Sensitivity to scale of willingness-to-pay within the context of menorrhagia.

OBJECTIVES: Willingness-to-pay (WTP) provides a broad assessment of well-being, capturing benefits beyond health. However, the validity of the approach has been questioned and the evidence relating to the sensitivity of WTP to changes in health status is mixed. Using menorrhagia (heavy menstrual bleeding) as a case study, this exploratory study assesses the sensitivity to scale of WTP to change in health status as measured by a condition-specific measure, MMAS, which includes both health and non-health benefits. The relationship between EQ-5D and change in health status is also assessed. METHODS: Baseline EQ-5D and MMAS values were collected from women taking part in a randomized controlled trial for pharmaceutical treatment of menorrhagia. Following treatment, these measures were administered along with a WTP exercise. The relationship between the measures was assessed using Spearman's correlation analysis, and the sensitivity to scale of WTP was measured by identifying differences in WTP alongside differences in MMAS and EQ5D values. RESULTS: Our exploratory findings indicated that WTP, and not EQ-5D, was significantly positively correlated with change in MMAS, providing some evidence for convergent validity. These findings suggest that WTP is capturing the non-health benefits within the MMAS measure. Mean WTP also increased with percentage improvements in MMAS, suggesting sensitivity to scale. CONCLUSION: When compared to quality of life measured using the condition-specific MMAS measure, the convergent validity and sensitivity to scale of WTP is indicated. The findings suggest that WTP is more sensitive to change in MMAS, than with EQ-5D.

Treatment of endometrioma for improving fertility.

Endometrioma is a frequent clinical manifestation of endometriosis. It is controversial how endometriomas may affect women's fertility. This review addresses: the impact of the endometrioma per se and of its surgical treatment on ovarian physiology, on the ovarian reserve, on spontaneous conception and pregnancy outcomes, and on IVF/ICSI outcomes. Based on current evidence, although there are plausible biological detrimental effects on the ovarian cortex surrounding the endometrioma and an impairment of the normal ovarian physiology, the clinical impact of the endometrioma per se is not significantly altered. There is a negligible detrimental effect on ovarian reserve with spontaneous ovulation not being impaired. Conversely, surgical excision of an endometrioma reduces ovarian reserve as measured by AMH levels. Studies investigating the impact of the endometrioma per se and of its surgical treatment in women requiring IVF/ICSI show similar implantation rates, clinical pregnancy rates and live birth rates between women with endometrioma and controls.

Endometrial ablation for heavy menstrual bleeding.

Endometrial ablation can be described as one of the great gynecological success stories. It has changed the management of heavy menstrual bleeding dramatically. The development of newer (second generation) endometrial ablative techniques has enabled clinicians to set up comprehensive 'one stop clinics' based on an outpatient service to treat heavy menstrual bleeding effectively without the need for general anesthetic or conscious sedation. This article describes the rationale and evidence for use of different endometrial auto-ablative systems along with relevant technical and clinical aspects. It also addresses the essentials of a successful approach to outpatient endometrial ablation along with discussion on risks, complications and contraindications of the procedure.

Hysteroscopic local anesthetic intrauterine cornual block in office endometrial ablation: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of a hysteroscopic local anesthetic intrauterine cornual block (ICOB) on pain experienced during office endometrial ablation (EA) in addition to a traditional direct local anesthetic cervical block (DCB). DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. SETTING: University teaching hospital. PATIENT(S): Women with heavy menstrual bleeding scheduled for an office endometrial ablation. INTERVENTION(S): Before office EA, DCB plus hysteroscopic ICOB just medial to each tubal ostium using local anesthetic mixture made up of 1 mL 3% mepivacaine plus 1 mL 0.5% bupivacaine versus control group receiving DBC plus ICOB with 2 mL of placebo (saline). PRIMARY OUTCOME: pain reported during procedure via visual analogue scale (VAS) from 0 to 10; secondary outcomes: postoperative pain, rescue analgesic requirement, and duration of hospital stay. RESULT(S): Most characteristics were similar across groups. The mean VAS score during the procedure was statistically significantly lower by 1.44 (95% confidence interval, -2.65 to -0.21) in the active group compared with the placebo group. There were no statistically significant differences between the two groups in the postprocedural mean VAS scores, rescue analgesic requirement, or duration of hospital stay. CONCLUSION(S): Used in addition to DCB, ICOB reduces the pain experienced during office EA compared with DCB alone. CLINICAL TRIAL REGISTRATION NUMBER: NCT01808898.

Exploring the Use of Cost-Benefit Analysis to Compare Pharmaceutical Treatments for Menorrhagia.

BACKGROUND: The extra-welfarist theoretical framework tends to focus on health-related quality of life, whilst the welfarist framework captures a wider notion of well-being. EQ-5D and SF-6D are commonly used to value outcomes in chronic conditions with episodic symptoms, such as heavy menstrual bleeding (clinically termed menorrhagia). Because of their narrow-health focus and the condition's periodic nature these measures may be unsuitable. A viable alternative measure is willingness to pay (WTP) from the welfarist framework. OBJECTIVE: We explore the use of WTP in a preliminary cost-benefit analysis comparing pharmaceutical treatments for menorrhagia. METHODS: A cost-benefit analysis was carried out based on an outcome of WTP. The analysis is based in the UK primary care setting over a 24-month time period, with a partial societal perspective. Ninety-nine women completed a WTP exercise from the ex-ante (pre-treatment/condition) perspective. Maximum average WTP values were elicited for two pharmaceutical treatments, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral treatment. Cost data were offset against WTP and the net present value derived for treatment. Qualitative information explaining the WTP values was also collected. RESULTS: Oral treatment was indicated to be the most cost-beneficial intervention costing £107 less than LNG-IUS and generating £7 more benefits. The mean incremental net present value for oral treatment compared with LNG-IUS was £113. The use of the WTP approach was acceptable as very few protests and non-responses were observed. CONCLUSION: The preliminary cost-benefit analysis results recommend oral treatment as the first-line treatment for menorrhagia. The WTP approach is a feasible alternative to the conventional EQ-5D/SF-6D approaches and offers advantages by capturing benefits beyond health, which is particularly relevant in menorrhagia.

Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

Hysteroscopic local anaesthetic intrauterine cornual 'focal local' block before endometrial ablation with direct cervical block in an outpatient setting: a feasibility study.

OBJECTIVE: To evaluate the safety, feasibility and efficacy of a hysteroscopic local anaesthetic intrauterine cornual block (ICOB) on women's perception of pain during outpatient Thermachoice endometrial ablation (TEA). STUDY DESIGN: Pre-menopausal women with heavy menstrual bleeding undergoing TEA were included in the study. The intervention used, ICOB, was a hysteroscopic injection of local anaesthetic into the myometrium just medial to each tubal ostium. The women also had a traditional direct cervical block (DCB). We measured the acceptability of ICOB and the pain score (visual analogue score scale) immediately after the procedure. RESULTS: We treated 30 patients (mean age 41 years, SD 6; BMI 29±7) between January 2012 and December 2012. All patients had a successful ICOB block and found TEA with ICOB acceptable. The mean VAS score was 3.5±2.7, which was two points lower compared to our earlier prospective cohort of patients undergoing TEA with only a DCB (mean 5.8±2.7, n=102). No serious complications occurred during the procedure or postoperatively. Three patients experienced a vasovagal response which resolved spontaneously. CONCLUSION: ICOB with DCB is a safe, feasible and efficacious method of pain control during TEA. There is however a need to evaluate efficacy of ICOB in a randomised placebo controlled trial.

Outpatient thermal balloon ablation of the endometrium.

OBJECTIVE: To determine the feasibility and potential efficacy of thermal balloon ablation of the endometrium in the outpatient setting without the need for general anesthesia or conscious sedation. DESIGN: Prospective observational study. SETTING: Outpatient hysteroscopy clinic in a university-affiliated teaching hospital. PATIENT(S): Fifty-three consecutively recruited women with menorrhagia that was unresponsive to medical treatment. INTERVENTION(S): Thermal balloon endometrial ablation using local anesthetic without conscious sedation. MAIN OUTCOME MEASURE(S): Procedure feasibility, change in menstrual symptoms, and patient satisfaction and quality of life (Menorrhagia Utility Scale and EuroQol) at 6-month follow-up. RESULT(S): Thermal balloon ablation was successfully completed in 50 (94%) of 53 women. The three failed procedures consisted of one case in which the woman could not tolerate the procedure because of severe discomfort, one case of equipment failure, and one case in which the balloon catheter could not be inserted into the uterine cavity. Completed outcome questionnaires were returned by 49 (98%) of 50 treated women. Improvement in menstrual loss was experienced by 39 (80%) of 49 women, and satisfaction with the outcome of treatment on menstrual symptoms was reported by 33 (67%) of 49 women. Significantly higher condition-specific quality-of-life scores were associated with treatment satisfaction. CONCLUSION(S): Thermal balloon ablation of the endometrium is feasible in the outpatient setting. Improvement in menstrual symptoms and satisfaction with the outcome of treatment appear to be comparable to published inpatient data. Further studies are required to determine the cost-effectiveness of outpatient compared with inpatient thermal balloon therapy.