Patient-reported Health Outcomes Research Articles

Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): short term effects of a randomised controlled trial in primary care

Purpose To evaluate short-term effects of the PREVention of Sickness Absence for Musculoskeletal disorders (PREVSAM) model on sickness absence and patient-reported health outcomes. Methods Patients with musculoskeletal disorders were randomised to rehabilitation according to PREVSAM or treatment as usual (TAU) in primary care. Sickness absence and patient-reported health outcomes were evaluated after three months in 254 participants. Results The proportion of participants remaining in full- or part-time work were 86% in PREVSAM vs 78% in TAU (p = 0.097). The PREVSAM group had approximately four fewer sickness benefit days during three months from baseline (p range 0.078–0.126). No statistically significant difference was found in self-reported sickness absence days (PREVSAM 12.4 vs TAU 14.5; p = 0.634), nor were statistically significant differences between groups found in patient-reported health outcomes. Both groups showed significant improvements from baseline to three months, except for self-efficacy, and only the PREVSAM group showed significantly reduced depression symptoms. Conclusions The findings suggest that for sickness absence, the PREVSAM model may have an advantage over TAU, although the difference did not reach statistical significance at the p < 0.05 level, and similar positive effects on patient-reported health outcomes were found in both groups. Long-term effects must be evaluated before firm conclusions can be drawn.

The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multi-Center Randomized Clinical Trial

A periacetabular osteotomy (PAO) is often sufficient to treat the symptoms and improve quality of life for symptomatic hip dysplasia. However, acetabular cartilage and labral pathologies are very commonly present, and there is a lack of evidence examining the benefits of adjunct arthroscopy to treat these. The goal of this study was to compare the clinical outcome of patients undergoing PAO with and without arthroscopy, with the primary endpoint being the International Hip Outcome Tool-33 (iHOT-33) at one year. In a multi-center study, two hundred and three patients who had symptomatic hip dysplasia were randomized: 97 patients undergoing an isolated PAO (mean age 27 years (range, 16 to 44); mean Body Mass Index (BMI) of 25.1 (range, 18.3 to 37.2); 86% women) and 91 patients undergoing PAO who had an arthroscopy [mean age 27 years (range, 16 to 49); mean BMI of 25.1 (17.5 to 25.1); 90% women]. At a mean follow up of 2.3 years (range, 1 to 5), all patients exhibited significant improvements in their functional score, with no significant differences between PAO plus arthroscopy versus PAO alone at 12 months post-surgery on all scores: pre-operative iHot-33 score of 31.2 (SD [standard deviation] 16.0) versus 36.4 (SD 15.9), and 12 months post-operative score of 72.4 (SD 23.4) versus 73.7 (SD 22.6)]. The pre-operative Hip disability and Osteoarthritis Outcome (HOOS)-pain score was 60.3 (SD 19.6) versus 66.1 (SD 20.0)] and 12 months post-operative [88.2 (SD 15.8) versus 88.4 (SD 18.3)]. The mean pre-operative physical health Patient-Reported Outcomes Measurement Information System (PROMIS) score was 42.5 (SD 8.0) versus 44.2 (SD 8.8) and 12 months post-operative [48.7 (SD 8.5) versus 52.0 (SD 10.6)]. There were four patients with PAO without arthroscopy who required an arthroscopy later to resolve persistent symptoms, and one patient from the PAO plus arthroscopy group required an additional arthroscopy. This Randomized Controlled Trial (RCT) has failed to show any significant clinical benefit in performing hip arthroscopy at the time of the PAO at one-year follow-up. Longer follow-up will be required to determine if hip arthroscopy provides added value to a PAO for symptomatic hip dysplasia.

Presence of Cerebrospinal Fluid on Preoperative Imaging and the Associated Cervical Myelopathy Diagnosis and Outcome.

Retrospective chart review. The objective of this study is to determine whether the presence of cerebrospinal fluid is associated with the severity of degenerative cervical myelopathy or postoperative outcomes. Degenerative cervical myelopathy (DCM) is a clinical diagnosis characterized as neurologic dysfunction. Preoperative imaging is used to determine the source of cord compression. In clinical practice, cerebrospinal fluid (CSF) around the cord is often used as an indicator to determine whether stenosis is relevant. It is unclear if the presence of CSF around the cord can serve as a metric for clinically relevant cord compression. Patients undergoing single-level anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy were identified from our institution's surgical database. Pre- and postoperative patient-reported health outcomes visual analog scale for neck pain (VAS-NP) and modified Japanese Orthopaedic Association (mJOA) were collected. The level of ACDF plus one level above and below were assessed for the presence of cerebrospinal fluid, as well as measuring the area of the spinal canal and spinal cord on preoperative magnetic resonance imaging. Two hundred forty-nine patients were included. Spearman correlation test comparing cord/canal ratios at the level of compression and preoperative mJOA shows a significant negative correlation (Rho = -0.206, P= 0.043). There was no significant correlation with postoperative change in mJOA scores (Rho = -0.002, P= 0.986). The presence of CSF around the cord was weakly correlated with the severity of myelopathy; however, it had no correlation with postoperative outcomes. The presence of CSF around the cord should not in isolation be used to rule in or rule out operative levels in cervical myelopathy.

Understanding Symptom Self-Monitoring Needs Among Postpartum Black Patients: Qualitative Interview Study.

Pregnancy-related death is on the rise in the United States, and there are significant disparities in outcomes for Black patients. Most solutions that address pregnancy-related death are hospital based, which rely on patients recognizing symptoms and seeking care from a health system, an area where many Black patients have reported experiencing bias. There is a need for patient-centered solutions that support and encourage postpartum people to seek care for severe symptoms. We aimed to determine the design needs for a mobile health (mHealth) patient-reported outcomes and decision-support system to assist Black patients in assessing when to seek medical care for severe postpartum symptoms. These findings may also support different perinatal populations and minoritized groups in other clinical settings. We conducted semistructured interviews with 36 participants-15 (42%) obstetric health professionals, 10 (28%) mental health professionals, and 11 (31%) postpartum Black patients. The interview questions included the following: current practices for symptom monitoring, barriers to and facilitators of effective monitoring, and design requirements for an mHealth system that supports monitoring for severe symptoms. Interviews were audio recorded and transcribed. We analyzed transcripts using directed content analysis and the constant comparative process. We adopted a thematic analysis approach, eliciting themes deductively using conceptual frameworks from health behavior and human information processing, while also allowing new themes to inductively arise from the data. Our team involved multiple coders to promote reliability through a consensus process. Our findings revealed considerations related to relevant symptom inputs for postpartum support, the drivers that may affect symptom processing, and the design needs for symptom self-monitoring and patient decision-support interventions. First, participants viewed both somatic and psychological symptom inputs as important to capture. Second, self-perception; previous experience; sociocultural, financial, environmental, and health systems-level factors were all perceived to impact how patients processed, made decisions about, and acted upon their symptoms. Third, participants provided recommendations for system design that involved allowing for user control and freedom. They also stressed the importance of careful wording of decision-support messages, such that messages that recommend them to seek care convey urgency but do not provoke anxiety. Alternatively, messages that recommend they may not need care should make the patient feel heard and reassured. Future solutions for postpartum symptom monitoring should include both somatic and psychological symptoms, which may require combining existing measures to elicit symptoms in a nuanced manner. Solutions should allow for varied, safe interactions to suit individual needs. While mHealth or other apps may not be able to address all the social or financial needs of a person, they may at least provide information, so that patients can easily access other supportive resources.

Development of a Patient-Reported Sexual Health Outcomes Battery for Use in Adolescent and Young Adult Cancer Clinical Trials.

Development of a Patient-Reported Sexual Health Outcomes Battery for Use in Adolescent and Young Adult Cancer Clinical Trials.

Everyday Discrimination and Sleep Among Migrant and Non-migrant Filipinos: Longitudinal Analyses from the Health of Philippine Emigrants Study (HoPES).

This study aimed to (1) identify differences in sleep patterns between Filipino migrants and non-migrants across 2 years and (2) explore the impact of discrimination trajectories on sleep trajectories. The Health of Philippine Emigrants Study (HoPES) consisted of a migrant (n = 832) and non-migrant cohort (n = 805), with baseline data collected in the Philippines. Both cohorts were followed longitudinally, with the non-migrants followed in the Philippines and the migrant cohort followed to the United States. Sleep duration, quality, and difficulty were assessed with the National Institutes of Health Patient-Reported Outcomes Information System (PROMIS) inventory, and discrimination was measured with an adapted version of the Everyday Discrimination scale. Migrants reported a faster decline in sleep duration (-12min a year) but higher sleep quality than non-migrants over 2 years. Migrants who reported high initial levels of everyday discrimination also reported faster declines in sleep duration and a slower decline in sleep difficulty. Further, migrants who reported stable (versus declining) levels of discrimination over 2 years reported a faster decline in sleep quality. These results speak to the complexity of immigrant health patterns and long-term associations between discrimination and sleep processes.

Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine.

Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. Multicenter study (112 centers in 11 countries). 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. DAPA+SAXA vs INS. Changes in CGM profiles, HbA1c, and PROs. Changes from baseline in HbA1c with DAPA+SAXA were similar to those observed with INS, with mean difference [95% CI] between decreases of -0.12% [-0.37 to 0.12%], P = .33. CGM analytics were more favorable for DAPA+SAXA, including greater percent time in range (> 3.9 and ≤ 10 mmol/L; 34.3 ± 1.9 vs 28.5 ± 1.9%, P = .033), lower percent time with nocturnal hypoglycemia (area under the curve ≤ 3.9 mmol/L; 0.6 ± 0.5 vs 2.7 ± 0.5%, P = .007), and smaller mean amplitude of glycemic excursions (-0.7 ± 0.1 vs -0.3 ± 0.1 mmol/L, P = .017). Improvements in CGM were associated with greater satisfaction, better body weight image, less weight interference, and improved mental and emotional well-being. DAPA+SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA+SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes.

(016) Sexual Health Toxicity Following MRI-Guided versus CT-guided Prostate SBRT

Abstract Introduction Sexual health toxicities remain an under-reported but important health outcome for patients undergoing radiotherapy for localized prostate cancer. With the increasing adoption of higher daily doses of radiation over shorter timeframes delivered using stereotactic body radiotherapy (SBRT), the precision of radiation delivery remains an important factor that can reduce patient toxicity. MRI-guided SBRT (MRgRT) allows for improved image quality, treatment gating, and planning target volume margin reduction, offering improved radiation precision, which may translate to reduced treatment-related toxicity as compared to traditional CT-guided SBRT (CTgRT). Objective We sought to evaluate the effect of MRI-guidance on sexual health toxicity in patients following prostate SBRT for the treatment of localized prostate cancer. Methods We conducted a post-hoc analysis of patients enrolled on a phase III single-center randomized trial (MIRAGE: NCT04384770). The trial overall seeks to study the relative benefit of MRI vs CT guided SBRT (40 Gy/5 fractions) in patients with localized prostate cancer. Right and left neurovascular bundles (NVBs) and internal pudendal arteries (IPAs) were contoured on treatment planning images. Dosimetric parameters for these structures (Dmax, Dmin, Dmean, and V20Gy) were collected. Patient-reported sexual function outcomes (SHIM and EPIC-26 surveys) were also collected prior to treatment and at 1, 3, and 12 months following treatment. A clinically relevant decrement was defined as a ≥24 point decrease in the EPIC-26 sexual domain scores and a ≥9 point decrease on SHIM surveys. Unpaired t-tests and chi-square tests were used to evaluate for statistical significance. Results 152 patients received either MRgRT (n = 77) or CTgRT (n = 75). MRgRT resulted in a significant improvement in the volume receiving 20 Gy or less of radiation (V20Gy) in the left NVB (7.3cc vs 10.9cc, p = 4.4x10-8), right NVB (7.0cc vs 10.7cc, p = 2.8x10-7), and right IPA (0.42cc vs 1.35cc, p = 0.049), and trended towards significance for the left IPA (0.3cc vs 1.1cc, p = 0.066). Only 48 patients were not given hormonal therapy with radiotherapy. No statistically significant differences in clinically relevant decrements in patient-reported SHIM or EPIC scores were seen between MRgRT and CTgRT in these patients. No clear association between acute or chronic (12-months post-RT) sexual health toxicity and radiation exposure to the NVBs or IPAs was identified. Conclusions Patients treated with MRgRT had decreased radiation exposure to the bilateral NVBs and IPAs compared to patients treated with CTgRT. These data highlight the dosimetric benefits of MRgRT with regard to sexually relevant organs at risk. Power to detect associations between dosimetry and patient-reported sexual health outcomes will increase as the data matures and more patients have recovered testosterone after use of hormonal therapy. Future work will assess the impact on MRI-guided vs CT-guided radiation on sexual health outcomes at later time points. Disclosure No.

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.

Association between opioid utilization and patient reported outcome measures following lumbar spine surgery

BACKGROUND CONTEXTThe patient-reported outcomes measurement information system (PROMIS), created by the National institute of Health, is a reliable and valid survey for patients with lumbar spine pathology. Preoperative opioid use has been shown to be an important predictor variable of self-reported health status in legacy patient reported outcome measures. PURPOSETo investigate the impact of chronic preoperative opiate use on PROMIS survey scores. STUDY DESIGNRetrospective database analysis. PATIENT SAMPLEBetween March 2019 and November 2021, 227 patients underwent lumbar decompression ± ≤ 2 level fusion. Fifty-seven patients (25.11%) had chronic preoperative opioid use. OUTCOME MEASURESOswestry disability index (ODI) and PROMIS survey scores. METHODSA retrospective analysis of a prospectively maintained single center patient-reported outcome database was performed with a minimum of 2 year follow-up. PROMIS Anxiety, Depression, Fatigue, Pain Interference (PI), Physical Function (PF), Sleep disturbance (SD), and Social Roles (SR) surveys were recorded at preoperative intake with subsequent follow-up at 6, 12, and 24 months postoperatively. Patients were grouped into chronic opioid users as defined by >6-month duration of use. Differences in mean survey scores were evaluated using Welch t-tests. RESULTSTwo hundred and twenty-seven patients met our inclusion criteria of completed PROMIS surveys at the designated timepoints. A total of 57 (25.11%) were chronic opioid users (COU) prior to surgery. Analysis of patient-reported health outcomes shows that long term opioid use correlated with worse ODI and PROMIS scores at baseline compared to nonchronic users (NOU). At 1 and 2 year follow-up, the COU cohort continued to have significantly worse ODI, PROMIS Fatigue, PF, PI, SD, and SR scores. There is a statistical difference in the magnitude of change in health status between the 2 cohorts at 1 year follow-up in PROMIS Depression (-5.04±7.88 vs. -2.49±8.73, p=.042), PF (6.25±7.11 vs. 9.03±9.04, p=.019), and PI (-7.40±7.37 vs. -10.58±9.87, p=.011) and 2 year follow-up in PROMIS PF (5.58±6.84 vs. 7.99±9.64, p=.041) and PI (-6.71±8.32 vs. -9.62±10.06, p=.032). Mean improvement in PROMIS scores for the COU cohort at 2 year follow-up exceeded minimal clinically important difference (MCID) in all domains except PROMIS Depression, SR and SD. CONCLUSIONPatients with chronic opioid use status have worse baseline PROMIS scores compared with patients who had nonchronic use. However, patients in the COU cohort displayed clinically significant postoperative improvement in multiple PROMIS domains. These results show that patients with chronic opioid use can benefit greatly from surgical intervention and will allow physicians to better set expectations with their patients.

Relationship between depression, anxiety, stress, and health-related quality of life in adults with and without chronic diseases: A cross-sectional study.

Health-related quality of life (HRQoL) in patients with chronic diseases is an important tool to measure patient-reported health outcomes and evaluate the usefulness of treatment, management, and rehabilitation programs. Patients with chronic diseases are more likely than those without to experience psychological problems such as depression, anxiety, and stress, all of which can affect HRQoL. This study evaluated the impact of psychological problems such as depression, anxiety, and stress on HRQoL in people with and without chronic diseases in South Korea. The study's descriptive survey included 501 participants (191 with and 310 without chronic diseases). Data were collected using structured questionnaires between April and May 2021. The general characteristics, DASS-21, and HRQOL of this study were analyzed using descriptive statistics. Differences in DASS-21 and HRQoL based on general characteristics were analyzed using t tests and ANOVA. The study analyzed the factors influencing the participants' HRQoL using stepwise multiple regression analysis with SPSS Win 27.0. HRQoL was generally lower for patients with chronic diseases than for patients without. In patients with chronic diseases, the major variables affecting HRQoL were depression (β = -0.244, t = -3.582, P < .001), exercise (β = 0.201, t = 2.927, P = .004), and economic status (β = -0.150, t = -2.184, P = .030), of which depression was the most influential. These variables explained 12.5% of the variance in the regression model for total HRQoL. These results emphasize the need to explore intervention measures that can reduce depression in patients with chronic diseases and anxiety in patients without chronic diseases to improve their HRQoL. In addition, national efforts are needed to provide economic support, as economic status is an influential factor in HRQoL regardless of the presence of chronic disease. The study's limitations include the fact that neither did it consider disease severity among chronically ill patients nor did it examine all the variables affecting HRQoL.

The Rhinoplasty Health Care Monitor: An Update on the Practical and Clinical Benefits after 10 Years of Prospective Outcome Measurements.

The era of value-based health care is characterized by an increasing interest in patient-reported health outcomes. For this purpose we developed the rhinoplasty health care monitor (RHM), a streamlined outcome measurement protocol, including all rhinoplasty patients since 2014. Statistical analyses of patient-reported outcome data are automated and visually presented on a custom web-based dashboard. We describe the clinical and practical benefits of the RHM and discuss how routine prospective outcome measurements have upgraded our care standards. For this prospective study, 979 consecutive patients referred for functional (revision) rhinoplasty from April 2014 to August 2023 were included. Preoperative and 3- and 12-month postoperative scores on the Nasal Obstruction Symptom Evaluation scale (NOSE), Utrecht Questionnaire (UQ), and visual analog scales (VAS) were obtained. Of 979 referred patients, 599 (61.2%) were eligible for rhinoplasty. One year postoperatively, mean NOSE scale sum score improved from 69.1 ± 22.8 to 23.1 ± 23.5 (p < 0.001). Functional VAS scores improved from 4.1 ± 2.8 (left) and 4.1 ± 2.8 (right) to 7.5 ± 1.9 (left) and 7.3 ± 2.0 (right; p < 0.001). Mean UQ sum score improved from 12.0 ± 6.4 to 6.8 ± 3.3 and aesthetic VAS score improved from 4.5 ± 2.5 to 7.4 ± 1.7 (p < 0.001) 1 year postoperatively. Benefits of the outcome routine were improved patient selection, data-driven expectation management and patient empowerment, and targeted critical appraisals of surgical performance. In conclusion, routine, automated, prospective outcome monitoring provides physicians with a response to the increasing demand for data-driven insights in health outcomes. The limited effort that is needed to gather and monitor outcome data is heavily repaid by valuable insights into aspects of care that can be improved.

Burden of impaired vitality in the general population and potential nutritional solution

A recent study based on the National Health and Wellness Survey, the world’s largest online database of patient-reported health outcomes, found that low vitality negatively impacts quality of life, daily activities and productivity. While dietary supplement solutions exist to prevent fatigue, the study also showed that people disengaged in self-managing their health have the lowest vitality level.

Outpatient Total Joint Arthroplasty at a High-Volume Academic Center: An Analysis of Failure to Launch

BackgroundUnanticipated failure to discharge home (failure to launch, FTL) following scheduled same-day discharge (SDD) total joint arthroplasty (TJA) is problematic for the surgical facility with respect to staffing, care coordination, and reimbursement concerns. The aim of this study was to review rates, etiologies, and contributing factors for FTL in SDD TJA at an inpatient academic medical center. MethodsAll patients who underwent primary TJA between February 2021 and February 2023 were retrospectively reviewed. Of those scheduled for SDD, risk factors for FTL were compared with successful SDD. Readmission and emergency department (ED) visits were compared with historical cohorts. There were 3,093 consecutive primary joint arthroplasties performed, of which 2,411 (78%) were scheduled for SDD. ResultsOverall, SDD was successful in 94.2% (n = 2,272) of patients who had an FTL rate of 5.8%. Specifically, SDD was successful in 91.4% with total hip arthroplasty, 96.0% with total knee arthroplasty, and 98.6% with unicompartmental knee arthroplasty. Factors that significantly increased the risk of FTL included general anesthesia versus spinal anesthesia (P < .0001), later surgery start time (P < .0001), longer surgical time (P = .0043), higher estimated blood loss (P < .0001), women (P = .0102), younger age (P = .0079), and lower preoperative mental health patient-reported outcomes scores (P = .0039). Readmission and ED visit rates were not higher in the SDD group when compared to historical controls (P = .6830). ConclusionsWith a comprehensive multidisciplinary approach dedicated to improving SDDs at an academic medical center, we have seen successful SDD in nearly 80% of primary TJA, with an FTL rate of 5.8%, and no increased risk of readmission or ED visits. Without adding many personnel, hospital recovery units, or other resources, simple interventions to help decrease FTL have included enhanced preoperative education and expectation settings, improved perioperative communications, reallocating personnel from the inpatient to the outpatient setting, the use of short-acting spinal anesthetics, and earlier scheduled surgery times.

Quality of Life in Individuals With Disabilities Through a Student-Led Service-Learning Program: Qualitative and Quantitative Analysis to Examine the Reciprocal Benefits of Service Learning

Purpose: The efficacy of service learning in physical activity (PA) intervention is generally not centered around perceptions of the service recipients, posing questions when the efficacy of an intervention is crucial, such as PA in people with disabilities. The present study examined perceptions of the recipients in a student-led service-learning program through a quality of life survey and interviews. Method: Undergraduate students led a 13-week PA intervention. Before and after the intervention, people with disabilities (N = 56) completed quality of life surveys (i.e., the National Institute of Health Patient-Reported Outcomes Measurement Information System). A face-to-face interview was conducted with N = 6. Results: All quality of life items, except for Mental Health–Anxiety, improved (p &lt; .01). The interviews suggested that environmental factors (i.e., encouragement from students, the open space that allowed interactions) positively impacted the program. Discussion: The environment may be a key factor in the program’s success in PA intervention from the recipients’ perspective.

Abstract B105: Evaluating the racial equity of a digital health patient-reported symptom management system in patients receiving chemotherapy

Abstract INTRODUCTION. The development of behavioral &amp; supportive care interventions to improve quality of life for people receiving chemotherapy treatment for cancer, even with demonstrated overall efficacy, may unintentionally result in unequal benefit including across racial subgroups. The purpose of this study was to determine if Symptom Care at Home (SCH), is efficacious, digital health patient-reported outcome (PROs) symptom managment system, provide equitable benefit across racial subgroups. METHODS. A randomized trial was conducted to determine the active components of SCH. Participants reported daily on 11 common treatment symptoms through an Interactive Voice Response (IVR) telephone-based system that transmitted data through telephone lines. Continuous measures &amp; standard deviations with ordinal &amp; categorical measures, frequencies &amp; percentages of the totals were summarized. Comparisons between participants across Georgia &amp; Utah &amp; between Black &amp; White race were completed using Students t-test &amp; chi-square tests. Statistical analyses were completed using a 5% level of significance. This analysis compared these two groups to determine if participation with the SCH digital health tool &amp; symptom reduction benefits were equitable. RESULTS. Participants were 239 Black plus 13 Other or mixrd-race patients (251; 86%) as compared with the 118 White patients (32%) receiving chemotherapy treatment in Atlanta, Georgia. Blacks had slightly lower call compliance 67.59% (25.92%) versus (vs) Utah Whites 72.75% (22.45%) p=0.005; lower days in study Blacks 48.9% (29.9%) vs 80.8% (50.3%), p&amp;lt;0.001; &amp; lower completion of study all 3 cycles of chemotherapy &amp; still calling (65.4% vs 75.2%), p&amp;lt;0.001. Georgians also had significantly lower average total alerts 5.08% (10.69%) vs Utah 8.12% (15.20%), p&amp;lt;0.001 and lower presence of at least one moderate/severe symptom for most of the 11 symptoms. Georgians were more likely to be Female (72.2% vs 49.2%, p&amp;lt;0.001); Non-marreid (37.7% vs 72.9%, p&amp;lt;0.001); Non-degree holder (59.9% vs 39.8%, p&amp;lt;0.001); &amp; have diagnosis of Breast Cancer (34.9% vs 12.7%). Blacks had slightly lower call complaince 65.17% (27.1%) vs Whites 72.75% (22.45%), p=0.005; but with no statistically significant difference in number of days in study 49.0% (30.2%) vs 48.6% (29.5%), p=0.911; no statistically significant difference in completion of all 3 cycles of chemotherapy (65.4% vs 63.5%, p=0.895); with difference in average number of total alerts 4.89% (10.93%) vs 5.48% (10.20%, p=0.621). CONCLUSIONS. This study found no racial diffrences in how participants engaged the SCH digital health platform or lenght of study, although the Black plus other raccial group reported daily symptoms 7.5% less days than the White grpup. The degree of benefit found from the SCH was equitably distributed across racial categories. Carefully designed digital health tools utilized to measure &amp; manage PROs in patients receiving chemotherapy can achieve equitable symptom benefit across racial groups &amp; may contribute to reducing racial diparities in cancer symptom care. Citation Format: Mary Gullatte, Eli Iacob, Gary Donaldson, Kathi Mooney. Evaluating the racial equity of a digital health patient-reported symptom management system in patients receiving chemotherapy [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B105.

Abstract 16635: Cost Effectiveness Analysis of the Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction REVIVED Trial Data

Introduction. Evidence on survival benefits of percutaneous coronary intervention (PCI) in patients with severe ischemic left ventricular systolic dysfunction (ILVD) is scant. The REVIVED trial showed that, compared to optimal medical therapy (OMT), revascularisation by PCI did not reduce the incidence of death from any cause or heart failure hospitalization (HF); it also failed to provide sustained improvements in health-related quality of life. REVIVED data are used to evaluate the economic consequences and health outcomes of PCI+OMT and OMT alone in HF patients in the UK. Methods. 700 patients with ILVD were randomised to either PCI+OMT or OMT. Healthcare resource use and patient-reported health outcomes data EuroQol on each patient were collected at baseline and over a period of 8 years post randomisation (median follow up of 3.5 years). Health resources were costed using publicly available national unit costs from the perspective of the UK health system. Within trial mean total costs and quality adjusted life years (QALYs) were estimated and incremental cost effectiveness was evaluated. Regression analysis on total costs and total QALYs was used to adjust for clinically relevant baseline covariables. Probabilistic sensitivity analysis was used to reflect parameter uncertainty. Results. Statistical modelling identified gender, BMI, hypertension, diabetes, NYHA grade and previous hospitalisation as the most relevant baseline predictors of costs and benefits. Over the 8 years of fu, patients undergoing PCI yielded, on average, similar health benefits (4.13 QALYs IC [4.10 - 4.16]) at higher costs (£14,674 IC[£14,334 - £15,014]), compared to OMT (4.16 QALYs [4.13 - 4.19]; £5154 IC [£5,034 - £5,273]). Conclusion. We found no difference in total QALYs between arms and PCI+OMT was not cost-effective compared to OMT, given its additional costs. Therefore, a strategy of routine PCI to treat ILVSD does not appear to be a justifiable use of healthcare resources.

Implementation of a methodology to assess patient reported outcomes in lung cancer patients: The PeOpLe (Patient-reported Outcomes in Lung cancer) study protocol

ObjectiveThe purpose of this article is to describe the PeOpLe study protocol, developed to assess patient-reported health outcomes in advanced or metastatic non-small-cell lung cancer in routine clinical practice using the methodology provided by the International Consortium for Health Outcomes Measurement tool. MethodThe study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group (followed up according to standard clinical practice) and an experimental group (followed up using the International Consortium for Health Outcomes Measurement methodology adapted to the Spanish setting for 6 months). The variables collected will be related to demography (age, sex, degree of family support), clinical factors (smoking, comorbidities, lung capacity), the neoplasm (histology, staging, mutations), pharmacotherapy (treatment schedule, modifications, and complications), health status (functional status, quality of life, satisfaction and overall survival) and resource consumption (emergency visits, hospital admissions and time spent by health providers). The PeOpLe study protocol has been approved by the Ethics Committee for Research into Medicinal Products of the Gregorio Marañón General University Hospital and will be conducted in compliance with prevailing ethical principles and standards. ConclusionsThe PeOpLe study will explore how patient-reported outcomes collection can be developed and integrated with the clinical processes used in the management of patients with locally advanced or metastatic non-small cell lung cancer what patient-reported outcomes can be measured with systems that can conveniently be used both by patients and by healthcare providers. Systematic evaluation of patient-reported outcomes will help determine their impact in terms of effectiveness (survival), safety (complications of systemic therapy), and quality of life and patient satisfaction. The multidisciplinary and multicenter nature of the study will facilitate a comprehensive view of the subject analyzed and allow external reproducibility.

Post-traumatic stress disorder symptoms are frequent among inflammatory bowel disease patients of South Asian descent-A case-control study.

Post-traumatic stress (PTS) is the psycho-physiological response to a traumatic or life-threatening event and is implicated in inflammatory bowel disease (IBD). IBD-PTS is present in up to 30% of white, non-Hispanic patients. The rates of IBD in Asian populations are expanding, making the exploration of IBD-PTS in this population imperative. Adult patients of South/Southeast (S/SE) Asian decent with IBD for more than 6months were recruited online via social media and patient-support groups. Participants completed the post-traumatic stress disorder (PTSD) Checklist-5 (PCL-5), the United States National Institutes of Health's Patient-Reported Outcomes Measurement Information System (NIH-PROMIS) -43 profile and demographics. S/SE Asian participants were age and sex matched (1:2) with randomly selected white, non-Hispanic controls. Statistical analyses evaluated differences in IBD-PTS symptoms between groups, the relationship between disease severity and health-related quality of life (HRQoL) and predictors of IBD-PTS severity. Forty-seven per cent of the 51 S/SE Asian participants met the diagnostic cut-off for PTSD on the PCL-5 compared to 13.6% of 110 IBD controls. The mean global score on the PCL-5 was three times higher in S/SE Asians. Patients of S/SE Asian decent were over five times more likely to have PTSD due to their IBD experiences than controls, nearly doubling when controlling for disease activity. More severe IBD-PTS was present in S/SE Asian patients with active disease and those with extraintestinal manifestations. Higher global levels of IBD-PTS were associated with poorer HRQoL in S/SE Asians where increased hyperarousal from IBD-PTS predicted more sleep disturbance. S/SE Asian patients are five times more likely to experience IBD-PTS than their white, non-Hispanic counterparts. Several cultural factors lead to IBD-PTS in S/SE Asian patients that must be considered by IBD providers. Preventing, screening for and treating IBD-PTS in this population appears warranted.

Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study.

Timely recognition of cancer progression and treatment complications is important for treatment guidance. Digital phenotyping is a promising method for precise and remote monitoring of patients in their natural environments by using passively generated data from sensors of personal wearable devices. Further studies are needed to better understand the potential clinical benefits of digital phenotyping approaches to optimize care of patients with cancer. We aim to evaluate whether passively generated data from smartphone sensors are feasible for remote monitoring of patients with cancer to predict their disease trajectories and patient-centered health outcomes. We will recruit 200 patients undergoing treatment for cancer. Patients will be followed up for 6 months. Passively generated data by sensors of personal smartphone devices (eg, accelerometer, gyroscope, GPS) will be continuously collected using the developed LAIMA smartphone app during follow-up. We will evaluate (1) mobility data by using an accelerometer (mean time of active period, mean time of exertional physical activity, distance covered per day, duration of inactive period), GPS (places of interest visited daily, hospital visits), and gyroscope sensors and (2) sociability indices (frequency of duration of phone calls, frequency and length of text messages, and internet browsing time). Every 2 weeks, patients will be asked to complete questionnaires pertaining to quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30]), depression symptoms (Patient Health Questionnaire-9 [PHQ-9]), and anxiety symptoms (General Anxiety Disorder-7 [GAD-7]) that will be deployed via the LAIMA app. Clinic visits will take place at 1-3 months and 3-6 months of the study. Patients will be evaluated for disease progression, cancer and treatment complications, and functional status (Eastern Cooperative Oncology Group) by the study oncologist and will complete the questionnaire for evaluating quality of life (EORTC QLQ-C30), depression symptoms (PHQ-9), and anxiety symptoms (GAD-7). We will examine the associations among digital, clinical, and patient-reported health outcomes to develop prediction models with clinically meaningful outcomes. As of July 2023, we have reached the planned recruitment target, and patients are undergoing follow-up. Data collection is expected to be completed by September 2023. The final results should be available within 6 months after study completion. This study will provide in-depth insight into temporally and spatially precise trajectories of patients with cancer that will provide a novel digital health approach and will inform the design of future interventional clinical trials in oncology. Our findings will allow a better understanding of the potential clinical value of passively generated smartphone sensor data (digital phenotyping) for continuous and real-time monitoring of patients with cancer for treatment side effects, cancer complications, functional status, and patient-reported outcomes as well as prediction of disease progression or trajectories. PRR1-10.2196/49096.