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Objectives: To evaluate whether an alternative model of care in aged care facilities, including in-house general practitioners, influenced health outcomes for residents.Design: Stepped wedge, cluster randomised controlled trial over 90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015).Participants, Setting: Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states.Intervention: Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development.Main (primary) Outcome Measures: Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy.Results: The new model of care could be implemented in all facilities, but four could not recruit in-house GPs at any time during the trial period. Intention-to-treat analyses found no statistically significant effect of the intervention on the primary outcome measures. Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).Conclusions: Recruiting GPs to work directly in residential aged care facilities is difficult, but may reduce the burden of unplanned presentations to hospitals and increase the reporting of adverse events.Trial Registration: Australia New Zealand Clinical Trial Registry, ACTRN12613000218796 (25 February 2013). [ABSTRACT FROM AUTHOR]

Background: The goal of this study was to characterize the efficacy and safety of stereotactic body radiation therapy (SBRT) versus conventionally fractionated radiation therapy with concurrent chemotherapy (CFRT) for the definitive treatment of locally advanced pancreatic cancer. The primary outcome measure was efficacy, defined by 2-year overall survival (OS). Secondary outcomes were incidence of any grade 3/4 toxicity and 1-year OS.Methods: A PICOS/PRISMA/MOOSE selection protocol was used to identify eligible studies. Inclusion criteria were: 1) patients diagnosed with locally advanced N0-1 M0 pancreatic cancer; 2) CFRT 1.8 to 2.0 Gy/fraction with chemotherapy per protocol or SBRT ≥5 Gy/fraction in ≤5 fractions; 3) either no control group or another definitive chemotherapy or radiation therapy arm; 4) at least 1 of the outcome measures reported; and 5) single or multi-arm phase 2/3 prospective study for CFRT and/or phase 1/2 or retrospective study for SBRT. Neoadjuvant and/or adjuvant chemotherapy was prescribed per protocol specifications. Weighted random effects meta-analyses were conducted using the DerSimonian and Laird method to characterize summary effect sizes for each outcome.Results: A total of 470 studies were initially screened; of these, 9 studies assessed SBRT and 11 studies assessed CFRT. For SBRT, the median dose was 30 Gy, and the most common regimen was 30 Gy/5 fractions. For CFRT, doses ranged from 45 to 54 Gy in 1.8- to 2.0-Gy fractions, with the majority of studies delivering 50.4 Gy in 28 fractions with concurrent gemcitabine. The random effects estimate for 2-year OS was 26.9% (95% CI, 20.6%-33.6%) for SBRT versus 13.7% (95% CI, 8.9%-19.3%) for CFRT and was statistically significant in favor of SBRT. The random effects estimate for 1-year OS was 53.7% (95% CI, 39.3%-67.9%) for SBRT versus 49.3% (95% CI, 39.3%-59.4%) for CFRT, and was not statistically significant. The random effects estimate for acute grade 3/4 toxicity was 5.6% (95% CI, 0.0%-20.0%) for SBRT versus 37.7% (95% CI, 24.0%-52.5%) for CFRT and was statistically significant in favor of SBRT. The random effects estimate for late grade 3/4 toxicity was 9.0% for SBRT (95% CI, 3.3%-17.1%) versus 10.1% (95% CI, 1.8%-23.8%) for CFRT, which was not statistically significant.Conclusion: These results suggest that SBRT for LAPC may result in a modest improvement in 2-year OS with decreased rates of acute grade 3/4 toxicity and no change in 1-year-OS or late toxicity. Further study into the use of stereotactic body radiation therapy for these patients is needed. [ABSTRACT FROM AUTHOR]

Background: The multidimensional array of clinical features and prognostic factors makes it difficult to optimize management within the heterogeneity of patients with common musculoskeletal pain. This study aimed to identify phenotypes across prognostic factors and musculoskeletal complaints. Concurrent and external validity were assessed against an established instrument and a new sample, respectively, and treatment outcome was described.Methods: We conducted a longitudinal observational study of 435 patients (aged 18-67 years) seeking treatment for nonspecific complaints in the neck, shoulder, low back or multisite/complex pain in primary health care physiotherapy in Norway. Latent class analysis was used to identify phenotypes based on 11 common prognostic factors within four biopsychosocial domains; pain, beliefs and thoughts, psychological and activity and lifestyle.Results: Five distinct phenotypes were identified. Phenotype 1 (n = 77, 17.7%) and 2 (n = 142, 32.6%) were characterized by the lowest scores across all biopsychosocial domains. Phenotype 2 showed somewhat higher levels of symptoms across the biopsychosocial domains. Phenotype 3 (n = 89, 20.5%) and 4 (n = 78, 17.9%) were more affected across all domains, but phenotype 3 and 4 had opposite patterns in the psychological and pain domains. Phenotype 5 (n = 49, 11.3%) were characterized by worse symptoms across all domains, indicating a complex phenotype. The identified phenotypes had good external and concurrent validity, also differentiating for the phenotypes in function and health-related quality of life outcome at 3-month follow-up.Conclusion: The phenotypes may inform the development of targeted interventions aimed at improving the treatment efficiency in patients with common musculoskeletal disorders.Significance: This observational prospective study identified five distinct and clinically meaningful phenotypes based on biopsychosocial prognostic factors across common musculoskeletal pain. These phenotypes were independent of primary pain location, showed good external validity, and clear variation in treatment outcome. The findings are particularly valuable as they describe the heterogeneity of patients with musculoskeletal pain and points to a need for more targeted interventions in common musculoskeletal disorders to improve treatment outcome. [ABSTRACT FROM AUTHOR]

Aim: Breastfeeding is associated with IQ, school attendance and income. Despite the known benefits of breastfeeding, the rate of exclusive breastfeeding up to 6 months is low globally. We examined the effect of short-term breastfeeding on long-term IQ.Methods: In this secondary analysis of the prospective Cork BASELINE Birth Cohort Study, children were categorised as predominantly breastfed (n = 288) versus exclusively formula-fed (n = 254) at 2-months of age. Infants (n = 404) receiving mixed feeding were excluded. Outcome was assessed using the KBIT-II at 5 years. Multivariable linear regression was used to adjust for confounding variables.Results: Following adjustment for confounding variables, children, predominately breastfed at 2 months of age, demonstrated increased overall IQ (2.00 points (95% CI: 0.35 to 3.65); P = .018) and non-verbal IQ at 5 years of age (1.88 points (95% CI: 0.22 to 3.54); P = .027) compared with those never breastfed. No significant relationship was found with verbal IQ (P = .154).Conclusion: A significant increase in composite and non-verbal IQ at 5 years of age was associated with short-term breastfeeding. This study adds to a growing body of evidence that short-term breastfeeding promotes healthy cognitive development. [ABSTRACT FROM AUTHOR]

Background: Hematopoietic cell infusion-related adverse events (HCI-AEs) in hematopoietic stem cell transplantations (HSCTs) have been largely attributed to toxicity of dimethyl sulfoxide (DMSO) for cryopreservation, but HSC products also contain various cells and plasma components. Our recent prospective study of 1125 HSCT recipients revealed the highest overall HCI-AE rate in bone marrow transplantation (BMT) using fresh/noncryopreserved products, although products of peripheral blood stem cell transplantation and cord blood transplantation (CBT) are generally cryopreserved with DMSO containing smaller plasma volumes. We aimed to clarify if product volume and component effects are more substantial in small recipients including children.Study Design and Methods: We performed subgroup analysis on 219 recipients of 45 kg or less body weight (whole small recipients), including 90 children (pediatric recipients), from the original cohort (general recipients).Results: Whereas overall HCI-AE rates did not differ among hematopoietic stem cell sources in the general recipients, bradycardia most often occurred after CBT in whole small recipients. Conversely, whole small and general recipients shared the same trend of having the highest rate of hypertension in BMT. The overall HCI-AE rate was higher in allogeneic HSCT compared with autologous HSCT. Notably, pediatric recipients showed a 10-fold higher incidence of nausea and vomiting in allogeneic HSCT compared with autologous HSCT, suggesting a possible role of allogeneic antigens. Multivariate analysis identified a relatively large infusion volume per body weight as a significant factor correlating with HCI-AE in whole small recipients.Conclusions: We should be aware of product volume and specific HCI-AEs such as nausea and vomiting in small patients including children. [ABSTRACT FROM AUTHOR]

Hypertensive crises are associated with high rates of target organ complications and poor outcomes. A recent shift from the definition of malignant hypertension to hypertension-multiorgan damage (MOD) contributes to the diagnosis and management of hypertensive crises. Here, we prospectively included 166 adult (≥18 years old) patients with hypertensive crises (blood pressure >180/120 mm Hg). Target organs and causes of hypertension were assessed. Patients who were diagnosed with malignant hypertensive retinopathy, the absence of malignant hypertensive retinopathy but the presence of damage to at least 3 organs, and the absence of both retinopathy and MOD were classified as the malignant hypertension (n = 48), hypertension-MOD (n = 42), and hypertension without MOD (n = 76) groups, respectively. Patients were followed to evaluate renal and cardiovascular prognoses. At baseline, patients with malignant hypertension had worse renal function, higher level of albuminuria, and more severe microvascular damage than those with hypertension-MOD. Both had similar proportions of malignant arteriolar nephrosclerosis (83% vs 64%), left ventricular hypertrophy (90% vs 88%), abnormal repolarization (71% vs 60%), and left ventricular dysfunction (12% vs 21%). At the twenty months of follow-up, both the malignant hypertension and hypertension-MOD groups had similar blood pressure control rates and proteinuria. Both groups had worse renal outcomes than the hypertension without MOD group (P = .002). Patients with hypertension-MOD (HR = 0.67, [95% CI: 0.30-1.46], P = .31) had similar renal event-free survival than patients with MHT after adjustments of age, sex, blood pressure, and proteinuria control. These results suggest that in hypertensive crises, both malignant hypertension and hypertension-MOD have impact on adverse renal outcomes. [ABSTRACT FROM AUTHOR]

Objective: Novel, highly effective disease-modifying therapies have revolutionized multiple sclerosis (MS) care. However, evidence from large comparative studies on important safety outcomes, such as cancer, is still lacking.Methods: In this nationwide register-based cohort study, we linked data from the Swedish MS register to the Swedish Cancer Register and other national health care and census registers. We included 4,187 first-ever initiations of rituximab, 1,620 of fingolimod, and 1,670 of natalizumab in 6,136 MS patients matched for age, sex, and location to 37,801 non-MS general population subjects. Primary outcome was time to first invasive cancer.Results: We identified 78 invasive cancers among treated patients: rituximab 33 (incidence rate [IR] per 10,000 person-years = 34.4, 95% confidence interval [CI] = 23.7-48.3), fingolimod 28 (IR = 44.0, 95% CI = 29.2-63.5), and natalizumab 17 (IR = 26.0, 95% CI = 15.1-41.6). The general population IR was 31.0 (95% CI = 27.8-34.4). Adjusting for baseline characteristics, we found no difference in risk of invasive cancer between rituximab, natalizumab, and the general population but a possibly higher risk with fingolimod compared to the general population (hazard ratio [HR] = 1.53, 95% CI = 0.98-2.38) and rituximab (HR = 1.68, 95% CI = 1.00-2.84).Interpretation: In this first large comparative study of 3 highly effective MS disease-modifying therapies, no increased risk of invasive cancer was seen with rituximab and natalizumab, compared to the general population. However, there was a borderline-significant increased risk with fingolimod, compared to both the general population and rituximab. It was not possible to attribute this increased risk to any specific type of cancer, and further studies are warranted to validate these findings. ANN NEUROL 2020;87:688-699. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to examine the associations of maternal early-pregnancy glucose and insulin concentrations with offspring cardiometabolic risk factors and fat distribution.Methods: In a population-based prospective cohort study among 3,737 mothers and their children, random maternal glucose and insulin concentrations were measured at a median gestational age of 13.2 (95% range 10.5-17.1) weeks. Childhood fat, blood pressure, and blood concentrations of lipids, glucose, and insulin at the age of 10 years were measured.Results: Higher maternal early-pregnancy glucose and insulin concentrations were associated with a higher risk of childhood overweight, and higher maternal early-pregnancy insulin concentrations were associated with an increased childhood risk of clustering of cardiometabolic risk factors (all P < 0.05). These associations were explained by maternal prepregnancy BMI. Independent of maternal prepregnancy BMI, one SD score (SDS) higher maternal early-pregnancy glucose and insulin concentrations were associated with higher childhood glucose (0.08 SDS, 95% CI: 0.04-0.11) and insulin concentrations (0.07 SDS, 95% CI: 0.03-0.10), but not with childhood blood pressure, lipids, and fat measures.Conclusions: These results suggest that maternal early-pregnancy random glucose and insulin concentrations are associated with childhood glucose and insulin concentrations but not with other childhood cardiometabolic risk factors. [ABSTRACT FROM AUTHOR]

Background: Our study aim was to evaluate neuromuscular ultrasound (NMUS) for the assessment of taxane chemotherapy-induced peripheral neuropathy (CIPN), the dose-limiting toxicity of this agent.Methods: This cross-sectional study of breast cancer patients with taxane CIPN measured nerve cross-sectional area (CSA) by NMUS and compared with healthy historical controls. Correlations were determined between CSA and symptom scale, nerve conduction studies, and intraepidermal nerve fiber density (IENFD).Results: A total of 20 participants reported moderate CIPN symptoms at a median of 3.8 months following the last taxane dose. Sural nerve CSA was 1.2 mm2 smaller than healthy controls (P ≤ .01). Older age and time since taxane were associated with smaller sural nerve CSA. For each 1 mm2 decrease in sural nerve CSA, distal IENFD decreased by 2.1 nerve/mm (R2 0.30; P = .04).Conclusions: These data support a sensory predominant taxane neuropathy or neuronopathy and warrant future research on longitudinal NMUS assessment of CIPN. [ABSTRACT FROM AUTHOR]

Aim: The contemporary incidence of heart failure (HF) in patients with chronic coronary syndrome is unclear. We aimed to study the incidence and predictors of cardiovascular (CV) death, HF hospitalization or new-onset HF not requiring hospitalization, in patients included in the CLARIFY registry.Methods and Results: CLARIFY is a contemporary, international registry of ambulatory patients with chronic coronary artery disease, conducted in 45 countries. At baseline, data on demographics, ethnicity, CV risk factors, medical history, cardiac parameters and medication were collected. Patients were followed up yearly up to 5 years. In this analysis, 26 769 patients with no HF history were included. At 5-year follow-up, 4393 patients (16.4%) reached the primary endpoint comprising CV death, HF hospitalization, or new-onset HF. Only 16.7% of them (n = 732) required hospitalization for HF. All-cause death occurred in 6.6% of patients (61.4% were CV). Age over 70 years, left ventricular ejection fraction <50%, Canadian Cardiovascular Society class ≥2 angina, atrial fibrillation or paced rhythm on the ECG, body mass index <20 kg/m2 , and a history of stroke, were the most robust predictors of the primary outcome. Age <50 years, Asian ethnicity, and percutaneous revascularization were negative predictors of the outcome.Conclusion: A sizeable proportion of patients with chronic coronary syndrome develop HF, which only infrequently requires hospitalization. Early identification of patients with HF may lead to early treatment, and help to further decrease mortality and morbidity. This concept needs confirmation in future studies. [ABSTRACT FROM AUTHOR]

Dynamic treatment regimes are sequential decision rules that adapt throughout disease progression according to a patient's evolving characteristics. In many clinical applications, it is desirable that the format of the decision rules remains consistent over time. Unlike the estimation of dynamic treatment regimes in regular settings, where decision rules are formed without shared parameters, the derivation of the shared decision rules requires estimating shared parameters indexing the decision rules across different decision points. Estimation of such rules becomes more complicated when the clinical outcome of interest is a survival time subject to censoring. To address these challenges, we propose two novel methods: censored shared-Q-learning and censored shared-O-learning. Both methods incorporate clinical preferences into a qualitative rule, where the parameters indexing the decision rules are shared across different decision points and estimated simultaneously. We use simulation studies to demonstrate the superior performance of the proposed methods. The methods are further applied to the Framingham Heart Study to derive treatment rules for cardiovascular disease. [ABSTRACT FROM AUTHOR]

Objectives: First, to compare the incidence of single and double fetal death between monochorionic (MC) and dichorionic (DC) twin pregnancies with two live fetuses at 11-13 weeks' gestation and no major abnormalities. Second, to investigate the relationship between gestational age at single fetal death and interval to delivery of the cotwin. Third, to determine the rate of early preterm birth in DC and MC twin pregnancies with two live fetuses and those with single fetal death.Methods: This was a retrospective analysis of prospectively collected data on twin pregnancies undergoing routine ultrasound examination at 11-13 weeks' gestation between 2002 and 2019. The outcome measures, which were stratified by chorionicity, were: first, death of both fetuses at presentation or death of one fetus followed by delivery of a live or dead cotwin within the subsequent 3 days at < 34 weeks' gestation; second, in pregnancies with single fetal death at < 34 weeks' gestation and a live cotwin ≥ 3 days later, the subsequent risk of fetal death and gestational-age distribution at birth of the cotwin; and, third, the gestational-age distribution at birth in pregnancies with two live fetuses.Results: The main findings of this study of 4896 DC and 1329 MC twin pregnancies with two live fetuses at 11-13 weeks' gestation were: first, the rate of death of both twins or death of one fetus and delivery of the live or dead cotwin within 3 days was higher in MC than in DC twin pregnancies; second, the rate of single fetal death with a live cotwin ≥ 3 days later was higher in MC than in DC twin pregnancies, but the rate of subsequent cotwin death in MC twin pregnancies was not significantly different from that in DC twin pregnancies; third, in pregnancies with two live fetuses, the rate of early preterm birth was significantly higher in MC than in DC twin pregnancies; fourth, the rate of early preterm birth in pregnancies with single fetal death and a live cotwin ≥ 3 days later was not significantly different between MC and DC twin pregnancies but the rates were substantially higher than in those with two live fetuses; and, fifth, in both MC and DC pregnancies with single fetal death and a live cotwin ≥ 3 days later, there was a significant inverse association between gestational age at death and interval to delivery (mean interval of 19 weeks for death at 15 weeks and mean interval of 2.5 weeks for death at 30 weeks).Conclusions: First, in MC twin pregnancies, the risk of single or double fetal death is higher than in DC twins. Second, in both MC and DC twin pregnancies, the rate of early preterm birth is higher in those with one fetal death than in those with two live fetuses. Third, in both MC and DC twins with one fetal death, the interval to delivery is related inversely to gestational age at fetal death. These data should be useful in counseling parents as to the likely outcome of their pregnancy after single fetal death and in defining strategies for surveillance in the management of these types of twin pregnancy. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: To assess whether sonographic diagnosis of intrauterine hematoma (IUH) in the first trimester of pregnancy is associated with first-trimester miscarriage and antenatal, delivery and neonatal complications.Methods: This was a prospective observational cohort study of women with an intrauterine singleton pregnancy between 5 and 14 weeks' gestation recruited at Queen Charlotte's and Chelsea Hospital, London, UK, between March 2014 and March 2016. Participants underwent serial ultrasound examinations in the first trimester, and the presence, location, size and persistence of any IUH was evaluated. First-trimester miscarriage was defined as pregnancy loss before 14 weeks' gestation. Clinical symptoms, including pelvic pain and vaginal bleeding, were recorded at each visit using validated symptom scores. Antenatal, delivery and neonatal outcomes were obtained from hospital records. Logistic regression analysis and the chi-square test were used to assess the association between the presence and features of IUH and the incidence of adverse pregnancy outcome. Odds ratios (OR) were first adjusted for maternal age (aOR) and then further adjusted for the presence of vaginal bleeding or pelvic pain in the first trimester.Results: Of 1003 women recruited to the study, 946 were included in the final analysis and of these, 268 (28.3%) were diagnosed with an IUH in the first trimester. The presence of IUH was associated with the incidence of preterm birth (aOR, 1.94 (95% CI, 1.07-3.52)), but no other individual or overall antenatal, delivery or neonatal complications. No association was found between the presence of IUH in the first trimester and first-trimester miscarriage (aOR, 0.81 (95% CI, 0.44-1.50)). These findings were independent of the absolute size of the hematoma and the presence of vaginal bleeding or pelvic pain in the first trimester. When IUH was present in the first trimester, there was no association between its size, content or position in relation to the gestational sac and overall antenatal, delivery and neonatal complications. Diagnosis of a retroplacental IUH was associated with an increased risk of overall antenatal complications (P = 0.04).Conclusions: Our findings demonstrate that there is no association between the presence of IUH in the first trimester and first-trimester miscarriage. However, an association with preterm birth, independently of the presence of symptoms of pelvic pain and/or vaginal bleeding, is evident. Women diagnosed with IUH in the first trimester should be counseled about their increased risk of preterm birth and possibly be offered increased surveillance during the course of their pregnancy. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

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Objective: EXTrauterine Environment for Neonatal Development (EXTEND) is a system to support ongoing fetal growth and organ development in an extrauterine environment, utilizing a pumpless low-resistance oxygenator circuit. The aim of this study was to evaluate hemodynamics and cardiac function in fetal sheep sustained on the EXTEND system.Methods: This was a prospective study of fetal sheep supported for a minimum of 3 weeks on EXTEND. Hemodynamic parameters were assessed weekly and included heart rate, mean arterial pressure (MAP), Doppler-echocardiography-derived cardiac output (CO), pulsatility indices (PIs) of the fetal middle cerebral artery (MCA), umbilical artery (UA) and ductus venosus and cardiac function, as assessed by speckle-tracking-derived global longitudinal strain and strain rate in the right (RV) and left (LV) ventricles. Parameters were compared at 0 days and 1, 2 and 3 weeks following placement on EXTEND.Results: Of 10 fetal sheep enrolled, seven survived for 3 weeks and were included in the analysis. Median gestational age at cannulation was 107 (range, 95-109) days. Heart rate decreased and MAP increased significantly, but within acceptable ranges, during the study period. The quantities and relative ratios of right and left CO remained stable within the anticipated physiological range throughout the study period. Vascular tracings and PIs appeared to be similar to those seen normally in the natural in-utero state, with MCA-PI being higher than UA-PI. UA tracings demonstrated maintained abundant diastolic flow despite the absence of placental circulation. In both the RV and LV, strain decreased significantly at 1 and 2 weeks relative to baseline but returned to baseline values by week 3.Conclusions: The EXTEND mechanical support system replicates natural physiology and creates a stable and sustainable cardiovascular construct that supports growth over a 3-week period. However, there is a period of depressed contractility within the first week with subsequent improvement by week 3. This may reflect a period of physiological accommodation that warrants further investigation. This study lays the foundation for further exploration as the EXTEND system moves towards human application. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Objective: To develop a model for identifying clinic performance at fulfilling next-day and walk-in requests after adjusting for patient demographics and risk.Data Source: Using Department of Veterans Affairs (VA) administrative data from 160 VA primary care clinics from 2014 to 2017.Study Design: Using a retrospective cohort design, we applied Bayesian hierarchical regression models to predict provision of timely care, with clinic-level random intercept and slope while adjusting for patient demographics and risk status. Timely care was defined as the provision of an appointment within 48 hours of any patient requesting the clinic's next available appointment or walking in to receive care.Data Collection/extraction Methods: We extracted 1 841 210 timely care requests from 613 263 patients.Principal Findings: Across 160 primary care clinics, requests for timely care were fulfilled 86 percent of the time (range 83 percent-88 percent). Our model of timely care fit the data well, with a Bayesian R2 of .8. Over the four years of observation, we identified 25 clinics (16 percent) that were either struggling or excelling at providing timely care.Conclusion: Statistical models of timely care allow for identification of clinics in need of improvement after adjusting for patient demographics and risk status. VA primary care clinics fulfilled 86 percent of timely care requests. [ABSTRACT FROM AUTHOR]

Objective: To develop a nurse staffing prediction model and evaluate deviation from predicted nurse staffing as a contributor to patient outcomes.Data Sources: Secondary data collection conducted 2017-2018, using the California Office of Statewide Health Planning and Development and the California Perinatal Quality Care Collaborative databases. We included 276 054 infants born 2008-2016 and cared for in 99 California neonatal intensive care units (NICUs).Study Design: Repeated-measures observational study. We developed a nurse staffing prediction model using machine learning and hierarchical linear regression and then quantified deviation from predicted nurse staffing in relation to health care-associated infections, length of stay, and mortality using hierarchical logistic and linear regression.Data Collection Methods: We linked NICU-level nurse staffing and organizational data to patient-level risk factors and outcomes using unique identifiers for NICUs and patients.Principal Findings: An 11-factor prediction model explained 35 percent of the nurse staffing variation among NICUs. Higher-than-predicted nurse staffing was associated with decreased risk-adjusted odds of health care-associated infection (OR: 0.79, 95% CI: 0.63-0.98), but not with length of stay or mortality.Conclusions: Organizational and patient factors explain much of the variation in nurse staffing. Higher-than-predicted nurse staffing was associated with fewer infections. Prospective studies are needed to determine causality and to quantify the impact of staffing reforms on health outcomes. [ABSTRACT FROM AUTHOR]

Background: Specific components of physical activity, such as vigorous exercise and heavy occupational work, are known to increase the risk of chronic low back pain (CLBP) and chronic knee pain (CKP), but impacts of other components are less known. This study aimed to assess the relationship between total physical activity and risk of CLBP and CKP from a public health perspective.Methods: Participants were 7,565 individuals, aged 40-74 years, who did not have CLBP or CKP, and who participated in the 5-year follow-up survey. A self-administered questionnaire was used to obtain information on demographics, body size and lifestyle (including physical activity) in the baseline survey in 2011-2013, and on CLBP and CKP using Short Form 36 (SF-36) in the follow-up survey. Sitting, standing, walking and strenuous work for occupational activity were assessed for total physical activity, and walking slowly, walking quickly, light to moderate exercise and strenuous exercise were assessed for leisure-time physical activity using metabolic equivalent hours/day (METs score).Results: Mean age of participants was 60.1 years (SD, 8.8). Participants with higher METs scores had a significantly higher risk of CKP (p for trend = 0.0089, OR of 4th quartile = 1.29, 95% CI: 1.04-1.59 vs. 1st quartile), but not CLBP. An intermediate leisure-time METs score was associated with a lower risk of CLBP (OR = 0.75, 95%CI: 0.61-0.92 vs. 0 METs-group).Conclusions: A high level of total physical activity may increase the risk of CKP, whereas an intermediate level of leisure-time physical activity may decrease the risk of CLBP, in middle-aged and elderly individuals.Significance: Evidence on the longitudinal association between total physical activity and CLBP and CKP in middle-aged and elderly people is lacking. We conducted a cohort study to assess this association, and found that high levels of total physical activity increased risk of CKP, and intermediate levels of leisure-time physical activity decreased risk of CLBP. This suggests that the effect of physical activity on chronic pain differed by pain site. [ABSTRACT FROM AUTHOR]

The aim of this study was to document the extent to which diabetic patients who adhered to required medical follow-ups in France experienced reduced hospital admissions over time. The main assumption was that enhanced monitoring and follow-up of diabetic patients in the primary care setting could be a substitute for hospital use. Using longitudinal claim data of diabetic patients between 2010 and 2015 from MGEN, a leading mutuelle insurance company in France, we estimated a dynamic logit model with lagged measures of the quality of adherence to eight medical follow-up recommendations. This model allowed us to disentangle follow-up care in hospitals from other forms of inpatient care that could occur simultaneously. We found that a higher adherence to medical guidance is associated with a lower probability of hospitalization and that the take-up of each of the eight recommendations may help reduce the rates of hospital admission. The reasons for the variation in patient adherence and implications for health policy are discussed. [ABSTRACT FROM AUTHOR]

Aims: Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx.Methods: A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years.Conclusion: The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx. [ABSTRACT FROM AUTHOR]

Objective: Prolonged grief disorder (PGD) and major depressive disorder (MDD) are common syndromes shaping bereaved caregivers' quality of life (QOL). However, distinctiveness of these syndromes warrants confirmation, and the temporal relationship of PGD and MDD symptoms has not been established. To fill these knowledge gaps, we conducted this longitudinal study.Methods: PGD symptoms, depressive symptoms, and psychological QOL were measured over 398 caregivers' first 2 years of bereavement using the Prolonged Grief-13 (PG-13) scale, Center for Epidemiologic Studies-Depression (CES-D) scale, and Short Form-36 Health Survey mental health summary, respectively. To clarify the distinctiveness of PGD and MDD symptoms, we examined their associations with psychological QOL by incremental validity testing. Distinctiveness and temporal relationship of PGD and MDD symptoms were also examined using longitudinal, lower-level mediation analysis with a lagged approach.Results: After the variance in psychological QOL was explained by CES-D scores (pseudo-R2 = 44.19%, P < .001), PG-13 scores significantly, incrementally increased the explained variance in psychological QOL (pseudo-R2 = 0.21%, P < .001), confirming the distinctiveness of PGD and MDD symptoms. CES-D scores mediated 40.7% of the time vs PG-13 score relationship, whereas PG-13 scores mediated 78.2% of the time vs CES-D score relationship with a better model fit, indicating that PG-13 scores assessed earlier mediated caregivers' current depressive status rather than vice versa.Conclusions: PGD and MDD are distinct constructs, and PGD precedes onset of MDD. Clinicians should distinguish between these two disorders and address bereaved caregivers' PGD to reduce PGD-associated distress and morbidity and to prevent MDD onset, thereby improving their QOL. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of publicly reporting a statewide fetal growth restriction (FGR) performance indicator.Design: Retrospective cohort study from 2000 to 2017.Setting: All maternity services in Victoria, Australia.Population: A total of 1 231 415 singleton births at ≥32 weeks of gestation.Methods: We performed an interrupted time-series analysis to assess the impact of publicly reporting an FGR performance indicator on the rate of detection for severe cases of small for gestational age (SGA). Rates of perinatal mortality and morbidity and obstetric intervention were assessed for severe SGA pregnancies and pregnancies delivered for suspected SGA.Main Outcome Measures: Gestation at delivery, obstetric management and perinatal outcome.Results: The public reporting of a statewide FGR performance indicator was associated with a steeper reduction per quarter in the percentage of severe SGA undelivered by 40 weeks of gestation, from 0.13 to 0.51% (P = 0.001), and a decrease in the stillbirth rate by 3.3 per 1000 births among those babies (P = 0.01). Of babies delivered for suspected SGA, the percentage with birthweights ≥ 10th centile increased from 41.4% (n = 307) in 2000 to 53.3% (n = 1597) in 2017 (P < 0.001). Admissions to a neonatal intensive care unit for babies delivered for suspected SGA but with a birthweight ≥ 10th centile increased from 0.8 to 2.0% (P < 0.001).Conclusions: The public reporting of an FGR performance indicator has been associated with the improved detection of severe SGA and a decrease in the rate of stillbirth among those babies, but with an increase in the rate of iatrogenic birth for babies with normal growth.Tweetable Abstract: The public reporting of hospital performance is associated with a reduction in stillbirth, but also with unintended interventions. [ABSTRACT FROM AUTHOR]

Objectives: To investigate blood lead levels in an Australian birth cohort of children; to identify factors associated with higher lead levels.Design, Setting: Cross-sectional study within the Barwon Infant Study, a population birth cohort study in the Barwon region of Victoria (1074 infants, recruited June 2010 - June 2013). Data were adjusted for non-participation and attrition by propensity weighting.Participants: Blood lead was measured in 523 of 708 children appraised in the Barwon Infant Study pre-school review (mean age, 4.2 years; SD, 0.3 years).Main Outcome Measure: Blood lead concentration in whole blood (μg/dL).Results: The median blood lead level was 0.8 μg/dL (range, 0.2-3.7 μg/dL); the geometric mean blood lead level after propensity weighting was 0.97 μg/dL (95% CI, 0.92-1.02 μg/dL). Children in houses 50 or more years old had higher blood lead levels (adjusted mean difference [AMD], 0.13 natural log units; 95% CI, 0.02-0.24 natural log units; P = 0.020), as did children of families with lower household income (per $10 000, AMD, -0.035 natural log units; 95% CI, -0.056 to -0.013 natural log units; P = 0.002) and those living closer to Point Henry (inverse square distance relationship; P = 0.002). Associations between hygiene factors and lead levels were evident only for children living in older homes.Conclusion: Blood lead levels in our pre-school children were lower than in previous Australian surveys and recent surveys in areas at risk of higher exposure, and no children had levels above 5 μg/dL. Our findings support advice to manage risks related to exposure to historical lead, especially in older houses. [ABSTRACT FROM AUTHOR]

Objective: To determine the association between maternal lipaemia and neonatal anthropometrics in Malaysian mother-offspring pairs.Design: Prospective observational cohort study.Setting: Single tertiary multidisciplinary antenatal clinic in Malaysia.Population: A total of 507 mothers: 145 with gestational diabetes mellitus (GDM); 94 who were obese with normal glucose tolerance (NGT) (pre-gravid body mass index, BMI ≥ 27.5 kg/m2 ), and 268 who were not obese with NGT.Methods: Maternal demographic, anthropometric, and clinical data were collected during an interview/examination using a structured questionnaire. Blood was drawn for insulin, C-peptide, triglyceride (Tg), and non-esterified fatty acid (NEFA) during the 75-g 2-hour oral glucose tolerance test (OGTT) screening, and again at 36 weeks of gestation. At birth, neonatal anthropometrics were assessed and data such as gestational weight gain (GWG) were extracted from the records.Main Outcome Measures: Macrosomia, large-for-gestational-age (LGA) status, cohort-specific birthweight (BW), neonatal fat mass (NFM), and sum of skinfold thickness (SSFT) > 90th centile.Results: Fasting Tg > 95th centile (3.6 mmol/L) at screening for OGTT was independently associated with LGA (adjusted odds ratio, aOR 10.82, 95% CI 1.26-93.37) after adjustment for maternal glucose, pre-gravid BMI, and insulin sensitivity. Fasting glucose was independently associated with a birthweight ratio (BWR) of >90th centile (aOR 2.06, 95% CI 1.17-3.64), but not with LGA status, in this well-treated GDM cohort with pre-delivery HbA1c of 5.27%. In all, 45% of mothers had a pre-gravid BMI of <23 kg/m2 and 61% had a pre-gravid BMI of ≤ 25 kg/m2 , yet a GWG of >10 kg was associated with a 4.25-fold risk (95% CI 1.71-10.53) of BWR > 90th centile.Conclusion: Maternal lipaemia and GWG at a low threshold (>10 kg) adversely impact neonatal adiposity in Asian offspring, independent of glucose, insulin resistance and pre-gravid BMI. These may therefore be important modifiable metabolic targets in pregnancy.Tweetable Abstract: Maternal lipids are associated with adiposity in Asian babies independently of pre-gravid BMI, GDM status, and insulin resistance. [ABSTRACT FROM AUTHOR]

Objective: To study the risk of vaginal cancer among hysterectomised women with and without cervical intraepithelial neoplasia (CIN).Design: Population-based national cohort study.Setting and Population: All Swedish women, 5 million in total, aged 20 and up, 1987-2011 using national registries.Methods: The study cohort was subdivided into four exposure groups: hysterectomised with no previous history of CIN3 and without prevalent CIN at hysterectomy; hysterectomised with a history of CIN3/adenocarcinoma in situ (AIS); hysterectomised with prevalent CIN at hysterectomy; non-hysterectomised.Main Outcome Measure: Vaginal cancer.Results: We identified 898 incident cases of vaginal cancer. Women with prevalent CIN at hysterectomy and those with a history of CIN3/AIS had incidence rates (IR) of vaginal cancer of 51.3 (95% CI 34.4-76.5) and 17.1 (95% CI 12.5-23.4) per 100 000, respectively. Age-adjusted IR-ratios (IRRs) compared with hysterectomised women with benign cervical history were 21.0 (95% CI 13.4-32.9) and 5.81 (95% CI 4.00-8.43), respectively. IR for non-hysterectomised women was 0.87 (95% CI 0.81-0.93) and IRR was 0.37 (95% CI 0.30-0.46). In hysterectomised women with prevalent CIN, the IR remained high after 15 years of follow up: 65.7 (95% CI 21.2-203.6).Conclusions: Our findings suggest that hysterectomised women with prevalent CIN at surgery should be offered surveillance. Hysterectomised women without the studied risk factors have a more than doubled risk of contracting vaginal cancer compared with non-hysterectomised women in the general population. Still, the incidence rate does not justify screening.Tweetable Abstract: High risk of contracting vaginal cancer among hysterectomised women having prevalent CIN at surgery. [ABSTRACT FROM AUTHOR]

Aim: To assess educational outcomes of twins and quantify the degree this is mediated by gestational age and other perinatal factors.Methods: We conducted a population-based record-linkage cohort study of all live births ≥24 weeks gestation in New South Wales, Australia with a corresponding standardised school test result for grade 3 in 2008-2014. The primary outcome was whether a child met the National Minimum Standard (NMS) cut-off in literacy and numeracy domains. Robust multivariable Poisson models were used to obtain adjusted relative risks (aRRs), and mediation analysis conducted to assess contributing factors on the causal pathway.Results: Of 351 791 liveborn infants, 10 365 (2.9%) were twins. After adjusting for maternal covariates and compared with singletons, twins had an increased risk of not meeting the NMS for all five literacy and numeracy domains (aRR 1.27-1.45, P < .001). Gestational age alone mediated up to 73% of aRRs and small for gestational age further attenuated these effects with only minimal risk remaining after adjusting for all mediators (aRR 0.94-1.07).Conclusion: Almost all of the educational disadvantage experienced by twins, compared with singletons, is attributable to the risk associated with shorter gestational age, and partly by poor foetal growth. These findings support efforts to prolong gestation of twin pregnancies. [ABSTRACT FROM AUTHOR]

Aim: We collected evidence and safety data for topical tacrolimus in small children with atopic dermatitis (AD) and compared the usage with topical corticosteroid.Methods: This was an interim analysis of 75 patients (55% female) at 1 year of an ongoing 3-year randomised open-label comparative follow-up study of topical tacrolimus vs corticosteroid treatment. One- to three-year-old children with moderate-to-severe eczema referred to the Skin and Allergy Hospital in Helsinki, Finland, were enrolled.Results: Efficacy parameters, the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), transepidermal water loss (TEWL), eczema area, serum total immunoglobulin E (IgE) and the blood eosinophil count, showed improvement in both groups during the study. However, patients with signs of early sensitisation at baseline (elevated serum total IgE, elevated eosinophil count, positive prick tests or specific IgEs to aero or food allergens) had statistically significantly lower TEWL at the eczema site and a smaller eczema area at 12 months in the tacrolimus group. No severe adverse effects were seen during the treatment.Conclusion: Children with AD and signs of early sensitisation appeared to benefit more from early tacrolimus than corticosteroid treatment. Small children may need stronger but nevertheless safe ointment options when treating moderate-to-severe AD. [ABSTRACT FROM AUTHOR]

Background: Digital impression techniques have seen many advancements, with new hardware and software being developed each year. The technical advantages of these systems are real-time visualization, evaluation and archive, segmental capture, ease of recapture if necessary, economical in terms of no use of impression material or trays or disinfection, easy file transfer and communication with the laboratory. However patient satisfaction is one major factor that might influence the choice of impression technique. The aim of this network meta-analysis was to identify statistically the evidence on overall patient preferences relative to digital versus conventional impression techniques, in addition to the time taken in making these impressions.Methodology: Randomized or prospective clinical studies were identified based on the inclusion criteria in PUBMED, DARE and COCHRANE databases; subsequently pertinent data were extracted. Risk of bias of the included studies was assessed using the Cochrane risk of bias tool and Newcastle-Ottawa scale. Heterogeneity amongst the studies in direct comparison was assessed by Chi-square and I2 tests using the Inverse variance heterogeneity model. Direct comparison estimates were derived by pooling the data from studies that compared the same intervention. Indirect comparison pooled estimates were derived by using the data amongst the studies, through a common comparator, using MetaXL software. Mean differences and Odds ratio at 95% confidence interval were used as the effect estimates, while inconsistencies were evaluated by H-statistics. GRADE working group approach was used to assess the quality of available evidence.Results: Fourteen studies were included. Results from 11 studies  on 471 patients (236-Digital; 235-conventional) were pooled for patient preference with 95% confidence interval. The Forest plot showed a pooled estimate of 31.23 [5.95, 163.87], showing a statistically significant number of patients favouring digital impressions. Results from 11 studies reported the time taken in 589 patients (278-digital; 311 conventional). The pooled estimate (2.72 [0.08, 5.32]) (95% confidence interval) showed a statistically significant increase in the time required to make digital impressions. The overall time taken in minutes for the interventions in the digital group in decreasing order were: LAVA Cos (8.14[3.64,12,26] (statistically significant); I tero (4.11[-1.02,9.24]; CEREC (0.34[-4.14,4.82]).Conclusion: There was an overall preference for digital impressions, although the time required is longer. The factors related to the digital system, the operator and the patient were studied, with recommendations forming a basis for possible hardware and software upgrades of the digital systems that can produce significant improvement in the acceptance rate for both the patient and the clinician. [ABSTRACT FROM AUTHOR]

Introduction: Global estimates suggest 2.6 million stillbirths and 2.5 million neonatal deaths occur annually worldwide. The majority of these deaths occur in low resource settings where analysis of health metrics and outcomes measurements may be challenging. We examined the misclassification of documented intrapartum stillbirth and factors associated with misclassification.Material and Methods: A prospective observational study was performed in 12 public hospitals in Nepal. Data were extracted from the medical records of all births that occurred during the 6-month period of the study. For the study purpose, we classified birth outcome based on the presence of fetal heart sound (FHS) at admission and use of neonatal resuscitation. The health worker-documented intrapartum stillbirths were considered potentially misclassified when there were FHS present at admission and no resuscitation initiated after birth. The association between potentially misclassified intrapartum stillbirth and complications during labor, birthweight and gestational age was assessed using Pearson's chi-square test, bivariate and multivariate logistic regression.Results: A total of 39 562 mother-infant dyads were enrolled in the study, all of whom had FHS at admission. Among the 391 intrapartum stillbirths recorded during the study, 180 (46.0%) of them had FHS at admission with no resuscitation initiated after birth and were considered potentially misclassified intrapartum stillbirths. Among these potentially misclassified intrapartum stillbirths, 170 (43.5%) had FHS present 15 minutes before birth and 10 had no FHS 15 minutes before birth Among the potentially misclassified intrapartum stillbirths, 23.3% had complications during labor, 93.3% had birthweight less than 2500 g and 90.0% were born preterm. The risk of intrapartum misclassification was nearly four times higher among low birthweight babies (adjusted odds ratio [aOR] 3.5, 95% confidence interval [CI] 1.8 to 7.0, P < 0.001) and five times higher among preterm babies (aOR 5.3, 95% CI 3.0 to 9.3, P < 0.001).Conclusions: We estimate that 46% of intrapartum stillbirths were potentially misclassified intrapartum stillbirths. Improving quality of both FHS monitoring and neonatal resuscitation as well as measurement of the care will reduce the risk of potentially misclassified intrapartum stillbirth and consequently intrapartum stillbirth. [ABSTRACT FROM AUTHOR]

Economic hardship can affect children's development through child-caregiver interactions, which may mediate cascading effects of other family stress processes. This study examined, simultaneously, the relations of financial strain, caregiver general stress, and child-caregiver conflict-each measured at two time points-with child self-regulatory outcomes in a high-poverty sample (age 5-7 years; n = 343). Increase in child-caregiver conflict mediated negative relations between other processes and development of executive function. In contrast, only increase in financial strain had direct, negative association with development of delay of gratification and did not significantly mediate relations between any other process and children's outcomes. Results have implications for understanding effects of family stress on self-regulatory outcomes and for interventions with low-income families. [ABSTRACT FROM AUTHOR]

Objectives: Operators performing fetal growth scans are usually aware of the gestational age of the pregnancy, which may lead to expected-value bias when performing biometric measurements. We aimed to evaluate the incidence of expected-value bias in routine fetal growth scans and assess its impact on standard biometric measurements.Methods: We collected prospectively full-length video recordings of routine ultrasound growth scans coupled with operator eye tracking. Expected value was defined as the gestational age at the time of the scan, based on the estimated due date that was established at the dating scan. Expected-value bias was defined as occurring when the operator looked at the measurement box on the screen during the process of caliper adjustment before saving a measurement. We studied the three standard biometric planes on which measurements of head circumference (HC), abdominal circumference (AC) and femur length (FL) are obtained. We evaluated the incidence of expected-value bias and quantified the impact of biased measurements.Results: We analyzed 272 third-trimester growth scans, performed by 16 operators, during which a total of 1409 measurements (354 HC, 703 AC and 352 FL; including repeat measurements) were obtained. Expected-value bias occurred in 91.4% of the saved standard biometric plane measurements (85.0% for HC, 92.9% for AC and 94.9% for FL). The operators were more likely to adjust the measurements towards the expected value than away from it (47.7% vs 19.7% of measurements; P < 0.001). On average, measurements were corrected by 2.3 ± 5.6, 2.4 ± 10.4 and 3.2 ± 10.4 days of gestation towards the expected gestational age for the HC, AC, and FL measurements, respectively. Additionally, we noted a statistically significant reduction in measurement variance once the operator was biased (P = 0.026). Comparing the lowest and highest possible estimated fetal weight (using the smallest and largest biased HC, AC and FL measurements), we noted that the discordance, in percentage terms, was 10.1% ± 6.5%, and that in 17% (95% CI, 12-21%) of the scans, the fetus could be considered as small-for-gestational age or appropriate-for-gestational age if using the smallest or largest possible measurements, respectively. Similarly, in 13% (95% CI, 9-16%) of scans, the fetus could be considered as large-for-gestational age or appropriate-for-gestational age if using the largest or smallest possible measurements, respectively.Conclusions: During routine third-trimester growth scans, expected-value bias frequently occurs and significantly changes standard biometric measurements obtained. © 2019 the Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Objectives: Accurate mid-pregnancy prediction of spontaneous preterm birth (sPTB) is essential to ensure appropriate surveillance of high-risk women. Advancing the QUiPP App prototype, QUiPP App v.2 aimed to provide individualized risk of delivery based on cervical length (CL), quantitative fetal fibronectin (qfFN) or both tests combined, taking into account further risk factors, such as multiple pregnancy. Here we report development of the QUiPP App v.2 predictive models for use in asymptomatic high-risk women, and validation using a distinct dataset in order to confirm the accuracy and transportability of the QUiPP App, overall and within specific clinically relevant time frames.Methods: This was a prospective secondary analysis of data of asymptomatic women at high risk of sPTB recruited in 13 UK preterm birth clinics. Women were offered longitudinal qfFN testing every 2-4 weeks and/or transvaginal ultrasound CL measurement between 18 + 0 and 36 + 6 weeks' gestation. A total of 1803 women (3878 visits) were included in the training set and 904 women (1400 visits) in the validation set. Prediction models were created based on the training set for use in three groups: patients with risk factors for sPTB and CL measurement alone, with risk factors for sPTB and qfFN measurement alone, and those with risk factors for sPTB and both CL and qfFN measurements. Survival analysis was used to identify the significant predictors of sPTB, and parametric structures for survival models were compared and the best selected. The estimated overall probability of delivery before six clinically important time points (< 30, < 34 and < 37 weeks' gestation and within 1, 2 and 4 weeks after testing) was calculated for each woman and analyzed as a predictive test for the actual occurrence of each event. This allowed receiver-operating-characteristics curves to be plotted, and areas under the curve (AUC) to be calculated. Calibration was performed to measure the agreement between expected and observed outcomes.Results: All three algorithms demonstrated high accuracy for the prediction of sPTB at < 30, < 34 and < 37 weeks' gestation and within 1, 2 and 4 weeks of testing, with AUCs between 0.75 and 0.90 for the use of qfFN and CL combined, between 0.68 and 0.90 for qfFN alone, and between 0.71 and 0.87 for CL alone. The differences between the three algorithms were not statistically significant. Calibration confirmed no significant differences between expected and observed rates of sPTB within 4 weeks and a slight overestimation of risk with the use of CL measurement between 22 + 0 and 25 + 6 weeks' gestation.Conclusions: The QUiPP App v.2 is a highly accurate prediction tool for sPTB that is based on a unique combination of biomarkers, symptoms and statistical algorithms. It can be used reliably in the context of communicating to patients the risk of sPTB. Whilst further work is required to determine its role in identifying women requiring prophylactic interventions, it is a reliable and convenient screening tool for planning follow-up or hospitalization for high-risk women. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

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Objective: Persistent symptoms and poor quality of life (QoL) are common following anterior cruciate ligament reconstruction (ACLR). We aimed to determine the influence of a combined ACL injury (i.e., concomitant meniscectomy and/or arthroscopic chondral defect at the time of ACLR and/or secondary injury/surgery to ACLR knee) and cartilage defects defined on magnetic resonance imaging (MRI), bone marrow lesions (BMLs), and meniscal lesions on patient-reported outcomes 1 to 5 years after ACLR.Methods: A total of 80 participants (50 men; mean ± SD age 32 ± 14 years) completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) questionnaires as well as a 3T MRI assessment at 1 and 5 years after ACLR. Median patient-reported outcome scores were compared between isolated and combined ACL injuries and with published normative values. Using multivariate regression, we evaluated the association between compartment-specific MRI cartilage, BMLs, and meniscal lesions and patient-reported outcomes at 1 and 5 years.Results: Individuals with a combined injury had significantly worse scores in the KOOS subscale of function in sport and recreation (KOOS sport/rec) and in the IKDC questionnaire at 1 year, and worse scores in the KOOS subscales of pain (KOOS pain), symptoms (KOOS symptoms), and QoL (KOOS QoL) and in the IKDC questionnaire at 5 years compared to those with an isolated injury. Although no feature on MRI was associated with patient-reported outcomes cross-sectionally at 1 year, patellofemoral cartilage defects at 1 year were significantly associated with worse 5-year KOOS symptoms (β = -9.79, 95% confidence interval [95% CI] -16.67, -2.91), KOOS sport/rec (β = -7.94, 95% CI -15.27, -0.61), KOOS QoL (β = -8.29, 95% CI -15.28, -1.29), and IKDC (β = -4.79, 95% CI -9.34, -0.24) scores. Patellofemoral cartilage defects at 5 years were also significantly associated with worse 5-year KOOS symptoms (β = -6.86, 95% CI -13.49, -0.24) and KOOS QoL (β = -11.71, 95% CI -19.08, -4.33) scores.Conclusion: Combined injury and patellofemoral cartilage defects shown on MRI are associated with poorer long-term outcomes. Clinicians should be vigilant and aware of individuals with these injuries, as such individuals may benefit from targeted interventions to improve QoL and optimize symptoms. [ABSTRACT FROM AUTHOR]

Background: Evaluation of clinical long-term results 20 years after connective tissue grafting (CTG) or guided tissue regeneration (GTR) using bioabsorbable barriers for root coverage therapy.Methods: Initially, 15 patients with 38 Miller Class I and II recession defects underwent CTG or GTR according to random assignment. At baseline, 3, 120 ± 12, and 240 ± 12 months after surgery, data on probing depth, clinical attachment level, recession depth and width, amount of keratinized tissue, and bleeding on probing were obtained. Additionally, patients' smoking habits and participation in supportive periodontal therapy were investigated.Results: Eight patients contributing 23 recessions were available at the 240 ± 12 months follow-up. Three and 120 ± 12 months after therapy with CTG, significantly better root coverage was observed compared with baseline (3 months: 3.01 ± 1.74 mm; P = 0.003; 120 ± 12 months: 2.11 ± 1.86 mm; P < 0.024). GTR resulted in significantly better root coverage compared with baseline after 3 months (2.25 ± 1.89 mm; P < 0.012). Although there were no significant changes in the recession depth between 3 and 240 ± 12 months in both groups (CTG: P = 0.097; GTR: P = 0.190), 1.57 ± 2.12 mm (CTG) and 1.19 ± 2.31 mm (GTR) of the achieved coverage after 3 months were lost. CTG showed significantly better relative root coverage percentage than GTR after 3 (P = 0.026) and 120 (P = 0.038) months. This study failed to detect a significant difference in the stability of root coverage after 240 ± 12 months between CTG and GTR (P = 0.448) and patients' assessments of their treatment outcomes (P = 0.503).Conclusion: Long-term stability of root coverage and patient-perceived esthetic outcomes failed to show significant differences between CTG and GTR at 20 years post-surgery. [ABSTRACT FROM AUTHOR]

Background: Overweight/obese patients' large fat mass can mask the loss of skeletal muscle, which is associated with mortality in the oncology setting. We investigated the prevalence of computed tomography (CT)-defined sarcopenia and myosteatosis across different levels of nutrition risk assessed by the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). We also evaluated whether the PG-SGA SF, sarcopenia, and myosteatosis were prognostic of overall survival.Methods: This was a prospective, observational study. Consecutive patients with body mass index ≥25.0 kg/m2 with newly diagnosed head and neck cancer (any stage) or lung and gastrointestinal tract cancer (locally recurrent or metastatic) were screened at presentation to oncology clinics. Nutrition risk was assigned based on PG-SGA SF triage recommendations. Based on CT, patients were classified with sarcopenia and/or myosteatosis using published cutoffs. Survival analyses were conducted.Results: Patients (n=1157) were 63.6 ± 11.4 years, 64% male, and 61% had stage IV disease. Sarcopenia and myosteatosis were prevalent across PG-SGA SF nutrition risk categories (scores 0-1 [no risk; 36% sarcopenic; 44% myosteatotic], scores 2-3 [37%; 37%], scores 4-8 [40%; 41%], and scores ≥9 [high risk; 50%; 49%]). In multivariable survival analysis, PG-SGA SF scores ≥9 (hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.66-2.60, P<0.001), sarcopenia (HR 1.25, 95% CI 1.06-1.46, P=0.006), and myosteatosis (HR 1.25, 95% CI 1.07-1.46, P<0.001) independently predicted reduced survival.Conclusion: CT-defined sarcopenia and myosteatosis are prevalent across different levels of nutrition risk in overweight/obese patients with cancer. Assessment of skeletal muscle using CT adds prognostic value to the PG-SGA SF. [ABSTRACT FROM AUTHOR]

Objective: To estimate Prenatal Care Coordination's (PNCC) effect on birth outcomes for Wisconsin Medicaid-covered deliveries.Data Source: A longitudinal cohort of linked Wisconsin birth records (2008-2012), Medicaid claims, and state-administered social services.Study Design: We defined PNCC treatment dichotomously (none vs. any) and by service level (none vs. assessment/care plan only vs. service uptake). Outcomes were birthweight (grams), low birthweight (<2500 g), gestational age (completed weeks), and preterm birth (<37 weeks). We estimated PNCC's effect on birth outcomes, adjusting for maternal characteristics, using inverse-probability of treatment weighted and sibling fixed effects regressions.Data Collection/extraction Methods: We identified 136 224 Medicaid-paid deliveries, of which 33 073 (24.3 percent) linked to any PNCC claim and 22 563 (16.6 percent) linked to claims for PNCC service uptake.Principal Findings: Sibling fixed effects models-which best adjust for unobserved confounding and treatment selection-produced the largest estimates for all outcomes. For example, in these models, PNCC service uptake was associated with a 1.3 percentage point (14 percent) reduction and a 1.8 percentage point (17 percent) reduction in the probabilities of low birthweight and preterm birth, respectively (all P < .05).Conclusions: PNCC's modest but significant improvement of birth outcomes should motivate stronger PNCC outreach and implementation of similar programs elsewhere. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether the male predominance of older people admitted to intensive care units (ICUs) is due to gender differences in the presence of spouses, partners, or children; rates of gender-specific disease; or triage decisions made by health system personnel.Data Sources and Collection: Three population-based datasets, 2004-2012, of Canadians ≥65 years: provincial health care data from Manitoba (n = 250 190) and national data of nursing home residents (n = 133 982) and community-based homecare recipients (n = 210 090).Study Design: Retrospective observational study, using multivariable Cox proportional hazards and logistic regression.Principal Findings: Males predominated in ICU admissions: from Manitoba (hazard ratio [HR] = 1.87, 95% CI = 1.80-1.95), nursing homes (HR = 1.47, 1.35-1.60), and homecare (odds ratio = 1.14, 1.11-1.17). Adjustment for spouses, partners, and children did not attenuate this effect. The HR for gender was lower by 13.5 percent, relative, after excluding ICU care for cardiac causes. Male predominance was not present during a second ICU admission among survivors of a first ICU-containing hospitalization (HR = 1.07, 0.96-1.20).Conclusions: In three older cohorts, the male predominance of ICU admission was not explained by gender differences in the presence of a spouse, partner, or children, or cardiac disease rates. The third finding suggests that triage bias is unlikely to be responsible for the male predominance. [ABSTRACT FROM AUTHOR]

Background: Pain is common in older adults, and associated with increased morbidity and reduced quality of life. Recent research has highlighted different classes of older adults with pain, each with differing impacts on their life. It has not yet been investigated if, and how, such classes change over time and what influences individuals to prospectively transition to a profile of either improved or worsened pain impact.Methods: Latent transition analysis (LTA) is a longitudinal model-based approach to identifying underlying subgroups in a population. LTA was used to model the change in pain of people aged 50 and above, from The Irish Longitudinal Study on Ageing, across three waves (n = 5,925). The LTA model was extended to include biopsychosocial covariates to predict transition probabilities between classes over time.Results: Three latent classes were identified based on three pain indicators (pain presence; pain affects daily life; pain requires medication) and were characterized as "No Pain", "Low-Moderate Impact Pain" and "High Impact Pain". Results indicate that the pain class of many changes over time. However, poor physical or mental health increased the risk of transitioning to a more severe pain class, from Wave 1 to Wave 2 and Wave 2 to Wave 3.Conclusions: These findings show the change in pain of older adults over time, with both marked improvement and deterioration being observed. Critically, the predictors of individuals transitioning between classes reflect the breadth of biopsychosocial factors involved in pain.Significant Statement: This article identified differing classes of pain in older adults, using latent transition analysis. The analysis demonstrated how the pain classes of older adults are broadly consistent over time, however both improvement and deterioration in pain impact were observed. Transitions between classes were associated with several biopsychosocial factors. These results have important implications for the health and quality of life of older adults. Consideration of health, lifestyle and socio-demographic factors may enhance assessment and management of pain in older adults. [ABSTRACT FROM AUTHOR]

Despite limited evidence on the association between physical activity (PA) and blood pressure (BP) in youth, experts recommend that adolescents engage regularly in moderate-to-vigorous PA. We examined the relationships between PA intensity and frequency and the likelihood of having high BP in a population-based cohort of adolescents from Montréal, Canada. PA was self-reported every 3 months from grade 7 to 11, and BP was measured at ages 12.8, 15.2, and 17.0 years on average. We analyzed data from 993 participants (mean [SD] age = 16.0 [1.0], 51.6% female) with BP data at ages 15.2 and/or 17.0 years, using pooled ordinal logistic regression. BP (normal/elevated/hypertensive range) was the outcome, and past-year PA intensity and frequency were potential predictors. Eight percent of participants had elevated BP (120-129/<80), and 3.2% had BP in the hypertensive range (≥130/≥80). Participants engaged in a median (interquartile range) of 7.0 (4.5, 9.3) and 5.5 (2, 10.8) moderate and vigorous PA sessions/week, respectively. After adjusting for age, sex, mother's education, use of alcohol and cigarette consumption, engaging in PA more intense than light during the previous year was associated with a lower odds of having BP in the hypertensive range (ORs [95% CIs] = 0.93 [0.88, 0.97] to 0.97 [0.94, 0.99]). The relationships were not altered by adjusting for BMI. Our findings support recommendations that adolescents engage in at least moderate PA on a regular basis to prevent development of BP in the hypertensive range. [ABSTRACT FROM AUTHOR]

Objective: To explore pregnant women's views of participation in a clinical research trial while pregnant. Design: Prospective nested qualitative cohort study embedded within a national, multi‐site randomized controlled trial of a diagnostic test for preeclampsia: Placental Growth Factor. One‐to‐one in‐depth semi‐structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site. The interviews were conducted in private, recorded digitally and transcribed verbatim. Setting: Single tertiary maternity hospital currently recruiting eligible women onto an on‐going randomized controlled trial (NCT 02881073). Participants: Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy. Methods: Thematic analysis was utilized. Each line of the transcribed interviews was coded into a category by two researchers. The resultant categories were reviewed, and those with similarities were pooled allowing the development of themes. Main Outcome Measures: Women's opinions and experience of participation in a randomized controlled trial of an interventional diagnostic test during their pregnancy. Results: Four major themes were identified as follows: (a) Understanding of preeclampsia, (b) Motivators for clinical trial participation, (c) Barriers to decision making and (d) Influence of PARROT Ireland on pregnancy experience. Conclusions: Women are generally interested and positively inclined to participate in research during pregnancy. The potential of risk is an important consideration for eligible pregnant woman. Information and support by both researchers and clinicians are paramount in aiding women's understanding of a research trial. [ABSTRACT FROM AUTHOR]

Objective: To investigate the value of intertwin discordance in fetal crown-rump length (CRL) at the 11-13-week scan in the prediction of adverse outcome in dichorionic (DC), monochorionic diamniotic (MCDA) and monochorionic monoamniotic (MCMA) twin pregnancies.Methods: This was a retrospective analysis of prospectively collected data on twin pregnancies undergoing routine ultrasound examination at 11-13 weeks' gestation between 2002 and 2019. In pregnancies with no major abnormalities, we examined the value of intertwin discordance in fetal CRL in DC, MCDA and MCMA twins in the prediction of fetal loss at < 20 and < 24 weeks' gestation, perinatal death at ≥ 24 weeks, preterm delivery at < 32 and < 37 weeks, birth of at least one small-for-gestational-age (SGA) neonate with birth weight < 5th percentile and intertwin birth-weight discordance of ≥ 20% and ≥ 25%.Results: First, the study population of 6225 twin pregnancies included 4896 (78.7%) DC, 1274 (20.4%) MCDA and 55 (0.9%) MCMA twin pregnancies. Second, median CRL discordance in DC twin pregnancies (3.2%; interquartile range (IQR), 1.4-5.8%) was lower than in MCDA twins (3.6%; IQR, 1.6-6.2%; P = 0.0008), but was not significantly different from that in MCMA twins (2.9%; IQR, 1.2-5.1%; P = 0.269). Third, compared to CRL discordance in DC twin pregnancies with two non-SGA live births at ≥ 37 weeks' gestation, there was significantly larger CRL discordance in both DC and MCDA twin pregnancies complicated by fetal death at < 20 and < 24 weeks' gestation, perinatal death at ≥ 24 weeks, preterm birth at < 32 and < 37 weeks, birth of at least one SGA neonate and birth-weight discordance ≥ 20% and ≥ 25%, and in MCDA twin pregnancies undergoing endoscopic laser surgery. Fourth, the predictive performance of CRL discordance for each adverse pregnancy outcome was poor, with areas under the receiver-operating-characteristics curves ranging from 0.533 to 0.624. However, in both DC and MCDA twin pregnancies with large CRL discordance, there was a high risk of fetal loss. Fifth, in DC twin pregnancies, the overall rate of fetal loss at < 20 weeks' gestation was 1.3% but, in the small subgroup with CRL discordance of ≥ 15%, which constituted 1.9% of the total, the rate increased to 5.3%. Sixth, in MCDA twin pregnancies, the rate of fetal loss or endoscopic laser surgery at < 20 weeks was about 11%, but, in the small subgroups with CRL discordance of ≥ 10%, ≥ 15% and ≥ 20%, which constituted 9%, < 3% and < 1% of the total, the risk was increased to about 32%, 49% and 70%, respectively. Seventh, in MCMA twin pregnancies, there were no significant differences in CRL discordance for any of the adverse outcome measures, but this may be the consequence of the small number of cases in the study population.Conclusions: In both DC and MCDA twin pregnancies, increased CRL discordance is associated with an increased risk of fetal death at < 20 and < 24 weeks' gestation, perinatal death at ≥ 24 weeks, preterm birth at < 37 and < 32 weeks, birth of at least one SGA neonate and birth-weight discordance ≥ 20% and ≥ 25%, but CRL discordance is a poor screening test for adverse pregnancy outcome. However, in DC twins, CRL discordance of ≥ 15% is associated with an increased risk of fetal loss at < 20 and < 24 weeks' gestation and, in MCDA twins, CRL discordance of ≥ 10%, and more so discordance of ≥ 15% and ≥ 20%, is associated with a very high risk of fetal loss or endoscopic laser surgery at < 20 and < 24 weeks and this information is useful in counseling women and defining the timing for subsequent assessment and possible intervention. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: Undiagnosed non-cephalic presentation in labor carries increased risks for both the mother and baby. Routine pregnancy care based on maternal abdominal palpation fails to detect the majority of cases of non-cephalic presentation. The aim of this study was to report the incidence of non-cephalic presentation at a routine scan at 35 + 0 to 36 + 6 weeks' gestation and the subsequent management of such pregnancies.Methods: This was a retrospective analysis of prospectively collected data in 45 847 singleton pregnancies that had undergone routine ultrasound examination at 35 + 0 to 36 + 6 weeks' gestation. Patients with breech or transverse/oblique presentation were divided into two groups; first, those who would have elective Cesarean section for fetal or maternal indications other than the abnormal presentation, and, second, those who would potentially require external cephalic version (ECV). The latter group was reassessed after 1-2 weeks and, if there was persistence of abnormal presentation, the parents were offered the option of ECV or elective Cesarean section at 38-40 weeks' gestation. Multivariable logistic regression analysis was carried out to determine which of the factors from maternal and pregnancy characteristics provided a significant contribution in the prediction of, first, non-cephalic presentation at the 35 + 0 to 36 + 6-week scan, second, successful ECV from non-cephalic to cephalic presentation, and, third, spontaneous rotation from non-cephalic to cephalic presentation that persisted until delivery.Results: First, at 35 + 0 to 36 + 6 weeks, the fetal presentation was cephalic in 43 416 (94.7%) pregnancies, breech in 1987 (4.3%) and transverse or oblique in 444 (1.0%). Second, multivariable analysis demonstrated that the risk of non-cephalic presentation increased with increasing maternal age and weight, decreasing height and earlier gestational age at scan, was higher in the presence of placenta previa, oligohydramnios or polyhydramnios and in nulliparous than parous women, and was lower in women of South Asian or mixed racial origin than in white women. Third, 22% of cases of non-cephalic presentation were not eligible for ECV because of planned Cesarean section for indications other than the malpresentation. Fourth, of those eligible for ECV, only 48.5% (646/1332) agreed to the procedure, which was successful in 39.0% (252/646) of cases. Fifth, the chance of successful ECV increased with increasing maternal age and was lower in nulliparous than parous women. Sixth, in 33.9% (738/2179) of pregnancies with non-cephalic presentation in which successful ECV was not carried out, there was subsequent spontaneous rotation to cephalic presentation. Seventh, the chance of spontaneous rotation from non-cephalic to cephalic presentation increased with increasing interval between the scan and delivery, decreased with increasing birth-weight percentile, was higher in women of black than those of white racial origin, if presentation was transverse or oblique rather than breech and if there was polyhydramnios, and was lower in nulliparous than parous women and in the presence of placenta previa. Eighth, in 109 (0.3%) cephalic presentations, there was subsequent rotation to non-cephalic presentation and, in 41% of these, the diagnosis was made during labor. Ninth, of the total 2431 cases of non-cephalic presentation at the time of the scan, presentation at birth was cephalic in 985 (40.5%); in 738 (74.9%) this was due to spontaneous rotation and in 247 (25.1%) this was due to successful ECV. Tenth, prediction of non-cephalic presentation at the 35 + 0 to 36 + 6-week scan and successful ECV from maternal and pregnancy factors was poor, but prediction of spontaneous rotation from non-cephalic to cephalic presentation that persisted until delivery was moderately good and this could be incorporated in the counseling of women prior to ECV.Conclusions: The problem of unexpected non-cephalic presentation in labor can, to a great extent, be overcome by a routine ultrasound examination at 35 + 0 to 36 + 6 weeks' gestation. The incidence of non-cephalic presentation at the 35 + 0 to 36 + 6-week scan was about 5%, but, in about 40% of these cases, the presentation at birth was cephalic, mainly due to subsequent spontaneous rotation and, to a lesser extent, as a consequence of successful ECV. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: Pregnancies complicated by fetal growth restriction (FGR) have a worse outcome than those with a small-for-gestational-age (SGA) fetus. There is increasing evidence of a maternal cardiovascular role in the pathophysiology of FGR. We aimed to compare maternal hemodynamic indices between pregnancies complicated by FGR and those delivering a SGA neonate, using a non-invasive device.Methods: This was a prospective study of normotensive pregnancies complicated by FGR (defined as estimated fetal weight (EFW) < 3rd centile or Doppler evidence of impaired placental-fetal blood flow), those with a SGA fetus (defined as EFW < 10th centile) and control pregnancies with an appropriately grown fetus. Assessment of maternal hemodynamics (heart rate (HR), cardiac output (CO), mean arterial pressure (MAP), systemic vascular resistance (SVR) and stroke volume) was performed using a non-invasive device (USCOM-1A®). Uterine artery (UtA) pulsatility index (PI) was measured using transabdominal ultrasound. Hemodynamic variables that are affected by gestational age and maternal characteristics were corrected for using device-specific reference ranges. Comparison between groups was performed using the chi-square test or the Mann-Whitney U-test, as appropriate.Results: A total of 102 FGR, 64 SGA and 401 control pregnancies, with a median gestational age of 36 weeks, were included in the analysis. Women with a pregnancy complicated by FGR and those with a SGA fetus were shorter and weighed less than did controls. Compared with controls, the FGR group had significantly lower median maternal HR (80 beats per min (bpm) vs 85 bpm; P = 0.001) and CO multiples of the median (MoM; 0.91 vs 0.98; P = 0.003), and higher median maternal MAP (90 mmHg vs 87 mmHg; P = 0.040), SVR MoM (1.2 vs 1.0; P < 0.001) and UtA-PI MoM (1.1 vs 0.96; P < 0.001), but there was no significant difference in stroke volume MoM (1.0 vs 0.98; P = 0.647). Compared with the SGA group, the FGR group had a significantly lower median HR (80 bpm vs 87 bpm; P = 0.022), and higher median maternal MAP (90 mmHg vs 85 mmHg; P = 0.025), SVR MoM (1.2 vs 1.0; P = 0.002) and UtA-PI MoM (1.1 vs 0.98; P = 0.005), but there was no significant difference in CO MoM (0.91 vs 0.96; P = 0.092) or stroke volume MoM (1.0 vs 1.0; P = 0.806). There were no significant differences in adjusted maternal hemodynamic indices between the SGA group and controls.Conclusion: Pregnancies complicated by FGR presented with impaired maternal hemodynamic function, as evidenced by lower HR and CO, as well as higher MAP, SVR and UtA resistance. Pregnancies delivering a SGA neonate, without evidence of FGR, had normal maternal hemodynamic function. Maternal hemodynamic indices may therefore be of value in distinguishing FGR from SGA pregnancies. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: To determine whether differences exist in the rate of levator ani muscle (LAM) avulsion between women who had undergone either Malmström vacuum delivery (MVD) or Kielland forceps delivery (KFD), allowing for potential confounding factors.Methods: This was a prospective observational study of nulliparous women undergoing instrumental delivery using Malmström vacuum extractor or Kielland forceps, at two hospital centers in Spain. Fetal head position (anterior, posterior or transverse) and fetal head station (low or mid) were assessed by ultrasound and digital examination, respectively. Avulsion was defined on tomographic ultrasound imaging as an abnormal insertion of the LAM in the three central slices from the plane of minimal hiatal dimensions.Results: In total, 414 patients were included in the study (212 MVD and 202 KFD). We observed a higher rate of LAM avulsion in the KFD group (KFD 49.5% vs MVD 32.5%; P = 0.001). When the results were evaluated according to fetal head position and station, we observed no differences in LAM avulsion. The crude odds ratio (OR) for the difference in avulsion between women in the KFD and MVD groups was 2.03 (95% CI, 1.36-3.03). However, when adjusted for duration of second stage of labor, fetal head circumference and fetal head station, the OR was no longer statistically significant (OR, 2.14 (95% CI, 0.95-4.85); P = 0.068).Conclusion: When potential confounding factors are taken into account, the rate of LAM avulsion does not differ between women according to whether they have undergone KFD or MVD. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate the use of ultrasound (US) soft markers as a first-line imaging tool to raise suspicion of rectosigmoid (RS) involvement in women suspected of having deep endometriosis.Methods: We included in this prospective observational study all patients with clinical suspicion of deep endometriosis who underwent diagnostic transvaginal US evaluation at our unit from January 2016 to February 2017. Several US soft markers were evaluated for prediction of RS involvement (presence of US signs of uterine adenomyosis, presence of an endometrioma, adhesion of the ovary to the uterus (reduced ovarian mobility), presence of 'kissing ovaries' (KO) and absence of the 'sliding sign'), using as the gold standard expert US examination for the presence of RS endometriosis.Results: Included were 333 patients with clinical suspicion of deep endometriosis. Of these, 106 had an US diagnosis of RS endometriosis by an expert. The only significant variables found in the prediction model were absence of the sliding sign (odds ratio (OR), 13.95; 95% CI, 7.7-25.3), presence of KO (OR, 22.5; 95% CI, 4.1-124.0) and the interaction between these two variables (OR, 0.03; 95% CI, 0.004-0.28). Regarding their interaction, RS endometriosis was present when KO was absent and the sliding sign was present in 10% (19/190) of cases, when both KO and the sliding sign were present in 71.4% (5/7) of cases, when both KO and the sliding sign were absent in 60.8% (76/125) of cases and when KO was present and the sliding sign was absent in 54.5% (6/11) of cases. Thus, when the sliding sign was absent and/or KO was present, transvaginal US showed a specificity of 75% (95% CI, 69-80%) and a sensitivity of 82% (95% CI, 73-88%).Conclusions: US findings of absence of the sliding sign and/or presence of KO in patients with clinical suspicion of endometriosis should raise suspicion of RS involvement and indicate referral for expert US examination, with a low rate of false-negative diagnosis. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: Left ventricular (LV) torsion is an important aspect of cardiac mechanics and is fundamental to normal ventricular function. The myocardial mechanics of the fetal heart and the changes that occur during the transition to the neonatal period have not been explored previously. The aim of this study was to evaluate perinatal changes in LV torsion and its relationship with myocardial function.Methods: This was a prospective study of 36 women with an uncomplicated term pregnancy. Fetal and neonatal conventional, spectral tissue Doppler and two-dimensional (2D) speckle tracking echocardiography were performed a few days before and within hours after delivery to measure cardiac indices including LV rotational parameters derived from short-axis views at the base and apex of the heart. Linear regression analysis was used to examine the relationship between LV rotational parameters and cardiac geometric and functional indices in term fetuses and neonates. Perinatal changes in LV rotational parameters were assessed.Results: There were three patterns of LV twist in term fetuses: those with reversed-apex-type LV twist had the lowest median values of LV torsion (0.1°/cm), with higher values (1.6°/cm) in those with infant-type LV twist and the highest values (4.4°/cm) in those with adult-type LV twist. LV torsion was associated significantly with cardiac geometric and functional indices. Perinatal evaluation revealed a significant increase in LV torsion following delivery in fetuses exhibiting reversed-apex-type LV twist (increase of 2.8°/cm, P = 0.009) and a significant decrease in those with adult-type LV twist (decrease of 3.2°/cm, P = 0.008).Conclusions: This study demonstrates the feasibility of 2D speckle tracking imaging for accurate assessment of rotational cardiac parameters in term fetuses. There are unique perinatal patterns of LV twist that demonstrate different values of LV torsion, which was found to correlate with indices of ventricular geometry and myocardial function. Differences in patterns of LV twist may therefore reflect differences in compensatory myocardial adaptation to the physiological environment/loading conditions in late gestation in fetuses and postnatal cardiac adjustment to the acute loading changes that occur at delivery. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Aims: Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of cardiovascular mediators. Its administration has been shown to be associated with impaired cardiac contraction and kidney haemodynamics while its inhibition restored cardiac contraction in a pre-clinical model of severe heart failure in mice. Circulating DPP3 (cDPP3) was found to be elevated in shock. The present study aims to assess the association between cDPP3 and worsening haemodynamics, namely refractory shock, in a cohort of cardiogenic shock (CS).Methods and Results: This is an ancillary study of OptimaCC, a prospective, double-blind, multicentre, randomized study assessing efficacy and safety of catecholamines in 57 patients with CS after acute myocardial infarction. cDPP3 was measured in plasma at inclusion, 24 h, 48 h, and 72 h, and haemodynamic and biological parameters were recorded at inclusion. cDPP3 values were higher in refractory CS than non-refractory CS at inclusion (median [interquartile range]; 76.1 [37.9-238.7] ng/mL vs. 32.8 [23.9-47.6] ng/mL, P = 0.014), at 24 h (P < 0.001) and up to 48 h (P = 0.027). Furthermore, cDPP3 at inclusion discriminated CS patients who did develop refractory shock vs. non-refractory with an area under the curve of 0.73 (95% confidence interval [CI] 0.55-0.92). The high cDPP3 group (cDPP3 ≥59.1 ng/mL) at inclusion had a higher Simplified Acute Physiology Score II (SAPS II), lower cardiac index and lower estimated glomerular filtration rate. More importantly, in CS patients with high cDPP3 at inclusion, those who rapidly decreased cDPP3 at 24 h exhibited a striking reduction in the occurrence of refractory shock and death.Conclusion: In CS patients, cDPP3 gives an early prediction of outcome, including development of refractory status and/or survival.Clinical Trial Registration: clinicaltrials.gov Identifier NCT01367743. [ABSTRACT FROM AUTHOR]

Background: This study was aimed to investigate if professional oral prophylaxis before scaling and root planing (SRP) has an effect on the outcome of non-surgical periodontal treatment in patients with chronic periodontitis.Methods: Fifty-two individuals with chronic periodontitis receiving non-surgical periodontal therapy by SRP with (test) and without (control) two appointments of professional tooth cleaning but with motivation and instruction were monitored for clinical variables, four selected microorganisms and two biomarkers at baseline, before SRP as well as 3 and 6 months after SRP. Statistical analysis included non-parametric tests for intra- and intergroup comparisons.Results: Probing depth (PD), attachment level, bleeding on probing (BOP), and interproximal plaque index (API) were significantly improved in both groups 3 and 6 months after SRP. PD, BOP, API, and the number of sites with PD ≥5 mm were significantly lower in the test group than in the control group at the appointment immediately before SRP. Tannerella forsythia was significantly reduced in both groups at 3 and 6 months, Porphyromonas gingivalis only in the test group. Interleukin-1β was significantly reduced in the control group 3 and 6 months after SRP, matrix metalloproteinase-8 level decreased in the test group 3 months after SRP. There was no significant difference of any clinical and non-clinical variable between both groups at 3 and 6 months after SRP.Conclusions: Professional tooth cleaning before the SRP does not improve the clinical results of the SRP. It has no obvious long-lasting effects on major periodontopathogens in the subgingival biofilm as well as on biomarkers in the gingival crevicular fluid after SRP. [ABSTRACT FROM AUTHOR]

Biomedical research often features continuous responses bounded by the interval [0, 1]. The well-known beta regression model addresses the constrained nature of these data, while its augmented and mixed-effects variants can address the presence of zeros and/or ones and longitudinal or clustered response values, respectively. However, these models are not robust to the presence of outliers and/or excessive number of observations near the tails. We propose a new augmented mixed-effects regression model based on a special beta mixture distribution that is capable of handling these issues. Extensive simulation studies show the superiority of the proposed model to the models most often used in the literature. The proposed model is applied to two real datasets: one taken from a long-term study of Parkinson's disease and the other taken from a study on reading accuracy. [ABSTRACT FROM AUTHOR]