DNA Cytometry Testing for Cervical Cancer Screening – Response

We appreciate the interest of Drs. Garner, Guillaud, and MacAulay in our work and thank them for their critical comments on our recent publication (1). Early detection of cancerous lesions is a pivotal step for reducing cervical cancer–associated mortality. Finding a method which possesses high sensitivity and specificity in screening of mass populations has been difficult for cancer researchers. False negatives are a major problem for cervical cancer testing using conventional cytologic methods and frequent retesting is required (2). Previous studies have reported that DNA ploidy testing could increase the positive prediction of precancerous and cancerous lesions of uterine cervix compared with cytology (3–5). However, there has been little data on DNA ploidy cytometry testing as a single detection method in low-resource countries where it might be used for large population screening. This was the basis for performing the randomized study under discussion. Our goal was to test the hypothesis that DNA ploidy cytometry testing would be superior to conventional cytologic screening to detect early precancerous or cancerous cervical lesions. First, we need to clarify the design of our study as to whether it was a randomized controlled trial or not. Garner et al. critically said that our study was not a randomized trial because the data analyzed in our study were pooled together from both arms. In fact, we did perform both DNA cytometry and the cytologic evaluation on all patients' specimens. This was done for ethical reasons because performing a single test on each arm would not have been approved by our institutional review boards. In Table 2 from our article, the results we reported included crossover screening. We apologize for not making this clear. However, all study processes were conducted in a randomized manner, i.e., patient's eligibility screening, randomization, blindness concealment and uncovering, intention-to-treat, and per protocol analyses. Such analyses, at first, gave an overall understanding as to the two