Health Economics and Health Technology Assessment (HEHTA)

Economic Evaluation alongside Clinical Trials

• Program lead  Professor Andrew Briggs

The Economic Evaluation in Clinical Trials Programme encompasses all research work associated with conducting an economic appraisal as part of a clinical trial.  Although modelling methods may still be required to provide a comprehensive appraisal, the characterising feature is the inclusion of an economic component to the trial and the availability of experimental data on both costs and effects of treatment.  The following projects are ongoing cost-effectiveness studies alongside clinical trials.

Short Course Oncology Therapy (SCOT)

Funded by MRC, this trial examines the possible effects of shortening the standard course of adjuvant chemotherapy from 24 to 12 weeks.  The planned cost-effectiveness analysis will explore whether short-course chemotherapy offers value for money, or whether the loss of effectiveness associated with the shorter treatment duration means that standard treatment should be maintained.  The trial is led by researchers at Glasgow’s Beatson Oncology Centre.
HEHTA contact person: Kathleen Boyd

Cryotherapy for prostate cancer (CROP)

Funded by CRUK, this trial examines the use of cryotherapy as an adjunct o deferred androgen therapy for men with localised radiation-resistant prostate cancer.  The accompanying economic evaluation includes a pre-trial model of potential cost-effectiveness that will be updated when the trial results become available.  The trial is led by Glasgow researcher’s at the Beatson.
HEHTA contact person: Kathleen Boyd

Surveillance in Barratt’s Oesophagus (BOSS)

Funded by the NIHR HTA programme, this study examines whether two-yearly endoscopic surveillance or endoscopy as needed only leads to superior performance in terms of the detection of cancer (oesophageal, gastric or all cancers).  The planned economic evaluation includes a model for the cost-effectiveness of planned screening with endoscopy.
HEHTA contact person: Andrew Briggs

Ankle Injury Management (AIM) trial

Funded by the NIHR HTA programme, this study hypothesised that the application of the “Close Contact Casting technique (CCC)” for displaced ankle fractures in older adults results in an equivalent outcome compared to the standard care of open surgical internal fixation (ORIF) in terms of function, complications, quality of life and patient satisfaction with treatment.
HEHTA contact person: Andrew Briggs

Smoking cessation in pregnancy trial (CPIT)

Funded by a consortium including CSO, GCPH and GGHB, this study examines the use of financial incentives to encourage pregnant mothers to quit smoking during their pregnancy.  The planned economic evaluation will relate the costs of the financial incentive intervention to the benefits in terms of confirmed quit rates and the long term impact on both maternal health and the health of her offspring.  A trial protocol for the study has been published and is available <here>.
HEHTA contact person: Kathleen Boyd

Evaluation of the New Orleans Intervention Model for Infant Mental Health in Glasgow (BeST)

Funded by the CSO and NSPCC this study investigates the New Orleans Intervention Model (NIM)  for maltreated children in the Scottish context.  The NIM provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families.  An economic model will be built and populated with data from the trial to assess cost-effectiveness using the ITSEA measure of child mental health. The aim of the economics component is to explore whether the NIM is likely to be cost-effective in Glasgow and, if so, what design parameters are required for the definitive Phase III trial.
HEHTA contact person: Kathleen Boyd

Port-a-cath and Hickman line devices for chemotherapy delivery

Funded by the CSO Scotland, this pilot trial aims to gather preliminary data on the use of two venous catheter devices in chemotherapy delivery.  In addition to determining feasibility, a pre-trial cost-effectiveness analysis based on the pilot data and existing evidence will be carried out to examine the potential cost-effectiveness of the devices and the associated uncertainty. 

HEHTA contact: Olivia Wu

 A Very Early Rehabilitation Trial (AVERT)

Funded by the National Health and Medical Research Council of Australia, Chest Heart and Stroke Scotland and the Stroke Association, this is a large-scale international trial to evaluate the effect of very early mobilisation in reducing death, disability and complications, and improving quality of life in patients post stroke.  The cost-effectiveness of this complex intervention will be evaluated. This trial is led by National Stroke Research Institute, Melbourne.

HEHTA contact: Olivia Wu

Treatment of fibroids with either embolism or myomectomy (FEMME)

Funded by the NIHR HTA programme, this trial examines the clinical and cost effectiveness of uterine artery embolisation in comparison to myomectomy in the treatment of symptomatic fibroids.  This trial is led by the University of Oxford.

HEHTA contact: Olivia Wu

Gabapentin for the management of chronic pelvic pain (GaPP)

Funded by the CSO Scotland, this pilot trial aims to determine the feasibility and acceptability of undertaking a large-scale randomised controlled trial on the use of gabapentin in women with chronic pelvic pain.  The planned pre-trial cost effectiveness analysis will examine the potential cost-effectiveness of gabapentin and its associated uncertainty surrounding the results, in order to support the design of the future large-scale trial.  This trial is led by University of Edinburgh.

HEHTA contact: Olivia Wu

Economic evaluation of deep brain stimulation in Parkinson’s (PD_SURG)

PD_SURG is funded by the Medical Research Council (MRC) and Parkinson’s UK. PD SURG is a large, pragmatic, multicentre “real-life” randomised trial to evaluate the role of surgery as therapy for Parkinson’s. The fundamental question being addressed in this trial is: Does early surgery provide more or less effective long-term control than medical therapy (with surgery deferred for as long as possible) and is this cost-effective? HEHTA is working in collaboration with the Universities of Birmingham and the University of Oxford.
HEHTA contact person: Emma McIntosh

Bronchiolitis in Infancy Discharge Study (BIDS) – Economic evaluation of early discharge of infants with bronchiolitis

BIDS is funded by the NIHR. The number of hospital admissions for bronchiolitis has doubled over the past 25 years whilst mortality has remained the same, suggesting that changes in clinical practice and not viral pathogenicity underlie this increase. Clinicians are responding to this additional demand by looking at alternative methods of care delivery in relation to the oxygen saturation discharge protocol. The economic analysis will estimate the incremental cost and effectiveness of the 90% oxygen saturation discharge protocol compared to the standard 94% oxygen discharge procedure in terms of health, social care and societal costs as well as the clinical and QOL outcome measures. The economic analysis will also take into consideration the ‘seasonality’ of the disease and the economic impact of this with regard to availability of ward space/beds during peak hospital times.
HEHTA contact person: Emma McIntosh

PDSAFE:  A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson’s

PDSAFE is funded by the NIHR HTA programme. PDSAFE will investigate whether people with Parkinson’s who undertake a personalised programme  ‘PDSAFE’ incur fewer falls and hence improved quality of life and less health care costs than people who do not undertake PDSAFE.  Additional economic analyses will explore the extent to which carer burden is reduced by PDSAFE outcomes.

HEHTA contact person: Emma McIntosh

THRIVE: A three-arm randomised controlled trial for mothers identified as vulnerable in pregnancy and their babies who are at high risk of maltreatment.

Women identified as vulnerable in pregnancy will be recruited to a 3-armed, randomised trial to compare the cost-effectiveness of two interventions in improving both mother-child interaction and maternal mental health: Enhanced Triple P for Baby (ETPB) and Mellow Bumps (MB). This trial will include a comprehensive economic evaluation which will assess the costs and outcomes associated with the delivery of each intervention and usual care from the NHS and Personal Social Services (PSS) perspective favoured by the National Institute for Health and Clinical Excellence (NICE). In keeping  with the public health nature of this economic evaluation a broader societal perspective will also be adopted to allow for the possibility of costs and outcomes beyond the NHS and PSS such as housing, education, employment and justice. The inclusion of the EQ-5D generic outcome measure will also allow the estimation of a cost-utility analysis.

HEHTA contact: Emma McIntosh

Football Fans in Training (FFIT) ): a randomized controlled trial of a gender-sensitive weight loss and healthy living programme delivered to men aged 35-65 by Scottish Premier League football clubs.

 
Funded by the NIHR Public Health Research Programme this study will assess the effectiveness and cost-effectiveness of a group-based, weight loss and healthy living programme, specifically designed to engage men who are often reluctant to join existing weight loss programmes. A within trial economic evaluation will relate the resources associated with providing the intervention as well as medication use and health care consultations  to the benefits in terms of numbers achieving at least 5% weight loss and changes in utility score. A trial protocol for the study has been published and is available here.

HEHTA contact:  Elisabeth Fenwick

SEED

Funded by the NIHR, Social and Emotional Education and Development (SEED). SEED is a Stratified, Cluster Randomised Trial of a Multi-component Primary School Intervention that follows the Pupils‟ Transition into Secondary School. SEED is based on the Seattle Social Development Project and the Gatehouse Project, with potential incorporation of Growing Confidence. A key component of SEED is the economic evaluation which will be integral to the main trial. Estimates of cost and utility will be collected for each trial arm and compared within an incremental cost-utility analysis framework.

HEHTA Contact person: Dr Elisabeth Fenwick

In addition to funded economic evaluations in clinical trials, the programme also covers more methodological work.  Including the use of pre-trial models to inform the design of clinical studies.  A recently published example relates to power and sample size calculations for cost-effectiveness analysis.
Boyd KA, Briggs AH, Fenwick E, Norrie J, and Stock S. Power and sample size for cost-effectiveness analysis: fFN neonatal screening. Contemporary Clinical Trials 2011, 32 (6). pp. 893-901.

HEHTA also hosts a continuing professional development course on Economic Evaluation in Clinical Trials.