Health and Quality of Life Outcomes

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Path diagram of the WHODAS 2.0 for dysmenorrhea
Background There is an association of dysmenorrhea with human functioning and disability. However, no patient-reported outcome measure has been developed to assess this construct in women with dysmenorrhea. WHODAS 2.0 has been recognized as an important generic patient-reported outcome information of physical function and disability. Thus, the aim of this study was to assess the measurement properties of the WHODAS 2.0 in women with dysmenorrhea. Methods This is an online and cross-sectional study conducted with Brazilian women aged 14 to 42 years with self-report of dysmenorrhea in the last three months. According to COSMIN, structural validity was evaluated by exploratory and confirmatory factor analysis; internal consistency by Cronbach’s Alpha; measurement invariance by multigroup confirmatory factor analysis between geographic regions of Brazil; and construct validity by correlating WHODAS 2.0 to the Numerical Rating Scale for pain severity. Results One thousand three hundred and eighty-seven women (24.7 ± 6.5 years) with dysmenorrhea participated in the study. WHODAS 2.0 presented a single factor by exploratory factor analysis and adequate model by confirmatory factor analysis (CFI = 0.924, TLI = 0.900, RMSEA = 0.038), excellent internal consistence (α = 0.892) for all items and an invariancy across geographic regions (ΔCFI ≤ 0.01 and ΔRMSEA < 0.015). Correlation between WHODAS 2.0 and numerical rating scale was positive and moderate (r = 0.337). Conclusion WHODAS 2.0 has a valid structure to assess functioning and disability related to dysmenorrhea in women.
 
Flow chart in the study
The standardized estimate of each coefficient in the confirmatory factor analysis model
Application of the Self-Management Efficacy Questionnaire among Patients with Psoriasis (SMEQ-PSO) in clinical practice
Background It is significant for the healthy outcome of patients with psoriasis (PSO) to improve their self-management efficacy. A standardized assessment tool, however, was lacking. Therefore, we aimed to develop a self-management efficacy questionnaire for patients with PSO (SMEQ-PSO) and evaluate its psychometric properties. Methods A cross-sectional study developing clinical evaluation tool was conducted from October 2021 to August 2022. In the process of developing SMEQ-PSO, three phases were involved: item generation, item evaluation, and psychometric evaluation. Results The SMEQ-PSO with five dimensions and 28 items was developed. The questionnaire’s content validity index was 0.976. Exploratory factor analysis indicated a five-factor structure (self-efficacy of psychosocial adaptation, self-efficacy of daily life management, self-efficacy of skin management, self-efficacy of disease knowledge management and self-efficacy of disease treatment management) that explained 62.039% of the total variance. Confirmatory factor analysis indicated appropriate fit of the five-factor model. The overall Cronbach’α coefficient was 0.930, the test-retest reliability was 0.768 and the split half reliability coefficients was 0.952. Conclusions The 28-item SMEQ-PSO is a reliable and valid tool that can be used to assess the self-management efficacy among patients with PSO and provide personalized interventions based on their individual circumstances to improve their health outcomes.
 
Background People with dementia living at home represent a growing group of social care services users in England. Many are unable to complete questionnaires due to cognitive impairment. The ASCOT-Proxy is an adapted version of an established measure, ASCOT, which was developed as a way of collecting social care-related quality of life (SCRQoL) data from this group of service users, either alone or alongside the ASCOT-Carer, a measure of SCRQoL for unpaid carers. The ASCOT-Proxy includes two perspectives, the proxy-proxy perspective (‘My opinion: What I think’) and proxy-person perspective (‘What I think the person I represent thinks’). We aimed to establish the feasibility, construct validity and reliability of the ASCOT-Proxy and ASCOT-Carer, with unpaid carers of people with dementia living at home unable to self-report. We also aimed to establish structural characteristics of the ASCOT-Proxy. Methods Cross-sectional data were collected using self-administered questionnaire (paper or online) among unpaid carers living in England between January 2020 and April 2021. Unpaid carers could take part if they supported someone living with dementia who was unable to self-complete a structured questionnaire. The person living with dementia or their unpaid carer had to use at least one social care service. We used the proportion of missing data to establish feasibility, ordinal exploratory factor analysis to establish structural characteristics, Zumbo’s ordinal alpha for internal reliability, and hypothesis testing for construct validity. We also conducted Rasch analysis. Results We analysed data for 313 carers (62.4(± 12.0) years, 75.7% (N=237) females). We were able to calculate the ASCOT-Proxy-proxy overall score for 90.7% of our sample, the ASCOT-Proxy-person overall score for 88.8% of our sample and in case of the ASCOT-Carer for 99.7% of our sample. As there was an issue with structural characteristics of the ASCOT-Proxy-proxy we conducted Rasch, reliability and construct validity analysis for the ASCOT-Proxy-person and ASCOT-Carer only. Conclusions This was a first study to explore psychometric characteristics of the ASCOT-Proxy and ASCOT-Carer with unpaid carers of people with dementia living at home unable to self-report. There are some aspects of the psychometric characteristics of the ASCOT-Proxy and ASCOT-Carer that warrant further investigation in future. Trial registration NA
 
Flow diagram
Joint associations between domain-specific physical activity and sedentary behavior with EQ5D index in Korean older adults
Abbreviation: physical activity; PA, sedentary behavior; SB, *p < 0.05 with Sedentary behavior ≥ 7 h/day & No PA/week group, #p < 0.05 with Sedentary behavior ≥ 7 h/day & any PA/week group. a=adjust for age, gender, income, material status, education level, disease (hypertension, diabetes, hyperlipidemia, arthritis, osteoporosis)
Purpose This study aims to investigate the association between domain-specific physical activity (PA), sedentary behavior, subjective health perception, and health-related quality of life (HR-QoL) in Korean adults aged ≥ 65 years. Methods This cross-sectional study analyzed 6,004 older adults from the Korean National Health and Nutrition Examination Survey 2017–2020. PA and sedentary behavior were measured using a global PA questionnaire, and HR-QoL was assessed using the EuroQol-5 Dimension (EQ-5D, three-level version). Multiple logistic regression was used to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) after adjusting for confounding parameters. Results Older adults who were physically active at work showed a negative association with subjectively good health and HR-QoL, whereas those physically active in transport or leisure time showed a positive association with subjectively good health and HR-QoL. Older adults highly engaged in sedentary behavior showed a worse perception of health and HR-QoL. Compared to high sedentary behavior and physical activity during leisure time or transport, the EQ-5D index was higher than that of their counterparts. Conclusion Both domain-specific PA and sedentary behavior were significantly associated with older adults’ perception of health and HR-QoL. Interventions are needed to improve HR-QoL by reducing sedentary behavior and encouraging physical activity in transportation or leisure time among adults aged 65 years and above.
 
Distribution of the CMAI-SF total score. Illustration of the absolute number of participants (y-axis) with the respective CMAI-SF score (x-axis). Higher scores indicate more pronounced agitation and aggression, range: 14–70
Scree plot for the principal component analysis (PCA) of the CMAI-SF total score
Background The Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) is a 14-item scale for assessing agitation and aggression, derived from the original 29-item CMAI, and completed by a proxy. Because the CMAI-SF has not yet been validated in German language, the aim of this study is to explore its construct validity. Methods Baseline data from a cluster-randomized trial to evaluate a non-pharmacological complex intervention for people living with dementia (PlwD) and mild cognitive impairment (MCI) were analyzed. The study sample consisted of 97 shared-housing arrangements (SHAs) in Germany, comprising N = 341 residents with mild to severe dementia and MCI. Trained nursing staff collected data by proxy-rating the CMAI-SF, Neuropsychiatric Inventory-Nursing Home Version (NPI-NH), and QUALIDEM. They also conducted the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Results In an exploratory factor analysis, three factors emerged: “aggressive behavior”, “verbally agitated behavior”, and “physically non-aggressive behavior”. The CMAI-SF total score showed good internal consistency (α = .85), and the factors themselves showed adequate internal consistency (α = .75/.76/.73). The CMAI-SF showed convergent validity with the NPI-NH agitation item (r = .66) and the NPI-NH “agitation & restless behavior” factor (r = .82). Discriminant validity was confirmed by a low (r = .28) correlation with the NPI-NH apathy item. Quality of life decreased significantly with agitation, as the CMAI-SF showed a moderate negative correlation with the QUALIDEM total score (r = -.35). Conclusions The 14-item CMAI-SF is a time-efficient, reliable, and valid assessment instrument. Three factors emerged that were similar to those already found in nursing home samples for the original CMAI and the CMAI-SF and in day care samples for the CMAI-SF. The findings provide preliminary evidence that the CMAI-SF can be used instead of the CMAI to reduce time, costs, and burden in future trials. Trial registration The DemWG study from which data were used to draft this manuscript was prospectively registered on 16 July 2019 at ISRCTN registry (ISRCTN89825211).
 
Violin plots reporting EQ-5D-5L utility scores (left) and EQ-VAS scores (right) between female and male groups, respectively. p-values for the differences between sexes were computed using the Student’s t-test
Correlations for knee function (KOOS-PS and Pain-VAS scores) and HRQoL. The Spearman's rank correlation coefficients are computed among EQ-5D-5L dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression), EQ-5D-5L utility score, EQ-VAS score, KOOS-PS score, and Pain-VAS score. Shown in each cell is the value of the corresponding Spearman's rank correlation coefficient
Purposes To investigate health-related quality of life (HRQoL) of patients with knee osteoarthritis (KOA) in Guangzhou, China, and examine its association with selected sociodemographic characteristics as well as knee function. Methods This multicenter cross-sectional study included 519 patients with KOA in Guangzhou from April 1 to December 30, 2019. Data on sociodemographic characteristics were obtained using the General Information Questionnaire. The disability was measured using the KOOS-PS, resting pain using the Pain-VAS, and HRQoL using the EQ-5D-5L. The association of selected sociodemographic factors, KOOS-PS and Pain-VAS scores with HRQoL (EQ-5D-5L utility and EQ-VAS scores) were analyzed using linear regression analyses. Results The median (interquartile range [IQR]) of EQ-5D-5L utility and EQ-VAS scores were 0.744 (0.571–0.841) and 70 (60–80) respectively, lower than the average HRQoL in the general population. Only 3.661% of KOA patients reported no problems in all EQ-5D-5L dimensions, with Pain/Discomfort being the most frequently affected dimension (78.805%). The correlation analysis showed that the KOOS-PS score, Pain-VAS score and HRQoL were moderately or strongly correlated. Patients with cardiovascular disease, no daily exercise, and high KOOS-PS or Pain-VAS scores had lower EQ-5D-5L utility scores; and patients with body mass index (BMI) > 28 ,high KOOS-PS or Pain-VAS scores had lower EQ-VAS scores. Conclusions Patients with KOA had relatively low HRQoL. Various sociodemographic characteristics as well as knee function were associated with HRQoL in regression analyses. Providing social support and improving their knee function through methods such as total knee arthroplasty might be crucial to improve their HRQoL.
 
Flowchart of inclusion and follow-up of patients with chronic diseases
D0: Days 0; D15: Day 15
Differential item functioning graph of the smoking status for item “I am smoking less”
Differential item functioning graph of the professional status for item “I allow myself sufficient resting periods”
Background The Generic Adherence for Chronic Diseases Profile is a French generic scale (GACID-P) developed to measure adherence in several disease areas such as cardiology, rheumatology, diabetes, cancer and infectiology. Method We aimed to study the measurement invariance of the Generic Adherence for Chronic Diseases Profile by an item response model, optimize the new instrument version from item response model and qualitative content analyses results, and validate the instrument. The metric properties of the optimized version were studied according to classical test theory and item response model analysis. Results A sample of 397 patients consulting at two French hospitals (in diabetes, cardiology, rheumatology, cancerology and infectiology) and in four private practices was recruited; 314 (79%) patients also completed the questionnaire 15 days later. Factor analyses revealed four dimensions: “Forgetting to take medication”, “Intention to comply with treatment”, “Limitation of risk-related consumer habits” and “Healthy lifestyle”. The item response model and content analyses optimized these four dimensions, regrouping 32 items in four dimensions of 25 items, including one item conditioned on tobacco use. The psychometric properties and scale calibration were satisfactory. One score per dimension was calculated as the sum of the items for the dimensions “Forgetting to take medication” and “Intention to comply with treatment” and as a weighted score according to the item response model analysis for the two other dimensions because of differential item functioning found for two items. Conclusion Four adherence profile scores were obtained. The instrument validity was documented by a theoretical approach and content analysis. The Generic Adherence for Chronic Diseases Profile is now available for research targeting adherence in a broad perspective.
 
Confirmatory Factor Analysis model. PHA: Physical Health and Activities; ES: Emotional State; SA: Social Activities
Background/objective Health-related quality of life is a concept that includes aspects about physical, emotional and social well-being. The aim of the study was to validate the PedsQL for parent report for toddlers in Spain and provide reference data in a Spanish population. Method The sample included 478 parents (89.5% mothers) of children aged 18–36 months (M = 26.75 months). Sociodemographic data were gathered, and the PedsQL and Kiddy-KINDL-R were completed by the participants. Results The fit of the original structure of the PedsQL was acceptable (CFI = 0.93; TLI = 0.92; RMSEA = 0.06), and the results showed good internal consistency (α = 0.85). The items about nursery school were excluded, since not all the toddlers attended this type of educational centre. Significant differences were found in physical health and activities and in the total mean in terms of parent education level, and in social activities regarding gender. For the normative interpretation of the PedsQL, the first, second and third quartiles corresponded to 77.78, 84.72 and 90.28, respectively. Conclusions This instrument is not only useful to individually evaluate the quality of life of a child with respect to his/her group, but also to measure the efficacy of a possible intervention.
 
Participants’ enrollment chart
Directed acyclic graph (DAG) illustrating relationship between dental caries and C-OIDP
Background Dental caries and child oral impact on daily performance (C-OIDP) have been linked in several studies. However, the studies used caries indices, which limit the ability to examine how C-OIDP prevalence varies across various stages of the dental caries process. Furthermore, cross-cultural differences between Zambia and other African countries where the C-OIDP instrument has been widely used necessitate testing its pychometric properties. This study’s primary aim was to evaluate the association between dental caries and C-OIDP. Secondarily, the study reports the psychometric properties of the C-OIDP index among Zambian adolescents. Methods A cross-sectional study was conducted between February and June 2021 among grade 8–9 adolescents in Copperbelt province, Zambia. A multistage cluster sampling method was used to select participants. Using a pretested self-administered questionnaire, socio-demographics, oral health behaviors, self-reported oral health, and C-OIDP were evaluated. The test-retest and internal consistency reliability of the C-OIDP were evaluated. The Caries Assessment and Treatment Spectrum (CAST) was used to evaluate dental caries. Adjusted odd ratios and 95% confidence intervals were used to evaluate the association between dental caries and C-OIDP after adjusting for confounders identified by a directed acyclic graph. Results Among 1,794 participants, 54.0% were females, while 56.0% were aged 11–14 years. About a quarter (24.6%) had one or more teeth at the pre-morbidity stage, 15.2% at the morbidity, 6.4% at the severe morbidity and 2.7 at the mortality stage. The internal consistency reliability of the C-OIDP Cohen’s Kappa was 0.940, while the Kappa coefficients of the C-OIDP items ranged from 0.960 to 1.00. Participants with severe caries had a high prevalence of C-OIDP, with rates for morbidity, severe morbidity, and mortality stages being 49.3%, 65.3%, and 49.3%, respectively. Oral impacts were 2.6 times (AOR 2.6, 95% CI 2.1–3.4) more likely to be reported by participants with dental caries than those without caries. Conclusions Dental caries was associated with high reporting of C-OIDP, and C-OIDP prevalence was high among participants in the severe stages of the caries process. The English version of the C-OIDP demonstrated adequate psychometric characteristics for assessing OHRQoL among Zambian adolescents.
 
Path Analysis Model
Background Understanding how health-related quality of life (HRQoL) is related to lifestyle factors during adolescence is crucial to effective health promotion. The aim of this analysis was to identify associations between HRQoL and lifestyle and to determine the degree to which they are mediated by food choices in adolescents. Methods The Wellbeing in Schools (NI) survey (N = 1609; 13–14 years) assessed HRQoL using the Kidscreen52. Food choice was assessed by Food Frequency Questionnaire (FFQ) and physical activity was assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A). Social media and alcohol abstinence were self-reported. Results Path analysis indicated that fruit and vegetable intake was associated with higher HRQoL on dimensions of moods and emotions, parent relations and home life, financial resources, and social support and peers. Bread and diary intake was related to higher physical wellbeing. Protein was associated with higher psychological wellbeing, moods and emotions, self-perception, parent relations and home life, financial resources, and lower social support and peers. Junk food was related to lower moods and emotions. Males had higher psychological wellbeing, moods and emotions, parental relations and home life. Females had higher self-perception, autonomy, and social support and peers. Greater physical activity explained higher HRQoL on all dimensions. Less social media was associated with higher psychological wellbeing, moods and emotions, self-perception, parent relations and home life, and school environment. Alcohol abstinence was associated with higher physical wellbeing, psychological wellbeing, moods and emotions, self-perception, parent relations and home life, and school environment dimensions. Conclusion Intervention to promote HRQoL in adolescents should consider food choices whilst encouraging physical activity, discouraging social media and deterring alcohol, and targeting boys and girls separately.
 
PRISMA diagram for fertility quality of life
Global disbursement of participants
Objectives To analyze and synthesize the reported psychometric properties of the Fertility Quality of Life (FertiQoL) instrument and describe its implications for use in practice and research in men and women with infertility. Methods A systematic literature search was performed to identify all articles using the FertiQoL tool. PubMed, CINAHL, and PsycINFO were searched from September 2006 through May 2022. Studies were eligible for inclusion if they reported psychometric data on the original FertiQoL tool using a sample population of individuals with infertility. Sample size, country of origin, and psychometric data were documented for each study. Results The initial search revealed 153 articles that had utilized the FertiQoL. Following abstract, title, and full-text screenings, 53 articles reported psychometric data and met criteria for inclusion. The FertiQoL is a sound measurement with satisfactory reliability and validity. Studies indicated adequate reliability in the overall scale (α=0.43-0.92\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\alpha=0.43-0.92$$\end{document}), as well as the core Emotional, Mind/Body, Social, and Relational scales (α=0.43-0.92\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\alpha=0.43-0.92$$\end{document}) and two optional Tolerability and Environment fertility treatment subscales (α=0.67-0.91\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$\alpha=0.67-0.91$$\end{document}). Although the Relational subscale exhibited slightly lower reliability in several studies, the internal consistency for the measurement as a whole was satisfactory. Results also indicate adequate: 1) face and content validity with extensive professional and patient feedback during development; 2) convergent validity with general quality of life, depression, and anxiety measurements; and 3) structural validity using both confirmatory and exploratory factor analyses. Conclusion The FertiQoL tool is the most commonly used instrument to measure the impact of fertility issues on quality of life in men and women with infertility. Understanding the impact of infertility on quality of life provides valuable insight into the areas of infertility-related care that need to be prioritized, such as mental health or relational stressors. While the instrument has been used in different patient populations with infertility and available in multiple translations, it is necessary to understand the updated psychometric properties and the implications for its use. This review shows that the FertiQoL is reliable and valid for cross-cultural use among individuals with various etiologies of infertility.
 
Characteristics of the participants
Means, standard deviations (in brackets), F values, and post hoc Bonferroni procedure for treatment type groups and HRQOL measures
Means, standard deviations (in brackets), and post hoc Bonferroni procedure for interaction time since primary treatment and age
Background Having a job has been associated with better Health-Related Quality of Life (HRQOL) in cancer survivors. However, the sociodemographic and disease-related profiles characterizing the survivors being employed and those having better HRQOL largely overlap. The present study aims to discern the degree to which employment status is independently associated with cancer survivors’ HRQOL or if it mainly reflects the impact of other sociodemographic and cancer-related variables. Methods Cross-sectional study on a heterogeneous sample of 772 working-age survivors of adult-onset cancer. An instrument specifically designed to assess HRQOL in cancer survivors and Multivariate Variance Analysis (MANOVA) were used. Results Survival phase, cancer type, and employment status showed the main effects on cancer survivors’ HRQOL. In particular, being employed (vs unemployed) had the greatest positive association with HRQOL, affecting ten of the twelve HRQOL domains considered. Also, interaction effects highlighted the role of age (younger) and marital status (single) as risk factors for a greater negative impact of variables affecting the survivor’s HRQOL. Conclusions The application of a multivariate methodology sheds new light on two relevant issues for the cancer survivor’s HRQOL: (i) the existence of differences between diagnostic groups that are not attributed to other variables such as sex, and (ii) the important and independent role that employment status plays. Comprehensive cancer survivorship care should focus more on high-risk groups and include having a job as an essential aspect to consider and prompt. The fact that the employment status is susceptible to change represents a valuable opportunity to care for the wellbeing of this population.
 
Background The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) is validated for measuring mental wellbeing in populations aged 11 + and has been translated into 30 + languages. The aims of this study were a) to translate and validate WEMWBS for use in Swahili-speaking populations to facilitate measurement and understanding of wellbeing, evaluation of policy and practice, and enable international comparisons; and b) to examine sociodemographic characteristics associated with higher and lower mental wellbeing in participants in the Girls’ Education Challenge (GEC) project in Tanzania. Methods A short questionnaire including WEMWBS and similar scales for comparison, socio-demographic information, and self-reported health was translated into Swahili using gold standard methodology. This questionnaire was used to collect data from secondary school students, learner guides, teacher mentors and teachers taking part in the GEC project in Tanzania. Focus groups were used to assess acceptability and comprehensibility of WEMWBS and conceptual understanding of mental wellbeing. These were audio-taped, transcribed and analysed thematically. Internal consistency of WEMWBS, correlation with comparator scales and confirmatory factor analysis were completed as quantitative validation. Finally, multivariable logistic regression was used to explore associations between individual characteristics and ‘high’ and ‘low’ mental wellbeing, defined as the highest and lowest quartile of WEMWBS scores. Results 3052 students and 574 adults were recruited into the study. Participants reported that WEMWBS was understandable and relevant to their lives. Both WEMWBS and its short form met quantitative standards of reliability and validity, were correlated with comparator scales and met the criteria to determine a single factor structure. For students in the GEC supported government schools: mental wellbeing was higher in students in the final two ‘forms’ of school compared with the first two. In addition: being male, urban residence, the absence of markers of social marginality and better self-reported health were all significantly associated with better mental wellbeing. For adults, urban residence and better self-reported health were associated with better mental wellbeing. Conclusions The Swahili translation of WEMWBS is available for use. Further work to explore how to intervene to increase mental wellbeing in vulnerable GEC participants is needed.
 
Background People living with HIV (PLWH) face structural and psychosocial factors that affect health-related quality of life (HRQoL). We aimed to evaluate how syndemic conditions affected HRQoL in PLWH. Methods A cross-sectional survey was conducted among 861 PLWH, to determine whether syndemic conditions (monthly income; sexual satisfaction; depressive symptoms; social role satisfaction; social isolation; cognitive function; nicotine dependence; perception of stigma) have an effect on HRQoL. A linear regression model and measures of Additive Interaction (AI) were used to determine the effects of syndemic conditions on HRQoL, controlling for other risk factors. Results Overall, the most frequently observed were stigma perception (56.9%), poor cognitive function (50.6%) and the perception of social isolation (51.6%). The presence of depressive symptoms was the risk factor most associated with worse Physical Health (PH) (B 3.93, 2.71–5.15) and Mental Health (MH) (B 5.08, 3.81–6.34) in linear regression model. Specifically, an interaction was observed between poor cognitive function and poor satisfaction with social role on worse PH and MH (AI 2.08, 0.14–4.02; AI 2.69, 0.15–5.22, respectively); and low income and perception of stigma (AI 2.98, 0.26–5.71), low income and perception of social isolation (AI 2.79, 0.27–5.32), and low income and poor satisfaction with social role (AI 3.45, 0.99–5.91) on MH. Conclusion These findings provide evidence that syndemic factors impact HRQoL. HIV prevention programs should screen and address co-occurring health problems to improve patient-centered health care and outcomes.
 
Boxplots Showing Distribution of PROMs Scores over Time
Preoperative Bland Altman Plots
Bland Altman Plots at 6 Weeks
Bland Altman Plots at 6 Months
Purpose To evaluate the Oxford Knee Score (OKS), EQ-5D-5L utility index and EQ-5D visual analogue scale (EQ-VAS) for health-related quality of life outcome measurement in patients undergoing elective total knee arthroplasty (TKA) surgery. Methods In this prospective multi-centre study, the OKS and EQ-5D-5L index scores were collected preoperatively, six weeks (6w) and six months (6 m) following TKA. The OKS, EQ-VAS and EQ-5D-5L index were evaluated for minimally important difference (MID), concurrent validity, predictive validity (Spearman's Rho of predicted and observed values from a generalised linear regression model (GLM)), responsiveness (effect size (ES) and standard response mean (SRM)). The MID for the individual patient was determined utilising two approaches; distribution-based and anchor-based. Results 533 patients were analysed. The EQ-5D-5L utility index showed good concurrent validity with the OKS (r = 0.72 preoperatively, 0.65 at 6w and 0.69 at 6 m). Predictive validity for the EQ-5D-5L index was lower than OKS when regressed. Responsiveness was large for all fields at 6w for the EQ-5D-5L and OKS (EQ-5D-5L ES 0.87, SRM 0.84; OKS ES 1.35, SRM 1.05) and 6 m (EQ-5D-5L index ES 1.31, SRM 0.95; OKS ES 1.69, SRM 1.59). The EQ-VAS returned poorer results, at 6w an ES of 0.37 (small) and SRM of 0.36 (small). At 6 m, the EQ-VAS had an ES of 0.59 (moderate) and SRM of 0.47 (small). It, however, had similar predictive validity to the OKS, and better than the EQ-5D-5L index. MID determined using anchor approach, was shown that for OKS at 6 weeks it was 8.84 ± 9.28 and at 6 months 13.37 ± 9.89. For the EQ-5D-5L index at 6 weeks MID was 0.23 ± 0.39, and at 6 months 0.26 ± 0.36. Conclusions The EQ-5D-5L index score and the OKS demonstrate good concurrent validity. The EQ-5D-5L index demonstrated lower predictive validity at 6w, and 6 m than the OKS, and both PROMs had adequate responsiveness. The EQ-VAS had poorer responsiveness but better predictive validity than the EQ-5D-5L index. This article includes MID estimates for the Australian knee arthroplasty population.
 
EQ-5D-5L individual dimensions – relative risk for problems. AD, antidepressant; CI, confidence interval; EQ-5D-5L, European Quality of Life-5 Dimension-5 Level; ESK, esketamine
Mean (SE) HSI and EQ-VAS changes over time. AD + PBO, oral antidepressant plus placebo nasal spray; EQ-VAS, EuroQol Visual Analogue Scale; ESK + AD, esketamine nasal spray plus oral antidepressant; HSI, health status index; SE, standard error. For HSI; A: 18–29-year-old healthy adult; B: Depressive disorder; C: Senility without psychosis. The 3 horizontal lines indicate preference-based EQ-5D-5L index scores for a healthy 18–29-year-old individual, a patient with depressive disorder, and a senile patient without psychosis. These values have been added to visualize the changes observed in the current study and put them into clinical context. For EQ-VAS scores; Higher EQ-VAS scores indicate better health. A: general adult population in the US; B: patients with any cancer; C: patient with first episode or a new recurrent episode of depression. The 3 horizontal lines A, B, and C indicate EQ-VAS scores in the general adult population in the US, patients with any cancer, and a patient with first episode or a new recurrent episode of depression
Change in the SDS score among patients included in the study using MMRM. AD + PBO, oral antidepressant plus placebo nasal spray; CI, confidence interval; ESK + AD, esketamine nasal spray plus oral antidepressant; LSM, least square mean; MMRM, mixed-effects model using repeated measures; SDS, Sheehan Disability Scale; SE, standard error. aTest for treatment effect is based on mixed model for repeated measures (MMRM) with change from baseline as the response variable and the fixed effect model terms for treatment), day, country, class of oral antidepressant (SNRI or SSRI), and treatment-by-day and baseline value as a covariate. A negative difference favors the ESK + AD group. Note: SDS total score ranges from 0 to 30; a higher score indicates greater impairment. Negative change in score indicates improvement
Background Patients with treatment-resistant depression (TRD) report significant deficits in physical and mental health, as well as severely impaired health-related quality of life (HRQoL) and functioning. Esketamine effectively enhances the daily functioning in these patients while also improving their depressive symptoms. This study assessed HRQoL and health status of patients with TRD, who were treated with esketamine nasal spray and an oral antidepressant (ESK + AD) vs. placebo nasal spray and an AD (AD + PBO). Methods Data from TRANSFORM-2, a phase 3, randomized, double-blind, short-term flexibly dosed study, were analyzed. Patients (aged 18–64 years) with TRD were included. The outcome assessments included the European Quality of Life Group, Five Dimension, Five Level (EQ-5D-5L), EQ-Visual Analogue Scale (EQ-VAS), and Sheehan Disability Scale (SDS). The health status index (HSI) was calculated using EQ-5D-5L scores. Results The full analysis set included 223 patients (ESK + AD: 114; AD + PBO: 109; mean [SD] age: 45.7 [11.89]). At Day 28, a lower percentage of patients reported impairment in the ESK + AD vs. AD + PBO group in all five EQ-5D-5L dimensions: mobility (10.6% vs. 25.0%), self-care (13.5% vs. 32.0%), usual activities (51.9% vs. 72.0%), pain/discomfort (35.6% vs. 54.0%), and anxiety/depression (69.2% vs. 78.0%). The mean (SD) change from baseline in HSI at Day 28 was 0.310 (0.219) for ESK + AD and 0.235 (0.252) for AD + PBO, with a higher score reflecting better levels of health. The mean (SD) change from baseline in EQ-VAS score at Day 28 was greater in ESK + AD (31.1 [25.67]) vs. AD + PBO (22.1 [26.43]). The mean (SD) change in the SDS total score from baseline to Day 28 also favored ESK + AD (-13.6 [8.31]) vs. AD + PBO (-9.4 [8.43]). Conclusions Greater improvements in HRQoL and health status were observed among patients with TRD treated with ESK + AD vs. AD + PBO. Trial registration ClinicalTrials.gov Identifier: NCT02418585.
 
The factorial structure of traditional Chinese PedsQL-CM with standardized factor loadings
Bland–Altman plots for self-reports and parent proxy-reports of traditional Chinese PedsQL-CM (The solid lines represent the mean of difference and its 95% of limit of agreement. The dash lines represent the 95% confidence intervals of the upper and lower limit of agreement)
Background In recent decades, 95% of children with congenital heart disease (CHD) can survive to adolescence and adulthood. However, adolescents with CHD are prone to poorer health-related quality of life (HRQoL). It is imperative to develop a reliable and valid instrument for health professionals to monitor the HRQoL. This study aims to: (1) evaluate the psychometric properties of the traditional Chinese version of Pediatric Quality of Life™ 3.0 Cardiac Module (PedsQL-CM) and measurement invariance across adolescents with CHD and their parents; and (2) investigate the adolescent-parent agreement in HRQoL. Methods A total of 162 adolescents and 162 parents were recruited. Internal consistency was examined using Cronbach’s alpha and McDonald’s Omega. The criterion-related validity was evaluated with intercorrelations between the PedsQL-CM and PedsQL™ 4.0 Generic Core (PedsQL-GC) Scale. The construct validity was examined by second-order confirmatory factor analysis (CFA). Measurement invariance was evaluated using the multi-group CFA. The adolescent-parent agreement was analyzed with the intraclass correlation (ICC), paired t-tests, and Bland–Altman plots. Results PedsQL-CM showed acceptable internal consistency (self-reports 0.88, proxy-reports 0.91). The intercorrelations were medium to large effect size (self-reports 0.34–0.77, proxy-reports 0.46–0.68). The CFA supported the construct validity (CFI = 0.967, TLI = 0.963, RMSEA = 0.036, 90% CI = 0.026–0.046, SRMR = 0.065). The multi-group CFA proved scalar invariance between self and parent proxy-reports. Parents significantly underestimated their adolescents’ HRQoL in cognitive problems (Cohen’s d = 0.21) and communication (Cohen’s d = 0.23) subscales, while there was a negligible difference in total HRQoL (Cohen’s d = 0.16). ICCs were poor to moderate effect size with the highest and lowest agreement in heart problems and treatment subscale (ICC = 0.70) and communication subscale (ICC = 0.27), respectively. The Bland–Altman plots showed lesser variability in the heart problem and treatment subscale and the total scale. Conclusion The traditional Chinese version of PedsQL-CM has acceptable psychometric properties to measure disease-specific HRQoL in adolescents with CHD. Parents may be proxies for adolescents with CHD to rate total HRQoL. When the patient-reported score is the primary outcome, the proxy-reported score could serve as a secondary outcome for research and clinical evaluation.
 
Insulin handling and injection experiences and practices
EQ VAS Average score classified based on both diabetes duration and insulin use duration
EQ VAS Average score classified based on age
Background: Insulin therapy can be inconvenient, painful, burdensome, and restrict patients' daily activities and health related quality of life (HRQOL) due to improper injection techniques or the nature of administration. Objective: This study aimed to assess insulin injection practice, HRQOL and predictors among patients treated with insulin at Tikur Anbessa Specialized Hospital (TASH). Methods: An institutional-based cross-sectional study was conducted among diabetes patients on insulin therapy from May to June 2022. A structured questionnaire was used to collect patient characteristics and insulin injection practice. The validated Amharic version of an EQ-5D-5L tool was used to assess the HRQOL. The data was analyzed using SPSS version 26. The patient data were summarized using descriptive statistics. One-way ANOVA using Kruskal-Wallis H tests was used to assess factors that predict insulin handling practice scores. Multivariate linear regression analysis was used to assess factors affecting HRQOL among diabetes patients treated with insulin. The EQ5D-5L utility scores of the patients were calculated using disutility coefficients taken from the Ethiopian general population. Statistical significance was declared at p-value < 0.05. Results: Of 319 patients who agreed and completed the survey, 51.1% of them were males. Almost half of the participants (n = 158) were > 50 years of age. Among the study participants, 62.1% were only on intermediate acting insulin. A significantly higher proportion of participants 291(91.2%) in this study were taking insulin two times per day. Most of the participants 234(73.4%) had fair practice with a median insulin handling practice score of 38 out of 56. Patient characteristics such as age, educational status, occupation, disease duration, and type of diabetes were significantly association with insulin injection practice (p < 0.05). The mean ± SD utility score of patients were 0.89 ± 0.19 (ranged from -0.04 to 1). Being female (β = -5.42, 95%CI:-8.63,-2.21, p = 0.001) and treated for type-I diabetes mellitus (β = + 9.04, 95%CI: 4.23,13.85, p-value < 0.0001) were significantly associated with HRQOL of patients on insulin therapy. Conclusion: The study participants had fair practices in insulin handling, storage, and administration techniques, and it was seen that male and type one diabetes patients have a better quality of life compared to their counterparts.
 
NCIQ total score. The three boxplots represent the scores from the three conditions of answering the questionnaires: preoperative acute (t0), preoperative retrospective (pre-t1, then-test), and postoperative acute (post-t1). Each boxplot shows the total range from minimum to maximum values, the first and third quartile, the median (i.e., second quartile, bold horizontal line) and the mean value (diamond). Three differences, i.e., changes in responses, can be calculated between the three conditions: 1) the post-t1 scores minus the t0 scores (A), 2) the pre-t1 (then-test) scores minus the t0 scores (B), 3) the post-t1 scores minus the pre-t1 (then-test) scores (C)
NCIQ general domains: physical, psychological, and social functioning. The boxplots represent the scores from the three conditions of answering the questionnaires: preoperative acute (t0), preoperative retrospective (pre-t1, then-test), and postoperative acute (post-t1). Each boxplot shows the total range from minimum to maximum values, the first and third quartile, the median (i.e., second quartile, bold horizontal line) and the mean value (diamond)
NCIQ subdomains: basic sound perception (BSP), advanced sound perception (ASP), speech production (SP), self-esteem (SE), activity level (AL), and social interaction (SI). The boxplots represent the scores from the three conditions of answering the questionnaires: preoperative acute (t0), preoperative retrospective (pre-t1, then-test), and postoperative acute (post-t1). Each boxplot shows the total range from minimum to maximum values, the first and third quartile, the median (i.e., second quartile, bold horizontal line) and the mean value (diamond)
Background Quality of life questionnaires are often used in the assessment of rehabilitation of hearing-impaired patients with a cochlear implant. However, a prospective study with a systematic retrospective evaluation of the preoperative quality of life after surgery has not yet been conducted and may reveal a change in internal standards, such as a response shift, due to the implantation and hearing rehabilitation. Methods The Nijmegen Cochlear Implant Questionnaire (NCIQ) was used for assessing hearing related quality of life. It has three general domains (physical, psychological and social) and six subdomains. Seventeen patients were tested before (t0) and retrospectively (then-test; pre-t1) and acutely postoperative (post-t1) after cochlear implantation. Observed changes, then-test changes, response shifts and effect sizes were calculated. Non-parametric statistical methods were used. Results The NCIQ total score was 52.32 ± 18.69 (mean, standard deviation) for t0, 59.29 ± 14.06 for pre-t1 and 67.65 ± 26.02 for post-t1 questioning. The observed change was statistically significant in all domains but in speech production. Response shift was statistically significant in the total score and in part of the domains. The effect sizes for the response shift were moderate (> 0.5) in the total score, psychological, social general scores and subdomains. Conclusions In this study we found that response shift does exist in adults with severe to profound hearing loss undergoing cochlear implantation. By advising the participants to deactivate the implant for the then-test, recall bias and noise were minimized. The clinical significance of the response shift was present in the total score and in the social and psychological domains. Trial Registration This study was retrospectively registered with the German Clinical Trial Register, TRN DRKS00029467, on 07/08/2022.
 
Abstract Background Measurement of health-related quality of life (HRQOL) enables identification of treatment-related side effects of a disease. Such aspects may negatively impact on patients’ lives and should be taken into consideration in medical decision-making. In sub-Saharan Africa, research from the perspective of patients with chronic kidney disease is scarce, and it is almost non-existent in patients undergoing hemodialysis. We aimed to determine HRQOL among end-stage renal disease patients undergoing maintenance hemodialysis in Ethiopia and to identify factors associated with HRQOL. Methods A multi-center cross-sectional study was conducted in Addis Ababa, Ethiopia directed to all patients receiving hemodialysis due to kidney failure at 11 randomly-selected government and private hospitals/dialysis centers in the capital of Ethiopia. Data were collected by trained nurses using the KDQOL-36 instrument with five subscales measuring generic and disease-specific HRQOL. Study-specific items were used to collect socio-demographic and clinical data. Factors associated with HRQOL were examined using multivariable linear regression models. Results Four hundred eighty-one patients completed the survey through face-to-face interviews (response rate 96%; mean age 45.34 ± 14.67). The mean scores of the subscales ranged from 25.6 to 66.68 (range 0–100), with higher scores reflecting better health. Factors associated with low HRQOL included older age, female sex, no formal education, poor medication adherence, > 2 hemodialysis sessions/week, lower body mass index (
 
Background The EQ-5D is a commonly used generic measure of health but evidence on its responsiveness to change in mental health is limited. This study aimed to explore the responsiveness of the five-level version of the instrument, the EQ-5D-5 L, in patients receiving treatment for depression and anxiety. Methods Patient data (N = 416) were collected at baseline and at end of treatment in an observational study in a Norwegian outpatient clinic. Patients were adults of working age (18–69 years) and received protocol-based metacognitive or cognitive therapy for depression or anxiety according to diagnosis. Responsiveness in the EQ-5D was compared to change in the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI). Effect sizes (Cohen’s d), Standardised response mean (SRM), and Pearson’s correlation were calculated. Patients were classified as “Recovered”, “Improved”, or “Unchanged” during treatment using the BDI-II and the BAI. ROC analyses determined whether the EQ-5D could correctly classify patient outcomes. Results Effect sizes were large for the BAI, the BDI-II, the EQ-5D value and the EQ VAS, ranging from d = 1.07 to d = 1.84. SRM were also large (0.93-1.67). Pearson’s correlation showed strong agreement between change scores of the EQ-5D value and the BDI-II (rs -0.54) and moderate between the EQ-5D value and the BAI (rs -0.43). The EQ-5D consistently identified “Recovered” patients versus “Improved” or “Unchanged” in the ROC analyses with AUROC ranging from 0.72 to 0.84. Conclusion The EQ-5D showed good agreement with self-reported symptom change in depression and anxiety, and correctly identified recovered patients. These findings indicate that the EQ-5D may be appropriately responsive to change in patients with depression and anxiety disorders, although replication in other clinical samples is needed.
 
Distribution (density plot) of EQ VAS score by patient group at baseline and at 1-year follow-up and in the general population (general population data, based on a cross-sectional survey) [BOA: Better management of patients with OsteoArthritis]
Ordinary least squares regressions in the 9 registers at baseline and in the general population
Ordinary least squares regressions in the 9 registers at 1-year follow-up and in the general population
Background The EQ VAS component of the EQ-5D questionnaire has been used to assess patients’ valuation of their own health besides its use for self-reporting of overall health status. The objective of the present study was to identify patients’ valuation of EQ-5D-3L health states using the EQ VAS in different patient groups over time and in comparison to the general population. Methods Data were obtained from patients from nine National Quality Registers (n = 172,070 patients) at baseline and at 1-year follow-up and compared with data from the general population (n = 41,761 participants). The correlation between EQ VAS scores and EQ-5D-3L index based on the Swedish experience-based VAS value set was assessed. Ordinary least squares (OLS) regression models were used to determine the association between EQ-5D-3L dimensions and EQ VAS valuation. Results EQ VAS scores showed consistency with severity of health states both at baseline and at 1-year follow-up in the nine selected EQ-5D-3L health states. The regression models showed mostly consistent decrements by severity levels in each dimension at both time points and similar to the general population. The dimension mainly associated with inconsistency was the self-care severity level three. Problems in the anxiety/depression dimension had the largest impact on overall health status in most of the patient groups and the general population. Conclusion The study has demonstrated the important role EQ VAS can play in revealing patients’ valuation of their health and showed the variation in valuation of EQ-5D-3L dimensions and levels of severity across different patient groups.
 
Background In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. Methods A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. Results In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16–5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45–8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22–7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. Conclusions AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.
 
PRISMA flow chart ([54]
Background Obesity can be a significant challenge to health and quality of life (QoL). Bariatric surgery assists with weight loss and may help improve QoL. However, not all patients benefit from surgery. Personality traits may be related to QoL outcomes after bariatric surgery, but these associations are unclear. Purpose This research reviews the published literature on the associations between personality and QoL among post‐operative bariatric patients. Method Four databases (CINAHL Complete, Medline with Full Text, APA PsycINFO, and Scopus) were searched from inception until March 2022. Forward searching was conducted using Google Scholar, and backward reference citation searches were also performed. Results Five studies met inclusion criteria yielding data from N = 441 post-bariatric patients including both pre/post and cross-sectional designs. Higher agreeableness was related to lower overall health-related QoL (HRQol) and gastric HRQol and positively associated with psychological HRQol. Higher emotional stability was positively related to overall HRQol. Higher impulsivity was negatively associated with mental HRQol and was unrelated to physical HRQol. Effects for the remaining traits were either mainly mixed or null. Conclusion Personality traits may be associated with HRQol outcomes. However, it is difficult to reliably discern the role of personality traits for HRQol and QoL outcomes given the methodological issues and few published studies. More rigorous research is needed to address these issues and clarify possible associations.
 
Flowchart of the Study
ROC curve of 3 outcomes. The ROC results of six machine learning models for death, readmission and MACEs. For each outcome, models built by general information are shown in model 1, by four domains of CHF-PRO are shown in model 2, by general information and CHF-PRO are shown in model 3, and by general information and CHF-PRO and adjusted parameters are shown in model 4. FPR, false positive rate; TPR, true positive rate
The weight of predictors in XGBoost models of general information and CHF-PRO. The weight of predictors in XGBoost models of (a) all-cause death, (b) HF readmission and (c) MACEs. The number at the end of the horizontal axis of each variable indicates its weight in the model. AF, atrial fibrillation; BMI, body mass index; CHD, coronary heart disease; DIA, diabetes; DP, diastolic pressure; FAMILYHISY, family history; HBP, hypertension; HR, heart rate; Renal, renal insufficiency; SP, systolic pressure
Explanation of the prediction results for specific instances. This figure shows the explanation for patients with the corresponding events (a) and patients without the corresponding events (b). The base values are the average values of predictive models; and the f(x)s are the predicted risks. The bars in red and blue represent the risk factors and protective factors, respectively; the longer bars represent greater feature importance. AF, atrial fibrillation; BMI, body mass index; CHD, coronary heart disease; DIA, diabetes; DP, diastolic pressure; HBP, hypertension; FAMILYHISY, family history; HR, heart rate; Renal, renal insufficiency; SP, systolic pressure
Self-made web-based risk calculator for specific instances. On the left side of the system is the variable input module, where continuous variables can be assigned by dragging, and categorical variables such as gender can be drop-down to select variable assignment. On the right is the results output window. Based on the results, the two-year mortality rate, re-hospitalization rate and MACEs incidence rate of patients that met the input conditions were 7.81%, 49.23% and 64.8% respectively
Background Patient-reported outcomes (PROs) can be obtained outside hospitals and are of great significance for evaluation of patients with chronic heart failure (CHF). The aim of this study was to establish a prediction model using PROs for out-of-hospital patients. Methods CHF-PRO were collected in 941 patients with CHF from a prospective cohort. Primary endpoints were all-cause mortality, HF hospitalization, and major adverse cardiovascular events (MACEs). To establish prognosis models during the two years follow-up, six machine learning methods were used, including logistic regression, random forest classifier, extreme gradient boosting (XGBoost), light gradient boosting machine, naive bayes, and multilayer perceptron. Models were established in four steps, namely, using general information as predictors, using four domains of CHF-PRO, using both of them and adjusting the parameters. The discrimination and calibration were then estimated. Further analyze were performed for the best model. The top prediction variables were further assessed. The Shapley additive explanations (SHAP) method was used to explain black boxes of the models. Moreover, a self-made web-based risk calculator was established to facilitate the clinical application. Results CHF-PRO showed strong prediction value and improved the performance of the models. Among the approaches, XGBoost of the parameter adjustment model had the highest prediction performance with an area under the curve of 0.754 (95% CI: 0.737 to 0.761) for death, 0.718 (95% CI: 0.717 to 0.721) for HF rehospitalization and 0.670 (95% CI: 0.595 to 0.710) for MACEs. The four domains of CHF-PRO, especially the physical domain, showed the most significant impact on the prediction of outcomes. Conclusion CHF-PRO showed strong prediction value in the models. The XGBoost models using variables based on CHF-PRO and the patient’s general information provide prognostic assessment for patients with CHF. The self-made web-based risk calculator can be conveniently used to predict the prognosis for patients after discharge. Clinical Trial Registration URL: http://www.chictr.org.cn/index.aspx; Unique identifier: ChiCTR2100043337. Graphical abstract
 
Sinicization flow chart of the PIMMHS/MHLC/PMHA/PIPS scale
Results of the confirmatory factor analysis for the modified a PIPS-C (n = 358), b PMHA-C (n = 135), c PIMMHS-C (n = 105)
Background The public health and economic implications of perinatal mental health problems are well documented. Maternity clinicians are ideally placed to effectively identify women at risk and facilitate early intervention. However, in China as globally a number of issues are implicated in a failure to recognise and treat. Aim The present study sought to develop and evaluate the Chinese version ‘professional issues in maternal mental health’ scale (PIMMHS), explore its psychometric properties and potential application. Methods A cross-sectional design and instrument translation and evaluation approach was taken to investigate the psychometric properties of the PIMMHS in a Chinese population. A total of 598 obstetricians, obstetric nurses, and midwives participated in this study from 26 hospitals across China. Findings The Chinese PIMMHS was not a good fit to the original two factor model. The emotion/communication subscale yielded an excellent fit to the data according to all fit indices, offering compelling evidence for a single factor solution. The training (PIMMHS: Training), proved problematic throughout the analysis with divergent validity for the training subscale also being poor with a concomitant impact on the total scale performance. The performance of this subscale may be related to the nature of medical training and PMH. Conclusion The Chinese PIMMHS comprises a unidimensional scale of emotion/ communication, which is simple and may provide insight into the emotional burden of providing PMH care, with the potential to mitigate that burden. Further development and investigation of the training sub-scale could be of value.
 
14 item IPOS-COV – brief patient-centred outcome measure for COVID
Receiver Operating Characteristic (ROC) curves for IPOS-COV subscale baseline-final change scores (n = 212)
Background: Patient-centred measures to capture symptoms and concerns have rarely been reported in severe COVID. We adapted and tested the measurement properties of the proxy version of the Integrated Palliative care Outcome Scale-IPOS-COV for severe COVID using psychometric approach. Methods: We consulted experts and followed consensus-based standards for the selection of health status measurement instruments and United States Food and Drug Administration guidance for adaptation and analysis. Exploratory Factor Analysis and clinical perspective informed subscales. We tested the internal consistency reliability, calculated item total correlations, examined re-test reliability in stable patients, and also evaluated inter-rater reproducibility. We examined convergent and divergent validity of IPOS-COV with the Australia-modified Karnofsky Performance Scale and evaluated known-groups validity. Ability to detect change was examined. Results: In the adaptation phase, 6 new items were added, 7 items were removed from the original measure. The recall period was revised to be the last 12-24 h to capture fast deterioration in COVID. General format and response options of the original Integrated Palliative care Outcome Scale were preserved. Data from 572 patients with COVID from across England and Wales seen by palliative care services were included. Four subscales were supported by the 4-factor solution explaining 53.5% of total variance. Breathlessness-Agitation and Gastro-intestinal subscales demonstrated good reliability with high to moderate (a = 0.70 and a = 0.67) internal consistency, and item-total correlations (0.62-0.21). All except the Flu subscale discriminated well between patients with differing disease severity. Inter-rater reliability was fair with ICC of 0.40 (0.3-0.5, 95% CI, n = 324). Correlations between the subscales and AKPS as predicted were weak (r = 0.13-0.26) but significant (p < 0.01). Breathlessness-Agitation and Drowsiness-Delirium subscales demonstrated good divergent validity. Patients with low oxygen saturation had higher mean Breathlessness-Agitation scores (M = 5.3) than those with normal levels (M = 3.4), t = 6.4 (186), p < 0.001. Change in Drowsiness-Delirium subscale correctly classified patients who died. Conclusions: IPOS-COV is the first patient-centred measure adapted for severe COVID to support timely management. Future studies could further evaluate its responsiveness and clinical utility with clinimetric approaches.
 
Flow diagram of identification, screening, eligibility and included studies via four databases
Background Over the past few decades the benefits of assessing Quality of Life (QoL) and mental health in patients with Type 2 Diabetes Mellitus (T2DM) have steadily increased with limited studies relating to the most useful method to assess these patients. This study aims to identify, review, summarise, and evaluate the methodological quality for the most validated commonly used health-related QoL and mental health assessment measurements in diabetic patients. Methods All original articles published on PubMed, MedLine, OVID, The Cochrane Register, Web of Science Conference Proceedings and Scopus databases were systematically reviewed between 2011 and 2022. A search strategy was developed for each database using all possible combinations of the following keywords: “type 2 diabetes mellitus”, “quality of life”, mental health”, and “questionnaires”. Studies conducted on patients with T2DM of ≥ 18 years with or without other clinical illnesses were included. Articles designed as a literature or systematic review conducted on either children or adolescents, healthy adults and/or with a small sample size were excluded. Results A total of 489 articles were identified in all of the electronic medical databases. Of these articles, 40 were shown to meet our eligibility criteria to be included in this systematic review. Approximately, 60% of these studies were cross-sectional, 22.5% were clinical trials, and 17.5% of cohort studies. The top commonly used QoL measurements are the SF-12 identified in 19 studies, the SF-36, included in 16 studies, and the EuroQoL EQ-5D, found in 8 studies. Fifteen (37.5%) studies used only one questionnaire, while the remaining reviewed (62.5%) used more than one questionnaire. Finally, the majority (90%) of studies reported using self-administered questionnaires and only 4 used interviewer mode of administration. Conclusion Our evidence highlights that the commonly used questionnaire to evaluate the QoL and mental health is the SF-12 followed by SF-36. Both of these questionnaires are validated, reliable and supported in different languages. Moreover, using single or combined questionnaires as well as the mode of administration depends on the clinical research question and aim of the study.
 
Mean scores in SF-36 subscales and in EQ-VAS, in the study population (first bar) and by month of evaluation (other bars). SF-36 the Short-Form 36-item questionnaire; EQ-VAS Visual Analogue Scale score of the EQ-5D; PF Physical Function; RP limitations due to physical health problems—Role Physical; BP Bodily Pain; GH General Health; VT vitality; SF social functioning; RE limitations due to emotional health problems—Role Emotional; MH mental health; PCS physical components score of the SF-36; MCS mental components score of the SF-36; * p-values for trend over time by month of evaluation after the acute infection, are shown
Background After the acute phase, symptoms or sequelae related to post-COVID-19 syndrome may persist for months. In a population of patients, previously hospitalized and not, followed up to 12 months after the acute infection, we aim to assess whether and to what extent post-COVID-19 syndrome may have an impact on health-related quality of life (HRQoL) and to investigate influencing factors. Methods We present the cross-sectional analysis of a prospective study, including patients referred to the post-COVID-19 service. Questionnaires and scales administered at 3, 6, 12 months were: Short-Form 36-item questionnaire (SF-36); Visual Analogue Scale of the EQ5D (EQ-VAS); in a subgroup, Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II) and Pittsburgh Sleep Quality Index (PSQI). Linear regression models were fitted to identify factors associated with HRQoL. Results We considered the first assessment of each participant (n = 572). The mean scores in SF-36 and in EQ-VAS were significantly lower than the Italian normative values and remained stable over time, except the mental components score (MCS) of the SF-36 and EQ-VAS which resulted in lower ratings at the last observations. Female gender, presence of comorbidities, and corticosteroids treatment during acute COVID-19, were associated with lower scores in SF-36 and EQ-VAS; patients previously hospitalized (54%) reported higher MCS. Alterations in BAI, BDI-II, and PSQI (n = 265)were associated with lower ratings in SF-36 and EQ-VAS. Conclusions This study provides evidence of a significantly bad perception of health status among persons with post-COVID-19 syndrome, associated with female gender and, indirectly, with disease severity. In case of anxious-depressive symptoms and sleep disorders, a worse HRQoL was also reported. A systematic monitoring of these aspects is recommended to properly manage the post-COVID-19 period.
 
The study area.
(source: Source for shape file-OpenAfrica)
Background Oral conditions remain a substantial population health challenge worldwide. Poor oral health affects the quality of life as a result of pain or discomfort, tooth loss, impaired oral functioning, disfigurement, missing school time, loss of work hours, and sometimes even death. This study assessed the magnitude of Oral Health-Related Quality of Life (OHRQoL) and oral hygiene status and associated factors among special needs school students in the Amhara region. Methods An institution-based cross-sectional study was conducted from November 2020 to April 2021 in the Amhara Region, Ethiopia. A total of 443 randomly selected special needs students were included. A structured pretested interview-administered questionnaire was used for data collection. Bivariable and multivariable ordinal logistic regression models were fitted to identify the factors associated with oral hygiene status. The statistical significance of differences in mean OHIP-14 scores was assessed using the Kruskal-Wallis equality-of-populations rank and Wilcoxon rank-sum tests. Variables with a p-value less than 0.05 were considered statistically significant. Results Almost half 46.6% (95% CI: 42.1%, 51.4%) of the study participant had poor oral hygiene status. The median OHIP-14 score was 16 with an interquartile range from 14 to 20. The highest score was for functional limitation (mean: 1.45 (SD ± 0.70)) and the lowest score was for psychological disability (mean: 1.08 (SD ± 0.45)). Mother education, frequency of taking sugared foods, and the types of disabilities were significant predictors of the poor oral hygiene status of special needs students in the Amhara region. The students living in Dessie had higher OHIP-14 scores compared to those living in other places (Gondar, Bahir Dar, and Debre Markos). The students who never brush their teeth had lower OHIP-14 scores than those who brush sometime and once a day. Whereas, students affiliated with the orthodox religion had lower OHIP-14 scores compared to those affiliated with all other religions (Catholic, Muslim, and Protestant). Conclusion A substantial amount of students with a disability had poor oral hygiene. The OHIP-14 scores indicated poor oral health-related quality of life. The study found that maternal education, frequency of taking sugared foods, and the types of disabilities were statistically significant factors associated with oral hygiene status.
 
The parallel analysis of all items from both the SWEMWBS (7 items) and EQ-5D-5L (5 items)
Response distributions of SWEMWBS and EQ-5D-5L. MO: Mobility; SC: Self-care; UA: Usual activities; PD: Pain/discomfort; AD: Anxiety/depression. OP: Feeling optimistic about the future; USE: Feeling useful; RE:Feeling relaxed; PR: Dealing with problems well; CL: Thinking clearly; CLO:Feeling close to other people; MI: Able to make up my own mind about things
Background The purpose of this study is to examine the relationship between the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) and EQ-5D-5L and compare their psychometric properties in 4 chronic conditions in China. Methods Participants were invited to complete the online survey. Spearman’s rank correlation was used to evaluate the correlation between SWEMWBS and EQ-5D-5L; exploratory factor analysis was used to ascertain the number of unique underlying latent factors measured by SWEMWBS and EQ-5D-5L. Next, we assessed the psychometric properties of SWEMWBS and EQ-5D-5L by reporting distributions and examining their known-group validity and convergent validity. Results In total, 500 individuals participated the online survey. Spearman’s rank correlation showed that EQ-5D-5L dimensions, except for the anxiety/depression dimension, were weakly correlated with all dimensions of SWEMWBS. The two-factor solution for exploratory factor analysis found that all of SWEMWBS dimensions loaded onto one factor, four EQ-5D-5L dimensions (mobility, self-care, usual activities and pain/discomfort) onto another, and the EQ-5D-5L item of anxiety/depression item loaded moderately onto both factors. Patients of four disease groups had different distributions of responses for both SWEMWBS and EQ-5D-5L. In terms of known-group validity, both the F statistic and AUROC value of EQ-5D-5L utility scores were significantly higher than SWEMWBS scores in all four pair-wised comparisons. The Pearson correlation coefficient between EQ-5D-5L utility scores, SWEMWBS scores and EQ-VAS was 0.44 (P < 0.01) and 0.65 (P < 0.01), respectively. Conclusions SWEMWBS and EQ-5D-5L measure different constructs and can be seen as complementary measures. Both measures demonstrated good convergent validity and known-group validity with EQ-5D-5L being a more sensitive measure, even for mental conditions.
 
Hospitals which collected THA PROs, and THA PROM RR per measurement time point per year. In 2016, pre-12 m RR data was not available yet. Pre = preoperative; Pre-12 m = between preoperatively and 12 months postoperatively; Pre-3 m = between preoperatively and 3 months postoperatively; PROs = patient-reported outcomes; RR = response rate; THA = total hip arthroplasty
THA PROM RR per measurement time point per year of included hospitals. In 2016, pre-12 m RR data was not available yet. Pre-12 m = between preoperatively and 12 months postoperatively; Pre-3 m = between preoperatively and 3 months postoperatively; RR = response rate; THA = total hip arthroplasty
Background Joint arthroplasty registries have incorporated patient-reported outcomes (PROs) to evaluate outcomes from a patients’ perspective to improve total hip arthroplasty (THA). To draw valid conclusions on PROs, a minimum response rate (RR) of 60% is advised. This study investigated (1) if the quality of THA health care based on PROs improved over the years in the Netherlands, (2) if RRs improved over the years, and (3) difference in PROs over the years in hospitals with RR ≥ 60% compared to RR < 60%. Methods Longitudinal study with publicly available datasets from 2016 to 2019. Primary outcome was increase/decrease in PRO change scores including 95%CI ranges over the years between preoperatively and 3 months postoperatively (pre-3 m), and 12 months postoperatively (pre-12 m). Improved quality of health care was arbitrary defined as when ≥ 3 of 4 included scores or ranges were statistically significant improved. Secondary outcome was increase/decrease in RRs over the years. Subgroups RR ≥ 60% and RR < 60% were compared. Results Hospitals (%) collecting THA PROs increased from 78 to 92%. EQ VAS change score increased over the years, and 95%CI ranges of EQ VAS, EQ-5D descriptive system and NRS pain during activity decreased over the years at pre-3 m (p < 0.05). All THA pre-12 m PRO change scores and 95%CI ranges remained equal (p > 0.05). Pre-3 m RR remained equal (around 43%, p = 0.107) and pre-12 m RR decreased 9% (49% to 40%, p = 0.008). Pre-3 m subgroup RR ≥ 60% was too small to analyse (5%). No difference was found between pre-12 m subgroups (RR ≥ 60% = 16%), p > 0.05). Conclusions Quality of THA health care based on PROs seems equal in the Netherlands between 2016 and 2019. Although more hospitals participated in PRO collection, low RRs with large IQRs are observed and only 16% of the hospitals achieved the advised RR ≥ 60%. Multiple recommendations are provided to improve PRO collection and use.
 
The war in Ukraine has generated an increase in the number of refugees. As one of the top recipients of refugees, Germany has introduced policies to ease the integration of Ukrainians. The current study explores mental health outcomes and their association with quality of life among a sample of Ukrainian refugees in Germany. Cross-sectional data were collected from a sample of Ukrainian refugees in Germany (n = 304) using standardised instruments. A t-test was used to check for possible significant differences based on gender. Multiple regression analysis was used to analyse potential associations between general health (GHQ-12) and depressive symptoms and anxiety (PHQ-4), and quality of life (EUROHIS-QOL 8 item). Female participants reported significantly higher psychological distress, depres-sive symptoms and anxiety. The significant model (p < .001) for the males accounts for 33.6% of the variance in quality of life. General psychological distress (β = − .240) and depressive symptoms and anxiety (β = − .411) are associated with decreased quality of life. For the female sample (p < .001), the model explains 35.7% of the variance in quality of life. General psychological distress (β = − .402) and depressive symptoms and anxiety (β = − .261) are associated with decreased quality of life. The current study provides the first knowledge on the prevalence of mental health problems and their associations with quality of life among Ukrainian refugees. The findings further identify the vulnerability of women refugees to poorer mental health outcomes. The results also confirm that traumatic experiences in the context of war explain a considerable bulk of mental health problems.
 
Background Sub-health which is the state between health and disease is a major global public health challenge. As a reversible stage, sub-health can work as a effective tool for the early detection or prevention of chronic disease. The EQ-5D-5L (5L) is a widely used, generic preference-based instrument while its validity in measuring sub-health is not clear. The aim of the study was thus to assess its measurement properties in individuals with sub-health in China. Methods The data used were from a nationwide cross-sectional survey conducted among primary health care workers who were selected on the basis of convenience and voluntariness. The questionnaire was composited of 5L, Sub-Health Measurement Scale V1.0 (SHMS V1.0), social-demographic characteristics and a question assessing the presence of disease. Missing values and ceiling effects of 5L were calculated. The convergent validity of 5L utility and VAS scores was tested by assessing their correlations with SHMS V1.0 using Spearman’s correlation coefficient. The known-groups validity of 5L utility and VAS scores was assessed by comparing their values between subgroups defined by SHMS V1.0 scores using the Kruskal–Wallis test. We also did an analysis in subgroups according to different regions of China. Results A total of 2063 respondents were included in the analysis. No missing data were observed for the 5L dimensions and only one missing value was for the VAS score. 5L showed strong overall ceiling effects (71.1%). The ceiling effects were slightly weaker on the “pain/discomfort” (82.3%) and “anxiety/depression” (79.5%) dimensions compared with the other three dimensions (nearly 100%). The 5L weakly correlated with SHMS V1.0: the correlation coefficients were mainly between 0.2 and 0.3 for the two scores. 5L was yet not sensitive in distinguishing subgroups of respondents with different levels of sub-health, especially the subgroups with adjacent health status (p > 0.05). The results of subgroup analysis were generally consistent with those of the full sample. Conclusions It appears that the measurement properties of EQ-5D-5L in individuals with sub-health are not satisfactory in China. We thus should be cautious to use it in the population.
 
Background Food insecurity is associated with worse general health rating, but little research exists investigating whether there is a dose response relationship across levels of food security and mental and physical health domains at the population level. Methods Data from the Medical Expenditure Panel Survey (2016–2017) with US adults aged 18 years and older was used. The physical component score (PCS) and mental component score (MCS) of Quality of Life, served as the outcome measures. Four categories of food insecurity (high, marginal, low, very low food security) served as the primary independent variable. Linear regression was used to run unadjusted followed by adjusted models. Separate models were run for PCS and MCS. Results In a sample of US adults, 16.1% reported some degree of food insecurity. For PCS, marginal (β = − 2.54 (p < 0.001), low (β = − 3.41, (p < 0.001), and very low (β = − 5.62, (p < 0.001) food security was associated with worse PCS scores, compared to adults with high food security. For MCS, marginal (β = − 3.90 (p < 0.001), low (β = − 4.79, (p < 0.001), and very low (β = − 9.72, (p < 0.001) food security was associated with worse MCS scores, compared to adults with high food security. Conclusion Increasing levels of food insecurity were associated with decreased physical and mental health quality of life scores. This relationship was not explained by demographic factors, socioeconomic factors, insurance, or comorbidity burden. This study suggests work is needed to mitigate the impact of social risk, such as food insecurity, on quality of life in adults, and understand pathways and mechanisms for this relationship.
 
Conceptual framework of RSV-iiiQ. RSV = Respiratory syncytial virus; RSV-iiiQ = RSV Infection, Intensity and Impact Questionnaire
Background Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure. Methods A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes. Results In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined. Conclusions The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.
 
Recruitment of children aged 5–7-years and 8–10-years
Comparison of the EQ-5D-Y-3L dimensions across age-groups
Abstract Objectives The aim of this study was to determine the validity and reliability of the EQ-5D-Y-3L interviewer-administered (IA) version in South African children aged 5–7-years compared to 8–10-years. Methods Children aged 5–10-years (n = 388) were recruited from healthcare facilities, schools for learners with special educational needs and mainstream schools across four known condition groups: chronic respiratory illnesses, functional disabilities, orthopaedic conditions and the general population. All children completed the EQ-5D-Y-3L IA, Moods and Feelings Questionnaire (MFQ), Faces Pain Scale-Revised (FPS-R) and a functional independence measure (WeeFIM) was completed by the researcher. Cognitive debriefing was done after the EQ-5D-Y-3L IA to determine comprehensibility. Test–retest of the EQ-5D-Y-3L IA was done 48 h later and assessed using Cohen’s kappa (k). Results Results from children aged 5–7-years (n = 177) and 8–10-years (n = 211) were included. There were significantly higher reports of problems in the Looking After Myself dimension in the 5–7-year-olds (55%) compared to the 8–10-year-olds (28%) (x 2 = 31.021; p = 0.000). The younger children took significantly longer to complete the measure (Mann-Whitney U = 8389.5, p
 
Flow chart of the review process
of the generic and disease-specific HRQoL measures and their subcomponents investigated in the studies included. BLCS Bladder Control Scale, BWCS Bowel Control Scale, EQ-5D EuroQoL-5 Dimensions, FSS Fatigue Severity Scale, IVIS Impact of Visual Impairment Scale, MFIS Modified Fatigue Impact Scale, MHI Mental Health Inventory, MSIS-29 Multiple Sclerosis Impact Scale, MSQLI Multiple Sclerosis Quality Of Life Inventory, MSQOL-54 Multiple Sclerosis Quality Of Life-54, MSSS Modified Social Support Survey, Neuro-QoL Quality of life in Neurological Conditions, NHP Nottingham Health Profile, PDQ Perceived Deficits Questionnaire, PDQ-39 Parkinson’s Disease questionnaire-39, PES Pain Effects Scale, PROMIS The Patient-Reported Outcomes Measurement Information Systems, RAND-36 Research and Development Corporation-36, SCI-QOL Spinal Cord Injury-Quality of Life Independence, SCIM-III Spinal Cord Independence Measure-Version 3, SF-8 SF-12, SF-36, Short Form Health Survey, SIS Stroke Impact Scale, SS-QOL Stroke Specific Quality Of Life Scale, SSS Sexual Satisfaction Scale, SWLS Satisfaction With Life Scale
Background In the field of neurorehabilitation, robot-assisted therapy (RAT) and virtual reality (VR) have so far shown promising evidence on multiple motor and functional outcomes. The related effectiveness on patients’ health-related quality of life (HRQoL) has been investigated across neurological populations but still remains unclear. The present study aimed to systematically review the studies investigating the effects of RAT alone and with VR on HRQoL in patients with different neurological diseases. Methods A systematic review of the studies evaluating the impact of RAT alone and combined with VR on HRQoL in patients affected by neurological diseases (i.e., stroke, multiple sclerosis, spinal cord injury, Parkinson’s Disease) was conducted according to PRISMA guidelines. Electronic searches of PubMed, Web of Science, Cochrane Library, CINAHL, Embase, and PsychINFO (2000–2022) were performed. Risk of bias was evaluated through the National Institute of Health Quality Assessment Tool. Descriptive data regarding the study design, participants, intervention, rehabilitation outcomes, robotic device typology, HRQoL measures, non-motor factors concurrently investigated, and main results were extracted and meta-synthetized. Results The searches identified 3025 studies, of which 70 met the inclusion criteria. An overall heterogeneous configuration was found regarding the study design adopted, intervention procedures and technological devices implemented, rehabilitation outcomes (i.e., related to both upper and lower limb impairment), HRQoL measures administered, and main evidence. Most of the studies reported significant effects of both RAT and RAT plus VR on patients HRQoL, whether they adopted generic or disease-specific HRQoL measures. Significant post-intervention within-group changes were mainly found across neurological populations, while fewer studies reported significant between-group comparisons, and then, mostly in patients with stroke. Longitudinal investigations were also observed (up to 36 months), but significant longitudinal effects were exclusively found in patients with stroke or multiple sclerosis. Finally, concurrent evaluations on non-motor outcomes beside HRQoL included cognitive (i.e., memory, attention, executive functions) and psychological (i.e., mood, satisfaction with the treatment, device usability, fear of falling, motivation, self-efficacy, coping, and well-being) variables. Conclusions Despite the heterogeneity observed among the studies included, promising evidence was found on the effectiveness of RAT and RAT plus VR on HRQoL. However, further targeted short- and long-term investigations, are strongly recommended for specific HRQoL subcomponents and neurological populations, through the adoption of defined intervention procedures and disease-specific assessment methodology.
 
Distribution of EQ-5D-5L and 15D index values
Bland–Altman plot of EQ-5D-5L and 15D index values. The horizontal red line represents the mean of the differences (D) between EQ-5D-5L and 15D index values, while the 95% confidence interval is represented by the dashed lines, which was obtained as D ± 1.96*SD (SD: standard deviation of the differences)
Characteristics of EQ-5D-5L and 15D health state profiles and index values
Background The EQ-5D-5L and 15D are generic preference-accompanied health status measures with similar dimensions. In this study, we aim to compare the measurement properties of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample. Methods In August 2021, an online cross-sectional survey was conducted in a representative adult general population sample (n = 1887). The EQ-5D-5L and 15D descriptive systems and index values were compared in terms of ceiling and floor, informativity (Shannon’s Evenness index), agreement, convergent and known-groups validity for 41 chronic physical and mental health conditions. Danish value sets were used to compute index values for both instruments. As a sensitivity analysis, index values were also estimated using the Hungarian EQ-5D-5L and Norwegian 15D value sets. Results Overall, 270 (8.6%) and 1030 (3.4*10⁻⁶%) unique profiles occurred on the EQ-5D-5L and 15D. The EQ-5D-5L dimensions (0.51–0.70) demonstrated better informativity than those of 15D (0.44–0.69). EQ-5D-5L and 15D dimensions capturing similar areas of health showed moderate or strong correlations (0.558–0.690). The vision, hearing, eating, speech, excretion and mental function 15D dimensions demonstrated very weak or weak correlations with all EQ-5D-5L dimensions, which may indicate potential room for EQ-5D-5L bolt-ons. The 15D index values showed lower ceiling than the EQ-5D-5L (21% vs. 36%). The mean index values were 0.86 for the Danish EQ-5D-5L, 0.87 for the Hungarian EQ-5D-5L, 0.91 for the Danish 15D and 0.81 for the Norwegian 15D. Strong correlations were found between the index values (Danish EQ-5D-5L vs. Danish 15D 0.671, Hungarian EQ-5D-5L vs. Norwegian 15D 0.638). Both instruments were able to discriminate between all chronic condition groups with moderate or large effect sizes (Danish EQ-5D-5L 0.688–3.810, Hungarian EQ-5D-5L 1.233–4.360, Danish 15D 0.623–3.018 and Norwegian 15D 1.064–3.816). Compared to the 15D, effect sizes were larger for the EQ-5D-5L in 88–93% of chronic condition groups. Conclusions This is the first study to compare the measurement properties of the EQ-5D-5L and 15D in a general population sample. Despite having 10 fewer dimensions, the EQ-5D-5L performed better than the 15D in many aspects. Our findings help to understand the differences between generic preference-accompanied measures and support resource allocation decisions.
 
Outcomes: true positive (TP), true negative (TN), false positive (FP), and false negative (FN) for unresectable advanced thoracic (TC) and colorectal cancer (CRC)
Purpose Patients with advanced cancer suffer significant decline of their psychological state. A rapid and reliable evaluation of this state is essential to detect and treat it and improve quality of life. The aim was to probe the usefulness of the emotional function (EF) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EF-EORTC-QLQ-C30) to assess psychological distress in cancer patients. Methods This is a multicenter, prospective, observational study involving 15 Spanish hospitals. Patients diagnosed with unresectable advanced thoracic or colorectal cancer were included. Participants completed the Brief Symptom Inventory 18 (BSI-18), the current the gold standard, and the EF-EORTC-QLQ-C30 to assess their psychological distress prior to initiating systemic antineoplastic treatment. Accuracy, sensitivity, positive predictive value (PPV), specificity, and negative predictive value (NPV) were calculated. Results The sample comprised 639 patients: 283 with advanced thoracic cancer and 356 with advanced colorectal cancer. According to the BSI scale, 74% and 66% displayed psychological distress with an EF-EORTC-QLQ-C30 accuracy of 79% and 76% in detecting psychological distress in individuals with advanced thoracic and colorectal cancer, respectively. Sensitivity was 79 and 75% and specificity was 79 and 77% with a PPV of 92 and 86% and a NPV of 56 and 61% (scale cut-off point, 75) for patients with advanced thoracic and colorectal cancer, respectively. The mean AUC for thoracic cancer was 0.84 and, for colorectal cancer, it was 0.85. Conclusion This study reveals that the EF-EORTC-QLQ-C30 subscale is a simple and effective tool for detecting psychological distress in people with advanced cancer.
 
Abstract Background Despite the advances in the treatment of HIV, people living with HIV (PLHIV) still experience impairment of health-related quality of life (HRQOL). The aim of the study was to explore factors associated with HRQOL in a well-treated Norwegian HIV population. Methods Two hundred and forty-five patients were recruited from two outpatient clinics to participate in this cross-sectional study of addiction, mental distress, post-traumatic stress disorder, fatigue, somatic health, and HRQOL. The latter was measured using the 36-Item Short Form Health Survey (SF-36). Stepwise multiple linear regression analysis was used to examine the adjusted associations between demographic and disease-related variables and HRQOL. Results The study population was virologically and immunologically stable. Their mean age was 43.8 (SD = 11.7) years, 131 (54%) were men, and 33% were native Norwegians. Compared with the general population (published in previous studies), patients reported worse SF-36 scores for five of eight domains: mental health, general health, social function, physical role limitation, and emotional role limitation (all p
 
Sequence of events during the four rounds
Background This paper presents a novel methodology for translation and cross-cultural adaptation of health-related quality-of-life patient-reported outcome measures, incorporating the Delphi method. Specifically, we describe the process of translating the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 from English to Norwegian using this method. Methods The multistep translation method combined the European Organization for Research and Treatment of Cancer Quality of Life guidelines, an Expert Panel review, and the Delphi method. It comprised two independent forward- and back-translations. While the bilingual pelvic floor Expert Panel ensured rigorous cross-checking and effective cross-cultural adaptation, the addition of the Delphi method (comprising the attributes of anonymity, controlled feedback, and statistical group response) further established consensus on translated items. Outcomes The application of the Delphi method in the Expert Panel phase proved adequate in producing comprehensible intermediate Norwegian versions ready for pilot testing. The Expert Panel reviewed the comments made by patients completing the instruments and offered advice to allow final translated versions to be produced and tested for measurement properties. This iterative approach, internal logic, and anonymity between rounds improved the evaluations that the panel members provided, which in turn enhanced the final translated Patient Reported Outcome Measures (PROMs). Conclusions To our knowledge, this work represents the first demonstration of the application of an Expert Panel review incorporating a Delphi method to assess health-related quality-of-life instruments. The controlled feedback approach, iterative nature, internal logic, and anonymity of the Delphi consensus method appeared to ensure a good cross-cultural adaptation of these PROMs.
 
(continued)
PRISMA study selection flowchart and exclusion criteria
Main characteristics of the studies included in the systematic review
Background Prostate cancer (PCa) and obesity are two ever-increasing public health issues that can independently impair the quality of life (QOL) of affected patients. Our objective was to evaluate the impact of overweight and obesity on the QOL of patients with PCa receiving an anticancer treatment. Methods We performed a systematic review of the literature using PubMed, Embase, Cochrane Library and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The search equation targeted studies that included PCa patients who had a body mass index (BMI) greater than 25 kg/m ² , who were receiving anticancer therapy, and whose QOL was analyzed according to validated or non-validated scores. Results Of 759 identified articles, we selected 20 studies published between 2000 and 2019 of 12,529 patients treated for PCa, including 5549 overweight or obese patients. QOL assessment was performed using nine validated scales and two non-validated questionnaires. Of seven studies on radiotherapy, six found obesity to have a negative impact on patients' QOL (especially urinary, sexual, and bowel-related QOL). Thirteen studies assessed the QOL of patients who underwent radical prostatectomy, with a BMI > 25 kg/m ² having no observed impact. In obese patients under 65 years of age and without comorbidities, nerve-sparing surgery appeared to limit the deterioration of QOL. Four studies on brachytherapy found discordant results. One study showed greater QOL impairment in obese patients receiving first-generation hormone therapy than in those with normal or decreased BMI. No study evaluated the QOL of overweight or obese patients receiving other types of systemic treatment. Conclusion Based on the published data, the level of evidence for an association between QOL and overweight or obesity in patients treated for PCa is not high. Prospective cohort studies including this type of patient population are warranted to answer this topical public health issue.
 
Distribution of QUALIDEM Scores from each subscale for patients with mild to severe dementia (n = 344)
Distribution of QUALIDEM Scores from each subscale for patients with very severe dementia (n = 182)
Background Quality of life (QoL) of people with dementia (PwD) is an important indicator of quality of care. Studying the impact of acute hospital settings on PwD’s QoL requires assessment instruments that consider environmental factors. Until now, dementia-specific QoL instruments have not yet demonstrated their feasibility in acute hospitals because their use takes up too much time or their validity depends on observation periods that usually exceed the average length of hospital stays. Therefore, validated instruments to study QoL-outcomes of patients with dementia in hospitals are needed. Methods Data stem from a study that analyzed the impact of a special care concept on the QoL of patients with dementia in acute hospitals. Total sample size consisted of N = 526 patients. Study nurses were trained in using an assessment questionnaire and conducted the data collection from June 2016 to July 2017. QoL was assessed with the QUALIDEM. This instrument consists of nine subscales that can be applied to people with mild to severe dementia (N = 344), while six of the nine subscales are applicable for people with very severe dementia (N = 182). Scalability and internal consistency were tested with Mokken scale analysis. Results For people with mild to severe dementia, seven out of nine subscales were scalable (0.31 ≤ H ≤ 0.75). Five of these seven subscales were also internally consistent (ρ ≥ 0.69), while two had insufficient reliability scores (ρ = 0.53 and 0.52). The remaining two ( positive self-image , feeling at home ) subscales had rather low scalability (H = 0.17/0.16) and reliability scores (ρ = 0.35/0.36). For people with very severe dementia, all six subscales were scalable (0.34 ≤ H ≤ 0.71). Five out of six showed acceptable internal consistency (ρ = 0.65–0.91). Only the item s ocial relations had insufficient reliability (ρ = 0.55). Conclusions In comparison with a previous evaluation of the QUALIDEM in a long-term care setting, the application in a hospital setting leads to very similar, acceptable results for people with mild to severe dementia. For people with very severe dementia, the QUALIDEM seems to fit even better in a hospital context. Results suggest either a revision of unsatisfactory items or a general reduction to six items for the QUALIDEM, for all PwD. In general, the QUALIDEM can be recommended as instrument to assess the QoL for PwD in the context of hospital research. Additionally, an investigation of the inter-rater reliability is necessary because the qualification of the nurses and the length of stay of the patients in the hospital differ from the previous investigations of the inter-rater reliability of QUALIDEM in the nursing home.
 
Standardized coefficient model of CFA
Background Childhood cancer negatively impacts a child's physical, mental, and behavioural health and significantly affects their health-related quality of life. The Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL™ 4.0 GCS) is one of the most commonly used measures of the quality of life in children. However, the Amharic version of PedsQL™ 4.0 GCS has not been validated in a paediatric oncology population. This study aimed to translate and evaluate the psychometric properties of the Amharic PedsQL™ 4.0 GCS (PedsQL™ 4.0 GCS (A)) for Ethiopian children with cancer. Methods A descriptive cross-sectional study was conducted among children aged 8–18 years with any type of cancer across the cancer trajectory. Cronbach’s alpha and intraclass correlation coefficient were computed to determine the internal consistency and test-retest reliability of the scale. The convergent validity was established by examining the correlation of the PedsQL™ 4.0 GCS (A) with the Amharic version of the Revised Child Anxiety and Depression Scale (RCADS-25(A)). Factorial validity was evaluated by conducting a confirmatory factor analysis. Results The study included 142 participants with childhood cancer. PedsQL™ 4.0 GCS (A) had good validity and reliability. It demonstrated high internal consistency with a Cronbach’s alpha of 0.96 for the scale and 0.82–0.95 for the subscales. The intraclass correlation coefficient for the scale was 0.9 and that for the subscales was 0.76–0.90. The PedsQL™ 4.0 GCS (A) was highly correlated with RCADS-25 (A) (r = − 0.97, p < 0.001), supporting its convergent validity. The four-factor structure of the model fitted the data satisfactorily (χ ² /df = 1.28; CFI = 0.97; TLI = 0.97; RMSEA = 0.05; SRMR = 0.05), supporting the factorial validity of the PedsQL™ 4.0 GCS (A). Conclusion The PedsQL™ 4.0 GCS (A) demonstrates desirable psychometric properties for assessing quality of life among Ethiopian children with cancer. The scale can be used in clinical settings for assessing and evaluating quality of life in children with cancer. The use of parent-report versions and studies in those with different health conditions and healthy populations are necessary to further establish the psychometric properties of the PedsQL™ 4.0 GCS (A).
 
Mean scores of the FACT-Cog total scale and its domains in two groups of patients differing by disease stage (stage I&II compared to stage III-IV)
Background The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) evaluates perceived cognitive functioning and their impact on quality of life. This study was designed to evaluate the factors associated with cognitive functioning in a sample of women with breast cancer (BC) in Lebanon. We also sought to explore the psychometric properties of the FACT-Cog Arabic version. Methods A cross-sectional study was carried out between March and August 2020 among women with BC. Socio-demographic and clinical characteristics were collected. In addition, patients were asked to complete the FACT-Cog Arabic version as well as the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30, the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder (GAD-7). The internal consistency of the FACT-Cog tool was evaluated using Cronbach’s alpha. Content, convergent, and known group validity of the FACT-Cog Arabic version were also evaluated. All statistical analyses were performed using SPSS version 23.0. Results A sample of 134 women with BC was collected. Internal consistencies of the FACT-cog total scale and its subscales were high (Cronbach’s α between 0.83 and 0.95). The convergent validity of the FACT-Cog Arabic version was supported by the positive correlation with the EORTC-cognitive functioning subscale. Moreover, negative correlations were found between FACT-Cog scale and fatigue, pain, anxiety, as well as depression. Known-group validity was supported by the statistically significant mean differences of the FACT-Cog total scale between patients in early (I &II) and late (III & IV) BC stages. Unmarried BC patients as well as those having higher depressive symptoms and a lower quality of life were found to be at higher risk of cognitive impairment. Conclusion The FACT-Cog Lebanese Arabic version is a valid and reliable tool for assessing perceived cognitive functioning in BC women. Higher level of depression and impaired quality of life were associated with a decline in cognitive functioning.
 
Associations between different health conditions and HRQoL across age groups based on inferred EQ-5D-Y. Notes: 1. The x axis represents the HRQoL difference between those with the condition compared with those without the condition. The points are the coefficients, with the line indicating the 95% confidence interval. The conditions are ranked according to the size of the HRQoL difference. 2. Anxiety and depression were only measured separately from the 6th wave of LSAC (10–13 years old for B cohort and 14–17 years old for K cohort), and were measured together between 4th and 7th waves (6–17 years). Thus, anxiety or depression were presented as one category in 5–12 years old age group, and as two separate categories in 13–18 years old
Associations between different health conditions and HRQoL across age groups based on inferred CHU9D. Notes: 1. 2–4 years old usually don’t attend school so the ‘schoolwork’ dimension is missing. 2. Anxiety and depression were only measured separately from the 6th wave of LSAC (10–13 years old for B cohort and 14–17 years old for K cohort), and were measured together between 4th and 7th waves (6–17 years). Thus, anxiety or depression were presented as one category in 5–12 years old age group, and as two separate categories in 13–18 years old
The HRQoL changes of different health conditions over a two-year period based on inferred EQ-5D-Y. Notes: 1. The x axis represents the HRQoL changes measured in standard response mean (SRM). The “Improved” represents those who recovered from the condition while the “Worse” represents those who newly developed the condition. Health conditions are ranked according to the HRQoL changes of the “Improved” group. 2. Anxiety and depression were only measured separately from the 6th wave of LSAC (10–13 years old for B cohort and 14–17 years old for K cohort), and they were measured together between 4th and 7th waves (6–17 years). Thus, anxiety or depression were presented as one category in 5–12 years old age group, and as two separate categories in 13–18 years old. 3. Children aged 2–4 years old had only three conditions available with status changes given no HRQoL data was available for 0–1 year olds
The HRQoL changes of different health conditions over a two-year period based on inferred CHU9D. Notes: 1. The x axis represents the HRQoL changes measured in standard response mean (SRM). The “Improved” represents those who recovered from the condition while the “Worse” represents those who newly developed the condition. Health conditions are ranked according to the HRQoL changes of the “Improved” group. 2. Anxiety and depression were only measured separately from the 6th wave of LSAC (10–13 years old for B cohort and 14–17 years old for K cohort), and they were measured together between 4th and 7th waves (6–17 years). Thus, anxiety or depression were presented as one category in 5–12 years old age group, and as two separate categories in 13–18 years old. 3. Children aged 2–4 years old had only three conditions available with status changes given no HRQoL data was available for 0–1 year olds
Background There is increasing interest in the validation of pediatric preference-based health-related quality of life measurement instruments. It is critical that children with various degrees of health-related quality of life (HRQoL) impact are included in validation studies. To inform patient sample selection for validation studies from a pragmatic perspective, this study explored HRQoL impairments between known-groups and HRQoL changes over time across 27 common chronic child health conditions and identified conditions with the largest impact on HRQoL. Methods The health dimensions of two common preference-based HRQoL measures, the EQ-5D-Y and CHU9D, were constructed using Pediatric Quality of Life Inventory items that overlap conceptually. Data was from the Longitudinal Study of Australian Children, a nationally representative sample with over 10,000 children at baseline. Seven waves of data were included for the analysis, with child age ranging from 2 to18 years. Impacts to specific health dimensions and overall HRQoL between those having a specific condition versus not were compared using linear mixed effects models. HRQoL changes over time were obtained by calculating the HRQoL differences between two consecutive time points, grouped by “Improved” and “Worsened” health status. Comparison among various health conditions and different age groups (2–4 years, 5–12 years and 13–18 years) were made. Results Conditions with the largest statistically significant total HRQoL impairments of having a specific condition compared with not having the condition were recurrent chest pain, autism, epilepsy, anxiety/depression, irritable bowel, recurrent back pain, recurrent abdominal pain, and attention deficit hyperactivity disorder (ADHD) for the total sample (2–18 years). Conditions with largest HRQoL improvement over time were anxiety/depression, ADHD, autism, bone/joint/muscle problem, recurrent abdominal pain, recurrent pain in other part, frequent headache, diarrhea and day-wetting. The dimensions included in EQ-5D-Y and CHU9D can generally reflect HRQoL differences and changes. The HRQoL impacts to specific health dimensions differed by condition in the expected direction. The conditions with largest HRQoL impacts differed by age group. Conclusions The conditions with largest HRQoL impact were identified. This information is likely to be valuable for recruiting patient samples when validating pediatric preference-based HRQoL instruments pragmatically.
 
Top-cited authors
Sarah Stewart-Brown
  • The University of Warwick
Ruth Tennant
  • Hull and East Yorkshire Hospitals NHS Trust
Jane Parkinson
  • Public Health Scotland
Ruth Fishwick
  • North Staffordshire Combined Healthcare NHS Trust
David Cella
  • Northwestern University