PROMIS Global Health Research Articles

Significant pre-post effects on a patient-reported outcome measure in inpatient rehabilitation

Abstract Background We conducted a pilot study for the Swiss National Association for Quality Development in Hospitals and Clinics (ANQ) in the inpatient rehabilitation setting. The aim was to assess the suitability of a generic health-related quality of life patient-reported outcome measure (PROM) as an outcome quality indicator for public reporting across all rehabilitation domains on a national level. Methods In a multi-stage expert-based selection process, the PROMIS Global Health 10 was selected for piloting. We collected data from 29 rehabilitation clinics from April to December 2023. Mean T-scores and effect sizes were analysed across different rehabilitation domains. Patients’ need for assistance in completing the questionnaire was also assessed. Results A dataset of 2261 cases yielded a cleaned sample of 2083, with 1217 complete cases. Mean T-scores for physical health (PHS) and mental health (MHS) significantly differed (p < 0.001) at admission and discharge across all rehabilitation domains. The largest effects were observed in PHS for pulmonary (38.9(7.3); 46.0(7.6); dz = 0.95) and cardiologic rehabilitation (41.7(7.4); 47.9(7.2); dz = 0.85), and in MHS for internal medicine (44.1(6.9); 49.1(5.6); dz = 0.80) and psychosomatic rehabilitation (36.0(7.2); 45.2(8.2); dz = 1.19), while the smallest effects were noted in PHS for paraplegia (36.3(7.2); 39.8(7.2); dz = 0.50) and in MHS for the musculoskeletal rehabilitation domain (46.2(7.9); 48.7(7.4); dz = 0.33). Of all complete cases, 40.5% needed assistance in filling in the PROM and support needs were distributed unequally across rehabilitation domains, ranging from 10.0% in psychosomatic to 70.3% in geriatric rehabilitation. Conclusions The study presents a nuanced understanding of HRQOL across various rehabilitation domains, with notable effects observed across all domains, alongside significant assistance needs. Key messages • PROMIS-GH10 shows significant pre-post effects on physical and mental health in Swiss inpatient rehabilitation, with notable effects observed across all domains. • Observable barriers in implementation are evident due to substantial assistance requirements.

Social isolation and psychosocial functioning among cancer survivors in the Cancer Prevention Study-3.

e23170 Background: Social isolation is a major public health concern due to its effects on morbidity and mortality in the general population. Emerging evidence suggests greater social isolation among individuals diagnosed with cancer, but there is limited understanding of its relationship with psychosocial functioning in cancer survivors. This study examined associations of social isolation and mental health, sleep quality, and health-related quality of life (HRQoL) among cancer survivors and age-matched controls in the Cancer Prevention Study-3 cohort. Methods: We included 4,137 cancer survivors and 12,411 controls who provided complete data for variables of interest on the 2018 survey. Social isolation was assessed on a 5-point scale by the Social Network Index, and classified as low (0-1), moderate (2), and high (3-4). Raw scores from the PROMIS Global Health Scale for HRQoL (10 items) and global mental health (GMH; 4 items) were converted to T-scores (higher score = better). Sleep quality was assessed by a single-item 4-point scale: 1 (very poor) to 4 (very well). ANCOVA analyses were adjusted for age, sex, BMI, education, smoking status, alcohol consumption, and physical activity (PA), as well as stratified by age, sex, and lifestyle factors. Results: Mean age of the population was 60 (34-77) years, 76% were female and 90% non-Hispanic White. Thirty-two percent of survivors and 30% of controls reported moderate to high levels of social isolation. Mean scores for sleep quality, GMH, and HRQoL were significantly lower among survivors vs. controls (all P ≤0.01). There were no significant cancer (yes/no) x social isolation interactions. Among all study participants, ANCOVAs showed that high (vs. low) social isolation was associated with poorer sleep quality (adjusted mean difference = 4%; effect size, ES = 0.14), worse GMH (adjusted mean difference = 12%; ES = 0.68), and lower HRQoL (adjusted mean difference = 8%; ES = 0.57; all Ptrend < 0.0001). Stratified analyses showed stronger associations between greater social isolation and lower HRQoL among females vs. males, less active ( < 15 MET-hr/wk) vs. more active (≥15 MET-hr/wk) participants, and infrequent (none/less than daily) vs. regular alcohol drinkers (≥1 drinks/day). The higher social isolation-lower GMH association was also stronger in females vs. males and less active vs. more active participants. The social isolation-sleep quality association was stronger among infrequent vs. regular alcohol drinkers. Conclusions: These results indicated that high social isolation is associated with poorer sleep quality, mental health, and health-related quality of life, independent of cancer diagnosis. Women and less active participants may be particularly at risk, suggesting that targeted interventions to reduce social isolation in these populations may be warranted. Support: The ACS funds the creation, maintenance, and updating of the CPS-3 cohort.

Outcomes for breast cancer survivors with metastatic disease in a physical activity program for medically underserved cancer survivors.

This study examined the effectiveness and feasibility of the Active Living After Cancer (ALAC) program for metastatic breast cancer (MBC) survivors. ALAC is a 12-session community-based program to help cancer survivors improve their physical functioning and quality of life through increased physical activity. ALAC participants with MBC (stage IV) were compared to survivors with early-stage breast cancer (stages I and II). The International Physical Activity Questionnaire, Godin Leisure-Time Physical Activity, 30-second sit-to-stand test, and PROMIS Global Health were administered at baseline and follow-up. Program satisfaction and retention were assessed at week 12. Repeated-measures mixed models were used to compare changes in outcomes between survivors with early-stage breast cancer and MBC. A total of 585 women (59.3 y ± 10.6), most of whom were Hispanic (54%) or non-Hispanic Black (22%), were included (early stage, n = 538; MBC, n = 47). After the ALAC program, a significant increase in physical activity (P < 0.001), improved physical and mental health T-scores (P < 0.001), and more sit-to-stand repetitions (P < 0.001) were observed for both survivors with early-stage breast cancer and MBC. Women with MBC showed significantly lower physical health (P = 0.037) and physical function (P = 0.010) compared to early-stage at baseline. The ALAC program increased physical activity and improved health-related quality of life and physical function among breast cancer survivors with both early-stage and metastatic disease. This study emphasizes the importance of incorporating physical activity interventions like the ALAC program into the comprehensive care of cancer survivors, including those with metastatic disease.

A Multimodal Ayurveda and Mind-Body Therapeutic Intervention for Chronic Symptoms Attributed to a Postinfectious Syndrome: A Pilot Study.

Objective: Evaluate feasibility and impact of a multimodal integrative therapeutic intervention in patients presenting with chronic symptoms attributed to a postinfectious syndrome. Design: This was a prospective longitudinal single-center pilot study conducted from January 2019 to December 2020. Setting/Location: University of Maryland Lyme Program, Baltimore Maryland. Subjects: Persons presenting for Lyme evaluation for symptoms attributed to Lyme disease. Interventions: Participants attended two 1-h individual instructional sessions consisting of Ayurveda-based dietary intervention and breath-coordinated mind-body practice to be used for home practice. Outcome measures: Standard measures of impact were obtained at baseline, 1, 3, 6, and 12 months using the following validated survey instruments: Perceived Stress Scale (PSS), PROMIS Global Health v1.2 (GH), and PROMIS 29 v2.0 survey. Results: From 216 patients presenting for Lyme evaluation, 19 participants enrolled with 84% completing the study (N = 16). Baseline PROMIS GH scores consisting of general Physical Health (GPH) and general Mental Health (GMH) scores were lower in the study population than in the general U.S. population. PROMIS 29 scores were higher for fatigue, anxiety, and pain than those in the general U.S. population. Over 12-month period, improvement in both the GPH and GMH was 6.09 (confidence interval [95% CI] = 2.71-9.46; p < 0.001) and 4.65 (95% CI = 1.50-7.80; p = 0.004), respectively. PROMIS 29 scores showed the greatest improvement in fatigue at -7.91 (95% CI = -12.34 to -3.48; p < 0.001), pain interference -5.08 (95% CI = -9.20 to -0.96; p = 0.016), and ability to participate in social roles and activities 7.48 (95% CI = 3.21-11.75; p = 0.001) and least with depression -1.82 (95% CI = -4.74 to 1.10; p = 0.223). Employment status had significant effects on almost all outcome scores. Postinfectious state was associated with improvement in anxiety and PSS scores. Conclusions: A multimodal Ayurvedic and breath-coordinated mind-body therapeutic intervention is feasible and a potential nonpharmacologic therapeutic option for persons presenting with pain, stress, fatigue, physical dysfunction, and sleep disturbance attributed to a postinfectious syndrome. Further research is needed to determine efficacy in this population and in other groups with similar symptom complexes due to postinfectious syndromes.

1082 Creation of a Spine Healthcare Resource Utilization Grouping (SHRUG) to Complement Patient-reported Outcome Measurements in Assessing Surgical Success

INTRODUCTION: Patient-reported outcome measures (PROs) are increasingly utilized to assess surgical success. However, when taken as the sole measure of surgical success they have limitations due to the requirement of collection time and infrastructure, response bias, and inherently subjective nature. The large volume of digital data generated by modern health systems may instead offer a method to track healthcare utilization and surgical outcome. METHODS: We retrospectively reviewed a consecutive patients undergoing elective surgery to the cervical and lumbar spine for degenerative pathologies at our institution. Pre- and post-operative 12-month change in PROMIS Global Health was collected. Post-operative measures of healthcare utilization included clinic visits, inpatient encounters, telephone encounters, opioid use, physical therapy, injections, and imaging. A SHRUG metric was then constructed through latent profile analysis. RESULTS: A total of 8039 surgeries were included in our analysis. Four utilization groups were identified: 1) low utilizer group, representing 53.9% of all patients; 2) moderate utilizer group (13.2%); 3) heterogenous utilizer group (25.2%); and 4) high utilizer group (7.7%). Patients were placed into one of four groups with high average probability (97%, 92%, 95%, 93% respectively). CONCLUSIONS: Our study developed a novel method for defining surgical outcomes based on healthcare utilization. These groupings have the potential to add an objective measure of operative success to supplement the use of PROs clinically. SHRUG can approximates PROMIS, nonbiased, provides new insight on outcome and healthcare utilization, and finally clinically feasible to implement.

Weight-related discrimination, perceived stress and psychological and physical well-being of persons with type 2 diabetes: A mediation analysis.

The aim of the study was to examine perceived stress as a mediator of the association between weight-related discrimination and physical and psychological well-being among persons with type 2 diabetes (T2D). Data were obtained from 5104 persons with self-reported T2D participating in the All of Us research programme in the United States. The Everyday Discrimination Scale, Cohen's Perceived Stress Scale (PSS) and PROMIS Global Health Scale were used to measure weight-related discrimination, perceived stress and health outcomes (physical and psychological), respectively. Mediation effects of PSS were tested by bootstrapping with 5000 random samples. Participants were, on average, 63.62 (SD 11.38) years old. Majority of them were female (55.53%), non-Hispanic White (72.61%), married or living with a partner (56.92%), had a household income of <$35,000 (31.99%) and had some college education (33.54%). We found that approximately 18% of study participants reported having experienced weight-related discrimination. We also found that weight-related discrimination was independently associated with poor physical and psychological well-being. These associations were partially mediated by perceived stress such that weight-related discrimination was associated with greater perceived stress, which was in turn associated with poorer physical and psychological well-being. Given that weight-related discrimination is associated with poor outcomes through elevated stress, interventions that target stress may disrupt this pathway thereby helping to reduce the health impact of weight-related discrimination. This assertion should, however, be tested in future studies.

Abstract 2240: An exploratory study of financial toxicity intervention components preferred by cancer survivors

Abstract Background: Despite growing research on financial toxicity (FT) in cancer survivors, few studies have examined cancer survivors’ preferences for FT interventions. Understanding cancer survivors’ preferences for specific intervention components may facilitate the development and implementation of such interventions, potentially reducing the financial burden of cancer treatment. Purpose: The current work is an exploratory study of cancer survivors’ FT intervention component preferences. Methods: Adult survivors (N=105) of colorectal cancer (CRC; n=55) or non-Hodgkin lymphoma (NHL; n=50) from three tertiary care centers self-reported demographic characteristics (gender, race, income, employment status, insurance), clinical characteristics (comorbidities), psychosocial characteristics (PROMIS Global Health scale for mental health, Brief Health Literacy Screen scale, eHealth Literacy Scale), financial impact of cancer (the 11-item comprehensive score for financial toxicity COST scale, and life-altering and care-altering coping strategy scales), and preferences for FT intervention components. Intervention preferences were assessed through survey items on intervention timing and specific content. We employed descriptive statistics to assess overall preferences, and unadjusted linear regression and ANOVAs to identify demographic, clinical, psychosocial and financial predictors of intervention preferences. Results: In terms of timing, 79% of participants favored initiating a FT intervention before treatment compared to during or after treatment. The majority of participants (57%) were interested in at least one FT intervention component. In terms of specific components, participants were most interested in help understanding out-of-pocket costs and insurance (49%), help applying for financial assistance (39%), financial education (32%), and help communicating with the treatment team (32%). Participants were less interested in online tools to manage cancer-related expenses (27%), finance-related stress management (25%), and budgeting (20%). Predictors of overall interest (i.e., number of components endorsed) were: having high FT (B=.413, p=&amp;lt;.001), adopting life-altering coping behaviors (B=.374, p=&amp;lt;.001), using care-altering coping behaviors (B=.241, p=.014), being a non-White survivor (B=.219, p=.024), and having poorer mental health (B=-.280, p=.004). Conclusions: Cancer survivors may prefer FT interventions offered before treatment, and providing guidance on out-of-pocket costs and insurance. FT interventions may be particularly desired by those who experience greater financial toxicity, life and care-altering costs, are a racial/ethnic minority, or have poorer mental health, suggesting potential priority groups and target outcomes for intervention development. Citation Format: Maisha Huq, Claire Conley, Heather Derry-Vick, Amanda Khoudary, Lia Sorgen, Osairys Billini, Thomas Gunning, Conor Luck, Shreya Kaushik, Vanessa Hurley, John Marshall, Benjamin Weinberg, Anteneh Tesfaye, Andrew Ip, Arnold Potosky, Marc D. Schwartz. An exploratory study of financial toxicity intervention components preferred by cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2240.

Mental and Physical Health Comorbidities in Traumatic Brain Injury: A Non-TBI Controls Comparison

ObjectiveTo examine whether aging with a TBI was associated with a greater burden of health-related comorbidities compared with a non-TBI control cohort and examine the associations between comorbidity burden, emotional outcomes, and health-related quality of life (HRQoL) after TBI across ages. DesignCross-sectional. SettingResearch center or telephone. ParticipantsThe study included 559 participants (NTBI=291, NControls=268). Participants with TBI were recruited during inpatient rehabilitation and had sustained a moderate-severe TBI 1-33 years previously. Non-TBI controls were a convenience sample recruited through advertisements in the community. InterventionsNot applicable. Main Outcome MeasuresThe number of cardiovascular, general physical health, and mental health comorbidities was compared between cohorts and age strata using Poisson regression. The relationships between comorbidities, age, emotional outcomes (Generalized Anxiety Disorder Scale-7, Patient Health Questionnaire-9), and HRQoL (PROMIS Global Health Measure) were examined with linear regression. Distinct subgroups of comorbidities were identified using latent class analysis. Associations between comorbidity classes with demographic and outcome variables were evaluated using multinomial logistic and linear regressions, respectively. ResultsTBI participants had a significantly higher comorbidity burden than controls, primarily driven by elevated rates of mental health disorders (RR=2.71, 95% confidence interval [1.37, 5.35]). Cardiovascular and physical health comorbidities were not elevated in the TBI group compared with controls. Both cohorts had 3 similar comorbidity subgroups, suggesting consistent patterns of co-occurring health conditions regardless of TBI exposure. Physical and mental health comorbidities were associated with elevated depression and anxiety symptoms and diminished HRQoL after TBI compared with controls. ConclusionTBI was associated with greater mental, but not physical, health comorbidities in the decades after injury. However, physical and mental health comorbidities significantly affected emotional and HRQoL status after TBI, underscoring a greater need for long-term support for individuals with TBI coping with both physical and mental health comorbidities.

Financial Toxicity, Time Toxicity, and Quality of Life in Multiple Myeloma

BackgroundPatients with multiple myeloma (MM) may be on therapy for years, which can lead to financial toxicity (FinTox) or time toxicity (TimeTox). The prevalence, predictors, and quality of life (QOL) impacts of FinTox and TimeTox during different phases of MM treatment have not been characterized. Patients and MethodsWe conducted a single-center cross-sectional survey of patients with MM who had undergone transplantation. FinTox+ was defined as a COST-FACIT score <23, TimeTox+ as MM-related interactions (including phone calls) ≥1x weekly or ≥1x monthly in-person among far-residing patients, QOL using PROMIS Global Health, and functional status using patient-reported Karnofsky performance status (KPS). ResultsOf 252 patients, 22% and 40% met FinTox+ and TimeTox+ criteria respectively. Respective FinTox+ and TimeTox+ proportions were 22%/37% for patients on maintenance, 22%/82% with active therapy, and 20%/14% with observation. FinTox+ predictors included annual income (P < .01) and out-of-pocket costs (P < .01). TimeTox+ predictors included disease status (P < .001), caregiver status (P = .01), far-residing status (P < .001), and out-of-pocket costs (P = .03). FinTox+ was associated with a clinically meaningful decrease in mental QOL, while TimeTox+ patients were more likely to have KPS ≤ 80. ConclusionsIn our large study, monetary status but not disease status predicted FinTox. Over a third of patients on maintenance reported TimeTox. FinTox+ was associated with decreased mental health, while TimeTox+ was associated with worse performance status. These two toxicities may negatively impact patient wellbeing, and studies of strategies to mitigate their impact are in development.

Abstract TP103: Association Between Neighborhood-Level Disadvantage and Patient-Reported Mental Health Outcomes in Intracerebral Hemorrhage Survivors

Introduction: The influence of social determinants of health (SDH) is well-documented across a range of medical conditions and health outcomes. Less clear is the impact of SDH on patient-reported outcomes, particularly mental health outcomes, in intracerebral hemorrhage (ICH). This study examines the association between the Area Deprivation Index (ADI), a measure of neighborhood-level disadvantage, and self-reported health outcomes in ICH survivors. Methods: This investigation is nested within the REDUCE clinical trial, an ongoing, randomized trial comparing standard-of-care to spironolactone-containing hypertension regimens in ICH survivors. Participants complete the PROMIS Global Health survey at baseline. Global Mental Health (GMH) and Global Physical Health (GPH) scores are standardized to t-scores (GMH 21.2-67.6; GPH 16.2-67.7) around a reference population mean (50 ± 10). ADI uses elements of income, education, employment, and housing quality to assign a composite score (1-100), with a higher score signifying greater disadvantage. Patients were grouped into tertiles based on ADI. GMH and GPH scores were analyzed against the reference mean via a one-sample t-test and across tertiles with a one-way ANOVA. Bivariable linear regression examined ADI as a continuous variable. Multivariable models adjusted for sex, age, race, ethnicity, ICH to baseline interval, and baseline mRS. Results: Fifty patients were included in the analysis. Those in the third, most disadvantaged, tertile had significantly lower GMH scores (39.5 ± 8.17) than the reference population (p&lt;0.001), the first tertile (54.10 ± 10.20, p&lt;0.001), and the second tertile (50.4 ± 8.90, p=0.003). In multivariable analysis, these differences remained significant (T3 vs. T1, B= -18.31, p&lt;0.001; T3 vs. T2, B= -14.67, p&lt;0.001). Further, ADI as a continuous variable was significantly associated with GMH scores in bivariable (B= -0.22, p&lt;0.001) and multivariable analysis (B= -0.23, p=0.005). No significant relationship was found between ADI and GPH. Conclusions: Higher ADI is associated with worse patient-reported mental health outcomes after ICH. Neighborhood disadvantage, and its constituting factors, should be considered in reporting post-ICH patient care and outcomes.

Abstract WP106: Patient Reported Outcomes as Ischemic Stroke and Transient Ischemic Attack Predictors

Introduction: The risk of early stroke recurrence is higher in patients who have experienced a previous event. Multimodal strategies involving the active participation of patients and family members are likely the most effective therapeutic option, the perspective of which can be standardized and validated through Patient-Reported Outcome Measures (PROMs). We aimed to explore the impact of PROMs as predictors of recurrent ischemic stroke and TIA. Methods: A multicenter study based on a prospective cohort of consecutive patients with TIA and ischemic stroke between January 2022 and March 2023. Demographic and clinical data, as well as outcomes from the PROMS program, were collected through the NORA application, including the PROMIS Global Health survey, Hospital Anxiety and Depression Scale (HADS), Fatigue Assessment Scale (FAS), and the Morisky-Green Scale (MG) at 30 days. Results: A total of 2589 patients were included, with a mean age of 72 +/- 13.8 years (42% females). Forty-five recurrences were observed with a mean time to recurrence of 257 days. Recurrent patients had a higher history of smoking (33.3% vs 14.8%; p&lt;0.001) and anticoagulant use (33.3% vs 20.8%; p&lt;0.041). Regarding the PROMs, these patients experienced greater fatigue (FAS 24.4 vs 19.69; p&lt;0.031), a lower tendency for therapeutic adherence (MG 14.2% vs 12.5%; p=0.77), and less return to their work (12.5% vs 32.4%; p&lt;0.02). After the second episode, recurrent patients engaged more in surveys (2.46x10 16 vs 2.46x10 16 ) and self-education on stroke (2.44x10 16 vs 1.92x10 16 ) (p&lt;0.01). Hypertension, previous smoking, and lower MG scores independently predicted recurrence (OR=2.72, 95% CI 1.20-6.14; OR 2.65, 95% CI 1.40-4.99; OR 0.33, 95% CI 0.11-1.01). Conclusions: In our series of TIA and minor strokes, assessing PROMs seems to be a potentially effective strategy for identifying key factors to reduce the risk of stroke recurrence and optimize secondary stroke prevention.

Changes in Health-Related Quality of Life following Surgery in Patients with High-Grade Extremity Soft-Tissue Sarcoma: A Prospective Longitudinal Study

Introduction: Changes in health-related quality of life (HRQoL) during the diagnostic and treatment trajectory of high-grade extremity soft-tissue sarcoma (eSTS) has rarely been investigated for adults (18–65 y) and the elderly (aged ≥65 y), despite a potential variation in challenges from diverse levels of physical, social, or work-related activities. This study assesses HRQoL from time of diagnosis to one year thereafter among adults and the elderly with eSTS. Methods: HRQoL of participants from the VALUE-PERSARC trial (n = 97) was assessed at diagnosis and 3, 6 and 12 months thereafter, utilizing the PROMIS Global Health (GH), PROMIS Physical Function (PF) and EQ-5D-5L. Results: Over time, similar patterns were observed in all HRQoL measures, i.e., lower HRQoL scores than the Dutch population at baseline (PROMIS-PF:46.8, PROMIS GH-Mental:47.3, GH-Physical:46.2, EQ-5D-5L:0.76, EQ-VAS:72.6), a decrease at 3 months, followed by an upward trend to reach similar scores as the general population at 12 months (PROMIS-PF:49.9, PROMIS GH-Physical:50.1, EQ-5D-5L:0.84, EQ-VAS:81.5), except for the PROMIS GH-Mental (47.5), where scores remained lower than the general population mean (T = 50). Except for the PROMIS-PF, no age-related differences were observed. Conclusions: On average, eSTS patients recover well physically from surgery, yet the mental component demonstrates no progression, irrespective of age. These results underscore the importance of comprehensive care addressing both physical and mental health.

HIGH-INTENSITY WALKING EXERCISE REDUCES FRAILTY AMONG PREFRAIL AND FRAIL OLDER ADULTS

Abstract Exercise is the most recommended therapeutic intervention for frailty, yet the precise exercise prescription remains elusive. The purpose of this study was to use a cluster randomized controlled trial to evaluate the impact of exercise intensity on frailty in older adults. We tested a high (HIW) vs. low (LIW) intensity walking intervention among n=165 pre-frail and frail residents from n=12 independent living communities. The 3x/week, 4 month supervised intervention targeted &amp;gt;70% heart rate reserve for HIW participants and &amp;lt; 50% heart rate reserve for LIW participants. The primary outcome was frailty category improvement as assessed by the SHARE-FI. We measured usual and fast gait speed, 6-minute walk test, Timed Up and Go, SPPB, Berg Balance, Falls Efficacy, and PROMIS Global Health. Participants were on average 79 years of age, 79% female, and 75% white. We analyzed outcomes based on a modified intention-to-treat principle using a linear or generalized linear mixed model with fixed arm, baseline outcome measure score and random cluster effects. We found increased odds of improving at least one SHARE-FI frailty category in the HIW group (OR=2.91 [reference group=LIW], 95% CI 1.19,7.13, p=0.02, N=103). Among secondary outcomes, there was a significant difference in change in usual gait speed (mean difference = 0.078, 95% CI = 0.026, 0.131, Hochberg adjusted P-value = 0.0357), as well as 6-minute walk test (mean difference = 160.72, 95% CI = 69.2, 252.2, Hochberg adjusted P-value = 0.0075). Results suggest that older adults should engage in more intensive/higher heart rate cardiovascular exercise to reduce frailty.

A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process.

Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method. Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set. In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually. A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.

Improved Post-Traumatic Stress Disorder Symptoms and Related Sleep Disturbances after Initiation of Medical Marijuana Use: Evidence from a Prospective Single Arm Pilot Study

Introduction: Post-traumatic stress disorder (PTSD) is a debilitating disorder experienced by a subgroup of individuals following a life-threatening trauma. Several US states have passed laws permitting the medical use of marijuana (MMJ) by individuals with PTSD, despite very little scientific indication on the appropriateness of marijuana as a therapy for PTSD. This prospective pilot study of adults with confirmed PTSD in Florida (FL) investigated whether PTSD symptoms, sleep quality, affect, and general physical and mental health/well-being improved post-initiation of MMJ treatment. Methods: Participants, N = 15, were recruited from two MMJ clinics in Gainesville and Jacksonville, FL. To be eligible, participants had to be 18 years of age or older, not currently on MMJ, and willing to abstain from recreational marijuana, if using any, until the State Medical Cannabis Card was obtained, screen positive for PTSD. Participants were assessed at baseline (pre-MMJ initiation) and 30 and 70 days post-MMJ initiation using the Pittsburgh Sleep Quality Index (PSQI), PTSD Checklist for DSM-5 (PCL-5), Positive and Negative Affect Schedule (PANAS), PROMIS Global Health V1.2, and semi-structured marijuana and other substance use assessment. Results: PTSD symptom severity as measured by total PCL-5 score improved significantly at 30- and 70-day follow-ups. Similarly, statistically significant reductions in nightmares were reported at 30- and 70-day follow-ups. Corresponding improvements in sleep were noticed with participants reporting increased duration of sleep hours, sleep quality, sleep efficiency, and total PSQI score. Likewise, negative affect and global mental health improved significantly at follow-up. According to the post hoc analyses, the most statistically significant changes occurred between baseline and 30-day follow-up. The exception to this pattern was nightmares, which did not show significant improvement until day 70. Conclusion: The findings of this study highlight the potential of MMJ in improving patient outcomes for those with PTSD, particularly concerning sleep disturbances, which often do not respond to currently available treatments.

Abstract 18758: Pain and Quality of Life in Older Adults With Advanced Heart Failure

Background: Over 80% of people with advanced heart failure (HF) experience pain; however, little is known about the relationship between pain and quality of life (QoL). Research Objectives: Examine the relationships between: 1) Total Pain Theory constructs and 2) pain and QoL across time. Methods: A secondary analysis of usual care participants in the ENABLE CHF-PC, a palliative care RCT (ClinicalTrials.gov: NCT02505425). Primary outcome was pain (PROMIS Pain Intensity &amp; Interference). Total Pain constructs include physical and mental health (PROMIS Global Health 10), social support (Multidimensional Scale of Perceived Social Support), and spirituality (Negative Religious Coping). Mixed models assessed the relationships between pain and Total Pain constructs. Cross-lagged path analysis examined the temporal relationship between pain and QoL (baseline, 24-weeks, 48-weeks). Results: Of 205 usual care participants, mean age was 64.15 (SD 9.14), 108 (52.7%) men, and 111 (54.1%) African American. At baseline, participants’ QoL was poor (35.98, SD 10.7) with greater pain interference (54.5, SD 10.70) but not pain intensity (45.09, SD 10.47) compared to the general population. Among Total Pain constructs, only physical health was significant. As physical health decreased, pain intensity (b = -0.80, SE = 0.09, CI = -0.99, -0.62, p &lt; .001) and pain interference (b = -0.69, SE = 0.10, CI = -0.89, -0.49, p &lt; .001) increased. An unadjusted path analysis suggested variable magnitude temporal relations: a significant, large relationship between pain intensity and QoL at baseline (standardized cov. = 0.53), but medium-sized across baseline to 24-weeks (B = 0.28), and across 24- to 48-weeks (B = 0.32). Relationship between pain interference and QoL was also significant at baseline (standardized cov. = 0.54) and across baseline to 24-weeks (B = 0.41). Conclusions: Variability in magnitude of relationships between pain intensity and interference and QoL demonstrates the complex nature of pain in advanced HF.

Financial Toxicity and Time Toxicity in Multiple Myeloma: Prevalence, Predictors, and Impact on QOL

Introduction: Patients with multiple myeloma (MM) are at ongoing risk of financial toxicity (FinTox) from medication costs and lost productivity (Richter CLML 2020, Fiala CLML 2023). Given MM's incurable nature with ongoing monitoring and supportive care, time toxicity (TimeTox) from frequent healthcare interactions may persist into the maintenance phase as well. The prevalence, predictors, and impact of FinTox and TimeTox on QOL have not been fully characterized in this population. Methods: We surveyed (by mail and online) English-speaking MM patients who had undergone auto-transplantation at our US institution. Survey questions included financial stressors (COST inventory), frequency/convenience of in-person vs telehealth visits, and physical/mental QOL [PROMIS Global Health, with minimum clinically important difference (MCID) 5]. FinTox+ was defined as COST score &amp;lt;23 (25th percentile). After discussions with local patients, we defined TimeTox+ as either (a) MM-related interactions (including in-person visits, telehealth / telephone calls, infusions, and labwork) ≥1x per week on average and/or (b) in-person MM-related interactions ≥1x per month in far-residing patients (defined as patients who reported that interactions with their primary MM provider usually required ≥4 hours away from home). Variables were compared descriptively using Fisher's and rank-sum test. Predictors of FinTox and TimeTox were identified using adjusted multivariable logistic regression. Results: Of 670 patients, 252 (38%) completed the survey as described in Table 1. 64% were on maintenance, 21% on observation, and 16% on active treatment for relapsed MM. Far-residing patients comprised 20% of respondents. Among n=207 (82%) who completed the COST inventory, the median COST score was 31 (IQR 23-37). Of these respondents, 22% (n=45) were FinTox+. Most (59%) reported monthly MM-related out-of-pocket costs &amp;lt;$100, but 15% reported MM-related expenses ≥$500 monthly. While physical QOL scores were comparable between FinTox+ and FinTox- respondents, FinTox+ respondents had significantly worsened mental QOL (median PROMIS scores 45.8 vs 50.8, p &amp;lt;0.01). Time toxicity was reported by 40% (n=101) overall, including 14% of 51 respondents on observation, 37% of 155 respondents on maintenance, and 82% of 38 respondents with relapse. Unsurprisingly, TimeTox was more prevalent among far-residing respondents (73% vs 31%, p&amp;lt;0.001). Far-residing respondents were less likely to rate in-person visits as convenient (Figure 1A, p&amp;lt;0.001), with 62% (far-residing) vs 89% (near-residing) agreeing that in-person visits were easy to attend. However, near-residing and far-residing respondents had similar frequencies of in-person visits (Figure 1B, p=0.37). Telehealth visits were rated similarly conveniently by both far-residing and near-residing respondents (Figure 1C, p=0.77). Telehealth visits were more common in the far-residing cohort (Figure 1D, p=0.01), with 54% vs 32% of respondents reporting ≥1 telehealth visit in the past year. Median physical QOL (44.9 vs 47.7) and mental QOL (48.3 vs 50.8) were both significantly worse in TimeTox+ respondents but within the MCID. In adjusted multivariable analyses, predictors of FinTox were younger age (OR=1.10, p&amp;lt;0.001) and annual income &amp;lt;$50K (OR=6.29, p&amp;lt;0.001). Predictors of TimeTox were disease status (reference: observation; relapsed OR=22.69, maintenance OR=3.21, p&amp;lt;0.001) and far-residing status (OR=5.72, p&amp;lt;0.001). Conclusion: In our study of over 250 patients with MM, 22% reported FinTox while 40% reported TimeTox. FinTox was associated with lower income as well as a clinically meaningful decrease in mental QOL, suggesting benefit for FinTox screening and early referral to financial navigation services. TimeTox was reported by over a third of patients on maintenance, and further research into reversible drivers of TimeTox is ongoing: for example, workflows to increase local lab monitoring and decrease in-person visit frequency for patients on oral maintenance. Limitations of our study include selection bias, recall bias, and lack of generalizability to transplantation-ineligible patients. Additionally, universal definitions for FinTox and TimeTox have not yet been standardized. However, this is the largest study of these toxicities in MM to date and serves as a starting point for larger more definitive prospective research.

Quality of Life and Comorbidities of Adult Survivors of Allogeneic Hematopoietic Cell Transplant Versus Their Siblings

Background: Survivors of allogeneic hematopoietic cell transplant (allo-HCT) are at risk of developing chronic health conditions. Prior studies have shown that survivors of allo-HCT in childhood/young adulthood who mainly received high dose total body irradiation (TBI)-based conditioning experience excess health conditions and more distress vs. their siblings. In recent years, allo-HCT is offered to adults of increasing age and there has been increasing use of chemotherapy +/- low dose TBI conditioning rather than high dose TBI. We set out to describe and compare the QoL and comorbidities of adults who underwent allo-HCT with chemotherapy +/- low dose TBI conditioning vs. their siblings. Methods: Allo-HCT recipients attending 1 of 2 survivorship clinics at ≥2 years post-HCT without active cGVHD or relapse, were enrolled. Beginning in 2023, participants were asked to forward an electronic version of the study survey to their biological sibling(s). The survey includes the PROMIS-Global Health instrument: raw scores are converted to a mental (MH) and physical health (PH) subscale T-score (population mean 50/SD 10). Comorbidities were scored with a published post allo-HCT morbidity index. Associations between MH and PH-related QoL, comorbidities, and patient/transplant-related variables were investigated with linear regression. Patient and sibling comparisons were made with paired sample and chi-square tests. A significance level of &amp;lt;0.05 was statistically significant &amp; a difference in QoL T-score of 5 was clinically significant. Results: Of 330 patients approached during their clinic visit, 320 consented to participate (97%). To date, 105 siblings of 57 recipients have been sent surveys and 47 siblings (45%) of 32 recipients (56%) have completed the survey. Among all recipients, median age at HCT is 47 (IQR 35-57) with 21% ≥60 years old, 48% are female, 78% are Caucasian, 69% are college educated or more &amp; 51% are working full/part-time. Median time post-HCT is 9 years (IQR 6-14). The mean PH T-score is 48.5 (SD 8.6). In the multivariable model, total number of comorbidities (p&amp;lt;0.01) and a work status of disability (p&amp;lt;0.01) are associated with inferior PH QoL. The mean MH T-score was 49.1 (SD 8.4). In the multivariable model, total number of comorbidities (p&amp;lt;0.01) and a work status of disability (p&amp;lt;0.01) are associated with inferior MH QoL. HCT characteristics, including history of moderate-severe cGVHD, and demographic characteristics are not associated with either QoL subscale. Among all recipients, the median number of comorbidities is 3 (IQR 1.5-4). The most common comorbidities include hyperlipidemia (39%), hypertension (25%) &amp; hypothyroidism (24%). At least one severe comorbidity (vascular disease, chronic heart/lung/liver/kidney disease or subsequent malignancy) is present in 23% of patients. In multivariable analysis, a greater number of years post-HCT is associated with a greater number of comorbidities (p=0.03) and full/part-time work status is associated with fewer comorbidities (p=0.01). In the sibling-recipient comparison, median age of siblings and recipients is 55 (IQR 37-66) &amp; 54 (IQR 40-64), respectively. The MH QoL of recipients is statistically, but not clinically, better than their siblings: T-score 52.9 (SD 7.1) versus 49.9 (SD 6.9), respectively, p=0.04. The PH QoL of recipients was not significantly different than their siblings: T-score 52.6 (SD 5.6) versus 50.7 (SD 8.2), respectively, p=0.23. Recipients are suffering from significantly more comorbidities vs. their siblings: median 2.5 (IQR 1.8-4) versus 1 (IQR 0-3), respectively, p=0.03. The prevalence of ≥1 severe comorbidity is greater in recipients vs. siblings, but not statistically significant (13% vs. 2%, p=0.06). Conclusion: Adult recipients of allo-HCT, living without cGVHD or relapse and conditioned without high dose TBI, in aggregate experience similar QoL but suffer excess chronic health conditions as compared to their siblings. One in 4 recipients are suffering from ≥1 severe chronic health condition(s). Time post-HCT is associated with comorbidities, suggesting that recipients continue to accumulate health conditions in the years post-HCT. Number of comorbidities, rather than transplant and demographic factors (including prior cGVHD), is associated with impaired MH and PH QoL. Preventative care after allo-HCT is critical, even in those receiving HCT in adulthood without high dose TBI.

The effects of medical comorbidity, cognition, and age on patient-reported outcomes in Parkinson's disease

ObjectiveThe purpose of this cross-sectional study was to compare the independent contributions of medical comorbidity, cognition, and age on patient-reported outcomes in Parkinson's disease (PD). Methods572 PD patients completed the Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v2.0 Profile (physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, pain interference) and PROMIS Global Health (mental health and physical health) scales. Comorbidity was measured with the Cumulative Illness Rating Scale–Geriatric (CIRS-G) and cognition with the Montreal Cognitive Assessment (MoCA). Multiple regression models examined the 9 PROMIS measures as predicted by comorbidity, cognition, and age, adjusting for demographic and clinical characteristics (UPDRS and disease duration). ResultsComorbidity was associated with poorer outcomes in all nine PROMIS domains. Cognition was associated with two of nine domains: physical function and anxiety. Age was associated with five domains: anxiety, depression, sleep disturbance, satisfaction with participation in social roles, and global mental health. Comorbidity showed greater effects on all nine domains than cognition or age (higher standardized beta coefficients). ConclusionMedical comorbidity, cognition, and age have different impacts on patient-reported outcomes in PD. Medical comorbidity has a greater impact than either cognition or age on a range of patient-reported physical and mental health domains. Medical comorbidity is an important contributor to the patient's perspective of their physical and mental health.

Poster 365: Initial outcomes after unicompartmental tibiofemoral bipolar osteochondral and meniscus allograft transplantation in the knee using high-viability tissues

Objectives: To report initial outcomes for unicompartmental tibiofemoral bipolar osteochondral allograft transplantation (OCAT) with meniscus allograft transplantation (MAT) using fresh high-cell- viability tissues for treatment of knee articular cartilage defects with meniscus deficiency. The study was designed to test the hypothesis that primary OCAT and MAT using high-viability tissues will be associated with successful short-term (2 to 6 years) outcomes based on statistically significant and clinically meaningful improvements in pain and function in the majority of patients. Methods: With IRB approval and documented informed consent, patients who underwent primary OCAT and MAT for large articular cartilage defects with meniscus deficiency involving at least one femoral condyle, tibial plateau, and meniscus, all of which were opposing (bipolar). Surgeries were defined as Uni when patients underwent OCAT and MAT involving one femoral condyle, tibial plateau, and meniscus in the same compartment or Uni-Plus when patients underwent Uni OCAT and MAT with at least one other OCA transplant to treat a large (&gt;2.5cm2) grade III or IV focal articular cartilage defect of the patella, trochlea, femoral condyle, or tibial plateau. Patients who had at least 2-year follow up data regarding complications, failures, adherence, and patient reported outcome measures (PROMs) were analyzed. Patients who required OCA and/or MAT revision or artificial arthroplasty were defined as treatment failures. Patient reported outcome measures (PROMs) including VAS pain, IKDC, SANE, PROMIS Global Health and Physical Function, were collected at 3 and 6 months and then yearly after transplantation. Outcomes were compared based on patient sex, age, and BMI, tobacco use, previous and concurrent procedures, differences in number of surfaces transplanted (Uni vs Uni-Plus), and adherence. Significance was set at P &lt; 0.05. Differences in PROMs were also assessed for minimum clinically important differences. Results: Seventy-six patients (n=52 males; 68%) met inclusion criteria (mean followup = 52 months; median = 56 months; range, 24-70 months). Mean age was 41.1 years (range, 15-69 years) and mean body mass index (BMI) was 28.9 kg/m2 (range, 17-46). Forty-eight patients underwent OCAT(s) in addition to Uni (Uni-Plus). Eight patients (10.5%) underwent concurrent ACL reconstruction, and 28 patients (36.8%) underwent ipsilateral lower extremity osteotomy in order to address co-morbidities. Twenty-three patients (30.3%) were documented to be non-adherent during the first year after transplantation. Initial (&gt;2-year) success rate was 77.6% with 8 patients (10.5%) undergoing OCA and/or MAT revision and 9 patients (11.8%) converted to arthroplasty. Variables associated with increased risk for treatment failure (revision or arthroplasty) included ipsilateral osteotomy (p = .046; OR = 3.3), ipsilateral concurrent procedure (p = .0057; OR = 5.5), and non-adherence (p = .0009; OR = 7.2). None of the patients undergoing OCA and/or MAT revision surgery in the present study required arthroplasty at the time of data analysis such that overall success rate for primary and revision unicompartmental bipolar OCA plus MAT was 88.2%. There were statistically significant (p &lt; .0001) and clinically important improvements from preoperative levels for all patient reported outcomes at each annual follow-up time point. Conclusions: Unicompartmental tibiofemoral bipolar osteochondral and meniscus allograft transplantation can result in successful short-term (2 to 6 years) outcomes and satisfaction in the majority (78%) of patients. Primary MOPS-preserved OCAT and MAT for treatment of femoral condyle and tibial plateau articular cartilage defects with concurrent meniscus deficiency was associated with statistically significant and clinically meaningful improvements in patient-reported measures of pain and function.