Looked after young people : reducing inequalities through an evidence-and theory-informed intervention

Objective: The study aimed to design and evaluate a health behaviour change intervention for looked after young people, targeting sexual health, smoking, exercise, healthy eating and non-dependent alcohol and drug use. Design: A pre–post intervention evaluation was undertaken exploring health behaviours and wellbeing. Methodology: The one-to-one intervention was individually tailored to each person. Young people eligible for the intervention were aged 11 years and over and were ‘looked after’, meaning they were under a supervision order with a local authority in Scotland, or were a care leaver. A total of 144 young people referred to the intervention service between March 2009 and January 2014 were eligible for the evaluation. Evaluation data were analysed using standard statistical tests on SPSS. Results: Behaviour change techniques, including goal setting, action planning, barrier identification/problem solving and motivational interviewing contributed to improvements in all areas. Difficulties with consent and follow-up were highlighted as barriers to effective evaluation. Conclusion: Improving the current health of looked after young people with a view to prevent future ill health using a tailored intervention with behaviour change techniques enables this group to improve health behaviours, despite numerous challenges in working with these vulnerable clients

Identifying the participant characteristics that predict recruitment and retention of participants to RCTs involving children : a systematic review

Background: Randomised controlled trials (RCTs) are recommended as the gold standard in evaluating healthcare interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim: To identify predictors of recruitment and retention in RCTs involving children. Methods/ Design: A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0-12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results: 28 studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socio economic status) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and low socio economic status (SES) appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion: Parent characteristics may predict participation of children and their families to RCTs, however, there was a lack of consensus. Whilst socio-demographics variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention

Cost-effectiveness Analysis of the Dental RECUR Pragmatic Randomized Controlled Trial: Evaluating a Goal-oriented Talking Intervention to Prevent Reoccurrence of Dental Caries in Children

BACKGROUND: The formation of dental caries is the most common chronic disease in children, and is preventable. The oral health-related quality of life has an immense impact on an individual’s daily functioning, well-being or overall quality of life. OBJECTIVES: This study aims to investigate the cost effectiveness of the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI). This 30-minute therapeutic “talk” by a dental nurse with a parent/guardian was compared with a placebo-controlled intervention in preventing reoccurrence of dental caries in children who have had a primary tooth extracted. METHODS: An economic model was developed to simulate the clinical progression of dental caries among children who have previously had a primary tooth extracted. The analysis was conducted using the UK NHS perspective. The main outcome was the incremental cost-effectiveness ratio (ICER) based on the quality-adjusted life years (QALYs). Estimates of costs and probabilities were obtained from the DR-BNI multicentre randomised controlled trial (RCT), while QALY values were obtained from published literature. Univariate and probabilistic sensitivity analyses were conducted to assess the uncertainty of the result and robustness of the model. Affordability and risk-aversion of the intervention were investigated to help decision makers make the best possible choices. RESULTS: With an intervention cost of £6.47, the results from the RCT showed the healthcare cost for the DR-BNI intervention was £115.90 per child while the control had a healthcare cost of £119.46 per child. The QALYs gained for the prevention of reoccurrence of dental caries was higher in the DR-BNI intervention arm by 0.023 QALYs; thus, the DR-BNI was the dominant intervention. At willingness to pay threshold of £3500/QALY gained, a maximum probability of being cost effectiveness is achieved at 86%. The secondary analysis showed a cost-savings of £20.94 per participant for the prevention of at least one filling or extraction. Affordability results showed that the DR-BNI programme is affordable to the UK health system at a moderately low budget. CONCLUSIONS: This study shows the proactive talking intervention to have a very moderate cost and to be effective in providing better health related quality-of-life gains. The intervention is cost savings with a dominant ICER even with a 200% increase in the cost of intervention. The NHS will be providing better oral health for children at a better net monetary benefit-to-risk ratio by adopting the DR-BNI intervention in preventing the reoccurrence of dental fillings and extractions for each participant. Trial Registration: This trial was registered prospectively on 27th September 2013 with the trial registration number ISRCTN 24958829. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40258-022-00720-5

A randomised controlled feasibility study of group cognitive behavioural therapy for people with severe asthma

Objectives: Evidence for the efficacy of Cognitive Behavioural Therapy (CBT) in asthma is developing but it is not known if this translates to benefits in severe asthma or if a group approach is acceptable to this patient group. This study aimed to assess the feasibility and acceptability of Group-CBT in severe asthma. Method: This was a two-centre, randomised controlled parallel group feasibility study. Eligible participants (patients with severe asthma and a clinically significant diagnosis of anxiety and/or depression – Hospital Anxiety and Depression Scale (HAD) score greater than 8 for the anxiety or depression sub-scale) received Group-CBT in weekly sessions for eight consecutive weeks and usual care or usual care only. Follow-up was for 16 weeks and end points were: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, HAD, Dyspnoea-12, EuroQual-5D and EuroQuol-VAS. Results: 51 patients were randomised: 36% (51 out of 140) consent rate and 25% (13/51) attrition at week 16. Screening logs indicated that study take-up was influenced by patients living long distances from the treatment centre and inability to commit to the weekly demands of the programme. Drop-out was higher in Group-CBT compared due to inability to commit to the weekly programme because of poor health. Participants who contributed to focus group discussions reported that Group-CBT contributed to a better understanding of their illness and related approaches to anxiety management and acceptance of their asthma condition. Although weekly face-to-face sessions were challenging, this was the preferred method of delivery for these participants. Conclusions: This feasibility study shows that Group-CBT warrants further investigation as a potentially promising treatment option for patients with severe asthma. It has been possible but not easy to recruit and retain the sample. Options for a less demanding intervention schedule, such as less frequent face-to-face visits and the use of web-based interventions, require careful consideration

A randomised controlled feasibility trial of Group Cognitive Behavioural Therapy for people with severe asthma

Evidence for the efficacy of Cognitive Behavioural Therapy (CBT) in asthma is developing but it is not known if this translates to benefits in severe asthma or if a group approach is acceptable to this patient group. This study aimed to assess the feasibility and acceptability of Group-CBT in severe asthma.This was a two-centre, randomised controlled parallel group feasibility study. Eligible participants (patients with severe asthma and a clinically significant diagnosis of anxiety and/or depression - Hospital Anxiety and Depression Scale (HAD) score greater than 8 for the anxiety or depression sub-scale) received Group-CBT in weekly sessions for eight consecutive weeks and usual care or usual care only. Follow-up was for 16 weeks and end points were: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, HAD, Dyspnoea-12, EuroQual-5D and EuroQuol-VAS.51 patients were randomised: 36% (51 out of 140) consent rate and attrition at week 16 was 12. Screening logs indicated that study take-up was influenced by patients living long distances from the treatment centre and inability to commit to the weekly demands of the programme. Drop-out was higher in Group-CBT compared due to inability to commit to the weekly programme because of poor health. Participants who contributed to focus group discussions reported that Group-CBT contributed to a better understanding of their illness and related approaches to anxiety management and acceptance of their asthma condition. Although weekly face-to-face sessions were challenging, this was the preferred method of delivery for these participants.This feasibility study shows that Group-CBT warrants further investigation as a potentially promising treatment option for patients with severe asthma. It has been possible but not easy to recruit and retain the sample. Options for a less demanding intervention schedule, such as less frequent face-to-face visits and the use of web-based interventions, require careful consideration

A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial

Background: In England and Scotland, dental extraction is the single highest cause of planned admission to the hospital for children under 11 years. Traditional dental services have had limited success in reducing this disease burden. Interventions based on motivational interviewing have been shown to impact positively dental health behaviours and could facilitate the prevention of re-occurrence of dental caries in this high-risk population. The objective of the study is to evaluate whether a new, dental nurse-led service, delivered using a brief negotiated interview based on motivational interviewing, is a more cost-effective service than treatment as usual, in reducing the re-occurrence of dental decay in young children with previous dental extractions. Methods/Design: This 2-year, two-arm, multicentre, randomised controlled trial will include 224 child participants, initially aged 5 to 7 years, who are scheduled to have one or more primary teeth extracted for dental caries under general anaesthesia (GA), relative analgesia (RA: inhalation sedation) or local anaesthesia (LA). The trial will be conducted in University Dental Hospitals, Secondary Care Centres or other providers of dental extraction services across the United Kingdom. The intervention will include a brief negotiated interview (based on the principles of motivational interviewing) delivered between enrolment and 6 weeks post-extraction, followed by directed prevention in primary dental care. Participants will be followed up for 2 years. The main outcome measure will be the dental caries experienced by 2 years post-enrolment at the level of dentine involvement on any tooth in either dentition, which had been caries-free at the baseline assessment. Discussion: The participants are a hard-to-reach group in which secondary prevention is a challenge. Lack of engagement with dental care makes the children and their families scheduled for extraction particularly difficult to recruit to an RCT. Variations in service delivery between sites have also added to the challenges in implementing the Dental RECUR protocol during the recruitment phase. Trial registration: ISRCTN24958829 (date of registration: 27 September 2013), Current protocol version: 5.0

Effectiveness of behavioral interventions to reduce the intake of sugar-sweetened beverages in children and adolescents: a systematic review and meta-analysis.

Context: Consumption of sugar-sweetened beverages (SSBs) among children has been associated with adverse health outcomes. Numerous behavioral interventions aimed at reducing the intake of SSBs among children have been reported, yet evidence of their effectiveness is lacking. Objective: This systematic review explored the effectiveness of educational and behavioral interventions to reduce SSB intake and to influence health outcomes among children aged 4 to 16 years. Data Sources: Seven databases were searched for randomized controlled trials published prior to September 2016. Studies identified were screened for eligibility. Study Selection: Trials were included in the review if they met the PICOS (Population, Intervention, Comparison, Outcome, and Study design) criteria for inclusion of studies. Data Extraction: Data were extracted by 2 reviewers following Cochrane guidelines and using Review Manager software. Results: Of the 16 trials included, 12 were school based and 4 were community or home based. Only 3 trials provided data that could be pooled into a meta-analysis for evaluating change in SSB intake. Subgroup analyses showed a trend toward a significant reduction in SSB intake in participants in school-based interventions compared with control groups. Change in body mass index z scores was not statistically significant between groups. Conclusions: The quality of evidence from included trials was considered moderate, and the effectiveness of educational and behavioral interventions in reducing SSB intake was modest. Systematic Review Registration: PROSPERO registration number CRD42014004432

Genetic Drivers of Heterogeneity in Type 2 Diabetes Pathophysiology

Type 2 diabetes (T2D) is a heterogeneous disease that develops through diverse pathophysiological processes1,2 and molecular mechanisms that are often specific to cell type3,4. Here, to characterize the genetic contribution to these processes across ancestry groups, we aggregate genome-wide association study data from 2,535,601 individuals (39.7% not of European ancestry), including 428,452 cases of T2D. We identify 1,289 independent association signals at genome-wide significance (P \u3c 5 × 10-8) that map to 611 loci, of which 145 loci are, to our knowledge, previously unreported. We define eight non-overlapping clusters of T2D signals that are characterized by distinct profiles of cardiometabolic trait associations. These clusters are differentially enriched for cell-type-specific regions of open chromatin, including pancreatic islets, adipocytes, endothelial cells and enteroendocrine cells. We build cluster-specific partitioned polygenic scores5 in a further 279,552 individuals of diverse ancestry, including 30,288 cases of T2D, and test their association with T2D-related vascular outcomes. Cluster-specific partitioned polygenic scores are associated with coronary artery disease, peripheral artery disease and end-stage diabetic nephropathy across ancestry groups, highlighting the importance of obesity-related processes in the development of vascular outcomes. Our findings show the value of integrating multi-ancestry genome-wide association study data with single-cell epigenomics to disentangle the aetiological heterogeneity that drives the development and progression of T2D. This might offer a route to optimize global access to genetically informed diabetes care

Genetic drivers of heterogeneity in type 2 diabetes pathophysiology

Type 2 diabetes (T2D) is a heterogeneous disease that develops through diverse pathophysiological processes1,2 and molecular mechanisms that are often specific to cell type3,4. Here, to characterize the genetic contribution to these processes across ancestry groups, we aggregate genome-wide association study data from 2,535,601 individuals (39.7% not of European ancestry), including 428,452 cases of T2D. We identify 1,289 independent association signals at genome-wide significance (P &lt; 5 × 10-8) that map to 611 loci, of which 145 loci are, to our knowledge, previously unreported. We define eight non-overlapping clusters of T2D signals that are characterized by distinct profiles of cardiometabolic trait associations. These clusters are differentially enriched for cell-type-specific regions of open chromatin, including pancreatic islets, adipocytes, endothelial cells and enteroendocrine cells. We build cluster-specific partitioned polygenic scores5 in a further 279,552 individuals of diverse ancestry, including 30,288 cases of T2D, and test their association with T2D-related vascular outcomes. Cluster-specific partitioned polygenic scores are associated with coronary artery disease, peripheral artery disease and end-stage diabetic nephropathy across ancestry groups, highlighting the importance of obesity-related processes in the development of vascular outcomes. Our findings show the value of integrating multi-ancestry genome-wide association study data with single-cell epigenomics to disentangle the aetiological heterogeneity that drives the development and progression of T2D. This might offer a route to optimize global access to genetically informed diabetes care.</p

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children : a systematic review

Background Randomised controlled trials (RCTs) are recommended as the ‘gold standard’ in evaluating health care interventions. The conduct of RCTs is often impacted by difficulties surrounding recruitment and retention of participants in both adult and child populations. Factors influencing recruitment and retention of children to RCTs can be more complex than in adults. There is little synthesised evidence of what influences participation in research involving parents and children. Aim To identify predictors of recruitment and retention in RCTs involving children. Methods A systematic review of RCTs was conducted to synthesise the available evidence. An electronic search strategy was applied to four databases and restricted to English language publications. Quantitative studies reporting participant predictors of recruitment and retention in RCTs involving children aged 0–12 were identified. Data was extracted and synthesised narratively. Quality assessment of articles was conducted using a structured tool developed from two existing quality evaluation checklists. Results Twenty-eight studies were included in the review. Of the 154 participant factors reported, 66 were found to be significant predictors of recruitment and retention in at least one study. These were classified as parent, child, family and neighbourhood characteristics. Parent characteristics (e.g. ethnicity, age, education, socioeconomic status (SES)) were the most commonly reported predictors of participation for both recruitment and retention. Being young, less educated, of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies. When analysed according to setting and severity of the child’s illness there appeared to be little variation between groups. The quality of the studies varied. Articles adhered well to reporting guidelines around provision of a scientific rationale for the study and background information as well as displaying good internal consistency of results. However, few studies discussed the external validity of the results or provided recommendations for future research. Conclusion Parent characteristics may predict participation of children and their families to RCTs; however, there was a lack of consensus. Whilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families. Further studies that explore variables that can be influenced are warranted. Reporting of studies in this field need greater clarity as well as agreed definitions of what is meant by retention