Dataset Information

Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability.

ABSTRACT: OBJECTIVE:Investigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability. DESIGN:Multicentre, single-blind, randomised controlled trial. SETTING:Recruitment through neurodisability teams; treatment by parents. PARTICIPANTS:Ninety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years). EXCLUSION CRITERIA:medication contraindicated; in a trial that could affect drooling or management. INTERVENTION:Children were randomised to receive a hyoscine skin patch or glycopyrronium liquid. Dose was increased over 4?weeks to achieve optimum symptom control with minimal side-effects; steady dose then continued to 12 weeks. PRIMARY AND SECONDARY OUTCOMES:Primary outcome: Drooling Impact Scale (DIS) score at week-4. SECONDARY OUTCOMES:change in DIS scores over 12 weeks, Drooling Severity and Frequency Scale and Treatment Satisfaction Questionnaire for Medication; adverse events; children's perception about treatment. RESULTS:Both medications yielded clinically and statistically significant reductions in mean DIS at week-4 (25.0 (SD 22.2) for hyoscine and 26.6 (SD 16) for glycopyrronium). There was no significant difference in change in DIS scores between treatment groups. By week-12, 26/47 (55%) children starting treatment were receiving hyoscine compared with 31/38 (82%) on glycopyrronium. There was a 42% increased chance of being on treatment at week-12 for children randomised to glycopyrronium relative to hyoscine (1.42, 95%?CI 1.04 to 1.95). CONCLUSIONS:Hyoscine and glycopyrronium are clinically effective in treating drooling in children with neurodisability. Hyoscine produced more problematic side effects leading to a greater chance of treatment cessation. TRIAL REGISTRATION NUMBERS:ISRCTN 75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003.

SUBMITTER: Parr JR

PROVIDER: S-EPMC5890631 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability.

Parr Jeremy R JR Todhunter Emma E Pennington Lindsay L Stocken Deborah D Cadwgan Jill J O'Hare Anne E AE Tuffrey Catherine C Williams Jane J Cole Mike M Colver Allan F AF

Archives of disease in childhood 20171130 4

<h4>Objective</h4>Investigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.<h4>Design</h4>Multicentre, single-blind, randomised controlled trial.<h4>Setting</h4>Recruitment through neurodisability teams; treatment by parents.<h4>Participants</h4>Ninety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years).<h4>Exclusion criteria</h4>medication contr ...[more]

PMID: 29192000

Similar Datasets

Project description:BackgroundDrooling saliva is a common problem in children with neurodevelopmental disorders. The negative consequences of drooling include skin breakdown, dehydration, and damage to clothing and equipment. Children and families often suffer social embarrassment due to drooling. There is no evidence about the relative effectiveness, side effect profiles or patient acceptability of the two medications most commonly used to reduce drooling - glycopyrronium and hyoscine. Consequently, there is no consensus or guideline to aid clinical decisions about which drug to use, and at what dose.Methods/designA multi-centre, randomised trial of treatment with glycopyrronium or hyoscine in children with problematic drooling and non-progressive neurodisability. Ninety children aged between 3 and 15 years who have never received medication for drooling will be stratified by severity of drooling and care centre. Randomisation to receive treatment with glycopyrronium or hyoscine will be computer generated from the trial randomisation website. Dose adjustment and side effect monitoring will occur via telephone consultation. Medication arm will be known to participants and clinicians but not the Trial Outcome Assessor.The primary outcome measure is the Drooling Impact Scale score at four weeks, at which time all children will be on the maximum tolerated dose of their medication. Secondary outcome measures include change in Drooling Impact Scale score between baseline, 4, 12 and 52 weeks, change in Drooling Severity and Frequency Scale score and difference between groups in the Treatment Satisfaction Questionnaire for Medication score. A structured interview with children and young people of sufficient age, cognitive and communication ability will explore their perceptions of drooling and the effectiveness and acceptability of the medications.DiscussionThe primary objective of the study is to identify whether glycopyrronium or hyoscine is more effective in treating drooling in children with non-progressive neurodisability. The study will also determine which medications at what doses are most acceptable and have fewest side effects. This information will be used to develop evidence based guidance to inform the medical treatment of drooling.Dri trial registrationCurrent Controlled Trials: ISRCTN75287237.EUDRACT: 2013-000863-94.Medicines and Healthcare products Regulatory Agency (MHRA): 17136/0264/001-0003.

Project description:Drooling, or sialorrhea, is a common condition in patients with cerebral palsy, rare diseases, and neurodevelopmental disorders. The goal of this review was to identify the different properties of sialorrhea outcome measures in children. Four databases were analysed in search of sialorrhea measurement tools, and the review was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. The COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist was used for quality appraisal of the outcome measures. The initial search yielded 891 articles, 430 of which were duplicates. Thus, 461 full-text articles were evaluated. Among these, 21 met the inclusion criteria, reporting 19 different outcome measures that encompassed both quantitative measures and parent/proxy questionnaires. Conclusions: Among the outcome measures found through this review, the 5-min Drooling Quotient can objectively discriminate sialorrhea frequency in patients with developmental disabilities. The Drooling Impact Scale can be used to evaluate changes after treatment. The modified drooling questionnaire can measure sialorrhea severity and its social acceptability. To date, the tests proposed in this review are the only tools displaying adequate measurement properties. The acquisition of new data about reliability, validity, and responsiveness of these tests will confirm our findings. What is Known: • Although sialorrhea is a recognized problem in children with disabilities, especially those with cerebral palsy (CP), there is a lack of confidence among physicians in measuring sialorrhea. What is New: • Few sialorrhea measures are available for clinicians that may guide decision-making and at the same time have strong evidence to provide confidence in the results. • A combination of both quantitative measures and parent/proxy questionnaires might provide an adequate measurement of sialorrhea in children.

Project description:BackgroundOlder adults spend more time sitting than any other age group, contributing to poor health outcomes. Effective behavioral interventions are needed to encourage less sitting among older adults, specifically those with obesity, but these programs must be acceptable to the target population. We explored participant acceptance of a theory-based and technology-enhanced sitting reduction intervention designed for older adults (I-STAND).MethodsThe 12-week I-STAND intervention consisted of 6 health coaching contacts, a study workbook, a Jawbone UP band to remind participants to take breaks from sitting, and feedback on sitting behaviors (generated from wearing an activPAL device for 7 days at the beginning and mid-point of the study). Semi-structured interviews were conducted with 22 participants after they completed the intervention. Interview transcripts were iteratively coded by a team, and thematic analysis was used to identify and refine emerging themes.ResultsOverall, participants were satisfied with the I-STAND intervention, thought the sedentary behavior goals of the intervention were easy to incorporate, and found the technologies to be helpful additions to (but not substitutes for) health coaching. Barriers to standing more included poor health, ingrained sedentary habits, lack of motivation to change sedentary behavior, and social norms that dictate when it is appropriate to sit/stand. Facilitators to standing more included increased awareness of sitting, a sense of accountability, daily activities that involved standing, social support, and changing ways of interacting in the home environment. Participants reported that the intervention improved physical health, increased energy, increased readiness to engage in physical activity, improved mood, and reduced stress.ConclusionsThe technology-enhanced sedentary behavior reduction intervention was acceptable, easy to incorporate, and had a positive perceived health impact on older adults with obesity.Trial registrationThe I-STAND study was registered at clinicaltrials.gov (ID: NCT02692560 ) February 2016.

Dataset Information

Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability.

Publications

Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets