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Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.

ABSTRACT: Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), previously validated in adults, consists of 25 questions grouped into 5 domains: emotional distress, sleep disturbance, food/drink problems, physical/social functioning, and vitality. The QOLRAD was administered at the baseline and week-8 (final) visits.Of the 149 patients randomized, 134 completed the QOLRAD at baseline and final visits and were eligible for analysis of their HRQOL data. Baseline QOLRAD scores indicated GERD had a negative effect on the HRQOL of these adolescents, especially in the domains of vitality and emotional distress, and problems with food/drink. At the final visit, mean scores for all 5 QOLRAD domains improved significantly (P < .0001); change of scores (ie, delta) for all domains met or exceeded the adult QOLRAD minimal clinically significant difference standard of 0.5 units.GERD had a negative effect on QOL in adolescents. After esomeprazole treatment, statistically and clinically significant improvements occurred in all domains of the QOLRAD for these adolescents.D9614C00098; ClinicalTrials.gov Identifier NCT00241501.

SUBMITTER: Gunasekaran T

PROVIDER: S-EPMC2784471 | biostudies-literature | 2009 Nov

REPOSITORIES: biostudies-literature

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Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.

Gunasekaran Thirumazhisai T Tolia Vasundhara V Colletti Richard B RB Gold Benjamin D BD Traxler Barry B Illueca Marta M Crawley Joseph A JA

BMC gastroenterology 20091118

<h4>Background</h4>Although gastroesophageal reflux disease (GERD) is common in adolescents, the burden of GERD on health-related quality of life (HRQOL) in adolescents has not been previously evaluated. Therefore, the objective of the study was to examine the effect of GERD on HRQOL in adolescents.<h4>Methods</h4>This international, 31-site, 8-week safety study randomized adolescents, aged 12 to 17 years inclusive, with GERD to receive esomeprazole 20 or 40 mg once daily. The Quality of Life in ...[more]

PMID: 19922626

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Project description:Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Project description:Harmful drinking among young people is common in Australia and many other countries. Social norms and their influence on adolescents' alcohol consumption behaviours have received much research attention in recent years. However, there is limited understanding of how social norms related to alcohol are developed and transmitted across social networks and a specific tool that measures these constructs has yet to be developed. This paper outlines the rationale and protocol for the design and validation of a multidimensional survey instrument which measures the development and transmission pathways of alcohol-related norms among adolescents. A longer term aim is to apply the instrument in a respondent-driven sampling study with a large adolescent cohort.Social Cognitive Theory (SCT) and relevant literature will guide the design of the online survey instrument. Feedback from a practitioner-based stakeholder committee, academic expert panel reviews, focus groups and interviews with adolescents aged 13-17 years in Perth, Western Australia (WA) will serve to ascertain content and face validity. A test-retest will be conducted using a purposive sample of students (n=400) at secondary schools in Perth. The instrument's psychometric properties will be analysed, including exploratory factor analyses, discriminant validity, internal consistency and test-retest reliability.The results of this research will provide public health researchers and practitioners with a comprehensive standardised instrument to explore the characteristics of individual-level and community-level social influences and norms associated with use of alcohol by adolescents and the routes through which these norms are transmitted. The data collected by the instrument is anticipated to inform the design of youth specific interventions with the potential to reduce alcohol-related harms. The Study findings will be disseminated widely through peer-reviewed publications and conference presentations. The study has received approval from the Curtin University Human Research Ethics Committee.

Project description:BackgroundThe aim of this study was to investigate bidirectional associations between (prolonged) sitting time and sleep duration in 12- to 14-year-old adolescents using a between-subjects and within-subjects analyses approach.MethodsObservational data were used from 108 adolescents (53% girls; mean age 12.9 (SD 0.7) years) from six schools in Flanders, Belgium. The Axivity AX3 triaxial accelerometer, worn on the thigh, was used to assess daily total sitting time and daily time spent in sedentary bouts of ≥30 min (as a proxy for prolonged sitting time). The Fitbit Charge 3 was used to assess nightly sleep duration. Both monitors were worn on schooldays only (ranging from 4 to 5 days). Linear mixed models were conducted to analyse the associations, resulting in four models. In each model, the independent variable (sleep duration, sitting time or prolonged sitting time) was included as within- as well as between-subjects factor.ResultsWithin-subjects analyses showed that when the adolescents sat more and when the adolescents spent more time sitting in bouts of ≥30 min than they usually did on a given day, they slept less during the following night (p = 0.01 and p = 0.05 (borderline significant), respectively). These associations were not significant in the other direction. Between-subjects analyses showed that adolescents who slept more on average, spent less time sitting (p = 0.006) and less time sitting in bouts of ≥30 min (p = 0.004) compared with adolescents who slept less on average. Conversely, adolescents who spent more time sitting on average and adolescents who spent more time sitting in bouts of ≥30 min on average, slept less (p = 0.02 and p = 0.003, respectively).ConclusionsBased on the between-subjects analyses, interventions focusing on reducing or regularly breaking up sitting time could improve adolescents' sleep duration on a population level, and vice versa. However, the within-subjects association was only found in one direction and suggests that to sleep sufficiently during the night, adolescents might limit and regularly break up their sitting time the preceding day.Trial registrationData have been used from our trial registered at ClinicalTrials.gov ( NCT04327414 ; registered on March 11, 2020).

Dataset Information

Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.

Publications

Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study.

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