A questionnaire for rating health-related quality of life

Background Translations of instruments for measuring quality of life developed in certain, mostly more developed, parts of the world usually do not cover regionally specific aspects of health-related quality of life, even after transcultural validation. The aim of this study was to develop and validate a reliable questionnaire in Serbian, Croatian, Bosnian, and Montenegrin languages suitable for measuring health-related quality of life in adults. Methods The study was of a cross-sectional type, assessing the reliability and validity of a newly developed questionnaire for measuring health-related quality of life (HRQoL) in adults residing in western Balkan states (WB-HRQoL). It was conducted on a sample of 489 adults from Serbia, Croatia, Bosnia & Herzegovina, and Montenegro, with a mean age of 52.2±14.4 years and a male/female ratio of 195/294 (39.9%/60.1%). Result The definitive version of the WB-HRQoL scale with 19 items showed very good reliability, with Cronbach’s alpha 0.905. The scale was temporally stable, and satisfactory results were obtained for divergent and convergent validity tests. Exploratory factorial analysis brought to the surface four domains of health-related quality of life, namely the physical, psychical, social, and environmental. Conclusion The WB-HRQoL scale is a reliable and valid generic instrument for measuring HRQoL that takes into account the cultural specifics of the western Balkan region.

A Brazilian Portuguese translation, cultural adaptation and validation of the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) health-related quality of life (HRQOL) scale

Introduction The health-related quality of life (HRQOL) of patients with tachyarrhythmia can be negatively influenced by the clinical manifestations. The evaluation of HRQOL with validated instruments can provide valuable information that will contribute to clinical decision-making and treatment. In Brazil, however, there is no available scale that evaluates HRQOL in different types of arrhythmia. The purpose of this study was to adapt the Arrhythmia-Specific Questionnaire in Tachycardia and Arrhythmia-HRQOL scale (ASTA-HRQOL scale) to the Brazilian culture, and to assess the psychometric properties of the adapted questionnaire. Methods The study used a methodological process of cultural adaptation based on international literature guidelines. The analyses were performed with 172 participants, 32 for cultural adaptation and 140 for psychometric validation. Calculation included analysis of reliability by Cronbach’s α coefficient, construct validity with convergent validity using the WHOQOL-BREF questionnaire and by the Spearman correlation coefficient, Average Variance Extracted, and assessment of confirmatory factor analysis. Results The translation and adaptation processes showed a satisfactory degree of comprehension and applicability (93% reported them to be easy to understand). Confirmatory factor analysis indicated exclusion of one item from the mental scale, but after qualitative analysis the item was retained. The items presented adequate internal consistency (Cronbach’s alpha coefficient = 0.88), and an inverse correlation of moderate magnitude with the physical domain (rho = -0.63) and with the mental domain (rho = -0.58) of the WHOQOL-BREF. Conclusions The Brazilian Portuguese version of the ASTA-HRQOL scale, the ASTA-Br-HRQOL scale, can be a valuable tool for use in clinical practice and research.

Weight Loss Improves HRQOL Physical Function and Vitality More in Blacks Than Whites

Participant-reported outcomes are important. Prior MOVE UP reports show ≥5% weight loss was not significantly associated with depressive symptoms but was associated with positive SPPB physical function and the Physical Component Score of the SF-36 HRQOL scale. We examined the SF-36 subscales that showed, a priori, clinically meaningful +5.0-point increases over 13 months, the change in subscales per 5% weight loss, and variability by race. Among all participants (n =240) several subscales show significant pre-post changes [mean (SD)] but only Vitality [+5.6 (15.4)] and Physical Function [+5.0 (16.7)] meet the criterion. Blacks (n = 60) compared to Whites (n = 172) had higher baseline scores on these subscales, were less likely to lose ≥5% (31.7% vs. 59.9%), but mixed regression models indicate that those who did demonstrated a larger change on Vitality (+5.2; p<0.048) than Whites (+3.1; p<0.0003). Studying weight loss and HRQOL associations in larger minority samples is needed.

Abstract 17277: Holistic Health-Related Quality of Life in Older Adults Undergoing Transcatheter Aortic Valve Replacement

Introduction: Health-related quality of life (HRQoL) is a prioritized outcome for older adults undergoing transcatheter aortic valve replacement (TAVR). Previous studies have used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to evaluate HRQoL, which is heavily weighted on heart failure symptoms with only one question on mental wellbeing. We sought to determine the incidence and determinants of poor HRQoL using a novel holistic scale. Methods: The FRAILTY-AVR prospective multi-centre cohort study of older adults undergoing TAVR was used to develop a holistic HRQoL scale. Construct validity was evaluated using the Spearman’s rank correlation with the 12-item KCCQ, and clinically meaningful change was evaluated using the anchor-based method. The primary endpoint was “poor outcome” defined as all-cause mortality or clinically meaningful decrease in HRQoL at 1 year. Results: The cohort consisted of 693 patients with a mean age of 82.9 years and 47% females. A 23-item HRQoL scale was developed, with the total score ranging from 0 (worst) to 40 (best) across 5 domains: disease burden (3 items), general health (1 item), physical (6 items), mental (5 items), and social (8 items) functioning. This scale was correlated with the KCCQ (Spearman’s rho 0.56, P<0.0001) and a 3-unit change was found to be clinically meaningful in longitudinal follow-up. A total of 269 (39%) patients experienced a poor outcome at 1 year post-TAVR, including 144 (21%) deaths. The predictors of poor outcome were Essential Frailty Toolset score >=3 [OR 1.88; 95% CI 1.28, 2.76], mean aortic gradient <40 mmHg [OR 1.83; 95% CI 1.27, 2.63] and Charlson comorbidity index [OR 1.09; 95% CI 1.01, 1.18]. Conclusions: Two of five patients had a poor outcome 1 year post-TAVR, despite a procedure success rate of 95%. The incidence and determinants of poor outcome using our holistic HRQoL scale, notably the impact of frailty, are highly consistent with previous studies using the KCCQ. These determinants should be integrated in patient-centered decision making and optimized to improve HRQoL post-procedure.

NCOG-16. THE IMPACT OF THE TIMING OF HEALTH-RELATED QUALITY OF LIFE ASSESSMENTS ON THE ACTUAL RESULTS IN GLIOMA PATIENTS: A RANDOMIZED PROSPECTIVE STUDY

BACKGROUND The aim of this study was to explore the impact of the timing of health-related quality of life (HRQoL) measurements in clinical care on obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression. METHODS Patients completed the EORTC Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) at two time points. All patients completed the first measurement on the day of the MRI-scan (t=0), but the second measurement (t= 1) depended on randomization; group 1 (n= 49) completed the questionnaires before and group 2 (n= 51) after the consultation with the physician. RESULTS Median HRQoL scale/item scores on t0/t1 and change scores were comparable between the two groups. Between 8-58% of patients changed to a clinically relevant extent (i.e. ≥ 10 points) on the evaluated HRQoL scales/items in about one week time, in both directions, with only 3% of patients remaining stable in all scales. The mean number of the 26 evaluated HRQoL scales/items that changed to a clinically relevant extent per patient was 7 (SD= 4). Patients with stable role functioning had a lower HADS anxiety change score. However, this association was no longer significant in the multivariable regression when corrected for confounding factors. The HADS depression score was not associated with a change in HRQoL. DISCUSSION Measuring HRQoL before or after the consultation did not impact HRQoL scores on group level. However, the large majority of patients reported a clinically relevant difference in at least one HRQoL scale/item between the two time points, which was in general not influenced by feelings of anxiety or depression. Nevertheless, these findings highlight the importance of a standardized timing (e.g. at the day of the scan, consultation or first day of treatment) of patient-reported outcome assessments in clinical trials.

The Impact of the Timing of Health-Related Quality of Life Assessments on the Actual Results in Glioma Patients: A Randomized Prospective Study

Background: The aim of this study was to explore the impact of the timing of Health-Related Quality of Life (HRQoL) measurements in clinical care on the obtained HRQoL scores in glioma patients, and the association with feelings of anxiety or depression. Methods: Patients completed the European Organisation for Research and Treatment of Cancer (EORTC)’s Quality of Life Questionnaires (QLQ-C30 and QLQ-BN20), and the Hospital Anxiety and Depression Scale (HADS) twice. All patients completed the first measurement on the day of the Magnetic Resonance Imaging (MRI) scan (t = 0), but the second measurement (t = 1) depended on randomization; Group 1 (n = 49) completed the questionnaires before and Group 2 (n = 51) after the consultation with the physician. Results: median HRQoL scale scores on t0/t1 and change scores were comparable between the two groups. Between 8–58% of patients changed to a clinically relevant extent (i.e., ≥10 points) on the evaluated HRQoL scales in about one-week time, in both directions, with only 3% of patients remaining stable in all scales. Patients with a stable role functioning had a lower HADS anxiety change score. The HADS depression score was not associated with a change in HRQoL. Conclusions: Measuring HRQoL before or after the consultation did not impact HRQoL scores on a group level. However, most patients reported a clinically relevant difference in at least one HRQoL scale between the two time points. These findings highlight the importance of standardized moments of HRQoL assessments, or patient-reported outcomes in general, during treatment and follow-up in clinical trials.

Translation of the Child and Adolescent HARDSHIP (Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation) Questionnaire into the Lithuanian Language and Validation of Its HRQoL (Headache-Related Quality of Life) Scale

Recently developed and originally published in English, the Child and Adolescent HARDSHIP (headache-attributed restriction, disability, social handicap and impaired participation) questionnaire is valid and acceptable for the global assessment of the burden of headache in children and adolescents. The present study aimed to translate, adapt and validate a Lithuanian version of this questionnaire. A total of 22 volunteers from 7 to 17 years of age completed the questionnaire with 24 h test-retest and a representative sample of 2505 schoolchildren of the same age participated in the main study. Test-retest reliability of the HRQoL (Headache Related Quality of Life) scale in the translated questionnaire showed substantial agreement (kappa: 0.604). Reliability and validity of the translated HRQoL scale were acceptable (Cronbach’s alpha: 0.749; test-retest kappa: 0.604, test for discriminant validity demonstrated that quality of life decreased by severity of headache). Factorial analysis revealed the two-dimensional structure of the HRQoL scale with indices of good model fit to the collected data. A total of 92.2% of the surveyed children had experienced headache in their lifetime, 74.2% during the last year. Girls and older children experienced headache more often than participants from the other groups. The translated Lithuanian version of the questionnaire seems to be a valid, feasible and acceptable instrument to measure the extent of the burden of headache in large populations.

Symptoms, acceptance of illness and health-related quality of life in patients with atrial fibrillation

Introduction: Acceptance of illness plays a key role, allowing the patient to adapt to the disease and its treatment, and to maintain their health-related quality of life (HRQOL) despite chronic conditions. Aim: The aim of the study was to assess the relationship between severity of arrhythmia symptoms, acceptance of illness and HRQOL in patients with atrial fibrillation. Methods: The study included 99 patients (mean age 64.6) treated for atrial fibrillation. Three standardized instruments were used: the World Health Organization Quality of Life (WHOQoL-BREF) questionnaire, the Arrhythmia-Specific Questionnaire in Tachycardia and Arrhythmia (ASTA) and the Acceptance of Illness Scale (AIS). Results: Patients with high illness acceptance levels obtained better results in all WHOQoL-BREF domains: physical (57.0±8.9 vs. 51.1±12.5 vs. 42.0±6.2; p<0.001), social (62.6±19.8 vs. 52.5±20.0 vs. 45.7±16.0; p=0.019) and environmental (62.9±12.7 vs. 52.7±7.6 vs. 60.7±3.6; p<0.001), and in the ASTA HRQOL scale (10.5±5.4 vs. 16.1±7.6 vs. 20.3±0.5; p<0.001). Multiple-factor analysis showed AIS to be a statistically significant independent determinant of HRQOL in the physical domain of the WHOQoL (β=0.242) and in the overall HRQOL assessment in the ASTA HRQOL scale (β= −0.362). Other statistically significant independent predictors included: the negative impact of female sex on the physical (β= −0.291) and social (β= −0.284) domains of the WHOQOL-BREF, and the positive impact of urban residence on the physical WHOQOL-BREF domain and on symptom intensity in the ASTA symptom scale. Conclusions: Acceptance of illness is an important factor which has been shown to impact on HRQOL in atrial fibrillation. Female sex is a predictor of worse HRQOL, while urban residence improves HRQOL in the physical domain and decreases symptom intensity (ASTA symptom scale).