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1.  Health state utility values for diabetic retinopathy: protocol for a systematic review and meta-analysis 
Systematic Reviews  2015;4:15.
People with diabetic retinopathy tend to have lower levels of health-related quality of life than individuals with no retinopathy. Strategies for screening and treatment have been shown to be cost-effective. In order to reduce the bias in cost-effectiveness estimates, systematic reviews of health state utility values (HSUVs) are crucial for health technology assessment and the development of decision analytic models. A review and synthesis of HSUVs for the different stages of disease progression in diabetic retinopathy has not previously been conducted.
We will conduct a systematic review of the available literature that reports HSUVs for people with diabetic retinopathy, in correspondence with current stage of disease progression and/or visual acuity. We will search Medline, EMBASE, Web of Science, Cost-Effectiveness Analysis Registry, Centre for Reviews and Dissemination Database, and EconLit to identify relevant English-language articles. Data will subsequently be synthesized using linear mixed effects modeling meta-regression. Additionally, reported disease severity classifications will be mapped to a four-level grading scale for diabetic retinopathy.
The systematic review and meta-analysis will provide important evidence for future model-based economic evaluations of technologies for diabetic retinopathy. The meta-regression will enable the estimation of utility values at different disease stages for patients with particular characteristics and will also highlight where the design of the study and HSUV instrument have influenced the reported utility values. We believe this protocol to be the first of its kind to be published.
Systematic review registration
PROSPERO CRD42014012891
Electronic supplementary material
The online version of this article (doi:10.1186/s13643-015-0006-6) contains supplementary material, which is available to authorized users.
PMCID: PMC4342097  PMID: 25875206
Systematic review; Utility; Economic evaluation; Cost-utility analysis; Diabetic retinopathy; Meta-regression; Modeling; Health technology assessment
2.  Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial 
BMJ Open  2014;4(12):e006838.
The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome.
Methods and analysis
This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice.
Ethics and dissemination
The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval.
Trial registration number
PMCID: PMC4256543  PMID: 25448628
ADHD; Continuous Performance Test (CPT); QbTest; Diagnosis; Treatment
3.  Protocol Evaluating the effectiveness of a school-based group programme for parents of children at risk of ADHD: the ‘PArents, Teachers and CHildren WORKing Together (PATCHWORK)’ cluster RCT protocol 
BMJ Open  2012;2(5):e001783.
Early 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 analysis
This 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 dissemination
The 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 registration
PMCID: PMC3437425  PMID: 22945963
4.  Persistent frequent attenders in primary care: costs, reasons for attendance, organisation of care and potential for cognitive behavioural therapeutic intervention 
BMC Family Practice  2012;13:39.
The top 3% of frequent attendance in primary care is associated with 15% of all appointments in primary care, a fivefold increase in hospital expenditure, and more mental disorder and functional somatic symptoms compared to normal attendance. Although often temporary if these rates of attendance last more than two years, they may become persistent (persistent frequent or regular attendance). However, there is no long-term study of the economic impact or clinical characteristics of regular attendance in primary care. Cognitive behaviour formulation and treatment (CBT) for regular attendance as a motivated behaviour may offer an understanding of the development, maintenance and treatment of regular attendance in the context of their health problems, cognitive processes and social context.
A case control design will compare the clinical characteristics, patterns of health care use and economic costs over the last 10 years of 100 regular attenders (≥30 appointments with general practitioner [GP] over 2 years) with 100 normal attenders (6–22 appointments with GP over 2 years), from purposefully selected primary care practices with differing organisation of care and patient demographics. Qualitative interviews with regular attending patients and practice staff will explore patient barriers, drivers and experiences of consultation, and organisation of care by practices with its challenges. Cognitive behaviour formulation analysed thematically will explore the development, maintenance and therapeutic opportunities for management in regular attenders. The feasibility, acceptability and utility of CBT for regular attendance will be examined.
The health care costs, clinical needs, patient motivation for consultation and organisation of care for persistent frequent or regular attendance in primary care will be explored to develop training and policies for service providers. CBT for regular attendance will be piloted with a view to developing this approach as part of a multifaceted intervention.
PMCID: PMC3390898  PMID: 22607525
High utilisers of care; Primary care; Cognitive behavior therapy; Hypochondriasis; Somatoform disorders; Health care economics and organizations
5.  Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder 
BMC Psychiatry  2010;10:100.
Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived.
Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ≥ 16 and global assessment of function (GAF) ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis incuding the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study.
This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and implementation.
Trial registration
Clinical identifier NCT01047124
PMCID: PMC3001706  PMID: 21114826
6.  Costs and benefits of a one stop clinic compared with a dedicated breast clinic: randomised controlled trial 
BMJ : British Medical Journal  2002;324(7336):507.
To determine the cost to the NHS and the impact on anxiety of a one stop clinic for assessing women with suspected breast cancer.
Study design
Randomised controlled trial.
Women aged 35 or over referred with a breast lump.
Study setting
Teaching hospital, north west England.
Women were randomly allocated to attend a one stop clinic or a dedicated breast clinic.
Outcome measures
Reduction in mean anxiety from baseline at 24 hours after the first visit and at 3 weeks and 3 months after diagnosis; mean cost per patient.
670 women were randomised. Compared with women who attended the dedicated clinic, patients attending the one stop clinic were less anxious 24 hours after the visit (adjusted mean change in state anxiety −5.7 (95% confidence interval −8.4 to −3.0)) but not at 3 weeks or 3 months after diagnosis. The additional cost to the NHS of a one stop attendance was £32 per woman; this was largely explained by greater cytopathological and radiological staff costs.
One stop clinics may not be justified in terms of a reduction in short term anxiety.
What is already known on this topicOne stop clinics have been set up for a wide range of conditionsRapid alleviation of anxiety has been observed in women attending a one stop clinic for assessing breast problemsThe additional costs of providing this service have not been adequately quantifiedWhat this study addsThe benefits of one stop clinics are, in the main, short termThe costs saved by the reduction in the frequency of outpatient visits are more than offset by those associated with same day reporting of diagnostic tests
PMCID: PMC67764  PMID: 11872547
7.  A decision analytical cost analysis of offering ECV in a UK district general hospital 
To determine the care pathways and implications of offering mothers the choice of external cephalic version (ECV) at term for singleton babies who present with an uncomplicated breech pregnancy versus assisted breech delivery or elective caesarean.
A prospective observational audit to construct a decision analysis of uncomplicated full term breech presentations.
The North Staffordshire NHS Trust.
All women (n = 176) who presented at full term with a breech baby without complications during July 1995 and June 1997.
Main outcome measures
The study determined to compare the outcome in terms of the costs and cost consequences for the care pathways that resulted from whether a women chose to accept the offer of ECV or not. All the associated events were then mapped for the two possible pathways. The costs were considered only within the hospital setting, from the perspective of the health care provider up to the point of delivery.
The additional costs for ECV, assisted breech delivery and elective caesarean over and above a normal birth were £186.70, £425.36 and £1,955.22 respectively. The total expected cost of the respective care pathways for "ECV accepted" and "ECV not accepted" (including the probability of adverse events) were £1,452 and £1,828 respectively, that is the cost of delivery through the ECV care pathways is less costly than the non ECV delivery care pathway.
Implementing an ECV service may yield cost savings in secondary care over and above the traditional delivery methods for breech birth of assisted delivery or caesarean section. The scale of these expected cost savings are in the range of £248 to £376 per patient. This converts to a total expected cost saving of between £43,616 and £44,544 for the patient cohort considered in this study.
PMCID: PMC35287  PMID: 11472641
8.  Cost effectiveness analysis of screening for sight threatening diabetic eye disease 
BMJ : British Medical Journal  2000;320(7250):1627-1631.
To measure the cost effectiveness of systematic photographic screening for sight threatening diabetic eye disease compared with existing practice.
Cost effectiveness analysis
A target population of 5000 diabetic patients invited for screening.
Main outcome measures
Cost effectiveness (cost per true positive) of systematic and opportunistic programmes; incremental cost effectiveness of replacing opportunistic with systematic screening.
Baseline prevalence of sight threatening eye disease was 14.1%. The cost effectiveness of the systematic programme was £209 (sensitivity 89%, specificity 86%, compliance 80%, annual cost £104 996) and of the opportunistic programme was £289 (combined sensitivity 63%, specificity 92%, compliance 78%, annual cost £99 981). The incremental cost effectiveness of completely replacing the opportunistic programme was £32. Absolute values of cost effectiveness were highly sensitive to varying prevalence, sensitivity and specificity, compliance, and programme size.
Replacing existing programmes with systematic screening for diabetic eye disease is justified.
PMCID: PMC27406  PMID: 10856062
9.  Cost implications of treatment non-completion in a forensic personality disorder service 
BackgroundA high proportion of individuals admitted to specialist secure hospital services for treatment of personality disorder do not complete treatment. Non-completion has been associated with poorer treatment outcomes and increased rates of recidivism and hospital readmission, when compared with individuals who do complete treatment or who do not receive treatment at all.
AimsIn this study, we sought to determine the economic consequences of non-completion of treatment, using case study data from a secure hospital sample. Both health and criminal justice service perspectives were taken into account.
MethodsData were collected from a medium secure hospital personality disorder unit. A probabilistic decision-analytic model was constructed, using a Markov cohort simulation with 10,000 iterations. The expected cost differential between those who do and those who do not complete treatment was estimated, as was the probability of a cost differential over a 10-year post-admission time horizon.
ResultsOn average, in the first 10 years following admission, those who do not complete treatment go on to incur £52,000 more in costs to the National Health Service and criminal justice system than those who complete treatment. The model estimates that the probability that non-completers incur greater costs than completers is 78%.
ConclusionIt is possible that an improvement in treatment completion rates in secure hospital personality disorder units would lead to some cost savings. This might be achievable through better selection into treatment or improved strategies for engagement and retention. Our study highlights a financial cost to society of individuals discharged from secure hospital care when incompletely treated. We suggest that it could, therefore, be useful for secure hospitals to introduce routine monitoring of treatment completion. © 2013 The Authors. Criminal Behaviour and Mental Health published by John Wiley & Sons, Ltd.
PMCID: PMC3920639  PMID: 23881873

Results 1-9 (9)