Assisted reproductive technology (ART) has expanded rapidly into a complex, highly regulated, and innovative field, with in vitro fertilisation (IVF) now accounting for millions of treatment cycles globally each year. Alongside these advances, numerous supplementary interventions, commonly referred to as "IVF add-ons," have been introduced into routine clinical practice with the aim of improving pregnancy or live birth rates, reducing miscarriage risk, or shortening time to conception. Despite their widespread adoption and substantial additional costs to patients, most IVF add-ons lack robust evidence of safety, efficacy, and cost-effectiveness. Regulatory and policy efforts to guide their use are constrained by significant methodological weaknesses in the existing evidence base, including heterogeneous definitions, suboptimal trial design, inconsistent outcome reporting, and limited translation of research findings into clinical practice. This article explores the principal methodological challenges that currently impede rigorous health technology assessment of IVF add-ons. These challenges include the absence of a clear, validated taxonomy to define and classify add-ons; lack of consensus on appropriate comparators and clinically meaningful outcomes; and failure to establish agreed thresholds for clinical utility and futility that incorporate economic considerations and patient perspectives. A major limitation arises from reliance on conventional parallel-group randomised controlled trials, which are often poorly suited to evaluating complex, multi-stage ART interventions in heterogeneous populations. We discuss the potential value of innovative trial designs-such as platform, basket, sequential multiple assignment randomised trials, hybrid pragmatic-explanatory approaches, and decentralised digital trials-to strengthen evidence generation. Collectively, these methods may enhance efficiency, improve interpretability, and better align research with real-world reproductive care.
BACKGROUND:Immersive virtual reality (VR) technology offers a non-invasive, non-pharmacological approach to reduce pain perception in patients undergoing diagnostic or interventional procedures. OBJECTIVE:To systematically evaluate the efficacy of immersive VR technology in reducing pain perception during obstetric and gynaecological procedures. SEARCH STRATEGY:We searched MEDLINE, EMBASE, CENTRAL, and CINAHL databases from inception to January 2025. SELECTION CRITERIA:We included randomised controlled trials (RCTs) evaluating VR interventions in women undergoing obstetric or gynaecological procedures. DATA COLLECTION AND ANALYSIS:We performed meta-analyses using random-effects models and assessed risk of bias using the Cochrane risk-of-bias tool for randomised trials. MAIN RESULTS:49 RCTs (5355 participants) were included. Due to clinical heterogeneity, data were analysed separately. VR resulted in a larger, consistent reduction in pain scores compared with standard care in labour (11 studies; SMD -0.93, 95% CI -1.25 to -0.60) compared to minor procedures (29 studies; SMD -0.64, 95% CI -0.97 to -0.32). VR also significantly reduced anxiety scores in both labour (8 studies; SMD -1.13, 95% CI -1.80 to -0.45) and minor procedures (17 studies; SMD -0.74, 95% CI -1.18 to -0.29). Our analysis was limited by high levels of heterogeneity and variability in procedural protocols. CONCLUSION:Immersive VR technology appears effective for reducing pain and anxiety during obstetric and gynaecological procedures, particularly during childbirth, despite substantial statistical heterogeneity. Further research is needed to optimise implementation strategies and establish clinical practice guidelines.
In the last two decades, we have consolidated our knowledge of the epidemiology and risk factors for ectopic pregnancies. Minimally invasive surgical skills are now widespread, and laparoscopic surgery is recognized as the best and safest operative treatment for extrauterine ectopic pregnancies. Based on the evidence from randomized trials published a decade ago, laparoscopic salpingectomy is accepted as the optimal surgical treatment for tubal ectopic pregnancy. However, with recent advances in surgical techniques and improvement in surgical skills, the appropriateness of tubal removal versus conservation is under increasing scrutiny. Improvements in the organization and provision of care for women presenting with early pregnancy complications, in conjunction with better quality and wider use of ultrasound imaging, have resulted in an increased ability to detect small failing ectopic pregnancies, which were impossible to diagnose in the past. Many of these pregnancies are destined to resolve spontaneously without the need for any intervention. The necessity to avoid overtreatment and the potential for iatrogenic harm in such cases has facilitated the introduction of expectant management into mainstream clinical practice. This represents one of the key developments in the care for women with ectopic pregnancies. By contrast, the efficacy of medical management with methotrexate has been questioned. Another important development in recent years has been a rapid rise in the prevalence of ectopic pregnancies that are located outside the uterine cavity but within the confines of the uterus, the largest burden of which is from Caesarean scar ectopic pregnancies. This has promoted the development of new terminology and classification of ectopic pregnancies, with the aim of raising awareness of these increasingly prevalent types and minimizing the risk of misdiagnosis. In comparison to ectopic pregnancies outside the uterus, uterine ectopic pregnancies are more difficult to diagnose and manage, and are also associated with increased maternal morbidity, mortality, and adverse reproductive outcomes. Another challenge, which is peculiar to uterine ectopic pregnancies, is their potential to progress to reach foetal viability, albeit with a high risk of extreme prematurity. This requires women and clinicians to make difficult decisions about whether these pregnancies should be terminated to protect maternal health, despite some possibility of a good foetal outcome. Herein, we provide a comprehensive review of published literature to summarize new evidence and explore emerging themes with respect to ectopic pregnancy. Our aim is to provide an overview of modern classification and diagnosis, to summarize available treatment options and recommendations, and to emphasize longer-term outcomes, including the potential psychological impact of ectopic pregnancy. We examine current knowledge gaps and outline priorities for further research.
The role of MRI pelvimetry and fetal size estimation in predicting mode of birth and risk of operative birth have been studied. However, there are no complete MRI studies that assess the maternal pelvis, fetal dimensions, and the placenta in a single protocol, in order to better inform the likelihood of operative vaginal birth or emergency caesarean section. Therefore, the aim of this pilot study was to assess the feasibility of obtaining a comprehensive prelabour assessment of maternal pelvimetry and fetal biometry using 3D MRI reconstructions, in addition to measures of placental function, in one MR examination. This was a retrospective cohort study of 29 women in late third trimester. Maternal pelvimetry and fetal measurements were performed using structural motion corrected T2 weighted MR images, placental T2* values (an indirect measure of placental oxygenation), and birth outcomes were also collected. Intra and inter-rater variability were calculated for the first 10 patients using the intraclass correlation coefficient. The correlation between manual (measuring the contour area) and calculated circumferences of maternal and fetal structures were also assessed to compare the practicability of performing the two alternative approaches. People were imaged between 36 + 1 to 38 + 4 weeks’ gestation. It was possible to obtain comprehensive maternal and fetal measurements. Intra-rater variability was generally excellent, and inter-rater reliability was moderate to excellent. There was a strong correlation between manually obtained and calculated circumferences; Spearman’s ranged from 0.75 to 0.95. Placental volume, mean T2* and kurtosis were available for 23 datasets. The median placental volume was 569.7, the median T2* mean was 44.2, and the median kurtosis was 1.4. It is possible to perform maternal pelvimetry, fetal biometry and assess placental oxygenation from one late gestation MRI examination. The approach could be employed in a large, prospective study to ascertain whether we can predict the likelihood of assisted birth or caesarean section, with automation of image analysis to minimise inter-rater variability.
INTRODUCTION:A quarter of women experience heavy periods in their lifetime, often significantly impairing their well-being, productivity and quality of life.Several treatment options are offered for heavy menstrual bleeding; however, there is limited evidence on the effectiveness, safety and cost of available treatments. We aim to conduct a comprehensive systematic review, network meta-analyses and health economic evaluation to compare all available treatment options while considering the views and treatment preferences of women with heavy menstrual bleeding. METHODS AND ANALYSIS:We will systematically search electronic databases (MEDLINE, EMBASE, CENTRAL) as well as the grey literature, conference proceedings and trial registries to identify all relevant randomised trials that evaluated any medical or surgical treatment for women with heavy menstrual bleeding regardless of their cause compared with placebo or other active treatments.We will perform pairwise and network meta-analyses using standard methods. We will report primarily on changes in menstrual blood loss (using Pictorial blood loss assessment chart scores or the Alkaline-Haematin method), quality-of-life measures, safety in addition to other important clinical outcomes.We will develop a health economic model to evaluate the cost-effectiveness of available treatments within a healthcare perspective using data inputs from the planned meta-analyses. We will calculate the incremental cost per change in alternative outcomes and present the net monetary benefit for a range of cost-effectiveness thresholds for quality-adjusted life-year gained. We will conduct consultations and a discrete choice experiment involving patient representatives to capture the factors influencing women's decision-making and treatment preferences in real life. ETHICS AND DISSEMINATION:The project was approved by the UCL Institute for Women's Health Low-Risk Research Ethics Committee (reference: 004_2023_24) and UCL Research Ethics Committee (ID 16351/003) for the planned patient involvement and qualitative research. We will produce an evidence-based decision aid toolkit and will publish the findings in peer-reviewed journals, as well as lay media outputs to inform health professionals, policymakers and the patient community. PROSPERO REGISTRATION NUMBERS: https://doi.org/10.17605/OSF.IO/4MUSF, CRD42023468055, CRD42024519622, CRD42024520558 and CRD42024520634.
IMPORTANCE:There is a need for interventions that employers and employees can adopt to optimize the health, safety, and productivity of women with menopause at the workplace. OBJECTIVE:We conducted a structured scoping review to summarize the literature and identify effective interventions that could help women manage menopausal symptoms at the workplace. EVIDENCE REVIEW:We searched electronic databases (MEDLINE and EMBASE) until July 2024 for all studies that evaluated any non-hormone interventions used among women with menopause at the workplace and reported as per PRISMA-ScR. We used a standardized data extraction tool to capture relevant data and conducted a thematic analysis to identify the prominent themes. FINDINGS:Out of 4,284 potentially relevant citations, we included seven studies, including four randomized trials and three observational studies. Four studies evaluated cognitive behavioral interventions showing improvement in hot flushes, workability, presenteeism, and quality of life, though results varied between studies. One randomized study examined the impact of a structured aerobic exercise program on menopausal symptoms and work-related outcomes showing slight improvement in workability and mental strain. Raja Yoga meditation combined with sleep hygiene education was evaluated in one randomized study showing improvements in insomnia, sleep quality, and menopausal symptoms. Offering regular consultations at an outpatient menopause clinic for managing symptoms through lifestyle modifications improved menopausal symptoms and workability at 3 months after adjusting for potential confounders. CONCLUSIONS AND RELEVANCE:Several behavioral and lifestyle interventions can help to optimize the health, productivity, and quality of life of women with menopause at the workplace. However, there is limited high-quality evidence on the best available intervention with wide variation in reported outcomes and measurement tools.
OBJECTIVES:Accurate and reliable heavy menstrual bleeding (HMB) specific quality of life (QoL) tools can offer a holistic assessment of HMB impact and response to treatment. We systematically reviewed published disease-specific QoL assessment tools for HBM to assess their methodological quality. METHODS:We searched PubMed and EMBASE until March 2024 complemented by a search of PROQOLID database and reference lists for studies reporting on the development or validation of HMB specific QoL instruments for adult women. We assessed them against the COSMIN checklist. We scored tools for their methodological quality to make recommendations for use in practice. RESULTS:We identified 2621 citations and included 17 studies reporting on the development and validation of 10 HMB specific QoL tools. All the studies were conducted in the USA and western Europe, and all were available in the English language except one. Three tools were in digital format, while seven were in paper format (7/10, 70 %). The median of QoL tool items was 21 (range 3-72) with a recall period of 1-3 months in 7/10 (70 %) tools. The overall quality was low to medium and none of the tools met all the COSMIN requirements to be recommended in clinical practice. The UFS-QOL and SAMANTA tools showed high quality for validity, responsiveness and interpretability but require further validation. CONCLUSION:None of the available QoL tools for HMB are appropriate for use in practice. There is a need to invest in developing and validating reliable tools that offer high quality qualitative and quantitative assessment.
The Coronavirus Disease 2019 (COVID-19) pandemic disrupted maternity care, highlighting the need for rapid, high-quality clinical practice guidelines (CPGs) to ensure safe care for pregnant women. We assessed the quality and recommendations of CPGs related to COVID-19 in pregnancy. Following prospective registration (PROSPERO number: CRD42022346031) we searched Medline, Web of Science, and UpToDate from inception until July 2024. The methodological quality was appraised using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). A total of 27 CPGs were included. High scores were achieved in scope and purpose (21/27, 78%) and clarity (17/27, 63%). The most poorly addressed domains were rigour of development and applicability to clinical practice (18/27, 67% and 19/27, 70% scored low quality, respectively). Overall, only four (15%) guidelines were recommended. Most CPGs (25/27, 93%) addressed COVID-19 screening and transmission prevention, but few covered psychological care (3/27, 11%) or maternal delivery preferences (4/21, 19%). Consensus was found on timing and mode of delivery (16/17, 94%), but there was disagreement on delayed cord clamping and virus transmission interventions. Evidence-based practice requires health care providers, patients and stakeholders to be aware of variations in both the quality and recommendations of CPGs, especially during times of uncertainty.
Abstract Background Male factor infertility affect up to 50% of couples unable to conceive spontaneously. Several non-hormonal pharmacological treatments have been proposed to boost spermatogenesis and increase chances of conception in men with infertility. Still, no clear evidence exists on the most effective treatment strategy. Objective We aimed to compare the effectiveness of non-hormonal pharmacological treatment options for men with infertility using a systematic review and network meta-analysis. Methods We searched MEDLINE, EMBASE, and CENTRAL until October 2023 for randomised/quasi-randomised trials that evaluated any non-hormonal pharmacological treatment options for men with idiopathic semen abnormalities or those with hypogonadism. We performed pairwise and network meta-analyses using a random effect model. We assessed risk of bias, heterogeneity, and network inconsistency. We calculated the mean rank and the surface under the cumulative ranking curve (SUCRA) for each intervention the maximum likelihood to achieve each of reported outcomes. We reported primarily on sperm concentration and other important semen and biochemical outcomes using standardised mean difference (SMD) and 95% confidence-intervals(CI). Results We included 14 randomised trials evaluating four treatments (Clomiphene citrate, Tamoxifen, Aromatase inhibitors, anti-oxidants) and their combinations in 1342 men. The overall quality of included trials was low. Sperm concentration improved with clomiphene compared to anti-oxidants (SMD 2.15, 95%CI 0.78–3.52), aromatase inhibitor (SMD 2.93, 95%CI 1.23–4.62), tamoxifen (SMD − 1.96, 95%CI -3.57; -0.36) but not compared to placebo (SMD − 1.53, 95%CI -3.52- 0.47). Clomiphene had the highest likelihood to achieve the maximum change in sperm concentration (SUCRA 97.4). All treatments showed similar effect for sperm motility, semen volume, and normal sperm morphology. FSH levels showed significant improvement with clomiphene vs.anti-oxidant (SMD 1.48, 95%CI 0.44–2.51) but not compared to placebo. The evidence networks for LH and testosterone suffered from significant inconsistency (p = 0.01) with similar trend of improvement with clomiphene compared to other treatments but not compared to placebo. Conclusion There is insufficient evidence to support the routine use of Clomiphene, tamoxifen, and aromatase inhibitors to optimise semen parameters in men with infertility. Future randomised trials are needed to confirm the efficacy of clomiphene in improving fertility outcomes in men. PROSPERO CRD42023430179.
ABSTRACT Objective To assess obstetric outcomes in pregnant women with ‘reactive hypoglycaemia’ (RH) during an oral glucose tolerance test (OGTT), defined as a 2‐h blood glucose level lower than the fasting value. Design Retrospective observational study. Setting Two tertiary maternity units in the United Kingdom. Population A total of 1498 women with singleton pregnancies attending for an OGTT between April 2019 and July 2020. Methods Maternal and neonatal outcomes were compared between three groups: gestational diabetes, reactive hypoglycaemia and normal OGTT. Both logistic and linear regression models were used, which adjusted for maternal age at booking, ethnicity, parity and BMI. Main Outcome Measures Abdominal circumference > 95th centile, polyhydramnios, gestational age at delivery, preterm birth, birthweight, neonatal hypoglycaemia, admission to neonatal unit, perinatal mortality. Results Of the 1498 women, 26.7% ( n = 400) had reactive hypoglycaemia, 27.8% ( n = 417) GDM and 45.4% ( n = 681) normal GTT. The reactive hypoglycaemia group were twice as likely to develop polyhydramnios compared with both the GDM (OR 2.77, 95% CI 1.40–5.50) and control groups (OR 2.47, 95% CI 1.31–4.65). Relative to those with GDM, women with reactive hypoglycaemia had a similar mean birthweight (mean difference 59.4 g, p = 0.06) but were less likely to experience neonatal hypoglycaemia (OR 0.30, 95% CI 0.001–0.15) or preterm birth (OR 0.33, 95% CI 0.18–0.60). No differences were found in maternal hypertensive disorders, abdominal circumference > 95th centile, shoulder dystocia, Apgar < 7, cord pH, admission to neonatal unit or perinatal mortality. Conclusion Women with reactive hypoglycaemia in this sample were at risk of adverse outcomes frequently associated with diabetes, including polyhydramnios.
Objective Ovarian Hyperstimulation syndrome (OHSS) is a common iatrogenic complication of controlled ovarian stimulation (COS) in assisted conception. OHSS can be life threatening and associated with significant morbidity. Several measures could help prevent OHSS, however, accurate risk prediction remains a challenge to enable early prevention. We aimed to review available prediction models for OHSS in women undergoing assisted conception to identify the best performing models for their accuracy, generalisability and applicability. Evidence review We searched electronic databases (MEDLINE, EMBASE, and CENTRAL) until October 2023. We included studies reporting on the development or evaluation of models predicting the risk of OHSS outcomes before or during COS among women undergoing assisted conception. We reported on models’ discrimination, calibration, type of validation, and any implementation tools for clinical practice. Results We screened 5699 citations and included 14 observational cohort studies reporting on 14 prediction models. The median sample size was 782 for participants (range 105-256381) and the majority of models were developed using logistic regression (13/14, 92.9%). The commonest predictor was maternal age (7/14, 50.0%) followed by number of antral and mature follicles (6/14, 42.9%). Six models were internally validated (6/14, 42.9%) and none were externally validated. Only one model had an implementation platform as a smartphone based-app (1/14, 7.1%). Most of the included studies had an unclear risk of bias (7/14, 50.0%) and only three studies were at low risk (3/13, 21.4%). Conclusion There are no clinically appropriate and validated prediction models for OHSS among women undergoing controlled ovarian stimulation. More research is needed to improve their generalizability and applicability into clinical practice.
Background Acute heavy menstrual bleeding is common, often leading to hospital admission and red blood cell transfusion for haemodynamic stabilisation. We aimed to evaluate the incidence, effect, and financial burden of acute heavy menstrual bleeding in the National Health Service (NHS). Methods We conducted a multi-centre, retrospective, observational service evaluation study across acute gynaecology units in NHS teaching hospitals. We collected data on all women admitted with acute heavy menstrual bleeding, who received at least one unit of red blood cell transfusion, from Jan 1 to June 30, 2024. Women who received blood transfusion for other causes, paediatric and adolescent patients, and pregnant women were excluded from the study. Data were collected by screening electronic and paper-based case notes of eligible participants. The primary outcome was the number of red blood cell units transfused per woman, and we also collected data on initiated inpatient treatment, and any treatments planned on discharge. We used descriptive statistics with multilevel regression analyses, adjusting for data clustering. We conducted a cost-analysis modelling of direct inpatient management cost and modelled the findings over 12 months. We used a prospective protocol registered on the OSF registry. Findings Between Jan 1 and June 30, 2024, 182 NHS hospitals were deemed eligible for study inclusion, 133 expressed interest to participate, 102 registered the study in the local governance department, and 98 completed the study. In total, 1332 women (1386 admissions) were included from the 98 acute gynaecology units. Most women were older than age 40 years old (n=809 [61%]), of White ethnicity (n=509 [38%]), and half had leiomyoma (uterine fibroids; n=649 [49%]). The median age at the time of admission was 42 years (IQR 36–47). In total, 3025 red blood cell units were transfused (mean 2·2 units per admission [SD 1·1]) with a median hospitalisation of 2 days (IQR 1–3). Most patients received additional tranexamic acid (862 [62%] of 1386 cases), ferrous sulphate (728 [53%] of 1386 cases), or oral hormonal therapy (709 [51%] of 1386 cases) as an inpatient, with a similar pattern for treatment on discharge. The mean direct cost per admission was £2972 (SD 2516 [95% CI 2846–3106) and mean cost of proposed management on discharge was £1735 per admission (SD 1367 [1668–1807]). The extrapolated cost of acute heavy menstrual bleeding treatment over a 12-month period assuming similar admission trends across 98 units was estimated at £13 152 580. Interpretation Acute heavy menstrual bleeding is contributing to a substantial use of red blood cells transfusion and treatment cost in the NHS. There is a need for robust, community-based early interventions that could reduce the health burden and cost associated with this condition. Funding None.
OBJECTIVE:Polycystic ovary syndrome (PCOS) is a chronic lifelong condition affecting up to 20% of women worldwide. There is limited input from affected women to guide the provision of healthcare services and future research needs. Our objective was to scope the healthcare and research priorities of women with PCOS in the United Kingdom.DESIGN:A three-staged modified Delphi method, consisting of two questionnaires and a consensus meeting involving lay representatives and healthcare professionals.PATIENTS AND MEASUREMENTS:Lay patient representatives of women with PCOS. Participants were asked to identify and rank healthcare and research priorities for their importance.RESULTS:Six hundred and twenty-four lay participants took part in our Delphi method. Over 98% were diagnosed with PCOS (614/624, 98.4%). More than half experienced difficulties to receive a PCOS diagnosis (375/624, 60%), and the majority found it difficult to access specialised PCOS health services in the NHS (594/624, 95%). The top two healthcare priorities included better education for health professionals on the diagnosis and management of PCOS (238/273, 87.1%) and the need to set up specialist PCOS services (234/273, 85.7%). The top two research priorities focused on identifying better treatments for irregular periods (233/273, 85.3%) followed by better tests for early PCOS diagnosis (230/273, 84.2%).CONCLUSIONS:We identified 13 healthcare and 14 research priorities that reflect the current health needs of women with PCOS in the United Kingdom. Adopting these priorities in future healthcare and research planning will help to optimise the health of women with PCOS and increase patient satisfaction.
BackgroundThe rising number of retracted randomised clinical trials (RCTs) is a concern over their trustworthiness. In today's digital landscape electronic observational data is easily accessible for research purposes. This emerging perspective, in tandem with the growing scrutiny of RCT credibility, may steer some researchers towards favouring non-randomized studies. It is crucial to emphasize the ongoing need for robust RCTs, shedding light on the areas within trial design that require enhancements and addressing existing gaps in trial execution.Main bodyEvidence-based medicine pivots on the nexus between empirical medical research and the theoretical and applied facets of clinical care. Healthcare systems regularly amass patient data, creating a vast reservoir of information. This facilitates large-scale observational studies, which may appear as potential substitutes for RCTs. These large-scale studies inherently possess biases that place them a notch below randomized evidence. Honest errors, data manipulation, lapses in professionalism, and methodological shortcomings tarnish the integrity of RCTs, compromising trust in trials. Research institutions, funding agencies, journal editors and other stakeholders have the responsibility to establish robust frameworks to prevent both deliberate and inadvertent mishandling of RCT design, conduct and analysis. Systematic reviews that collate robust RCTs are invaluable. They amalgamate superior evidence instrumental in improving patient outcomes via informed health policy decisions. For systematic reviews to continue to retain trust, validated integrity assessment tools must be developed and routinely applied. This way it will be possible to prevent false or untrustworthy research from becoming part of the recommendations based on the evidence.ConclusionHigh-quality RCTs and their systematic reviews play a crucial role in acquiring valid and reliable evidence that is instrumental in improving patient outcomes. They provide vital information on healthcare effectiveness, and their trustworthiness is key to evidence-based medicine.
BJOG: An International Journal of Obstetrics & GynaecologyEarly View LETTER TO THE EDITOR International collaboration is needed to preserve the use of Kielland's forceps in modern obstetrics Bassel H. Al Wattar, Corresponding Author Bassel H. Al Wattar [email protected] orcid.org/0000-0001-8287-9271 Beginnings Assisted Conception Unit, Epsom and St Helier University Hospitals, London, UK Comprehensive Clinical Trials Unit, Institute for Clinical Trials and Methodology, University College London, London, UK Correspondence BH Al Wattar, Beginnings Assisted Conception Unit, Epsom and St Helier University Hospitals, Block E, Wrythe Lane, Sutton, Carshalton SM5 1AA, London, UK. Email: [email protected]Search for more papers by this authorWilliam Parry-Smith, William Parry-Smith Department of Obstetrics and Gynaecology, Shrewsbury and Telford Hospitals NHS Trust, Telford, UKSearch for more papers by this author Bassel H. Al Wattar, Corresponding Author Bassel H. Al Wattar [email protected] orcid.org/0000-0001-8287-9271 Beginnings Assisted Conception Unit, Epsom and St Helier University Hospitals, London, UK Comprehensive Clinical Trials Unit, Institute for Clinical Trials and Methodology, University College London, London, UK Correspondence BH Al Wattar, Beginnings Assisted Conception Unit, Epsom and St Helier University Hospitals, Block E, Wrythe Lane, Sutton, Carshalton SM5 1AA, London, UK. Email: [email protected]Search for more papers by this authorWilliam Parry-Smith, William Parry-Smith Department of Obstetrics and Gynaecology, Shrewsbury and Telford Hospitals NHS Trust, Telford, UKSearch for more papers by this author First published: 22 June 2023 https://doi.org/10.1111/1471-0528.17579Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. REFERENCES 1Matsubara S, Lefor AK. Are Kielland forceps the exclusive possession of doctors from the UK? BJOG. 2023. https://doi.org/10.1111/1471-0528.17491 2Nash Z, Nathan B, Mascarenhas L. Kielland's forceps. From controversy to consensus? Acta Obstet Gynecol Scand. 2015; 94(1): 8–12. 3Al Wattar BH, Mahmud A, Janjua A, Parry-Smith W, Ismail KM. Training on Kielland's forceps: a survey of trainees' opinions. J Obstet Gynaecol. 2017; 37(3): 280–3. 4Attilakos G, Draycott T, Gale A, Siassakos D, Winter C, editors. ROBuST: RCOG operative birth simulation training. Cambridge: Cambridge University Press; 2013. 5Tao H, Wang R, Liu W, Zhao Y, Zou L. The value of intrapartum ultrasound in the prediction of persistent occiput posterior position: systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2019; 238: 25–32. 6Cardozo LD, Gibb DM, Studd JW, Cooper DJ. Should we abandon Kielland's forceps? Br Med J. 1983; 287(6388): 315–7. 7Gurney L, Al Wattar BH, Sher A, Echevarria C, Simpson H. Comparison of perinatal outcomes for all modes of second stage delivery in obstetric theatres: a retrospective observational study. BJOG. 2021; 128(7): 1248–55. 8Parris D, Siassakos D. Are Kielland forceps a safe option for birth? BJOG. 2023; 130: 865. Early ViewOnline Version of Record before inclusion in an issue ReferencesRelatedInformation
Abstract Background Effective pain control is crucial to optimise the success of medical procedures. Immersive virtual reality (VR) technology could offer an effective non-invasive, non-pharmacological option to distract patients and reduce their experience of pain. We aimed to evaluate the efficacy of Immersive virtual reality (VR) technology in reducing patient’s pain perception during various medical procedures by conducting a systematic review and meta-analysis. Methods We searched MEDLINE, EMBASE, CENTRAL, CINAHL, and SIGLE until December 2022 for all randomised clinical trials (RCT) evaluating any type of VR in patients undergoing any medical procedure. We conducted a random effect meta-analysis summarising standardised mean differences (SMD) with 95% confidence intervals (CI). We evaluated heterogeneity using I 2 and explored it using subgroup and meta-regression analyses. Results In total, we included 92 RCTs (n = 7133 participants). There was a significant reduction in pain scores with VR across all medical procedures (n = 83, SMD − 0.78, 95% CI − 1.00 to − 0.57, I 2 = 93%, p = < 0.01). Subgroup analysis showed varied reduction in pain scores across trial designs [crossover (n = 13, SMD − 0.86, 95% CI − 1.23 to − 0.49, I 2 = 72%, p = < 0.01) vs parallel RCTs (n = 70, SMD − 0.77, 95% CI − 1.01 to − 0.52, I 2 = 90%, p = < 0.01)]; participant age groups [paediatric (n = 43, SMD − 0.91, 95% CI − 1.26 to − 0.56, I 2 = 87%, p = < 0.01) vs adults (n = 40, SMD − 0.66, 95% CI − 0.94 to − 0.39, I 2 = 89%, p = < 0.01)] or procedures [venepuncture (n = 32, SMD − 0.99, 95% CI − 1.52 to − 0.46, I 2 = 90%, p = < 0.01) vs childbirth (n = 7, SMD − 0.99, 95% CI − 1.59 to − 0.38, I 2 = 88%, p = < 0.01) vs minimally invasive medical procedures (n = 25, SMD − 0.51, 95% CI − 0.79 to − 0.23, I 2 = 85%, p = < 0.01) vs dressing changes in burn patients (n = 19, SMD − 0.8, 95% CI − 1.16 to − 0.45, I 2 = 87%, p = < 0.01)]. We explored heterogeneity using meta-regression which showed no significant impact of different covariates including crossover trials (p = 0.53), minimally invasive procedures (p = 0.37), and among paediatric participants (p = 0.27). Cumulative meta-analysis showed no change in overall effect estimates with the additional RCTs since 2018. Conclusions Immersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity. Further research is needed to inform the safe adoption of this technology across different medical disciplines.
By 2050 more than 1.6 billion women worldwide will be of post-reproductive age, with >75% reporting severe menopausal symptoms. The last few years saw a gradual uplift in public awareness reaffirming the health needs of women with menopause. Still, effective translation of available evidence on menopause treatments is hindered by several methodological limitations and poor research conduct. We argue that a paradigm shift is required in menopause research to address the remaining knowledge gap and guide safe evidence-based care provision. A critical misconception across studies on menopause is the assumption that women represent a homogeneous group who respond similarly to a particular therapy irrespective of their exposure and individual risk factors. We highlight potential solutions to optimize the quality of future research in menopause including adopting robust trial methodology, standardize outcome reporting to capture quality-of-life measures, and improve lay patient and public involvement in future research.