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Досліджуване питання: якою є оптимальна тактика лікування жінок з ендометріозом, виходячи з найкращих наявних доказів, представлених у літературних джерелах?Резюмуюча відповідь: за допомогою структурованої методології Інструкції для розробки гайдлайнів ESHRE, були сформульовані 83 рекомендації, які відповіли на 22 ключових запитання щодо оптимальної тактики ведення жінок з ендометріозом.Що вже було відомо: упродовж багатьох років орієнтиром для клінічної допомоги при ендометріозі було керівництво ESHRE з діагностики та лікування ендометріозу (2005), але це керівництво потребувало оновлення.Дизайн дослідження, розмір, тривалість: керівництво було розроблене групою фахівців у даній області з використанням методології Інструкції для розробки гайдлайнів ESHRE, зокрема шляхом ретельного систематичного пошуку літературних даних, оцінки якості включених даних за період до січня 2012 року і висновки з усіх рекомендацій.Основні результати і роль випадку: керівництво надає 83 рекомендації щодо діагностики ендометріозу і лікуванню пов’язаних з ендометріозом болю і безпліддя, та менеджменту жінок, у яких хвороба виявлена випадково (без болю або безпліддя), з профілактики рецидивів захворювання та/або больових симптомів, лікуванню симптомів менопаузи у хворих з анамнезом ендометріозу і про можливий зв’язок ендометріозу та злоякісних новоутворень.Обмеження: ми визначили кілька областей допомоги жінкам з ендометріозом, для яких не достатньо надійних доказів. Ці області були оцінені як належна клінічна практика (GPP), що грунтується на експертних думках учасників групи з розробки керівництва.Широкі наслідки висновків: 32 із 83 рекомендацій з менеджменту жінок з ендометріозом не засновані на доказах високого рівня, і тому були віднесені до GPP, робоча група сформулювала дослідницькі рекомендації для майбутніх досліджень з метою підвищення рівня доказів.Фінансування дослідження/конкуруючий інтерес (и): керівництво розроблене та фінансується ESHRE. Участь членів робочої групи не оплачувалася.Всі учасники робочої групи вказали відповідні конфлікти інтересів, Study question: What is the optimal management of women with endometriosis based on the best available evidence in the literature?Summary answer: Using the structured methodology of the Manual for ESHRE Guideline Development, 83 recommendations were formulated that answered the 22 key questions on optimal management of women with endometriosis.What is known already: The European Society of Human Reproduction and Embryology (ESHRE) guideline for the diagnosis and treatment of endometriosis (2005) has been a reference point for best clinical care in endometriosis for years, but this guideline was in need of updating.Study design, size, duration: This guideline was produced by a group of experts in the field using the methodology of the Manual for ESHRE Guideline Development, including a thorough systematic search of the literature, quality assessment of the included papers up to January 2012 and consensus within the guideline group on all recommendations.Main results and the role of chance: The guideline provides 83 recommendations on diagnosis of endometriosis and on the treatment of endometriosis-associated pain and infertility, on the management of women in whom the disease is found incidentally (without pain or infertility), on prevention of recurrence of disease and/or painful symptoms, on treatment of menopausal symptoms in patients with a history of endometriosis and on the possible association of endometriosis and malignancy.Limitations: We identified several areas in care of women with endometriosis for which robust evidence is lacking. These areas were addressed by formulating good practice points (GPP), based on the expert opinion of the guideline group members.Wider implications of the findings: Since 32 out of the 83 recommendations for the management of women with endometriosis could not be based on high level evidence and therefore were GPP, the guideline group formulated research recommendations to guide future research with the aim of increasing the body of evidence.Study funding/competing interest(s): The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, with the literature searches and with the implementation of the guideline. The guideline group members did not receive payment. All guideline group members disclosed any relevant conflicts of interest.

ObjectiveTo harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration.

Introduction Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >£150 million. Proven interventions for CPP are limited, and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting value in CPP specifically. The mechanism by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, the authors believe that a large, multicentre, placebo-controlled, double-blind randomised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future randomised controlled trial. Methods and analysis The authors plan to perform a two-arm, parallel, randomised controlled pilot trial. The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian (UK) and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire compared at 0, 3 and 6 months. The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment, randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin. Ethics and dissemination Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005). Data will be presented at international conferences and published in peer-reviewed journals. Trial registration number ISRCTN70960777., Article summary Article focus Is it possible to achieve acceptable recruitment and retention rates in a two-arm, parallel, randomised controlled pilot trial of women with CPP given gabapentin and placebo? Are the proposed methods of recruitment, randomisation, drug treatments and assessment tools in this pilot trial effective and acceptable to participants? Is gabapentin likely to be cost effective for the management of CPP in women given the current level of uncertainty? Key messages CPP affects >1 million UK women, and treatments are often unsatisfactory. Gabapentin is being increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting its value in CPP specifically. A large, multicentre, placebo-controlled, double-blind randomised controlled trial (RCT) to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future RCT. Strengths and limitations of this study We recognise that there may be potential difficulties in mounting a large RCT for a chronic pain condition using gabapentin (a medication with known sedating side effects). We have designed this pilot study to assess practical feasibility. The study has been designed following the ‘Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials’ recommendations for the design of chronic pain clinical trials. Gabapentin requires titration to achieve an efficacious dose so that the rate and severity of adverse effects are minimised. We have included focus group assessment of the acceptability of the drug treatment and titrating regime in our study to inform the design of the future RCT. We plan to use a wide range of data collection tools in our study, but it is our intention to use fewer in our future RCT depending on their effectiveness in the pilot study (defined by lack of missing data, ability to detect effect and independence) and participant feedback on acceptability.

Background - There is a debate about the cost-efficiency of methotrexate for the management of ectopic pregnancy (EP), especially for patients presenting with serum human chorionic gonadotrophin levels of >1500 IU/L. We hypothesised that further experience with methotrexate, and increased use of guideline-based protocols, has reduced the direct costs of management with methotrexate.\ud \ud Methods - We conducted a retrospective cost analysis on women treated for EP in a large UK teaching hospital to (1) investigate whether the cost of medical management is less expensive than surgical management for those patients eligible for both treatments and (2) to compare the cost of medical management for women with hCG concentrations 1500–3000 IU/L against those with similar hCG concentrations that elected for surgery. Three distinct treatment groups were identified: (1) those who had initial medical management with methotrexate, (2) those who were eligible for initial medical management but chose surgery (‘elected’ surgery) and (3) those who initially ‘required’ surgery and did not meet the eligibility criteria for methotrexate. We calculated the costs from the point of view of the National Health Service (NHS) in the UK. We summarised the cost per study group using the mean, standard deviation, median and range and, to account for the skewed nature of the data, we calculated 95% confidence intervals for differential costs using the nonparametric bootstrap method.\ud \ud Results - Methotrexate was £1179 (CI 819–1550) per patient cheaper than surgery but there were no significant savings with methotrexate in women with hCG >1500 IU/L due to treatment failures.\ud \ud Conclusions - Our data support an ongoing unmet economic need for better medical treatments for EP with hCG >1500 IU/L.

Introduction: Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >£150 million. Proven interventions for CPP are limited, and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting value in CPP specifically. The mechanism by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, the authors believe that a large, multicentre, placebo-controlled, double-blind randomised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future randomised controlled trial.\ud \ud Methods and analysis: The authors plan to perform a two-arm, parallel, randomised controlled pilot trial. The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian (UK) and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire compared at 0, 3 and 6 months. The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment, randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin.\ud \ud Ethics and dissemination: Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005). Data will be presented at international conferences and published in peer-reviewed journals.