Measurement Information System Global Health Research Articles

Incorporating routine mental health assessment into survivorship.

350 Background: Cancer survivors experience higher rates of mental health (MH) symptoms including anxiety and depression compared to the general population. To address this in our longitudinal survivorship clinic, the Patient-Reported Outcome Measurement Information System (PROMIS) Global health measure is routinely administered and reviewed at point-of-care with psychosocial status incorporated in survivorship care (SC) plans. The uncertainly and social isolation that occurred during the COVID-19 pandemic increased the risk of adverse MH outcomes. This study examines PROMIS Global MH subscale scores and discussions of MH prior to, during and following the pandemic. Methods: Patients who had at least one SC visit and a completed PROMIS-Global measure within 22 months prior to and after the Massachusetts COVID-19 state of emergency (SoE) (March 20, 2020-June 15, 2021) were evaluated. MH subscale scores were calculated using scoring algorithms. A paired t-test was used to compare scores from each time period. Patient characteristics were summarized from the clinic’s database. Clinician notes were analyzed to determine if MH discussions occurred. Results: All 41 patients had been diagnosed during childhood, adolescence, or young adulthood (median age of 12 years, range 0-36), with a median current age of 31 years (range 19-54). 61% were diagnosed with leukemia or lymphoma, 66% were female, 80% were White. Patients had been in the clinic from 0-7 years, with 15% of the initial visits occurring within the pre-SOE period. At time of entry into clinic 73% had a known late effect, 32% had a comorbidity and 29% had a known MH disorder. At some point in their SC, 41% of patients had been encouraged to pursue MH care. During the SoE, those with MH concerns were triaged for outreach; 78% of patients received virtual and/or in-person visits; PROMIS was not collected during virtual visits. Mean PROMIS-Global MH subscale scores were not statistically different by time period: 49.9 mean (9.3SD) pre vs 48.3 mean (10.1SD) post SoE (p=0.10) and did not differ from population norms. MH discussions occurred prior to (54%), during (53%) and following (49%) the SoE. Conclusions: Despite the additional barriers to providing care brought on by the pandemic, the MH tools in place supported quick identification of patients at risk and ongoing MH discussions. Consistent inclusion of MH assessment into SC should be encouraged as part of ongoing quality care, not only in response to the pandemic.

Translation and cross-cultural adaptation of the ICHOM standard set for stroke: the Dutch version.

The International Consortium for Health Outcomes Measurement (ICHOM) developed a standard set of patient-centered outcome measures for use in stroke patients. In addition to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health, it is comprised of 25 questions that are not part of a specific questionnaire. This study aimed to translate these 25 single questions into Dutch. Two native Dutch-speaking translators independently translated the original ICHOM questions into Dutch. A consensus translation was made by these translators and a third person. This translation was subsequently translated back to English independently by two native English-speaking translators. Afterwards a pre-final version was made by consensus of a committee. After field-testing among 30 stroke patients, a final version was made. The forward and backward translations led to eight cross-cultural adaptations. Based on the interviews with stroke patients, 12 questions were changed to enhance comprehensibility leading to a final Dutch translation of the 25 single questions. A Dutch translation of the 25 single questions of the ICHOM Standard Set for Stroke was developed. Now a complete ICHOM Standard Set for Stroke can be used in Dutch populations allowing comparison and improvement of stroke care.

Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction.

Disorders of the Gut-Brain Interaction (DGBIs) account for 50% of pediatric gastrointestinal (GI) consultations. Children with DGBIs have worse quality of life (QoL) than those with organic GI disorders such as inflammatory bowel disease and gastroesophageal reflux disease. Pediatric DGBIs patients, especially those with chronic abdominal pain (AP), have impaired QoL and increased psychological distress in the form of anxiety and depression. Percutaneous Electrical Nerve Field Stimulation (PENFS) therapy has been shown to be effective in improving symptoms and functioning in children with DGBIs. The treatment's impact on these patients' QoL is unknown. This prospective study evaluated changes in QoL, gastrointestinal symptoms, functional disability, somatization, global health, anxiety, and depression in patients aged 11-18 years who received PENFS therapy (IB-stim, NeurAxis, Versailles, IN) for treatment of pain related DGBIs, once a week for four consecutive weeks. This study included 31 patients with an average age of 15.7 years (SD = 2); 80.6% were female. After PENFS therapy, patients reported significant reductions in abdominal pain, nausea severity, functional disability, somatization, and anxiety from baseline to week 4 (p < 0.05). Parents reported significant improvement in their child's QoL regarding physical function, psychosocial function, and generic core scale scores (p < 0.05). Parents also noted reduced abdominal pain, functional disability, and somatization. Average scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale significantly improved based on both patient and parent reports (p < 0.05). Our patients' QoL was significantly lower than healthy controls at baseline and after treatment (p < 0.05). Our research demonstrates that PENFS significantly enhances the QoL of children suffering from pain-related DGBIs, in addition to improvement in GI symptoms, daily functioning, somatization, global health, and psychological comorbidities. These findings demonstrate the effectiveness of PENFS and its potential to alleviate the suffering of countless children.

Do Patients Living in Rural Areas Report Inferior 1-Year Outcomes After Total Knee Arthroplasty? A Matched Cohort Analysis

BackgroundRural status has been associated with poor outcomes for several health problems, but its relationship and outcomes following total knee arthroplasty (TKA) has not been fully characterized. Patient-reported outcomes (PROs) are key measures of success following TKA. Therefore, this matched cohort study was designed to test the hypothesis that patients who live in rural settings will report significantly worse PRO scores 1 year after TKA when compared to those who live in urban or suburban settings. MethodsPatients undergoing TKA at our institution were categorized into urban, suburban, and rural cohorts based on Rural Urban Commuting Area scores using reported living setting zip codes. Cohorts were matched for body mass index classification. Demographic data were extracted from the medical records, and PRO data (Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS JR), Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health and Mental Health, University of California, Los Angeles (UCLA) Activity Score, and Visual Analog Scale Pain were collected preoperatively and 1-year postoperatively. Comparisons across living settings were made using analysis of variance (ANOVA) tests or Chi-square tests. A total of 882 TKA patients (n = 294 per cohort) were analyzed. ResultsPatients living in urban areas had significantly lower preoperative pain scores compared to suburban and rural residents. All measured PROs significantly improved from preoperative levels at 1 year post-TKA with no significant differences among living setting cohorts. ConclusionsIn cohorts matched for body mass index, living in a rural setting was not associated with inferior PROs 1 year after TKA. Level of evidenceLevel 4, retrospective cohort study.

Determinants of post-stroke cognitive impairment and dementia: association with objective measures and patient-reported outcomes

BackgroundPost-stroke cognitive impairment and dementia (PSCID) is a sequel of ischemic stroke (IS), highly prevalent and linked to poor long-term outcomes. Thus, early recognition of the clinical determinants of PSCID is urgent for identifying high-risk individuals who are susceptible to PSCID. And investigating objective measures of PSCID in relation to patient-reported outcome measures (PROMs) is essential for understanding the impact of IS. Here we identify the clinical determinants associated with PSCID and the relationship of PSCID to patient-reported outcomes in a population with IS.MethodsThis was a cohort study. We enrolled 138 patients who were admitted to our hospital between February 2017 and February 2020, with IS and no pre-stroke diagnosis of dementia. Clinical variables were acquired on admission. At 3 months, patients underwent a follow-up evaluation including the Telephone Interview for Cognitive Status (TICS), modified Rankin scale (mRS), Barthel Index (BI), and PROMs, using the Patient-Reported Outcomes Measurement information System Global Health (PROMIS GH). MCI/Dementia was defined as a TICS score of &amp;lt;36. Regression analyses were used to identify clinical, functional, and patient-reported outcome determinants of the 3-month TICS score. Analyses were adjusted for age, stroke severity, and prior IS.ResultsAt follow-up, 113 participants (82%) were found to have MCI/Dementia. Patients with PSCID were more likely to be older, and at 3-months post-stroke they had lower rates of PROMIS GH T Mental (mean 47.69 vs. 52.13) and T Physical (mean 46.75 vs. 50.64). In multivariable linear regression analyses, increasing age (β = −0.07, p = 0.03) and Peripheral Artery Disease (PAD; β = −3.60, p = 0.03) were independently associated with a lower TICS score. Functional and patient-reported outcomes were also associated with worse TICS, including mRS ≥ 2, BI, T Mental, Global Mental, T Physical, and Global Physical in adjusted analyses. Individual components of PROMs were also associated with TICS, including quality of life, mental health, social satisfaction, and physical activities.ConclusionsIn patients with IS, increased age and a pre-admission diagnosis of PAD are independently associated with worse objective measures of PSCID. Worse functional and patient-reported outcomes are also strongly linked to PSCID.

Long-Term Outcomes of Pediatric Traumatic Brain Injury Following Inpatient Rehabilitation.

Assess residual disability in youth with traumatic brain injury (TBI) treated in a pediatric inpatient rehabilitation unit and examine associations of disability with inpatient status and measures of concurrent functioning. Large, urban, quaternary care children's hospital in the Midwestern United States. Forty-five youth aged 6 to 18 years treated in an inpatient rehabilitation unit for mild-complicated to severe TBI at a minimum of 12 months postdischarge (mean = 3.5 years). Retrospective chart review of clinical data collected from standard clinical care at admission and discharge combined with follow-up data examining current functioning at the time of study enrollment. Glasgow Outcome Scale-Extended, Pediatric Revision (GOS-E Peds), Neurology Quality of Life Measurement System Short Form (NeuroQOL) Social Interaction with Peers and Cognitive Short Forms, Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Strengths and Difficulties Questionnaire, and the Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2). Based on parent report at follow-up, 62% of the children had residual TBI-related disabilities on the GOS-E Peds, while 38% reported "good recovery." Children with residual disability also reported more long-term problems in overall health, social relationships, emotional regulation, behaviors, and executive functioning than those with no residual disability. Measures of functional independence and cognitive recovery at discharge were associated with these impairments. More than half of the children with TBI in this study had residual disability more than 1 year after inpatient rehabilitation. Findings highlight the associations between measures of functional independence and cognitive recovery during inpatient rehabilitation with later outcomes and underscore the need for continued services to support the needs of children with TBI following their inpatient rehabilitation stay.

What is the Impact of Social Deprivation on Mental and Physical Health Before and After Primary Total Knee Arthroplasty?

The purpose of the present study was to investigate the relationship between socioeconomic status and Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) scores before and after primary total knee arthroplasty (TKA). We hypothesized that patients with greater social deprivation would have lower PROMIS-GH scores at 3 months and 1 year following primary TKA. We retrospectively reviewed data from patients who underwent unilateral primary TKA and completed PROMIS-GH preoperatively and at 3 months (n= 257) or 1year (n= 154) postoperatively. Area Deprivation Index (ADI), calculated from 9-digit zip codes, was used to measure social deprivation. Participants were grouped into quartiles by ADI score. Minimal clinically important difference in PROMIS-GH mental (PROMIS-MH) and physical health (PROMIS-PH) component scores were compared between ADI groups. Participants in the highest ADI quartile (most disadvantaged) had significantly lower PROMIS-MH and PROMIS-PH scores at every time point relative to the lowest ADI quartile (least disadvantaged) (P < .05 for all). Both ADI groups experienced significant improvements in PROMIS-PH following TKA (P < .001 for all), but not in PROMIS-MH (P > .05 for all) at 3-months and 1-year postoperatively. Magnitude of improvement in PROMIS-PH and rates of achievement of minimal clinically important difference did not significantly differ between ADI groups (P > .05 for all). Socially disadvantaged patients benefit equally from primary TKA but are more likely to have persistently lower 1-year postoperative PROMIS-GH scores relative to less disadvantaged patients. Social deprivation should be accounted for when using PROMIS-GH to assess clinical outcomes for research and quality measures. IV, retrospective cohort study.

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

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

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

The Impact of Sinonasal Symptoms in Relation to Potentially Life-Threatening Comorbidities.

While general health may be influenced by sinonasal symptoms, their effects may be overshadowed by comorbid states which may be more serious. To assess the validity of this postulate, we measured the extent to which sinonasal symptoms and concurrent conditions influenced general health. Observational outcomes study. Academic medical center, community care sites. Adults with sinonasal symptoms completed the 22-item Sinonasal Outcome Test, along with the Patient-Reported Outcomes Measurement Information System global health short form. Comorbidities were categorized with the Deyo modification of the Charlson comorbidity index. Multivariate regression analyses were utilized to determine the relative impact of sinonasal symptoms and concurrent comorbid conditions on general health. Data from 219 consecutive patients demonstrated that sinonasal symptoms were associated with significantly diminished general physical (β = -1.431, p < .001), mental (β = -1.000, p < .001), overall (β = -1.026, p < .001), and social health (β = -0.872, p = .003), regardless of the presence of potentially life-threatening comorbid conditions. Comorbid conditions included cardiovascular disease, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer, diabetes mellitus, and hepatic disease. The effect of sinonasal symptoms was neither subsumed nor overshadowed by the effects of comorbid states. Nasal, ear, sleep, and psychological domain scores were also associated with general physical, mental, and global health while adjusting for the impact of comorbidities. Sinonasal symptoms have a substantial effect on general health which is not subsumed by the presence of potentially life-threatening concurrent comorbidities. These data may help support the importance of funding and resource allocation for conditions causing sinonasal symptoms.

A randomized phase III clinical trial of yoga for chemotherapy-induced peripheral neuropathy treatment.

TPS12143 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, painful, and debilitating side effect of many standard chemotherapy regimens. CIPN symptoms include pain, paresthesia, and muscle weakness, and patients may exhibit functional decline and lower quality of life. Our prior study showed more than half of breast cancer survivors experience persistent CIPN up to a mean duration of 5.6 years, which is associated with a doubled fall risk. Identifying non-pharmacological approaches to reduce CIPN symptoms and improve cancer survivors’ outcomes is urgently needed. Yoga is a meditative movement therapy that includes stretching, and flexibility and balance training. Our pilot study (NCT03292328) demonstrated that yoga reduced CIPN-related symptoms, and improved quality of life and functional reach scores compared to waitlist control. We hypothesize that yoga can reduce CIPN symptoms, improve function, and reduce the risk of falls. Methods: We are conducting a three-arm randomized education and usual care-controlled trial in cancer survivors with chronic CIPN pain at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. Participants in the intervention arm will receive twice-weekly one-hour Hatha yoga classes taught virtually by MSK instructors and practice yoga at home daily for eight weeks. Participants in the education control arm will receive one-hour virtual education classes twice per week taught by an MSK instructor for eight weeks. Participants in the usual care arm will continue their usual care for CIPN for eight weeks. The primary endpoint is the Brief Pain Inventory-Short Form average pain item at weeks 8 and 24. Secondary outcomes include the Neuropathic Pain Scale, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, Patient-Reported Outcomes Measurement Information System Global Health, Brief Fatigue Inventory, Insomnia Severity Index, Hospital Anxiety and Depression Scale, Quality of Life Questionnaire of CIPN twenty-item scale, functional assessments, and quantitative sensory testing at weeks 0, 4, 8, 12, 18, and 24. Eligibility criteria include: 1) Moderate-to-severe CIPN pain, defined by a score of 4 or greater on a 0-10 numerical rating scale; 2) completion of neurotoxic chemotherapy at least three months prior; 3) no changes in anti-neuropathy medications within three months of enrollment; and 4) changes in balance and functionality. As of February 2023, we have accrued 64 of our total target of 268 participants. We anticipate completing accrual in March 2025. We have 35 participants in the yoga intervention, 15 participants in education control, and 14 participants in usual care control. The majority (89%) of participants are female and 11% are male. 78% of our participants are white, 16% are black or African American, 1% are Asian, and 5% identify as more than one race. Clinical trial information: NCT05121558 .

Randomized Controlled Trial of Isha Kriya versus Observation to Improve Quality of Life in Hematopoietic Cell Transplantation Recipients

Hematopoietic cell transplantation (HCT) impacts its recipients' quality of life (QoL). Few mindfulness-based interventions (MBI) in HCT recipients have shown feasibility, but heterogeneous practices and outcome measures have questioned the real benefit. We hypothesize that a self-guided meditation as a mobile app will improve QoL in the acute HCT setting. This single-center, open-label, randomized controlled trial was conducted in 2021-2022. The study was cleared by Institutional Ethics Committee and registered at the Clinical Trial Registry of India. Recipients were included after obtaining written informed consent. Recipients without access to smartphones or regular practitioners of yoga, meditation, or other mind-body practice were excluded. Autologous + allogeneic HCT recipients of age ≥ 18 years were included in the study. Recipients were randomized to the control arm or Isha kriya arm in a 1:1 ratio stratified by type of transplant. Patients in the Isha kriya arm were recommended to perform the kriya twice daily from pre-HCT to day+30 post-HCT. Isha Kriya is 12-minute guided meditation based on the principles of yoga, focussing on breath, awareness, and thought. The primary endpoint was the QoL summary scores assessed by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) and the Patient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) questionnaires. The secondary endpoints were the difference in QoL domain scores. The validated questionnaires were self-administered before the intervention, day +30, and day +100 after HCT. The analysis of endpoints was done on an intention-to-treat basis. Domain and summary scores were calculated for each instrument as recommended by the developers. A p-value <0.05 was used for statistical significance, and cohen's d effect size determined clinical significance. A total of 72 HCT recipients were randomized to the Isha kriya and the control arm. Patients in both arms were matched for age, gender, diagnosis, and type of HCT. Both arms had no difference in the pre-HCT QoL domain, summary, and global scores. Post-HCT at day+30, there was no difference in the mean FACT-BMT total scores (112.9 ± 16.8 vs.101.2 ± 13.9, p = 0.2) and the mean global health scores (Global mental health 45.1 ± 8.6 vs. 42.5 ± 7.2, p = 0.5, global physical health 44.1 ± 6.3 vs. 44.1 ± 8.3, p = 0.4) in the two groups. There was similarly no difference in the physical, social, emotional, and functional domain scores. However, the mean BMT-subscale scores, which addresses BMT-specific quality-of-life concerns, were statistically and clinically significantly higher in the Isha kriya arm than the control arm (27.9 ± 5.1 vs. 24.4 ± 9.2, p = 0.03, Cohen's d 0.5, medium effect size). This effect was transient as the day+100 scores showed no difference (28.3 ± 5.9 vs. 26.2 ± 9.4, p = 0.3). Isha kriya did not improve the FACT-BMT total and global health scores in the acute HCT setting. However, practicing Isha kriya for a month did show a transient improvement in the FACT-BMT subscale scores on day +30 but not on day +100 post-HCT.

The health impact of long COVID: a cross-sectional examination of health-related quality of life, disability, and health status among individuals with self-reported post-acute sequelae of SARS CoV-2 infection at various points of recovery

ObjectiveThe novel Coronavirus (COVID-19) has continued to present a significant burden to global public health efforts. The purpose of this study was to estimate the health-related quality of life, disability, and health status of individuals with self-reported long COVID at various lengths of recovery.MethodsWe conducted a cross-sectional online survey of individuals with self-reported long COVID. Participants were asked to complete the five-item EuroQOL EQ-5D-5L and EQ visual analog scale, the 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0 and the 10-item Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1.2 short form. Descriptive and inferential statistics were used to characterize the responses and differences across groups.ResultsEighty-two participants from 13 countries completed the EQ-5D-5L, 73 completed the WHODAS 2.0 and 80 participants completed the PROMIS. The mean EQ-5D-5L utility score was 0.51. The mean WHODAS score was 49.0. In the previous 30 days, participants reported their symptoms affected them for a mean of 24 days, they were totally unable to carry out usual activities for 15 days, and they cut back or reduced activities for 26 days. The mean PROMIS physical health and mental health scores were 10.7 and 8.6, respectively, corresponding to below-average health. No significant differences were detected across time or according to severity of acute infection.ConclusionsLong COVID presents a significant chronic health burden to adults in the US and abroad. This health burden may persist for many months post-acute infection.

The Fibrodysplasia Ossificans Progressiva Physical Function Questionnaire (FOP-PFQ): A patient-reported, disease-specific measure.

To assess the reliability and validity of age-specific versions of the Fibrodysplasia Ossificans Progressiva Physical Function Questionnaire (FOP-PFQ), developed to measure the impact of FOP on physical function and activities of daily living. FOP-PFQ development included a literature review, two iterative phases of qualitative work involving individuals with FOP, and clinical expert review. The analysis used pooled FOP-PFQ data from an FOP natural history study (NCT02322255), a patient registry (NCT02745158), and phase II trials (NCT02190747; NCT02279095; NCT02979769). Item-level and factor analysis informed item retention and determined factor structure. Reliability was evaluated using Cronbach's alpha and intraclass correlation coefficients. Convergent validity was assessed by comparing scores with age, the Cumulative Analogue Joint Involvement Scale (CAJIS), the Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS), and heterotopic ossification (HO) volume. Known-groups validity assessment used age, CAJIS, and HO volume. Factor analysis confirmed a two-factor solution: Mobility and Upper Extremity. Results reflected high internal consistency and were supportive of test-retest reliability; correlation coefficients >0.90 demonstrated FOP-PFQ scores were stable over a one- to three-week period. The majority of scores were moderately (r=0.30-0.50) to highly (r≥0.50) correlated with CAJIS and HO volume, supporting convergent validity. With the exception of some age-based and functional groups, FOP-PFQ scores were significantly worse in groups with more severe disease, demonstrating known-groups validity. The FOP-PFQ was demonstrated to be a reliable, valid measure that may be responsive to change in individuals with FOP, although some results were inconclusive for pediatric versions.

Abstract P4-05-04: Health-Related Quality of Life and Work Impairment Among Individuals Living with HER2+ Breast Cancer with Brain Metastases

Abstract Background: Roughly 20% of people diagnosed with breast cancer (BC) will be considered HER2+. HER2+ BC patients are among those at highest risk for developing brain metastases, with up to 50% developing brain metastases. Brain metastases are associated with faster disease progression, shorter survival, and myriad increased impairments. Despite the significant burden faced by HER2+ BC patients living with brain metastases (BMBC), there is little empirical research available regarding the unique experiences of this population. The goals of this exploratory study were to examine the feasibility of recruiting HER2+ BMBC patients to complete an online survey, and to describe their health-related quality of life (HRQOL) and experiences with work impairment. Methods: 62 women with HER2+ metastatic BC were recruited via advocacy partners, Living Beyond Breast Cancer and Metastatic Breast Cancer Alliance, and completed an online survey in January 2022. Participants reported sociodemographics, clinical history, current caregiving support received, physical health (Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health 2av1.2), HRQOL (PROMIS-29v2.0 and PROMIS Cognitive Function Short Form 8a) and work impairment (Work Productivity and Activity Impairment Questionnaire–Specific Health Problem (WPAI-SHPv2.0)). Descriptive statistics were calculated for study variables; PROMIS measures were converted to T scores (M=50, SD=10), enabling comparisons to established population benchmarks. Results presented in this study are restricted to the 30 HER2+ participants living with BMBC. Results: Participants were 47% White, 23% Hispanic, 23% Asian, 3% Black/African American, 3% American Indian/Alaska Native; mean age=43y (range: 33-72); 83% held a Bachelor degree or higher; 70% were married or partnered; mean years since BMBC diagnosis=2.7 (range: &amp;lt; 1-20); mean years between diagnosis and onset of metastatic disease=1.8 (range: 0-11). 67% of participants reported receiving constant care from a caregiver; the remaining participants reported receiving an average of 10.2 hours/week of care. 50% of participants reported physical health corresponding to poor levels (&amp;gt;2 SD on PROMIS). The majority of participants reported HRQOL impairments corresponding to moderate to severe levels (&amp;gt;1SD on PROMIS): Anxiety (84%); Physical Function (80%); Pain Interference (77%); Depression (70%); Fatigue (70%); Sleep Disturbance (67%); Cognitive Function (63%); and Ability to Participate in Social Roles and Activities (53%). Mean symptom burden T-scores (range: 60.4-67.7) and mean functional impairment T-scores (range: 36.0-39.9) were poorer relative to several reference groups (i.e., other women with HER2+ MBC, overall BC population benchmarks, general US population benchmarks). At the time of the survey, 73% of participants were not employed due to disability. Among those employed (n=7); 100% reported that BMBC negatively affected their employment in the past week: mean percent of scheduled work hours missed=37% (range: 14-74%); mean percent of reduced productivity while working=39% (range: 0-80%); and mean overall work impairment=60% (range: 39-95%). Conclusions: HER2+ BMBC patients experience substantial emotional, physical, social, and cognitive quality of life impairments, high work absenteeism, reduced productivity, and overall work impairment, suggesting significant unmet needs for this population. Efforts to recruit HER2+ BMBC patients were successful, suggesting high feasibility of future work with a more robust sample. Despite the small sample size, our descriptive results provide a key foundation for future research with HER2+ BMBC patients to formally test hypotheses and evaluate predictor variables impacting patient HRQOL and work impairment. Citation Format: Victoria G. Morris, Alexandra K. Zaleta, Heather Badt. Health-Related Quality of Life and Work Impairment Among Individuals Living with HER2+ Breast Cancer with Brain Metastases [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-05-04.

One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial

Empirical elimination diets are effective for achieving histological remission in eosinophilic oesophagitis, but randomised trials comparing diet therapies are lacking. We aimed to compare a six-food elimination diet (6FED) with a one-food elimination diet (1FED) for the treatment of adults with eosinophilic oesophagitis. We conducted a multicentre, randomised, open-label trial across ten sites of the Consortium of Eosinophilic Gastrointestinal Disease Researchers in the USA. Adults aged 18-60 years with active, symptomatic eosinophilic oesophagitis were centrally randomly allocated (1:1; block size of four) to 1FED (animal milk) or 6FED (animal milk, wheat, egg, soy, fish and shellfish, and peanut and tree nuts) for 6 weeks. Randomisation was stratified by age, enrolling site, and gender. The primary endpoint was the proportion of patients with histological remission (peak oesophageal count <15 eosinophils per high-power field [eos/hpf]). Key secondary endpoints were the proportions with complete histological remission (peak count ≤1 eos/hpf) and partial remission (peak counts ≤10 and ≤6 eos/hpf) and changes from baseline in peak eosinophil count and scores on the Eosinophilic Esophagitis Histology Scoring System (EoEHSS), Eosinophilic Esophagitis Endoscopic Reference Score (EREFS), Eosinophilic Esophagitis Activity Index (EEsAI), and quality of life (Adult Eosinophilic Esophagitis Quality-of-Life and Patient Reported Outcome Measurement Information System Global Health questionnaires). Individuals without histological response to 1FED could proceed to 6FED, and those without histological response to 6FED could proceed to swallowed topical fluticasone propionate 880 μg twice per day (with unrestricted diet), for 6 weeks. Histological remission after switching therapy was assessed as a secondary endpoint. Efficacy and safety analyses were done in the intention-to-treat (ITT) population. This trial is registered on ClinicalTrials.gov, NCT02778867, and is completed. Between May 23, 2016, and March 6, 2019, 129 patients (70 [54%] men and 59 [46%] women; mean age 37·0 years [SD 10·3]) were enrolled, randomly assigned to 1FED (n=67) or 6FED (n=62), and included in the ITT population. At 6 weeks, 25 (40%) of 62 patients in the 6FED group had histological remission compared with 23 (34%) of 67 in the 1FED group (difference 6% [95% CI -11 to 23]; p=0·58). We found no significant difference between the groups at stricter thresholds for partial remission (≤10 eos/hpf, difference 7% [-9 to 24], p=0·46; ≤6 eos/hpf, 14% [-0 to 29], p=0·069); the proportion with complete remission was significantly higher in the 6FED group than in the 1FED group (difference 13% [2 to 25]; p=0·031). Peak eosinophil counts decreased in both groups (geometric mean ratio 0·72 [0·43 to 1·20]; p=0·21). For 6FED versus 1FED, mean changes from baseline in EoEHSS (-0·23 vs -0·15; difference -0·08 [-0·21 to 0·05]; p=0·23), EREFS (-1·0 vs -0·6; difference -0·4 [-1·1 to 0·3]; p=0·28), and EEsAI (-8·2 vs -3·0; difference -5·2 [-11·2 to 0·8]; p=0·091) were not significantly different. Changes in quality-of-life scores were small and similar between the groups. No adverse event was observed in more than 5% of patients in either diet group. For patients without histological response to 1FED who proceeded to 6FED, nine (43%) of 21 reached histological remission; for patients without histological response to 6FED who proceeded to fluticasone propionate, nine (82%) of 11 reached histological remission. Histological remission rates and improvements in histological and endoscopic features were similar after 1FED and 6FED in adults with eosinophilic oesophagitis. 6FED had efficacy in just less than half of 1FED non-responders and steroids had efficacy in most 6FED non-responders. Our findings indicate that eliminating animal milk alone is an acceptable initial dietary therapy for eosinophilic oesophagitis. US National Institutes of Health.

Abstract P239: Impact of American Heart Association/American Stroke Association Online Support Network on Quality of Life

Introduction: Support of patients with cardiovascular (CV) disease and stroke is often associated with improved health-related quality of life (HRQOL). Hypothesis: We assessed the hypothesis that change in patient HRQOL, perception of emotional and informational support, and satisfaction with the American Heart Association/American Stroke Association’s (AHA/ASA) online Support Network (SN) would be observed from before joining the SN to two months after joining the SN. Methods: Using a pre/post-test design, between April 2018 and March 2020, 2,542 adult patients completed a baseline online survey, of whom 412 completed a survey two months later (response rate=16%). Self-report instruments included: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire, Emotional Support (ES), Informational Support (IS), and an AHA/ASA-developed measure of satisfaction with the SN. After converting raw scores into T-scores, linear mixed effects models were used to compare pre and post T-scores. Results: Patients were on average 56± 12.8 years of age, female (63.3%), non-Hispanic White (76.5%), married (58.3%), employed (49.8%), and &gt;high school education (85.0%). 83.5% reported having a CV condition, most commonly hypertension (38.8%), myocardial infarction (31.3%), high cholesterol (31.1%), atrial fibrillation (25.2%); 58.0% reported ≤ 4 co-morbidities. T-scores (mean±SD) did not differ significantly from before to two months after joining the SN: physical health domain (pre=39.2±3.6, post=39.3±3.4) and mental health domain (pre=43.3±9.6, post=44.5±9.7); ES (pre=49.5±9.8, post=49.3±9.8), and IS (pre=49.8±10.3, post=50.5±10.5). At two months, satisfied, neutral, and dissatisfied with SN were 46.3%,44.2%, and 5.1% respectively. 61.5% were likely to recommend the SN to others. Conclusions: In conclusion, HRQOL measures remained stable. Before and after SN participation, physical and mental domain global health scores were lower than the U.S. general population mean of 50, while ES and IS scores approximated the U.S. general population mean. Satisfaction with the SN was moderate with the majority of respondents likely to recommend to others. Future research might explore extending the timeframe to observe change in global health scores.

Patient-Reported Data Augment Prediction Models of Persistent Opioid Use after Elective Upper Extremity Surgery.

Opioids play a role in pain management after surgery, but prolonged use contributes to developing opioid use disorder. Identifying patients at risk of prolonged use is critical for deploying interventions that reduce or avoid opioids; however, available predictive models do not incorporate patient-reported data (PRD), and it remains unclear whether PRD can predict postoperative use behavior. The authors used a machine learning approach leveraging preoperative PRD and electronic health record data to predict persistent opioid use after upper extremity surgery. Included patients underwent upper extremity surgery, completed preoperative PRD questionnaires, and were prescribed opioids after surgery. The authors trained models using a 2018 cohort and tested in a 2019 cohort. Opioid use was determined by patient report and filled prescriptions up to 6 months after surgery. The authors assessed model performance using area under the receiver operating characteristic, sensitivity, specificity, and Brier score. Among 1656 patients, 19% still used opioids at 6 weeks, 11% at 3 months, and 9% at 6 months. The XGBoost model trained on PRD plus electronic health record data achieved area under the receiver operating characteristic 0.73 at 6 months. Factors predictive of prolonged opioid use included income; education; tobacco, drug, or alcohol abuse; cancer; depression; and race. Protective factors included preoperative Patient-Reported Outcomes Measurement Information System Global Physical Health and Upper Extremity scores. This opioid use prediction model using preintervention data had good discriminative performance. PRD variables augmented electronic health record-based machine learning algorithms in predicting postsurgical use behaviors and were some of the strongest predictors. PRD should be used in future efforts to guide proper opioid stewardship. Risk, III.

Randomized Controlled Study of Self-Managed Music-Guided Exercise Intervention Following Intensive Care.

Patients who are discharged from the intensive care unit (ICU; termed ICU survivors) often experience persistent physical impairment. The aim of this study was to explore the effects of a self-managed, music-guided exercise intervention on physical outcomes and adherence rates among ICU survivors. A randomized controlled design was used. Following ICU discharge, participants admitted to the ICU for at least 5 days were randomly assigned to a music group ( n = 13) or an active control group ( n = 13). Activity counts were measured using an Actiwatch, and the physical health score was measured using the Patient-Reported Outcomes Measurement Information System global health subscale. Adherence to exercise was documented daily. Independent t -tests were used for data analysis. Data were analyzed for 26 participants. The mean age was 62.8 ± 13.8 years, 53.8% were male, 65.4% were White, and mean Acute Physiology and Chronic Health Evaluation severity of illness score was 59 ± 23.4. Global health physical scores were significantly higher in the music group than in the active control group. Although not significantly different, music group participants tended to be more active and had higher physical activity and adherence rates compared to those in the active control group. A self-managed, music-guided exercise intervention demonstrated positive benefits on physical outcomes. Future clinical trials with a larger sample size should be conducted to examine the effects of this tailored, cost-effective, innovative, self-managed exercise intervention among ICU survivors.

Restoring Balance: a physical activity intervention for Native American cancer survivors and their familial support persons.

Exercise interventions among Native American cancer survivors are lacking, despite major cancer health disparities in survivorship. The purpose of this study was to evaluate a 12-week randomized controlled trial (RCT) of culturally tailored exercise on cancer risk biomarkers and quality of life among Native American cancer survivors and family members. Participants were randomized to immediate start versus 6-week waitlist control at two rural and two urban sites. Participants enrolled in a small feasibility pilot study (only cancer survivors evaluated, n=18; cohort 1) or larger efficacy pilot study where cancer survivors (n=38; cohort 2) and familial supporters (n=25; cohort 3) were evaluated concurrently. Resistance, aerobic, flexibility, and balance exercises were tailored by cultural experts representing ten tribes. Exercises was supervised on-site one day per week and continued in home-based settings two to five days per week. Fat mass, blood pressure, hemoglobin A1c, 6-min walk, sit-to-stand test, and quality of life (Patient-Reported Outcomes Measurement Information System Global Health short form and isolation subscale) were measured. Mixed effects models evaluated differences between RCT arms from baseline to 6 weeks, and 12-week intervention effects in combined arms. There were no consistent differences at 6 weeks between randomized groups. Upon combining RCT arms, 6-min walk and sit-to-stand tests improved in all three cohorts by 12 weeks (both survivors and familial support persons, p<0.001); social isolation was reduced in all three cohorts (p≤0.05). Familial support persons additionally improved blood pressure and HbA1c (p≤0.05). Exercise improved cardiorespiratory fitness and physical function among Native American cancer survivors and familial supporters. A longer intervention may influence other important health outcomes among Native American survivors. Additional improvements demonstrated among Native American family members may have a meaningful impact on cancer prevention in this underserved population with shared heritable and environmental risks.