Mental Domains Research Articles

P1169 Guselkumab maintenance treatment improves health-related quality of life in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR maintenance study

Abstract Background Ulcerative colitis (UC) symptoms are associated with impaired health-related quality of life (HRQoL). The Phase 3 QUASAR maintenance study (NCT04033445) evaluated the efficacy and safety of guselkumab (GUS) in participants (pts) with moderately to severely active UC who demonstrated a clinical response to GUS intravenous (IV) induction. GUS is a selective dual-acting IL-23p19 subunit inhibitor that potently blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. Here we report the effect of GUS subcutaneous (SC) maintenance therapy on HRQoL at Week (W) 44 in QUASAR pts as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Methods At maintenance baseline (BL), GUS IV induction W12 responders and placebo (PBO)→GUS IV induction W24 responders were randomized 1:1:1 to SC GUS 200 mg every 4 W (q4w; N=190), GUS 100 mg every 8 W (q8w; N=188), or PBO (GUS withdrawal; N=190) maintenance therapy. PROMIS-29 consists of 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and social participation) and a pain intensity numeric rating scale (NRS, range 0-10). The raw score of each domain is converted into a standardized T-score with a general population mean of 50 and standard deviation of 10. Physical component summary (PCS) and mental component summary (MCS) scores are derived from physical and mental domain T-scores, respectively. Higher scores indicate better outcomes for physical function and social participation domains and PCS and MCS scores and worse outcomes for all other symptom domains. Depending on the domain/score, improvement of ≥3 to ≥9 points from induction BL was identified as clinically meaningful.1 Results At maintenance BL, mean PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores in all treatment groups reflected values in-line with the general population, as expected for clinical responders to GUS IV induction (Table). At W44, the PROMIS-29 domain T-scores, pain intensity NRS score, and PCS/MCS scores observed at maintenance BL were sustained in both GUS SC maintenance groups but had worsened in the PBO group (Table). The proportion of pts achieving clinically meaningful improvement from induction BL at W44 was greater with GUS vs PBO for each PROMIS-29 domain T-score, pain intensity NRS score, and PCS/MCS scores (Figure). Conclusion Among pts with moderately to severely active UC who responded to GUS IV induction, GUS SC maintenance therapy sustained clinically meaningful improvements in HRQoL at W44 as measured by the PROMIS-29. This study was funded by Janssen Research & Development, LLC.

Comparison of clinical and radiological outcomes of three-column lumbar osteotomies with and without interbody cages for adult spinal deformity.

Correcting sagittal malalignment in adult spinal deformity (ASD) is a challenging task, often requiring complex surgical interventions like pedicle subtraction osteotomies (PSOs). Different types of three-column osteotomies (3COs), including Schwab 3, Schwab 4, Schwab 4 with interbody cages, and the "sandwich" technique, aim to optimize alignment and fusion outcomes. The role of interbody cages in enhancing fusion and segmental correction remains unclear. This study aimed to compare outcomes among these 4 3CO techniques, evaluating the impact of cage use at the osteotomy site on postoperative radiographic imaging and clinical outcomes. This is a multicenter retrospective study utilizing data from a prospective multicenter database of patients undergoing complex ASD surgery. Ninety-seven patients who underwent 1 of 4 3CO techniques for thoracolumbar ASD correction with at least 2 years of follow-up were included. The sample consisted of 29 patients who underwent Schwab 3 osteotomy, 20 Schwab 4, 28 Schwab 4 with interbody cages, and 20 who underwent "sandwich" osteotomy. The Scoliosis Research Society-22 revised (SRS22r) questionnaire evaluating pain, activity, appearance, mental health, and satisfaction was used to evaluate patient reported outcomes and radiographic measures including segmental lordosis and fusion rates determined by 3 blinded reviewers were used to evaluate physiologic outcomes. This study analyzed demographic data, radiographic outcomes, patient-reported outcomes, complications, and fusion rates over a 2-year follow-up period. Fusion status was determined via serial radiographs and evaluated independently by 3 blinded reviewers. Univariate and multivariate statistical analyses were performed to assess differences among the groups and the impact of interbody cage use on outcomes. Patients undergoing "sandwich" osteotomy exhibited worse preoperative leg pain scores and lower SRS22r activity (p=.015), appearance (p=.007), and mental health domain scores (p=.0015). No differences in complications were found among groups (p>.05). Patients who underwent osteotomy with a cage were more likely to have had previous spine fusion (91.7% vs. 71.4%, p=.010). Additionally, these patients had lower preoperative SRS22r mental domain (2.9±1 vs. 3.5±1, p=.009), satisfaction (2.3±1 vs. 2.7±1.2, p=.034), and SRS22r total scores (2.3±0.6 vs. 2.6±0.6, p=.0026) but demonstrated the greatest improvement in the mental health domain (0.9±0.7 vs. 0.3±0.9, p=.002). Cage use was associated with a larger mean change in segmental lordosis at the osteotomy site (32.9±9.6 vs. 28.7±9.5, p=.038). Fusion rates were significantly higher in the cage group (79.2% vs. 55.1%, p=.0012). Regression analysis identified cage use as an independent predictor for fusion (odds ratio, 3.338; 95% confidence interval, 1.108-10.054, p=.032). Interbody cage use at the osteotomy site during 3COs for ASD correction was associated with improved fusion rates and greater segmental lordosis without increasing complication rates. Incorporating cages may provide enhanced alignment and fusion outcomes in complex ASD surgeries.

Definition and Identification of Honey Bee Welfare Practices Within the Five Domains Framework for Sustainable Beekeeping

This paper aims to define and identify the Honey Bee Welfare Practices (HBWPs) that beekeepers should adopt within a modern framework for sustainable apiculture. Once identified, HBWPs were categorized according to the Five Domains Model used in other animal species. Drawing on findings of the European BPRACTICES Horizon 2020 project, we identified, for the first time, 243 HBWPs: while all practices were considered impacting the mental state domain, 38 were assigned to nutrition/hydration, 90 to environment, 220 to health, and 50 to behavior. The proposed HBWPs aim to fill existing gaps by introducing a new approach that more fully respects honey bee behavior and helps prevent unnecessary suffering for each bee and the whole beehive at the same time. Future efforts should focus on maximizing welfare benefits within the One Welfare framework, moving beyond the previously considered One Health perspective. This welfare-oriented focus benefits honey bees, supports beekeepers, and promotes environmental sustainability, aligning with the principles of One Welfare.

Life course patterns of work history and cognitive trajectories among community-dwelling older adults.

Prior research indicated that diverse work experiences in early and middle life stages are associated with cognitive function in later life. However, whether life course patterns of work history are associated with later life cognitive function in China remains unknown. Data were derived from the China Health and Retirement Longitudinal Study, and 5,800 participants aged 60 years or older were included. We used sequence analysis to identify the work history patterns between age 18 and 60. Growth curve modeling was performed to evaluate how the work-history patterns are associated with global and domain-specific (i.e., mental intactness and episodic memory) cognitive function. We identified eight work patterns, distinguished by duration, transitions, timing, and sequence of work history. Compared to individuals exposed to lifelong agricultural work, those engaged in lifelong non-agricultural employed work had better cognitive function in later life and experienced slower rates of cognitive decline in both global cognitive function and the mental intactness domain. In addition, individuals who shifted from agricultural to non-agricultural employed work early (around age 30) had better global cognitive function in later life, while the association was not significant for such a transition later (around age 50). Our study highlights the importance of the duration, sequence, and timing of transitions in work history for cognitive health among older Chinese. Future interventions and policies aimed at improving cognitive function should fully consider the cumulative and dynamic nature of work from a life course perspective.

Cyberchondria and quality of life: a cross-sectional study in Brazilian individuals

Introduction: Cyberchondria is a newly described entity in which patients recurrently search health information on the internet developing distress and suffering with the obtained information. Objective: To study cyberchondria in a sample of the Brazilian population: its association with epidemiological variables and interference with quality of life. Methods: This is a cross-sectional observational study, with 948 participants. Three questionnaires were applied through the internet: one epidemiological; the Cyberchondria Severity Scale (CSS) questionnaire and the SF-12 (12-Item Short-Form Health Survey) quality of life (QoL) questionnaire. Results: CSS was weakly and negatively correlated with the age of participants in the subscale “compulsion” (r=-0.08, p=0.01) and “distress” (r=-0.12, p<0.0001). Men had higher scores on “compulsion” (p=0.02). A weak and negative correlation was found between the subscales of “compulsion,” “distress,” “excessiveness” and “reassurance seeking” of CSS and SF-12-physical domains and the subscales of “compulsion” and “distress” with SF-12 mental domain. An independent relationship was found between the male sex (p=0.009), living in rural areas (p=0.002), having less than 10 years of formal education (p<0.0001), and earning less than 5 minimal wages/month (p=0.0002) with the subscale “mistrust of medical professional”. Conclusion: Males and younger individuals have higher levels of compulsion in the CSS than females and the elderly. Mistrust of medical professionals was less common in females, in those living in urban areas, and in those with better education and higher income. Cyberchondria interferes with mental and physical QoL.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ON STANDARDIZED FENUGREEK SEED EXTRACT COMPOSITION FOR ENDURANCE ENHANCEMENT IN RECREATIONALLY ACTIVE YOUNG SUBJECTS

Objective: To evaluate the efficacy and safety of 8-week supplementation with FEΔE (fenugreek seed extracts composition, standardized to 4-hydroxyisolecuine, trigonelline, and select glycosides) on endurance capacity in recreationally active young male subjects, in a randomized, double-blind, Placebo-controlled manner. Methods: The 153 male participants were randomized equally into three groups and received either 300 mg or 600 mg of FeΔE capsules or a matching Placebo. Each participant performed endurance exercise training four times per week and visited the study center on the day of recruitment (baseline) and end of week-4, and week-8. The efficacy outcome measures were endurance (overall, cardiovascular, respiratory, and metabolic), power, work, physical and central fatigue, and stress, whereas safety outcomes were adverse events monitoring, compliance, and biochemical laboratory measurements. Results: FEΔE supplementation (but not Placebo) showed statistically significant beneficial changes in overall (increased time to exhaustion and total distance run), respiratory (increased oxygen consumption), metabolic (increased metabolic equivalent and decreased non-esterified fatty acids levels), physical fatigue (decreased Wingate fatigue index), central fatigue (reduced visual analog score), and mental endurance (decreased mental domain score in the Multidimensional Fatigue Symptom Inventory-Short Form) during within the group (vs. baseline) comparisons. The safety outcome measures did not differ between the groups (FEΔE vs. Placebo). Conclusion: Eight weeks of FEΔE supplementation in recreationally active participants resulted in comprehensive endurance enhancement, including respiratory, metabolic, and mental endurance. FEΔE supplementation was found to be safe without serious adverse events.

Translation into Portuguese (Brazil), cultural adaptation and validation of Parathyroid Assessment of Symptoms (PAS) in patients with chronic kidney disease and hyperparathyroidism.

Chronic kidney disease (CKD) is related to high morbidity and mortality and loss of quality of life. Likewise, hyperparathyroidism is associated to progressive loss of renal function, with increased phosphate and decrease calcium levels, which induce the secretion of parathyroid hormone. To translate into Portuguese (Brazil), culturally adapt and validate the questionnaire Parathyroid Symptoms Assessment (PAS), following reliability and validity criteria in patients with chronic kidney disease and hyperparathyroidism. Methodological and cross-sectional study, carried out at São Lucas Hospital/PUCRS, Porto Alegre, Brazil. The PAS questionnaire validation process followed protocols from previous studies. After translating into Portuguese, it was applied to 100 patients with secondary (SHPT) and tertiary or persistent (THPT) hyperparathyroidism. For PAS validation data, patients responded to the Short Form Health 36 (SF-36) questionnaire. Reliability criteria were evaluated using intraclass correlation coefficient (ICC) and Cronbach's alpha (α-C). Validity was assessed by Spearman's correlation coefficient between PAS and SF-36 values. Participant's mean age was 55.6 ± 15.6 years, 61% was male, and 68% was diagnosed with SHPT. Among 100 patients, 53% performed a PAS retest (ICC = 0.83). The internal reliability by α-C was 0.86. Negative correlations were observed between PAS questions and SF-36 physical and mental domains, which ranged from 0.3 to 0.7. The Brazilian version of the PAS questionnaire was found to be valid and reliable. The PAS questionnaire can be used to evaluate quality of life in Brazilian patients with hyperparathyroidism who speak Portuguese.

Associations between momentary mental states and concurrent social functioning after remission from first episode psychosis: A HAMLETT ecological momentary assessment study.

Symptom severity and social functioning are important outcomes after first episode psychosis (FEP), yet current evidence about associations between them is inconsistent and lacks (subclinical) momentary insights. The current Ecological Momentary Assessment (EMA) study was conducted in 58 people in remission from FEP, as part of the HAMLETT (Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment) trial. At baseline, participants were prompted to report momentary mental states and social context 10x/day for eight consecutive days, including psychotic experiences (PEs), motivation/drive and negative affect, that may indicate proxies of (subclinical) psychotic, negative and general affective symptoms, respectively. We employed multilevel mixed-effects regressions to investigate associations between self-reported mental states and concurrent activity or social company and subjective appraisal thereof. We also conducted retrospective clinical assessments of symptoms (PANSS) and social functioning (WHODAS 2.0) and investigated their cross-sectional associations using multivariable linear regression. Analyses of 3101 EMA-questionnaires showed that lower motivation/drive was associated with more passive activity and less company (OR=0.96 [95%CI: 0.96; 0.97], OR=0.95 [95%CI: 0.93; 0.96], N.B. ORs per 1-point symptom-score change). PEs and negative affect were associated with more proactive activity (OR=1.02 [95%CI: 1.00; 1.03], OR=1.02 [95%CI: 1.01; 1.03]). All three mental state domains were associated with lower activity appraisal overall, though activity-specific associations differed. PEs and negative affect were associated with lower company appraisal (B=-0.25 [95%CI: -0.36; -0.14], B=-0.15 [95%CI: -0.23; -0.06]). When assessed retrospectively, only PANSS general psychopathology was associated with poorer social functioning (B=2.52 [95%CI: 1.69; 3.34]). Self-reported PEs, momentary motivation/drive and general affective symptoms are associated with daily-life functioning after remission from FEP. Retrospective observer-rated and momentary self-report assessment methods do not measure the same aspects or intensity of psychopathology.

The IMPACT Survey: the humanistic impact of osteogenesis imperfecta in adults

BackgroundThe IMPACT Survey explored the humanistic, clinical, and economic burden of osteogenesis imperfecta (OI) on individuals with OI, their families, caregivers, and wider society. Two previous publications report research methodology, initial insights of the survey, and cost of illness of OI. Here, we present data on the impact of OI on the quality of life (QoL) of adults with OI and explore potential drivers of this impact.MethodsThe IMPACT Survey was an international mixed methods online survey in eight languages (fielded July–September 2021), aimed at adults (aged ≥ 18 years) or adolescents (aged 12–17 years) with OI, caregivers (with or without OI) of individuals with OI, and other close relatives. Survey domains included demographics, socioeconomic factors, clinical characteristics, treatment patterns, QoL, and health economics. We conducted a descriptive analysis of the QoL data, as well as exploratory regression analyses to identify drivers of impact of OI on QoL (independent associations between patient characteristics and the impact on QoL).Results1,440 adults with OI participated in the survey. The proportion who reported an impact of OI on their QoL across individual areas in the physical, socioeconomic, and mental well-being domains ranged between 49 and 84%. For instance, 84% of adults reported an impact of OI on the types of leisure activities they could do and 74% on the type of job they could do. More severe self-reported OI and higher fracture frequency were consistently identified as drivers of OI’s impact on QoL. The proportion of adults who reported worrying about different aspects of their lives due to their OI, such as mobility loss, future fractures, and ageing, ranged between 31 and 97%.ConclusionIMPACT provides insights into the humanistic burden of OI on adults, revealing that OI has a substantial impact on the QoL of adults. OI severity and fracture frequency were consistently identified as drivers of impact on QoL across all domains. Understanding these drivers may aid in identifying areas for targeted interventions, such as fracture prevention.

Digital Gaming and Subsequent Health and Well-Being Among Older Adults: Longitudinal Outcome-Wide Analysis.

Digital gaming has become increasingly popular among older adults, potentially offering cognitive, social, and physical benefits. However, its broader impact on health and well-being, particularly in real-world settings, remains unclear. This study aimed to evaluate the multidimensional effects of digital gaming on health and well-being among older adults, using data from the Japan Gerontological Evaluation Study conducted in Matsudo City, Chiba, Japan. Data were drawn from 3 survey waves (2020 prebaseline, 2021 baseline, and 2022 follow-up) of the Japan Gerontological Evaluation Study, which targets functionally independent older adults. The exposure variable, digital gaming, was defined as regular video game play and was assessed in 2021. In total, 18 outcomes across 6 domains were evaluated in 2022; domain 1-happiness and life satisfaction, domain 2-physical and mental health, domain 3-meaning and purpose, domain 4-character and virtue, domain 5-close social relationships, and domain 6-health behavior. Furthermore, 10 items from the Human Flourishing Index were included in domains 1-5, with 2 items for each domain. Overall flourishing was defined as the average of the means across these 5 domains. In addition, 7 items related to domains 2, 5, and 6 were assessed. The final sample consisted of 2504 participants aged 65 years or older, with questionnaires containing the Human Flourishing Index randomly distributed to approximately half of the respondents (submodule: n=1243). Consequently, we used 2 datasets for analysis. We applied targeted maximum likelihood estimation to estimate the population average treatment effects, with Bonferroni correction used to adjust for multiple testing. Digital gaming was not significantly associated with overall flourishing or with any of the 5 domains from the Human Flourishing Index. Although initial analyses indicated associations between digital gaming and participation in hobby groups (mean difference=0.12, P=.005) as well as meeting with friends (mean difference=0.076, P=.02), these associations did not remain significant after applying the Bonferroni correction for multiple testing. In addition, digital gaming was not associated with increased sedentary behavior or reduced outdoor activities. This study provides valuable insights into the impact of digital gaming on the health and well-being of older adults in a real-world context. Although digital gaming did not show a significant association with improvements in flourishing or in the individual items across the 5 domains, it was also not associated with increased sedentary behavior or reduced outdoor activities. These findings suggest that digital gaming can be part of a balanced lifestyle for older adults, offering opportunities for social engagement, particularly through hobby groups. Considering the solitary nature of gaming, promoting social gaming opportunities may be a promising approach to enhance the positive effects of digital gaming on well-being.

Exploring Health-Related Quality of Life (HRQOL) among patients with HIV-associated TB in Khayelitsha, South Africa.

Health-related quality of life (HRQOL) is an important and frequently used patient-reported outcome in health research. However, little qualitative research exists in this field in South Africa. This study was set in Khayelitsha, one of the largest informal settlements in South Africa, where the burden of HIV and tuberculosis (TB) co-infection are amongst the highest in the world and significantly affect HRQOL. To explore the experience of HRQOL among patients living with HIV-associated TB. We conducted sixteen interviews with male (n = 10) and female (n = 6) adult participants (ages 24-56; median age 35) to explore their HRQOL living with HIV-associated TB, related treatment and how this impacted on life domains they considered relevant for HRQOL. We used thematic analysis to analyse data, using both an inductive and deductive analysis using an interpretive phenomenological approach (IPA). Experiences of HRQOL were identified along the predominantly emerging themes of physical, social, and mental aspects of HRQOL. Identified sub-themes included well-being, loss of strength, and self-care for the physical domain; usual activities and stigma for the social domain; concerns and coping for the mental domain. The findings illustrate that HRQOL domains are interconnected through social experience. The social experience of HRQOL was identified as the common denominator connecting all domains, around which HRQOL revolved for these participants. HRQOL is experienced socially. The interpersonal connections patients have with significant others present as key to high HRQOL among patients living with HIV-associated TB. This study adds to the existing literature of HRQOL and examines HRQOL using IPA which may help to inform future interventions to improve HRQOL among HIV/TB patients.

Effectiveness of telerehabilitation versus face-to-face pulmonary rehabilitation on physical function and quality of life in people with post COVID-19 condition: a systematic review and network meta-analysis.

Post COVID-19 condition (PCC) is characterized by the persistence of symptoms associated with COVID-19 infection for more than 12 weeks, with worsening quality of life and physical function deconditioning being among the most commonly reported persistent symptoms. Pulmonary rehabilitation has emerged as a safe and viable option for these patients. Administered either face-to-face (FTF) or telemedicine (TL), it has been shown to improve symptoms associated with PCC. However, little is known about which approach is best for this population. Therefore, we conducted a systematic review and network meta-analysis on the efficacy of FTF versus TL compared to usual care in improving physical function and quality of life (physical and mental) in patients with PCC. A systematic search of PubMed, Cochrane Library, and Web of Science was performed from 2020 to January 5th, 2024. Two independent reviewers performed study selection, data extraction, and risk of bias assessment; this selection included only randomized controlled trials. A network meta-analysis was performed to compare the effects of FTF and TL with usual care. Multivariate and univariate analysis were performed to evaluate the best intervention. Data were extracted from 10 studies, five of which were treated with FTF and five of which were TL, involving 765 adults with PCC, ranging in age from 22 to 66 years. Interventions consisted of isolated or combined exercises (aerobic, resistance, breathing) and lasted between three and ten weeks in most of the included studies. Multivariate analysis found that FTF produced significant differences compared to TL or usual care with moderate quality of evidence. Univariate analysis found that significant differences were only found for physical function and mental domain of quality of life for TL vs. usual care, with moderate quality of evidence. This study supports the use of FTF as a therapy to improve physical function and quality of life in patients with PCC. However, in the absence of differences between FTF and TL in the univariate model for any of the outcomes studied, the choice of the form of pulmonary rehabilitation administration should be individualized. Future studies should compare FTF with TL directly to clarify which is the best approach.

Associations Between Physical, Cognitive, and Mental Health Domains of Post-Intensive Care Syndrome and Quality of Life: A Longitudinal Multicenter Cohort Study.

To explore associations between the physical, cognitive, and mental post-intensive care syndrome (PICS) health domains with changes in health-related quality of life (HRQoL) following ICU admission. A longitudinal prospective multicenter cohort study. Patients (n = 4092) from seven Dutch ICUs. None. At ICU admission, 3 and 12 months post-ICU, patients completed validated questionnaires regarding physical health problems, cognitive health problems, mental health problems, and HRQoL. Composite scores were created for the physical health domain (physical problems and fatigue) and mental health domain (anxiety, depression, and post-traumatic stress disorder). Adjusted multivariable linear regression analyses were performed, including covariables (e.g., patient characteristics, disease severity, pre-ICU HRQoL, etc.) to explore associations between the physical, cognitive, and mental health domains of PICS and changes in HRQoL at 3 and 12 months post-ICU. At 3 months (n = 3368), physical health problems (β = -0.04 [95% CI, -0.06 to 0.02]; p < 0.001), cognitive health problems (β = -0.05 [95% CI, -0.09 to -0.02]; p < 0.001), and mental health problems (β = -0.08 [95% CI, -0.10 to -0.05]; p < 0.001) were negatively associated with changes in HRQoL. Also, at 12 months (n = 2950), physical health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001), cognitive health problems (β = -0.04 [95% CI, -0.08 to -0.01]; p < 0.015), and mental health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001) were negatively associated with changes in HRQoL. PICS symptoms in the physical, cognitive, and mental domains are all negatively associated with changes in HRQoL at 3 and 12 months post-ICU. At 3 months, PICS symptoms in the mental domain seem to have the largest negative associations. At 12 months, the associations of PICS in the mental and physical domains are the same. This implies that daily ICU care and follow-up care should focus on preventing and mitigating health problems across all three PICS domains to prevent a decrease in HRQoL.

A comparative study of comorbidities, symptom profiles, and childhood trauma in PTSD and non-PTSD trauma patients at Oslo University Hospital

Purpose To explore the differences in mental health symptom profiles, trauma profiles, childhood trauma and comorbidities in patients with PTSD and those without PTSD. Materials and methods A cross-sectional study was carried out on 110 adult patients with trauma backgrounds attending a mental health outpatient clinic in Southern Oslo, Norway. In addition to self- report questionnaires, several standardized validated diagnostic tools were used to assess mental disorders. Multiple linear regression models were used to assess the association between trauma history, the mental health symptom profile of the patients, and PTSD diagnosis. Bivariate logistic regression was used to examine if childhood trauma/adversities were associated with PTSD. Results Patients diagnosed with PTSD had significantly higher rates of comorbid major depressive disorder, panic disorder, agoraphobia disorder, and social phobia compared to those without PTSD. We also found a positive association between PTSD diagnosis and all the different mental health symptoms domains of the Symptom Checklist-90-Revised instrument. When adjusted for age, gender, education, smoking habits, immigration, relationship, and employment status, these associations persisted with varying effects. We did not find any association between PTSD and childhood trauma/adversities, however, sexual abuse trended towards an association. Conclusion Adult trauma patients with PTSD may have more comorbid disorders and mental health symptoms. Childhood trauma may be less critical for the PTSD diagnosis in this group. In clinical practice, personalized treatment plans addressing both the symptom burden and its comorbidities may be beneficial.

Modelling the factors associated with quality of life in women with osteoporosis: A cross-sectional study

BackgroundConsidering the important factors contributing to different health-related quality of life (HRQoL) subscales is essential for implementing preventive measures to increase the HRQoL among women with osteoporosis. We here evaluated the variables related to the mental and physical HRQoL in a sample of Iranian osteoporotic women. MethodsIn this cross-sectional study, the participants included 111 women with osteoporosis in 2013. Physical and mental of HRQoL were measured by the ECOS-16 questionnaire. Other variables included BMD t-score (Osteoporosis was diagnosed based on bone mineral density (BMD) with BMD t-score < −2.5), age, body mass index, educational level, marital status, duration of the disease, history of bone fracture in the past year, the number of pregnancies, and weekly walking hours. Final regression coefficients were obtained based on the total effects of estimations (decompositions of effects into direct, indirect and total effects) by structural equation model (SEM) analysis. ResultsThe mean scores of physical and mental domains of HRQoL were 54(21) and 54(25), respectively. The mean of BMD t-score was −3.2 (0.9). Based on the regression coefficients obtained in the SEM model, weekly walking hours(2.2), number of pregnancies (−1.2), and history of bone fracture in past year(−2.9) were the more important determinants of physical aspect of HRQoL than other included variables of this study. Furthermore, age over than 60 (−9.1), history of bone fracture in past year(−4.8), weekly walking hours(2.3), marital status(−5), and education level (3.9)influenced the mental aspect of HRQoL. ConclusionsSocial and life style factors tend to impact on physical and mental domains of HRQoL, a measure that is influenced by multiple factors among postmenopausal women. In this respect, these obtained factors should be considered for health planning to improve the physical and mental domains of HRQoL among postmenopausal women.

5184 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p&amp;lt;0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p&amp;lt;0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1] Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

9229 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p&amp;lt;0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p&amp;lt;0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1]Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

Frustrative Nonreward: Behavior, Circuits, Neurochemistry, and Disorders.

The surprising omission or reduction of vital resources (food, fluid, social partners) can induce an aversive emotion known as frustrative nonreward (FNR), which can influence subsequent behavior and physiology. FNR is an integral mediator of irritability/aggression, motivation (substance use disorders, depression), anxiety/fear/threat, learning/conditioning, and social behavior. Despite substantial progress in the study of FNR during the twentieth century, research lagged in the later part of the century and into the early twenty-first century until the National Institute of Mental Health's Research Domain Criteria initiative included FNR and loss as components of the negative valence domain. This led to a renaissance of new research and paradigms relevant to basic and clinical science alike. The COVID-19 pandemic's extensive individual and social restrictions were correlated with increased drug and alcohol use, social conflict, irritability, and suicide, all potential consequences of FNR. This article highlights animal models related to these psychiatric disorders and symptoms and presents recent advances in identifying the brain regions and neurotransmitters implicated.

Predictive Value of CCQ and its Subdomains for Hospitalized Exacerbations in Chronic Obstructive Pulmonary Disease: A 3-Year Observational Prospective Study.

The prediction capacity of the Clinical COPD Questionnaire (CCQ) and its functional, symptom, and mental subdomain for COPD hospitalized exacerbation were rarely studied. To examine the prognostic capacity of the total CCQ and its three subdomains for 3-year COPD hospitalized exacerbations. We analyzed the predictive ability of total CCQ score and its subdomains for hospitalized exacerbations in an observational cohort of 987 subjects with stable COPD from the RealDTC, an ongoing multicenter prospective study. Hospitalized exacerbations were prospectively collected every 6month for a maximum of 3years. The total CCQ and its functional and symptom domain, but not the mental domain, were significantly associated with 3-year hospitalized exacerbations by multivariate Cox regression analysis. The predictive capacity of functional domain was similar to that of the total CCQ, but significantly stronger than the symptom and mental domain by ROC analysis (P < 0.05). ROC curves also showed that the AUC of exacerbation history combined with CCQ functional domain was larger than that of exacerbation history alone (P < 0.0001). Additionally, the predictive value of multivariable models that contains CCQ functional domain was significantly better than the corresponding model without CCQ functional domain (P < 0.05). The total CCQ and its functional and symptom domain were independent risk factors of 3-year hospitalized exacerbations. The prognostic capacity of the functional domain was similar to that of total CCQ, and was significantly stronger than the symptom and mental domain. The CCQ functional domain was able to increase the predictive power of exacerbation history and other multivariable prediction models, indicating it may have an important role in the multivariable prediction tool for hospitalized exacerbation, and its combination with other clinical variables might be used as a low-cost approach for assessments of the disease severity and severe exacerbation in COPD patients in the future.

Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA.

This post hoc analysis of VOLTAIRE-RA compared patient-reported outcomes, including health-related quality of life (HRQoL), in patients with rheumatoid arthritis (RA) before and after treatment with biosimilar adalimumab-adbm or adalimumab reference product. HRQoL was assessed by 36-Item Short Form Survey (SF-36) Physical and Mental Component Summary (PCS and MCS, respectively) and domain scores at baseline and weeks12/24. Results were considered clinically meaningful if improvements were greater than or equal to minimum clinically important differences (MCIDs) of 2.5 for PCS and MCS and 5.0 for domain scores. Comparisons with age- and sex-matched norms and treatment-associated changes in domain scores from baseline were quantified using spydergrams and the health utility SF-6D measure. All comparisons between treatment groups were descriptive in nature. No differences in PCS scores were reported between treatment groups at baseline or weeks12/24. MCS scores slightly favored the reference product group at baseline, and differences in scores at weeks12/24 generally reflected those differences. Improvements in PCS scores greater than or equal to MCID at weeks12/24 were reported by over 65% of patients in both treatment groups, while over 56% experienced improvements in MCS scores greater than or equal to MCID at weeks12/24. Similar proportions receiving reference product and adalimumab-adbm reported scores greater than or equal to US age- and sex-matched normative values at week24: 14-39% versus 15-36%, respectively, compared with baseline (1-17%). In patients with moderate to severely active RA, adalimumab-adbm and adalimumab reference product were both associated with clinically meaningful improvements in SF-36 PCS, MCS, and domain scores that were highly similar at weeks12/24. The high proportion of patients reporting scores greater than or equal to normative values in both treatment groups is notable, as this represents a treatment goal that was difficult to achieve in earlier RA trials. Video abstract available for this article. VOLTAIRE-RA (ClinicalTrials.gov number, NCT02137226; EudraCT number, 2012-002945-40). Video abstract (MP4 29755 KB).