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- W2892079479 abstract "Background Response to treatment is determined by HRA guided-biopsies. Complete response (CR) indicates resolution of HSIL; partial response (PR) indicates clinically-significant improvement in HSIL (Table 1). HRA may be inexact with missed or obscured lesions. We evaluated potential confounding factors affecting assessment of response in a double-blind study comparing topical Chinese medicine vs. placebo (28 per arm). Methods HRA adjudication of 36 responses including all CR and PR was performed by two clinicians blinded to study arm and each other's classifications (Table 2). HRA descriptions and photodocumentation were reviewed, comparing exams during and at 12-weeks post-treatment. Clinicians determined if resolved or improved lesions were missed, recurred, had late clinical response (LCR) post-treatment, or biopsy-induced regression. Disagreements were downgraded to the lesser response. Results 17/36 responses were reclassified: 11 PR to NR, 3 PR to LCR, 2 NR to CR with recurrence, and 1 NR to PR. 2/10 CR were considered possibly biopsy-induced or too small for evaluation, but were not reclassified. Reasons for reclassification included: missed lesions, Conclusions Determination of treatment efficacy is related to HRA quality. CR was confirmed in all 10 cases, but additional 4 LCR were considered post-treatment effect, which has been noted for other topical therapies. The majority of PR was reclassified. PR may indicate clinically-important response but was difficult to validate. Exclusion of patients with obscured exams or small lesions and better documentation may assure more accurate determination of response. Blind HRA adjudication may help verify findings." @default.
- W2892079479 created "2018-09-27" @default.
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- W2892079479 date "2018-06-01" @default.
- W2892079479 modified "2023-09-27" @default.
- W2892079479 title "Adjudicated response of anal high-grade squamous intraepithelial (HSIL) to topical therapy assessed by high-resolution anoscopy (HRA)" @default.
- W2892079479 doi "https://doi.org/10.1016/j.pvr.2018.07.015" @default.
- W2892079479 hasPublicationYear "2018" @default.
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