Childhood predictors of healthcare use and health status in early adulthood: findings from the twins early development study

The use of healthcare services is likely to be associated with need but also the factors relating to the care system and the ability to negotiate around it. Healthcare use and health status may also be associated with the factors that exist in childhood. This study aims to identify the demographic, clinical, and cognitive characteristics of children at age 4 that impact healthcare use and health status at age 21. The data from the Twins Early Development Study were used. Health problems, healthcare use, and cognitive ability at age 4 were entered into generalised estimating equations to predict the use of general practitioners, outpatient services, counselling, emergency clinic visits, and a healthcare helpline at age 21. Similar models existed for the prediction of whether problems were recorded on the EQ-5D-5L EuroQol instrument. The data on up to 6707 individuals were available for analysis. Sex was a significant predictor of service use, with boys being more likely than girls to later use all services, except for emergency clinic visits. Certain health conditions at age 4 predicted the use of services with models differing according to service type. Greater general cognitive ability predicted higher use of general practitioners, outpatient care, and health helplines. The current health status was strongly predictive of service use. Service use in young adulthood was significantly related to concurrent health status as well as health conditions in childhood. General cognitive ability was significantly associated with the use of general practitioner contacts, outpatient visits, and the use of a health helpline

Cognitive remediation therapy for patients with bipolar disorder: a randomised proof-of-concept trial

Objectives: Cognitive remediation therapy (CRT) may benefit people with bipolar disorder type I and II for whom cognitive impairment is a major contributor to disability. Extensive research has demonstrated CRT to improve cognition and psychosocial functioning in people with different diagnoses, but randomised trials of evidenced therapy programmes are lacking for bipolar disorders. The Cognitive Remediation in Bipolar (CRiB) study aimed to determine whether an established CRT programme is feasible and acceptable for people with bipolar disorders. Methods: This proof‐of‐concept, single‐blind randomised trial recruited participants aged 18‐65 with bipolar disorder, not currently experiencing an episode. They were 1:1 block randomised to treatment‐as‐usual (TAU) with or without individual CRT for 12 weeks. The partly computerised CRT programme (“CIRCuiTS”) was therapist‐led and is evidence‐based from trials in those with psychotic illnesses. Data were collected and analysed by investigators blinded to group allocation. The main outcomes (week 13 and 25) examined participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention‐to‐treat analyses. Trial registration: ISRCTN ID32290525. Results: Sixty participants were recruited (02/2016‐06/2018) and randomised to CRT (n = 29) or TAU (n = 31). Trial withdrawals were equivalent (CRT n = 2/29; TAU n = 5/31). CRT satisfaction indicated high acceptability. Intention‐to‐treat analyses (N = 60) demonstrated greater improvements for CRT‐ than TAU‐randomised participants: at both week 13 and 25, CIRCuiTS participants showed larger improvements in the following domains (week 25 effect sizes reported here): IQ (SES = 0.71, 95% CI [0.29,1.13]), working memory (SES = 0.70, 95% CI [0.31,1.10]), executive function (SES = 0.93, 95% CI [0.33,1.54]), psychosocial functioning (SES = 0.49, 95% CI [0.18,0.80]) and goal attainment (SES = 2.02, 95% CI [0.89,3.14]). No serious adverse events were reported. Conclusions: CRT is feasible for individuals with bipolar disorders and may enhance cognition and functioning. The reported effect sizes from this proof‐of‐concept trial encourage further investigation in a definitive trial

Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties.

BACKGROUND: Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE: Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN: Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS: Two National Health Service health trusts and local authority children's social care. PARTICIPANTS: Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION: HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES: Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS: Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION: HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER: ISRCTN14573230

The impact of a computerised test of attention and activity (QbTest) on diagnostic decision-making in children and young people with suspected ADHD: single-blind randomised controlled trial

Background: Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision making in children with suspected ADHD. Methods: Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within six-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). Results: One hundred and thirty two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (Hazard Ratio 1.44, 95% CI 1.04 to 2.01). At six-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (Time Ratio 0.85, 95% CI 0.77 to 0.93), increased clinicians’ confidence in their diagnostic decisions (Odds Ratio 1.77, 95% CI 1.09 to 2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance, however cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as ‘cost neutral’. Conclusion: QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy

The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm.

OBJECTIVE: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. DESIGN: Feasibility randomized controlled trial with economic evaluation. SETTING: A specialist stroke unit in Nottinghamshire. SUBJECTS: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. INTERVENTIONS: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. MEASURES: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. RESULTS: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. CONCLUSION: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective

The evolving SARS-CoV-2 epidemic in Africa: Insights from rapidly expanding genomic surveillance

INTRODUCTION Investment in Africa over the past year with regard to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sequencing has led to a massive increase in the number of sequences, which, to date, exceeds 100,000 sequences generated to track the pandemic on the continent. These sequences have profoundly affected how public health officials in Africa have navigated the COVID-19 pandemic. RATIONALE We demonstrate how the first 100,000 SARS-CoV-2 sequences from Africa have helped monitor the epidemic on the continent, how genomic surveillance expanded over the course of the pandemic, and how we adapted our sequencing methods to deal with an evolving virus. Finally, we also examine how viral lineages have spread across the continent in a phylogeographic framework to gain insights into the underlying temporal and spatial transmission dynamics for several variants of concern (VOCs). RESULTS Our results indicate that the number of countries in Africa that can sequence the virus within their own borders is growing and that this is coupled with a shorter turnaround time from the time of sampling to sequence submission. Ongoing evolution necessitated the continual updating of primer sets, and, as a result, eight primer sets were designed in tandem with viral evolution and used to ensure effective sequencing of the virus. The pandemic unfolded through multiple waves of infection that were each driven by distinct genetic lineages, with B.1-like ancestral strains associated with the first pandemic wave of infections in 2020. Successive waves on the continent were fueled by different VOCs, with Alpha and Beta cocirculating in distinct spatial patterns during the second wave and Delta and Omicron affecting the whole continent during the third and fourth waves, respectively. Phylogeographic reconstruction points toward distinct differences in viral importation and exportation patterns associated with the Alpha, Beta, Delta, and Omicron variants and subvariants, when considering both Africa versus the rest of the world and viral dissemination within the continent. Our epidemiological and phylogenetic inferences therefore underscore the heterogeneous nature of the pandemic on the continent and highlight key insights and challenges, for instance, recognizing the limitations of low testing proportions. We also highlight the early warning capacity that genomic surveillance in Africa has had for the rest of the world with the detection of new lineages and variants, the most recent being the characterization of various Omicron subvariants. CONCLUSION Sustained investment for diagnostics and genomic surveillance in Africa is needed as the virus continues to evolve. This is important not only to help combat SARS-CoV-2 on the continent but also because it can be used as a platform to help address the many emerging and reemerging infectious disease threats in Africa. In particular, capacity building for local sequencing within countries or within the continent should be prioritized because this is generally associated with shorter turnaround times, providing the most benefit to local public health authorities tasked with pandemic response and mitigation and allowing for the fastest reaction to localized outbreaks. These investments are crucial for pandemic preparedness and response and will serve the health of the continent well into the 21st century

The ESCAPS study: a feasibility randomised controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm

Objective: to establish feasibility of initiating electrical stimulation treatment ofwrist extensors and flexors in patients early after stroke to prevent musclecontractures and pain.Design: feasibility randomised controlled trial with economic evaluation.Setting: a specialist stroke unit in Nottinghamshire.Subjects: forty patients recruited within 72 hours post-stroke with armhemiparesis.Interventions: participants were randomised to receive usual care or usualcare and electrical stimulation to wrist flexors and extensors for 30 minutes,twice a day, five days a week for three months. Initial treatment was deliveredby an occupational therapist or physiotherapist who trained participants to selfmanage subsequent treatments.Measures: measures of feasibility included recruitment and attrition rates,completion of treatment, successful data collection. Outcome data on wristrange of motion, pain, arm function, independence, quality of life and resourceuse were measured at 3, 6- and 12-months post-randomisation.Results: forty participants (of 215 potentially eligible) were recruited in 15months [20 men; mean age 72(SD 13.0)]. Half the participants lacked mentalcapacity and were recruited by consultee consent. Attrition at three-monthfollow-up was 12.5% [death (n=2), end-of-life care (n=2), unable to contact(n=1)]. Compliance varied [mean 65 (SD 53)] and ranged from 10 to 166treatments per patient (target dosage was 120). Data for a valid economicanalysis can be adequately collected.Conclusion: early initiation of electrical Stimulation was acceptable andfeasible. Data collection methods used were feasible and acceptable toparticipants. A large definitive study is needed to determine if electricalstimulation is efficacious and cost effective

Economic threshold analysis of delivering a task-sharing treatment for common mental disorders at scale: the Friendship Bench, Zimbabwe

BACKGROUND: Task-sharing treatment approaches offer a pragmatic approach to treating common mental disorders in low-income and middle-income countries (LMICs). The Friendship Bench (FB), developed in Zimbabwe with increasing adoption in other LMICs, is one example of this type of treatment model using lay health workers (LHWs) to deliver treatment. OBJECTIVE: To consider the level of treatment coverage required for a recent scale-up of the FB in Zimbabwe to be considered cost-effective. METHODS: A modelling-based deterministic threshold analysis conducted within a 'cost-utility' framework using a recommended cost-effectiveness threshold. FINDINGS: The FB would need to treat an additional 3413 service users (10 per active LHW per year) for its scale-up to be considered cost-effective. This assumes a level of treatment effect observed under clinical trial conditions. The associated incremental cost-effectiveness ratio was $191 per year lived with disability avoided, assuming treatment coverage levels reported during 2020. The required treatment coverage for a cost-effective outcome is within the level of treatment coverage observed during 2020 and remained so even when assuming significantly compromised levels of treatment effect. CONCLUSIONS: The economic case for a scaled-up delivery of the FB appears convincing in principle and its adoption at scale in LMIC settings should be given serious consideration. CLINICAL IMPLICATIONS: Further evidence on the types of scale-up strategies that are likely to offer an effective and cost-effective means of sustaining required levels of treatment coverage will help focus efforts on approaches to scale-up that optimise resources invested in task-sharing programmes. © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ

Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial

Background: Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste, sight) is common, and might include feeling overwhelmed or distressed by loud or constant low-level noise (e.g. in the classroom). Affected children may also show little or no response to these sensory cues. These 'sensory processing difficulties' are associated with behaviour and socialisation problems, and affect education, relationships, and participation in daily life. Sensory integration therapy (SIT) is a face-to-face therapy or treatment provided by trained occupational therapists who use play-based sensory-motor activities and the just-right challenge to influence the way the child responds to sensation, reducing distress, and improving motor skills, adaptive responses, concentration, and interaction with others. With limited research into SIT, this protocol describes in detail how the intervention will be defined and evaluated. Methods: This is a two-arm pragmatic individually 1:1 randomised controlled trial with an internal pilot of SIT versus usual care for primary school aged children (aged 4 to 11 years) with ASD and sensory processing difficulties; 216 children will be recruited from multiple sources. Therapy will be delivered in clinics meeting full fidelity criteria for manualised SIT over 26 weeks (face-to-face sessions: two per week for 10 weeks, two per month for 2 months; telephone call: one per month for 2 months). Follow-up assessments will be completed at 6 and 12 months post-randomisation. Prior to recruitment, therapists will be invited to participate in focus groups/interviews to explore what is delivered as usual care in trial regions; carers will be invited to complete an online survey to map out their experience of services. Following recruitment, carers will be given diaries to record their contact with services. Following intervention, carer and therapist interviews will be completed. Discussion: Results of this trial will provide high-quality evidence on the clinical and cost effectiveness of SIT aimed at improving behavioural, functional, social, educational, and well-being outcomes for children and well-being outcomes for carers and families. Trial registration: ISRCTN14716440. Registered on 8 November 2016

Cognitive remediation therapy to enhance cognition and improve recovery in early psychosis:the ECLIPSE research programme including an RCT

Background: Despite the effectiveness of cognitive remediation, it is not widely implemented because we do not know whether teams will accept it, how much therapist time is needed, whether there are factors which predict lower benefits, whether it is cost-effective and what is required for large-scale roll-out. Objective: To understand the factors that will enhance implementation and benefits of cognitive remediation in Early Intervention Services. Design: Four work packages: (1) focus groups and interviews exploring the development of satisfaction and preference measures for staff and service users; participant team interviews to collect data, before and after introducing cognitive remediation, to understand team dynamics; (2) an observational study of a newly developed therapist e-training programme; (3) a multiarm multistage four-arm randomised controlled trial comparing different amounts of therapist input with Treatment as Usual; and (4) an analysis of trial data to understand potential mediating and moderating factors that affect treatment benefits. Setting: Early Intervention Services in the United Kingdom National Health Service. Participants: Staff and service users in touch with Early Intervention Services. Interventions: For the e-training, we piloted and then provided an e-learning system for training cognitive remediation therapists. For the randomised trial, we provided a cognitive remediation software programme (CIRCuiTS™, King's College London, London) that was delivered in three conditions, all offering up to 42 sessions of cognitive remediation. The conditions were: Intensive (one to one with a therapist), Group treatment with a therapist, Independent with drop-in sessions. Main outcome measures: Work package 1: We developed two satisfaction measures and tested a team dynamic model. Work package 2: Feasibility and acceptability questionnaire, time to complete e-training modules. Work package 3: The personal recovery measure – Goal Attainment Scale. Results: Work package 1: The service user satisfaction with cognitive remediation was reliable and valid. Although it did not show statistically significant differences between the arms of the trial, the most preferred methods (Group and Intensive) had higher associated satisfaction. Team leadership and especially a flattened hierarchy, resources and time were identified as vital for implementation. Our team dynamic model supported the importance of leadership in influencing organisational climate, which then affected staff attitudes. However, this was only significant before staff had any experience of their patients receiving cognitive remediation. Although the sample was much smaller after therapy, this may indicate that experience of the beneficial therapy changes team dynamics. Work package 2: The e-training modules were completed by 43% of the recruited participants. They judged the training to be feasible and acceptable, but it did take longer to complete than expected. COVID-19 with the increased workload may have had some effects, but our data exploration shows that it was individuals who had most recently qualified who had the best outcomes. This may be because of a lighter workload or that they were more used to online training. Adaptations suggested are now being implemented. Work package 3: Following the interim analysis we closed two arms – Independent therapy and Treatment as Usual. Four hundred and forty-eight patients consented and 377 were eligible and completed baseline assessment. They were randomised: Group 134, Independent 65, Intensive 112 and Treatment as Usual 66. At post therapy, there were no differences between Group and Intensive or between Independent and Treatment as Usual, but the combined Group and Intensive versus Treatment as Usual was significant (mean difference: 5.734; standard error = 1.958; p = 0.003; lower confidence interval = 1.898 to upper confidence interval = 9.571). Our economic analysis showed that Group and Intensive cognitive remediation were not different with respect to quality-adjusted life-years (difference £150, 95% confidence interval –£1132 to £1905). Both conferred significant benefit compared with standard care (Group and Treatment as Usual: difference £257, 95% confidence interval –£1694 to £2615; Intensive vs. Treatment as Usual: difference £260, 95% CI –£1654 to £2239). Their cost–benefit for quality-adjusted life-year improvement was well below the National Institute for Health and Care Excellence threshold for adopting the intervention to National Health Service services. Work package 4: Cognition had a small mediation effect, and negative symptoms moderated the transfer of cognitive benefits to goal attainment. Limitations: The trial suffered from recruitment difficulties which were overcome when we switched from block to individual randomisation. The final target was large enough to test our main outcomes and moderating and mediating variables. Conclusions: Cognitive remediation should be provided in the National Health Service, involving a trained therapist on a Group or Intensive format with team and training support. Future work: We have a large database and will continue to investigate factors that affect cognitive remediation benefits. Study registration: This study is registered as ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860.</p