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Item Effect of Baseline Menstrual Bleeding Pattern on Copper Intrauterine Device Continuation(Elsevier, 2018) Hobby, James H.; Zhao, Qiuhong; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineBackground Heavy menstrual bleeding is a leading cause of copper intrauterine device (IUD) discontinuation. Thus, women with heavy baseline menstrual bleeding may be at increased risk for early copper IUD discontinuation. Our objective was to assess if there was an association between baseline menstrual bleeding pattern prior to IUD insertion and discontinuation rate at 12 months among study participants who chose copper IUD at baseline. Study Design We performed a secondary analysis of the Contraceptive CHOICE Project, a prospective observational cohort study of 9,256 women offered no cost contraception for 2-3 years. Included in our study were participants who chose copper IUD for contraception and for whom method continuation data at 12 months were available. Prior to contraception initiation, participants were asked to qualify their menstrual bleeding over the past year as: light, moderate, moderately heavy or heavy. Light bleeding corresponded to using 10 or fewer pads/tampons per period. Moderate, moderately heavy and heavy bleeding corresponded to 11-20 pads/tampons, 21-30 pads/tampons, and more than 30 pads/tampons per period, respectively. Subjects were then categorized into either a “heavy” baseline group (those reporting moderately heavy or heavy bleeding at baseline), or a “not heavy” group (those reporting light or moderate bleeding). The 12-month continuation rate for each group was then calculated using Kaplan-Meier survival function, and hazard ratio for risk of discontinuation was evaluated using a Cox proportional hazard model to determine if moderately heavy or heavy bleeding at baseline was associated with early discontinuation. Results Of the 918 women meeting the inclusion criteria for this analysis, 165 were in the heavy baseline bleeding group, while 753 were in the not heavy bleeding group. The 12-month continuation rates for groups were similar: 80.2% (heavy) and 85.0% (not heavy; P=0.24). Patients reporting either moderately heavy or heavy baseline bleeding were not at increased risk for early discontinuation of copper IUD (hazard ratio 1.21, 95% CI 0.88, 1.66). Our sample size provided greater than 90% power to detect a clinically important difference of 15% (assuming 20% discontinuation rate in not heavy bleeding group and a 35% discontinuation rate in the heavy bleeding group). Conclusions We did not find that women who reported baseline moderately heavy or heavy menstrual bleeding were at increased risk for early discontinuation. Thus, we do not believe that women with heavy menstrual bleeding should be discouraged from using this safe and highly-effective form of contraception.Item Menorrhagia: The Importance of Treatment in Women with Disorders of Hemostasis(2021-03-25) Essex, Amanda; Sommers, Kit; Colomb, Elaine; Watters, MelissaCase A 37 yo female was admitted to the hospital for potential Immune Thrombocytopenic Purpura after laboratory findings noted a platelet count of 12k and mild anemia. Her history revealed new onset petechiae, gingival bleeding and recently worsening menorrhagia. Treatment began with IVIG, prednisone and iron and she was ultimately discharged with instructions to follow up. Within 2.5 months of her initial presentation of ITP, the patient had a recurrence of petechiae and a platelet count of 4k. Upon readmission, IVIG and steroids were restarted. At this time, she was also experiencing cramping, fatigue, and heavy menstrual bleeding that led to another drop in hemoglobin. Discussions about outpatient management of menorrhagia were started. After 5 days, she was discharged and began Tranexamic Acid to address excessive menstrual losses at home. In follow up, she expressed significant anxiety about her diagnosis of ITP and felt that her ongoing menorrhagia was causing her ITP to recur. Conclusions Finding the best treatment option for patients experiencing menorrhagia requires consideration of numerous factors including the patient’s medical history, cause and severity of menorrhagia, future childbearing plans, patient preference and more. Without proper management, menorrhagia has been linked to decreased quality of life in terms of physical, mental, and social health. Anxiety surrounding menorrhagia can be compounded when patients do not have a clear understanding of the etiology of their condition. Clinical Significance Managing disorders of hemostasis like ITP can be complex especially in cases of early relapse. Menorrhagia in the setting of a bleeding disorder can further complicate management and can lead to worsening physical and psychosocial consequences. While prompt recognition and treatment of menorrhagia in patients with disorders of hemostasis is important for improving physical outcomes, it also plays a critical role in improving quality of life for patients.Item Preference Elicitation Tool for Abnormal Uterine Bleeding Treatment: A Randomized Controlled Trial(Springer, 2015-04) Hess, Lisa M.; Litwiller, Abigail; Byron, John; Stutsman, John; Kasper, Kelly; Learman, Lee A.; Department of Epidemiology, Richard M. Fairbanks School of Public HealthBackground It is estimated that one-third of women will experience abnormal menstrual bleeding. The majority of these cases are not due to cancer or pregnancy complications and, as a result, women are faced with a variety of treatment alternatives, the selection of which is largely dependent on personal preferences for care rather than clinical outcomes. Objective This randomized trial was designed to evaluate a preference elicitation tool to promote physician–patient collaborative decision making for treatment of abnormal uterine bleeding (AUB). Methods Adaptive conjoint analysis (ACA) was used to create a preference elicitation tool in English and in Spanish. Women with AUB were enrolled to the study and randomly assigned to ACA or usual counseling at the initial clinic visit at four clinics (three in Indianapolis, IN, USA, and one in Southern Pines, NC, USA). The ACA tool elicited preferences across eight attributes: treatment efficacy; sexual function; medical care; cost; fertility; frequency of medication use; permanence; and recovery time. t tests were used to compare differences in the primary outcomes of decision regret and treatment satisfaction at the follow-up visit. The study was designed to have 80 % power to detect significant differences between groups for the primary outcomes of regret and satisfaction. Results Women were enrolled in the study between September 2009 and March 2012. 183 participants were randomized to ACA and 191 to usual counseling. Overall, mean (standard deviation) treatment satisfaction was high at 35.71 (9.72) (scale of 0–44), and decision regret was low at 25.9 (21.0) (scale of 0–100), creating ceiling effects for the selected outcome variables; there were no significant differences between the ACA and control groups at the follow-up assessment. There was a strong inverse relationship between age and decision regret (p = 0.007). Exploratory subgroup analysis in the youngest quartile comprising 64 women aged 19–35 years showed a statistically non-significant difference in mean regret scores for the ACA group versus usual counseling (24.6 vs. 34.6, respectively; p = 0.08). Conclusions A preference elicitation tool at the initial consultation visit did not reduce decision regret or improve treatment satisfaction among patients with AUB; however, there is a need for additional research to further understand this tool’s potential role in promoting collaborative decision making, which may be particularly important among younger women.