The proposed social media crisis mapping platform for natural disasters uses locations from gazetteer, street map, and volunteered geographic information (VGI) sources for areas at risk of disaster ...and matches them to geoparsed real-time tweet data streams. The authors use statistical analysis to generate real-time crisis maps. Geoparsing results are benchmarked against existing published work and evaluated across multilingual datasets. Two case studies compare five-day tweet crisis maps to official post-event impact assessment from the US National Geospatial Agency (NGA), compiled from verified satellite and aerial imagery sources.
Summary Background Screening for congenital heart defects relies on antenatal ultrasonography and postnatal clinical examination; however, life-threatening defects often are not detected. We ...prospectively assessed the accuracy of pulse oximetry as a screening test for congenital heart defects. Methods In six maternity units in the UK, asymptomatic newborn babies (gestation >34 weeks) were screened with pulse oximetry before discharge. Infants who did not achieve predetermined oxygen saturation thresholds underwent echocardiography. All other infants were followed up to 12 months of age by use of regional and national registries and clinical follow-up. The main outcome was the sensitivity and specificity of pulse oximetry for detection of critical congenital heart defects (causing death or requiring invasive intervention before 28 days) or major congenital heart disease (causing death or requiring invasive intervention within 12 months of age). Findings 20 055 newborn babies were screened and 53 had major congenital heart disease (24 critical), a prevalence of 2·6 per 1000 livebirths. Analyses were done on all babies for whom a pulse oximetry reading was obtained. Sensitivity of pulse oximetry was 75·00% (95% CI 53·29–90·23) for critical cases and 49·06% (35·06–63·16) for all major congenital heart defects. In 35 cases, congenital heart defects were already suspected after antenatal ultrasonography, and exclusion of these reduced the sensitivity to 58·33% (27·67–84·83) for critical cases and 28·57% (14·64–46·30) for all cases of major congenital heart defects. False-positive results were noted for 169 (0·8%) babies (specificity 99·16%, 99·02–99·28), of which six cases were significant, but not major, congenital heart defects, and 40 were other illnesses that required urgent medical intervention. Interpretation Pulse oximetry is a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography. The early detection of other diseases is an additional advantage. Funding National Institute for Health Research Health Technology Assessment programme.
Summary Background Fetal lower urinary tract obstruction (LUTO) is associated with high perinatal and long-term childhood mortality and morbidity. We aimed to assess the effectiveness of ...vesicoamniotic shunting for treatment of LUTO. Methods In a randomised trial in the UK, Ireland, and the Netherlands, women whose pregnancies with a male fetus were complicated by isolated LUTO were randomly assigned by a central telephone and web-based randomisation service to receive either the intervention (placement of vesicoamniotic shunt) or conservative management. Allocation could not be masked from clinicians or participants because of the invasive nature of the intervention. Diagnosis was by prenatal ultrasound. The primary outcome was survival of the baby to 28 days postnatally. All primary analyses were done on an intention-to-treat basis, but these results were compared with those of an as-treated analysis to investigate the effect of a fairly large proportion of crossovers. We used Bayesian methods to estimate the posterior probability distribution of the effectiveness of vesicoamniotic shunting at 28 days. The study is registered with the ISRCTN Register, number ISRCTN53328556. Findings 31 women with singleton pregnancies complicated by LUTO were included in the trial and main analysis, with 16 allocated to the vesicoamniotic shunt group and 15 to the conservative management group. The study closed early because of poor recruitment. There were 12 livebirths in each group. In the vesicoamniotic shunt group one intrauterine death occurred and three pregnancies were terminated. In the conservative management group one intrauterine death occurred and two pregnancies were terminated. Of the 16 pregnancies randomly assigned to vesicoamniotic shunting, eight neonates survived to 28 days, compared with four from the 15 pregnancies assigned to conservative management (intention-to-treat relative risk RR 1·88, 95% CI 0·71–4·96; p=0·27). Analysis based on treatment received showed a larger effect (3·20, 1·06–9·62; p=0·03). All 12 deaths were caused by pulmonary hypoplasia in the early neonatal period. Sensitivity analysis in which non-treatment-related terminations of pregnancy were excluded made some slight changes to point estimates only. Bayesian analysis in which the trial data were combined with elicited priors from experts suggested an 86% probability that vesicoamniotic shunting increased survival at 28 days and a 25% probability that it had a large, clinically important effect (defined as a relative increase of 55% or more in the proportion of neonates who survived). There was substantial short-term and long-term morbidity in both groups, including poor renal function—only two babies (both in the shunt group) survived to 2 years with normal renal function. Seven complications occurred in six fetuses from the shunt group, including spontaneous ruptured membranes, shunt blockage, and dislodgement. These complications resulted in four pregnancy losses. Interpretation Survival seemed to be higher in the fetuses receiving vesicoamniotic shunting, but the size and direction of the effect remained uncertain, such that benefit could not be conclusively proven. Our results suggest that the chance of newborn babies surviving with normal renal function is very low irrespective of whether or not vesicoamniotic shunting is done. Funding UK National Institute of Health Research, Wellbeing of Women, Hannah Eliza Guy Charity (Birmingham Children's Hospital Charity).
Learning pointsSometimes new treatments with known advantages, such as being better tolerated, easier to administer or more accessible, might be good alternatives to the standard treatment, despite ...potentially being less effective.Non-inferiority trials allow the assessment of whether these new treatments are less effective, but only by an acceptable degree.Determining non-inferiority should be based on comparing confidence intervals of treatment differences with a suitable predetermined margin, known as the non-inferiority margin.In a randomised controlled trial (RCT) we are usually trying to answer the question of which treatment is best. Sometimes, though, we may be considering a treatment that we do not believe will perform better than an existing option but has other benefits: it could be cheaper, easier to deliver or more acceptable to patients. For example, the need for urodynamic testing compared with simple office evaluation before stress incontinence surgery was evaluated in an RCT (Nager et al. N Engl J Med 2012;366:1987–97). The authors believed that simple office-based evaluation would be less invasive than urodynamic testing and that it may also reduce the risk of urinary tract infections. It was also expected that simple office-based evaluation was unlikely to reduce treatment success.
Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For ...women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.
We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.
A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval CI, 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.
Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).
Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could ...reduce the incidence of such adverse outcomes.
We conducted a double-blind, placebo-controlled trial to investigate whether levothyroxine treatment would increase live-birth rates among euthyroid women who had thyroid peroxidase antibodies and a history of miscarriage or infertility. A total of 19,585 women from 49 hospitals in the United Kingdom underwent testing for thyroid peroxidase antibodies and thyroid function. We randomly assigned 952 women to receive either 50 μg once daily of levothyroxine (476 women) or placebo (476 women) before conception through the end of pregnancy. The primary outcome was live birth after at least 34 weeks of gestation.
The follow-up rate for the primary outcome was 98.7% (940 of 952 women). A total of 266 of 470 women in the levothyroxine group (56.6%) and 274 of 470 women in the placebo group (58.3%) became pregnant. The live-birth rate was 37.4% (176 of 470 women) in the levothyroxine group and 37.9% (178 of 470 women) in the placebo group (relative risk, 0.97; 95% confidence interval CI, 0.83 to 1.14, P = 0.74; absolute difference, -0.4 percentage points; 95% CI, -6.6 to 5.8). There were no significant between-group differences in other pregnancy outcomes, including pregnancy loss or preterm birth, or in neonatal outcomes. Serious adverse events occurred in 5.9% of women in the levothyroxine group and 3.8% in the placebo group (P = 0.14).
The use of levothyroxine in euthyroid women with thyroid peroxidase antibodies did not result in a higher rate of live births than placebo. (Funded by the United Kingdom National Institute for Health Research; TABLET Current Controlled Trials number, ISRCTN15948785.).
Pelvic congestion syndrome (PCS) is described as chronic pelvic pain (CPP) arising from dilated and refluxing pelvic veins, although the causal relationship between pelvic vein incompetence (PVI) and ...CPP is not established. Non-invasive screening methods such as Doppler ultrasound and magnetic resonance venography are used before confirmation by venography. Percutaneous embolisation has become the principal treatment for PCS, with high success rates often cited.
Our proposal aimed to systematically and critically review the definitions and diagnostic criteria of PCS, the association between PVI and CPP, the accuracy of various non-invasive imaging techniques and the effectiveness of embolisation for PVI; and to identify factors associated with successful outcome. We also wished to survey clinicians and patients to assess awareness and management of PCS and gauge the enthusiasm for further research.
A comprehensive search strategy encompassing various terms for pelvic congestion, pain, imaging techniques and embolisation was deployed in 17 bibliographic databases, including MEDLINE, EMBASE and Web of Science. There was no restriction on study design.
Methodological quality was assessed using appropriate tools. Online surveys were sent to clinicians and patients. The quality and heterogeneity generally precluded meta-analysis and so results were tabulated and described narratively.
We identified six association studies, 10 studies involving ultrasound, two studies involving magnetic resonance venography, 21 case series and one poor-quality randomised trial of embolisation. There were no consistent diagnostic criteria for PCS. We found that the associations between CPP and PVI were generally fairly similar, with three of five studies with sufficient data showing statistically significant associations (odds ratios of between 31 and 117). The prevalence of PVI ranged widely, although the majority of women with PVI had CPP. Transvaginal ultrasound with Doppler and magnetic resonance venography are both useful screening methods, although the data on accuracy are limited. Early substantial relief from pain symptoms was observed in approximately 75% of women undergoing embolisation, a figure which generally increased over time and was sustained. Reintervention rates were generally low. Transient pain was a common occurrence following foam embolisation, while there was a < 2% risk of coil migration. Confidence in the embolisation technique is reasonably high, although there is a desire to strengthen the evidence base. Even among women with CPP, fewer than half had any knowledge about PCS.
The data supporting the diagnosis and treatment of PCS are limited and of variable methodological quality. There is some evidence to tentatively support a causative association, but it cannot be categorically stated that PVI is the cause of CPP in women with no other pathology, as the six most pertinent drew on clinically disparate populations and defined PVI inconsistently. Embolisation appears to provide symptomatic relief in the majority of women and is safe. However, the majority of included studies of embolism were relatively small case series and only the randomised controlled trial was considered at risk of potential biases. There is scope and demand for considerable further research. The question of the association of PVI and CPP requires a well-designed and well-powered case-control study, which will also provide data to derive a diagnostic standard. An adequately powered randomised trial is essential to provide evidence on the effectiveness of embolisation, but this faces methodological challenges.
This study is registered as PROSPERO CRD42012002237 and CRD42012002238.
The National Institute for Health Research Health Technology Assessment programme.
To evaluate whether hysteroscopic morcellation or bipolar electrosurgical resection is more favorable for removing endometrial polyps in an office setting in terms of feasibility, speed, pain, and ...acceptability.
A multicenter, single-blind, randomized, controlled trial of office hysteroscopic morcellation compared with electrosurgical resection was conducted. A total of 121 women were randomly allocated to polyp removal by one of the two methods in an office setting. The outcomes assessed were time taken to complete the endometrial polypectomy, defined as the time from insertion to removal of vaginal instrumentation, completeness of polyp removal, acceptability, and pain measured on a 100-mm visual analog scale.
The median time taken to complete the procedure was 5 minutes and 28 seconds for morcellation compared with 10 minutes and 12 seconds for electrosurgical resection (P<.001). The polyps were completely removed in 61 out of 62 (98%) women assigned to morcellation compared with 49 out of 59 (83%) women treated with electrosurgical resection (odds ratio 12.5; 95% confidence interval CI 1.5-100.6; P=.02). The mean pain scores during the procedure favored morcellation by 16.1 points on average (35.9 compared with 52.0; 95% CI for difference, -24.7 to -7.6; P<.001). Overall, 99% of women found office polypectomy to be acceptable, with only one woman in the electrosurgical resection group considering the procedure unacceptable.
In comparison to electrosurgical resection during hysteroscopic polypectomy, morcellation was significantly quicker, less painful, more acceptable to women, and more likely to completely remove endometrial polyps compared with electrosurgical resection.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01509313.
Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women ...wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options.
We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids.
A multicentre, open, randomised trial with a parallel economic evaluation.
Twenty-nine UK hospitals.
Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation.
Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance.
The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective).
A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% (
= 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1,
= 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5;
= 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years.
There were a substantial number of women who were not recruited because of their preference for a particular treatment option.
Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desiring pregnancy.
This trial is registered as ISRCTN70772394.
This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in
; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.
To describe the prevalence of and factors associated with different thyroid dysfunction phenotypes in women who are asymptomatic preconception.
Observational cohort study.
A total of 49 hospitals ...across the United Kingdom between 2011 and 2016.
Women aged 16 to 41years with history of miscarriage or subfertility trying for a pregnancy.
Prevalences and 95% confidence intervals (CIs) were estimated using the binomial exact method. Multivariate logistic regression analyses were conducted to identify risk factors for thyroid disease.
None.
Rates of thyroid dysfunction.
Thyroid function and thyroid peroxidase antibody (TPOAb) data were available for 19213 and 19237 women, respectively. The prevalence of abnormal thyroid function was 4.8% (95% CI, 4.5-5.1); euthyroidism was defined as levels of thyroid-stimulating hormone (TSH) of 0.44 to 4.50 mIU/L and free thyroxine (fT4) of 10 to 21 pmol/L. Overt hypothyroidism (TSH > 4.50 mIU/L, fT4 < 10 pmol/L) was present in 0.2% of women (95% CI, 0.1-0.3) and overt hyperthyroidism (TSH < 0.44 mIU/L, fT4 > 21 pmol/L) was present in 0.3% (95% CI, 0.2-0.3). The prevalence of subclinical hypothyroidism (SCH) using an upper TSH concentration of 4.50 mIU/L was 2.4% (95% CI, 2.1-2.6). Lowering the upper TSH to 2.50 mIU/L resulted in higher rates of SCH, 19.9% (95% CI, 19.3-20.5). Multiple regression analyses showed increased odds of SCH (TSH > 4.50 mIU/L) with body mass index (BMI) ≥ 35.0 kg/m2 (adjusted odds ratio aOR 1.71; 95% CI, 1.13-2.57; P = 0.01) and Asian ethnicity (aOR 1.76; 95% CI, 1.31-2.37; P < 0.001), and increased odds of SCH (TSH ≥ 2.50 mIU/L) with subfertility (aOR 1.16; 95% CI, 1.04-1.29; P = 0.008). TPOAb positivity was prevalent in 9.5% of women (95% CI, 9.1-9.9).
The prevalence of undiagnosed overt thyroid disease is low. SCH and TPOAb are common, particularly in women with higher BMI or of Asian ethnicity. A TSH cutoff of 2.50 mIU/L to define SCH results in a significant proportion of women potentially requiring levothyroxine treatment.
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