ObjectivesTo determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. Patients and MethodsIn this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015. Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. ResultsIn all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. ConclusionsThis study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process.

ObjectivesTo assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial.DesignA single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control.Setting37 primary schools in York, UK.Participants50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27).Outcome measuresAcceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial.ResultsAn assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups.ConclusionsResults suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools.Trial registration numberISRCTN96286707; Results.

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

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BackgroundThe preschool years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood and establishing habitual physical activity early in life is therefore vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school-aged children. There are few preschool, playground-based interventions and these have given inconclusive results. A report published by the UK’s Chief Medical Officer (CMO) highlighted the need for new interventions to promote movement in the early years (0–5 years).ObjectivesThis study aimed to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged from 18 months to 4 years (Preschoolers in the Playground or PiP) and to assess the feasibility of conducting a full-scale cluster RCT.DesignThe study was a two-armed pilot cluster RCT with economic and qualitative evaluations. Participants were randomised on a 1 : 1 basis to the PiP intervention (n = 83) or usual practice (control;n = 81).SettingBradford, West Yorkshire, UK.ParticipantsChildren aged from 18 months to 4 years.InterventionThe PiP intervention is grounded in behavioural theory (social cognitive theory) and is in accordance with CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. The intervention was delivered in primary school playgrounds. Six 30-minute PiP sessions per week were available for 30 weeks; families were encouraged to come to three a week. The 10-week initiation phase was facilitated by a member of school staff and the maintenance phase was unsupervised.Main outcome measuresRecruitment and retention of schools and families to the trial were the main outcome measures. The acceptability of trial procedures and the intervention, the feasibility of collecting health outcome data and the fidelity of the implementation of the intervention were also evaluated. A preliminary assessment of cost-effectiveness and a sample size calculation for a full trial were conducted.ResultsIn total, 37% of schools and 48% of parents approached agreed to take part. Levels of retention were good at 10 and 52 weeks’ follow-up (82.3% and 83.5% respectively). Both the trial procedures and the intervention were acceptable. However, attendance was low during the autumn and winter/spring initiation phases but somewhat better in the summer initiation phase. Attendance was poor throughout all maintenance phases. The accelerometry protocol for measuring physical activity requires modification. The fidelity of intervention implementation was good (81% adherence). The intervention was borderline cost-effective. A sample size of 600 children from 38 schools is required for a full trial.ConclusionA full RCT of the PiP intervention is feasible. The PiP intervention requires some modification, for example running the intervention during the summer term only, but was found to be acceptable to schools and families.Trial registrationCurrent Controlled Trials ISRCTN54165860.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 5. See the NIHR Journals Library website for further project information.

BackgroundFew evidence-based physical activity interventions for pre-school children are available. This two-armed pilot cluster randomised controlled trial aimed to evaluate the feasibility of conducting a full-scale trial and of delivering an outdoor physical activity intervention for pre-school children.MethodsSchool was the unit of randomisation, and follow-up occurred at 10 and 52 weeks. Trial feasibility was assessed by recruitment, retention and completion rates of primary (daily moderate-to-vigorous physical activity (MVPA)) and secondary (anthropometric, quality of life, self-efficacy) outcomes. Potential effectiveness was assessed for the primary outcome using a linear regression model comparing MVPA between trial arms adjusting for clustering by school. Feasibility of delivering the intervention was assessed by intervention fidelity and attendance. Semi-structured interviews with parents, intervention facilitators, and head teachers explored acceptability and capability to deliver the intervention as well as acceptability of the study design.ResultsRecruitment rates were 37 % of schools (n = 10 schools) and 48 % of pre-school children (n = 164 children). Retention of children to the trial at 52 weeks was 83.5 %. Thirty-nine percent of children had valid primary outcome accelerometer data at baseline and 52 weeks. Response rates for secondary outcome measures ranged from 52 to 88 % at 10 weeks and 59 to 80 % at 52 weeks. The mean difference in daily MVPA between trial arms at 52 weeks was 0.4, 95 % CI 16.3 to 17.0; p = 0.96. Fidelity of intervention implementation was 81 %. Intervention attendance was higher (82 %) during the summer initiation phase compared to autumn/spring initiation (50 %). Parents, facilitators and head teachers found the intervention acceptable and beneficial.ConclusionsRecruitment and retention rates suggest a trial in this outdoor setting with this population was feasible but is weather sensitive. However, strategies to increase accelerometer wear-time would need to be implemented for reliable primary outcome data to be obtained. There was high implementation fidelity by facilitators, and the intervention was seen as acceptable and deliverable. However, attendance was low and preliminary data showed no evidence of intervention effectiveness. A revised intervention, building on the successful elements of this pilot alongside adapting implementation strategies to improve attendance, should therefore be considered.Trial registrationTrial registry name and number: Current Controlled Trials, ISRCTN54165860. Date of registration: 4 September 2012.

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Background:In the United Kingdom, men of Bangladeshi and Pakistani origin have higher smoking rates than the general population. This makes non-smokers in their households more vulnerable to second-hand smoke (SHS) exposure than the general population.Aims:The aim of this study was to investigate the feasibility of implementing and pilot testing the effectiveness and cost-effectiveness of a ‘Smoke-free Homes’ (SFH) intervention in Islamic religious settings to encourage families of Bangladeshi and Pakistani origin to apply smoking restrictions in their homes.Methods:We allocated Islamic religious settings (clusters) to either receive SFH—an educational intervention—or to a control arm. Within each cluster, we recruited households with at least one smoker and one non-smoker. SHS exposure among non-smokers was measured using salivary cotinine.Results:Seven (50%) clusters were randomised to each trial arm. A total of 468 households were assessed for eligibility and 62% (n=289) were eligible, of which 74% (n=213) agreed to participate in the trial. Six of the seven intervention clusters delivered the intervention, and all clusters were retained throughout the trial. In all, 81% (n=172) of households provided data at follow-up. No evidence of a difference in log cotinine level was observed (adjusted mean difference −0.02, 95% confidence interval (CI) −1.28–1.23, P=0.97) between the two trial arms. The direct mean cost of delivering the intervention was £18.18 per household (range £3.55–42.20).Conclusions:It was possible to recruit, randomise and retain Islamic religious settings and participant households. However, some of the original assumptions, in particular our ability to collect primary outcome data, need to be revisited before a definitive trial.