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Validity of the energy-restricted Mediterranean Diet Adherence Screener.
Schröder, H, Zomeño, MD, Martínez-González, MA, Salas-Salvadó, J, Corella, D, Vioque, J, Romaguera, D, Martínez, JA, Tinahones, FJ, Miranda, JL, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(8):4971-4979
Abstract
BACKGROUND Short dietary assessment tools can be useful to estimate food intake and diet quality in large-scale epidemiological studies with time constraints. OBJECTIVE To determine the concurrent validity of the 17-item energy-restricted Mediterranean Adherence Screener (er-MEDAS) used in the PREDIMED (PREvención con DIeta MEDiterránea)-Plus trial and to analyse its capacity to detect 1-year changes in diet and cardiometabolic risk factors. METHODS Validation study nested in the PREDIMED-Plus (n = 6760, 55-75 years). Dietary data were collected by the 17-item er-MEDAS and a 143-item validated semiquantitative food frequency questionnaire (FFQ) at baseline and after 1-year intervention. Cardiometabolic risk markers were measured at both time points. A Mediterranean diet (MedDiet) score was derived from both instruments. Concurrent validity was evaluated by Pearson and intra-class correlation coefficients (ICC) and Bland and Altman limits of agreement. Construct validity was evaluated by assessing 1-year changes in FFQ-reported dietary intake and cardiometabolic profile changes in relation to changes in er-MEDAS. RESULTS A moderate to good correlation between the MedDiet score calculated by both measurement instruments was found: r = 0.61 and ICC = 0.60 (both p < 0.001). Agreement of each of the er-MEDAS items ranged from 55.4% to 85.0% with a moderate mean concordance (kappa = 0.41). Between baseline and 1-year follow-up, energy intake measured by the FFQ decreased by 242 kcal, while Mediterranean food consumption increased in participants with the highest increase in the er-MEDAS MedDiet score. An increase in the er-MEDAS MedDiet score ratings was associated with a decrease in BMI, waist circumference, triglycerides, fasting glucose, diastolic blood pressure, and triglycerides/HDL-cholesterol ratio (p < 0.001 for all), and with an increase in HDL-cholesterol (p = 0.006). CONCLUSION The er-MEDAS shows a modest to good concurrent validity compared with FFQ data. It shows acceptable construct validity, as a greater er-MEDAS score was associated with more favourable dietary and cardiometabolic profiles over time. TRIAL REGISTRY ISRCTN89898870; registration date, 24 July 2014. https://www.isrctn.com/ISRCTN89898870.
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Reliability and validity of body weight and body image perception in children and adolescents from the South American Youth/Child Cardiovascular and Environmental (SAYCARE) Study.
González-Zapata, LI, Restrepo-Mesa, SL, Aristizabal, JC, Skapino, E, Collese, TS, Azzaretti, LB, Nascimento-Junior, WV, Moreno, LA, De Moraes, ACF, Carvalho, HB, et al
Public health nutrition. 2019;(6):988-996
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OBJECTIVE To assess the reliability and validity of body weight (BW) and body image (BI) perception reported by parents (in children) and by adolescents in a South American population. DESIGN Cross-sectional study. BW perception was evaluated by the question, 'Do you think you/your child are/is: severely wasted, wasted, normal weight, overweight, obese?' BI perception was evaluated using the Gardner scale. To evaluate reliability, BW and BI perceptions were reported twice, two weeks apart. To evaluate validity, the BW and BI perceptions were compared with WHO BMI Z-scores. Kappa and Kendall's tau-c coefficients were obtained. SETTING Public and private schools and high schools from six countries of South America (Argentina, Peru, Colombia, Uruguay, Chile, Brazil).ParticipantsChildren aged 3-10 years (n 635) and adolescents aged 11-17 years (n 400). RESULTS Reliability of BW perception was fair in children's parents (κ=0·337) and substantial in adolescents (κ=0·709). Validity of BW perception was slight in children's parents (κ=0·176) and fair in adolescents (κ=0·268). When evaluating BI, most children were perceived by parents as having lower weight. Reliability of BI perception was slight in children's parents (κ=0·124) and moderate in adolescents (κ=0·599). Validity of BI perception was poor in children's parents (κ=-0·018) and slight in adolescents (κ=0·023). CONCLUSIONS Reliability of BW and BI perceptions was higher in adolescents than in children's parents. Validity of BW perception was good among the parents of the children and adolescents with underweight and normal weight.
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Health-related Quality of Life in the Phase III LUME-Colon 1 Study: Comparison and Interpretation of Results From EORTC QLQ-C30 Analyses.
Lenz, HJ, Argiles, G, Yoshino, T, Lonardi, S, Falcone, A, Limón, ML, Sobrero, A, Hastedt, C, Peil, B, Voss, F, et al
Clinical colorectal cancer. 2019;(4):269-279.e5
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INTRODUCTION We used European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) data from the LUME-Colon 1 study to illustrate different methods of statistical analysis for health-related quality of life (HRQoL), and compared the results. PATIENTS AND METHODS Patients were randomized 1:1 to receive nintedanib 200 mg twice daily plus best supportive care (n = 386) or matched placebo plus best supportive care (n = 382). Five methods (mean treatment difference averaged over time, using a mixed-effects growth curve model; mixed-effects models for repeated measurements (MMRM); time-to-deterioration (TTD); status change; and responder analysis) were used to analyze EORTC QLQ-C30 global health status (GHS)/QoL and scores from functional scales. RESULTS Overall, GHS/QoL and physical functioning deteriorated over time. Mean treatment difference slightly favored nintedanib over placebo for physical functioning (adjusted mean, 2.66; 95% confidence interval [CI], 0.97-4.34) and social functioning (adjusted mean, 2.62; 95% CI, 0.66-4.47). GHS/QoL was numerically better with nintedanib versus placebo (adjusted mean, 1.61; 95% CI, -0.004 to 3.27). MMRM analysis had similar results, with better physical functioning in the nintedanib group at all timepoints. There was no significant delay in GHS/QoL deterioration (10%) and physical functioning (16%) with nintedanib versus placebo (TTD analysis). Status change analysis showed a higher proportion of patients with markedly improved GHS/QoL and physical functioning in the nintedanib versus placebo groups. Responder analysis showed a similar, less pronounced pattern. CONCLUSION Analyses of EORTC QLQ-C30 data showed that HRQoL was not impaired by treatment with nintedanib versus placebo. Analysis and interpretation of HRQoL endpoints should consider symptom type and severity and course of disease.
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Psychometric Validation of the Heart Failure Caregiver Questionnaire (HF-CQ®).
Strömberg, A, Bonner, N, Grant, L, Bennett, B, Chung, ML, Jaarsma, T, Luttik, ML, Lewis, EF, Calado, F, Deschaseaux, C
The patient. 2017;(5):579-592
Abstract
BACKGROUND The Heart Failure Caregiver Questionnaire (HF-CQ®) was developed to assess subjective outcomes of heart failure caregivers. The HF-CQ® comprises 21 questions on three domains, namely physical, emotional/psychological and lifestyle. The objective of this study was to evaluate the psychometric properties of the HF-CQ®. METHODS Patients (n = 150) with heart failure and their primary caregivers (n = 150) were recruited from 11 sites in USA. Caregivers completed the HF-CQ® and additional questionnaires, namely Caregiver Reaction Assessment, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain, and the Hospital Anxiety and Depression Scale. Patient-completed Global Impression of Severity, construct validity, concurrent validity, reliability and responsiveness of the HF-CQ® were also assessed. RESULTS In the physical and lifestyle domains, all items showed acceptable validity. No high correlations between HF-CQ® scores and other caregiver-completed instruments, including the Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain or Caregiver Reaction Assessment, were reported. The intra-class correlation coefficient exceeded the threshold for reliability (>0.7) across the physical well-being (0.785), emotional/psychological (0.797), lifestyle (0.787) and total scores (0.850), indicating acceptable reliability. Internal consistency results using Cronbach's alpha showed the total aggregate score of 0.942 to be reliable. In the responsiveness analyses, each of the three scales and the total score showed responsiveness to changes defined by the Caregiver Global Impression of Severity. The overall caregiver burden score increased with increased severity of illness in the cared-for patients. CONCLUSIONS The study provides initial evidence for the acceptable validity of the HF-CQ® as an instrument to measure heart failure caregiver burden.
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Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples.
Petrillo, J, Cano, SJ, McLeod, LD, Coon, CD
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2015;(1):25-34
Abstract
OBJECTIVE To provide comparisons and a worked example of item- and scale-level evaluations based on three psychometric methods used in patient-reported outcome development-classical test theory (CTT), item response theory (IRT), and Rasch measurement theory (RMT)-in an analysis of the National Eye Institute Visual Functioning Questionnaire (VFQ-25). METHODS Baseline VFQ-25 data from 240 participants with diabetic macular edema from a randomized, double-masked, multicenter clinical trial were used to evaluate the VFQ at the total score level. CTT, RMT, and IRT evaluations were conducted, and results were assessed in a head-to-head comparison. RESULTS Results were similar across the three methods, with IRT and RMT providing more detailed diagnostic information on how to improve the scale. CTT led to the identification of two problematic items that threaten the validity of the overall scale score, sets of redundant items, and skewed response categories. IRT and RMT additionally identified poor fit for one item, many locally dependent items, poor targeting, and disordering of over half the response categories. CONCLUSIONS Selection of a psychometric approach depends on many factors. Researchers should justify their evaluation method and consider the intended audience. If the instrument is being developed for descriptive purposes and on a restricted budget, a cursory examination of the CTT-based psychometric properties may be all that is possible. In a high-stakes situation, such as the development of a patient-reported outcome instrument for consideration in pharmaceutical labeling, however, a thorough psychometric evaluation including IRT or RMT should be considered, with final item-level decisions made on the basis of both quantitative and qualitative results.
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Rankin scale as a potential measure of global disability in early Parkinson's disease.
Simuni, T, Luo, ST, Chou, KL, Fernandez, H, He, B, Parashos, S
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2013;(9):1200-3
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We conducted an exploratory analysis of the utility of the modified Rankin Scale (mRS) as a global measure of disability in early Parkinson's diesase (PD) using the baseline data from a large cohort of PD patients enrolled in a longitudinal study of creatine. The mRS is scored 0-6 with lower scores reflecting less disability. For the analysis the mRS score was dichotomized at <2 versus ≥2. We explored the association of the mRS with multiple measures of PD-related impairments, including the Unified Parkinson Disease Rating Scale (UPDRS); cognitive function characterized by the Symbol Digit Modalities--verbal, and Scales for Outcomes in Parkinson's disease--cognition (SCOPA-COG); quality of life (Parkinson's disease questionnaire [PDQ-39]) and EuroQOL; Beck Depression Inventory II (BDI); and Total Functional Capacity (TFC). We also investigated the interaction between variables. One thousand seven hundred forty-one patients were included in the analysis of which 374 had a mRS score of 2 or above. In the univariate model, all interested measures except SCOPA-COG (p=0.23) had significant association with mRS (p<0.001) after controlling for confounders. In the multivariate model, UPDRS Part II and III (activities of daily living and motor), BDI, TFC and PDQ-39 were significant (p<0.05). The mRS has a significant association with the wide spectrum of measures of impairment and quality of life in early PD and shows good potential to be a global measure of disability in early PD. The sensitivity of the mRS to change and performance of the scale in more advanced PD will have to be established longitudinally.