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This study investigated the moderating effect of financial strain or social support on depressive symptoms among older people living alone in Taiwan. Data were collected from the "Taiwan Longitudinal Study on Aging (TLSA)," which included 1513 participants aged 65 and over, among them, 153 (10.1%) were living alone, while 1360 (89.9%) were living with others. Measurement tools included the Depression scale (CES-D), financial stress scale, social support scale, ADL scale, IADL scale, and stress scale, with Cronbach's α coefficients were 0.85, 0.78, 0.67, 0.91, 0.90, and 0.70 respectively. Hierarchical multiple regression was used to examine the moderator effect. The findings revealed that (1) Financial strain was found to moderate the relationship between living alone and depressive symptoms, acting as a promotive moderator among older men living alone. For older women, financial stress does not moderate the relationship between living alone and depressive symptoms. However, financial strain was also identified as a significant factor associated with depressive symptoms among older women living alone. (2) Social support does not moderate effect on the relationship between living alone and depressive symptoms in older men or older women. These results underscore the importance of considering financial stress in mental health policy development by government agencies. It is imperative to address the unique challenges faced by older individuals living alone, particularly in relation to financial strain, in order to promote their mental well-being.
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Depressão , Estresse Financeiro , Apoio Social , Humanos , Masculino , Idoso , Feminino , Depressão/psicologia , Depressão/epidemiologia , Depressão/economia , Estudos Longitudinais , Idoso de 80 Anos ou mais , Estresse Financeiro/psicologia , Estresse Financeiro/epidemiologia , Taiwan/epidemiologiaRESUMO
Latino immigrants within the United States experience various stressors, which have been linked to the development and exacerbation of internalizing symptoms among Latino youth. Therefore, it is crucial to explore factors that may buffer the impact of stress among immigrant families. Fathers may influence child outcomes through positive parenting behaviors, yet Latino fathers have been underrepresented in research. This study examined how paternal warmth and support may moderate the association between the accumulation of stress and child internalizing symptoms among low-income, Latino immigrant families. Participants included 62 children between the ages of 6 and 10, and their paternal caregivers (94% fathers; 90% born in Mexico). This study utilized a multi-method approach including parent-report, child-report and observational measures. Participants completed questionnaires and video-recorded family interaction tasks during home visits. Stress was positively associated with child-reported depression. Self-reported paternal warmth was associated with fewer parent-reported child internalizing symptoms and moderated the effects of stress on symptoms. Analyses showed a significant positive association between paternal stress and child internalizing symptoms for children with the lowest levels of parental warmth. However, when paternal warmth was high, accumulation of stress and child internalizing symptoms were not related. Thus, high levels of warmth buffered the impact of stress on internalizing symptoms. This study highlights the importance of Latino fathers' parenting behaviors on child internalizing symptoms.
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Objective In randomized clinical trials and real-world studies, calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs), including erenumab, have demonstrated efficacy for migraine prevention. However, there have been no real-world studies focusing on erenumab in East Asia that investigated its efficacy on migraine-associated symptoms and patient-reported satisfaction levels. Methods This single-center, observational, retrospective, real-world study examined patients who received at least three doses of erenumab at Keio University Hospital, Tokyo, Japan, between December 2021 and March 2023 as their first CGRP mAb treatment in a real-world setting. The patients were administered 70 mg of erenumab monthly. We assessed changes in monthly migraine days (MMDs), responder rates, migraine-associated symptoms including photophobia, phonophobia, nausea/vomiting, and patient-reported satisfaction levels. In addition, injection site reactions and other adverse events were recorded to investigate safety. Results Nineteen patients were considered eligible for the analysis. At 3 months, erenumab decreased MMDs by 6.6 (95% confidence interval, 2.3-10.8; p<0.01). The 50% responder rate was 42%. A total of 83% (n=15), 56% (n=10), and 71% (n=10) of patients reported either improvement in or disappearance of photophobia, phonophobia, and nausea/vomiting, respectively, and 44% (n=8) and 28% (n=5) answered "very satisfied" and "somewhat satisfied", respectively, with erenumab treatment, leaving only 28% (n=5) as "unsatisfied". Injection site reactions (n=6, 32%) and constipation (n=4, 21%) were frequent adverse events. Conclusion In a real-world setting in Japan, erenumab proved to be effective in not only reducing migraine and headache frequency but also improving migraine-associated symptoms and satisfying the majority of patients.
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The aim of this study is to describe the patterns of prescription of benzodiazepine-receptor agonists in hospitalised patients in four psychogeriatric units in Switzerland. This is a retrospective cross-sectional study that included patients aged 65 years or more hospitalised in one of the four psychogeriatric units of a university hospital in Switzerland during 2019. The presence, type and dose of benzodiazepine-receptor agonists was assessed at admission and at discharge. Three-hundred and eighty-six patients (214 women, 78.2 ± 8.1 years) were included in the study; 33.4% of patients had at least one benzodiazepine-receptor agonist at admission and 22.5% at discharge. The relative reduction of benzodiazepine-receptor agonists prescription in standardised dose was 78%. Age was found to be a protective factor against benzodiazepine-receptor agonists prescription at admission (adjusted odds ratio 0.94, confidence interval 0.91-0.98), and diagnosis of substance abuse was found to be a risk factor (adjusted odds ratio 4.43, confidence interval 1.42-17.02). Longer hospital stays (> 14 days) were associated with higher reduction of benzodiazepine-receptor agonists. The prevalence of a prescription of benzodiazepine-receptor agonists at admission was high, but during the psychogeriatric hospitalisation benzodiazepine-receptor agonists prescription decreased both in absolute and relative terms.
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The number of Shidu parents (parents over the age of 45 years who have lost their only child) has been increasing in China, which is important because Shidu parents experience depressive symptoms. This study investigated the potential mediating roles of mindfulness and resilience in the relation between social support and depressive symptoms among Shidu parents. From June to December 2021, 111 Shidu parents in Baoji city, China, completed a web-based survey on social support, depressive symptoms, mindfulness, and resilience. The results indicated that Shidu parents suffer from a high risk of depressive symptoms, and significant correlations were found between the study variables. Path analysis models showed that the relation between social support and depressive symptoms in Shidu parents was fully mediated by a combination of mindfulness and resilience. These findings further highlighted the significance of social support, mindfulness, and resilience in potentially alleviating depressive symptoms among Shidu parents.
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BACKGROUND: Depression is a major global health concern, particularly in India, where it significantly impacts the population's well-being. The interplay of various factors, including education, employment status, and spiritual intelligence, contributes to the complex landscape of depressive symptoms among adults. METHODOLOGY: A community-based cross-sectional study was conducted in the rural service areas of a tertiary care medical institution in rural India from March 2021 to September 2022. The study employed structured questionnaires and validated scales to assess depressive symptoms, spiritual intelligence, educational status, and occupational status among participants. Structural equation modelling was used for mediation analysis to evaluate the effect of spiritual intelligence and employment status on the association between education and depressive symptoms. RESULTS: The study included 381 participants, with a prevalence of depressive symptoms at 14.4%. Higher educational attainment was associated with lower odds of depressive symptoms (aOR = 0.34, 95% CI [0.17, 0.67]). Employment status mediated the relationship between education and depression, with employed individuals exhibiting lower odds of depressive symptoms (aOR = 0.42, 95% CI [0.22, 0.82]). While spiritual intelligence was higher among those with formal education, its direct impact on depression was not statistically significant. The mediation analysis revealed that a significant portion (77.5%) of the total effect of education on depression was mediated through employment status and spiritual intelligence. CONCLUSION: The study underscores the importance of education and employment opportunities in mitigating depressive symptoms among rural adults. It suggests targeted interventions that promote education and employment support to enhance mental health resilience. While spiritual intelligence may influence mental health outcomes, its exact role requires further investigation.
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This review focuses on late-onset schizophrenia and schizophrenia-like psychosis with very late onset (VLOSLP) with focus on their psychopathologic, neuropsychologic, and neurobiologic aspects. A literature review on late-onset schizophrenia and VLOSLP was conducted based on publications from PubMed, Scopus, and Google Scholar databases up to December 2023. It may be noted that research into schizophrenia has largely focused on early-onset patients, and research into the mental health of older people has focused primarily on dementia and depression, with relatively little information on late-onset schizophrenia and VLOSLP. The nosology of late-onset functional psychoses is still poorly understood. There is currently no consensus on the diagnostic framework for psychosis labeled by the term VLOSLP. These deficiencies need to be addressed in order to understand the background of VLOSLP, the course and prognosis of the illness, and to develop successful management and treatment strategies for these patients, as older adults are more susceptible to the adverse effects of psychotropic medications. Therapy should be holistic, including not only medication but also psychotherapy, and the key role of caregivers of elderly schizophrenia patients should be taken into account. There should be judicious use of pharmacotherapy with an assessment of its risks and benefits.
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Idade de Início , Transtornos Psicóticos , Esquizofrenia , Humanos , Esquizofrenia/diagnóstico , Esquizofrenia/tratamento farmacológico , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/etiologia , Idoso , Prognóstico , Antipsicóticos/uso terapêutico , Psicologia do EsquizofrênicoRESUMO
OBJECTIVE: To evaluate the frequency and severity of various clinical symptoms of Parkinson's disease (PD) depending on the BDNF rs6265 polymorphism. MATERIAL AND METHODS: The study included 533 patients with PD. The stage of PD was assessed using the Hoehn and Yahr scale (1967), motor symptoms were evaluated with MDS-UPDRS. Assessment of non-motor symptoms (NMS) in PD was conducted using the Beck Depression Inventory II (BDI-II); the Hospital Anxiety and Depression Scale (HADS); the Apathy Scale; the Montreal Cognitive Assessment (MoCA test); the Questionnaire for Impulsive-Compulsive Disorders in PD -Rating Scale (QUIP-RS). Genotyping of the BDNF variant (rs6265) was performed using real-time PCR with TaqMan probes. RESULTS: Most PD patients have a combination of NMS increasing as the disease progresses and is determined by molecular-genetic individual characteristics. There are significant differences in the severity of motor symptoms and NMS: individuals with the AA genotype showed significantly pronounced motor symptoms (p<0.0001); emotional-affective symptoms (p<0.0001); cognitive and impulsive behavioral disorders (p<0.0001). CONCLUSION: The rs6265 BDNF allele A is associated with a wide range of NMS, increasing the risk of their development in patients with PD, thus playing the important role in the etiopathogenesis of this pathology.
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Fator Neurotrófico Derivado do Encéfalo , Doença de Parkinson , Polimorfismo de Nucleotídeo Único , Humanos , Fator Neurotrófico Derivado do Encéfalo/genética , Doença de Parkinson/genética , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Genótipo , Índice de Gravidade de Doença , Depressão/genéticaRESUMO
OBJECTIVE: To test for differences in recovery of lower urinary tract symptoms (LUTS) between patients with storage-positive vs -negative symptoms after laser enucleation of the prostate (LEP). PATIENTS AND METHODS: Consecutive storage-positive (severe storage symptoms, International Prostate Symptom Score [IPSS] storage subscore >8) vs storage-negative patients treated with LEP (November 2017-September 2022) within our tertiary-care database were identified. Mixed linear models tested for changes in IPSS and quality of life (QoL) at 1, 3 and 12 months after LEP. Multiple linear regression models tested for LUTS and QoL recovery risk factors at 1, 3 and 12 months. RESULTS: Of 291 study patients, 180 (62%) had storage-positive symptoms. There were no differences between storage-positive and -negative patients in mean adjusted total IPSS, IPSS-storage, IPSS-voiding and QoL at 12 months after LEP. In multiple linear regression models, storage-positive status was identified as a risk factor for higher IPSS at 1 month (ß coefficient 2.98, P = 0.004) and 3 months (ß coefficient 2.24, P = 0.04), as well as for more unfavourable QoL at 1 month (ß coefficient 0.74, P = 0.006) and 3 months (ß coefficient 0.73, P = 0.004) after LEP. Conversely, at 12 months there were no differences between storage-positive vs -negative patients. CONCLUSION: Storage-positive patients appear to experience similar long-term benefits from LEP compared to storage-negative patients. However, significant storage symptoms are associated with higher total IPSS and less favourable QoL at 1 and 3 months after LEP. These findings advocate for the consideration of LEP also in storage-positive cases with the need for thorough patient education especially in the initial post-LEP period.
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OBJECTIVES: COVID-19 lockdowns were introduced to control the pandemic, however, they resulted in a global disruption of daily life and of individual and global health. Reduced accessibility of health services, unavailability of food and drugs, and mental health challenges had a huge impact on older people and on people living with disabling conditions such as Parkinson's disease (PD). We assessed whether and to what extent the more disabled and vulnerable people with Parkinson's (PwP) were affected by lockdowns. METHOD: We analysed responses collected through a web-based survey of PwP according to their self-sufficiency [self-sufficient (SS); nearly self-sufficient (nSS); non-self-sufficient, cared for by family (NSS/F); non-self-sufficient, needs professional care (NSS/PC)]. RESULTS: Fears due to COVID-19 and difficulties with food supply were highest in NSS/F PwP. Difficulties with the supply of Parkinson's medication or other drugs were apparently not an issue, while problems accessing primary care physicians and neurologists were similar across all patient groups. On the contrary, difficulties with daily and motor activities were higher in NSS/F and NSS/PC PwP. PwP symptoms worsened in all groups, with NSS/F and NSS/PC participants experiencing the worst deterioration. Notably, the deterioration of PwP symptoms was specifically related to changes in daily and motor activities, with participants who reported less engagement in daily and motor activities experiencing the worst deterioration. CONCLUSION: Findings strongly support the need for decision-makers and healthcare providers to carefully re-evaluate the risk-benefit ratio of limiting healthcare accessibility for PwP, since evidence shows that lockdown measures primarily impact the groups who are most fragile and vulnerable.
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BACKGROUND AND HYPOTHESIS: Young people (YP) with psychotic experiences (PE) have an increased risk of developing a psychiatric disorder. Therefore, knowledge on continuity of care from child and adolescent (CAMHS) to adult mental health services (AMHS) in relation to PE is important. Here, we investigated whether the self-reported trajectories of persistent PE were associated with likelihood of transition to AMHS and mental health outcomes. STUDY DESIGN: In this prospective cohort study, interviews and questionnaires were used to assess PE, mental health, and service use in 763 child and adolescent mental health service users reaching their service's upper age limit in 8 European countries. Trajectories of self-reported PE (3 items) from baseline to 24-month follow-up were determined using growth mixture modeling (GMM). Associations were assessed with auxiliary variables and using mixed models. Study results. At baseline, 56.7% of YP reported PE. GMM identified 5 trajectories over 24 months: medium increasing (5.2%), medium stable (11.7%), medium decreasing (6.5%), high decreasing (4.2%), and low stable (72.4%). PE trajectories were not associated with continuity of specialist care or transition to AMHS. Overall, YP with PE reported more mental health problems at baseline. Persistence of PE or an increase was associated with poorer outcomes at follow-up. CONCLUSIONS: PE are common among CAMHS users when reaching the upper age limit of CAMHS. Persistence or an increase of PE was associated with poorer mental health outcomes, poorer prognosis, and impaired functioning, but were less discriminative for continuity of care.
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BACKGROUND AND AIMS: Dysphagia is the hallmark symptom in eosinophilic esophagitis (EoE). However, data are limited regarding the overall prevalence and potential implications of atypical symptoms like odynophagia and retrosternal pain. METHODS: Patients enrolled into the Swiss EoE cohort study (SEECS) were analyzed regarding the presence of odynophagia and retrosternal pain. Demographics, other EoE-related symptoms, histologic and endoscopic activity were compared between EoE-patients with vs. without odynophagia and/or retrosternal pain. RESULTS: 474 patients (75.2% male) were analyzed. In their individual course of disease 110 (23.2%) patients stated to have ever experienced odynophagia and 64 (13.5%) retrosternal pain independent of food intake, 24 (5%) patients complained about both symptoms. Patients with odynophagia consistently scored higher in symptom severity (p < 0.001), EREFS score (median 3.0 vs. 2.0, p = 0.006), histologic activity and a lower quality of life (p = 0.001) compared to patients without odynophagia. Sex, age at diagnosis, EoE-specific treatment, complications such as candida or viral esophagitis and disease duration were similar in patients with vs. without odynophagia. Also patients with retrosternal pain scored higher in symptom severity (2.0 vs. 1.0, p = 0.001 and 2.0 vs. 1.0, p < 0.001 in physician and patient questionnaire assessment, respectively). However, there was neither a difference in endoscopic/histologic disease activity nor in quality of life according to presence or absence of retrosternal pain. Due to logistic reasons, a stratification regarding the presence of concomitant dysphagia was not possible. CONCLUSION: Odynophagia and swallowing-independent retrosternal pain are common symptoms in patients with EoE, associate with an overall higher EoE-related symptom severity and for the case of odynophagia lower quality of life. However, the influence of concomitant dysphagia and its severity remains unclear and needs to be included in future analyses.
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Although previous studies have shown that self-compassion is associated with self-esteem and depressive symptoms, little is known about the intra-individual processes and the temporal dynamics of these variables. This study used a longitudinal design to explore the association between self-compassion, self-esteem and depressive symptoms among 5785 college students (aged 17-22 years; Mage = 18.63, SD = 0.88; 48.2% females). The participants were assessed six times in a six-month interval over three years. The random intercept cross-lagged panel models (RI-CLPMs) were used to disentangle within-person processes from stable between-person differences. Results of RI-CLPMs indicated that at the within-person level, self-compassion can positively predict subsequent self-esteem and negatively predict subsequent depressive symptoms, and vice versa. Self-esteem played a longitudinal mediating role in the prediction from self-compassion to depressive symptoms at the within-person level. These results indicate that cultivating self-compassion in college students is crucial as it can bolster their self-esteem and alleviate depressive symptoms.
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Background/Objective: Socioeconomic disparities in mental health are well-established. Previous research suggests that relative income rank is associated with depressive symptoms above and beyond absolute income. This study aimed to investigate the predictive value of income rank for future depressive symptoms while accounting for absolute income. Exploring potential reverse pathways from depressive symptoms to income rank was a secondary objective. Method: A two-wave cross-lagged panel design with a 5-year follow-up was used to analyze data for income rank, absolute income, and two dimensions of depressive symptoms (i.e., cognitive-affective and somatic symptoms) from initially 4,201 employees. Income rank was calculated for reference groups, based on the same gender, the same 5-year age band, and the same occupational skill level. Results: Lower income rank at baseline predicted a higher severity of cognitive-affective depressive symptoms at five-year follow-up, even after adjusting for absolute income. In contrast, income rank did not demonstrate a significant unique longitudinal association with somatic depressive symptoms when simultaneously taking absolute income into account. There was no evidence for the assumption that depressive symptoms are predictive for future income rank (i.e., reverse pathway). Conclusions: Cognitive-affective symptoms of depression might be particularly responsive to social comparisons and a relatively low social rank.
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To examine the feasibility, utility and safety of superimposed lower body negative pressure (LBNP) and tilt during supine cycling in individuals suffering from persisting post-concussive symptoms (PPCS). Eleven individuals aged 17-31 (6 females/5 males) participated in two randomized separate visits, 1 week apart. A ramp-incremental test was performed during both visits until volitional failure. Visits included no pressure (control) or LBNP at -40 Torr (experimental) with head-up tilt at 15 degrees (females) or 30 degrees (males). Transcranial Doppler ultrasound was utilized to quantify middle cerebral artery velocity (MCAv), while symptom reports were filled out before and 0, 10, and 60 min post-exertion. Ratings of exertion and overall condition followed similar trends for participants across both tests. The relative increase in MCAv was blunted during the experimental condition (8%) compared to control (24%), while a greater heart rate (17 beats/min) was achieved during the LBNP condition (P = 0.047). Symptom severity at the 0 and 10 min post-exertion time points displayed negligible-to-small effect sizes between conditions (Wilcoxon's r < 0.11). Symptom reporting was lower at the 60 min post-exertion time point with these displaying a moderate effect size (Wilcoxon's r = 0.31). The combination of LBNP and tilt during supine cycling did not change the participants' subjective interpretation of the exertional test but attenuated the hyperpnia-induced vasodilatory MCAv response, while also enabling participants to achieve a higher heart rate during exercise and reduced symptoms 1 h later. As this protocol is safe and feasible, further research is warranted in this area for developing PPCS treatment options. HIGHLIGHTS: What is the central question of this study? What are the feasibility, safety and utility of combining head-up tilt with lower body negative pressure during supine cycling for blunting the increase in cerebral blood velocity seen during moderate-intensity exercise in individuals experiencing persisting post-concussion symptoms? What is the main finding and its importance? Although no differences were found in symptoms between conditions within the first 10 min following exertion, symptom severity scores showed a clinically meaningful reduction 60 min following the experimental condition compared to the non-experimental control condition.
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Recent evidence challenges the belief that Duffy-negative individuals are resistant to Plasmodium vivax due to lacking Duffy Antigen Receptor for Chemokines (DARC). Erythrocyte Binding Protein (EBP/DBP2) has shown moderate binding to Duffy-negative erythrocytes in vitro. Reticulocyte Binding Protein 2b (RBP2b) interactions with Transferrin Receptor 1 (TfR1) suggest involvement in Duffy-negative infections. Gene copy number variations (CNVs) in PvDBP1, PvEBP/DBP2, and PvRBP2b were investigated in Duffy-positive and Duffy-negative P. vivax-infected individuals from Ethiopia. Among Duffy-positive samples, 34% displayed PvDBP1 duplications (Cambodian-type). In Duffy-negative infections, 30% showed duplications, mostly Cambodian-type. For PvEBP/DBP2 and PvRBP2b, Duffy-positive samples exhibited higher duplication rates (1-8 copies for PvEBP/DBP2, 1-5 copies for PvRBP2b 46% and 43% respectively) compared to Duffy-negatives (20.8% and 26% respectively). The range of CNVs was lower in Duffy-negative infections. Demographic and clinical factors associated with gene multiplications in both Duffy types were explored, enhancing understanding of P. vivax evolution in Duffy-negative Africans.
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AIM: To determine the longitudinal trajectories of anxiety and depression among pregnant women who have experienced pregnancy loss, and to explore the association between post-traumatic stress symptoms (PTSS) related to pregnancy loss and these trajectories. DESIGN: A prospective longitudinal study. METHODS: Between October 2022 and August 2023, pregnant women with a history of pregnancy loss were recruited from four hospitals in Guangdong Province, China. Eligible participants were screened for PTSS related to pregnancy loss upon enrolment. Anxiety and depression symptoms were assessed in early, mid and late pregnancy using the Pregnancy-related Anxiety Questionnaire-Revised 2 and the Patient Health Questionnaire-9, respectively. Latent class growth analysis was employed to categorize anxiety and depression trajectories, and multinomial logistic regression analysis was conducted to examine the association between PTSS and these trajectories. RESULTS: Of the 388 participants included in the analysis, 158 individuals (40.7%) reported high PTSS scores. The best-fitting models identified three trajectories for both anxiety and depression: low (anxiety: 35.6%, depression: 48.7%), moderate (anxiety: 44.8%, depression: 40.5%) and high (anxiety: 19.6%, depression: 10.8%). Pregnant women with high PTSS levels were significantly more likely to experience moderate-to-high trajectories of anxiety and depression compared to those with low PTSS levels. CONCLUSION: Pregnant women who have experienced pregnancy loss exhibit higher incidences of elevated anxiety and depression trajectories. Screening for PTSS and targeted supportive care are recommended to alleviate anxiety and depressive symptoms in this population. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: This study underscores the importance of early psychological screening and tailored interventions for pregnant women with a history of pregnancy loss. Trauma-informed care should be prioritized to mitigate anxiety and depression trajectories in this vulnerable population. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public involvement.
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Caregivers of older adults with dementia (dementia caregivers) often experience high role overload (i.e., feeling overwhelmed by caregiving demands that exceed available resources), which can take a toll on their mental health. Moreover, dementia caregiving can restrict caregivers' participation in valued social activities. This study aims to examine the mediating effect of social participation restriction on the relationship between role overload and mental health among dementia caregivers. A total of 894 dementia caregivers (mean age = 61.77) were selected from the National Study of Caregiving. The sample was predominantly women (64%) and White (78%). Path analysis shows that social participation restriction partially mediated the associations between (1) role overload and psychological distress (indirect effect ß = .08, p < .001) and (2) role overload and psychological wellbeing (indirect effect ß = -.05, p < .05). Interventions targeting coping strategies and healthcare-recreation programs are needed to improve social participation among dementia caregivers.
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INTRODUCTION: Individuals living with Crohn's disease (CD) experience burdensome symptoms. As such, it is important to measure CD symptom severity in clinical research. The goal of this study was to evaluate the content validity, psychometric performance, and score interpretability of a new patient-reported instrument, the Crohn's Symptom Severity (CSS) questionnaire, among adolescents and adults with moderately to severely active CD. METHODS: Cognitive debriefing interviews (N = 30; n = 20 adults, n = 10 adolescents) were conducted to evaluate the content validity of the CSS. Additionally, the CSS scores were evaluated for reliability and validity using data from a phase 3 randomized clinical trial of risankizumab (NCT03105128; N = 850). Meaningful within-patient change (MWPC) thresholds were estimated using anchor-based methods. RESULTS: All interview participants (n = 30/30, 100.00%) reported the CSS was easy to complete and most participants (n = 28/29, 96.55%) reported that the CSS was relevant to their experience of CD. Among the clinical trial subjects (N = 850) the following was found for the CSS: mostly acceptable item-total correlations (0.26-0.79); weak to moderate inter-item correlations (r = 0.07-0.57), good internal consistency (Cronbach's α = 0.76-0.87); intraclass correlation coefficients ranged from 0.48 to 0.70, not consistently exceeding the acceptable range for test-retest reliability (0.70); acceptable convergent validity and known-groups results; and demonstrated sensitivity to change. Analyses supported an MWPC estimate of 6-11 points. CONCLUSIONS: This study supports use of the CSS for measuring CD symptoms and sleep impact among adolescents and adults aged 16 and older with moderately to severely active CD in clinical research. TRIAL REGISTRATION: NCT03105128 (registration date 4 April 2017).
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Clinical congestion remains a major cause of hospitalization and re-hospitalizations in patients with chronic heart failure (HF). Despite the high prevalence of this issue and clinical concern in HF practice, there is limited understanding of the complex pathophysiology relating to the "congestion" of congestive HF. There is no unifying definition or clear consensus on what is meant or implied by the term "congestion." Further, the discordance in study findings relating congestion to physical signs and symptoms of HF, cardiac hemodynamics, or metrics of weight change or fluid loss with diuretic therapy has not added clarity. In this review, these factors will be discussed to add perspective to this issue and consider the factors driving "congestion." There remains a need to better understand the roles of fluid retention promoting intravascular and interstitial compartment expansions, blood volume redistribution from venous reservoirs, altered venous structure and capacity, elevated cardiac filling pressure hemodynamics, and heterogeneous intravascular volume profiles (plasma volume and red blood cell mass) with a goal to help demystify "congestion" in HF. Further, this includes highlighting the importance of recognizing that congestion is not the result of a single pathway but a complex of responses some of which produce symptoms while others do not; yet, we confine these varied responses to the single and somewhat vague term "congestion."