Keywords:
Performed at one institution, Not applicable, Prospective, Quality assurance, Screening, Mammography, Breast
Authors:
M. KINOSHITA1, H. Goto1, M. Sakamoto1, H. Matuzuki1, D. Nagase1, A. Manabe1, R. ISHII2, J. Ikeda1; 1Ashiya/JP, 2Habikino/JP
DOI:
10.26044/ecr2020/C-00113
Methods and materials
Patients
After receiving approval from the local institutional review board and obtaining informed written consent, 104 patients aged 28-87(60.4±14.8) coming for bilateral mammography testing between April 2019 and September 2019, who received an explanation about and understood the process of the CCS and agreed to the testing, were included prospectively in the study. The study population was patients referred for diagnostic and screening purposes. Patients with breast implants or who were pregnant, breastfeeding or had had a mastectomy were excluded from the study. The study analyzed results exclusively of patients who were given the 2D exam and excluded those given the 3D and 3D + 2D exams.
Mammography equipment and procedure
The mammography unit used was an Amulet Innovality (FUJIFILM Digital Mammography System) equipped with the CCS and included automated quantitative measurements of volumetric breast density (VBD), showing a high correlation with MRI. Mammographic views were all obtained in the same order: right craniocaudal, left craniocaudal, right mediolateral oblique, and left mediolateral oblique. The radiographers performed the examinations using the CCS after a compression force of 140N, the same as that of the conventional method, were administered. Once the maximum pressure had reached 140N, the pressure reduction button was pressed and the CCS automatically decompressed to the maximum 80N or Δ 3mm (increment CBT) pressure range. After each compression, radiographers asked the patient to score their pain level on a numerical rating scale (NRS) (score range: 0 [no pain] to 10[worst pain imaginable]) [10] both before and after use of the CCS. ΔNRS was calculated in order to see the effect of pain reduction. ΔNRS was calculated by the NRS after using CCS subtracted by the NRS of 140N before using CCS. Technical factors, such as CBT (mm) per view, compression force (N), breast volume (㎤) and breast composition [11] were also recorded from the DICOM headers. The participants were also given a questionnaire to determine their levels of satisfaction.
Statistical analysis
The Wilcoxon signed-rank test was used to compare the differences in pain level experienced before and after using CCS. We have identified the metric on 0-10 NRS for stratifying pain severity into the following levels: no pain (0), mild (1-4), moderate (5-6), and severe (7-10) [12]. The Steel-Dwass test was used to assess the statistical significance of differences in breast volume and the pain level category scores before and after CCS, respectively. The Steel-Dwass test was used to assess the statistical significance of differences in ΔNRS and pain level category scores before using CCS. Any p<0.05 was considered statistically significant.