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Background: Acute rhinosinusitis (ARS) is a self-limiting inflammation of the nose and sinuses caused by viral or bacterial infections that requires primarily symptomatic treatment. Patient-reported outcome measures (PROMs) are suitable tools for the assessment of the effectiveness of remedies for ARS from the patient's perspective in clinical trials and real-world studies. Data regarding the quality of existing PROMs for ARS are limited. Purpose: To conduct a systematic review of the quality of existing disease-specific PROMs for use in adults and children with ARS according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, and to derive recommendations for use of the identified instruments in future clinical studies. Methods: We systematically searched PubMed, Web of Science and Embase for studies reporting on the development and/or validation of PROMs for ARS. We assessed the methodological quality of each included study, evaluated the quality of measurement properties per PROM and study, and graded the evidence. Based on the overall evidence, we derived recommendations for use of the instruments. Results: We identified four studies on three PROMs measuring symptoms of ARS and quality of life in adults (Sinonasal Outcome Test-16, SNOT-16; Measurement of Acute Rhinosinusitis, MARS; Rhinosinusitis Quality-of-Life Assessment, RhinoQoL). For ARS in children, we identified two studies on two PROMs measuring symptoms of ARS (Pediatric Rhinosinusitis Symptom Scale, PRSS; Sinus Symptom Questionnaire, S5). Our assessment of measurement properties indicates that all instruments require further validation before they can be unrestrictedly recommended for use in future research (COSMIN category B). In particular, there were no content validity studies for any of the identified instruments, but also data on other important measurement properties, e.g., structural validity, are lacking. Conclusion: Currently, no PROM for ARS in adults and children can be unrestrictedly recommended based on the evaluation of their quality. Further validation is required for all identified PROMs. Content validation involving patients and experts should be given priority. Systematic review registration: OSF (https://doi.org/10.17605/OSF.IO/VAP8U). [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQL) has become an important outcome parameter in cardiology. The MOS 36-ltem Short-Form Health Survey (SF-36) and the PROMIS-29 are two widely used generic measures providing composite HRQL scores. The domains of the SF-36, a well-established instrument utilized for several decades, can be aggregated to physical (PCS) and mental (MCS) component summary scores. Alternative scoring algorithms for correlated component scores (PCSc and MCSc) have also been suggested. The PROMIS-29 is a newer but increasingly used HRQL measure. Analogous to the SF-36, physical and mental health summary scores can be derived from PROMIS-29 domain scores, based on a correlated factor solution. So far, scores from the PROMIS-29 are not directly comparable to SF-36 results, complicating the aggregation of research findings. Thus, our aim was to provide algorithms to convert PROMIS-29 data to well-established SF-36 component summary scores. Methods: Data from n = 662 participants of the Berlin Long-term Observation of Vascular Events (BeLOVE) study were used to estimate linear regression models with either PROMIS-29 domain scores or aggregated PROMIS-29 physical/mental health summary scores as predictors and SF-36 physical/mental component summary scores as outcomes. Data from a subsequent assessment point (n = 259) were used to evaluate the agreement between empirical and predicted SF-36 scores. Results: PROMIS-29 domain scores as well as PROMIS-29 health summary scores showed high predictive value for PCS, PCSc, and MCSc (R2 ≥ 70%), and moderate predictive value for MCS (R2 = 57% and R2 = 40%, respectively). After applying the regression coefficients to new data, empirical and predicted SF-36 component summary scores were highly correlated (r > 0.8) for most models. Mean differences between empirical and predicted scores were negligible (|SMD|<0.1). Conclusions: This study provides easy-to-apply algorithms to convert PROMIS-29 data to well-established SF-36 physical and mental component summary scores in a cardiovascular population. Applied to new data, the agreement between empirical and predicted SF-36 scores was high. However, for SF-36 mental component summary scores, considerably better predictions were found under the correlated (MCSc) than under the original factor model (MCS). Additionally, as a pertinent byproduct, our study confirmed construct validity of the relatively new PROMIS-29 health summary scores in cardiology patients. [ABSTRACT FROM AUTHOR]

Objective: To evaluate and compare the measurement properties and consistency between the Chinese versions of EQ-5D-3L and EQ-5D-Y-3L among Chinese adolescent populations aged 15–17 years. Methods: Chinese adolescents aged 15–17 studying in high school were recruited through online survey. Social-demographic characteristics and self-reported EQ-5D-3L and EQ-5D-Y-3L responses were collected in the survey. The consistency of responses between the two measures was assessed using redistribution property, and the consistency of utility values was assessed by intraclass correlation coefficients (ICC). Convergent validity and known-group validity were examined using Spearman's rank correlation, F-test and effect sizes, respectively. Sensitivity was compared using relative efficiency (RE). Results: 762 respondents (48.8% male; age 15–17 years;) were recruited. The EQ-5D-3L showed a more severe ceiling effect than EQ-5D-Y-3L (78.2% vs. 66.0%). Respondents reported higher proportions of having problems in four dimensions using the EQ-5D-Y-3L than using the EQ-5D-3L. The consistency of corresponding dimensions between the two measures was relatively good, while non-negligible proportions of inconsistency were observed in "pain/discomfort" (11.4%) and "anxiety/depression" (15.7%) dimensions. The ICC of the utility values between the EQ-5D-3L and EQ-5D-Y-3L was 0.852 (p < 0.001). The Spearman's rank correlation (range: 0.385–0.620) indicated an acceptable convergent validity between the correlative dimensions of the EQ-5D-3L and EQ-5D-Y-3L. The EQ-5D-Y-3L had a higher efficiency than the EQ-5D-3L at detecting differences across EQ VAS subgroups (ES = 1.793 for EQ-5D-3L, ES = 1.920 for EQ-5D-Y-3L). Mixed results were observed in sensitivity. Conclusions: Both the EQ-5D-3L and EQ-5D-Y-3L are demonstrated to be valid and generally consistent for measuring HRQoL among adolescents aged 15–17 years in China. Respondents reported higher proportions of having problems using the EQ-5D-Y-3L than using the EQ-5D-3L. More research is warranted to compare the discriminant validity and test-retest reliability between the two measures. [ABSTRACT FROM AUTHOR]

Background: To provide both preventive and rehabilitative conditions in a workplace, one must understand how employees experience work demands. Such an understanding can be obtained from each individual with valid and quality-assured questionnaires. The Work Environment Impact Questionnaire (WEIQ) is a new questionnaire for measuring employees' self-perceived work ability in relation to their specific workplace environment. The purpose of this study was to assess the measurement properties in terms of construct validity of the WEIQ. Methods: A cross-sectional survey study was conducted with 288 respondents from three different workplaces involving assisted living personnel, vocational rehabilitation personnel and personnel at a research institute. The measurement properties of the WEIQ were assessed according to Rasch Measurement Theory (RMT), including assessment of item-to-sample targeting, threshold ordering, item fit statistics, unidimensionality and reliability. Results: Item fit, i.e., fit residuals, item characteristic curves (ICC) and chi square values, were all satisfactory, and no disordered thresholds were present after collapsing the lowest response categories. However, issues with local dependent (LD) item correlations was present in 7.6% cases, four items showed statistically significant differential item functioning (DIF), where 11% of the respondents had person fit residuals outside the recommended range of ± 2.5 and the t-test for unidimensionality did not meet the criterion of 5%. Scale-to-sample targeting and reliability (0.92) were good. LD could be resolved with testlets and at the same time maintaining fit and improving dimensionality, but then the reliability decreased to 0.82. Conclusions: This study provides an initial validation of the WEIQ to be used for assessing employees' self-perceived work ability. Most measurement properties were acceptable, but further exploration of LD, DIF and unidimensionality in additional work settings and with larger sample sizes is warranted. Trial registration: Not applicable. [ABSTRACT FROM AUTHOR]

Objectives: Spinal muscular atrophy (SMA) is a rare monogenic neuromuscular disorder caused by loss of function mutations. Measuring health-related quality of life to support economic evaluations in this population is encouraged. However, empirical evidence on the performance of preference-based measures (PBMs) in individuals with SMA is limited. This study aimed to assess the psychometric properties of the EQ-5D-5L and the Patient-Reported Outcomes Measure Information System Preference measure (PROPr) in individuals with SMA. Methods: The data used in this study were obtained via a web-based, cross-sectional survey. All participants completed the self-reporting EQ-5D-5L and PROMIS-29 questionnaires. Information about their socioeconomic and health status was also obtained. Ceiling and floor effects, convergent and divergent validity, known-group validity, and the agreement between the two measures were assessed. Results: Strong ceiling and floor effects were observed for four dimensions of the EQ-5D-5L and three subscales, including pain intensity, pain interference, and physical function, of the PROMIS-29. All hypothesized associations between EQ-5D-5L/PROMIS-29 and other neuromuscular questions were confirmed, supporting good convergent validity. Moreover, both EQ-5D-5L and PROPr scores differentiated between impaired functional groups, demonstrating good discriminative ability. Poor agreement between the EQ-5D-5L and PROPr utility scores was observed. Conclusions: The EQ-5D-5L and PROPr both appear to be valid PBMs for individuals with SMA. However, PROPr yielded considerably lower utility scores than EQ-5D-5L and their agreement was poor. Therefore, these two PBMs may not be used interchangeably in economic evaluations of SMA-related interventions. [ABSTRACT FROM AUTHOR]

Background: The PROMIS Preference score (PROPr) is a new health state utility (HSU) score that aims to comprehensively incorporate the biopsychosocial model of health and apply favorable psychometric properties from the descriptive PROMIS system to HSU measurements. However, minimal evidence concerning comparisons to the EQ-5D-3L and the PROPr's capability to differentiate clinical severity are available. Therefore, the aim of this study was to compare the PROPr to the EQ-5D-3L in terms of scale agreement, ceiling/floor effects, distribution, construct validity, discriminatory power, and relative efficiency (RE) in terms of the Oswestry Disability Index (ODI) for patients with low back pain (LBP). Methods: We used intra-class correlation coefficients (ICC) and Bland–Altman plots to compare the PROPr and EQ-5D-3L with regared to scale agreement in a cross-sectional routine sample of LBP patients. For distribution, we used the Pearson's coefficient for skewness and for ceiling/floor effects, a 15%-top/bottom threshold. For convergent validity, we used Pearson's correlation coefficients. For known-groups validity, we applied a linear regression with interaction terms (predictors sex, age, and ODI level) and an analysis of variance (ANOVA). For discriminatory power, we calculated the effect size (ES) using Cohen's d and the ratio of the area under the receiver-operating characteristics curves (AUROC-ratio = AUROCPROPr/AUROCEQ-5D-3L). RE was measured using the ratio of F-values (RE = FPROPr/FEQ-5D-3L). Results: Of 218 LBP patients, 50.0% were female and the mean age was 61.8 years. The mean PROPr (0.20, 95%CI: 0.18; 0.22) and EQ-5D-3L scores (0.55, 95%CI: 0.51; 0.58) showed low agreement (d = 0.35, p < 0.001; ICC 0.27, 95%CI: -0.09; 0.59). The PROPr's distribution was positively skewed, whereas the EQ-5D-3L's was negative. Neither tool showed ceiling/floor effects, but all EQ-5D-3L dimensions did. Pearson correlation was r = 0.66 (95%CI: 0.58; 0.73). Differences were invariant to sex and age but not to ODI severity: ESEQ-5D-3L > ESPROPr and RE < 1 in higher ODI severity; ESEQ-5D-3L < ESPROPr and RE > 1 in lower ODI severity. AUROC-ratios did not show significant differences in terms of ODI severity. Conclusions: All PROPr and EQ-5D-3L biopsychosocial dimensions of health showed impairment in LPB patients. The capability of EQ-5D-3L and PROPr to differentiate ODI levels depends on ODI severity. Joint application of both tools may provide additional information. [ABSTRACT FROM AUTHOR]

Background: A questionnaire developed in one language must be translated and adapted when it will be used with patients speaking a different language and care should be taken to maintain equivalence between the source language (SL) version and its translated version. The objective of this study was to test the linguistic and cultural validity of a Nepali language version of the Supportive Care Need Survey – Short Form 34 (SCNS-SF34) used with the Nepali population. Methods: Translation of the SCNS-SF34 was carried out by following Beaton's guidelines and Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) by a research team. The translated version was administered to patients with cervical cancer in Nepal. The following steps were performed as part of the study: translation, content validity assessment, reliability assessment and measurement of errors. Results: The study reports item content validity (I-CVI) was > 0.78 and scale content validity (S-CVI) was − 0.89, 0.91 and 0.90 respectively in semantic, cultural, and conceptual aspects. The study found a content validity ratio (CVR) of 0.9 to 1, Cronbach's α of 0.90, correlation significant at the 0.01 level (2-tailed), and clarity of the questionnaire at 91.29%. The standard error of measurement (SEM) and small detectable changes (SDC) for overall care need scores were measured 2.70 and 7.47 respectively. All items were accepted as per the original SCNS-SF34. Following the respondents' suggestions, simpler Nepali words were chosen in some items to replace the words in the preliminary Nepali version of SCNS-SF34. Conclusion: Preliminary findings show that the Nepali translation of SCNS-SF34 is practical and applicable to the Nepali population. Financial supportive care needs, supportive care for caretakers and problems during patient hospital stays are essential to include in the questionnaire to further explore supportive care needs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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%) (x2 = 31.021; p = 0.000). The younger children took significantly longer to complete the measure (Mann-Whitney U = 8389.5, p < 0.001). Known-group validity was found at dimension level with children receiving orthopaedic management reporting more problems on physical dimensions across both age-groups. Convergent validity between Looking After Myself and WeeFIM items of self-care showed moderate to high correlations for both age-groups with a significantly higher correlation in the 8–10-year-olds for dressing upper (z = 2.24; p = 0.013) and lower body (z = 2.78; p = 0.003) and self-care total (z = 2.01; p = 0.022). There were fair to moderate levels of test-retest reliability across age-groups. Conclusion: The EQ-5D-Y-3L IA showed acceptable convergent validity and test–retest reliability for measuring health in children aged 5–7-years. There was more report of problems with the dimension of Looking After Myself in the 5–7-year group due to younger children requiring help with dressing, including buttons and shoelaces due to their developmental age, rather than their physical capabilities. Therefore, it may be useful to include examples of age-appropriate dressing tasks. There was further some reported difficulty with thinking about the dimensions in the younger age-group, most notably for Usual Activities which includes a large number of examples. By decreasing the number of examples it may reduce the burden of recall for the younger age-group. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Quality of Life-Aged Care Consumers (QOL-ACC) is a new older-person-specific quality of life instrument designed for application in quality assessment and economic evaluation in aged care. The QOL-ACC was designed from its inception with older people receiving aged care services ensuring its strong content validity. Given that the QOL-ACC has already been validated in home care settings and a preference-weighted value set developed, we aimed to assess feasibility, construct validity and reliability of the QOL-ACC in residential aged care settings.  METHODS: Individuals living in residential aged care facilities participated in an interviewer-facilitated survey. The survey included the QOL-ACC, QCE-ACC (quality of aged care experience measure) and two other preference-based quality of life instruments (ASCOT and EQ-5D-5L). Feasibility was assessed using missing data and ceiling/floor effects. Construct validity was assessed by exploring the relationship between the QOL-ACC and other instruments (convergent validity) and the QOL-ACC's ability to discriminate varying levels of self-rated health and quality of life. Internal consistency reliability was assessed using Cronbach's alpha (α).Results: Of the 200 residents (mean age, 85 ± 7.7 years) who completed the survey, 60% were female and 69% were born in Australia. One in three participating residents self-rated their health as fair/poor. The QOL-ACC had no missing data but had small floor effects (0.5%) and acceptable ceiling effects (7.5%). It demonstrated moderate correlation with ASCOT (r = 0.51, p < 0.001) and EQ-5D-5L (r = 0.52, p < 0.001) and a stronger correlation with the QCE-ACC (r = 0.57, p < 0.001). Residents with poor self-rated health and quality of life had significantly lower scores on the QOL-ACC. The internal consistency reliability of the QOL-ACC and its dimensions was good (α = 0.70-0.77).Conclusions: The QOL-ACC demonstrated good feasibility, construct validity and internal consistency reliability to assess aged care-related quality of life. Moderate correlations of the QOL-ACC and other instruments provide evidence of its construct validity and signifies that the QOL-ACC adds non-redundant and non-interchangeable information beyond the existing instruments. A stronger correlation with the QCE-ACC than other instruments may indicate that quality of life is more intimately connected with the care experience than either health- or social-related quality of life in residential aged care settings. [ABSTRACT FROM AUTHOR]

Objectives: To explore through a systematic review, the convergent validity of EQ-5D (EQ-5D-3L and EQ-5D-5L (total score and dimensions)) with core outcomes in dementia and investigate how this may be impacted by rater-type; with the aim of informing researchers when choosing measures to use in dementia trials.Methods: To identify articles relevant to the convergent validity of EQ-5D with core dementia outcomes, three databases were electronically searched to September 2022. Studies were considered eligible for inclusion within the review if they included individual level data from people with dementia of any type, collected self and/or proxy reported EQ-5D and collected at least one core dementia outcome measure. Relevant data such as study sample size, stage of dementia and administration of EQ-5D was extracted, and a narrative synthesis was adopted.Results: The search strategy retrieved 271 unique records, of which 30 met the inclusion criteria for the review. Twelve different core outcome measures were used to capture dementia outcomes: cognition, function, and behaviour/mood across the studies. Most studies used EQ-5D-3L (n = 27). Evidence related to the relationship between EQ-5D and measures of function and behaviour/mood was the most robust, with unanimous directions of associations, and more statistically significant findings. EQ-5D dimensions exhibited associations with corresponding clinical outcomes, whereby relationships were stronger with proxy-EQ-5D (than self-report).Conclusion: Measuring health-rated quality of life in dementia populations is a complex issue, particularly when considering balancing the challenges associated with both self and proxy report. Published evidence indicates that EQ-5D shows evidence of convergent validity with the key dementia outcomes, therefore capturing these relevant dementia outcomes. The degree of associations with clinical measures was stronger when considering proxy-reported EQ-5D and differed by EQ-5D dimension type. This review has revealed that, despite the limited targeted psychometric evidence pool and reliance on clinical and observational studies, EQ-5D exhibits convergent validity with other dementia outcome measures. [ABSTRACT FROM AUTHOR]

Background: Assessing health-related quality of life (HRQoL) among persons with dementia poses several challenges due to cognitive decline and limited perception. As a result, proxy ratings by family members or health professionals are used. The EQ-5D is the most commonly used generic and preference-based HRQoL instrument. Methodological drawbacks of the three-level version (EQ-5D-3L) prompted the development of the five-level version (EQ-5D-5L) by expanding the range in the domains. However, no comparison of the psychometric properties of both versions and different proxy ratings exist so far. Therefore, the objective of this study was to compare the psychometric properties of the EQ-5D-5L and EQ-5D-3L by application of different proxy ratings in dementia.Methods: The EQ-5D-3L and -5L were completed by n = 52 family caregivers and one care manager at baseline and three and six months later. In total, 106 caregiver and 133 care manager proxy ratings were completed. The EQ-5D-3L and 5L were evaluated in terms of acceptability (missing values), agreement, ceiling effects, redistribution properties and inconsistency, and informativity (Shannon, H', and Shannon Evenness, J', indices) as well as convergent and discriminative validity.Results: Mean proxy index scores were higher for the 5L than the 3L. Missing values occurred less frequently in both proxy ratings and versions (< 1%). Agreement between both measures was high but higher in caregiver than care-manager ratings (ICC 0.885 vs. 0.840). The relative ceiling effect decreased from the 3L to the 5L, more intensively in the care-manager (75%) than the caregiver rating (56%). Inconsistency between both versions was low. Informativity increased from the 3L to the 5L version, nearly equally in both proxy ratings. The 5L also demonstrated a better discriminative ability and convergent validity than the 3L, especially in the caregiver rating.Conclusion: Compared to the EQ-5D-3L, the EQ-5D-5L had higher feasibility and acceptability and was slightly superior by a reduction of ceiling effects and an improvement in informativity, discriminative ability and convergent validity. Proxy ratings by informal caregivers overall demonstrated better psychometric properties than professional care-manager ratings. [ABSTRACT FROM AUTHOR]

Background: Self-report is the standard for measuring people's health-related quality of life (HRQoL), including children. However, in certain circumstances children cannot report their own health. For this reason, children's HRQoL measures often provide both a self-report and a proxy-report form. It is not clear whether the measurement properties will be the same for these two forms. We investigated whether it would be beneficial to extend the classification system of the EQ-5D-Y proxy questionnaire from 3 to 5 response levels. The agreement between self-report and proxy-report was assessed for both EQ-5D-Y measures.Methods: The study included 286 pediatric patients and their caregivers as proxies. At three consecutive measurements-baseline, test-retest and follow-up-the proxies assessed the child's HRQoL using the EQ-5D-Y-3L, EQ-5D-Y-5L, the PedsQL Generic, and matched disease-specific instruments. The proxy versions of EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of feasibility, distribution properties, convergent validity, test-retest and responsiveness. Agreement between both EQ-5D-Y proxy versions to their respective self-report versions was assessed at baseline and follow-up.Results: The proportion of missing responses was 1% for the EQ-5D-Y-3L and 1.4% for the EQ-5D-Y-5L. The frequency of health state with no problems in all dimensions (11111) was slightly lower for the EQ-5D-Y-5L (21.3% vs 16.7%). Regarding the convergent validity with the PedsQL and disease-specific measures, the proxy versions of EQ-5D-Y-3L and EQ-5D-Y-5L had similar magnitudes of associations between similar dimensions. The means of test-retest coefficients between the two versions of the EQ-5D-Y proxy were comparable (0.83 vs. 0.84). Regarding reported improved conditions, responsiveness of the EQ-5D-Y-5L proxy (26.6-54.1%) was higher than that of the EQ-5D-Y-3L proxy (20.7-46.4%). Except for acutely ill patients, agreement between the EQ-5D-Y-5L proxy and self-reports was at least moderate.Conclusions: Extending the number of levels of the proxy version of EQ-5D-Y can improve the classification accuracy and the ability to detect health changes over time. The level structure of EQ-5D-Y-5L was associated with a closer agreement between proxy and self-report. The study findings support extending the EQ-5D-Y descriptive system from 3 to 5 levels when administered by a proxy, which is often the case in the pediatric population. [ABSTRACT FROM AUTHOR]

Background: The RAND-36 and RAND-12 (equivalent to versions 1 of the SF-36 Health Survey and SF-12 Health Survey, respectively) are widely used measures of health-related quality of life. However, there are diverging views regarding how to create the physical health and mental health composite scores of these questionnaires. We present a simple approach using an unweighted linear combination of subscale scores for constructing composite scores for physical and mental health that assumes these scores should be free to correlate. The aim of this study was to investigate the criterion validity and convergent validity of these scores.Methods: We investigated oblique and unweighted RAND-36/12 composite scores from a random sample of the general Norwegian population (N = 2107). Criterion validity was tested by examining the correlation between unweighted composite scores and weighted scores derived from oblique principal component analysis. Convergent validity was examined by analysing the associations between the different composite scores, age, gender, body mass index, physical activity, rheumatic disease, and depression.Results: The correlations between the composite scores derived by the two methods were substantial (r = 0.97 to 0.99) for both the RAND-36 and RAND-12. The effect sizes of the associations between the oblique versus the unweighted composite scores and other variables had comparable magnitudes.Conclusion: The unweighted RAND-36 and RAND-12 composite scores demonstrated satisfactory criterion validity and convergent validity. This suggests that if the physical and mental composite scores are free to be correlated, the calculation of these composite scores can be kept simple. [ABSTRACT FROM AUTHOR]

Introduction: The Swedish version of the patient-reported Clinical Outcomes in Routine Evaluation Outcome Measures (CORE-OM) has demonstrated high reliability and acceptable convergent validity in explanatory factor analyses. However, the fundamental scale properties have not yet been validated according to item response theory. The aim of this study was to analyze the measurement properties of the Swedish CORE-OM in a cohort of psychiatric out-patients with depression and anxiety in a multicultural area and to explore combinations of items based on shorter versions of the scale (CORE-10, CORE-6D) to improve measurement properties.Methods: Data from CORE-OM assessments of 337 patients were analyzed using Rasch analysis. The patients had a mean age of 30 ± 14 years, the majority were women (72%). Requirements for measurement properties were checked: overall model fit, item fit residuals, targeting, internal consistency, differential item functioning and thresholds. Sensitivity to change was also analyzed.Results: The CORE-OM showed high internal consistency (person separation index = 0.947) and adequate targeting, but there was overall model misfit (item trait interaction χ2 = 917.53, p < 0.001), indication of local dependency, and differential item functioning in 9 items. The risk items showed problems with disordered thresholds. The emotional component of the shorter CORE-6D showed the best fit for our sample. Adding 3 items to include depressive and trauma-related content resulted in a unidimensional 8-item set with acceptable reliability, model fit, targeting and sensitivity to change.Conclusion: For out-patients with diagnosed depression or anxiety in a multicultural area, the Swedish CORE-OM showed high internal consistency, but also validity problems. Based on the shorter CORE-6D version, a unidimensional 8-item set could be an alternative brief measure of psychological distress for this population, but further validity studies are required. Qualitative studies exploring the CORE-OM items in non-native speakers are also warranted. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is a head-to-head comparison of the instrument performance and responsiveness of the EQ-5D-Y-3L and the expanded English version of the EQ-5D-Y-5L in children/adolescents receiving acute orthopaedic management in South Africa.Methods: Children/adolescents aged 8-15 years completed the EQ-5D-Y-5L, EQ-5D-Y-3L, self-rated health (SRH) question and PedsQL at baseline. The EQ-5D-Y-5L, EQ-5D-Y-3L and SRH question were repeated after 24 and 48 h. Performance of the EQ-5D-Y-5L and EQ-5D-Y-3L was determined by comparing feasibility (missing responses), redistribution of dimensions responses, discriminatory power, concurrent validity, and responsiveness.Results: Eighty-three children/adolescents completed baseline measures and seventy-one at all three time-points. Reporting of 11111 decreased by 20% from the EQ-5D-Y-3L to the EQ-5D-Y-5L. Informativity of dimensions improved on average by 0.267 on the EQ-5D-Y-5L with similar evenness. There was a range of 11-27% inconsistent responses when moving from the EQ-5D-Y-3L to the EQ-5D-Y-5L. There was a low to moderate and significant association on the EQ-5D-Y-3L and EQ-5D-Y-5L to similar items on the PedsQL and SRH scores. Percentage change over time was greater for the EQ-5D-Y-5L (range 0-182%) than EQ-5D-Y-3L (range 0-100%) with the largest reduction for both measures between 0 and 48 h. For those who respondents who showed an improved SRH the EQ-5D-Y-5L and EQ-5D-Y-3L showed significant paired differences.Conclusion: The English version of the EQ-5D-Y-5L appears to be a valid and responsive extension of the EQ-5D-Y-3L for children receiving acute orthopaedic management. The expanded levels notably reduce the ceiling effect and has greater discriminatory power. Concurrent validity of the EQ-5D-Y-3L and EQ-5D-Y-5L was low to moderate with similar PedsQL items and SRH. The EQ-5D-Y-5L generally showed greater change than the EQ-5D-Y-3L across all dimensions with the greatest change observed for 0-48 h. Responsiveness was comparable across the EQ-5D-Y-3L and EQ-5D-Y-5L for those with improved SRH. Greater sensitivity to change may be observed on comparison of utility scores, once preference-based value sets are available for the EQ-5D-Y-5L. [ABSTRACT FROM AUTHOR]

Background: The adult versions EQ-5D-3L and EQ-5D-5L have been extensive compared. This is not the case for the EQ-5D youth versions. The study aim was to compare the measurement properties and responsiveness of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients.Methods: A sample of patients 8-16 years old with different diseases and a wide range of disease severity was asked to complete EQ-5D-Y-3L, EQ-5D-Y-5L, PedsQL Generic Core Scale, and selected, appropriate disease-specific instruments, three times. EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of: feasibility, (re-)distribution properties, discriminatory power, convergent validity, test-retest reliability, and responsiveness.Results: 286 participating patients suffered from one of the following diseases: major beta-thalassemia, haemophilia, acute lymphoblastic leukaemia, acute illness. Missing responses were comparable between versions of the EQ-5D-Y, suggesting comparable feasibility. The number of patients in the best health state (level profile 11111) was equal in both EQ-5D-Y versions. The projection of EQ-5D-Y-3L scores onto EQ-5D-Y-5L for all dimensions showed that the two additional levels in EQ-5D-Y-5L slightly improved the accuracy of patients in reporting their problems, especially if severe. Convergent validity with PedsQL and disease-specific measures showed that the two EQ-5D-Y versions performed about equally. Test-retest reliability (EQ-5D-Y-3L 0.78 vs EQ-5D-Y-5L 0.84), and sensitivity for detecting health changes, were both better in EQ-5D-Y-5L.Conclusions: Extending the number of levels did not give clear superiority to EQ-5D-Y-5L over EQ-5D-Y-3L based on the criteria assessed in this study. However, increasing the number of levels benefitted EQ-5D-Y performance in the measurement of moderate to severe problems and especially in longitudinal study designs. [ABSTRACT FROM AUTHOR]

Aim: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy.Methods: Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman's correlation and the level of agreement was explored using Bland-Altman plots.Results: Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores.Conclusion: The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L.Trial Registration: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011. [ABSTRACT FROM AUTHOR]

Background: Although there is emerging data regarding the psychometric properties of the Child Health Utility-9D instrument, more evidence is required with respect to its validity for use in different country settings. The aim of this study was to examine the construct validity of the CHU-9D-CHN instrument in Chinese children.Methods: Baseline Health-Related Quality of Life (HRQoL) and demographic data were collected from children recruited to the CHIRPY DRAGON obesity prevention intervention randomised controlled trial in China. HRQoL was measured using the Chinese version of the CHU-9D instrument (CHU-9D-CHN) and the PedsQL instrument. CHU-9D-CHN utility scores were generated using two scoring algorithms [UK and Chinese tariffs]. Discriminant validity, known-group validity and convergent validity were evaluated using non-parametric test for trend, Kruskal-Wallis test and Spearman correlation coefficient analysis respectively.Results: Data was available for 1,539 children (mean age 6 years). The CHU-9D-CHN was sensitive to known group differences determined by the median PedsQL total score. Furthermore, the mean CHU-9D-CHN utility values decreased linearly with increasing levels of severity on each dimension of the PedsQL for emotional and social functioning domains. They decreased monotonically with increasing levels of severity on each dimension of the PedsQL for physical and school functioning domains (p < 0.001). Contrary to studies conducted in Western countries, and although not statistically significant, we found an indication that HRQoL, using both the CHU-9D-CHN and the PedsQL, was higher in children whose parents had lower levels of education, compared to those whose parents were university educated. The correlation between the CHU-9D-CHN utility values using UK and Chinese tariffs, and PedsQL total scores showed a statistically significant moderate positive correlation (Spearman's rho = 0.5221, p < 0.001 and Spearman's rho = 0.5316, p < 0.001), respectively. However, each CHU-9D-CHN dimension was either weakly, or very weakly correlated with each of the predetermined PedsQL domain functioning scores.Conclusions: Overall, the findings provide some support for the construct validity of the CHU-9D-CHN within a Chinese population aged 6-7 years. However, some uncertainty remains. We recommend future studies continue to test the validity of the CHU-9D in different country settings.Trial Registration: ISRCTN Identifier ISRCTN11867516, Registered on 19/08/2015. [ABSTRACT FROM AUTHOR]

Background: Valid measures of the well-being of older people are important for the evaluation of health and social care services. The nine-item Well-being of Older People measure (WOOP) was based on a novel framework derived from a recent Q-methodology study, and was developed to capture a comprehensive set of well-being domains relevant to older people, as identified by themselves. This study introduces the WOOP and describes the qualitative assessment of its feasibility and content validity.Methods: Between December 2017 and January 2018, a sampling agency retrieved data from 269 adults aged 65 years and older in the Netherlands. Using an online survey, participants were asked to complete the WOOP and to indicate the importance of each item to their well-being. Open-ended questions were used to collect information about participants' own definition of well-being, their interpretation of the items of the WOOP, and their assessment of the descriptions and response options provided with each item. Data were analysed using inductive content analysis with the software package ATLAS.ti.Results: The WOOP closely resembled respondents' own description of what well-being means to them. The majority of the respondents reported no important well-being aspects to be missing from the WOOP, and indicated all WOOP items to be at least 'reasonably important' to their well-being. Many linked the WOOP items to well-being aspects as intended, and only a few had suggestions for improving the items' descriptions and response options.Conclusions: Given these results, all nine items were retained, and no items were added to the measure. Based on respondents' feedback, minor changes were made to the wording of some descriptions and response options of items. Concluding, the feasibility and content validity of the WOOP seem satisfactory. Further validation of this new measure is required, in different health and social care settings and among subgroups of older people with potentially different views on what constitutes well-being. [ABSTRACT FROM AUTHOR]

Background: The Suboptimal Health Status Questionnaire-25 (SHS-Q-25) developed to measure Suboptimal Health Status has been used worldwide, but its construct validity has only been tested in the Chinese population. Applying Structural Equation Modelling, we investigate aspects of the construct validity of the SHS-Q-25 to determine the interactions between SHS subscales in a Ghanaian population.Methods: The study involved healthy Ghanaian participants (n = 263; aged 20-80 years; 63% female), who responded to the SHSQ-25. In an exploratory factor and parallel analysis, the study extracted a new domain structure and compared to the established five-domain structure of SHSQ-25. A confirmatory factor analysis (CFA) was conducted and the fit of the model further discussed. Invariance analysis was carried out to establish the consistency of the instrument across multi-groups.Results: The extracted domains were reliable with Cronbach's [Formula: see text] of 0.846, 0.820 and 0.864 respectively, for fatigue, immune-cardiovascular and cognitive. The CFA revealed that the model fit indices were excellent [Formula: see text]. The fit indices for the three-domain model were statistically superior to the five-domain model. There were, however, issues of insufficient discriminant validity as some average variance extracts were smaller than the corresponding maximum shared variance. The three-domain model was invariant for all constrained aspects of the structural model across age, which is an important risk factor for most chronic diseases.Conclusion: The validity tests suggest that the SHS-Q25 can measure SHS in a Ghanaian population. It can be recommended as a screening tool to early detect chronic diseases especially in developing countries where access to facilities is diminished. [ABSTRACT FROM AUTHOR]

Background: Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient's health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients' HRQoL.Methods: The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test-retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity.Results: The Portuguese DrHy-Q showed adequate internal consistency (Cronbach's ɑ = 0.938), good test-retest reliability [ICC = 0.713 (95% CI 0.488-0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = - 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (β = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (β = 7.770; 95% CI 2.600; 12.940) and other manifestations (β = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with ≥ 2 suspected drugs are also more likely to have worse QoL (β = 7.927; 95% CI 3.687; 12.166).Conclusion: The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients' HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient's DrHy-QoL. [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the validity of the EQ-5D-5L in respondents with self-reported diabetes coming from a representative general population survey.Methods: 2974 respondents from the general adult population of Poland, chosen with multi-stage random sampling, were surveyed with HRQoL instruments (EQ-5D-5L, EQ VAS, SF-12, EQ-5D-3L) and a screening question about diabetes. To obtain EQ-5D index values, we used country-specific Polish value sets. We compared the instruments in terms of the ceiling effect, discriminatory power and frequency of individual health states. We evaluated construct validity in terms of known-groups validity and convergent validity of EQ-5D-5L dimensions and index values with other HRQoL measures.Results: In respondents with diabetes (n = 247), the percentage reporting 'no problems' with EQ-5D-3L was reduced by 34.5% with the use of EQ-5D-5L (from 14.2% to 9.3%, respectively). A significant improvement in informativity was noticed in mobility and pain/discomfort dimensions (a relative increase of 23.1% and 22.7%, respectively). Known-groups construct validity analysis confirmed prior hypotheses-index scores were higher in the following groups: younger respondents, males, those taking no medication or oral antidiabetic drugs, and respondents with higher levels of education. The convergence between related EQ-5D-5L and EQ-5D-3L or SF-6D dimensions was stronger than between unrelated dimensions. The Bland-Altman analysis showed a mean difference between EQ-5D-5L and EQ-5D-3L, SF-6D, EQ VAS/100 index scores of 0.047, 0.165 and 0.231 respectively.Conclusions: Our results support the validity of the EQ-5D-5L descriptive system and EQ-5D-5L index, based on the directly measured value set in respondents with self-reported diabetes coming from the general population. [ABSTRACT FROM AUTHOR]

Background: The translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.Methods: The instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, and effect size measures.Results: Item non-response varied between 1.8%/1.1% (SFVR-36/RESF-36) and 6.5%/8.6% (GHVR-36/GHSF-36). PCS was normally distributed (Kolmogorov-Smirnov tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7 [13.8-66.1]) and VR-36 (38.5 ± 10.1 [11.7-67.8]), SF-12 (36.9 ± 10.9 [15.5-61.6]) and VR-12 (36.2 ± 11.5 [12.7-59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR-36: 36.2 ± 14.2 [12.9-66.6], MCSSF-36: 39.0 ± 15.6 [2.0-73.2], MCSVR-12: 37.2 ± 13.8 [8.4-70.2], MCSSF-12: 39.0 ± 12.3 [17.6-65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (≥ 0.3) to high (≥ 0.5) correlations with convergent (PCSVR: 0.55-0.76, MCSVR: 0.60-0.78) and small correlations (< 0.1) with divergent (PCSVR: < 0.12, MCSVR: < 0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation.Conclusions: The psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations. [ABSTRACT FROM AUTHOR]

Background: Fatigue negatively influences health-related quality of life. It is questionable whether fatigue is sufficiently covered by the EQ-5D. This study investigated whether fatigue is covered by the existing domains of the EQ-5D.Methods: A Dutch general population sample completed the EQ-5D (3L and 5L version) and the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), of which the fatigue item was used. Outcomes were compared between participants with and without a chronic health condition. Convergent validity was assessed, and multivariate regression analyses was used to predict the RPQ fatigue item from the EQ-5D-3L and EQ-5D-5L domains separately.Results: 3027 people completed the survey, of whom 52% had ≥ 1 chronic health condition. Fatigue was reported by 48% of the participants. Fatigue was moderately correlated to the EQ-5D domains 'pain/discomfort', 'usual activities', and 'anxiety/depression' for the 3L (r = 0.379-0.426) and 5L version (r = 0.411-0.469). For the 5L, also a moderate correlation with 'mobility' (r = 0.335) was observed. The remaining correlations were weak. All EQ-5D-3L and 5L domains except for 'mobility' were significantly associated with the RPQ fatigue item (unstandardized Beta = - 0.20-0.67; p < 0.01 to p = 0.04). Comparable outcomes were found for participants with and without ≥ 1 chronic health condition.Conclusions: The extent to which fatigue is covered by the EQ-5D domains is small to moderate, with the EQ-5D-5L being slightly more sensitive to capture fatigue compared to the EQ-5D-3L. An extra fatigue item for the EQ-5D may add value, as fatigue is not fully captured by the existing domains, both in people with and without a chronic health condition. [ABSTRACT FROM AUTHOR]

Background: Currently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the 'Patient Enablement Instrument', we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test-retest reliability, measurement error, responsiveness and floor and ceiling effects.Methods: The PEI-BP consists of 6 items that are rated on a 0-10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test-retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire-physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain.Results: The PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test-retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population.Conclusions: The PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended.Trial Registration: Not applicable. [ABSTRACT FROM AUTHOR]

Background: Generic preference-based measures (GPBMs) are health-related quality of life (HRQoL) measures commonly used to evaluate the cost-utility of interventions in healthcare. However, the degree to which the content of GPBMs reflect the HRQoL of individuals with chronic obstructive pulmonary disease (COPD) has not yet been assessed. The purpose of this study was to examine the content and convergent validity of GPBMs in people with COPD.Methods: COPD patients were recruited from healthcare centers in Ontario, Canada. The Patient-Generated Index (PGI) (an individualized HRQoL measure) and the RAND-36 (to obtain SF-6D scores; a GPBM) were administered. Life areas nominated with the PGI were coded using the International Classification of Functioning Disability and Health and mapped onto GPBMs.Results: We included 60 participants with a mean age of 70 and FEV1% predicted of 43. The mean PGI score was 34.55/100 and the top three overarching areas that emerged were: 'mobility' (25.93%), 'recreation and leisure' (25.19%) and 'domestic life' (19.26%). Mapping of the nominated areas revealed that the Quality of Well-Being scale covered the highest number of areas (84.62%), Health Utilities Indices covered the least (15.38% and 30.77%) and other GPBMs covered between 46 and 62%. A correlation of 0.32 was calculated between the SF-6D and the PGI.Conclusions: The majority of GPBMs covered approximately half of the areas reported as being important to individuals with COPD. When areas relevant to COPD are not captured, HRQoL scores generated by these measures may inaccurately reflect patients' values and affect cost-effectiveness decisions. [ABSTRACT FROM AUTHOR]

Background: Health education basing on patients' information-seeking styles can improve the effectiveness of health education and patients' health outcomes. The Miller Behavioral Style Scale (MBSS) is widely used to identify individual's information-seeking styles, but the Chinese version is lacking. The study aim was to translate and culturally adapt the MBSS into Chinese version and test the content validity, construct validity and internal consistency reliability of the Chinese version of MBSS (C-MBSS).Methods: The forward-back-translation procedure was adopted in the translation of the MBSS. Content validity was assessed in a panel of experts. In a sample of 1343 individuals including patients, patients' caregivers, university students, and medical staff, reliability and construct validity were assessed using Cronbach's alpha coefficient and factor analysis. The measurement invariance across samples was tested using multigroup confirmatory factor analysis (MGCFA). Floor and ceiling effects were checked.Results: The C-MBSS achieved conceptual and semantic equivalence with the original scale. The item-level content validity index (I-CVI) of each item ranged from 0.78 to 1, and the averaging scale-level content validity index (S-CVI/ Ave) was 0.95. The exploratory factor analysis resulted in 2-factor assumption for each hypothetical threat-evoking scenario. Confirmatory factor analysis demonstrated a good fit between theoretical model and data, which provided confirmatory evidence for the second-order factor structure of 2-factor solution (Monitoring and Blunting). The Cronbach's alpha coefficients for the Monitoring and Blunting sub-scales of the C-MBSS were 0.75 and 0.62 respectively. MGCFA results supported the measurement invariance for the Monitoring sub-scale of the C-MBSS across samples. No floor or ceiling effects occurred.Conclusions: This study indicates that the C-MBSS has good content and construct validity. The Monitoring sub-scale of the C-MBSS had acceptable internal consistency reliability while the Blunting sub-scale had unsatisfactory one, which suggest that the Monitoring sub-scale of the C-MBSS can be used to identify individuals' information-seeking styles in Chinese contexts across different populations. [ABSTRACT FROM AUTHOR]

Background: The Trunk Impairment Scale (TIS) has been translated into Chinese, but the psychometric properties of the Chinese version of the TIS (TIS-C) have not yet been established. We aimed to examine the reliability and validity of the TIS-C for assessing sitting balance among Chinese people with a stroke.Methods: A descriptive, cross-sectional design was used. We recruited a convenience sample of 170 subacute stroke patients aged 18 years or over from the neurology departments of four traditional Chinese medicine hospitals in China. Patients completed the TIS-C, the Berg Balance Scale and the Modified Barthel Index. The psychometric properties of the TIS-C were examined to establish test-retest reliability, internal consistency, equivalence, and content, criterion, and construct validity.Results: Intraclass correlation coefficients for inter-rater and intra-rater reliability ranged from 0.75 to 0.89 and from 0.90 to 0.97, respectively. The TIS-C Cronbach α was 0.86. The strong correlation between the total score of the TIS-C and the Berg Balance Scale (rs = 0.81, p < 0.001) or Modified Barthel Index (rs = 0.84, p < 0.001) suggested good concurrent and convergent validity, respectively. Known-group validity was supported by the significant difference (p < 0.001) in TIS-C scores between participants with mild and moderate stroke.Conclusions: The TIS-C is a valid and reliable tool for assessing static and dynamic sitting balance as well as coordination of trunk movement among stroke survivors with mild and moderate stroke. [ABSTRACT FROM AUTHOR]

Background: Limitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs).Methods: PubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach.Results: Eleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments.Conclusions: The first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness. [ABSTRACT FROM AUTHOR]

Objective: To sinicize the Supportive Supervisory Scale (SSS) and analyze the psychometric properties of the Chinese version of SSS (SSS-C).Methods: The SSS (the original English version) was firstly sinicized and adjusted, then its psychometric properties were examined in 300 health care aides from four long-term care (LTC) facilities. SPSS 22.0 was used to process the data and calculate the reliability and validity.Results: The 15-item SSS-C had satisfactory internal consistency (Cronbach's α coefficient = 0.852), split half reliability (Spearman-Brown coefficient = 0.834) and test-retest reliability (Pearson correlation coefficient = 0.784), and three factors were extracted. If the four items with their communality < 0.4 were deleted, the remaining 11 items could explain 55.654% of the total variance. The discriminant validity of the SSS-C varied significantly between sites.Conclusions: The Chinese version of SSS can be used to effectively measure the supervisory support of the nurses within the LTC settings. [ABSTRACT FROM AUTHOR]

Background: The Short Form 36 (SF-36) is a scoring system comprising of 36 items categorized into eight constructs corresponding to patients' health-related quality of life. It has been used extensively in various countries on different sub-populations and used to indicate the health status and help to ascertain the effect of clinical interventions on the particular population.Objective: To examine the psychometric properties of the Malay version of SF-36 (Malay SF-36) summated rating scales and validate the scale among post-coronary artery bypass grafting surgery (CABG) patients at the National Heart Institute (IJN), Kuala Lumpur.Methods: Five hundred and nine post-CABG patients at the IJN, Malaysia completed the questionnaires between 1 July and 31 December 2017. Psychometric tests endorsed by the "International Quality of Life Assessment Project" were utilised.Results: The data quality was excellent with a high questionnaire completion rate (100%). As hypothesized, the ordering of item means within scales was clustered. In unison, scaling assumptions were satisfied. Good discriminant validity was shown between subsets of patients with various levels of health status. Notwithstanding, there were probably translation issues of the Physical Functioning scale which showed small ceiling effects. We clearly observed high ceiling and floor effects in both Role Physical and Role Emotional scale most probably attributed to the dichotomous style of their choice of responses. Cronbach alpha values of the eight scales ranged from 0.73 to 0.90, showing good internal consistency reliability. Confirmatory Factor Analysis (CFA) confirmed the 8-factor solution and Composite Reliability revealed internal consistency reliability except for Vitality and Social Functioning. Based on the Average Variance Extracted (AVE), convergent validity was adequate except for two domains. Discriminant Validity is good for the eight constructs as the √AVE are generally higher than the correlation coefficients between the latent constructs.Conclusion: The scoring for the Malay SF-36 based on the summated ratings method was proven to be valid to be applied in our local clinical population. The CFA, fitness estimates, reliability and validity assessments suggest that the Malay version of SF36 is a valid and reliable instrument. However, further work is warranted to further refine the convergent validity and reliability of some scales. [ABSTRACT FROM AUTHOR]

Background: An increasing number of subjects are recovering from COVID-19, raising the need for tools to adequately assess the course of the disease and its impact on functional status. We aimed to assess the construct validity of the Post-COVID-19 Functional Status (PCFS) Scale among adult subjects with confirmed and presumed COVID-19.Methods: Adult subjects with confirmed and presumed COVID-19, who were members of an online panel and two Facebook groups for subjects with COVID-19 with persistent symptoms, completed an online survey after the onset of infection-related symptoms. The number and intensity of symptoms were evaluated with the Utrecht Symptom Diary, health-related quality of life (HrQoL) with the 5-level EQ-5D questionnaire, impairment in work and activities with the Work Productivity and Activity Impairment questionnaire and functional status with the PCFS Scale.Results: 1939 subjects were included in the analyses (85% women, 95% non-hospitalized during infection) about 3 months after the onset of infection-related symptoms. Subjects classified as experiencing 'slight', 'moderate' and 'severe' functional limitations presented a gradual increase in the number/intensity of symptoms, reduction of HrQoL and impairment in work and usual activities. No differences were found regarding the number and intensity of symptoms, HrQoL and impairment in work and usual activities between subjects classified as experiencing 'negligible' and 'no' functional limitations. We found weak-to-strong statistical associations between functional status and all domains of HrQoL (r: 0.233-0.661). Notably, the strongest association found was with the 'usual activities' domain of the 5-level EQ-5D questionnaire.Conclusion: We demonstrated the construct validity of the PCFS Scale in highly-symptomatic adult subjects with confirmed and presumed COVID-19, 3 months after the onset of symptoms. [ABSTRACT FROM AUTHOR]

Purpose: The Autism Behavior Inventory (ABI) is an observer-reported outcome scale measuring core and associated features of autism spectrum disorder (ASD). Extensive scale development (reported elsewhere) took place, in alignment with the Food and Drug Administration's patient-reported outcome guidance, to address the need for instruments to measure change and severity of ASD symptoms.Methods: Cognitive interviewing was used to confirm understanding and content validity of the scale prior to its use in clinical trials. Respondents were caregivers of individuals with ASD (N = 50). Interviews used a hybrid of the "think-aloud" and verbal probing approach to assess ABI's content validity and participant understanding of the instrument, including: item clarity and relevance; item interpretation; appropriateness of response scales; and clarity of instructions. Audio-recordings of the interviews were transcribed for qualitative data analysis. The scale was revised based on participant feedback and tested in a second round of interviews (round 1 N = 38, round 2 N = 12).Results: In total, 67/70 items reached ≥ 90% understandability across participants. Caregivers were able to select an appropriate response from the options available and reported finding the examples helpful. Based on participant feedback, instructions were simplified, 8 items were removed, and 10 items were reworded. The final revised 62-item scale was presented in round 2, where caregivers reported readily understanding the instructions, response options, and 61/62 items reached ≥ 90% understandability.Conclusions: Cognitive interviews with caregivers of a diverse sample of individuals with ASD confirm the content validity and relevance of the ABI to assess core and associated symptoms of ASD. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization's Quality of Life Questionnaire (WHOQOL-Bref) is a frequently used instrument to assess the quality of life in both healthy and ill populations. Inquiries of the psychometric properties of the WHOQOL-Bref report that the validity and reliability is generally satisfactory. However, some studies fail to support a four-factor dimensionality; others report poor reliability of the social and environmental domain; and there may be some challenges of supporting construct validity across age. This paper evaluates the psychometric properties of the Norwegian WHOQOL-Bref and extends previous research by testing for measurement invariance across age, gender and education level. In addition, we provide updated normative data for the Norwegian population.Methods: We selected a random sample of the Norwegian population (n = 654) aged 18-75 years. Participants filled out the WHOQOL-Bref, the Utrecht Work Engagement Scale and various sociodemographic variables.Results: We found an acceptable convergent and discriminate validity and internal consistency of the physical, psychological and environmental domains, but a marginal reliability was found for the social domain. The factor loadings were invariant across gender, education and age. Some items had low factor loadings and explained variance, and the model fit for the age group 60-75 years were less satisfactory.Conclusions: The original four-factor dimensionality of the WHOQOL-Bref displayed a better fit to the data compared to the one-factor solution and is recommended for use in the Norwegian population. The WHOQOL-Bref is suitable to use across gender, education and age, but for assessment in the oldest age group, the WHOQOL-Old module could be a good supplementary, but further studies are needed. [ABSTRACT FROM AUTHOR]

Background: Early prelingual auditory development (EPLAD) is a fundamental and important process in the speech and language development of infants and toddlers. The Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) is a widely used measurement tool for EPLAD, however it has not yet undergone a comprehensive psychometric analysis. The aim of this research was to modify and verify the psychometric properties of ITMAIS using a combination of Item Response Theory (IRT) and Classical Test Theory (CTT).Methods: Stage 1-1730 children were retrospectively recruited to enable the application of an IRT model, specifically the graded response model, to modify the ITMAIS. Stage 2-another 450 infants and toddlers with normal hearing or permanent hearing loss before auditory intervention were recruited to verify the psychometric properties of the modified ITMAIS (ITMAIS-m) using the CTT method.Results: Using the metric of the graded response model, by removing item 2 from the ITMAIS, ITMAIS-m demonstrated discrimination parameters ranging from 3.947 to 5.431, difficulty parameters from - 1.146 to 1.150, item information distributed between 4.798 and 9.259 and a test information score of 48.061. None of the items showed differential item functioning. ITMAIS-m was further verified in Stage 2, showing Cronbach's α of 0.919 and item-total correlations ranging from 0.693 to 0.851. There was good convergent validity of ITMAIS-m with other auditory outcome measure (r = 0.932) and pure tone average thresholds (r ranging from - 0.670 to - 0.909), as well as a high ability to discriminate between different hearing grades (Cohen d ranging from 0.41 to 5.83).Conclusions: The ITMAIS-m is a reliable and valid tool for evaluating EPLAD in infants and toddlers, which can be efficiently and precisely applied in clinical practice. The combined use of IRT and CTT provides a powerful means to modify psychometrically robust scales aimed at childhood auditory outcome measurements. [ABSTRACT FROM AUTHOR]

Background: Accurate diagnosis of carpal tunnel syndrome (CTS) is essential for directing appropriate treatment; and for making decisions about work injury claims. The Kamath and Stothard Questionnaire (KSQ) is a self-reported tool used for the diagnosis of CTS. Comprehensibility and comprehensiveness of this questionnaire are critical to diagnostic performance and need to be established. The purpose of the study was to describe how potential respondents, clinicians, and measurement researchers interpret KSQ questions in order to identify and resolve potential sources of misclassification.Methods: Hand therapists, measurement researchers, participants with CTS, and a control group were interviewed using cognitive interviewing techniques (talk aloud, semi-structured interview probes) in Hamilton, Canada. All interviews were recorded and transcribed verbatim. A directed content analysis was done to analyze the interviews using a previously established framework.Findings: Eighteen participants were interviewed. Areas, where questions were unclear to some participants, were recorded and categorized into five themes: Clarity and Comprehension (52%), Relativeness (38%), Inadequate Response Definition (4%), Perspective Modifiers (4%), and Reference Point (2%). Respondents also identified several symptoms of CTS that are not covered by the KSQ that might be of diagnostic value, e.g., weakness and dropping items.Conclusion: The content validity of the current iteration of the KSQ was not established. The problematic questions identified in the study have been reported to have low specificity and negative predictive values in a previous quantitative study. The content validity issues identified may explain the poor performance. Recommendations were made to modify the wording of the KSQ and the potential addition of three new questions. Future studies should determine whether the modified questionnaire can provide better diagnostic accuracy and psychometric properties. The results of this study may assist in ruling in or out CTS diagnosis to a wide variety of target audience, such as hand specialists, physical and occupational therapists, as well as family doctors. [ABSTRACT FROM AUTHOR]

Background: This study was focused on translation and cultural adaptation of the English Lequesne Algofunctional index (LAI) into Bengali for patients with primary knee osteoarthritis (OA) and testing reliability and validity of the Bengali version of the LAI.Methods: This study was carried out in the Department of Rheumatology, BSM Medical University, Dhaka, Bangladesh. Using the forward-backward method the English LAI was translated into Bengali including cultural adaptation. For pretesting, A sample of 40 patients with primary knee osteoarthritis were screened using the Bengali version of LAI. Following the pretest, 130 consecutive patients with symptomatic knee OA completed the interviewer administered Bengali LAI, the validated Bengali version of SF-36, Visual Analogue Scale for Pain, Distance Walked and Activities of Daily Living. For the retest 60 randomly selected patients from the cohort were administered the Bengali LAI 7 days later. An item by item analysis was performed. Internal consistency was assessed by Cronbach's alpha, test-retest reliability by intraclass correlation coefficient (ICC) and Kappa coefficient, construct validity was measured using the Spearman rank correlation coefficient.Results: It took 3.25 ± 0.71 min to complete the Bengali LAI and the mean score was 9.23 ± 4.58. For the Bengali LAI Cronbach's alpha score was 0.88, test-retest reliability assessed by ICC was 0.97. For construct validity, excellent convergent validity was achieved (ρ = 0.93) but the divergent validity was moderate (ρ = 0.43).Conclusions: The Bengali LAI showed excellent convergent validity, internal consistency and test-retest reliability, only the divergent validity was moderate. So, the Bengali LAI can be applied as a HRQoL assessment tool for primary knee OA patients. [ABSTRACT FROM AUTHOR]

Background: The Older people Quality of Life-7 domains (OQoL-7) is a 28-item multidimensional questionnaire developed to measure community-dwelling older people's QoL. The OQoL-7 assesses both importance of and satisfaction in seven QoL domains (Material resources; Close entourage; Social and cultural life; Esteem and recognition; Health and mobility; Feeling of safety; and Autonomy). This study aimed to investigate concurrent and construct validity of the OQoL-7. A secondary aim was to compare different methods of weighting participants' ratings of satisfaction according to their individual ratings of importance, as compared to the OQoL-7 total score (unweighted).Methods: Data came from the first and second samples of the Lausanne cohort 65+ study, assessed at the same age of 72-77 years in 2011 (N = 1117) and 2016 (N = 1091), respectively. To assess concurrent validity, the OQoL-7 was compared to other measures of the same concept (single QoL item) or related concepts (self-rated health, SF-12). Construct validity was tested by comparing subscores in the seven QoL domains in the presence and absence of two stressful events during the preceding year (financial difficulties and relationship difficulties). The effect of importance weighting was assessed using moderated regression analysis.Results: The OQoL-7 total score was significantly associated with the single QoL item (Spearman's rho 0.46), self-rated health (Spearman's rho 0.34), SF-12 physical (Spearman's rho 0.22) and mental (Spearman's rho 0.28) component scores. Large differences (Cohen's d > 0.8) were observed in the presence or absence of stressful events in the expected QoL domains: "Material resources" in the presence or absence of "Financial difficulties" (Cohen's d 1.34), and "Close entourage" in the presence or absence of "Relationship difficulties" (Cohen's d 0.84). Importance weighting resulted in a very small improvement in the prediction of the single QoL item (ΔR2 0.018). All results were highly consistent across 2011 and 2016 samples.Conclusions: The OQoL-7 showed adequate concurrent and construct validity in two samples of older people. In future studies, the decision to use weighted or unweighted scores will depend on the priority given to either optimizing the prediction of QoL or limiting the burden on respondents and the amount of missing data. [ABSTRACT FROM AUTHOR]

Background: The Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Patient-Rated Wrist/Hand Evaluation (PRWHE) and the Thumb Disability Exam (TDX) are patient-reported outcome measures (PROM) designed to assess pain and hand function in patients with hand arthritis, hand pain and disability, or thumb pathology respectively. This study evaluated the content validity of AUSCAN, PRWHE and TDX in people with hand arthritis.Methods: This study enrolled participants with hand arthritis to rate the items of all 3 PROM in terms of relevance and clarity. The Content Validity Index (CVI) was computed for each item in each scale (I-CVI) as well as for the overall scale (S-CVI). Kappa was used to determine the inter-rater agreement among the raters.Results: Overall, 64 individuals with hand arthritis (27% with OA, 67% with rheumatoid arthritis and 6% with psoriatic arthritis) participated in the study. The I-CVI for all items and all scales were very high (I-CVI > 0.76) and the modified Kappa agreement among the raters demonstrated excellent agreement (k > 0.76). The S-CVI for all PROMs was very high for relevance (AUSCAN = 0.92, 95% CI 0.90 to 0.94; PRWHE = 0.85, 95% CI 0.82 to 0.88 and TDX = 0.87, 95% CI 0.85 to 0.89) and for clarity (AUSCAN = 0.99, 95% CI 0.98 to 1.00; PRWHE = 0.95, 95% CI 0.93 to 0.97 and TDX = 0.91, 95% CI 0.89 to 0.94), respectively.Conclusions: This study demonstrated very high content validity indices for the AUSCAN, PRWHE and TDX; with strong consensus across raters. This augments prior studies demonstrating appropriate statistical measurement properties, to provide confidence that all three measures assess important patient concepts of pain and disability. [ABSTRACT FROM AUTHOR]

Duchenne muscular dystrophy (DMD) is an inherited X-linked neuromuscular disorder. A number of questionnaires are available to assess quality of life in DMD, but there are concerns about their validity. This systematic review aimed to appraise critically the content and structural validity of quality of life instruments for DMD. Five databases (EMBASE, MEDLINE, CINAHL, PsycINFO, and Cochrane Library) were searched, with supplementary searches in Google Scholar. We included articles with evidence on the content and/or structural validity of quality of life instruments in DMD, and/or instrument development. Evidence was evaluated against the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. Fifty five articles featured a questionnaire assessing quality of life in DMD. Forty instruments were extracted and 26 underwent assessment. Forty-one articles contained evidence on content or structural validity (including 37 development papers). Most instruments demonstrated low quality evidence and unsatisfactory or inconsistent validity in DMD, with the majority not featuring direct validation studies in this population. Only KIDSCREEN received an adequate rating for instrument design and a satisfactory result for content validity based on its development, yet, like the majority of PROMs, the measure has not been directly validated for use in DMD. Further research is needed on the validity of quality of life instruments in DMD, including content and structural validity studies in this population. [ABSTRACT FROM AUTHOR]

Background: It is essential to better understand the caregiving burden and its determinants to support caregivers. The aim of this study was to test the validity and reliability (internal consistency) of the caregiver burden inventory (CBI) in Iranian caregivers of elderly patients with Alzheimer.Methods: A cross sectional study was conducted to translate and validate the CBI in Iran. The structural validity of the scale was evaluated by exploratory factor analysis. The concurrent validity was tested correlating the CBI scores with the Beck Anxiety Inventory (BAI) and the Beck Depression Inventory (BDI) scores. The internal consistency reliability was assessed using the Cronbach's alpha coefficient.Results: In total, we enrolled 315 caregivers of elderly patients with Alzheimer disease (79% women, mean age 56.5 ± 13.9). The structural validity of the CBI as assessed by exploratory factor analysis indicated three factors (emotional/psychological, time-dependence and physical burden) that jointly explained 45.21% of the total variance observed. The Pearson correlation coefficient for the relationship between the scores obtained on the Caregiver Burden Inventory and the BAI and the BDI were 0.69 and 0.49 respectively, confirming the concurrent validity. The Cronbach's alpha for the CBI was 0.91 ranging from 0.78 to 0.92 for its subscales.Conclusion: Used in clinical practice and research, the CBI was verified to be a proper multidimensional instrument for evaluating the burden in caregivers of elderly patients with Alzheimer disease. [ABSTRACT FROM AUTHOR]

Background: Literature on the validity of outcome measurement in lymphedema and lipedema is very sparse. This study aimed to examine the convergent, divergent and discriminant validity of a set of 5 instruments in both conditions.Methods: Cross-sectional outcome was measured by the generic Short Form 36 (SF-36), the lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), the knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), the Symptom Checklist-90-revised (SCL-90R), and the Six-Minute Walk Test (6 MWT). Construct convergent/divergent validity was quantified by bivariate correlations and multivariate factor analysis, and discriminant validity by standardized mean differences (SMDs).Results: Health was consistently better in lymphedema (n = 107) than in lipedema (n = 96). The highest construct convergence was found for physical health between the SF-36 and KOS-ADL (bivariate correlations up to 0.78, factor loads up to 0.85, explained variance up to 56.8%). The second most important factor was mental health (bivariate correlations up to 0.79, factor loads up to 0.86, explained variance up to 13.3%). Discriminant validity was greatest for the FLQA-lk Physical complaints (adjusted SMD = 0.93) followed by the SF-36 Bodily pain (adjusted SMD = 0.83), KOS-ADL Function (adjusted SMD = 0.47) and SF-36 Vitality (adjusted SMD = 0.39).Conclusions: All five instruments have specific strengths and can be implemented according to the scope and aim of the outcome examination. A minimum measurement set should comprise: the SF-36 Bodily pain, SF-36 Vitality, FLQA-lk Physical complaints, FLQA-lk Social life, FLQA-lk Emotional well-being, FLQA-lk Health state, KOS-ADL Symptoms, KOS-ADL Function, and the SCL-90R Interpersonal sensitivity. [ABSTRACT FROM AUTHOR]

Background: People living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centred care. Routine use of patient reported outcome measures can improve outcomes. There is no brief patient reported outcome measure (PROM) that currently reflects the breadth of concerns for people living with HIV. This study aimed to develop and cognitively test a brief novel patient reported outcome measure for use within routine adult HIV care- the "Positive Outcomes" HIV PROM.Methods: Development followed the COSMIN taxonomy and guidance for relevance and comprehensiveness, and Rothrock guidance on development of valid patient reported outcome measures. The Positive Outcomes HIV PROM was developed by a steering group (people living with HIV, HIV professionals and health services researchers) using findings from a previously reported qualitative study of priority outcomes for people living with HIV. The prototype measure was cognitively tested with a purposive sample of people living with HIV.Results: The Positive Outcomes HIV PROM consists of 23 questions (22 structured, and one open question) informed by the priorities of key stakeholders (n = 28 people living with HIV, n = 21 HIV professionals and n = 8 HIV commissioners) to ensure face and content validity, and refined through cognitive testing (n = 6 people living with HIV). Cognitive testing demonstrated high levels of acceptability and accessibility.Conclusions: The Positive Outcomes HIV PROM is the first brief patient reported outcome measure reflecting the diverse needs of people living with HIV designed specifically for use in the clinical setting to support patient assessment and care, and drive service quality improvement. It is derived from primary data on the priority outcomes for people living with HIV and is comprehensive and acceptable. Further psychometric testing is required to ensure reliability and responsiveness. [ABSTRACT FROM AUTHOR]

Background: The aim of the current study was to examine the internal structure and convergent and discriminant validity of the Multicultural Quality of Life Index (MQLI) in a Greek sample of community-dwelling adults in a major Greek city.Methods: The authors developed a Greek version of the Multicultural Quality of Life Index (MQLI-Gr). It was translated following cross-cultural adaptation procedures for self-report measures and administered to community members (N = 884). Participants completed a brief demographic survey, the MQLI-Gr, and the Depression Anxiety Stress Scales (DASS-42).Results: The MQLI-Gr is brief, easy to use, and demonstrates strong internal consistency (Cronbach alpha = .90). In terms of internal structure there were mixed results. In terms of discriminant validity, statistically significant differences in mean MQLI-Gr scores were observed between two groups: those with none-mild symptoms versus those with severe symptoms of depression, anxiety, and stress (p < .05). The MQLI-Gr was also able to discriminate among groups assumed to vary on quality of life; marital status, income, and employment. In terms of convergent validity, results were in the expected direction, with participants reporting high levels of depression, anxiety, and stress, also reporting lower quality of life on the MQLI-Gr (p < .001).Conclusion: Consistent with other translations, the MQLI-Gr demonstrated feasibility, strong internal consistency, and good convergent and discriminant validity. This is the first step in the development of a psychometrically sound measure to assess quality of life in a community-dwelling population in Greece. With the addition of further validation studies, this measure will be a useful tool for assessing the quality of life in the Greek community. [ABSTRACT FROM AUTHOR]