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Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder.
López, FA, Faraone, SV, Newcorn, JH, Doll, HA, Rhoten, S, Lewis, HB, Khan, TF, DeSousa, NJ, Sallee, FR, Incledon, B
Journal of child and adolescent psychopharmacology. 2021;(3):179-186
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Abstract
Objectives: Inadequately controlled symptoms and associated impaired functioning have a significant negative impact on caregivers of children with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the impact of evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) treatment on caregiver strain, measured by the Caregiver Strain Questionnaire (CGSQ), and present post hoc psychometric analyses assessing the reliability and validity of the CGSQ, its ability to detect change (responsiveness), and to derive responder definitions. Methods: The CGSQ was an exploratory efficacy endpoint in a phase 3, 3-week, randomized, double-blind, multicenter, placebo-controlled, forced-dose titration trial of DR/ER-MPH in children aged 6-12 years with ADHD (NCT02520388). Psychometric properties of the CGSQ evaluated post hoc included internal consistency using Cronbach's alpha; test/retest reliability using intraclass correlation coefficients (ICCs); construct validity (known groups and convergent/divergent validity); responsiveness to changes in assessments of ADHD severity (ADHD Rating Scale-IV [ADHD-RS-IV], Conners' Global Index-Parent [CGI-P], and Clinical Global Impression-Severity [CGI-S]/CGI-Improvement [CGI-I]); and meaningful change threshold (MCT) using receiver operating characteristic curves, which were used to compare response between DR/ER-MPH and placebo groups. Results: Randomized DR/ER-MPH (54.5) and placebo (54.9) groups had similar mean CGSQ scores at screening. Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p < 0.001). The CGSQ demonstrated strong internal consistency (Cronbach's alpha = 0.93) and good test/retest reliability (ICC = 0.72). Known groups, convergent/divergent validity, and responsiveness were demonstrated from relationships between the CGSQ and the CGI-S, ADHD-RS-IV, and CGI-P. The mean anchor-based MCT for CGSQ total score was estimated as -9.0 (DR/ER-MPH vs. placebo: 53.2% vs. 29.9% p = 0.003). Conclusions: CGSQ scores significantly decreased after 3 weeks of DR/ER-MPH treatment versus placebo, and the CGSQ was found to be a valid and reliable measure of strain in caregivers of children with ADHD. Clinical trial registration identification number: NCT02520388.
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Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.
Parpia, TC, Elwood, SE, Scharf, RJ, McDermid, JM, Wanjuhi, AW, Rogawski McQuade, ET, Gratz, J, Svensen, E, Swann, JR, Donowitz, JR, et al
The American journal of tropical medicine and hygiene. 2020;(4):1397-1404
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Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z-score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.
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Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil.
Pinto, LCS, Andrade, MC, Chaves, RO, Lopes, LLB, Maués, KG, Monteiro, AM, Nascimento, MB, Barros, CAV
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2020;(4):e51-e57
Abstract
OBJECTIVES To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis. METHODS The first stage of the work was the development, installation, and establishment of the instructions to use the phone app as an instrument to aid in the control of fluid and food intake of 52 patients undergoing dialysis. In the second stage, the patients were monitored for 3 months and evaluated using questionnaires to measure the improvement in quality of life (Kidney Disease Quality of Life Instrument) and self-management of disease (Perceived Medical Condition Self-Management Scale) by the app. In addition, laboratory tests were performed before app use and in the first, second, and third months of its use (January to April 2018). Analysis of variance was used to analyze the laboratory data, and a paired Student's t test was used to analyze the responses to the questionnaires and as a posttest (P < .05). RESULTS Among the laboratory test results, serum phosphorus levels showed a significant difference (P < .04) after the app was used. A significant improvement was observed in self-management of the disease according to the Perceived Medical Condition Self-Management Scale questionnaire (P < .03). The usability of the app reached a median score of 9.65 from a total score of 10. CONCLUSION The NefroPortatil app improved the degree of perception of self-care of patients undergoing dialysis with chronic kidney failure, in addition to favoring nutritional control.
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Relationships between observations and parental reports of 3-5 year old children's emotional eating using the Children's Eating Behaviour Questionnaire.
Blissett, J, Farrow, C, Haycraft, E
Appetite. 2019;:104323
Abstract
BACKGROUND The Children's Eating Behaviour Questionnaire [CEBQ) is a widely used, brief, psychometrically sound parent-report measure of children's eating behaviour traits. However, the relationship between parent report of children's emotional over-eating [EOE) and emotional under-eating [EUE) using the CEBQ and children's eating behaviour under conditions of negative emotion has not been examined. METHODS Sixty-two mothers with children between 34 and 59 months of age (mean = 46.0 months, SD = 6.8; 33 boys, 29 girls) attended the laboratory and ate a meal to satiety. Children were randomly allocated to a negative mood induction or neutral condition. Children had access to snack foods for 4 min and their intake was measured. Mothers completed the CEBQ. All participants were weighed and measured from which BMI (mothers) and BMI SDS (child) scores were calculated. RESULTS Adjusting for covariates, children who were rated as higher in EUE on the CEBQ ate fewer kilocalories from crisps/potato chips and cookies when in a negative mood state, but not when in neutral mood. There were no significant relationships between maternal ratings of EOE on the CEBQ and children's snack food intake in either condition. CONCLUSIONS This study provides moderate support for the validity of the EUE scale of the CEBQ in 3-5-year-old children. Further work, including induction of different mood states, is required to explore whether the EOE scale truly captures young children's emotional over-eating.
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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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Validation of a Shortened Version of the Children's Eating Behavior Questionnaire and Associations with BMI in a Clinical Sample of Latino Children.
Behar, AI, Crespo, NC, Garcia, ML, Ayala, GX, Campbell, N, Shadron, LM, Elder, JP
Journal of nutrition education and behavior. 2018;(4):372-378.e1
Abstract
OBJECTIVE To examine the validity of the Children's Eating Behavior Questionnaire (CEBQ) through the associations of its 3 subscale scores (food responsiveness, slowness in eating, and satiety responsiveness) with body mass index (BMI). DESIGN Cross-sectional study of baseline data from a clinic-based obesity prevention and control randomized controlled trial. PARTICIPANTS Latino pediatric patients (n = 295) aged 5-11 years from a federally qualified health center in San Diego County, CA, with BMI percentiles ranging from 75.5 to 99.0. MAIN OUTCOME MEASURE Child BMI-for-age percentile computed using the standardized program for the 2000 Centers for Disease Control and Prevention growth charts. ANALYSIS Principal components analysis and multivariate linear regressions. RESULTS Principal components analysis showed a factor structure relatively similar to that of the original 3 CEBQ subscales, with acceptable internal consistency and between-subscale correlations. Analyses demonstrated the validity of the 3 subscales: child BMI was positively associated with food responsiveness (β = .336; P ≤ .001) and negatively associated with slowness in eating (β = -.209; P ≤ .001) and satiety responsiveness (β = -.211; P ≤ .001). CONCLUSIONS AND IMPLICATIONS The 14-item CEBQ scale may be useful for assessing obesogenic eating behaviors of Latino children. Further study is needed to replicate these findings.
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Measuring personal recovery - psychometric properties of the Swedish Questionnaire about the Process of Recovery (QPR-Swe).
Argentzell, E, Hultqvist, J, Neil, S, Eklund, M
Nordic journal of psychiatry. 2017;(7):529-535
Abstract
BACKGROUND Personal recovery, defined as an individual process towards meaning, is an important target within mental health services. Measuring recovery hence requires reliable and valid measures. The Process of Recovery Questionnaire (QPR) was developed for that purpose. AIMS The aim was to develop a Swedish version of the QPR (QPR-Swe) and explore its psychometric properties in terms of factor structure, internal consistency, construct validity and sensitivity to change. METHODS A total of 226 participants entered the study. The factor structure was investigated by Principal Component Analysis and Scree plot. Construct validity was addressed in terms of convergent validity against indicators of self-mastery, self-esteem, quality of life and self-rated health. RESULTS A one-factor solution of QPR-Swe received better support than a two-factor solution. Good internal consistency was indicated, α = 0.92, and construct validity was satisfactory. The QPR-Swe showed preliminary sensitivity to change. CONCLUSIONS The QPR-Swe showed promising initial psychometric properties in terms of internal consistency, convergent validity and sensitivity to change. The QPR-Swe is recommended for use in research and clinical contexts to assess personal recovery among people with mental illness.
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Respondent selection in a repeated survey on lifestyle within the randomized colorectal cancer screening programme.
Jäntti, M, Heinävaara, S, Helander, S, Sarkeala, T, Malila, N
European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP). 2017;(4):309-313
Abstract
Screening for colorectal cancer (CRC) has been shown to decrease colorectal cancer mortality in randomized-controlled trials. However, screening may have an adverse impact on an individual's lifestyle. We describe here the design of a repeated survey study on lifestyle and assess response in the survey target population by randomization to CRC screening and demographic factors. The survey study population (n=10271) included Finnish men and women born in 1951 who were randomized for the CRC screening programme in 2011 and received a questionnaire on lifestyle in 2010 and 2012. We assessed responding by randomization to CRC screening, calendar time and demographic factors using the population-averaged Poisson model. Responding to survey was overall similar in 2010 and 2012. Those invited for CRC screening increased responding in time [incidence rate ratio (IRR) 1.06, confidence interval (CI) 1.03-1.09], whereas controls decreased their responding (IRR 0.97, CI 0.94-1.00). Women were more likely to respond than men (IRR 1.17, CI 1.12-1.23). Also, secondary (IRR 1.20, CI 1.13-1.27) and tertiary (IRR 1.31, CI 1.23-1.40) level education increased the response proportion compared with primary-level education. We could reliably assess the effect of CRC screening invitation and demographic factors on survey response. Although invitation to CRC screening increased responding, the self-selection was similar on both survey rounds. Self-selection should be taken into account when generalizing results from survey studies to their target population.
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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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Using the stress and adversity inventory as a teaching tool leads to significant learning gains in two courses on stress and health.
Slavich, GM, Toussaint, L
Stress and health : journal of the International Society for the Investigation of Stress. 2014;(4):343-52
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The ability to measure cumulative stress exposure is important for research and teaching in stress and health, but until recently, no structured system has existed for assessing exposure to stress over the lifespan. Here, we report the results of two experimental studies that examined the pedagogical efficacy of using an automated system for assessing life stress, called the Stress and Adversity Inventory (STRAIN), for teaching courses on stress and health. In Study 1, a randomized, wait-list controlled experiment was conducted with 20 college students to test whether the STRAIN, coupled with a related lecture and discussion, promoted learning about stress and health. Results showed that this experiential lesson led to significant learning gains. To disentangle the effects of completing the STRAIN from participating in the lecture and discussion, we subsequently conducted Study 2 on 144 students using a 2 (STRAIN versus control activity) by 2 (STRAIN-specific lecture versus general stress lecture) repeated-measures design. Although the STRAIN-specific lecture was sufficient for promoting learning, completing the STRAIN also generated significant learning gains when paired with only the general stress lecture. Together, these studies suggest that the STRAIN is an effective tool for promoting experiential learning and teaching students about stress and health.