All gynaecology departments should provide a dedicated outpatient hysteroscopy service to aid care of women and people with abnormal uterine bleeding, reproductive problems, and insertion/retrieval of intrauterine devices. [Grade A] Written information should be provided to the woman prior to their appointment. This should include details about the procedure, the benefits and risks, advice regarding pre-operative analgesia, as well as alternative options for care and contact details for the hysteroscopy unit. [Good Practice Point] Women should be made aware of other settings and modes of anaesthesia for hysteroscopy (e.g. under general or regional anaesthesia or intravenous sedation). [GPP] The woman should be advised that if they find the procedure too painful or distressing at any point, they must alert the clinical team who will stop the procedure immediately. The clinical team should alert the hysteroscopist if the woman appears to be in too much pain or is experiencing a vasovagal episode and therefore unable to voice the concerns so that the procedure can be stopped. [GPP] Women should be advised to take standard doses of oral non-steroidal anti-inflammatory agents (NSAIDs) one hour before their scheduled appointment. Vaginoscopy should be the standard technique for outpatient hysteroscopy unless the use of a vaginal speculum is required (e.g. for administering local cervical anaesthesia or dilating the cervix). [Grade A] When performing operative hysteroscopy, the smallest diameter hysteroscope should be used, with consideration given to the use of hysteroscopes with expandable outer working channels because they are associated with less pain. [Grade B] Mechanical hysteroscopic tissue removal systems should be preferred over miniature bipolar electrodes to remove endometrial polyps. [Grade A] Local anaesthesia should not be routinely administered prior to outpatient hysteroscopy where a vaginoscopic approach is used. It should be considered where use of a vaginal speculum is planned e.g. for cervical dilatation if anticipated, due to either cervical stenosis and/or the utilisation of larger-diameter hysteroscopes (>= 5mm outer diameter). [Grade A] Saline should be instilled at the lowest possible pressure to achieve a satisfactory view. [Grade A] Conscious sedation should not be routinely used in outpatient hysteroscopic procedures. [Grade B]

All gynaecology departments should provide a dedicated outpatient hysteroscopy service to aid care of women and people with abnormal uterine bleeding, reproductive problems, and insertion/retrieval of intrauterine devices. [Grade A] Written information should be provided to the woman prior to their appointment. This should include details about the procedure, the benefits and risks, advice regarding pre-operative analgesia, as well as alternative options for care and contact details for the hysteroscopy unit. [Good Practice Point] Women should be made aware of other settings and modes of anaesthesia for hysteroscopy (e.g. under general or regional anaesthesia or intravenous sedation). [GPP] The woman should be advised that if they find the procedure too painful or distressing at any point, they must alert the clinical team who will stop the procedure immediately. The clinical team should alert the hysteroscopist if the woman appears to be in too much pain or is experiencing a vasovagal episode and therefore unable to voice the concerns so that the procedure can be stopped. [GPP] Women should be advised to take standard doses of oral non-steroidal anti-inflammatory agents (NSAIDs) one hour before their scheduled appointment. Vaginoscopy should be the standard technique for outpatient hysteroscopy unless the use of a vaginal speculum is required (e.g. for administering local cervical anaesthesia or dilating the cervix). [Grade A] When performing operative hysteroscopy, the smallest diameter hysteroscope should be used, with consideration given to the use of hysteroscopes with expandable outer working channels because they are associated with less pain. [Grade B] Mechanical hysteroscopic tissue removal systems should be preferred over miniature bipolar electrodes to remove endometrial polyps. [Grade A] Local anaesthesia should not be routinely administered prior to outpatient hysteroscopy where a vaginoscopic approach is used. It should be considered where use of a vaginal speculum is planned e.g. for cervical dilatation if anticipated, due to either cervical stenosis and/or the utilisation of larger-diameter hysteroscopes (≥5mm outer diameter). [Grade A] Saline should be instilled at the lowest possible pressure to achieve a satisfactory view. [Grade A] Conscious sedation should not be routinely used in outpatient hysteroscopic procedures. [Grade B].

OBJECTIVE:To develop a core outcome set for heavy menstrual bleeding (HMB). DESIGN:Core outcome set (COS) development methodology described by the COMET initiative. SETTING:University hospital gynaecology department, online international survey and web-based international consensus meetings. POPULATION OR SAMPLE:An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. METHODS:Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. MAIN OUTCOME MEASURES:Outcome importance was assessed in the Delphi survey on a 9-point scale. RESULTS:From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. CONCLUSIONS:The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.

Background: Cervical cancer affects 3,197 women in the UK, and 604000 women worldwide annually, with peak incidence seen between 30-34 years of age. For many, fertility-sparing surgery is an appealing option where possible. However, absence of large-scale data, along with a notable variation in reported outcomes in relevant studies may undermine future efforts for consistent evidence synthesis. Objectives: To systematically review the reported outcomes measured in studies that include women who underwent fertility-sparing surgery for cervical cancer and identify whether variation exists. Search Strategy: We searched MEDLINE, EMBASE, and CENTRAL from inception to February 2019. Selection Criteria: Randomised controlled trials, cohort and observational studies, and case studies of more than 10 participants from January 1990 to date. Data Collection and Analysis: Study characteristics and all reported treatment outcomes. Main results: 104 studies with a sum of 9535 participants were identified. Most studies reported on oncological outcomes (97/104), followed by fertility and pregnancy (86/104), post-operative complications (74/104), intra-operative complications (72/104), and quality of life (5). There were huge variation and heterogeneity in reported outcomes, with only 12% being good quality and 87% being of poor quality. Conclusions: There is significant heterogeneity in the reported outcomes. An agreed Core Outcome Set (COS) is necessary for future studies to effectively harmonise reported outcomes that are measurable and relevant to patients, clinicians, and researchers. This systematic review sets the groundwork for the development of a COS for fertility sparing surgery in cervical cancer. Funding: British Medical Association’s Strutt and Harper Grant.

OBJECTIVE:This work contributed to the development of a core outcome set (COS) for heavy menstrual bleeding (HMB). The objective was to determine which research outcomes best reflect how HMB affects women's lives and to identify additional research outcomes, not previously reported. It was important to explore and record participants' reasoning for prioritising outcomes and use this information to reinforce the patients' voice during later phases of the COS development.DESIGN:Patient workshop discussions and telephone interviews.SETTING:East London teaching hospital.PARTICIPANTS:Inclusion criteria were that participants must be over 18 years old, that either they or their partner had a history of HMB and that they had a good understanding of written and spoken English.RESULTS:41 participants were recruited for the study. 8 women and 1 man completed the study. The eight female participants were representative of the different underlying causes and treatments for HMB. Participants ranged in age from their early 20s to their 60s and represented a range of ethnic groups. The five main themes that were identified as being important to patients were: 'restriction', 'relationships and isolation', 'emotions and self-perception', 'pain' and 'perceptions of treatment'. We identified eight coding nodes that did not correspond with our list of previously reported outcomes in studies of HMB. These nodes were consolidated and became five new outcomes for potential inclusion in the COS.CONCLUSIONS:HMB stops women living their lives as they would wish. It affects their relationships, education, careers, reproductive wishes, social life and mental health. This is a condition of girls and women in the prime of their lives, but for many, the constant threat of a heavy period starting means that they sacrifice that freedom. The societal and economic costs of women being incapacitated every month has an effect on everyone.TRIAL REGISTRATION:The COS study is registered with the COMET (Core Outcome Measures in Effectiveness Trials) Initiative-project reference number 789.

Introduction/Background Cervical cancer affects 3,197 UK-women and 570,000 women worldwide annually, with peak incidence seen between 30–34 years age. For many, fertility-sparing surgery is an appealing option where possible. However, absence of large-scale data, along-with a notable variation in reported outcomes in relevant studies may undermine future efforts for consistent evidence synthesis. We aimed to systematically review the reported outcomes measured in studies that include women who underwent fertility-sparing surgery for cervical cancer and identify whether variation exists. Methodology We searched MEDLINE, EMBASE, and CENTRAL from inception to February 2019. We included randomised controlled trials, cohort and observational studies, and case studies of more than 10 participants from January 1990 to date. We extracted data on study characteristics and all reported treatment outcomes. Results 104 studies with a sum of 9535 participants were identified. Most studies reported on oncological outcomes (97/104), followed by fertility and pregnancy (86/104), post-operative complications (74/104), intra-operative complications (72/104), and quality-of-life (5). There was huge variation and heterogeneity in reported outcomes, with only 12% being good quality and 87% being of poor quality. Conclusion There is significant heterogeneity in the reported outcomes. An agreed Core Outcome Set (COS) is necessary for future studies to effectively harmonise reported outcomes that are measurable and relevant to patients, clinicians, and researchers. This systematic-review sets the groundwork for the development of a COS for fertility sparing surgery in cervical cancer.

Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently.

Pain is subjective. The level of pain a person experiences is affected not only by the painful stimulus but also by the person’s psychological interpretation of the pain and previous experiences. Medical procedures are inevitably associated with some level of discomfort but, by using analgesic and anaesthetic medications appropriately, we can minimise the pain experienced. In the outpatient setting, pain is the main driver of procedure acceptability. When appropriate techniques and equipment are used, and when analgesic use is tailored to the patient and the procedure, most women deem outpatient hysteroscopic procedures acceptable. Although performing hysteroscopic procedures under general anaesthetic means that perioperative pain is not an issue, it is still important to recognise the possibility of post-operative pain and provide adequate analgesia to manage it accordingly. The aim of this chapter is to cover techniques that can minimise pain and to discuss the use of analgesic and anaesthetic medication for hysteroscopic procedures.

BackgroundThere is a substantial body of research evaluating ways to prevent and manage miscarriage, but all studies do not report on the same outcomes.ObjectiveTo review systematically, outcomes reported in existing miscarriage trials.Search strategyMEDLINE, Embase, CINAHL, and Cochrane were searched from inception until January 2017.Selection criteriaRandomised controlled trials (RCTs) reporting prevention or management of miscarriage. Miscarriage was defined as a pregnancy loss in the first trimester.Data collection and analysisData about the study characteristics, primary, and secondary outcomes were extracted.Main resultsWe retrieved 1553 titles and abstracts, from which 208 RCTs were included. For prevention of miscarriage, the most commonly reported primary outcome was live birth and the top four reported outcomes were pregnancy loss/stillbirth (n = 112), gestation of birth (n = 68), birth dimensions (n = 65), and live birth (n = 49). For these four outcomes, 58 specific measures were used for evaluation. For management of miscarriage, the most commonly reported primary outcome was efficacy of treatment. The top four reported outcomes were bleeding (n = 186), efficacy of miscarriage treatment (n = 105), infection (n = 97), and quality of life (n = 90). For these outcomes, 130 specific measures were used for evaluation.ConclusionsOur review found considerable variation in the reporting of primary and secondary outcomes along with the measures used to assess them. There is a need for standardised patient‐centred clinical outcomes through the development of a core outcome set; the work from this systematic review will form the foundation of the core outcome set for miscarriage.Tweetable abstractThere is disparity in the reporting of outcomes and the measures used to assess them in miscarriage trials.

Fetal fibronectin (fFN) is a validated test for assessing risk of preterm birth for women presenting with symptoms. Our aim was to evaluate the accuracy of fFN to detect the risk of preterm birth in asymptomatic women.

Clinical trials produce research that is intended to add to medical knowledge and improve the way we treat patients. Unfortunately, trials of the same condition don't always report the same outcomes, making synthesis of results from different studies challenging. A core outcome set (COS) is a condition-specific set of outcomes, which should be agreed and established as a minimum reporting standard for all clinical trials of interventions for that condition. This will ensure that the results can contribute to future data synthesis. Additionally, use of COS will minimise reporting biases by standardising the outcomes that are reported for a condition. A systematic review investigating caesarean rates in trials of induction of labour identified 157 trials with 31,085 included patients (Mishanina et al. CMAJ Canadian Medical Association Journal 2014;186:665–73). All of the trials reported rates of caesarean section but only 20 trials reported maternal mortality rates. Synthesis of the data for the rate of caesarean section gave a result with narrow confidence intervals (RR 0.88, 95% CI 0.84–0.93) but because the maternal mortality data was scarce and because this outcome is rare, the synthesis of the results gave a wide confidence interval (RR 1.00, 95% CI 0.10–9.57). Had all 157 trials reported maternal mortality as a core outcome, synthesis of these results would have been more likely to have produced a useful result that would be able to inform clinical guidelines. COS development has been driven by the COMET (Core Outcome Measures in Effectiveness Trials) initiative. One of the most important aspects of a COS is that all potential stakeholders are involved during the development, to ensure that the final set of outcomes is relevant to the people whom the interventions directly or indirectly target; not only researchers but health professionals, policy makers and most importantly patients and their relatives. It is envisaged that in the future, a COS will exist for all medical conditions. When designing a clinical trial, researchers should search the COMET database to check whether a COS exists for their condition of interest and if it does they should use the specified outcome in their trial or justify why they have chosen not to. NAMC is an editor for the series but was excluded from the peer-review process of this article. Full disclosure of interests available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

This systematic review with meta-analysis aimed to address the following question: what is the effect of yoga-based exercise on balance and mobility in populations who are at risk for balance and mobility impairment?

Fetal fibronectin (fFN) is a validated test for assessing risk of preterm birth for women presenting with symptoms. Our aim was to evaluate the accuracy of fFN to detect the risk of preterm birth in asymptomatic women. Searches were conducted to identify studies where fFN was performed in asymptomatic women beyond 22 weeks' gestation. EMBASE, MEDLINE, CINHAL, AMED and BNI were searched between 2005 and 2017. Studies before 2005 were identified from a published systematic review. Women were grouped as singleton pregnancies, with and without risk factors for preterm birth, and multiple pregnancy. Quality assessment was performed using QUADAS-2. When possible, data were pooled using a hierarchical, bivariate random effects model. Fifteen studies met the inclusion criteria: six studies of singleton pregnancies in women without risk factors (1236 women), four in women with risk factors for preterm birth (2628 women) and five studies were of multiple pregnancy (1427 women). The pooled sensitivity and specificity of fFN in “no risk factors singletons” were 0.48 (95% CI 0.20–0.77), and 0.96 (95% CI 0.86–0.99), respectively. The likelihood ratio of a positive test result was 12 (95% CI 4.70–30.68). The pooled sensitivity and specificity of fFN in “risk factors singletons” were 0.34 (95% CI 0.24–0.43), and 0.91 (95% CI 0.88–0.93). The accuracy of fFN in multiple pregnancies was inconclusive. Our findings suggest in asymptomatic singleton pregnancies without risk factors, a positive fFN result indicates a large shift from pre- to post-test probability, possibly identifying women at increased risk of preterm birth.

Introduction 'Core outcome sets' are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials. Methods and analysis Systematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions. Ethics and dissemination The use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services.

OBJECTIVE:The aim of this study was to identify what components of a postpartum lifestyle intervention would engage postpartum mothers who had a diagnosis of gestational diabetes.STUDY DESIGN:Two online surveys were conducted, one involving postnatal mothers with GDM (n=83), and a second for health professionals (n=46).RESULTS:Seventy-eight percent of mothers were aware that healthy eating, exercise and weight management were all important to reduce risk of subsequent type 2 diabetes. However, 80% of women in this survey were not ready to engage in a postpartum lifestyle intervention within the first 6 months of giving birth; in contrast 52% of health professionals recommended they should be engaged in the first six weeks. Group sessions were the most commonly chosen format to deliver an intervention (30%). A community setting was preferred to a medical one. Mothers wanted recipe ideas (95%) in preference to general dietary advice (76%) or cooking skills courses (39%). Walking was the main form of exercise for 79% of mothers in this sample. Women highlighted difficulty in focusing on their own health goals because of competing demands of looking after a baby (41% agreed, Median 3, IQR 2), tiredness (65% agreed, Md 4, IQR 1) and the need for childcare (64% agreed, Md 4, IQR 2).CONCLUSION:A walking programme, recipe ideas and weight monitoring may be useful components when designing a postpartum lifestyle intervention. Barriers to engagement are evident and the intervention should allow women to engage at a time that is appropriate for them.

Anemia in pregnancy affects 25% of all pregnancies in Europe with iron deficiency affecting even more. Despite supplementation, iron deficiency persists. This review will assess the effect on serum ferritin (iron stores) and hemoglobin (oxygen-carrying capacity) following iron supplementation in pregnant women with anemic and non-anemic iron deficiency. A systemic search of electronic databases and trial registers was conducted from inception to January 2014. Randomized controlled trials of iron supplementation that measured serum ferritin and hemoglobin levels before and after supplementation were selected. Two independent reviewers selected studies, extracted data and assessed quality. Descriptive analyses were carried out. The review included 23 randomized controlled trials (3525 women). In iron deficiency anemia, more studies described statistically significant increases in serum ferritin levels than in hemoglobin levels following intravenous iron supplementation. In non-anemic iron deficiency there were more statistically significant increases in serum ferritin levels than in hemoglobin levels following oral supplementation. There were no studies reporting maternal quality of life outcomes. Serum ferritin appears to change more than hemoglobin following iron supplementation. The clinical effects of this need further investigation.