Preterm neonatal survival: what is the role of prognostic models?Elizabeth M McClure, PhD1Robert L Goldenberg, MD21Social, Statistical and Environmental Sciences, RTI International, Durham, NC2Columbia University, New York, NYEven before the 1960’s and the introduction of the specialty of neonatology, and continuing to the present, numerous efforts have been made to understand the relationship between newborn birthweight and the risk of mortality. (1) With the development of neonatal intensive care units (NICUs), attention to survival rates and neurologic outcomes among those at the lowest birthweights and gestational ages (GA) has grown. (2) Defining the lower limits of GA or birthweight associated with the neonatal outcomes is important for clinicians, families, and others to inform appropriate decision-making and clinical care.To predict newborn survival, numerous models have been developed to estimate risk at specific birthweights and/or GAs. To date, more than 35 have been published, almost exclusively from high-income countries with advanced NICU care. In a study published recently, van Beek et al sought to validate one of these predictive models from the United Kingdom (UK), deemed to be among the highest quality, with the objective of assessing its value for clinical use. (3)Van Beek et al used an independent Dutch population to validate survival among very preterm infants using the UK model’s parameters. Because they found relatively good performance, the authors’ concluded that the model could inform daily clinical practice. However, the generalizability of their results, especially to other populations differing by ethnicity or socioeconomic status, is questionable. The parameters for the model quality focused on birthweight, GA, and gender, but many other metrics (including the racial diversity, quality of care, etc.) were limited. In particular, the interventions available and utilized for obstetric and neonatal care were not specified, which would be important for their goal of clinical use of the model. Importantly, the quality of obstetric care is not considered. (4) Both the availability and quality of specific obstetric and neonatal interventions in any given setting may be among the most important factors impacting survival.Especially important for clinical considerations, long-term outcomes, including severe disabilities, were not addressed. Concerns about neurodevelopmental outcomes in infants at the lower limits of birthweight and GA are as or more important to parents and caregivers than survival. (5) It is thus unclear how this – or virtually any other model - can be useful for “daily clinical practice”.A better strategy to inform clinical care is for individual health-care facilities to maintain neonatal survival and neurological outcome statistics. These types of data within a specific context may be more helpful to physicians, including obstetricians and neonatologists, who often, together with parents and caregivers, make decisions related to interventions prior to delivery or during NICU care. Newborn outcomes, especially at the extreme lower limits of birthweight and GA, remains an area of intense interest. While models may provide some supportive information, it is difficult to imagine that these will ever replace clinical decisions informed by actual outcome data from the specific facility.Conflicts of interest: The authors declare no conflicts of interest.References:1. Goldenberg RL, Nelson KG, Dyer RL, Wayne JB. The variability of viability: the effect of physicians’ perceptions of viability on the survival of very low birth weight infants. Am J Obstet Gynecol 1982; 143:678-84.2. Bottoms SF, Paul RH, Mercer BM, MacPherson CA, Caritis SN, Moawad AW. Obstetric determinants of neonatal survival: antenatal predictors of neonatal survival and morbidity in extremely low birth weight infants. Am J Obstet Gynecol. 1999 80(3 Pt 1):665-9.3. Van Beek P.E, Groenendaal F, Onland W, Koole S, Dijk PH, Dijkmanet KP et al. Prognostic model for predicting survival in very preterm infants: an external validation study. BJOG (in press)4. Goepfert AR, Goldenberg RL, Hauth JC, Bottoms SF, Iams JD, Mercer BM Obstetrical determinants of neonatal neurological morbidity in < or = 1000-gram infants. Am J Perinatol. 1999;16(1):33-42.5. Iams JD, Mercer BM. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. What we have learned about antenatal prediction of neonatal morbidity and mortality. Semin Perinatol 2003:247-52.
Mini commentary on BJOG-21-0823: Pregnancy outcomes in women with Budd-Chiari syndrome or portal vein thrombosis - A multicentre retrospective cohort study.Budd-Chiari syndrome (BCS) and portal vein thrombosis (PVT) are rare thrombotic disorders which can affect females of reproductive age. Physiological changes in pregnancy may result in or exacerbate pre-existing known portal hypertension related issues associated with these conditions. These conditions may also present de-novo in pregnancy with acute onset ascites or variceal haemorrhage. Both in pregnancy and in the non-pregnant state, in those with established disease, in general, the overall balance of risk, favours continued anticoagulation.The study by Wiegers et al. has shown favourable maternal and foetal outcomes once greater than 20 weeks gestation is reached in patients with BCS and/or PVT. However, the risk of preterm birth and early pregnancy loss remains. These results are in keeping with the recent study by Andrade et al. (Journal of Hepatology 2018; 69: 1242-1249) looking at pregnancy outcomes from 24 pregnancies in 16 women with idiopathic non-cirrhotic portal hypertension (INCPH). Rautou et al. (Journal of Hepatology 2009; 51: 47-54) reviewed 24 pregnancies in 16 women with BCS and also reported similar findings. Taken as a whole, these results support the concept that patients with vascular liver disease can achieve favourable pregnancy outcomes but warrant careful consideration in pregnancy.Preconception counselling is a crucial opportunity to optimise patients with vascular liver disease who are considering pregnancy. This can be achieved in a multidisciplinary forum with input from obstetricians, haematologists and hepatologists. It is useful to identify those women with significant portal hypertension and varices before pregnancy so that appropriate surveillance and eradication with endoscopic band ligation and/or prophylaxis with beta blockers is undertaken. If pregnancy is achieved before surveillance, then a second trimester endoscopy for those with significant portal hypertension should be performed. In patients with portal and mesenteric vein thrombosis, magnetic resonance imaging of the pelvis may be needed to assess for the presence of abdominal wall/pelvic varices. This stratifies the risk of a variceal bleed and allows planning of the mode of delivery (caesarean, vaginal or assisted vaginal delivery). Wiegers et al. reported 2 variceal bleeds in pregnancy but did not find a significant association with adverse maternal outcomes, though this may be related to the low number of patients. Andrade et al. also reported 2 variceal bleeds including 1 patient with PVT without adequate endoscopic prophylaxis who required a portosystemic shunt. This outlines the need for appropriate screening and portal hypertension management according to findings.The majority of patients with BCS and PVT have an underlying pro-thrombotic tendency and the intra-partum and the post-partum periods are associated with thrombotic events. Vitamin K antagonists are historically the commonest anticoagulation used in BCS and PVT which should be switched to low molecular heparin ideally before conception. The use of anticoagulation is more common in patients with BCS and PVT than in INCPH (38/45 women in BCS and/or PVT compared to 4/16 in INCPH). 4 out of 6 women with BCS and/or PVT who experienced post-partum haemorrhage (PPH) were on anticoagulation. 2 patients with INCPH had PPH whilst on anticoagulation which may be confounded by the thrombocytopenia and type-2 error. In the study by Rautou et al., 17/24 pregnancies received anticoagulation and the 4 women who experienced post-partum bleeding (vaginal or intrauterine/parietal haematoma) were on anticoagulation which includes one woman with an ectopic pregnancy. No maternal deaths were reported in the three studies and the continued use of anticoagulation when indicated is safe and appropriate.The mode of delivery did not affect the risk of PPH in the three studies. The mode of delivery should be decided based on the individual risk profile taking into account the severity of portal hypertension, distribution of venous thrombosis, presence of coagulopathy and thrombocytopenia, obstetric indications and the presence of oesophageal or abdominal wall/pelvic varices.The live birth rates may be lower in patients with BCS compared to PVT (75% versus 82% after excluding first trimester pregnancy loss) but due to the low number of patients it remains difficult to interpret the results in this study. In the study by Andrade et al., all 18 pregnancies reaching 20 weeks gestation were delivered with 2 infant deaths (both preterm births). Rautou et al. reported 16/17 live births in pregnancies reaching 20 weeks gestation.To conclude, patients with BCS and PVT after 20 weeks gestation and appropriate planning can have a reasonable expectation for delivery and successful outcomes. Preconception counselling and antenatal care with multidisciplinary input is key to achieving this goal.
Unlike many viral infections such as influenza, and the two previous incarnations of the coronavirus, SARS and MERS, Covid-19 originally appeared to be of similar severity, after adjusting for age, BMI and other co-morbidities, in the pregnant as in the non-pregnant population. Worryingly the paper from the Italian Obstetric Surveillance System COVID-19 Working Group (p …), suggests that, in pregnancy, the virus may be getting more virulent with the advent of newer variants. Specifically the need for ventilation or ICU admission was significantly increased during the second wave (alpha variant predominant) compared to the first (wild-type predominant), albeit with no maternal deaths during the first wave and only one during the second. If real, this is both unexpected and concerning. Unexpected, because viruses tend to mutate in the direction of reduced severity; it is not in the interests of the virus that the host dies. Concerning, because it suggest that the newer variants are behaving more like other viral diseases; causing more severe disease in pregnancy.The evidence from Italy is supported by at least three other sources. In August a preprint from the UK Obstetric Surveillance Service (Vousden et al. MedRxiv 2021.07.22.21261000; doi: https://doi.org/10.1101/2021.07.22.21261000 accessed 30 September) reported disease severity in pregnancy when wild type predominated, when alpha predominated and when delta predominated. In each succeeding phase disease severity in increased. On 24 September the UK Intensive Care National Audit & Research Centre reported (ICNARC 17 September 2021 https://www.icnarc.org/Our-Audit/Audits/Cmp/Reports accessed 30 September) that the absolute numbers of pregnant women admitted to critical care with Covid were significantly higher in the second (alpha) wave than the first (wild type), and looked set to be significantly higher again in the third (delta) wave. Finally a large series from Nair Hospital, the largest hospital caring for Covid in Mumbai (Mahajan et al. Obstet Gynecol: July 7, 2021 doi: 10.1097/AOG.0000000000004529), reported significantly higher maternal mortality during the second (alpha predominant) wave than the first (wild type).The lesson for women is simple, get vaccinated. Vaccines are safe and if the disease is really getting more severe, the balance of risks and benefits will be moving overwhelmingly in favour of vaccination. The lesson for obstetricians is more complicated. Encourage women to get vaccinated and take the disease seriously. Keep women with Covid out of hospital if possible, but monitor them with saturation monitors reliably, so those who deteriorate can be picked up quickly. When they need admission follow evidence-based treatment guidelines, and keep using personal protective equipment. We’re not yet done with Covid.Jim Thornton MD FRCOGEmeritus Professor of Obstetrics & Gynaecology, University of Nottingham.
Objectives. To investigate the obstetrical management of cancer in pregnancy and to determine adverse pregnancy and neonatal outcomes. Design. A register-based nationwide historical prospective cohort study. Setting and population. We assessed all pregnancies (N = 4,071,848) in Denmark from 1 January 1973 to 31 December 2018. Methods. We linked data on maternal cancer, obstetrical, and neonatal outcomes. Exposure was defined as pregnancies exposed to maternal cancer (n = 1,068). The control group comprised pregnancies without cancer. The groups were compared using logistic regression analysis and adjusted for potential confounders. Main outcome Measures. The primary outcome was the iatrogenic termination of the pregnancy (induced abortions/labor induction or elective caesarean section). Secondary outcomes were adverse neonatal outcomes. Results. More women with cancer in pregnancy, as compared to the control group, experienced first-trimester induced abortion; adjusted odds ratio (aOR) 3.7 (95% CI 2.8─4.7), second-trimester abortion; aOR 9.0 (6.4─12.6), iatrogenic preterm delivery; aOR 10.9 (8.1─14.7), and iatrogenic delivery below 32 gestational weeks; aOR 16.5 (8.5─32.2). Neonates born to mothers with cancer in pregnancy had a higher risk of respiratory distress syndrome; aOR 1.5 (1.2─2.0), but not of low birth weight; aOR 0.6 (0.4─0.8), admission to neonatal intensive care unit more than seven days; aOR 1.4 (1.1─1.9), neonatal infection; aOR 0.9 (0.5─1.5) nor neonatal mortality; aOR1.3 (0.6─2.6). Conclusion. Cancer in pregnancy implies an increased risk of iatrogenic termination of pregnancy and iatrogenic premature birth. Neonates born to mothers with cancer in pregnancy had no increased risk of severe adverse neonatal outcomes.
Objective: To study the impact of absolute uterine factor infertility (AUFI) and uterus transplantation (UTx) on women, and UTx recipients’ perceptions of Utx and reproductive autonomy Design: Convergent mixed-methods study. Setting: UTx program in a large academic medical centre in the United States. Population/Sample: 20 Utx recipients Methods: A medical chart review was conducted to collect patient demographic information, and clinical outcomes. Semi-structured interviews collected information regarding participants’ experience. Main Outcome Measure(s): The outcomes of interest were participants’ experience of infertility, experience with UTx, and general perceptions of UTx. Results: 7 participants were pregnant (one with a second child), 6 had experienced early graft failure and removal, 5 had delivered a healthy baby, and 4 had a viable graft and were awaiting embryo transfer. The primary themes identified were: the negative impact of AUFI diagnosis on psychological wellbeing, relationships, and female identity; the positive impact of UTx on healing the emotional scars of AUFI, female identity, and value of research trial participation; and the perception of UTx as an expansion of reproductive autonomy. All participants reported Utx was worthwhile, regardless of individual outcome. On bivariate analysis, disease aetiology, having a child after uterus transplantation, experiencing graft failure and current pregnancy were not significantly associated with the impact of AUFI or of UTx on participants’ identities. Conclusion: AUFI has a negative impact on women from a young age, affects multiple relationships, and challenges female identity. UTx helps reverse this impact, transforming women’s life narrative of infertility and enhancing female identity.
Objectives: Our primary objective to determine the cumulative retention of Ob/Gyns since the inception of the program, to determine the demographic and practice characteristics of all Ob/Gyns who have been trained by the Ghana postgraduate Ob/Gyn programs, and to compare the geographic distribution of Ob/Gyns throughout Ghana between 2010 when a prior study was conducted and the current practice locations of all graduates in 2017. Design: Cross-sectional, Quantitative Investigation Setting: Fieldwork for this study was conducted in Ghana between June 21, 2017, and August 20, 2017. Methods: A roster of certified Ob/Gyns, year certified, and email contact information was obtained from the Ghana College of Physicians and Surgeons, a roster of practice locations was obtained from Ghana Medical Board. Main Outcome Measures: retention of Ob/Gyns, geographic distribution of providers, fand comparisons between 2010 and 2017 Results: Significant geographic spread and increase in in-country medical programs have occurred over the seven-year period. In recent years, the Ghana College of Physicians and Surgeons surpassed that of the West African College of Surgeons. Conclusion: Establishing an Ob/gyn training program with national certification provides a cadre of certified Ob/Gyns that can be trained and retained in low-income settings. Moreover, this allows for long term commitment in multiple relevant sectors that may serve to establish a comprehensive obstetric and gynecology capacity beyond urban centers.
Sexual Function the First Year Postpartum: A Mini-CommentaryRachel Pope MD, MPHUrology Insitute, Division of Female Sexual HealthUniversity Hospitals, Cleveland Medical Center11100 Euclid Avenue, Cleveland, OH 44106Rachel.firstname.lastname@example.orgRunning Title: Postpartum Sexual FunctionIn the first year postpartum, women tend to be burdened by physical exhaustion due to interrupted and lack of sleep, breastfeeding and the potential challenges therein, and chemically-induced anxiety and depression. Literature in the field of behavioral health has long-since described the high prevalence of postpartum mental health disturbances of 20% of all women, and the impact of mental health on quality of life documented world-wide (O’Hara MW et al. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12). Sexual dysfunction, however, is a lesser-known challenge and one that is notably under-reported and addressed in the medical literature, likely due to other dominating discomforts and an overall stigmatization of female sexual health. Furthermore, scheduled visits with medical providers rarely extend beyond six weeks postpartum and most women have not resumed sexual activity at this time.Sexual function is an important aspect of quality of life. There is straight-forward treatment for dysfunction and dyspareunia that may be caused by hypo-oestrogenized tissues and pelvic floor injuries. Cattani et al. highlight the experiences of women around the world through a comprehensive systematic review. It is not surprising then, that obstetric anal sphincter injuries (OASIS), episiotomies, and instrumental vaginal birth are all associated with sexual dysfunction and/or dyspareunia. While anal sphincter injuries affect approximately 6% of women (Jha S et al. Risk factors for recurrent obstetric anal sphincter injury (rOASI): a systematic review and meta-analysis. Int Urogynecol J. 2016 Jun;27(6):849-57.) and episiotomies continue to be on the decline, the paper by Cattani et al does show less dyspareunia among women who deliver by cesarean compared to spontaneous vaginal birth. One might assume this is related to the pelvic floor injuries. However, mode of delivery is not associated with overall sexual dysfunction. Strikingly, OASIS was associated with an odds ratio of 3 (1.28-7.03) for sexual dysfunction and 1.92 (1.47-2.52) for dyspareunia. While these injuries are not easily preventable, these data inform and strengthen the need for specialized clinics, follow-up care and increased attention to individuals who have sustained them (Madsen A, Hickman L, and Propst K. Recognition and Management of Pelvic Floor Disorders in Pregnancy and the Postpartum Period, Obstetrics and Gynecology Clinics of North America. 2021. 48; (3):571-584). For example, if an individual with a third or fourth degree laceration is identified as having increased risk for pain and dysfunction sexually, she should be counseled on this as to empower her to seek care should the concern arise. Lubricants, vaginal estrogens and DHEA can all be appropriately prescribed even if breastfeeding and could greatly improve her experience (Donders GGG, et al. Pharmacotherapy for the treatment of vaginal atrophy. Expert Opin Pharmacother. 2019 May;20(7):821-835.). Furthermore, this information underscores the need for women who have sustained a higher order laceration to present for pelvic floor physical therapy and rehabilitate as a preventive and therapeutic measure. Specialized clinics can help patients navigate this.Vaginal dryness from lactation is extremely common. This review only identified one study on vaginal dryness and sexual concerns. This does not indicate that vaginal dryness is not a problem, but rather that more research is indicated. Another unexplored variable is urinary incontinence. A large proportion of women experience urinary incontinence in the first year postpartum. It would be worth exploring the connection between UI and sexual dysfunction.Therefore, while this review represents progress in understanding the mechanism of sexual dysfunction and dyspareunia the first year postpartum, there is still more to be learned in the form of empiric evidence, especially regarding vaginal dryness and urinary incontinence.
Objective: Vaginal birth after caesarean (VBAC) has been suggested to be associated with an increased risk of obstetric anal sphincter injury (compared with primiparous women who birth vaginally). However, prior studies have been small, or used outdated methodology. We set out to validate whether the risk of obstetric anal sphincter injury among women having their first VBAC is greater than that among primiparous women having a vaginal birth. Design: State-wide retrospective cohort study. Setting: Victoria, Australia. Population: All births (455,000) between 2009-2014. Methods: The risk of severe perineal injury between first vaginal birth and first vaginal birth after previous caesarean section was compared, after adjustment for potential confounding variables. Covariates were examined using logistic regression for categorical data and Wilcoxon rank-sum test for continuous data. Missing data were handled using multiple imputation; the analysis was performed using regression adjustment and Stata v16 multiple imputation and teffects suites. Results: Women having a VBAC (n=5,429) were significantly more likely than primiparous women (n=123,353) to sustain a 3rd or 4th degree tear during vaginal birth (7.1 vs 5.7%, p<0.001). After adjustment for mode of birth, body mass index, maternal age, infant birthweight, episiotomy and epidural, there was a 21% increased risk of severe perineal injury (relative risk 1.21 (95%CI 1.07 – 1.38)). Conclusions: Women having their first vaginal birth after caesarean section have a significant increased risk of sustaining a 3rd or 4th degree tear, compared with primiparous women having a vaginal birth. Patient counselling and professional guidelines should reflect this increased risk.
Obstetric care for women that use antidepressants in pregnancyLine Kolding, MD, PhDVera Ehrenstein, MPH, DSc, ProfessorLars Pedersen, MSc, PhD, ProfessorPuk Sandager, MD, PhD, Associate ProfessorOlav B. Petersen, MD, PhD, ProfessorNiels Uldbjerg, MD, DMSc, ProfessorLars H. Pedersen, MD, PhD, ProfessorCorresponding:Lars Henning PedersenAarhus University Hospital / Aarhus UniversityPalle Juul-Jensens Blvd. 99, 8200 Aarhus N, DenmarkEmail: email@example.comPhone: +45 50526512We are grateful to Drs. Braillon and Bewley for their interest in our recent paper in the BJOG 1 and would like to elaborate on some of the important points they raise.We agree with Braillon and Bewley on the urgent need for improved pharmacovigilance of medication in pregnancy in general, and for antidepressants in particular. There are excellent international collaborations (e.g., the EuroCat) and local initiatives (e.g., the Swedish JanusInfo), but clinically we’re often forced to rely on very limited information indeed. Systematic international recording as suggested by Braillon and Bewley would represent an important step forward.On a smaller scale, we are establishing an automated surveillance system based on curated data that include information on both pre- and postnatally diagnosed malformations. We have, however, faced substantial legal and bureaucratic challenges, and have been forced to use data from the Central Denmark Region only, instead of national data. The surveillance system is consequently based on information on approx. 75,000 pregnancies, and even though it has the potential to aide clinical management, it is a drop in the ocean of the huge potential of for instance a comparable European collaboration.In our study, we used ≥2 redeemed prescriptions to define exposure with a prevalence 1.1%.1 The prevalence of pregnant women that redeemed ≥1 prescription was 3.2% (p. 3/ Table S1), and even though this is likely an overestimation due to non-adherence, the estimates are in line with previously reported prevalences in Scandinavia.2Braillon and Bewley emphasise the need to also consider non-pharmacological treatment of some pregnant women with depression and, further, to provide evidence-based and individualised treatment of women in the reproductive ages. Optimal individualised care will definitely result in non-pharmacological treatment of some pregnant women but, reversely, will cause yet other women to continue or initiate pharmacological treatment. This is in line with what is almost a truism in this field, that the potential harmful foetal effects must be balanced against the potential benefits of a pharmacological treatment, but it is no easy task. Pregnant women might overestimate the foetal risks associated with use of medication3 and discontinue important treatment, on the other hand some may use medication when there may be a better alternative for them. Regardless, we need to provide optimal obstetric care for the pregnant women that choose treatment with antidepressants. If our results are correct, prenatal follow-up of pregnant women treated with venlafaxine may include targeted foetal heart scans, even though the underlying causal explanation for the observed association with cardiac malformations is undetermined.1. Kolding L, Ehrenstein V, Pedersen L, Sandager P, Petersen OB, Uldbjerg N, et al. Antidepressant use in pregnancy and severe cardiac malformations: Danish register-based study. BJOG. 2021 May 25.2. Zoega H, Kieler H, Norgaard M, Furu K, Valdimarsdottir U, Brandt L, et al. Use of SSRI and SNRI Antidepressants during Pregnancy: A Population-Based Study from Denmark, Iceland, Norway and Sweden. PLoS One. 2015;10(12):e0144474.3. Wolgast E, Lindh-Åstrand L, Lilliecreutz C. Women’s perceptions of medication use during pregnancy and breastfeeding—A Swedish cross-sectional questionnaire study. Acta Obstetricia et Gynecologica Scandinavica. 2019;98(7):856-64.
BJOG-21-0667.R1: Our Guidelines Are Not Good EnoughAlexandra Wojtaszewskaa, Martin HirschbaWatford General Hospital, Watford, United KingdombOxford Endometriosis CaRe Centre, Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, United Kingdom.Declarations of interest: noneFinancial support received: noneBJOG-21-0667.R1: Our Guidelines Are Not Good EnoughAmoah et al. highlight the lack of high-quality fibroid guidelines in their appraisal of uterine fibroid management guidelines. This paper sheds light on the association between low quality research informing low quality clinical guidance. The authors included nine national and international guidelines on fibroid management in their analysis and screened 189 recommendations and statements made across these documents. Guideline quality was assessed using the AGREE-II instrument and no high-quality guidelines were identified. No guidelines reported involvement of patients with fibroids in their development and across all guidelines consensus was reached on only three (1.6%) of 189 statements. The authors explored the quality of evidence base behind the recommendations concluding that 25.3% were developed from good-quality evidence while 27.7% were based on lowest quality evidence (expert opinion or clinical consensus).These findings of poor quality and high discrepancy between guideline recommendations for fibroids are not unique to the condition. Other systematic reviews found similar results when analysing guidelines for management of endometriosis (Hirsch et al. BJOG 2018;125:556-564) and uncomplicated birth (Zhao et al. BJOG 2020;127:789-797).When writing or updating guidelines, locally or nationally, authors must consider how to ensure highest possible quality. There are several validated tools for quality assessment available (including AGREE II, ADAPTE, AMTAR and INAHTA and iCAHE Guideline Quality Checklists).The landscape for guideline development is changing. The rapid development of novel technologies requires a prompt response and evaluation of not only efficacy but the wider environmental impact and health economic assessment. The current system of laborious static single point assessments of evidence-based medicine producing clinical guidelines every few years is no longer appropriate. The National Institute for Health and Care Excellence (NICE) acknowledge the need for proactive, fluid, and flexible processes to enable the digitalisation of health systems to inform practice through real-world evidence (NICE 2021, The NICE Strategy 2021 to 2026 ). Guidelines will respond in a dynamic manner to population changes using contemporaneous evaluation of clinical data available from digitalised care systems. We look forward to integrated care systems delivering population-based healthcare on a regional basis. Guidelines will extend across health, social care, and public health focusing on health prevention, reducing health inequality, and delivering those interventions that offer the greatest benefit.As highlighted by this study, the development of guidelines without standardised methods is commonplace. This may lead to exclusion of beneficial treatments, a paucity of comparable recommendations, recommendations based on poor quality data, and poor patient outcomes. Looking to the future we do not see the need to fix a fractured guideline development system but rather build a new one. We must adapt and adopt the integration of digitalised real-world health system data to facilitate rapid and robust clinical decisions on a regional or national basis.
Objective: To evaluate objective and subjective outcomes of patients who underwent sacrocolpopexy using autologous rectus fascia to provide more data regarding non-mesh alternatives in pelvic organ prolapse surgery. Design: Cohort study with retrospective and prospective data. Setting: A single academic medical center. Population: Women who underwent abdominal sacrocolpopexy using autologous rectus fascia between January 2010 and December 2019 Methods: Patients were recruited for a follow-up visit including completing the Pelvic Floor Distress Inventory (PFDI) and Pelvic Organ Prolapse Quantification (POPQ) exam. Demographic and clinical characteristics were collected. Main Outcome Measures: Composite failure, anatomic failure, symptomatic failure, and retreatment. Results: During the study period, 132 women underwent sacrocolpopexy using autologous rectus fascia. Median follow-up time was 2.2 years. Survival analysis showed that composite failure was 0.8% (CI 0.1-5.9%) at 12 months, 3.5% (CI 1.1-10.7%) at 2 years, 13.2% (CI 7.0-24.3%) at 3 years, and 28.3% (CI 17.0-44.8%) at 5 years. Anatomic failure was 0% at 12 months, 1.4% (CI 0.2-9.2%) at 2 years, 3.1% (CI 0.8-12.0%) at 3 years, and 6.8% (CI 2.0-22.0%) at 5 years. Symptomatic failure rate was 0% at 12 months, 1.3% (CI 0.2-9.0%) at 2 years, 2.9% (CI 0.7-11.3%) at 3 years, and 13.1% (CI 5.3-30.3%) at 5 years. Retreatment rate was 0.8% (CI 0.1-5.9%) at 12 months and 2 years, 9.4% (CI 4.2-20.3%) at 3 years, and 13.0% (CI 6.0-27.2%) at 5 years. Conclusions: Autologous rectus fascia sacrocolpopexy may be considered a safe and effective alternative for patients who desire to avoid synthetic mesh.
BJOG-21-0722 Statistical associations versus causal inference.Øjvind Lidegaard, professor 11Department of Gynaecology, Rigshospitalet, University of Copenhagen, DenmarkMany clinicians are of the opinion that observational studies may provide only “statistical associations”, but not “causal inference”. And further, that only randomized designs ensure causal interpretation. For the same reason, many medical journals have made rules for all observational studies finding significant statistical associations to be presented as just “associations” often emphasizing that a causal inference is not possible.I hereby sign up to the growing group of epidemiologists, who are of the opinion that just well confounder controlled observational studies are the very design most often providing convincing evidence of a causal interference. Prospective cohort studies better than retrospective case-control studies, but even the latter design has given us important knowledge of risk factors of rare clinical outcomes such as thrombotic diseases, a long list of cancers, obstetrical complications, including latest stillbirths.In a new original Swedish study, Heiddis Valgeirsdottir et al. demonstrate in a nationwide historical follow-up study, that women with polycystic ovary syndrome (PCOS) once pregnant have a 50% increased risk of experiencing stillbirth, as compared to women without PCOS (1). Further, that the rate ratio of stillbirth between women with and without PCOS increased by increasing gestational age, peaking at 42 weeks with 4.3 deaths per 1000 ongoing pregnancies in women with PCOS versus 1.0 deaths per 1000 ongoing pregnancies in women without PCOS.Any such association should certainly be controlled for a long list of potential confounders, the most important being maternal age, calendar year, parity, hypertensive disorders, diabetes, and educational length. Adiposity (BMI) was undertaken in an additional adjustment, because this covariate correctly could be considered as both a confounder (adiposity being a risk factor for stillbirth, and PCOS women more often being adipose), but also as a mediator; women with PCOS are more likely to develop adiposity due to their PCOS. The authors chose carefully to present the BMI adjusted results as the main results, thereby if anything underestimating the risk of stillbirths in women with PCOS.This is far from the first contribution from Scandinavian National Health Registers, identifying and quantifying risk factors for different diseases. We should always be aware that some unknown or unmeasured potential confounders not being controlled for, could reduce (or enhance) the results, and that other research groups should confirm the Swedish findings. A causal inference was made more likely with a suggested biomedical mechanism by which PCOS could confer such a risk. But already with this new carefully provided observational evidence, we should reasonably consider pregnant women with PCOS not to go too far beyond term, to prevent stillbirths in this group, which according to the study results accounts about 5% of all stillbirths. A pragmatic first recommendation could be induction of women with PCOS at 41 gestational weeks.Valgeirsdottir H et al. BJOG 2021; 128: xxx-xxx.