Health-related Quality Of Life Instruments Research Articles

Factors Associated With Frequent Opioid Use in Children With Acute Recurrent and Chronic Pancreatitis.

The aim of the study was to understand the association of frequent opioid use with disease phenotype and pain pattern and burden in children and adolescents with acute recurrent (ARP) or chronic pancreatitis (CP). Cross-sectional study of children <19 years with ARP or CP, at enrollment into the INSPPIRE cohort. We categorized patients as opioid "frequent use" (daily/weekly) or "nonfrequent use" (monthly or less, or no opioids), based on patient and parent self-report. Of 427 children with ARP or CP, 17% reported frequent opioid use. More children with CP (65%) reported frequent opioid use than with ARP (41%, P = 0.0002). In multivariate analysis, frequent opioid use was associated with older age at diagnosis (odds ratio [OR] 1.67 per 5 years, 95% confidence interval [CI] 1.13-2.47, P = 0.01), exocrine insufficiency (OR 2.44, 95% CI 1.13-5.24, P = 0.02), constant/severe pain (OR 4.14, 95% CI 2.06-8.34, P < 0.0001), and higher average pain impact score across all 6 functional domains (OR 1.62 per 1-point increase, 95% CI 1.28-2.06, P < 0.0001). Children with frequent opioid use also reported more missed school days, hospitalizations, and emergency room visits in the past year than children with no frequent use (P < 0.0002 for each). Participants in the US West and Midwest accounted for 83% of frequent opioid users but only 56% of the total cohort. In children with CP or ARP, frequent opioid use is associated with constant pain, more healthcare use, and higher levels of pain interference with functioning. Longitudinal and prospective research is needed to identify risk factors for frequent opioid use and to evaluate nonopioid interventions for reducing pain and disability in these children.

Health related quality of life in Friedreich Ataxia in a large heterogeneous cohort

IntroductionThis study assessed the Health Related Quality of Life (HRQOL) of individuals with Friedreich Ataxia (FRDA) through responses to HRQOL questionnaires. MethodsThe SF-36, a generic HRQOL instrument, and symptom specific scales examining vision, fatigue, pain and bladder function were administered to individuals with FRDA and analyzed by comparison with disease features. Multiple linear regression models were used to study independent effects of genetic severity and age. Assessments were performed at baseline then intermittently after that. ResultsSubjects were on average young adults. For the SF36, the subscale with the lowest HRQOL score was the physical function scale, while the emotional well-being score was the highest. The physical function scale correlated with age of onset, duration, and subject age. In assessment of symptom specific scales, bladder control scores (BLCS) correlated with duration and age, while impact of visual impairment scores (IVIS) correlated with duration. In linear regression models, the BLCS, Pain Effect Score, and IVIS scores were predicted by age and GAA length; modified fatigue impact scale scores were predicted only by GAA length. Physical function and role limitation scores declined over time. No change was seen over time in other SF-36 subscores. Symptom specific scales also worsened over time, most notably the IVIS and BLCS. ConclusionThe SF-36 and symptom specific scales capture dysfunction in FRDA in a manner that reflects disease status. HRQOL dysfunction was greatest on physically related scales; such scales correlated with disease duration, indicating that they worsen with progressing disease.

Associations between health-related quality of life and health care costs among children with atopic dermatitis and their caregivers: A cross-sectional study.

Atopic dermatitis is associated with a decreased health-related quality of life and contributes to substantial health care costs. It is important to understand what accelerates health care costs to inform various stakeholders, so they can effectively meet health care needs. This cross-sectional study aims to explore associations between health-related quality of life, health care costs, and cost-accelerating variables. Information on health-related quality of life (HRQoL) was collected through generic and disease-specific instruments from caregivers and children <16years of age with a physician-confirmed diagnosis of atopic dermatitis. The economic impact of atopic dermatitis was evaluated by analyzing information on health service utilization and other health care costs related to managing the condition. Children with high impact on health-related quality of life presented an annual health care cost of US$3787 compared with US$2548 for moderately impacted and US$2258 among children for which the condition had low impact. The severity of atopic dermatitis, disease duration, and a lower health-related quality of life was associated with greater health care costs. Analyses of subdomains of health-related quality of life revealed correlations between "mood" and "personal relationships" on one hand and caregivers' physical health and health care costs on the other hand. Highly affected HRQoL is associated with increased health care costs and could be a valuable complement to traditional severity assessments. By using HRQoL instruments, burdens and symptoms beyond severity can be identified and addressed with interventions to increase HRQoL and subsequently reduce health care costs.

Rasch model of the child perceptions questionnaire in multi-country data

ObjectiveTo be fit-for-purpose, oral health-related quality of life instruments must possess a range of psychometric properties which had not been fully examined in the 16-item Short Form Child Perceptions Questionnaire for children aged 11 to 14 years (CPQ11-14 ISF-16). We used advanced statistical approaches to determine the CPQ’s measurement accuracy, precision, invariance and dimensionality and analyzed whether age range could be extended from 8 to 15 years. MethodsFit to the Rasch model was examined in 6648 8-to-15-year-olds from Australia, New Zealand, Brunei, Cambodia, Hong Kong, Malaysia, Thailand, Germany, United Kingdom, Brazil and Mexico. ResultsIn all but two items, the initial five answer options were reduced to three or four, to increase precision of the children’s selection. Items 10 (Shy/embarrassed) and 11 (Concerned what others think) showed an ‘extra’ dependency between item scores beyond the relationship related to the underlying latent construct represented by the instrument, and so were deleted. Without these two items, the CPQ was unidimensional. The three oral symptoms items (4 Food stuck in teeth, 3 Bad breath and 1 Pain) were required for a sufficient person-item coverage. In three out of 14 items (21 %), Europe and South America showed regional differences in the patterns of how the answer options were selected. No differential item functioning was detected for age. ConclusionExcept for a few modifications, the present analysis supports the combination of items, the cross-cultural validity of the CPQ with 14 items and the extension of the age range from 8 to 15 years. Clinical significanceThe valid, reliable, shortened and age-extended version of the CPQ resulting from this study should be used in routine care and clinical research. Less items and a wider age range increase its usability. Symptoms items are needed to precisely differentiate between children with higher and lower quality of life.

Adaptation of MacNew Heart Disease Health-Related Quality of Life Instrument in Indonesian Myocardial Infarction Patients

Abstract Lack of adapted health-related quality of life measurement in Bahasa Indonesia may create difficulties in concluding the effects of heart disease and its treatment on a patient's health-related quality of life in Indonesia. MacNew heart disease health-related quality of life questionnaire (MacNew) has been proven a valid and reliable health-related quality of life measurement. It also has been adapted in several languages. This study aimed at translating and assessing the Indonesian version of MacNew questionnaire validity evidence based on the relation with other variables on and internal consistency. Validity evidence based on the relation with other variables was assessed by correlating the Indonesian version of the MacNew questionnaire score with cardiac anxiety, gender, age, education level, left ventricular ejection fraction score, and comorbidity. Two hundred thirty-six patients diagnosed with myocardial infarction (MI) filled out the questionnaire at a one-time intake. Results from confirmatory factor analysis revealed three domains of health-related quality of life, namely emotional, physical, and social. The three-domain explained 42.31% of the health-related quality of life total variance. The internal consistency of the questionnaire was good (0.816-0.900). Health-related quality of life was negatively correlated with cardiac anxiety. Male patients had a higher health-related quality of life compare to female patients. However, there was no significant correlation between health-related quality of life and left ventricular ejection fraction and comorbidity. The Indonesian version of MacNew questionnaire demonstrated satisfactory psychometric properties and can be recommended to measure HRQOL in heart patients in Indonesia. Keywords: Health-related quality of life , MacNew Heart Disease HRQOL instrument, instrument adaptation

The Outcome of Unilateral Cochlear Implantation in Adults: Speech Recognition, Health-Related Quality of Life and Level of Anxiety and Depression: a One- and Three-Year Follow-Up Study.

Introduction Hearing impairment is a common disease worldwide, with a comprehensive impact, and cochlear implantation (CI) is an intervention for profound hearing impairment. Objective To study the outcome one and three years after unilateral CI on hearing, health-related quality of life and level of depression and anxiety, and the correlation between the outcomes. Second, to study whether age, gender, etiology, operated side, residual hearing or cognitive performance can predict the outcome. Methods A prospective longitudinal study including adults with profound postlingual hearing impairment, with respect to hearing (speech recognition), health-related quality of life (Health Utilities Index 3) and level of depression and anxiety (Hospital Anxiety and Depression scale), pre-CI, and one and three years post-CI. The total sample was composed of 40 participants (40% of men), with a mean age of 71 years. Results Speech recognition and the overall health-related quality of life improved one year post-CI ( p = 0.000), without correlation (ρ= 0.27), and with no difference three years post-CI. The hearing attribute (in the health-related quality of life instrument) improved one and three years post-CI ( p = 0.000). The level of anxiety did not change one and three years post-CI. The level of depression improved one year post-CI ( p = 0.036), and deteriorated three years post-CI ( p = 0.031). Age, etiology, operated side, residual hearing and cognitive performance did not predict the outcome, but the female gender did significantly improve speech recognition compared with men ( p = 0.009). Conclusion The CI significantly improved speech recognition, health-related quality of life and level of depression one year post-CI without mutual correlation, and women performed significantly better than men. There were no further improvements three years post-CI, apart from the hearing attribute.

Validation of the German HeartQoL: a short health-related quality of life questionnaire for cardiac patients

PurposeThe aim of this study was to evaluate psychometric properties of the core disease-specific 14-item German HeartQoL questionnaire.MethodsAs an extension of the international HeartQol Project, cross-sectional and longitudinal health-related quality of life (HRQL) data were collected from 305 patients with angina (N = 101), myocardial infarction (N = 123), or ischemic heart failure (N = 81) in Austria and Switzerland using German versions of the HeartQoL, the Short Form-36 Health Survey (SF-36), and the Hospital Anxiety and Depression Scale. The underlying factor structure was examined with Mokken Scaling analysis; then convergent, divergent, and discriminative validity, internal consistency reliability, and responsiveness were assessed.ResultsThe highest HRQL scores were reported by patients with myocardial infarction followed by ischemic heart failure and then angina. The two-factor structure was confirmed with strong physical, emotional, and global scale H coefficients (> .50). Divergent and convergent validity (from r = .04 to .78) were shown for each diagnosis; discriminative validity was verified as well (partially: age, sex, and disease severity; largely: SF-36 health status/transition; totally: anxiety and depression). Internal consistency reliability was excellent (Cronbach’s alpha = .91). In terms of responsiveness, physical and global scale scores improved significantly after percutaneous coronary intervention (p < .01) while after cardiac rehabilitation all scale scores improved significantly (p < .001).ConclusionsThe German HeartQoL questionnaire is a valid and reliable HRQL instrument with these data supporting its potential use in clinical practice and research to assess and compare HRQL in German-speaking patients with ischemic heart disease. The shortness of the tool may prove to be helpful particularly in clinical practice.

Pelvic organ prolapse surgery and quality of life—a nationwide cohort study

Patient satisfaction and health-related quality of life are nowadays considered as the most important outcomes of pelvic organ prolapse treatment, and large, prospective clinical studies reporting the patient-reported surgical outcomes are needed. To evaluate the effect of female pelvic organ prolapse surgery on health-related quality of life and patient satisfaction and to determine predictors of outcome. This prospective nationwide cohort study consisted of 3515 women undergoing surgery for pelvic organ prolapse in 2015. The outcomes were measured by validated health-related quality of life instruments (generic 15D, Pelvic Floor Distress Inventory-20, and Patient Global Impression of Improvement) at 6 months and 2 years postoperatively. The baseline predictors of outcomes were studied with logistic regression analysis. In total, 2528 (72%) women were eligible for analysis at 6 months and 2351 (67%) at 2 years. The mean change in the total 15D score suggested a clinically important improvement at 6 months but not at 2 years. However, an improvement in sexual activity, discomfort and symptoms, and excretion was observed during both follow-up assessments. Altogether, 77% and 72% of the participants reported a clinically significant improvement in Pelvic Floor Distress Inventory-20 at the 6-month and 2-year follow-ups, respectively. A total of 84% were satisfied with the outcome and 90% reported an improvement in comparison with the preoperative state with Patient Global Impression of Improvement-I. The strongest predictive factors for a favorable outcome were advanced apical prolapse (adjusted odds ratio, 2.06; 95% confidence interval, 1.58-2.70) and vaginal bulge (1.90, 1.30-2.80). Smoking was associated with an unfavorable outcome as measured by Patient Global Index of Improvement-I (1.69, 1.02-2.81). Pelvic organ prolapse surgery improved health-related quality of life in 7 of 10 patients over a 2-year follow-up period, and patient satisfaction was high. Apical prolapse beyond the hymen and vaginal bulge were the most consistent predictors for improvement. Our results suggest that patients should be encouraged to stop smoking to avoid an unfavorable outcome.

The construct validity of the Child Health Utility 9D-DK instrument

BackgroundRelative to their application with adults there is currently little information about the application of preference-based health-related quality of life (HRQL) instruments among populations of young people. The Child Health Utility 9D (CHU9D) is a paediatric-specific generic preference-based HRQL instrument, recently translated and linguistically validated into Danish (CHU9D-DK). The purpose of this study was to investigate the construct validity of the CHU9D-DK in a sample of Danish high school students.MethodsAll students attending a Danish High School were invited to participate in a web-based survey in January 2018 (N = 272). The survey included the CHU9D-DK, the young adult version of the Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales (PedsQL), self-reported health status, presence/absence of disability/chronic diseases, life satisfaction, and socio-economic questions. CHU9D-DK utility scores were generated by employing the two scoring algorithms developed from adults in the UK and adolescents in Australia, respectively. Internal consistency, reliability and construct validity of the CHU9D-DK instrument were investigated.ResultsTwo hundred and twenty-eight (84%) students consented to participate and completed the survey. The mean ± (standard deviation) values of the CHU9D-DK utilities were 0.84 (0.11) when the UK adult algorithm was applied and 0.70 (0.22), when the Australian adolescent algorithm was applied. The mean PedsQL score was 82.32 (13.14). The CHU9D-DK showed good internal consistency reliability (Cronbach’s alpha = 0.803). Higher levels of health status and life satisfaction were significantly associated with higher CHU9D-DK utility scores regardless of which scoring algorithm was applied (p-values < 0.001). Students living with a disability/chronic disease exhibited significantly lower utility scores relative to their healthy peers (p-values < 0.05). Higher socio-economic status (approximated by financial situation and frequency of family vacations) was also associated with higher utility scores (p-values < 0.005).ConclusionThe CHU9D-DK demonstrated good psychometric performance overall and shows potential as a valid and reliable instrument for assessing the HRQL of Danish young people.Trial registrationClinicalTrials.gov identifier: NCT03391999, Registered 15 October 2017.

Informational Practices of Postacute Brain Injury Patients During Personal Recovery: Qualitative Study.

BackgroundThe effects of brain injury, structural damage, or the physiological disruption of brain function last far beyond initial clinical treatment. Self-tracking and management technologies have the potential to help individuals experiencing brain injury in their personal recovery—helping them to function at their best despite ongoing symptoms of illness. However, current self-tracking technologies may be unsuited for measuring the interconnected, nonlinear ways in which brain injury manifests.ObjectiveThis study aimed to investigate (1) the current informational practices and sensemaking processes used by postacute brain injury patients during personal recovery and (2) the potential role of quality-of-life instruments in improving patient awareness of brain injury recovery, advocacy, and involvement in care used outside the clinical context. Our objective was to explore the means of improving awareness through reflection that leads to compensatory strategies by anticipating or recognizing the occurrence of a problem caused by impairment.MethodsWe conducted a qualitative study and used essentialist or realist thematic analysis to analyze the data collected through semistructured interviews and questionnaires, 2 weeks of structured data collection using brain injury–specific health-related quality of life instrument, quality of life after brain injury (QoLIBRI), and final interviews.ResultsInformational practices of people with brain injury involve data collection, data synthesis, and obtaining and applying the insights to their lifestyles. Participants collected data through structured tools such as spreadsheets and wearable devices but switched to unstructured tools such as journals and blogs as changes in overall progress became more qualitative in nature. Although data collection helped participants summarize their progress better, the lack of conceptual understanding made it challenging to know what to monitor or communicate with clinicians. QoLIBRI served as an education tool in this scenario but was inadequate in facilitating reflection and sensemaking.ConclusionsIndividuals with postacute brain injury found the lack of conceptual understanding of recovery and tools for making sense of their health data as major impediments for tracking and being aware of their personal recovery. There is an urgent need for a better framework for recovery and a process model for choosing patient-generated health data tools that focus on the holistic nature of recovery and improve the understanding of brain injury for all stakeholders involved throughout recovery.

Mapping WOMAC Onto the EQ-5D-5L Utility Index in Patients With Hip or Knee Osteoarthritis

ObjectivesTo map the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) onto the EQ-5D-5L in patients with hip or knee osteoarthritis (OA). MethodsA prospective observational study was conducted on 758 patients with hip or knee OA who completed the EQ-5D-5L and WOMAC questionnaires, of whom 644 completed them both again 6 months later. Baseline data were used to derive mapping functions. Generalized additive models were used to identify to which powers the WOMAC subscales should be raised to achieve a linear relationship with the response. For the modeling, general linear models (GLM), Tobit models, and beta regression models were used. Age, sex, and affected joints were also considered. Preferred models were selected based on Akaike and Bayesian information criteria, adjusted R2, mean absolute error (MAE), and root mean squared error (RMSE). The functions were validated with the follow-up data using MAE, RMSE, and the intraclass correlation coefficient. ResultsThe preferred models were a GLM with Pain2+Pain3+Function+Pain·Function as covariates and a beta model with Pain3+Function+Function2+Function3 as covariates. The adjusted R2 were similar (0.6190 and 0.6136, respectively). The predictive performance of these models in the validation sample was similar and both models showed an overprediction for health states worse than death. ConclusionTo our knowledge, these are the first functions mapping the WOMAC onto the EQ-5D-5L in patients with hip or knee OA. They showed an acceptable fit and precision and could be very useful for clinicians and researchers when cost-effectiveness studies are needed and generic preference-based health-related quality of life instruments to derive utilities are not available.

Systematic collection of patient-reported outcomes in atrial fibrillation: feasibility and initial results of the Utah mEVAL AF programme.

Incorporating patient-reported outcomes (PROs) into routine care of atrial fibrillation (AF) enables direct integration of symptoms, function, and health-related quality of life (HRQoL) into practice. We report our initial experience with a system-wide PRO initiative among AF patients. All patients with AF in our practice undergo PRO assessment with the Toronto AF Severity Scale (AFSS), and generic PROs, prior to electrophysiology clinic visits. We describe the implementation, feasibility, and results of clinic-based, electronic AF PRO collection, and compare AF-specific and generic HRQoL assessments. From October 2016 to February 2019, 1586 unique AF patients initiated 2379 PRO assessments, 2145 of which had all PRO measures completed (90%). The median completion time for all PRO measures per visit was 7.3 min (1st, 3rd quartiles: 6, 10). Overall, 38% of patients were female (n = 589), mean age was 68 (SD 12) years, and mean CHA2DS2-VASc score was 3.8 (SD 2.0). The mean AFSS symptom score was 8.6 (SD 6.6, 1st, 3rd quartiles: 3, 13), and the full range of values was observed (0, 35). Generic PROs of physical function, general health, and depression were impacted at the most severe quartiles of AF symptom score (P < 0.0001 for each vs. AFSS quartile). Routine clinic-based, PRO collection for AF is feasible in clinical practice and patient time investment was acceptable. Disease-specific AF PROs add value to generic HRQoL instruments. Further research into the relationship between PROs, heart rhythm, and AF burden, as well as PRO-guided management, is necessary to optimize PRO utilization.

Health-related quality of life and exercise-based cardiac rehabilitation in contemporary acute coronary syndrome patients: a systematic review and meta-analysis.

To review the literature on health-related quality of life (HRQoL) outcomes for exercise-based cardiac rehabilitation (EBCR) in contemporary acute coronary syndrome (ACS) patients. Electronic databases (CENTRAL, MEDLINE, Embase, and CINAHL) were searched from January 2000 to March 2019 for randomised controlled trials (RCTs) comparing EBCR to a no-exercise control in ACS patients recruited after year 2000, follow-up of at least 6months, and HRQoL as outcome. Potential papers were independently screened by two reviewers. Risks of bias were assessed using the Cochrane Tool. Data analyses were performed using RevMan v5.3, random effects model. Fourteen RCTs (1739 participants) were included, with eight studies suitable for meta-analyses. EBCR resulted in statistically significant and clinically important improvements in physical performance (mean difference [MD] 7.09, 95% CI 0.08, 14.11) and general health (MD 5.08, 95% CI 1.03, 9.13) (SF-36) at 6months, and in physical functioning (MD 9.82, 95% CI 1.46, 18.19) at 12months. Statistically significant and sustained improvements were also found in social and physical functioning. Meta-analysis of two studies using the MacNew Heart Disease HRQoL instrument did not show any significant benefits. Of the six studies unsuitable for meta-analyses, five reported significant changes in overall HRQoL, general physical activity levels and functional capacity, or quality-adjusted life-years (QALYs). In an era where adherence to clinical practice guidelines has improved survival, EBCR still achieves clinically meaningful improvements in physical performance, general health, and physical functioning in the short and long term in contemporary ACS patients.

PSY45 PATIENT-REPORTED OUTCOMES USED IN CLINICAL TRIALS OF SYSTEMIC LUPUS ERYTHEMATOSUS: A REVIEW OF SUITABILITY FOR FDA LABELLING CLAIMS

This review sought to identify patient-reported outcome (PRO) instruments that have been used in clinical trials of systemic lupus erythematosus (SLE) and examine their suitability for FDA labelling claims, based on proximity of the concept they measure to symptoms of SLE and evidence of content validity in SLE patients. A search was conducted on clinicaltrials.gov to identify PROs used as primary and/or secondary endpoints in SLE clinical trials. A literature review of identified PROs was then conducted, examining their structure, the concept they measure and evidence of content validity as per FDA standards, including involvement of SLE patients in instrument development. 49 different PRO instruments, used across 129 trials, were identified. The majority (39) measured multi-dimensional constructs or distal concepts of disease, including health-related quality of life (HRQOL), impacts on mental function (depression, anxiety, stress, anger), cognition, physical activity, sleep, social functioning and work performance, as well as self-management/efficacy, coping strategies and global impression of change. 10 identified PROs measured proximal concepts/symptoms of disease, namely fatigue and pain. Out of all 49 instruments that were identified, only 4 PROs, all HRQOL instruments, were SLE-specific and three of those, the LupusQoL, LupusPro and SLEQOL, had satisfactory evidence of content validity. A further review of these three instruments revealed that only LupusQOL contained domains that measure well-defined and proximal concepts/symptoms of disease, namely pain and fatigue. Despite a considerable number of PROs that have been used in SLE clinical trials, only three instruments had satisfactory evidence of content validity in SLE patients in line with FDA standards. Only one of these instruments, the LupusOOL, contains domains measuring proximal concepts/symptoms of disease (pain and fatigue) that could be considered suitable for inclusion in endpoint models in SLE drug development with intended PRO-based labelling claims in the US.

PCN481 METHODOLOGICAL ASPECTS OF HEALTH-RELATED QUALITY OF LIFE MEASUREMENT IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER IN CLINICAL TRIALS: A SYSTEMATIC REVIEW.

HER2-positive breast cancer is characterized by the overexpression of human epidermal growth factor receptor 2 (HER2) and is associated with poor prognosis. While there is no cure for HER2-positive metastatic breast cancer (MBC), survival outcomes have improved over the last decade due to the availability of novel agents. Health-related quality of life (HRQoL) data is becoming increasingly important to understand the long-term treatment impact on patients’ well-being. This systematic review aimed to identify the methodological aspects of HRQoL measurement among HER2+ MBC patients and critically appraise their strengths and weaknesses. A comprehensive search was conducted using PubMed, Embase, and Cochrane from database initiations to March 30, 2019, to identify publications of HER2+ MBC clinical trials that have reported HRQoL data in the English language. Following the PRISMA guideline, we screened 1566 articles and identified 14 studies that met our inclusion and exclusion criteria. Seven HRQoL instruments (EORTC QLQ-C30, FACT-G, FACT-B, FACT-B TOI, EORTC QLQ-BR23, FACT-Br, and EORTC QLQ-BN20) were identified, among which FACT-Br and EORTC QLQ-BN20 were used in breast cancer with brain metastasis. Five out of the fourteen studies used more than one instrument. Across the seven instruments, EORTC QLQ-C30 (9/14 studies) was most frequently used. All publications reported HRQoL as secondary endpoints. The literature demonstrates the complementary value of HRQoL when assessing clinical effectiveness and safety outcomes. However, significant diversity in the applied HRQoL instruments, the HRQoL assessment strategies, the timing of HRQoL data collection, and the data analysis methods was noted. Notably, non-response(NR) rates to HRQoL questionnaire as high as 26-38% were observed, but the impact of NR was not discussed in most of the studies. The development of standardized best practice guidelines in breast cancer HRQoL data collection and analysis is recommended to improve data quality to assist evidence-based clinical decision making.

Unsupervised neural network for evaluating the ability of the SF-36 instrument to differentiate individuals.

Health-related quality of life (HRQoL) and well-being refer to the positive, subjective state that is contrary to illness. HRQoL instruments include some common questionnaires, which may often be understood differently depending on the level of individuals' knowledge. To investigate the ability of 36 Short Form Health Survey (SF-36) as a well-known questionnaire in evaluating people's well-being. We compared unsupervised artificial neural networks with a self-organized map learning algorithm and k-means clustering method. Understanding of the content of the questionnaire was also checked according to age group and sex. The study included 1087 people aged > 18 years (640 healthy individuals and 447 patients with chronic diseases) in Shiraz, Islamic Republic of Iran between 2011 and 2013. The eight subscale scores of the SF-36 instrument were not able to evaluate the well-being of people. The ability of all 36 items in the questionnaire was > 60% in both self-organized map and k-means methods. The self-organized map learning algorithm evaluated people better than the k-means clustering method, based on the accuracy rate in prediction. The SF-36 instrument was better understood by young people. Differences in people's health conditions may not appear on the SF-36 subscale scores; therefore, the findings from the subscale scores of SF-36 should be cautiously interpreted.

PDB99 UNDERSTANDING THE HUMANISTIC BURDEN AND PATIENT IMPACT IN NON-ALCOHOLIC STEATOHEPATITIS (NASH)

NASH is a chronic and progressive form of non-alcoholic fatty liver disease (NAFLD) leading to cirrhosis and hepatocellular carcinoma (HCC). NAFLD is associated with significant impairment in health-related quality of life (HRQoL), but the humanistic burden of NASH is still unclear. This review aimed to understand the evidence defining the impact of NASH on patients’ QoL. A structured literature review across multiple databases was conducted to investigate the QoL, patient reported outcomes (PRO) and productivity in NASH patients. Searches were restricted to publications reporting on NASH, English language and articles published between January 2009 and May 2019. A grey literature search was also conducted. In total, only 13 publications were found reporting on the humanistic burden of NASH - the majority of studies demonstrated an impairment in HRQoL with poor physical and mental health across multiple PRO measures. No publications reported on the HRQoL in patients with early stages of NASH; however, four publications reported that NASH patients overall experience a range of symptoms, including pain, fatigue, anxiety and depression, and two publications reported a loss in productivity. A recent study showed that NASH patients with cirrhosis (F4) had lower physical health-related scores than with bridging fibrosis (F3) in all but one domain of CLDQ-NASH, SF-36, and EQ-5D HRQoL instruments (p≤0.01). Cirrhosis also poses a substantial emotional and financial burden to patients and caregivers, but not this has not been investigated specifically in NASH. Overall, HRQoL is significantly impaired in NASH patients; however, there is a gap in the literature for HRQoL in NASH with early stages of fibrosis. Additionally, there is a lack of data on the wider humanistic burden of NASH, including loss of productivity, activities of daily living and caregiver burden, highlighting that further research is needed.

Quality of life of patients on treatment for latent tuberculosis infection: a mixed-method study in Stockholm, Sweden

BackgroundUnlike active tuberculosis, latent tuberculosis infection (LTBI) is asymptomatic and often considered not to affect the health-related quality of life (HRQoL) of patients. However, being diagnosed with and treated for LTBI can be associated with adverse clinical evens such side effects of treatment as well as psychosocial challenges. Therefore, the aims of this study were to qualitatively explore patients’ experiences during diagnosis and treatment of LTBI in Stockholm measure their HRQoL, and contrast and merge the results to better understand how the HRQoL of these patients is affected.MethodsLTBI patients who were treated in Stockholm during September 2017 and June 2018and who fulfilled the inclusion criteria were invited to fill a survey that included a HRQoL instrument, EQ-5D-3 L, and a mental health screening instrument, RHS-15. After filling the survey, a subset of these patients was asked to participate in an interview with open-ended questions that focused on their experiences during the diagnosis and treatment.ResultsIn total 108 participants filled that survey and interviews were conducted with 20 patients. Patients scored relatively high on EQ-5D: the scores of utility and VAS scale are similar to those reported by the general population of Stockholm. Very few patients reported problems on the physical health domains of EQ-5D which was supported by the quantitative data that showed no effect on physical health and usual activity. Thirty-eight percent screened positive for RHS-15 and 27.8% reported problems with anxiety/depression domain of EQ-5D which could be related to many stressing factors mentioned in the interviews such as: fear and distress related to lack of clarity about LTBI diagnosis, perceived risk of infecting others and uncertainties about the future.ConclusionThe quantified HRQoL of LTBI patients in Stockholm is similar to the general population and there is thus no HRQoL decrements that is detectable with EQ-5D. However, the study reinforces the importance of tackling anxiety and fear and ensuring good health information for persons diagnosed with and treated for LTBI.

Health-Related Quality of Life in Children With Low Language or Congenital Hearing Loss, as Measured by the PedsQL and Health Utility Index Mark 3

ObjectivesTo examine health-related quality of life (HRQoL) in young children with low language or congenital hearing loss and to explore the value of assessing HRQoL by concurrently administering 2 HRQoL instruments in populations of children. MethodsData were from 2 Australian community-based studies: Language for Learning (children with typical and low language at age 4 years, n = 1012) and the Statewide Comparison of Outcomes study (children with hearing loss, n = 108). HRQoL was measured using the parent-reported Health Utilities Index Mark 3 (HUI3) and the Pediatrics Quality of Life Inventory 4.0 (PedsQL) generic core scale. Agreement between the HRQoL instruments was assessed using intraclass correlation and Bland-Altman plots. ResultsChildren with low language and with hearing loss had lower HRQoL than children with normal language; the worst HRQoL was experienced by children with both. The lower HRQoL was mainly due to impaired school functioning (PedsQL) and speech and cognition (HUI3). Children with hearing loss also had impaired physical and social functioning (PedsQL), vision, hearing, dexterity, and ambulation (HUI3). Correlations between instruments were poor to moderate, with low agreement. ConclusionsChildren with low language and congenital hearing loss might benefit from interventions targeting overall health and well-being, not just their impairments. The HUI3 and PedsQL each seemed to provide unique information and thus may supplement each other in assessing HRQoL of young children, including those with low language or congenital hearing loss.

Bayesian Hierarchical Models for Meta-Analysis of Quality-of-Life Outcomes: An Application in Multimorbidity.

Health-related quality of life (HRQoL) is a key outcome in cost-utility analyses, which are commonly used to inform healthcare decisions. Different instruments exist to evaluate HRQoL, however while some jurisdictions have a preferred system, no gold standard exists. Standard meta-analysis struggles with the variety of outcome measures, which may result in the exclusion of potentially relevant evidence. Using a case study in multimorbidity, the objective of this analysis is to illustrate how a Bayesian hierarchical model can be used to combine data across different instruments. The outcome of interest is the slope relating HRQoL to the number of coexisting conditions. We propose a three-level Bayesian hierarchical model to systematically include a large number of studies evaluating HRQoL using multiple instruments. Random effects assumptions yield instrument-level estimates benefitting from borrowing strength across the evidence base. This is particularly useful where little evidence is available for the outcome of choice for further evaluation. Our analysis estimated a reduction in quality of life of 3.8-4.1% per additional condition depending on HRQoL instrument. Uncertainty was reduced by approximately 80% for the instrument with the least evidence. Bayesian hierarchical models may provide a useful modelling approach to systematically synthesize data from HRQoL studies.