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:22 April 2013
Reviewer: Kelli Hall
Reviewer's report:
Major Compulsory Revisions
This paper represents an interesting analysis on factors associated with
contraceptive adherence (by method type) and the role of provider counseling
and recommendations using data from the MIA study. The dataset is
comprehensive and the variables that were assessed provide thorough (and
what I believe to be new) details regarding method adherence, reasons for
non-adherence and the role of the provider in counseling and method
recommendations. While I feel that this paper does potentially have something
innovative to contribute to the broad literature on this subject, there are major
limitations that prevent me from recommending it for publication in its current
state. Most notably, the paper could be improved to highlight the most novel and
interesting findings, in particular those relating to the role of the provider. There is
a large amount of rich but overwhelming information presented, and so I think the
authors could be more concise and clear in summarizing and emphasizing the
take home messages and what this study contributes to the science on this topic.
The methods also need significant work. I have suggested some major revisions,
which I hope will result in an improved paper more suitable for publication.
1. Title: It is a bit unclear, after having read the entire piece – do the authors
mean the role of contraceptive counseling in user adherence? Or other factors
related to adherence? I think it needs to be more concise.
2. Abstract: The abstract methods need to be better described – it is unclear
whether medical records data were used or a survey was administered
separately in health care settings by physicians? Was this a survey of only
patients or both patients and providers after a clinical encounter? The authors
also need to define noncompliant and the reference category for the multivariable
models (ie was noncompliant coded 1 or was compliant coded 1)?
3. Abstract results: what was the percentage who reported forgetfulness? What
do the authors mean by “switching was proposed?” Were these data reported by
the providers? Same question for “reasons for recommending a switch.”
Confidence intervals are needed with the ORs in the results. Also, why is the
comparison focused on the vaginal ring? Were these the only 3 methods
examined in this study. What about LARC methods?
4. Overall, the abstract needs to be much more clear about the methods and
study design and who the sample was – patients or providers?
Also, a large part of the abstract results seems to have focused on method
switching – this was not mentioned in the purpose statement.
5. The abstract conclusion that “physicians play a key role in compliance” does
not follow from the authors results – at least it appears they only have data on
what the recommendations were, not how the recommendations changed
method use or adherence subsequently.
6. Main text Introduction:
The sentence in the first introduction paragraph “therefore, methods that reduce
the frequency of dosing could increase compliance” seems out of place and
distracts from the flow of the introduction. This sentence should be moved to the
next paragraph.
7. The second introduction paragraph is a bit confusing. The first sentence is
appropriate but then the discussion about side effects and risks seems to be only
loosely related to the initial focus of the paper (at least as its presented in the first
paragraph). I would rework this paragraph to emphasize the potential benefits of
extended dosing methods like the ring and the patch and why it these methods
contribute (hypothetically) to improved adherence.
8. A related point - what is the hypothesis? That method characteristics
contribute to improved adherence? Or that provider counseling regarding
methods and their features improve adherence? This should be clarified and
stated directly.
9. The introduction seems incomplete. There does not seem to be a paragraph
commenting on why this study was undertaken and in particular how it
contributes to the broad literature on this subject. Many studies have looked at
adherence rates of these methods comparatively so it is not clear what this study
is trying to add. It seems that a major point of the authors’ purpose is described
in the line “Analyzing data on the advice given to users by gynecologists and the
acceptance of this advice should place clinicians in a better position to help
women select the method that is most suitable for them or to recommend a more
effective method when necessary.” However, the entire introduction until this
point does not mention the role of provider counseling on method adherence and
particularly as it relates to method type. If this is the major focus of this paper,
then the introduction needs to be reframed to reflect the role of the provider.
Also, a more concise but comprehensive background on “reasons for
noncompliance” with these methods should be presented as there is a significant
body of research on this topic.
10. Methods: I am not clear on what is meant by “an overlap of 80% was
assumed between the 2 types of user (young women and women with little
experience of their contraceptive method).” Also, what is meant by “The overall
precision of the theoretical sample (N=12,000) was 0.9%. The overall precision
reached with the final sample was 1%. In conclusion, the final precision reached
with the sample analyzed (8,762) does not differ significantly from the initially
proposed sample. Therefore, the precision by subgroups was acceptable (<0.05,
standard value)”?
11. Methods: The comment “in order to exclude the effect of recall bias
associated with the length of time on the combined contraceptive method” is
incorrect – there are two types of potential bias here – one is recall (that you
address by limiting the time frame) and the other is bias due to confounding
based upon previous experience with the methods.
12. The line “seen at the doctors’ offices, were consecutively invited to
participate” Is confusing (what do the authors mean by consecutively), and there
should not be a comma.
13. A better description of the definition of the primary outcome is needed. Were
women “who took/used her contraceptive method without delays or omissions at
least once since the last visit” all considered compliant? What if these women
had experiences with noncompliance too? What does “at least once since last
visit” indicate? I’m still not clear on the definition of compliance – were compliant
women those who had no reports of noncompliance? Or did the authors create
an outcome variable of “level of compliance”?
14. It appears within the methods section that the sample for this study was
actually both patients and providers given that the providers counseling and
recommendations were the source of at least part of the data and analysis. This
is an extremely important point in the study design and that directly addressed
the research questions, so it needs to be more explicit in the methods.
15. Results: There is a significant and interesting but overwhelming amount of
descriptive results here. This information would be better presented in a table
and then only highlighted in the text. I would recommend cutting this section
significantly.
16. The variables for the regression analyses should not be listed in the results
but rather in the methods section. Only the variables that were significant in the
models should be highlighted in the text. Also, it is unclear what the reference
group is for the compliance outcome (was compliance coded a 0 and
noncompliance the outcome (coded 1). The abstract presents it in the opposite
way. This needs to be clarified in the methods section and also when describing
the multivariable results, as well as in the tables.
17. Overall, the multivariable results are also very interesting but the presentation
of them in the text is very distracting and wordy. I would recommend
summarizing (not repeating the questions/responses in quotes so often) and then
presenting them in greater detail in the table.
18. The early parts of the discussion (first 3 paragraphs) seem to only repeat the
findings and don’t add anything insightful. I would synthesize and comment only
on the most important finding here. In fact, I would recommend considering
allowing a single paragraph for your current first 4 paragraphs and then jumping
straight into the new findings that your study contributes starting with your current
paragraph 5 top of page 16 (regarding the role of the provider
recommendations). However, this section needs to be significantly embellished
as these are your main findings.
The last paragraph on page 16 does not belong here (should be condensed into
your introduction) and serves only to distract from your main findings. Same
comment applies for the lines “Compliance varies according to the delivery
method chosen. One study showed that compliance was greater with the vaginal
ring than with the pill [18], whereas others show consistent perfect compliance
with the transdermal patch [19,20]. Availability of high-quality information is key
to ensuring that women use their contraceptive method correctly.”
Overall, the authors need to more concisely and clearly emphasize their novel
findings regarding the role of the provider in this study.
Table 2: I would add method type variable to these bivariate results.
Table 3: The authors need to clarify which are the reference groups for each of
their categories of method types. Also, why was the outcome examined in this
way, rather than a multinomial regression model?
The authors need to consider an abbreviated concise list their variables in Table
3 and include reference groups for each variable and the definitions (coding) for
each variable. As it stands, it is very difficult to sort through and reads as if they
just pasted the questionnaire.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests