Background: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations.
We determined the re-attendance rate at screening mammography after a single or a repeated false positive recall and we assessed the effects of transition from screen-film mammography (SFM) to full-field digital mammography (FFDM) on screening outcome in women recalled twice for the same mammographic abnormality. The study population consisted of a consecutive series of 302,912 SFM and 90,288 FFDM screens. During a 2 years follow-up period (until the next biennial screen), we collected the breast imaging reports and biopsy results of all recalled women. Re-attendance at biennial screening mammography was 93.2 % (95 % CI 93.1-93.3 %) for women with a negative screen (i.e., no recall at screening mammography), 65.4 % (95 % CI 64.0-66.8 %) for women recalled once, 56.7 % (95 % CI 47.1-66.4 %) for women recalled twice but for different lesions and 44.3 % (95 % CI 31.4-57.1 %) for women recalled twice for the same lesion. FFDM recalls comprised a significantly larger proportion of women who had been recalled twice for the same lesion (1.9 % of recalls (52 women) at FFDM vs. 0.9 % of recalls (37 women) at SFM, P < 0.001) and the positive predictive value of these recalls (PPV) was significantly lower at FFDM (15.4 vs. 35.1 %, P = 0.03). At review, 20 of 52 women (39.5 %, all with benign outcome) would not have been recalled for a second time at FFDM if the previous hard copy SFM screen had been available for comparison. We conclude that a repeated false positive recall for the same lesion significantly lowered the probability of screening re-attendance. The first round of FFDM significantly increased the proportion of women recalled twice for the same lesion, with a significantly lower PPV of these lesions. Almost 40 % of repeatedly recalled women would not have been recalled the second time if the previous hard copy SFM screen had been available for comparison at the time of FFDM.
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