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Objective To develop a core outcome set for endometriosis. Design Consensus development study. Setting International. Population One hundred and sixteen healthcare professionals, 31 researchers and 206 patient representatives. Methods Modified Delphi method and modified nominal group technique. Results The final core outcome set includes three core outcomes for trials evaluating potential treatments for pain and other symptoms associated with endometriosis: overall pain; improvement in the most troublesome symptom; and quality of life. In addition, eight core outcomes for trials evaluating potential treatments for infertility associated with endometriosis were identified: viable intrauterine pregnancy confirmed by ultrasound; pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy; live birth; time to pregnancy leading to live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital abnormalities. Two core outcomes applicable to all trials were also identified: adverse events and patient satisfaction with treatment. Conclusions Using robust consensus science methods, healthcare professionals, researchers and women with endometriosis have developed a core outcome set to standardise outcome selection, collection and reporting across future randomised controlled trials and systematic reviews evaluating potential treatments for endometriosis. Tweetable abstract @coreoutcomes for future #endometriosis research have been developed @jamesmnduffy.

Objective To compare the levonorgestrel intrauterine system (LNG-IUS) (Mirena Ò ; Schering Co., Turku, Finland) and thermal balloon ablation (ThermachoiceÔ; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding.Design An open, pragmatic, prospective randomised trial.Setting A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand.Population Seventy-nine women with heavy menstrual bleeding randomised to the LNG-IUS (40 women) or the thermal balloon ablation (39 women).Methods Women were randomised to treatment with the LNG-IUS or thermal balloon ablation and followed up by a postal and telephone questionnaire.Main outcome measures Menstrual loss measured by a pictorial bleeding assessment chart (PBAC) at 3, 6, 12 and 24 months. Patient satisfaction, quality of life and menstrual symptoms were assessed by questionnaire administered at 3, 6, 12 and 24 months. Treatment side effects and treatment failures were also recorded.Results Both the treatments resulted in a significant reduction in PBAC scores. At 12 and 24 months, median PBAC scores were significantly lower in women treated with the LNG-IUS compared with women treated by thermal balloon ablation (11.5 versus 60.0 at 12 months [P = 0.002]; 12.0 versus 56.5 [P = 0.002] at 24 months). At 24 months, nine (35%) women still using the LNG-IUS had amenorrhoea compared with one (5%) woman successfully treated by thermal balloon ablation (P = 0.025). There were no significant differences in patient satisfaction between two treatments during follow up. Treatment failed in 11 (28%) women using the LNG-IUS and in 10 (26%) women treated with thermal balloon ablation. Overall, women in both groups showed an increased quality of life as a result of the treatment, with Short Form-36 scores increasing from 63.7 at randomisation to 76.1 at 24 months.Conclusions At 12 and 24 months of follow up, women with heavy menstrual bleeding treated with the LNG-IUS have significantly lower PBAC scores than women treated with thermal balloon ablation. Both the treatments resulted in a significant increase in overall quality of life, but there were no significant differences between either treatment in quality of life, patient satisfaction or the number of women requesting an alternative treatment during 24 months of follow up.Keywords Endometrial ablation, levonorgestrel intrauterine system, menorrhagia, thermal balloon ablation.Please cite this paper as: Busfield R, Farquhar C, Sowter M, Lethaby A, Sprecher M, Yu Y, Sadler L, Brown P, Johnson N. A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding.

Background  The presence of a wide range of tests of ovarian reserve suggests that no single test provides a sufficiently accurate result. Many tests are used without reference to an evidence base. So far, individual studies conducted on these tests are too small to give precise estimates of prognostic accuracy. Objectives  To systematically assess the accuracy of the available tests of ovarian reserve in terms of prediction of fertility outcomes. Search strategy  The search will be conducted using the name of the respective index test being studied (as listed on the MESH database), if more than 2000 citations are listed, ‘ovary’ and or ‘ovarian’, ‘fertility’ and or ‘reserve’ will be combined with the original search term as required. Studies of the accuracy of tests of ovarian reserve will be obtained without language restrictions from 1980 to 2005 using the following electronic databases and Ovid software: MEDLINE, EMBASE, PUBmed, Biological extracts, Pascal, Cochrane Library (CDSR, DARE, CCTR, HTA), Best Evidence databases, SCISEARCH, Conference Proceedings (ISI Proceedings, Healthstar, Current Contents, Science Citation Index, Cancerlit and Econlit and NHS Economic Evaluation database. The National Research Register, the Medical Research Council’s Clinical Trials Register, MEDION, DARE, and the US Clinical Trials register. Selection criteria  Studies will be selected if accuracy of tests are compared with a reference standard and include data that can be abstracted into a two‐by‐two table to calculate sensitivity and specificity. The studies to be included in this review will examine one of the following index ‘tests’ within a study population of women undergoing assisted reproductive technology: Clinical variables—age, history of cancelled cycles. Basal blood tests—follicle‐stimulating hormone (FSH), lutenising hormone (LH), FSH:LH ratios, estradiol (E2), inhibin A and B, progesterone (P4), P4:E2 ratios, antimullerian hormone, testosterone, vascular endothelial growth factor, insulin‐like growth factor‐1:insulin‐like growth factor binding protein‐1 ratios. Dynamic tests—clomiphene citrate challenge test, gonadotropin analogue stimulating test, exogenous FSH ovarian reserve test. Ultrasound tests—antral follicle count, ovarian volume, ovarian stromal peak systolic velocity, including waveform and pulsatility index, ovarian follicular vascularity. Histology—ovarian biopsy. Data collection and analysis  Two independent reviewers will perform quality assessment and data extraction. Prognostic accuracy will be determined by calculating positive and negative likelihood ratios for the following outcomes or reference standards: live birth, ongoing pregnancy, clinical pregnancy, biochemical pregnancy, embryos available for transfer, eggs obtained at oocyte retrieval, cycles cancelled prior to oocyte retrieval. Main results and conclusions  N/A.

Objective  To compare the cost‐effectiveness of levonorgestrel intrauterine system (LNG‐IUS) (Mirena®; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice™; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. Design  An open, pragmatic, prospective randomised trial. Setting  A menstrual disorders clinic at National Women’s Hospital, Auckland, New Zealand. Population  Seventy‐nine women with self‐defined heavy menstrual bleeding randomised to the LNG‐IUS (40 women) or the thermal balloon ablation (39 women). Methods  Decision tree modelling using primary source data was used to identify the incremental cost‐effectiveness of the two treatments. Main outcome measures  Direct and indirect costs of medical treatment, including treatment costs, subsequent medical procedures, lost income and medical treatment for failed procedures. The change in quality of life as assessed by the Short Form‐36 (SF‐36) measured between time of treatment and 24 months was the primary outcome measure. Economic modelling examined the expected cost and outcome for a woman entering each treatment. Sensitivity analysis explored the robustness of the results. Results  The expected cost of treatment was $NZ1241 ($US869) for the LNG‐IUS and $NZ2418 ($US1693) for the thermal balloon ablation. The LNG‐IUS was associated with an increase of 15 points on the SF‐36 scale, compared with 12 points for the thermal balloon ablation. Sensitivity analysis indicates that the results are robust to a 25% decrease in the price of the primary cost drivers and to variations in the rates of failed treatment between the conditions. Conclusion  The LNG‐IUS would appear to be cost‐effective when compared with the thermal balloon ablation for treatment of heavy menstrual bleeding.