Statistical analysis plan for the SOLUTIONS randomised controlled trial with internal pilot: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at policy custody

Background: Within England, children and young people entering police custody are referred to Liaison and Diversion (L&D) teams. These teams liaise with healthcare and other support services aiming to divert children and young people away from the criminal justice system. Although targeted psychological interventions are not typically offered to children and young people by L&D teams, evidence suggests that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems. Methods: A two-arm individually randomised controlled trial (RCT) with internal pilot and process evaluation will be conducted with approximately 448 children and young people aged 10–17 years presenting at police custody suites who are referred to the L&D team or recruited via online routes if they have previously presented at any police custody suite in England. The primary outcome is the Self-Report Delinquency Measure (SRDM) at 6 months post-randomisation. Analyses will be performed using intention-to-treat. Results: The statistical analysis plan (SAP) for the trial is described. The plan details of analyses to be undertaken which will be reported in the primary and any secondary publications. The plan was developed and published prior to locking our database and unblinding to treatment allocation. Discussion: This RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites including testing of moderating factors and sensitivity of the primary analyses. Trial registration: ClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

Objective: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464

Evaluation of an online interactive Diabetes Needs Assessment Tool (DNAT) versus online self-directed learning: a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Methods for the dissemination, understanding and implementation of clinical guidelines need to be examined for their effectiveness to help doctors integrate guidelines into practice. The objective of this randomised controlled trial was to evaluate the effectiveness of an interactive online Diabetes Needs Assessment Tool (DNAT) (which constructs an e-learning curriculum based on individually identified knowledge gaps), compared with self-directed e-learning of diabetes guidelines.</p> <p>Methods</p> <p>Health professionals were randomised to a 4-month learning period and either given access to diabetes learning modules alone (control group) or DNAT plus learning modules (intervention group). Participants completed knowledge tests before and after learning (primary outcome), and surveys to assess the acceptability of the learning and changes to clinical practice (secondary outcomes).</p> <p>Results</p> <p>Sixty four percent (677/1054) of participants completed both knowledge tests. The proportion of nurses (5.4%) was too small for meaningful analysis so they were excluded. For the 650 doctors completing both tests, mean (SD) knowledge scores increased from 47.4% (12.6) to 66.8% (11.5) [intervention group (n = 321, 64%)] and 47.3% (12.9) to 67.8% (10.8) [control group (n = 329, 66%)], (ANCOVA p = 0.186). Both groups were satisfied with the usability and usefulness of the learning materials. Seventy seven percent (218/284) of the intervention group reported combining the DNAT with the recommended reading materials was "<it>very useful"/"useful"</it>. The majority in both groups (184/287, 64.1% intervention group and 206/299, 68.9% control group) [95% CI for the difference (-2.8 to 12.4)] reported integrating the learning into their clinical practice.</p> <p>Conclusions</p> <p>Both groups experienced a similar and significant improvement in knowledge. The learning materials were acceptable and participants incorporated the acquired knowledge into practice.</p> <p>Trial registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN67215088">ISRCTN67215088</a></p

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. Trial registration Current Controlled Trials ISRCTN61568050

Preparing for practice - calibration of dental undergraduate students in the Index of Orthodontic Treatment Need

Objectives The aim of this study was to establish the success in calibrating dental students in the use of the Index of Orthodontic Treatment Need (IOTN). Design Single-centre, evaluation of teaching study. Setting University department, UK, 2013. Subjects and method Third-year dental students were divided into four groups and received IOTN instruction via clinical and non-clinical teaching over a three-month period. This was followed by a calibration exercise where the whole year assessed 30 study models for orthodontic treatment need using the dental health component (DHC) and modified aesthetic component (AC) of the IOTN. Main outcome measures Student IOTN scores were compared to a gold standard using kappa statistics (κ). Results Results showed that although substantial agreement was achieved in both the DHC (κ = 0.65) and a modified AC (unweighted κ = 0.63), the year only calibrated successfully in the DHC. Conclusion Third year dental students taught at Cardiff University applied the DHC of IOTN better than the AC

Cost-effectiveness of home versus hospital management of children at onset of type 1 diabetes: the DECIDE randomised controlled trial

Objective The aim of this economic evaluation was to assess whether home management could represent a cost-effective strategy in the patient pathway of type 1 diabetes (T1D). This is based on the Delivering Early Care In Diabetes Evaluation trial (ISRCTN78114042), which compared home versus hospital management from diagnosis in childhood diabetes and found no statistically significant difference in glycaemic control at 24 months.Design Cost-effectiveness analysis alongside a randomised controlled trial.Setting Eight paediatric diabetes centres in England, Wales and Northern Ireland.Participants 203 clinically well children aged under 17 years, with newly diagnosed T1D and their carers.Outcome measures The base-case analysis adopted n National Health Service (NHS) perspective. A scenario analysis assessed costs from a broader societal perspective. The incremental cost-effectiveness ratio (ICER), expressed as cost per mmol/mol reduction in glycated haemoglobin (HbA1c), was based on the mean difference in costs between the home and hospital groups, divided by mean differences in effectiveness (HbA1c). Uncertainty was considered in terms of the probability of cost-effectiveness.Results At 24 months postintervention, the base-case analysis showed a difference in costs between home and hospital, in favour of home management (mean difference −£2,217; 95% CI −£2825 to −£1,609; p&lt;0.001). Home care dominated, with an ICER of £7434 (saved) per mmol/mol reduction of HbA1c. The results of the scenario analysis also favoured home management. The greatest driver of cost differences was hospitalisation during the initiation period.Conclusions Home management from diagnosis of children with T1D who are medically stable represents a less costly approach for the NHS in the UK, without impacting clinical effectiveness.Trial registration number ISRCTN78114042

A population-based cross-sectional study of the association between facial morphology and cardiometabolic risk factors in adolescence

Objective: To determine whether facial morphology is associated with fasting insulin, glucose and lipids independent of body mass index (BMI) in adolescents. Design: Population-based cross-sectional study. Setting: Avon Longitudinal Study of Parents and Children (ALSPAC), South West of England. Participants: From the ALSPAC database of 4747 three-dimensional facial laser scans, collected during a follow-up clinic at the age of 15, 2348 white British adolescents (1127 males and 1221 females) were selected on the basis of complete data on cardiometabolic parameters, BMI and Tanner's pubertal stage. Main outcome measures: Fasting insulin, glucose and lipids (triglycerides, high-density lipoprotein cholesterol (HDLc) and low-density lipoprotein cholesterol (LDLc)). Results: On the basis of the collection of 63 x, y and z coordinates of 21 anthropometric landmarks, 14 facial principal components (PCs) were identified. These components explained 82% of the variation in facial morphology and were used as exposure variables. With adjustment for age, gender and pubertal stage, seven PCs were associated with fasting insulin, none with glucose, three with triglycerides, three with HDLc and four with LDLc. After additional adjustment for BMI, four PCs remained associated with fasting insulin, one with triglycerides and two with LDLc. None of these associations withstood adjustment for multiple comparisons. Conclusions: These initial hypotheses generating analyses provide no evidence that facial morphology is importantly related to cardiometabolic outcomes. Further examination might be warranted. Facial morphology assessment may have value in identifying other areas of disease risk

Determining true glomerular filtration status in newly presenting type 2 diabetic subjects using age and sex adjustment

OBJECTIVE: To determine age- and sex-adjusted reference ranges (ASARRs) for glomerular filtration status using data from nondiabetic subjects and to apply these to newly presenting type 2 diabetic subjects. RESEARCH DESIGN AND METHODS: Glomerular filtration rate corrected for body surface area (cGFR) was determined using a radionuclide (51Cr-EDTA) method in 75 non-diabetic subjects (37 men, 38 women) and 219 type 2 diabetic subjects (157 men, 62 women). The 95% constant reference ranges (CRRs) were calculated as mean nondiabetic cGFR+/-1.96 SD. The 95% ASARRs were calculated by Altman's method from the nondiabetic cGFR versus age regression residuals for both male and female subjects. RESULTS: Using Altman's method, the intercepts, but not the gradients, of the cGFR versus age regressions were significantly different between male and female subjects (intercept difference [95% CI] 8.2 [1.3-15.1], gradient difference -0.4 [-1.1 to 0.3]). Fitting a common gradient, 95% ASARRs for normofiltration were found to be from 123.9 - (0.89 X age) to 181.7 - (0.89 x age) for male subjects, and from 116.0 - (0.89 X age) to 173.2 - (0.89 X age) for female subjects. The 95% CRR for normofiltration was 70.2-138.1 ml x min(-1) x (1.73 m)(-2). When applied to the diabetic cGFRs, the CRRs and ASARRs gave, respectively, 17% (37/219) versus 21% (46/219) hyperfiltrators and 83% (181/219) versus 79% (172/219) normofiltrators. Using the ASARRs, 14 normofiltrators (6 men, 8 women) were reclassified as hyperfiltrators (change [n/total n] [95% CI] 8% [14/181] [4-12]), and 5 hyperfiltrators (5 men, 0 women) were reclassified as normofiltrators (change 14% [5/37] [5-30]). CONCLUSIONS: We conclude that age and sex adjustment are essential to assess glomerular filtration status