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:8 December 2014
Reviewer: Sara Holton
Reviewer's report:
The manuscript, ‘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’, reports on an issue
that has important clinical implications. Such research assists in understanding
whether counselling on contraceptive methods can assist individuals to choose a
method that is most appropriate to their needs.
Nevertheless, although this is a potentially interesting paper, it is my opinion that
the paper requires revisions before it could be published in BMC Women’s
Health.
Major Compulsory Revisions
General
The paper needs to clearly state why only combined hormonal contraception was
chosen to be investigated and not other methods, given that the main justification
provided by the authors for this study is that it is important to help individuals
choose the most appropriate method for them (it maybe that other methods such
as LARC would be the most suitable and therefore, an individual should be
counselled about all available methods?). What is it about hormonal
contraception that means it should be encouraged for use? Is it more effective
than other methods? Independent from coitus? Cost-effective? Are these the
most widely used methods in Italy? Or are current rates for Italy low (how they
compare to those of other countries)? Is an objective of this study to improve
usage rates of CHC methods? If so, why? Etc The relevant reasons need to be
identified.
Further, what is the ‘so what' of this study? Why is it important to know this?
What are the implications of the findings for clinical practice, women, health
policy, sex education etc? Is it good/beneficial that women select a different CHC
method than originally intended after counselling? Why? What difference will this
make to women, clinical practice etc? Based on the findings, would the authors
recommend that all women seeking contraception should be counselled etc?
Minor Essential Revisions
General
“Callback rate” needs to be defined as this term may not be familiar to all readers
or understood in the context of this study.
Background
Line 63: please specify/list the “country-specific differences”.
Line 91: I think this last sentence about callbacks belongs in the Methods.
Materials and Methods
Line 100: Given this study is limited to investigation of CHC methods only, I think
the objective should be restated to “The objective of the study was to monitor the
effects of counselling on combined hormonal contraceptive choice using a
standardised counselling questionnaire and guide.”
Line 141: Please include more details about the procedure for the “callbacks”.
For example, who did the women “callback”? Did they only call back because
they were part of this study or do women in Italy routinely “callback”?
Line 144: Is “AEs” Adverse events? Please to write in full the first time the
acronym is used.
Statistical analyses
Line 150 & Line 212 (results): Were any multivariate analyses undertaken to
determine which factors associated/predict use of CHC methods? If not, why not
and what analysis method was used to determine (line 212) that “no predictors …
could be identified”?
Line 162-163: Please provide references for these two points.
Results
Why did many women (38%) select a CHC method that was different from the
originally intended one? Was it because women were unaware of these methods
previously? Did they have misperceptions about them? eg side effects, cost,
access etc?
Line 173: What is the response rate? Please specify how many women were
approached to recruit 1919 women.
Line 195: “were” instead of “was”
Line 199: “opted” instead of “opting”
Discussion
Line 279: “HCPs”. Please to write in full the first time the acronym is used.
Line 285: Can you provide reasons or speculate as to why “the biggest change”
was an increase in preferences for the vaginal ring after counselling?
Line 289 (onwards): I think these reasons and numbers/percentages would be
better reported in the Results.
Tables
Table 1: How do the sample's characteristics compare to the general population
in Italy? Is the sample representative? Why was weight measured? Did it affect
the findings? Was there a relationship between choice of CHC methods and
weight? Why weren’t hormonal IUDs (eg Mirena) included in the list of the “last
contraceptive method” used?
Discretionary Revisions
N/A
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