HRQOL Domains Research Articles

Quality of life among borderline ovarian tumor survivors: A comparison with survivors of early-stage ovarian cancer and a cancer-free population: A cross-sectional population-based PROFILES study

ObjectiveThis study assessed the health-related quality of life (HRQo) of women surviving a borderline ovarian tumor (BOT) in comparison with early-stage ovarian cancer survivors treated surgically alone and with a matched cancer-free population. MethodsSurvivors of BOT and ovarian cancer were invited in two Dutch cross-sectional, population-based studies. Ovarian cancer survivors with tumor stage I who were treated surgically only were included. A random sample from the cancer-free population was matched on sex, age and education to the sample of BOT survivors. The EORTC QLQ-C30 (version 3.0) and the EORTC QLQ-OV28 were completed by the cancer-free population and the BOT and ovarian cancer survivors in study 1 and 2. The Hospital Anxiety and Depression Scale (HADS) was only completed by the cancer-free population and the survivors of BOT and ovarian cancer in study 1. BOT survivors were compared to early-stage ovarian cancer survivors and the general population using linear regression analyses and effect sizes regarding clinical importance. Results83 BOT (42%), 88 early-stage ovarian cancer survivors (52%), and 82 women from the general population were included. In most HRQoL domains, BOT survivors were not significantly different from early-stage ovarian cancer survivors and the cancer-free population, except that BOT survivors reported significantly less insomnia than early-stage ovarian cancer survivors and more dyspnea than the cancer-free population (small clinical difference). ConclusionIn general, BOT survivors' HRQoL lies between the HRQoL of early-stage ovarian cancer survivors and of the cancer-free population, but clinical effect sizes between the groups were mostly only trivial.

Predictive validity of Lupus Patient-Reported Outcome for damage accrual in patients with systemic lupus erythematosus: the LUNA Registry.

The predictive validity of disease-specific quality of life (QOL) remains unknown in patients with systemic lupus erythematosus (SLE), although disease-specific measures are equally or more responsive to changes than generic QOL. We aimed to examine the predictive validity of the Lupus patient-reported outcome (PRO) for damage accrual. Patients with SLE and ≥2 measurements over time were included in Japanese nationwide multicentre registry (LUNA). The Lupus PRO questionnaire contains both health-related (HR) and non-HR-QOL measures. Damage accrual was evaluated using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). We examined the association between the Lupus-PRO score at baseline and longitudinal SDI scores using mixed-effects models adjusted for prognostic factors. Among 1295 patients, those with higher HR-QOL of Lupus PRO at baseline demonstrated a significantly lower increase in SDI (-0.005/year, 95% confidence interval [CI]: -0.007 to - 0.004, p < 0.001). According to the categorisation of HR-QOL based on tertile, a similar dose-dependent effect of HR-QOL on longitudinal SDI was identified (second vs first tertile category: -0.101/year, 95% CI: -0.172 to - 0.030; third tertile category: -0.211/year, 95% CI: -0.281 to - 0.142). Non-HR-QOL was not significantly associated with the SDI scores. Among the HR-QOL domains, cognition, procreation, and physical health were significantly associated with the total SDI scores over time. HR-QOL was associated with corticosteroid-dependent and -independent SDI scores. A higher HR-QOL of Lupus PRO was associated with a lower increase in SDI scores. Our findings imply the importance of disease-specific HR-QOL measurements in assessing prognosis.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease severity, and frailty

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.ObjectiveTo assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI...

The Symptom Experience of Patients with Advanced Melanoma Undergoing Immune Checkpoint Inhibitor (ICI) Therapy

ObjectivesThe advent of immune checkpoint inhibitor (ICI) therapy has vastly improved outcomes for patients with advanced melanoma. However, the symptom burden and intensity with their impact on quality-of-life (HRQoL) and functionality are heterogeneous and unpredictable. We used descriptive exploratory content analysis from interviews to capture the patient experience after they had completed quantitative data collection of their symptom burden and interference with the use of two patient-reported outcome (PRO) instruments. Data SourcesParticipants from a single center with advanced melanoma (n = 19) who are undergoing ICI therapy completed the Modified MD Anderson Symptom Inventory and Functional Assessment of Cancer Therapy-Melanoma and recorded semistructured interviews. Interpretive description informed the inductive and iterative analysis approach. ConclusionParticipants had a heterogenous experience of ICI and melanoma-related symptoms: distress (84%), fatigue (68%), rash or skin changes (53%), pain (30%), diarrhea (30%), itching (26%), and shortness of breath (21%), with varying interference within HRQoL domains, mood (47%), relations with other people (26%), and activity (21%). Some noted a lack of physical interference (79%). Uncertainty was a pervasive theme in the interviews (68%) despite the majority having positive thoughts about ICI therapy (58%) and expectations of the success of therapy (53%). The physical and emotional burden of a melanoma diagnosis, undergoing therapy, and the uncertainty of the outcomes are pervasive for patients. Implications for Nursing PracticeCommunication surrounding the diagnosis, prognosis, treatment options, and outcomes need to be clear and acknowledge there are unknowns. Nurses may benefit from using a validated PRO instrument to help document and understand the patient's symptom experience while undergoing ICI therapy.

The Impact of Diabetic Disease on Health-Related Quality of Life in Type 2 Diabetic Patients Karbala. Iraq: Across sectional study

The present study aimed to assess the health-related quality of life of a group of Iraqi diabetics in Karbala and investigate the sociodemographic and disease-related factors that influence it. The present study included 200 Iraqi patients with type 2 diabetes who visited the Endocrinology Center/Al-Huja Hospital in Karbala between November 2020 and December 2021. A control group of 120 healthy people was also included. The Arabic version of the Short Form 8 was used to assess the medical quality of life. The measure used a 5-point Likert scale with responses ranging from 1 to 5. Each domain is scaled oppositely, so a more excellent score reflects a worse quality of life rating. In general, diabetes impacted the HRQoL of diabetic patients at a very significant level, with median scores for all HRQoL domains being significantly higher in patients than in controls (P&lt;0.001). Obesity, education level, monthly income and glycemic control are all affected overall. Glycemic control is the most potent variable influencing the total domains of HRQOL. In conclusion, Type 2DM showed significantly lower health-related quality of life in various domains than healthy control subjects. Glycemic control is the most potent variable influencing all domains of HRQoL. Keywords: Health-Related Quality of Life; type 2 DM; Short Form.

Identifying domains of health-related quality of life: the perspective of individuals with low back pain

BackgroundIdentifying the most relevant HRQOL domains for LBP from the perspective of individuals with lived experience with LBP is necessary to prioritize domains that will be most informative for evaluating the impact of pain and interventions while overcoming the burden of using long-form assessment tools. This study aimed to identify which domains of HRQOL are most important from the perspective of individuals with chronic LBP.MethodsSemi-structured interviews were conducted with 26 individuals with LBP. Participants first responded to questions related to the impact of their LBP on their HRQOL. Then, using a card sorting method, they were asked to select and indicate HRQOL domains that were most relevant to them from a list of 18 cards that represented different HRQOL domains. Participants were asked to explain the reasoning for their selection.ResultsParticipants identified physical activity restriction (50%), severity of pain (31%), social activity restriction (23%), and work performance restriction (23%) as the most important domains. The most frequently selected HRQOL domains during card sorting were social function (69%), pain intensity (62%), physical function (58%), fatigue (58%), and pain interference (42%).ConclusionThe most important domains of HRQOL perceived by participants were pain intensity, social function, physical function, fatigue, and pain interference. Identifying these domains will inform clinical decision-making and guide treatment choices for health care providers.

The relationship between internalized weight stigma and physical and mental health-related quality of life in a large sample of women: a structural equation modeling analysis

PurposeHealth-related quality of life (HRQOL) refers to an individual's perception of their physical and mental health status over time. Although emerging evidence has documented a negative association between weight stigma (i.e., negative weight-related attitudes and beliefs towards individuals with overweight or obesity) and mental HRQOL, its influence on physical HRQOL still needs to be fully clarified. This study aims to investigate the impact of internalized weight stigma on mental and physical HRQOL by employing a structural equation modeling (SEM) approach.MethodsThe Short Form Health Survey 36 (SF-36) and the Weight Bias Internalization Scale (WBIS) were administered to a sample of 4450 women aged 18–71 (Mage = 33.91 years, SD = 9.56) who self-identified in a condition of overweight or obesity (MBMI = 28.54 kg/m2; SD = 5.86). Confirmatory factor analysis (CFA) was conducted to assess the dimensionality of the scales before testing the proposed structural model.ResultsAfter establishing the adequacy of the measurement model, SEM results revealed that internalized weight stigma was significantly and negatively associated with both mental (β = − 0.617; p < 0.001) and physical (β = − 0.355, p < 0.001) HRQOL.ConclusionThese findings offer additional support to prior research by confirming the association between weight stigma and mental HRQOL. Moreover, this study contributes to the existing literature by strengthening and extending these associations to the physical HRQOL domain. Although this study is cross-sectional in nature, it benefits from a large sample of women and the use of SEM, which offers advantages over traditional multivariate techniques, e.g., by explicitly accounting for measurement error.Level of evidence: Level V, descriptive cross-sectional study.

Sociodemographic factors and use of pain medication are associated with health-related quality of life: results from an adult community mental health service in Norway.

Health-related quality of life (HRQoL) is an important aspect of mental health outcomes. There are few studies on HRQoL in heterogeneous patient populations seeking help at community mental health services. The aims of the study were to compare how HRQoL, measured by the EuroQol five dimensions with five levels (EQ-5D-5L), was distributed compared to other samples from national and international studies, and to explore what factors are associated with HRQoL. In a cross-sectional study, 1379 Norwegian outpatients reported their HRQoL before starting treatment. Associations with demographic variables, job status, socio-economic status, and use of pain medication were examined using multiple regression analysis. Most of the sample, 70% to 90%, reported problems with usual activities, pain/discomfort, and anxiety/depression; 30% to 65% reported that these problems were of a moderate to extreme degree. Forty percent reported problems with mobility, and about 20% reported problems with self-care. The sample's HRQoL was considerably lower than the general population, and comparable to patient-groups from specialist mental health services. Originating from a developing country, lower level of education, lower yearly household income, being on sick leave or unemployed, and using pain medication were associated with lower HRQoL. Age, gender, and relationship status were not associated with HRQoL. This is the first study to simultaneously examine the unique contribution of these variables in one study. The most impacted domains of HRQoL were pain/discomfort, anxiety/depression, and usual activities. Lower HRQoL was associated with several socio-demographic factors and use of pain medication. These findings might have clinical implications and suggest that mental health professionals should routinely measure HRQoL in addition to symptom severity, to identify areas that should be targeted to improve HRQoL.

753-P: Tirzepatide Improves HRQoL Compared with Insulin Lispro in Poorly Controlled Basal Insulin–Treated Adults with Long-Standing T2D (SURPASS-6)

Tirzepatide, a first-in-class GIP/GLP-1 receptor agonist, resulted in significant improvements in HbA1c and body weight compared to insulin lispro (iLispro) at 52 weeks in the SURPASS-6 study. We compared the HRQoL of participants with T2D treated with tirzepatide (all doses pooled) versus iLispro, both added to basal insulin, in SURPASS-6. Adults with T2D and inadequate glycemic control were randomized (1:1:1:3) to tirzepatide 5, 10, or 15 mg QW, or iLispro TID, as add-on to optimized insulin glargine, with or without metformin, for 52 weeks in this open-label, multicenter, Phase 3b study. HRQoL was measured at baseline and endpoint (Week 52) using the SF-36v2 acute form comprised of 8 domains and 2 component summary scores. Overall, 1428 participants with mean baseline age 59 y, T2D duration 14 y, HbA1c 8.8% and BMI 33.1 kg/m2 were randomized. At endpoint, tirzepatide-treated participants had statistically significantly improved scores across all SF-36v2 domains and component summaries compared to iLispro-treated participants, with the largest differences observed in the General health (LS mean [SE] change 3.0 [0.31] vs. -0.1 [0.32]) and Vitality (1.5 [0.31] vs. -1.1 [0.32]) domains (Table). Tirzepatide treatment resulted in greater improvements across multiple domains of HRQoL than iLispro in adults with long standing T2D already treated with basal insulin. Disclosure K.Boye: Employee; Eli Lilly and Company. H.Sapin: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.Poon: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L.Fernandez lando: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. R.Huh: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M.Wang: None. H.Patel: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Effects of prior injury on long term patient reported outcomes after trauma.

Trauma is an episodic, chronic disease with substantial, long-term physical, psychological, emotional, and social impacts. However, the effect of recurrent trauma on these long-term outcomes remains unknown. We hypothesized that trauma patients with a history of prior traumatic injury (PTI) would have poorer outcomes 6 months (6mo) after injury compared with patients without PTI. Adult trauma patients admitted at an urban, academic, Level I trauma center were screened for inclusion (October 2020 to November 2021). Enrolled patients were administered the PROMIS-29 instrument, the primary care post-traumatic stress disorder screen, and standardized questions about prior trauma hospitalization, substance use, employment, and living situation at baseline and 6mo after injury. Assessment data was merged with clinical registry data, and outcomes were compared with respect to PTI. Of 3,794 eligible patients, 456 completed baseline assessments and 92 completed 6mo surveys. Between those with or without PTI, there were no differences at 6mo after injury in the proportion of patients reporting poor function in social participation, anxiety, depression, fatigue, pain interference, or sleep disturbance. Prior traumatic injury patients reported poor physical function less often than patients without PTI (10 [27.0%] vs. 33 [60.0%], p = 0.002). After controlling for age, gender, race, injury mechanism, and Injury Severity Score, PTI correlated with a fourfold decrease in poor physical function risk (adjusted odds ratio, 0.243; 95% confidence interval, 0.081-0.733; p = 0.012) in the multivariable logistic regression model. Compared with patients suffering their first injury, trauma patients with PTI have better self-reported physical function after a subsequent injury and otherwise equivalent outcomes across a range of HRQoL domains at 6mo. There remains substantial room for improvement to mitigate the long-term challenges faced by trauma patients and to facilitate their societal reintegration, regardless of the number of times they are injured. Prognostic and Epidemiological; Level III.

Cognition and Health-related Quality of Life in Multiple Sclerosis

Background: Cognitive dysfunctions are considered as a poor prognostic factor that influence health-related quality of life in multiple sclerosis. Objective: The aim of the study was to evaluate the impact of cognitive impairment on the quality of life in multiple sclerosis patients. Methods: This study included 60 MS patients treated at the Department of Neurology, Clinical Center University of Sarajevo. Inclusion criteria were clinically definite diagnosis of multiple sclerosis, 18 years of age or older and were able to give written informed consent. Cognitivefunction was evaluated by the Montreal Cognitive Assessment (MoCa) screening test. Quality of life was evaluated by SF36 questionnaire. Results: 88.33% of patients had cognitive impairment with 68.33% with mild cognitive impairment. Abstraction (60,83%), language (56,66%), executive functions (53.66%) and delayed recall (28.33%) were rated the worst. The median value of SF-36 score was 54.1 (27.7-70.01). The lowest results were achieved in the QOL domains of psycial limitation with a median value of 12.5 (0-75) and emotional limitation 33.3 (0-100). It is found statistically significant correlation of the MoCa score with social functioning, energy, vitality and general health (p&lt;0.05) and physical functioning (p&lt;0.001) domains of quality of life, as well as with SF -36 total scores (p&lt;0.05). Among group of patients with cognitive impairment, statistically significant positive correlation between cognitive status mental health HRQOL domain (rho=0.427; p&lt;0.001) was found. Conclusion: Cognitive impairment is very often presented in patients with multiple sclerosis with significant contribution to a poorer quality of life. It is associated with physical and emotional limitations, as well as poorer mental health. Further studies are needed, especially when we take into account very important clinical and prognostic role of cognition in multiple sclerosis.

Health-Related Quality of Life in pre-dialysis patients with chronic kidney disease: the role of Big-Five personality traits and illness denial

Health-Related Quality of Life (HRQoL) in patients with chronic kidney disease (CKD) is significantly affected, regardless of the stage of the disease, as regards the physical, psychological and social functioning dimension. Big-Five personality traits can affect patients' HRQoL and willingness to take treatment options. Illness denial consists of denial of negative emotions, resistance to change and conscious avoidance. Poorer HRQoL can predict a higher risk of hospitalization and mortality, and broadly a worse adjustment to the dialytic therapy. Thus, a clearer knowledge of the psychological variables associated with a worse HRQoL in the predialysis stage might improve the interventionplanning. No study investigated illness denial and personality traits simultaneously. We investigated the role of illness denial and Big-Five personality traits in the domains of HRQoL in predialysis patients with CKD. One hundred adults (mean age: 75.87years) with CKD participated. The Kidney Disease Quality of Life Short form, the Italian version of Ten Item Personality Inventory Revised, the Illness Denial Questionnaire, and the State-Trait Anxiety Inventory Form-Y were administered. Illness denial was associated with increased HRQoL relatedto symptoms/problems, effectand burden of CKD and cognitive functions domains, and it was a predictor of higher HRQoL in the last three domains mentioned above. Extraversion was related to better work status and sexual function; agreeableness was linked to elevated cognitive function, quality of social interaction and sexual function; conscientiousness was related to better sexual function; neuroticism was linked to improved cognitive and sexual functions; in the end, openness to experience was related to fewer symptoms and problems. This is the first study which simultaneously assessed Big-Five personality traits and illness denial in different domains of HRQoL of CKD patients. Personalised psychological interventions aimed at improving HRQoL in this population might focus on specific illness denial processes and personality traits.

Health-Related Quality of Life Assessment in Post-Covid Patients: A Cross-Sectional Online Survey

Aims:&#x0D; &#x0D; To compare the impact of covid-19 infection and its associated factors among various domains of quality of life (general health (GH), physical health (PH), mental health, and pain).&#x0D; To determine the variation and it’s contributing factors to the quality of life (QoL).&#x0D; To identify the most common persisting symptoms after covid-19 infection.&#x0D; &#x0D; Study Design: Cross-sectional community based online survey.&#x0D; Place and Duration of Study: Community-based online survey done for a period of 6 months (March 2021- September 2021) among patients who recovered from covid-19.&#x0D; Methodology: A validated self-made questionnaire with informed consent was used to gather information on the patient’s demographics (age, gender, educational qualification, occupation, marital status, and risk factors) covid-19 details (vaccination, severity, and hospitalization details), persisting symptoms, andHealth Related Quality of Life (HRQoL).&#x0D; The HRQoL questions with scored options were framed under four domains general health, physical health, mental health, and pain. A convenient sample of 120 participants was included in our study.&#x0D; Results: The median and inter-quartile ranges were used to describe the HRQoL score. For normal data, Multiple Linear Regression (MLR) was used to investigate the relationship between the dependent and independent variables.MLR results demonstrated that risk factors, severity, and length of hospital stay were negatively associated with QoL.&#x0D; For non-normal data, the Kruskal Wallis test (KWT) and Mann Whitney U (MWU) test were used to compare the effect of covid-19 and its associated factors among various domains of HRQoL. KWT and MWT showed that the ability to perform physical activity was highly impaired in most post-covid patients. Cough, myalgia, arthralgia, and headache were the significant persisting symptoms of covid-19, reported by our participants. IBM SPSS software version 28.0 was used for statistical analysis.&#x0D; Conclusion: We conclude that health care intervention is needed to manage persisting symptoms and to improve HRQoL.

Health-Related Quality of Life in Adults with Cystic Fibrosis: Familial, Occupational, Social, and Mental Health Predictors.

Background: Cystic Fibrosis (CF) adult patients experience daily physical symptoms and disabilities that may impact their quality of life and mental health. Methods: This prospective study aimed to evaluate the relative contribution of the familial, occupational, and social environment, besides that of the main physical and mental health factors, to the quality of life of CF adult patients using the Cystic Fibrosis Questionnaire-Revised (CFQ-R) in a multivariate model. Results: Fifty patients were analyzed (70% of men; median age of 25 years; median body mass index of 21 kg/m²; median FEV1 of 57%). Anxiety and depression scores were negatively associated with 9 of the 12 CFQ-R domains. When controlling for anxiety and depression, FEV1% and BMI were significant positive predictors of several domains of the CFQ-R. All the familial, occupational, and social components analyzed but one (professional training) were predictors of at least one domain of the CFQ-R. Conclusion: Anxiety and depression explained a greater proportion of the variance than physical variables (age, sex, BMI, FEV1%, and exacerbation in the last year) in CF HRQoL. Many familial, occupational, and social components were also specifically and independently predictors of some HRQoL domains. Their screening might help identifying CF patients eligible for specific interventions, focusing on the impaired QoL dimensions.

MO985: Physical Function Trajectories Predict Patient Survival in Older Recipients of Deceased Donor Kidneys

Abstract BACKGROUND AND AIMS Health-related quality of life (HRQOL) outcomes have been positively associated with patient survival after kidney transplantation (KT). In older recipients, poor HRQOL may indicate risk for clinical deterioration. We aimed to prospectively evaluate if, in older recipients of deceased brain-dead donor (DBD) kidneys, changes in HRQOL during the first year post-transplantation differed between survivor and non-survivors. METHOD KT candidates aged ≥65 years who were enlisted between January 2013 and November 2016 at the Norwegian national transplant center and received a deceased brain-dead donor (DBD) kidney were included. HRQOL was assessed using the Kidney Disease Quality of Life Short Form, version 1.3. HRQOL outcomes were collected prior to KT, at 10 weeks, 6 months and 12 months post-KT. A mixed-effect linear regression model was used to examine the development of HRQOL during the first year post-KT in survivors versus non-survivors. Longitudinal HRQOL trajectories were identified using a group-based trajectory modelling. A Cox proportional hazard regression was used to investigate the association of longitudinal HRQOL trajectories for each domain with patient survival. RESULTS We included 289 waitlisted candidates, of whom 192 received a DBD kidney. Mean age at KT was 72 (4.1) years, 133 (69%) were males, 47 (24%) were transplanted preemptively and 80% received an expanded criteria donor organ. During a median observation time of 4.6 (3.2, 6.3) years post-KT, 66 recipients died. In survivors, all the generic and kidney-specific HRQOL domains substantially improved during the first year post-KT, whereas HRQOL deteriorated in non-survivors (Figure 1). Three developmental trajectories, describing poor, fair and good outcomes were identified for most of the HRQOL domains. Recipients perceiving poor physical development during the first post-transplant year had a 2.5 higher mortality risk, while recipients with fair physical development had 1.4 increased mortality risk, compared with recipients with good physically development (Figure 2). CONCLUSION In elderly kidney transplant recipients, poor post-transplant physical function trajectory may indicate impaired survival. The systematic HRQOL monitoring following KT is warranted to identify high-risk patients and guide therapeutic decisions.

Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.

Radical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD. Patients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction. Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046). This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms.

PREVALENCE AND IMPACTS OF POST-TRAUMATIC STRESS SYMPTOMS IN IBD PATIENTS FROM UNDER-REPRESENTED MINORY GROUPS

Abstract INTRODUCTION Post Traumatic Stress (PTS) is a chronic psychological condition that occurs in response to a traumatic event, and includes symptoms of re-experiencing, avoidance behaviors, changes in mood, and hyperarousal. Left untreated, PTS is associated with poor outcomes and significant impairments in quality of life (HRQoL). Recent studies find 20-30% of IBD patients report significant PTS symptoms due to IBD experiences. The majority of participants in these studies are white, non-Hispanic making results difficult to generalize to other populations. As such, we aim to characterize IBD related PTS in under-represented minority (URM) patients. METHODS Adult patients 18+ who identify as a URM (Latino/a, African American, Asian, Middle Eastern, Native American or Native Pacific Islander) recruited via social media and researchmatch.org website completed an anonymous online survey: demographics, disease information, Harvey Bradshaw Index (HBI) or simple clinical colitis activity index (SCCAI) with &amp;gt;4 = active IBD, NIH-PROMIS QoL module (fatigue, sleep disturbance, social isolation, pain interreference), and PTSD Checklist-5 (PCL5) with &amp;gt;30 = suggested IBD-PTS, with subscale scores. Independent samples t-Test, Pearson’s correlation, and hierarchical linear regression statistics were used. RESULTS 67 participants: 46% UC, 79% female, 73% South/Southeast Asian, 6% Hispanic, Age (Mean±SD) = 35.42±9.79 years. 55% had active IBD (HBI/SCCAI &amp;gt; 4; 5.57±4.51). 43% scored &amp;gt;30 on PCL5. Specifically, 55.2% reported re-experiencing trauma, 59.7% avoiding trauma triggers, 62.7% mood changes/irritability, and 67.2% autonomic hyperarousal. Patients with active IBD reported higher IBD-PTS (p=.001) as well as more fatigue, sleep disturbance, pain interference, and social isolation (all p&amp;lt;.001); no differences by IBD diagnosis, gender, or age. When controlling for HBI/SCCAI score, IBD-PTS severity was a significant predictor, but smaller than disease severity, of fatigue (β=.223, p=.025) and pain interference (β=.254, p=.006), and a larger predictor of sleep disturbance (β=.424, p&amp;lt;.001) and social isolation (β= -.417, p&amp;lt;.001). Only the PTS symptoms of hyperarousal and mood contributed to these relationships. CONCLUSION 43% of URM met criteria for PTS, and scored above 50% in each symptom category of the PCL-5, suggesting URM patients are at even higher risk for IBD-related PTS. Despite disease severity, IBD-PTS severity predicted fatigue, pain interference, sleep disturbance, and social isolation domains of HRQoL; mood changes or hyperarousal presence appear to be the most important symptoms to address. IBD-PTS could have a greater influence on HRQoL than disease activity and should be assessed in patients with both active and inactive disease. More research is necessary to evaluate this relationship and the prevalence of IBD-PTS in URM.

QOLP-02. HEALTH-RELATED QUALITY OF LIFE (HRQOL) AMONG PEDIATRIC PATIENTS WITH NEUROFIBROMATOSIS TYPE 1 (NF1) AND PLEXIFORM NEUROFIBROMA (PN) IN THE UNITED STATES: PERSPECTIVES OF THE PATIENTS AND CAREGIVERS

Abstract BACKGROUND PNs occur in 30-50% of pediatric patients with NF1, often resulting in debilitating pain, mobility limitations, significant disfigurement, and may be life-threatening. Real-world evidence on the HRQoL of pediatric NF1 PN patients is limited. METHODS Patients ages 8-18 years with NF1 PN (treatment-naïve/new on selumetinib [≤ 1 month of use]) and their caregivers were recruited through Children’s Tumor Foundation to participate in an online cross-sectional survey (12/2020-1/2021). HRQoL measures included Pediatric Quality of Life Inventory (PedsQL; Acute version), Pain Interference Index (PII), and Patient-Reported Outcomes Measurement Information System (PROMIS) mobility and upper extremity functioning subscales. Patients provided self-reported responses; caregivers provided proxy responses and patient characteristics. Agreement between patient-reports and caregiver proxies was assessed using intra-class correlation coefficients (ICCs). RESULTS 61 patient-caregiver dyads participated in the survey. Patients were mostly white/Caucasian (90.2%), 50.8% female, with a median (range) age of 13.0 (11-16) years. Most were treatment-naïve (96.7%), with NF1 and PN diagnosis for &amp;gt; 5 years (91.8%, 82.0%). On the PedsQL (range: 0-100; higher=better; healthy patient mean scores typically &amp;gt; 80), patient-reported mean scores were 50.3, 56.1, 60.7, and 63.7 for school, emotional, social, and physical functioning; mean total score= 58.5. Caregiver-proxy mean scores ranged from 49.9-61.5 across subscales; mean total score= 55.4. Among patients reporting pain in the last 7 days, PII mean scores (range: 0-6; higher=more interference) were 3.0 (patient-reports) and 2.9 (caregiver proxies). Among patients with movement difficulty in the past 7 days, mean PROMIS scales t-scores (distribution mean= 50; higher=better) were 40.2 and 39.5 (patient-reports), and 35.6 and 30.1 (caregiver proxies), for mobility and upper extremity functioning. ICCs were very good, ranging from 0.85-0.93 across HRQoL measures. CONCLUSION NF1 PN can have substantial negative impact on pediatric patients, as demonstrated across various HRQoL domains, highlighting the importance of collecting patient-centered outcomes to guide treatment decisions.

Association of multimorbidity and changes in health-related quality of life following myocardial infarction: a UK multicentre longitudinal patient-reported outcomes study

BackgroundMultimorbidity is prevalent for people with myocardial infarction (MI), yet previous studies investigated single-health conditions in isolation. We identified patterns of multimorbidity in MI survivors and their associations with changes in HRQoL.MethodsIn this national longitudinal cohort study, we analysed data from 9566 admissions with MI from 77 National Health Service hospitals in England between 2011 and 2015. HRQoL was measured using EuroQol 5 dimension (EQ5D) instrument and visual analogue scale (EQVAS) at hospitalisation, 6, and 12 months following MI. Latent class analysis (LCA) of pre-existing long-term health conditions at baseline was used to identify clusters of multimorbidity and associations with changes in HRQoL quantified using mixed effects regression analysis.ResultsOf 9566 admissions with MI (mean age of 64.1 years [SD 11.9], 7154 [75%] men), over half (5119 [53.5%] had multimorbidities. LCA identified 3 multimorbidity clusters which were severe multimorbidity (591; 6.5%) with low HRQoL at baseline (EQVAS 59.39 and EQ5D 0.62) which did not improve significantly at 6 months (EQVAS 59.92, EQ5D 0.60); moderate multimorbidity (4301; 47.6%) with medium HRQoL at baseline (EQVAS 63.08, EQ5D 0.71) and who improved at 6 months (EQVAS 71.38, EQ5D 0.76); and mild multimorbidity (4147, 45.9%) at baseline (EQVAS 64.57, EQ5D 0.75) and improved at 6 months (EQVAS 76.39, EQ5D 0.82). Patients in the severe and moderate groups were more likely to be older, women, and presented with NSTEMI. Compared with the mild group, increased multimorbidity was associated with lower EQ-VAS scores (adjusted coefficient: −5.12 [95% CI −7.04 to −3.19] and −0.98 [−1.93 to −0.04] for severe and moderate multimorbidity, respectively.The severe class was more likely than the mild class to report problems in mobility, OR 9.62 (95% confidence interval: 6.44 to 14.36), self-care 7.87 (4.78 to 12.97), activities 2.41 (1.79 to 3.26), pain 2.04 (1.50 to 2.77), and anxiety/depression 1.97 (1.42 to 2.74).ConclusionsAmong MI survivors, multimorbidity clustered into three distinct patterns and was inversely associated with HRQoL. The identified multimorbidity patterns and HRQoL domains that are mostly affected may help to identify patients at risk of poor HRQoL for which clinical interventions could be beneficial to improve the HRQoL of MI survivors.Trial registrationClinicalTrials.gov NCT01808027 and NCT01819103

Health-related quality of life in men with localized prostate cancer treated with radiotherapy: validation of an abbreviated version of the Expanded Prostate Cancer Index Composite for Clinical Practice in Spain

BackgroundHealth-related quality of life (HRQoL) is greatly affected by prostate cancer (PCa) and associated treatments. This study aimed to measure the impact of radiotherapy on HRQoL and to further validate the Spanish version of the 16-item Expanded Prostate Cancer Index Composite (EPIC-16) in routine clinical practice.MethodsAn observational, non-interventional, multicenter study was conducted in Spain with localized PCa patients initiating treatment with external beam radiotherapy (EBRT) or brachytherapy (BQT). Changes from baseline in EPIC-16, University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), and patient-perceived health status were longitudinally assessed at end of radiotherapy (V2) and 90 days thereafter (V3). Psychometric evaluations of the Spanish EPIC-16 were conducted.ResultsOf 516 patients enrolled, 495 were included in the analysis (EBRT, n = 361; BQT, n = 134). At baseline, mean (standard deviation [SD]) EPIC-16 global scores were 11.9 (7.5) and 10.3 (7.7) for EBRT and BQT patients, respectively; scores increased, i.e., HRQoL worsened, from baseline, by mean (SD) of 6.8 (7.6) at V2 and 2.4 (7.4) at V3 for EBRT and 4.2 (7.6) and 3.9 (8.2) for BQT patients. Changes in Spanish EPIC-16 domains correlated well with urinary, bowel, and sexual UCLA-PCI domains. EPIC-16 showed good internal consistency (Cronbach’s alpha = .84), reliability, and construct validity.ConclusionThe Spanish EPIC-16 questionnaire demonstrated sensitivity, strong discriminative properties and reliability, and validity for use in clinical practice. EPIC-16 scores worsened after radiotherapy in different HRQoL domains; however, a strong tendency towards recovery was seen at the 3-month follow-up visit.