Reviewer ’s report  
 
Title: Self-administered multi -level pregnancy tests in simplified follow -up of medical abortion 
in Tunisia  
 
 
Version: 0 Date: 06 May 2016  
 
 
Reviewer: Kirti  Iyengar  
 
 
Reviewer's report:  
 
BMWH -D-16-00055  
Self-administered multi -level pregnancy tests in simplified follow -up of medical abortion in 
Tunisia  
 
This study assesses the efficacy and acceptability of a Multi -level pregnancy test combined with 
telephonic follow -up for medical abortion in Tunisia. T he presentation of data in tables ands 
figures is clear and informative. There are a few issues that need to be addressed:  
 
Aim of the study: In the abstract, the aim of the study is clearly mentioned. It should also be 
mentioned as clearly in the main ma nuscript as well. The aim mentioned in lines 125 -128 is not 
as clear.  
 
Methods, line 137 -142: For assessment of gestational age, an ultrasound technician conducted 
ultrasound in all clinics. Do all reproductive health clinics in Tunisia have an ultrasound 
technician? Please provide the staffing pattern of all the participating clinics.   
 
Method, line 143 -145 and results: The criteria for ineligibility have been provided. Authors need 
to present in results section on the number of women who presented to the se clinics during the 
study period with unwanted pregnancy up to 70 days, and were considered to be ineligible due to 
various reasons. For example, how many women were ineligible on grounds of lack of 
telephone, or not agreeing to provide results of her PT  by telephone.  
 
Methods, line 125 -127 and discussion, line 253 -255:  
 
* The study used MLPT. What was the cost of the test? Which other alternatives were 
considered?   
 
* Authors need to discuss about scaling up. If the test is to be scaled up in the health 
system, what will be the cost implications?  
 
* Some studies have used tests with a single or two levels of hCG. Since this study used the 
MLPT, authors need to discuss which levels were most relevant for detecting ongoing 
pregnancy, or for confirming all those with complete abortions.  
 
* If tests with a single / fewer than five levels of hCG were used, how are the results of test 
expected to change. For example, if a tes t with 1000 or 2000 IU/ L was used, would all 
those with ongoing pregnancy have had a positive result?  
 
Results, line 186 -187: It is a bit confusing as to what number of women did not make a phone 
call. At one place, the paper mentions that 63 women did n ot administer the test or were lost to 
follow -up. This is not clearly reflected in the flowchart.  Data on the number of women who did 
not administer the test and the number that were lost to follow -up should be separately presented.  
 
Discussion:  
If 63 w omen did not administer the test, it is significant proportion out of 404, and has 
implications on the acceptability of the method. The authors need to present information more 
clearly on their reasons why these women did not administer the test. The findi ng should also be 
discussed in discussion section.  
 
Choice of MLPT: The authors need to discuss as to how does the MLPT used in this study, 
compare with other alternatives used in studies on self assessment.  
 
Line 282 -284: (Despite the increasing availabi lity of ultrasound…….):  Please present 
information on what proportion of RH clinics have ultrasound available in Tunisia. Also, please 
present a citation for …  ultrasound resulting in higher intervention rates.   
 
Lines 266 -268: (large proportion of wome n using misoprostol only regimen….): Please discuss 
the legal situation of abortion in Tunisia and access issues. Why a large proportion of women use 
misoprostol only regimen? Where do they seek it from?  
 
If there are problems with regards of supply of mi fepristone tablets, then how smooth will it be 
introduce MLPT in the health system in Tunisia? What kinds of procurement and supply issues 
are expected in the actual implementation?  
 
Table 1: Participant profile has been presented. How do the participants compare with all women 
seeking abortions at these clinics?  
 
Figures: There are 2 figures labeled as 1. The flowchart should present information on total 
number of women with unwanted pregnancy and those ineligible for the study.  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments t o the authors.  
 
Yes 
 
Does the work include the necessary controls?  
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 comment s to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comment s to the editors.  
 
Not relevant to this ma nuscript  
 
Quality of written English  
Please indicate the quality of language in the man uscript:  
 
Acceptable  
 
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, fees, funding, or salary from 
an organisation that  may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, eith er now or in the future?  
 
3. Do you hold or are you currently 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 declare tha t I have no competing interests  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my  report to the authors and, if the manuscript is accepted for publication, my named report  
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 C reative 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 included as confidential comments  
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal