Reviewer ’s report  
 
Title:  Pictorial method s to assess heavy menstrual bleeding in research and clinical practice: a 
systematic literature review  
 
Version: 1 Date: 22 May 2019  
 
Reviewer: LUIS BAHAMONDES  
 
Reviewer's report:  
 
Please include all comments for the authors in this box rather than uploading your report as an 
attachment. Please only upload as attachme nts annotated versions of manuscripts, graphs, 
supporting materials or other aspects of your report which cannot be included in a text format.  
 
Please overwrite this text when adding your comments to the authors.  
 
The authors submitted a manuscript entitle d: "Pictorial methods to assess heavy menstrual 
bleeding in research and clinical practice: a systematic literature review". The authors proposed 
essential criteria to bear in mind when using or validating a pictorial chart for study trials, and 
consider t he feasibility of their application in routine clinical practice.    
 
My comments  
"Key -words: Please remove the word "menorrhagia". According to the FIGO (Please see the 
many papers from Munro M and Fraser IS) this word must be abolished. Also at line 41 o f 
background section. Also at line 44 and through the manuscript.  
Line 69 of page 7 please change "oligomenorrhoea" by abnormal uterine bleeding  
Lines 117 -119: Please clarify which means the acronyms "LR" and "DOR" because many 
readers could not be familiar.  
 
There is no doubt that alkaline haematin is the gold standard to measure blood loss in women 
with abnormal uterine bleeding or heavy menstru al bleeding and albeit the cost is high is a 
perfect tool when a pharmaceutical company is conducted a clinical trial to test any therapeutics 
in women suffering HMB or AUB. The example is when Bayer conducted the trial to labeled 
Mirena as treatment of HM B by the USFDA (see Kaunitz a et al. Obstetrics and Gynecology)  
Nevertheless alkaline haematin presents high cost and it is not useful in clinical practice. For this 
reason in many settings clinicians adopted PBCA as tool to evaluate women with HMB or AUB.  
Nevertheless, the definition established by the UK NICE do not require any tool to identify 
women with HMB, only her complaint and their opinion about bad quality of life.  
Otherwise, in my opinion, PBAC or other pictorial charts do not use in clinical tri al as a tool to 
test the effectiveness of any therapy of HMB.  
In my opinion this review is an excellent manuscript very useful to clinician as a tool to evaluate 
women with HMB, but, in my opinion is not a tool to researchers when presents data about any 
new (old) therapy of women with HMB and use this pictorial chart to evaluate if the treatment 
improved or not menstrual loss.  
In conclusion, the manuscript is an important tool for clinicians devoted to treat women with 
HMB and AUB. It is well written and well conducted review.   
 
 
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your c omments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistic al review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Decl aration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the  manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below.  If yo ur reply is yes to any, please give details below.  
 
The authors submitted a manuscript entitled: “Pictorial methods to assess heavy menstrual 
bleeding in research and clinical practice: a systematic literature review”. The authors proposed 
essential criteria to bear in mind when using or validating a pictorial chart for study trials, and 
consider the feasibility of thei r application in routine clinical practice.    
 
My comments  
 
“Key -words: Please remove the word “menorrhagia”. According to the FIGO (Please see the 
many papers from Munro M and Fraser IS) this word must be abolished. Also at line 41 of 
background section. Also at line 44 and through the manuscript.  
Line 69 of page 7 please change “oligomenorrhoea” by abnormal uterine bleeding  
Lines 117 -119: Please clarify which means the acronyms “LR” and “DOR” because many 
readers could not be familiar.  
 
There is no doubt that alkaline haematin is the gold standard to measure blood loss in women 
with abnormal uterine bleeding or heavy menstrual bleeding and albeit the cost is high is a 
perfect tool when a pharmaceutical company is conducted a clinical tria l to test any therapeutics 
in women suffering HMB or AUB. The example is when Bayer conducted the trial to labeled 
Mirena as treatment of HMB by the USFDA (see Kaunitz a et al. Obstetrics and Gynecology)  
 
Nevertheless alkaline haematin presents high cost an d it is not useful in clinical practice. For this 
reason in many settings clinicians adopted PBCA as tool to evaluate women with HMB or AUB. 
Nevertheless, the definition established by the UK NICE do not require any tool to identify 
women with HMB, only he r complaint and their opinion about bad quality of life.  
 
Otherwise, in my opinion, PBAC or other pictorial charts do not use in clinical trial as a tool to 
test the effectiveness of any therapy of HMB.  
 
In my opinion this review is an excellent manuscript very useful to clinician as a tool to evaluate 
women with HMB, but, in my opinion is not a tool to researchers when presents data about any 
new (old) therapy of women with HMB and use this pictorial chart to evaluate if the treatment 
improved or not menstr ual loss.  
 
In conclusion, the manuscript is an important tool for clinicians devoted to treat women with 
HMB and AUB. It is well written and well conducted review.  
 
 
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I agree to the open peer review policy of the journal