Reviewer's report 
 Cytologic Features of Nipple Aspirate Fluid Using an Automated Non-Invasive Collection Title: 
Device: A Prospective Observational Study 
 1  25 March 2005 Version: Date: 
 Carol Fabian Reviewer: 
Reviewer's report: 
General 
The manuscript is a report of a cohort study evaluating the efficacy of NAF collection with an automatic nipple suction device. Eligible women were those over the age of 18 who had no breast 
symptoms and were not pregnant or lactating. Subjects were all drawn from two large OBGYN office 
practices. Only a single NAF attempt was made, fluid/cells were place in Cytolyt fixative, and were 
shipped to a central lab for processing ( using a Millipore filter) and assessment in a central 
cytopathology laboratory. Cytomorphology was assessed by traditional criteria and discomfort was rated on a verbal scale from 0-10 immediately after the procedure. The average age of participants 
was 41, only 14% had one or more 1st degree relatives and 11% had a history of prior breast 
biopsy. Thus, this was a young group at average risk for breast cancer. No information is given on 
the proportion of women who had previously lactated. Thirty-eight percent of women produced NAF. 
Only half the NAF samples were cellular such that only 19% of the entire cohort produced NAF and 
had cells which could be evaluated. Atypia was present in 1% of all women presenting for the 
procedure. Average pain score was 5 on a 0 to 10 scale. The authors are suggesting the device may 
be useful as a screening tool for cytologic atypia in women predominately at average risk for breast 
cancer. 
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Major Compulsory Revisions (that the author must respond to before a decision on publication can 
be reached) 
1. More information is needed regarding preparation of women for NAF harvest. Was the entire 
breast warmed? Was the nipple scrubbed to remove the keratin plug? 
2. Information is needed regarding prior lactation and success of the NAF collection procedure. 3. A table should be constructed as part of the discussion (now labeled conclusions) which 
compares the authors results in a succinct manner with those of others who have attempted to 
collect NAF manually with or without a Sartorius type pump. Included in this table or as part of another table should be results obtained from ductal lavage (DL) and random peri-areolar fine needle aspiration (RPFNA). Suggested column headings include author or series , type of 
procedure, proportion of subjects with evaluable cytomorphology (numerator is proportion of 
evaluable cellular specimens and denominator is all subjects presenting for the procedure), whether 
the series was performed in high or average risk subjects and median or average discomfort ratings. 
4. Neither the proportion of subjects yielding NAF or cellular specimens nor the pain scores seem to 
represent an advance over series using manual NAF collection. In fact results seem worse. 
Consequently the conclusion both in the abstract and the body of the paper needs to be softened. 
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Minor Essential Revisions (such as missing labels on figures, or the wrong use of a term, which the 
author can be trusted to correct) 1. The background makes a number of poorly referenced statements. 2. I would delete the last portion of the second paragraph beginning on page 5 with “While” and 
ending with high risk on page 6. 
3. The abstract needs to do a better job of summarizing the source of the cohort and subject 
demographics. The abstract should clearly state that only 19% of subjects presenting for the 
procedure produced NAF and evaluable epithelial cells. Further only 1% of subjects presenting for 
the procedure had atypical cells. We don’t need to know about followup care and outcomes in the abstract. 4. The discussion, currently called “ Conclusions” needs to be shorted and focused. 
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Discretionary Revisions (which the author can choose to ignore) 
 Unable to decide on acceptance or rejection until the authors have responded to the What next?: 
major compulsory revisions 
 An article whose findings are important to those with closely related research Level of interest: 
interests 
 Needs some language corrections before being published Quality of written English: 
 No Statistical review: 
Declaration of competing interests: 
'I declare that I have no competing interests'