Background: Most frequent attendance in primary care is temporary, but persistent frequent attendance is expensive and may be suitable for psychological intervention. To plan appropriate intervention and service delivery, there is a need for research involving standardised psychiatric interviews with assessment of physical health and health status.
Objective: To assess the feasibility of conducting a randomized controlled trial of occupational therapy predischarge home visits for people after stroke. Design: Randomized controlled trial and cohort study. We randomized eligible patients for whom there was clinical uncertainty about the need to conduct a home visit to a randomized controlled trial; patients for whom a visit was judged 'essential' were enrolled into a cohort study. Setting: Stroke rehabilitation unit of teaching hospital. Participants: One hundred and twenty-six participants hospitalized following recent stroke. Interventions: Predischarge home visit or structured, hospital-based interview. Main outcome measures:The primary objective was to collect information on the feasibility of a randomized controlled trial, including eligibility, control intervention and outcome assessments. The primary outcome measure was the Nottingham Extended Activities of Daily Living Scale at one month after discharge from hospital. Secondary outcomes included mood, quality of life and costs at one week and one month following discharge. Results: Ninety-three people were allocated to the randomized controlled trial; 47 were randomized to intervention and 46 to control. Thirty-three were enrolled into the cohort study. More people were allocated to the randomized controlled trial as the study progressed. One hundred and thirteen people (90%) received the proposed intervention, although there was a need for stricter protocol adherence. Follow-up was good: at one month 114 (90%) were assessed. There were no significant differences Clinical Rehabilitation 27(5) between the groups in the randomized controlled trial for the primary outcome measure at one month. The average cost of a home visit was £208. Conclusion: A trial is feasible and warranted given the resource implications of predischarge occupational therapy home visits.
Occupational therapy interventions, such as home visits, have been identified as being resource-intensive, but cost-effectiveness analyses are rarely, if ever, carried out. We sought to estimate the cost-effectiveness of occupational therapy home visits after stroke, as part of a feasibility study, and to demonstrate the value and methods of economic evaluation. Method: We completed a cost-effectiveness analysis of pre-discharge occupational therapy home visits after stroke compared with a hospital-based interview, carried out alongside a feasibility randomized controlled trial. Our primary outcome was quality-adjusted life years. Full cost and outcome data were available for 65 trial participants. Findings: We found that the mean total cost of a home visit was £183, compared with £75 for a hospital interview. Home visits are shown to be slightly more effective, resulting in a cost per quality-adjusted life year of just over £20,000. Conclusion: Our analysis is the only economic evaluation of this intervention to date. Home visits are shown to be more expensive and more effective than a hospital-based interview, but our results are subject to a high level of uncertainty and should be treated as such. Further economic evaluations in this field are encouraged.
Background: Three-dimensional laser scanning has been used for patient measurement for cranial helmets and spinal braces. Ankle–foot orthoses are commonly prescribed for children with orthopaedic conditions. This trial sought to compare ankle–foot orthoses produced by laser scanning or traditional plaster casting. Objectives: Assessment of the effectiveness and efficiency of using laser scanning to produce ankle–foot orthoses. Study design: Randomised controlled trial with blinding of orthotists and patients to the construction technique used. Methods: A randomised double-blind trial comparing fabrication of ankle–foot orthoses from casts or laser scans. Results: The time spent in the rectification and moulding of scanned ankle–foot orthoses was around 50% less than for cast ankle–foot orthoses. A non-significant increase of 9 days was seen in the time to delivery to the patient for laser scanning with computer-aided design and computer-aided manufacturing. There was a higher incidence of problems with the scan-based ankle–foot orthoses at delivery of the device, but no difference in how long the ankle–foot orthoses lasted. Costs associated with laser scanning were not significantly different from traditional methods of ankle–foot orthosis manufacture. Conclusion: Compared with conventional casting techniques, laser scan–based ankle–foot orthosis manufacture did not significantly improve either the quality of the final product or the time to delivery. Clinical relevance Ankle–foot orthoses (AFOs) are a common requirement for chronic neurological conditions during childhood. Improved efficiency of provision of AFOs would benefit children and families by reducing the delay in provision of devices and would benefit the health service by making best use of valuable orthotist time.
Transparency in decision modelling is an evolving concept. Recently, discussion has moved from reporting standards to open source implementation of decision analytic models. However, in the debate about the supposed advantages and disadvantages of greater transparency, there is a lack of definition. The purpose of this article is not to present a case for or against transparency, but rather to provide a more nuanced understanding of what transparency means in the context of decision modelling and how it could be addressed. To this end, we review and summarise the discourse to date, drawing on our collective experience. We outline a taxonomy of the different manifestations of transparency, including reporting standards, reference models, collaboration, model registration, peer review, and open source modelling. Further, we map out the role and incentives for the various stakeholders, including industry, research organisations, publishers, and decision-makers. We outline the anticipated advantages and disadvantages of greater transparency with respect to each manifestation, as well as the perceived barriers and facilitators to greater transparency. These are considered with respect to the different stakeholders and with reference to issues including intellectual property, legality, standards, quality assurance, code integrity, health technology assessment processes, incentives, funding, software, access and deployment options, data protection, and stakeholder engagement. For each manifestation of transparency, we discuss the 'what', 'why', 'who', and 'how'. Specifically, their meaning, why the community might (or might not) wish to embrace them, whose engagement as stakeholders is required, and how relevant objectives might be realised. We identify current initiatives aimed to improve transparency to exemplify efforts in current practice and for the future. KEY POINTS FOR DECISION-MAKERS There is a variety of manifestations of transparency in decision modelling, ranging in the amount of information and accessibility of information that they tend to provide. There is a broad array of stakeholders who create, manage, influence, evaluate, use, or are otherwise affected by, decision models. Given the range of stakeholders and interests related to increased transparency of decision models, achieving the benefits while managing the risks requires careful consideration. Issues such as intellectual property, legal matters, funding, use, and sharing of software need to be addressed.
IntroductionEarly intervention for childhood behavioural problems may help improve health and educational outcomes in affected children and reduce the likelihood of developing additional difficulties. The National Institute for Health and Clinical Excellence guidelines for attention deficit/hyperactivity disorder (ADHD), a common childhood behavioural disorder, recommend a stepped care approach for the identification and management of these problems. Parents of children with high levels of hyperactivity and inattention may benefit from intervention programmes involving behavioural management and educational approaches. Such interventions may be further enhanced by providing training and feedback to teachers about the strategies discussed with parents. In relation to children with high levels of hyperactivity, impulsiveness and inattention, we aim to test the feasibility and effectiveness of a parenting programme (with and without an accompanying teacher session) in primary schools.Methods and analysisThis clustered (at the level of school) randomised controlled trial (RCT) focuses on children in their first four school years (ages 4–8 years) in the East Midlands area of England. Parents will complete a screening measure, the Strengths and Difficulties Questionnaire, to identify children with high levels of hyperactivity/inattention. Three approaches to reducing hyperactivity and attention problems will be compared: a group programme for parents (parent-only intervention); group programme for parents combined with feedback to teachers (combined intervention); and waiting list control (no intervention). Differences between arms on the short version of Conners’ Parent and Teacher Rating Scales Revised will be compared and also used to inform the sample size required for a future definitive cluster RCT. A preliminary cost-effectiveness analysis will also be conducted.Ethics and disseminationThe outcomes of this study will inform policy makers about the feasibility, acceptability and effectiveness of delivering targeted behavioural interventions within a school setting. The study has received ethical approval from the University of Nottingham Medical School Ethics Committee.Trial registrationISRCTN87634685
For children at risk of ADHD, this school-based parenting programme was not associated with improvement in core ADHD symptoms. Secondary analyses suggested a possible reduction in parent-reported hyperactivity and parental mental health problems. Future research should compare targeted interventions against watchful waiting and specialist referral.
IntroductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.Methods and analysisPWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.Ethics and disseminationEthical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.Trial registration numberISRCTN87561257; Pre-results.
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