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Objective: To identify outcomes relevant to women with lived experience of pre-eclampsia.Design: Qualitative interview study.Setting: A national study conducted in the United Kingdom.Sample: Purposive sample of women with lived experience of pre-eclampsia.Methods: Thematic analysis of qualitative interview transcripts.Results: Thirty women with lived experience of pre-eclampsia were interviewed. Thematic analysis identified 71 different treatment outcomes. Fifty-nine of these had been previously reported by pre-eclampsia trials. Outcomes related to maternal and neonatal morbidity, commonly reported by pre-eclampsia trials, were frequently discussed by women with lived experience of pre-eclampsia. Twelve outcomes had not been previously reported by pre-eclampsia trials. When compared with published research, it was evident that the outlook of women with lived experience of pre-eclampsia was broader. They considered pre-eclampsia in relation to the 'whole' person and attached special significance to outcomes relating to emotional wellbeing and the future health, development and wellbeing of their offspring.Conclusions: Selecting, collecting and reporting outcomes relevant to women with pre-eclampsia should ensure that future pre-eclampsia research has the necessary reach and relevance to inform clinical practice. Future core outcome set development studies should use qualitative research methods to ensure that the long list of potential core outcomes holds relevance to patients.Tweetable Abstract: What do women want? A national study identifies key treatment outcomes for women with pre-eclampsia. Next step: @coreoutcomes for #preeclampsia @NIHR_DC. [ABSTRACT FROM AUTHOR]

The article presents a comment to the gold standard in reproductive medicine and advances in assisted reproductive technology (ART). It discusses the expensive cost for fertility treatments, the gap between clinical practice and evidence, and the challenges for evidence-based ART. It also examines the risk of informed patient choice.

Background: Selecting appropriate outcomes to reflect both beneficial and harmful effects is a critical step in designing childbirth trauma trials.Objective: To evaluate the outcomes and outcome measures reported in randomised controlled trials evaluating interventions for childbirth trauma.Search Strategy: Randomised trials were identified by searching bibliographical databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE.Selection Criteria: Randomised trials evaluating the efficacy and safety of different techniques in the management of perineal lacerations.Data Collection and Analysis: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted the relevant data. Spearman's ρ correlation and multivariate linear regression analysis using the backward stepwise model were used for analysis.Main Results: Forty-eight randomised trials, reporting data from 20 308 women, were included. Seventeen different interventions were evaluated. Included trials reported 77 different outcomes and 50 different outcome measures. Commonly reported outcomes included pain (34 trials; 70%), wound healing (20 trials; 42%), and anorectal dysfunction (16 trials, 33%). In the multivariate analysis, no relationship was demonstrated between the quality of outcome reporting and year of publication (P = 0.31), journal impact factor (P = 0.49), and methodological quality (P = 0.13).Conclusion: Outcome reporting in childbirth trauma research is heterogeneous. Developing, disseminating, and implementing a core outcome set in future childbirth trauma research could help address these issues.Tweetable Abstract: Developing @coreoutcomes for childbirth trauma research could help to reduce #research waste. [ABSTRACT FROM AUTHOR]

Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions.Objective: To assess safety reporting in pre-eclampsia trials.Search Strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017.Selection Criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia.Data Collection and Analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting.Main Results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports.Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms.Funding: National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK.Tweetable Abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. [ABSTRACT FROM AUTHOR]

Background: The development of clinical guidelines requires standardised methods informed by robust evidence synthesis.Objectives: We evaluated the methodological quality of endometriosis guidelines, mapped their recommendations, and explored the relationships between recommendations and research evidence.Search Strategy: We searched EMBASE, MEDLINE, and PubMed from inception to February 2016.Selection Criteria: We included guidelines related to the diagnosis and management of endometriosis.Data Collection and Analysis: The search strategy identified 879 titles and abstracts. We include two international and five national guidelines. Four independent authors assessed the methodological quality of the included guidelines, using the Appraisal of Guidelines for Research & Evaluation (AGREE-II) instrument, and systematically extracted the guideline recommendations and supporting research evidence.Main Results: One hundred and fifty-two different recommendations were made. Ten recommendations (7%) were comparable across guidelines. The European Society of Human Reproduction and Embryology was objectively evaluated as the highest quality guideline (methodological quality score: 88/100). There was substantial variation between the supporting evidence presented by individual guidelines for comparable recommendations. Forty-two recommendations (28%) were not supported by research evidence. No guideline followed the standardised guideline development methods (AGREE-II).Conclusions: There is substantial variation in the recommendations and methodological quality of endometriosis guidelines. Future guidelines should be developed with reference to high-quality methods in consultation with key stakeholders, including women with endometriosis, ensuring that their scope can truly inform clinical practice and eliminate unwarranted and unjustified variations in clinical practice. TWEETABLE ABSTRACT: #Endometriosis guidelines vary in recommendations and quality. @EndometriosisUK. [ABSTRACT FROM AUTHOR]

Background: The development of a non-invasive and accurate diagnostic biomarker for endometriosis is urgently needed.Objective: Evaluate the diagnostic accuracy of serum cancer antigen 125 (CA 125) for endometriosis.Search Strategy: We searched EMBASE, MEDLINE, and Web of Science from inception to January 2016.Selection Criteria: Diagnostic accuracy studies of serum CA 125 (index test) for histologically confirmed endometriosis (reference standard) were included.Data Collection and Analysis: Two authors independently selected trials, extracted study characteristics and data. Methodological quality was assessed using Quality Assessment of Comparative Diagnostic Accuracy Studies (QUADAS-2) checklist.Main Results: Twenty-two studies (16 cohort, six case-control), 3626 participants, were identified. Bivariate hierarchical models were used to pool accuracy data of 14 studies (2920 participants) using CA 125 ≥ 30 units/ml. Pooled specificity was 93% (95% CI 89-95%) and sensitivity 52% (95% CI 38-66%). CA 125 was significantly more sensitive for the diagnosis of moderate or severe endometriosis compared with minimal disease (63%, 95% CI 47-77% versus 24%, 95%CI 19-32%, P-value = 0.001).Conclusions: CA 125 performs well as a rule-in test facilitating expedited diagnosis and ensuring investigation and treatment can be confidently tailored for the management of endometriosis. Unfortunately, a negative test, CA 125 < 30 units/ml, is unable to rule out endometriosis.Tweetable Abstract: Blood test CA 125: a rule-in test for the diagnosis of women presenting with symptoms of endometriosis. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of the dimensions of the uterine cavity in relation to the expulsion, or removal for displacement, of intrauterine devices (IUDs) MLCu375 and TCu380A.Design: A case-control study nested in a multicentre clinical trial.Setting: Eighteen family planning clinics in China.Population: Forty-eight pairs of TCu380A users and 118 pairs of MLCu375 users.Methods: The women were classified as cases if IUD expulsion or displacement occurred during the first year of follow-up after insertion. One control was randomly selected for each case matched by IUD model, centre, age, service provider for insertion, and date of insertion. Axial length of the uterine cavity (LUC) and the largest transverse diameter of the coronal section of the uterine cavity (LTD) were measured using abdominal ultrasound. We used multivariate conditional logistic regressions to estimate the adjusted odds ratios (aORs) of expulsions or displacements among women with different sizes of uterine cavity according to the quartile of LUC and LTD, respectively.Results: Among MLCu375 users, women with LTD ≥ 27 mm had a higher risk of expulsion or displacement (aOR 2.40; 95% confidence interval, 95% CI, 1.02-5.63), after adjusting for the volume of menstrual flow, dysmenorrhoea, parity, uterine position, MLCu375 type, and LUC. Among TCu380A users, the association between LTD ≥ 37 mm and expulsion or displacement (aOR 4.98; 95% CI 1.01-22.49) was statistically significant, after adjusting for LUC and potential confounding factors.Conclusion: Our study suggests that LTD should be considered when making the decision of which IUD model to use. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy and safety of human chorionic gonadotropin (hCG), gonadotropin-releasing hormone (GnRH) agonist, dual, and double triggers in predicted healthy responders undergoing ovarian stimulation and in vitro fertilization., Design: A systematic review and network meta-analysis of randomized controlled trials (RCTs)., Data Sources: Randomized controlled trials indexed in PubMed, MEDLINE, EMBASE, clinical trial registries, and Cochrane Database of Systematic Reviews up to December 2023., Study Selection and Synthesis: Twelve high-integrity RCTs comprising 1,931 women were included, which compared hCG trigger with GnRH agonist trigger, dual trigger, and double trigger. Statistical analysis was performed using STATA version 16., Main Outcome Measures: Key outcomes included clinical pregnancy rates (CPR), live birth rates (LBR), number of oocytes, number of mature oocytes, miscarriage rates, and rates of ovarian hyperstimulation syndrome., Results: The network meta-analysis for CPR were risk ratio (RR), 1.13; (95% confidence interval [CI], 0.80-1.60) for hCG vs. GnRH agonist trigger, RR, 1.23 (95% CI, 0.92-1.65) for hCG vs. dual trigger, RR, 0.38 (95% CI, 0.21-0.69) for hCG vs. double trigger, RR, 1.09 (95% CI, 0.70-1.70) for GnRH agonist vs. dual trigger and 0.34 (95% CI, 0.17-0.67) for GnRH agonist vs. double trigger, and RR, 0.31 (95% CI, 0.16-0.60) for double vs. dual trigger. Dual trigger demonstrated the highest Surface Under the Cumulative Ranking (85.1%), indicating superior efficacy for CPR. For LBR, although connectivity was limited, the RR was 1.31 (95% CI, 1.00-1.70) for dual vs. hCG trigger, and RR, 1.60 (95% CI, 1.05-2.43) for dual vs. GnRH agonist trigger. Ovarian hyperstimulation syndrome rates were significantly lower with the GnRH agonist compared with hCG trigger (RR, 0.56; 95% CI, 0.19-1.75). There were no RCTs reporting ovarian hyperstimulation syndrome rates with the use of dual or double trigger. No significant differences were observed in the number of oocytes retrieved, mature oocytes, or miscarriage rates among the trigger protocols., Conclusion and Relevance: The findings indicate that there is no evidence to suggest that using GnRH agonist, dual, or double protocols is superior to hCG trigger in improving CPR. Although LBR may benefit from dual trigger, results are limited by available RCTs. Larger, multicenter trials are needed for further evaluation of LBR and understanding of long-term outcomes., Competing Interests: Declaration of Interests Y.B. has nothing to disclose. T.C. has nothing to disclose. J.M.N.D. has nothing to disclose. I.S. reports honoraria from Ferring, Merck, and Gideon Richter; and travel support from Ferring, Merck, and Institut Biochimique SA, outside the submitted work. M.S. has nothing to disclose. R.W. has nothing to disclose. S.K.S. has nothing to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To develop a core set of prenatal and neonatal outcomes for clinical studies evaluating perinatal interventions for congenital diaphragmatic hernia, using a validated consensus-building method., Methods: An international steering group comprising 13 leading maternal-fetal medicine specialists, neonatologists, pediatric surgeons, patient representatives, researchers and methodologists guided the development of this core outcome set. Potential outcomes were collected through a systematic review of the literature and entered into a two-round online Delphi survey. A call was made for stakeholders with experience of congenital diaphragmatic hernia to review the list and score outcomes based on their perceived relevance. Outcomes that fulfilled the consensus criteria defined a priori were discussed subsequently in online breakout meetings. Results were reviewed in a consensus meeting, during which the core outcome set was defined. Finally, the definitions, measurement methods and aspirational outcomes were defined in online and in-person definition meetings by a selection of 45 stakeholders., Results: Overall, 221 stakeholders participated in the Delphi survey and 198 completed both rounds. Fifty outcomes met the consensus criteria and were discussed and rescored by 78 stakeholders in the breakout meetings. During the consensus meeting, 93 stakeholders agreed eventually on eight outcomes, which constituted the core outcome set. Maternal and obstetric outcomes included maternal morbidity related to the intervention and gestational age at delivery. Fetal outcomes included intrauterine demise, interval between intervention and delivery and change in lung size in utero around the time of the intervention. Neonatal outcomes included neonatal mortality, pulmonary hypertension and use of extracorporeal membrane oxygenation. Definitions and measurement methods were formulated by 45 stakeholders, who also added three aspirational outcomes: duration of invasive ventilation, duration of oxygen supplementation and use of pulmonary vasodilators at discharge., Conclusions: We developed with relevant stakeholders a core outcome set for studies evaluating perinatal interventions in congenital diaphragmatic hernia. Its implementation should facilitate the comparison and combination of trial results, enabling future research to better guide clinical practice. © 2023 International Society of Ultrasound in Obstetrics and Gynecology., (© 2023 International Society of Ultrasound in Obstetrics and Gynecology.)

Objective: To address methodological deficiencies in published randomized controlled trials and systematic reviews, this study has developed a core outcome set to guide future research in ectopic pregnancy (EP)., Design: To identify potential outcomes, we performed a comprehensive literature review and interviews with individuals with lived experience in EP. Potential core outcomes were then entered into a 3-round Delphi survey. A total of 154 participants from 6 continents, comprising health care professionals, researchers, and individuals with lived experience in EP, completed all 3 rounds of the Delphi survey. Outcomes were prioritized at 3 consensus development meetings, and recommendations were developed on how to report these outcomes where possible., Setting: Not applicable., Patient(s): Health care professionals, researchers, and individuals with lived experience in EP., Intervention(s): Not applicable., Main Outcome Measure(s): Consensus for inclusion in core outcome set., Result(s): Six outcomes reached full consensus, including treatment success, resolution time, the number of additional interventions, adverse events, mortality and severe morbidity, and treatment satisfaction., Conclusion(s): The core outcome set with 6 outcomes for EP will help standardize reporting of clinical trials, facilitate implementation of findings into clinical practice, and enhance patient-centered care., (Copyright © 2023 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which have been identified as an important research priority., Objectives: To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth., Search Strategy: Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021., Selection Criteria: Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention., Data Collection and Analysis: Interventions, outcomes reported, definitions and outcome measurement tools were extracted., Main Results: Forty randomised and 200 non-randomised studies were included. Fifty-eight different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). A total of 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. A total of 242 outcome measurement instruments were used, with 0-22 tools per outcome., Conclusions: Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Study Question: We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research., What Is Known Already: Research into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to male infertility research., Study Design Size Duration: Stakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the modified Delphi method, modified Nominal Group Technique and the National Institutes of Health's consensus development conference., Participants/materials Setting Methods: An international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes., Study Funding/competing Interests: This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open . K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests., Trial Registration Number: Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586., Trial Registration Date: N/A., Date of First Patient’s Enrolment: N/A., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)

Study Question: What are the primary outcomes and outcome measures used in randomized controlled trials (RCTs) evaluating potential treatments for male infertility in the last 10 years?, Summary Answer: Outcome reporting across male infertility trials is heterogeneous with numerous definitions and measures used to define similar outcomes., What Is Known Already: No core outcome set for male infertility trials has been developed. Male infertility trials are unique in that they have potentially three participants, a man, a female partner and their offspring and this will likely lead to significant variation in outcome reporting in randomized trials., Study Design Size Duration: A systematic review of RCTs mapping outcomes and outcome measures evaluating potential treatments for men with infertility registered in the Cochrane Register of Controlled Trials (CENTRAL) between January 2010 and July 2021., Participants/materials Setting Methods: Abstract screening and study selection was undertaken in duplicate using a review protocol that was developed prior to commencing the review. No risk of bias assessment was undertaken as this review aims to report on outcome reporting only., Main Results and the Role of Chance: One hundred and seventy-five RCTs were identified, and given the large number of studies we limited our review to the 100 largest trials. Seventy-nine different treatments were reported across the 100 largest RCTs including vitamin and dietary supplements (18 trials), surgical treatments (18 trials) and sperm selection techniques (22 trials). When considering the largest 100 trials (range: 80-2772 participants), 36 primary and 89 secondary outcomes were reported. Forty-seven trials reported a primary outcome and 36 trials clearly defined their primary outcome. Pregnancy outcomes were inconsistently reported and included pregnancy rate (51 trials), pregnancy loss including miscarriage, ectopic pregnancy, stillbirth (9 trials) and live birth (13 trials). Trials consistently reporting the same outcome frequently used different definitions. For example, semen quality was reported by 75 trials and was defined in 7 different ways, including; the World Health Organization (WHO) 2010 criteria (32 trials), WHO 1999 criteria (18 trials), WHO 1992 criteria (3 trials), WHO 1999 and 1992 criteria (1 trial) and the Kruger strict morphology criteria (1 trial)., Limitations Reasons for Caution: We only evaluated the 100 largest trials published in the last 10 years and did not report outcomes on the remaining 75. An outcome was included as a primary outcome only if clearly stated in the manuscript and we did not contact authors to clarify this. As our review mapped outcomes and outcome measures, we did not undertake an integrity assessment of the trials included in our review., Wider Implications of the Findings: Most randomized trials evaluating treatments for male infertility report different outcomes. Only half of the RCTs reported pregnancy rate and even fewer reported live birth; furthermore, the definitions of these outcomes varies across trials. Developing, disseminating and implementing a minimum data set, known as a core outcome set, for male infertility research could help to improve outcome selection, collection and reporting., Study Funding/competing Interests: A.P.-chairman of external scientific advisory committee of Cryos International Denmark ApS, member of the scientific advisory board for Cytoswim LDT and ExSeed Health. Guest lecture at the 'Insights for Fertility Conference', funded by MERK SERONO Limited. M.v.W.-holds a ZON-MW research grant. No external funding was obtained for this study., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.)