To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.
Although only 4.5% to 16% of ovarian cysts in children are malignant, oophorectomy is common in such patients. Conservative expectant management and ovarian sparing surgery would avoid bilateral oophorectomies in children with ovarian cysts at low risk of malignancy. Pediatric or general surgeons who have limited expertise with pediatric gynecology often manage these children because of limited availability of pediatric and adolescent gynecologists with the special skills needed.The objective of this retrospective case-note study was to investigate the nature and surgical management of ovarian cysts in children at a large children's hospital to determine whether current management practices could be improved. Between 1991 and 2007, 155 cases identified through use of clinical coding of surgical cases and pathology databases were analyzed by use of Snap 9.Sixty-two ovarian cysts were found in children under 9 years of age who were prepubertal. There were 58 neoplastic cysts, but 36 (62%) were benign teratomas. Ten of the cysts were malignant. Preoperative diagnostic investigation was preformed in a minority of the patients: Of the 155 children, only 16 (10%) were investigated for tumor markers; 61 (39%) had an ultrasound scan; and 16 (10%) had a computed tomography or magnetic resonance imaging scan. An oophorectomy was performed in 90 (58%) of the children and an ovarian cystectomy was performed in 40 (26%). The ovary was removed in all cases with malignant cysts, and in 75 cases with benign or normal pathology (including 5 benign epithelial, 9 functional and 4 paraovarian cysts; 5 cases with normal ovarian tissue; 30 oophorectomies for benign teratomas, 21 for torsion and 1 for hemorrhage). Referral to a pediatric gynecologist occurred for only 24 (15.5%) of the patients following surgery for an ovarian cyst. This number excluded the 10 girls who were still in pain. None of the referrals were before surgery.These findings show that a large number of young girls with benign cysts who are at low risk of malignancy have cystectomy or oophorectomy when a conservative expectant management approach or ovarian-sparing surgery could have been justified. To prevent this practice, the investigators recommend greater use of preoperative diagnostic investigations including tumor markers and imaging, and the training of more gynecologists with the special skills in pediatric and adolescent gynecology needed to manage these patients. EDITORIAL COMMENT(In this retrospective analysis of ovarian cysts in children and adolescents from England, a surprisingly large number of patients were man-aged by oophorectomy and open laparotomy. Cases in this review (and certainly in most reports) were identified by searching the pathol- GYNECOLOGY Volume 65, Number 3 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACTBecause hysterectomy, the standard treatment option for women of reproductive age with menorrhagia, is associated with serious complications and requires a relatively long-recovery period, the levonorgestrel-releasing intrauterine sys...
Although the numbers of exposures are not sufficient to rule out a very low risk, data collected in the pregnancy registry to date do not support a relationship between the occurrence of congenital varicella syndrome or other birth defects and varicella vaccine exposure during pregnancy.
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