Dr Morro ML Touray

Background Dementia care is a key priority for both NHS England and the UK Government. National guidelines highlight the importance of care coordination to address the challenges people living with dementia and their carers can encounter when trying to access the health and care system. To counter these challenges, Kent and Medway Integrated Care Board (ICB) have recently implemented a proactive Dementia Care Coordinator (DCC) service to support people with dementia and their carers from pre diagnosis to end of life care. Aim To understand how the DCC service works, (or not) for whom and in what circumstances. The findings will inform service development and future investment decisions. Design and setting This study uses a realist approach to evaluate the DCC service in Kent and Medway ICB, south-east England, population 1.9 million, comprising 42 Primary Care Networks (groups of general practices) each having a DCC. Methods An initial programme theory will be developed from existing literature, and in collaboration with stakeholders. Mixed methods including questionnaires to DCCs; service provider metrics; and qualitative interviews will be used to collect data on service provider and service user experiences. Interpretive comparative analysis and narrative synthesis including evaluation of service costs against outcomes will produce a refined final programme theory. Results Results from this project will produce evidence-based recommendations to help improve service delivery and possible service expansion. Conclusion This protocol describes a realist evaluation designed to investigate the recently implemented DCC service in Kent and Medway ICB. How this fits in Dementia services in primary care are undergoing a period of transformation. In Kent and Medway, a recent implemented service has been that of the dementia care coordinator, a proactive role to help people living with dementia and carers navigate the care system. Yet challenges exist when implementing a new role and new service into existing primary care organisation. This realist evaluation will explore what works, for whom, how, why and under what circumstances. Findings will provide evidence capable of informing future decisions about the DCC service including how the service can be successfully improved and expanded where appropriate.

Introduction: Obesity is one of the leading causes of preventable morbidity and mortality world-wide. The behavioural nature of the condition has been highlighted by the fact that it is largely the result of an energy imbalance between calories consumed and calories expended. In that respect, obesity related morbidity and mortality can be reduced through preventive behaviours. As behavioural scientists, economists have done little to date to explain and understand why the demand for obesity preventing activities is low. The aim of this paper is to develop an economic theory-based dynamic model to gain better understanding of people’s obesity preventive behaviours. Methods: A literature search using a PICO approach was developed to identify the relevant variables considered to influence the demand for obesity preventive goods. To inform the model, a framework was developed to group variables and help determine appropriate linkages between them. Results: Anchors, anxiety and anxiety driven variables are fundamental influences of people’s risk reduction actions. The anchors, which are environmental as well as personal in character, serve as references and stimulate anxieties. However, anxiety levels are driven by many other variables including stigma and perceived health outcomes. In response to one’s anxiety an individual will take actions which can be explained, at least in part, by conventional economic theories particularly in terms of costs and utilities. Conclusions: Conventional economic theories of consumer behaviour cannot fully explain the demand for obesity preventive goods. The model demonstrates that many factors have to be considered including health economic, psychological and behavioural economic theories. The model should be tested through a well designed questionnaire before using it in a general adult population.

A dementia care coordinator (DCC) service has recently been implemented across Kent and Medway Integrated Care Board (ICB). DCCs are provided at the Primary Care Network (PCN) level and work closely with GP practice teams. The service is intended to help service users navigate the care system and provide proactive support to mitigate crisis points. However, the value of this service, from key stakeholder perspectives is not yet known. The University of Surrey is conducting a realist evaluation into the service to explore what works, for whom, how, why and under what circumstances. This working paper reports on interim findings from an analysis of: (1) staffing and key performance indicators at the 12 month point in the project (October 2023); and (2) responses to an initial questionnaire sent to coordinators. Findings indicate DCCs enjoy being people-focused in their approach, and value being empathetic, well organised and effective. This may facilitate their ability to make a difference, provide individualised support, advocate for service users, and achieve job satisfaction. Working to high standards, in a joined-up way, with embedded knowledge and networks are important components to this. There is now a crucial need to enhance the support of this workforce (e.g. through formal, recognised training, caseload management, time, and knowledgeable management) in order to ensure sustainability of this service. This evaluation is on-going.

Background The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. Methods This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. Discussion If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK’s National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. Trial registration Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Abstract Objectives  To evaluate the cost effectiveness of the use of nine-valent pneumococcal polysaccharide conjugate vaccine in a routine infant immunisation programme based on the Pneumococcal Vaccine Trial (PVT) study in The Gambia. Methods  This was a clinical trial-based cost-effectiveness study conducted as part of the PVT study. The PVT was an intention-to-treat double-blind placebo-controlled trial of a nine-valent pneumococcal polysaccharide conjugate vaccine. The trial was conducted in the eastern parts of The Gambia, West Africa and recruited 17 437 children aged 40–364 days. A deterministic static cohort model was developed to evaluate direct benefits and costs of pneumococcal conjugate vaccine in The Gambia's routine immunisation programme. The incremental cost-effectiveness ratio (iCER) is defined as vaccinating infants against pneumococcal disease compared with no vaccination from a public provider's perspective using The Gambia's 2005 projected under-one-year population. Key findings  The results show the use of the vaccine in The Gambia's routine infant vaccination programme to be cost effective using an assumed price of US$5.00 per vial in single-dose vials. Compared with offering no vaccination, the incremental cost per DALYs averted would be 30 DALYs from the public provider perspective. At least 1569 and 340 invasive childhood pneumococcal illnesses and deaths respectively among the cohort would be prevented. In the absence of the vaccine 16 871 DALYs would be lost while with the use of the vaccine 7804 DALYs would be lost. Given the average treatment cost of pneumococcal illnesses to be US$191 (95% confidence interval 180 to 203) the introduction of the vaccine programme would lead to an additional cost of US$274 279 (about US$8.43/child). Conclusions  The availability of a cost-effective vaccine that can prevent thousands of pneumococcal illnesses and related deaths is a major development towards improving the disease burden in sub-Saharan African countries. This study supports the introduction of nine-valent pneumococcal vaccine into the infant immunisation programme of The Gambia as it is cost effective and will avert many preventable deaths and illnesses. Despite differences in distribution of serotypes between countries, the static model used in the analysis makes the results applicable to other developing countries, particularly those in sub-Saharan Africa.

Background: mhealth, predominantly wearable technology and mobile apps, have been considered in Parkinson’s Disease to provide valuable ecological data between face to face visits and improve monitoring of motor symptoms remotely. Objective: In this study we explore the feasibility of using a technology based mhealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in the present study as the PD_manager system, to collect clinically meaningful data. We also explore outcomes and disease related factors which are important determinants to establish feasibility. Finally, we further validate a tremor evaluation method with data collected while patients perform their daily activities. Methods: PD_manager trial was an open label parallel group randomized study. The mheath platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps and a knowledge platform) serving as the cloud backend. The compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective UPDRS estimations by clinicians were explored. Results: There were 65 of the 75 study participants (87%) who completed the protocol. They used the PD_manager system for a median 11.57 days (Std. dev. 3.15). The regression analysis suggests that the main factor associated with high usage was caregivers’ burden. Motor Aspects of Experiences of Daily Living and patients’ self-rated health status also influence the system’s usage. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. Conclusions: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11-14 days. The study further supports that mhealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mhealth platform can improve disease management and care.

Background: Parkinson’s disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_ Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice. Methods/design: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson’s disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson’s diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD_Manager vs control, stratifying by age (1 ≤ 70 : 1 > 70) and gender (60% M: 40% F). The PD_Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD_ Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework Discussion: Information gathered will inform further development of the PD_Manager system and a larger effectiveness trial. Trial registration: ISRCTN Registry, ISRCTN17396879. Registered on 15 March 2017.

Background: Despite the established evidence and theoretical advances explaining human judgments under uncertainty, developments of mobile health (mHealth) Clinical Decision Support Systems (CDSS) have not explicitly applied the psychology of decision making to the study of user needs. We report on a user needs approach to develop a prototype of a mHealth CDSS for Parkinson’s Disease (PD), which is theoretically grounded in the psychological literature about expert decision making and judgement under uncertainty. Methods: A suite of user needs studies was conducted in 4 European countries (Greece, Italy, Slovenia, the UK) prior to the development of PD_Manager, a mHealth-based CDSS designed for Parkinson’s Disease, using wireless technology. Study 1 undertook Hierarchical Task Analysis (HTA) including elicitation of user needs, cognitive demands and perceived risks/benefits (ethical considerations) associated with the proposed CDSS, through structured interviews of prescribing clinicians (N=47). Study 2 carried out computational modelling of prescribing clinicians’ (N=12) decision strategies based on social judgment theory. Study 3 was a vignette study of prescribing clinicians’ (N=18) willingness to change treatment based on either self-reported symptoms data, devices-generated symptoms data or combinations of both. Results: Study 1 indicated that system development should move away from the traditional silos of ‘motor’ and ‘non-motor’ symptom evaluations and suggest that presenting data on symptoms according to goal-based domains would be the most beneficial approach, the most important being patients’ overall Quality of Life (QoL). The computational modelling in Study 2 extrapolated different factor combinations when making judgements about different questions. Study 3 indicated that the clinicians were equally likely to change the care plan based on information about the change in the patient’s condition from the patient’s self-report and the wearable devices. 3 Conclusions: Based on our approach, we could formulate the following principles of mHealth design: 1) enabling shared decision making between the clinician, patient and the carer; 2) flexibility that accounts for diagnostic and treatment variation among clinicians; 3) monitoring of information integration from multiple sources. Our approach highlighted the central importance of the patient-clinician relationship in clinical decision making and the relevance of theoretical as opposed to algorithm (technology)-based modelling of human judgment.

Objectives The objectives were to investigate the impact of ‘time-effect’ on the estimation of quality-adjusted life years (QALYs) along prospective clinical trials’ outcomes using an assumed fixed time duration versus the actual time durations for each case. The ‘time’ duration is the length of time in a health state. Methods Two methods were used in the estimation of QALYs based using EQ-5D 3L scores collected at specific time-point intervals. One method used the actual time durations for each case based on CRF records, and the other used an assumed time duration and globally applied it to all the cases. Using SPSS® software program, we used paired-sample t-tests to assess whether the ‘time-effect’ can potentially affect trial results using CONSTRUCT trial data as reported in the trial results publications. The trial compared use of Infliximab with Cyclosporine for patients with Ulcerative Colitis and it involved some 270 participants. Key findings The results largely indicate statistically significant differences between the two methods of QALY estimations. QALYs at the respective time-points indicate no statistical difference between the two approaches. However, the difference in terms of total QALYs between the two QALY estimation approaches is statistically significant with considerable impact on costs/QALY. Conclusions Considering the possible impact of the time-effect on QALY estimations, the result implies that it can have significant implications for resources allocations decisions. In this respect, researchers have to pay due considerations to the approach they use and where possible, actual time durations must be used in QALY estimations along prospective clinical trials.

Objective: Complex cardiac devices including implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices can safely be implanted as a day case procedure as opposed to overnight stay. We assess how common day case complex device therapy is and the cost implications of more widespread adoption across the UK. Methods: A freedom of information request was sent to all centres performing complex cardiac devices across the UK to assess the adoption of this technique. Cost implications were assessed using Department of Health National Schedule of Reference Costs 2016–2017. Results: 100 UK centres were surveyed, 80% replied. Eighty per cent of UK centres already implant complex cardiac devices as a day case to some extent. 64.06% of centres have a protocol for this. 12.82% of centres do ˂25% of complex devices as a day case. 15.38% do 25%–50% as day case. 17.95% do 50%–75% as day case and 33.33% do ˃75% as day case. There was no relationship between centre volume and the proportion of devices done as a day case as opposed to overnight stay. The cost saving of performing a complex device as a day case as opposed to overnight stay was £412 per ICD, £525 per CRT-pacemaker and £2169 per CRT-defibrillator. Conclusions: Day case complex devices are already widespread across the UK, however, there is scope for increase. An increase in proportion of day case devices could translate to £5 583 265 in savings annually for the National Health Service if all centres performed 75% of devices as a day case.

Background:

Abstract Background Individuals who are ‘moderately’ or ‘severely’ dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members) and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? Methods This is a pragmatic, parallel, two-arm, feasibility RCT comparing SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. Results We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial for the whole period of the 12 months was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months, respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n = 54.5) versus control (n = 41.5). Conclusions The results of this feasibility trial indicate that with the appropriate modifications, a full multicentred trial would be possible to test the effectiveness and cost-effectiveness of a pre-habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. Trial registration Name of registry: ISRCTN; Trial Registration Number: 14621127; Date of Registration: 22/02/2017.

Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

Palliative care remains suboptimal in end-stage liver disease.

The purpose of this paper is to highlight a fundamental gap in the economic research on obesity -- the demand for unnecessary weight gain preventive goods. Such research is important as it will provide understanding of people's preventive behaviours and for that matter inform policies and practices with regards to influencing people's uptake of obesity preventive goods. Using MeSH and PICO approaches, a search strategy was developed to search for relevant articles in a number of academic and scientific journal repositories including PubMed Central, EconLit, Medline, Medscape and relevant (economic) journals' archives. A total of 1351 potentially relevant articles (titles and abstracts) were reviewed. No publications could be found that concerned people's preventive behaviours in terms of demand with respect to obesity preventive goods. Only one article which was not specific to obesity looked into people's preventive behaviours using an economic model. Despite the huge economic and health burden of obesity, participations in activities deemed supportive to weight gain prevention are dismal.

Background and aims: Ascites develops in about 90% with advanced cirrhosis; when refractory to medical therapy, standard of care is repeated large volume paracentesis (LVP) with albumin support. Refractory ascites (RA) confers a median life expectancy of six months without liver transplantation (LT). LVP is not an optimal palliative strategy. One alternative is long-term abdominal drains (LTAD), used in advanced malignant ascites, also enabling community management. Our ultimate aim is to improve end of life care (EoLC) in advanced cirrhosis and RA. This feasibility randomised controlled trial (RCT) aimed to resolve uncertainties in designing a definitive RCT. Method: Multicentre feasibility RCT with 1:1 randomisation between standard of care (LVP) vs. LTAD (Rocket Medical) in adults with RA, ineligible for LT. Both arms received prophylactic antibiotics. LTAD were inserted under ultrasound guidance. Community nurses undertook home visits to drain ascites dependent on symptoms; (maximum 6L/week), without albumin support. Follow-up was 12 weeks with home visits every two weeks for the following assessments: clinical, questionnaire based to include quality of life, palliative care needs, carer burden and health economics (HE). Here we report clinical and HE outcomes. Results: Thirty six patients were randomised; 19 LVP (two withdrew, wanting LTAD) and 17 LTAD (one withdrew-insufficient ascites). Mean age (years) LTAD vs. LVP 66 + 10.4 vs. 68 ± 12; predominately male (76% vs. 74%). Participants were well matched at baseline in liver tests and prognostic scores: LTAD vs. LVP (serum bilirubin (μmol/L) 26 ± 15.8 vs. 16 ±10, serum albumin (g/L) 33 ± 4.2 vs. 31 ± 3.3, serum creatinine (mmol/L) 113 ± 46.7 vs.118 ± 53.1; MELD 14 ± 4.6 vs. 16 ± 7.2). One LTAD participant required hospitalisation for repeated LVP. Serum albumin (g/L) in the LTAD arm declined to 29 ± 3.3 at week two, subsequently remaining stable LTAD vs. LVP (29 ± 5.6 vs. 31 ± 5.5). Serum creatinine remained stable in both arms. There were no LTAD related serious adverse reactions. LTAD related adverse reactions included mild cellulitis (n = 4) and small volume leakage around LTAD insertion site (n = 3), all resolving rapidly. Peritonitis was rare, LTAD (possible) n = 1 and LVP n = 2. Overall mortality was 36% (12/33). Mortality and median survival (days in those who died) were 7/16 (44%) vs. 5/17 (29%), 53 days (IQR 43) vs. 61 days (IQR 35) in LTAD vs. LVP respectively. All but one death was liver related. Those in LTAD arm spent ≈20% less time in hospital. All nine alive in the LTAD arm at end of study elected to keep LTAD in. Detailed clinical and HE analysis is underway. Conclusion: Preliminary data from the REDUCe study supports the safety and efficacy of palliative LTAD in RA due to advanced cirrhosis. LTAD allows successful management in the community with reduction in health resource utilisation. Proceeding to a definitive RCT is justified.

Objective To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis. Design A multicentre randomised controlled trial (January 2008/October 2013). Setting Eight paediatric diabetes centres in England, Wales and Northern Ireland. Participants 203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers. Intervention Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care. Main outcome measures Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources. Results 203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms. Conclusions There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.