ABSTRACT
BACKGROUND: The traditional long-term treatment goal of Crohn's disease [CD] is maintenance of corticosteroid-free clinical remission. Additional treatment targets, such as biochemical, endoscopic and patient-reported remission, are advocated. The relapsing-remitting nature of CD provides a challenge to the timing of target assessment. Cross-sectional assessment at predetermined moments disregards the health state in between measurements. In this systematic review, we provide an overview of outcomes used to assess long-term efficacy in clinical trials in CD. METHODS: A systematic search of the PubMed and EMBASE databases was performed to identify clinical trials in luminal CD reporting on maintenance treatment [strategies] since 1995. Two independent reviewers selected eligible articles for full text retrieval, and assessed if long-term corticosteroid-free clinical, biochemical, endoscopic or patient-reported efficacy outcomes were used. RESULTS: The search resulted in 2452 hits and 82 articles were included. Clinical activity was used in 80 studies [98%] as the long-term efficacy outcome, and in 21 [26%] of these concomitant corticosteroid use was taken into account. C-reactive protein was used in 32 studies [41%], faecal calprotectin in 15 studies [18%], endoscopic activity in 34 studies [41%] and patient-reported outcome in 32 studies [39%]. In seven studies, clinical, biochemical, endoscopic activity and the patient's perspective were measured. In most studies cross-sectional measures or multiple measurements over time were used. CONCLUSION: In none of the published clinical trials in CD was sustained remission on all treatment targets reported. Cross-sectional outcomes at predetermined times were widely applied, leading to lack of information regarding sustained corticosteroid-free remission for this relapsing-remitting chronic disease.
ABSTRACT
OBJECTIVE: To provide an accurate incidence of adnexal masses in children and young women which can significantly improve the performance of current risk prediction models. METHODS: We used the PALGA database, a nationwide network and registry of histopathology and cytopathology, as the primary source of our study. Reports on ovarian histology of girls, years 1991-2014, and women aged 21-39, years 2011-2013, were included. Reports were labeled using the WHO-classification and classified as benign, borderline malignant, or malignant. Surgical procedure was scored separately. RESULTS: Included were 11,595 patients. The incidence of adnexal masses increased exponentially with age, from 0.43 per 100,000womenyears at age 1 to 152 per 100,000womenyears at age 35. A (borderline) malignancy was found in 898 (7.7%) patients, ratios between benign and malignant masses varied with age and were lowest in premenarchal children. Histology varied widely with surface epithelial tumors (35.1%), germ cell tumors (29.8%), and other cysts, tumors and tumorlike lesions (32.8%) being evenly distributed while sex cord stromal tumors were rare and only represented 2.3%. The proportion of malignancies was 6.3% in germ cell tumors while the type of malignant germ cell tumor was dependent on age. Oophorectomy was more often performed in the premenarchal age group and in women approaching the end of their reproductive age. CONCLUSION: Our results show that adnexal masses in different age groups do not only differ in histological subgroups but also in malignancy rate which is of high value in presurgical risk evaluation.
