Adequate menstrual suppression in adolescents with inherited bleeding disorders often requires multiple treatment changes: Retrospective cohort study of a multidisciplinary clinic.

Heavy menstrual bleeding (HMB) is often the presenting symptom for females with inherited bleeding disorders (IBD). Multidisciplinary clinics leverage the expertise of hematologists and women's health specialists. This study characterizes the complexity of HMB management for adolescents with IBDs from a large multidisciplinary clinic. Adolescents often required multiple different menstrual suppression treatments, with only about 20% achieving acceptable suppression with their first treatment. Adolescents switched therapy most often for uncontrolled bleeding, followed by adverse effects, and patient preference. Given the difficulty in achieving adequate menstrual suppression, multidisciplinary clinics offer necessary expertise in accomplishing bleeding control with minimal adverse effects.

Standardizing the evaluation and management of iron deficiency anemia secondary to heavy menstrual bleeding in the emergency department.

BACKGROUND: Comprehensive guidelines for the management of iron deficiency anemia (IDA) in adolescents with heavy menstrual bleeding (HMB) presenting to the emergency department (ED) are lacking, leading to variability in care. We aimed to standardize the evaluation and management of these patients through the development and implementation of an evidence-based algorithm using quality improvement methodology. METHODS: Baseline data of the target population identified variability across four key measures of clinical management: therapy choice and administration, laboratory evaluation, hematology service consultation, and patient disposition. Literature review and consensus from pediatric hematology and gynecology providers informed a draft algorithm that was refined in an iterative multidisciplinary process. From December 2022 to July 2023, we aimed to achieve a 25% relative increase in patients to receive optimal management per the algorithm, while using sequential Plan-Do-Study-Act (PDSA) cycles. Process measures focusing on provider documentation and balancing measures, such as ED length of stay, were assessed concurrently. RESULTS: Forty-nine patients were evaluated during four PDSA cycles. Improvement of ≥40% above baseline regarding recommended therapy administration was achieved across four PDSA cycles. Adherence to recommended therapy choice improved from 57% (baseline) to 100%, minimal laboratory evaluation from 14% to 83%, hematology consultation from 36% to 100%, and appropriate disposition from 71% to 100%. ED length of stay remained stable. CONCLUSION: Implementation of a standardized algorithm for management of IDA secondary to HMB in adolescents in the ED increased adherence to evidence-based patient care.

Patients' motives and considerations on treatment decision-making for heavy menstrual bleeding: a qualitative study.

BACKGROUND: Several treatment modalities for heavy menstrual bleeding are available. However, many women report being unsatisfied in their search for an appropriate and effective treatment. The aim of this study is to gain insights in the experienced impact of heavy menstrual bleeding and the motives and considerations of women during the decision-making process for treating heavy menstrual bleeding. METHODS: An interpretative qualitative study was performed, using in-depth interviews. In total, 14 semi-structured interviews were conducted with patients who consulted a physician for treatment of heavy menstrual bleeding. Participants were recruited via the Netherlands Patients Federation (N = 10) or via the outpatient clinic in the Máxima Medical Center (N = 4). The interviews were conducted by phone or online between February 2020 and March 2021. In the interviews three topics were addressed: (1) participant's experience with heavy menstrual bleeding, (2) experience with patient journey of treatment decision-making and (3) elaborating on alternative treatments for heavy menstrual bleeding. A thematic analysis was conducted. RESULTS: Fourteen participants aged between 30 and 59 years old were interviewed. Three main themes emerged; "Considerations in taking the (next) step to seek help", "Various sources of information can contribute, confuse or frighten decision-making process" and "A physician's understanding and a relationship of trust are needed to guide the decision-making process". CONCLUSION: Our results show that women's considerations and decision making strongly depend on the obtained information and experience, the relationship with the physician, the influence of the social environment, the pre-visit expectations/desires, the fear of treatment complications and uncertainty of the effect of the treatment. It is a physicians role to create a trusting and open atmosphere during consultation. Patient-centered communication is helpful to share knowledge, and gain insights into a patient's hopes, fears and worries.

Factors associated with dysmenorrhoea and menorrhagia improvement in patients with adenomyosis after uterine artery embolisation.

BACKGROUND: This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation (UAE) in women with symptomatic adenomyosis and identified factors that could predict the improvement of dysmenorrhoea and menorrhagia. METHODS: This retrospective study included women with adenomyosis who underwent bilateral UAE between December 2014 and December 2016. The percentage of the volume of the absence of contrast enhancement on T1-weighted images was evaluated 5-7 days after UAE. A receiver operating characteristic (ROC) analysis was used to determine a cut-off point and predict the improvement of dysmenorrhoea and menorrhagia. RESULTS: Forty-eight patients were included. At 24 and 36 months after UAE, the improvement rates for dysmenorrhoea and menorrhagia were 60.4% (29/48) and 85.7% (30/35), and the recurrence rates were 19.4% (7/36) and 9.1% (3/33), respectively. Only the percentage of the volume of the absence of contrast enhancement on T1-weighted images was associated with the improvement of dysmenorrhoea (p = 0.001, OR = 1.051; 95% CI: 1.02-1.08) and menorrhagia (p = 0.006, OR = 1.077; 95% CI: 1.021-1.136). When the cut-off value of the ROC analysis was 73.1%, sensitivity, specificity, positive predictive value, and negative predictive value for the improvement of dysmenorrhoea were 58.6%, 94.7%, 94.4%, and 60%, while they were 58.9%, 80%, 100%, 100%, and 45.5% for the improvement of dysmenorrhoea. CONCLUSION: Bilateral UAE for symptomatic adenomyosis led to good improvement of dysmenorrhoea and menorrhagia. The percentage of the volume of the absence of contrast enhancement on T1-weighted images of the uterus in postoperative magnetic resonance imaging might be associated with the improvement of dysmenorrhoea and menorrhagia.

This study examined the improvement of dysmenorrhoea and menorrhagia after uterine artery embolisation in women with symptomatic adenomyosis and identified factors that could predict the improvement of dysmenorrhoea and menorrhagia. This retrospective study included women with adenomyosis who underwent uterine artery embolisation. A total of 48 patients were included. Only the percentage of the volume of the absence of contrast enhancement on T1-weighted images was associated with improvement of dysmenorrhoea and menorrhagia. Bilateral uterine artery embolisation for symptomatic adenomyosis led to good improvement. The percentage of the volume of the absence of contrast enhancement on images in postoperative T1-weighted magnetic resonance imaging of the uterus might be associated with the improvement of dysmenorrhoea and menorrhagia.

Efficacy of intrauterine device procedural analgesics.

ABSTRACT: Nearly half of all pregnancies worldwide are unintended. Intrauterine devices are an effective, long-acting form of pregnancy prevention that require minimal maintenance, and also can be used in patients with menorrhagia. However, they are underused because of pain associated with their insertion. Topical and local anesthesia are good options for reducing procedural pain in select patients. IUD placement falls within the scope of practice for physician associates/assistants (PAs) practicing in family medicine, internal medicine, and women's health. PAs should be aware of these additional analgesia options available to patients in order to increase use of effective contraception.

Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set.

OBJECTIVE: To develop a core outcome set for heavy menstrual bleeding (HMB). DESIGN: Core outcome set (COS) development methodology described by the COMET initiative. SETTING: University hospital gynaecology department, online international survey and web-based international consensus meetings. POPULATION OR SAMPLE: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. METHODS: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. MAIN OUTCOME MEASURES: Outcome importance was assessed in the Delphi survey on a 9-point scale. RESULTS: From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. CONCLUSIONS: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.

Gynaecological management of women with inherited bleeding disorders. A UK Haemophilia Centres Doctors' Organisation Guideline.

Women with inherited bleeding disorders (IBDs) may present to healthcare professionals in a variety of ways and commonly will be encountered by either haematology or gynaecology services. Heavy menstrual bleeding is very often the first manifestation of an IBD. There is a wide variation in severity of bleeding for women with IBD and diagnosis and subsequent management of their condition requires multidisciplinary specialised care which is tailored to the individual and includes excellent cross-specialty communication between gynaecology and haematology teams. This guideline is intended for both haematologists and gynaecologists who are involved in the diagnosis and management of women with bleeding disorders. It sets out recommendations about how to investigate heavy menstrual bleeding (HMB), the commonest presentation for women with IBD to hospital services, to guide physicians about how to diagnose an IBD and covers the management of women with known IBD and HMB. The second section sets out recommendations for patients known to have IBD and covers management of patients with IBD in the setting of gynaecological surgery and management for all other non-surgical gynaecological situations.

Fifteen-minute consultation: Guide to the young person with menorrhagia and dysmenorrhoea.

Adolescents who menstruate commonly present to acute paediatric services.

Evaluation and management of abnormal uterine bleeding.

Abnormal uterine bleeding (AUB) is one of the commonest complaints of women in reproductive age and non-gravid state that brings them to the attention of the primary care doctor or the gynaecologist. Anovulation without any medical illness or pelvic pathology seems to be the common cause. Bleeding due to a wide variation in pathology both inside and outside the reproductive tract can be termed as anovulatory bleeding. Therefore, it is mandatory to elicit a focused menstrual history and appropriate evaluation followed by a pelvic examination. This includes a vaginal speculum examination to differentiate anovulatory bleeding from other causes of bleeding. In contrast, Heavy menstrual bleeding (HMB) is referred to as an ovulatory bleeding exceeding 8 days duration and is often caused by uterine fibroids or adenomyosis, a copper IUD or coagulation disorders. PALM-COEIN classification is a system designed by the Federation Internationale de Gynaecologie et d'Obstetrique to define the precise underlying causes of AUB. Aetiology of AUB can be classified as the following acronym "PALM-COEIN": Polyp, Adenomyosis, Leiomyoma, Malignancy and hyperplasia, Coagulopathy, Ovulatory dysfunction, Endometrial, Iatrogenic and Not yet classified. AUB describes a range of symptoms, such as HMB, intermenstrual bleeding (IMB) and a combination of both heavy and prolonged menstrual bleeding (MB). Dysfunctional uterine bleeding (DUB) and menorrhagia are now better described as AUB. Newborn girls sometimes spot for a few days after birth, due to placental oestrogenic stimulation of the endometrium in utero.

Managing women-specific bleeding in inherited bleeding disorders: A multidisciplinary approach.

INTRODUCTION: Multidisciplinary management of women-specific bleeding is important to preserve quality of life, healthy reproduction and social participation of women and girls with bleeding disorders (WBD). AIM: To support appropriate multidisciplinary care for WBD in haemophilia treatment centres. METHODS: Two case examples are presented and management issues discussed from different health care perspectives, including the nurse, patient, psychologist, gynaecologist, geneticist, psychosexual therapist and haematologist. RESULTS: Woman with bleeding disorders may experience heavy menstruation from menarche onwards. This has a physical and psychosocial impact requiring a multidisciplinary approach. If a woman with an inherited bleeding disorder desires to become pregnant, preconception counselling is essential, to discuss genetic diagnosis, state of the art treatment options for the bleeding disorder in question and possible choices to prevent having an affected child, as well as maternal bleeding risks during conception, delivery and the post-partum period. CONCLUSION: Adequate management and good education of WBD requires a patient-centred multidisciplinary approach with experienced specialists in a haemophilia treatment centre.

Evaluating the effectiveness of let's talk period's high school educational outreach program: A pilot study.

INTRODUCTION: Menorrhagia impacts ~40% of adolescent females, with about half having an underlying bleeding disorder, most commonly von Willebrand Disease (VWD). VWD affects ~1 in 1000 individuals, though many are unaware of their condition. Let's Talk Period (LTP) is an online knowledge translation platform aimed at increasing awareness of bleeding disorders symptoms, with a validated self-administered bleeding assessment tool (Self-BAT). AIM: To evaluate the effectiveness of the LTP high school outreach program in Grade 9 girls' health classes quantitatively, using baseline, post-presentation, and follow-up quiz scores, and qualitatively, with student and teacher feedback forms. METHODS: The 75-minute in-class presentations, developed in alignment with the 2015 Ontario Curriculum for Grade 9 Health and Physical Activity, were led by a haemophilia nurse, clinical research assistant, and undergraduate student from the LTP team. Students completed baseline, post-presentation, and 4-6-week follow-up Kahoot quizzes featuring the same nine questions to evaluate change in knowledge levels and retention. Both student and teacher feedback were collected. RESULTS: There was a significant increase (p < 0.001) from baseline to post-presentation scores, with a significant gain in knowledge, for all questions (p < 0.01). Students found content related to the basics and management of menstruation to be most interesting. Many had constructive feedback on how the presentation method could be improved. On average, the presentations were rated an 8.6 of 10 by students and 8.75 of 10 by teachers. CONCLUSION: The LTP high school outreach program effectively increases student knowledge of menorrhagia and bleeding disorders. It was well-received by students and staff alike.

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding. OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding. STUDY DESIGN: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function. RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups. CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.

The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. METHODS: Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point. CONCLUSIONS: A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept. TWEETABLE ABSTRACT: Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.

The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: A systematic review.

INTRODUCTION: Despite endometrial ablation/resection being a very successful treatment for women with heavy menstrual bleeding, re-intervention with additional surgery is needed in 12%-25% of cases. Introducing a levonorgestrel-intrauterine system (LNG-IUS) immediately after ablation could preserve the integrity of the uterine cavity and suppress the regenerated or non-ablated endometrial tissue. Therefore, this combined treatment can perhaps lower the re-intervention rate. The aim of this systematic review was to assess the impact of the combined treatment. MATERIAL AND METHODS: The MEDLINE, EMBASE, and Cochrane library were systematically searched. No language restrictions were applied. All types of studies were included reporting on the results of endometrial ablation or resection combined with immediate insertion of LNG-IUS for treatment of heavy menstrual bleeding. The primary outcome was the number of hysterectomies after the ablation procedure. Secondary outcomes included re-intervention rates, removals of LNG-IUS, bleeding pattern, patient satisfaction, adverse effects, and complications. Our protocol was registered in PROSPERO, an international prospective register of systematic reviews under registration number CRD42020151384. RESULTS: Six studies with a retrospective design and one case series with a follow-up duration varying from 6 to 55 months were included. In total, 427 women were treated with the combined treatment. The studies described a lower hysterectomy and re-intervention rate after combined treatment compared with treatment with endometrial ablation/resection alone. Hysterectomy rate varied from 0% to 11% after combined treatment compared with 9.4% to 24% after endometrial ablation/resection alone. Bleeding patterns and patient satisfaction appeared to be in favor of the combined treatment group. No intra- or post-operative complications or complications in the removal of LNG-IUS were described. The most reported adverse effects after combined treatment were weight gain, mood changes, and headaches. An additional 11 studies with only an abstract available substantiated these findings. All the included studies had poor methodological quality. CONCLUSIONS: Based on the available literature, inserting an LNG-IUS immediately after endometrial ablation/resection seems to lower the hysterectomy and re-intervention rates compared with ablation/resection alone. However, as only limited observational studies of low methodological quality are available, high-quality research is necessary to confirm the findings of this systematic review.

Evaluation and management of heavy menstrual bleeding in adolescents: the role of the hematologist.

Heavy menstrual bleeding (HMB) is frequently reported by adolescents. The role of the hematologist is threefold in the evaluation of such patients: 1) perform a clinical and laboratory evaluation for an underlying bleeding disorder based on the degree of clinical suspicion, 2) identify and manage any concomitant iron deficiency, and 3) provide input to the referring provider regarding the management of HMB, particulary for patients with identified hemostatic defects. Several clues in the menstrual history should raise suspicion for an underlying bleeding disorder, such as menses lasting >7 days, menstrual flow which soaks >5 products daily or requires product change during the night, passage of large blood clots, or failure to respond to conventional therapies. A detailed personal and family history of other bleeding symptoms should also be obtained. Iron deficiency with and without anemia is commonly found in young women with HMB. Therefore, it is important to obtain not only a hemoglobin, but also a ferritin level, when evaluating these patients. Iron supplementation is often a key component of management in the adolescent with heavy menses, and is still needed even in those who have received packed red cell transfusions due to severe anemia. Strategies for decreasing menstrual blood flow are similar between adults and adolescents with heavy menses, with combined hormonal contraceptives recommended as first-line therapy. However, adolescent-specific considerations exist for many of these agents, and must be incorporated into shared decision making when selecting the most appropriate treatment.

Clinical management of woman with bleeding disorders: A survey among European haemophilia treatment centres.

INTRODUCTION: The impact of bleeding for women with bleeding disorders (WBD) is of increasing focus and importance. Despite this, optimal management strategies are unclear and knowledge gaps persist. AIM: To examine practices and define research priorities on diagnosis and management of WBD in Europe. METHODS: An electronic survey on clinical management of WBD was sent to 136 European haemophilia treatment centres (HTCs), including open questions on knowledge gaps and research priorities. RESULTS: Fifty-nine HTCs from 12 Western (WE) and 13 Central/Eastern European (CEE) countries completed the survey. Less than half runs a joint clinic (24 HTCs, 42%). Most centres without a joint clinic have a named obstetrician (81%) and/or gynaecologist (75%) available for collaboration. Overall 18/54 (33%) European HTCs do not offer preimplantation genetic diagnosis. Third trimester amniocentesis to guide obstetric management is available 28/54 HTCs (52%), less frequent in CEE compared to WE countries (5/17 vs 23/37, P = .03). 53% of HTCs (28/53) reported that only 0%-25% of WBD seek medical advice for heavy menstrual bleeding (HMB). An algorithm managing acute HMB in WBD is lacking in 22/53 (42%) HTCs. The main reported knowledge and research gaps are lack of awareness & education on WBD among patients and caregivers, optimal diagnostic strategies and effective multidisciplinary management of pregnancy & HMB. CONCLUSION: Joint clinics, prenatal diagnostics and algorithms for managing acute HMB are lacking in many European HTCs. HMB may be an underestimated issue. This survey highlights the need to prioritize improvement of knowledge and patient care for WBD across Europe.

Combined transcervical endometrial resection and levonorgestrel device treatment compared to transcervical endometrial resection for abnormal uterine bleed.

INTRODUCTION: Transcervical resection of the endometrium (TCRE) is a first-line surgical treatment of abnormal uterine bleeding. However, many women experience unsuccessful results, causing hysterectomy in up 17% of cases. The aim of this study was to describe the odds of hysterectomy in women with abnormal uterine bleeding, treated with TCRE and levonorgestrel intrauterine contraceptive device (TCRE + LNG-IUCD) or TCRE alone. The secondary aim was to analyze the rate of amenorrhea. MATERIAL AND METHODS: Designed as a retrospective cohort study, and conducted at Odense University Hospital, Denmark, the study included women with abnormal uterine bleeding, who underwent TCRE from January 2013 to December 2015. The decision of treatment with respect to LNG-IUCD was at the woman's discretion. Data were collected from medical records and a self-reported retrospective bleeding-pattern questionnaire. A multivariate regression model was used, enabling adjustment for potential and identified confounders. RESULTS: Out of 432 women, 276 (62%) consented to inclusion and of these, 16 (4%) were excluded. In total 88 (34%) received combined treatment and 172 (66%) received TCRE alone. Ten women (11%) treated with TCRE + LNG-IUCD underwent hysterectomy, compared with 27 (16%) treated with TCRE alone (OR = 0.69, 95% CI 0.28-1.56; P = .34). Multivariate analysis disclosed a significant effect of TCRE + LNG-IUCD (OR = 0.35, 95% CI 0.13-0.97; P = .04) on hysterectomy. The presence of fibromas was shown to increase the odds of treatment failure, resulting in hysterectomy (OR 2.69, 95% CI 1.15-6.31; P = .02). Furthermore, the incidence of amenorrhea was 59% in the TCRE + LNG-IUCD group and 36% in the TCRE alone group (OR = 2.56, 95% CI 1.46-4.49; P < .01). CONCLUSIONS: The study showed significantly lower odds of hysterectomy in the TCRE + LNG-IUCD group when adjusted for confounders. Combination treatment improves the bleeding patterns significantly compared with monotherapy with TCRE.

HMB in the Adolescent: A Review of the Modern Approach to Diagnosis and Management.

Heavy menstrual bleeding in the adolescent is a cause for concern whether occurring acutely or chronically. There are a number of important considerations during the initial presentation that will help guide the practitioner during workup, which ultimately guides management strategies. The cornerstone of management in the adolescent is that of medical therapy (hormonal and nonhormonal), with avoidance of invasive and irreversible measures, as maintenance of fertility is paramount. Ultimately, the majority of adolescents can be successfully managed in the acute setting and transitioned to maintenance therapy for long-term control of heavy menses. Here, we will review the modern approach to this condition as well as tips and tricks for the practitioner.

Optimising the two-stage randomised trial design when some participants are indifferent in their treatment preferences.

Outcomes in a clinical trial can be affected by any underlying preferences that its participants have for the treatments under comparison and by whether they actually receive their preferred treatment. These effects cannot be evaluated in standard trial designs but are estimable in the alternative two-stage randomised trial design, in which some patients can choose their treatment, while the rest are randomly assigned. We have previously shown that, when all two-stage trial participants have a preferred treatment, the preference effects can be evaluated, in addition to the usual direct effect of treatment. We also determined criteria by which to optimise how many participants should be given a choice of treatment vs being randomised. More recently, we extended our methodology to allow for participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group. In this paper, we show how to optimise the two-stage design when some participants are undecided about their treatment. We demonstrate that the undecided group should be regarded as distinct in the analysis, to obtain valid estimates of the preference effects. We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%. More generally, the optima depend on the preference rates for treatments and the proportion of undecided participants, and the parameters of primary interest. We discuss some advantages and disadvantages of the two-stage trial design in this situation and describe a practical example.

Current practices in menstrual management in adolescents with cancer: A national survey of pediatric oncology providers.

BACKGROUND: Adolescents and young adult (AYA) women with cancer are at risk of heavy menstrual bleeding (HMB) due to thrombocytopenia, coagulopathy, and/or disruption of the hypothalamic-pituitary-gonadal axis. Currently, little is known about current practices to help prevent and treat HMB in AYA women with cancer. METHODS: We surveyed providers from 100 pediatric oncology centers. Face and content validity were assessed prior to distribution. Descriptive statistics, Chi-squared and Fisher exact tests were used for analysis. RESULTS: Ninety-four percent of respondents have recommended preventative menstrual suppression. More than half of respondents agreed that patients with the following types of cancers should receive preventative menstrual suppression: sarcomas, acute leukemias, lymphomas, and germ cell tumors. The most preferred form of menstrual suppression was GnRH agonists. Almost 95% of respondents felt that it is important to consider menstrual suppression and that a formal guideline about initiation of menstrual suppression would be helpful. Only 46% felt comfortable personally managing menstrual suppression. CONCLUSIONS: The vast majority of pediatric oncologists who responded to this national survey have used preventative menstrual suppression and feel that it is important to consider in many types of AYA cancers. Although pediatric oncologists are most often managing menstrual suppression, they do not feel comfortable doing so and desire guidelines to help with management. Future studies to assess which patients require menstrual suppression and which menstrual suppression is best tolerated and efficacious is needed.