Evaluation of the safety profile of the quadrivalent vaccine against human papillomavirus in the risk of developing autoimmune, neurological, and hematological diseases in adolescent women in Colombia.

BACKGROUND: Cervical cancer eradication is one of the main goals for 2030 by the World Health Organization, which can only be achieved with high vaccination rates against Human Papilloma Virus. In Colombia, more and better scientific evidence is required to increase confidence in vaccination. The objective of this study is to evaluate the safety profile of the quadrivalent vaccine against HPV in the risk of developing autoimmune, neurological, and hematological diseases in adolescent women in Colombia. METHODS: We designed a cohort study based on national HPV vaccination records and incident diagnostic data for the diseases of special interest during 2012 and 2021. We included adolescent women between 9 and 19 years old and compared vaccinated and non-vaccinated cohorts using an Inverse Probability of Treatment Weighting (IPWT) method for each scenario disease and follow-up period (180 and 360 days). FINDINGS: The Odds Ratio (OR) of developing diseases of interest was estimated during two follow up periods, 180 and 360 days after the follow-up index date (Vaccination Day). The OR for developing rheumatoid arthritis was 4·4; CI95% (1·74 - 11·14), juvenile idiopathic arthritis was 2·76 IC95% (1·50 - 5·11), idiopathic thrombocytopenic purpura was 2·54 IC95% (1·28 - 5·02) and thyrotoxicosis was 2·86 IC95% (1·03 - 7·95), when comparing the vaccinated versus unvaccinated population. However, the temporal distribution of cases incident did not reveal a clear difference between the cohorts, since the rate of appearance of new cases has a constant linear behavior for the two groups. INTERPRETATION: For rheumatoid arthritis, juvenile idiopathic arthritis, idiopathic thrombocytopenic purpura, and thyrotoxicosis; the application of the vaccine had an effect on the development of the disease. Nevertheless, our results should be interpreted with caution and be further studied, considering that the biological plausibility of the events occurred without a clear temporal pattern in relation to the exposure to the vaccine.

Cost-effectiveness analysis of spontaneous vaginal delivery vs elective cesarean delivery for maternal outcomes in Colombia.

BACKGROUND: In worldwide literature, it has been found that cesarean deliveries represent higher costs and are associated with maternal morbidity and other complications. OBJECTIVE: This study aimed to estimate the cost-effectiveness of elective cesarean delivery compared with spontaneous vaginal delivery in short-term maternal outcomes for low-risk obstetrical population in Colombia. STUDY DESIGN: A cost-effectiveness study using a healthcare-system perspective was performed in 2019 in Colombia. The reference population were women with full-term and low-risk pregnancy, either by spontaneous vaginal delivery or elective cesarean delivery under medical or nonmedical indications. An analytical decision model (decision tree) was designed for maternal outcomes. The time horizon was 42 days postpartum, and the health effects were measured by Quality Adjusted Life Years. A review of the literature and a validation process by a national expert committee were conducted to determine the maternal outcomes and estimate their probabilities. Costs were estimated with a top-down analysis, an incremental cost-effectiveness ratio was calculated, and finally, a sensitivity analysis was performed. RESULTS: Within a 42-day time horizon, it was found that spontaneous vaginal delivery is the less-expensive and more-effective mode of delivery, it showed a reduction in costs (324 USD) and a gain in Quality Adjusted Life Years (0.03) compared with elective cesarean delivery. Our analysis suggests that spontaneous vaginal delivery is the dominant alternative compared with elective cesarean delivery. CONCLUSION: Spontaneous vaginal delivery showed to be the cost-effective mode of delivery for low-risk obstetrical population in Columbia. These results are useful not only for obstetricians but for decision makers, who should encourage nationwide health policies in favor of spontaneous vaginal delivery.

Two-Step Strategy for Optimizing the Preoperative Classification of Adnexal Masses in a University Hospital, Using International Ovarian Tumor Analysis Models: Simple Rules and Assessment of Different NEoplasias in the adneXa Model.

OBJECTIVES: To evaluate the performance of a two-step strategy compared with the International Ovarian Tumor Analysis (IOTA) - Assessment of Different NEoplasias in the adneXa (ADNEX) model for preoperative classification of adnexal masses. METHODS: An ambispective diagnostic accuracy study based on ultrasound data collected at one university hospital between 2012 and 2018. Two ultrasonographers classified the adnexal masses using IOTA Simple Rules (first step). Not classifiable masses were evaluated using the IOTA ADNEX model (second step). Also, all masses were classified using the IOTA ADNEX model. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-), and receiver operating characteristic (ROC) curve were estimated. A P value of <.05 was used to determine statistical significance. RESULTS: The study included 548 patients and 606 masses. Patients' median age was 41 years with an interquartile range between 32 and 51 years. In the first step, 89 (14%) masses were not classifiable. In the second step, 55 (61.8%) masses were classified as malignant. Furthermore, for the totality of 606 masses, the IOTA ADNEX model estimated the probability that 126 (20.8%) masses were malignant. The two-step strategy had a sensitivity, specificity, PPV, NPV, LR+, LR-, and ROC curve of 86.8%, 91.01%, 51.9%, 98.4%, 9.7, 0.1, and 0.889, respectively; compared to IOTA ADNEX model that had values of 91.8%, 87.16%, 44.4%, 99%, 7.1, 0.09, and 0.895, respectively. CONCLUSION: The two-step strategy shows a similar diagnostic performance when compared to the IOTA ADNEX model. The IOTA ADNEX model involves only one step and can be more practical, and thus would be recommended to use.