TY - JOUR
T1 - Improved anal Cytology Sampling
T2 - Tush Brush Compared with Dacron Swab
AU - Ferris, Daron Gale
AU - Darragh, Teresa M.
AU - Kavuri, Sravan
AU - Patel, Nikhil
AU - Waller, Jennifer L
AU - Goebel, Angela
N1 - Funding Information:
1Department of Obstetrics and Gynecology, Augusta University, Augusta, GA; 2Georgia Cancer Center, Augusta University, Augusta, GA; 3Department of Pathology, University of California San Francisco, San Francisco, CA; 4Department of Pathology, Augusta University, Augusta, GA; and 5Department of Population Health Sciences, Division of Biostatistics and Data Science, Augusta University, Augusta, GA Correspondence to: Daron G. Ferris, MD, Department of Obstetrics and Gynecology, Medical College of Georgia, Georgia Cancer Center, HH-1013, Augusta University, Augusta, GA 30912. E-mail: dferris@augusta.edu D.G.F. is the inventor of the Tush Brush and Augusta University holds patent rights. The other authors have declared they have no conflicts of interest. Supported by Georgia Research Alliance. The IRB status was approved by Augusta University IRB. © 2018, ASCCP DOI: 10.1097/LGT.0000000000000447
Funding Information:
The authors thank the Georgia Research Alliance for their financial support of the development of the Tush brush. The authors also thank the Copeland Enterprises (Stone Mountain, GA) for creating Tush brush prototypes and engineering modifications that greatly improve the device.
Publisher Copyright:
© Lippincott Williams & Wilkins.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Objective The objective of this study was to determine the performance characteristics of the Tush brush (TB) compared with a saline moistened Dacron swab (DS) as anal cytology sampling devices. Materials and Methods TB and DS anal cytology tests were randomly collected from 146 patients presenting for anal cytology. High-resolution anoscopy and biopsies were obtained as indicated. Sensitivity and specificity as well as rates of satisfactory specimens were determined for each method using the areas under the receiver operating characteristic curve (AUCROC) and McNemar's test, respectively. Perceived discomfort of each device was determined using a visual analog scale and compared using a paired t test. Results The adjudicated AUCROC, sensitivity, and specificity were greater, but not significantly different, for the brush (0.63, 85.5, and 40.0, respectively) compared with the swab (0.50, 79.6, and 33.3, respectively) when the anal biopsy results were considered the criterion standard. In the 1 subject diagnosed with anal cancer, the swab cytology result was normal, but the brush result was abnormal. Specimen adequacy was 95.2% for the brush and 93.2% for the swab. Mean discomfort (visual analog scale) scores were swab 28.5 mm versus brush 35.6 mm (p =.0003) with both scores within the minimal to moderate discomfort range. Conclusions Anal cytology AUCROC, sensitivity, and specificity in detecting anal neoplasia were greater using the TB when compared with the DS. A novel anal cytology sampling device designed specifically to increase the detection of anal neoplasia would be clinically beneficial.
AB - Objective The objective of this study was to determine the performance characteristics of the Tush brush (TB) compared with a saline moistened Dacron swab (DS) as anal cytology sampling devices. Materials and Methods TB and DS anal cytology tests were randomly collected from 146 patients presenting for anal cytology. High-resolution anoscopy and biopsies were obtained as indicated. Sensitivity and specificity as well as rates of satisfactory specimens were determined for each method using the areas under the receiver operating characteristic curve (AUCROC) and McNemar's test, respectively. Perceived discomfort of each device was determined using a visual analog scale and compared using a paired t test. Results The adjudicated AUCROC, sensitivity, and specificity were greater, but not significantly different, for the brush (0.63, 85.5, and 40.0, respectively) compared with the swab (0.50, 79.6, and 33.3, respectively) when the anal biopsy results were considered the criterion standard. In the 1 subject diagnosed with anal cancer, the swab cytology result was normal, but the brush result was abnormal. Specimen adequacy was 95.2% for the brush and 93.2% for the swab. Mean discomfort (visual analog scale) scores were swab 28.5 mm versus brush 35.6 mm (p =.0003) with both scores within the minimal to moderate discomfort range. Conclusions Anal cytology AUCROC, sensitivity, and specificity in detecting anal neoplasia were greater using the TB when compared with the DS. A novel anal cytology sampling device designed specifically to increase the detection of anal neoplasia would be clinically beneficial.
KW - anal cancer
KW - anal cytology
KW - anal cytology test
KW - sampling device
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U2 - 10.1097/LGT.0000000000000447
DO - 10.1097/LGT.0000000000000447
M3 - Article
C2 - 30407936
AN - SCOPUS:85059028912
SN - 1089-2591
VL - 23
SP - 48
EP - 53
JO - Journal of Lower Genital Tract Disease
JF - Journal of Lower Genital Tract Disease
IS - 1
ER -