Generic Health-related Quality Of Life Research Articles

QOL-14. HEALTH-RELATED QUALITY OF LIFE AND COGNITIVE FUNCTIONING IN SURVIVORS OF OLIGODENDROGLIOMA: AN INTERNATIONAL CROSS-SECTIONAL INVESTIGATION

Abstract BACKGROUND Patients with oligodendroglioma have a relatively favourable prognosis. Treatment modalities used vary, and the long-term impacts of the tumour itself and its treatment on health-related quality of life (HRQOL) and cognition remain largely unclear. We investigated associations between treatment and functioning of oligodendroglioma patients. METHODS In this international cross-sectional observational study, patients with oligodendroglioma (IDH-mutant and 1p/19q-codeleted) diagnosed ≥5 years ago, were recruited through the European Organisation for Research and Treatment of Cancer (EORTC) networks. Diagnosis and treatment data were collected from medical records; patients completed outcomes for HRQOL (EORTC QLQ-C30; BN20), self-reported cognitive functioning (MOS Cognitive Complaints Scale) and cognitive tests (HVLT-R, TMT, COWAT). Associations between HRQOL and cognition outcomes, and clinical variables (time since diagnosis; progression; tumour location; treatments delivered; current medication; Karnofsky Performance Status (KPS)) were explored with regression analyses. RESULTS 242 oligodendroglioma patients on average 9.9 years post-diagnosis (sd=4.3, range=5.0-26.3) took part from 33 sites across 9 countries. Patients were M=52 years old (sd=12, range=23-78), the majority were men (N=145; 60%). Higher KPS, no radiotherapy (ever), no current medication (anxiolytics/sedatives; antidepressants; dexamethasone) were associated with better generic HRQOL outcomes (QLQ-C30 functioning scale models; R2 range 0.068-0.371, all p<.001). Higher KPS, fewer recurrences, no radiotherapy treatment (ever), and no current antidepressant use were linked to better disease-specific HRQOL (BN20 multi-item scale models; R2 range 0.067-0.246, p<0.001). Fewer subjective cognitive complaints were associated with higher KPS and no current antipsychotic medication (R2=0.153, p<0.001). Better KPS, right hemispheric tumours, longer time since diagnosis, no chemotherapy (ever), no radiotherapy (ever), and no current medications (dexamethasone; antipsychotics) were predictive of better cognitive functioning (R2 range 0.056-0.248, p<0.001). CONCLUSION In oligodendroglioma survivors, better HRQOL and cognitive outcomes appeared consistently linked with higher KPS, no current medication use, and never having received radiotherapy. Additionally, better cognitive outcomes were associated with no chemotherapy treatment.

Sex-related differences in health-related quality-of-life measured using the EuroQol 5-Dimension questionnaire across the LVEF spectrum in DAPA-HF and DELIVER

Abstract Background Although sex-related differences in response to disease-specific health-related quality-of-life (HRQL) instruments such as the KCCQ have been investigated in patients with heart failure (HF), this is not the case for generic HRQL instruments. Purpose To assess the sex-specific differences in health status measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) in patients with HF with reduced and mildly reduced or preserved ejection fraction (HFrEF and HFmrEF/HFpEF), and to assess the effect of dapagliflozin on EQ-5D-5L index scores. Methods Using patient-level data from the DAPA-HF and DELIVER trials comparing dapagliflozin to placebo, we analysed patient-reported outcomes for each dimension of the EQ-5D index scores between men and women. The 5 dimensions of the descriptive section of the EQ-5D-5L include mobility ("walking around"), self-care ("washing or dressing self"), usual activities ("e.g., work, study, housework, family or leisure activities"), pain/discomfort ("pain or discomfort"), and anxiety/depression ("anxious or depressed"). Each dimension is divided into 5 levels (1-5) i.e., no problem, slight problem, moderate problem, severe problem, and extreme problem (cannot do activity/extreme symptom). Results Of 4744 patients with HFrEF, 4390 completed the EQ-5D-5L index scores (3408 men and 982 women, 77.6% vs. 22.4%). The correresponding numbes in 6263 patients with HFmrEF/HFpEF were 5745 overall and 3320 men vs. 2425 women (57.8% vs. 42.2%). Regardless of HF phenotype, women had significantly worse (lower) baseline index scores overall compared to men (0.849 vs. 0.899 in HFrEF and 0.844 vs. 0.884 in HFmrEF/HFpEF, both p<0.001). Although scores varied markedly by question, women generally had worse health status in all the dimensions as compared with men in patients with HFrEF (39% vs. 29% reporting a moderate or greater problem for mobility, 17% vs. 9% for self-care, 36% vs. 25% for usual activities, 29% vs. 19% for pain/discomfort, and 21% vs. 13% for anxiety/depression, all p<0.001) (Figure, top panel). A broadly similar pattern was observed in HFmrEF/HFpEF (Figure, bottom panel). In all patients, across the range of LVEF, there dapagliflozin led to a significant placebo corrected increase (improvement) in index score (0.008, 95% CI 0.002 to 0.014), with no interaction between sex and the effect of dapagliflozin (p for interaction with sex = 0.50). Conclusions Women reported significantly poorer health status in both HFrEF and HFmrEF/HFpEF compared to men. Dapagliflozin treatment improved EQ-5D index scores irrespective of sex across the range of ejection fraction. Figure Sex differences in the distribution of responses to EQ-5D-5L questionnaire. EQ-5D-5L, EuroQol 5-Dimension 5-Level questionnaire; HFmrEF, heart failure with mildly reduced ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction.

Deriving the PedsUtil health state classification system to measure health utilities for pediatric populations based on the PedsQL: a confirmatory factor analysis.

An important methodological challenge in conducting pediatric economic evaluations is estimating the preference-based health-related quality of life (HRQoL) of children. Current methods are highly variable and there is no single instrument available to value HRQoL consistently across multiple pediatric age groups. The Pediatric Quality of Life Inventory (PedsQL) is a non-preference-based generic HRQoL instrument validated for children 2-18 years, but it cannot be directly used in economic evaluations. The aim of this study was to establish the core dimension structure of the PedsUtil health state classification system using confirmatory factor analysis, which is the first step of deriving a preference-based measure of HRQoL based on the PedsQL. Four competing dimension structures of the PedsUtil health state classification system were developed based on published literature and expert opinion. Using data from the Longitudinal Study of Australian Children (LSAC) (n = 45,207), the 4 dimension structures were evaluated using the robust weighted least squares estimation method. The analyses were stratified by 2-year age intervals (from 2 to 17 years) to reflect the study design of the LSAC, as well as special healthcare needs status of the child. Model fit was evaluated by examining standardized factor loadings and various fit indices including the comparative fit index (CFI), Tucker-Lewis Index (TLI), and the root mean square error of approximation (RMSEA). Modification indices and residual correlations were examined to re-specify the models to improve model fit when necessary. The findings supported a 7-dimension structure (i.e., Physical Functioning, Pain, Fatigue, Emotional Functioning, Social Functioning, School Functioning, and School Absence) of the PedsUtil health state classification system. The 7-dimension model exhibited adequate fit across subgroups with CFI values that ranged from 0.929 to 0.954, TLI values from 0.916 to 0.946, and RMSEA values from 0.058 to 0.102. This study established the core dimension structure of the PedsUtil health state classification system using confirmatory factor analysis. The 7-dimension structure was found to be applicable across diverse pediatric populations. Research is currently ongoing to select the most representative item within each dimension of the PedsUtil health state classification system and valuation surveys will be fielded to estimate the PedsUtil scoring system.

Impact of comorbidity on health-related quality of life in newly diagnosed patients with lymphoma or multiple myeloma: results from the PROFILES-registry.

With the increasing prevalence of comorbidity in an ageing population, it is crucial to better understand the impact of comorbidity on health-related quality of life (HRQoL) after lymphoma or multiple myeloma (MM) diagnosis. We included 261 newly diagnosed patients (67% response rate) diagnosed with lymphoma or MM between October 2020 and March 2023 in a longitudinal survey. The European Organisation for Research and Treatment of Cancer (EORTC) questionnaires were used to measure generic and disease-specific HRQoL. Evidence-based guidelines for interpretation of the EORTC questionnaires were used to identify clinical importance. Patients were classified as having 'no comorbidity', 'mild comorbidity' (e.g. arthrosis or rheumatism), or 'moderate-severe comorbidity' (e.g. heart or lung disease), using the adapted self-administered comorbidity questionnaire. At diagnosis, the mean age was 64 years, 63% were male and 38% reported no comorbidity, 33% mild comorbidity, and 29% moderate-severe comorbidity. Patients with mild or moderate-severe comorbidity reported clinically relevant worse HRQoL at diagnosis than patients without comorbidity. One year post-diagnosis most outcomes showed clinically relevant improvement, irrespective of comorbidity. However, outcomes of physical functioning (β=-7.9, p < 0.05), global health status (β=-7.6, p < 0.05), bone pain (β = 8.1 to 9.1, p < 0.05), muscle/joint pain (β = 14.5 to 18.8, p < 0.01) and muscle weakness (β = 10.4 to 15.6, p < 0.05) improved less among those with comorbidity, and clinically relevant differences between comorbidity groups persisted over time. With clinically relevant worse HRQoL at diagnosis and less recovery of HRQoL during the first year after diagnosis in patients with comorbidity, consideration of both prognosis and HRQoL is important when making treatment decisions.

Efficacy of the mHealth-Based Exercise Intervention re.flex for Patients With Knee Osteoarthritis: Pilot Randomized Controlled Trial.

Exercise therapy is recommended by international guidelines as a core treatment for patients with knee osteoarthritis. However, there is a significant gap between recommendations and practice in health care. Digital exercise apps are promising to help solve this undersupply. This study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health-related outcomes, performance measures, and adherence in patients with knee osteoarthritis. This closed user group trial included participants with moderate to severe unicondylar painful knee osteoarthritis. Randomization was 1:1:2 into an intervention group (IG) with 2 subgroups (app-based training [IG A] and app-based training and a supportive knee brace [IG AB]) and a control group (CG). The intervention included a 12-week home exercise program with 3 sessions per week. Instructions for the exercises were given via the app and monitored using 2 accelerometers placed below and above the affected knee joint. Participants in the CG did not receive any study intervention but were allowed to make use of usual care. Osteoarthritis-specific pain (Knee Injury and Osteoarthritis Outcome Score) was defined as the primary outcome, and secondary outcomes included all other Knee Injury and Osteoarthritis Outcome Score subscales, general health-related quality of life (Veterans RAND 12-item Health Survey), psychological measures (eg, exercise self-efficacy), performance measures (strength and postural control), and the monitoring of adherence and safety. Outcomes were assessed at baseline and after 12 weeks. Intervention effects were calculated using baseline-adjusted analysis of covariance for the joint comparison of IG A and IG AB versus the CG using a per-protocol approach. Subgroup analyses were conducted for each IG separately. A total of 61 participants were included (IG: n=30, 49%; CG: n=31, 51%; male: n=31, 51%; female: n=30, 49%; mean age 62.9, SD 8.5 years; mean BMI 27.7, SD 4.5 kg/m2). Analysis revealed statistically significant effects in favor of the IG for pain reduction (P<.001; effect size [ES]=0.76), improvements in physical function (P<.001; ES=0.64), improvements in symptoms (P=.01; ES=0.53), improvements in sport and recreation activities (P=.02; ES=0.47), improvements in knee-related quality of life (P<.001; ES=0.76), and improvements in the physical component of general health-related quality of life (P<.001; ES=0.74). Mean differences ranged from 6.0 to 13.2 points (scale range 0-100). ESs indicated small to medium effects. No effects were found for psychological and performance measures. Participants adhered to 92.5% (899/972) of all scheduled exercise sessions. Individuals with knee osteoarthritis undergoing a 12-week sensor-assisted app-based exercise intervention with or without an additional knee brace experienced clinically meaningful treatment effects regarding pain relief and improvements in physical function as well as other osteoarthritis-specific concerns compared to controls. German Clinical Trials Register (DRKS) DRKS00023269; https://drks.de/search/de/trial/DRKS00023269.

Efficacy of arch contouring foot orthoses for midfoot osteoarthritis: Protocol for a randomised controlled trial.

Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12weeks; the primary endpoint for assessing efficacy being 12weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events. This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Short-term impact of cardiovascular screening by traditional risk assessment or coronary artery calcium score on health-related quality of life: the ROBINSCA trial.

Evidence on the impact of screening for cardiovascular diseases (CVDs) on health-related quality of life (HRQoL) is important for policy decisions about screening implementation and to uncover teachable moments to motivate healthy lifestyle choices. It is unknown whether screening by cardiac computed tomography (CT) scan has a stronger impact on HRQoL than screening by traditional risk prediction models. The study aims to investigate differences in HRQoL across the screening process between participants who were randomized to CVD risk estimation by coronary artery calcium score or Systematic COronary Risk Evaluation. A subset of 2687 ROBINSCA participants filled in questionnaires at (T0) randomization, (T1) invitation, (T2) 1-3 days before screening, (T3) 1-3 days after, and (T4) screening result. Generic HRQoL (SF-12; EQ-5D) and anxiety (STAI-6) were measured. We investigated the differences in changes in HRQoL across the screening process with linear mixed models. We found comparable levels of HRQoL at all screening moments for the two intervention groups. Mental health scores were worse at invitation and randomization than at the later time points, irrespective of screening group (all P < 0.001). A result indicating a heightened CVD risk was associated with increased anxiety in the CT screening group. Computed tomography screening for CVD risk has no detrimental impact on HRQoL and anxiety levels compared to screening by traditional risk assessment. Receiving an invitation to screenning or a result implying increased CVD risk could function as teachable moments for high-risk individuals. ROBINSCA trial registration number: NTR6471 in Dutch Trial Register (NTR).

The Role and Importance of Quality of Life among Preschool Children as a Prerequisite for a Positively Oriented Upbringing

The aim of this study was to evaluate the health-related quality of life (QoL) in a sample of healthy preschool children in the Republic of Croatia and comment on whether and how the research results open the preconditions for positive individual scenarios of the future related to positively oriented upbringing. The Pediatric quality of life inventory generic core scales (PedsQLTM) was completed by 230 healthy preschool children (5-6 years old) and their parents as a proxy-report. The data was descriptively analysed first. Reliability was assessed by Cronbach’s alpha. The statistically significant difference between the PedsQLTM scales (physical, emotional, social, kindergarten and psychosocial functioning) for preschool children and their parent’s proxy-report were analysed. The PedsQLTM scale score means for children’s self-report ranged 71.32-76.49, with the total score was 74.53. Score means for their parent’s proxy-report scale ranged 73.59-85.46, with the total score of 80.93. All the self-report and proxy-report scales showed satisfactory reliability with Cronbach’s alpha varying between 0.64 and 0.89. Statistically significant difference between scales in self-report and proxy-report was for physical (t=-7.12, p&lt;0.01), social (t=-6.42, p&lt;0.01) and school functioning (t=-2.62, p&lt;0.01) as well as psychosocial (t=-4.82, p&lt;0.01) and total health (t=-6.85, p&lt;0.01). The Croatian PedsQLTM is valid and reliable generic pediatric health-related QoL measurement that can be recommended for children’s self-reports and their parent’s proxy-reports. The results of the research open a precondition for positive individual scenarios of the future related to positively oriented upbringing.

Health-related quality of life in vibrant soundbridge patients: generic and specific measures, short-term and long-term outcomes.

The goal of the study was to determine the short- and long-term outcome of health-related quality of life (HRQoL) in adults implanted with a Vibrant Soundbridge (VSB). Twenty-one adults (8 females, 13 males; mean age at implantation: 57 ±10 years) who received a unilateral VSB for combined or conductive hearing loss, were administered two questionnaires: the Nijmegen Cochlear Implant Questionnaire (NCIQ) as a measure of hearing-specific HRQoL, and the Health Utility Index 3 (HUI 3) as a measure of generic HRQoL. The questionnaires were administered before implantation and three, six, 12 and 24 months after processor activation. The NCIQ total score raised significantly from 62 points before implantation to 76 points at three months after processor activation (p < 0.005). Thereafter, no significant increases occurred anymore. The HUI 3 multi-attribute score (MAUS) increased from 0.59 before implantation to 0.70 at three months and at six months after processor activation and then declined slightly to 0.68 at 24 months after processor activation. Similar values were observed with the HUI 3 single-attribute score (SAUS) of Hearing. The increases of the HUI 3 scores were not statistically significant, but all pre-post-implantation differences were clinically relevant. VSB recipients experienced a quick improvement of their HRQoL. After just three months of device use, a significant improvement of hearing-specific HRQoL and a clinically relevant improvement of generic HRQoL were seen. After three months, no essential changes of HRQoL occurred in our sample, suggesting that the achieved level of HRQoL may remain stable in the long term.

Confirmatory analysis of the 13-MD and ranking of its meta-dimensions and items.

The 13-MD is a new generic instrument developed to measure general health-related quality of life (GHRQoL). This instrument considers all aspects of health (i.e., physical, mental, and social) in a balanced way. A previous study led to minor changes in the original version of the 13-MD. The objective of this study was to confirm the validity of the modified 13-MD. Validity was assessed with recent data from the general population of Quebec, Canada. The meta-dimensions and items composing the 13-MD were also subjected to a ranking procedure, which allowed to determine the most important aspects for respondents. A total of 1337 French-speaking participants were recruited with 1099 completing the 13-MD for validation purposes and 1084 completing the ranking procedure. The 13-MD showed very satisfactory results and confirmed to be a valid instrument. The ranking of the meta-dimensions revealed that "Well-being" received the most points, followed by "Sleep and energy" and "Body functioning." These results will be very useful in the continuous improvement of the 13-MD, ultimately leading to the valuation stage (i.e., development of a value set).

A novel multisite model to facilitate hepatitis C virus elimination in people experiencing homelessness

Background/aims: Only a handful of countries are on target to achieve hepatitis C virus (HCV) elimination by 2030. People experiencing homelessness (PEH) remain an important HCV reservoir. The END C study evaluated clinical, patient reported and health economic outcomes of a decentralised integrated model. MethodsThis prospective study assessed a decentralised regional service based at multiple homeless sites in southeast England. Novel linkage-care strategies were utilised. We assessed generic and liver specific health-related quality of life (HRQoL) (SF-12v2; EQ-5D-5L and SFLDQol) pre/post HCV treatment and cost per HCV case detected and cured. Primary outcome was intention-to-treat (ITT) sustained virological response (SVR12). ResultsWe recruited 418 individuals, mean age 44.45 ± 10.6, 78% were male, 74% being currently homeless, current injecting drug use/alcohol use being 25% and 65% respectively. Prevalence of cirrhosis (liver stiffness measurement >12kPa) was 12%. Twenty-eight percent (n=116) were HCV PCR positive, of whom n=105 received direct acting antiviral treatment. ITT SVR12 rates were 81% (95% CI 72%-88%), the only predictor of SVR12 being >80% treatment adherence (OR 20.69, 95% CI 6.227-68.772, p<0.001). HRQoL improved significantly after SVR12: SF-12v2 (General Health, Mental Health, Social Functioning, Mental Health Composite Score p<0.049); SFLDQoL (Symptoms/Effects of Liver Disease, Distress, Loneliness p<0.004) and EQ-5D-5L (Index Score, Visual Analog Scale p<0.001). Costs (British pound 2022) per HCV case detected and per case cured were £359 and £257 respectively. Reinfection rates were 6.82/100 person years. ConclusionThe END C study endorses a multisite decentralised service for PEH enabling excellent linkage to care, high SVR12 rates and significant improvements in generic and liver specific HRQoL, all being achieved at modest costs. Such services are paramount to help achieve HCV elimination. Impact and implicationsIn people experiencing homeless, we found a high prevalence of HCV, alcohol and substance misuse including overdoses and mental health issues. Despite this, an integrated and decentralised service resulted in excellent linkage to care with high SVR12 rates. Even in this complex cohort with multiple comorbidities, SVR12 was associated with significant improvements in both generic and liver specific health-related quality of life. This was all achieved at modest costs in a community setting. Such models of care are feasible, easy to replicate and essential if we are to achieve HCV elimination.

The impact of preoperative 5-alpha reductase inhibitors on functional outcomes and health-related quality of life following radical prostatectomy – A propensity score matched longitudinal study

ObjectivesWhile the impact of treatment with 5-alpha Reductase Inhibitors (5-ARI) on the risk of cancer-related mortality in men with prostate cancer (PC) has been extensively studied, little is known about the impact of preoperative 5-ARI use on patient-reported outcomes (PROs) following radical prostatectomy (RP).MethodsWithin our prospectively maintained institutional database of 5899 patients treated with RP for PC (2008– 2021), 99 patients with preoperative 5-ARI therapy were identified. A 1:4 propensity-score matched analysis of 442 men (n = 90 5-ARI, n = 352 no 5-ARI) was conducted. Primary endpoint was continence recovery using daily pad usage and ICIQ-SF. Health-related quality of life (HRQOL) was assessed using the validated EORTC QLQ-C30 and PR25 questionnaires. Multivariable Cox-regression-models tested the effect of preoperative 5-ARI treatment on continence-recovery (p < 0.05).ResultsPatients were followed up perioperatively, followed by annual assessments up to 60mo postoperatively. Preoperative mean ICIQ-SF score (2.2 vs. 0.9) was significantly higher in the 5-ARI cohort (p = 0.006). 24mo postoperatively, 68.6% (no 5-ARI) vs. 55.7% (5-ARI) had full continence recovery (p = 0.002). Multivariable Cox regression analysis, revealed preoperative 5-ARI treatment as an independent predictor for impaired continence recovery (HR 0.50, 95% CI 0.27–0.94, p = 0.03) In line, general HRQOL was significantly higher for patients without 5-ARI only up to 24mo postoperatively (70.6 vs. 61.2, p = 0.045). There was no significant impact of preoperative 5-ARI treatment on erectile function, biochemical recurrence-free survival and metastasis-free survival.ConclusionsPre-RP 5-ARI treatment was associated with impaired continence outcomes starting 24mo postoperatively, suggesting that preoperative 5-ARI treatment can impair the long-term urinary function recovery following RP.

A comprehensive systematic review of health-related quality of life measures in short stature paediatric patients

This systematic review investigates Patient-reported Outcome Measures (PROMs) and Observed Reported Outcome Measures (ObsROMs) pertinent to assessing Health-Related Quality of Life (HRQoL) in short-stature paediatric patients, focusing on Achondroplasia (ACH), Growth Hormone Deficiency (GHD), Isolated Growth Hormone Deficiency (IGHD), and Small-for-Gestational-Age (SGA) diagnoses. Utilising rigorous selection criteria, 53 studies published from 1998 to 2023 were analysed, revealing a predominance of European-based research. Notably, the review elucidated the utilisation of disease-specific and generic HRQoL measures, showcasing the multifaceted nature of short-stature conditions and their impact across physical, emotional, and social domains. The Quality of Life in Short Stature Youth (QoLISSY), Paediatric Quality of Life Inventory (PedsQL), and KIDSCREEN emerged as frequently employed instruments, offering nuanced insights into HRQoL perceptions across diverse age demographics. Additionally, the review highlighted the adaptation of adult HRQoL measures for adolescent populations, signalling a need for age-appropriate assessment tools. Furthermore, integrating PROMs and ObsROMs in HRQoL assessment underscored a comprehensive approach, considering both subjective patient perspectives and observed outcomes. Future research directions encompass comprehensive search strategies, longitudinal studies with diverse populations, and the development of age-appropriate HRQoL assessment tools. In conclusion, this review emphasises the importance of comprehensive HRQoL assessment to address the diverse needs of short-stature paediatric patients effectively.

Selecting PedsQL items to derive the PedsUtil health state classification system to measure health utilities in children

BackgroundThere is a lack of preference-based health-related quality of life (HRQoL) measures that consistently value health across a full range of child age groups. The PedsQL is a generic HRQoL instrument validated for children 2–18 years, but it is not preference-based. The objective of this study was to derive the PedsUtil health state classification system from the PedsQL as a basis for a preference-based HRQoL measure for children.MethodsA two-step process was used to select PedsQL items to include in the health state classification system: 1) exclude poorly functioning items according to Rasch analysis in each of the previously established seven dimensions of the PedsUtil health state classification system and 2) select a single item to represent each dimension based on Rasch and psychometric analyses, as well as input from child health experts and parents. All secondary analyses were conducted using data from the Longitudinal Study of Australian Children (LSAC). Analyses were stratified by age group (i.e., 2–5 years, 6–13 years, and 14–17 years) to represent the different developmental stages of children and to reflect the study design of the LSAC. Rasch analyses were also performed on five random subsamples for each age group to enhance robustness of results.ResultsTwelve items were excluded from the PedsUtil health state classification system after the first step of the item selection process. An additional four items were excluded in the second step, resulting in seven items that were selected to represent the seven dimensions of the PedsUtil health state classification system: Physical Functioning (“participating in sports activity or exercise”), Pain (“having hurts or aches”), Fatigue (“low energy level”), Emotional Functioning (“worrying about what will happen to them”), Social Functioning (“other kids not wanting to be their friend”), School Functioning (“keeping up with schoolwork”), and School Absence (“missing school because of not feeling well”).ConclusionsThe PedsUtil health state classification system was derived from the PedsQL based on several criteria and was constructed to be applicable to children two years and older. Research is ongoing to elicit preferences for the PedsUtil health state classification system to construct the PedsUtil scoring system.

Is There a Relationship of Cortisol and Sex Steroid Hormones With Mental Health in Middle-Aged Adults? The FIT-AGEING Study

ObjectiveMental health has emerged as a worldwide concern given the increasing incidence of anxiety and depression disorders in the last years. Cortisol and sex steroid hormones have been demonstrated to be important regulators of mental health processes in older adults. However, the evidence considering these integrated variables in apparently healthy middle-aged individuals has not been thoroughly addressed. The present study aimed to investigate the association of the plasma cortisol, testosterone, free testosterone, sex hormone–binding globulin (SHBG), and dehydroepiandrosterone sulfate (DHEAS) levels with mental health in middle-aged adults. MethodsThis cross-sectional study included a cohort of 73 middle-aged adults aged 45 to 65 years (women, 53%). Plasma cortisol, testosterone, SHBG, and DHEAS were assessed using a competitive chemiluminescence immunoassay. Free testosterone was calculated from the total testosterone and SHBG. Self-reported depression severity, generic health-related quality of life, hope, satisfaction with life, and optimism-pessimism were evaluated using the Beck Depression Inventory-II (BDI-II), 36-Item Short-Form Health Survey, Adult Hope Scale, Satisfaction with Life Scale, and Life Orientation Test-Revised, respectively—with higher total scores of these scales indicating greater levels of these variables. ResultsThe testosterone and free testosterone levels were inversely associated with the BDI-II values in men (all P ≤ .042). The cortisol levels were positively related with the Satisfaction with Life Scale scores, whereas the testosterone, free testosterone, SHBG, and DHEAS levels were negatively correlated with the BDI-II values in women (all P ≤ .045). ConclusionIn summary, these results suggest that the increased levels of steroid hormones—within the normal values—are associated with better mental health in middle-aged adults.

General and Specific Quality of Life Course of Individuals with Different Levels of Stroke Severity: A One-Year Prospective Longitudinal Study

ABSTRACT Objectives To compare the course of generic and specific health-related quality of life (HRQOL) of individuals with stroke, and its physical, mental, and social domains, at three, six, and 12 months after hospital discharge, considering the levels of stroke severity. Methods This is a longitudinal study, in stroke individuals, assessed during hospital admission by the National Institutes of Health Stroke Scale (NIHSS), and divided into mild (NIHSS ≤3) or moderate/severe (NIHSS ≥4) disease. At three, six, and 12 months after hospital discharge, the individuals were assessed for generic (Short Form Health Survey–36: total score and physical and mental domains) and specific (Stroke Specific Quality of Life Scale: total score and social domain) HRQOL. A 2 × 2 repeated measures analysis of variance (ANOVA) with post-hoc was applied. Results 146, 122, and 103 individuals were assessed at three, six and 12 months, respectively HRQOL courses showed different behaviors according to stroke severity (3.37≤F ≤ 4.62; 0.010≤p ≤ .036). Individuals with mild stroke showed significant changes in the physical domain, with a reduction between three and six months, and an increase between six and 12. Moderate/severe individuals showed a significant increase in all HRQOL variables between three and six months, and a maintenance of values for almost all variables, except for physical domain, which improved significantly between three and six months, and got significantly worse between six and 12. Conclusions HRQOL during the first year after stroke showed distinct trajectories, being stroke severity an important factor in identifying stroke subjects at risk of HRQOL decline. Clinical Implications These results demonstrate the importance of considering not only the phase of the stroke, the severity, and the general and specific HRQOL, but also the physical, social, and mainly the mental domain, which has long been neglected, when assessing this population.

Burden of Disease Associated with Refractory and Unexplained Chronic Cough in Canada: Results from a National Survey.

Chronic cough (persisting for ≥ 8weeks) is a common disorder that includes refractory chronic cough (RCC; cough that persists despite treatment of underlying disease) and unexplained chronic cough (UCC; cough with no identifiable cause). We evaluated self-reported health-related quality of life (HR-QoL) and work/activity impairment associated with RCC/UCC in Canada. Our exploratory study included Canadians in the Leger Opinion Panel with RCC or UCC. Key entry criteria were ≥ 18years of age, cough for ≥ 8weeks, not currently smoking/quit ≥ 1year ago, no serious respiratory disease or lung cancer, and not taking angiotensin-converting enzyme inhibitors. Respondents completed a 30-min online survey with general and cough-specific HR-QoL questionnaires, including the EuroQol (EQ) visual analogue scale (VAS), EQ-5-dimension 5-level (EQ-5D-5L), cough severity VAS, Leicester Cough Questionnaire (LCQ), and Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SPH). Of 49,076 individuals who completed the chronic cough screening questionnaire (July 30-September 1, 2021), 1,620 (3.3%) met entry criteria for RCC/UCC and 1,046 (2.1%) completed the survey. The mean age of respondents was 45years and 61% were female. Respondents reported impairments in global HR-QoL (EQ-VAS 73.8, 61% with anxiety/depression on the EQ-5D-5L) and cough-specific HR-QoL (mean cough severity VAS score 29.7, LCQ index 15.2). Work and non-work activities were reduced by 34% and 30%, respectively, on the WPAI-SPH. RCC/UCC is prevalent in Canada and associated with impaired HR-QoL, particularly in mental health domains. Additional support and management options may be required to fully address this burden.

Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease

ObjectivesTo evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials. MethodsContent validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn’s disease (Crohn’s disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn’s disease (N = 360) and UC (N = 518). ResultsCommon (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain. ConclusionsPROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.

Health-related quality of life and subjective well-being among children aged 9–12 years in Shandong Province, China

PurposeTo investigate the health-related quality of life (HRQoL) and subjective well-being (SWB) of children aged 9–12 years in eastern China, and examine concordance within child self-reported and parent proxy-assessed.MethodsData was collected from 9 to 12 years old children (including their parents) in Shandong Province in 2018. Participants self-completed a hard-copy questionnaire including Child Health Utility 9D (CHU9D), Pediatric Quality of Life Inventory (PedsQL)™ 4.0 Short Form 15 Generic Core Scales (hereafter the PedsQL™), Student’s Life Satisfaction Scale (SLSS), as well as information on socio-demographic characteristics and self-report health status. Spearman’s correlation coefficients and the difference between sub-groups were conducted to assess and compare the agreement on HRQoL and SWB instruments. Exploratory factor analysis (EFA) was used to ascertain the number of unique underlying latent factors that were associated with the items covered by the two generic HRQoL and the SWB instruments. The concordance of child self-reported and parent proxy-assessed was analyzed using weighted kappa coefficient and Bland-Altman plots.ResultsA total of 810 children and 810 parents were invited to participate in the survey. A valid sample of 799 (98.6%) children and 643 (79.4%) parents completed the questionnaire. The child self-reported mean scores were CHU9D = 0.87, PedsQL™ = 83.47, and SLSS = 30.90, respectively. The parent proxy-assessed mean scores were PedsQL™ = 68.61 and SLSS = 31.23, respectively. The child self-reported PedsQL™ was moderately correlated with the CHU9D (r = 0.52). There was a weak correlation between CHU9D and SLSS (r = 0.27). The EFA result found 3 factors whilst seven SLSS items grouped into a standalone factor (factor 3), and the nine dimensions of CHU9D shared two common factors with the PedsQL™ (factor 1 and factor 2). A low level of concordance was observed across all comparisons and in all domains (weighted kappa < 0.20) between parents and their children. Furthermore, a high level of discordance was observed between child self-reported and father proxy-assessed.ConclusionsCHU9D and PedsQL™ instruments have a higher agreement in measuring the HRQoL in children. CHU9D/PedsQL™ and SLSS instruments showed a low agreement and EFA result suggested that measuring SWB in children potentially may provide further information, which might be overlooked by using HRQoL instruments exclusively. Concordance of child self-reported and parent proxy-assessed was poor. Overall, mother-child concordance was higher than father-child concordance.

Linking patient-reported oral and general health-related quality of life.

The relationship between oral and overall health is of interest to health care professionals and patients alike. This study investigated the correlation between oral health-related quality of life (OHRQoL) and health-related quality of life (HRQoL) in a general adult population. This cross-sectional study used a convenience sample of adult participants (N = 607) attending the 2022 Minnesota County and State fairs in USA, the 5-item Oral Health Impact Profile (OHIP-5) assessed OHRQoL, and the 10-item PROMIS v.1.2 Global Health Instrument assessed HRQoL. Spearman and Pearson correlations were used to summarize the bivariable relationship between OHRQoL and HRQoL (both physical and mental health dimensions). A structural equation model determined OHRQoL-HRQoL correlations (r). Correlations' magnitude was interpreted according to Cohen's guidelines (r = 0.10, 0.30, and 0.50 to demarcate "small," "medium," and "large" effects, respectively). OHRQoL and HRQoL correlated with r = 0.52 (95% confidence interval, CI: [0.50-0.55]), indicating that the two constructs shared 27% of their information. According to Cohen, this was a "large" effect. OHRQoL, and the physical and mental HRQoL dimensions correlated with r = 0.55 (95% CI: [0.50-0.59]) and r = 0.43 (95% CI: [0.40-0.46]), respectively, indicating a "large" and a "medium" effect. OHRQoL and HRQoL were substantially correlated in an adult population. Using OHIP-5 to assess their dental patients' oral health impact allows dental professionals to gain insights into patients' overall health-related wellbeing.