Reviewer's report
Title:Observational, prospective, multicentre study to evaluate the effects of
counselling on the choice of combined hormonal contraceptives in Italy--the
ECOS (Educational COunselling effectS) study
Version:1Date:1 December 2014
Reviewer: angelo cagnacci
Reviewer's report:
I read with interest this paper by Gambera et al. The study is a complement of
the european CHOICE thta was not performed in Italy. Accordingly, it presents
data in a population not previously investigated. The results are in line with the
European CHOICE study. Nevertheless there are several minor points and some
critical points that require further evaluation by the authors:
Critical points:
1. The study was performed in a selected population of women, i.e. those
wishing to receive contraceptive hormones. This is not the general Italian
population. The main bias in this selected population is that switchers were
allowed to enter into the study. A switcher is a woman that is not satisfied with
the method she is using, Accordingly, she is prone to change. Because the pill is
the contraceptive most frequently used a shift towards alternative routes of
administration is favoured. This may have baised the results. Analysis without
switchers or taking into consideration the switchers as a confounder should be
presented.
2. In the Introduction and somewhere into the discussion it is said that HCP
opinion greatly influences woman’s contraceptive choice. This is contradicted in
lines 347 of the Discusson (it is unclear what the author think about this).
Nevertheless, it is the opinion of this reviewer that the way the counselling is
performed may influence woman perception of the different contraceptives. Now,
this is a sponsored study, and the counselling leaflet was used only in 85% of
cases. This means that objective unbiased counselling was not a prerequisite of
the study. Only 60% of women reported that the counselling was balanced and
fair and this is of additional concern (40% did not perceive that it was balanced
and fair). This is highly concerning. I suggest to exclude the data where the
leaflet was not used and to see whether the results are the same. This will not
completely remove the bias but may furnish some insight on its possible
presence.
3. It is scientifically incorrect to maintain that the vaginal ring overcomes the first
pass hepatic metabolism of EE. There is no first pass hepatic metabolism of EE.
In order to be metabolized EE should go through the liver for 15-20 times.
Accordingly, it is not metabolized at the first pass, and the route of administration
is irrelevant. Please remove this specification from the Introduction. In addition if
this concept was expressed in the counselling this may have markedly flawed the
results.
Minor Points
1. In the Introduction the first sentence is not supported by references.
2. The counselling leaflet is not presented. We do not know how the
characteristics of the different contraceptives were presented. For example what
is said about safety with the 3 types of contraceptives?
3. Sentence on line 80 reporting the importance of counselling for contraceptive
choice needs a reference.
4. Last two sentences of the Introduction pertains to Materials and Methods.
5. At the end of the Methods Demographics….were analyzed or evaluated? In
addition this sentence should precede the description of the power of the study.
6. Line 175 …used should be preceded by “ever”
7. Line 246 please remove “use”. This is not a study on contraceptive use in the
Italian population.
8. It is said that talking about the vagina may improve the use of the vaginal ring.
This is not supported by any literature, at least not by the one cited.
9. It is said that counselling reduced the callback. In this study there is no control
group and thus this cannot be maintained. Data of the literaure refers to a
different population and are not appliable to a selected population of Italian
women familiar or wishing to receive a hormonal contraceptive
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
Ia have received fees for talks, or reimbursement from MSD