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Purpose Endometrial carcinoma is the most common gynecologic malignancy in both developed and some developing countries. Unlike cervical cancer, for which there is routine screening, only patients symptomatic for endometrial carcinoma typically seek medical help for its diagnosis and treatment. Dilatation and curettage (D&C) has been the standard procedure for evaluating suspicious endometrial lesions. The discomfort and injury caused by the D&C procedure, however, restrict its use as a screening method for early diagnosis of endometrial lesions. High-risk endometrial cancer patients would benefit from an effective and low-cost screening test. In recent years, several endometrial devices have been developed and proposed as screening tools. Methods We have reviewed and evaluated the literature relating to the endometrial sampling devices in clinical use or clinical trials, with the goal of comparing devices and identifying the most appropriate ones for screening for endometrial lesions. Eligible literature was identified from systematic PubMed searches, and the relevant data were extracted. Comments, letters, unpublished data, conference proceedings, and case reports were excluded from our search. Seventy-four articles on endometrial sampling devices were obtained for this review. Results The main screening devices for endometrial carcinoma are aspiration devices (such as the Vabra aspirator), Pipelle, Tao Brush, and SAP-1 device. Among these devices, the Tao Brush is the most promising endometrial sampler for screening for endometrial lesions. However, its sampling insufficiency, cost, and unsuccessful insertion rate (20 % in nulliparous and 8 % in parous women) are problematic. Conclusions A more accurate and low-cost endometrial sampler, with improved specimen sufficiency and higher sensitivity for endometrial lesions, needs tobe developed and clinically verified.

Background The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. Methods The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4–10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. Results The package was implemented with high fidelity (85% of HCP trained, n  = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% ( n  = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. Conclusions This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. Trial registration ISRCTN41244132 ; Registered 24/11/2015.

Purpose To ascertain the spectrum of clinical management of endometrial carcinoma (EC) the largest international survey was conducted to evaluate and identify differences worldwide. Methods After validation of a 15-item questionnaire regarding surgical and adjuvant treatment of EC in Germany, an English-adapted questionnaire was put online and posted to all the major gynecological cancer Societies worldwide for further distribution commencing in 2010 and continued for 26 months. Results A total of 618 Institutions around the world participated: Central Europe (CE), Southern Europe (SE), Northern Europe (NE), Asia and USA/Canada/UK. Both a therapeutic and staging value was attributed to systematic pelvic and paraaortic lymph node dissection (LND) in CE (74.6 %) and in Asia (67.2 %), as opposed to USA/UK where LND was mainly for staging purposes (53.5 %; p  < 0.001). LND was performed up to the renal veins in CE in 86.8 %, in Asia in 80.8 %, in USA/UK in 51.2 % and in SE in 45.1 % ( p  < 0.001) of cases. In advanced disease, centers from Asia were treated most with adjuvant chemotherapy alone (93.6 %), as opposed to centers in SE, CE and UK/USA that employed combination chemo-radiotherapy in 90.9 % ( p  < 0.001) of cases. Paclitaxel/carboplatin was mostly used followed by doxorubicin/cisplatin (75 vs. 23.3 %; p  < 0.001). In total, 94 % of all participants supported the concept of treating EC patients within appropriate clinical trials. Conclusions There is broad range in both the surgical and adjuvant treatment of EC across different countries. Large-scale multicenter prospective trials are warranted to establish consistent, evidence-based guidelines to optimize treatment worldwide.

Background The partograph is a vital tool for health professionals who need to be able to identify pathological labor. It is used to recognize complications in childbirth on time and to take appropriate actions. We aimed to assess the knowledge and utilization of the partograph and associated factors among health professionals at public health institutions in eastern Ethiopia. Methods An institution based cross-sectional quantitative study was carried out among health professionals who were working in public health institutions. Multistage sampling with proportional to size allocation was used to recruit a total of 441 study participants. Self-administered questionnaire was used to collect data in this study. Eight midwives were recruited and trained to facilitate the data collection activities. Data were entered into Epi data software and exported into SPSS (22.0) for analysis. Descriptive statistics, bivariate and multiple logistic regression were computed to determine proportions and significant association with knowledge and use of the partograph among health professionals. Results More than half of health professionals, 232(53.7%) had a good level of knowledge about the partograph. However, only 196(45.4%) of health professionals had fair knowledge of partograph. Nevertheless, the proportion of the partograph utilization to follow labor progress by health professionals was 92.6%. Working in the health center [AOR = 0.31, 95% CI: 0.20, 0.48], being a midwife [AOR = 2.80, 95% CI: 1.60, 5.60] and in-service training [AOR = 2.0, 95% CI: 1.22, 3.42] were significantly associated with good level of knowledge. Health professionals who had in-service training about the partograph [AOR = 3.10, 95% CI: 1.35, 4.98] and who had positive attitude about the partograph [AOR = 2.90, 95% CI: 1.30, 6.30] were significantly associated with utilization of the partograph. Conclusion Only less than half of health professionals had fair knowledge about the partograph. Having in-service obstetric care training, type of health institutions and profession were significantly associated with knowledge of the partograph. Health professionals who had positive attitude towards use of the partograph were significantly associated with the partograph utilization. We suggest regular in-service training of health professionals can enhance their knowledge and utilization of the partograph.

To determine the factors associated with participation in cervical cancer screening and follow-up treatment in the context of a randomized controlled trial. The trial was initiated to evaluate the efficacy and cost effectiveness of visual inspection with acetic acid, cytological screening and testing for human papillomavirus in reducing the incidence of and mortality from cervical cancer in Maharashtra, India. Between October 1999 and November 2003 women aged 30-59 years were randomized to receive one of the three tests or to a control group. Participation was analysed for all three intervention arms. The differences between those who were screened versus those who were not was analysed according to the sociodemographic characteristics of the 100,800 eligible women invited for screening. Those who were treated versus those who were not were analysed according to the sociodemographic characteristics of the 932 women diagnosed with high-grade lesions. Participation in screening and compliance with treatment were also analysed according to the type of test used. Compared with women who were not tested, screened women were younger (aged 30-39), better educated and had ever used contraception. A higher proportion of screened women were married and a lower proportion had never been pregnant. Of the 932 women diagnosed with high-grade lesions or invasive cancer, 85.3% (795) received treatment. Women with higher levels of education, who had had fewer pregnancies and those who were married were more likely to comply with treatment. There were no differences in rates of screening or compliance with treatment when results were analysed by the test received. Irrespective of the test being used, good participation levels for cervical cancer screening can be achieved in rural areas of developing countries by using appropriate strategies to deliver services. Communication methods and delivery strategies aimed at encouraging older, less-educated women, who have less contact with reproductive services, are needed to further increase screening uptake.

Objectives Evaluation of the performance of VIA (visual inspection with acetic acid) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable, hand-held colposcope; the Gynocular, as compared to doctors. Design A crossover randomised clinical trial. Setting The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. Participants 932 women attending the clinic as either screening naïve for VIA screening (404) or women referred as VIA positive (528) from other VIA screening centres in the Dhaka region. Intervention VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method. The Swede score grade cervical acetowhiteness, margins plus surface. vessel pattern, lesion size and iodine staining. The women were randomised to start the examination by either a stationary colposcope or the Gynocular. Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor. Primary and secondary outcome measures Agreement between nurses and doctors in Swede scores was evaluated using the weighted κ statistic for the Gynocular and standard colposcope. The ability to predict CIN 2+ (CIN 2, CIN 3 and invasive cervical cancer) using Swede scores was evaluated using receiver-operating characteristic curves. Results The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a κ statistic of 0.858 and 0.859, respectively, and no difference in detecting cervical lesions in biopsy. Biopsy detected CIN 2+ in 39 (4.2%) women. Conclusions Our study showed that VIA nurses can perform colposcopy. There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system. Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings. Trial registration number ISRCTN53264564.

Background Gestational diabetes mellitus (GDM) has lifelong implications for the woman and her infant. Treatment reduces adverse maternal and perinatal outcomes although uncertainty remains about the optimal diagnostic criteria. The GEMS Trial aims to assess whether detection and treatment of women with GDM using the lower International Association of Diabetes in Pregnancy Study Groups diagnostic criteria compared with the higher criteria recommended in New Zealand reduces infant morbidity without increasing maternal morbidity. Methods GEMS is a multicentre, randomised trial. Women with a singleton pregnancy at 24 to 34 weeks’ gestation are eligible who give written informed consent. Women are randomly allocated to the Lower Criteria Group or the Higher Criteria Group. Women with a normal OGTT by their allocated criteria receive routine care (Higher criteria: fasting plasma glucose < 5.5 mmol/L, AND 2 hour < 9.0 mmol/L; Lower criteria: fasting plasma glucose < 5.1 mmol/L, AND 1 hour < 10.0 mmol/L, AND 2 hour < 8.5 mmol/l). Women with GDM on OGTT by their allocated criteria receive standard care for GDM (Higher criteria: fasting plasma glucose ≥ 5.5 mmol/L, OR 2 hour ≥ 9.0 mmol/L; Lower criteria: fasting plasma glucose ≥ 5.1 mmol/L, OR 1 hour ≥ 10.0 mmol/L, OR 2 hour ≥ 8.5 mmol/L). The primary outcome is large for gestational age (birth weight > 90th centile). Secondary outcomes for the infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score < 4 at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity. A study with 4,158 women will detect an absolute difference of 2.9% in the proportion of large for gestational age infants from 10.0% using the lower criteria to 12.9% with the higher criteria. Discussion The GEMS Trial will provide high-level evidence relevant for clinical practice. If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes. Trial registration Australian New Zealand Clinical Trials Registry registration number ACTRN12615000290594 . Date registered: 27th March 2015.

Objective The purpose of our study was to determine whether the anatomic threshold for pelvic organ prolapse (POP) diagnosis and surgical success remains valid when the patient sees what we see on exam. Methods Two hundred participants were assigned, by computer-generated block randomization, to see one of four videos. Each video contained the same six clips representative of various degrees of anterior vaginal wall support. Participants were asked questions immediately after each clip. They were asked: “In your opinion, does this patient have a bulge or something falling out that she can see or feel in the vaginal area?” Similarly, they were asked to give their opinion on surgical outcome on a 4-point Likert scale. Results The proportion of participants who identified the presence of a vaginal bulge increased substantially at the level of early stage 2 prolapse (1 cm above the hymen), with 67 % answering yes to the question regarding bulge. The proportion of participants who felt that surgical outcome was less desirable also increased substantially at early stage 2 prolapse (1 cm above the hymen), with 52 % describing that outcome as “not at all” or “somewhat” successful. Conclusion Early stage 2 POP (1 cm above the hymen) is the anatomic threshold at which women identify both a vaginal bulge and a less desirable surgical outcome when they see what we see on examination.

Background:The current International Federation of Gynecology and Obstetrics (FIGO) grade in endometrial carcinomas requires the evaluation of histologic features with proven prognostic value but with questionable reproducibility. This study tests the prognostic power and reproducibility of a new binary grading system.Study Design:Specimens from 254 hysterectomies were graded according to the new 3- and 2-tiered FIGO grading systems described by Alkushi et al. The selected morphologic parameters for the new grading system included the presence of predominant solid or papillary architecture pattern, severe nuclear atypia, tumor necrosis, and vascular invasion. The Cox proportional hazards and κ statistics were used for comparisons.Results:On multivariate analysis, and looking at all tumor cell types, the 4 tested grading systems were independent predictors of survival, with the 3-tiered FIGO grading system being the most predictive (P = 0.005). In the subset of endometrioid tumors, the 3- and 2-tiered FIGO grading systems and the new grading system retained their statistical significance as predictors of survival (P = 0.004, P = 0.03, and P = 0.007, respectively), whereas the grading system of Alkushi et al did not (P = 0.1). In nonendometrioid tumors, the new grading system proved to be the best predictor of survival, reaching near statistical significance (P = 0.06). The new grading system had acceptable intraobserver and interobserver reproducibility assessment (κ = 0.87 and κ = 0.45, respectively).Conclusion:The 3-tiered FIGO grading system retained its superior prognostic power. However, available binary grading systems remain an attractive option by being highly reproducible and by eliminating the clinical ambiguity of intermediate grades of disease.

Ultrasound has become a core skill in many specialties. We evaluated the learning and assessment of ultrasound skills in Obstetrics-Gynaecology in a series of eight studies. In the clinical setting, we found that trainees as well as experienced clinicians struggle with technical aspects of performance such as image optimization. We examined how to improve these aspects of performance in the simulated setting by determining mastery learning levels and exploring learning curves for novices. We then examined how to improve the efficiency of training as well as transfer of learning through the use of dyad practice as compared with single practice. We found that the use of simulation-based training focusing on technical aspects of performance in addition to clinical training led to sustained improvements in performance after two months of clinical training in all aspects of performance. In addition, we found an interaction effect between initial simulation-based training and subsequent clinical training on trainees’ need for supervision. These findings suggest that simulation-based training can work as preparation for future learning rather than merely as added learning. Finally, we found that the use of simulation-based initial training led to a large decrease in patients’ discomfort, improvements in their perceived safety and confidence in their ultrasound operator. However, simulation-based training comes at a cost and in the final study we developed a model for conducting cost-effectiveness studies and provided data from an example study on how to link training costs with quality of care.