Reviewer’s report
Title: 
User testing a patient information resource about potential complications
of vaginally inserted synthetic mesh
Version: 
0 
Date: 
19 May 2020
Reviewer's report:
The authors of this manuscript are attempting to evaluate the patient information
document created by NHSScotland for the use of mesh in the female pelvis. I
commend their approach to taking a critical approach to this document, rather
than just allowing a clinical expert to create a document for wide circulation.
My comments are listed as "general" or itemized line by line:
General - I would recommend the authors just type out of the entire words
"patient information" rather than use the non standard acronym of "PI". It is
jarring to read and you are only saving 1 word each time you use it
General - I would add more keywords, these are not the terms I would use if
searching for manuscript such as this
General - I really enjoyed the way narrative detail from participants is
interspersed in the manuscript. 
Lines 75-77 - mesh surgeries for POP and SUI CAN NOT be lumped together
into the same vague category. Certainly regulatory bodies such as FDA and
Health Canada separate them out, yet this paper and the NHSScotland document
appear to treat them as the same class
Line 89 - I think there should be more information about how Scotland's
approach is different than New Zealand's by banning SUI procedures as well.
Some context about what is now being offered as surgical treatment of SUI
should be given
Line 111 - when you say "professional association/societies" do you mean within
the UK/NHS? Or do you mean internationally? Only English speaking?
Clarification needed
Line 116 - when I see "transvaginal mesh procedures" I think of TVM kits for
POP. I think most Urogynecologists also have this association, so again I would
ask the authors to separate out POP and SUI when they are discussing mesh
Line 161 - why were women who had already undergone SUI and POP
procedures the group targeted for recruitment? Would they not have had higher
levels of understanding than someone who was contemplating surgery or had yet
to have a consultation with a doctor about surgery? I am surprised the sample
didn't include the least knowledgable group of women to improve this study's
external validity
Line 174 - what types of roles did these women have? Nurses? Aides? Physios?
We need to know if they inherently had a higher level of health literacy by
nature of their jobs/training
Table 1 - I am concerned these women are quite educated. 9/13 have post high
school education. In Canada we would aim to include women with a reading
literacy of grade 6. When producing documents for the public, this is the level
we aim to achieve with the readability of documents. 9/13 women being this
educated surely can't be reflective of the average Scottish woman.
Figure 2 - this comment is not really about the manuscript, 
but about this Figure
in the NHS document. Agree with the participants, it's not very good. Is this
included in the final document which will be widely circulated?
Line 304 - the comment about "pick it up" - can the authors comment more on
how will be distributed? is it intended for women who already have mesh or who
are considering a mesh SUI or POP procedure in the future? will it be available
without seeing an MD? can women order a copy from somewhere?
Line 381 - what sort of retesting was done before this final version was
allowed/planned to go into wider circulation?
General - I think a copy of the document under review in this study, and a copy
of the "final" document" should both be included as appendices. This way
readers can see how much this study influenced the final version. Ie did it result
in meaningful change?
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 comments to the
authors.
Unable to assess
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 statistical review?
If an additional statistical review is recommended, 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:
Acceptable
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 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 your reply is yes to any, please give details below.
I have received a grant from Boston Scientific, a manufacturer of mid urethral
slings and mesh for POP. This project is completed and published.
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