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1.
Haemophilia ; 30(2): 490-496, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38385952

RESUMO

INTRODUCTION: There are a significant number of patients with mucocutaneous bleeding, specifically heavy menstrual bleeding (HMB), who do not have a diagnosed bleeding disorder. These patients receive nontargeted interventions and may have suboptimal treatments. Functional assays, particularly for fibrinolytic and rare platelet function defects, are not robust and not readily available. AIM: We aimed to prospectively evaluate the prevalence of genetic defects associated with rare bleeding disorders and describe alterations of coagulation and fibrinolysis in a cohort of adolescents with HMB. METHODS: We performed a prospective observational cohort study of patients with HMB and unexplained bleeding. The study utilized a next generation sequencing panel and investigational global assays of coagulation and fibrinolysis. Additionally, specific functional assays were performed to help characterize novel variants that were identified. RESULTS: In 10 of the 17 patients (∼59%), genetic variants were identified on molecular testing. Thrombin generation by calibrated thromboelastography was not significantly altered in this patient population. The clot formation and lysis assay showed a trend towards increased fibrinolysis with rapid phase of decline in 23% of the patients. Further corresponding functional assays and study population are described. CONCLUSION: Our study describes a unique correlative model in a homogenous cohort of patients with HMB and unexplained bleeding which may inform future diagnostic algorithms, genotype-phenotype correlations as well as aid in specific targeted treatment approaches. Larger future studies may inform risk stratification of patients and improve health related outcomes in patients with HMB.


Assuntos
Transtornos da Coagulação Sanguínea , Transtornos Hemorrágicos , Menorragia , Feminino , Humanos , Adolescente , Menorragia/complicações , Estudos Prospectivos , Hemorragia/complicações , Transtornos da Coagulação Sanguínea/diagnóstico , Transtornos Hemorrágicos/epidemiologia
2.
J Pediatr Adolesc Gynecol ; 37(2): 137-141, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38122960

RESUMO

STUDY OBJECTIVE: YouTube, the largest accessible media-sharing platform, has become an important tool for pursuing health-related information. Adolescents may find it challenging to seek counseling or access adolescent-friendly services for menstruation-related problems, so YouTube may be a useful resource. The aim of this study was to examine the reliability, quality, and accuracy of YouTube videos concerning abnormal uterine bleeding in adolescents. METHODS: A YouTube search using the key words "adolescent, teens, heavy period, abnormal uterine bleeding, heavy menstrual bleeding" yielded 109 videos. Video features (duration, time since upload, likes, views, comments), sources of upload, and content were recorded. All the videos were reviewed by 2 adolescent medicine specialists and scored using the Journal of the American Medical Association, the 5-point modified DISCERN tool, and the Global Quality Scale. RESULTS: Fifty-eight videos met the inclusion criteria. Most (62.1%) were created by non-professionals, and a significant portion (81%) contained general descriptions. On the basis of the DISCERN classification, 50% exhibited poor quality. Similarly, the Journal of the American Medical Association assessment indicated that only 36.2% satisfied the requirements for good quality. The videos uploaded by professionals exhibited notably superior quality in comparison with those uploaded by non-professionals. Additionally, higher-quality videos were longer (P = .040) and more recent (P = .011). CONCLUSION: Mot YouTube videos about adolescent abnormal uterine bleeding provide low-quality information. We believe that increasing the number of videos tailored by health care providers specializing in adolescent gynecology to address the specific physical and psychosocial needs of adolescents with menstrual problems would be beneficial.


Assuntos
Menorragia , Mídias Sociais , Doenças Uterinas , Estados Unidos , Feminino , Adolescente , Humanos , Reprodutibilidade dos Testes , Hemorragia , Emoções , Distúrbios Menstruais
3.
Health Technol Assess ; 27(17): 1-50, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37924269

RESUMO

Background: Heavy menstrual bleeding is a common problem that can significantly affect women's lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding. Objectives: To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women. Design: This was a prospective observational cohort study, with a parallel qualitative study. Setting: Primary care. Participants: A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews. Interventions: The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment. Main outcome measures: The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women's experiences of heavy menstrual bleeding; and the influences on their decisions around treatment. Results: Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, n = 34 (17%); endometrial ablation, n = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women's treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status. Limitations: Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population. Conclusions: Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context. Future work: Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence. Trial registration: The original ECLIPSE trial was registered as ISRCTN86566246. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 17. See the NIHR Journals Library website for further project information.


Heavy menstrual bleeding is a common problem that can significantly affect women's lives, yet many women do not seek medical help. Medical treatments, such as tablets and a hormonal coil inserted in the womb, were shown to help women with heavy menstrual bleeding in a previous clinical trial that we conducted, called ECLIPSE. In the ECLIPSE trial, women provided information for 5 years after their treatment started. We planned to continue to ask these women about their periods, their symptoms and quality of life, and the treatments that they chose about 10 years after they first joined the trial. We did this using questionnaires and by interviewing women. We received questionnaires from 206 out of the 490 women (42%) who had participated in the ECLIPSE trial 10 years earlier. Responders were, on average, 54 years old, and half reported that they had reached the menopause. About 3 in 10 women overall had either received a hysterectomy or undergone destruction of the womb lining. Just over one-quarter of women were using the hormonal coil. Quality of life remained improved and was generally higher than that before treatment. There was no big difference in quality of life or in the numbers of women having surgery between those who first used tablets and those who received the coil. Women described the wide-ranging impact of heavy bleeding on their lives and the taboo around periods. Women's experience of good or poor communication with their doctors, and thoughts about fertility and menopause, influenced the treatment choices that they made. Women's quality of life was improved by medical treatments for heavy menstrual bleeding, even as menopause approached, and this shows the importance of these treatments. This research can help doctors and women to make more informed decisions about medical and surgical treatments.


Assuntos
Dispositivos Intrauterinos Medicados , Menorragia , Feminino , Humanos , Pessoa de Meia-Idade , Seguimentos , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Menorragia/cirurgia , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
J Obstet Gynaecol Res ; 49(7): 1838-1845, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37141923

RESUMO

AIM: Many women with inherited bleeding disorders are not diagnosed because of a lack of appropriate indicators. This study aimed to assess the predictability of the pictorial blood loss assessment chart (PBAC) as an indicator of menorrhagia and identify an easy indicator of menorrhagia resulting from bleeding disorders. METHODS: A multicenter study enrolled 9 patients with von Willebrand disease (VWD), 23 hemophilia carriers, and 71 controls aged 20-45 years who completed PBACs for two menstrual cycles as well as questionnaires. RESULTS: The PBAC scores of the VWD were significantly higher than those of other groups, even in multivariate analysis with age and sanitary item factors (p = 0.014). A PBAC score of 100 was not an appropriate cutoff because of its low specificity (VWD: sensitivity, 100; specificity, 29.5; hemophilia carriers: 74 and 29.5, respectively). In the ROC analysis, the cutoff of optimal PBAC for VWD was 171 (sensitivity, 66.7; specificity, 72.3; AUC, 0.7296). As the pad length increased, the total length of the pads used during one menstrual period could be a new and easy indicator. However, the cutoff for VWD was 735 cm (sensitivity, 42.9; specificity, 94.3; AUC 0.6837). A threshold could not be established for the hemophilia carrier. Therefore, we multiplied the coefficient by the length of thick pads, which caused a lower PBAC. For the VWD, the sensitivity increased to 85.7 (specificity, 77.1). For the hemophilia carrier, sensitivity (66.7) and specificity (88.6) could be separated from the control. CONCLUSIONS: The total length of the pads with a thick-pad adjustment can be a simple method to identify bleeding disorders.


Assuntos
Hemofilia A , Menorragia , Doenças de von Willebrand , Feminino , Humanos , Hemofilia A/complicações , Hemorragia , Menorragia/diagnóstico , Menorragia/etiologia , Inquéritos e Questionários , Doenças de von Willebrand/complicações , Adulto , Pessoa de Meia-Idade
5.
Turk J Pediatr ; 65(2): 301-308, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37114695

RESUMO

BACKGROUND: Heavy menstrual bleeding (HMB) is a common condition in adolescents. However, bleeding disorders are known to be one of the causes of HMB in adolescent girls, so they should be considered. Simple methods that can be used in primary health care are needed to determine whether patients have bleeding disorders. The aim of this study was to evaluate the bleeding score of patients admitted with HMB and to determine the diagnostic value of patients who were symptomatic but whose initial hemostatic tests were normal. METHODS: A total of 113 adolescents with HMB and 20 healthy adolescent girls were included in the study. The Pediatric Bleeding Questionnaire (PBQ) and the International Society of Thrombosis Haemostasis-Bleeding Assessment Tool (ISTH-BAT) were used for evaluation. RESULTS: Overall, approximately 18% (n= 20) of the adolescents in the study were diagnosed with a bleeding disorder. The cut off value for the `clinically significant bleeding score` was found to be 3.5. CONCLUSIONS: The PBQ and ISTH-BAT can help distinguish a significant bleeding history from an otherwise trivial bleeding and can be included in the algorithm for the primary care of adolescents with HMB with suspected bleeding disorders.


Assuntos
Menorragia , Trombose , Feminino , Humanos , Criança , Adolescente , Menorragia/diagnóstico , Menorragia/etiologia , Hemostasia , Trombose/diagnóstico , Inquéritos e Questionários
6.
Haemophilia ; 29(2): 411-422, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36097135

RESUMO

INTRODUCTION: Debilitating clinical complications in von Willebrand disease (VWD) can affect health-related quality of life (HRQoL), increase healthcare costs and cause long-lasting consequences. However, the magnitude of these burdens needs to be more fully explored. AIM: To estimate the prevalence and burden of clinical complications, the impact on HRQoL and the economic burden associated with VWD. METHODS: Embase® , MEDLINE® , the Cochrane Library and conference proceedings were searched for studies on VWD evaluating clinical complications, HRQoL and cost and resource use. RESULTS: Among 16 studies assessing clinical complications in VWD, the most prevalent bleeding symptoms were menorrhagia (2%-95% [n = 7 studies]), epistaxis (12%-80% [n = 6]) and easy bruising (46%-65% [n = 2]). Among 17 studies evaluating HRQoL, the most common assessment scales were the generic SF-36 (n = 8 studies) and the EQ-5D (n = 2). Bleeding symptoms were associated with reduced QoL in six of seven studies, and of six studies evaluating treatment impact, four reported improvements in one or more HRQoL components. Among 25 studies on cost and resource use, key observations included higher post-surgery healthcare costs in VWD versus non-VWD patients (n = 1 study) and higher costs and resource use in VWD patients with bleeding complications versus those without (n = 1). CONCLUSION: Although limited, available evidence suggests that VWD patients experience a high burden of clinical complications, reduced QoL and high healthcare costs. Haemarthrosis is more common in severe VWD than is often assumed, and bleeds (including haemarthrosis) can reduce QoL. Research efforts to improve QoL and other outcomes should be prioritized.


Assuntos
Menorragia , Doenças de von Willebrand , Feminino , Humanos , Adulto , Criança , Doenças de von Willebrand/complicações , Doenças de von Willebrand/epidemiologia , Doenças de von Willebrand/diagnóstico , Hemartrose/complicações , Qualidade de Vida , Menorragia/complicações , Epistaxe , Fator de von Willebrand/uso terapêutico
7.
Pediatr Emerg Care ; 38(5): e1266-e1270, 2022 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-35482504

RESUMO

OBJECTIVE: Iron deficiency is extremely common in adolescents with heavy menstrual bleeding (HMB) presenting to the emergency department; however, patients are rarely screened for this. The objective of this study was to evaluate screening for iron deficiency in adolescents presenting to the emergency department for HMB. METHODS: This is a secondary analysis of a single-center, cross-sectional observational study using retrospective chart review. The study subjects are adolescents ages 11 to 19 years with International Classification of Diseases, Ninth Revision, Clinical Modification/International Classification of Diseases, Tenth Revision, Clinical Modification, codes for HMB who presented to the emergency department at a national tertiary care hospital from 2006 to 2018. Pregnant adolescents with HMB were excluded. Chart abstraction for demographic data, symptoms, laboratory tests, treatments, and outcomes was performed. The main outcome measure was the number of adolescents who had an iron evaluation in the emergency department and were discharged on oral iron. RESULTS: Of the 258 nonpregnant adolescents who sought care for HMB in the emergency department, 225 (87.2%) were evaluated with serum hemoglobin testing. Ninety-four (41.7%) of those tested were anemic. Only 23 of the 258 patients (8.9%) had iron studies (serum ferritin) performed; 18 of 23 (78.3%) had iron deficiency and 21 of 23 (92.3%) were anemic. Subjects presenting with fatigue, headache, or palpitations were more likely to have iron studies performed than those without these symptoms (all P < 0.01). Thirty-two of the 258 subjects (12.4%) were discharged on oral iron therapy, which included only 15 of the 18 subjects (83.3%) with iron deficiency determined by ferritin testing. CONCLUSIONS: Adolescents presenting to the emergency department with HMB are at significant risk of iron deficiency but are not being screened or treated, which may have significant consequences.


Assuntos
Anemia , Deficiências de Ferro , Menorragia , Adolescente , Anemia/complicações , Criança , Estudos Transversais , Serviço Hospitalar de Emergência , Feminino , Ferritinas , Humanos , Ferro/uso terapêutico , Menorragia/diagnóstico , Menorragia/epidemiologia , Menorragia/etiologia , Estudos Retrospectivos , Adulto Jovem
8.
Br J Haematol ; 196(1): 215-223, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34536019

RESUMO

Congenital platelet disorders (CPDs) are rare bleeding disorders that are associated with mucocutaneous bleeds. However, data on vaginal bleeding in women with CPDs are scarce. A set of generic and bleeding-specific questionnaires were used to evaluate the prevalence of vaginal bleeding, its impact on quality of life (QoL) and sexual functioning and the consequences for pregnancy, miscarriage and delivery in a cohort of women who were referred for diagnostic evaluation for CPDs. A total of 78 women included in the study were either diagnosed with a CPD (n = 35) or were clinically suspected of a CPD (n = 43). Heavy menstrual bleeding (HMB) was reported by a large proportion of women, which mainly started at menarche. In all, 76% of women received any kind of HMB treatment, often leading to surgical prodecures. HMB was shown to have a high impact on QoL, which improved upon treatment. Even though women reported that vaginal bleeding affects sexuality, this topic is not frequently discussed with physicians. Heavy blood loss frequently occurred after miscarriage/delivery, often requiring treatment. Women with (suspected) CPDs frequently encounter HMB, negatively impacting daily life and sexual functioning. Together with peripartum bleeding, these data highlight the burden of vaginal bleeding in CPDs and importance of adequate treatment.


Assuntos
Transtornos Plaquetários/complicações , Transtornos Plaquetários/epidemiologia , Hemorragia Uterina/epidemiologia , Hemorragia Uterina/etiologia , Adulto , Idade de Início , Transtornos Plaquetários/etiologia , Efeitos Psicossociais da Doença , Estudos Transversais , Gerenciamento Clínico , Suscetibilidade a Doenças , Feminino , Humanos , Menorragia , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Prevalência , Vigilância em Saúde Pública , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento , Hemorragia Uterina/diagnóstico , Hemorragia Uterina/terapia
9.
J Womens Health (Larchmt) ; 31(6): 856-863, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-34591695

RESUMO

Background: Heavy menstrual bleeding (HMB) is one of the most common distressing complications of uterine fibroids (UF); however, data on the health care costs for treatments in women experiencing HMB associated with UF are lacking. The objective of this study was to compare the direct costs and treatments patterns for women diagnosed with UF+HMB, UF only, and HMB only in the United States. Materials and Methods: The study design was retrospective matched cohort study using claims data. Women, aged 18-51 years, comprising four cohorts (HMB only, UF only, UF+HMB, and controls) were identified in the IBM MarketScan® Commercial Claims and Encounters Database (October 1, 2007‒September 30, 2018) and matched by demographics and Charlson Comorbidity Index score. Baseline characteristics and treatments during the 12 months post-diagnosis were summarized descriptively. Costs (2018 U.S. dollars) during the post-diagnosis year were compared using analysis of variance. Results: Before matching, women with UF+HMB represented 54% of UF cases. Following diagnosis, 32% in the matched UF+HMB cohort had no treatment, 49% underwent surgeries/procedures with (12%) or without (37%) medications, and 18% received medications only. The mean all-cause total costs for UF+HMB ($16,762) exceeded that for UF only by 24% ($13,506) and HMB only by 50% ($11,135), and almost tripled the mean cost for the control cohort ($6,691) (all, p < 0.001). The mean diagnosis-related costs were significantly higher for UF+HMB ($8,741) than for UF only ($4,550) and HMB only ($3,081) (all, p < 0.0001). Surgery/procedure costs comprised 80% of diagnosis-related medical costs for UF+HMB. Conclusions: UF with HMB were associated with significant economic burden, driven primarily by surgical/procedural costs and treatment patterns.


Assuntos
Leiomioma , Menorragia , Estudos de Coortes , Feminino , Custos de Cuidados de Saúde , Humanos , Revisão da Utilização de Seguros , Leiomioma/complicações , Leiomioma/terapia , Menorragia/tratamento farmacológico , Menorragia/terapia , Estudos Retrospectivos , Estados Unidos/epidemiologia
10.
Hong Kong Med J ; 27(6): 399-404, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34949729

RESUMO

INTRODUCTION: Heavy menstrual bleeding is a common gynaecological problem, but some women may prefer not to articulate their menstrual problems. The objective of this study was to evaluate the usefulness and acceptability of the Pictorial Blood Loss Assessment Chart (PBAC) as a selfscreening tool in evaluation of menstrual blood loss among Asian women in Hong Kong. METHODS: This prospective cohort study recruited 206 women from the general gynaecology ward and out-patient clinic: 118 had self-perceived heavy menstrual bleeding and 88 had self-perceived normal menstrual flow. Participants were asked to fill in the PBAC for one menstrual cycle. RESULTS: Compared with women who had self-perceived normal menstrual flow, women with self-perceived heavy menstrual bleeding had significantly higher total PBAC scores and numbers of flooding episodes, larger clot sizes and numbers, more days of bleeding, and lower haemoglobin levels. Receiver-operating characteristic curve analysis demonstrated good pairwise associations of self-perceived symptoms with PBAC score and haemoglobin level. CONCLUSIONS: The PBAC can be used to differentiate self-perceived heavy and normal menstrual bleeding in Asian women in Hong Kong. It can also serve as an additional indicator of possible heavy menstrual bleeding to alert women of the need to seek early medical attention.


Assuntos
Menorragia , Feminino , Hong Kong , Humanos , Menorragia/diagnóstico , Estudos Prospectivos
11.
J Gynecol Obstet Hum Reprod ; 50(10): 102229, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34520876

RESUMO

BACKGROUND: This economic evaluation and literature review was conducted with the primary aim to compare the cost-effectiveness of laparoscopic assisted supracervical hysterectomy (LASH) with NICE's gold-standard treatment of Levonorgestrel-releasing intrauterine system (LNG-IUS) for menorrhagia. MATERIALS AND METHODS: A cost-utility analysis was conducted from an NHS perspective, using data from two European studies to compare the treatments. Individual costs and benefits were assessed within one year of having the intervention. An Incremental Cost-Effectiveness Ratio (ICER) was calculated, followed by sensitivity analysis. Expected Quality Adjusted Life Years (QALYS) and costs to the NHS were calculated alongside health net benefits (HNB) and monetary net benefits (MNB). RESULTS: A QALY gain of 0.069 was seen in use of LNG-IUS compared to LASH. This yielded a MNB between -£44.99 and -£734.99, alongside a HNB between -0.0705 QALYs and -0.106 QALYS. Using a £20,000-£30,000/QALY limit outlined by NICE,this showed the LNG-IUS to be more cost-effective than LASH, with LASH exceeding the upper bound of the £30,000/QALY limit. Sensitivity analysis lowered the ICER below the given threshold. CONCLUSIONS: The ICER demonstrates it would not be cost-effective to replace the current gold-standard LNG-IUS with LASH, when treating menorrhagia in the UK. The ICER's proximity to the threshold and its high sensitivity alludes to the necessity for further research to generate a more reliable cost-effectiveness estimate. However, LASH could be considered as a first line treatment option in women with no desire to have children.


Assuntos
Histerectomia/economia , Dispositivos Intrauterinos/economia , Levanogestrel/normas , Menorragia/cirurgia , Análise Custo-Benefício/métodos , Análise Custo-Benefício/estatística & dados numéricos , Feminino , Humanos , Histerectomia/métodos , Histerectomia/estatística & dados numéricos , Dispositivos Intrauterinos/estatística & dados numéricos , Laparoscopia/economia , Laparoscopia/métodos , Laparoscopia/estatística & dados numéricos , Levanogestrel/economia , Levanogestrel/farmacologia , Menorragia/economia , Qualidade de Vida/psicologia , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal/organização & administração , Medicina Estatal/estatística & dados numéricos
12.
BJOG ; 128(12): 2003-2011, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34245652

RESUMO

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.


Assuntos
Técnicas de Ablação Endometrial/economia , Dispositivos Intrauterinos Medicados/economia , Levanogestrel/economia , Menorragia/economia , Menorragia/terapia , Adulto , Análise Custo-Benefício , Feminino , Humanos , Levanogestrel/administração & dosagem , Países Baixos , Resultado do Tratamento
14.
Eur J Contracept Reprod Health Care ; 26(5): 390-398, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34047657

RESUMO

PURPOSE: Up to 30% of women of reproductive age experience HMB, which has a substantial impact on their quality of life. A clinical care pathway for women with HMB is an unmet need, but its development requires better understanding of the factors that characterise current diagnosis and management of the condition. MATERIALS AND METHODS: This observational, survey-based study assessed the burden, personal experiences, and path through clinical management of women with HMB in Canada, the USA, Brazil, France and Russia using a detailed, semi-structured online questionnaire. After excluding those reporting relevant organic pathology, responses to the questionnaire from 200 women per country were analysed. RESULTS: Around 75% of women with HMB had actively sought information about heavy periods, mostly through internet research. The mean time from first symptoms until seeking help was 2.9 (Standard deviation, 3.1) years. However, 40% of women had not seen a health care professional about the condition. Furthermore, 54% had never been diagnosed or treated. Only 20% had been diagnosed and received appropriate treatment. Treatment was successful in 69% of those patients currently receiving treatment. Oral contraceptives were the treatment most commonly prescribed for HMB, although the highly effective levonorgestrel-intrauterine system was used by only a small proportion of women. CONCLUSIONS: This study provides insight into the typical journey of a woman with HMB which may help patients and health care professionals improve the path to diagnosis and treatment, although further research with long-term outcomes is needed.


Assuntos
Contracepção Hormonal/métodos , Levanogestrel/uso terapêutico , Menorragia/tratamento farmacológico , Qualidade de Vida/psicologia , Adolescente , Adulto , Anticoncepcionais Orais/administração & dosagem , Diagnóstico Tardio , Feminino , Acessibilidade aos Serviços de Saúde , Inquéritos Epidemiológicos , Humanos , Levanogestrel/administração & dosagem , Menorragia/psicologia , Pessoa de Meia-Idade , Inquéritos e Questionários , Resultado do Tratamento
15.
J. bras. econ. saúde (Impr.) ; 12(3): 264-272, Dezembro/2020.
Artigo em Português | ECOS, LILACS | ID: biblio-1141360

RESUMO

Objetivo: Definir um limiar de custo para o sistema intrauterino liberador de levonorgestrel 52 mg (SIU-LNG 52 mg) para o tratamento do sangramento uterino anormal (SUA) sob a perspectiva do Sistema de Saúde Suplementar brasileiro. Métodos: Foi elaborado um modelo de custo-efetividade para definir o limiar de custo de inserção de SIU-LNG 52 mg em mulheres com SUA em comparação à histerectomia. Um modelo de Markov foi estruturado com ciclos anuais para reproduzir o tratamento do SUA em um e cinco anos, considerando custos médicos diretos e o percentual de histerectomias evitadas como desfecho. O custo da histerectomia foi variado até o valor de 10.000 reais brasileiros (BRL) com incrementos de 500 BRL a cada nova simulação para avaliar o limiar de custo do SIU-LNG 52 mg para igualar o custo total de tratamento de ambas as estratégias analisadas. Resultados: O SIU-LNG 52 mg demonstrou ser uma opção de tratamento dominante quando comparada à histerectomia, levando à redução da frequência de realização do procedimento cirúrgico em 59,62% das mulheres e redução de 2.557,91 BRL no custo total de tratamento em cinco anos. Ao considerar a histerectomia a 6.000 BRL, o custo do procedimento com SIU-LNG 52 mg poderia ser de até 6.150,35 BRL e 3.994,60 BRL para igualar o custo total de tratamento, em horizontes temporais de um e cinco anos, respectivamente. Conclusão: SIU-LNG 52 mg demonstrou ser uma opção dominante para o manejo do SUA, sendo capaz de atrelar economia para o sistema de saúde a benefícios para a mulher perante a cirurgia.


Objective: To define a cost threshold for the use of levonorgestrel-releasing intrauterine system 52 mg (LNG-IUS 52 mg) for the treatment of heavy menstrual bleeding (HMB) in the Brazilian Supplementary Health System perspective. Methods: A cost-effectiveness model was built to define the cost threshold for insertion of LNG-IUS 52 mg considering women with diagnosis of HMB as the target population and hysterectomy as the comparator. A Markov model was structured with annual cycles to reproduce HMB treatment in 1 and 5 years, considering direct medical costs and the percentage of avoided hysterectomies as the outcome. Hysterectomy cost was varied up to 10,000 Brazilian real (BRL) with increments of 500 BRL at each new simulation to define LNG-IUS 52 mg cost threshold, to provide equal total treatment costs for both strategies. Results: LNG-IUS 52 mg proved to be a cost-saving option when compared to hysterectomy, leading to a reduction in the frequency of the surgical procedure by 59.62% and a total treatment cost reduction of 2,557.91 BRL in 5 years. When considering hysterectomy at 6,000 BRL, the cost of the procedure with LNG-IUS 52 mg could be up to 6,150.35 BRL and 3,994.60 BRL to provide equal total treatment cost in 1 and 5 years time horizon, respectively. Conclusion: LNG-IUS 52 mg has proven to be a cost-saving option for the health system in the management of HMB, in addition to the known benefits for women against surgery.


Assuntos
Levanogestrel , Custos e Análise de Custo , Saúde Suplementar , Dispositivos Intrauterinos , Menorragia
16.
JBI Evid Implement ; 19(2): 190-197, 2020 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-32604392

RESUMO

AIM: The aim of this evidence implementation project is to make a contribution to promoting evidence-based practice in the assessment and management of women with heavy menstrual bleeding (HMB) attending the gynaecology outpatient clinic at Kenyatta National Hospital (KNH) and thereby improve patient outcomes and resource utilization. METHODS: The evidence implementation project was carried out at the gynaecology outpatient clinic of the largest referral facility in Kenya. The Joanna Briggs Institute Practical Application of Clinical Evidence System and Getting Research into Practice audit and feedback tool were used. A baseline audit was conducted using a sample of 40 patient files; this was followed by interventions such as trainings, developing of visual tools and updating of protocols. A follow-up audit was then conducted 4 months post intervention. RESULTS: Baseline audit results demonstrated varying results in each of the nine criteria selected. Four of the criteria recorded less than 51% compliance, with two of these recording 0% compliance. Postintervention results showed a remarkable increase in most of the audit criteria selected, with eight of these having compliance levels of 90% or more. CONCLUSION: The implementation project served the dual purpose of enlightening health care workers on best practices and educating patients on what they need to know about their condition. This led to an overall improvement in the management of HMB.


Assuntos
Fidelidade a Diretrizes/estatística & dados numéricos , Menorragia/diagnóstico , Menorragia/terapia , Instituições de Assistência Ambulatorial/organização & administração , Contagem de Células Sanguíneas , Prática Clínica Baseada em Evidências , Feminino , Ginecologia/educação , Humanos , Ciência da Implementação , Quênia
17.
N Engl J Med ; 383(5): 440-451, 2020 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-32726530

RESUMO

BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options. METHODS: We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score. RESULTS: A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. CONCLUSIONS: Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).


Assuntos
Leiomioma/cirurgia , Qualidade de Vida , Embolização da Artéria Uterina , Miomectomia Uterina , Neoplasias Uterinas/cirurgia , Adulto , Feminino , Humanos , Histeroscopia , Análise de Intenção de Tratamento , Complicações Intraoperatórias , Laparoscopia , Leiomioma/terapia , Tempo de Internação , Menorragia , Pessoa de Meia-Idade , Reserva Ovariana , Complicações Pós-Operatórias , Reoperação/estatística & dados numéricos , Embolização da Artéria Uterina/efeitos adversos , Miomectomia Uterina/efeitos adversos , Miomectomia Uterina/métodos , Neoplasias Uterinas/terapia , Útero/cirurgia
18.
Pediatrics ; 146(2)2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32690806

RESUMO

Long-acting reversible contraceptives are the most effective methods to prevent pregnancy and also offer noncontraceptive benefits such as reducing menstrual blood flow and dysmenorrhea. The safety and efficacy of long-acting reversible contraception are well established for adolescents, but the rate of use remains low for this population. The pediatrician can play a key role in increasing access to long-acting reversible contraception for adolescents by providing accurate patient-centered contraception counseling and by understanding and addressing the barriers to use.


Assuntos
Contracepção Reversível de Longo Prazo , Adolescente , Amenorreia/induzido quimicamente , Confidencialidade , Aconselhamento , Pessoas com Deficiência , Dismenorreia/tratamento farmacológico , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Consentimento Livre e Esclarecido , Capacitação em Serviço , Dispositivos Intrauterinos , Contracepção Reversível de Longo Prazo/efeitos adversos , Contracepção Reversível de Longo Prazo/economia , Menorragia/tratamento farmacológico , Pediatras/educação , Relações Médico-Paciente , Gravidez , Gravidez na Adolescência/prevenção & controle , Estados Unidos
19.
BMJ ; 368: l6764, 2020 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-31900245

RESUMO

The studyCooper K, Breeman S, Scott NW, et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet 2019;394:1425-36.The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000837/keyhole-hysterectomy-is-effective-for-women-with-heavy-menstrual-bleeding.


Assuntos
Técnicas de Ablação Endometrial , Laparoscopia , Menorragia/cirurgia , Feminino , Humanos , Histerectomia , Avaliação da Tecnologia Biomédica
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