Reviewer ’s report  
 
Title:  Validation of the Pelvic Organ Prolapse Simple Screening Inventory (POPSSI) in a 
populatio n of Ethiopian women.  
 
Version: 0 Date: 27 Apr 2018 
 
Reviewer:  Douglas  Tincello  
 
Reviewer’s report:  
 
This is an important piece of research, attempting to evaluate the diagnostic test performance of 
the POPSSI tool to identify Ethiopian women with prolapse, without the recourse to pelvic 
examination by a trained health care profession al. This is a very important aim and I do hope to 
see this published. However, in it's current form, I think there are some methodological issues 
which need to be addressed and the results section is not clear enough to allow readers to assess 
the value of  the work.  
 
Firstly, the authors should provide a description of the original POPSSI tool for the readers, 
including what questions are included, how it is scored and some more detail of how it was 
originally developed and validated. At present, nowhere is it described what questions are asked 
and thus it is difficult to interpret the results (see below). Are the questions you describe 
elements of the POPSSI? Is there a scoring system?  If there is scoring system, then you must use 
the score to test, not the  individual questions.  
 
Secondly, we need much more detail on how the questionnaire was translated and back 
translated. Stating you have done so is not sufficient. Who translated the questionnaire into 
Amharic? Were they fluent in the source language from a clinical view point? How did you test 
the translation to ensure it made sense? Were any questions rephrased or altered in Amharic? 
Who back translated the questionnaire? How did you confirm the back translation had retained 
the original sense? Perhaps mo st importantly, did you do any test validity analysis of the 
translated questionnaire before using it on this patient population as a diagnostic tool?  
 
In terms of the actual research I have the following questions about your methods: why did you 
exclude w omen with known prolapse? And why also did you exclude women who were found 
not to have a prolapse on examination? If you had included both groups, you would a) have a 
larger cohort of women with prolapse, and b) a cohort of women without prolapse to inclu de in 
your test accuracy studies. Given that all your women you analysed had prolapse, you do not 
have any women who are "disease negative" and so I cannot see how you are able to calculate 
the sensitivity etc for prolapse overall, since you have no women without prolapse. Thus, you are 
constrained to only use the tool to identify compartment of prolapse, which is probably not 
scientifically valid or clinically useful, since I imagine your intention is to be able to screen a 
large number of women in rural a reas to identify only those who may need to be examined or 
treated. I think it is essential to include a group of women without prolapse; ideally all women 
should complete the screening tool before being examined, and only examined to identify if they 
are cases or controls afterwards.  
You need to explain why you think reported incontinence, and pain with defection could be 
discriminatory for prolapse. (results line 16 -23). Are these questions from the POSSI? Also, the 
same for the report of vaginal bulge; is this a question from the POPSSI? Any questions from the 
POPSSI cannot be used alone, if your intention is to use the whole instrument as a screening 
tool. 
 
Your results are poorly presented. I do not understand why table one only has patients labelled 
by compartment of prolapse, when you have full POPQ stage data on all women. It would be 
much more information to include the numbers of women with each stage of prolapse in each 
compartment in this table, especially since you refer to stage later, but nowh ere have included 
the numbers of women with any given stage. In Table 2, you must include numbers as well as the 
percentage figures. Here i have a fundamental problem with separating out each compartment of 
prolapse. Surely, the first thing you have to dem onstrate is that the POPSSI has utility to identify 
ANY prolapse? Only then, can you begin to explore if it might be compartment -specific. There 
is published literature which suggests symptoms are not discriminatory of compartment (Digesu 
et al, I forget t he exact citation).  Really, you need to present one table of sensitivity/specificity 
etc of the questions and the POPSSI scale for prolapse as a whole with a single ROC curve first; 
and then perhaps site -specific data, although I am not convinced this is necessary or valid.  
 
The discussion is rather short, somewhat simplistic and does not compare/contrast or embed your 
findings in the existing literature. it needs a thoughtful re -write.  
 
Please do not be discouraged by my comments; they are intended to be  helpful. I think this is 
extremely important work, and my primary aim is to ensure that you publish high quality work 
which will genuinely be useful to make a difference. I think you have some way to go to achieve 
this, but I hope this comments will help you achieve that.  
 
Are the methods appropriate and we ll described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional statistical review?  
If an additional statistical review is re commended, please specify what aspects require further 
assessment in your comments to the editors.  
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
Declaration 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 yo u 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 your reply is yes to any, please give details below.  
 
I am currently collaborating with gynaecological colleagues in Gondar University Hospital to 
develop a programme of work for inter ventions for urinary incontinence and prolapse in northern 
Ethiopia. One of the PhD students at this institution is currently conducting similar work for the 
PhD,  but i have had no input into his research, nor made any comment on his work to date.  
 
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