Etonogestrel-releasing subdermal contraceptive implant: Budget impact analysis based on the Brazilian private healthcare system.

High rates of unplanned pregnancies persist despite pharmacological developments and advancements in contraceptive methods. Here, we demonstrate that the etonogestrel-releasing subdermal contraceptive implant (IMP-ETN) may be an appropriate and cost-effective alternative to levonorgestrel-releasing intrauterine systems (LNG-IUSs) for women in Brazil. For our pharmacoeconomic analysis, we reviewed the literature on IMP-ETN regarding its acceptance, eligibility criteria, choice, relations with age, adverse events and, finally, the unmet need in the fee-for-service private healthcare sector. We considered qualitative observations in combination with quantitative analysis and performed a deterministic sensitivity analysis to investigate whether this technology can be self-sustainable over a period of five years. The target population for this analysis comprised 158,696 women. Compared with the continued use of LNG-IUSs, adopting the IMP-ETN can result in a cost avoidance of $ 7.640.804,02 in the first year and $ 82,455,254.43 in five years. Disseminating information among physicians will promote this change and strengthen the potential cost avoided by private health system payers. These savings can be used to improve other healthcare programs and strategies. Moreover, the principles of care can be promoted by improving and adapting healthcare systems and expanding treatment and follow-up strategies. This would also provide support to women's reproductive rights and improve their quality of life. Our results suggest that the IMP-ETN has a favorable cost-effectiveness profile. Given all its advantages and negative incremental cost impact over a period of five years, the IMP-ETN may be a more favorable alternative to LNG-IUSs. Therefore, it should be offered to beneficiaries with a private healthcare plan. This analysis overcomes previous barriers to the use of cost-benefit models, and our results may help balance decision-making by policymakers, technical consultants, and researchers.

Cervical Cancer-Related Knowledge, Attitudes, Practices and Self-Screening Acceptance Among Patients, Employees, and Social Media Followers of Major Brazilian Hospital.

BACKGROUND: Brazil has a high burden of cervical cancer, even though it is preventable, traceable and treatable. Hence, this study evaluated levels of knowledge, attitudes and practices (KAP) related to cervical cancer screening and diagnosis and acceptance of self-screening techniques among women aged 24 and greater. METHODS: A cross-sectional KAP survey was administered to n = 4206 women and spanned questions relating to cervical cancer, HPV, speculum, Pap test and colposcopy. Questionnaire was disseminated through a major hospital's social media platforms, intranet and gynecologic-oncology clinics. Logistic regressions evaluated associations between sociodemographic characteristics and knowledge, attitudes, and preventative behaviors against cervical cancer. Participants indicated willingness to try DNA-HPV self-sampling and cervix self-visualization (self-colposcopy). FINDINGS: Participants were mostly white individuals (70.5%) with higher education and from social classes A and B. They demonstrated superior levels of KAP than described in the literature, with over 57.8% having answered 80+% of questions correctly. KAP scores were predicted by social class, educational attainment, race, history of premalignant cervical lesions and geographic location. About 80% and 63% would be willing to try DNA-HPV self-sampling and cervix self-visualization, respectively. Interest in self-screening was associated with adequate attitude (OR = 1.85) and inadequate practice (OR = .83). INTERPRETATION: Adequate KAP are fundamental for the successful implementation of a self-screening program. Participants were interested in methods that provide them with greater autonomy, control and practicality. Self-screening could address barriers for under-screened women such as shame, discomfort, distance from clinics and competing commitments, enabling Brazil to reach the WHO's cervical cancer elimination goals. It could also decrease excess medical intervention in over-screened populations by promoting shared decision-making.

Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study.

BACKGROUND: Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement. OBJECTIVE: Although health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone-based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system. METHODS: The MyIUS app is classified as a medical device and uses an artificial intelligence-based bleeding pattern prediction algorithm to estimate a woman's future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility and concept finalization, product development, and product deployment or localization stages. RESULTS: The MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting. CONCLUSIONS: By providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting.

Heavy menstrual bleeding: a global survey of health care practitioners' perceptions.

OBJECTIVES: This study sought to assess the perceptions of health care practitioners (HCPs) regarding heavy menstrual bleeding (HMB). METHODS: We developed an online survey for HCPs administered in 10 countries (Brazil, Canada, China, France, Germany, Korea, Russia, Spain, UK and USA), in order to assess their perceptions regarding HMB. RESULTS: We received 1032 responses. Most HCPs considered more than 7 days of bleeding abnormal. There was a significant difference in the definition of HMB between countries (p < .001). Most HCPs measured menstrual blood loss by the number of sanitary pads or tampons needed, followed by the impact on patients' daily activities. The majority of HMB patients (61%) were diagnosed as having a non-structural disorder with no causative identifiable coagulopathy. Patient acceptance and compliance were each relevant for the treatment decisions of half of the HCPs. Treatment options for idiopathic HMB featured mainly oral contraceptives and the levonorgestrel-releasing intrauterine system. Surgery was mentioned as a treatment option for idiopathic HMB by 44% of HCPs. CONCLUSION: The definition of HMB and HCP perceptions of HMB regarding diagnostic and therapeutic issues varied between countries. Surgery was mentioned as a treatment for idiopathic HMB by nearly half of HCPs. Clinician education is greatly needed to improve the management of women with HMB.

Identification of local angiogenic and inflammatory markers in the menstrual blood of women with endometriosis.

The aim of this study was to evaluate the presence of myeloperoxidase (MPO), N-acetyl-ß-D-glucosaminidase (NAG), tumor necrosis factor alpha (TNF-α) and vascular endothelial growth factor (VEGF) in peripheral and menstrual blood in women with (n=10) and without (n=7) endometriosis. NAG and MPO activities were evaluated by enzymatic methods, whereas TNF-α and VEGF by immunoassay. No significant differences were found for these markers, neither in menstrual nor in peripheral blood between groups. Menstrual blood NAG (P=0.039) and MPO (P=0.0117) activities in the endometriosis group were significantly higher than in peripheral blood. NAG and MPO presented positive linear correlation in peripheral (P=0.07; r=0.641) and menstrual blood (P=0.01; r=0.603). These findings point to the existence of an increased local inflammatory activity in women with endometriosis.

TRAIL-R3-related apoptosis: epigenetic and expression analyses in women with ovarian neoplasia.

OBJECTIVE: To assess the expression of TRAIL-R3 and the methylation of a CpG island within the TRAIL-R3 promoter both in cystadenoma tumors and primary and metastatic epithelial ovarian carcinoma (EOC). METHODS: RNA was obtained from women with normal ovarian (NO) tissues (n=18), ovarian serous cystadenoma tumors (n=11) and EOC (n=16) using Trizol. Quantitative PCR (qRT-PCR) was performed to quantify the relative levels of TRAIL-R3. The methylation frequency of the CpG island in the TRAIL-R3 promoter was assessed using the methylation-specific PCR (MSP) assay after DNA bisulfite conversion. The differences between the groups were evaluated using the chi-square, Student's t, ANOVA, Mann-Whitney U, Wilcoxon or Kruskal-Wallis tests as indicated. The survival rates were calculated using the Kaplan-Meier method. RESULTS: Cystadenoma and metastatic EOC tumors expressed significantly more TRAIL-R3 mRNA than primary EOC tumors. Methylation of the TRAIL-R3 promoter was absent in NO tissues, while hemimethylation of the TRAIL-R3 promoter was frequently found in the neoplasia samples with 45.4% of the cystadenoma tumors, 8.3% of the primary EOC samples and 11.1% of the metastatic EOC samples showing at least partial methylation (p=0.018). Neither the expression of TRAIL-R3 nor alterations in the methylation profile were associated to cumulative progression-free survival or the overall survival in EOC patients. CONCLUSIONS: Primary EOC is associated to a lower TRAIL-R3 expression, which leads to a better understanding of the complex disease and highlighting potential therapeutic targets. Promoter DNA methylation was not related to this finding, suggesting the presence of other mechanisms to transcriptional control.

Pelvic floor muscle strength predicts stress urinary incontinence in primiparous women after vaginal delivery.

INTRODUCTION AND HYPOTHESIS: This study aimed to investigate obstetrical, neonatal, and clinical predictors of stress urinary incontinence (SUI) focusing on pelvic floor muscle (PFM) strength after vaginal delivery. METHODS: A cross-sectional study was used, and potential predictors of SUI were collected 5-7 months postpartum on 192 primiparous women. Predictors that reached significance in the bivariate analysis were entered into the Classification and Regression Tree that identified interactions among them and cutoff points to orient clinical practice. RESULTS: PFM strength was the strongest predictor of SUI. A combination of PFM strength ≤ 35.5 cmH(2)O, prior SUI, newborn weight > 2.988 g, and new onset of SUI in pregnancy predicted SUI. The model's accuracy was high (84%; p = 0.00). CONCLUSIONS: From the four predictors identified, three are modifiable by physical therapy. This could be offered to women targeting at PFM strength >35.5 cmH(2)O at the postpartum as well as at the prevention of SUI before and during pregnancy.