Title: ONLINE INFORMATION ABOUT MAMMOGRAPHY SCREENING IN ITALY
FROM 2014 TO 2021
Version: 4 Date: 15 Mar 2022
Reviewer's report:
PLEASE SEE "REVIEWER REPLY" ONLY
RESPONSE TO EDITOR
1) Almost all Italian screening programs are organized by local (or in some cases regional) health
units, sending a letter of invitation to women, often with a leaflet. These two have some of the
information the authors searched in the websites, but both are not considered in the present work.
There are Italian studies about the information provided by them (e.g Castagno, Giordano…).
The authors could discuss the difference between the results provided by invitation letters and
websites. Therefore, it’s important to keep the difference between information given on the
website and to women invited to attend breast cancer screening. So, it isn’t correct to affirm
that “almost half of these sites merely invite women to undergo screening without giving any
information about it”, it’s correct to affirm that the website doesn’t give any information…. As
well on page 7: “Some women also received justified absence from work (14,2%)”, should be
“some websites report women can obtain a justification…”
REPLY
the sentence you criticize (“almost half of these sites merely invite women to undergo screening
without giving any information about it”) is in the RESULTS. Therefore, it is still without
comment and discussion. Then, in the limitation section, at the end of the manuscript, we
said: “Our study has limitations. One is that it did not analyse informed consent forms given
to women before undergoing mammography, which could contain more information than the
corresponding websites”. If you prefer a comment also in the discussion we could add the
following sentence:
NEW VERSION (at the end of DISCUSSION):
However, our findings could be underestimated as we have investigated only one of the three
moments where it is possible to inform women. In addition to active web searching, most italian
women receive at home a letter of invitation to undergo screening. Furthermore, if they go
for screening, they must sign an informed consent. It is the task of each care facility to best
distribute information among these three documents. Our study has limitations. As just said,
one is that it did not analyse invitation letters, brochures or informed consent forms given
to women before undergoing mammography, which could contain more information than the
corresponding websites.
Reviewer REPLY
To leave the sentence in the “RESULTS” the author should write that “therefore, almost half of
these websites, don’t give any information about risk/benefit…” because that “websites invite
women to undergo screening without giving any information about it” it’s untrue, as the website
doesn’t invite woman, the screening program does, with an invitation letter (and leaflet, informed
consent…);
2) There’s a difference between risk factor (e.g. false negative result) and harms like
overdiagnosis or false positive results. I suggest the authors to use the correct term through the
manuscript, or at least explain the two terms.
REPLY
When applicable, we have corrected based on your suggestion by replacing harms with risk
factors.
Reviewer REPLY
However, the suggestion wasn’t replacing harms with risk factors, as they have different
meaning.
3) A limit the author may have not consider it’s that a website can have more than one page with
information available to women about risk/benefit/harm and underreport them, also there may
be links to other sites to get more information.
REPLY
We were fully aware of this possibility. Therefore, in each site a very thorough search was made
using also other key-words and searching other links. This was specified in the METHODS with
this sentence:
… “When no documents appeared in the search using these terms, we performed additional
searches in the websites”...
On the other hand, we don't think women who look for this information on the web, they go
so deep into the search!
4) The reasons cited for the lack of information are:
1. Information on potential harms could reduce adherence to screening
2. Practitioners are not well updated
3. Professional interest
4. The paradox of breast cancer screening… as women receive less information on breast cancer
screening than on any other health topic.
The research shows that 54% of the web pages report at least one risk factor and 58% the benefit
of reducing mortality, it seems like there is a lack of information more than a on purpose biased
information.
Breast cancer screening programs are known as a good example of a health intervention
constantly monitored with a large number of performance indicators, with results published in
many websites, do the authors really think that public health organizations have advantage to
hide risk to women on purpose? Avoiding to give risk information merely for fear of dissuading
them?
REPLY
The 4 hypotheses reported in my manuscript are also described in the scientific literature but,
as far as I know, there are no quantitative data on the weight of each of these factors. I have
a direct professional experience on this topic (informal talk, conferences, updating courses for
professionals …) and I think the main cause is the lack of updating (2); The well-known problem
of the gap between research and practice has not yet been resolved; for example, overdiagnosis
is still unknown among many healthcare operators. When, on the other hand, operators are
aware of the risk-benefit ratio, they could be reluctant to communicate it for various reasons:
for psychological rejection of this update due to the implicit and unconscious influence of
professional interest (3), or for responding to politically correct (4) or for maintaining high
adherence to screening (1). (About point (4) Peter Gotzsche writes in his book: Mammography
Screening: Truth, Lies and Controversy “… Mammography screening is one the greatest
controversies in healthcare, and the extent to which some scientists have sacrificed sound
scientific principles in order to arrive at politically acceptable results in their research is
extraordinary …”)
Moreover, there are many risk/harm factors and one benefit reported.
Do the authors think that giving information about 5-6 risk/harm factors without reasonable
understandable quantitative data and one benefit would be correct information? Or might be
confusing and not helpful in making informed decision?
Explaining risk/benefit/harm of breast cancer screening in a simple and short way could be very
difficult, especially if addressed to all women, this is not even mentioned as a possible reason for
lack of information. In 2014 the authors found less websites, but whit more information about
risk/benefit, do they think this is to be considered an improvement or not?
REPLY
I agree with you that “Explaining risk/benefit/harm of breast cancer screening in a simple and
short way could be very difficult”. However, comprehensive information to patients on the
risks benefit ratio of any health intervention has become a widely accepted health paradigm,
sometimes even an obligation, in the Western country.
Reviewer REPLY
If you agree, why it’s not event mentioned as a possible reason for lack of information? It could
be mentioned and discussed as you said “However, comprehensive information to patients on
the risks benefit ratio of any health intervention has become a widely accepted health paradigm,
sometimes even an obligation, in the Western country”.
You say: In 2014 the authors found less websites, but whit more information about risk/benefit
… did you mean in 2021?
Reviewer REPLY
Yes, I did.
5) I think the authors could add their own suggestions to fill the lack of information in the
discussion, this would be useful to public health organizations and would give the manuscript
a more objective look.
REPLY
NEW VERSION (added in the DISCUSSION):
Whatever the causes of this lack of information for women, the main way to overcome them
is the training of operators. If operators are not up to date, they will receive the correct update
on thebenefits ratio of mammography. If the operators are aware of this ratio, they will receive
the correct update to provide, in Italy through informed consent forms, women with complete
information on the risks and benefits of mammography.
Minor issues
6) Risk factors such as false negative and interval cancer are the same concept, they both are
consequences of a negative screening test when cancer was probably already there (not seen,
minimal signs or not detectable). They could be considered the same risk factor.
REPLY
Our aim was to report what websites indicated in their documents: 42 times they reported false
negative and 48 times they reported interval cancer. If we unified the two items, we would
misrepresent what has been detected on the websites.
Reviewer REPLY
The aim is to report what has been detected on websites, and therefore also what is missed; in
this sense interval cancer and false negative could be considered the same risk factor, though,
there are some differences (difficult to explain),  so I agree to skip it.
7) The aim of a screening test is to select women at higher risk to have breast cancer, therefore
a positive screening test means there’s need of further assessments. There are no diagnostic
tests with a 100% accuracy, even though usually people are not told there is a possibility
of a false positive (FP) and false negative (FN) result, and even less the quantitative data,
which are often not even collected for some tests. Therefore, FP and FN are more a matter of
giving information about quantitative data and the number of women to be screened, as well
as of assessments necessary to detect one breast cancer. FP are performance indicators easily
monitored by screening programs and quantitative data should be available to women. On the
other hand, quantifying FN results it’s not easy and population tumors register are needed.
REPLY
I agree with you “Explaining risk/benefit/harm of breast cancer screening in a simple and short
way could be very difficult”. However, comprehensive information to patients on risks and
benefits of any health intervention has become a widely accepted health paradigm in the Western
culture.
Reviewer REPLY
Again, this is never reported in the manuscript, it only says that quantitative data are difficult of
summarizing. Authors could also discuss the difficulty to achieve quantitative data, which need
resource information often outside the screening programs.
8) Table 3 is not very informative because national and regional sites, for example, cannot report
age group if they are different in health local programs.
REPLY:
We added in Table 3 the following footnote for age group 50-69 (see Table 3 in the manuscript):
NEW VERSION: * Guidelines of Italian Ministry of Health
Reviewer REPLY
The point was: if at national/regional level the screening has some local programs (ASL/AO)
that invite different age groups, how are them represented in table 3? National and regional
websites should not be showed in table 3.
9) It would be helpful to add a table that resumes the type of websites included in the work, as
how many national, regional, ASL and AO websites.
REPLY
we have added this as a note to table 1
NEW VERSION in Table 1: * 4 national, 20 regional, 41 AO, 101 ASL.