Reviewer’s report
Title: 
Alleviating psychological distress associated with a positive cervical
cancer screening result: a randomized control trial
Version: 
0 
Date: 
14 Sep 2020
Reviewer's report:
This is a nicely written paper describing an RCT evaluation of the impact of a
leaflet about cervical screening on psychological outcomes following a
hypothetical screening result. The study was carried out in a sample of women
waiting for a cervical screening appointment, ensuring that the issue was salient
for them, even though the results were hypothetical. The trial was pre-registered. 
I have a few comments that I hope might further improve the paper.
1) Throughout the paper, there was a sense that cervical screening aims to detect
cervical cancer, rather than aiming to detect and treat pre-cancer to prevent
cancer. Examples are the focus on mortality (rather than prevalence) in the
Introduction, and the sentence in the Discussion (page 13 line 225) which says
'the large majority of women with screen-positive results are free from cervical
cancer'. 
It would be useful to make it explicit that the aim of cervical screening
is to prevent cancer.
2) Possibly related to the above point, the Introduction includes a statement that
'among 95% of women who screen positive, the result is a false positive'. I'm not
sure this means that 95% of women with abnormal results do not have cancer?
This is not usually considered a false positive, since the aim of screening is to
detect pre-cancer. 
3) It would be helpful to clarify in the Introduction that screening is Japan is
cytology (rather than HPV) based, and to explain whether women are regularly
invited for screening or whether they have to request it.
4) The power calculation makes an assumption that 50% of women who imagine
receiving an abnormal result will be distressed in the control group. Was this
based on any previous literature?
5) It would be useful to have a little more information about the instructions
participants were given for the follow-up questionnaire. Presumably they were
asked to imagine they had received the results letter?
6) Did the authors calculate Cronbach's alphas for the measures to confirm the
internal reliability within their sample? 
7) I'm not sure why between group differences in baseline characteristics were
tested statistically, since chance is the only possible reason for difference
between the randomised groups.
8) There is a typo on page 12 (line 196) - <15 should be >15.
9) Some of the Discussion is rather speculative e.g. 'Presumably our study
participants understood the information well' - it's hard to conclude this without
having assessed knowledge and 'This is possibly because…' - again, hard to
know without baseline knowledge assessment.
10) Line 229 (page 14) 'which was contradictory to our assumption' - this
assumption of differences between the different positive result groups wasn't
articulated in the aims of the study or the analysis plan.
11) Could the authors comment on the ecological validity of the study? In the
study setting, women may have been much more likely to read the information
leaflet than would be the case in a routine clinical setting.
12) The conclusion is similar to that of the 1990 Wilkinson et al paper (ref 13).
Could the authors make it clearer what this study adds to the previous literature?
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