Timeliness of diagnostic evaluation for postmenopausal bleeding: A retrospective cohort study using claims data.

BACKGROUND: Postmenopausal bleeding (PMB) is a common gynecologic condition. Although it can be a sign of uterine cancer, most patients have benign etiology. However, research on quality of diagnostic evaluation for PMB has been limited to cancer patients. To extend this research, we examined the timeliness of diagnostic evaluation for PMB among patients with benign conditions. METHODS: Using the 2008-2019 MarketScan Research Databases, we identified 499176 patients (456741 with commercial insurance and 42435 with Medicaid insurance) who presented with PMB but did not have gynecologic cancer. For each patient, we measured the time from their PMB reporting to the date of their first diagnostic procedure. The association between patient characteristics and time to first diagnostic procedure was examined using Cox proportional hazards models (for the overall sample and then stratified by insurance type). RESULTS: Overall, 54.3% of patients received a diagnostic procedure on the same day when they reported PMB and 86.6% received a diagnostic procedure within 12 months after reporting PMB. These percentages were 39.4% and 77.1%, respectively, for Medicaid patients, compared to 55.7% and 87.4%, respectively, for commercially insured patients (p<0.001 for both). Medicaid patients had an 18% lower rate of receiving a diagnostic procedure at any given time point than commercially insured patients (adjusted hazard ratio = 0.82, 95% CI: 0.81-0.83). Meanwhile, older age and non-gynecologic comorbidities were associated with a lower rate whereas concomitant gynecologic conditions and recent use of preventive care were associated with a higher rate of receiving diagnostic procedures. Analysis stratified by insurance type identified additional risk factors for delayed diagnostic procedures (e.g., non-metropolitan versus metropolitan location for commercially insured patients and Black versus White race for Medicaid patients). CONCLUSION: A sizable proportion of patients did not receive prompt diagnostic evaluation for PMB. Both clinical and non-clinical factors could affect timeliness of evaluation.

Cost-effectiveness analysis of molecular testing in minimally invasive samples to detect endometrial cancer in women with postmenopausal bleeding.

INTRODUCTION: New approaches are being developed to early detect endometrial cancer using molecular biomarkers. These approaches offer high sensitivities and specificities, representing a promising horizon to develop early detection strategies. OBJECTIVE: To evaluate the effectiveness and cost-effectiveness of introducing molecular testing to detect endometrial cancer in women with postmenopausal bleeding compared to the current strategy using the national healthcare service perspective. METHODS: A Markov model was developed to assess the two early detection strategies. The model predicts the number of hysterectomies, lifetime expectancy, quality-adjusted life-years, endometrial cancer prevalence and incidence, mortality from endometrial cancer and the lifetime cost of screening, diagnosis, and treatment. Strategies were compared using the incremental cost-effectiveness ratio. RESULTS: The molecular strategy reduces 1.9% of the overall number of hysterectomies and the number of undetected cancer cases by 65%. Assuming a molecular test cost of 310€, the molecular strategy has an incremental cost of -32,952€ per QALY gained, being more effective and less expensive than the current strategy. CONCLUSIONS: The introduction of molecular testing to diagnose endometrial cancer in women presenting postmenopausal bleeding provides more health benefit at a lower cost, and therefore has the potential to be cost-effective.

Evaluation of a Standardized Questionnaire for Initial Assessment of Abnormal Uterine Bleeding in Premenopausal Women.

OBJECTIVE: To assess the effect of a standardized questionnaire for premenopausal women with abnormal uterine bleeding (AUB) on clinical information collection and duration of consultation. METHODS: We conducted a before and after study involving 100 premenopausal women undergoing consultation for AUB. During stage 1, 50 consultations were recorded on a consultation sheet with no specific template. During stage 2, 50 women completed a 26-item auto-administered standardized questionnaire before the consultation, which was then reviewed with the consultant and added to the medical record. The duration of consultation was assessed in subgroups of 27 women in each stage. Two independent evaluators assessed the quality and completeness of data collected in the medical records using a score sheet developed by experts. Outcomes from both stages were compared using the t test. RESULTS: The descriptive characteristics were similar in both groups. The mean global scores of the quality and completeness of data collected improved significantly between stages 1 and 2, from 67% ± 12% to 95% ± 5% (P < 0.0001), as did medical background scores (54% ± 29% vs. 85% ± 13%; P < 0.0001) and AUB-related symptoms scores (69% ± 13% vs. 97% ± 5%; P < 0.0001). A mean reduction in duration of consultation of nearly 4 minutes was observed (24.6 ± 4.3 min vs. 20.7 ± 4.8 min; P < 0.0001). CONCLUSION: The AUB-specific standardized questionnaire improves quality and completeness of data collected in medical records and reduces duration of consultation.

Prevalence, burden and treatment effects of vaginal bleeding in women with (suspected) congenital platelet disorders throughout life: a cross-sectional study.

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.

Risk assessment of endometrial cancer and endometrial intraepithelial neoplasia in women with abnormal bleeding and implications for clinical management algorithms.

BACKGROUND: Most endometrial cancer cases are preceded by abnormal uterine bleeding, offering a potential opportunity for early detection and cure of endometrial cancer. Although clinical guidelines exist for diagnostic workup of abnormal uterine bleeding, consensus is lacking regarding optimal management for women with abnormal bleeding to diagnose endometrial cancer. OBJECTIVE: We report the baseline data from a prospective clinical cohort study of women referred for endometrial evaluation at the Mayo Clinic, designed to evaluate risk stratification in women at increased risk for endometrial cancer. Here, we introduce a risk-based approach to evaluate diagnostic tests and clinical management algorithms in a population of women with abnormal bleeding undergoing endometrial evaluation at the Mayo Clinic. STUDY DESIGN: A total of 1163 women aged ≥45 years were enrolled from February 2013 to May 2019. We evaluated baseline absolute risks and 95% confidence intervals of endometrial cancer and endometrial intraepithelial neoplasia according to clinical algorithms for diagnostic workup of women with postmenopausal bleeding (assessment of initial vs recurrent bleeding episode and endometrial thickness measured through transvaginal ultrasound). We also evaluated risks among women with postmenopausal bleeding according to baseline age (<60 vs 60+ years) as an alternative example. For this approach, biopsy would be conducted for all women aged 60+ years and those aged <60 years with an endometrial thickness of >4 mm. We assessed the clinical efficiency of each strategy by estimating the percentage of women who would be referred for endometrial biopsy, the percentage of cases detected and missed, and the ratio of biopsies per case detected. RESULTS: Among the 593 women with postmenopausal bleeding, 18 (3.0%) had endometrial intraepithelial neoplasia, and 47 (7.9%) had endometrial cancer, and among the 570 premenopausal women with abnormal bleeding, 8 (1.4%) had endometrial intraepithelial neoplasia, and 7 (1.2%) had endometrial cancer. Maximum risk was noted in women aged 60+ years (17.7%; 13.0%-22.3%), followed by those with recurrent bleeding (14.7%; 11.0%-18.3%). Among women with an initial bleeding episode for whom transvaginal ultrasound was recommended, endometrial thickness did not provide meaningful risk stratification: risks of endometrial cancer and endometrial intraepithelial neoplasia were nearly identical in women with an endometrial thickness of >4 mm (5.8%; 1.3%-10.3%) and ≤4 mm (3.6%; 0.9%-8.6%). In contrast, among those aged <60 years with an endometrial thickness of >4 mm, the risk of endometrial cancer and endometrial intraepithelial neoplasia was 8.4% (4.3%-12.5%), and in those with an endometrial thickness of ≤4 mm, the risk was 0% (0.0%-3.0%; P=.01). The most efficient strategy was to perform biopsy in all women aged 60+ years and among those aged <60 years with an endometrial thickness of >4 mm, with the lowest percentage referred to biopsy while still detecting all cases. CONCLUSION: Existing clinical recommendations for endometrial cancer detection in women with abnormal bleeding are not consistent with the underlying risk. Endometrial cancer risk factors such as age can provide important risk stratification compared with the assessment of recurrent bleeding. Future research will include a formal assessment of clinical and epidemiologic risk prediction models in our study population as well as validation of our findings in other populations.

Competence of healthcare professionals in diagnosing and managing obstetric complications and conducting neonatal care: a clinical vignette-based assessment in district and subdistrict hospitals in northern Bangladesh.

BACKGROUND: This study assesses the competency of maternal and neonatal health (MNH) professionals at district-level and subdistrict-level health facilities in northern Bangladesh in managing maternal and newborn complications using clinical vignettes. The study also examines whether the professional's characteristics and provision of MNH services in health facilities influence their competencies. METHODS: 134 MNH professionals in 15 government hospitals were interviewed during August and September 2016 using structured questionnaire with clinical vignettes on obstetric complications (antepartum haemorrhage and pre-eclampsia) and neonatal care (low birthweight and immediate newborn care). Summative scores were calculated for each vignette and median scores were compared across different individual-level and health facility-level attributes to examine their association with competency score. Kruskal-Wallis test was performed to identify the significance of association considering a p value<0.05 as statistically significant. RESULTS: The competency of MNH professionals was low. About 10% and 24% of the health professionals received 'high' scores (>75% of total) in maternal and neonatal vignettes, respectively. Medical doctors had higher competency than nurses and midwives (score=11 vs 8 out of 19, respectively; p=0.0002) for maternal vignettes, but similar competency for neonatal vignettes (score=30.3 vs 30.9 out of 50, respectively). Professionals working in health facilities with higher use of normal deliveries had better competency than their counterparts. Professionals had higher competency in newborn vignettes (significant) and maternal vignettes (statistically not significant) if they worked in health facilities that provided more specialised newborn care services and emergency obstetric care, respectively, in the last 6 months. CONCLUSIONS: Despite the overall low competency of MNH professionals, exposure to a higher number of obstetric cases at the workplace was associated with their competency. Arrangement of periodic skill-based and drill-based in-service training for MNH professionals in high-use neighbouring health facilities could be a feasible intervention to improve their knowledge and skill in obstetric and neonatal care.

Endometrial sampling in low-risk patients with abnormal uterine bleeding: a systematic review and meta-synthesis.

BACKGROUND: One million women per year seek medical advice for abnormal uterine bleeding (AUB) in the United Kingdom. Many low-risk patients who could be managed exclusively in primary care are referred to hospital based gynaecology services. Performing endometrial sampling (ES) in the community may improve care, reduce the rate of referrals and minimise costs. We aimed to search and synthesise the literature on the effectiveness of ES (Pipelle versus other devices) in managing AUB in low-risk patients. METHODS: We undertook an electronic literature search in MEDLINE via OvidSP, Scopus, and Web of Science for relevant English-language articles from 1984 to 2016 using a combination of MeSH and keywords. Two reviewers independently pre-selected 317 articles and agreed on 60 articles reporting data from over 7300 patients. Five themes were identified: sample adequacy, test performance, pain and discomfort, cost-effectiveness, and barriers and complications of office ES. RESULTS: Pipelle seems to perform as well as dilation and curettage and, as well or better than other ES devices in terms of sampling adequacy and sensitivity. It also seems to be better regarding pain/discomfort and costs. However, Pipelle can disrupt the sonographic appearance of the endometrium and may be limited by cervical stenosis, pelvic organ prolapse and endometrial atrophy. CONCLUSIONS: The current evidence supports the use of Pipelle in the management of low-risk women presenting in the outpatient setting with symptomatic AUB when combined with clinical assessment and ultrasound scanning. However, the implications of its widespread use in primary care are uncertain and more research is required.

Health Seeking Behavior of Patients Diagnosed with Cervical Cancer in Addis Ababa, Ethiopia.

BACKGROUND: Cervical cancer is increasingly recognized as one of the public health problems among women in developing countries. Most women with cervical cancer are seen in the health care system late with advanced stage of cancer. This study aims to explore the care seeking behavior of women with cervical cancer. METHODS: A qualitative study was conducted to explore the health seeking behavior of women with cervical cancer for patients who were admitted with cervical cancer in Tikur Anbessa Hospital. In-depth interviews were conducted with purposively selected participants. Interviews were transcribed verbatim and then translated into English and analyzed using a content analysis approach. The study period was from October 2013 to April 2014. RESULTS: The study found that women diagnosed with cervical cancer lack prior awareness about cervical cancer and availability of screening services. Moreover, decision making to seek medical care up on experiencing early symptoms seems to be delayed. Women reported the first symptom was unusual vaginal bleeding that forces them to seek care. The bleeding could be profound and accompanied by offensive odor. Fear of stigmatization could make women reluctant to seek timely care. Once treatment is started most women found it shockingly expensive. CONCLUSION: Women lack general awareness about the nature and symptoms of cervical cancer. All health services providers serving women need to sensitize women to seek timely screening services and timely treatment services if cervical cancer is confirmed.

Prolonged Vaginal Bleeding in an Adolescent Secondary to a Foreign Body: Need for a Comprehensive Assessment and Complex Surgery.

BACKGROUND: Heavy, prolonged menstrual bleeding is common in adolescents and results from a variety of etiologies. CASE: A 13-year-old, virginal girl was referred for prolonged, heavy vaginal bleeding despite combined oral contraceptive use and elected management with a levonorgestrel intrauterine device. A preprocedure exam revealed a plastic foreign body embedded in the posterior vaginal fornix, however, attempted removal in the office was unsuccessful. Subsequent computed tomography imaging of the pelvis revealed a vaginal foreign body, complex adnexal mass, and hydroureter. The patient underwent exam under anesthesia and diagnostic laparoscopy, but required conversion to exploratory laparotomy for removal of a foreign body because of vaginal perforation abutting the rectum. SUMMARY AND CONCLUSION: Foreign bodies not easily removed in the outpatient setting should be considered for surgical removal with consideration of preoperative multidisciplinary coordination when imaging reveals intra-abdominal pathology, such as tubo-ovarian abscess and hydroureter.

Comparison of endometrial assessment by transvaginal ultrasonography and hysteroscopy.

OBJECTIVE: To compare transvaginal ultrasonography and hysteroscopy for the diagnosis of endometrial pathologies. METHODS: In the present retrospective cohort study, data were reviewed from women with ultrasonography findings suggestive of endometrial lesions and/or abnormal uterine bleeding who underwent hysteroscopy at a single center in Campinas, Brazil, between January 2011 and December 2013; data were stratified based on reproductive-aged and postmenopausal groups. The accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasonography and hysteroscopy for the diagnosis of endometrial lesions were determined. Histopathology was used as the gold standard. RESULTS: There were 754 patients included (256 reproductive age, 498 postmenopausal). In the reproductive-age group, ultrasonography had a sensitivity of 96.0%, specificity of 58.0%, PPV of 94.4%, NPV of 66.6%, and accuracy of 91.5%, whereas hysteroscopy had a sensitivity of 91.8%, specificity of 76.6%, PPV of 96.0%, NPV of 60.5%, and accuracy of 89.7% for the diagnosis of endometrial disease. In the postmenopausal group, ultrasonography had a sensitivity of 99.0%, specificity of 19.0%, PPV of 96.1%, NPV of 50.0%, and accuracy of 95.3%, whereas hysteroscopy had a sensitivity of 96.7%, specificity of 86.9%, PPV of 99.2%, NPV of 58.8%, and accuracy of 96.2%. CONCLUSION: Ultrasonography was found to be an effective method for the diagnosis of endometrial disease, especially among postmenopausal women.

No. 292-Abnormal Uterine Bleeding in Pre-Menopausal Women.

BACKGROUND: Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. OBJECTIVE: To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. OUTCOMES: Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. METHODS: Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. RESULTS: This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. CONCLUSIONS: Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. EVIDENCE: Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e. g., uterine hemorrhage, menorrhagia) and key words (e. g., menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology- related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered. SUMMARY STATEMENTS: RECOMMENDATIONS.

Cost-effectiveness analysis of biopsy strategies for endometrial cancer diagnosis in women with postmenopausal bleeding: Pipelle sampling curette versus dilatation & curettage.

BACKGROUND: Endometrial sampling is widely used for accurate diagnosis of endometrial cancer (EC), which is the most common gynecologic cancer in US women. The objective of this study was to explore the cost-effectiveness of two endometrial sampling procedures for diagnosing EC: (1) Pipelle endometrial sampling (Pipelle), and (2) dilatation & curettage (D&C), while accounting for sampling procedure failure rates and diagnostic accuracy in women with postmenopausal bleeding (PMB). METHOD: The decision analytic model was built to compare the cost-effectiveness of Pipelle and D&C strategies in a hypothetical cohort of PMB women. The analysis was performed from the perspective of a public healthcare payer (Medicare, US). We used 2017 Medicare reimbursement data for cost estimation. The effectiveness of these two diagnostic strategies was measured by analyzing the remaining life expectancy after EC diagnosis and subsequent treatment. RESULTS: The base case analysis suggested that Pipelle was not only equally effective (32.11 vs. 32.11 years of life), but also less costly ($1897.80 vs. $2999.11) based on Medicare reimbursement when compared to D&C. In one-way sensitivity analyses and Monte Carlo probabilistic sensitivity analysis, the Pipelle remained the more cost-effective sampling strategy even after accounting for sampling failure rate associated with each sampling strategy. CONCLUSION: The Pipelle is the more cost-effective sampling strategy compared to D&C for EC diagnosis in women with PMB. From the cost-effectiveness perspective, the higher sampling failure rate of Pipelle should not be regarded as a limitation in its clinical application.

Sangramento uterino anormal: proposta de abordagem do Grupo Heavy Menstrual Bleeding: Evidence-Based Learning for Best Practice (HELP) / Heavy menstrual bleeding: management proposal of the Heavy Menstrual Bleeding: Evidence-Based Learning for Best Practice Group (HELP)

O Sangramento Uterino Anormal (SUA) representa um problema de saúde pública complexo que pode acometer 1/3 das mulheres em todo o mundo. Apresenta um impacto negativo importante na qualidade de vida de mulheres e associa-se a elevados custos econômicos diretos e indiretos. Trata-se de uma condição desafiadora tanto para as mulheres afetadas quanto para os profissionais de saúde. A nomenclatura atribuída ao SUA é confusa e faltam ainda recomendações diagnósticas e terapêuticas padronizadas. Foi criado o grupo Heavy Menstrual Bleeding: Evidence-based Learning for Best Practice (HELP) com proposta abordar os aspectos inconclusivos do SUA. Foram avaliados 134 documentos, incluindo 121 artigos científicos e 14 revisões de medicamentos, para desenvolvimento dos protocolos HELP. Foram elaborados protocolos simplificados referentes ao diagnóstico e tratamento do SUA, visando contribuir de forma mais eficaz com os médicos em seus diferentes cenários de atuação. O roteiro diagnóstico sugerido, compreendendo perguntas chaves e ações específicas, sinaliza para indicação de métodos propedêuticos adicionais. O tratamento proposto visa reduzir a perda do sangue menstrual e melhorar de a qualidade de vida das pacientes.(AU)

Abnormal uterine bleeding (AUB) is a complex public health problem that can affect one third of women worldwide. It has a significant negative impact on quality of life of women and is associated with high direct and indirect economic costs. It is a challenging condition for both the women affected and for the health professionals. The nomenclature assigned to the AUB is confusing and still miss diagnostic and therapeutic recommendations standardized. The Heavy Menstrual Bleeding: Evidence-based Learning for Best Practice Group (HELP) was created with the proposal to address the inconclusive aspects of AUB. The group evaluated 134 documents, including 121 scientific articles and 14 reviews of drugs for the development of protocols HELP. Simplified protocols were drawn up relating to the diagnosis and treatment of AUB, to contribute more effectively with doctors at different scenarios of operation. The script diagnostic suggested, comprising keys questions and specific actions, can indicate additional diagnostic methods. The proposed treatment aims to reduce the loss of menstrual blood and improve the quality of life of patients.(AU)

Endometrial ablation in the management of abnormal uterine bleeding.

BACKGROUND: Abnormal uterine bleeding (AUB) is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for the problem during their reproductive years. OBJECTIVE: To provide current evidence-based guidelines on the techniques and technologies used in endometrial ablation (EA), a minimally invasive technique for the management of AUB of benign origin. METHODS: Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of both location in Canada and type of practice, as well as subspecialty expertise and general background in gynaecology. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated surgical and patient outcomes for the various EA techniques. Recommendations were established by consensus. EVIDENCE: Published literature was retrieved through searches of MEDLINE and The Cochrane Library in 2013 and 2014 using appropriate controlled vocabulary and key words (endometrial ablation, hysteroscopy, menorrhagia, heavy menstrual bleeding, AUB, hysterectomy). RESULTS were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English from January 2000 to November 2014. Searches were updated on a regular basis and incorporated in the guideline to December 2014. Grey (unpublished) literature was identifies through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). RESULTS: This document reviews the evidence regarding the available techniques and technologies for EA, preoperative and postoperative care, operative set-up, anaesthesia, and practical considerations for practice. BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve the provision of EA as an effective treatment of AUB. Following these recommendations would allow the surgical procedure to be performed safely and maximize success for patients. CONCLUSIONS: EA is a safe and effective minimally invasive option for the treatment of AUB of benign etiology. Summary Statements 1. Endometrial ablation is a safe and effective minimally invasive surgical procedure that has become a well-established alternative to medical treatment or hysterectomy to treat abnormal uterine bleeding in select cases. (I) 2. Endometrial preparation can be used to facilitate resectoscopic endometrial ablation (EA) and can be considered for some non-resectoscopic techniques. For resectoscopic EA, preoperative endometrial thinning results in higher short-term amenorrhea rates, decreased irrigant fluid absorption, and shorter operative time than no treatment. (I) 3. Non-resectoscopic techniques are technically easier to perform than resectoscopic techniques, have shorter operative times, and allow the use of local rather than general anaesthesia. However, both techniques have comparable patient satisfaction and reduction of heavy menstrual bleeding. (I) 4. Both resectoscopic and non-resectoscopic endometrial ablation (EA) have low complication rates. Uterine perforation, fluid overload, hematometra, and cervical lacerations are more common with resectoscopic EA; perioperative nausea/vomiting, uterine cramping, and pain are more common with non-resectoscopic EA. (I) 5. All non-resectoscopic endometrial ablation devices available in Canada have demonstrated effectiveness in decreasing menstrual flow and result in high patient satisfaction. The choice of which device to use depends primarily on surgical judgement and the availability of resources. (I) 6. The use of local anaesthetic and blocks, oral analgesia, and conscious sedation allows for the provision of non-resectoscopic EA in lower resource-intense environments including regulated non-hospital settings. (II-2) 7. Low-risk patients with satisfactory pain tolerance are good candidates to undergo endometrial ablation in settings outside the operating room or in free-standing surgical centres. (II-2) 8. Both resectoscopic and non-resectoscopic endometrial ablation are relatively safe procedures with low complication rates. The complications perforation with potential injury to contiguous structures, hemorrhage, and infection. (II-2) 9. Combined hysteroscopic sterilization and endometrial ablation can be safe and efficacious while favouring a minimally invasive approach. (II-2) Recommendations 1. Preoperative assessment should be comprehensive to rule out any contraindication to endometrial ablation. (II-2A) 2. Patients should be counselled about the need for permanent contraception following endometrial ablation. (II-2B) 3. Recommended evaluations for abnormal uterine bleeding, including but not limited to endometrial sampling and an assessment of the uterine cavity, are necessary components of the preoperative assessment. (II-2B) 4. Clinicians should be vigilant for complications unique to resectoscopic endometrial ablation such as those related to fluid distention media and electrosurgical injuries. (III-A) 5. For resectoscopic endometrial ablation, a strict protocol should be followed for fluid monitoring and management to minimize the risk of complications of distension medium overload. (III-A) 6. If uterine perforation is suspected to have occurred during cervical dilatation or with the resectoscope (without electrosurgery), the procedure should be abandoned and the patient should be closely monitored for signs of intraperitoneal hemorrhage or visceral injury. If the perforation occurs with electrosurgery or if the mechanism of perforation is uncertain, abdominal exploration is warranted to obtain hemostasis and rule out visceral injury. (III-B) 7. With resectoscopic endometrial ablation, if uterine perforation has been ruled out acute hemorrhage may be managed by using intrauterine Foley balloon tamponade, injecting intracervical vasopressors, or administering rectal misoprostol. (III-B) 8. If repeat endometrial ablation (EA) is considered following non-resectoscopic or resectoscopic EA, it should be performed by a hysteroscopic surgeon with direct visualization of the cavity. Patients should be counselled about the increased risk of complications with repeat EA. (II-2A) 9. If significant intracavitary pathology is present, resectoscopic endometrial ablation combined with hysteroscopic myomectomy or polypectomy should be considered in a non-fertility sparing setting. (II-3A).

Contexte : Les saignements utérins anormaux (SUA) sont directement à l'origine d'un fardeau de santé considérable que doivent porter les femmes, leur famille et la société en général. Jusqu'à 30 % des femmes chercheront à obtenir l'aide d'un médecin pour contrer ce problème au cours de leurs années de fertilité. Objectif : Fournir des lignes directrices factuelles à jour quant aux techniques et aux technologies utilisées aux fins de l'ablation de l'endomètre (AE), soit une intervention à effraction minimale permettant la prise en charge des SUA d'origine bénigne. Méthodes : Les membres du comité sur la directive clinique ont été sélectionnés en fonction de leurs spécialisations respectives en vue de représenter une gamme d'expériences pratiques et universitaires : le milieu de pratique au Canada, le type de pratique, la sous-spécialité et les antécédents généraux en gynécologie ont donc été pris en considération. Le comité a analysé les données pertinentes issues de la littérature médicale anglophone (y compris les lignes directrices publiées), en plus d'évaluer les issues chirurgicales et les issues qu'ont connues les patientes à la suite de l'utilisation de diverses techniques d'AE. Les recommandations ont été formulées par consensus. Données : La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans MEDLINE et The Cochrane Library en 2013 et en 2014 au moyen d'un vocabulaire contrôlé et de mots clés appropriés (p. ex. « endometrial ablation ¼, « hysteroscopy ¼, « menorrhagia ¼, « heavy menstrual bleeding ¼, « AUB ¼, « hysterectomy ¼). Les résultats ont été restreints aux analyses systématiques, aux études observationnelles et aux essais comparatifs randomisés / essais cliniques comparatifs publiés en anglais entre janvier 2000 et novembre 2014. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en décembre 2014. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales. Valeurs : La qualité des résultats a été évaluée au moyen des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs (Tableau). Résultats : Le présent document passe en revue les données quant aux techniques et aux technologies disponibles en ce qui concerne l'AE, les soins préopératoires et postopératoires, le milieu d'intervention, l'anesthésie et les facteurs pratiques à prendre en considération. Avantages, désavantages et coûts : La mise en œuvre des recommandations de la présente directive clinique entraînera une amélioration de l'offre de l'AE à titre de traitement efficace contre les SUA. Le respect de ces recommandations permettrait l'exécution de l'intervention chirurgicale en cause de façon sûre et en maximiserait la réussite pour les patientes. Conclusions : L'AE est une option à effraction minimale sûre et efficace pour la prise en charge des SUA d'étiologie bénigne. Déclarations sommaires 1. L'ablation de l'endomètre est une intervention chirurgicale à effraction minimale sûre et efficace qui en est venue à constituer, dans certains cas, une solution de rechange bien établie au traitement médical ou à l'hystérectomie pour la prise en charge des saignements utérins anormaux. (I) 2. Une préparation de l'endomètre peut être mise en œuvre pour en faciliter l'ablation résectoscopique et peut également être envisagée dans le cas de certaines techniques non résectoscopiques. Lorsque l'on a recours à l'ablation résectoscopique de l'endomètre, l'amincissement préopératoire de ce dernier donne lieu à une hausse des taux d'aménorrhée à court terme, à une atténuation de l'absorption du liquide de distension et à une réduction de la durée opératoire, par comparaison avec l'absence de traitement. (I) 3. Les techniques non résectoscopiques sont techniquement plus faciles à utiliser que les techniques résectoscopiques, nécessitent des temps opératoires plus courts et permettent l'utilisation d'une anesthésie locale (plutôt que d'avoir recours à une anesthésie générale). Toutefois, ces deux techniques comptent des taux comparables de satisfaction des patientes et d'atténuation des saignements menstruels abondants. (I) 4. Les techniques résectoscopiques et non résectoscopiques d'ablation de l'endomètre comptent toutes de faibles taux de complication. La perforation utérine, la surcharge liquidienne, l'hématomètre et les lacérations cervicales sont plus courantes dans le cas de l'AE résectoscopique; les crampes utérines, la douleur et les nausées / vomissements périopératoires sont plus courants dans le cas de l'AE non résectoscopique. (I) 5. L'efficacité de tous les dispositifs d'ablation non résectoscopique de l'endomètre disponibles au Canada a été démontrée en ce qui concerne l'atténuation du flux menstruel; de plus, ils mènent tous à des taux élevés de satisfaction des patientes. Le choix du dispositif à utiliser dépend principalement de l'opinion du chirurgien et de la disponibilité des ressources. (I) 6. L'utilisation d'anesthésiques et de blocs locaux, d'une analgésie orale et d'une sédation consciente permet la tenue d'une ablation non résectoscopique de l'endomètre au sein de milieux nécessitant des ressources moindres, y compris dans des milieux non hospitaliers réglementés. (II-2) 7. Les patientes n'étant exposées qu'à de faibles risques et présentant une tolérance satisfaisante à la douleur sont de bonnes candidates pour ce qui est de la tenue d'une ablation endométriale dans un milieu autre qu'en salle d'opération ou dans un centre chirurgical autonome. (II-2) 8. Les techniques d'ablation de l'endomètre tant résectoscopiques que non résectoscopiques sont relativement sûres et ne comptent que de faibles taux de complication. Parmi les complications les plus graves, on trouve la perforation (s'accompagnant de lésions potentielles aux structures adjacentes), l'hémorragie et l'infection. (II-2) 9. La tenue concomitante d'une stérilisation hystéroscopique et d'une ablation endométriale peut être sûre et efficace tout en favorisant une approche à effraction minimale. (II-2) Recommandations 1. L'évaluation préopératoire devrait être exhaustive, de façon à pouvoir écarter toute contre-indication à l'ablation de l'endomètre. (II-2A) 2. Les patientes devraient être avisées de la nécessité d'une contraception permanente à la suite de l'ablation de l'endomètre. (II-2B) 3. Les évaluations recommandées en présence de saignements utérins anormaux (dont, entre autres, le prélèvement endométrial et l'évaluation de la cavité utérine) sont des composantes nécessaires de l'évaluation préopératoire. (II-2B) 4. Les cliniciens devraient demeurer à l'affût des complications propres à l'ablation résectoscopique de l'endomètre, comme celles qui sont associées au produit de distension et aux lésions électrochirurgicales. (III-A) 5. Dans le cas de l'ablation résectoscopique de l'endomètre, un protocole strict devrait être respecté pour ce qui est de la surveillance liquidienne et de la prise en charge, et ce, afin de minimiser le risque de voir se manifester des complications associées à la surcharge de produit de distension. (III-A) 6. Lorsque l'on soupçonne qu'une perforation utérine s'est manifestée au cours de la dilatation cervicale ou dans le cadre de l'utilisation du résectoscope (sans électrochirurgie), l'intervention devrait être abandonnée et la patiente devrait faire l'objet d'une surveillance étroite de façon à ce que l'on puisse demeurer à l'affût des signes d'hémorragie intrapéritonéale ou de lésion viscérale. Lorsque la perforation se manifeste dans le cadre d'une électrochirurgie ou lorsque le mécanisme de la perforation demeure incertain, la tenue d'une exploration abdominale est justifiée pour assurer l'hémostase et écarter la présence de lésions viscérales. (III-B) 7. Dans le cas de l'AE résectoscopique, lorsque la présence d'une perforation utérine a été écartée, l'hémorragie aiguë pourrait être prise en charge au moyen d'un tamponnement intra-utérin par sonde de Foley, d'une injection intracervicale de vasopresseurs ou de l'administration de misoprostol par voie rectale. (III-B) 8. Lorsqu'une nouvelle ablation de l'endomètre est envisagée à la suite d'une intervention non résectoscopique ou résectoscopique, elle devrait être menée par un chirurgien hystéroscopique sous visualisation directe de la cavité. Les patientes devraient bénéficier de services de counseling au sujet des risques de complications qui sont associés à la tenue d'une nouvelle ablation de l'endomètre. (II-2A) 9. En présence d'une pathologie intracavitaire considérable, la tenue concomitante d'une ablation résectoscopique de l'endomètre et d'une myomectomie / polypectomie hystéroscopique devrait être envisagée. (II-3A).

Does probability guided hysteroscopy reduce costs in women investigated for postmenopausal bleeding?

OBJECTIVE: To evaluate whether a model to predict a failed endometrial biopsy in women with postmenopausal bleeding (PMB) and a thickened endometrium can reduce costs without compromising diagnostic accuracy. DESIGN, SETTING, AND POPULATION: Model based cost-minimization analysis. METHODS: A decision analytic model was designed to compare two diagnostic strategies for women with PMB: (I) attempting office endometrial biopsy and performing outpatient hysteroscopy after failed biopsy and (II) predicted probability of a failed endometrial biopsy based on patient characteristics to guide the decision for endometrial biopsy or immediate hysteroscopy. Robustness of assumptions regarding costs was evaluated in sensitivity analyses. MAIN OUTCOME MEASURES: Costs for the different strategies. RESULTS: At different cut-offs for the predicted probability of failure of an endometrial biopsy, strategy I was generally less expensive than strategy II. The costs for strategy I were always € 460; the costs for strategy II varied between € 457 and € 475. At a 65% cut-off, a possible saving of € 3 per woman could be achieved. CONCLUSIONS: Individualizing the decision to perform an endometrial biopsy or immediate hysteroscopy in women presenting with postmenopausal bleeding based on patient characteristics does not increase the efficiency of the diagnostic work-up.

Contribution of antepartum and intrapartum hemorrhage to the burden of maternal near miss and death in a national surveillance study.

OBJECTIVE: To evaluate the occurrence of severe obstetric complications associated with antepartum and intrapartum hemorrhage among women from the Brazilian Network for Surveillance of Severe Maternal Morbidity. DESIGN: Multicenter cross-sectional study. SETTING: Twenty-seven obstetric referral units in Brazil between July 2009 and June 2010. POPULATION: A total of 9555 women categorized as having obstetric complications. METHODS: The occurrence of potentially life-threatening conditions, maternal near miss and maternal deaths associated with antepartum and intrapartum hemorrhage was evaluated. Sociodemographic and obstetric characteristics and the use of criteria for management of severe bleeding were also assessed in these women. MAIN OUTCOME MEASURES: The prevalence ratios with their respective 95% confidence intervals adjusted for the cluster effect of the design, and multiple logistic regression analysis were performed to identify factors independently associated with the occurrence of severe maternal outcome. RESULTS: Antepartum and intrapartum hemorrhage occurred in only 8% (767) of women experiencing any type of obstetric complication. However, it was responsible for 18.2% (140) of maternal near miss and 10% (14) of maternal death cases. On multivariate analysis, maternal age and previous cesarean section were shown to be independently associated with an increased risk of severe maternal outcome (near miss or death). CONCLUSION: Severe maternal outcome due to antepartum and intrapartum hemorrhage was highly prevalent among Brazilian women. Certain risk factors, maternal age and previous cesarean delivery in particular, were associated with the occurrence of bleeding.

Cost-effectiveness of office hysteroscopy for abnormal uterine bleeding.

BACKGROUND AND OBJECTIVES: Office diagnostic hysteroscopy allows physicians to directly view the endometrial cavity, tubal ostia, and endocervical canal without taking the patient to the operating room (OR). We sought to determine whether office hysteroscopy performed to evaluate abnormal uterine bleeding decreases the need for hysteroscopy performed in the OR and the associated financial and risk implications. METHODS: One hundred thirty patients who underwent office diagnostic hysteroscopy between January 2009 and March 2012 at 2 outpatient clinics in an academic university setting were identified. Records were reviewed from paper charts and electronic medical records. Hospital charts for patients who required hysteroscopy in the OR were reviewed as well. Charge estimates were obtained from our billing department. These results were analyzed for review of the data. RESULTS: Seventy-five of the 130 women who underwent diagnostic office hysteroscopy for abnormal bleeding did not need to undergo hysteroscopy in the OR. This represents estimated savings of $1498 per patient (95% confidence interval, $1051-$1923) in procedure charges. Among the 55 women who underwent OR hysteroscopy, there was 71% agreement between findings on hysteroscopy in the office and in the OR. CONCLUSION: Office hysteroscopy is a useful diagnostic tool that can help decrease the rate of diagnostic hysteroscopy in the OR under anesthesia when used in a select patient population.

Cost-effectiveness of diagnostic strategies for the management of abnormal uterine bleeding (heavy menstrual bleeding and post-menopausal bleeding): a decision analysis.

BACKGROUND: Heavy menstrual bleeding (HMB) and post-menopausal bleeding (PMB) together constitute the commonest gynaecological presentation in secondary care and impose substantial demands on health service resources. Accurate diagnosis is of key importance to realising effective treatment, reducing morbidity and, in the case of PMB, reducing mortality. There are many tests available, including transvaginal scan (TVS), endometrial biopsy (EBx), saline infusion sonography and outpatient hysteroscopy (OPH); however, optimal diagnostic work-up is unclear. OBJECTIVES: To determine the most cost-effective diagnostic testing strategy for the diagnosis and treatment of (i) HMB and (ii) PMB. DATA SOURCES: Parameter inputs were derived from systematic quantitative reviews, individual patient data (IPD) from existing data sets and focused searches for specific data. In the absence of data estimates, the consensus view of an expert clinical panel was obtained. METHODS: Two clinically informed decision-analytic models were constructed to reflect current service provision for the diagnostic work-up of women presenting with HMB and PMB. The model-based economic evaluation took the form of a cost-effectiveness analysis from the perspective of the NHS in a contemporary, 'one-stop' secondary care clinical setting, where all indicated testing modalities would be available during a single visit. RESULTS: Two potentially cost-effective testing strategies for the initial investigation of women with HMB were identified: OPH alone or in combination with EBx. Although a combination testing strategy of OPH + EBx was marginally more effective, the incremental cost-effectiveness ratio (ICER) was approximately £21,000 to gain one more satisfied patient, whereas for OPH it was just £360 when compared with treatment with the levonorgestrel intrauterine system (LNG-IUS) without investigation. Initial testing with OPH was the most cost-effective testing approach for women wishing to preserve fertility and for women with symptoms refractory to empirical treatment with a LNG-IUS. For the investigation of PMB, selective use of TVS based on historical risk prediction for the diagnostic work-up of women presenting with PMB generated an ICER compared with our reference strategy of 'no initial work-up' of £129,000 per extra woman surviving 5 years. The ICERs for the two other non-dominated testing strategies, combining history and TVS or combining OPH and TVS, were over £2M each. LIMITATIONS: In the absence of IPD, estimates of accuracy for test combinations presented some uncertainty where test results were modelled as being discordant. CONCLUSIONS: For initial investigation of women presenting to secondary care with HMB who do not require preservation of their fertility, our research suggests a choice between OPH alone or a combination of OPH and EBx. From our investigation, OPH appears to be the optimal first-line diagnostic test used for the investigation of women presenting to secondary care with HMB wishing to preserve their fertility or refractory to previous medical treatment with the LNG-IUS. We would suggest that the current recommendation of basing the initial investigation of women with PMB on the universal TVS measurement of endometrial thickness at a 5-mm threshold may need to be replaced by a strategy of restricting TVS to women with risk factors (e.g. increasing age-raised body mass index, diabetes or nulliparity), obtained from the preceding clinical assessment. FUNDING: The National Institute for Health Research Health Technology Assessment programme.