   d  e   d   f  r  o  m   i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m   b  y   M  e  r  c   k   &   C  o .   (   A  c   t   i  v  e   )  o  n   1   2   /   0   5   /   1   1   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .
 
 Influence of counselling on contraceptive choice Merckx et al.
420
The European Journal of Contraception and Reproductive Health Care 
power analysis on this secondary objective led to thedetermination that 1070 women needed to participatein each country to yield a power of 90% to detect anincrease of at least 3% in either the selection of thepatch or ring, and maintain a false-positive (or type I)error of 5%. Since two comparisons (one for the patchand one for the ring) were required, a one-sided sta-tistical significance level of 1.25% was used.After accounting for these considerations, we deter-mined that we would need to recruit at least 1500 par-ticipants in each country to meet the statistical objectivesof the CHOICE study. The sample size needed to beadjusted upwards by about 20% to compensate for non-evaluable questionnaires and erroneous study entry,resulting in a target sample size of 1850 women.For the post-counselling selection of contraceptivemethods, simultaneous 95% CIs were calculated basedon the 5-cell multinomial probability distribution. Thedifference in proportions between the chosen and theintended methods is presented with the two-sided97.5% CI for the patch and the ring. The statisticalsignificance of these differences was assessed usingMcNemar s test for differences in proportions. Allother analyses are exploratory and a two-sided signifi-cance level of 5% was used.The questionnaires included questions about wom-ens perceptions regarding the efficacy, safety and useaspects of the three CHC methods after counselling.To assess the association between these perceptions andwhether or not women decided to use the methodconcerned, the probability of choosing a method wasmodelled against agreement or disagreement with theperception statements (with the categories ‘no opinionand ‘do not know’ as a combined reference category).The participants age was included in the models as acovariate.
RESULTS
The characteristics of the participating gynaecologistsare summarised in Table 1. Most of the gynaecologistswere women (56%) and one in three was more than49 years old. HCPs were most likely to recommendCOCs to women who were consulting for contracep-tion (90%), followed by the levonorgestrel releasing-intrauterine system (LNG-IUS, 5%).Of all the collected questionnaires (
 
1843), 42(2%) were excluded from analysis because of violationfour of the authors of this manuscript: MM, GD, PG,SW) supervised the study from start to finish.Before the counselling session, the gynaecologist askedthe woman if she already had a preference for any CHC.The gynaecologist then counselled the woman about allthree CHC options (and/or other methods if deemedsuitable). Use of the counselling leaflet was optional butrecommended. The content of the counselling guide waswell known to all the gynaecologists, and if they – for oneor more reasons – decided not to use the counsellingleaflet during the contraceptive discussion, they werenonetheless supposed to provide their patients with thesame information and to counsel them as extensively aspossible on each of the three methods. The gynaecologistchecked whether contraindications existed for any of theCHC methods and documented on the questionnairewhether the counselling leaflet had been used. Thepatient provided demographic information and ratedvarious characteristics of the CHC methods describedto her by her gynaecologist. She also indicated whichmethod she ultimately chose and the reasons for her choice. The questionnaire included 18 questions andtook about ten minutes to complete.
Statistics and sample size
A primary statistical objective of the study was todetermine with sufficient precision the selection ratesof the pill, patch, ring or other method after counsel-ling or whether the woman was still undecided. Aprecision of 2% (the half-width of the simultaneoustwo-sided 95% confidence interval [CI] for choosingeach the weekly patch or monthly ring) was selected;it was also assumed that 10% of women in each coun-try would select the patch and 10% would select thering after counselling. This resulted in 1500 requiredparticipants per country.A secondary statistical objective of the CHOICEstudy was to demonstrate that the selection of a methodother than the pill (e.g., patch or ring) undergoes astatistically significant increase after contraceptive coun-selling compared with the womans pre-counsellingcontraceptive choice. For the patch and the ring, weaimed at detecting differences of at least 3% betweenpost-counselling and pre-counselling contraceptivechoices. It was assumed that 5% of the women whochose the patch and 5% of those who chose the ringprior to counselling would change their mind andselect another method after counselling. Statistical
   E  u  r   J   C  o  n   t  r  a  c  e  p   t   R  e  p  r  o   d   H  e  a   l   t   h   C  a  r  e   D  o  w  n   l  o  a   d  e   d   f  r  o  m   i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m   b  y   M  e  r  c   k   &   C  o .   (   A  c   t   i  v  e   )  o  n   1   2   /   0   5   /   1   1   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .

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