Health-related Quality Of Life Outcomes Research Articles

Patient-reported outcomes after minimally invasive sacro-iliac joint surgery: a cohort study based on the Swedish Spine Registry.

There is conflicting evidence regarding treatment outcomes after minimally invasive sacroiliac joint fusion for long-lasting severe sacroiliac joint pain. The primary aim of our cohort study was to investigate change in patient-reported outcome measures (PROMs) after minimally invasive sacroiliac joint surgery in daily practice in the Swedish Spine Registry. Secondary aims were to explore the proportion of patients reaching a patient acceptable symptom score (PASS) and the minimal clinically important difference (MCID) for pain scores, physical function, and health-related quality of life outcomes; furthermore, to evaluate self-reported satisfaction, walking distance, and changes in proportions of patients on full sick leave/disability leave and report complications and reoperations. Data from the Swedish Spine Registry was collected for patients with first-time sacroiliac joint fusion, aged 21 to 70 years, with PROMs available preoperatively, at 1 or 2 years after last surgery. PROMs included Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for low back pain (LBP) and leg pain, and EQ-VAS, in addition to demographic variables. We calculated mean change from pre- to postoperative and the proportion of patients achieving MCID and PASS. 68 patients had available pre- and postoperative data, with a mean age of 45 years (range 25-70) and 59 (87%) were female. At follow-up the mean reduction was 2.3 NRS points (95% confidence interval [CI] 1.6-2.9; P < 0.001) for LBP and 14.8 points (CI 10.6-18.9; P < 0.001) for ODI. EQ-VAS improved by 22 points (CI 15.4-30.3, P < 0.001) at follow-up. Approximately half of the patients achieved MCID and PASS for pain (MCID NRS LBP: 38/65 [59%] and PASS NRS LBP: 32/66 [49%]) and physical function (MCID ODI: 27/67 [40%] and PASS ODI: 24/67 [36%]). The odds for increasing the patient's walking distance to over 1 km at follow-up were 3.5 (CI 1.8-7.0; P < 0.0001), and of getting off full sick leave or full disability leave was 0.57 (CI 0.4-0.8; P = 0.001). In the first 3 months after surgery 3 complications were reported, and in the follow-up period 2 reoperations. We found moderate treatment outcomes after minimally invasive sacroiliac joint fusion when applied in daily practice with moderate pain relief and small improvements in physical function.

Quality of life with neoadjuvant ipilimumab (IPI) and nivolumab (NIVO) versus adjuvant nivolumab in resectable stage III melanoma: 36-week data from the phase 3 NADINA trial.

LBA9584 Background: Neoadjuvant (neoadj) ipilimumab (IPI) + nivolumab (NIVO) showed improved event-free survival compared to adjuvant (adj) NIVO, but at the cost of increased immune related toxicity (irAEs). In the PRADO trial, impairment of health-related quality of life (HRQoL) was predominantly driven by the extent of the surgery and not by irAEs. To evaluate the effect of neoadj IPI+NIVO on HRQoL, we report the 36w HRQoL outcomes from the phase 3 NADINA trial. Methods: Eligible patients (pts) with resectable, macroscopic stage III melanoma were randomly assigned to receive 2 cycles of neoadj IPI+NIVO followed by a therapeutic lymph node dissection (TLND; w6) and only in partial- or non-responders, 1y of adj systemic treatment; or TLND (w0) followed by 12 cycles adj NIVO. EORTC QLQ-C30 questionnaires (qtn) were digitally collected at baseline, w6, w12 and thereafter q12w. The unadjusted HRQoL scores (scale 0-100) were assessed for pts who completed 39w of follow-up (FU) on January 12, 2024. Results: 261/423 randomized pts had 39w FU at data cutoff. 81% completed the qtn at BL, with thereafter an average compliance of 80%. QLQ-C30 data were available for 107 pts in the neoadj arm and 103 in the adj arm. Physical-, role-, emotional functioning, and pain were comparable between the neoadj and adj arm across all timepoints (Table), as were fatigue and the summary score. A numerical trend towards worsening of physical-, role functioning, and pain was seen at w6 for the adj arm and at w12 for the neoadj arm, representing the post-surgery QoL timepoints. Conclusion: Using fully digitalized data collection, this first HRQoL analysis of neoadj vs adj immunotherapy in stage III melanoma showed comparable results between the neoadj and adj arms. Physical-, role functioning, and pain were impaired in both groups at the first post-surgery timepoint. Clinical trial information: NCT04949113 . [Table: see text]

Dietary intakes and nutritional status in adults with Muscular Dystrophy

Muscular dystrophy (MD) is a group of inherited conditions causing progressive muscle weakness and wasting, for which no widely implementable treatment currently exists, although resistance training (Bostock et al., 2019, Frontiers in Neurology, 10) and corticosteroid treatment (Angelini, 2007, Muscle &amp; Nerve, 36, 424-435), have been shown to improve health-related quality of life (HQoL). Compared to physical activity, dietary manipulation may be more modifiable to improve dystrophic populations HQoL as disease outcomes often restrict physical capabilities. Data exploring the relationship between diet, disease and HQoL outcomes in adults with MD is insufficient. This study evaluated the habitual dietary intake of a sex-inclusive dystrophic population, to identify possible links between dietary intake, HQoL, and physical function. Participants included 5 women (age 65 ± 14 yrs, BMI 23.2 ± 2.7 kg/m2) and 10 men (age 55 ± 19 yrs, 31.6 ± 7.9 kg/m2) with different MDs (varied distribution and severity of muscle weakness). Participants' dietary intake data was collected using 3-day food records: analysed using Nutritics. Dominant hand maximal grip strength was measured using a hand-held dynamometer; upper extremity function and pain were assessed using the upper extremity functional index-15 and visual analogue scale, respectively. QoL was assessed through three tools: SF-36V2, Barthel Index and EQ5D, previously used in dystrophic populations. We observed that 50% of men and 20% of women did not meet the recommended daily intake (RDI) for protein (0.8 g·kg−1), however women (1.13 ± 0.26 g·kg−1) had increased protein intake compared to men (0.82 ± 0.27 g·kg−1, p &lt; 0.05). Of all participants 40% had a daily fat intake exceeding the RDI, with women having significantly higher relative average fat intakes (women = 1.03 ± 0.36 g·kg−1, men = 0.68 ± 0.29 g·kg−1, p &lt; 0.05). RDI for calcium was met by 46% participants (1000 mg) whilst all failed to meet the vitamin D RDI (10 μg). Positive correlations between age and protein intake as a percentage of RDI (r2 = 0.82), protein (r2 = 0.82), carbohydrate intake (r2 = 0.55) relative to body mass, vitamin D intake (r2 = 0.54), and total caloric intake (r2 = 0.59, all p&lt; 0.05) were observed. No other significant associations between dietary habits, physical function or HQoL outcomes were apparent. Despite these findings being observed in a small population it is apparent that many adults with muscular dystrophy may fail to meet RDI for protein, vitamin D, and calcium. This places this population at risk for nutritional deficiencies, incurring negative impacts on the musculoskeletal system. Further study of nutritional status in a larger population sample is needed to confirm these findings.

Evaluating the Health-Related Quality of Life in Patients with COPD and Chronic Heart Failure Post-Hospitalization after COVID-19 Using the EQ-5D and KCCQ Questionnaires.

Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) frequently coexist, significantly impacting health-related quality of life (HRQoL). This study evaluated HRQoL in patients with CHF, COPD, or both, three months post-COVID-19 discharge using EQ-5D and KCCQ questionnaires to guide targeted healthcare interventions. We conducted a cross-sectional study at "Victor Babes" Hospital in Timisoara, enrolling 180 patients who had recovered from COVID-19 (60 in each group including CHF, COPD, and both conditions). HRQoL was assessed via EQ-5D and KCCQ. Significant disparities in HRQoL measures were noted across the groups. Patients with both CHF and COPD reported the worst outcomes, especially in terms of hospital stay lengths due to COVID-19 (11.63 days) and initial oxygen saturation levels (88.7%). HRQoL improvements from discharge to three months post-discharge were significant, with EQ-5D mobility scores improving notably across all groups (CHF and COPD: 2.87 to 2.34, p = 0.010). KCCQ results reflected substantial enhancements in physical limitation (CHF and COPD: 38.94 to 58.54, p = 0.001) and quality of life scores (CHF and COPD: 41.38 to 61.92, p = 0.0031). Regression analysis revealed that dual diagnosis (CHF and COPD) significantly impacted usual activities and quality of life (β = -0.252, p = 0.048; β = -0.448, p = 0.017), whereas the initial severity of COVID-19 was a significant predictor of worse HRQoL outcomes (β = -0.298, p = 0.037; β = -0.342, p = 0.024). The presence of both CHF and COPD in patients recovering from COVID-19 was associated with more severe HRQoL impairment compared with either condition alone. These findings emphasize the need for specialized, comprehensive post-COVID-19 recovery programs that address the complex interplay among chronic conditions to optimize patient outcomes and enhance quality of life.

The role of symptom reduction in improving health-related quality of life through brief cognitive behavioral therapy

Objective Brief cognitive behavior therapy (bCBT) is effective in reducing symptoms of depression and anxiety disorders and improving health-related quality of life (HRQoL). However, the mechanisms through which cognitive behavior therapy impact HRQoL are not well understood. This study evaluated whether anxiety and depression symptom reduction is a mechanism of treatment for HRQoL outcomes. Method: Using secondary data from a multisite, pragmatic, randomized trial, this study evaluated bCBT vs enhanced usual care in 16 VA community-based outpatient clinics. Ordinary least-squares path analysis testing multiple mediators was used to evaluate the role of change in depression and anxiety symptoms in the relationship between treatment condition and HRQoL. Results: Receiving bCBT (vs. enhanced usual care) was significantly negatively associated with change (reduction) in depression and anxiety scores. The indirect effect of treatment on mental HRQoL was significant with change in depression scores as mediator. A similar pattern was observed for physical HRQoL and change in anxiety scores as mediator. Conclusion: Findings suggest reduction of depression and anxiety symptoms as a mechanism through which bCBT for depression promoted improvements in HRQoL, with important implications for understanding how CBT impacts functioning, as well as the utility of bCBT in nontraditional mental health settings. Trial registration: ClinicalTrials.gov identifier: NCT02466126.

Low resilience is associated with worse health-related quality of life in caregivers of service members and veterans with traumatic brain injury: a longitudinal study.

To examine [a] the association of caregiver health-related quality of life (HRQOL) and service member/veteran (SMV) neurobehavioral outcomes with caregiver resilience; [b] longitudinal change in resilience at the group and individual level; and [c] the magnitude of change at the individual level. Caregivers (N = 232) of SMVs with traumatic brain injury completed a resilience measure, and 18 caregiver HRQOL and SMV neurobehavioral outcome measures at a baseline evaluation and follow-up evaluation three years later. Caregivers were divided into two resilience groups at baseline and follow-up: [1] Low Resilience (≤ 45T, baseline n = 99, follow-up n = 93) and [2] High Resilience (> 45T, baseline n = 133, follow-up n = 139). At baseline and follow-up, significant effects were found between Low and High Resilience groups for the majority of outcome measures. There were no significant differences in resilience from baseline to follow-up at the group-mean level. At the individual level, caregivers were classified into four longitudinal resilience groups: [1] Persistently Low Resilience (Baseline + Follow-up = Low Resilience, n = 60), [2] Reduced Resilience (Baseline = High Resilience + Follow-up = Low Resilience, n = 33), [3] Improved Resilience (Baseline = Low Resilience + Follow-up = High Resilience, n = 39), and [4] Persistently High Resilience (Baseline + Follow-up = High Resilience, n = 100). From baseline to follow-up, approximately a third of the Reduced and Improved Resilience groups reported a meaningful change in resilience (≥ 10T). Nearly all of the Persistently High and Persistently Low Resilience groups did not report meaningful change in resilience (< 10T). Resilience was not a fixed state for all caregivers. Early intervention may stall the negative caregiving stress-health trajectory and improve caregiver resilience.

Social Determinants of Health and Health-Related Quality of Life Following Pediatric Septic Shock: Secondary Analysis of the Life After Pediatric Sepsis Evaluation Dataset, 2014-2017.

Social determinants of health (SDOH) are associated with disparities in disease severity and in-hospital outcomes among critically ill children. It is unknown whether SDOH are associated with later outcomes. We evaluated associations between SDOH measures and mortality, new functional morbidity, and health-related quality of life (HRQL) decline among children surviving septic shock. Secondary analysis of the Life After Pediatric Sepsis Evaluation (LAPSE) prospective cohort study was conducted between 2014 and 2017. Twelve academic U.S. PICUs were involved in the study. Children younger than 18 years with community-acquired septic shock were involved in the study. None. We assessed associations between race, ethnicity, income, education, marital status, insurance, language, and home U.S. postal code with day 28 mortality, new functional morbidity at discharge per day 28, and HRQL decline using logistic regression. Of 389 patients, 32% ( n = 98) of families had household income less than $50,000 per year. Median Pediatric Risk of Mortality (PRISM) score was 11 (interquartile range 6, 17). We found that English language and Area Deprivation Index less than 50th percentile were associated with higher PRISM scores. Mortality was 6.7% ( n = 26), new functional morbidity occurred in 21.8% ( n = 78) of patients, and HRQL decline by greater than 10% occurred in 31.0% of patients ( n = 63). We failed to identify any association between SDOH measures and mortality, new functional morbidity, or HRQL decline. We are unable to exclude the possibility that annual household income greater than or equal to $50,000 was associated with up to 81% lesser odds of mortality and, in survivors, more than three-fold greater odds of HRQL decline by greater than 10%. In this secondary analysis of the 2014-2017 LAPSE dataset, we failed to identify any association between SDOH measures and in-hospital or postdischarge outcomes following pediatric septic shock. This finding may be reflective of the high illness severity and single disease (sepsis) of the cohort, with contribution of clinical factors to functional and HRQL outcomes predominating over prehospital and posthospital SDOH factors.

Pediatric Acute Respiratory Distress Syndrome Severity and Health-Related Quality of Life Outcomes: Single-Center Retrospective Cohort, 2011-2017.

To determine factors associated with health-related quality of life (HRQL) decline among pediatric acute respiratory distress syndrome (PARDS) survivors. Retrospective cohort study. Academic children's hospital. Three hundred fifteen children 1 month to 18 years old with an unplanned PICU admission from December 2011 to February 2017 enrolled in the hospital's Outcomes Assessment Program. None. Pre-admission baseline and median 6-week post-discharge HRQL were assessed using the Pediatric Quality of Life Inventory or the Functional Status II-R. Patients meeting retrospectively applied Second Pediatric Acute Lung Injury Consensus Conference criteria for PARDS were identified, and PARDS severity was classified using binary (mild/moderate, severe) and trichotomous (mild, moderate, severe) categorization for noninvasive ventilation and invasive mechanical ventilation (IMV). PARDS occurred in 41 of 315 children (13.0%). Clinically important HRQL decline (≥ 4.5 points) occurred in 17 of 41 patients (41.5%) with PARDS and 64 of 274 without PARDS (23.4%). On multivariable generalized linear regression adjusted for age, baseline Pediatric Overall Performance Category, maximum nonrespiratory Pediatric Logistic Organ Dysfunction score, diagnosis, length of stay, and time to follow-up, PARDS was associated with HRQL decline (adjusted relative risk [aRR], 1.70; 95% CI, 1.03-2.77). Four-hour and maximum PARDS severity were the only factors associated with HRQL decline. HRQL decline occurred in five of 18 patients with mild PARDS at 4 hours, five of 13 with moderate PARDS (aRR 2.35 vs. no PARDS [95% CI, 1.01-5.50]), and seven of ten with severe PARDS (aRR 2.56 vs. no PARDS [95% CI, 1.45-4.53]). The area under the receiver operating characteristic curve for discrimination of HRQL decline for IMV patients was 0.79 (95% CI, 0.66-0.91) for binary and 0.80 (95% CI, 0.69-0.93) for trichotomous severity categorization. HRQL decline is common among children surviving PARDS, and risk of decline is associated with PARDS severity. HRQL decline from baseline may be an efficient and clinically meaningful endpoint to incorporate into PARDS clinical trials.

Quality of life outcomes in patients with resectable dedifferentiated liposarcoma treated with neoadjuvant immunotherapy.

e23552 Background: Currently there is a lack of robust data on health-related quality of life outcomes for patients with retroperitoneal sarcoma. The purpose of this study was to look at trends in health-related quality of life outcomes for patients and determine what symptoms impacted patients the most. Patients with surgically resectable dedifferentiated liposarcoma who were participating in a randomized, phase II, non-comparative trial of combination nivolumab (nivo) and ipilimumab (ipi/nivo) were selected to participate in this study. Methods: Five patients were randomized to participate in structured qualitative interviews. Three patients were randomized to the nivo/ipi arm and 2 to the nivo arm. The interviews were conducted at 6 separate time points, both during receipt of neoadjuvant therapy and after tumor resection. Questions were structured around ten themes which included treatment side effects, abdominal complications, appetite, energy levels, quality of life effects, and financial complications. Patient responses were transcribed, coded, and themes in symptoms during treatment were identified. Results: Different themes in symptoms emerged during each time-period of treatment. During the pretreatment period patients were more likely to report abdominal complaints that they attributed to their primary tumor. During neoadjuvant immunotherapy (week 3) patients reported more skin complaints, including the development of rashes and pruritis. These tended to improve by their preoperative visit. Patients reported typical postoperative symptoms at their 6-week post operative visit including increases in pain medications, muscle pain, and some abdominal soreness. By one year patients reported no significant symptoms and demonstrated resolution of all prior symptoms. Overall patients reported few energy and sleep related symptoms throughout their treatment course. Conclusions: For patients with resectable dedifferentiated liposarcoma receiving immune checkpoint blockade, health-related quality of life symptoms were present throughout their treatment course. Common themes that emerged demonstrated a lack of severe symptoms experienced by patients in either arm and resolution of symptoms by one year post treatment. Our interview results can help clinicians focus on symptoms that are impactful to patients in future clinical trials.

Evaluation of elranatamab vs EPd, PVd, or Kd in patients with relapsed or refractory multiple myeloma and prior anti-CD38–directed therapy: MagnetisMM-32.

TPS7576 Background: Elranatamab (ELRA), a humanized B-cell maturation antigen (BCMA)-CD3 bispecific antibody, has shown efficacy and manageable safety as a monotherapy in patients with relapsed or refractory multiple myeloma (RRMM). This study will evaluate ELRA monotherapy vs elotuzumab-pomalidomide-dexamethasone (EPd), pomalidomide-bortezomib-dexamethasone (PVd), or carfilzomib-dexamethasone (Kd) in patients with RRMM to determine whether ELRA can provide superior clinical benefit. Methods: MagnetisMM-32, a phase 3, open-label, multicenter, randomized study, will enroll ≈492 patients. Patients will receive ELRA (Arm A) or investigator’s choice of EPd, PVd or Kd (Arm B), until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, or study termination. Patients treated with ELRA will receive 2 step-up priming doses followed by weekly doses in a 28-day cycle. Patients who achieve a PR or better for ≥2 months will be eligible for reduced dosing frequency. Patients will be randomized 1:1 (stratified by prior line of therapy [1 vs 2 vs 3/4] and International Staging System disease stage [1/2 vs 3]). Key inclusion criteria include age of ≥18 years, prior multiple myeloma diagnosis with measurable disease (per IMWG criteria), evidence of progressive disease or failure to achieve a response to last line of multiple myeloma therapy, 1 to 4 prior lines of therapy including an anti–CD38 antibody–containing regimen (for ≥2 consecutive cycles) and a lenalidomide-containing regimen (for ≥2 consecutive cycles), adequate bone marrow function, and an ECOG performance status of ≤2. Key exclusion criteria include stem cell transplant ≤12 weeks prior to enrollment; active, uncontrolled infection; prior BCMA-directed or CD3-redirecting therapy; and unable to receive EPd, PVd, or Kd. The primary and key secondary endpoints are progression-free survival (PFS) by blinded independent central review (BICR) per IMWG criteria and overall survival (OS), respectively. Other secondary endpoints include PFS by investigator, objective response rate, duration of response, time to response by BICR, PFS on next line of therapy per IMWG criteria, MRD negativity rate, safety, pharmacokinetics of ELRA, immunogenicity, and health-related quality of life outcomes. The primary endpoint and OS will be compared statistically between treatment arms by stratified log-rank tests. Clinical trial information: NCT06152575 .

The short-term impact of Schistosoma mansoni infection on health-related quality of life: implications for current elimination policies.

The WHO aims to eliminate schistosomiasis as a public health problem by 2030. However, standard morbidity measures poorly correlate to infection intensities, hindering disease monitoring and evaluation. This is exacerbated by insufficient evidence on Schistosoma's impact on health-related quality of life (HRQoL). We conducted community-based cross-sectional surveys and parasitological examinations in moderate-to-high Schistosoma mansoni endemic communities in Uganda. We calculated parasitic infections and used EQ-5D instruments to estimate and compare HRQoL utilities in these populations. We further employed Tobit/linear regression models to predict HRQoL determinants. Two-thirds of the 560 participants were diagnosed with parasitic infection(s), 49% having S. mansoni. No significant negative association was observed between HRQoL and S. mansoni infection status/intensity. However, severity of pain urinating (β = -0.106; s.e. = 0.043) and body swelling (β = -0.326; s.e. = 0.005), increasing age (β = -0.016; s.e. = 0.033), reduced socio-economic status (β = 0.128; s.e. = 0.032), and being unemployed predicted lower HRQoL. Symptom severity and socio-economic status were better predictors of short-term HRQoL than current S. mansoni infection status/intensity. This is key to disentangling the link between infection(s) and short-term health outcomes, and highlights the complexity of correlating current infection(s) with long-term morbidity. Further evidence is needed on long-term schistosomiasis-associated HRQoL, health and economic outcomes to inform the case for upfront investments in schistosomiasis interventions.

A Retrospective Observational Study of Quality of Life in a Northern Greece Population of People with Haemophilia.

Haemophilia presents a significant challenge to the quality of life of affected individuals. Evaluating the health-related quality of life (HRQoL) of people with haemophilia (PwH) provides a valuable mean of assessing their perception of overall care outcomes, while also identifying influential factors across various age and condition severity demographics. This observational retrospective study determined the HRQoL of 100 adult PwH in Northern Greece through comprehensive analysis and interpretation of their HRQoL levels, particularly in domains concerning their physical, emotional, and mental well-being, obtained through the Haem-A-QoL index questionnaire. Disease severity and young age were significantly associated with the administration of prophylactic treatment (84.2% of patients with severe haemophilia and 65.2% of patients aged 18-30). The mean Haem-A-QoL score was 40.11 ± 17.38, with the lowest HRQoL observed in the 46-60 age group (46.16), and the highest in the ≥61 age groups (35.16). Notably, the 'Sports/Leisure' and 'Physical Health' domains exhibited the highest scores, in contrast to 'Family Planning' and 'Relationships/Sexuality'. Individuals with mild haemophilia recorded the lowest mean score (39.38), while those with a severe condition exhibited the highest (41.23). Age, disease severity, and physical activity emerged as primary determinants significantly affecting HRQoL outcomes.

Health-related quality of life in adults with hematological cancer: a 2023 cross-sectional survey from Qatar.

Hematological cancers impose a complex burden on individuals, affecting their physical health and mental and emotional well-being. This study evaluated the health-related Quality of Life (HRQOL) and its determinants among adults with hematological cancers in Qatar in 2023. A cross-sectional study used a validated structured questionnaire conducted among adult patients diagnosed with hematological cancers. All adult patients who attended The National Centre for Cancer Care and Research (NCCCR) in Qatar during the Data collection period (January to March 2023) and agreed to participate were included in the study. A total of 257 participants were enrolled in the study. The highest median (IQR) score of the HRQOL domain was observed in the functionating score of 90.6 (13.8), followed by the global health score of 83.3(25. 0). The median (IQR) of the symptoms burden score was 07.4(12.3). Gender significantly affects HRQOL, with males reporting better functioning and lower symptom burden than females. Employment status is positively associated with functioning scores. Regular exercise correlates with higher global health and functioning scores and lower symptom burden, while depressive symptoms are linked to poorer HRQOL outcomes. Patients experiencing cancer recurrence or active disease report lower global health and functioning scores and higher symptom burden. Treatment modalities such as chemotherapy and bone marrow transplant (BMT) timing also influence HRQOL, with recent treatment recipients showing lower global health and higher symptom burden scores. Depressive symptoms were the primary factor, lowering the global health score by 15.2%. Regarding the low functioning score predictors, female gender, depressive symptoms, and cancer recurrence emerged as significant predictors of the low functioning score. Furthermore, Regular exercise increased the functioning score by 03.4 units (p-value=0.018). Finally, Multiple linear regression analysis reinforced the significance of depressive symptoms, active disease status, and recurrence within the past five years as substantial predictors of higher symptom scores. The study emphasizes the profound impact of depressive symptoms on all aspects of Health-Related Quality of Life (HRQOL), mainly affecting global health. It highlights the positive role of regular exercise in enhancing global health, functioning, and symptom burden scores.

Health-related quality of life in children with childhood acute myeloid leukemia in China: A five-year prospective study

PurposeThis study aims to identify the key factors influencing health-related quality of life (HRQoL) of pediatric acute myeloid leukemia (AML) patients following their initial diagnosis and examine their impact on the five-year survival prognosis. MethodsA chart review and follow-up were conducted for children with AML who participated in a prospective cohort study between 2017 and 2020. We identified factors influencing HRQoL through Pediatric Quality of Life Inventory™ (PedsQL™ 4.0), PedsQL™ Cancer Module 3.0 (CM 3.0) and PedsQL™ Family Impact Module 2.0 (FIM 2.0), as well as assessed the impact of impaired HRQoL on the overall outcomes of patients. ResultsSixty-four subjects enrolled in the study had complete HRQoL outcome data, and 61 of them completed the 5-year follow-up. In CM 3.0, age was positively associated with parental proxy reports (p = 0.040), whereas divorced families were negatively associated with child self-reports (p = 0.045). A positive medical history correlates with FIM 2.0 (p = 0.025). Residence (p = 0.046), the occupation of caregivers (p = 0.014), disease severity (p = 0.024), and the only child (p = 0.029) exhibited statistically significant associations with the impairment of HRQoL. Impaired HRQoL scores shown by the PedsQL™4.0 parent proxy report (p = 0.013) and FIM 2.0 (p = 0.011) were associated with a reduced 5-year survival rate. ConclusionsThis study demonstrated that early impairment of HRQoL in pediatric acute myeloid leukemia patients has predictive value for long-term prognosis. Once validated, these findings may provide some guidance to clinicians treating children with AML.

#2320 The impact of interventions for people with chronic kidney disease on health-related quality of life: a systematic review

Abstract Background and Aims Health-related quality of life (HRQoL) is poorer for those with chronic kidney disease (CKD) than the general population and worsens as CKD progresses. Evidence is mixed as to which interventions improve HRQoL for those with CKD, and HRQoL is often under-reported in randomised controlled trials where it is most commonly a secondary outcome. Reviews including HRQoL as an outcome have thus far focused on the impact per intervention, therefore we aimed to ascertain which interventions, of any type, have an impact on HRQoL outcomes for those with non-dialysis dependent CKD (NDD-CKD). Method The protocol was prospectively registered on PROSPERO (CRD42022364474) and PRISMA guidelines were followed. Inclusion criteria were randomised controlled trials in an NDD-CKD population (excluding transplant recipients), any intervention type, usual care/placebo comparators, using validated and reported HRQoL outcomes measures. Databases searched were Embase, Medline, PsychINFO, CINAHL plus, Web of Science, PubMed, and Google Scholar, with reference searching of included studies. Reports were independently screened by two researchers who also performed data extraction and quality assessment (using the Cochrane Risk of Bias 2.0 tool). Synthesis was undertaken using Synthesis without Meta-analysis (SWiM) methods. Conversion to one-sided p-values, synthesising outcomes in albatross plots and combining p-values via Fisher's method was performed using the metap package in R. HRQoL measures were broken down into physical, mental, kidney disease symptoms, adverse effects of kidney disease, burden of kidney disease, overall kidney disease, and overall HRQoL domains for analysis. Results Searches yielded 8983 records, and 39 studies met inclusion criteria, with a total of 11,940 participants. Nine groups were formed based on type of intervention, with data synthesis possible in the eight groups with more than one study (Fig. 1). 26 (66%) studies were rated as having high risk of bias, largely due to frequent lack of blinding and HRQoL being a patient reported outcome. 37 studies had sufficient data for presentation in albatross plots (Fig. 2). Using combined p-values for all HRQoL outcomes in each group of studies, benefit to HRQoL in at least one study was shown for education interventions (p &amp;lt; 0.001, seven studies, none with low risk of bias), exercise interventions (p &amp;lt; 0.001, eight studies, all with high risk of bias), medications to treat CKD-related anaemia (p &amp;lt; 0.001, eight studies, four with low risk of bias), nutritional interventions (p &amp;lt; 0.001, four studies, all with high risk of bias) and weight loss interventions (p &amp;lt; 0.001, two studies, one with low risk of bias). No benefit to HRQoL was shown for medications aimed at slowing CKD progression (p = 0.492, five studies), medications for depression (p = 0.266, two studies) and medications to treat acidosis (p = 0.99, two studies). Conclusion This review identified several interventions with evidence of benefit to HRQoL for people with NDD-CKD, including medications to treat anaemia and weight loss interventions. Studies of education, exercise and nutritional interventions showed potential benefit, but with high risk of bias. Further high-quality randomised controlled trials of interventions for people with NDD-CKD should include and report HRQoL outcomes, in addition to targeting potentially modifiable determinants of HRQoL in these groups.

#2285 Potentially modifiable factors influencing longitudinal health-related quality of life for those with chronic kidney disease in the NURTuRE-CKD cohort

Abstract Background and Aims Factors affecting poor health-related quality of life (HRQoL) for people with chronic kidney disease (CKD) have been previously described in literature, and worse HRQoL is associated with CKD progression and death. Little emphasis has been placed on which factors may be potentially modifiable, and longitudinal HRQoL outcome analyses in non-dialysis dependent CKD cohorts are few in number. Baseline analysis of the NURTuRE-CKD cohort identified several associations between these factors and HRQoL and these associations can now be examined with longitudinal data. Method The NURTuRE-CKD cohort study recruited 2996 participants with non-dialysis dependent CKD between 2017-2019, collecting biochemical, anthropometric, sociodemographic, medical history and patient reported outcome measure (PROM) data. Face-to-face follow-up repeated these measures. Longitudinal worsening overall HRQoL was the main outcome of interest, represented by mapped EQ-5D-3L index value and visual analogue score (VAS). Multivariable linear mixed effects models were fitted in R using the lmer and lmerTest packages. Models for index value were fit separately for each independent variable of interest and collated, as well as fitting models with all variables of interest. Models were adjusted for available confounders, repeated measures and follow-up time. P-values were adjusted for multiple testing using false discovery rate correction. Results 2054/2996 (68.6%) had complete HRQoL data at follow-up, of whom most had CKD stage G3a-G4 (n = 1597, 77.8%). 1817 (88.5%) were white and 1196 (58.2%) were male. Mean age was 63.7 (SD ±14.5) years and the mean number of comorbidities was 3.7 (SD ±2.2). Median (IQR) time between baseline and follow-up was 518 (410) days. At follow-up, mean mapped EQ-5D-3L index value was 0.72 (SD ±0.3) and mean VAS score was 70.4/100 (SD ±20.6). 1595 (77.7%) reported problems in at least one EQ-5D-5L dimension, with 255 (12.4%) developing issues since baseline. 1203 (58.6%) reported worse HRQoL index values at follow up and 910 (44.3%) reported worse VAS. The dimension with the highest number of newly reported issues at follow-up was ‘usual activities’ with 301 (14.7%). Multivariable linear mixed methods models showed independent associations with worse HRQoL (Figs 1 and 2) for those on ten or more medications (β −0.118, CI −0.137 to −0.100, p &amp;lt; 0.001), current smokers (β −0.036, CI −0.067 to −0.006, p = 0.0.012), obesity (β-0.059, CI −0.080 to-0.039, p &amp;lt; 0.001), haemoglobin of &amp;lt;100g/L (β-0.044, CI −0.073 to-0.016, p = 0.014), hospital anxiety and depression scale scores of 8 or above for anxiety (β-0.146, CI −0.161 to-0.130, p &amp;lt; 0.001) and depression (β-0.202, CI-0.219 to −0.186, p &amp;lt; 0.001), worse health literacy (β −0.099, CI −0.136 to −0.063, p &amp;lt; 0.001), and pain (β −0.148, CI −0.161 to −0.135, p ≤ 0.001), weakness (β −0.106, CI −0.120 to −0.092, p &amp;lt; 0.001) and shortness of breath symptoms (β −0.074, CI −0.087 to −0.060, p &amp;lt; 0.001). Conclusion Potentially modifiable factors influencing longitudinal worsening of HRQoL for people with CKD include polypharmacy, smoking, obesity, anaemia, depression and anxiety, limited health literacy, pain, weakness and shortness of breath symptoms. This highlights the need for high quality randomised controlled trials to test interventions addressing these factors with reported HRQoL outcomes. Further work in this cohort is required, examining a third timepoint for HRQoL and linked clinical outcome data.

Longitudinal associations of plasma kynurenines and ratios with fatigue and quality of life in colorectal cancer survivors up to 12 months post-treatment.

Fatigue is prevalent in colorectal cancer (CRC) survivors, impacting their health-related quality of life (HRQoL). Inflammation-induced activation of the kynurenine pathway may play a role in cancer-related fatigue and HRQoL, but evidence is scarce. Therefore, we aimed to investigate longitudinal associations of plasma tryptophan, kynurenines, and ratios with fatigue and HRQoL in CRC survivors up to 12 months post-treatment. Repeated measurements at 6 weeks, 6 months, and 12 months post-treatment were performed in 249 stage I-III CRC survivors. Plasma tryptophan and eight kynurenines were analyzed using liquid chromatography-tandem mass spectrometry (LC/MS-MS). Fatigue and HRQoL outcomes were evaluated using validated questionnaires. Confounder-adjusted linear mixed models were conducted to analyze longitudinal associations, with false discovery rate (FDR) correction. Higher tryptophan (Trp), kynurenic acid (KA), and xanthurenic acid (XA) concentrations, as well as a higher kynurenic acid-to-quinolinic acid ratio (KA/QA), were associated with less fatigue and better functioning, while a higher kynurenine-to-tryptophan ratio (KTR) and 3-hydroxykynurenine ratio (HKr) were associated with more fatigue and worse functioning. Finally, higher KA and XA concentrations and a higher KA/QA ratio were associated with a higher overall HRQoL summary score, while a higher HKr was associated with a lower overall HRQoL summary score. In conclusion, we observed that tryptophan and several kynurenines were longitudinally associated with fatigue and HRQoL in CRC survivors up to 12 months post-treatment. Future research is needed to validate our findings and explore the potential of the kynurenine pathway as intervention target for reducing fatigue and enhancing HRQoL after CRC treatment.

#686 The impact of Ferric Derisomaltose (FDI) on role physical functioning in iron deficient but not anaemic patients with chronic kidney disease

Abstract Background and Aims Chronic kidney disease (CKD) is a progressive disorder affecting physiological function, specifically iron deficiency. Iron is crucial for red blood cell production, oxygen transport, mitochondrial function, and cardiac function. Iron deficiency in patients with CKD results from decreased absorption and mobilization, which leads to anaemia, reduced functional capacity, increased cardiac risk, and poorer quality of life. The Iron and the Heart Trial investigated whether correcting iron deficiency in CKD patients (using a single dose of 1000 mg of intravenous (IV) ferric derisomaltose (FDI)) improved functional capacity, as measured by the six-minute walk test, and health-related quality of life (HRQoL) outcomes, including Physical and Mental Health. The SF-36v2 Health Survey tool was used to quantify HRQoL outcomes. Patients identify that whilst clinical outcomes such as survival and functional capacity are important; HRQoL and the symptoms associated with disease burden are far more debilitating. Currently research on how Role Physical functioning, which assesses limitations in routine activities, affects QoL in people with CKD and iron deficiency is limited. This study aimed to explore if correcting iron deficiency in people with CKD without anaemia using IV FDI, improved Role Physical outcomes compared to a placebo group post-infusion at 3 months from the Iron and Heart Trial. Method The Iron and the Heart Trial was a multicentre double blinded randomised study in which non-anaemic CKD patients with iron deficiency were given 1000 mg of IV iron (FDI), compared to a placebo infusion at baseline, and assessed at 1 month and 3-months post-infusion, to evaluate the impact on exercise capacity. Secondary objectives of the trial included impact of iron therapy on QoL. This analysis focused on “Role Physical” as a QoL parameter in the trial participants. A total of 54 CKD patients with iron deficiency but no anaemia (Group 1) were enrolled in the trial and randomly assigned in a 1:1 ratio to either the FDI or placebo group. Within the 54 patients, 26 patients received FDI, and 28 patients received placebo. 10 CKD patients without anaemia or iron deficiency (Group 2) were also included, they did not receive any treatment and were followed up at the same time points as Group 1. Each group completed the Role Physical parameter of the SF-36v2 survey which assessed if participants had cut down the amount of time spent on activities, accomplished less, were limited, or performed tasks with more difficulty because of their condition. The collected responses were categorical variables that were summarised using number (%) and then normalised and summarised using mean (standard deviations). All analyses were undertaken using Microsoft Excel. Results At baseline the Role Physical means (SD) were as follows: placebo 42.8 ± 11.9, FDI 42.1 ± 11.0, Group 2 45.9 ± 9.4. Prior to any intervention, mean Role Physical outcomes were numerically poorer in those with CKD and iron deficiency (placebo and FDI) compared to those with CKD and no iron deficiency (Group 2) (Fig. 1a). Following intervention at 3 months the mean (SD) scores for each group were—placebo 37.5 ± 14.6, FDI 40.9 ± 11.4, Group 2 44.0 ± 13.2. The placebo group experienced a decrease of 12.3% in the mean score for Role Physical outcomes in comparison to their baseline whilst, FDI group only experienced a 3% decrease. For Group 2, there was a decrease of 4% from baseline to 3 months (Fig. 1b). Conclusion Our study showed that while FDI may not improve QoL outcomes, Role Physical functioning, in individuals with CKD and iron deficiency, it may still play a role in slowing the deterioration of these outcomes. Caution must be exercised when interpreting our findings due to the limitations of our study, and further research with sufficient power is needed to extend the findings of the study with a larger sample size to be able to make treatment recommendations for individuals with CKD and iron deficiency.

Predictors of health-related quality of life in a large cohort of adult patients living with sickle cell disease in France: the DREPAtient study.

Sickle cell disease (SCD) is an inherited autosomal recessive disorder exhibiting a range of symptoms and acute and/or chronic complications that affect the quality of life. This study aimed to assess health-related quality of life (HRQoL) and to identify the associated factors in adult patients with SCD in France. DREPAtient is a cross-sectional, multicenter study conducted from June 2020 to April 2021 in France and in certain French overseas territories where SCD is highly prevalent. Sociodemographic and clinical data were collected online. HRQoL was assessed by the French version of the 36-Item Short Form Survey (SF-36) questionnaire. HRQoL determinants were identified using multivariable linear regression analysis. In total, 570 participants were included, mostly women (68.9%), with a mean age of 33.3 (±10.7) years. The highest mean score HRQoL was found in the Physical functioning domain (67.5 ± 21.8) and the lowest mean score in the General Health perception domain (37.7 ± 20.3). The mean score of the physical composite (PCS) and mental composite (MCS) of SF-36 summary scores was 40.6 ± 8.9 and 45.3 ± 9.8, respectively. Participants receiving oxygen therapy (β = -3.20 [95%CI: -5.56; -0.85]), those with a history of femoral osteonecrosis (-3.09 [-4.64; -1.53]), those hospitalized for vaso-occlusive crisis (VOC) or acute chest syndrome (ACS) (-2.58 [-3.93; -1.22]), those with chronic complications (-2.33 [-4.04; -0.62]), female participants (-2.17 [-3.65; -0.69]), those with psychological follow-up (-2.13 [-3.59; -0.67]), older participants (-1.69 [-3.28; -0.09]), and those receiving painkillers (-1.61 [-3.16; -0.06]) reported worse PCS score. By contrast, those who had completed secondary or high school (4.36 [2.41; 6.31]) and those with stable financial situation (2.85 [0.94, 4.76]) reported better PCS scores. Worse MCS scores were reported among participants with psychological follow-up (-2.54 [-4.28; -0.80]) and those hospitalized for VOC/ACS in the last 12 months (-2.38 [-3.99; -0.77]), while those who had relatives' support (5.27 [1.92; 8.62]) and those with stable financial situation (4.95 [2.65; 7.26]) reported better MCS scores. Adults with major SCD reported poor physical and mental HRQoL scores. Hospitalization for VOC/ACS, chronic complications, use of painkillers, perceived financial situation, and support from relatives are important predictors of HRQoL in SCD patients. Interventions to improve HRQoL outcomes SCD should be considered.

Disease Control and Treatment Satisfaction in Patients with Chronic Spontaneous Urticaria in Japan.

Background: Chronic spontaneous urticaria (CSU), characterized by the recurrence of pruritic hives and/or angioedema for >6 weeks with no identifiable trigger, has a negative impact on health-related quality of life (HRQoL). Methods: The objective of this web-based cross-sectional study was to evaluate disease control, disease burden, and treatment satisfaction in Japanese adults with CSU using the Urticaria Control Test (UCT), HRQoL outcomes, and the Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9). Results: In total, 529 adults were included in the analysis (59.9% female), with a mean ± standard deviation (SD) in CSU duration of 13.2 ± 13.0 years. Based on UCT scores, two-thirds of patients had poor (score of 0-7; 23.6%) or insufficient (score of 8-11; 43.3%) symptom control, and one-third had good control (score of 12-16; 33.1%). Overall treatment satisfaction was not high, with mean ± SD TSQM-9 scores of 55.5 ± 17.6% for effectiveness, 68.2 ± 18.8% for convenience, and 59.2 ± 18.4% for global satisfaction. No apparent differences in TSQM-9 scores were observed between patients receiving different medications. HRQoL outcomes were worse among patients with poor/insufficient symptom control. Conclusions: Japanese adults with CSU have a high disease burden, and better treatment options are needed to increase treatment satisfaction.