Environmental sustainability in obstetrics and gynaecology: A systematic review.

BACKGROUND: The healthcare sector is responsible for 4%-10% of global greenhouse gas emissions. Considering the broad range of care that obstetricians and gynaecologists provide, mitigation strategies within this specialty could result in significant reductions of the environmental footprint across the whole healthcare industry. OBJECTIVES: The aim of this review was to identify for what services, procedures and products within obstetric and gynaecological care the environmental impact has been studied, to assess the magnitude of such impact and to identify mitigation strategies to diminish it. SEARCH STRATEGY: The search strategy combined terms related to environmental impact, sustainability, climate change or carbon footprint, with the field of obstetrics and gynaecology. SELECTION CRITERIA: Articles reporting on the environmental impact of any service, procedure or product within the field of obstetrics and gynaecology were included. Included outcomes covered midpoint impact categories, CO2 emissions, waste generation and energy consumption. DATA COLLECTION AND ANALYSIS: A systematic literature search was conducted in the databases of MEDLINE (Ovid), Embase (Ovid) and Scopus, and a grey literature search was performed on Google Scholar and two websites of gynaecological associations. MAIN RESULTS: The scope of the investigated studies encompassed vaginal births, obstetric and gynaecological surgical procedures, menstrual products, vaginal specula and transportation to gynaecological oncologic consultations. Among the highest yielding mitigation strategies were displacing disposable with reusable materials and minimising content of surgical custom packs. The lowest yielding mitigation strategy was waste optimisation, including recycling. CONCLUSIONS: This systematic review highlights opportunities for obstetricians and gynaecologists to decrease their environmental footprint in many ways. More high-quality studies are needed to investigate the environmental impact of other aspects of women's and reproductive health care.

Patient preferences for disposable and reusable vaginal specula and their willingness to compromise in the era of climate change: A cross-sectional study.

OBJECTIVE: To evaluate patient satisfaction on gynaecological examination with metal, plastic and biobased plastic vaginal specula, and to investigate whether patients are willing to compromise on comfort for a more sustainable healthcare system. DESIGN: Cross-sectional study: population-based survey. SETTING: Gynaecological outpatient clinics in five Dutch hospitals. POPULATION: Patients during general gynaecology consultation hours. METHODS: A survey containing two questions about patient demographics, four about comfort and five about sustainability and healthcare was distributed. MAIN OUTCOME MEASURES: Comfort score (scale 1-10). SECONDARY OUTCOMES: (1) temperature, size and ease of insertion, (2) willingness to compromise for a more sustainable healthcare system. RESULTS: In all, 196 patients completed the survey. Biobased plastic vaginal specula scored significantly higher on comfort than the metal ones (mean 8.03 ± 1.65 versus 7.26 ± 1.51 respectively; P < 0.001). The biobased plastic vaginal speculum is significantly the most comfortable on temperature, whereas the metal speculum is the least comfortable (P < 0.007). Most patients are willing to compromise on comfort or are open to the reuse of disposables to contribute to a more sustainable healthcare. The majority of patients (77%) urge healthcare organisations to combat climate change. CONCLUSIONS: There is a small but statistically significant difference in favour of a biobased plastic speculum regarding comfort score, although it might be questioned whether this is clinically relevant. Furthermore, patients are willing to compromise on comfort for a more sustainable healthcare, which should be a contributing factor in speculum selection.

['Is there a doctor on board?' Reducing air travel associated with international medical conferences]. / 'Is er een dokter aan boord?'.

International medical conferences aim to improve health outcomes, but the associated air travel-related carbon emissions are a significant contributor to the environmental impact of medical scientific activities. The COVID-19 pandemic has urged the medical world to shift towards virtual conferences, decreasing associated carbon emissions by 94% to 99%. However, virtual conferences are still not the norm and doctors are returning to business as usual. Various stakeholders need to be mobilized to minimize carbon-intensive flights to conferences. Doctors, (academic) hospitals, conference organizers and universities all hold a responsibility to incorporate every effort to decarbonize and build climate mitigation into their decisions. These efforts include sustainable travel policies, selecting accessible venues, decentralizing host locations, encouraging low carbon alternatives to air travel, increasing virtual attendance and increasing awareness.

[Unrecognised sexual abuse and abdominal and pelvic complaints]. / Miskend seksueel geweld bij buik- en bekkenklachten.

Sexual abuse is a risk factor for developing various abdominal and pelvic complaints. In this clinical lesson we present one case, highlighting this connection and how it can be missed by different medical professionals. Early identification of the underlying connection with sexual abuse can prevent re-traumatization by medical treatments, reduce the risk of the patient being abused again and raises the opportunity for a more appropriate treatment, such as addition or trauma therapy and/or pelvic physiotherapy.

[Experiences of (care) professionals during a COVID-19 outbreak and results of serological tests in the staff of a heavily affected nursing home.] / Ervaringen van (zorg)medewerkers tijdens een COVID-19 uitbraak en resultaten van serologische testen bij personeel in een zwaar getroffen verpleeghuis.

Despite compliance with national (RIVM) guidelines, nursing home Mariënburght (the Netherlands) was severely affected during the first COVID-19 wave: 68 (68%) of the residents were infected. This resulted in a large emotional impact on the (nursing) staff. This study aims to describe the experiences of (nursing) staff, as well as the results of serological tests on COVID-19 that have been administered to professionals. All professionals (n=281) were invited for group interviews to share their experiences concerning the COVID-19 outbreak and for a serological test for COVID-19. The 29 professionals participating in the group interviews mentioned negative and positive experiences about their fear and anxiety, the changed care for residents, the team spirit, the use of personal protective equipment and the testing policy. Out of 240 professionals who underwent the serological test and completed a questionnaire, 94 professionals (39%) had COVID-19 antibodies. In this group, 18 professionals (19%) indicated not having experienced any (physical) complaints related to COVID. Insight into the experiences of professionals resulted in essential learning points, in particular the importance of clear communication with and emotional support for staff. This study also reveals that many professionals of nursing home Mariënburght were affected by COVID-19. An important finding is the high percentage of asymptomatic employees (19% of 94 infected). Our results contributed to changed national testing policies and adapted recommendations in the use of personal protective equipment in nursing homes.

Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study.

BACKGROUND: In premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. RATIONALE AND DESIGN: A direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant-associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open-label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. OUTCOMES: Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.

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

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

Implementation of uterine artery embolization for symptomatic fibroids in the Netherlands: an inventory and preference study.

BACKGROUND AND PURPOSE: The Dutch national guideline on heavy menstrual bleeding was updated and published in 2013. It recommended (for the first time) that uterine artery embolization (UAE) should be part of counseling of women with symptomatic fibroids. We aimed to evaluate the implementation of UAE for symptomatic uterine fibroids in the Netherlands and to investigate gynecologists preference and other influential factors. METHODS: The primary outcome was to examine the UAE/hysterectomy ratio before and after introduction of the 2013 guideline by the use of annual hospital reports. The secondary outcome assessed factors that could influence implementation by means of a questionnaire to gynecologists. RESULTS: A total of 29/30 (97%) UAE+ hospitals and 36/52 (69%) UAE- hospitals sent their annual reports. The UAE/hysterectomy percentages in 2012, 2013 and 2014 were 7,0%, 7.0% and 6.9%, respectively. Regarding the questionnaire, the response rates were 88% and 91%, respectively. In both groups we observed a high self-perceived tendency for UAE counseling (90% versus 70%, p = .001). Approximately 50% of gynecologists from UAE- hospitals indicate they have insufficient information about UAE for appropriate counseling and 40% doubts the effectiveness of UAE. Furthermore, in the majority of gynecologists some 'urban myths' about the effectiveness and side-effects of UAE seem to persevere. CONCLUSION: Adding UAE as a treatment option to the national guideline did not change the number of performed UAEs for symptomatic fibroids. It might be useful to develop an option grid in order to offer appropriate, independent counseling and encourage shared decision making.

Niches after cesarean section in a population seeking hysteroscopic sterilization.

OBJECTIVE: To study the prevalence of hysteroscopically evaluated disruptions of the integrity of the uterine wall ('niches') in women with and without a previous cesarean section. STUDY DESIGN: A prospective cohort study was performed in a teaching hospital in the Netherlands. Women seeking hysteroscopic sterilization were included. A hysteroscopic evaluation of the anterior wall of the uterus and cervix to identify the existence of disruptions (niches) was performed in a standard manner. Primary outcome was the presence of a uterine niche, defined as any visible defect, disruption, or concavity (gap) in the anterior wall. Secondary outcome was to develop a registration form of niche features for hysteroscopic evaluation. RESULTS: In total, 713 women were included, 603 without and 110 with a previous cesarean section. In women with a previous cesarean Section 83 (75%) niches were observed using hysteroscopy. Anterior wall disruptions were not observed in women without a cesarean section. The following niche features were identified and incorporated in a registration form: polyps, cysts, myometrium defect, fibrotic tissue, (abnormal) vascular pattern, lateral branches, mucus production inside the defect, and bleeding. CONCLUSION: In a prospective cohort study among women undergoing hysteroscopic sterilization, a uterine niche could be detected by hysteroscopy in 75% of women with a previous cesarean section.

Endometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial): a national survey and a study protocol of a multicenter RCT.

Postmenopausal bleeding can be the first clinical sign of an endometrial abnormality. Because of an increased risk of malignancy, evaluation is advocated. Polyps are reported up to 40% in women with postmenopausal bleeding. These polyps carry a risk of 6% for a focal (pre-) malignancy. To perform complete diagnostic work-up, recent guidelines recommend endometrial sampling and a saline infusion sonography if a previous transvaginal ultrasound shows an endometrial thickness of more than 4 mm. The current guideline shows no consensus of the sequence of both diagnostic procedures. Hypothetically, the fluid of the saline infusion sonography (SIS) could affect the quality of the endometrial sample. We designed a randomized trial (the ESPRESSO Trial; Trial Registration No. NTR5690) to investigate the quality of the endometrial sample (Pipelle®) when performed before or after SIS in postmenopausal women. We will perform a randomized trial comparing two diagnostic work-ups (SIS and subsequent Pipelle® versus Pipelle® and subsequent SIS) in women with postmenopausal bleeding. The study will be performed in one teaching and one Academic hospital in the Netherlands. Women with postmenopausal bleeding and an endometrial thickness of more than 4 mm are eligible. The gynecologist will evaluate quality of the SIS and the quality of the Pipelle® will be evaluated by a pathologist (possible to diagnose or not). Furthermore, the incidence and intensity of pain will be evaluated. The results will give insight whether the quality of the Pipelle® is influenced by the SIS or not.

Abnormal vaginal bleeding in women with venous thromboembolism treated with apixaban or warfarin.

Abnormal vaginal bleeding can complicate direct oral anticoagulant (DOAC) treatment. We aimed to investigate the characteristics of abnormal vaginal bleeding in patients with venous thromboembolism (VTE) receiving apixaban or enoxaparin/warfarin. Data were derived from the AMPLIFY trial. We compared the incidence of abnormal vaginal bleeding between patients in both treatment arms and collected information on clinical presentation, diagnostic procedures, management and outcomes. In the AMPLIFY trial, 1122 women were treated with apixaban and 1106 received enoxaparin/warfarin. A clinically relevant non-major (CRNM) vaginal bleeding occurred in 28 (2.5 %) apixaban and 24 (2.1 %) enoxaparin/warfarin recipients (odds ratio [OR] 1.2, 95 % confidence interval [CI] 0.7-2.0). Of all CRNM bleeds, 28 of 62 (45 %) and 24 of 120 (20 %) were of vaginal origin in the apixaban and enoxaparin/warfarin group, respectively (OR 3.4; 95 % CI 1.8-6.7). Premenopausal vaginal bleeds on apixaban were characterised by more prolonged bleeding (OR 2.3; 95 %CI 0.5-11). In both pre- and postmenopausal vaginal bleeds, diagnostic tests were performed in six (21 %) and in seven (29 %) apixaban and enoxaparin/warfarin treated patients, respectively. Medical treatment was deemed not necessary in 16 (57 %) apixaban and 16 (67 %) enoxaparin/warfarin recipients. The severity of clinical presentation and course of the bleeds was mild in 75 % of the cases in both groups. In conclusion, although the absolute number of vaginal bleeding events is comparable between apixaban and enoxaparin/warfarin recipients, the relative occurrence of vaginal bleeds is higher in apixaban-treated women. The characteristics and severity of bleeding episodes were comparable in both treatment arms.

The accuracy of endometrial sampling in women with postmenopausal bleeding: a systematic review and meta-analysis.

Postmenopausal bleeding (PMB) can be the first sign of endometrial cancer. In case of thickened endometrium, endometrial sampling is often used in these women. In this systematic review, we studied the accuracy of endometrial sampling for the diagnoses of endometrial cancer, atypical hyperplasia and endometrial disease (endometrial pathology, including benign polyps). We systematically searched the literature for studies comparing the results of endometrial sampling in women with postmenopausal bleeding with two different reference standards: blind dilatation and curettage (D&C) and hysteroscopy with histology. We assessed the quality of the detected studies by the QUADAS-2 tool. For each included study, we calculated the fraction of women in whom endometrial sampling failed. Furthermore, we extracted numbers of cases of endometrial cancer, atypical hyperplasia and endometrial disease that were identified or missed by endometrial sampling. We detected 12 studies reporting on 1029 women with postmenopausal bleeding: five studies with dilatation and curettage (D&C) and seven studies with hysteroscopy as a reference test. The weighted sensitivity of endometrial sampling with D&C as a reference for the diagnosis of endometrial cancer was 100% (range 100-100%) and 92% (71-100) for the diagnosis of atypical hyperplasia. Only one study reported sensitivity for endometrial disease, which was 76%. When hysteroscopy was used as a reference, weighted sensitivities of endometrial sampling were 90% (range 50-100), 82% (range 56-94) and 39% (21-69) for the diagnosis of endometrial cancer, atypical hyperplasia and endometrial disease, respectively. For all diagnosis studied and the reference test used, specificity was 98-100%. The weighted failure rate of endometrial sampling was 11% (range 1-53%), while insufficient samples were found in 31% (range 7-76%). In these women with insufficient or failed samples, an endometrial (pre) cancer was found in 7% (range 0-18%). In women with postmenopausal bleeding, the sensitivity of endometrial sampling to detect endometrial cancer and especially atypical hyperplasia and endometrial disease, including endometrial polyps, is lower than previously thought. Therefore, further diagnostic work-up for focal pathology is warranted, after a benign result of endometrial sampling.

Annexin-A1 and caldesmon are associated with resistance to tamoxifen in estrogen receptor positive recurrent breast cancer.

Tamoxifen therapy resistance constitutes a major cause of death in patients with recurrent estrogen receptor (ER) positive breast cancer. Through high resolution mass spectrometry (MS), we previously generated a 4-protein predictive signature for tamoxifen therapy outcome in recurrent breast cancer. ANXA1 and CALD1, which were not included in the classifier, were however the most differentially expressed proteins. We first evaluated the clinical relevance of these markers in our MS cohort, followed by immunohistochemical (IHC) staining on an independent set of tumors incorporated in a tissue microarray (TMA) and regression analysis in relation to time to progression (TTP), clinical benefit and objective response. In order to assess which mechanisms ANXA1 and CALD1 might been involved in, we performed Ingenuity pathway analysis (IPA) on ANXA1 and CALD1 correlated proteins in our MS cohort. ANXA1 (Hazard ratio [HR] = 1.83; 95% confidence interval [CI]: 1.22-2.75; P = 0.003) and CALD1 (HR = 1.57; 95% CI: 1.04-2.36; P = 0.039) based patient stratification showed significant association to TTP, while IHC staining on TMA showed that both ANXA1 (HR = 1.82; 95% CI: 1.12-3.00; P = 0.016) and CALD1 (HR = 2.29; 95% CI: 1.40-3.75; P = 0.001) expression was associated with shorter TTP independently of traditional predictive factors. Pearson correlation analysis showed that the majority of proteins correlated to ANXA1 also correlated with CALD1. IPA indicated that ANXA1 and CALD1 were associated with ER-downregulation and NFκB signaling. We hereby report that ANXA1 and CALD1 proteins are independent markers for tamoxifen therapy outcome and are associated to fast tumor progression.

Treatment of Women With an Endometrial Polyp and Heavy Menstrual Bleeding: A Levonorgestrel-Releasing Intrauterine Device or Hysteroscopic Polypectomy?

We performed a literature review of reports comparing a levonorgestrel-releasing intrauterine device (LNG-IUD) with transcervical polyp resection (TCRP) as a treatment for heavy menstrual bleeding (HMB). Our second objective was to investigate the effectiveness of LNG-IUD and TCRP in reducing menstrual bleeding and the patient satisfaction with each technique. No previously reported studies have compared TCRP and LNG-IUD as treatment for HMB in premenopausal women with an endometrial polyp. Likewise, no studies are available on LNG-IUD as a treatment for HMB in the presence of an endometrial polyp. Several studies have found the LNG-IUD to be an effective treatment option for HMB, with high patient satisfaction rates. Evidence of the effectiveness of TCRP as treatment of HMB is scarce. Patient satisfaction is reported relatively good, although persistent or recurrent symptoms appear to be frequent. We conclude that no evidence is available on LNG-IUD as treatment for HMB in women with an endometrial polyp. We hypothesize that LNG-IUD could be a good alternative to TCRP for treating HMB in premenopausal women with a polyp; however, further evidence is needed, and a randomized controlled trial should be performed.

Tumor-associated inflammation as a potential prognostic tool in BRCA1/2-associated breast cancer.

The prognosis of BRCA1/2-associated breast cancer partly depends on histologic characteristics. Most of these breast cancers, however, are poorly differentiated. BRCA1-associated cancers are mainly negative for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2. Consequently, the use of these histologic features for risk stratification in BRCA1/2 breast cancer is limited. We assessed the prognostic value of additional histologic features, including tumor-associated inflammation and tumor-associated stroma in BRCA1/2 breast cancer patients. From the Rotterdam Family Cancer Clinic database, we collected demographics, tumor characteristics, and follow-up data from female BRCA1/2 breast cancer patients. Tumor samples were centrally reviewed including histologic subtype, differentiation grade, tumor-associated inflammation density, amount of tumor-associated stroma, and intratumor necrosis. The impact of these factors on recurrence-free survival (RFS) was evaluated using univariate and multivariate Cox regression, adjusted for established prognostic features and year of diagnosis. We included 138 BRCA1 and 37 BRCA2 breast cancer patients. Median follow-up after diagnosis was 9.7 years. Independent prognostic factors for RFS were tumor size (hazard ratio [HR], 2.47 for >2 versus ≤2 cm; 95% confidence interval [95% CI], 1.10-5.57), tumor-associated inflammation (HR, 0.18 for moderate/marked versus absent/mild; 95% CI, 0.05-0.61), and intratumor necrosis (HR, 2.60 for presence versus absence; 95% CI, 1.12-6.05). Established prognostic factors as nodal status and differentiation grade were not significantly related to RFS. Subgroup analyses of 138 BRCA1 and 118 triple-negative breast cancer cases showed similar results. Tumor-associated inflammation density was the strongest predictor for RFS in this series of BRCA1/2 breast cancer patients. This provides a potential risk stratification tool that can easily be implemented in routine histologic examination.

Hypertension risk in Dutch women with symptomatic uterine fibroids.

BACKGROUND: Female-specific risk factors for cardiovascular disease are understudied. We assessed whether women with uterine fibroids have a greater hypertension risk, independent of the shared risk factors for both conditions. METHODS: Blood pressure was measured in women scheduled for fibroid surgery compared to women scheduled for nonfibroid gynecological surgery and women randomly sampled from the general population. We used multivariable binary logistic regression to assess whether hypertension was more common with surgically treated fibroids, independent of age, body mass index, and African ancestry. RESULTS: We included 1,342 women (542 of African ancestry), of which 272 scheduled for fibroid surgery, 385 controls scheduled for nonfibroid gynecological surgery, and 685 random population controls, with a mean age (SD) of, respectively, 43.4 (6.6), 41.3 (10.2), and 45.1 (6.6) years; and a mean body mass index (SD) of, respectively, 27.4 (5.3), 25.7 (5.7), and 28.2 (5.6) kg/m(2). Hypertension was found more frequently with surgically treated fibroids, with an occurrence of 41.9% in women with fibroids vs. 27.5% in surgical controls, and 28.3% in population controls (P < 0.001 for fibroids vs. controls). The association with hypertension was independent of age, body mass index, and African ancestry (odds ratio, 2.4; 95% confidence interval, 1.7-3.4). CONCLUSIONS: Hypertension risk is higher in Dutch women with surgically treated fibroids than in surgery or population controls, independent of age, body mass index, and African ancestry. Our data add to the body of evidence indicating that women with uterine fibroids are eligible for hypertension screening.

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.