Reviewer ’s report  
 
Title:  Real-world experience of women using extended -cycle vs monthly -cycle combined oral 
contraception in the United States: the National Health and Wellness Survey  
 
Version: 0 Date: 30 Oct 2017 
 
Reviewer:  Salvatore  Caruso  
 
Reviewer’s report:  
 
I reviewed the Manuscript  titled "Real -world experience of women using extended -cycle vs 
monthly -cycle combined oral contraception in the United States: The National Health and 
Wellness Survey" (BMWH -D-17-00225). The study compares data of women used extended 
cycle combined oral c ontraception versus traditional 21/7 combined oral contraception with the 
purpose to evaluate therapy satisfaction, adherence and menstrual cycle symptoms. The analyzed 
data refers to a large cohort of women (aged 18 -50) enrolled. I really appreciated the Manuscript 
topic and I think that  the study should be very helpful to guide the clinicians in contraceptive 
management. However, it would be interesting to deep into several elements that could strongly 
improve the study validity as suggested in my review . 
 
 
The Manuscript may benefit from some revisions, as suggested below:  
 
- Materials and Methods: Inclusion and exclusion criteria are not clear. For example, 
comorbidities that may affect women before starting the oral contraception treatment are not 
report ed. In this view, it becomes necessary specify which estroprogestinic drug and which 
dosage are used in the treatment and if the therapy solve manifestations .  
 
- Materials and Methods: The validity of the study should be significantly improved by the 
analy sis of the sexual grade of satisfaction. We think that it represents an important element that 
could really impact the quality of daily life. In our opinion, thus, sexual grade of satisfaction 
deserves a deep evaluation during the cycle combined oral contr aception. Moreover, also for this 
aspect, it should be auspicial to clarify which estroprogestinic and which dosage are used in the 
treatment to have a better acknowledgment of the outcomes (1 -2). Did  both regimens contain the 
same quality and quantity of  estrogen and progestogen? This information could be interesting for 
the reader  
 
(1) Caruso S, Cicero C, Malandrino C, Cianci A, Agnello C. Quality Of Sexual Life Of 
Women On Oral Contraceptive Continued -regimen: Pilot Study. J Sex Med. 2013 
Feb;10(2):46 0-466. doi:10.1111/j.1743 -6109.2012.03004. Epub 2012 Nov 21.  
 
(2) Caruso S, Iraci Sareri M, Agnello C, Romano M, Lo Presti L, Malandrino C, Cianci A. 
Conventional vs. extended ‐cycle oral contraceptives on the quality of sexual life: Comparison 
between two r egimens containing 3 mg drospirenone and 20 µg ethinyl estradiol. J Sex Med 
2011 May;8(5):1478 -85. doi: 10.1111/j.1743 -6109.2011.02208. Epub 2011 Feb 16.  
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not,  please explain in your comments 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 f urther 
assessment in your comments to the editors.  
 
I am able to asse ss the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of comp eting 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, either now or in the future?  
 
3. Do you hold or ar e 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 ha ve 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, pl ease give details below.  
 
I declare that I have no competing interests  
 
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