Reviewer’s report
Title: 
User testing a patient information resource about potential complications
of vaginally inserted synthetic mesh
Version: 
0 
Date: 
14 Sep 2020
Reviewer's report:
The authors present findings from testing a patient information leaflet on
complications of mesh vaginal implants for managing stress urinary incontinence
and pelvic organ prolapse in Scotland. I have the following comments for the
authors to consider to improve the paper further.
1) Background:
a) Third paragraph, fourth statement (pages 3-4, lines 91-94): Change "which
would consider" to "to consider" as the former has some elements of uncertainty.
b) Fifth paragraph, second statement (page 4, lines 111-112): It would be good to
follow this statement with one that explains what DISCERN was all about for
the benefit of readers who may not be conversant with the context should the
paper be accepted for publication.
c) Sixth paragraph, second statement (page 5, line 119): Change "reason" to
"reasons", i.e.: "There are two main reasons …" 
2) Methods:
a) User testing, first paragraph, first statement (page 5, lines 139-140): This
statement does not read well. Perhaps consider deleting "to" after "informing".
b) Participants and setting, last paragraph, last statement (page 7, lines 174-176):
Consider rephrasing this statement to read: "The aim of using a convenient
sample was to recruit participants with …" to enhance clarity. Otherwise it is not
clear how many participants were eventually recruited. Seven women with lived
experiences and one carer were recruited through the first approach but it is not
clear how many were recruited through the second approach of sending
invitations.
c) Analysis, last paragraph, first statement (page 7, lines 184-185): Change
"categorised" to "grouped" to avoid the colloquial, "categorised … into …
categories".
3) Results:
a) First paragraph, fourth statement (page 8, lines 197): Rephrase to read: "The
distribution of participants by socio-demographic characteristics is presented in
Table 1."
b) Second paragraph, last statement (page 9, line 205): Change "can be found" to
"is presented".
c) Third paragraph, last statement (page 9, lines 208-209): Provide examples of
themes that cut across several categories.
d) Table 2 (pages 9-10): First, the table can be made more readable if each item
under each category is bulleted. Second, spell out abbreviations used in the table
in a footnote below it given that illustrations (tables, figures or charts) should be
sufficiently labelled such that they can stand alone independent of the main text.
e) Understandability:
* First paragraph, first statement (page 10, line 213): Language, in and of itself,
cannot be a theme. Rather there was something about it that was the theme, and
as the subsequent text shows, it was clarity and ease of understanding the
language. Thus, something like, "The principal theme under understandability
was clarity and the ease of understanding the language" would be clearer.
* Second paragraph, first statement (page 10, lines 217-219): Insert "that" after
"suggested" for the statement to read well.
* Second quote (page 11, lines 227-231): The last part of this quote is not clear
simply because of the use of the word "cause", which means to make something
happen. It is not clear how it fits with the rest of the text here.
* Fourth paragraph, second statement (page 11, lines 233-236): This statement
indicates that even the two participants who liked the diagram agreed that it was
confusing, which is confusing in itself. If the participants who indicated that the
diagram was confusing were different from the two, then it would be good to
say, "… other participants agreed …" instead of "…the participants agreed …"
* Figure 1 (page 11): This figure appears like it has been extracted from some
material. If so, the authors should indicate the source as a footnote below it.
Also, if the source was copyrighted material, the authors should indicate in the
declarations section later on (under 'Consent for publication') whether permission
to reproduce it was obtained from the copyright holder. The same applies to
material in Additional File 1, i.e. the authors should declare whether it was NHS
material, and whether permission was obtained from the agency to publish it
together with its logo. 
* Last paragraph, first statement (page 11, lines 246-248): The authors refer to
the illustration following the text here as "Figure 2", yet what one can see is a
table. This is confusing. Tables should be captioned as such, e.g. "Table 2".
Otherwise I looked for Figure 2 at the end of the paper and in the additional file
but did not see anything. 
f) Usefulness:
* Second paragraph, third statement (page 12, lines 262-263): I struggled to
understand this statement and I am sure readers who are not conversant with the
context would. In particular, what are these types of operations that use mesh
implants? If it is clear in this statement, then the subsequent statement which
also has the same phrase will be clear.
* Second quote (page 13, lines 276-278): The authors should explain what the
participant meant by "wee bit" in brackets for the benefit of readers who may not
be conversant with the context, e.g.: "…wee bit [XXXX] is fine …"
* Last paragraph (page 13, lines 279-281): Change "included signposting" to "is
signposting" to avoid the colloquial, "…useful to include … included". Also,
rephrase the last part to active voice to make it authoritative, i.e., "…which
participants described as valuable services". 
g) Usability:
* First paragraph, first statement (page 13, line 283): "Format" is vague as a
theme. There must be something about the format that emerged as a theme, and
from the text that follows, it reads like it was "user-friendly format", i.e.
participants preferred a format that was friendly, and that is the theme.
* First paragraph, last statement (page 13, lines 287-289): Delete "to" after
"navigate" for the statement to read well.
* Second paragraph, first statement (page 13, lines 294-296): Consider changing
the phrase, "which cause participants to flip" to "which make participants flip".
* Second paragraph, last statement (page 14, lines 100-102): Delete "Finally"
from the statement as this is not the last thing one is reading in the paper. In any
case, "also" takes care of the need to highlight this as additional point.
h) Desirability:
* Second paragraph, first statement (page 14, lines 312-314): What does "This
category" exactly refer to? If the authors meant "desirability", then the statement
should be rephrased to read: "Desirability also manifested in the emotional
reaction of the majority …"
* Second paragraph, second statement (page 14, line 314): Rephrase to read:
"Such reaction was expressed by …"
* First quote (page 14, lines 315-316): The authors should provide an
explanation of what the participant meant by "kinda" in brackets, i.e. "…kinda
[XXXXX] shaking …"
* Second paragraph, first statement (page 14, lines 317-318): Delete "appear to"
from the statement as it connotes that the authors are not sure of what they are
talking about here.
* Second paragraph, second statement (page 14, lines 318-319): Delete "In fact"
from the statement. The authors should instead concentrate on presenting their
evidence and leave it to readers to determine whether what they have presented
are facts. 
i) Affiliation:
* First paragraph, first statement (page 15, lines 325-326): Change "do users" to
"whether users".
* Second paragraph, first statement (page 15, lines 327-329): Change
"Comments captured by this category" to "Insights on affiliation" as it is not
clear what "this category" exactly means.
* Second paragraph, last statement (page 15, lines 333-335): Insert "the material"
at the end of the statement so that it is clear we are talking about the patient
leaflet rather than mesh itself. 
j) Credibility:
* First paragraph, second statement (page 15, lines 342-344): Delete "it looked
like" since it connotes some level of uncertainty regarding the source of the
material, and change "this was promoted by" to "due to".
* First paragraph, second statement (page 15, lines 344-346): Rephrase to read:
"One participant reported that he/she would trust the information in the resource
…"
* Last quote (page 16, lines 358-359): Again, provide an explanation of what the
participant meant by "wee bit" in brackets. Also, the phrase "that's refutes it" at
the end of the quote is incorrect English, and if this was the participant's mistake,
then the authors should insert "(sic)" after the phrase.
k) Accessibility:
* First paragraph (page 16, line 361): Change "this category" to "accessibility"
as it is not clear what exactly "this category" refers to.
* Last paragraph (page 16, lines 369-372): Rephrase to read: "Although not
discussed by participants directly, concerns about the technical language,
illustrations used, and volume of information identified earlier indicate …"
Otherwise it was not clear what the authors meant by "that public" (which public
is this?) and "lower reading age" (what kind of age is this?). Also, change "lower
health literacy" to "low health literacy" since the comparison was not clear, as in
"lower … than…" or "lower … compared to …" 
4) Discussion:
a) First paragraph:
* Second statement (page 17, lines 376-379): Change "has now been" to "were",
"have taken place" to "were made", and "these findings" to "the findings of this
study".
* Third and last statements (page 17, lines 379-380): Change "includes" in the
third statement to "included", and rephrase the last statement to read: "By the
time of writing this article, the revised material was due for wider circulation
across Scotland." 
b) Third paragraph:
* First statement (page 17, lines 386-388): Again, it is not clear what "low
reading age" exactly means, especially for those who are not conversant with the
study setting. Is reading based on age or educational attainment?
* Third statement (page 17, lines 389-391): Change "describes" to "is" given that
the text that follows simply defines what health literacy is.
* Fourth statement (page 17, lines 391-394): Change "to use a decision aid
independently" to "to independently use a decision aid", and delete the bit from
"contributing" to "outcomes" as it is not clear how it relates to the first part of the
statement.
* Last statement (page 17, lines 394-395): This statement can only add value to
the argument if the authors expound on what exactly "appropriately designed"
should entail, e.g.: "The finding suggests that the information in the resource
should be appropriately designed to include … to be usable by all audiences."
c) Fourth paragraph: 
* First statement (page 18, lines 396-397): Insert "to the understanding of the
patient leaflet on complications of mesh implants" at the end of the statement to
enhance clarity on what the outcome is.
* Second statement (page 18, lines 397-398): Change "described these" to
"considered them" so that it is clear we are still referring to the elements
referenced in the preceding statement. Also, insert what needs to be understood
at the end of the statement to make the statement complete, i.e.: "…
understanding of …"
* Third statement (page 18, lines 398-400): Delete "table of" from the statement,
and insert the phrase, "than those who felt otherwise" at the end to make it
complete, i.e.: "…more participants … than …"
* Last statement (page 18, lines 401-404): Change "sought" to "aimed". The
edits aside, were these clinical guidelines for all diseases or for specific ones,
and where was this project implemented? Whatever the case, that needs to be
clear in the statement. Also, the authors should end the paragraph with what we
learn from the DECIDE project that may be relevant for the mesh patient leaflet
in terms of addressing the challenges identified.
d) Fifth paragraph (page 18, lines 405-410): The authors provide suggestions on
how layering can be achieved in online platforms but they do not offer any
suggestions on how this can be achieved in hard-copy materials, which some
participants preferred. 
e) Sixth paragraph: 
* First statement (page 18, 411-413): Insert "to understanding the mesh implant
patient information leaflet" after "barriers". The edits aside, the statement can
only be meaningful if the authors follow it with one that highlights what these
best practices are.
* Last statement (page 18, lines 413-416): Change "were able to highlight" to
"identified", and delete "helped to identify" from the statement.
f) Seventh paragraph:
* First statement (page 18, line 417): Change 'to emerge" to "that emerged", and
insert "of the mesh implant patient information leaflet" at the end of the
statement to enhance clarity.
* Second statement (page 18, lines 418-419): Delete the apostrophe after
"Participants", and delete "to" after "navigate".
* Third statement (page 18, lines 419-420): This statement is incomplete.
* Last statement (pages 18-19, lines 420-422): Insert "adverse" before
"emotional" so that it is clear that we are not referring to positive emotional
reactions to the leaflet.
g) Last paragraph:
* First statement (page 19, lines 423-425): Change "will clearly" to "can" since
the authors have no way of verifying whether what they are talking about here
will actually happen.
* Third statement (page 19, lines 427-429): Insert "for mesh implant" after
"resource" to enhance clarity of what the authors are talking about.
* Last statement (page 19, lines 429-432): Change "will be" to "is", and delete
the phrase, "through the resources" at the end of the statement as it is redundant. 
5) Strengths and limitations:
a) First statement (page 19, lines 434-436): The authors should explain why what
they talk about here are strengths of the study. In other words, what limitations
do the issues they talk about here address?
b) Third statement (page 19, lines 437-439): It is not clear how participants
having existing knowledge of mesh implants was a limitation here. Was that not
a criterion for selection? And what insights would have been obtained from
participants who did not have such knowledge?
c) Fourth statement (page 19, lines 439-441): Rephrase to read: "Furthermore,
although there were no variations in user experience by level of education, …"
The edits aside, "reading age" appears here as well and the authors would do
justice to explain somewhere what it means in the context of the study for the
benefit of readers who may not be conversant with how ability to read is
determined in the study setting.
d) Last statement (page 19, lines 441-444): Delete "Finally" from the statement
as this is not the final thing the reader is encountering in the paper. Otherwise
how can men be potential users of mesh vaginal implants? Perhaps, just delete
"for example" from the statement as men cannot be examples of users of the
device but can exert influence on its use. 
6) Conclusions:
a) First paragraph (page 20, lines 446-449): This is not a conclusion, i.e. it is not
a summary of any message(s) the authors would like the reader to take away
from the paper based on the key findings of the research; it can as well be
deleted without much loss to the flow of arguments.
b) Second paragraph:
* First statement (page 20, lines 450-452): The authors should relate this
conclusion to a particular finding of the paper, e.g.: "The finding that …
illustrates the challenge … audience." Otherwise as previously noted, the last
part of the statement can only make sense if the authors expound on what these
good practices are. 
* Second statement (page 20, lines 452-454): Delete "here" from the statement.
* Last statement (page 20, lines 458-460): Again, this is not a conclusion, but a
discussion of the findings; it therefore fits best in the discussion section.
c) Third paragraph:
* First statement (page 20, lines461-463): Again, this statement can only make
sense as a conclusion if the authors clearly state what these contextual factors
are, e.g.: "Importantly, the user testing exercise identified XYZ as contextual
factors that need to be considered when designing a patient information leaflet
for vaginal mesh …"
* Last statement (page 20, lines 463-465): Similar to previous comment, this is
not a conclusion but a discussion of the finding, which best fits in the discussion
section. 
d) Last paragraph (page 20, lines 466-469): First, delete "Finally" from the
statement. Second, be clear about what "these insights" exactly mean. Third, it is
not clear who "developers" exactly refer to. Fourth, replace "and" after "patients"
with a comma. 
7) Abstract:
a) Results:
* First statement (page 2, lines 54-56): The use of the word "random" here is
misleading as the HIS staff were not randomly sampled. In the main text, the
authors indicate that they were just a convenient sample.
* Third statement (page 2, lines 57-59): Change "highlighted" to "reported".
* Last statement (page 2, lines 60-63): This is not a result of the study but an
implication of the findings, which does not fit here. Otherwise as already noted,
even as an implication it can only make sense if the authors expounded on what
these good practice principles are.
b) Conclusion (page 2, lines 64-68): This is not a conclusion, i.e. it is not a
summary of key message(s) the authors would like the reader to take away based
on the results presented in the abstract.
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
Yes
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes