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Background: This paper presents the baseline characteristics and their moderators in the Healthy Learning Mind (HLM)– school-based cluster-randomized controlled trial. Objectives: The paper evaluates the state of various measures of well-being, their moderators and how these results compare to national and global norms/population studies. Methods: Data were collected from all participants prior to the intervention and further analyzed by gender, grade and perceived socioeconomic status, including standardized measures for resilience, depressive symptoms and socioemotional functioning; health-related quality of life, dispositional mindfulness, satisfaction with life, compassion/self-kindness, self-rated health and morning tiredness. Results: Participating 2793 students (1425 girls, 1368 boys), ages 12 to 15 years, filled in the questionnaires. The outcomes were in line with previous research, demonstrating gender differentiation and lower wellbeing among older children and adolescents. Conclusions: All outcomes were associated with perceived socioeconomic status, suggesting that perceived low socioeconomic status should be addressed as a serious risk factor and included as a moderator in similar trials. [ABSTRACT FROM AUTHOR]

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

One of the most common chronic diseases that causes missed school days and workdays is pediatric asthma, producing education, health and economic delays in low and middle-income countries. A patient-centered remarkable therapeutic strategy in the prevention and treatment of chronic diseases is the Therapeutic Patient Education (TPE) which denotes an outstanding difference in the outcomes, from the awareness, to the personal treatment adaption to prevent crises. In this paper, an intervention of TPE with learning objects (LOs) of a pediatric asthma course, designed to train the uncontrolled patient and the caregiver as a team on the specific knowledge to self-control the disease, was carried out at a health facility in Mexico. The Asthma Control Test (ACT) was used and the learning performance was evaluated with formative quizzes. A randomized controlled trial was designed, with pairs of children patients and caregivers during 60 days; the control group was trained with the usual approach, receiving general information about the disease. ACT measures showed statistical significance for the TPE group after the use of the LOs, achieving a controlled state, while the control group did not show difference. Also, the intervention group obtained a higher score in learning performance assessment. The users learned how to avoid risks, the personal triggers of the patient, how to correctly use the different treatments and accessories, consequently, they learned how to self-manage the disease. Our study also confirmed that control of asthma is not only a matter of knowledge, but financial issues to afford the treatment. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are designed to assess patients' perceived health states or health-related quality of life. However, PROMs are susceptible to missing data, which can affect the validity of conclusions from randomised controlled trials (RCTs). This review aims to assess current practice in the handling, analysis and reporting of missing PROMs outcome data in RCTs compared to contemporary methodology and guidance. Methods: This structured review of the literature includes RCTs with a minimum of 50 participants per arm. Studies using the EQ-5D-3L, EORTC QLQ-C30, SF-12 and SF-36 were included if published in 2013; those using the less commonly implemented HUI, OHS, OKS and PDQ were included if published between 2009 and 2013. Results: The review included 237 records (4-76 per relevant PROM). Complete case analysis and single imputation were commonly used in 33 and 15 % of publications, respectively. Multiple imputation was reported for 9 % of the PROMs reviewed. The majority of publications (93 %) failed to describe the assumed missing data mechanism, while low numbers of papers reported methods to minimise missing data (23 %), performed sensitivity analyses (22 %) or discussed the potential influence of missing data on results (16 %). Conclusions: Considerable discrepancy exists between approved methodology and current practice in handling, analysis and reporting of missing PROMs outcome data in RCTs. Greater awareness is needed for the potential biases introduced by inappropriate handling of missing data, as well as the importance of sensitivity analysis and clear reporting to enable appropriate assessments of treatment effects and conclusions from RCTs. [ABSTRACT FROM AUTHOR]

The goal of this paper is to describe the baseline characteristics of Live Well (intervention to prevent weight gain in recent immigrant mother-child dyads from Brazil, Haiti, and Latin America) participants, and to explore self-reported changes in diet and physical activity post-immigration. Baseline data from 383 mothers were used for this study. Dyads attended a measurement day where they completed self-administered surveys collecting information about socio-demographics, diet, physical activity, other psychosocial variables, and height and weight. Haitian mothers' socio-demographic profile differed significantly from that of Brazilians' and Latinas': they have been in the US for a shorter period of time, have higher rates of unemployment, are less likely to be married, more likely to have ≥3 children, more likely to be obese, and have immigrated for family or other reasons. In multivariate models, self-reported changes in diet and physical activity since migrating to the US were significantly associated with BMI with non-linear relationships identified. Future research is needed to understand how diet and physical activity change while acculturating to the US and explore the adoption of both healthy and unhealthy dietary changes. [ABSTRACT FROM AUTHOR]

Summary: We have developed a short, patient-reported outcome questionnaire-the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 ( n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. [ABSTRACT FROM AUTHOR]

A transdisciplinary approach incorporating biological, psychological, behavioral, and genetic factors was taken to better identify proposed moderators of the effectiveness of an intervention to increase physical activity. This paper illustrates how theory-based individual difference variables can be integrated into a complex randomized controlled trial. The transdisciplinary framework guiding the selection of moderators, the COSTRIDE intervention study and sample, and the relationships among baseline variables are provided. Participants were non-active individuals randomly assigned to either the STRIDE exercise or health-and-wellness contact control condition. Structural equation modeling was utilized to demonstrate that relationships among baseline variables confirm hypothesized relationships in the transdisciplinary framework. Preliminary data from COSTRIDE suggest that interventions among sedentary individuals may be more effective if a broader range of factors influencing physical activity are considered. [ABSTRACT FROM AUTHOR]

The negative impacts of parental mental health problems on children and adolescents are well known, but the relationship between a child's depression and their parents' health is not so well understood. Being a carer/parent of someone with mental illness can be associated with negative outcomes for the caregiver. This paper reports the associations between the mental health of adolescents with major depression and their parents, before and after treatment of the adolescent's depression. Data were collected as part of the Adolescent Depression Antidepressants and Psychotherapy Trial, a randomised controlled trial of selective serotonin reuptake inhibitors with and without cognitive behaviour therapy in 208 clinic-recruited adolescents with major depression. The baseline severity of depression in the adolescent was significantly associated with both maternal and paternal mental health (as rated by the General Health Questionnaire). This effect was not confounded by other psychiatric symptoms. The degree of improvement in parental and child mental health was positively correlated across time. Our results support the hypothesis that there is a significant association between parental mental health and adolescent depressive symptoms. This study was not able to establish the direction of this association. In clinical practice, the findings demonstrate the importance of considering the mental health of the parents when treating depressed adolescents. [ABSTRACT FROM AUTHOR]