Health-related Quality Of Life Profile Research Articles

Health-related quality of life profile of newly diagnosed patients with Hodgkin and non-Hodgkin lymphomas: A real-world study including 3922 patients from the French REALYSA cohort

IntroductionConsidering the notable advances made in the treatment of lymphoma, assessment of health-related quality of life (HRQoL) of lymphoma patients has become a critical aspect to consider both in clinical research and routine practice. However, there is paucity of information about lymphoma specific HRQoL profile at diagnosis. Patients and methodsHRQoL at diagnosis was assessed for 3922 adult patients with newly diagnosed high-grade (HG) (n = 1994), low-grade (LG) (n = 1053) non-Hodgkin (NHL) and Hodgkin (HL) (n = 875) lymphomas included in REal world dAta in LYmphoma and Survival in Adults (REALYSA, NCT03869619), a prospective non-interventional multicentric cohort in France. Disease-specific HRQoL aspects were assessed with three validated EORTC questionnaires, namely, the QLQ‐NHL‐HG29, the QLQ-NHL-LG20 and the QLQ-HL27, for patients with NHL-HG, NHL-LG and HL, respectively. ResultsWe confirmed the high-level of completion of these questionnaires in REALYSA cohort, ranging from 84 % for QLQ-HG29 to 88 % for QLQ-HL27. The proportion of patients with impaired global health status was as follows: T-cell NHL, 67 %; diffuse large B-cell (DLBCL), 62 %; Burkitt, 61 %; HL, 53 %; marginal zone, 49 %; mantle cell, 48 %; follicular, 47 %. Multivariable regression analyses for DLBCL, follicular and HL showed that gender, performance status and B symptoms were independently associated with all HRQoL dimensions. However, a variable effect of age and stage were observed among these three subtypes. ConclusionsA comprehensive analysis was made describing the HRQoL profile of newly diagnosed patients with different types of lymphomas. Our data may help to enhance the interpretation of HRQoL results in future studies using the recently validated EORTC lymphoma specific questionnaires.

General population normative values for the EORTC QLQ-C30 by age, sex, and health condition for the French general population

BackgroundGeneral population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population.MethodsFrench general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate general population values for each QLQ-C30 scale, separately for sex, age, and presence of one- and more chronic health conditions. A multivariate linear regression model has been developed to allow estimating the effect of sex, age, and the presence for one- and more chronic health conditions on EORTC QLQ-C30 scores. Data was weighted according to United Nation statistics adjusting for the proportion of sex and age groups.ResultsIn total, 1001 French respondents were included in our analyses. The weighted mean age was 47.9 years, 514 (51.3%) participants were women, and 497 (52.2%) participants reported at least one health condition. Men reported statistically significant better scores for Emotional Functioning (+9.6 points, p = 0.006) and Fatigue (−7.8 point; p = 0.04); women reported better profiles for Role Functioning (+8.7 points; p = 0.008) and Financial Difficulty (−7.8 points, p = 0.011). According to the regression model, the sex effect was statistically significant in eight scales; the effect of increasing age had a statistically significant effect on seven of the 15 EORTC QLQ-C30 scales. The sex- and age effect varied in its direction across the various scales. The presence of health conditions showed a strong negative effect on all scales.ConclusionThis is the first publication of detailed French normative values for the EORTC QLQ-C30. It aims to support the interpretation of HRQoL profiles in French cancer populations. The strong impact of health conditions on QLQ-C30 scores highlights the importance of considering the impact of comorbidities in cancer patients when interpreting HRQoL data.

Heterogeneity of health-related quality of life after mild traumatic brain injury with systemic injury: a cluster analytic approach

Purpose Health-related quality of life (HRQoL) is a key component of evaluating outcome after mild traumatic brain injury (mTBI). As outcome is heterogeneous following mTBI, it is relevant to examine individual differences in HRQoL. This study investigated whether multiple homogenous subgroups could be meaningfully identified, 10 weeks after hospitalised mTBI with systemic injury, on the basis of HRQoL profiles. Methods Ninety-one adults were assessed for HRQoL, pain, fatigue, sleep quality, psychological distress, cognition and post-concussion symptoms. Results Cluster analyses revealed three separate subgroups based on physical, mental, social and energy HRQoL. One group (42%) demonstrated normative levels of HRQoL on all subdomains. The remaining two groups demonstrated significantly reduced HRQoL on all subdomains. These groups had equivalently poor mental, social and energy HRQoL, but the smallest group (27%) had significantly poorer physical HRQoL. Multinomial logistic regression revealed that pain significantly and independently predicted group membership for the particularly poor physical HRQoL group. Fatigue was the only significant independent predictor of group membership for the remaining group with reduced HRQoL. Conclusion These findings suggest more than 50% of hospitalised individuals with mTBI and systemic injury, have reduced HRQoL, 10 weeks after mTBI. Pain and fatigue warrant clinical attention in these individuals. IMPLICATIONS FOR REHABILITATION Mild traumatic brain injury is a common event that has been shown to be associated with persistently reduced health-related quality of life in approximately 50% of individuals 6 to 12 months after injury. Health-related quality of life likely varies between individuals after injury Relative to the “normal” population, most individuals in this cohort of individuals with mTBI and systemic injury had reduced mental, social and energy quality of life 10 weeks after injury. Fatigue and pain are important factors in reduced health-related quality of life after mTBI with systemic injury. Further research is needed to determine whether these fatigue and pain issues are related to mTBI-factors, such as headache, and/or related to systemic injury factors, which are common in the mTBI population.

Demographic and Clinical Factors Associated With Health-Related Quality-of-Life Profiles Among Prostate Cancer Survivors.

Our purpose was to describe the prevalence and predictors of symptom and function clusters related to physical, emotional, and social components of general health-related quality of life (HRQOL) in a population-based sample of prostate cancer (PCa) survivors. Participants (N = 1,162) completed a baseline survey at a median of 9 months after diagnosis to ascertain the co-occurrence of eight symptom and functional domains that are common across all cancers and not treatment-specific. We used latent profile analysis (LPA) to identify subgroup profiles of survivors with low, moderate, or high HRQOL levels. Multinomial logistic regression models were used to identify clinical and sociodemographic factors associated with survivors' membership in the low versus moderate or high HRQOL profile. The LPA identified 16% of survivors who were categorized in the low HRQOL profile at baseline, indicative of the highest symptom burden and lowest functioning. Factors related to survivors' membership in the low versus higher HRQOL profile groups included less than age 65 years at diagnosis, identifying as non-Hispanic Black race, not working, being a former versus never smoker, systemic therapy, less companionship, more comorbidities, lower health care financial well-being, or less spirituality. Several factors remained associated with remaining in the low versus higher HRQOL profiles on the follow-up survey (n = 699), including younger age, Black race, comorbidity, and lower financial and spiritual well-being. About one of six PCa survivors experienced elevated physical and psychosocial symptoms that were independent of local curative therapy, but with younger age, race, comorbidity, and lower financial and spiritual well-being as stable risk factors for poor HRQOL over time.

Financial Toxicity and Health-Related Quality of Life Profile of Patients With Hematologic Malignancies Treated in a Universal Health Care System.

We investigated the association of financial toxicity (FT) with the health-related quality of life (HRQoL) profile of patients with hematologic malignancies treated in a universal health care system. We did a secondary analysis of six multicenter studies enrolling patients with hematologic malignancies. FT was evaluated using the financial difficulties item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Multivariable linear regression models were used to assess the mean differences in HRQoL scores between patients with or without FT, while adjusting for key potential confounding factors. We also examined the prevalence of clinically important problems and symptoms by the experience of FT, using established thresholds for the EORTC QLQ-C30. Multivariable binary logistic regression analysis was performed to explore the risk factors associated with FT. Overall, 1,847 patients were analyzed, of whom 441 (23.9%) reported FT. We observed statistically and clinically relevant worse scores for patients with FT compared with those without FT for all the EORTC QLQ-C30 scales. The three largest clinically relevant mean differences between patients with and without FT were observed in pain (∆ = 19.6 [95% CI, 15.7 to 23.5]; P < .001), social functioning (∆ = -18.9 [95% CI, -22.5 to -15.2]; P < .001), and role functioning (Δ = -17.7 [95% CI, -22.1 to -13.3]; P < .001). Patients with FT tended to report a higher prevalence of clinically important problems and symptoms across all EORTC QLQ-C30 scales. In the univariable and multivariable analyses, the presence of FT was associated with the presence of comorbidities, an Eastern Cooperative Oncology Group performance status ≥1, and not receiving a salary. Patients with hematologic malignancies treated in the setting of a universal health care system who experience FT have a worse HRQoL profile compared with those without FT.

Health-related quality of life among people living with HIV in the era of universal test and treat: results from a cross-sectional study in KwaZulu-Natal, South Africa

Background The World Health Organisation’s (WHO) key population-based strategy for ending the human immunodeficiency virus (HIV) epidemic is universal HIV test and treat (UTT) along with pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP). Despite the successful scale-up of the UTT strategy in sub-Saharan Africa (SSA), the quality of life (QoL) of people living with HIV (PLHIV) remains sub-optimal. Poor QoL in PLHIV may threaten the UNAIDS 95-95-95 programme targets. Monitoring QoL of PLHIV has become a key focus of HIV research among other outcomes so as to understand health-related QoL (HRQoL) profiles and identify interventions to improve programme performance. This study aimed to describe HRQoL profiles and identify their predictors in PLHIV in KwaZulu Natal, South Africa. Methods We conducted a secondary data analysis of a cross-sectional survey conducted between May and June 2022 among PLHIV (n = 105) accessing HIV services at an outpatient clinic in KwaZulu-Natal, South Africa. Socio-demographic, HRQoL (EQ-5D-5L index scores), clinical data, depressive symptoms (CES-D-10), and viral load data were collected from all participants. We examined predictors of HRQoL using generalised linear models controlling for age and sex. Results The mean age of the participants was 45 years (SD = 13). The proportion of participants with disabilities and comorbidities were 3% and 18%, respectively. Depressive symptoms were present in 49% of the participants. Participant’s mean EQ-5D-5L index score was 0.87 (SD = 0.21) and ranged from 0.11 to 1.0. The mean general health state (EQ-VAS) was 74.7 (SD = 18.8) and ranged from 6 to 100. Factors that reduced HRQoL were disability (β = −0.607, p ≤ 0.001), comorbidities (β = − 0.23, p ≤ 0.05), presence of depressive symptoms (β = −0.10, p ≤ 0.05), and old age (β = −0.04, p ≤ 0.05). Factors that increased HRQoL were a good perceived health state (β = 0.147, p ≤ 0.001) and availability of social support (β = 0.098, p ≤ 0.05). Conclusion A combination of old age (60 years and above), any disability and comorbidities had a considerable effect on HRQoL among PLHIV. Our findings support the recommendation for an additional fourth UNAIDS target that should focus on ensuring that 95% of PLHIV have the highest possible HRQoL. Psycho-social support interventions are recommended to improve the HRQoL of PLHIV.

Health-Related Quality of Life and Symptom Burden Profile of Patients with Pre-Fibrotic and Overt Myelofibrosis: A Preliminary Report from the Gimema-Prophecy Observational Study

Background Patients with overt myelofibrosis (MF) suffer a significant symptom burden and impairment of health-related quality of life (HRQoL). However, very little evidence-based data is available on HRQoL and the symptom burden of patients with pre-fibrotic MF. Aim The primary objective of this study was to describe the HRQoL profile of patients with pre-fibrotic MF relative to patients with overt MF. The secondary objective was to examine disease-specific symptom prevalence in both groups. Methods. Baseline data from an ongoing prospective multicenter observational study by the GIMEMA Group were analyzed. The inclusion criteria of this study were: adult patients diagnosed with Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), according to the 2016 WHO classification, within one year before the registration date. For the purpose of this analysis, only patients with pre-fibrotic and overt MF were considered. HRQoL profile was assessed with the EORTC QLQ-C30, which consists of 30 items and includes five functional scales (physical, role, emotional, social, and cognitive), three symptoms (fatigue, nausea, vomiting, and pain), a global health status/QoL scale and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Well-established evidence-based guidelines for interpreting the QLQ-C30 were used to determine clinically meaningful differences between groups (i.e., pre-fibrotic vs overt MF). Given the exploratory nature of the study, n o statistical testing was performed on mean score differences. Symptom prevalence was assessed by items of the MPN-SAF TSS. The MPN-SAF TSS is a comprehensive and brief 10-item instrument that concisely assesses the prevalence and severity of debilitating symptoms of MF. The percentage of patients who reported symptoms on the MPN-SAF TSS was based on the number of patients who answered at least 1 on a given item. Results. Overall, 104 patients with a median age of 68 years (IQR: 59-76) were enrolled across 20 community and university-based hospitals. More than half of the patients were male (n=58; 56%), and 55 (53%) revealed splenomegaly. Thirty-five patients (34%) reported at least one comorbidity. The median time since diagnosis for the overall group was 4 months (IQR: 1-7), and there were 69 and 35 patients diagnosed with overt and pre-fibrotic MF, respectively. The median age of patients with overt MF and pre-fibrotic MF was 69 (IQR: 61-76) and 63 (IQR: 57-75), respectively. At study entry, no statistically significant differences were observed between the two groups regarding age, sex, prevalence of comorbidities, WBC, and PLT counts. However, patients with overt MF had lower Hb levels (p=.003). Inspection of the HRQoL profile, according to the EORTC QLQ-C30, showed that patients with overt MF had a statistically and clinically meaningful worse global HRQoL compared to patients' pre-fibrotic MF (Δ=11.4). The following functioning scales were also mostly impaired in patients with overt MF: role functioning (Δ=14.2), cognitive functioning (Δ=4.7), and social functioning (Δ=8.1) (Figure 1). With regard to symptoms severity, patients with overt MF reported clinically meaningful higher severity for fatigue (Δ=6), pain (Δ=7.2), insomnia (Δ=6), constipation (Δ=5.4), and appetite loss (Δ=6.8). However, patients with pre-fibrotic MF reported clinically meaningful higher severity for dyspnea (Δ=5.5). The prevalence of symptoms according to the MPN-SAF TSS, overall and by disease group, is reported in Table 1. The prevalence of symptoms in the overall group of patients was high, with the top three most prevalent symptoms being fatigue (78%), concentration problems (53%), and inactivity (50%). Notably, the prevalence of symptoms was also high in patients with pre-fibrotic MF, with some one-third of them reporting: fatigue, concentrations problem, inactivity, early satiety, abdominal discomfort, night sweats, itching, and bone pain. Conclusions. To the best of our knowledge, this is one of the first evidence describing HRQoL and the symptom burden of patients with pre-fibrotic MF. Although our preliminary data suggest that the HRQoL profile of patients with pre-fibrotic MF was generally worse than those with overt MF, our findings also indicate a high symptom prevalence in patients with pre-fibrotic MF.

Health-Related Quality of Life Profile and Symptom Burden of Patients with Aggressive B-Cell Lymphomas Just before CAR-T-Cell Therapy: A Real-World Study By the Gimema

Background Although efficacy and safety data on chimeric antigenic receptor (CAR) T-cell therapy for patients aggressive B-cell lymphomas are being accumulated, there is limited research on health-related quality of life (HRQoL) and symptom burden of these patients. Additionally, the few HRQoL data available mainly stems from selected patients enrolled in clinical trial settings. Objective The primary objective of this study was to compare HRQoL of patients with relapsed/refractory aggressive B-cell lymphomas just before receiving CAR T-cell infusion in real-life, with that of their peers in the general population. Secondary objectives were to describe the prevalence of disease-specific symptoms and worries, and to investigate the relationships between symptom burden and HRQoL and functional outcomes. Methods: Baseline data from an ongoing prospective observational study by the Italian GIMEMA Group were analyzed. Inclusion criteria were: adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma, scheduled to receive CAR T-cell therapy. HRQoL was assessed with the EORTC QLQ-C30 and its recently validated module for patients with high-grade non-Hodgkin lymphoma (EORTC QLQ-NHL-HG29). Multivariable linear regression analyses were performed to estimate the overall mean difference in the QLQ-C30 scores between patients and the general population, adjusting for age, sex and comorbidity. Evidence-based guidelines for interpretation of the QLQ-C30 were used to determine clinically meaningful differences between groups. The prevalence of patients who reported symptoms and worries on the QLQ-NHL-HG29 was based on the number of patients who answered, “a little,” “quite a bit,” or “very much” on a given item. This was assessed overall and by age groups. For descriptive purposes, we divided the sample by the median age, deriving two subgroups: younger (with a median age of 50 years; IQR: 41 - 56) and older patients (with a median age of 65 years; IQR: 63 - 71). Mean scores of functional and global QoL scales of the EORTC QLQ-C30 were analyzed by severity of symptom burden. Patients were categorized as having high or low symptom burden based on the median score of the validated symptom burden scale of the QLQ-NHL-HG29 questionnaire. Results Overall, 65 patients enrolled across 9 centers were analyzed. Median age at study entry was 61 years (IQR, 50-65) and 21 (32%) were women. Median time since diagnosis was 2 years (IQR, 1-4). Eighteen patients (28%) had already received autologous hematopoietic stem cell transplantation (auto-HSCT) before study inclusion. Median number of previous lines of therapy was 2 (IQR: 2-3), and eleven patients (18%) reported at least 1 comorbidity. Patients reported statistically and clinically meaningful worse scores across several domains, compared with their peers in the general population. The top three largest statistically and clinically meaningful differences with regard to functional scales were observed for role functioning (Δ=26.8, p&amp;lt;.001), social functioning (Δ=17.6, p&amp;lt;.001) and the global QoL scale (Δ=14.3, p&amp;lt;.001). With regard to symptoms, the two largest statistically and clinically meaningful worse symptoms, compared to the general population, were observed for fatigue (Δ=14.2, P&amp;lt;.001), dyspnea (Δ=10.9, p=.003) and financial difficulty (Δ=10.6, p=.001). Prevalence of symptoms and worries was high with more than 50% of patients reporting 14 different symptoms and worries. Younger patients tended to report a higher prevalence in regard to specific worries. The top ten most prevalent symptoms and worries by the QLQ-NHL-HG29, overall and by age groups, are reported in Table 1. Patients with a greater symptom burden had a clinically meaningful worse global QoL, and worse physical, role, social, and cognitive functioning compared to those with a lower symptom burden (Figure 1). Conclusion: Using a validated disease-specific measure for high-grade non-Hodgkin lymphoma, we observed that just before CAR T-cell therapy in real-life, patients report substantial HRQoL impairments and a high prevalence of symptoms and worries. Our findings also suggest to pay special attention to patients with a greater symptom burden, being a vulnerable group with important HRQoL and functional impairments.

Patient-Reported Outcomes (PROs) Among Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Receiving Pirtobrutinib: Analysis from the BRUIN Phase 1/2 Study

Background PROs including health-related quality of life (HRQoL) and symptom burden can provide helpful information to support benefit-risk assessment of a new treatment. Pirtobrutinib, a highly selective, non-covalent (reversible) Bruton tyrosine kinase inhibitor (BTKi), inhibits both wildtype and C481-mutant BTK with equal low nM potency, and has favorable oral pharmacology that enables continuous BTK inhibition throughout the dosing interval regardless of intrinsic rate of BTK turnover. Pirtobrutinib recently received regulatory approval in the US for the treatment of patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a covalent BTKi (cBTKi). BRUIN (NCT03740529) is an ongoing, open-label, multi-center phase 1/2 study investigating the safety and efficacy of pirtobrutinib for the treatment of B-cell malignancies, including CLL/SLL. This current analysis reports PROs among patients enrolled in the BRUIN study with relapsed or refractory (R/R) CLL/SLL treated with prior cBTKi-containing regimens. Methods Pretreated patients with R/R CLL/SLL in the BRUIN study completed PRO assessments at each clinic visit. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) was used to measure physical function (PF) and HRQoL via PF and Global Health Status/QoL subscales. Patient-reported CLL/SLL symptoms and fatigue were assessed using 13 and 6 EORTC Item Library (IL) items, respectively. All subscales are scored 0-100. Higher scores represent better PF and HRQoL; and higher scores represent worse CLL/SLL symptoms and fatigue. Pre-specified clinically meaningful within patient change (MWPC) thresholds of at least 10-point changes in each PRO score were used to categorize patients based on their individual change from Cycle 1 Day 1 (i.e., baseline). Mean changes from baseline and proportions of patients with improved, stable, and worsened PROs from baseline were summarized by treatment cycle. PRO data were presented from Cycle 1 to 24 (a 28-day cycle) since the study median progression-free survival by investigator assessment was 19.6 months. The data cutoff date was 22 July 2022. Results There were 263 patients with CLL/SLL at the time of analysis; median (Quartile 1 and 3) age was 69 (62, 74) years and the majority were male (68%). All patients had received prior cBTKi; 21% received 2 or more prior cBTKi lines and 20% discontinued from their most recent cBTKi treatment due to toxicity. The mean overall completion rate of PRO instruments was 83% at baseline. 76% of all patients in the analysis completed at least one subsequent PRO assessment. Baseline mean (±SD [standard deviation]) score was 80.8 (±19.5) for PF, 61.6 (±23.2) for QoL, 24.8 (±18.4) for CLL/SLL symptoms, and 33.5 (±24.7) for fatigue. The majority of patients reported stable or clinically improved outcomes from baseline at each of the post-baseline visits (through Cycle 24) for PF (proportion of stable/improved ranged from 72.5% to 95.5%), QoL (range 80.4% to 95.0%), CLL/SLL symptoms (range 77.8% to 96.3%), and fatigue (range 77.3% to 89.9%). Conclusion Overall, consistent with the favorable safety profile of pirtobrutinib, HRQoL and symptoms were stable or improved for over 70% of patients with pretreated R/R CLL/SLL throughout the first 24 cycles of pirtobrutinib treatment. These PRO data should be interpreted with caution due to single arm trial design and small numbers of patients available for assessment in later cycles.

Lifestyle Behaviors and Health-Related Quality of Life in Long-Term Survivors of Acute Myeloid Leukemia: An International Survivorship Study By the Gimema, EORTC Quality of Life and Leukemia Groups

Background Major advances have been made in the treatment of acute myeloid leukemia (AML), and the number of survivors is expected to rise over the coming years. Therefore, a better understanding of the relationships between lifestyle behaviors and health-related quality of life (HRQoL) is important to better inform survivorship care programs. Although valuable evidence exists in this area of research for survivors of solid tumors, little data is available on patients with AML. Objective We aimed to investigate the prevalence of lifestyle behaviors of long-term AML survivors and to identify associations with HRQoL profile. A secondary objective was to describe the prevalence of clinically important functional problems and symptoms by level of physical activity (PA). Methods: In this international AML survivorship study, patients were eligible if they were diagnosed at least 5 years before and were disease-free at study entry. Patients were invited to participate by their treating hematologist and all consenting patients were requested to complete a survey booklet. Clinical data were retrieved via hospital medical records. The following lifestyle behaviors were assessed: PA, maintaining a healthy weight, eating pattern, smoking status, and alcohol consumption. PA was assessed by the Godin Leisure-Time Exercise questionnaire. Using only moderate and strenuous scores, those with a leisure score index≥24 were classified as active and those with a score≤23 were classified as insufficiently active. Maintaining a healthy weight was evaluated by the BMI and patients were categorized into: non-overweight/obese (BMI &amp;lt;25) and overweight/obese (BMI ≥25). HRQoL profile was assessed by the EORTC QLQ-C30 questionnaire. Univariable and multivariable linear regression analyses were used to investigate the associations of lifestyle behaviors and HRQoL. The summary score of the EORTC QLQ-C30 was used as outcome variable in regression analyses and the following covariates were considered: sex, age at study entry, time since AML diagnosis, ECOG performance status at diagnosis, education, living arrangements, hematopoietic stem cell transplantation history, being treated within a randomized controlled trial (RCT), and current comorbidity. Prevalence of clinically important problems and symptoms, by PA, was assessed based on recently developed thresholds for the EORTC QLQ-C30. Results Overall, 225 AML survivors with a median time from diagnosis to study entry of 8.8 years (IQR 6.4-11.9) were enrolled across 24 centers in 6 countries (Italy, France, Turkey, North Macedonia, Belgium, Slovenia). Median age at study entry was 58.0 years (IQR 47.3-66.9) and 119 (52.9%) were women. Overall, there were 165 (73.7%) patients who received at least one stem cell hematopoietic transplantation, and 70 (31.1%) patients treated in the setting of a RCT as first line therapy. One hundred ninety-five survivors (88.6%) reported at least one comorbidity and 103 (46.8%) reported four or more comorbidities. Overall, 74 (33.8%) patients were considered physically active, 121 (55.3%) were considered as overweight/obese, and 43 (19.8%) reported healthy eating habits. The majority of patients were non-smoker (n=184, 83.6%) and reported low alcohol consumption (n=209, 95.9%). In univariable analyses, no comorbidity (p=.046), no smoking habits (p=.035), higher level of education (p=.017), and being physically active (p&amp;lt;.001) were associated with a higher EORTC QLQ-C30 summary score. However, in multivariable analysis, only being physically active (p=.005) remained independently associated with a higher EORTC QLQ-C30 summary score. Marked differences were observed in the prevalence of clinically important functional problems and symptoms between the two groups. For example, the prevalence of patients reporting clinically important fatigue and dyspnea in patients who were physically active versus those who were not, was: 8.1% vs. 23.6% and 23% vs 43.1%, respectively. Likewise, patients who were physically active tended to report a lower prevalence of clinically important functional problems (Figure 1). Conclusion: We found an independent association between being physically active and reporting a better HRQoL profile in long-term survivors of AML. Our findings suggest that interventions aimed to increase PA in survivors of AML may be critical to improve their functional outcomes and reduce symptom burden.

Identification of health-related quality of life profiles among long-term survivors of primary central nervous system tumors

PurposeWe aimed to identify health-related quality of life (HRQOL) latent classes among primary central nervous system tumor (PCNST) long-term survivors (LTS) and to evaluate differences between classes in survivor sociodemographic characteristics, clinical characteristics, and symptoms to guide the development of survivorship care programs tailored to unique class needs.MethodsData from 298 PCNST LTS reporting HRQOL on the EQ-5D-3L were analyzed using latent profile analysis. Correlations and independent group t-tests were performed to identify differences between identified HRQOL classes by sociodemographic, clinical characteristics, and symptoms.ResultsSample mean age was 48 years, 54% were male, 82% Caucasian, 56% employed, 60% had a high-grade glioma, and 52% had a KPS ≥ 90. Two HRQOL classes, good (61%) and poor (39%), were identified. The good HRQOL class reported no problems with self-care and few problems with mobility or usual activities. Thirty-eight percent reported anxiety and depression and 21% pain. Over 94% of the poor HRQOL class had at least moderate problems with mobility and usual activities, and over 50% had pain, self-care issues, anxiety, and depression. Older age (φ = 0.21), unemployment (φ = 0.30), spine tumors (φ = 0.18), active treatment (φ = 0.20), tumor recurrence (φ = 0.28), and poorer KPS scores (φ = 0.61) were associated with membership in the poor HRQOL class.ConclusionsIn the poor PCNST LTS HRQOL class, an overwhelming majority faced significant physical challenges, and the good HRQOL class experienced mood-related disturbance but limited physical challenges. These HRQOL profiles can be used to guide survivorship programs and tailored interventions.

Health-Related Quality-of-Life Profile of Pediatric Patients with β Thalassemia after Hematopoietic Stem Cell Transplantation.

Matched hematopoietic stem cell transplantation (HSCT) is a feasible and curative treatment in pediatric patients with beta thalassemia major (β-TM). However, little data are available regarding patients and their parents' health-related quality of life (HRQoL) after the procedure. As such, we investigated the HRQoL of pediatric patients with β-TM after HSCT compared to that of patients treated with blood transfusions and iron chelation. The health-related quality of life of 43 β-TM pediatric patients and 43 parents were evaluated using the Pediatric Quality of Life Inventory (PedsQL). A total of 25 patients underwent HSCT: 15 from a sibling and 10 from an HLA-matched donor. The median follow-up time from HSCT was 5 years (range 1-13 years). The mean ages at the survey were 10.1 years (range 5-15) and 9.6 years (range 5-15) for transfused and transplanted patients, respectively. A significant reduction in HRQoL was reported in the group of transfused patients compared with that of patients transplanted in the following PedsQL domains: children's and parents' physical functions, Δ = -15.4, p = 0.009 and Δ = -11.3, p = 0.002, respectively; children's and parents' emotional functioning, Δ = -15.2, p = 0.026 and Δ = -15.2, p = 0.045, respectively; child's and parents' school functioning, Δ = -25, p = 0.005 and Δ = -22.5, p = 0.011, respectively; total child and parents scores, Δ = -14.5, p = 0.004 and Δ = -13.2, p = 0.005, respectively. The results of a multivariable analysis showed that the HSCT procedure was significantly associated with a higher total child PedsQL score (adjusted mean difference = 15.3, p = 0.001) and a higher total parent PedsQL score (adjusted mean difference = 14.1, p = 0.006). We found no significant difference in the HRQoL measured after sibling or unrelated human leukocyte antigen (HLA)-matched HSCT. Finally, a significant positive correlation across all the PedsQL domains was found between the scores reported by the children and those reported by their parents. In conclusion, our study shows that HSCT in pediatric patients with β-TM is associated with a good overall HRQoL profile. This information further supports physicians when counseling patients and their parents before the HSCT procedure.

Health-related Quality of Life Profile of Newly Diagnosed Patients With Myelodysplastic Syndromes by Age, Sex, and Risk Group: A Real-world Study by the GIMEMA.

Health-related quality of life (HRQoL) is an important goal of therapy for patients with myelodysplastic syndromes (MDS); however, little is known about HRQoL of these patients at clinical presentation. We report HRQoL profile of newly diagnosed patients with MDS across both the the International Prognostic Scoring System (IPSS) and IPSS-Revised (IPSS-R) classifications, stratified by sex and age group categories, aiming to also establish European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) reference values for these patients. Analysis was based on 927 patients with a median age of 73.3 years (, 66.0-79.2), of whom 506 and 421 with lower- and higher-risk disease respectively, according to the IPSS classification. HRQoL was assessed with the EORTC QLQ-C30 and substantial differences by age groups and sex, between and within lower- and higher-risk disease categories were observed. For example, within higher-risk disease patients, the youngest group (ie, 30-59 years) tended to report clinically meaningful worse outcomes across various functional and symptom domains compared with older age groups. We also developed 2 regression models allowing for the prediction of EORTC QLQ-C30 reference scores for patients classified according to either the IPSS or the IPSS-R. Investigation of prevalence rates for clinically important problems and symptoms at diagnosis revealed a substantial burden of the disease with >50% of patients reporting clinically important problems with physical functioning and dyspnea in both lower- and higher-risk disease. Our findings may help to enhance the interpretation of HRQoL outcomes in future MDS studies and to better contextualize HRQoL data from routine practice settings.

Comparison of painful temporomandibular disorders, psychological characteristics, sleep quality, and oral health-related quality of life of patients seeking care before and during the Covid-19 pandemic

BackgroundLiterature concerning Temporomandibular disorders (TMDs) and the Covid-19 pandemic is limited and disparate findings related to TMD frequencies, psychological distress, and quality of life were presented. This study investigated the prevalence of painful Temporomandibular disorders (TMDs) and compared the psychological, sleep, and oral health-related quality of life profiles of patients seeking TMD care before and during the Covid-19 pandemic.MethodsData were accrued from consecutive adult patients 12 months before (BC; control) and during (DC; case group) the Covid-19 pandemic. The Diagnostic Criteria for TMDs (DC/TMD), Depression, Anxiety, Stress Scales (DASS)-21, Pittsburgh Sleep Quality Index (PSQI), and Oral Health Impact Profile (OHIP)-TMDs were utilized and statistical analysis was performed using Chi-square/non-parametric tests (α = 0.05).ResultsThe prevalence of painful TMDs was 50.8% before and 46.3% during the pandemic. Significant differences in PSQI and OHIP component scores were discerned between the BC and DC groups contingent on TMD pain. Total-DASS was moderately correlated to total-PSQI/OHIP (rs = 0.41–0.63).ConclusionThe covid-19 pandemic did not appear to exacerbate psychological distress but affected sleep and increased unease over TMD dysfunction.

Health-related quality of life profiles in adolescents and young adults with chronic conditions.

To assess health-related quality of life (HRQOL) among adolescents and young adults (AYAs) with chronic conditions. AYAs (N = 872) aged 14-20years completed NIH's Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, pain interference, fatigue, social health, depression, anxiety, and anger. Latent profile analysis (LPA) was used to group AYAs into HRQOL profiles using PROMIS T-scores. The optimal number of profiles was determined by model fit statistics, likelihood ratio test, and entropy. Multinomial logistic regression models were used to examine how LPA's HRQOL profile membership was associated with patient demographic and chronic conditions. The model prediction accuracy on profile membership was evaluated using Huberty's I index with a threshold of 0.35 for good effect. A 4-profile LPA model was selected. A total of 161 (18.5%), 256 (29.4%), 364 (41.7%), and 91 (10.4%) AYAs were classified into Minimal, Mild, Moderate, and Severe HRQOL Impact profiles. AYAs in each profile had distinctive mean scores with over a half standard deviation (5-points in PROMIS T-scores) of difference between profiles across most HRQOL domains. AYAs who were female or had conditions such as mental health condition, hypertension, and self-reported chronic pain were more likely to be in the Severe HRQOL Impact profile. The Huberty's I index was 0.36. Approximately half of AYAs with a chronic condition experience moderate to severe HRQOL impact. The availability of risk prediction models for HRQOL impact will help to identify AYAs who are in greatest need of closer clinical care follow-up.

Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life

ABSTRACT The impact of chronic diseases on health-related quality of life (HRQOL) in adolescents and young adults (AYAs) is understudied. Latent profile analysis (LPA) can identify profiles of AYAs based on their HRQOL scores reflecting physical, mental, and social well-being. This paper will (1) demonstrate how to use LPA to identify profiles of AYAs based on their scores on multiple HRQOL indicators; (2) explore associations of demographic and clinical factors with LPA-identified HRQOL profiles of AYAs; and (3) provide guidance on the selection of adult or pediatric versions of Patient-Reported Outcomes Measurement Information System® (PROMIS®) in AYAs. A total of 872 AYAs with chronic conditions completed the adult and pediatric versions of PROMIS measures of anger, anxiety, depression, fatigue, pain interference, social health, and physical function. The optimal number of LPA profiles was determined by model fit statistics and clinical interpretability. Multinomial regression models examined clinical and demographic factors associated with profile membership. As a result of the LPA, AYAs were categorized into 3 profiles: Minimal, Moderate, and Severe HRQOL Impact profiles. Comparing LPA results using either the pediatric or adult PROMIS T-scores found approximately 71% of patients were placed in the same HRQOL profiles. AYAs who were female, had hypertension, mental health conditions, chronic pain, and those on medication were more likely to be placed in the Severe HRQOL Impact Profile. Our findings may facilitate clinicians to screen AYAs who may have low HRQOL due to diseases or treatments with the identified risk factors without implementing the HRQOL assessment.

Health-related quality of life in Chinese medical staff: a latent profile analysis.

To investigate subgroups of health-related quality of life (HRQoL) in the Chinese medical staff and identify the demographic factors associated with these profiles. 574 Chinese medical staff were surveyed online. HRQoL was measured by using the 36-Item Short Form Health Survey, Version 2. Latent profile analysis (LPA) was used to identify the profiles of HRQoL. The associations between HRQoL profiles and covariates were assessed using multinomial logistic regression. Three HRQoL profiles were developed: low HRQoL at 15.6%, moderate HRQoL at 46.9%, and high HRQoL at 37.6%. Multinomial logistic regression showed night shift times, aerobic exercise conditioning, and personality type significantly predicted the profile membership. Our findings develop earlier approaches that only used total scores to evaluate this group's HRQoL and help them with tailored interventions to promote better HRQoL.

Subjective HRQoL in Patients with Sleep Apnea Syndrome Who Underwent PAP Therapy in a Rehabilitation Setting: A Longitudinal Study

Obstructive sleep apnea (OSA) is often associated with decreased health-related quality of life (HRQoL). The aims of this study were to evaluate HRQoL, the clinical and psychological profile of suspected or verified OSA patients, and the impact of PAP therapy at 1-year follow-up. At T0, OSA-suspected subjects underwent clinical, HRQoL, and psychological assessment. At T1, OSA patients underwent PAP therapy in a multidisciplinary rehabilitation setting. At 1 year follow-up, OSA patients were evaluated for the second time. At T0, OSA patients (n = 283) and suspected OSA subjects (n = 187) differed for AHI, BMI, and ESS. At T0, the PAP-treatment group (n = 101) showed moderate-severe anxious (18.7%) and depressive (11.9%) symptoms. At 1 year follow-up (n = 59), the sleep breathing pattern had normalized and there was a reduction of ESS scores and anxious symptoms. There was also an improvement in HRQoL (0.6 ± 0.4 vs. 0.7 ± 0.5, p = 0.032; 70.4 ± 19.0 vs. 79.2 ± 20.3, p = 0.001) and in satisfaction with sleep quantity (52.3 ± 31.7 vs. 71.4 ± 26.2, p = 0.001), sleep quality (48.1 ± 29.7 vs. 70.9 ± 27.1, p = 0.001), mood (58.5 ± 24.9 vs. 71.0 ± 25.6, p = 0.001), and physical resistance (61.6 ± 28.4 vs. 67.8 ± 27.4, p = 0.039). Considering the impact of PAP treatment on patients' psychological and HRQoL evaluations that we observed, our data are valuable for unveiling different profiles characterizing this clinical population.

Patterns of Health-Related Quality of Life among Stroke Survivors: A Longitudinal Study.

Six months poststroke is critical for optimizing stroke survivors' recovery and improving their health-related quality of life (HRQoL). Understanding HRQoL profiles in specific domains can provide a more typical plan for stroke survivors. This pilot study aimed to explore the HRQoL patterns among 39 stroke survivors within 6 months following diagnosis. The results revealed that there were four patterns based on HRQoL domains. Pattern 1: energy, family role, mobility, self-care, social role, and work/productivity domains likely to improve; Pattern 2: language and vision domains likely to improve and be stable; Pattern 3: thinking and upper extremity function domains likely to worsen and improve later; and Pattern 4: mood and personality domains likely to worsen and be constant. Health care providers can apply these results by continuing to assess and provide care to stroke survivors focusing on functional status, cognitive status, and depression over time. Further study should explore the factors predicting HRQoL.

Health-Related Quality of Life and Financial Burden of Ethiopian Patients with Chronic Myeloid Leukemia Receiving Tyrosine Kinase Inhibitors

Background Assessment of health-related quality of life (HRQoL) of patients with chronic myeloid leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) is critical to support informed decision-making. However, HRQoL data currently available mainly stems from patients enrolled in high-income countries. Little is known about HRQoL of patients with CML living in low-income African countries and on the potential impact of financial difficulties experienced by these patients. Purpose The main objective of this study was to examine prevalence of clinically relevant problems and symptoms of Ethiopian patients with CML. A secondary objective was to investigate the impact of financial burden on HRQoL profile of these patients. Methods This was an observational cross-sectional study conducted at Tikur Anbessa Hospital (Addis Ababa), which is the only Ethiopian center providing TKI therapy to CML patients from all over the country. Adult patients (at least 18 years old) with a confirmed diagnosis of CML were eligible for this study. At study entry, HRQoL was assessed with the EORTC QLQ-C30 and the QLQ-CML24 questionnaires. Prevalence of clinically important problems and symptoms, at the patient level, was examined using established criteria for the use of the EORTC QLQ-C30 in routine clinical practice. This prevalence reflects the number of patients indicating limitations of everyday life, worrying, or need for help or care related to a specific symptom or functional impairment (Giesinger JM. J Clin Epidemiol. 2020;118:1-8). For descriptive purposes, EORTC QLQ-CML24 scores of Ethiopian patients were compared to that of patients included in the validation study of this questionnaire, who were mainly enrolled from high-income countries (Efficace F, et al Leuk Lymphoma. 2021;62:669-678). Multivariable linear regression analysis was performed to examine the association between financial difficulty (EORTC QLQ-C30) on "impact on daily life" scale (EORTC QLQ-CML24) while controlling for key potential observed confounding factors. The study was approved from ethical committee of the institution and all patients provided informed consent. Results Between February 2021 and June 2021, 395 patients were consecutively enrolled. Median age of patients was 39 years (range 18-82) and there were 62.8%, and 37.2% of males and females' patients respectively. Median time since diagnosis was 3.9 years (range 0.2-16) and 94% were diagnosed in chronic phase (CP) of the disease. The majority of patients (92.7%) were in treatment with imatinib and, overall, 82.3% were in complete hematologic response but unknown molecular remission status. The majority of patients (82.8%) were not able to afford follow-up BCR-ABL tests to monitor molecular response. The top three most prevalent clinically important problems were found for physical functioning (60%), emotional functioning (40%) and social functioning (38%). Pain was the most prevalent clinically important symptom reported by 43% of patients. Notably, 89% of patients reported relevant financial difficulties. Mean EORTC QLQ-C30 global health status/QoL score of patients with higher financial difficulties was 14 points lower (worse) than those with lower financial difficulties (P<0.001). Gender specific descriptive comparison of Ethiopian patients with CML patients mainly from high-income countries, revealed worse mean scores in key domains of the EORTC QLQ-CML24. For example, male Ethiopian patients reported a higher (worse) mean score (+25.2 points) than male patients from high-income countries (Table 1). In the multivariable analysis, higher financial difficulty, was associated (P<.001) with a greater impact on daily life (EORTC QLQ-CML24) and this was independent of other key variables including: age, sex, time since diagnosis, comorbidity, distance to hospital as well as fatigue and symptom burden. Conclusions Financial burden is a major problem affecting a large proportion of Ethiopian patients with CML receiving TKIs. Our findings also suggest that financial difficulties of these patients are also associated with worse HRQoL outcomes. Future studies are needed to assess whether efforts to reduce financial burden in these patients could improve HRQoL and facilitate adherence to therapy, thereby maximizing TKIs efficacy. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal