Design of the PROCON trial: a prospective, randomized multi – center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

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. METHODS/DESIGN: Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. DISCUSSION: The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN4168184

Frequency and characteristics of contralateral breast abnormalities following recall at screening mammography

PurposeTo determine the frequency and characteristics of contralateral, non-recalled breast abnormalities following recall at screening mammography.MethodsWe included a series of 130,338 screening mammograms performed between 1 January 2014 and 1 January 2016. During the 1-year follow-up, clinical data were collected for all recalls. Screening outcome was determined for recalled women with or without evaluation of contralateral breast abnormalities.ResultsOf 3,995 recalls (recall rate 3.1%), 129 women (3.2%) underwent assessment of a contralateral, non-recalled breast abnormality. Most lesions were detected at clinical mammography and/or breast tomosynthesis (101 women, 78.3%). The biopsy rate was similar for recalled lesions and contralateral, non-recalled lesions, but the positive predictive value of biopsy was higher for recalled lesions (p = 0.01). A comparable proportion of the recalled lesions and contralateral, non-recalled lesions were malignant (p = 0.1). The proportion of ductal carcinoma in situ was similar for both groups, as well as invasive cancer characteristics and type of surgical treatment.ConclusionsAbout 3% of recalled women underwent evaluation of contralateral, non-recalled breast lesions. Evaluation of the contralateral breast after recall is important as we found that 15.5% of contralateral, non-recalled lesions were malignant. Contralateral cancers and screen-detected cancers show similar characteristics, stage and surgical treatment.Key Points center dot 3% of recalled women underwent evaluation of contralateral, non-recalled lesions center dot One out of seven contralateral, non-recalled lesions was malignant center dot A contralateral cancer was diagnosed in 0.5% of recalls center dot Screen-detected cancers and non-recalled, contralateral cancers showed similar histological characteristics center dot Tumour stage and surgical treatment were similar for both group

Re-attendance at biennial screening mammography following a repeated false positive recall

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 FFD

Interval breast cancer characteristics before, during and after the transition from screen-film to full-field digital screening mammography

Abstract Background To determine the proportion of “true” interval cancers and tumor characteristics of interval breast cancers prior to, during and after the transition from screen-film mammography screening (SFM) to full-field digital mammography screening (FFDM). Methods We included all women with interval cancers detected between January 2006 and January 2014. Breast imaging reports, biopsy results and breast surgery reports of all women recalled at screening mammography and of all women with interval breast cancers were collected. Two experienced screening radiologists reviewed the diagnostic mammograms, on which the interval cancers were diagnosed, as well as the prior screening mammograms and determined whether or not the interval cancer had been missed on the most recent screening mammogram. If not missed, the cancer was considered an occult (“true”) interval cancer. Results A total of 442 interval cancers had been diagnosed, of which 144 at SFM with a prior SFM (SFM-SFM), 159 at FFDM with a prior SFM (FFDM-SFM) and 139 at FFDM with a prior FFDM (FFDM-FFDM). The transition from SFM to FFDM screening resulted in the diagnosis of more occult (“true”) interval cancers at FFDM-SFM than at SFM-SFM (65.4% (104/159) versus 49.3% (71/144), P < 0.01), but this increase was no longer statistically significant in women who had been screened digitally for the second time (57.6% (80/139) at FFDM-FFDM versus 49.3% (71/144) at SFM-SFM). Tumor characteristics were comparable for the three interval cancer cohorts, except of a lower porportion (75.7 and 78.0% versus 67.2% af FFDM-FFDM, P < 0.05) of invasive ductal cancers at FFDM with prior FFDM. Conclusions An increase in the proportion of occult interval cancers is observed during the transition from SFM to FFDM screening mammography. However, this increase seems temporary and is no longer detectable after the second round of digital screening. Tumor characteristics and type of surgery are comparable for interval cancers detected prior to, during and after the transition from SFM to FFDM screening mammography, except of a lower proportion of invasive ductal cancers after the transition