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Background: Systematic reviews and meta‐analyses are instrumental in shaping clinical practice. However, their findings can sometimes be marred by discrepancies and potential biases, thereby diluting the strength of the evidence presented. Umbrella reviews serve to comprehensively assess and synthesise these reviews, offering a clearer insight into the quality of the evidence presented. In the context of the relationship between sperm DNA fragmentation (SDF) and assisted conception outcomes, there is a divergence in the literature. Some reviews suggest a clear cause‐and‐effect linkage, whereas others present conflicting or inconclusive results. Objectives: In this umbrella review we aimed to synthesise the evidence collated in systematic reviews and meta‐analyses summarising the association of SDF with assisted reproductive technology (ART) outcomes. Search strategy: After preregistration (https://doi.org/10.17605/OSF.IO/6JHDP), we performed a comprehensive search of the PubMed, Scopus, Cochrane Library, Web of Science and Embase databases. We conducted a search for systematic reviews on the association between SDF and ART without any restrictions on language or publication date. Selection criteria: Systematic reviews and meta‐analyses assessing the association between SDF and ART outcomes were eligible. Data collection and analysis: We assessed the quality of the included reviews using AMSTAR 2 and ROBIS, and determined the degree of overlap of primary studies between reviews estimating the corrected covered area (CCA), adjusted for structural missingness. We evaluated the most recent reviews assessing the association of SDF with live birth, pregnancy, miscarriage, implantation, blastulation and fertilisation. The synthesis of evidence was harmonised across all included quantitative syntheses, re‐estimating the odds ratio (eOR) in random‐effects meta‐analyses with 95% confidence intervals (95% CIs) and 95% prediction intervals (95% PIs). We categorised the evidence strength into convincing, highly suggestive, suggestive, weak or nonsignificant, according to the meta‐analysis re‐estimated P‐value, total sample size, I2 statistic for heterogeneity, small study effect, excess significance bias and the largest study significance. Main results: We initially captured and screened 49 332 records. After excluding duplicate and ineligible articles, 22 systematic reviews, 15 of which were meta‐analyses, were selected. The 22 reviews showed a moderate degree of overlap (adjusted CCA 9.2%) in their included studies (overall n = 428, with 180 unique studies). The 15 meta‐analyses exhibited a high degree of overlap (adjusted CCA = 13.6%) in their included studies (overall n = 274, with 118 unique studies). AMSTAR 2 categorised the quality of evidence in 18 reviews as critically low and the quality of evidence in four reviews as low. ROBIS categorised all the reviews as having a high risk of bias. The re‐estimated results showed that the association of SDF with live birth was weak in one and nonsignificant in four meta‐analyses. Similarly, the association of SDF with pregnancy, miscarriage, implantation, blastulation and fertilisation was also weak or nonsignificant. The association of high SDF with different ART outcomes was also weak or nonsignificant for different interventions (IVF, ICSI and IUI) and tests. Conclusions: This umbrella review did not find convincing or suggestive evidence linking SDF with ART outcomes. Caution should be exercised in making any claims, policies or recommendations concerning SDF. [ABSTRACT FROM AUTHOR]

Background: There is no consensus on tests required to either diagnose unexplained infertility or use for research inclusion criteria. This leads to heterogeneity and bias affecting meta‐analysis and best practice advice. Objectives: This systematic review analyses the variability of inclusion criteria applied to couples with unexplained infertility. We propose standardised criteria for use both in future research studies and clinical diagnosis. Search strategy: CINAHL and MEDLINE online databases were searched up to November 2022 for all published studies recruiting couples with unexplained infertility, available in full text in the English language. Data collection and analysis: Data were collected in an Excel spreadsheet. Results were analysed per category and methodology or reference range. Main results: Of 375 relevant studies, only 258 defined their inclusion criteria. The most commonly applied inclusion criteria were semen analysis, tubal patency and assessment of ovulation in 220 (85%), 232 (90%), 205 (79.5%) respectively. Only 87/220 (39.5%) studies reporting semen analysis used the World Health Organization (WHO) limits. Tubal patency was accepted if bilateral in 145/232 (62.5%) and if unilateral in 24/232 (10.3%). Ovulation was assessed using mid‐luteal serum progesterone in 115/205 (56.1%) and by a history of regular cycles in 87/205 (42.4%). Other criteria, including uterine cavity assessment and hormone profile, were applied in less than 50% of included studies. Conclusions: This review highlights the heterogeneity among studied populations with unexplained infertility. Development and application of internationally accepted criteria will improve the quality of research and future clinical care. Linked article: This article is commented on by Tarek El‐Toukhy, pp. 898 in this issue. To view this mini commentary visit https://doi.org/10.1111/1471‐0528.17778 [ABSTRACT FROM AUTHOR]

Background: Findings related to the association between persistent organic pollutants (POPs) and gestational diabetes mellitus (GDM) are inconclusive. Objectives: To estimate the strength of the association between POP exposure and GDM in a systematic review with meta‐analysis. Search strategy: MEDLINE, Scopus and Web of Science were searched until July 2023. Selection criteria: Cohort and case–control studies analysing the association between POPs and GDM. Data collection and analysis: We assessed the risk of bias using the Quality in Prognosis Studies scale (QUIPS). Standardised mean differences were pooled using random‐effect models. Main results: Sixteen articles including 12 216 participants were selected. The risk of bias was high in four articles (25%), moderate in 11 (68.75%) and low in one (6.25%). Small mean difference between GDM cases and controls was observed for PFHpA (0.26, 95% confidence interval [CI] 0.1–0.35, I2 = 0.0%), PCB180 (0.37, 95% CI 0.19–0.56; I2 = 25.3%), BDE47 (0.23, 95% CI 0.0–0.45, I2 = 0%), BDE99 (0.36, 95% CI 0.14–0.59; I2 = 0%), BDE100 (0.42, 95% CI 0.19–0.64; I2 = 0%) and HCB (0.22, 95% CI 0.01–0.42, I2 = 39.6%). No considerable difference was observed for the rest of POPs. Conclusion: Small mean differences between GDM cases and controls were observed for some POPs. However, evidence shows mostly moderate quality and results were heterogeneous. Improved research methodology is needed to assess POPs and GDM risk. [ABSTRACT FROM AUTHOR]

Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi‐stakeholder consensus. Methods: The consensus was developed via: multi‐country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two‐round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer‐reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder‐provided, 46 systematic review‐generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder‐provided, 41 systematic review‐generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post‐publication concerns (n = 12), and future research and development (n = 13). Conclusion: Implementation of this multi‐stakeholder consensus statement is expected to enhance RCT integrity. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer affects 3197 women in the UK, and 604 000 women worldwide annually, with peak incidence seen in women between 30 and 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 ten participants from January 1990 to date. Data collection and analysis: Study characteristics and all reported treatment outcomes. Main results: A total of 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), postoperative complications (74/104), intra-operative complications (72/104) and quality of life (5/104). There was 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 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 Core Outcome Set for fertility-sparing surgery in cervical cancer. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate novel prediction models to personalise the risk of conversion from laparoscopic to open hysterectomy in benign conditions. Design: Retrospective cohort study. Settings: English NHS Hospitals between 2011 and 2018. Population: 68 752 women undergoing laparoscopic hysterectomy for benign conditions. Methods: We developed two multivariable logistic models using readily available clinical information, one for the pre‐operative setting and another for operative decision‐making using additional surgical information, using 2011–2016 data in five regions (24 806 women). We validated them (a) temporally in the same regions using 2017–2018 data (12 438 women); (b) geographically in the same time‐period using data from three different regions (22 024 women); and (c) temporally and geographically using 2017–2018 data in three different regions (9484 women). Main Outcome Measures: Conversion from laparoscopic to open hysterectomy. Results: Conversions occurred in 6.8% (1687/24 806) of hysterectomies in the development group, and in 5.5% (681/12 438) in the temporal, 5.9% (1297/22 204) in the geographical and 5.2% (488/9484) in the temporal and geographical validation groups. In the development cohort, the area under the receiver operating characteristic curve values for the pre‐operative and operative models were 0.65 and 0.67, respectively. In the validation cohorts the corresponding values were 0.65 and 0.66 (temporal), 0.66 and 0.68 (geographical) and 0.65 and 0.68 (temporal and geographical), respectively. Factors predictive of conversion included age, Asian ethnicity, obesity, fibroids, adenomyosis, endometriosis and adhesions. Adhesions were the most predictive (odds ratio 2.54, 95% confidence interval 2.22–2.90). Conclusion: The models for predicting conversions showed acceptable performance and transferability. Novel tool to personalise the risk of conversion from laparoscopic to open hysterectomy in benign conditions. Novel tool to personalise the risk of conversion from laparoscopic to open hysterectomy in benign conditions. [ABSTRACT FROM AUTHOR]

Objective: To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers.Design: Mixed methods study.Setting: A core outcome set for pre-eclampsia was used as an exemplar.Sample: A long list of potential core outcomes was developed by undertaking a systematic review of pre-eclampsia trials and performing a thematic analysis of in-depth patient interviews.Methods: Specific methods used to generate long lists of potential core outcomes were evaluated.Results: Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-eclampsia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-eclampsia trials reduced the number and diversity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified.Conclusions: Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. TWEETABLE ABSTRACT: @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers. [ABSTRACT FROM AUTHOR]

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]

Objective: To determine the accuracy of ultrasonographically estimated fetal weight (EFW) and abdominal circumference (AC) in the prediction of macrosomia. Design: Systematic quantitative review. Methods: Studies were identified without language restrictions from MEDLINE (1966-2003), EMBASE (1980-2003), Cochrane Library (2003:4), SCISEARCH (1974-2003) and manual searching of bibliographies of known primary and review articles. Studies were selected if accuracy of ultrasonographically EFW or AC was evaluated for predicting macrosomia using birthweight as the reference standard. Data were extracted on study characteristics, quality and accuracy. Data were pooled to produce summary receiver operating characteristic curves (sROC) for studies with various test thresholds. Summary likelihood ratios for positive (LR+) and negative (LR-) test results were generated for an EFW of 4000 g and an AC of 36 cm for predicting birthweight of over 4000 g. Main Outcome Measures: Birthweight over various thresholds. Results: There were 36 primary articles consisting of 63 accuracy studies (51 evaluating the accuracy of EFW, and 12 accuracy of fetal AC), including a total of 19,117 women. The sROC area for EFW was not different from the area for fetal AC (0.87 vs 0.85, P= 0.91). For predicting a birthweight of over 4000 g, the summary LRs were 5.7 (95% CI: 4.3 to 7.6) for a positive test and 0.48 (95% CI: 0.38 to 0.60) for a negative test, using Hadlock's method of ultrasonographically estimating fetal weight. For ultrasound fetal AC of 36 cm, the respective LRs for predicting a birthweight over 4000 g were 6.9 (95% CI: 5.2 to 9.0) and 0.37 (0.30-0.45). Conclusion: There is no difference in accuracy between ultrasonographically EFW and AC in the prediction of a macrosomic baby at birth. A positive test result is more accurate for ruling in macrosomia than a negative test result for ruling it out. [ABSTRACT FROM AUTHOR]

To explore gynaecologists'‘prior’ beliefs on effectiveness of laparoscopic uterosacral nerve ablation (LUNA), a structured survey was used to gather information on the distribution of their prior beliefs regarding the effects of LUNA on pelvic pain, both numerically [on a 10-point visual analogue scale] and by responses to a questionnaire. None of the 25 gynaecologists responding to the questionnaire stated that LUNA would increase pain, while two of the 25 gave numerical answers suggesting they believed that the intervention would worsen the pain. The most widely held‘prior belief’, reflected in both questionnaire and numerical responses, was that LUNA would have a small beneficial effect on pain. [ABSTRACT FROM AUTHOR]

The study aims to compare the utility of unadjusted with customised weight standards in the identification of intrauterine growth restriction (IUGR) among unexplained stillborn infants undergoing postmortem examination. Unadjusted and customised birthweight centiles were determined for 51 unexplained stillborn infants undergoing perinatal autopsy. Unadjusted centiles were calculated from an ultrasonically derived fetal weight standard. Customised centiles were calculated from an online calculator which adjusts the standard to account for important physiological variables. IUGR was defined as moderate or severe according to brain/liver ratios of>3 and>5, respectively. The relationship between the weight centiles and abnormal brain/liver weight ratios was explored. Neither unadjusted nor customised standards identify stillborn infants with brain/liver ratios>3:1. Both unadjusted and customised weight standards identify stillborn infants with brain/liver ratios>5 equally well with high sensitivity (95%) but low specificities (63% and 66%, respectively). Customising weight standards to account for physiological variables does not identify growth restricted stillborn infants more usefully than an unadjusted fetal weight standard. [ABSTRACT FROM AUTHOR]

Looks at the accuracy of laparoscopy in the diagnosis of endometriosis. Description of endometriosis; Procedure in laparoscopic diagnosis of endometriosis; Association of laparoscopic ablative treatment with improved reproductive outcome.

To determine the accuracy with which various types of tests for bacterial vaginosis predict spontaneous preterm birth in pregnant women.Studies were identified without language restrictions through nine different databases, and manual searching of bibliographies of known primary and review articles.There are four different bacterial vaginosis testing methods: Gram staining tests using either Nugent's or Spiegel's criteria, and gas liquid chromatography are laboratory based, and the fourth method uses clinical (Amsel's) criteria to diagnose bacterial vaginosis. Two reviewers independently selected studies and extracted data on their characteristics, quality and accuracy. Accuracy data were used to form 2× 2 contingency tables of the bacterial vaginosis test results with spontaneous preterm birth as the reference standard.Data on asymptomatic women and women with symptoms of threatened preterm labour were analysed separately. Data were pooled to produce summary estimates of likelihood ratios for positive (LR+) and negative (LR−) test results for the various types of tests.There were 18 primary articles, involving altogether 17,868 women. There was unexplained heterogeneity in the meta-analyses of the accuracy results, which requires caution in their interpretation. Meta-analyses of studies testing asymptomatic women in the second trimester showed that clinical criteria had a LR+ of 0.98 (95% confidence interval 0.59 to 1.6) and a LR− of 1.00 (0.93 to 1.1), Gram staining (Nugent's criteria) had a LR+ of 1.6 (1.4 to 1.9) and a LR− of 0.9 (0.8 to 0.9), and Gram staining (Spiegel's criteria) had a LR+ of 2.4 (1.4 to 4.9) and a LR− of 0.81 (0.64 to 1.0). Among symptomatic women, Gram staining (Spiegel's criteria) had a LR+ of 1.3 (1.0 to 1.6) and LR− of 0.9 (0.7 to 1.0).There was a lack of difference in the accuracy of the various bacterial vaginosis tests for predicting preterm birth in both asymptomatic and symptomatic women of threatened preterm labour. [ABSTRACT FROM AUTHOR]

: Objectives1.To determine the value of third trimester customised estimated fetal weight centile ranking in the prediction of infants born with anthropometric features of intrauterine growth restriction (IUGR). 2. To compare the performance of customised centiles with fetal growth velocity in the prediction of IUGR.: DesignProspective, observational study.: SettingDepartment of Obstetric Ultrasound.: PopulationTwo hundred and seventy-four women with low risk pregnancies who were participants in a previously published longitudinal study of fetal biometry.: MethodsThird trimester estimated fetal weight customised centiles were obtained after adjustment for gestational age at the time of ultrasound, birth order and gender, maternal weight, height and ethnic origin. Fetal growth velocity was calculated using the increment in the fetal abdominal area over a mean 28-day interval. Fetal abdominal area growth velocity was expressed as a standard deviation (Z score). Three neonatal anthropometric measures were used to define IUGR: subscapular or triceps skinfold thickness <10th centile, ponderal index <25th centile, mid-arm circumference to occipito-frontal circumference <−1 SD. The ability of estimated fetal weight customised centiles <5th centile and <10th centile to identify growth restriction was determined by calculating likelihood ratios.: Main outcome measureLikelihood ratios for the prediction of neonatal anthropometric features of IUGR.: ResultsTwo hundred and fifty-eight infants had an estimated fetal weight customised centile calculated and one or more anthropometric measurements. The mean customised estimated fetal weight centile for cases with and without a low skinfold thickness were 16.4 vs 41.7 (P < 0.01); the mean values of customised estimated fetal weight centile for cases with and without ponderal index <25th centile were 22.8 vs 42.7 (P < 0.01); mean estimated fetal weight customised centiles for cases with and without mid-arm circumference to occipito-frontal circumference <−1 SD were 26.3 vs 40.5 (P > 0.05). A customised estimated fetal weight centile of 5 or less had likelihood ratios (95% CI) of 4.9 (2.7–6.3), 6.8 (4.5–10.6) and 6.3 (3.7–14) for skinfold thickness <10th centile, ponderal index <25th centile and mid-arm circumference to occipito-frontal circumference <−1 SD, respectively. An estimated fetal weight customised centile of 10 or less had likelihood ratios of 4.5 (2.6–8.6), 4.1 (2.5–7.2) and 7.1 (3.5–24) for skinfold thickness <10th centile, ponderal index <25th centile and mid-arm circumference to occipito-frontal circumference <−1 SD, respectively. In the prediction of a ponderal index <25th centile, the fetal abdominal area velocity likelihood ratio for a positive test is higher than the likelihood ratio for the 10th estimated fetal weight customised centile (P = 0.04) but is not significantly higher for the other outcomes. The fetal abdominal area velocity likelihood ratio is not significantly higher than the likelihood ratios for the fifth estimated fetal weight customised centile for any of the three outcomes.: ConclusionCustomised estimated fetal weight centiles in the late third trimester are moderately useful in the identification of infants with IUGR but are less accurate than calculated growth velocity in the prediction of an infant with a low ponderal index. [Copyright &y& Elsevier]

: ObjectiveTo determine the relationship between customised birthweight centiles (adjusted for maternal and fetal physiological variables) and neonatal anthropometric features of intrauterine growth restriction (IUGR).: DesignObservational study.: PopulationTwo-hundred and seventy women with low risk pregnancies participating in a cohort study of serial ultrasound biometry.: MethodsCustomised birthweight centiles were calculated following adjustment for maternal weight, height and ethnic origin, gestational age at delivery, birth order, and sex of the infant. Three separate neonatal anthropometric measures were used to define IUGR: subscapular or triceps skinfold thickness <10th centile; ponderal index <25th centile; and mid-arm circumference to occipito-frontal circumference ratio (MAC/OFC) <−1 standard deviation (SD). Relationship of the centiles to these outcomes was evaluated using likelihood ratios (LR) and kappa statistic. These approaches allowed us to examine the strength of the association: an LR of 5–10 would be expected to generate moderate changes in the pre-test probability of IUGR, whereas a kappa value of 0.2–0.4 would reflect fair agreement between customised birthweight centiles and neonatal anthropometric measures.: ResultsCustomised birthweight centile of 10 or less had the following LR values for the various anthropometric criteria for IUGR: 5.1 (95% CI 3–8.5) for low skinfold thickness; 4.3 (95% CI 2.5–7.1) for low ponderal index; and 3.9 (95% CI 2–6.6) for low MAC/OFC ratio. The kappa values were: 0.4 (95% CI 0.26–0.51) for low skinfold thickness; 0.33 (95% CI 0.21–0.46) for low ponderal index; and 0.13 (95% CI 0–0.26) for low MAC/OFC ratio.: ConclusionIn a low risk population, customised birthweight centiles can only be moderately useful in the identification of neonates with low skinfold thickness and low ponderal index. [Copyright &y& Elsevier]

I Sir, i We would like to thank E. Mirza1 and colleagues for their interest in our study, Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial.2 We would like to point out that in light of the fact that the sample size was limited to 40 patients, the interpretation of further subgroup analysis is likely to be limited. Two patients in the VR group reported average pain scores of 0 whereas all patients in the SP group experienced some degree of pain. [Extracted from the article]

Authors' reply re: Effects of oral probiotic supplements on vaginal microbiota during pregnancy: a randomised double-blind, placebo-controlled trial with microbiome analysis It is important to recognise not only the diversity of potential probiotic bacteria and the diversity of probiotic characteristics (as the authors of this letter have done), but also the dynamic relationship with the host. Effects of oral probiotic supplements on vaginal microbiota during pregnancy: a randomised, double-blind, placebo-controlled trial with microbiome analysis. [Extracted from the article]

Presents an introduction on an international initiative on the Standards for Reporting of Diagnostic accuracy called STARD checklist for authors, reviewers and readers of test accuracy studies on evidenced-based obstetric and gynecologic diagnosis. Information on the development of STARD; Factors that readers must consider in order to comprehend and use the results of test accuracy studies; Components of the STARD checklist.