Expected impact of MRI-related interreader variability on ProScreen prostate cancer screening trial: a pre-trial validation study.

BACKGROUND: The aim of this study is to investigate the potential impact of prostate magnetic resonance imaging (MRI) -related interreader variability on a population-based randomized prostate cancer screening trial (ProScreen). METHODS: From January 2014 to January 2018, 100 men aged 50-63 years with clinical suspicion of prostate cancer (PCa) in Helsinki University Hospital underwent MRI. Nine radiologists individually reviewed the pseudonymized MRI scans of all 100 men in two ProScreen trial centers. All 100 men were biopsied according to a histological composite variable comprising radical prostatectomy histology (N = 38) or biopsy result within 1 year from the imaging (N = 62). Fleiss' kappa (κ) was used to estimate the combined agreement between all individual radiologists. Sample data were subsequently extrapolated to 1000-men subgroups of the ProScreen cohort. RESULTS: Altogether 89% men of the 100-men sample were diagnosed with PCa within a median of 2.4 years of follow-up. Clinically significant PCa (csPCa) was identified in 76% men. For all PCa, mean sensitivity was 79% (SD ±10%, range 62-96%), and mean specificity 60% (SD ±22%, range 27-82%). For csPCa (Gleason Grade 2-5) MRI was equally sensitive (mean 82%, SD ±9%, range 67-97%) but less specific (mean 47%, SD ±20%, range 21-75%). Interreader agreement for any lesion was fair (κ 0.40) and for PI-RADS 4-5 lesions it was moderate (κ 0.60). Upon extrapolating these data, the average sensitivity and specificity to a screening positive subgroup of 1000 men from ProScreen with a 30% prevalence of csPCa, 639 would be biopsied. Of these, 244 men would be true positive, and 395 false positive. Moreover, 361 men would not be referred to biopsy and among these, 56 csPCas would be missed. The variation among the radiologists was broad as the least sensitive radiologist would have twice as many men biopsied and almost three times more men would undergo unnecessary biopsies. Although the most sensitive radiologist would miss only 2.6% of csPCa (false negatives), the least sensitive radiologist would miss every third. CONCLUSIONS: Interreader agreement was fair to moderate. The role of MRI in the ongoing ProScreen trial is crucial and has a substantial impact on the screening process.

Transanal or vaginal approach to rectocele repair: a prospective, randomized pilot study.

PURPOSE: This study was designed to compare outcomes of transanal and vaginal techniques for rectocele repair. METHODS: Thirty females with symptomatic rectocele were enrolled in a prospective, randomized study. Fifteen underwent transanal rectoceleplasty, the other 15 underwent vaginal posterior colporrhaphy. Patients were assessed by clinical interview and examination, defecography, colon transit study, and anorectal manometry before randomization and 12 months postoperatively. Patients with compromised anal sphincter function or other symptomatic prolapse were excluded. RESULTS: The study groups were comparable in terms of demographic factors and rectocelerelated symptoms and signs. Eleven (73 percent) patients in the vaginal group and 10 (66 percent) in the transanal group digitally assisted rectal emptying preoperatively. The mean depth of the rectocele was 6.0 +/- 1.6 cm vs. 5.6 +/- 1.8 cm (P = 0.53) in the respective groups. At follow-up, 14 (93 percent) patients in the vaginal group and 11 (73 percent) in the transanal group reported improvement in symptoms (P = 0.08). Need to digitally assist rectal emptying decreased significantly in both groups, to one (7 percent) for the vaginal group and four (27 percent) for the transanal group (P = 0.17 between groups). The respective recurrence rates of rectocele were one (7 percent) vs. six (40 percent) (P = 0.04), and enterocele rates were zero vs. four (P = 0.05). In the vaginal group defecography showed a significant decrease in rectocele depth whereas in the transanal group the difference did not reach statistical significance. None of the patients reported de novo dyspareunia, but 27 percent reported improvement. CONCLUSION: Patients' symptoms were significantly alleviated by both operative techniques. The transanal technique was associated with more clinically diagnosed recurrences of rectocele and/or enterocele. Adverse effects on sexual life were avoided by use of both techniques.