Mental Health Composite Scores Research Articles

Leveraging Mobile Health to Improve Capecitabine Adherence Among Women With Breast Cancer: A Pilot Randomized Controlled Trial.

Oral capecitabine improves convenience compared to intravenous therapies but presents monitoring challenges. We conducted a randomized pilot trial to evaluate a mobile health intervention to remotely monitor capecitabine adherence and patient-reported outcomes (PROs) among women with breast cancer. Patients with breast cancer prescribed capecitabine, an oral chemotherapy with a complex, cyclical regimen, were randomly assigned to enhanced usual care (EUC) or PRO arm. Participants were asked to use a smart pill bottle to measure adherence (timing and dose) and complete baseline and 90-day follow-up surveys. PRO participants received text messages for missed or incorrect doses and weekly text-based symptom assessments, and their oncologists received alerts for severe symptoms or missed doses. We compared nonadherence (<80%) and changes from enrollment to follow-up on reported physical and mental health quality-of-life scores and number of severe symptoms by study arm. Overall, 32 women were randomly assigned (17 EUC and 15 PRO): 28 (87.5%) received the intervention and 24 (78.1%) completed the follow-up survey. Among participants who received the intervention, PRO participants responded to 83.3% of symptom questions; 7.7% of PRO participants were nonadherent compared with 40.0% of EUC participants (P = .049). Among those who completed the follow-up survey, 12.5% of PRO participants had reductions in their mental health composite scores compared with 69.2% of EUC participants (P = .011); 10% of PRO participants had more severe symptoms at follow-up compared with 57.1% of EUC participants (P = .019). A mobile health intervention using text message reminders and symptom assessments improved medication adherence and mental health quality-of-life scores and lowered symptom burden of patients with breast cancer prescribed capecitabine. Future work should evaluate the longer-term impacts of this intervention.

Analysis of disease burden in patients with hereditary angioedema from Japan by patient-reported outcomes.

Hereditary angioedema (HAE) symptoms can vary greatly. Disease burden evaluation is essential for providing adequate treatments for patients. Patient-reported outcome measures (PROMs), including the 12-Item Short Form Health Survey (SF-12), the Angioedema Quality of Life (AE-QoL), the Hospital Anxiety and Depression Scale (HADS), and the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaires, were collected in 2021, before modern medications for long-term prophylaxis (LTP) of HAE were licensed in Japan. Patients also reported their HAE attack frequency as "annual" (several attacks annually), "monthly" (several attacks monthly) or "weekly" (several attacks weekly). Multiple linear regression analyses were conducted on the relationship between independent parameters (sex, age, attack frequency, HAE type, and HADS scores) and dependent parameters (AE-QoL and SF-12 scores). Fifty-four patients reported PROMs. All PROMs showed substantial health-related quality of life (HRQoL) impairment. Overall, the higher the attack frequencies, the greater the reported impairment in the PROMs tended to be. In multiple linear regression analyses, higher AE-QoL Fatigue/Mood and Fears/Shame domain scores (greater impairment) were associated with higher HADS anxiety subscale scores; higher AE-QoL total scores (greater HRQoL impairment) and lower SF-12 Physical and Mental Health Composite scores (greater general health impairment) were associated with higher HADS depression subscale scores. Patients with monthly or weekly HAE attacks reported numerically low absenteeism and numerically high presenteeism and work productivity loss as measured by the WPAI:SHP questionnaire. In this study, conducted before modern LTP options were available in Japan, patients with HAE reported notable impairment in HRQoL and work productivity. Weekly or monthly HAE attack frequencies were associated with a high disease burden. Furthermore, a substantial number of patients reported notable fatigue/mood impairment as measured by the AE-QoL and depression as measured by the HADS regardless of attack frequency. These results provide a basis for future studies evaluating the effect of LTP on the clinical manifestations and HRQoL in patients with HAE.

A novel multisite model to facilitate hepatitis C virus elimination in people experiencing homelessness

Background/aims: Only a handful of countries are on target to achieve hepatitis C virus (HCV) elimination by 2030. People experiencing homelessness (PEH) remain an important HCV reservoir. The END C study evaluated clinical, patient reported and health economic outcomes of a decentralised integrated model. MethodsThis prospective study assessed a decentralised regional service based at multiple homeless sites in southeast England. Novel linkage-care strategies were utilised. We assessed generic and liver specific health-related quality of life (HRQoL) (SF-12v2; EQ-5D-5L and SFLDQol) pre/post HCV treatment and cost per HCV case detected and cured. Primary outcome was intention-to-treat (ITT) sustained virological response (SVR12). ResultsWe recruited 418 individuals, mean age 44.45 ± 10.6, 78% were male, 74% being currently homeless, current injecting drug use/alcohol use being 25% and 65% respectively. Prevalence of cirrhosis (liver stiffness measurement >12kPa) was 12%. Twenty-eight percent (n=116) were HCV PCR positive, of whom n=105 received direct acting antiviral treatment. ITT SVR12 rates were 81% (95% CI 72%-88%), the only predictor of SVR12 being >80% treatment adherence (OR 20.69, 95% CI 6.227-68.772, p<0.001). HRQoL improved significantly after SVR12: SF-12v2 (General Health, Mental Health, Social Functioning, Mental Health Composite Score p<0.049); SFLDQoL (Symptoms/Effects of Liver Disease, Distress, Loneliness p<0.004) and EQ-5D-5L (Index Score, Visual Analog Scale p<0.001). Costs (British pound 2022) per HCV case detected and per case cured were £359 and £257 respectively. Reinfection rates were 6.82/100 person years. ConclusionThe END C study endorses a multisite decentralised service for PEH enabling excellent linkage to care, high SVR12 rates and significant improvements in generic and liver specific HRQoL, all being achieved at modest costs. Such services are paramount to help achieve HCV elimination. Impact and implicationsIn people experiencing homeless, we found a high prevalence of HCV, alcohol and substance misuse including overdoses and mental health issues. Despite this, an integrated and decentralised service resulted in excellent linkage to care with high SVR12 rates. Even in this complex cohort with multiple comorbidities, SVR12 was associated with significant improvements in both generic and liver specific health-related quality of life. This was all achieved at modest costs in a community setting. Such models of care are feasible, easy to replicate and essential if we are to achieve HCV elimination.

Health-related Quality of Life following Mild (COVID)-19 Illness

Objectives: A cluster analysis was undertaken to help explain reported differences in health-related quality of life among acute respiratory illness (ARI) outpatients. Methods: Symptomatic enrollees (18-87 years) completed the Short Form Health Survey at enrollment and 6-8 weeks later from March 30, 2020 through April 30, 2021. We compared changes in physical health composite score (PCS) and mental health composite score (MCS) across high, medium, and low functioning clusters within COVID-19 cases and non- COVID cases by multivariable regression. Results: Improvements in PCS and MCS among 973 participants were significantly and inversely related to high function at enrollment in both COVID-19 and in non-COVID cases. PCS improvements also were related to more days between surveys and having shortness of breath (SOB) at enrollment in COVID-19 cases, and to younger age and higher educational attainment among non-COVID cases. Improvements in MCS were related to higher educational achievement and older age and inversely related to SOB at enrollment in COVID-19 cases; in non-COVID cases, increases in MCS were significantly related to being male, time between surveys, and inversely related to SOB at enrollment. Conclusion: High functioning COVID-19 cases and non-COVID cases reported smaller improvements in PCS than lower functioning groups. Not experiencing SOB was related to greater improvements in MCS.

Influence of Education, Cognition, and Physical Disability on Quality of Life of Romanian Patients with Multiple Sclerosis-A Cohort Study.

Background and Objectives: objective measures of disability and neurological impairmentare used to search for disease activity and monitor disease evolution in multiple sclerosis (MS). These are sometimes in disagreement with subjective quality-of-life measures. We aimed to establish the relations between the Multiple Sclerosis Quality of Life instrument (MSQOL-54) and objective measures of neurological impairment. Materials and Methods: 107 patients with MS were evaluated with the Single Digit Modalities Test (SDMT) for cognition, Nine Holes Peg Test (9HPT) for upper limb function, 25 Feet Walk Test (25FWT) for gait, and EDSS for global disability in a cohort study. Age and education level were recorded as sociodemographic factors. Results: the median EDSS was 3.5 (IQR 2.5); average SDMT score was 30.38 ± 13.54; and 9HPT speed was significantly higher for the dominant upper limb (0.3 ± 0.1 pegs/s versus 0.28 ± 0.11 pegs/s) (p = 0.016). The mental health composite score of the MSQOL-54 correlated with the SDMT, education level, and EDSS. Education level correlated with cognition and quality of life. The physical health composite score of the MSQOL-54 correlated with motor-function parameters and with SDMT. The motor-function parameters correlated well among themselves. A linear regression model found an important influence of SDMT and education level on the mental health composite score of the MSQOL-54. Although the linear regression model predicting the physical health composite score from physical disability parameters was statistically sound, none of the determinants had a significant individual influence. Conclusions: the subscores of the MSQOL-54 correlated well with the objective parameters. The strongest correlations were those with the cognitive function. Correlations with physical disability were less powerful, probably reflecting their indirect and more limited influence on quality of life compared to cognition and perception of disability.

Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.

Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL). To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS. Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed. MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1-2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed. CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.

Positive maternal mental health during pregnancy and psychiatric problems in children from early childhood to late childhood.

Negative maternal mental health during pregnancy increases the risk of psychiatric problems in children, but research on the potential benefits of positive maternal mental health during pregnancy is scarce. We investigated associations between positive maternal mental health composite score, based on reports of maternal positive affect, curiosity, and social support during pregnancy, and children's psychiatric problems (Child Behavior Checklist) at ages 1.9-5.9 and 7.1-12.1 years among 2636 mother-child dyads of the Prediction and Prevention of Preeclampsia and Intrauterine Growth Restriction study. For each standard deviation higher positive maternal mental health score during pregnancy, total psychiatric problems were 1.37 (95% confidence interval (CI) -1.79,-0.95) t-scores lower in early childhood and 1.75 (95% CI -2.24,-1.26) t-scores lower in late childhood. These associations were independent of covariates and of negative maternal mental health. Total psychiatric problems remained stably lower from early childhood to late childhood in children of mothers with higher positive mental health during pregnancy, whereas they increased in children of mothers with lower positive mental health. Positive maternal mental health in child's late childhood partially mediated the effects of positive maternal mental health during pregnancy on children's psychiatric problems. Supporting positive maternal mental health may benefit mothers and children.

Associations of effort-reward imbalance at work and quality of life among workers after stroke: a one-year longitudinal study in Thailand

Stroke incidence is increasing among working-age population, but the role of psychosocial stress in the workplace in predicting quality of life (QoL) after stroke onset is understudied. This longitudinal study aimed to investigate the relationship between work stress, measured by the effort-reward imbalance (ERI) model, and QoL over one-year period among 103 Thai workers who had experienced a stroke. The study evaluated the effort (E)-reward (R) ratio and over-commitment, the extrinsic and intrinsic components of the ERI model, before discharge; QoL was repeatedly measured at baseline, six months, and 12 months after discharge, respectively, using the Short Form Version 2 (SF-12v2) indicators of physical and mental health composite scores. Generalized estimating equations were used to examine longitudinal relationships between work stress at baseline and QoL over one year by testing the hypotheses that E-R ratio and over-commitment would have direct effects on QoL, and potential moderating effects of over-commitment on E-R ratio and QoL. The results supported the ERI model partially, as over-commitment was significantly associated with poor mental health (coefficient − 8.50; 95% CI: -13.79, -3.20) after adjusting baseline sociodemographic, behavioral, and clinical characteristics, while the E-R ratio was not significantly associated with physical or mental health; the interaction between the E-R ratio and over-commitment was also not significant. These findings suggest that more attention should be paid to workers’ personal coping skills and ability to handle work-related problems and prioritize interventions that address over-commitment to promote long-term mental health among workers with stroke.

Partners of persons with severe swallowing dysfunction have significantly reduced mental health.

Dysphagia can result in malnutrition, dehydration, social isolation, depression, pneumonia, pulmonary abscess, and death. The effect of dysphagia on the health and quality of life (QOL) of the life partners of persons with dysphagia is uncertain. We hypothesize that the partners of individuals with significant dysphagia will experience a significant reduction in quality of life. To evaluate the QOL of the significant others of persons with swallowing dysfunction. Persons with significant swallowing dysfunction (defined as EAT10® > 10) and their significant others were prospectively administered the 10-item Eating Assessment Tool (EAT10®) patient-reported outcome measure and the 12-item SF quality of life instrument (SF12). Summary data from the 8 mean health domains were compared between patients and their significant others. Mean scores for each domain are calibrated at 50, and a score below 47 implies significantly diminished QOL for a particular domain. Twenty-three couples were evaluated. The mean ± SD EAT10 score for persons with significant dysphagia was 21 ± 7; mean EAT10 for their significant others or for couples in the control group was 0.3 ± 0.8. The mean physical health composite score (PCS) was significantly lower for patients with dysphagia compared to their significant others (39.1 ± 10 and 46.2 ± 11, respectively) (p < 0.05). Both patients and their significant others had comparable mean mental health composite scores (MCS) of 46.6 ± 10 and 46.4 ± 10, respectively (p > 0.05). Although significant others of persons with swallowing dysfunction have higher physical well-being than their partners, they exhibit the same reduction in mental well-being, which is significantly lower than the general population. The data suggest that clinicians should address the mental well-being of the partners of persons with severe swallowing dysfunction.

The Subglottic Stenosis 6 Questionnaire: A Novel Quality-of-Life Survey Validated to Predict Need for Intervention in Patients With Idiopathic Subglottic Stenosis

Idiopathic subglottic stenosis (iSGS) is a recurrent, chronic disease defined by fibroinflammatory narrowing of the subglottic airway. A key challenge in treatment is monitoring disease progression, which may be debilitating and unpredictable in its timing. Can the Subglottic Stenosis 6 (SGS-6) questionnaire be validated as a novel quality-of-life (QOL) instrument to monitor breathing, disease progression, and disease severity proactively in patients with iSGS? Panel data from 51 patients with iSGS were collected from January 2012 through June 2022, representing 1,684 patient encounters including routine office visits and treatment encounters. Subjective QOL scores (including the novel SGS-6 and established RAND-36 and EuroQol Five Dimensions [EQ-5D] Visual Analog Scale) and objective pulmonary function test (PFT) results were collected at each visit. Subjective SGS-6 QOL scores were repeated within 1week of initial reporting. Panel regression analyses were performed to assess the relationship between SGS-6 scores, PFT results, and a patient's need for intervention. Minimal clinically important differences (MCIDs) for SGS-6 and peak expiratory flow percentage (PEF%) were assessed using receiver operating characteristic (ROC) curve analysis and a patient's need for intervention as the external anchor. Each one-point increase in SGS-6 score (of a maximum of 27) was associated with a 3.26%decrease in PEF%, a 1.93-point decrease in RAND-36 Physical Health composite score, a 1.27-point decrease in RAND-36 Mental Health composite score, and a 0.88-point decrease in EQ-5D Visual Analog Scale score. The intracorrelation coefficient for the SGS-6 composite score is 0.838 (95%CI, 0.770-0.888). Compared with patient baselines, SGS-6 scores were 4.66 points greater at the time of intervention with an MCID of 2.25 from a patient's baseline. The area under the ROC curve for SGS-6 and a patient's intervention point was 0.81. iSGS disease severity can be modeled using the SGS-6 questionnaire, offering physicians and patients a potentially new method of tracking disease progression and need for intervention remotely.

Poster 367: Is Mental Health a Predictor of Worse One-Year PROMs in Arthroscopic Surgery: Prospective Cohort Study

Objectives: Mental health is a potential risk factor for worse patient-reported outcomes measures (PROMs) of pain, function, and quality of life across surgical disciplines. With poorer mental health being a risk factor for worse PROMs. In the orthopaedic literature, greater emphasis is being placed on understanding the role mental health has on postoperative outcomes. This has not, however, been extensively explored across all sports medicine arthroscopic surgeries. Furthermore, there is a paucity of data collected from cohorts that control for confounding variables with multivariate analysis. As such, we had the unique opportunity in the orthopaedic Outcome Measurement Evaluation system (OME) cohort to evaluate mental health (mental health composite (MCS) score in VR-12) in arthroscopic procedures of the hip, knee, and shoulder. We hypothesize that worse MCS scores (lower mental health) would be a predictor of worse PROMs in Rotator Cuff Repair, Shoulder Instability, Hip Arthroscopy, Arthroscopic Partial Meniscectomy, and ACLR. Methods: We performed an internal review of all prospective studies from the Orthopaedic Outcome Measurement Evaluation system (OME) prospective cohort where multivariate analysis for 1-year patient-reported outcome measures (PROMs) was performed. OME is a cost-effective, scientifically valid, scalable electronic system for collecting PROMs and clinical information surrounding an episode of care. OME leverages the Research Electronic Data Capture (REDCap) database for structured data storage and Health Insurance Portability and Accountability Act (HIPAA) compliance and augments it with additional functionality for multimodal communication with patients and surgeons. Mental health was evaluated with the Veterans RAND 12-Item Health Survey (VR-12), which provides a Mental Component Summary (MCS) score. Selected PROMs (Tables 1 and 2) included those that assess pain and function as well as achievement of a patient-acceptable symptom state (PASS). Results: We identified 5 studies that met our inclusion and exclusion criteria (Table 1). Baseline MCS was found to be predictive of statistically significant improvements in 1-year pain and function PROMs for arthroscopic partial meniscectomy, hip arthroscopy, and rotator cuff repair (p&lt;0.05), but not for shoulder instability surgery (Table2). Baseline MCS was not found to be predictive of achievement of a PASS for anterior cruciate ligament reconstruction see (Table 2). Conclusions: Our findings demonstrate that MCS is potentially modifiable risk factor for worse PROMs in several of the most common arthroscopic sports medicine procedures being performed. The potentially modifiable risk factor warrants further evaluation to improve outcomes of these common arthroscopic procedures. These could involve randomized control trials that aim to improve preoperative or immediately postoperative MCS in at-risk individuals to determine whether this can lead to a minimal clinically important difference in PROMs. [Table: see text][Table: see text]

Psychometric properties and general population reference values for PROMIS Global Health in Hungary

ObjectivesPatient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) is a widely used generic measure of health status. This study aimed to (1) assess the psychometric properties of the Hungarian PROMIS-GH and to (2) develop general population reference values in Hungary.MethodsAn online cross-sectional survey was conducted among the Hungarian adult general population (n = 1700). Respondents completed the PROMIS-GH v1.2. Unidimensionality (confirmatory factor analysis and bifactor model), local independence, monotonicity (Mokken scaling), graded response model fit, item characteristic curves and measurement invariance were examined. Spearman’s correlations were used to analyse convergent validity of PROMIS-GH subscales with SF-36v1 composites and subscales. Age- and gender-weighted T-scores were computed for the Global Physical Health (GPH) and Global Mental Health (GMH) subscales using the US item calibrations.ResultsThe item response theory assumptions of unidimensionality, local independence and monotonicity were met for both subscales. The graded response model showed acceptable fit indices for both subscales. No differential item functioning was detected for any sociodemographic characteristics. GMH T-scores showed a strong correlation with SF-36 mental health composite score (rs = 0.71) and GPH T-scores with SF-36 physical health composite score (rs = 0.83). Mean GPH and GMH T-scores of females were lower (47.8 and 46.4) compared to males (50.5 and 49.3) (p < 0.001), and both mean GPH and GMH T-scores decreased with age, suggesting worse health status (p < 0.05).ConclusionThis study established the validity and developed general population reference values for the PROMIS-GH in Hungary. Population reference values facilitate the interpretation of patients’ scores and allow inter-country comparisons.

PCR184 Impact of COVID-19 Symptoms on Patients' Health-Related Quality of Life

This study examined the impact of COVID-19 symptoms on overall patient health-related quality of life outcome among adults currently experiencing COVID-19. Data on 4,706 US adults currently experiencing COVID-19 symptoms were analyzed from the 2022 National Health and Wellness Survey. Analysis included 26 symptoms of COVID asked in the survey, as well as duration of each symptom in weeks. Patient health-related quality of life at the time of the survey was measured by the RAND 36-Item Health Survey 1.0 Questionnaire. Specifically, Physical Health Composite (PHC) score and the Mental Health Composite (MHC) score were outcomes of interest. Correlation tests were done to evaluate which symptoms or duration of symptoms were highly correlated with lower MHC and PHC scores. XGBoost regression model will be run as the next step to select top important features. Mean PHC and MHC scores were 37.78 and 36.11, respectively. Changes in color of skin/lips/nails was most strongly correlated with lower PHC scores, followed by persistent pain or pressure in the chest, and pink eye (Spearman rho = -0.19, -0.14, -0.12, respectively; all p<0.001). Anxiety/depression was most strongly correlated with lower MHC scores, followed by mood changes, and inability to wake or stay awake (Spearman rho = -0.20, -0.14, -0.11, respectively; p<0.001). However, duration of symptoms experienced were found to have stronger correlations with outcomes. Duration of pink eye, sore throat, and fever or chills were most strongly correlated with lower PHC scores (Pearson rho = -0.47, -0.46, and -0.39; all p<0.001) as well as lower MHC scores (Pearson rho = -0.26, -0.34, -0.30; all p<0.001). Duration of COVID-19 symptoms experienced were found to have stronger correlations with PHC and MHC scores compared to the type of symptoms experienced. Duration of pink eye, sore throat and fever or chills were most strongly correlated with lower health outcomes.

Effect of mild COVID-19 on health-related quality of life

BackgroundLittle is known about the effects of a mild SARS-CoV-2 infection on health-related quality of life. MethodsThis prospective observational study of symptomatic adults (18–87 years) who sought outpatient care for an acute respiratory illness, was conducted from 3/30/2020 to 4/30/2021. Participants completed the Short Form Health Survey (SF-12) at enrollment and 6–8 weeks later, to report their physical and mental health function levels as measured by the physical health and mental health composite scores (PHC and MHC, respectively). PHC and MHC scores for COVID-19 cases and non-COVID cases were compared using t-tests. Multivariable regression modeling was used to determine predictors of physical and mental health function at follow-up. ResultsOf 2301 enrollees, 426 COVID-19 cases and 547 non-COVID cases completed both surveys. PHC improved significantly from enrollment to follow-up for both COVID-19 cases (5.4 ± 0.41; P < 0.001) and non-COVID cases (3.3 ± 0.32; P < 0.001); whereas MHC improved significantly for COVID-19 cases (1.4 ± 0.51; P < 0.001) and decreased significantly for non-COVID cases (−0.8 ± 0.37; P < 0.05). Adjusting for enrollment PHC, the most important predictors of PHC at follow-up included male sex (β = 1.17; SE = 0.5; P = 0.021), having COVID-19 (β = 1.99; SE = 0.54; P < 0.001); and non-white race (β = −2.01; SE = 0.70; P = 0.004). Adjusting for enrollment MHC, the most important predictors of MHC at follow-up included male sex (β = 1.92; SE = 0.63; P = 0.002) and having COVID-19 (β = 2.42; SE = 0.67; P < 0.001). ConclusionBoth COVID-19 cases and non-COVID cases reported improved physical health function at 6–8 weeks’ convalescence; whereas mental health function improved among COVID-19 cases but declined among non-COVID cases. Both physical and mental health functioning were significantly better among males with COVID-19 than females.

Weight regain and mental health outcomes following behavioural weight management programmes: A systematic review with meta-analyses.

Behavioural weight management programmes (BWMPs) lead to weight loss but subsequent weight regain may harm mental health outcomes. We searched for randomised trials of BWMPs in adults with overweight/obesity with follow-up ≥12 months from baseline that measured weight change both at and after programme-end. We included only studies reporting mental health at or after programme-end. We meta-analysed changes in various mental health outcomes using a random-effects model by nature of the comparator group and by time since programme end. Subgroup analysis explored heterogeneity. We used mixed models and meta-regression to analyse the association between change in weight and change in depression and/or anxiety over time, with higher scores indicating greater depression and/or anxiety. We included 47 studies. When comparing BWMPs (diet and/or exercise) to control, most estimates included the possibility of no difference, but pooled estimates for psychological wellbeing, self-esteem and mental-health composite scores at programme-end, anxiety at 1-6months, and depression at 7-12 months after programme-end suggested improvements in intervention arms relative to control, with 95% CIs excluding no difference. Pooled estimates found no evidence that BWMPs harmed mental health at programme end or beyond. Mental health composite scores at programme-end favoured diet and exercise interventions over diet alone, with 95% CIs excluding no difference. All other measures and timepoints included the possibility of no difference or could not be meta-analysed due to high heterogeneity or a paucity of data. Mixed models and meta-regression of the association between change in depression and/or anxiety scores over time, and change in weight, were inconclusive. Despite weight regain after BWMPs, our meta-analyses found no evidence of mental health harm and some evidence that BWMPs may improve some dimensions of mental health at and after programme-end.

570 FRAILTY AND DISABILITY IN OLDER PATIENTS AND THE EFFECTS OF APIXABAN ON QUALITY OF LIFE AND DEPRESSIVE SYMPTOMS. THE EXPERIENCE OF THE APULEIO STUDY

Abstract Introduction The APULEIO study was designed to describe the psychological effects of apixaban in Italian elderly patients with non-valvular atrial fibrillation (NVAF), deep vein thrombosis (DVT) or pulmonary embolism (PE). The existence of implications of treatment on health-related quality of life (HRQL) and mood is among the most important knowledge gaps in cardiovascular care of older subjects. Real-world data on these issues, essential to improve therapy adherence, are lacking. Aim of the present analysis was to evaluate the presence of a different response to oral anticoagulation in the disabled, frail and robust subjects enrolled in the study. Methods APULEIO was a multicenter, prospective, observational study including apixaban eligible patients. The 12-Item Short Form Health Survey (SF-12), the Beck Depression Inventory-II (BDI-II) and the Frail non-Disabled (FiND) questionnaire were used to evaluate, respectively, HRQL, depressive symptoms and the presence of disability and frailty. The findings of the baseline and the 6-month evaluation - end of the study - will be presented. Results Overall, 376 patients had complete data. Of these, 163 (43.4%), 111 (29.5%) and 102 (27.1%) subjects were, respectively, defined disabled, frail and robust. No differences for reason to anticoagulate were observed by FiND category (p=0.797; overall, AF: 77.1%; DVT/PE: 22.9%). Patients with disability were older (Disabled – D: 79±11; Frail - F: 72±12; Robust – R: 72±12 years; p&amp;lt;0.0001), more frequently women (D: 66.9; F: 43.2; R: 24.5%; p&amp;lt;0.0001), with a greater clinical complexity, as expressed by the CHA2DS2-VASc score (D: 4.3±1.5; F: 3.2±1.5; R: 2.9±1.6; p&amp;lt;0.0001), and showed a higher heart rate (D: 82±17; F: 77±14; R: 77±15 bpm; p=0.0414). BMI (overall, 27.5±4.7 Kg/m2; p=0.328), left ventricular ejection fraction (overall, 53±10%; p=0.453), and systolic (overall, 129±15 mmHg; p=0.219) and diastolic (overall, 76±10 mmHg; p=0.285) arterial pressure were similar among groups. The incidence of any adverse event was higher in those with disability (D: 14.1; F: 8.1; R: 3.9%; p=0.0190), but the proportion of those with serious adverse events was similar among categories (overall, 6.9%; p=0.105). When studying HRQL, at enrollment, the Physical Health composite score of the SF-12 was significantly different among groups (D: 32.7±7.9; F: 42.4±9.3; R: 45.6±8.0; p&amp;lt;0.0001). At the 6-month evaluation (D: 37.0±10.1; F: 43.9±8.8; R: 47.2±7.3; p&amp;lt;0.0001), only the improvement for disabled subjects was significant (p=0.0020). At Baseline, the Mental Health composite score of the SF-12 was lower in disabled and frail patients, when compared to robust ones (D: 46.8±9.8; F: 47.7±9.2; R: 51.4±8.6; p&amp;lt;0.0001). After 6 months, once again, only the improvement for disabled subjects (D: 37.0±10.1; F: 43.9±8.8; R: 47.2±7.3; p=0.0004) was significant (p&amp;lt;0.0001) and statistically greater than that observed for frail and robust patients. Regarding depressive symptoms, at enrollment, the BDI-II score was worse in the disabled and frail groups (D: 14.7±9.8; F: 9.0±8.1; R: 4.7±4.5; p&amp;lt;0.0001). At the 6-month assessment, it was possible to observe an improvement (D: 10.5±8.5; F: 6.8±7.8; R: 4.2±4.5; p&amp;lt;0.0001) in disabled (p&amp;lt;0.0001) and frail subjects (p=0.0112), but not in robust ones (p=0.1705). Conclusions The APULEIO study demonstrates that disability and frailty are common conditions in older subjects anticoagulated for AF and DVT/PE. Disabled patients present a higher clinical complexity than frail and robust ones. After 6 months of therapy, the use of apixaban is associated with a significant improvement of HRQL in disabled individuals and of depressive symptoms in disabled and frail ones. No changes were found in robust subjects. No differences by group were observed in the incidence of serious adverse events. These findings confirm the efficacy and safety of apixaban also when applying a multidimensional approach to high-risk geriatric populations.

Assessment of Health-Related Quality of Life, Medication Adherence, and Prevalence of Depression in Kidney Failure Patients.

Kidney failure is a global health problem with a worldwide mean prevalence rate of 13.4%. Kidney failure remains symptomless during most of the early stages until symptoms appear in the advanced stages. Kidney failure is associated with a decrease in health-related quality of life (HRQOL), deterioration in physical and mental health, and an increased risk of cardiovascular morbidity and mortality. This study aimed to evaluate the factors associated with decreased HRQOL and other factors affecting the overall health of patients. Another objective was to measure how medication adherence and depression could affect the overall HRQOL in patients with kidney failure. The study used a prospective follow-up mix methodology approach with six-month follow-ups of patients. The participants included in the study population were those with chronic kidney disease grade 4 and kidney failure. Pre-validated and translated questionnaires (Kidney Disease Quality of Life-Short Form, Hamilton Depression Rating Scale Urdu Version, and Morisky Lewis Greens Adherence Scale) and assessment tools were used to collect data. This study recruited 314 patients after an initial assessment based on inclusion criteria. The mean age of the study population was 54.64 ± 15.33 years. There was a 47.6% male and a 52.4% female population. Hypertension and diabetes mellitus remained the most predominant comorbid condition, affecting 64.2% and 74.6% of the population, respectively. The study suggested a significant (p &lt; 0.05) deterioration in the mental health composite score with worsening laboratory variables, particularly hematological and iron studies. Demographic variables significantly impact medication adherence. HRQOL was found to be deteriorating with a significant impact on mental health compared to physical health. Patients on maintenance dialysis for kidney failure have a significant burden of physical and mental symptoms, depression, and low HRQOL. Given the substantial and well-known declines in physical and psychological well-being among kidney failure patients receiving hemodialysis, the findings of this research imply that these areas related to health should receive special attention in the growing and expanding population of kidney failure patients.

The effects of incontinence on functionality, disability, and quality of life in male and female patients with multiple sclerosis

PurposeTo determine the effects of incontinence on male and female patients with multiple sclerosis in terms of functionality, disability, and quality of life. MethodsThe study included 90 patients (45 male, 45 female) with multiple sclerosis (MS) with a median age of 37 years. After recording the sociodemographic characteristics, urinary incontinence was evaluated in terms of quality of life with the International Consultation of Incontinence Questionnaire-Short Form (ICIQ-SF), overactive bladder symptoms with Overactive Bladder Questionnaire-V8 (OAB-V8), quality of life with Multiple Sclerosis Quality of Life Questionnaire-54 (MSQOL-54), and function was evaluated with the Lower Extremity Functional Scale (LEFS). ResultsThe demographic and clinical features, types of incontinence, total and sub-dimensions of ICIQ-SF, LEFS, OAB-V8, MSQOL-54 were determined to be similar in both males and females with MS (p>0.05). The education level of males was higher than that of females (p<0.05). A positive correlation was found between the mean LEFS score and MSQOL-total, MSQOL-PHC(physical health composite) and MSQOL-MHC(mental health composite) scores, and a negative correlation was found between the mean LEFS score and the ICIQ-SF and OAB-V8 scores (p<0.05). ConclusionUrinary incontinence, overactive bladder and lower extremity functionality may be similar in males and females with MS. It should not be ignored that lower extremity functionality may negatively affect incontinence symptoms.

Can Personalization or Creativity Reduce Banner Blindness?

<h3>Introduction</h3> Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations. <h3>Methods and analysis</h3> The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context. <h3>Ethics and dissemination</h3> This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners. <h3>Trial registration number</h3> ISRCTN19193075

Subjective age and its relationships with physical, mental, and cognitive functioning: A cross-sectional study of 1,004 community-dwelling adults across the lifespan

Perceived younger age is associated with positive health outcomes in existing literature. Few studies have examined these associations using a wide range of variables in large sample of adults of all ages. The objective of present study was to characterize the discrepancy between chronological age (CA) and subjective age (SA) in a large sample of community-dwelling adults across the lifespan, investigate associations with mental, physical, and cognitive health, and examine how it is related to a broad array of psychosocial variables relevant to well-being. Cross-sectional data from 1,004 individuals aged 21–100+ years from the Successful AGing Evaluation (SAGE) study were used for this analysis. Data included self-report measures of physical health (SF-36 – Physical Component), mental health composite score (created using CES-D Happiness scale, Satisfaction with Life Scale, SF-36 Mental Component, Brief Symptom Inventory Anxiety Scale, Patient Health Questionnaire-9, and Perceived Stress Scale), Telephone Interview for Cognitive Status - modified (TICS-m), and validated measures of various positive psychological variables such as meaning in life and optimism. On average, SA was 11.5 years younger than CA (SD 11.3). The discrepancy increased with CA. A younger SA compared to CA was associated with better mental and physical health in all age groups and was positively associated with measures of presence of meaning in life, successful aging, optimism, personal mastery, resilience, curiosity, hope, and social support. The association between age discrepancy and cognitive functioning was not statistically significant. These findings indicate that SA is potentially valuable for the purposes of clinical assessment and intervention, and this possibility should be investigated in future research.