Developing a core outcome set for evaluating medication adherence interventions for adults prescribed long-term medication in primary care.

BACKGROUND: Approximately half of people prescribed medications do not take them as prescribed. There is a significant unmet need regarding the barriers to medication adherence not being addressed in primary care. There is no agreement on which outcomes should be measured and reported in trials of medication adherence interventions. OBJECTIVE: To develop a core outcome set (COS) for trials of medication adherence interventions in primary care for adults prescribed medications for long-term health conditions. METHODS: A list of potentially relevant outcomes from the literature was developed. Using a two-round Delphi survey of stakeholder groups representing patients and their carers; primary care staff; and academic researchers with an interest in medication adherence; each outcome was scored in terms of importance for determining the effectiveness of medication adherence interventions in primary care. This was followed by two consensus workshops, where importance, as well as feasibility and acceptability of measurement, were considered in order to finalise the COS. RESULTS: One hundred and fifty people took part in Delphi Round 1 and 101 took part in Round 2. Eight people attended the workshops (four attendees per workshop). Seven outcomes were identified as most important, feasible and acceptable to collect in medication adherence trials: Health-related quality of life, number of doses taken, persistence with medicines, starting (initiating) a medicine, relevance of the medication adherence intervention for an individual, mortality, and adverse medicine events. CONCLUSIONS: This COS represents the minimum outcomes that should be collected and reported in all medication adherence trials undertaken in primary care. When developing and finalizing the COS, feasibility and acceptability of collection of outcomes has been considered. In addition to the COS, medication adherence trials can choose to include outcomes to suit their specific context such as the health condition associated with their medication adherence intervention.

The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs.

Background: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets. Design: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources' evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people. Setting: United Kingdom trials involving patients aged under 18. Participants: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials). Interventions: Multimedia information resources (comprising text, audio, 'talking heads' video, trial-specific and trial-generic animations). Printed participant information sheets. Main outcome measures: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis. Results: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of 'information was easy to understand' (Z = 3.03; p = 0.003) and 'I had confidence in decision-making' (Z = 2.00; p = 0.044) than printed participant information sheet-only provision. Limitations: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings. Conclusions: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets. Future work: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents. Study registration: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

Clinical trials are important to National Health Service care, but it can be difficult to recruit enough people. We do not know enough about how to improve recruitment, especially when trying to recruit children and young people. People are normally told about a trial through printed information, which is often long and complex. Multimedia information (text, audio, cartoons and video) might be a better way of telling people. It is important to test whether multimedia interventions can help. One way of doing this is to run a 'Study Within A Trial' where people receive information in different ways. We created two multimedia interventions, one for parents and young people being asked for consent, and a simpler one for younger children. Some content applied to all trials, and some about the specific trial people were being asked to consider. We designed these by working closely with children and young people, parents and healthcare staff. We tested the multimedia information in six trials (although only three gave us enough data). Children, young people and their parents saw either standard printed information or our multimedia information. We then collected data on their decision-making, trial recruitment and whether people stayed in the trial. Children and young people who saw multimedia information were more likely to be recruited than those who received standard printed information. Once recruited to a trial, people given multimedia or printed information were similarly likely to remain in the trial. People's views on multimedia and printed information were also similar, but this finding could have been affected by small numbers of people returning questionnaires. Our study provides evidence that multimedia information can be used in trials with children and young people and that it increases the number of people who agree to take part, but further work is needed.

CompreHensive geriAtRician-led MEdication Review (CHARMER): protocol for a feasibility study of a hospital deprescribing behaviour change intervention.

INTRODUCTION: Over 50% of older adults are prescribed a medicine where the risk of harm outweighs the chances of benefit. During a hospital admission, older adults and carers expect medicines to be reviewed for appropriateness and any inappropriate medicines proactively deprescribed. While the principle of proactive deprescribing is an expectation of good prescribing practice, it is yet to become routine. The CompreHensive geriAtRician-led MEdication Review (CHARMER) study aims to develop and test a five-component behaviour change intervention to equip geriatricians and pharmacists to proactively deprescribe inappropriate medicines with older adults in hospital. This study aims to test the feasibility and acceptability of study processes and CHARMER implementation. METHODS AND ANALYSIS: A two-arm purposive allocation feasibility study is being undertaken at four acute hospitals in England, UK (three intervention and one control). The target sample is 400 patients across all hospitals. Primary outcome measures are: (1) participant recruitment rate and (2) participant attrition rate. Secondary outcome measures are: (1) hospital readmission rate; (2) mortality rate and (3) quality of life. Quantitative data will be checked for completeness and quality, and practitioner and patient demographics descriptively analysed. We will undertake a rapid qualitative analysis on observations, interviews and study meeting minutes data. A subsequent thematic analysis will be undertaken with codes mapped to the Theoretical Domains Framework and Normalisation Process Theory. Triangulation of qualitative and quantitative data will be undertaken. ETHICS AND DISSEMINATION: Ethics approval was obtained from Wales Research Ethics Committee 1 (IRAS ID 312494) and study approval from the Health Research Authority (22/WA/0087). Informed consent will be sought from all hospital staff involved in data collection activities and for patients involved in enhanced data collection activities. The findings of this study will be disseminated in peer-reviewed journals and conference presentations. TRIAL REGISTRATION: ISRCTN11899506.

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs.

BACKGROUND: Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. METHODS: We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. RESULTS: Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. CONCLUSIONS: Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

Supportive use of digital technologies during transition to adult healthcare for young people with long-term conditions, focusing on Type 1 diabetes mellitus: A scoping review.

Type 1 diabetes mellitus (T1DM) is the second most common chronic or long-term condition (LTC) affecting young people (YP); when transitioning from paediatric to adult healthcare, young people with LTCs such as T1DM are expected to self-manage medication, diet and clinical appointments. This scoping review aimed to analyse research examining ways digital health technologies were used to support YP with LTCs during transition from paediatric to adult healthcare and to establish YP's needs, experiences and challenges when transitioning. We aimed to identify knowledge gaps and inform development of a novel chatbot with components such as avatars and linked videos to help YP with T1DM gain self-management confidence and competence during transition. Nineteen studies identified through searching five electronic databases were included in this review. A combination of digital health technologies was used to support transition of YP with LTCs to adult healthcare. Barriers to successful transition were reported and YP described the importance of social relationships and transition readiness and expressed the need for individualised interventions that acknowledge social factors such as work and college. No supportive chatbots with components to help YP with T1DM were identified. This contribution will inform future development and evaluation of such a chatbot.

Characterizing asset-based studies in public health: development of a framework.

Asset-based approaches are becoming more common within public health interventions; however, due to variations in terminology, it can be difficult to identify asset-based approaches. The study aimed to develop and test a framework that could distinguish between asset-based and deficit-based community studies, whilst acknowledging there is a continuum of approaches. Literature about asset-based and deficit-based approaches were reviewed and a framework was developed based on the Theory of Change model. A scoring system was developed for each of the five elements in the framework based on this model. Measurement of community engagement was built in, and a way of capturing how much the study involved an asset approach. The framework was tested on 13 studies examining community-based interventions to investigate whether it could characterize asset-based versus deficit-based studies. The framework demonstrated how much the principles underpinning asset-based approaches were present and distinguished between studies where the approach was deficit-based to those that had some elements of an asset-based approach. This framework is useful for researchers and policymakers when determining how much of an intervention is asset-based and identifying which elements of asset-based approaches lead to an intervention working.

Deficit-based approaches are a common approach to addressing public health issues within a community and involve identifying a health problem or need and finding a way to solve these. However, asset-based approaches, those that involve the community using its assets, or strengths, to enable community members to have more control over their health and wellbeing, are increasingly common. The terminology used to describe these methods varies greatly so it can be difficult to identify whether an approach is more deficit-based or asset-based. To address this a framework was developed to identify and score elements of asset-based studies. We did this by reviewing academic information describing asset-based approaches and built into this a scoring system. This framework was used to assess and measure the degree to which 13 community-based studies took an asset-based approach. The framework was able to identify studies which were more asset-based in their approach compared to those which were more deficit-focused, acknowledging that some studies may have elements of each approach. This framework will be useful for people working in health policy and research who want a resource to help identify asset-based approaches in practice and which aspects of the approach were important for its success in the community.

Developing a core outcome set for hospital deprescribing trials for older people under the care of a geriatrician.

BACKGROUND: Half of older people are prescribed unnecessary/inappropriate medications that are not routinely deprescribed in hospital hence there is a need for deprescribing trials. We aimed to develop a Core Outcome Set (COS) for deprescribing trials for older people under the care of a geriatrician during hospital admission. METHODS: We developed a list of potentially relevant outcomes from the literature. Using a two-round Delphi survey of stakeholder groups representing older people and carers, hospital clinicians, hospital managers, and ageing/deprescribing researchers, each outcome was scored according to Grading of Recommendations Assessment, Development and Evaluation, followed by two consensus workshops to finalise the COS. RESULTS: Two hundred people completed Round 1 and 114 completed Round 2. Representing all stakeholder groups, 10 people participated in workshop 1 and 10 in workshop 2. Six outcomes were identified as most important, feasible and acceptable to collect in a trial: number of prescribed medicines stopped; number of prescribed medicines with dosage reduced; quality of life; mortality; adverse drug events and number of hospital stays. Three other outcomes were identified as important, but currently too burdensome to collect: number of potentially inappropriate medicines prescribed; burden from medication routine; and medication-related admissions to hospital. CONCLUSIONS: A COS represents the minimum outcomes that should be collected and reported. Whilst uncommon practice for COS development, the value of considering outcome collection feasibility is demonstrated by the removal of three potential outcomes that, if included, may have compromised COS uptake due to challenges with collecting the data.

Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT).

OBJECTIVES: To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information. DESIGN: Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study. SETTING: Emergency departments in 23 UK hospitals. PARTICIPANTS: 1409 children aged 4-16 years attending with a torus (buckle) fracture, and their parents/guardian. Children's mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language. INTERVENTIONS: Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728). OUTCOME MEASURES: Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three 'free text' questions (deriving subjective evaluations) and trial retention. RESULTS: MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI -1.23 to 1.32, p=0.94). The MMI group was more likely to report the information 'very easy' to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks' timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%). CONCLUSIONS: MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively. TRIAL REGISTRATION NUMBER: ISRCTN73136092 and ISRCTN13955395.

Engaging children, young people, parents and health professionals in interviews: Using an interactive ranking exercise within the co-design of multimedia websites.

When planning paediatric trials, it is important to consider how best to communicate with children and young people (CYP) so they understand what they are taking part in. It is also important to consider what information they need. Involving CYP as research participants leads to research that is more relevant although it can be difficult to engage CYP in qualitative research to improve trial materials due to the topic area. This paper describes how a visual ranking exercise within qualitative interviews acted as a helpful conduit to engaging discussions to inform a co-designed website with information for trial participants. 40 people participated in interviews during which the ranking exercise was used (11 CYP aged 9-18 years, 14 parents, 15 professionals). We found the ranking exercise supported participant engagement and prevented them feeling that particular responses were expected. It also enabled participants to discuss their ranking (and decisions behind this) with other participants and the researcher. Co-design interviews with CYP that use interactive exercises such as ranking are likely to elicit richer data than those relying on traditional questioning techniques.

Predictors of meningococcal vaccine uptake in university and college students: a systematic review and meta-analysis.

Objective: To identify predictors of meningococcal vaccine uptake among university and college students, the most common carriers of meningococcal disease. Participants: University or college students aged 18 to 25 years. Methods: Multiple databases, citations, and gray literature were systematically searched in April 2017 and January 2019, for articles reporting rates and predictors of vaccine uptake. Included studies underwent quality appraisal, and, where suitable, meta-analyses were performed. Results: Twenty-one articles, covering 18 studies from six countries, were included. They were mostly cross-sectional surveys of routine vaccination. Meta-analyses were conducted on six predictors. Higher vaccination uptake was associated with being a first year student, an undergraduate student, not being an international student, perceiving meningococcal disease as a risk, and being female. Conclusion: Identified key predictors correspond with previous studies and other vaccines. The findings should inform the delivery and communication of meningococcal vaccination to university and college students.

Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial.

OBJECTIVE: To compare two methods of providing information about the Bone Anchored Maxillary Protraction (BAMP) trial: standard printed information and multimedia websites, for their quality and ease of understanding, and impact on decision-making. DESIGN: Randomised controlled trial. SETTING: Orthodontic outpatient clinic in the UK. METHODS: Participants were 109 adolescents (aged 11-14 years) attending for orthodontic treatment. While awaiting treatment they were asked to imagine being recruited to the BAMP clinical trial. They were individually randomised to receive the printed or the multimedia website information (comprising text, animations and 'talking head' videos). After reading or viewing the information, they completed a 9-item Likert scale Decision-Making Questionnaire (DMQ) (score range 0-36) plus three free-text questions on their evaluation of the information. RESULTS: A total of 104 participants completed the questionnaire. Mean total DMQ scores were higher (more positive) in the website group (28.1 vs. 27.0), although the difference was small and not statistically significant (P = 0.20). Analysis of individual questionnaire items showed two statistically significant differences: the website information had higher ratings on 'easy to understand' (Z = 3.03; P = 0.003) and 'confidence in decision-making' (Z = 2.00; P = 0.044). On the three free-text questions, more positive and fewer negative comments were made about the websites than the printed information. CONCLUSION: In this hypothetical trial setting, adolescent patients found that trial information conveyed on a multimedia website was easier to understand and made them more confident in their decision about trial participation. Their subjective evaluations of the website were also more positive and less negative than about the printed information. Multimedia information has the potential to increase the quality of engagement and information exchange when seeking consent for research.

Correction to: Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.

An amendment to this paper has been published and can be accessed via the original article.

Children and young people's concerns and needs relating to their use of health technology to self-manage long-term conditions: a scoping review.

BACKGROUND: The use of patient-facing health technologies to manage long-term conditions is increasing; however, children and young people may have particular concerns or needs before deciding to use different health technologies. AIMS: To identify children and young people's reported concerns or needs in relation to using health technologies to self-manage long-term conditions. METHODS: A scoping review was conducted. We searched MEDLINE, PsycINFO and CINAHL in February 2019. Searches were limited to papers published between January 2008 and February 2019. We included any health technology used to manage long-term conditions. A thematic synthesis of the data from the included studies was undertaken. We engaged children with long-term conditions (and parents) to support review design, interpretation of findings and development of recommendations. RESULTS: Thirty-eight journal articles were included, describing concerns or needs expressed by n=970 children and/or young people aged 5-18 years. Most included studies were undertaken in high-income countries with children aged 11 years and older. Studies examined concerns with mobile applications (n=14), internet (n=9), social media (n=3), interactive online treatment programmes (n=3), telehealth (n=1), devices (n=3) or a combination (n=5). Children and young people's main concerns were labelling and identity; accessibility; privacy and reliability; and trustworthiness of information. DISCUSSION: This review highlights important concerns that children and young people may have before using technology to self-manage their long-term condition. In future, research should involve children and young people throughout the development of technology, from identifying their unmet needs through to design and evaluation of interventions.

Are Australian parents following feeding guidelines that will reduce their child's risk of dental caries?

BACKGROUND: Early childhood is an important time to establish eating behaviours and taste preferences, and there is strong evidence of the association between the early introduction of sugar-sweetened beverages and obesity and dental caries (tooth decay). Dental caries early in life predicts lifetime caries experience, and worldwide expenditure for dental caries is high. METHODS: Questionnaire data from the Splash! longitudinal birth cohort study of young children in Victoria, Australia was used to examine beverage consumption and parental feeding behaviours of young children, aiming to provide contemporary dietary data and assess consistency with the Australian dietary guidelines. RESULTS: From 12 months of age, the proportion of children drinking sugar-sweetened beverages consistently increased with age (e.g. fruit juice consumed by 21.8% at 12 months and 76.7% at 4 years of age). However, the most common beverages for young children are milk and water, consistent with Australian dietary guidelines. In relation to other risk factors for dental caries, at 6 months of age children were sharing utensils, and at 12 months three quarters of carers tasted the child's food before feeding. CONCLUSIONS: The increasing consumption of sugar-sweetened beverages and prevalence of other risk factors for dental caries and obesity through early childhood continues to be a problem despite efforts to raise awareness of these issues with parents.

Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.

BACKGROUND: Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to identify effective strategies to increase research participation. METHODS: Qualitative and quantitative systematic reviews were systematically identified. No date or language limits were applied. Two reviewers independently selected reviews. Methodological quality was rated using AMSTAR, and poor-quality reviews (scoring 0-3) were excluded. Barriers and facilitators were coded to psychological theory (Theoretical Domains Framework) and empirical recruitment research (recruitment interventions that had been subjected to randomised controlled trial evaluation). RESULTS: We included 26 systematic reviews (429 unique primary studies), covering a wide range of patient populations and health settings. We identified five groups of facilitators, of which three were dominant (potential for personal benefit, altruism, trust) and appear to be relevant across research setting and design. We identified nine groups of barriers, which were more dependent on the particular study (context, population, design). Two determinants (participant information, social influences) were found to be both barriers and facilitators. Barriers and facilitators could be coded to the Motivation and Opportunity components of the Theoretical Domains Framework; only one was coded to a Capability component. There was some overlap between psychosocial determinants and empirical recruitment research, but some barriers and facilitators had not been tested at all. CONCLUSIONS: Identifying effective recruitment strategies could increase the efficiency and generalisability of primary research. We identified a number of barriers and facilitators that could be addressed by researchers. There is a need for more research to identify effective recruitment strategies that draw on the psychosocial facilitators and barriers identified in this overview.

Addressing disparities in oral disease in Aboriginal people in Victoria: where to focus preventive programs.

The aim of this study is to determine where Aboriginal people living in Victoria attend public oral health services; whether they access Aboriginal-specific or mainstream services; and the gap between dental caries (tooth decay) experience in Aboriginal and non-Aboriginal people. Analysis was undertaken on routinely collected clinical data for Aboriginal patients attending Victorian public oral health services and the distribution of Aboriginal population across Victoria. Approximately 27% of Aboriginal people attended public oral health services in Victoria across a 2-year period, with approximately one in five of those accessing care at Aboriginal-specific clinics. In regional Victoria, 6-year-old Aboriginal children had significantly higher levels of dental caries than 6-year-old non-Aboriginal children. There was no significant difference in other age groups. This study is the first to report where Aboriginal people access public oral health care in Victoria and the disparity in disease between Aboriginal and non-Aboriginal users of the Victorian public oral healthcare system. Aboriginal people largely accessed mainstream public oral healthcare clinics highlighting the importance for culturally appropriate services and prevention programs to be provided across the entire public oral healthcare system. The findings will guide development of policy and models of care aimed at improving the oral health of Aboriginal people living in Victoria.

SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials.

BACKGROUND: Randomised controlled trials are considered the best method for determining the effectiveness and safety of health interventions. Trials involving children are essential to ensure that treatments are safe and effective. However, many trials, in both adult and paediatric populations, do not achieve recruitment targets and/or maintain retention of participants, which can lead to a reduction in the internal and external validity of the results. Identifying ways of improving trial efficiency are important in order to increase the successful completion of trials. MAIN BODY: A 'Study Within A Trial' (SWAT) is a self-contained study embedded within an ongoing trial, which aims to establish evidence to improve the management and delivery of trials in healthcare. Increasing numbers of SWATs have been undertaken in recent years yet very few within paediatric trials. Herein, we describe some of the challenges with undertaking a programme of SWATs within paediatric clinical trials in the UK. The TRECA (TRials Engagement in Children and Adolescents) study involves developing multimedia websites for use within paediatric trials to provide recruitment information to children, young people and their families about the clinical trial. Challenges encountered included governance issues such as host trial approval processes and sharing of anonymised data, funding issues for host trials, internet quality and accessibility within the healthcare setting, and ethical concerns associated with SWAT methodology. We believe the ethical concerns are more pronounced in the paediatric setting, perhaps because of the fewer SWATs undertaken in these settings or that a more cautious, risk-averse approach to undertaking research with children is taken. CONCLUSION: SWATs are becoming increasingly common to provide an evidence base for methods to improve trial efficiency. However, we encountered a number of unanticipated challenges to embedding TRECA that have not been previously reported within the scientific literature. We believe that, if these issues were addressed through wider promotion and explanation of undertaking SWATs involving all key stakeholders, as well as by exploration of alternative funding models for SWATs, this would enable more streamlined, appropriate and timely processes for SWATs and a stronger evidence base for what works to increase trial efficiency. TRIAL REGISTRATION: The TRECA study is registered on ISRCTN, ID 73136092 . Registered on 24 August 2016.

Supporting children and young people when making decisions about joining clinical trials: qualitative study to inform multimedia website development.

OBJECTIVES: To understand stakeholders' views regarding the content and design of paediatric clinical trial multimedia websites. To describe how this knowledge informed the development of the multimedia websites. DESIGN: Qualitative study comprising two rounds of interviews or focus groups, with thematic analysis of interview transcripts. PARTICIPANTS: Sixty-two people (21 children and young people with long-term health conditions, 24 parents and 17 professionals). SETTING: One UK children's hospital and one UK Young Persons' Advisory Group. RESULTS: When asked what was important in deciding whether to join a trial, children, young people and parents prioritised information about what participation would involve, what the trial was testing, potential benefits and risks of participation and knowing they could leave the trial if they later changed their minds. Young people and parents trusted trial teams to follow regulatory and quality requirements and therefore did not think such information was a priority for the websites, although logos of trusted organisations could lend credibility. Professionals largely concurred with these views. Children and young people advised on the importance of designing the multimedia website to ensure its appearance, tone and wording suited the intended audience and on using animated characters to facilitate children's engagement. CONCLUSIONS: Our study provides insights into the information that families value when deciding about healthcare trial participation. It provides guidance on the design of information resources to appeal to children and young people, while also being acceptable to parents and professionals who are often gatekeepers of children's access to information. Our findings will be of use to others developing similar multimedia websites. We report specific information needs and new visual preferences that are not usually addressed in printed trial information. Our work illustrates what qualitative research and participatory design practices can contribute to the development of information resources more generally. TRIAL REGISTRATION NUMBER: ISRCTN73136092; Pre-results.

User testing digital, multimedia information to inform children, adolescents and their parents about healthcare trials.

Digital, multimedia information resources (MMIs) containing text, video, animation and pictures are a promising alternative to written participant information materials designed to inform children, adolescents and parents about healthcare trials, but little research has tested whether they are fit for purpose. This study employed a consecutive groups design and user testing questionnaire to assess whether participants were able to find and understand key information in multimedia resources. Two rounds of testing were completed. In each round, seven children aged 7-11 tested the MMI with a parent; six adolescents aged 12-17 and seven parents tested the MMI independently. After round 1, the resources were revised based on participant scores, behaviour and feedback. Round 1 identified problems with 2/10 information items (length of trial and use of insulin pump); only 3/20 participants could locate all information items without difficulty. After revisions, 14/20 participants scored a clear round. Information comprehension was high: 96% understood in round 1 and 99% in round 2. Participant feedback on the multimedia resources was positive, although presentation preferences varied. User testing was employed successfully with children, adolescents and parents to identify issues with, and improve, multimedia resources developed to inform potential healthcare trial participants.