Health-related Quality Of Life Measures Research Articles

Social relationships and their impact on health-related quality of life in a long-term breast cancer survivor cohort.

Health-related quality of life (HRQOL) has become increasingly important for breast cancer survivors, but clinically relevant declines often persist for many years after treatment. This study aimed to investigate whether social relationships can mitigate or prevent this decline in HRQOL. Data were used from the German population-based Mamma Carcinoma Risk Factor Investigation (MARIE) cohort of 2022 breast cancer cases with follow-up information for more than 15 years after diagnosis. Correlations between social integration, social support, and global health status (GHS) as an overall measure of HRQOL were analyzed, and linear regression analysis was performed with structural equation modeling. The majority of participants reported high levels of social integration and social support and moderate levels of GHS. Social integration 5 years after diagnosis was associated with GHS 5 years after diagnosis (β=1.12; 95% CI,0.25-1.99), but no longitudinal effects were found. Social support 5 years after diagnosis was associated with better GHS 5 years (β=0.42; 95% CI,0.36-0.48) and 10 years after diagnosis (β=0.12; 95% CI,0.02-0.22), whereas social support 10 years after diagnosis was associated with GHS 10 years (β=0.29; 95% CI,0.20-0.39) and 15 years after diagnosis (β=0.10; 95% CI,0.01-0.21). These results confirm that social relationships positively influence HRQOL in long-term breast cancer survivors and that their association should receive more attention clinically and beyond routine care.

Supplementation with selenium and coenzyme Q10 in an elderly Swedish population low in selenium — positive effects on thyroid hormones, cardiovascular mortality, and quality of life

BackgroundSelenium-dependent deiodinases play a central role in thyroid hormone regulation and metabolism. In many European countries, insufficient selenium intake may consequently lead to adverse effects on thyroid function. In this randomised placebo-controlled double-blind study, we examined the effect of supplementation with selenium and coenzyme Q10 on thyroid hormonal status, cardiovascular (CV) mortality and health-related quality of life (Hr-QoL).MethodsFree T3, free T4, reverse T3, and TSH were determined in 414 individuals at baseline, and the effect of selenium yeast (200 µg/day) and coenzyme Q10 (200 mg/day) supplementation on hormone concentrations, CV mortality and Hr-QoL was evaluated after 48 months using Short Form 36 (SF-36). Pre-intervention plasma selenium was low, mean 67 µg/L, corresponding to an estimated intake of 35 µg/day. Changes in concentrations of thyroid hormones following the intervention were assessed using T-tests, repeated measures of variance, and ANCOVA analyses.ResultsIn the total population, the group with the lowest selenium concentration at baseline presented with significantly higher levels of TSH and lower levels of fT3 as compared to subjects with the highest selenium concentration. Supplementation with selenium and coenzyme Q10 for 4 years significantly increased fT3 and rT3, decreased fT4, and diminished the increase in TSH levels compared with placebo treatment (p = 0.03, all). In the placebo group, TSH and fT4 values above the median were associated with an increase in 10-year CV mortality, as compared with the mortality rate among those with TSH and fT4 below the median (p < 0.04, both), with no difference in mortality rate according to TSH and fT4 levels in the active intervention group. Similarly, TSH > median and fT3 < median were associated with a decline in mental Hr-QoL measures vs. TSH < and fT3 > median in the placebo group during 4 years of follow-up, but this was wiped out in the active group.ConclusionsSupplementation with selenium and coenzyme Q10 had a beneficial effect on thyroid hormones with respect to CV mortality and Hr-QoL outcomes. The initial deficient selenium status was associated with an impaired thyroid function and the changes in thyroid hormone levels can be explained by increased activity of deiodinases. We conclude that a substantial part of the elderly study population might suffer from suboptimal thyroidal function with adverse clinical implications due to selenium deficiency.Trial registrationThis study was registered at ClinicalTrials.gov and has the identifier NCT01443780. Since it was not mandatory to register at the time the study began, the study has been registered retrospectively.

Association between adverse childhood experiences and health related quality of life in adult cancer survivors in the United States.

The impact of adverse childhood experiences (ACEs) on health-related quality of life (HRQOL) is increasingly recognized, however, this has not been studied in cancer survivors in the United States. This study investigates if ACEs are associated with HRQOL in cancer survivors. We conducted a cross-sectional analysis of the 2020 Behavioral Risk Factor Surveillance System from states that administered ACEs and Cancer Survivorship modules. Eligibility criteria included being a cancer survivor and not currently receiving cancer treatment. Primary exposure was number of ACEs (categorized as 0, 1-2, 3, or ≥ 4). Primary outcomes were self-reported measures of HRQOL including worse overall health and ≥ 14 unhealthy days (mentally or physically) per month. Mantel-Haenszel stratified analyses were performed and prevalence ratios were adjusted for age. Of 5,780 participants, 62.0% were female and 67.8% were ≥ 65 years. Prevalence of worse overall health was 22.5% for individuals with no ACEs compared to 30.2% for 2-3 ACEs (aPR = 1.4, 95% CI 1.2, 1.5) and 38.5% for ≥ 4 ACEs (aPR = 1.7, 95% CI 1.5, 2.0). Prevalence of ≥ 14 unhealthy days was 18.1% with no ACEs compared to 21.0% for 1 ACE (aPR = 1.3, 95% CI 1, 1.3), 29.0% for 2-3 ACEs (aPR = 1.6, 95% CI 1.4, 1.8), and 44.8% for ≥ 4 ACEs (aPR = 2.2, 95% CI 2.0, 2.5). Our study provides novel evidence of the association of multiple ACEs with higher prevalence of poor HRQOL in cancer survivors. Screening for ACEs is warranted in all patients to guide targeted interventions to improve HRQOL and mitigate the impact of ACEs on HRQoL in cancer survivors.

Abstract PS02-03: Is de-escalation of treatment by omission of radiotherapy associated with fear of cancer recurrence and health-related quality of life in women with early breast cancer? An exploratory study

Abstract Background: There is growing interest in treatment optimization in early breast cancer (EBC). PROSPECT (ANZ-1002) provided compelling evidence that a combination of pre-operative MRI and pathological features could identify a substantial group of patients with localised EBC in whom radiotherapy (RT) could be safely omitted. The patient experience of de-escalation or its association with health-related quality of life (HRQoL) and fear of cancer recurrence (FCR), was not examined in PROSPECT but is a key consideration of treatment decision-making. We conducted a retrospective, mixed methods, cross-sectional study to explore this association. Methods: Psychometrically validated measures including the Fear of Cancer Recurrence Inventory Short-Form, Depression Anxiety Stress Scale, Breast Cancer Treatment Outcomes Scale, EORTC QLQ-C30 and its breast-specific module, the BR23, and the Decision Regret Scale were completed by three groups of women with early EBC: Women in the PROSPECT clinical trial who underwent pre-surgical MRI and omitted RT (A), women who underwent pre-surgical MRI and received RT (B); and women who received usual care (no MRI, received RT; C). Between group differences were analysed with ANOVA or equivalent non-parametric tests. A subset from each group participated in a semi-structured interview. These data (n=44) were analysed with directed content analysis. Results: Data from 400 women were analysed. Median age was 65 years, and median time since diagnosis was 4.4 years. There were no group differences in neuroticism, mental health, age, medical comorbidities, parity, or time since diagnosis. Significantly lower FCR was observed in Group A (n=125) than in Group B (n=102; p=.002) or Group C (n=173; p=.001), and when participants were categorized by RT status (omitted RT vs received RT; p&amp;lt; .001). The proportion of women with normal FCR was significantly (p &amp;lt; .05) larger in Group A (62%) than in Group B (35%) or Group C (40%). There were no differences between groups on depression and anxiety. Women in Group A had fewer breast symptoms than in Group B (p=.003) and Group C (p= &amp;lt; .001), fewer arm symptoms than in Group B (p=.004) and Group C (p=.011), and better body image than Group C (p=.041). Compared to Groups B and C, Group A performed better on cosmetic (both p&amp;lt; .001), functional (A vs C: p=.011) and breast-specific pain measures (both p&amp;lt; .001). Pre-operative MRI and omission of RT were highly acceptable and decision regret was low. A secondary analysis was conducted to eliminate any potential impact of disease severity on the analysis. All cases (n=126) with any positive nodes, a Grade 3 tumour and tumour size &amp;gt;20mm were removed. The remaining sample comprised 274 women. The results were similar to the primary analysis. Qualitative analysis showed that women who omitted RT viewed this as appropriate treatment, not undertreatment. Women considered RT toxic but endured it as a necessity, if prescribed. Few women experienced ongoing negative effects from RT but there was a tendency to minimize RT treatment burden. Women managed their FCR by having trust in their treatment and faith in the medical advice they received. Conclusions: In the setting of the PROSPECT trial, treatment de-escalation via omitting RT was associated with less FCR, better HRQoL and functional and cosmetic outcomes and was highly acceptable. Clinicians should consider the potential for preserved HRQoL associated with omission of RT in treatment decision-making. Positive perceptions about tailored care, lower treatment burden, and trust in clinicians appear to be protective against FCR. Future studies should include prospective collection of FCR and HRQoL measures. Citation Format: Bruce Mann, Michelle Sinclair, Phyllis Butow, Janemary Hughes, Allan Park, Leslie Gilham, Allison Rose, Lesley Stafford. Is de-escalation of treatment by omission of radiotherapy associated with fear of cancer recurrence and health-related quality of life in women with early breast cancer? An exploratory study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PS02-03.

Anorectal sexual function index: Development and validation of a health-related quality of life measure

ObjectivesTo assess the reliability and validity of measuring receptive anal intercourse (RAI) sensation and associated satisfaction and bother MethodsBetween July 2022 and January 2023, we conducted a survey on sensations during RAI among people with prostates (i.e. cisgender men and transgender women). The survey content was developed based on our previous qualitative study. We assessed internal reliability and consistency through time. Sensations experienced during RAI were correlated with health-related quality of life (HRQOL) measures to ensure construct validity. ResultsThe final index contained four scales: pleasure (four items), pain (seven items), urinary (four items), and bowel (four items). Overall, 1084 individuals filled out the questionnaire. The internal consistency for all subscales was at or above 0.79. Scores tended to be stable across time with all test-retest coefficients at or above 0.72. Pleasure scores were inversely correlated with pain scores (r=-0.46). Pleasure was positively correlated with erections (r=0.36) and orgasms (r=0.44) during RAI, and sexual satisfaction (r=0.39). Notable positive correlations for pain scores were with bowel scores (r=0.49), internalized homophobia (r=0.35), and prostatitis symptoms (r=0.37). Urinary scores were moderately associated with IPSS scores (r=0.22). Bowel scores were positively correlated with GI symptoms (r=0.24), mental health symptoms (r=0.28), and chronic prostatitis symptoms (r=0.29). ConclusionsThe results of the current study provide evidence that the ASFI is both reliable and valid. The ASFI may be a particularly useful HRQOL measure to assess outcomes regarding a host of urologic issues that may affect RAI.

Patients undergoing robotic arm-assisted total knee arthroplasty have a greater improvement in knee-specific pain but not in function.

The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA). A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points. There were no clinically or statistically significant differences between the knee-specific measures (WOMAC, Oxford Knee Score (OKS), Forgotten Joint Score (FJS)) or HRQoL measures (EuroQol five-dimension questionnaire (EQ-5D) and EuroQol visual analogue scale (EQ-VAS)) at 12 months between the groups. However, the rTKA group had significantly (p = 0.029) greater improvements in the WOMAC pain component (mean difference 9.7, 95% confidence interval (CI) 1.0 to 18.4) over the postoperative period (two, six, and 12 months), which was clinically meaningful. This was not observed for function (p = 0.248) or total (p = 0.147) WOMAC scores. The rTKA group was significantly (p = 0.039) more likely to have expectation of 'Relief of daytime pain in the joint' when compared with the mTKA group. There were no other significant differences in expectations met between the groups. There was no significant difference in patient satisfaction with their knee (p = 0.464), return to work (p = 0.464), activities (p = 0.293), or pain (p = 0.701). Patients undergoing rTKA had a clinically meaningful greater improvement in their knee pain over the first 12 months, and were more likely to have fulfilment of their expectation of daytime pain relief compared with patients undergoing mTKA. However, rTKA was not associated with a clinically significant greater knee-specific function or HRQoL, according to current definitions.

Disease Burden and Health-Related Quality of Life (HRQoL) of Chronic Obstructive Pulmonary Disease (COPD) in the US - Evidence from the Medical Expenditure Panel Survey (MEPS) from 2016-2019.

Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with reduced life expectancy, increased morbidity, mortality, and cost. This study characterized the US COPD burden, including socioeconomic and health-related quality of life (HRQoL) outcomes. In this retrospective, cross-sectional study using nationally representative estimates from Medical Expenditures Survey (MEPS) data (2016-2019), adults (≥18 years) living with and without COPD were identified. Adults living without COPD (control cohort) and with COPD were matched 5:1 on age, sex, geographic region, and entry year. Demographics, clinical characteristics, socioeconomic, and generic HRQoL measures were examined to include a race-stratified analysis of people living with COPD. A total of 4,135 people living with COPD were identified; the matched dataset represented a weighted non-institutionalized population of 11.3 million with and 54.2 million people without COPD. Among people living with COPD, 66.3% had ≥1 COPD-related condition; 62.7% had ≥1 cardiovascular condition, compared to 33.5% and 50.5% without COPD. More people living with COPD were unemployed (56.2% vs 45.3%), unable to work due to illness/disability (30.1% vs 12.1%), had problems paying bills (16.1% vs 8.8%), reported poorer perceived health (fair/poor: 36.2% vs 14.4%), missed more working days due to illness/injury per year (median, 2.5 days vs 0.0 days), and had limitations in physical functioning (40.1% vs 19.4%) (all P<0.0001). In race-stratified analyses for people living with COPD, people self-reporting as Black had higher prevalence of cardiovascular-risk conditions, poorer socioeconomic and HRQoL outcomes, and higher healthcare expenses than White or Other races. Adults living with COPD had higher clinical disease burden, lower socioeconomic status, and reduced HRQoL than those without, with greater disparities among Black people living with COPD compared to White and other races. Understanding the characteristics of patients helps address care disparities and access challenges.

P041 Health-related quality of life in patients receiving glucocorticoids for a rheumatic disease and associated factors : a cross-sectional study

Abstract Background/Aims Glucocorticoids (GCs) used in the treatment of inflammatory rheumatic conditions can impact on patients in different ways. The objective of this study was to identify socio-demographic and clinical factors associated with health-related quality of life (HRQoL) in patients undertaking GCs for a rheumatic disease. Methods This was a cross-sectional study using online survey methods. Participants taking GCs for a rheumatic disease from Australia, United Kingdom and the United States of America were included. HRQoL was measured using the EQ-5D-5L converted into a linear EQ5D index value. Eight explanatory factors (age, sex, country, educational level, employment status, disease group, self-reported disease state, and dose of GCs) were tested for potential association with HRQoL using univariable and multivariable (hierarchical) analyses. Factors found to have a significant association with EQ5D index at a P &amp;lt; 0.05 level in the multivariable model were considered to be independently associated with HRQoL. Results A total of 945 patients completed the EQ-5D-5L with no missing values: UK n = 742 (79%); USA n = 139 (15%); Australia/New Zealand n = 64 (7%); mean age 57.6 (SD = 13.6); 833 (88%) women. Participants with inflammatory arthritis n = 197 (21%), connective tissue disease and/or vasculitis n = 402 (43%), giant cell arteritis and/or polymyalgia rheumatica n = 346 (37%) were included. Those with self-reported active disease were 726 (77%). Mean (SD) EQ5D index was 0.64 (0.25); there were significant differences between groups in EQ-5D-5L index by age (median split, t=-3.77, p &amp;lt; 0.001); sex (t = 3.40, p &amp;lt; 001); educational level (F[3]=10.51, p &amp;lt; 0.001); employment status (F[6]=37.67, P &amp;lt; 0.001); disease group (T[2]=20.23, p &amp;lt; 0.001); disease state (T=-8.46, p &amp;lt; 0.001); and the dose of GCs(T = 2.95, p &amp;lt; 0.001). Worse HRQoL was associated with older age, being female, low educational attainment, being unemployed, having an inflammatory arthritis or a CTD, disease being active, and taking a higher dose of GC. Of the eight factors that were tested in the multivariable model, five were found to be independently associated with HRQoL. These were: disease state (β = 0.12, p &amp;lt; 0.001), disease group (β = 0.06, p &amp;lt; 0.001), employment status (β = 0.05, p &amp;lt; 0.001), sex (β = 0.05, p &amp;lt; 0.001), and educational level (β = 0.04, p &amp;lt; 0.001). This 5-factor model explained 18% of the variance in EQ5D index scores (F[1, 926] = 4.97, P = 0.026). The excluded factors in the model were age, dose, and country. Conclusion In our data, we identified 5 factors independently associated with worse HRQoL in patients being treated with GCs. Over 80% of the variance was not explained by our model likely due to use of a generic HRQoL measure (EQ-5D-5L) as outcome variable, and the small number of explanatory variables tested within this survey. Further research is required to identify potential targets to support interventions. Disclosure S. Janagan: None. K. Lim: None. R. Bhogal: None. S. Bridgewater: Grants/research support; Vifor pharma. C. Silverthorne: None. P. Richards: None. J. Dawson: None. E. Dures: Grants/research support; Vifor pharma. C. Hill: None. S. Goodman: Consultancies; UCB. Grants/research support; Novartis. S.L. Mackie: Consultancies; Consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, AstraZeneca, Pfizer. Other; Investigator on clinical trials for Sanofi, GSK, Sparrow, speaking/lecturing on behalf of her institution for Roche/Chugai, Vifor, Pfizer, UCB, Novartis and AbbVie, ; chief investigator on STERLING-PMR trial, funded by NIHR; patron of the charity PMRGCAuk, No personal remuneration was received for any of the above activities. Support from Roche/Chugai to attend EULAR2019 in person and from Pfizer to attend ACR Convergence 2021 virtually., SLM is supported in part by the NIHR Leeds Biomedical Research Centre., The views expressed in this article are those of the authors and not necessarily those of the NIHR,the NIHR Leeds Biomedical Research Centre, the National Health Service or the UK Department of Health. M. Ndosi: Grants/research support; Vifor pharma. J.C. Robson: Consultancies; Vifor Pharma. Member of speakers’ bureau; Vifor Pharma. Grants/research support; Unrestricted Grant/research support from: Vifor Pharma.

P047 Mortality in patients with rheumatic disease over a three year period encompassing the COVID-19 pandemic: clinically extremely vulnerable status and short form 12 scores are predictive

Abstract Background/Aims In the United Kingdom (UK), to combat the coronavirus disease 2019 (COVID-19) pandemic, social distancing measures were implemented to varying degrees between March-2020 and December-2021. UK policy deemed patients with rheumatic disease (RD) at higher risk from COVID-19 and many were categorised as ‘clinically extremely vulnerable’ (CEV), these patients were required to follow more stringent social distancing measures. Social isolation and loneliness are implicated as predictors of mortality; the impact of these strict social distancing measures in patients with RD on mortality is unknown. In addition, Health related quality of life (HRQoL) measures provide useful insights into a patients physical and mental wellbeing. HRQoL is recognised as an important measure of health outcomes and there is limited evidence suggesting HRQoL measures such as the Health Assessment Questionnaire (HAQ) and the Short Form-36 questionnaire (SF-36) are associated with mortality in patients with rheumatoid arthritis. The predictive value of the SF-12 (a validated, shortened version of the SF-36) in RD patient’s mortality is unknown. In this UK-based, observational cohort study we evaluated the impact of stricter social distancing measures during the pandemic on 3-year mortality and assessed the utility of the SF-12 in predicting mortality in patients with RD. Methods We distributed a web-based survey via a linked mobile-phone SMS message, to all rheumatology patients, with a validated mobile number, under follow-up at the Royal Wolverhampton Trust, April-2020. We collected demographics, CEV status, and Short Form-12 mental (MCS) and physical health component scores (PCS) for health-related quality of life. Mortality was audited July-2023. Data were analysed using SPSS version 26 and R. Results There were 7,911 active follow up patients with linked mobile numbers. Survey responses were received from 1605 (20%); responders were female (69%), white (94%), CEV (47%), had a mean age of 61years, and most had autoimmune rheumatic disease (78%). Of the responders, 58 (4%) had died by July-2023 - compared to the alive group these patients had significantly worse MCS (p &amp;lt; 0.001) and PCS (p = 0.004) at baseline; significantly more in those that had died were CEV (p &amp;lt; 0.001), and older (p &amp;lt; 0.001), while gender, ethnicity, and diagnosis did not differ. Conclusion These data demonstrate in a large cohort of patients with RD over a 3-year period those patients considered CEV, advised to follow more stringent social isolation measures were at significantly greater risk of death. Further, baseline SF-12 scores for both mental and physical components were lower in patients that died over a 3-year period. These data potentially highlight the utility of the SF-12 and assessing social isolation and loneliness in patients with RD to predict mortality. In addition, our methods demonstrate the merits of communicating with patients through SMS-messaging and can be used in delivering important health-care communications in future. Disclosure N. Cox: None. J. Bateman: None.

“Quality of Life in Epidermolysis Bullosa” and “Epidermolysis Bullosa Burden of Disease”: Italian translation, cultural adaptation, and pilot testing of two disease-specific questionnaires

BackgroundInherited epidermolysis bullosa (EB) is a clinically and genetically heterogeneous group of skin fragility disorders characterized by blister formation following minor trauma. Four major types are distinguished based on the level of cleavage within the skin. Most EB forms present severely disabling cutaneous and systemic signs and symptoms. Management relies on daily time-consuming and distressing topical medications, and symptomatic treatment of systemic findings. Disease manifestations, symptoms, and daily care strongly affect patient and caregiver quality of life (QoL). To date, there are two validated EB-specific questionnaires, the “Quality of Life in Epidermolysis Bullosa” (QOLEB) and the “Epidermolysis Bullosa Burden of Disease” (EB-BoD) for the evaluation of patient and family disease burden, respectively. The aim of our study was to develop an Italian translation of the two questionnaires and to pilot-test them.MethodsThe guidelines for translation and cross-cultural adaptation of health-related QoL measures were followed. Initially, two separate translations were generated for each questionnaire, and subsequently reconciled by an expert committee. This was followed by a back-translation process. The original texts and all translations underwent revision by the expert committee, resulting in definitive versions. The final versions were then tested in a pilot study involving cognitive debriefing in a group of 17 families, representative of all EB major types.ResultsThe translation and reconciliation process led to minor changes to obtain semantic/idiomatic/cultural equivalence of the Italian versions with the original ones and to reconcile the questions with the answer options. The cognitive debriefing process showed a good understanding and did not require text modifications.ConclusionsThe Italian versions of the QOLEB and EB-BoD provide valuable tools in everyday clinical practice of reference centers, and they allow the participation in multicenter international real-life observational studies as well as in controlled clinical trials. They enable the identification of disease-specific psychological and socioeconomic challenges for EB patients and their families, guiding targeted interventions to ensure appropriate and timely care.

Improvement of immune dysregulation in individuals with long COVID at 24-months following SARS-CoV-2 infection

This study investigates the humoral and cellular immune responses and health-related quality of life measures in individuals with mild to moderate long COVID (LC) compared to age and gender matched recovered COVID-19 controls (MC) over 24 months. LC participants show elevated nucleocapsid IgG levels at 3 months, and higher neutralizing capacity up to 8 months post-infection. Increased spike-specific and nucleocapsid-specific CD4+ T cells, PD-1, and TIM-3 expression on CD4+ and CD8+ T cells were observed at 3 and 8 months, but these differences do not persist at 24 months. Some LC participants had detectable IFN-γ and IFN-β, that was attributed to reinfection and antigen re-exposure. Single-cell RNA sequencing at the 24 month timepoint shows similar immune cell proportions and reconstitution of naïve T and B cell subsets in LC and MC. No significant differences in exhaustion scores or antigen-specific T cell clones are observed. These findings suggest resolution of immune activation in LC and return to comparable immune responses between LC and MC over time. Improvement in self-reported health-related quality of life at 24 months was also evident in the majority of LC (62%). PTX3, CRP levels and platelet count are associated with improvements in health-related quality of life.

Gait speed at the acute phase predicted health-related quality of life at 3 and 12 months after stroke: a prospective cohort study.

To investigate the association between acute-phase gait speed and health-related quality of life (HRQoL) at 3 and 12 months post-stroke. Prospective cohort study. 1,475 patients with first-ever ischaemic stroke. The patients were divided into 3 groups according to tertiles of gait speed, namely ≤0.8, 0.8-1.1, ≥1.1 m/s. Gait speed was assessed by the 10-m walking test within 2 weeks of hospitalization for acute stroke and before the rehabilitation programme. HRQoL measurements include the 3-level EuroQol five dimensions (EQ-5D-3L) index and EuroQoL visual analogue scale (EQ-VAS) scores. Linear and logistic regression analyses were used to identify associations between gait speed and HRQoL. Adjusted for all covariates, the highest gait speed tertile group were associated with higher EQ-5D-3L index (B = 0.0303 and B = 0.0228, respectively, p < 0.001), and higher EQ-VAS (B = 3.3038 and B = 3.8877, respectively, p < 0.001), and lower odds of having problems with mobility (OR = 2.55 [95% CI: 0.141-0.458] and 0.485 [0.289-0.812], respectively, p < 0.01), self-care (OR = 0.328 [95% CI: 0.167-0.646] and 0.412 [0.217-0.784], respectively, p < 0.01), and usual activities (OR = 0.353 [95% CI: 0.211-0.590] and 0.325 [0.198-0.536], respectively, p < 0.0001) at 3 and 12 months, and pain/discomfort at 12 months (OR = 0.558 [95% CI:0.335-0.930], p < 0.05). Acute-phase gait speed was predictive of post-stroke HRQoL at 3 and 12 months, especially when associated with domain-specific EQ-5D-3L.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

A psychometric investigation of health-related quality of life measures for paediatric neurodevelopment assessment: Reliability and concurrent validity of the PEDS-QL, CHU-9D, and the EQ-5D-Y.

There is a need for tools that can provide a brief assessment of functioning for children with neurodevelopmental conditions, including health-related quality of life (HR-QoL). This study evaluated the psychometric properties of three commonly used and well known HR-QoL measures in a cohort of children presenting to clinical developmental assessment services. The most common diagnoses received in these assessment services were autism spectrum disorders. Findings showed good internal consistency for the PedsQL and the CHU-9D, but not the EQ-5D-Y. This research also found that the CHU-9D, EQ-5D-Y, and PedsQL correlated with relevant functioning domains assessed by the VABS-III. Overall, the measures showed that children with neurodevelopmental conditions experienced poor HR-QoL. The majority of children (>86%) met cut-off criteria for significant health concerns on the PedsQL. On the EQ-5D-Y and CHU-9D, they showed reduced HR-QoL particularly on domains relating to school and homework, being able to join in activities, looking after self, and doing usual activities. This study supports the use of the CHU-9D and PedsQL in this population to assess and potentially track HR-QoL in a broad neurodevelopment paediatric population.

Exploratory and confirmatory factor analysis of emPHasis-10: The health-related quality-of-life measure in pulmonary hypertension.

The emPHasis-10 is a health-related quality of life (HRQoL) unidimensional measure developed specifically for adults with pulmonary hypertension. The tool has excellent psychometric properties and is well used in research and clinical settings. Its factor structure has not been examined, which may help to identity a complimentary approach to using the measure to examine patient functioning. We performed an exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) on a data set collected from 263 adults with PH recruited from a community setting. The EFA suggested the emPHasis-10 consists of three underlying latent variables, which based on the loading of items, were termed "fatigue" (Items 3, 4, and 5), "independence" (Items 7, 8, 9, and 10), and "breathlessness" (Items 1, 2, and 6). All factors were found to have good internal consistency. "Independence" accounted for most of the variance (29%), followed by "breathlessness" (22%) and "fatigue" (19%). The CFA looked to confirm the fit of a three-factor model. A higher-order model was found to be the best fit consisting of HRQoL as a superordinate factor, for which the association between this factor and the 10 items was mediated through the three latent factors. Further analyses were performed testing the validity of the latent variables revealing all were significantly correlated with self-reported measures of depression, anxiety, health-anxiety, and dyspnea. Our analyses support the emPHasis-10 as a measure of HRQoL, while also proposing the clinical utility of examining the three emergent factors, which could be used to glean additional insight into the respondent's functioning and inform care.

Defining Trajectories of Linguistic, Cognitive-Communicative, and Quality of Life Outcomes in Aphasia: Longitudinal Observational Study Protocol

ObjectiveTo describe the trajectories of linguistic, cognitive-communicative, and health-related quality of life (HRQOL) outcomes after stroke in persons with aphasia. DesignLongitudinal observational study from inpatient rehabilitation to 18 months after stroke. SettingFour US mid-west inpatient rehabilitation facilities (IRFs). ParticipantsWe plan to recruit 400 adult (older than 21 years) English speakers who meet the following inclusion criteria: (1) Diagnosis of aphasia after a left-hemisphere infarct confirmed by CT scan or magnetic resonance imaging (MRI); (2) first admission for inpatient rehabilitation due to a neurologic event; and (3) sufficient cognitive capacity to provide informed consent and participate in testing. Exclusion criteria include any neurologic condition other than stroke that could affect language, cognition or speech, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, or the presence of right-hemisphere lesions. InterventionsNot applicable. Main Outcome MeasuresSubjects are administered a test battery of linguistic, cognitive-communicative, and HRQOL measures. Linguistic measures include the Western Aphasia Battery-Revised and the Apraxia of Speech Rating Scale. Cognitive-communicative measures include the Communication Participation Item Bank, Connor's Continuous Performance Test-3, the Communication Confidence Rating Scale for Aphasia, the Communication Effectiveness Index, the Neurological Quality of Life measurement system (Neuro-QoL) Communication short form, and the Neuro-QoL Cognitive Function short form. HRQOL measures include the 39-item Stroke & Aphasia Quality of Life Scale, Neuro-QoL Fatigue, Sleep Disturbance, Depression, Ability to Participate in Social Roles & Activities, and Satisfaction with Social Roles & Activities tests, and the Patient-Reported Outcome Measurement and Information System 10-item Global Health short form. The test battery is administered initially during inpatient rehabilitation, and at 3-, 6-, 12-, and 18-months post-IRF discharge. Biomarker samples are collected via saliva samples at admission and a subgroup of participants also undergo resting state fMRI scans. ResultsNot applicable. ConclusionsThis longitudinal observational study will develop trajectory models for recovery of clinically relevant linguistic, cognitive-communicative, and quality of life outcomes over 18 months after inpatient rehabilitation. Models will identify individual differences in the patterns of recovery based on variations in personal, genetic, imaging, and therapy characteristics. The resulting models will provide an unparalleled representation of recovery from aphasia resulting from stroke. This improved understanding of recovery will enable clinicians to better tailor and plan rehabilitation therapies to individual patient's needs.

Construct validity of EQ-5D-5L among patients with inflammatory bowel disease—a study based on real-world data from the Swedish Inflammatory Bowel Disease Registry

ObjectivesThe Swedish Inflammatory Bowel Disease Registry (SWIBREG) includes approximately 84% of all patients with inflammatory bowel disease (IBD) treated with immunomodulators, biologics or surgery in Sweden. Data on health-related quality of life (HRQoL) have been collected using EQ-5D-5L in the registry since 2012. Nevertheless, there are few studies assessing the validity of EQ-5D-5L in this patient population. Thus, the aim of this study was to assess the construct validity of EQ-5D-5L amongst patients with IBD (ulcerative colitis and Crohn’s disease).MethodsIndividual-level data on EQ-5D-5L and other disease-specific measures were extracted from SWIBREG. Known-groups validity was assessed by analysing whether the EQ-5D-5L captured expected differences between patient groups with different activity levels of the disease. Convergent validity was assessed by analysing whether the reported problems in the dimensions of EQ-5D-5L, EQ VAS, and the EQ-5D-5L index value correlated, as hypothesized, with the four dimensions in the Short Health Scale, a symptom index question, and the Physician Global Assessment (PGA) score.ResultsIn total, 9769 patients with IBD were included in the study. Patients with active IBD reported more health problems in the EQ-5D-5L descriptive system than patients being in remission. The effect sizes for the differences in reported problems between patients with active and inactive disease were at least small (≥0.1) or medium (≥0.3) in all dimensions except self-care. Differences in the mean EQ-5D-5L index and EQ-VAS score between patients with active and inactive disease were statistically significant (p < 0.001) and larger than pre-defined cut-offs for minimally important differences (>0.08 for the index and >11.0 for EQ-VAS). The analysis of convergent validity showed that EQ-5D-5L results correlated as expected with the disease-specific measures in 16 of the 21 analyses. In total, 22 (79%) of the 28 hypotheses were supported.ConclusionThe findings support the construct validity of EQ-5D-5L amongst patients with IBD and contribute to the scarce literature on the validity of the five-level version of EQ-5D in this patient population. These findings have important implications for the choice of HRQoL measure in routine health care registries like SWIBREG as well as for future clinical or health economic studies considering using EQ-5D-5L as a measure of HRQoL.

Relative importance of selected predictors of health-related quality-of-life (HRQOL) among U.S. adults.

Many factors have been associated with health-related quality of life (HRQOL), and researchers often have tried to rank these contributing factors. Variable importance quantifies the net independentcontribution of each individual predictor in a set of predictors to the prediction accuracy of the outcome. This study assessed relative importance (RI) of selected contributing factors to respondents' physically unhealthy days (PUD), mentally unhealthy days (MUD), activity limitation days (ALD), and EuroQol EQ-5D index derived from the Healthy Days measures (dEQ-5D). Using data from the 2021 Behavioral Risk Factor Surveillance Systems (BRFSS), we estimated the RI of seven socio-demographics and seventeen chronic conditions and risk behaviors. Avariable's importance was measured asthe average increase in the coefficient of determination after adding the variable to all possible sub-models. After controlling for socio-demographics, arthritis and no physical activity were the most important variables for PUD with a RI of 10.5 and 10.4, respectively, followed by depression (RI = 8.5) and COPD (RI = 8.3). Depression was the most important variable for MUD with RI = 23.0 while all other 16 predictors had a RI < 7.0. Similar results were observed for ALD and dEQ-5D: depression was the most important predictor (RI = 16.3 and 15.2, respectively), followed by no physical activity, arthritis, and COPD (RI ranging from 7.1 to 9.2). This study quantified and ranked selected contributing factors of HRQOL. Results of this analysis also can be used to validate HRQOL measures based on domain knowledge of HRQOL.

Assessing the diversity and determinants of health-related quality of life measures in patients with acute heart failure.

Heart failure with reduced ejection fraction (HFrEF) significantly impacts health-related quality of life (HR-QoL). Existing HR-QoL questionnaires can show inconsistencies, potentially misrepresenting patient self-reports. This study examines the variation in HR-QoL measurement tools for HFrEF patients, identifying related determinants. We retrospectively analysed 134 hospitalized patients with acute decompensated HFrEF at a Taiwanese tertiary centre's Heart Failure Post-Acute-Care (HF-PAC) programme. Participants completed the EuroQol-5 dimension (EQ-5D) questionnaire, the EQ-5D visual analogue scale (VAS), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Utility values were obtained from the EQ-5D questionnaire. Demographic features were depicted using descriptive statistics, while multivariate regression was used to ascertain relationships between HR-QoL measurements and determinants. Average scores for EQ-5D, MLHFQ, EQ-5D utility, and VAS were 6.1±1.6, 21.8±21.3, 81.7±27.0, and 59.5±14.6, respectively. Significant correlations were observed among the three tools. The New York Heart Association functional class showed a notable association with all tool scores. Other associations encompassed EQ-5D with coronary artery disease, mineralocorticoid receptor antagonists, and the 6min walk test; EQ-5D VAS with chronic kidney disease; and MLHFQ with age. This study illuminates the variance in HR-QoL measurement tools for Taiwanese HFrEF patients. Using a range of these tools is beneficial in unveiling diverse determinants and approaching comprehensive patient-centred care. However, for a more precise HR-QoL assessment in Taiwanese HFrEF patients, recalibrating the EQ-5D-derived utility scores might be necessary, emphasizing the importance of patient-specific considerations within the HF-PAC programme.

Examining Associations Between Baseline Health-Related Quality of Life and Depression and Physical Functioning Improvement Following Pulmonary Rehabilitation.

This study examined whether health-related quality of life (HRQL) and depression assessed prior to pulmonary rehabilitation (PR) participation (ie, at baseline) predicted change in 6-min walk distance (6MWD) from baseline to end of PR. Patients with pulmonary disease were consecutively referred/enrolled in a PR program from 2009-2022 (N = 503). Baseline 6MWD was assessed along with self-report measures of HRQL (St George's Respiratory Questionnaire [SGRQ]) and depression (Geriatric Depression Scale [GDS]). The SGRQ total score was used to assess overall HRQL, and SGRQ subscales assessed pulmonary symptoms, activity limitations, and psychosocial impacts of pulmonary disease. Multiple linear regression was used to examine whether baseline SGRQ scores and depression predicted Δ6MWD. Baseline SGRQ total score ( F(1,389) = 8.4, P = .004) and activity limitations ( F(1,388) = 4.8, P = .03) predicted Δ6MWD. Patients with an SGRQ activity limitation score ≤ 25th percentile showed the most 6MWD improvement (mean = 79.7 m, SE = 6.7), and significantly more improvement than participants scoring between the 50-75th percentiles (mean = 54.4 m, SE = 6.0) or >75th percentile (mean = 48.7 m, SE = 7.5). Patients scoring between the 25-50th percentiles (mean = 70.2 m, SE = 6.1) did not differ significantly from other groups. The SGRQ symptoms and impacts subscales were unrelated to Δ6MWD ( F(1,388) = 1.2-1.9, P > .05), as was depression ( F(1,311) = 0.0, P >.85). Patients with greater HRQL at baseline may experience greater physical functioning improvement following PR. Additional support for patients with lower HRQL (eg, adjunctive self-management interventions) may enhance PR outcomes, particularly for patients who report greater activity limitations. Alternatively, early referral to PR (ie, when less symptomatic) may also benefit physical function outcomes.