Reviewer's report
Title:Evaluation of noncompliance and contraceptive counseling in users of
combined hormonal contraceptive methods: a cross-sectional study. Results
from the MIA study.
Version: 1Date:17 January 2013
Reviewer: Isabel Serrano
Reviewer's report:
Comments made by Dr Isabel Serrano. Discretionary revisions.
The question posed is original, important and well defined. It is of special interest
in Spain and in other countries where there is a high percentage of use of
modern contraceptive methods coinciding with a not very good compliance in its
use. As result of this, along with other reasons, the rate of unwanted
pregnancies, for example in Spain, and its consequences of abortion, is not
reducing. The method used in the article seems adequate and the data
presented are wide and appropriate for reaching the conclusions. However, I
attach some comments encouraging the authors to make some corrections.
Title and Abstract:
The aim of the MIA study is to know the compliance/noncompliance and
determine the factors that influence it in users of pill, ring and patch. According to
the contents I recommend to delete “and contraceptive counseling” because this
has not been included as a central item.
I do not know the preferences of the editors of BMC about the points of the
Abstract. Although this is a minor comment, personally I prefer to start for
“Objectives” instead of “Background”. In the second paragraph (Background) I
think that to determine the factors that influence the noncompliance is clearer
than “the reasons” and “using” clearer than “taking” because patch and ring
cannot be taken.
Results: I recommend reviewing the second paragraph (starting in “Switching”)
because in accordance to the whole text this is not relevant and results a little
confusing. Anyway this part should be clarified because I miss an explanation
about the reasons to propose switching contraceptive method to a certain
percentage of women. I miss also a more complete explanation about the results
of the multivariate analysis, which is the core of the investigation.
Conclusions: Pay attention to the last sentence. I am not sure that it is a clear
conclusion of this study although it is probably true. According to the results
summarized in the Table 3, there are other important factors in ensuring
compliance.
Keywords: “Contraceptive counseling” ¿?
Background: On page 4 when it is said “The amount of drug delivered is lower
than the pill” it should be more exact because is not true in all cases. Some pills
have lower hormonal contents. In the last paragraph “Our primary objective” I
recommend explaining better the inclusion criteria; Young women or women with
little experience? Later it will be said that they found an overlap of 80% between
the 2 types of users, however a clarification of the population included in the
survey is needed.
Methods: Could the authors explain how and why they calculated n= 12,000?
Once more, I recommend clarifying (page 6) the inclusion criteria. It seems clear
that the age of women was limited to 18 to 28 years so it is confusing when “or
have had little experience…” is written. Probably the population object of study is
young women between 18 and 28 years old with a maximum of 2 years of
previous use of pill, ring or patch (before of the visit) but this has to be clarified.
In addition I think that the meaning of the “2 years of previous use” should be
pointed out. According to a sentence about the time of use of the different
hormonal methods (page 9), “Mean 31 months vs 20 and 22 months…” I
suppose that the women could be users of pill, ring o patch for more than 2 years
in their lives but in separate periods in such a way that at the date of the visit of
study they had not used one of these methods more than 2 years continuously.
Please, review.
On page 7 the definition of “a compliant user” is confusing.
In the last paragraph of page 7 it would be necessary to explain a little more de
criteria and procedure of the recommendations. As the questionnaire was
self-administered, at what moment were the recommendation made?
Results: I wonder if it is correct to say that 9,367 women were recruited. Does it
mean that 9,367 women users of pill, ring o patch were consecutively asked if
they accept participating in the study and later excluded those who were over 28
years? The first paragraph must be better drafted.
I would recommend a little more order in the presentation of the results in order
to facilitate the understanding.
Page 9 is OK: Socio-demographic data, contraceptive methods used and
compliance/noncompliance in relation to the method. I recommend deleting the
last sentence “Nevertheless, 25,0 % of women…” because it is repeated at the
end of page 13.
Page 10: The first part (reasons for non compliance) is OK. I propose placing the
part related to the routine (“Most women had a routine…) before “The most
common course of action after noncompliance”.
After that, I would include the results of the multivariate analysis (page 12) since
it responds to the main objective of the study. However I would reduce the
contents of page 13 in order to facilitate the interest of reading. I recommend
pointing out only the most significant factors influencing the
compliance/noncompliance avoiding the repetition of the same information in the
Tables and in the text.
Finally, I would include the remaining part presenting it (“Among those women …
were recommended to switch”) as a complementary result. I consider that on
page 11 it is not clear enough the selection of the percentage of women who
received the recommendations. Could the authors explain why the
recommendation were offered to a certain percentage of women (39,7 %; 3,8 %
and 1,9 % respectively)? A little reduction of this part is recommended.
Last sentence on page 13 have to be reviewed; it seems contradictory.
Discussion: I do not consider necessary to repeat the kind of study performed.
So I recommend deleting the first sentence.
It is not easy to understand the expression “more than half of pill users took their
pill late and almost half forgot to take it”. Does it mean that nobody uses the pill
well? Nevertheless, the data that support this affirmation have not been found in
the Results. I think that every mention in the Discussion has to be supported by
data included in the Results. Please, include them, delete or clarify that
affirmation.
In the middle of page 15 it is written “In the case of the patch more than half
consulted a health professional” whereas in the middle of the page 10 it is said
that “Women also consulted a health care provider: … 21,1% for the patch…”.
Please, review.
On page 16 the limitations of the study have been included. According to the
rules of edition of other issues, this part could be placed at the end of the
Results. So, it depends on the editor´s criteria. I do not share the opinion of the
lack of information about the use of emergency contraception is a limitation.
Simply it has not been included in the same way that the study excluded
information about the compliance/noncompliance of other contraceptive
methods.
The authors stress the importance of the role of the clinicians in ensuring good
information and advice for the women. It is said in the first sentence on page 16,
on page 17 and in the first part of page 17. However in the 21 variables studied
and summarized in the Table 3, only 4-5 are related with the cited role.
Therefore, I recommend improving the balance of the concerns included in the
Discussion, referring especially to those that have a bigger significance and
reducing the aspect related to the role of clinicians. If the extension of this
concerns is maintained an increase in the related data in the Results is
recommended.
Conclusions: According to the former comments, I recommend including more
explenation about the factors affecting the compliance/noncompliance with
higher statistical significance. Please, pay attention to the concordance between
the conclusions written in the Abstract and here.
Comments about Tables
I propose to reduce a little bit the Tables, above all the 3rd. I recommend
reviewing the second column with special attention to extremely long items and
reducing the last lines specifying only the clearest. Please if the authors agree to
reduce this Table 3 I would recommend excluding/reducing the variables with
less significance.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I have collaborated as speakers for Merck, Sharp&Dohme (MSD), Spain, but I
did not receive funding o salary for this. I have received occasionally fees from
MSD as a support to participating in Spanish Congressess related to my
specialization.