Evaluation of the Efficacy of Clinical Breast Examination Gloves in the Diagnosis of Breast Lumps.

Abstract

Recent studies have questioned the efficacy of mammography in reducing breast cancer-related mortality. Additionally, the efficacies of commercially available gloves marketed as aiding the detection of breast lumps have not been independently verified. To evaluate the efficacy of clinical breast examination gloves in the detection of breast lumps. During the period from October 2011 to June 2012, patients were submitted to clinical examination with and without gloves. This prospective study involved 202 patients who underwent conventional clinical breast examination (test 1) or clinical breast examination with Sensifemme® gloves (test 2). All patients underwent subsequent bilateral ultrasonography (test 3) to confirm the findings of the physical examinations. The Chi-square test was used to compare values, while the kappa concordance index was used to determine the concordance between the diagnostic tests. The mean age of the patients was 43 years; 298 breast lumps were detected. In the clinical examination group (test 1), sensitivity was 54%, specificity was 78%, and accuracy was 57%. These rates for clinical breast examinations with gloves (test 2) were 68%, 58%, and 66%, respectively. The glove increased the diagnosis of breast nodules by 14%; the rate of false-positives was also higher (42% for test 2 compared to 22% for test 1). The accuracy of the glove was found to be superior to clinical examination after 100 patients had been examined. The kappa indices for test 1 vs. test 3 and for test 2 vs. test 3 were 0.15 and 0.16, respectively. Clinical examination using the glove was more effective than clinical examination with bare hands for the diagnosis of breast lumps, as it increased the sensitivity and accuracy of lump detection. However, this was at the expense of a higher false-positive rate, which can lead to further tests, unnecessary biopsies, and patient anxiety. The concordance of clinical examination results (whether performed with or without the glove) with those of ultrasonography is weak. Moreover, the glove has a steep learning curve that may discourage its use in certain circumstances.