National Prospective Cohort Study Research Articles

Outcomes for women with diabetes admitted for labour care to midwifery units in the UK: a national prospective cohort study and survey of practice using the UK Midwifery Study System (UKMidSS)

ObjectivesTo describe outcomes in women admitted for labour care to midwifery units with gestational or pre-existing diabetes, compare outcomes with other women admitted to the same units and describe admission...

Burnout among intensive care nurses, physicians and leaders during the COVID-19 pandemic: A national longitudinal study.

Burnout is frequent among intensive care unit (ICU) healthcare professionals and may result in medical errors and absenteeism. The COVID-19 pandemic caused additional strain during working hours and also affected off-duty life. The aims of this study were to survey burnout levels among ICU healthcare professionals during the first year of COVID-19, describe those who reported burnout, and analyse demographic and work-related factors associated with burnout. This was a national prospective longitudinal cohort study of 484 nurses, physicians and leaders working in intensive care units with COVID-19 patients in Norway. Burnout was measured at 6- and 12-month follow-up, after a registration of baseline data during the first months of the COVID epidemic. The Copenhagen Burnout Inventory (CBI), was used (range 0-100), burnout caseness defined as CBI ≥50. Bi- and multivariable logistic regression analyses were performed to examine baseline demographic variables and work-related factors associated with burnout caseness at 12 months. At 6 months, the median CBI score was 17, increasing to 21 at 12 months (p = .037), with nurses accounting for most of the increase. Thirty-two per cent had an increase in score of more than 5, whereas 25% had a decrease of more than 5. Ten per cent reported caseness of burnout at 6 months and 14% at 12 months (n.s.). The participants with burnout caseness were of significantly lower age, had fewer years of experience, reported more previous anxiety and/or depression, more moral distress, less perceived hospital recognition, and more fear of infection in the bivariate analyses. Burnout was the single standing most reported type of psychological distress, and 24 out of 41 (59%) with burnout caseness also reported caseness of anxiety, depression and/or post-traumatic stress disorder (PTSD) symptoms. Multivariate analysis showed statistically significant associations of burnout caseness with fewer years of professional experience (p = .041) and borderline significance of perceived support by leader (p = .049). In Norway, a minority of ICU nurses, physicians and leaders reported burnout 1 year into the pandemic. A majority of those with burnout reported anxiety, depression and/or PTSD symptoms combined. Burnout was associated with less years of professional experience.

Changing Epidemiology and Outcomes of Hemolytic Uremic Syndrome in Children: A Prospective National Cohort Study from the Polish Pediatric HUS Registry and the Polish Registry of Renal Replacement Therapy in Children.

Background/Objectives: Hemolytic uremic syndrome (HUS) is a known cause of acute kidney injury in children, but there are few recent reports on its epidemiology and outcome. We aimed to investigate trends in the incidence and the long-term outcomes of both Shiga toxin-producing Escherichia coli -HUS (STEC-HUS) and atypical HUS (aHUS) in Poland over the last 12 years (2012-2023), based on the Polish Pediatric HUS and Pediatric Renal Replacement Therapy (RRT) Registries. Methods: A total of 436 patients (301 with STEC-HUS and 135 with aHUS) were included. Results: The incidence of STEC-HUS increased during the observation period, with a mean of 3.9 cases per million age-related population (marp). The incidence of aHUS was relatively constant with a mean of 1.8/marp. The majority of patients fully recovered, although kidney sequelae were observed at 5-year follow-ups in 31% of children with STEC-HUS, 57% of aHUS subjects in the pre-eculizumab era, and 37% of aHUS subjects who had received eculizumab. The overall mortality rate was 2% for STEC-HUS and 3.7% for aHUS, with no deaths reported in children on eculizumab and mortality mainly attributed to neurological damage. A decreasing incidence of chronic kidney disease stage 5 (CKD5) due to HUS was observed. Conclusions: Despite an unchanging incidence of aHUS and an increasing incidence of STEC-HUS, the kidney outcomes of both diseases have improved significantly over the last 12 years. Mortality from HUS has dropped due to improved symptomatic treatment and the introduction of anti-C5 therapy. The development of CKD5 in childhood as a consequence of HUS has become exceptional.

Association of estimated glucose disposal rate with incident cardiovascular disease under different metabolic and circadian rhythm states: findings from a national population-based prospective cohort study

BackgroundRecent studies have shown that both metabolic syndrome and circadian rhythm syndrome are firmly associated with the occurrence of cardiovascular disease (CVD), with insulin resistance playing a significant role. The estimated glucose disposal rate (eGDR) is considered to be a reliable surrogate marker for insulin resistance. However, the relationship between eGDR and CVD under different metabolic and circadian rhythm states has not been thoroughly studied, and large-scale prospective cohort studies are needed to clarify this relationship.MethodsThis study is based on the China Health and Retirement Longitudinal Study (CHARLS), recruiting individuals aged 45 and above with complete eGDR data. The eGDR was calculated by the formula: eGDR(mg/kg/min) = 21.158 − (0.09 × WC) − (3.407 × hypertension) − (0.551 × HbA1c) [WC (cm), hypertension (yes = 1/no = 0), and HbA1c (%)] (Zabala et al. in Cardiovasc Diabetol 20(1):202; 2021).Participants were divided into four subgroups based on the quartiles (Q) of eGDR.The cumulative incidence rates and hazard ratios (HR) with 95% confidence intervals (CI) were calculated, with the lowest eGDR quartile (representing the highest degree of insulin resistance) as the reference. Participants were further divided into subgroups based on the diagnosis of Metabolic syndrome (MetS) or circadian syndrome (CircS) to explore the relationship between eGDR and CVD under different metabolic and circadian rhythm conditions. The dose–response relationship between eGDR and CVD incidence was investigated using a restricted cubic spline (RCS) based on a Cox regression model. Receiver operating characteristic (ROC) curves were generated to assess the predictive value of eGDR for CVD incidence. A clinical decision curve analysis (DCA) was also conducted to assess the clinical utility of the basic model.Results6507 participants were included, with a median age of 58 years [52 years, 64 years], and 55% were female. Over a median follow-up duration of 87 months, 679 first-episode CVD events were recorded, including heart disease and stroke. The RCS curves demonstrated a significant dose–response relationship between eGDR and the incidence of first-presentation CVD in different metabolic and circadian rhythm subgroups (all P-values < 0.001, non-linearity P > 0.05). eGDR exhibited a significant linear relationship with all outcomes (non-linearity P < 0.05). The Kaplan–Meier cumulative incidence curves showed that as eGDR levels increased, the cumulative incidence rates of first CVD, heart disease, and stroke gradually decreased from Q1 to Q4 groups. Significant differences were observed across all metabolic and circadian rhythm subgroups (log-rank test P < 0.001). Through the Cox proportional hazards model, we confirmed a significant association between baseline eGDR levels and first-onset CVD, heart disease, and stroke. Subgroup analyses indicated that the predictive ability of eGDR for CVD risk varied across different Body mass index (BMI) (P for interaction = 0.025) and age (P for interaction = 0.045) subgroups. Mediation analysis revealed that CircS partially mediated this association. Furthermore, time-dependent ROC curves demonstrated the potential of eGDR as a predictor of CVD risk, revealing possible differences in the model's application across different cardiovascular conditions.ConclusioneGDR is an independent predictor of CVD risk, with lower eGDR levels being closely associated with a higher risk of CVD (including heart disease and stroke). In populations with MetS or CircS, the association between lower eGDR levels and increased risk is more pronounced.

Reducing research participant disparities through use of a co-developed video intervention: A cohort nested pre-post study

Background Evidence on effective approaches for the recruitment of diverse populations remains limited. This study aimed to assess whether a co-developed study information video would improve participant ethnic diversity within a paediatric study cohort. Methods Pre-post study nested within the Uveitis in childhood prospective national inception cohort study, UNICORNS. Intervention of interest: study information and recruitment video with format and content co-developed with a patient expert group. Outcome of interest: the proportion of families from ethnic minority groups, and of families with primary caregivers without a higher educational degree who were recruited to the study, and the proportion of families who engaged in study activities (returned patient reported outcome metrics following recruitment) pre and post intervention implementation. Results During the study period, 191 children were recruited to UNICORNS (110 pre-intervention era, 81 post-intervention era). A larger proportion of families recruited in the post-intervention era were of an ethnic minority background (36% versus 20%, Fisher’s exact test p=0.02). A larger proportion of families returned self-descriptions of their sociodemographic background (100% versus 87%, Fisher’s exact test p=0.0003) and a larger proportion returned study specific patient reported outcome measures (70% versus 55%, Fisher’s exact test p=0.003). Conclusion Co-created digital research information resources can be an effective tool for ensuring better representation in research studies and may also support participant engagement overall. Our reported methods and findings should support other researchers in developing patient-centred and patient co-developed strategies and tools for the purposes of equitable access to medical research.

Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study)

BackgroundReFLECT was a French, prospective, multicenter, observational cohort study evaluating the effectiveness and safety of the infliximab (IFX) biosimilar CT-P13 in a real-world setting. Here, we describe the results for adults with inflammatory bowel disease (IBD). MethodsEligible patients with IBD were recruited and received intravenous CT-P13 induction and/or maintenance therapy; patients were either naive to IFX (IFX-naive) or previously treated with IFX originator or another IFX biosimilar (IFX-switched). The primary objective was CT-P13 persistence, which was measured as a time-dependent variable during a two-year follow-up period with four prespecified visits. Safety was assessed. ResultsThe adult IBD population comprised 530 patients with Crohn's disease (CD), including 327 categorized as IFX-naive, 188 as IFX-switched, 11 as other (i.e., previously received IFX but received another treatment before switching to CT-P13), and 4 with missing data; and 221 patients with ulcerative colitis (UC), including 152 categorized as IFX-naive, 59 as IFX-switched, 8 as other, and 2 with missing data. After two years of follow-up, the rates of CT-P13 persistence were 71.7 % (95 % CI: 66.7, 77.0) and 63.7 % (55.3, 73.3) in patients with CD and UC, respectively. CT-P13 persistence was greater for IFX-switched patients than for IFX-naive patients (CD: 83.7 % [95 % CI: 78.0, 89.9] vs 65.7 % [58.6, 73.7]; UC: 91.2 % [81.7, 100.0] vs 53.4 % [43.0, 66.2]). The main reason for CT-P13 discontinuation was loss of response (CD/UC) in both IFX-naive (14.7 %/21.7 %) and IFX-switched (7.4 %/5.1 %) groups. Among patients (CD and UC, respectively), 51.3 % and 45.2 % reported ≥1 adverse event (AE), and 13.2 % and 12.7 % reported serious AEs, respectively. ConclusionAfter two years of follow-up, the effectiveness of intravenous CT-P13 was maintained in >80 % of IFX-switched patients. CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile. Trial registrationClinicalTrials.gov identifier: NCT02925338

Cardiovascular health metrics and all-cause mortality in osteoarthritis, inflammatory arthritis, and unclassified arthritis patients: a national prospective cohort study

BackgroundArthritis notably elevates mortality risk. It remains unclear whether the cardiovascular health (CVH) metrics improves the risk of all-cause mortality in patients with all types of arthritis.MethodsThis study data from the National Health and Nutrition Examination Survey to probe the link between CVH and all-cause mortality among arthritis sufferers in the United States. CVH evaluation employed the Life's Essential 8 metrics. Mortality outcomes were scrutinized using Cox proportional hazard regression models. Additionally, a restricted cubic spline analysis delineated the linear relationship between CVH and mortality. The study also delved into the singular impact of each CVH component on mortality.ResultsIn the cohort of 5919 patients with arthritis, improved CVH was linked to lower all-cause mortality. Specifically, each 10-point increment in CVH score was associated with a substantial decline in all-cause mortality risk [unadjusted hazard ratio (HR): 0.77, 95% Confidence Interval (95% CI): 0.71–0.83, P < 0.001]. Adjustments for age, sex, race, and social determinants of health further refined the HR to 0.72 (95% CI: 0.67–0.79, P < 0.001). Higher versus lower CVH scores at baseline markedly reduced mortality risk, with the most substantial decrease seen in those with ideal CVH metrics (HR: 0.39, 95% CI: 0.26–0.59, P < 0.001). Similar results were not observed in patients with inflammatory arthritis, but were seen in those with osteoarthritis or degenerative arthritis, and unknown types of arthritis.ConclusionIdeal CVH substantially decreases all-cause mortality risk among patients with arthritis, confirming the critical role of CVH in arthritis management. This study advocates for CVH interventions as part of comprehensive arthritis treatment plans.

Atherogenic index of plasma and obesity-related risk of stroke in middle-aged and older Chinese adults: a national prospective cohort study.

The association between the atherogenic index of plasma (AIP) and stroke risk is uncertain. Overweight and obese individuals frequently develop atherosclerosis, suggesting AIP may mediate the relationship between body mass index (BMI) and stroke risk. This study investigates whether AIP mediates the BMI-stroke association and evaluates the interaction effects of AIP and BMI on stroke risk in middle-aged and older Chinese adults. This study analyzes data from the China Health and Retirement Longitudinal Study (CHARLS), an ongoing nationally representative prospective cohort study that began in 2011. It includes 8598 middle-aged and older Chinese adults without stroke at baseline. A mediation analysis, employing a novel two-stage regression method, was conducted to evaluate the indirect effect of BMI on stroke through AIP. During a median follow-up of 7.1years, 615 (7.2%) participants developed a stroke. After adjusting for confounders, AIP was significantly associated with stroke risk (hazard ratio [HR] per 1-SD increase, 1.24; 95% CI 1.14-1.35). Mediation analysis indicated that compared to normal weight, obesity similarly raised stroke risk by 78.0% (HR 1.78, 95% CI 1.40-2.27), with 29.67% (95% CI 14.27-45.08%) of the association mediated through AIP (HR 1.15, 95% CI 1.08-1.23). No significant multiplicative or additive interactions were observed between BMI and AIP on stroke. This study found that the AIP appeared to be associated with stroke risk and mediates the association between obesity and stroke among middle-aged and older Chinese adults.

Trajectories and predictors of suicidal ideation in clinical characteristics and pharmacological treatments for major depressive disorder: a study based on a national multi-centered prospective cohort

Suicidal ideation (SI) is a significant precursor and risk marker for suicide behaviors in major depressive disorder (MDD). Exploration of SI trajectory from a longitudinal framework are essential for treatment guidelines and clinical management of suicide risk. This study sought to explore SI trajectories and its associated clinical, sociodemographic characteristics, and initial treatment among patients with MDD. We used data from a non-interventional, national multi-centered prospective cohort study. 1 461 patients with MDD were included in the growth mixture modeling using SI at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months, 9 months, and 12 months as the indicator. A multinomial regression was employed with SI trajectory as the outcome and anhedonia, depressive symptoms, atypical depressive symptoms, pharmacological treatments, and other covariates as the predictors. Four distinct SI trajectories were identified: a consistently low SI trajectory(50.7%), a persistently mild SI trajectory(20.6%), a fast declined SI trajectory(8.9%), and a slowly declined trajectory(19.8%). Compared to those with a consistently low SI trajectory, a higher score of anhedonia was associated with an increased risk of experiencing persistently mild (RRR = 1.20, 95%CI: 1.05, 1.38) and slowly declined SI (1.54, 95%CI: 1.32, 1.80). Severity of depressive symptom was also positively associated with the risk of experiencing persistently mild (1.15, 95%CI: 1.13, 1.18) and slowly declined SI (1.17, 95%CI: 1.14, 1.21). And the risk of experiencing slowly declined SI was higher for those use SSRI(1.49, 95%CI: 1.02, 2.31), and for those use antidepressant and antipsychotic/mood stabilizer combined therapy (3.78, 95%CI: 1.48, 9.61). The findings of this study are potentially useful for clinical practice as critical indicators of profiles and interventions for prognosis among patients with MDD. Further research is warranted to explore potential modifiable factors and the association between SI trajectories and suicide behavior.

Association of dietary diversity and weight change with cognitive impairment among Chinese elderly: A prospective national cohort study

BackgroundDietary diversity is reported to be beneficial for cognitive function, while the effect may be offset by weight change status. We aimed to examine the association of dietary diversity and weight change with cognitive impairment among older adults. MethodsWe used three waves from 2008 to 2014 of the Chinese Longitudinal Survey of Health and Longevity, which included 16,954 participants for the subsequent screening and analysis. Dietary diversity information was collected from the food frequency questionnaire. Cognitive function was assessed using the Mini Mental State Examination. The relation of dietary diversity and weight change with cognitive impairment was investigated using Cox proportional hazards models and cubic spline regression. ResultsCompared with those reported poor dietary diversity at baseline, participants with good dietary diversity had a 16 % (hazard ratio [HR] = 0.84, 95 % confidence interval [CI]: 0.71–0.99) lower risk of cognitive impairment. The HR and 95 % CI of participants with consistently good dietary diversity from 2008 to 2011 was 0.71 (0.57–0.89) for cognitive impairment compared to those with consistently poor dietary diversity. Compared with the weight stable group, the HRs and 95 % CI for cognitive impairment were 1.34 (1.10–1.64) in weight loss group, and 1.08 (0.88–1.33) in weight gain group. Restricted cubic splines showed the risk of cognitive impairment decreased with higher dietary diversity score or less weight change, though no significant interaction between dietary diversity and weight change was found. LimitationGiven the observational nature of this study, there might be a reverse causation for the observed association. ConclusionEstablishing and maintaining good dietary diversity were associated with a lower risk of cognitive impairment regardless of weight change status, whereas weight loss was associated with increased cognitive impairment risk independently among older Chinese adults.

Immunosuppressive agents or intravenous immunoglobulin in addition to glucocorticoids in the treatment of Susac syndrome: a French national cohort study

Susac syndrome is a rare disease affecting mainly young women and is characterised by an occlusive microvessel disease limited to the brain, retina, and inner ear. No randomised controlled trial has been published or declared as ongoing to investigate treatments for Susac syndrome. We aimed to compare the effect of glucocorticoids given alone or in combination with immunosuppressive agents or intravenous immunoglobulin for the prevention of relapse in patients with Susac syndrome. The Phenotypic and Etiological Characterization of Susac Syndrome-National Clinical Research Hospital Program study is a prospective national cohort study that started enrolling on Nov 29, 2011, and included all consecutive patients aged 18 years or older with Susac syndrome who were referred to the French reference centre (Department of Internal Medicine, Bichat-Claude Bernard Hospital, Paris). Susac syndrome was defined by either the triad of encephalopathy with typical brain MRI abnormalities, cochleo-vestibular damage, and multiple occlusions of retinal central artery branches, or at least two of the three criteria without any alternative diagnosis. Collected data included fundoscopy, retinal angiography, audiometry, cerebrospinal fluid, brain MRI, and treatment received at diagnosis; months 1, 3, 6, and 12 after diagnosis; and then annually for 5 years or in the case of a relapse. The primary outcome was defined as the first relapse occurring within a 36-month follow-up period from the first day of treatment, characterised by new clinical symptoms or signs, and new abnormalities observed on retinal angiography, audiometry, or brain MRI, necessitating treatment intensification. There was no involvement of people with lived experience at any stage. The study is registered at ClinicalTrials.gov, NCT01481662. Between Nov 29, 2011, and Dec 2, 2022, 64 patients were included in the study, with a mean age at diagnosis of 35 years (SD 11); 41 (64%) were women and 23 (36%) were men. At diagnosis, 60 patients received glucocorticoids; 40 (63%) of 64 patients received glucocorticoids alone as a first-line therapy while 20 (31%) received glucocorticoids in combination with immunosuppressive agents or intravenous immunoglobulin. Overall, 46 (72%) of 64 patients had a first relapse with a median relapse-free survival time of 3·96 months (95% CI 2·24-16·07). Comparison of relapse-free survival showed no significant difference between the two treatment strategies (hazard ratio [HR] 1·11 [95% CI 0·56-2·17], p=0·76), compared with glucocorticoids alone as the reference group. In patients who first relapsed while treated with glucocorticoids alone, there was no significant difference in second relapse-free survival between those who did or did not receive immunosuppressive agents or intravenous immunoglobulin as a second-line therapy (HR 2·66 [95% CI 0·63-11·18], p=0·18). The combination of glucocorticoids with immunosuppressive agents or intravenous immunoglobulin did not appear to reduce the risk of Susac syndrome relapse compared with glucocorticoids alone. Our findings did not support the systematic use of immunosuppressive agents in Susac syndrome. French Ministry of Health.

Monitoring the psychopathological profile of inflammatory bowel disease patients treated with biological agents: a pilot study.

Biological agents were found to alter the psychopathological profile of a small subgroup of patients treated for a variety of conditions, including inflammatory bowel disease (IBD) and psychiatric disorders. The association between the administration of biological agents and psychopathology needs to be further investigated. In this naturalistic prospective cohort study, patients with IBD were assigned to two treatment groups, i.e., a biological agent (which also included tofacitinib) or conventional therapy. Clinician-administered scales were used to assess psychosomatic symptoms (Hamilton Depression Rating Scale [Ham-D], Hamilton Anxiety Rating Scale [Ham-A], Young Mania Rating Scale [YMRS], and Brief Psychiatric Rating Scale [BPRS]) and disease activity (Mayo Score and Harvey-Bradshaw Index [HBI]) at baseline, after one, three, and six months of treatment. Each group was assessed for the course of their scores during the observation period at each assessment point. Patients on biological drugs who completed three months of treatment (N.=32) and six months of treatment (N.=20) scored significantly lower on the Mayo compared to baseline. Patients on conventional treatment obtained significant drops from baseline on the HBI after one and three months of treatment (N.=30) and also at the six-month endpoint (N.=11). Both groups showed no improvement or worsening on the psychiatric rating scales. In this study, we found no evidence of psychiatric symptom worsening, as some literature would suggest. Our data suggest that the use of biological agents in IBD is safe.

Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study

BackgroundImmune checkpoint inhibitors (ICIs) have been a major advance in cancer management. However, we still lack prospective real-world data regarding their usage in people with HIV infection (PWH).MethodsThe ANRS CO24...

Financial hardship after COVID-19 infection among US Veterans: a national prospective cohort study

BackgroundResearch suggests an association between COVID-19 infection and certain financial hardships in the shorter term and among single-state and privately insured samples. Whether COVID-19 is associated with financial hardship in the longer-term or among socially vulnerable populations is unknown. Therefore, we examined whether COVID-19 was associated with a range of financial hardships 18 months after initial infection among a national cohort of Veterans enrolled in the Veterans Health Administration (VHA)—the largest national integrated health system in the US. We additionally explored the association between Veteran characteristics and financial hardship during the pandemic, irrespective of COVID-19.MethodsWe conducted a prospective, telephone-based survey. Out of 600 Veterans with COVID-19 from October 2020 through April 2021 who were invited to participate, 194 Veterans with COVID-19 and 194 matched comparators without a history of infection participated. Financial hardship outcomes included overall health-related financial strain, two behavioral financial hardships (e.g., taking less medication than prescribed due to cost), and seven material financial hardships (e.g., using up most or all savings). Weighted generalized estimating equations were used to estimate risk ratios (RR) and 95% confidence intervals (CI) of financial hardship by COVID-19 status, and to assess the relationship between infection and Veteran age, VHA copay status, and comorbidity score, irrespective of COVID-19 status.ResultsAmong 388 respondents, 67% reported at least one type of financial hardship since March 2020, with 21% reporting behavioral hardships and 64% material hardships; 8% reported severe-to-extreme health-related financial strain. Compared with uninfected matched comparators, Veterans with a history of COVID-19 had greater risks of severe-to-extreme health-related financial strain (RR: 4.0, CI: 1.4–11.2), taking less medication due to cost (RR: 2.9, 95% CI: 1.0–8.6), and having a loved one take time off work to care for them (RR: 1.9, CI: 1.1–3.6). Irrespective of COVID-19 status, Veterans aged < 65 years had a greater risk of most financial hardships compared with Veterans aged ≥ 65 years.ConclusionsHealth-related financial hardships such as taking less medication due to cost and severe-to-extreme health-related financial strain were more common among Veterans with a history of COVID-19 than among matched comparators. Strategies are needed to address health-related financial hardship after COVID-19.Trial registrationNCT05394025, registered 05–27-2022.

Fetal Therapy for Congenital Pulmonary Malformations: A Prospective Population-Based National Cohort Study.

To assess the frequency of fetal therapy for fetuses with congenital pulmonary malformations (CPMs) and to investigate their short-term outcomes. The study population included 435 singleton fetuses diagnosed with CPMs from a national population-based cohort study in France in 2015-2018. Information was obtained from medical records on CPM volume ratio (CVR), signs of compression, fetal therapy and perinatal outcomes. The characteristics and outcomes of fetuses with and without fetal therapy were compared using a univariate test. Twenty six fetuses (6.0%, 95% CI: 4.1-8.6) received at least one fetal therapy including thoracoamniotic shunts only (n=3), antenatal steroids only (n=12), and a combination of several therapies including thoracentesis and amniodrainage, in addition to shunts and steroids (n=11). Compared with fetuses without fetal therapy, those who did have higher CVR (1.6±0.3 vs. 0.7±0.04, p<0.001) and more severe signs of compression (73.1% vs. 12.8%, p<0.001). The proportion of live births after fetal therapy was 84.6% versus 98.5% (p<0.001) for those without fetal therapy and the hospital mortality rate was 13.6% versus 1.0% (p=0.004), respectively. A small minority of fetuses with CPMs underwent fetal therapy. These patients had a lower survival compared with those who did not receive fetal therapy. NCT02352207.

The impact of potentially morally injurious experience of betrayal on PTSD and depression following the October 7th terror attack

With about 1200 individuals murdered, the massacre of October 7th was one of the deadliest terrorist attacks in modern history. The mental health consequences of terrorist attacks have been documented. However, little is known of the impact of the potentially morally injurious experience (PMIE) of betrayal––in which individuals feel betrayed by leaders they once trusted––on levels of psychological burden in the aftermath of such an attack. In this national prospective cohort study, we examined to what extent the PMIE of betrayal exacerbates the risk for posttraumatic stress disorder (PTSD) and depression in the wake of the October 7th terrorist attack. A representative sample of 710 Israeli adults (362 female, 51.1%), Jews (557, 79.9%) and Arabs (153, 20.1%), aged 18–85 (M = 41.01, SD = 13.72) completed validated self-report questionnaires assessing PTSD, depression, and PMIE-betrayal at two timepoints: T1, in August 2023 (6–7 weeks before the attack) and T2, in November 2023 (5–6 weeks after the attack). In two hierarchical logistic regressions, we found that experience of PMIE-betrayal predicted diagnoses of both PTSD (OR 1.92, 95% CI 1.26–2.92) and depression (OR 2.03, 95% CI 1.37–3.01) at T2, beyond probable PTSD/depression at T1 and demographic and trauma-related variables. Moreover, in two repeated-measure analyses predicting PTSD/depression symptoms, we found significant interactions between PTSD/depression trajectories and PMIE-betrayal, meaning that the increase of PTSD/depression symptoms was significantly higher among participants experiencing betrayal in the context of the attack. Our study highlights the impact of PMIE of betrayal on the dramatic increase in psychopathology following the October 7th terror attack on Israel’s population. Clinicians treating individuals coping with PTSD and depression should attend to their patients’ possible exposure to betrayal following the attack. Moreover, national leaders and policymakers should take significant steps to repair the public’s betrayal experience.

Cohort profile: the ‘Biomarkers of heterogeneity in type 1 diabetes’ study—a national prospective cohort study of clinical and metabolic phenotyping of individuals with long-standing type 1 diabetes in the Netherlands

PurposeThe ‘Biomarkers of heterogeneity in type 1 diabetes’ study cohort was set up to identify genetic, physiological and psychosocial factors explaining the observed heterogeneity in disease progression and the development...

Survival outcomes associated with first-line PCV or temozolomide in combination with radiotherapy in IDH-mutant 1p/19q-codeleted grade 3 oligodendroglioma.

2004 Background: Patients with IDH-mutant 1p/19q-codeleted grade 3 oligodendroglioma (O3IDHmt/Codel) benefit from adding alkylating chemotherapy to radiotherapy (RT). However, the optimal chemotherapy regimen between Procarbazine, CCNU, and Vincristine (PCV) and Temozolomide (TMZ) remains unclear given the lack of randomized trial data comparing both regimens. Methods: The objective was to assess the overall (OS) and progression-free (PFS) survival associated with first-line PCV/RT versus TMZ/RT in patients diagnosed with O3IDHmt/Codel. We included patients with histologically-proven O3IDHmt/Codel (according to WHO criteria) from the French national prospective cohort study POLA. All tumours underwent central pathological review. OS and PFS from surgery were estimated using Kaplan-Meier method and Cox regression model. Results: 305 newly-diagnosed O3IDHmt/Codel patients treated with RT and chemotherapy between 2008 and 2022 were included. 67.9% of patients (n=207) were treated with PCV/RT and 32.1% with TMZ/RT (n=98). Median follow-up was 78.4 months (IQR=44.3-102.7). Median OS was not reached (95%CI: NR-NR) and 140 months (95%CI: 110-NR) in the PCV/RT and TMZ/RT groups, respectively (log-rank P&lt;0.0001). On univariable analysis, there was a significant difference in favor of PCV/RT in both 5-year (PCV/RT: 89%, 95%CI: 85-94; TMZ/RT: 75%, 95%CI: 66-84) and 10-year OS (PCV/RT: 72%, 95%CI: 61-85; TMZ/RT: 60%, 95%CI: 49-73), which was confirmed in the multivariable Cox model adjusted for age, type of surgery, gender, ECOG performance status and CDKN2A homozygous deletion (HR 0.53 for PCV/RT, 95%CI: 0.30-0.92, P=0.025). Conclusions: In patients with newly-diagnosed O3IDHmt/Codel from the POLA cohort, first line PCV/RT was associated with better OS outcomes compared to TMZ/RT. Our data suggest that the improved safety profile associated with TMZ comes at the cost of inferior efficacy in this population. Further investigation using prospective randomized studies is warranted.

Associations between factors in childhood and young adulthood and childlessness among women in their 40s: A national prospective cohort study

BackgroundWhile the risk factors for infertility are well-established, research on factors associated with voluntary childlessness is limited and mainly focused on adulthood factors. Thus, we examined the associations between factors in childhood and young adulthood and different types of childlessness. MethodsThe analysis included 4653 women from the Australian Longitudinal Study on Women's Health from 1996 to 2021. Childlessness was categorised as: voluntary, due to infertility issues, or due to other reasons. The associations between factors in childhood and young adulthood and childlessness were assessed using multinomial logistic regression models. ResultsIn their 40s, 4.8 % of women were voluntarily childless, 6.7 % were childless due to infertility issues, and 7.8 % were childless due to other reasons. Regardless of types of childlessness, being childless was associated with poorer self-rated health during childhood and having been unpartnered and obese in young adulthood. Ex-smokers in young adulthood had lower odds of childlessness. Childhood physical abuse was associated with childlessness due to infertility issues and other reasons. Voluntary childlessness and childlessness due to infertility issues were associated with having identified as non-exclusively heterosexual in early adulthood. Lower social support in early adulthood was associated with voluntary childlessness and childlessness due to other reasons. LimitationsThe direction of the associations could not be determined and using self-reported data may introduce recall bias. ConclusionsFactors in childhood and young adulthood were associated with different types of childlessness, highlighting the importance of adopting a life course perspective when studying childlessness.

Clinical characteristics of cerebral amyloid angiopathy and risk factors of cerebral amyloid angiopathy related intracerebral hemorrhage.

There is limited understanding of the differences between cerebral amyloid angiopathy (CAA) with and without intracerebral hemorrhage (ICH). This article aimed to describe the characteristics of CAA and identify the risk factors of CAA-ICH in a multicenter cohort. Patients consecutively enrolled in the national multicenter prospective Cerebral Small Vessel Disease Cohort Study who met the Boston diagnostic criteria for CAA or CAA-related inflammation were included in this study. The demographic characteristics and clinical data were collected. The clinical and radiographic differences between CAA with and without ICH were compared to identify the risk factors for CAA-ICH. A total of 219 CAA patients were included, with an average age of 67.12 ± 9.93. Of all patients, 26.0% were CAA with ICH. Univariate analysis showed that CAA-ICH is associated with carrying more APOE ε2 allele, less lobar cerebral microbleeds (CMBs), cortical superficial siderosis (cSS), lower Fazekas scale, a tendency of gait disorder, and acute onset (P < 0.05). The generalized linear mixed model yielded statistically significant associations between CAA with ICH and carrying the APOE ε2 allele, cSS, the lower number of lobar CMBs, and the lower Fazekas scale (P < 0.05). It is meaningful to classify CAA with and without ICH, as there may be different mechanisms between the two. CAA with ICH has a susceptibility to carrying APOE ε2, cSS, and a relatively small number of CMBs. Fewer CMBs do not mean lower susceptibility to ICH in CAA. Larger prospective cohort studies are necessary to further clarify these conclusions.