Reviewer's report
Title:Abnormal vaginal bleeding in women of reproductive age: descriptive study
of initial management by GPs
Version: 1Date:15 January 2008
Reviewer: Mark Shapley
Reviewer's report:
I enjoyed reading the paper and discovering commonalities and
differences between Dutch and UK practice but there are a number of
issues that need clarifying.
Major compulsory revisions
1. Objectives
The title suggests that this is a descriptive study and that the
objective is to describe the actions Dutch GP's take when women first
present with abnormal vaginal bleeding. For this objective the study
works reasonably well. However the authors appear to have a second
objective, which is to determine the proportion of these women who have
detectable pathology. This fails because not all women under went
investigations and there was an inadequate follow-up period.
As an example of conclusions unsupported by their data they state
"uterine fibroids were found in 44% of 48 examined women" and that
"uterine fibroids are frequently found". Whilst this is true of women
who under went the investigation their study concerns a population of
women who presented with abnormal vaginal bleeding. Only 48 of the 306
study population under went ultrasound and only 7% of the study
population were found to have fibroids. This contradicts their
conclusion. Fibroids were infrequently found in the study population
(women with abnormal vaginal bleeding).
2. Definition of a "new consultation".
The authors define a new consultation "as a consultation for abnormal
vaginal bleeding after a consultation-free period of three months for
this particular reason". The National Institute of Health and Clinical
Excellence in the UK in their heavy menstrual bleeding guidelines
recommends prescribing a treatment for at least 3 cycles to judge
effectiveness and thus a woman presenting after this trial of therapy
would be regarded as a new episode in this study when in reality it is a
continuation. This "new episode" would not reflect "initial management".
There does not appear to be a "run in" period. How do the authors know
that women who had consultations in the first 3 months of the study were
"new consultations" and had not consulted in the previous 3 months?
3. Generalisability
The study reports data from a single primary healthcare centre. Little
information is provided to help to decide whether or not the practice is
different from other Dutch practices (e.g. urban or rural, age-sex
distribution, socio-economic class). It is difficult to decide the
degree to which the data is generalisable.
4. Purpose of some of the reported data.
I did not understand the purpose of reporting separately data concerning
"second consultation" or the data concerning the number of patients with
one consultation during the study period. The latter data suffers from
not knowing what occurred during the 3 months before and after the study
period. If this information were important it would be better to report
it on a sub-group who first consulted 3 months after the start of the
study and 3 months before the end of the study period.
5. Causality and association.
In the discussion section there appears to be an assumption that the
presence of fibroids implies causality in the menstrual disturbance.
This is not so as many asymptomatic women have fibroids. As a
consequence of this I cannot agree with their implications for clinical
practice.
Discretionary revisions
Whilst the use of English is excellent certain phrases suggests that
this is written by someone in whom English is not their first language.
The ease of reading the manuscript would probably be improved from it
being read and edited by someone in whom English is his or her first
language.
Minor essential revisions
I have not proof read the document but there is a mistake in one of the
references (National Institute of Health and Clinical Excellence and not
science).
Based on your assessment of the validity of the manuscript, what do you
advise should be the next step?
Unable to decide on acceptance or rejection until the authors have
responded to the major compulsory revisions
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
Overall there are a number of problems with the study many of which
could be overcome. The study updates the earlier work of Grant /et al
/(2000) using a study population that differs mainly in geographical
location, age group and follow-up. It is interesting to see Dutch
practice and I am grateful for being allowed to read the study but there
are major concerns regarding methodology, conclusions, implications and
originality