Reviewer's report
Title:Satisfaction and compliance in hormonal contraception: the result of a
multicentre clinical study on women's experience with the
ethinylestradiol/norelgestromin contraceptive patch in Italy
Version: 1Date:13 February 2009
Reviewer: Maria Gallo
Reviewer's report:
Major Compulsory Revisions
This study measured the satisfaction and “compliance” to the use of the COC
patch. The development of highly-effective, acceptability contraceptive methods
is important given the difficulties that many women have in adhering to daily COC
use. Thus, research to understand the acceptability of the patch is important.
This study would be strengthened by conducting more in-depth analysis and
presenting additional data. First, how many women contributed data for each
cycle? Did the women who adhered to the regimen differ by any characteristics
from those who did not? Similarly, were there any factors associated with the
women who were satisfied with the patch? Did the women who dropped out of
the study early differ from those who completed it? (This is important to address
the possibility that study attrition was higher among women who did not like the
method.) Was adherence related to acceptability? How did the adherence
assessed by visual inspection of the study medication boxes correspond with the
woman’s self reports of adherence? Which measure was used to calculate the
adherence if the two measures did not agree?
Being in a monogamous relationship without the need for STI protection was not
an eligibility requirement. Therefore, women could use condoms while in the
study. How common was this? The contraceptive effectiveness rates are not
convincing without knowing whether women were also using other methods.
Also, because routine pregnancy tests only occurred at baseline and the last
follow-up visit, it would be important to know what steps were taken to capture
other pregnancies (e.g., the collection of data on pregnancies that were
terminated outside of the context of the study). At the very least, these issues
should be discussed in the limitations section.
Some of the references are out-dated or are not considered to be definitive
references. For example, the first two references should be replaced by more
appropriate references. The third reference is for an older edition of the book; it
should be replaced with the 18th edition.
The discussion should include a more detailed discussion of the study strengths
and limitations. What new research findings does this study contribute? The
study is limited in several ways. First, this was a single-arm study with limited
generalizability. Because all of the women agreed to use the patch, the
adherence and acceptability results might not be representative of the general
population. Also, because women who did not like the product might have been
more likely to not initiate use after enrollment or to drop out of the study early, the
results might have over-estimated the satisfaction and adherence.
Minor Essential Revisions
1. Background, first paragraph, first sentence (“Combined oral contraceptives are
the most effective and commonly used form of reversible contraception…”) This
statement is not true. Norplant has lower typical-use and perfect-use rates and
the IUD has lower typical-use rates.
2. Background, fifth paragraph, first sentence (“The same pooled analysis
showed…”). The references for this sentence differ from the one previously given
for the “pooled analysis.”
3. Background, fifth paragraph, second sentence (“Another pooled analysis also
showed…”). This sentence does not have a citation. What article was this? What
studies were included? Did the studies overlap with the previously described
“pooled analysis?”
4. Background, fifth paragraph, fifth sentence. The odds ratio cited need
accompanying confidence intervals.
5. Background, six paragraph, third and fourth sentences (“Obviously, women
who…” “So subject’s satisfaction…”) These sentences should have citations to
support the claims.
6. Background, six paragraph. Does the parent study (“a pan-European study”)
have a name? The primary article(s) describing the parent study should be
referenced.
7. Methods, “Statistical analysis” section. First paragraph, second sentence (“All
subjects who used at least 1 study patch were included in the analysis (ITT
population).”) This is not consistent with the definition of intent-to-treat analysis.
To conduct an ITT analysis, the study should have attempted to collect data on
all women who were enrolled in the study (regardless of whether they used the
product) and should have included them in the analysis.
8. Results, first paragraph, first sentence. (“…all subjects provided diary data and
reached the study endpoint. 175 women (84.5% completed the 6-month
study)…) I don’t understand this part; it appears contradictory. What was the
study endpoint if not the 6-month visit?
9. Results, “Efficacy” section, first paragraph, second sentence (“One on-therapy
pregnancy occurred…”) I don’t understand the meaning of this sentence.
Discretionary Revisions
1. Methods. More details about or a reference for SF-12 Health Survey should be
included.
2. Methods. “Study evaluation” section. How were the questionnaires
administered? And by whom?
3. Methods. More details about or a reference for SF-12 Health Survey should be
included.
4. Methods, “Study evaluation” section. How were the questionnaires
administered? And by whom?
5. Discussion, fifth paragraph, second sentence. (“Only 1 pregnancy was
reported during this study.”) Could you clarify whether this only measured
pregnancies reported by the woman or the total number of positive pregnancies
test results?
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: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.