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Objective: Unintentional injuries are the leading cause of death for children under 19 years of age. For preschoolers, many injuries occur in the home. Addressing this issue, this study assessed if a storybook about home safety could be effective to increase preschoolers' safety knowledge and reduce their injury-risk behaviors.Methods: Applying a randomized controlled trial design, normally developing English speaking preschool children (3.5-5.5 years) in Southwestern Ontario Canada were randomly assigned to the control condition (a storybook about healthy eating, N = 30) or the intervention condition (a storybook about home hazards, N = 29). They read the assigned storybook with their mother for 4 weeks; time spent reading was tracked, and fidelity checks based on home visits were implemented.Results: Comparing postintervention knowledge, understanding score, and risk behaviors across groups revealed that children who received the intervention were able to identify more hazards, provide more comprehensive safety explanations, and demonstrate fewer risky behaviors compared with children in the control group (ηp2 = 0.13, 0.19, and 0.51, respectively), who showed no significant changes over time in safety knowledge, understanding, or risk behaviors. Compliance with reading the safety book and fidelity in how they did so were very good.Conclusions: A storybook can be an effective resource for educating young children about home safety and reducing their hazard-directed risk behaviors. [ABSTRACT FROM AUTHOR]

Background: Worldwide, most adolescent girls do not meet physical activity (PA) recommendations and very few PA programs are tailored specifically towards them. Even fewer information exists about the long-term effects of such programs. Some Canadian schools have implemented the FitSpirit PA intervention designed specifically for girls aged 12 to 17 years old. This paper describes the protocol of a quasi-experimental study evaluating long-term changes in health behaviours and outcomes following FitSpirit participation.Methods: The study is conducted among schools that partner with FitSpirit every year. It started in 2018 and will be completed in 2022. The intervention comprises motivational talks, a turnkey running program, PA sessions and special events. Study participants fill out an online questionnaire twice a year. Follow-up questionnaires are sent at the end of each school year to the study participants who dropout from FitSpirit. The main outcome, changes in PA levels, is evaluated using questions validated for adolescents. Secondary outcomes are health (perceived health); lifestyle habits (sedentary activities, eating and sleeping habits); psychosocial outcomes (physical self-efficacy and body satisfaction); and FitSpirit appreciation (activity participation and satisfaction). Most questions originate from questionnaires validated for the adolescent population. Cross-sectional and longitudinal analyses will be performed.Discussion: This study will provide one of the first longitudinal reports on the impact of a large extra-curricular PA intervention designed specifically for adolescent girls. The current study will uniquely contribute to PA research by assessing outcomes additional to PA levels, including markers of health, lifestyle habits and psychosocial determinants.Trial Registration: NCT, NCT03804151 , Registered on January 22, 2019; retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Family carers of older persons with Alzheimer's' disease and related dementia (ADRD) and multiple chronic conditions (MCC) experience significant, complex, and distressing transitions such as changes to their environment, roles and relationships, physical health, and mental health. An online intervention (My Tools 4 Care) was developed for family carers of persons with ADRD and MCC living at home, with the aim of supporting these carers through transitions and increasing their self-efficacy, hope, and health related quality of life (HRQoL). This study will evaluate My Tools 4 Care (MT4C) by asking the following research questions: 1. Does use of MT4C result in a 3 month (immediately post intervention) and 6-month (3 months after intervention) increase in HRQoL, self-efficacy, and hope, in carers of persons with ADRD and MCC compared to an educational control group? 2. Does use of MT4C help carers of community-dwelling older adults with ADRD and MCC deal with significant changes they experience as carers? and 3. Are the effects/benefits of the MT4C intervention achieved at no additional cost compared to an educational control group?Methods/design: Using a pragmatic mixed methods randomized controlled trial design, 180 family carers of community dwelling older persons (65 years of age and older) with ADRD and MCC will participate in the study. Data will be collected from the intervention and an educational control group at four time points: baseline, 1 month, 3 and 6 months. We expect to find that family carers using MT4C will show greater improvement in hope, self-efficacy and HRQoL, at no additional cost from a societal perspective, compared to those in the educational control group. General estimating equations will be used to determine differences between groups and over time.Discussion: Data collection began in Ontario and Alberta Canada in June 2015 and is expected to be completed in June 2017. The results will inform policy and practice as MT4C can be easily revised for local contexts and is scalable in terms of posting on websites such as those hosted by the Alzheimer Society.Trial Registration: ClinicalTrials.gov Identifier: NCT02428387. [ABSTRACT FROM AUTHOR]

Objective: To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence in women.Design: Cost-utility and cost-effectiveness analyses from a public-payer perspective, conducted alongside a randomised clinical trial.Setting: Health services provided in Alberta, Canada.Sample: A total of 195 women participated in the randomised clinical trial, followed to 5 years postsurgery.Methods: Comparisons were undertaken between study groups for cost and two health-outcome measures. Multiple imputation was used to estimate the 14% of missing data. Bootstrapping was used to account for sampling uncertainty. Sensitivity analyses were based on complete case analyses and the removal of a TVT patient with extreme health service cost.Main Outcome Measures: The 15D instrument was used to calculate quality-adjusted life-years (QALYs) for the primary analysis. Absence of serious adverse events was also analysed. Costs were based on inpatient and outpatient hospital use data and practitioner fee-for-service claims data.Results: The TOT group had a nonsignificant average saving of $2368 (95% CI -$7166 to $2548) and incremental gain of 0.04 QALYs (95% CI -0.06 to 0.14) compared with TVT. TOT was dominant in over 71% of bootstrap replications and cost-effective over a wide range of willingness-to-pay. Cost-effectiveness analysis using the absence of an serious adverse events provided similar results.Conclusion: The results suggest that TOT is cost-effective compared with TVT in the treatment of stress urinary incontinence.Tweetable Abstract: The results of a 5-year cost-effectiveness analysis suggest that trans-obturator tape is cost-effective compared with tension-free vaginal tape in the treatment of stress urinary incontinence. [ABSTRACT FROM AUTHOR]

Background: Physicians often administer corticosteroids for the treatment of fluid and vasoactive infusion dependent pediatric shock. This use of corticosteroids is controversial, however, and has never been studied in a pediatric randomized controlled trial (RCT). This pilot trial will determine the feasibility of a larger RCT on the role of corticosteroids in pediatric shock.Methods/design: Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) is a pragmatic, seven-center, double-blind, pilot RCT. We aim to randomize 72 pediatric patients with fluid and vasoactive infusion dependent shock to receive either hydrocortisone or a saline placebo for 7 days or until clinical stability, whichever occurs first. The primary outcome of this pilot trial is the feasibility of recruitment, defined as the number of patients enrolled over a 1-year period. Secondary outcomes include the frequency of, and reasons for, open-label steroid use, protocol adherence, incidence of mortality and corticosteroid-associated adverse events, time to discontinuation of inotropes, and feasibility of blood sampling.Discussion: Corticosteroids are used for the treatment of pediatric shock without sufficient evidence to support this practice. While there is a scientific rationale and limited data supporting their use in this setting, there is also evidence from other populations suggesting potential harm. The STRIPES pilot study will assess the feasibility of a larger, much needed trial powered for clinically important outcomes.Trial Registration: ClinicalTrials.gov: NCT02044159. [ABSTRACT FROM AUTHOR]

Objectives: To conduct a feasibility study on investigating the effectiveness of an alcohol-free essential oil mouthwash (AF-EOMW) to reduce plaque accumulation and oral pathogen levels in institutionalised elders receiving long-term care and to obtain preliminary results.Background: Although simple, cost-effective strategies to improve oral hygiene in seniors such as the use of mouthwashes have been shown to reduce the risks of respiratory diseases, little information is available on the feasibility of implementing these measures.Methods: Twenty-five elderly participants with significant loss of autonomy were initially recruited and divided into two groups. A test group rinsed with an AF-EOMW twice a day, and a control group rinsed with tap water. Data on demographic characteristics, dental history and tobacco use were collected from a questionnaire. Problems encountered during recruitment and data collection were documented. Plaque index, denture cleanliness and salivary levels of several pathogens were measured at three time points: baseline (T0 ), day 22 (T1 ) and day 45 (T2 ).Results: Eighteen participants completed the study. Several problems were encountered during recruitment and execution of the study protocol. No significant differences in clinical or microbiological measures were found between the test group and controls at three time points (p > 0.05).Conclusion: This pilot study shows that, if sufficient logistical and financial resources are available, it is feasible to conduct randomised clinical trials in a seniors' facility. The use of an AF-EOMW to improve oral hygiene in seniors was not found to be superior to tap water. However, larger controlled clinical studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Background: In clinical trials of medications to treat attention-deficit/hyperactivity disorder (ADHD) in children, effects on functional impairment have been less well-studied than changes in ADHD symptoms.Objective: Data regarding functional impairment were analyzed from a multicenter, double-blind, placebo-controlled study of guanfacine extended release (GXR) in children with ADHD, using the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). The correspondence of changes in WFIRS-P scores with symptomatic and global response to GXR treatment was also examined, with treatment response defined by scores on both the ADHD Rating Scale IV (ADHD-RS-IV) and the Clinical Global Impressions-Improvement Scale (CGI-I).Methods: In this 8-week, double-blind, placebo-controlled, dose optimization study at 47 sites across the USA and Canada, children aged 6-12 years with a diagnosis of ADHD [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, and an ADHD-RS-IV score ≥28 and CGI-Severity of Illness Scale score ≥4 at baseline], were randomized 1:1:1 into three groups: GXR AM [GXR (1-4 mg/day) in the morning, placebo in the evening], GXR PM [placebo in the morning, GXR (1-4 mg/day) in the evening], or twice-daily placebo. Parents rated their children on the WFIRS-P at screening, baseline, the end of dose optimization, and at the final on-treatment assessment.Results: The efficacy population was composed of 333 subjects (GXR AM: n = 107; GXR PM: n = 114; placebo: n = 112). At the final on-treatment assessment, there were significant improvements from baseline in the placebo-adjusted difference in least-squares (LS) mean (95 % confidence interval) WFIRS-P Total scores for both GXR treatment groups combined [GXR all-active: -0.16 (-0.25, -0.07), effect size (ES) = 0.448, P <0.001] and separately [GXR AM: -0.15 (-0.26, -0.05), ES = 0.417, P = 0.004; GXR PM: -0.18 (-0.28, -0.07), ES = 0.478, P = 0.001]. Significant improvements in WFIRS-P domain scores for Family, Learning and School (including Academic Performance and Behavior in School), Social, and Risky Behavior were found for both GXR cohorts compared with placebo. However, the Life Skills and Self-Concept domain scores of the WFIRS-P did not improve with GXR treatment. Post hoc stratification by responder status revealed that significant (P <0.001) improvements in WFIRS-P Total and all domain scores were associated with symptomatic treatment response in the GXR all-active group.Conclusions: GXR treatment in children with ADHD was associated with reductions in WFIRS-P functional impairment scores compared with placebo, regardless of time of GXR administration. Changes in WFIRS-P scores were congruent with clinical response, as determined by both ADHD symptom reduction and CGI-I scores. CLINICALTRIALS.Gov Identifier: NCT00997984. [ABSTRACT FROM AUTHOR]

To elucidate processes underlying therapeutic change in a large-scale randomized clinical trial, we examined whether alterations in self-reported parenting practices were associated with the effects of behavioral, medication, or combination treatments on teacher-reported outcomes (disruptive behavior, social skills, internalizing symptoms) in children with attention-deficit hyperactivity disorder (ADHD). Participants were 579 children with Combined-type ADHD, aged 7-9.9 years, in the Multimodal Treatment Study of Children with ADHD (MTA). We uncovered 2 second-order factors of parenting practices, entitled Positive Involvement and Negative/Ineffective Discipline. Although Positive Involvement was not associated with amelioration of the school-based outcome measures, reductions in Negative/Ineffective Discipline mediated improvement in children's social skills at school. For families showing the greatest reductions in Negative/Ineffective Discipline, effects of combined medication plus behavioral treatment were pronounced in relation to regular community care. Furthermore, only in combination treatment (and not in behavioral treatment alone) was decreased Negative/Ineffective Discipline associated with reduction in children's disruptive behavior at school. Here, children in families receiving combination treatment who showed the greatest reductions in Negative/Ineffective Discipline had teacher-reported disruptive behavior that was essentially normalized. Overall, the success of combination treatment for important school-related outcomes appears related to reductions in negative and ineffective parenting practices at home; we discuss problems in interpreting the temporal sequencing of such process-outcome linkages and the means by which multimodal treatment may be mediated by psychosocial processes related to parenting. [ABSTRACT FROM AUTHOR]