Mental Health Summary Scores Research Articles

Cognitive performance, mental health, and quality of life in β-thalassemia individuals: a comprehensive analysis

IntroductionBeta-thalassemia is a prevalent autosomal recessive haemolytic disorder, particularly in the Middle East. Patients with beta-thalassemia major (βTM) require iron chelation therapy and regular blood transfusions, while those with beta-thalassemia intermedia (βTI) exhibit milder symptoms. This study aimed to evaluate cognitive function, behavioural problems, quality of life, and related aspects in individuals with βTM and βTI.MethodsThe cross-sectional study included 20 βTM participants, 20 βTI participants, and 19 healthy controls. Participants underwent psychiatric interviews, the Wechsler Adult Intelligence Scale (WAIS-III), Symptom Checklist-90 Revised (SCL-90R), and Short-Form Health Survey (SF-36). Clinical data and laboratory investigations were also collected.ResultsβTM participants exhibited lower vocabulary and picture completion scores on the WAIS-III compared to other groups. βTI participants had significantly higher scores on SCL-90R subscales for somatization, depression, anxiety, paranoid ideation, and psychoticism. Both patient groups reported poorer quality of life across all SF-36 domains compared with controls. Longer disease duration correlated with lower levels of somatization, interpersonal sensitivity, depression, anxiety, and paranoid ideation. Less frequent blood transfusions were associated with better physical and mental health summary scores but also higher somatization. Elevated serum iron levels corresponded with increased anxiety, hostility, and psychoticism symptoms, while higher serum ferritin related to more obsessive–compulsive behaviours but less somatization and psychoticism.ConclusionsIndividuals with thalassemia exhibit cognitive deficits, psychological disturbances, and diminished quality of life, with distinct patterns depending on disease severity. Regular monitoring and appropriate interventions are crucial for optimizing their overall well-being and functioning.

Impact of arterial stiffness on health-related quality of life in older Thai adults with treated HIV infection: a multicenter cohort study.

Despite advancements in antiretroviral therapy (ART) that extend life expectancy, older adults with HIV (OAHIV) face elevated cardiovascular disease risks. This study examines the impact of arterial stiffness on health-related quality of life (HRQoL) among OAHIV in rural Northern Thailand. We conducted a 5-year prospective cohort study from 2015, including 338 OAHIV aged ≥ 50 without prior cardiovascular disease who received ART in 12 community hospitals in Chiang Mai. Arterial stiffness was assessed using Cardio-Ankle Vascular Index (CAVI), with values ≥ 8 indicating significant stiffness. HRQoL was measured using the MOS-HIV Health Survey at baseline, one year, and five years. Analysis adjusted for HIV/AIDS severity, cardiovascular comorbidities, and socioeconomic factors. Elevated CAVI (≥ 8) was associated with lower HRQoL scores. The elevated CAVI group showed lower physical health summary scores (average difference:-2.2 points, 95%CI: -3.5 to -0.9) and mental health summary scores (average difference: -1.2 points, 95%CI: -2.2 to -0.3) compared to the normal CAVI group (CAVI < 8). Findings highlight the importance of routine screening for arterial stiffness and support the implementation of comprehensive care strategies that incorporate cardiovascular risk management. Such approaches could guide public health interventions and clinical practices to enhance the overall health and well-being of OAHIV, potentially through targeted cardiovascular risk reduction programs and personalized care plans. However, the study's regional focus in rural Northern Thailand and participant attrition over the five-year period limit the generalizability of the findings. Future research in diverse settings with larger sample sizes is needed to confirm these results.

Supplementation with whey peptide rich in β-lactolin improves trait anxiety and subjective stress in healthy adults: a randomized, double-blind, placebo-controlled study.

Mental disorders have become one of the most burdensome health concerns. We have previously demonstrated that whey-derived β-lactolin (glycine-thereonine-tryptophan-tyrosine tetrapeptide) activates dopaminergic systems and improves psychiatric function in rodents. However, the effects of β-lactolin on human mood states have not been investigated. This randomized, double-blind, placebo-controlled study aimed to evaluate the effects of supplementation with β-lactolin-rich whey peptide on human mood states. Sixty healthy adults (aged 45-64 years) with relatively low psychological health were randomly allocated to receive either whey peptide (containing β-lactolin 1.6mg/day) or placebo for 6 weeks. Mood states (primary outcomes) were evaluated using self-reporting questionnaires. Health-related quality of life (QOL), salivary stress marker and lipid mediator levels were evaluated as secondary outcomes. Compared with placebo, supplementation with β-lactolin improved changes in trait anxiety (p = 0.046), as assessed using the state-trait anxiety inventory, and in subjective stress (p = 0.043), as assessed using the Perceived Stress Scale. In the assessment of QOL, changes in the vitality subscale and mental health summary score of the 36-Item Short-Form Health Survey were improved in the β-lactolin group. The levels of salivary immunoglobulin A were significantly higher in the β-lactolin group. In a subgroup analysis by median age (54.5 years), subjective stress and salivary prostaglandin levels were significantly decreased by β-lactolin supplementation in the 45-54 -year-old subgroup. In conclusion, supplementation with β-lactolin improves trait anxiety, subjective stress, and psychological QOL, which may be associated with immunologic responses detected via salivary analysis.

Health-related quality of life and associated factors among people living with HIV/AIDS in Lagos, Nigeria.

Although people living with HIV (PLWH) now have a longer life expectancy due to antiretroviral therapy, several factors impact their health-related quality of life (HRQoL). Understanding the dimensions and determinants of HRQoL among PLWH is crucial to developing solutions to improve their overall wellbeing. This research aimed to explore the HRQoL and its associated factors among PLWH in Lagos, Nigeria. Seven HIV testing and treatment centres in Lagos. A cross-sectional survey was conducted with 385 participants. Socio-demographic and HRQoL data were obtained using questionnaires and the Medical Outcomes Study HIV Health Survey (MOS-HIV). Logistic regression models were used to identify variables that were associated with quality of life. The physical health summary and mental health summary scores measured by the MOS-HIV were 54.2 ± 5.3 and 56.3 ± 6.7, respectively. Being married, having higher levels of education, shorter duration of HIV and higher income levels were significantly associated with better HRQoL. The duration of HIV was found to have an inversely proportional influence on the quality of life of PLWH, both in physical health (χ2= 9.477,p= 0.009) and mental health (χ2= 11.88,p= 0.004) dimensions. The HRQoL of PLWH in Lagos, Nigeria was relatively low. Education, duration of HIV, marital status and income level are predictors of HRQoL.Contribution:This study is valuable for healthcare professionals and policymakers, providing them with essential information to tailor interventions and allocate resources effectively to improve the overall wellbeing of PLWH in Nigeria.

Converting PROMIS®-29 v2.0 profile data to SF-36 physical and mental component summary scores in patients with cardiovascular disorders

BackgroundHealth-related quality of life (HRQL) has become an important outcome parameter in cardiology. The MOS 36-ltem Short-Form Health Survey (SF-36) and the PROMIS-29 are two widely used generic measures providing composite HRQL scores. The domains of the SF-36, a well-established instrument utilized for several decades, can be aggregated to physical (PCS) and mental (MCS) component summary scores. Alternative scoring algorithms for correlated component scores (PCSc and MCSc) have also been suggested. The PROMIS-29 is a newer but increasingly used HRQL measure. Analogous to the SF-36, physical and mental health summary scores can be derived from PROMIS-29 domain scores, based on a correlated factor solution. So far, scores from the PROMIS-29 are not directly comparable to SF-36 results, complicating the aggregation of research findings. Thus, our aim was to provide algorithms to convert PROMIS-29 data to well-established SF-36 component summary scores.MethodsData from n = 662 participants of the Berlin Long-term Observation of Vascular Events (BeLOVE) study were used to estimate linear regression models with either PROMIS-29 domain scores or aggregated PROMIS-29 physical/mental health summary scores as predictors and SF-36 physical/mental component summary scores as outcomes. Data from a subsequent assessment point (n = 259) were used to evaluate the agreement between empirical and predicted SF-36 scores.ResultsPROMIS-29 domain scores as well as PROMIS-29 health summary scores showed high predictive value for PCS, PCSc, and MCSc (R2 ≥ 70%), and moderate predictive value for MCS (R2 = 57% and R2 = 40%, respectively). After applying the regression coefficients to new data, empirical and predicted SF-36 component summary scores were highly correlated (r > 0.8) for most models. Mean differences between empirical and predicted scores were negligible (|SMD|<0.1).ConclusionsThis study provides easy-to-apply algorithms to convert PROMIS-29 data to well-established SF-36 physical and mental component summary scores in a cardiovascular population. Applied to new data, the agreement between empirical and predicted SF-36 scores was high. However, for SF-36 mental component summary scores, considerably better predictions were found under the correlated (MCSc) than under the original factor model (MCS). Additionally, as a pertinent byproduct, our study confirmed construct validity of the relatively new PROMIS-29 health summary scores in cardiology patients.

Outcomes Among Mexican American and Non-Hispanic White Informal Stroke Caregivers.

Informal home care is prevalent among Mexican American stroke survivors, but data on the impact on caregivers are not available. The aim was to assess ethnic differences in informal stroke caregiving and caregiver outcomes at 90 days poststroke. Informal caregivers were recruited from the population-based Brain Attack Surveillance in Corpus Christi Project (2019-2023), conducted in a bi-ethnic community in Texas. Caregivers of community-dwelling stroke survivors who were not cognitively impaired and not employed by a formal caregiving agency were interviewed. Interviews included sociodemographics, dyad characteristics, Modified Caregiver Strain Index (range 0-26, higher more positive), Positive Aspects of Caregiving scale (range, 5-45, higher more), Patient Health Questionnaire-8 (range, 0-30, higher worse), and PROMIS (Patient-Reported Outcomes Measurement Information System)-10 physical (range, 16.2-67.7, higher better) and mental health (range, 21.2-67.6, higher better) summary scores. Stroke survivor data was from interviews and medical records. Propensity score methods were used to balance caregiver and patient factors among Mexican American and Non-Hispanic White caregivers by fitting a model with ethnicity of caregiver as the outcome and predictors being caregiver sociodemographics, patient-caregiver dyad characteristics, and patient sociodemographics and functional disability. Propensity scores were included as a covariate in regression models, considering the association between ethnicity and outcomes. Mexican American caregivers were younger, more likely female, and more likely a child of the stroke survivor than Non-Hispanic White caregivers. Mexican American caregiver ethnicity was associated with less caregiver strain (β, -1.87 [95% CI, -3.51 to -0.22]) and depressive symptoms (β, -2.02 [95% CI, -3.41 to -0.64]) and more favorable mental health (β, 4.90 [95% CI, 2.49-7.31]) and positive aspects of caregiving (β, 3.29 [95% CI, 1.35-5.23]) but not associated with physical health. Understanding the mechanisms behind more favorable caregiver outcomes in Mexican American people may aid in the design of culturally sensitive interventions to improve both caregiver and stroke survivor outcomes, potentially across all race and ethnic groups.

The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID

BackgroundIndividuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID. MethodsThe PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir. Participants are recruited via patient groups, cultural ambassadors, and social media platforms. Medical records are reviewed through a platform facilitating participant-mediated data acquisition from electronic health records nationwide. During the drug treatment, participants complete daily digital diaries using a web-based application. Blood draws for eligibility and safety assessments are conducted at or near participants' homes. The study drug is shipped directly to participants' homes. The primary endpoint is the PROMIS-29 Physical Health Summary Score difference between baseline and Day 28, evaluated by a mixed model repeated measure analysis. Secondary endpoints include PROMIS-29 (Mental Health Summary Score and all items), Modified GSQ-30 with supplemental symptoms questionnaire, COVID Core Outcome Measures for Recovery, EQ-5D-5L (Utility Score and all items), PGIS 1 and 2, PGIC 1 and 2, and healthcare utilization. The trial incorporates immunophenotyping to identify long COVID biomarkers and treatment responders. ConclusionThe PAX LC trial uses a novel decentralized design and a participant-centric approach to test a 15-day regimen of nirmatrelvir/ritonavir for long COVID.

The PROMIS-16 reproduces the PROMIS-29 physical and mental health summary scores accurately in a probability-based internet panel.

The Patient-Reported Outcomes Measurement Information System® (PROMIS)-16 assesses the same multi-item domains but does not include the pain intensity item in the PROMIS-29. We evaluate how well physical and mental health summary scores estimated from the PROMIS-16 reproduce those estimated using the PROMIS-29. An evaluation of data collected from 4130 respondents from the KnowledgePanel. Analyses include confirmatory factor analysis to assess physical and mental health latent variables based on PROMIS-16 scores, reliability estimates for the PROMIS measures, mean differences and correlations of scores estimated by the PROMIS-16 with those estimated by the PROMIS-29, and associations between differences in corresponding PROMIS-16 and PROMIS-29 scores by sociodemographic characteristics. A two-factor (physical and mental health) model adequately fits the PROMIS-16 scores. Reliability estimates for the PROMIS-16 measures were slightly lower than for the PROMIS-29 measures. There were minimal differences between PROMIS physical and mental health summary scores estimated using the PROMIS-16 or the PROMIS-29. PROMIS-16 and PROMIS-29 score differences by sociodemographic characteristics were small. Using the PROMIS pain intensity item when scoring the PROMIS-16 produced similar estimates of physical and mental health summary scores. The PROMIS-16 provides similar estimates of the PROMIS-29 physical and mental health summary scores. The high reliability of these scores indicates they are accurate enough for use with individual patients.

Effect of Adding Virtual Reality Training to Traditional Exercise Program on Pain, Mental Status and Psychological Status in Unilateral Traumatic Lower Limb Amputees: A Randomized Controlled Trial.

Background: Lower limb amputation is an emotionally devastating condition that causes a complete change in the quality of life, may lead to phantom limb pain in most of the cases, and puts the individual in a high risk of developing psychological disorders. The objective of this study is to evaluate the consequence of adding virtual reality (VR) to a traditional exercise program on pain, mental status, and psychological status in traumatic unilateral lower limb amputees (LLAs). Methods: Thirty-two traumatic LLAs were randomly assigned into two equal groups in this randomized control trial. Participants did accomplish a postfitting exercise program at least 6 months before enrolment; the control group (CG) underwent a traditional rehabilitation program, and experimental group (EG) had the same program, in addition to VR training. Data were collected before and after 6 weeks of intervention using visual analog scale (VAS) for pain, Beck's depression inventory (BDI) for depression, and 12-item short form survey for mental health summary (MHS) and physical health summary (PHS). Results: Thirty-two amputees (29 males and 3 females) were included with mean age in CGs and EG (27.6 ± 4) and (27.6 ± 7.6) years, respectively. Postintervention, the VAS score was significantly reduced only in EG (P = 0.003). Both groups showed significant improvement in BDI, MHS, and PHS (P < 0.05). However, the EG showed a superior significance in BDI and MHS scores (P < 0.05). There was no significance between groups in PHS score. Conclusion: Adding VR to conventional training is beneficial in decreasing pain and in improving depression and MHS of traumatic unilateral LLAs.

The association of self-perceived changes due to COVID-19 with mental and physical health among adult primary care patients with multiple chronic conditions: A US-based longitudinal study.

This study explores the association between self-perceived personal and community changes due to COVID-19 and health among vulnerable primary care patients experiencing multiple chronic conditions. Between September 2017 and February 2021, we obtained data from 2,426 primary care patients managing multiple chronic conditions from across the United States. We assessed the relationship between self-perceived personal and community changes due to COVID-19 and change in health measured by the PROMIS-29 mental and physical health summary scores, GAD-7 (anxiety), andPHQ-9 (depression), and DASI (functional capacity) adjusting for relevant demographic, neighborhood characteristics, and county covariates. After adjustment, self-perceived personal and community changes due to COVID-19 were associated with significantly worse mental health summary scores (ß = -0.55; 95% Confidence Interval (CI) = -0.72, -0.37), anxiety (ß = 0.28; 95% CI = 0.16, 0.39), depression (ß = 0.35; 95% CI = 0.22, 0.47), and physical health summary scores (ß = -0.44; 95% CI = 0.88, 0.00). There was no association with functional capacity (ß = - 0.05; 95% CI = -0.16, 0.05). Among adults managing multiple chronic conditions, self-perceived personal and community changes due to COVID-19 were associated with health. This vulnerable population may be particularly susceptible to the negative effects of COVID-19. As we do not know the long-term health effects of COVID, this paper establishes a baseline of epidemiological data on COVID-19 burden and health among primary care patients with multiple chronic conditions.

Association among cardiopulmonary and metabolic rehabilitation, arrhythmias, and myocardial ischemia responses of patients with HFpEF or HFmrEF.

There's limited evidence of the potential benefits of cardiopulmonary and metabolic rehabilitation (CPMR) in patients with heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF) and coronary artery disease (CAD). The aim of this study was to investigate the impact of CPMR on the myocardial ischemia response (MIR), exercise-induced arrhythmias (EIA), New York Heart Association (NYHA) functional class, heart rate recovery (HRR), Borg CR10 perceived symptoms, and the SF-36 physical and mental health summary scores. A prospective cohort study was conducted with 106 patients undergoing 12 weeks of CPMR who completed two exercise tests pre- and post-CPMR: 1) maximum incremental test (CPX) and 2) submaximal constant load test (SUB). After CPMR, the effects on MIR, EIA, NYHA functional class, and HRR during both tests were analyzed. There was a significant change in NYHA functional classes after CPMR, with 96% of the patients in class I (vs 62% pre-CPMR, P<0.0001), 4% in class II (vs 32%), and none in class III (vs 6%). There was a significant reduction in the frequency of EIA (P<0.05) and MIR (P<0.001) and a significantly improved performance on both CPX and SUB tests (P<0.0001). Lastly, there was significant progress in the recovery metrics like HRR (P<0.0001), the Borg CR10 (P<0.0001), and the SF-36 summary scores (P<0.0001). The CPMR resulted in a significant decrease in EIA, delayed ischemia threshold in CPX and SUB tests, increased functional capacity, and improved quality of life.

Quality of life of elderly users of long-term health care in and outside the institution

&amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Introduction. &amp;lt;/strong&amp;gt;Long-term care is series of health and social care services provided at home or in an institutional environment to people with reduced functional capacity. Even though it is known that the quality of life (QoL) of elderly is on a lower level when compared to younger people, there is a small amount of information about QoL of long-term health care patients. The aim of our study was to determine the difference in QoL, depression, anxiety and stress of longterm health care users placed in and outside the institution.&amp;lt;/p&amp;gt; &amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Methods.&amp;lt;/strong&amp;gt; This cross-sectional study included 100 long-term healthcare users, divided in two groups. First group consisted of 50 respondents from primary level of health care and second group consisted of 50 residents of nursing home. The research was conducted in the period from June to July 2022. A general socio-demographic questionnaire, SF-36 health questionnaire for estimating the QoL and the scale of depression, anxiety and stress (DASS-21) were used as instruments in this study.&amp;lt;/p&amp;gt; &amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Results. &amp;lt;/strong&amp;gt;Respondents who were institutionalized had significantly lower values of domains and summary scores of QoL compared to respondents whose health care took place outside of institutions, where the difference was observed in physical health summary score (37.67&amp;amp;plusmn;6.20% vs. 50.39&amp;amp;plusmn;10.74%, p&amp;amp;lt;0.001), and the mental health summary score (44.87&amp;amp;plusmn;11.82% vs. 51.83&amp;amp;plusmn;16.01%, p =0.015). Respondents who received long-term health care institutionally had significantly (p=0.011) more mild anxiety (12%) and moderate anxiety (34%) compared to respondents who received long-term health care outside the institution (4% vs. 14%).&amp;lt;/p&amp;gt; &amp;lt;p&amp;gt;&amp;lt;strong&amp;gt;Conclusion. &amp;lt;/strong&amp;gt;Our results showed that residents of nursing home had significantly worse physical and mental functioning, as well as more frequent occurrence of anxiety symptoms compared to users of longterm health care placed outside institutions, in home environment.&amp;lt;/p&amp;gt;

Comparison of patient-reported outcomes measurement information system (PROMIS®)-29 and PROMIS global physical and mental health scores

PurposeThe Patient-Reported Outcomes Measurement and Information System (PROMIS®): includes the PROMIS-29 physical and mental health summary and the PROMIS global physical and mental health scores. It is unknown how these scores coincide with one another. This study examines whether the scores yield similar or different information.MethodsThe PROMIS-29 and the PROMIS global health items were administered to 5804 adults from Amazon’s Mechanical Turk (MTurk) in 2021–2022 and to 4060 adults in the Ipsos KnowledgePanel (KP) in 2022.ResultsThe median age of those in MTurk (KP) was 36 (54) and 53% (50%) were male. Mean T-scores on the PROMIS-29 and PROMIS global physical health scales were similar, but PROMIS global mental health was 3–4 points lower than the PROMIS-29 mental health summary score. Product-moment correlations ranged from 0.69 to 0.81 between the PROMIS-29 physical health and PROMIS global physical health scales and 0.56–0.69 between the mental health scales. Multi-trait multimethod analyses indicated that only a small proportion of the correlations between the two methods of measuring mental health were significantly more highly correlated with one another than correlations between physical and mental health.ConclusionsPROMIS-29 and PROMIS global mental health scales provide different information and, therefore, study conclusions may vary depending on which measure is used. Interpretation of results needs to consider that the PROMIS-29 mental health scale is a weighted combination of specific domains while the PROMIS global mental health scale is based on general mental health perceptions. Further comparisons of methods of assessing mental health are needed.

Estimating individual health-related quality of life changes in low back pain patients

BackgroundThere is a need to evaluate different options for estimating individual change in health-related quality of life for patients with low back pain.MethodsSecondary analysis of data collected at baseline and 6 weeks later in a randomized trial of 749 adults with low back pain receiving usual medical care (UMC) or UMC plus chiropractic care at a small hospital at a military training site or two large military medical centers. The mean age was 31; 76% were male and 67% were White. The study participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 v 1.0 physical function, pain interference, pain intensity, fatigue, sleep disturbance, depression, anxiety, satisfaction with participation in social roles, physical summary, and mental health summary scores (T-scored with mean = 50 and standard deviation (SD) = 10 in the U.S. general population).ResultsReliability estimates at the baseline ranged from 0.700 to 0.969. Six-week test–retest intraclass correlation estimates were substantially lower than these estimates: the median test–retest intraclass correlation for the two-way mixed-effects model was 0. 532. Restricting the test–retest reliability estimates to the subset who reported they were about the same as at baseline on a retrospective rating of change item increased the median test–retest reliability to 0.686. The amount of individual change that was statistically significant varied by how reliability was estimated, and which SD was used. The smallest change needed was found when internal consistency reliability and the SD at baseline were used. When these values were used, the amount of change needed to be statistically significant (p < .05) at the individual level ranged from 3.33 (mental health summary scale) to 12.30 (pain intensity item) T-score points.ConclusionsWe recommend that in research studies estimates of the magnitude of individual change needed for statistical significance be provided for multiple reliability and standard deviation estimates. Whenever possible, patients should be classified based on whether they 1) improved significantly and perceived they got better, 2) improved significantly but did not perceive they were better, 3) did not improve significantly but felt they got better, or 4) did not improve significantly or report getting better.

Successful Incorporation of Electronic Patient Reported Outcomes Using Promis-29 into Standard of Care after Hematopoietic Stem Cell Transplant and Chimeric Antigen Receptor T Cell Therapy

Background: Cellular therapies including hematopoietic stem cell transplant (HCT) and CAR T are mainstays of treatment for hematologic malignancies, but can have significant and prolonged side effects. Patient reported outcome (PRO) measures are instruments which allow a patient to self-report symptoms to their care team and have been shown to be more comprehensive and reliable than provider assessment. Using our center's electronic platform, we aimed to integrate PRO collection into standard of care to improve the clinical experience after HCT and CAR T. Methods: Patients received the PROMIS-29 survey through the patient portal. Baseline surveys were automatically generated by a chemotherapy order, and follow-up surveys on Day 0 (infusion), weekly for the first month, monthly for the first year, and every 3 months for the second year were generated off the cell infusion order. Patients were manually censored from further surveys at time of relapse or progression of disease. Survey responses in pre-identified severe ranges prompted instructions to call the clinician's office and for the clinical team to call the patient. Results: From May 2019 to December 2022, 1025 patients underwent a cell therapy at MSK (323 allo HCT, 450 allo HCT, 228 commercial CAR T, 24 with both HCT and CAR T) with overall median age of 63 (range 20 -85), 44% female. HCT patients had leukemia (22%), myelodysplastic syndrome (10%), myeloproliferative neoplasm (3%), non-Hodgkin lymphoma (NHL, 18%), Hodgkin lymphoma (5%), plasma cell disorders (40%), or other diseases (1%); while CAR T cell patients had NHL (85%), multiple myeloma (12%), or leukemia (3%). Seventy-eight percent answered at least one survey over the two years, with response rates at baseline, Day 0, week 1, week 2, week 3, and week 4 of 51%, 27%, 26%, 26%, 29% and 29%, respectively (Figure 1). PROMIS-29 physical health summary scores at at baseline, Day 0, week 1, week 2, week 3, and week 4 were 49 [21 - 59], 45 [22 - 59], 43 [21 - 59], 41 [21 - 59], and 42 [21 - 59], respectively (Figure 2). Mental health summary scores were 51 [30 - 64], 49 [29 - 64], 48 [29 - 64], 47 [26 - 64], 48 [24-64] and 49 [30 - 64], respectively. Conclusions: We demonstrate the feasibility of incorporating patient reported outcomes into standard of care practice after HCT and CAR T cell therapy. Missing surveys were more common while inpatient, which may be due to toxicity or less use of the patient portal while admitted. Additional work is ongoing to improve the response rates at all time points. Importantly, the electronic system allowed us to capture later timepoints when patients have less frequent visits and may be followed locally. Full survey results will be presented.

Factors Affecting Health-Related Quality of Life Among Individuals with Histiocytic Neoplasms

Purpose: Advances in targeted therapeutics for histiocytic neoplasms have led to a growing survivor population, especially for Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), and Rosai-Dorfman disease (RDD). This growing population is at risk of adverse health-related quality of life (HRQoL) as a result of the disease or treatments received. Patient-reported outcomes in this population remain understudied, and we aim to define their HRQoL using a validated tool. Methods: We enrolled patients from 2 histiocytosis centers and an international conference from Aug 2022-April 2023 to complete the PROMIS © (Patient-Reported Outcomes [PROs] Measurement Information System) 29+2 profile v2.1, which captures 8 domains of physical/mental health and functioning. Domains are reported as T-scores, with 50 being the general population mean. We calculated summary T-scores for Physical Health (PH) and Mental Health (MH), and differences of 3 from general population were considered clinically meaningful. We then used these T-scores to calculate each patient's PROMIS-Preference (PROPr) score, which is a health-utility score that measures overall HRQoL. A mean PROPr score difference of 0.4 from the US population mean of 0.52 was considered meaningful. We ran independent-samples t-tests to examine differences in PH/MH summary scores and PROPr between sub-cohorts. Finally, we performed a multinomial logistic regression analysis to identify factors associated with worse scores, and calculated odds ratios (OR) for each factor. Results: We included a total of 77 participants. Specific diagnoses included ECD (n=33, 42.9%), LCH (n=21, 27.3%), RDD (n=19, 24.7%), and other/unknown (n=4, 5.2%). Median age at diagnosis was 50y (9-79) and at survey was 54y (18-82), with a median 4 year difference between diagnosis and survey completion. Racial demographics included white (n=64, 83.1%), Black (n=12, 15.6%), and Asian (n=1, 1.3%). 4 patients (5.2%) identified as having a Hispanic ethnicity. Disease extent included unifocal (n=13, 16.9%), single system multifocal (ss-M, n=8, 10.4%), single system lung LCH (ss-L, n=3, 3.9%), or multisystem (n=53, 68.8%) disease. The most commonly involved organs included bone (n=44, 57.1%), kidney (n=24, 31.2%), skin (n=24, 31.2%), CNS (n=24, 31.2%), and pituitary (n=19, 24.7%). PH and MH summary scores were lower in various diagnostic categories as compared with the US population, and PROPr scores were reduced in all diagnostic categories. Bone involvement was associated with worse PH (-6.16, 95%CI -10.81, -1.52, [p=0.005]), MH (-7.96, 95%CI -12.48, -3.44, [p=&amp;lt;0.001]), and PROPr (-0.184, 95%CI -0.313, -0.056, [p=0.003]) scores. CNS involvement was associated with worse PH (-4.78, 95%CI -9.14, -0.42, [p=0.016]). We initially constructed a multinomial regression model using diagnosis, race, age at survey completion, and CNS and bone involvement. This model was not statistically significant, and in particular, diagnosis and age did not significantly contribute to the model. We then removed diagnosis and age and constructed a new model using the remaining variables, which was statistically significant for all 3 scores (p&amp;lt;0.05). We found that factors associated with worse PH score were disease involvement of bone (OR=6.19, 95%CI 1.88, 20.43 [p=0.003]) and CNS (OR=10.36, 95%CI 2.01, 53.39 [p=0.005] Figure 2). Factors associated with worse MH scores included female sex (OR=4.12, 95%CI 1.24, 13.66 [p=0.021]) and CNS involvement (OR=10.74, 95%CI 2.47, 46.79 [p=0.002]). Having race/ethnic group other than white/Non-Hispanic or Black was associated with improved MH. However, as this group had only 4 members, the significance of this is uncertain. Finally, CNS involvement was found to be associated with worse odds of having a low PROPr score (OR=10.46, 95%CI 2.17, 50.37 [p=0.003]). Conclusions: Several PROs were worse in patients with histiocytic neoplasms as compared with the general population. We further found that CNS involvement was independently associated with worse HRQoL, regardless of the diagnosis type. Additionally, female sex was associated with worse MH scores, and bone involvement with worse PH scores. PROPr score was particularly low among patients with ECD. Future research is warranted to assess the impact of treatments on HRQoL, as well as the economic loss resulting from loss of productivity as highlighted by low PROPr scores.

Mediation of race/ethnicity (R/E) disparities in mental health patient reported outcomes (PROS) among elderly female patients with breast cancer (BC) in the Surveillance, Epidemiology, and end results-medicare health outcomes survey (SEER-MHOS) database.

e22527 Background: Variations in mental health PROs between Non-Hispanic Black (NHB) and Hispanic compared to Non-Hispanic White (NHW) elderly women with BC may be attributable to differences in socioeconomic position (SEP), comorbid disease (CD), tumor biology (TB), social support (SS), and treatment factors (TF). We examine the extent to which the R/E disparity in patient reported mental health summary scores (MCS) is transmitted through these domains. Methods: Data is from SEER-MHOS and the analytic sample (n = 17,465) included 12,493 NHW, 2,503 NHB, and 2,019 Hispanic women with newly diagnosed BC between 2010-2017. MCS were calculated using the SF-36/V linear transformation of 0-100 versions of the scale that yield a population mean of 50 and standard deviation of 10 based on 1990 population means. We estimated average controlled direct associations (ACDA) using regression models with predictive margins (risk difference %) to evaluate crude and age/body mass index (BMI)-adjusted MCS by R/E and performed a series of ACDA [with comparison of rescaled coefficients (RC)] controlling for the domains of (1) SEP [household income (&lt; 30K, 30K-80K, &gt; 80K) and education attainment [ &lt; High School (HS), HS, &gt; HS)]; (2) CD [smoking status (current smoker/current non-smoker), diabetes (yes/no), and hypertension (yes/no)]; (3) TB [stages (1-3), grade (well/moderate/poor), and subtype (luminal A/ triple negative)]; (4) SS [domestic partner (yes/no); and (5) TF [systemic therapy (yes/no)]. Results: Overall, NHB and Hispanic women were younger and had higher BMI than NHW women and crude models showed MCS disparity for NHBs (-4.13%; 95% CI: -4.63, -3.63) and Hispanics (-5.91%, 95%CI: -6.49, -5.34) compared with NHWs. In baseline age/BMI adjusted models, NHBs and Hispanics had worse MCS, -3.78% (95% CI: -3.2, -4.35) and -5.7% (95% CI: -5.04, -6.36) respectively, compared with NHWs. Control for TF had minimal effect on the observed disparity [NHB (-3.85%; 95% CI: -4.56, -3.15) and Hispanics (-4.79%; 95% CI: -5.6, -3.97) compared with NHW], but control for SEP largely reduced the disparity [NHB (-1.56%; 95% CI: -0.89, -2.23) and Hispanics (-2.8%; 95% CI: -1.99, -3.6)]. Inclusion of all 5 domains also attenuated the magnitude of the disparity to a degree such that it was still considered a minimally important difference for Hispanics (-2.34%, 95% CI: -3.75, -0.94), but not for NHBs (0.12%; 95% CI: -1.08, 1.32). However, low acculturation in Hispanics appeared to modify (worsen) the disparity. Based on the method of RC, we determined that SEP accounted for the largest fraction of mediated effects. Conclusions: Our findings suggest that observed R/E differences in mental health PROs in elderly BC patients are largely mediated by differences in SEP rather than treatment.

Health-related quality of life in patients with primary biliary cholangitis: a cross-sectional study from a single centre in Denmark.

The impact of primary biliary cholangitis (PBC) on health-related quality of life (HRQOL) is poorly understood. The aim of this study was to compare HRQOL in Danish patients with PBC to the general population and to assess associations to clinical and laboratory data. We conducted a single-centre, cross-sectional questionnaire study in patients with PBC using the SF-36 and EQ-5D-5L. Clinical and paraclinical data were obtained from patients' healthcare records. SF-36 scores were compared to an age- and gender-matched Danish general population. A general linear model was used to explore which variables were associated with main SF-36 scores. Sixty-nine patients with PBC were included. Compared to the Danish general population, patients with PBC had a significantly lower HRQOL in the domains bodily pain, general health, vitality, social functioning, mental health and mental component summary score. No clinical characteristics (gender, age at inclusion, concurrent autoimmune hepatitis, pruritus or cirrhosis) or biochemical markers were significantly associated with main SF-36 scores (physical and mental component summary). The study is the first to report on HRQOL in a well-characterized PBC patient population from Denmark. Danish patients with PBC had a significantly impaired HRQOL compared to the general population with the greatest impairment in mental aspects. Reductions in HRQOL were independent of clinical characteristics and biochemical markers why HRQOL should be considered as an independent outcome.

Comparison of changes in health-related quality of life between elderly and non-elderly patients undergoing elective surgery for colorectal cancer.

Elderly people are thought to be more likely than their non-elderly counterparts to experience a decline in activities of daily living (ADL) and quality of life (QOL) due to the onset and treatment of disease. In this study, we investigated whether there was an age-related difference in changes in health-related QOL indices after surgical resection of colorectal cancer (CRC). Patients who underwent elective surgery for primary CRC at our hospital between September 2017 and November 2021 were enrolled. Changes in QOL after surgery were evaluated after dividing the study population into a non-elderly (NE) group (younger than 75 years) and an elderly (E) group. A Short-Form 36-Item Health Survey was used as an index of QOL. The subscale and component summary scores before and 6 months after surgery were compared. Forty-seven patients were included in the E group and 166 patients were the NE group. The E group had significantly worse preoperative performance and physical status than the NE group. However, indices of physical function were not worsened after surgery in either group. In the NE group, there were significant decreases in role physical and role component summary scores and significant increases in general health, mental health, and mental component summary scores. In the E group, there were no significant changes in the subscale or component summary scores after surgery. Our study demonstrated elderly patient did not necessarily show a decline in QOL more than non-elderly patients after CRC surgery. Surgical resection for CRC should be considered even for elderly patients, while considering possible risk factors for worsening ADL and QOL.

Patient Perspectives on the Burden of Heart Failure with Preserved Ejection Fraction in a US Commercially Insured and Medicare Advantage Population: A Survey Study.

Patient-reported health related quality of life (HRQOL) is not routinely assessed in clinical practice. Little is known about health status outcomes reported by patients with heart failure with preserved ejection fraction (HFpEF) in non-clinical trial settings. To better understand patient burden of HFpEF in terms of HF-specific functional and symptom status, HRQOL, healthcare resource utilization (HCRU) and costs in a US-based commercial and Medicare Advantage insured population. We conducted a cross-sectional survey of patients with HFpEF and linked their survey and administrative claims data. Consenting, eligible patients completed a survey that included the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and the PROMIS Global Health-10 (GH-10) questionnaire, as well as clinical and demographic questions. HF medication use, HCRU and costs during the 12-month baseline period before the survey were determined from claims data. Generalized linear regression was used to assess the associations between baseline characteristics and the KCCQ-23 overall summary score. Of 598 survey respondents with survey and claims data, 54.7% were female with mean age 74.0 years. The KCCQ-23 overall summary and clinical summary scores were 64.8 and 63.0, respectively, and the GH-10 physical and mental health summary scores were 39.9 and 45.5. Factors related to lower KCCQ-23 overall summary scores were HF treatment and symptom changes during the past 4-weeks before the survey, hospital admission during the past year, low household income, high comorbidity index, and morbid obesity (BMI>40). Total all-cause healthcare costs were $38,243 during the year prior to the survey, of which 42% were HF-related. Patient-reported outcome measure scores indicated impairment due to HF symptoms and physical limitations in this real-world sample of patients with HFpEF, highlighting a need to assess patient-reported outcomes as well as the clinical and economic outcomes traditionally assessed by clinicians, health systems and payers.