scholarly journals Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

2017 ◽  
Vol 23 (13) ◽  
pp. 1578-1591 ◽  
Author(s):  
David R. Coghill ◽  
Alain Joseph ◽  
Vanja Sikirica ◽  
Mark Kosinski ◽  
Caleb Bliss ◽  
...  

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Achievement and Risk Avoidance ( r ≈ .4), but weakly with Resilience, Satisfaction, and Comfort ( r ≈ .2); and moderately with Weiss Functional Impairment Rating Scale–Parent (WFIRS-P) total score ( r ≈ .5). CHIP-CE:PRF Achievement and Risk Avoidance correlated moderately to strongly with WFIRS-P total score ( r ≈ .6). Conclusion: The ADHD-RS-IV, CHIP-CE:PRF, and WFIRS-P capture distinct but interconnected aspects of treatment response in individuals with ADHD.

2021 ◽  
Vol 7 (1) ◽  
pp. 960-966
Author(s):  
SM Abul Kalam Azad ◽  
Nur E Nahid Shilvy ◽  
Ata A Rabby

Parents of children with developmental disabilities, particularly Autism Spectrum disorder, are known to be at risk for high levels of psychological distress. The present study aimed to adapt the Quality of Life in Autism Questionnaire (QoLA, parent-version) in the context of Bangladeshi culture. The sample included 50 participants. Participants were selected from the Institute of Paediatric Neurology and Autism (IPNA, BSMMU) and some special schools of Dhaka city. World Health Organization’s (WHO, 2009) guidelines were followed in translating the QoLA and adaptation for use in Bangladesh. For the parent-report version of the QoLA, Cronbach’s coefficients were 0.880 and 0.725 for part A and part B subscale items, respectively. The Pearson correlation coefficients for the test-retest reliability were r =0.964 for part A of the scale and r = 0.954 for part B. These psychometric properties are comparable to those obtained in the initial QoLA validation study (Eapen et al. 2014). Results of this study demonstrate that the Bangla version of the QoLA (Parent version) provides a valid measure of quality of life and is suitable for use in Bangladesh. Bioresearch Commu. 7(1): 960-966, 2021 (January


2010 ◽  
Vol 2 (1) ◽  
pp. 35 ◽  
Author(s):  
Ssu-Yu (Suei) Lin ◽  
Ngaire Kerse ◽  
Christine McLean ◽  
Simon Moyes

INTRODUCTION: Quality of life (QoL) and functional status are important aspects of health especially for older people. Efficient and valid ways of measuring older people’s health is of great importance. AIM: This project aims to establish the reliability of use of (1) a quality of life measure, the WHOQOL-BREF, and (2) a functional measure, the Nottingham Extended Activities of Daily Living scale (NEADL), for use over the telephone. METHODS: With ethical approval, patients over age 75 years (65 years if Maori) have been enrolled in the BRIGHT trial; a randomised controlled trial testing a practice-based screening initiative to prevent disability. Participants with possible disability, defined as being unable to get in and out of the car or take hot drinks from one room to another, completed a telephone interview including the two measures. Seventy participants repeated the two measures during a face-to-face interview within three months. RESULTS: Both WHOQOL-BREF and NEADL scores for the two forms of administration produced high Pearson correlation coefficients. There was good agreement for the WHOQOL-BREF as shown by the Bland-Altman graphs; however there was a tendency of a greater negative difference the greater the average score became (higher level of function) for the NEADL. DISCUSSION: This study shows that telephone interviews can generally provide a valid method to assess the quality of life and function in older people. KEYWORDS: Reliability; Quality of life; WHOQOL-BREF; functional status; NEADL; telephone administration


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.


2020 ◽  
Vol 19 ◽  
pp. 153473542092551
Author(s):  
Si-Yeon Song ◽  
Ji-Hye Park ◽  
Jin Sun Lee ◽  
Je Ryong Kim ◽  
Eun Hee Sohn ◽  
...  

Background: This study examined the effect of a portable low-frequency electrostimulation (ES) device on patients diagnosed with chemotherapy-induced peripheral neuropathy (CIPN) immediately after chemotherapy for breast cancer. Methods: A single-center, randomized, placebo-controlled trial was conducted. A total of 72 patients newly diagnosed with CIPN were enrolled and randomly placed into the ES (n = 36) or the sham ES group (SES; n = 36). Duloxetine or pregabalin was prescribed to all participants from the initial assessment. The devices for 14 days, at least twice a day, for at least 120 minutes. The primary outcomes were the overall intensities of the CIPN symptoms as assessed using Numerical Rating Scale (NRS). Secondary outcomes included Total Neuropathy Score (TNS), European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ), Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20), Functional Assessment of Cancer Therapy-Breast (FACT-B), and Instrument on Pattern Identification and Evaluation for CIPN (IPIE-CIPN). Results: No differences in NRS scores were found between the patients in the ES and the SES group ( P = 0.267). Patients in both groups showed significantly reduced CIPN intensities (ES P < .001; SES P < .001). No significant differences between the groups were found in TNS, EORTC-QLQ, CIPN20, and FACT-B. The general symptoms of CIPN diagnosed as cold arthralgia showed significance only in the ES group ( P = .006). Conclusion: Compared with a placebo, the effectiveness of the low-frequency ES device with pharmacological intervention was not significantly different, but a therapeutic effect was possible.


2019 ◽  
Vol 37 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Jingru Jiang ◽  
Yi Li ◽  
Qingyu Shen ◽  
Xiaoming Rong ◽  
Xiaolong Huang ◽  
...  

Purpose Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain. Patients and Methods This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale. Result There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%). Conclusion Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.


Author(s):  
Maryam Mohajeranirad ◽  
Naser Saeidi ◽  
Mohammad Kamali Nejad ◽  
Amir Almasi-Hashiani ◽  
Mehdi Salehi ◽  
...  

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.


2008 ◽  
Vol 126 (5) ◽  
pp. 257-261 ◽  
Author(s):  
Carlos Zubaran ◽  
Karina Persch ◽  
Desire Tarso ◽  
Ana Ioppi ◽  
Juan Mezzich

CONTEXT AND OBJECTIVE: The interconnections between quality of life and health status as assessed via questionnaires have not been thoroughly investigated. The objective of this study was to investigate a possible correlation between the constructs of general health status and quality of life as assessed by the Portuguese versions of two questionnaires recently adapted and tested in Brazil. DESIGN AND SETTING: This was a cross-sectional study in which two self-administered questionnaires were used. This investigation was conducted at healthcare services associated with the Universidade de Caxias do Sul, Brazil. METHODS: This study presents data from a sample of 120 volunteers who completed the Portuguese versions of the Personal Health Scale and the Multicultural Quality of Life Index questionnaires. Bivariate linear regression analysis and Pearson correlation coefficients were generated from the scores of the two questionnaires. RESULTS: A significant correlation between the concepts of quality of life and health status as evaluated by the Portuguese versions of both questionnaires was observed. Almost all of the health-related questions displayed strong correlations with the overall concept of quality of life. The magnitude of this correlation accounted for almost half of the observed variance. CONCLUSIONS: These findings indicate that, within this sample, health-related issues were key factors for the overall experience of wellbeing and quality of life. The similarities observed across the different groups indicate that the interrelation between health status and quality of life was homogenous, regardless of presence and/or type of ailments.


2011 ◽  
Vol 129 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Carlos Zubaran ◽  
Ivanor Tres

CONTEXT AND OBJECTIVE: Computerized data collection is an efficient process and well accepted by patients with different disorders. Although computer-based systems have been used to assess health status and quality of life in various areas of healthcare, there is a lack of studies to investigate the effectiveness of these instruments in Brazil. The aims here were to assess the usability of the Portuguese-language versions of the Personal Health Scale (PHS) and the Multicultural Quality of Life Index (MQLI) in southern Brazil and to determine the correlation between these two questionnaires. DESIGN AND SETTING: This was a cross-sectional community-based survey in which participants completed computerized versions of these two questionnaires. METHODS: In a survey conducted in 16 different locations, 458 volunteers completed both questionnaires. Pearson correlation coefficients were generated between the scores of the two questionnaires. The inclusion criteria allowed all volunteers who were able to understand the questions in both questionnaires to participate in the study. RESULTS: The percentage of proper data collection via the computerized versions of the two questionnaires combined was 97.45%. A significant correlation (P < 0.01) between the PHS and the MQLI was observed. CONCLUSION: The computerized versions of the PHS and MQLI demonstrated efficient data collection patterns during the field survey trials. Health-related issues were significantly correlated with the overall experience of wellbeing and quality of life. The computerized versions of the PHS and MQLI are valid tools for research and clinical use in Brazil


2017 ◽  
Vol 51 (8) ◽  
pp. 829-840 ◽  
Author(s):  
Olivia M Dean ◽  
Buranee Kanchanatawan ◽  
Melanie Ashton ◽  
Mohammadreza Mohebbi ◽  
Chee Hong Ng ◽  
...  

Objective: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. Methods: A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery–Asberg Depression Rating Scale (primary outcome), Clinical Global Impression–Improvement and Clinical Global Impression–Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Results: Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery–Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression–Improvement score – effect size (95% confidence interval) = −0.62 [−1.8, −0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score – effect size (confidence interval) = −0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score – 0.79 [−4.5, −1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [−1.7, −0.4], p = 0.017. Conclusion: While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.


2016 ◽  
Vol 2016 ◽  
pp. 1-13 ◽  
Author(s):  
Nadeeka N. W. Dissanayaka ◽  
Farah Idu Jion ◽  
Nancy A. Pachana ◽  
John D. O’Sullivan ◽  
Rodney Marsh ◽  
...  

Background. Motor and nonmotor symptoms negatively influence Parkinson’s disease (PD) patients’ quality of life. Mindfulness interventions have been a recent focus in PD. The present study explores effectiveness of a manualized group mindfulness intervention tailored for PD in improving both motor and neuropsychiatric deficits in PD.Methods. Fourteen PD patients completed an 8-week mindfulness intervention that included 6 sessions. The Five Facet Mindfulness Questionnaire (FFMQ), Geriatric Anxiety Inventory, Hamilton Depression Rating Scale, PD Cognitive Rating Scale, Unified PD Rating Scale, PD Quality of Life Questionnaire, and Outcome Questionnaire (OQ-45) were administered before and after the intervention. Participants also completed the FFMQ-15 at each session. Gains at postassessment and at 6-month follow-up were compared to baseline using pairedt-tests and Wilcoxon nonparametric tests.Results. A significant increase in FFMQ-Observe subscale, a reduction in anxiety, depression, and OQ-45 symptom distress, an increase in PDCRS-Subcortical scores, and an improvement in postural instability, gait, and rigidity motor symptoms were observed at postassessment. Gains for the PDCRS were sustained at follow-up.Conclusion. The mindfulness intervention tailored for PD is associated with reduced anxiety and depression and improved cognitive and motor functioning. A randomised controlled trial using a large sample of PD patients is warranted.


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