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      Análisis de la costo-efectividad del sistema intrauterino liberador de levonorgestrel, como alternativa a histerectomías, en dos países latinoamericanos Translated title: Analysis of the cost-effectiveness of the levonorgestrel intrauterine system as alternative to histerectomies in two latin american countries

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          Abstract

          Resumen Objetivo: El sistema intrauterino con levonorgestrel ha demostrado un fuerte efecto supresor endometrial de mucha utilidad en gran variedad de problemas ginecológicos. Existen numerosos estudios y revisiones del sistema intrauterino con levonorgestrel que avalan su uso en sangrado uterino anormal, como también bastantes publicaciones que demuestran su costo-efectividad. No se encontraron publicaciones latinoamericanas. El objetivo del estudio es desarrollar un modelo para valorar el beneficio en costos del uso del dispositivo como manejo alternativo del sangrado uterino anormal. Métodos : Se realizó modelo fármaco-económico que ayudará a comparar costos y efectividad de sistema intrauterino con levonorgestrel, inserción, controles clínicos más ultrasonido transvaginal al mes, y anuales, y se comparó con los costos directos de histerectomía. Los costos de histerectomía se obtienen mediante GRD-WinSIG en Chile y los costos reales directos en Costa Rica. El modelo es básicamente comparar los costos de la inserción de sistema intrauterino con levonorgestrel más las fallas del tratamiento versus histerectomías. Resultados: El modelo permite demostrar que al utilizar el sistema intrauterino con levonorgestrel como alternativa a la histerectomía en pacientes seleccionadas, se produce un ahorro en costos, aun asumiendo el costo de las fallas. Estos modelos no consideran los costos asociados a las complicaciones eventuales de todo acto quirúrgico, de tal forma que el ahorro generado por el uso del sistema intrauterino con levonorgestrel podría ser mayor. Conclusión: La inclusión del sistema intrauterino con levonorgestrel en guías de práctica clínica permite la posibilidad de disminuir las histerectomías en pacientes refractarias a tratamiento médico convencional, y que cumplan con criterios de inclusión y exclusión estrictos. El modelo permitió demostrar que al utilizar el sistema intrauterino con levonorgestrel como alternativa a la histerectomía, se produce un gasto que es solo un tercio del generado al realizar histerectomías.

          Translated abstract

          Summary Objective: The intrauterine system with levonorgestrel has demonstrated a strong endometrial suppressive effect that is useful in a wide variety of gynecological problems. There are numerous studies and reviews of the levonorgestrel intrauterine system that support its use in abnormal uterine bleeding, as well as numerous publications that demonstrate its cost-effectiveness. As far as we know, there are no Latin American publications in this regard. The objective of the present study was to develop a model to assess the costs benefits of the use of the devices as alternative management of abnormal uterine bleeding. Methods: A pharmacoeconomic model was performed comparing costs and effectiveness with costs of levonorgestrel intrauterine system, insertion, clinical controls plus ultrasounds per month and annually, compared with the direct costs of hysterectomy. Hysterectomy costs were obtained through DRG-WinSIG or direct real costs in Chile and Costa Rica respectively. Results: Our model demonstratde that when using the levonorgestrel intrauterine systsem as an alternative to hysterectomy in selected patients there is an expenditure of only one third of the costs of performing the hysterectomies in the same patients, even assuming failures with the dispositive. These model did not consider the costs associated with the eventual complications of any surgical act, thus, savings generated by use of the levonorgestrel intrauterine system in these patients could be even greater. Conclusión: The inclusion of the levonorgestrel intrauterine system in clinical practice guidelines could allow the possibility of reducing hysterectomies in patients refractory to conventional medical treatment and who meet strict inclusion and exclusion criteria. Our models demonstrate that when using the levonorgestrel intrauterine system as an alternative to hysterectomy in selected patients there is a reduction in costs.

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          The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization.

          Our purpose was to determine the risk of pregnancy after tubal sterilization for common methods of tubal occlusion. A multicenter, prospective cohort study was conducted in U.S. medical centers. A total of 10,685 women who underwent tubal sterilization was followed up for 8 to 14 years. The risk of pregnancy was assessed by cumulative life-table probabilities and proportional hazards models. A total of 143 sterilization failures was identified. Cumulative 10-year probabilities of pregnancy were highest after clip sterilization (36.5/1000 procedures) and lowest after unipolar coagulation (7.5/1000) and postpartum partial salpingectomy (7.5/1000). The cumulative risk of pregnancy was highest among women sterilized at a young age with bipolar coagulation (54.3/1000) and clip application (52.1/1000). Although tubal sterilization is highly effective, the risk of sterilization failure is higher than generally reported. The risk persists for years after the procedure and varies by method of tubal occlusion and age.
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            A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss.

            To validate a simple, highly predictive test to discriminate between menorrhagia and normal menstrual blood loss. The sanitary wear of 489 menstrual bleeding episodes was collected by 288 women for objective measurement of menstrual blood loss (alkaline hematin method); the women made a subjective assessment of the volume and, based on a pictorial chart, recorded the amount of and the degree to which their sanitary wear was soiled. Based on that degree, a score was calculated for each episode and a suitable cutoff point was chosen, above which the presence of menorrhagia was likely and below which it was unlikely. Using a score of 185 as the cutoff point, the predictive values of positive and negative tests were almost equally high, 85.9 and 84.8%, respectively. Whether or not the presence of clots was recorded, these values did not change. The predictive value of a woman's complaint of heavy bleeding for the presence of menorrhagia was 55.9% and that of anemia (hemoglobin less than 12.0 g/dL) was 74.4%. We validated and refined a new, simple, visual assessment technique and demonstrated that it is superior to a woman's subjective assessment of menstrual blood loss and the occurrence of anemia for predicting menorrhagia, even if it is performed only once. We also demonstrated that the volume that clots contribute to menstruation is not as large as many clinicians believe. With this technique, the quality of therapy can be enhanced by making it more adequate and rational.
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              Efficacy, acceptability and side effects of the levonorgestrel intrauterine system for menorrhagia.

              To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrel-releasing intrauterine system for menorrhagia. Sixty-three women with menorrhagia but without uterine enlargement, endometrial hyperplasia with atypia, or endometrial carcinoma were enrolled in this prospective, open, nonrandomized clinical trial. An intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS; Mirena, Shering, Finland) was inserted in the postmenstrual phase. Menstrual pattern, number of bleeding days, and subjective and objective estimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years. Hemoglobin levels and endometrial thickness were evaluated at baseline and at 12 months. Treatment continuation and hysterectomy rates were noted as well as side effects. The device was expelled spontaneously in 6 patients (9.52%) and removed prematurely in 9 patients (14.3%); 3 patients (4.8%) were lost to follow-up; and 45 patients (71.4%) continued with the LNG-IUS. Menorrhagia was cured in 35 (77.7%) of these 45 patients at 3 months and in all patients at 36 months. There was a significant decrease in the mean number of bleeding days (P=0.01) and PBAC score (P=0.00) at 1 month, and the decrease continued with treatment duration. The subjective blood loss reduction was considerable as well, and at 12 months the mean+/-SD rise in hemoglobin concentration was 1.06+/-1.7 g/dL (P=0.000). Endometrial thickness was decreased by 3.4+/-3.53 mm (P=0.0001) at 12 months. The most common side effect was intermenstrual spotting during the first 6 months, and 18 patients (28.57%) developed amenorrhea. Using the LNG-IUS is an effective and well-accepted option overall for the medical management of menorrhagia.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Journal
                amc
                Acta Médica Costarricense
                Acta méd. costarric
                Colegio de Médicos y Cirujanos de Costa Rica (San José, San José, Costa Rica )
                0001-6012
                0001-6002
                September 2019
                : 61
                : 3
                : 94-98
                Affiliations
                [1] Santiago de Chile orgnameUniversidad de Chile orgdiv1Hospital Clínico San Borja-Arriarán orgdiv2Servicio de Obstetricia, Ginecología y Neonatología Chile
                [2] San José orgnameUniversidad de Costa Rica orgdiv1Servicio Ginecología Hospital “Dr. Rafael Ángel Calderón Guardia Costa Rica
                Article
                S0001-60022019000300094
                d22228dc-ef97-4b63-b616-9a39cdcc65cb

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 International License.

                History
                : 23 May 2019
                : 09 October 2018
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 18, Pages: 5
                Product

                SciELO Costa Rica

                Categories
                Original

                cost-effectiveness,hysterectomy,costo - efectividad,abnormal uterine bleeding,levonorgestrel intrauterine system,histerectomía,sistema intrauterino con levonorgestrel,sangrado uterino anormal

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