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Comment & Response
July 2019

Limitations in the Methodology Assessing Subjective Data With Lack of Blinding in Mammography Screening—Reply

Author Affiliations
  • 1Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lés-Nancy, France
JAMA Intern Med. 2019;179(7):996-997. doi:10.1001/jamainternmed.2019.1445

In Reply We thank Drs Kotecha and Ramadoss for their interest in our article.1

We made the choice to perform a randomized clinical trial between self-compression and standard-compression techniques. If our study would have been only designed to demonstrate the self-compression noninferiority to achieve the minimal breast thickness, the crossover design of the study would have been preferable. In such a study, 1 breast would have been compressed with 1 of the 2 techniques and the second breast with the other. However, we wanted to evaluate pain as a secondary outcome. It appears that the main factor that limits breast compression is discomfort or pain. Whatever the technique used, if the compression on the first breast is painful, it could influence the patient experience when the second breast is compressed. This has been described as the carryover effect.2 The prevention of this effect is to have a sufficiently long time between the 2 compression periods.3 This “wash-out” was not suitable for our study.

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