Technical note: Low clinical efficacy, but good acceptability of a point-of-care electronic palpation device for breast cancer screening for a lower middle-income environment.

Abstract

Late-stage breast cancer rates in the Pacific where mammography services are limited are exceedingly high: Marshall Islands (61%), Palau (94%), and Samoa (79%). Due to the limited medical resources in these areas an alternative accessible technology is needed. The iBreast Exam (iBE) is a point-of-care electronic palpitation device that has a reported sensitivity of 86%. However, little is known about the performance and acceptability of this device for women in the Pacific. A total of 39 women (ages 42-73 years) were recruited in Guam with 19 women having a mammogram requiring biopsy (Breast Imaging-Reporting and Data System [BI-RADS] category 4 or above) and 20 women with a negative screening mammogram before the study visit. Participants received an iBE exam and completed a 26-item breast health questionnaire to evaluate the iBE. Furthermore, the performance characteristics of the iBE were tested using gelatin breast phantoms in terms of tumor size, tumor depth, and overall breast stiffness. The iBE had a sensitivity of 20% (two true positives to eight false negatives) and specificity of 92% (24 false positives to 278 true negatives) when analyzed based on the location of the tumor by quadrant. The iBE also had generally poor agreement according to a Cohen's kappa value of 0.068. The phantom experiments showed that the iBE can detect tumors as deep as 2.5cm, but only if the lesion is greater than 8mm in diameter. However, the iBE did demonstrate acceptability; 67% of the women reported that they had high trust in iBE as an early detection device. The iBE had generally poor sensitivity and specificity when tested in a clinical setting which does not allow its use as a screening tool. This study demonstrates the need for an alternative screening method other than electronic palpation for lower-middle-income areas.