Health-related Quality Of Life Constructs Research Articles

Reference Values for the German Version of the Quality of Life after Brain Injury in Children and Adolescents (QOLIBRI-KID/ADO) from a General Population Sample.

Assessment of health-related quality of life (HRQoL) after pediatric traumatic brain injury (TBI) has been limited in children and adolescents due to a lack of disease-specific instruments. To fill this gap, the Quality of Life after Traumatic Brain Injury for Children and Adolescents (QOLIBRI-KID/ADO) Questionnaire was developed for the German-speaking population. Reference values from a comparable general population are essential for comprehending the impact of TBI on health and well-being. This study examines the validity of the German QOLIBRI-KID/ADO in a general pediatric population in Germany and provides reference values for use in clinical practice. Overall, 1997 children and adolescents aged 8-17 years from the general population and 300 from the TBI population participated in this study. The questionnaire was tested for reliability and validity. A measurement invariance (MI) approach was used to assess the comparability of the HRQoL construct between both samples. Reference values were determined by percentile-based stratification according to factors that significantly influenced HRQoL in regression analyses. The QOLIBRI-KID/ADO demonstrated strong psychometric properties. The HRQoL construct was measured largely equivalently in both samples, and reference values could be provided. The QOLIBRI-KID/ADO was considered reliable and valid for assessing HRQoL in a general German-speaking pediatric population, allowing for clinically meaningful comparisons between general and TBI populations.

Patient Experiences with Clostridioides difficile Infection and Its Treatment: A Systematic Literature Review.

Clostridioides difficile infection (CDI) is a globally recognized cause of morbidity and mortality with devastating effects on health-related quality of life (HRQoL). The objective of this study was to conduct the first systematic literature review (SLR) to assess the humanistic burden of CDI on patient experiences, including HRQoL and related constructs, and attitudes towards treatment alternatives. An SLR was conducted to identify peer-reviewed articles that assessed CDI, including recurrent CDI (rCDI), and patient-reported outcomes or HRQoL. PubMed, Embase, and the Cochrane Collaboration abstracting services were used to conduct literature searches from 2010 to 2021 in the English language. This SLR was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) criteria. Of 511 identified articles, 21 met study inclusion criteria. The SLR showed CDI has a devastating impact on patients' overall HRQoL that continues well beyond infection clearance. The impact of CDI on physical, emotional, social, and professional well-being rivaled abdominal symptoms of uncontrollable diarrhea, being worse for patients with rCDI. Patients with CDI feel isolated, depressed, lonely, and continue to be frightened of recurrences as well as being contagious to others. Most believe that they will never be free of CDI. CDI and rCDI are debilitating conditions affecting physical, psychological, social, and professional functioning of patients' HRQoL, even long after the event has occurred. The results of this SLR suggest that CDI is a devastating condition in need of better prevention strategies, improved psychological support, and treatments that address the microbiome disruption to break the cycle of recurrence. Additional safe and effective therapies are needed to address this unmet medical need.

P035 Patient-reported outcome measures for rheumatoid arthritis disease activity: using Rasch measurement theory to achieve more meaningful measurement

Abstract Background/Aims Disease activity (DA) monitoring is a standard of care in rheumatoid arthritis (RA), and there is demand for achieving this through patient-reported outcome measures (PROMs). A systematic review of PROMs for RA DA following COSMIN guidelines demonstrated a lack of sufficient evidence for content validity for the 10 existing PROMS, thus none could be recommended for use. The aim of this study was to use Rasch measurement theory (RMT) to develop a valid item pool for measurement of DA in RA. Methods Paper questionnaires were sent to people aged 18 or over with RA from four South Wales University Health Boards between September 2020 and November 2021. The questionnaire included 268 individual RA DA items extracted from the 10 PROMs identified by the systematic review, another four PROMs and a non-measurement group of items. Further items suggested by patient feedback were incorporated, including a Pain Activity Scale, discomfort when walking, standing, and exercising, plus fear of falling when walking. Items were grouped into domains established by OMERACT: tenderness and swelling, patient global, pain, fatigue, physical functioning; and additionally stiffness, swelling, discomfort/fear and mood. Exploratory factor analyses (EFA) were used to indicate which items from which domains loaded onto factors together. For each separate domain, psychometric properties were assessed by RMT analyses. This provided results on targeting, model fit, internal consistency, local dependency, unidimensionality and item threshold ordering. Results A test dataset of n = 398 and a validation dataset of n = 293 were available. EFA of the test dataset showed that 30 items from across the tenderness and swelling, patient global, pain, fatigue, physical functioning and stiffness domains loaded together. RMT analyses of these items in the test dataset indicated that the patient global domain comprised two distinct domains, which followed a clear content difference of general health and disease activity items. In assessing the best items to measure the now 7 domains, 12 items were discarded. These 7 domains were confirmed in the validation data. Subtest analyses indicated that patient global general health and fatigue did not measure the same overall construct as the other 5 domains, and instead worked together to measure a separate construct. This structure was confirmed using bi-factor model confirmatory factor analyses in the validation data. Conclusion Patient global items relating to general health and disease activity were two separate domains. RA DA can be measured using tenderness and swelling, patient global disease activity, pain, physical functioning and stiffness items, whilst fatigue and patient global general health items measure a health-related quality of life construct. The next steps are to undertake cognitive interviews to establish content validity and to develop a computer adaptive test based on anchored locations calculated using these data. Disclosure T. Pickles: None. M. Horton: None. K.B. Christensen: None. R. Phillips: None. D. Gillespie: None. N. Mo: None. E. Choy: None.

Reference Values of the Quality of Life after Brain Injury (QOLIBRI) from a General Population Sample in Italy.

Traumatic brain injury (TBI) may affect the lives of the individuals concerned and their relatives negatively in many dimensions. Health-related quality of life (HRQoL) is a comprehensive and complex concept that can assess one's satisfaction with a broad range of areas of life and health. The Quality of Life after Traumatic Brain Injury (QOLIBRI) questionnaire is a TBI-specific measure for HRQoL which is used in research and health services worldwide. When evaluating self-reported HRQoL after TBI, reference values from a general population are helpful to perform clinically relevant evaluations and decisions about the condition of an affected person by comparing the patient scores with reference values. Despite the widespread use of the QOLIBRI, reference values have until now only been available for the Netherlands and the United Kingdom. The aim of this study was to validate the QOLIBRI for the general population in Italy and to provide reference values. An adapted form of the QOLIBRI was administered to 3298 Italians from a healthy general population using an online survey. Their scores were compared with those of 298 individuals post-TBI recruited within the international longitudinal observational cohort CENTER-TBI study in Italian hospitals, who completed the original questionnaire. The psychometric characteristics and the measurement invariance of the QOLIBRI were assessed. A regression analysis was performed to identify predictors relevant for HRQoL in the general population. Reference values were provided using percentiles. Measurement invariance analysis showed that the QOLIBRI captures the same HRQoL constructs in an Italian general population and Italian TBI sample from the observational Center-TBI study. Higher age, higher education and the absence of a chronic health condition were associated with higher QOLIBRI scores, suggesting better HRQoL. Reference values were provided for a general Italian population adjusted for age, sex, education and presence of chronic health conditions. We recommend using these for a better interpretation of the QOLIBRI score in clinical practice and research in Italy.

Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial

Intensive lifestyle interventions (ILIs) stimulate weight loss in underserved patients with obesity, but the mediators of weight change are unknown. We aimed to identify the mediators of weight change during an ILI compared with usual care (UC) in underserved patients with obesity. The PROPEL (Promoting Successful Weight Loss in Primary Care in Louisiana) trial randomly assigned 18 clinics (n=803) to either an ILI or UC for 24 mo. The ILI group received an intensive lifestyle program; the UC group had routine care. Body weight was measured; further, eating behaviors (restraint, disinhibition), dietary intake (percentage fat intake, fruit and vegetable intake), physical activity, and weight- and health-related quality of life constructs were measured through questionnaires. Mediation analyses assessed whether questionnaire variables explained between-group variations in weight change during 2 periods: baseline to month 12 (n=779) and month 12 to month 24 (n=767). The ILI induced greater weight loss at month 12 compared with UC (between-group difference: -7.19kg; 95% CI: -8.43, -6.07kg). Improvements in disinhibition (-0.33kg; 95% CI: -0.55, -0.10kg), percentage fat intake (-0.25kg; 95% CI: -0.50, -0.01kg), physical activity (-0.26kg; 95% CI: -0.41, -0.09kg), and subjective fatigue (-0.28kg; 95% CI: -0.46, -0.10kg) at month 6 during the ILI partially explained this between-group difference. Greater weight loss occurred in the ILI at month 24, yet the ILI group gained 2.24kg (95% CI: 1.32, 3.26kg) compared with UC from month 12 to month 24. Change in fruit and vegetable intake (0.13kg; 95% CI: 0.05, 0.21kg) partially explained this response, and no variables attenuated the weight regain of the ILI group. In an underserved sample, weight change induced by an ILI compared with UC was mediated by several psychological and behavioral variables. These findings could help refine weight management regimens in underserved patients with obesity.This trial was registered at clinicaltrials.gov as NCT02561221.

Reference Values and Psychometric Properties of the Quality of Life After Traumatic Brain Injury-Overall Scale in Italy, The Netherlands, and the United Kingdom

ObjectivesThe Quality of Life after Brain Injury-Overall Scale (QOLIBRI-OS) is a short screening instrument for assessing disease-specific health-related quality of life (HRQoL) after traumatic brain injury. To date, no reference values are available for the QOLIBRI-OS in general populations. Thus, this study aimed to establish reference values for the QOLIBRI-OS in general population samples from Italy, The Netherlands, and the United Kingdom. MethodsData were collected using an online survey. The total sample comprised 11759 participants, consisting of 3549 Italian, 3564 Dutch, and 4646 British subjects. In this sample, 49% of the total sample did not report any health complaints, whereas 51% had at least 1 chronic health condition. Reference values were deduced for the QOLIBRI-OS for health-condition–related samples and total general population samples per country. To ensure the comparability of these values, measurement invariance was assessed using a multigroup confirmatory factor analysis. Covariates characterizing the reference values were selected with the help of regression analyses. ResultsThe confirmatory factor analysis confirmed that the QOLIBRI-OS scores measured the same traumatic brain injury–specific HRQoL construct across the 3 countries. Healthy individuals reported significantly higher HRQoL than individuals with at least 1 chronic health condition. Older age and higher education levels were significantly associated with higher HRQoL. ConclusionsBecause the reference values displayed differences in terms of age and education level across the 3 countries, we recommend using country-specific reference values stratified by sociodemographic and health status in research and clinical practice.

Food intake, physical activity and quality of life among children and youth.

The health-related quality of life construct (QoL) implies a relationship with eating habits (EA) and physical activity (PA). Sociodemographic and anthropometric variables (gender, age and Body Mass Index - BMI) are highlighted in the definition of healthy lifestyle habits promotion strategies. We aim to characterize and relate PA, EA and QoL in children/youth and explore gender, age and BMI influences. It is a non-experimental study, with 337 children/youth, ages between 8 and 17 years (12.61±2.96), mostly from the rural inland of Portugal. In data collection we used a sociodemographic and anthropometric questionnaire, a weekly register table of EA and Kid-Kindl (QoL). Statistical analysis (p < 0.05) were performed in SPSS-IBM 25. Lower BMI was associated with better EA (p < 0.001), PA (p < 0.05) and self-esteem (p < 0.01) and worse scores on family subscale of QoL. Female showed higher fruit intake (p < 0.05). The older has shown better results. PA is positively correlated with QoL (p < 0.01) and EA (p < 0.05). It is important to explore other relevant social and family dimensions, to promote intervention programs with parents, school and community, as well as healthy practices policies. The intervention in these age groups is critical for a longer-term impact in improving healthy life habits.

The Unfolding Method to Explore Health-Related Quality of Life Constructs in a Chinese General Population

ObjectivesHealth-related quality of life (HRQOL) is a complicated concept that can be measured using multiple health items. Although HRQOL is closely associated with people’s subjective assessment of their own health, a limited number of studies have investigated which health items are considered most important and relevant by the general population. Even fewer empirical studies have investigated how HRQOL is understood in non-Western populations. This study used multidimensional unfolding analysis in a Chinese general population to explore the constructs of HRQOL. MethodsA scoping review of Chinese generic HRQOL measures and a series of qualitative interviews produced a list of 42 potentially important health items in a Chinese cultural setting; 110 Chinese participants in face-to-face interviews ranked the health items from most important to least important. Responses were coded into a rectangular 110 × 42 matrix, and multidimensional unfolding was conducted to analyze participants’ preferences for health items. ResultsIt was found that demographic characteristics and one’s health condition affected views of HRQOL. Meanwhile, 3 health items were considered to be most important across the whole sample: sleep quality, body constitution, and spiritual appearance. ConclusionThis study used a novel approach to explore how people coming from a Chinese cultural setting may perceive HRQOL and which aspects of HRQOL are most important to them. The study shows that multidimensional unfolding is a feasible approach to assess preferences in a general population. Future studies using this approach are recommended to further explore the constructs of HRQOL in other general populations.

Pediatric health-related quality of life and school social capital through network perspectives

BackgroundDespite their importance in population health among children and adolescents, our understanding of how individual items mutually interact within and between pediatric health-related quality of life (HRQOL) and school social capital is limited.MethodsWe employed network analysis in a general population sample of 7759 children aged 9–15 years to explore the network structure of relations among pediatric HRQOL and school social capital items measured using validated scales. Furthermore, network centrality was examined to identify central items that had stronger and more direct connections with other items in the network than others. Network structure and overall strength of connectivity among items were compared between groups (by sex and age).ResultsOur analysis revealed that the item related to school/academic functioning and the item related to shared enjoyment among students had the highest strength centrality in the network of HRQOL and school social capital, respectively, underpinning their critical roles in pediatric HRQOL and school social capital. Additionally, the edge connecting “I trust my friends at school” and “trouble getting along with peers” had the strongest negative edge weight among ones connecting school social capital and pediatric HRQOL constructs. Network comparison test revealed stronger overall network connectivity in middle schoolers compared to elementary schoolers but no differences between male and female students.ConclusionThe network approach elucidated the complex relationship of mutually influencing items within and between pediatric HRQOL and school social capital. Addressing central items may promote children’s perceived health and school social capital.

Association Between Oral Health-Related and Health-Related Quality of Life.

ObjectivesTo investigate the correlation between the four dimensions of Oral Health-Related Quality of Life (OHRQoL) and Health-Related Quality of Life (HRQoL) constructs in a dental patient population.MethodsA cross-sectional study carried out at HealthPartners, Minnesota, USA. This study is a secondary data analysis of available adult dental patients’ data. The instruments used to assess the OHRQoL and HRQoL constructs were the Oral Health Impact Profile–version with 49 items (OHIP-49) and Patient-Reported Outcome Measures Information System (PROMIS) measures v.1.1 Global Health instruments Patient Reported Outcome Measures (PROMs), respectively. We used Structural Equation Modeling to determine the correlation between OHRQoL and HRQoL.ResultsTwo thousand and seventy-six dental patients participated in the study. OHRQoL and HRQoL scores correlated with 0.56 (95%CI:0.52–0.60). The OHRQoL and Physical Health dimension of HRQoL correlated with 0.55 (95%CI:0.51–0.59). The OHRQoL and Mental Health dimension of HRQoL correlated with 0.51 (95%CI:0.47–0.55). When adjusted for age, gender, and depression, the correlation coefficients changed only slightly and resulted in 0.52 between OHRQoL and HRQoL Physical Health, and 0.47 between OHRQoL and HRQoL Mental Health. Model fit statistics for all analyses were adequate and indicated a good fit.ConclusionsOHRQoL and HRQoL overlap greatly. For dental practitioners, the OHRQoL score is informative for their patients’ general health status and vice versa. Study results indicate that effective therapeutic interventions by dentists improve patients’ OHRQoL as well as HRQoL.

Psychometric properties of Short Form-36 Health Survey, EuroQol 5-dimensions, and Hospital Anxiety and Depression Scale in patients with chronic pain.

Recent research has highlighted a need for the psychometric evaluation of instruments targeting core domains of the pain experience in chronic pain populations. In this study, the measurement properties of Short Form-36 Health Survey (SF-36),EuroQol 5-dimensions (EQ-5D) and Hospital Anxiety and Depression Scale (HADS) were analyzed within the item response-theory framework based on data from 35,908 patients. To assess the structural validity of these instruments, the empirical representations of several conceptually substantiated latent structures were compared in a cross-validation procedure. The most structurally sound representations were selected from each questionnaire and their internal consistency reliability computed as a summary of their precision. Finally, questionnaire scores were correlated with each other to evaluate their convergent and discriminant validity. Our results supported that SF-36 is an acceptable measure of 2 independent constructs of physical and mental health. By contrast, although the approach to summarize the health-related quality of life construct of EQ-5D as a unidimensional score was valid, its low reliability rendered practical model implementation of doubtful utility. Finally, rather than being separated into 2 subscales of anxiety and depression, HADS was a valid and reliable measure of overall emotional distress. In support of convergent and discriminant validity, correlations between questionnaires showed that theoretically similar traits were highly associated, whereas unrelated traits were not. Our models can be applied to score SF-36 and HADS in chronic pain patients, but we recommend against using the EQ-5D model due to its low reliability. These results are useful for researchers and clinicians involved in chronic pain populations because questionnaires' properties determine their discriminating ability in patient status assessment.

Sex Differences in Quality of Life in Patients With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) predominantly affects women. Clinical phenotype and outcomes in SLE may vary by sex and are further complicated by unique concerns that are dependent upon sex-defined roles. We aimed to describe sex differences in disease-specific quality of life (QoL) assessment scores using the Lupus Patient-Reported Outcome (LupusPRO) tool in a large international study. Cross-sectional data from 1,803 patients with SLE on demographics, self-identified sex status, LupusPRO, and disease activity were analyzed. The LupusPRO tool has 2 constructs: health-related QoL (HRQoL) and non-HRQoL. Disease activity and damage were evaluated using the Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, respectively. Nonparametric tests were used to compare QoL and disease activity by sex. A total of 122 men and 1,681 women with SLE participated. The mean age was similar by sex, but the damage scores were greater among men. Men fared worse on the non-HRQoL social support domain than women (P = 0.02). When comparing disease and QoL among men and women ages ≤45 years, men were found to have greater damage and worse social support than women. However, women fared significantly worse on lupus symptoms, cognition, and procreation domains with trends for worse functioning on physical health and pain-vitality domains. In the largest study of a diverse group of SLE patients, utilizing a disease-specific QoL tool, sex differences in QoL were observed on both HRQoL and non-HRQoL constructs. Although men performed worse in the social support domain, women (especially those in the reproductive age group) fared worse in other domains. These observations may assist physicians in appropriately addressing QoL issues in a sex-focused manner.

Empirical Assessment of Patient-Reported Outcomes and Exemplary Introduction to Health-Related Quality of Life

Health-related quality of life (HRQoL) acquires increased importance as a target parameter for different stakeholders in healthcare, e. g. to assess treatment outcome in chronically ill patients. In this educational article, we explain the levels of the health-related quality of life construct and associated main dimensions including physical, mental and social health. State-of-the-art approaches for assessment of patient-reported outcomes (PROs) are introduced on the basis of the HRQoL model. Furthermore, modern test-theoretical approaches and their applications are presented, which are aimed at standardizing and improving the assessment of PROs (e. g., computer-adaptive testing). Finally, we present 2 major international PRO initiatives (PROMIS® and EORTC Quality of Life Group) that have been influential in advancing the assessment of patient outcomes over the last few years.

Health-Related Quality of Life and Fatigue After Transient Ischemic Attack and Minor Stroke

BackgroundStudies suggest that fatigue and cognitive impairment may be present after transient ischemic attack (TIA) or minor stroke, but little is known about consequences in daily life. The main aim was to explore the presence of fatigue, cognitive impairment, and consequences in daily life after minor stroke-TIA. MethodsPatients (n = 92) were consecutively recruited from the Stroke Unit and were assessed within 2 weeks of hospital admission for first-ever and 3 months later. Control participants (n = 89) were recruited from the same population as the patients. Measures included the Fatigue Assessment Scale (FAS), Montreal Cognitive Assessment (MoCA), and The European Quality of Life index (EQ-5D-5L). ResultsThe prevalence of substantial fatigue was 65.2% (confidence interval [CI] 95%: 54.6%-74.8%) and extreme fatigue was 20.7% (CI 95%: 12.9%-30.4%) in minor stroke-TIA patients. The prevalence of substantial fatigue in controls was 23.5% (CI95%: 15.0%-34.0%) and extreme fatigue was 4.5% (CI 95%: 1.8%-11.0%). The mean (SD) score on the MoCA was 24.1 (3.2) for the patients group and 27.3 (2.4) for controls (P < .001). FAS showed the strongest negative correlation score with the EQ-5D-5L index (r = −0.480; P < .0001), higher levels of mental and physical fatigue are associated with lower EQ-5D-5L index (r = −0.376; P < .001 and r = −0.497; P <.001, respectively). The correlations between the FAS and the MoCA measures were no significant. MoCA was not significantly correlated with EQ-5D-5L. ConclusionsFatigue was a very common symptom in TIA/minor stroke patients. The fatigue had a significant impact on the health-related quality of life construct in its entirety, even after accounting for the influence of several factors.

Health-Related Quality of Life in Tehran Lipid and Glucose Study.

ContextBeyond the objective outcomes of metabolic syndrome (MetS), the association between this syndrome and its patient-centered outcomes need to be investigated in Middle-Eastern countries. This report aims to summarize the Tehran lipid and glucose study (TLGS) findings regarding the association between MetS and health-related quality of life (HRQoL) and its influential factors through the past decade.Evidence AcquisitionThe current review has been conducted on the TLGS published data regarding different aspects of the association between MetS and HRQoL in adult participants through the last decade. To assess HRQoL, the Iranian version of short form health survey (SF-36) was used. To define MetS the most commonly used insulin resistance (IR)-and waist circumference (WC) - based MetS definitions have been applied in the publications reviewed.ResultsAs a whole, MetS was a determinant of poor physical HRQoL only in women (OR: 1.78; 95% CI: 1.21 - 2.61), particularly in those with more component of MetS (P < 0.001). Results further showed that only reproductive aged women with MetS were more likely to report poor PCS compared to those without MetS even after adjusting for age (OR: 1.7, 95% CI: 1.0 - 3.0; P < 0.05). Different structures of MetS and physical HRQoL constructs in men and women as well as age and smoking with significant gender-specific effects on mental HRQoL were factors responsible for the gender specific pattern observed. Considering the duration of MetS, only women with intermittent MetS indicated higher risk for reporting poor PCS (OR: 2.75, 95% CI: 1.19 - 6.37; P < 0.001) compared to those without MetS. The observed sex-specific pattern used to detect poor HRQoL in those with MetS was confirmed by all WC-based definitions except for the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) definition. However, none of IR-based definitions could detect poor physical and mental HRQoL in either gender.ConclusionsIn summary, in the TLGS population, the association between MetS and HRQoL followed a sex specific pattern, mainly significant only in women and in the physical aspect.

Influence of physical activity on the health-related quality of life of young adults with and without autism spectrum disorder

Background: Health-related quality of life constructs has been used to understand the multiple dimensions (i.e., physical health, psychological, environment and social relationships) that affect a person’s health status. In order to improve health-related quality of life for young adults, it is important to understand the factors that influence each dimension. The purpose of this paper was to examine the influence of the presence of autism spectrum disorder and physical activity on the multiple domains of health-related quality of life for young adults.Methods: Three-hundred and twenty participants, including young adults with ASD, completed a questionnaire about their physical activity and health-related quality of life.Results: Five multiple regressions revealed that the presence of autism spectrum disorder significantly predicted overall health-related quality of life, the physical health domain, psychological domain, and the environment domain. Additionally, physical activity significantly predicted each domain and overall health-related quality of life regardless of the presence of autism spectrum disorder.Conclusion: Practitioners should recognize the limitations that individuals with autism spectrum disorder may experience regarding their health-related quality of life, and utilize physical activity as a tool for improving health-related quality of life.Implications for RehabilitationIn order to address an individual’s overall health, practitioners must consider multiple dimensions of health-related quality of life.Autism spectrum disorders influence how people perceive multiple dimensions of their health.Physical activity is a tool for improving perceptions of the multiple dimensions of health for individuals with and without autism spectrum disorders.

Response shift in parents' assessment of health-related quality of life of children with new-onset epilepsy

ObjectiveDiagnosis of epilepsy is known to impact health-related quality of life (HRQOL) of children with new-onset epilepsy and can also influence their conceptualization and valuation of HRQOL construct, also known as response shift. This study investigates the presence of response shift in a cohort of children with new-onset epilepsy. MethodsData are from the HEalth-Related QUality of Life in children with Epilepsy Study, a prospective cohort study of 373 children with new-onset epilepsy. Hypotheses about the presence of reconceptualization, reprioritization, and recalibration response shift were tested in the Quality of Life in Childhood Epilepsy (QOLCE-55) Questionnaire, a parent-reported, disease-specific HRQOL measure, using Oort's structural equation model between baseline and 1-year follow-up. Model fit was assessed using log-likelihood ratio test, root mean square error of approximation, and comparative fit index. ResultsSmall positive uniform recalibration response shift effects were observed on physical, emotional, and social functioning domains of the QOLCE-55, but negligibly small negative nonuniform recalibration response shift effect was observed on social functioning domain. There was no significant change in overall QOLCE-55 scores over time after adjusting for response shift effects. SignificanceParents of children with new-onset epilepsy are likely to positively recalibrate (upward bias) their assessments of their children's HRQOL over a 1-year period after diagnosis. This study highlights the potential benefits of response shift as a desired consequence in parents' perception of changes in HRQOL of children with new-onset epilepsy.

Evaluation of Fatigue in Previously Untreated CLL Patients with Comorbidities Treated with Obinutuzumab (GA101) + Chlorambucil (GClb) or Rituximab + Chlorambucil (RClb)

Introduction: Chronic lymphocytic leukemia (CLL) is an indolent lymphoproliferative disease that mainly affects older people, the majority of whom have medical comorbidities. Fatigue is a common symptom of CLL and patients will present with varying levels of fatigue at the start of treatment. The standard of care in such patients is CD20-based chemoimmunotherapy. Among available CD20-targeting antibodies is obinutuzumab (GA101, Gazyva/Gazyvaro), a glycoengineered type 2 antibody shown to be superior to rituximab with regard to several survival endpoints. Next to the prolongation of survival, maintaining or improving quality of life - including controlling fatigue - is an important goal of chemoimmunotherapy in CLL, especially in older patients with comorbidities. Understanding fatigue in this patient population relative to other measures of health-related quality of life (HRQOL), baseline clinical variables, and treatment outcome, therefore is of considerable interest.Methods: We studied HRQOL with a focus on fatigue in patients receiving chemoimmunotherapy within the CLL11 study. This randomized trial enrolled 663 patients, with previously untreated CLL and increased comorbidity burden, to be treated with obinutuzumab plus chlorambucil (GClb, n=333) or rituximab plus chlorambucil (RClb, n=330). The EORTC QLQ-C30 and QLQ-CLL16 questionnaires were used to capture HRQOL at baseline, during chemoimmunotherapy, and during the post-treatment period until documented disease progression. Both questionnaires assess fatigue among several other HRQOL constructs. Association of fatigue with baseline clinical and demographic variables was conducted. Means and changes in means of the QLQ-C30/CLL16 scales (including fatigue) were examined, with a 10 point change considered the limit for clinical meaningfulness. Time to clinically meaningful deterioration in fatigue between the two treatment groups was examined using Kaplan-Meier curves.Results: Among the 663 patients treated with chemoimmunotherapy in the CLL11 study, 625 (312 in the GClb and 313 in the RClb arm) completed baseline HRQOL measures. Baseline mean HRQOL scores were similar for both treatment arms. Evaluation of fatigue quartiles for both groups revealed that those in the worst quartile were more likely to have a poorer ECOG performance status (ECOG PS score of 2 or 3), higher comorbidity burden (Cumulative Illness Rating Scale >6), higher scores on HRQOL symptom scales, and lower scores on HRQOL functioning scales at baseline. Mean hemoglobin levels at baseline were lowest in the worst fatigue quartile for both treatment groups (with the GClb arm having lower levels than the RClb arm). Over the course of treatment, HRQOL scores were similar for both treatment arms, although at several points during treatment the GClb arm reported improvement on several scales, including fatigue, appetite loss, disease effects, and global health status, that exceeded the minimal threshold for clinically meaningful difference. Among those patients in the worst fatigue cohort at baseline, clinically meaningful improvements in fatigue were observed for both treatment arms, starting at the first post-baseline assessment (Fig.1). The median time to clinically meaningful deterioration in fatigue was 23.2 months in the GClb arm and 19.1 months in the RClb arm (Fig.2). Noticeable increases in hemoglobin levels were observed by cycle (C) 2 day (D) 15 in the GClb arm and C4D15 in the RClb arm, with values continuing to increase over subsequent treatment and follow-up (FU; Fig.3).Conclusions: These data highlight that in older patients with previously untreated CLL and comorbidities, fatigue appears to have an impact on clinical baseline variables and vice versa. The clinical benefit observed in chemoimmunotherapy with GClb or RClb is also observed in patients' HRQOL, including fatigue, particularly in those individuals with significant fatigue at baseline. In addition, GClb appears to be associated with a longer time to development of clinically meaningful fatigue than RClb, thus favoring its use in this patient population. [Display omitted] [Display omitted] [Display omitted] DisclosuresGoede:GlaxoSmithKline: Honoraria; Gilead: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Other: Travel grant, Research Funding. Trask:Genentech, Inc.: Employment, Equity Ownership. Uguen:Roche: Employment. Bazeos:Roche: Employment, Other: This year I am employed by Roche full time but I am on secondment from Imperial College where I am a hematologist in training. I return there on Sept 1st. This abstract was the result of full time work at Roche and Imperial College played no part in it.. Fischer:Hoffmann-LaRoche: Other: Travel grants. Hallek:AbbVIe: Consultancy, Honoraria; Mundipharma: Consultancy, Honoraria; Glaxo-SmithKline: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Pharmacyclics: Consultancy, Speakers Bureau; Celgene: Consultancy, Honoraria; Roche: Consultancy, Research Funding, Speakers Bureau.

Value-Based Model: A New Perspective in Medical Decision-making.

The problem of how to use financial resources beneficially in health care, despite limited budgets, reduced personnel, and inadequate time, goes beyond the realm of health economists (1). How do we use existing resources to prioritize one health program over another? Does a specific program provide a real and measurable improvement in terms of perceived health-related quality of life (HRQOL)? What decisions should we make? In the recent years, the HRQOL index has become an asset for evaluating patient health status in health programs, therapies, and clinical trials (2). Created as a specific psychological construct for use in health contexts, the HRQOL index is now widely used and evaluated by health economists, epidemiologists, clinicians, and nurses. Today, the notion that health status is not only determined by survival or absence of disease but also closely related to quality of health is universally accepted (3, 4). Health-related quality of life has been defined as the functional effect of a medical condition and/or treatment on a patient. Thus, HRQOL is a subjective and multidimensional parameter that encompasses physical and occupational functioning, psychological state, social interaction, and somatic sensation (5). Health is perceived by the person as a state that lies beyond the presence of a disease or the severity of a condition. HRQOL is influenced by several factors that include not only psychological and emotional aspects, individual behavior, and attitudes but also personal experiences, culture, and religious beliefs (6, 7). Owing to this subjectivity, patients with the same medical condition may have very different perceptions of HRQOL. For example, patients with some hematological conditions, such as hemophilia, may experience a good HRQOL despite having several disease-related complications, whereas others with the same disorder but better clinical conditions may perceive a poor HRQOL (8–12). Similar results have been obtained in patients with other chronic conditions, such as back pain (13, 14). Evaluation of HRQOL has been encouraged over the last two decades to obtain a broader perspective of health status in patients and to identify which therapeutic choices and programs to pursue (15). Health economists may use the HRQOL construct as a deciding factor in applying economic analyses. For example, in cost-benefit, cost-effectiveness, or cost-utility analyses, HRQOL may represent one indicator for measuring effectivenes. (e.g., success of a health program, specific treatment, or regulatory policy) (16). In this context, effectiveness may be measured as a final outcome, such as the number of life-years gained or number of lives saved, by applying a certain program or proposing a certain treatment. Alternatively, it may be measured as an intermediate outcome in a health program, such as the number of days lost from school or work, perceived HRQOL, treatment satisfaction, or psycho-emotional well-being (17). The HRQOL construct focuses on the patient’s perceived state of health as a reference value in evaluating programs and making medical decisions. In this light, we wish to discuss the potential of the HRQOL and psychological science in a new medical paradigm that has been recently described as an alternative approach to the traditional paradigm of evidence-based medicine, namely, the value-based medicine approach.

Impact of oral health on health-related quality of life: a cross-sectional study.

BackgroundDespite the consensus regarding the existence of a relationship between “impacts on oral health” and “health-related quality of life”, this relationship, considering the latent nature of these variables, is still poorly investigated. Thus, we performed this study in order to determine the magnitude of the impacts of oral health, demographic and symptom/clinical variables on the health-related quality of life in a Brazilian sample of dental patients.MethodsA total of 1,007 adult subjects enrolled in the School of Dentistry of São Paulo State University (UNESP) - Araraquara Campus for dentistry care between September/2012 and April/2013, participated. 72.4 % were female. The mean age was 45.7 (SD = 12.5) years. The Oral Health Impact Profile (OHIP-14) and the Short Form Health Survey (SF-36) were used. The demographic and symptom/clinical variables collected were gender, age, economic status, presence of pain and chronic disease. The impact of studied variables on health-related quality of life were evaluated with a structural equation model, considering the factor “Health” as the central construct. The fit of the model was first analyzed by the evaluation of the goodness of fit indices (χ2/df ≤ 2.0, CFI and TLI ≥ 0.90 and RMSEA < 0.10) and the evaluation of the variables’ impact over health-related quality of life was based on the statistical significance of causal paths (β), evaluated by z tests, for a significance level of 5 %.ResultsWe observed adequate fit of the model to the data (χ2/df = 3.55; CFI = 0.95; TLI = 0.94; RMSEA = 0.05). The impacts on oral health explained 28.0 % of the variability of the health-related quality of life construct, while the total variance explained of the model was 39.0 %. For the demographic and symptom/clinical variables, only age, presence of pain and chronic disease showed significant impacts (p < 0.05).ConclusionThe oral health, age, presence of pain and chronic disease of individuals had significant influence on health-related quality of life.