Impaired Health-related Quality Of Life Research Articles

Impaired health-related quality of life in idiopathic inflammatory myopathies: a cross-sectional analysis from the COVAD-2 e-survey.

To investigate health-related quality of life in patients with idiopathic inflammatory myopathies (IIMs) compared with those with non-IIM autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs) and without autoimmune diseases (controls) using Patient-Reported Outcome Measurement Information System (PROMIS) instrument data obtained from the second COVID-19 vaccination in autoimmune disease (COVAD-2) e-survey database. Demographics, diagnosis, comorbidities, disease activity, treatments and PROMIS instrument data were analysed. Primary outcomes were PROMIS Global Physical Health (GPH) and Global Mental Health (GMH) scores. Factors affecting GPH and GMH scores in IIMs were identified using multivariable regression analysis. We analysed responses from 1582 IIM, 4700 non-IIM AIRD and 545 nrAID patients and 3675 controls gathered through 23 May 2022. The median GPH scores were the lowest in IIM and non-IIM AIRD patients {13 [interquartile range (IQR) 10-15] IIMs vs 13 [11-15] non-IIM AIRDs vs 15 [13-17] nrAIDs vs 17 [15-18] controls, P < 0.001}. The median GMH scores in IIM patients were also significantly lower compared with those without autoimmune diseases [13 (IQR 10-15) IIMs vs 15 (13-17) controls, P < 0.001]. Inclusion body myositis, comorbidities, active disease and glucocorticoid use were the determinants of lower GPH scores, whereas overlap myositis, interstitial lung disease, depression, active disease, lower PROMIS Physical Function 10a and higher PROMIS Fatigue 4a scores were associated with lower GMH scores in IIM patients. Both physical and mental health are significantly impaired in IIM patients, particularly in those with comorbidities and increased fatigue, emphasizing the importance of patient-reported experiences and optimized multidisciplinary care to enhance well-being in people with IIMs.

Impairment of health-related quality of life and its determinants among patients with podoconiosis in East Wollega Zone, Oromia Regional State, Ethiopia: institutional-based cross-sectional study

ObjectiveThis study aimed to assess the impairment of health-related quality of life (HRQoL) and its determinants among patients diagnosed with podoconiosis in East Wollega Zone, Oromia Regional State, Ethiopia.MethodsAn institutional-based...

Self-compassion and health-related quality of life in individuals with endometriosis

Objective International research highlights the detrimental impact of endometriosis on health-related quality of life (HRQoL), yet few studies have examined positive resources such as self-compassion and resilience as correlates. This cross-sectional study aimed to examine the relationship between self-compassion and HRQoL in individuals with endometriosis in Aotearoa New Zealand. Resilience and perceived symptom severity were examined as potential mediators. Methods and measures Six hundred and three individuals with endometriosis completed an online questionnaire measuring demographic and endometriosis-related information, endometriosis symptoms (number and severity), HRQoL, self-compassion and resilience. Results In line with international research, the current sample reported significant impairment in all aspects of HRQoL. As expected, those with higher levels of self-compassion reported less impairment in HRQoL, and this relationship was partially mediated by perceived symptom severity (all aspects of HRQoL). Resilience mediated the relationship between self-compassion and two aspects of HRQoL (emotional wellbeing and control/powerlessness). Conclusion These findings confirm that HRQoL is significantly impaired in individuals with endometriosis in Aotearoa New Zealand and point to the potential role of self-compassion and resilience as protective factors in encouraging positive coping styles to manage symptoms and maintain high HRQoL. Interventions targeting self-compassion may be a promising tool to improve wellbeing in individuals with endometriosis.

Role of Repetitive Transcranial Magnetic Stimulation in Treatment of Fibromyalgia: A Randomized Controlled Trial.

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread, persistent musculoskeletal pain in association with impaired health-related quality of life. Repetitive transcranial magnetic stimulation (rTMS) is an emerging tool for the management of fibromyalgia. There is no standardized protocol of rTMS for the treatment of FMS, and both low- and high-frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) are described in the literature with variable efficacy. The objective of this study was to determine the effectiveness of rTMS in people with fibromyalgia and compare the response of low- and high-frequency stimulation with sham stimulation. This study was a single-blinded, randomized, placebo-controlled trial. Ninety patients with the diagnosis of FMS were randomly allocated into one of the following three groups: low-frequency (1 Hz) group, high-frequency (10 Hz) group, and sham group. Pain, depression, anxiety, and quality of life were measured using the Numerical Pain Rating Scale (NPRS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HDRS), and Revised Fibromyalgia Impact Questionnaire (FIQR) immediately following treatment as well as at 1 and 3 months after treatment. The data was statistically analyzed using Statistical Package for the Social Sciences version 23 software. P value < 0.05 was considered statistically significant. Intergroup analysis revealed a significant improvement in NPRS, HAM-A, HDRS, and FIQR scores in both low- and high- frequency groups immediately following treatment and for 3 months after treatment. No significant difference in the efficacy of low- and high-frequency stimulation was noticed. rTMS is an effective mode of treatment in people with FMS. Both low and high frequencies of stimulation at DLPFC are equally effective in reducing pain and associated symptoms.

Longitudinal impact of intracerebral low-grade glioma disease on health-related quality of life.

The aim of this study was to assess health-related quality of life (HRQOL) before and after treatment for intracerebral low-grade glioma. Patients with low-grade glioma who underwent surgical tumor removal between 2012 and 2018 were eligible for this study. All individuals and their closest relatives received thorough preoperative (<seven days before surgery) and posttreatment (12 months after surgery) neuropsychological testing investigating quality of life. The assessment consisted of the Aachen Life Quality Inventory (ALQI) and the Short Form 36 (SF36) questionnaire. Calculated SF36 values were compared with reference values from population-based studies. A set of clinical features were investigated for their association with longitudinal HRQOL deterioration. A total of 25 patients were referred for further analysis, after adjustment to the 2021 WHO classification for central nervous system tumors. Compared to the values of a healthy reference population, the patients expressed significant limitations in several SF36 items, both before and after treatment. Under treatment, there were no significant changes in the SF36 items, but the ALQI questionnaire indicated decreasing HRQOL over time. Data derived from relatives revealed a high degree of concordance with the rating results of the patients. Univariate analysis identified neurological deterioration and ongoing epileptic seizures as predictors for unfavorable HRQOL after one year. Low-grade glioma disease has a significant impact on HRQOL and treatment might contribute to further deterioration. New-onset neurological deficits and ongoing epileptic seizures are predictors of limitations in quality of life. Since the results are based on a small cohort with limited follow-up time, the generalizability of these statements is limited and further studies are required.

Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy

Background and objectiveIn comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL). MethodsFor patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation. We analyzed the QLQ-C30 change from baseline to week 12, the confirmed improvement rate, and the time to improvement or deterioration. Key findings and limitationsBaseline PRO compliance rates were 91% for the EV arm (n = 301) and 89% for the chemotherapy arm (n = 307); the corresponding average rates from baseline to week 12 were 70% and 67%. Patients receiving EV versus chemotherapy had reduced pain (difference in change from baseline to week 12: −5.7, 95% confidence interval [CI] −10.8 to −0.7; p = 0.027) and worsening appetite loss (7.3, 95% CI 0.90–13.69; p = 0.026). Larger proportions of patients in the EV arm reported HRQoL improvement from baseline than in the chemotherapy arm; the odds of a confirmed improvement across ten QLQ-C30 function/symptom scales were 1.67 to 2.76 times higher for EV than for chemotherapy. Patients in the EV arm had a shorter time to first confirmed improvement in global health status (GHS)/QoL, fatigue, pain, and physical, role, emotional, and social functioning (all p < 0.05). EV delayed the time to first confirmed deterioration in GHS/QoL (p = 0.027), but worsening appetite loss occurred earlier (p = 0.009) in comparison to chemotherapy. Conclusions and clinical implicationsHRQoL with EV was maintained, and deterioration in HRQoL was delayed with EV in comparison to chemotherapy. Better results with EV were reported for some scales, with the greatest difference observed for pain. These findings reinforce the EV safety and efficacy outcomes and benefits observed in EV-301. Patient summaryPatients with previously treated advanced cancer of the urinary tract receiving the drug enfortumab vedotin maintained their HRQoL in comparison to patients treated with chemotherapy.The EV-301 trial is registered on ClinicalTrials.gov as NCT03474107 and on EudraCT as 2017-003344-21.

Health Implications of Lipedema: Analysis of Patient Questionnaires and Population-Based Matched Controls.

We conducted a comparative study involving 39 female patients with lipedema and group-matched controls at a ratio of 1:5. The primary survey tool was the German Health Update (GEDA 2019/2020-EHIS) questionnaire, which was developed by the Robert Koch Institute (RKI), Germany. The secondary survey tool was the German Pain Questionnaire. The prevalence of hypertension (p = 0.041) and high blood lipids (p = 0.024) was lower in the lipedema group compared to the control group. General health and well-being indicators demonstrated lower overall health ratings (p < 0.001) and higher physiotherapy use in patients with lipedema (p = 0.016). Mental health assessment revealed higher depression prevalence and severity (p = 0.001), together with a lower number of close contacts (p = 0.032). Furthermore, patients with lipedema experienced higher levels of pain (p < 0.001) and more significant pain-related disability in daily activities (p < 0.001) than controls. Correlation analysis among patients with lipedema showed a positive correlation between pain severity and depressive symptoms (ρ = 0.612, p < 0.001) and a moderate positive correlation with impaired health-related quality of life (ρ = 0.418, p = 0.010). In summary, our findings highlight significant differences in health and well-being between patients with lipedema and matched controls, especially in overall, metabolic, and mental health, as well as pain perception. The findings emphasize the need for a validated lipedema-specific questionnaire and a multidisciplinary treatment approach with a combination of physical therapies, lifestyle adjustments, and psychological strategies.

Child and family health-related quality of life and participation outcomes and goals after acquired brain injury: a cross-sectional survey

ABSTRACT Objective To explore longer-term health-related quality of life (HRQoL) and participation outcomes and goals of children and young people (CYP) with acquired brain injuries (ABI) and their families in a region of the UK and the impact of the COVID-19 pandemic. Methods Cross-sectional survey of (5-18 CYP) and their parent-carers 12–43 months following ABI. Included measures of HRQoL, participation, family function and parental wellbeing and demographic and free text questions. Results Ninety-five responses (30% response) were received. 67% of CYP were at risk of impaired HRQoL, 72% had severely impaired participation. 53% of parent-carers reported reduced HRQoL and family functioning, 37% of parent-carers screened positive for anxiety/depression. Relationships exist between CYP participation and HRQoL and parental HRQoL and family functioning. Goals were overwhelmingly activity and participation focused. Participants described the global impact of an ABI on the CYP and family as well as the additional impact of the COVID-19 pandemic on CYP and family wellbeing. Conclusion ABI significantly impacts CYP participation and both CYP and parent-carer wellbeing in the long-term, potentially further impacted by the COVID-19 pandemic. Rehabilitation interventions should address both participation and the psychological wellbeing of CYP with ABI and their parent-carers.

Exploring 5-year changes in general and skin health-related quality of life in psoriatic arthritis patients.

Psoriatic arthritis (PsA) carries a severe disease burden, often leading to deterioration of health-related quality of life (HRQoL). Different comorbidities that are relatively prevalent in PsA are also responsible for compromised HRQoL. To assess real-world data of a 5-year follow-up cohort of PsA patients, focusing on changes in general HRQoL, skin HRQoL, and comorbidities. In this prospective observational study, 114 outpatients diagnosed with PsA were examined at baseline and after 5years. Data collection included demographics, clinical disease activity measures, and patient-reported outcome measures (PROMs). General HRQoL was assessed with a 15D instrument, and skin HRQoL was assessed with the Dermatology Life Quality Index (DLQI). During the 5-year follow-up, no significant deterioration in HRQoL assessed by 15D (23.53 vs. 23.08, p = 0.85) and DLQI (3.48 vs. 2.68, p = 0.07) was observed. There was no observed decline in other PROMs. The mean total number of comorbidities increased (1.13 vs. 1.39, p < 0.01). A significant improvement in disease activity measures, including 66/68 swollen/tender joint count, Disease Activity Index for Psoriatic Arthritis (all p < 0.01), and Psoriatic Arthritis Severity Index (p = 0.04) was seen. A higher proportion of patients at 5years were treated with b/tsDMARDs (37.7% vs. 46.5%, p = 0.03). Despite an increased number of comorbidities over 5years, our PsA cohort showed no decline in HRQoL. This can be attributed to the widespread adoption of modern treatments, leading to improved disease control and the preservation of baseline HRQoL.

Factors of impaired health-related quality of life in patients with precapillary pulmonary hypertension

Factors of impaired health-related quality of life in patients with precapillary pulmonary hypertension

Exploring the Perspectives of Patients Living With Lupus: Retrospective Social Listening Study.

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease affecting various organs with a wide range of clinical manifestations. Cutaneous lupus erythematosus (CLE) can manifest as a feature of SLE or an independent skin ailment. Health-related quality of life (HRQoL) is frequently compromised in individuals living with lupus. Understanding patients' perspectives when living with a disease is crucial for effectively meeting their unmet needs. Social listening is a promising new method that can provide insights into the experiences of patients living with their disease (lupus) and leverage these insights to inform drug development strategies for addressing their unmet needs. The objective of this study is to explore the experience of patients living with SLE and CLE, including their disease and treatment experiences, HRQoL, and unmet needs, as discussed in web-based social media platforms such as blogs and forums. A retrospective exploratory social listening study was conducted across 13 publicly available English-language social media platforms from October 2019 to January 2022. Data were processed using natural language processing and knowledge graph tagging technology to clean, format, anonymize, and annotate them algorithmically before feeding them to Pharos, a Semalytix proprietary data visualization and analysis platform, for further analysis. Pharos was used to generate descriptive data statistics, providing insights into the magnitude of individual patient experience variables, their differences in the magnitude of variables, and the associations between algorithmically tagged variables. A total of 45,554 posts from 3834 individuals who were algorithmically identified as patients with lupus were included in this study. Among them, 1925 (authoring 5636 posts) and 106 (authoring 243 posts) patients were identified as having SLE and CLE, respectively. Patients frequently mentioned various symptoms in relation to SLE and CLE including pain, fatigue, and rashes; pain and fatigue were identified as the main drivers of HRQoL impairment. The most affected aspects of HRQoL included "mobility," "cognitive capabilities," "recreation and leisure," and "sleep and rest." Existing pharmacological interventions poorly managed the most burdensome symptoms of lupus. Conversely, nonpharmacological treatments, such as exercise and meditation, were frequently associated with HRQoL improvement. Patients with lupus reported a complex interplay of symptoms and HRQoL aspects that negatively influenced one another. This study demonstrates that social listening is an effective method to gather insights into patients' experiences, preferences, and unmet needs, which can be considered during the drug development process to develop effective therapies and improve disease management.

Patient health-related quality of life deteriorates significantly while waiting six to 12 months for total hip or knee arthroplasty.

The primary aim was to assess change in health-related quality of life (HRQoL) of patients as they waited from six to 12 months for a total hip (THA) or total or partial knee arthroplasty (KA). Secondary aims were to assess change in joint-specific function, mental health, quality of sleep, number living in a state worse than death (WTD), wellbeing, and patient satisfaction with their healthcare. This prospective study included 142 patients awaiting a THA (mean age 66.7 years (SD 11.4); 71 female) and 214 patients awaiting KA (mean age 69.7 years (SD 8.7); 117 female). Patients completed questionnaires (EuroQol five-dimension health questionnaire (EQ-5D), Oxford Hip and Knee Scores (OHS/OKS), Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Score (HADS), University of California, Los Angeles Activity Scale, wellbeing assessment, and satisfaction with their healthcare) at six and 12 months while awaiting surgery. There was a clinical and statistically significant deterioration in the EQ-5D while awaiting THA (mean change 0.071 (95% confidence interval (CI) 0.018 to 0.124); p = 0.009) and KA (mean change 0.069 (95% CI 0.032 to 0.106); p < 0.001). For patients awaiting a THA, there were deteriorations in OHS (p = 0.003), PSQI (p = 0.008), both HADS depression (p = 0.001) and anxiety (p = 0.002), and an increased prevalence in those in a state WTD (p = 0.010). For those awaiting KA, there were significant deteriorations in OKS (p < 0.001), UCLA (p = 0.001), and HADS depression (p < 0.001) and anxiety (p < 0.001). There were significant decreases in wellbeing (satisfaction with life, feeling life to be worthwhile, and happiness) and increases in anxiety for those awaiting THA or KA (p < 0.001). Those awaiting THA (odds ratio (OR) 0.52 (95% CI 0.31 to 0.89); p = 0.016) and KA (OR 0.46 (95% CI 0.31 to 0.71); p < 0.001) had a significant decrease in satisfaction with their healthcare. As patients waited from six to 12 months for THA or KA, they experienced a clinically significant deterioration in HRQoL. There were also deteriorations in joint-specific function, mental health, wellbeing, and patient satisfaction with healthcare.

Quality of Life in Youth Soccer Players After Mild Traumatic Brain Injury.

Pediatric mild traumatic brain injuries (mTBIs) represent an evolving field of interest in youth athletics. Although most players recover within 4 weeks, some have symptoms that last longer. Little is known about youth health-related quality of life (HRQoL) after mTBI. To characterize youth HRQoL after soccer-related mTBI and to identify predictors of individual differences in HRQoL recovery. Prospective cohort study. Youth soccer. Soccer players, aged 8 to 17 years, who sustained an mTBI (n = 23) or orthopaedic injury (OI, n = 24) or remained uninjured (n = 23) during a single season. We assessed HRQoL via the Pediatric Quality of Life Inventory, version 4.0, and postconcussive symptoms via the Health and Behavior Index. Serial assessments occurred at 24 to 48 hours, 7 days, 30 days, and 90 days postinjury via telephone interview. At 7 days postinjury, the mTBI and OI groups had poorer total HRQoL (F2,67 = 11.35, P < .001) than the uninjured control group. At 7 days, the mTBI group had the poorest psychosocial HRQoL, whereas the OI group had the poorest physical HRQoL. Differences between the mTBI and uninjured control groups resolved by 30 days. Within the mTBI group, players with significant postconcussive symptoms at 7 days had poorer total (F1,21 = 23.071, P ≤ .001; F1,21 = 5.798, P = .028), psychosocial (F1,21 = 16.488, P = < .001; F1,21 = 5.050, P = .039), and physical (F1,21 = 21.671, P = < .001; F1,21 = 5.119, P = .038) HRQoL at 7 and 30 days, respectively, than players with minimal symptoms; these differences resolved by 90 days. As a group, youth soccer players who sustained mTBI had transient impairments in HRQoL that resolved by 30 days. A subset of players with significant postconcussive symptoms at 7 days postinjury had poorer HRQoL for at least 30 days postinjury than those whose postconcussive symptoms had resolved within a week of injury. This suggests ongoing recovery in this subset at 30 days and the potential utility of HRQoL as a measure of recovery.

Vasculitic neuropathy-related disability, pain, quality of life, and autonomic symptoms: a survey of 312 patients.

To assess self-reported symptoms of neuropathy, disability, pain, health-related quality of life (HR-QOL) and autonomic dysfunction in patients with vasculitis. Patients with vasculitis (with or without neuropathy) were invited by Vasculitis UK to complete an anonymous online survey. Three hundred and twelve patients (71% female) responded. Median age was 61-70 years. Median duration of vasculitis was 4 years (<2 months to >15 years). Vasculitic types included granulomatosis with polyangiitis (34%), unspecified ANCA-associated vasculitis (13%), microscopic polyangiitis (11%), eosinophilic granulomatosis with polyangiitis (11%), giant cell arteritis (10%), non-systemic vasculitic neuropathy (2%) and other (19%). Many patients reported foot/hand symptoms suggestive of neuropathy, including numbness (64%), pain (54%) or weakness (40%). Two hundred and forty-two patients (78%) met our definition of probable vasculitic neuropathy: diagnosis of neuropathy by vasculitis team OR numbness OR weakness in feet/hands. Only 52% had been formally diagnosed with neuropathy. Compared with 70 patients without neuropathy, neuropathy patients had greater disability measured by the inflammatory Rasch-built Overall Disability Scale (centile mean 63.1 [s.d. 17.3] vs 75.2 [16.7]; P < 0.0001), Inflammatory Neuropathy Cause and Treatment scale (median 2 [interquartile range 1-4] vs 0.5 [0-2]; P < 0.0001) and modified Rankin scale (median 2 [interquartile range 1-3] vs 2 [1-2)]; P = 0.0002); greater pain on an 11-point rating scale (mean 4.6 [s.d. 2.6] vs 3.5 [2.8]; P = 0.0009); and poorer HR-QOL on the EQ5D-3L (summary index mean 0.58 [s.d. 0.29] vs 0.69 [0.28]; P < 0.0001). Two-thirds reported autonomic symptoms (not associated with neuropathy). Neuropathy is common and associated with significant disability, pain and impaired HR-QOL in patients with systemic vasculitis.

Determination of a cut-off COmprehensive Score for financial Toxicity (COST) for identifying cost-related treatment nonadherence and impaired health-related quality of life among Chinese patients with cancer

PurposeThis study aimed to determine a cut-off for the simplified Chinese version of the COmprehensive Score for financial Toxicity (COST) that could identify cost-related treatment nonadherence among Chinese patients with cancer. The study also sought to validate this cut-off score by using it to assess impaired health-related quality of life (HRQoL) in the same population.MethodsA secondary analysis was conducted using data from a cross-sectional survey of 1208 Chinese patients with cancer who were recruited from 12 hospitals in six cities across three provinces of the Chinese mainland. Sociodemographic information and data on financial toxicity (FT), cost-related treatment nonadherence, and HRQoL were used in the analysis. Receiver operating characteristic (ROC) analysis was used to determine the optimal cut-off for the simplified Chinese version of the COST.ResultsThe ROC analysis identified a COST cut-off of 18.5 for identifying cost-related treatment nonadherence, yielding a sensitivity of 76.5% and specificity of 71.4%. In the validation study, this cut-off score yielded a sensitivity of 64.2% and a specificity of 67.1% for identifying impaired HRQoL.ConclusionEarly and dynamic assessment of cancer-related FT in routine clinical practice may play a crucial role in the early identification and management of FT. Accordingly, a COST cut-off of 18.5 was identified to indicate cost-related treatment nonadherence and impaired HRQoL in a population of patients with cancer from the Chinese mainland. This finding may facilitate the implementation of universal FT screening among patients with cancer in specific settings such as the Chinese mainland.

Malnutrition prevalence in cancer patients in Belgium: The ONCOCARE study

RationaleUnintentional weight loss and malnutrition are common among cancer patients. Malnutrition has been associated with impaired health-related quality of life, less well-tolerated chemotherapy regimens and shorter life duration. In Belgium there is a lack of epidemiological data on malnutrition in oncology patients at advanced stages of the disease.MethodsMalnutrition assessment data was collected through a prospective, observational study in 328 patients who started a neoadjuvant anticancer therapy regimen or who started 1st, 2nd or 3rd line anticancer therapy for a metastatic cancer via 3 visits according to regular clinical practice (baseline visit (BV) maximum 4 weeks before start therapy, 1st Follow up visit (FUV1) ± 6 weeks after start therapy, FUV2 ± 4 months after start therapy). Malnutrition screening was evaluated using the Nutritional Risk Screening score 2002 (NRS-2002)and the diagnosis of malnutrition by the GLIM criteria. In addition, SARC-F questionnaire and Fearon criteria were used respectively to screen for sarcopenia and cachexia.ResultsPrevalence of malnutrition risk at BV was high: 54.5% of the patients had a NRS ≥ 3 (NRS 2002) and increased during the study period (FUV1: 73.2%, FUV2: 70.1%). Prevalence of malnutrition based on physician subjective assessment (PSA) remained stable over the study period but was much lower compared to NRS results (14.0%—16.5%). At BV, only 10% of the patients got a nutrition plan and 43.9% received ≤ 70% of nutritional needs, percentage increased during FU period (FUV1: 68.4%, FUV2: 67.6%). Prevalence of sarcopenia and cachexia were respectively 12.4% and 38.1% at BV and without significant variation during the study period, but higher than assessed by PSA (11.6% and 6.7% respectively). Figures were also higher compared to PSA. There were modifications in cancer treatment at FUV1 (25.2%) and at FUV2 (50.8%). The main reasons for these modifications at FUV1 were adverse events and tolerability. Patient reported daily questionnaires of food intake showed early nutritional deficits, preceding clinical signs of malnutrition, and therefore can be very useful in the ambulatory setting.ConclusionsPrevalence of malnutrition and cachexia was high in advanced cancer patients and underestimated by physician assessment. Earlier and rigorous detection of nutritional deficit and adjusted nutritional intake could lead to improved clinical outcomes in cancer patients. Reporting of daily caloric intake by patients was also very helpful with regards to nutritional assessment.

Indirect effects of health-related quality of life on suicidal ideation through psychological distress among cancer patients.

The interrelationships of suicidal ideation, psychological distress, and impaired health-related quality of life (HRQoL) in cancer patients are complex and multifaceted. Limited empirical evidence exists on the indirect effects of impaired HRQoL on suicidal ideation through psychological distress among cancer patients. To fill this research gap, 250 cancer patients were recruited through a cross-sectional hospital-based research design. Structural equation model (SEM) results indicated that impaired HRQoL is a predictor of psychological distress (β = 0.153; p < 0.05), and psychological distress positively predicts suicidal ideation (β = 0.647; p < 0.000). The study found no direct effects of impaired HRQoL on suicidal ideation (β = -0.05; p = 0.223). Indirect effects of HRQoL on suicidal ideation was confirmed, showing a full-mediation effect β = 0.099 (SE = 0.048, CI = [0.030, 0.189], p < 0.05) (i.e. the pathway impaired HRQoL predict suicidal ideation is through psychological distress). Cognitive-behavioral therapy and other emotional support programs should be considered for cancer patients to mitigate psychological vulnerabilities linking impaired HRQoL to suicidal ideation.

Health-related quality of life and its influencing factors in patients with primary cutaneous B-cell lymphomas: A multicentric study in 100 patients.

Primary cutaneous B-cell lymphomas (CBCL) are a group of rare malignant skin diseases that represent approximately 20%-30% of all primary cutaneous lymphomas (PCL). Previous studies revealed impaired health-related quality of life (HRQoL) in patients diagnosed with primary cutaneous T-cell lymphoma (CTCL). Currently, only small-sized studies investigated HRQoL in CBCL patients and lacked detailed analysis of respective subtypes. This study aims to investigate HRQoL in CBCL patients to identify independent factors of HRQoL impairment in CBCL patients. One hundred CBCL patients were recruited from eight German PCL centres in this multicentric, cross-sectional study from 2021 to 2022. The patients completed the dermatologic HRQoL questionnaire Skindex-29 and an investigator-designed 'CBCL-Questionnaire' with additional questions on HRQoL and clinical characteristics. The Skindex-29 revealed that HRQoL in CBCL patients is impaired on a mild to moderate level. The multiple regression analysis identified parameters like worries about dying, feeling prejudiced/discriminated and impairment of daily activities to be independently associated with impairment of HRQoL. Highest scores for HRQoL impairment were found in patients with primary cutaneous follicle centre lymphoma while on rituximab treatment and in patients with primary cutaneous marginal zone lymphoma while on watchful waiting. HRQoL is impaired in CBCL patients, even though, in the face of indolent disease course and favourable prognosis in the majority of cases. Of note, our investigator-designed tool identified worries about dying, feeling prejudiced/discriminated, and the type of treatment to have a negative impact on patients' HRQoL. Our study highlights the importance of a thorough patient-doctor communication to capture overall disease burden because generic HRQoL tools might lack of disease-specific items.

DOP49 Guselkumab improves health-related quality of life as measured by PROMIS-29 in patients with moderately to severely active Ulcerative Colitis: Phase 3 QUASAR induction study

Abstract Background Patients (pts) with ulcerative colitis (UC) suffer from symptoms that impair health-related quality of life (HRQoL). The Phase 3 QUASAR induction study (NCT04033445) evaluated the efficacy and safety of guselkumab (GUS), an IL-23 p19 subunit antagonist, in pts with moderately to severely active UC who had demonstrated inadequate response, loss of response, or intolerance to conventional and/or advanced therapies (ie, tumor necrosis factor-alpha antagonists, integrin receptor antagonists, and/or Janus kinase inhibitors). Here we report the effect of GUS IV induction on HRQoL at Week (Wk) 12 as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Methods Pts were randomized 3:2 to receive GUS 200 mg IV or placebo (PBO) IV at Wks 0/4/8. PROMIS-29 consists of 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, physical function, and social participation) and a pain intensity numeric rating scale (NRS, range 0-10). The raw score of each domain was converted into a standardized T-score based on a general population mean of 50 and standard deviation (SD) of 10. Higher scores indicate better outcomes for physical function and social participation and worse outcomes for all other domains. The physical component summary (PCS) and mental component summary (MCS) scores were calculated based on the domain T-scores for physical and mental HRQoL, with higher scores representing better outcomes. Minimum clinically meaningful improvement was defined as a ≥3-point improvement in the pain intensity NRS score, a ≥5-point (one-half SD of the population) improvement in each domain, and a ≥5-point improvement in the PCS/MCS scores. More stringent thresholds (eg, ≥7- or ≥9-point improvements) were also examined and will be presented. Results Among the primary analysis population, baseline mean PROMIS-29 domain scores were similar between treatment groups, with functional domain scores &amp;lt;50 and symptom domain scores &amp;gt;50, indicating impaired HRQoL (Table). GUS-treated pts achieved a greater mean change from baseline at Wk 12 in each domain T-score, the pain intensity NRS score, and the PCS/MCS than PBO-treated pts. Additionally, the percentage of pts achieving minimum clinically meaningful improvement at Wk 12 was greater for GUS vs PBO in each domain, the pain intensity NRS score, and the PCS/MCS scores (Figure). Conclusion Pts with moderately to severely active UC treated with GUS IV induction experienced broad and clinically meaningful improvements in HRQoL as measured by the PROMIS-29 at Wk 12.

Epidemiology, treatment patterns, and humanistic and economic burden of biliary tract carcinoma: A systematic and targeted literature review.

443 Background: Patients with biliary tract cancers (BTC) are typically diagnosed at late stage, with limited treatment options. As such, BTC is associated with poor prognosis, high economic burden and reduced health-related quality of life (HRQoL). As the treatment paradigm is evolving, with multiple immunotherapies showing promise, this study aimed to assess the current disease and treatment landscape. Methods: Systematic literature reviews (Embase, MEDLINE, Cochrane, NHS-EED; database inception to Feb 10, 2023) were conducted for HRQoL and economic burden. Targeted literature reviews (Embase, MEDLINE) were conducted for epidemiology (Jan 01 2017–Feb 06 2023) and treatment guidelines/patterns (Jan 01 2012–Feb 06 2023). Conference abstracts were also searched (2019–2022). Eligibility criteria included global studies (English language) in adults with metastatic and/or unresectable BTC. Results: Overall, 264 studies were included (epidemiology=170, treatment guidelines=14, treatment patterns=50, HRQoL=12, economic burden=18). In the US, Europe and Asia, age-standardized incidence rates were 5.04, 8.39–8.78 and 9.1–10.1 (per 100,000 person-years) and prevalence rates were 0.01%, 0.02–0.34% and 0.02–2.61%, respectively. Treatment pattern studies were mainly from Asia, Europe (n=19 each) and North America (n=10). Gemcitabine [gem]-based chemotherapy was most common in 1L BTC (24–100%) and fluorouracil-based regimens were common in 2L+ BTC (12.3–74.3%). Median overall survival (mOS) for gem-based and fluorouracil-based 1L regimens were 7.7–14.8 months and 7–16.7 months, respectively. Disease progression/toxicity frequently led to treatment discontinuation/dose modifications. In the US, use of non-guideline-based regimens increased by line of therapy (LOT). Among the clinical studies (n=5) reporting HRQoL in 1L, n=4 assessed gem-based combinations. BTC impaired HRQoL domains for anxiety, tiredness (EORTC QLQ-BIL21), work productivity, activity impairment (WPAI scale) and depression (PHQ-9). BTC was associated with substantial economic burden. Mean total all-cause healthcare costs per patient per month (PPPM) increased by LOT (US; 1L: $19,589–25,517, 2L: $22,617–29,721, 3L: $23,256–33,534). US healthcare resource utilization in 1L was driven by outpatient visits (98%), emergency department visits (33–80%) and hospitalization (70–80%). Mean hospital stay ranged from 0.6–7 days PPPM. Conclusions: Epidemiology data varied between Western and Asian populations, but gem-based chemotherapy was identified as the standard of care across regions. There is high unmet need in advanced BTC, as existing options are characterized by poor survival outcomes and considerable economic burden. These findings indicate a need for novel approaches for the management of BTC.