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JAMA Intern Med. 2019 Feb 4. doi: 10.1001/jamainternmed.2018.7169. [Epub ahead of print]

Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial.

Author information

1
Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France.
2
Department of Radiology, Institut Bergonié, Bordeaux, France.
3
Department of Radiology, Centre François Baclesse, Caen, France.
4
Centre de Radiologie, Nancy, France.
5
Department of Radiology, Institut Curie, Paris, France.
6
Centre d'Imagerie Majorelle, Nancy, France.

Abstract

Importance:

Many women dread undergoing mammography, and some may not attend or reattend breast cancer screening because of the discomfort or pain induced by breast compression.

Objective:

To evaluate the noninferiority of the self-compression mammography technique for reducing breast thickness compared with standard compression.

Design, Setting, and Participants:

This prospective, parallel-group, noninferiority randomized clinical trial was conducted from May 7, 2013, to October 26, 2015, at 6 cancer care centers in France. Participants were women aged 50 to 75 years, without a history of recent breast surgical procedure or treatment, and who could perform self-compression. Analyses were performed on intention-to-treat basis from January 27, 2017, to March 30, 2018.

Interventions:

Patients were randomized 1:1 to the self-compression group or the standard compression group.

Main Outcomes and Measures:

Primary end point was breast thickness expressed as the mean of 4 views: right and left craniocaudal and right and left mediolateral oblique. The predefined noninferiority margin was a difference of 3 mm, with a 1-sided 95% CI. Secondary end points included compression force, image quality, requirement for additional views, pain, and patient satisfaction and radiographer assessment questionnaires.

Results:

Among the 549 women randomized, 548 (97.3%) completed the trial. Of these, 275 (48.8%) (mean [SD] age, 61.35 [6.34] years) were randomized to the self-compression arm and 273 (48.5%) (mean [SD] age, 60.84 [6.41] years) to the standard compression arm. The difference in the mean thickness between the 2 arms was lower than the noninferiority margin, with an upper 1-sided 95% CI less than 3 mm (-0.17; 95% CI,-∞ to 1.89 mm; P < .05). Compression force was higher in the self-compression group compared with the standard compression arm for the 4 mammographic views. Pain was statistically significantly lower in the self-compression group (n = 274) compared with the standard compression group (n = 269) (median [interquartile range (IQR)] score, 2 [1-5] vs 3 [1-5]; P = .009). No difference was reported in the image quality scores of the 2 groups or in the number of additional views performed (median [IQR] extra views, 2 [2-2] vs 2 [2-3] extra views; P = .64), whatever the indication, including insufficient image quality (29 [16.8%] vs 27 [15.0%] insufficient quality views; P = .65). No adverse effects or pain were reported by the participants after the self-compression mammography.

Conclusions and Relevance:

Self-compression does not appear to be inferior to standard compression mammography in achieving minimal breast thickness without increasing pain or compromising image quality; this technique may be an effective option for women who want to be involved in their breast examination.

Trial Registration:

ClinicalTrials.gov identifier: NCT02866591.

PMID:
30715083
PMCID:
PMC6440229
[Available on 2020-02-04]
DOI:
10.1001/jamainternmed.2018.7169

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