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:5 December 2014
Reviewer: Ingrid Rowlands
Reviewer's report:
Offering women information and support throughout their reproductive lives is
important. This study evaluated the impact of counselling on women’s
decision-making regarding contraception. Although an interesting and well written
paper, some of the conclusions of the study require revision, and the potential for
the study to add to the existing literature is not well described.
Major Compulsory Revisions
Introduction
The study is based on the methods of the European Choice study, but there is no
reference to this in the introduction of the paper. A brief mention of the Choice
study, its outcomes and how the present study builds on this work is needed.
Methods
Additional details about how women’s “perceptions” were measured in both Part
A and B of the questionnaire would be useful (e.g. number of questions and
examples of questions used). Similarly, can the authors provide any information
about the average duration of the counselling sessions?
It is also not clear how information about the adverse events was collected?
Were AEs based on physician diagnoses?
My major concern is with the use of call back rates to assess a) women’s
satisfaction with the contraceptive method selected and b) the ‘clarity’ of the
counselling session (see page 4). This is a lot to assume, particularly from the
small number of women who made calls to physicians following their counselling
session. On page 14, the conclusions that the low call back rates suggest that
“gynaecologists had explained how to deal with potential problems…” and
“enabled women to manage their first months of contraception successfully” are
not well justified and should be revised. Many of the women in this study had
previously used some form of contraception, particularly the pill, which is just as
likely to explain the low call back rates. The information offered by the call back
rates requires revision, and the limitations of this data should be acknowledged in
the discussion.
Discretionary Revisions
To determine the effectiveness of the counselling services, it would be much
stronger to have subjective measures of women’s satisfaction with both a) the
method of contraception and b) the information presented at the counselling
session. On page 9, it appears that the study did include questions about the
quality of the information provided but this is not well described in the measures
section. This is an interesting aspect of the study and may offer some new
insights. Did the authors consider comparing the demographic and clinical
characteristics of women who rated the quality of the information as ‘good’ to
those who did not? And did quality ratings differ by contraception method?
On page 13, the authors raise an important point that counselling may provide an
opportunity to openly talk about ‘embarrassing’ or ‘sensitive’ issues related to
certain contraceptive methods. Can the authors comment on the opportunity
offered within the counselling sessions for these types of discussions? Is this a
topic that needs to be added to (or revised) in the counselling schedule? What
recommendations can be made from this study?
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests