JerMa88/BMC_Womens_Health_Peer_Reviews huggingface dataset:
Reviewer's report
Title:Pattern recognition in menstrual bleeding diaries by statistical cluster
analysis
Version: 1Date:25 April 2009
Reviewer: Eileen Manalo
Reviewer's report:
Answers to Guide Questions:
1. Is the question posed by the authors well-defined?
Basically, the paper is asking the question “What are the bleeding patterns
among women who used sex hormone-containing drugs, kept bleeding diaries,
and were involved in clinical studies involving the use of such sex
hormone-containing drugs “
The phrasing of the aim of the paper, however was not clear. (major compulsory
revision)
2. Are the methods appropriate and well-described?
The population studied was not clearly defined. What were the demographic
characteristics of the women studied (e.g., age, body weight, BMI, purpose of
sex hormone drug use, duration of treatment) (major compulsory revision)
“Bleeding intensity” categories were standardized according to WHO terminology
as “none”, “spotting”, and “bleeding”. Although the authors defined “spotting” and
“bleeding”, “none” was not defined. Does “none” mean total amenorrhea, or
merely the absence of intermenstrual bleeding? (major compulsory revision)
I also could not understand the statement “The bleeding patterns in the diaries
should be found by unsupervised pattern recognition”. (minor essential revision)
The clinical trials involving use of sex hormone-containing drugs were not cited.
(major compulsory revision)
3. Are the data sound?
The Ward Method tends to join clusters with a small number of observations and
is strongly biased toward producing clusters with roughly the same number of
observations (Milligan, 1980) (major compulsory revision)
There is a need for a more detailed description of the bleeding patterns identified.
In this aspect, the paper fell short of achieving its objective. (major compulsory
revision)
Legends used are likewise rather confusing. (minor essential revision)
4. Are the limitations of the work clearly stated?
Limitations of the study are not clearly stated (major compulsory revision)
5. Is the writing acceptable?
Grammar and sentence construction have to be improved. (minor essential
revision)
NOTE: I emailed a copy of the whole journal with my suggested corrections
(especially on grammar/sentence construction using email address
editorial@biomedcentral.com
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I have received honoraria for lectures given in behalf of Bayer Schering, and
funding for travels for scientific congresses
Reviewer's report
Title:Pattern recognition in menstrual bleeding diaries by statistical cluster
analysis
Version: 1Date:31 May 2009
Reviewer: Antonio Cano
Reviewer's report:
This manuscript aims at finding clinically meaningful bleeding patterns as
reported in bleeding diaries from clinical studies with steroidal hormones, either
contraceptives or hormone therapy. The topic is of much interest since there has
been considerable heterogeneity in studies reporting bleeding/spotting episodes
in studies on women using hormones. Given this relevance, the own World
Health Organization has issued recommendations for analyzing bleeding
patterns in clinical trials, as adequately cited by the authors. Additional strengths
of the manuscript include a good definition of the objectives, a well-selected list
of references, and an adequate total length.
The main problem, however, is that the concrete content and conclusions will
perhaps be of little interest for clinicians. The analysis is focused on cluster
algorithms that many clinical investigators/practitioners may find difficult to
understand due to the lack of familiarity with these research tools.
Another point refers to the limitation imposed by the fact that actually 27.9% of
the women never bled during the period analyzed, and an additional 68.8%
experienced a bleeding pattern that occurred only once. Authors should include
in the manuscript an indication on whether this may, or may not, affect the
consistency of their conclusions.
In summary, I think this is a well designed and developed study, but perhaps it
will be more adequate to submit it to journals with a more specialized profile on
this type of analytical models.
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 have no conflict of interest relative to this paper.
Reviewer's report
Title:Tolerability of Breast Ductal Lavage in Women from Families at High
Genetic Risk of Breast Cancer
Version: 1Date:25 February 2009
Reviewer: Ahti Anttila
Reviewer's report:
This manuscript concerning tolerability of ductal lavage in screening and
follow-up of among high breast cancer risk patients is interesting, because
methods to integrate biological-level markers in the breast cancer diagnostics are
under development; This is expected to bring better options in comparison with
the imaging methods of tumors. The main finding indicating that the lavage will
not be useful due to its intolerability (leading to refusal in subsequent service)
deserves attention and it seems that development of proper sampling methods is
not straightforward yet at the moment.
The paper is analysed thoroughyl and well-written, so I have only few minor
comments:
1. The authors should briefly provide more detailed information about the validity
of the markers available from the ductal lavage. Now it is mentioned that the
method might improve early breast cancer detection (for example page 3, 3rd
line) but details about the real validity of the biomarkers were not given. Before
making conclusions from this study, it might be helpful to discuss briefly also
about the diagnostic gain in comparison with the more tolarable methods (such
as imaging, or nipple aspiration).
2. Also, weighing the potential variation in sampling error could be briefly
discussed, e.g. in pages 14-15 while discussing about the various potential
sampling options.
3. Limitations, page 13: I felt that it was not really a limitation that the study used
selected high-risk subjects, as one could think that importance of the discomfort
would be even larger among healthy women than among the selected group
under the study. The authors could reformulate this section a little and perhaps
explain better that the limitation did not really cause a bias.
4. In the discussion there was missing a section or paragraph comparing
systematically the current study with the earlier studies. Is it possible that not only
the statistical methods differed (c.f. references 1, 6, 7, 8 as mentioned briefly in
page 3-4) but also some other aspects e.g. instruments or anesthesia differed? It
is a little embarrassing that some earlier studies had quite contradictive results to
the current study.
Level of interest: An article of importance in its field
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
Reviewer's report
Title:Tolerability of Breast Ductal Lavage in Women from Families at High
Genetic Risk of Breast Cancer
Version: 2Date:23 June 2009
Reviewer: Ahti Anttila
Reviewer's report:
No further comments.
Level of interest: An article of importance in its field
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
Reviewer's report
Title:Effects of Multiparity and Prolonged Breast-Feeding on Maternal Bone
Mineral Density: A Community-Based Cross-Sectional Study
Version: 1Date:31 January 2009
Reviewer: Mark Brincat
Reviewer's report:
As the authors themselves admit in the discussion, since this is a retrospective
study, there is a recall bias, especially in the subjects who are elderly (patients
over 90 years have been included). This might contribute to the fact that there
was no significant association between parity+breastfeeding and bone mineral
density.
Major Compulsory Revision- In the section STUDY SAMPLE, the authors state :
"When a child was reported to
have been breast-fed for more than 24 months, a maximum of 24 months was
noted as it
was assumed that intermittent breast-feeding beyond 24 months had no
substantial effect on maternal bone metabolism." HOWEVER in the section
STATISTICAL ANALYSIS, they state that women were divided according to the
total duration of
breast-feeding (never breast-fed, 1-48 months, 49-96 months, more than 97
months).This needs to be clarified. This may be the reason why no differences
were found in age-adjusted BMD when groups of women with different total
durations of breast-feeding were compared.
Level of interest: An article of limited interest
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
Reviewer's report
Title:Effects of Multiparity and Prolonged Breast-Feeding on Maternal Bone
Mineral Density: A Community-Based Cross-Sectional Study
Version: 1Date:10 February 2009
Reviewer: Marco Gambacciani
Reviewer's report:
MANUSCRIPT : Effects of Multiparity and Prolonged Breast-Feeding on Maternal
Bone Mineral Density: A Community-Based Cross-Sectional Study
The AA evaluated BMD values in a group of elderly women and divided them in
different groups accordinf to the n. of children and duration of breast feeding.
Their results suggest that either variables (multiple pregnancies and long total
duration of breast-feeding) are not essential in determining BMD.
Major Compulsory Revisions
The question posed is well defined but other BMD determinants are not defined:
age at menopause, years since menopause, OCs, HRT, calcium supplements.
These data should be provided, and the statistical analysis should be fully
reported in the manuscript
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.
Reviewer's report
Title:Effects of Multiparity and Prolonged Breast-Feeding on Maternal Bone
Mineral Density: A Community-Based Cross-Sectional Study
Version: 2Date:4 June 2009
Reviewer: Marco Gambacciani
Reviewer's report:
The methods are appropriate and well described. The discussion is balanced and
supported by the data? The limitations of the work are clearly stated.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
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:26 January 2009
Reviewer: David Archer
Reviewer's report:
Title page contains all of the necessary information.
No Running title (condensation) was available.
Abstract was organized and identified the outcomes.
No Key Words were provided.
Introduction (background) was organized, focused and provided a
comprehensive review of the literature on transdermal hormonal contraception
with ethinyl estradiol/norelgestromin. The data are specifically related to the
acceptance of the method by the consumer.
Materials and Methods are well described. Ethical committee approval was
obtained at each site, and Informed consent obtained prior to enrollment.
Inclusion and exclusion criteria were provided.
Statistical analysis is appropriate, and use of Pearl Index and cumulative
pregnancy rate analysis is excellent.
Results are well organized and clearly presented.
Discussion is relevant to the outcomes in the results section. and each point in
the Results section is addressed.
References are acceptable.
Tables are clear with adequate legends.
Figures are clearly presented.
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:
No to all of the questions. david archer
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: 2Date:27 April 2009
Reviewer: Maria Gallo
Reviewer's report:
Major Compulsory Revisions
1. The authors state that “…all subjects who used at least 1 study patch were
included in the analyses population (ITT population).”
First, this is not consistent with the definition of ITT (see Schulz KF, Grimes DA.
Lancet 2002;359(9308):781-5.) The ITT population should consist of all women
enrolled in the study who had any follow-up data available. To avoid confusion,
the authors could describe their analysis population as a “modified” ITT
population.
Second, this definition only explains the analysis population for outcomes with
women as the unit of analysis. Some of the analyses had cycles as the unit of
analyses. Are we to infer that cycles were only included in the ITT analysis if the
study patch was used at least once during the cycle? The authors define the
“subject compliance score” in the section “Study evaluation” as “… number [sic]
perfect compliant cycles/number ITT cycles per each participant.” However, the
denominator should include all cycles with data from the participant – regardless
of whether she used the patch at all during the cycle. Otherwise, the subject
compliance score will suggest higher adherence than that attained. The authors
should either 1) recalculate the subject compliance score, using a true ITT
analysis population, or 2) if the calculation was correct but inadequately
described, the authors should define the population used for the cycle-based
analyses.
2. The authors added a sentence to explain how the study medication boxes and
Diary Cards were used to assess adherence to the use of the patch: “Conflicting
information were [sic] analysed and fixed by the Investigator during each visit;
adherence was calculated from data collected on Diary Cards.” The use of study
medication boxes as a second method of assessing adherence sounds good but
this process of reconciling the two sources of data still is not clear to me. The
second part of the sentence implies that the Investigator used only the Diary
Cards. However, the first part of the sentence states that he “fixed” conflicting
information. How did he “fix” it?
Level of interest: An article of limited interest
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.
Reviewer's report
Title:Informing women about hormone replacement therapy: the Consensus
conference statement
Version: 2Date:12 February 2009
Reviewer: Deborah Legorreta
Reviewer's report:
Major Compulsory Revisions: None
Minor Essential Revisions: None
Discretionary Revisions: None
An article of importance in its field that may serve as a guide of a multidisciplinary
and scientific work procedure to address information needs of menopausal
women. Specially useful for menopause societies worldwide. The inclusion of an
open population survey to know user's perspective on HRT is extremely valuable
and makes this article even more interesting.
Level of interest: An article of importance in its field
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.
Reviewer's report
Title:Effect of long-term of physical exercise on the nitrate/nitrite levels in
hypertensive postmenopausal women
Version: 1Date:13 February 2009
Reviewer: Amos Pines
Reviewer's report:
This study evaluated hemodynamic and blood chemistry parameters, including
nitric/nitrate levels in hypertensive women who started a training program.
The main conclusion was that exercise reduced arterial blood pressure and
increased nitric/nitrate levels.
My comments:
1. a very small sample size, which precludes significant scientific
results.
2. in the Method section, selection of participants, it is not
mentioned that women were hypertensive, and that a postmenopausal state was
established by the usual criteria.
3. because of the small sample, a change of 2 cm in waist
circumference (Table 1) was not significant, although it is definitely substantial.
This is similarly true for the reduction in weight and BMI.
4. it is very strange that exercising in about 120 beats per minute
(50% of heart rate reserve) was not associated with any change in triglycerides
(Table 2), while weight, BP were reduced.
5. the investigators should discuss the following: a) the Griess
method is more sensitive to i-NOS, whereas the endothelial function (e-NOS) is
better evaluated by measurement of c-GMP. b) diet and any inflammatory state
may easily effect blood NO. Was this taken into account by the investigators?
6. page 9, Discussion, second paragraph. The authors should mention
that weight may not change in physically active persons while fat is reduced,
because of building of muscle mass instead of fat tissue.
7. page 9, Discussion, second paragraph, line 10. It is usually
accepted that the increase in BP between premenopause and postmenopause is
age-related rather than menopause-related.
8. as the title of the article suggests, the focus of the study is on
exercise, hypertension and menopause. There is no discussion on the effects of
menopause per se on NO and endothelial function, as well as that of HRT in this
respect (see for example Salhorta S, Maturitas Jan 19, 2009, ahead of print).
Also, although I guess it will be difficult to get the following article, it may help the
discussion in the current study: the control group included 36 postmenopausal,
hypertensive women undergoing exercise testing, with measurements of NO
(Czarnecka D. Med Sci Monit. 2004 Feb;10(2):CR55-61.
In conclusion, this is a nice, but small-scale study with some innovation.
However, the authors must address several methodological problems and revise
the Discussion paragraph as suggested before considering its acceptance for
publication.
Reviewer's report
Title:Effect of long-term of physical exercise on the nitrate/nitrite levels in
hypertensive postmenopausal women
Version: 1Date:13 February 2009
Reviewer: José Luis NEYRO
Reviewer's report:
I would like to sugest a change of the paper's title as I think that the words
"long-term" make s think on years... and the program of the physical exercise in
this paper has been only of 6 mounths.
The title I would like to proposse is " Effect of six mounths of physical exercise on
the nitrate/nitrite levels in hypertensive postmenopausal women".
Level of interest: An article of importance in its field
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'
Reviewer's report
Title:Postmenopausal hormone therapy and social life and behaviour - results
from the EPHT trial
Version: 1Date:17 January 2009
Reviewer: Martina M Dören
Reviewer's report:
I do not fully understand which of the instruments used in this trial were validated
in the Estonian population related to: effects on work, social activities, partner
relationships and sexual life
Level of interest: An article of importance in its field
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
Reviewer's report
Title:Postmenopausal hormone therapy and social life and behaviour - results
from the EPHT trial
Version: 1Date:2 February 2009
Reviewer: Mireille van Poppel
Reviewer's report:
The title indicated that the paper is about hormone therapy and social life and
behaviour. As they indicate, this has been a topic that has not been studied
earlier.
However, the authors should provide more justification for looking at the effects
of HT on social variables in the background. Only stating that this has not been
looked at is not enough! Why is it to be expected that HT would influence these
variables? Is there a plausible working mechanism/pathway for this? In the
discussion, some information is given why it would be interesting to look at these
variables. I would suggest moving some of this to the background and also giving
a medical/physiological hypothesis how HT could influence social variables.
Methods:
The RCT is well conducted as far as I can judge, and the number of participants
is sufficient for the purpose of these analyses. As the authors indicate in the
discussion, the variables are a bit crude, and not all of them designed for the
research question of this paper.
Results:
Too many tables for little extra information (most is given in the text). Would
suggest combining tables and only providing information on combined groups
(HT vs no-HT).
Furthermore, the purpose of the study was to look at the effect of HT on social
variables and behaviour, but in the paper the effects on a wide range of variables
is presented, that are not related to this purpose. Either some of the results
should be omitted or the purpose of the study should be more clearly indicated,
especially that it includes sexual functioning and exercise. This should be
reflected in the title of the paper as well.
Discussion:
The authors mention low exposure as a problem. Presumably they refer to low
compliance with HT during the study. Could a per-protocol analysis be
performed, studying whether women who were compliant with HT medication
showed more effects?
The final conclusion of the paper could be more prominent: HT is not a good
therapy for sexual functioning (other measures might be more appropriate)!!
However this conclusion is not really related to the purpose of the study as it has
been formulated at the moment. I think it is worth mentioning the (mis)use of HT
for improving sexual functioning in the background, and coming back to it in the
discussion section.
Some typos in the text: please check carefully.
Level of interest: An article of limited interest
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