Reviewer ’s report  
 
Title: Life situation of women impaired by Tha lidomide embryopathy in North Rhine 
Westphalia - a comparative analysis of a recent cross -sectional study with earlier data  
 
Version: 0 Date: 15 Jun 2018  
 
Reviewer: Anne Kjersti Daltveit  
 
Reviewer's report:  
 
Review "Life situation of women affecte d by Thalidomide embryopathy in North Rhine -
Westphalia - a comparative analysis of a recent cross -sectional study with earlier data"  
 
In this paper data from two studies are compared - one study published in 2002 with 104 women 
(N2002) and one study publis hed in 2015 with 115 women (P2015). For both studies data are 
collected in North Rhine -Westphalia. The aim of this paper is "to compare the previously 
collected data of N2002 with the recently collected data of P2015 and therefore close this gap of 
knowled ge as to current health problems and anticipated health problems, medical care and 
assistance."   
 
 
Some comments:  
 
Title: I would prefer "Women impaired by Thalidomide embryopathy" before "Women affected 
by Thalidomide embryopathy", as the term "affected b y" could also relate other persons than the 
impaired person (family etc.).   
 
 
Abstract:   
 
I am not familiar with use of the term "inferential statistical methods" in such studies.  
 
In the abstract it is stated that "…face a poorer health status than women  their age in the general 
population". In the Results section of the text no comparison with the general population is 
made, only comparisons between 2002 and 2015. Comparison with the general population is, 
however, mentioned in the Discussion. If these c omparisons are suggested to represent a main 
result of this study - as indicated in the abstract, I suggest that they should be included in the 
Results section. I understand that it will not be possible to perform statistical tests with the 
general populat ion, but they can still be included as observed data and for example added to the 
tables.  
 
Introduction/background:  
In the aims you state that you want to "close the gap of knowledge…"  Based on a relatively 
weak study design with crossectional data as c ompared to a stronger design with longitudinal 
data, I think it is too ambitious to say "close this gap" here.  
Methods:  
 
There is a flowchart for the data collection for the 2015 survey but not for the 2002 survey - why 
not?  
 
What were the data collecti on periods for the two surveys? This is to some extent mentioned in 
the Methods section for the 2015 data, but could be more clearly presented for example in the 
tables.  
 
Since the two surveys took part in the same geographical area it is relevant to know if the 
participants to some extent participated in both surveys. The problem is mentioned under 
"strengths and limitations", but no estimate is given. Can this be estimate d, for example based on 
an estimate of number of impaired women in the district?  In principle, alternative statistical 
methods shold be used if participants are measured more than once, but the bias due to this most 
likely minor.  
  
 
Results:  
 
Table 1: I wou ld like to have range of age in addition to mean. The range of age is for example 
relevant in order to understand the increased level of education between the two surveys. (Range 
for the 2015 data are given in the Results).  
 
Table 1: Statistical testing i s not performed for all variables, the reason for this is explained in 
the Methods section but could also be given in a footnote.   
 
What is the meaning of the last sentence in Results: "Additional data that was collected in 2002 
was provided by the author "? I suggest that you had access to original data from the 2002 study.  
 
Discussion lines 228+ and 236+. You compare your population with the German female general 
population. To me this is as interesting as the presented comparison between the two surveys . 
Have you considered to include some descriptive numbers for the general population in the 
tables?     
 
Discussion lines 269+. The large differences found in the educational background is discussed, 
and a possible selection bias is considered. Because thi s is a very descriptive study, I would not 
put too much focus on the statistical tests in tables 1 & 2 and think that the interpretation of the 
tables should be based on observed data. But since you suggest that much of the difference in 
education is due t o selection, have you considered to perform tests with adjustment for 
education?       
 
   
 
  
 
 
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 c ontrols?  
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.  
 
No 
 
Are you able to asse ss any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please speci fy 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:  
 
Needs some language corrections before being published  
 
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, f ees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publi cation of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation t hat 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 curr ently 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 no competing interests.  
 
I agree to the open peer review policy of the journal. I understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted for publication, my named repor t 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available under an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand  that any comments 
which I do not wish to be included in my named report can be in cluded as confidential comments 
to the editor s, which will not be published.  
 
I agree to the open peer review policy of the journal